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Document 32024R3110 文件 32024R3110
Regulation (EU) 2024/3110 of the European Parliament and of the Council of 27 November 2024 laying down harmonised rules for the marketing of construction products and repealing Regulation (EU) No 305/2011 (Text with EEA relevance)
Regulation (EU) 2024/3110 of the European Parliament and of the Council of 27 November 2024 laying down harmonised rules for the marketing of construction products and repealing Regulation (EU) No 305/2011 (Text with EEA relevance)
欧洲议会和理事会于 2024 年 11 月 27 日通过的第(EU) 2024/3110 号条例,规定了建筑产品市场营销的统一规则,并废止了第(EU) 305/2011 号条例(具有欧洲经济区相关性的文本)
Regulation (EU) 2024/3110 of the European Parliament and of the Council of 27 November 2024 laying down harmonised rules for the marketing of construction products and repealing Regulation (EU) No 305/2011 (Text with EEA relevance)
PE/12/2024/REV/1
OJ L, 2024/3110, 18.12.2024, ELI: http://data.europa.eu/eli/reg/2024/3110/oj
(BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
官方公报 L,2024/3110,2024 年 12 月 18 日,ELI:http://data.europa.eu/eli/reg/2024/3110/oj(保加利亚语、西班牙语、捷克语、丹麦语、德语、爱沙尼亚语、希腊语、英语、法语、爱尔兰语、克罗地亚语、意大利语、拉脱维亚语、立陶宛语、匈牙利语、马耳他语、荷兰语、波兰语、葡萄牙语、罗马尼亚语、斯洛伐克语、斯洛文尼亚语、芬兰语、瑞典语)
In force
生效
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Official Journal 官方公报 |
EN 英文 L series L 系列 |
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2024/3110 |
18.12.2024 |
REGULATION (EU) 2024/3110 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
欧洲议会和理事会条例(EU)2024/3110
of 27 November 2024 2024 年 11 月 27 日
laying down harmonised rules for the marketing of construction products and repealing Regulation (EU) No 305/2011
制定建筑产品销售的统一规则并废止第(欧盟)305/2011 号条例
(Text with EEA relevance)
(与欧洲经济区相关的文本)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
欧洲议会和欧盟理事会,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,
鉴于《欧洲联盟运行条约》,特别是其第 114 条,
Having regard to the proposal from the European Commission,
鉴于欧洲委员会的提案,
After transmission of the draft legislative act to the national parliaments,
在将立法草案提交各国议会后,
Having regard to the opinion of the European Economic and Social Committee (1),
鉴于欧洲经济和社会委员会的意见(1),
Acting in accordance with the ordinary legislative procedure (2),
根据普通立法程序(2)行事,
Whereas: 鉴于:
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(1) |
Regulation (EU) No 305/2011 of the European Parliament and of the Council (3) was adopted in the context of the internal market, in order to harmonise conditions for the marketing of construction products and to remove obstacles to trade in construction products between Member States. |
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(2) |
Under Regulation (EU) No 305/2011, in order for a construction product covered by a harmonised technical specification to be placed on the market, the manufacturer is obliged to draw up a declaration of performance for such product. The manufacturer assumes the responsibility for the conformity of the product with such declared performance and with applicable requirements. Manufacturers are exempted from this obligation for certain products. |
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(3) |
Experience with the implementation of Regulation (EU) No 305/2011, the evaluation conducted by the Commission in 2019 as well as the report on the European Organisation for Technical Assessment have shown the underperformance of the framework on construction products in various respects, including as regards the development of standards and the market surveillance. In addition, feedback received in the course of the evaluation has pointed to the need of reducing the overlaps, removing contradictions and repetitive requirements, including in relation to other Union legislation, in order to provide more legal clarity and limit the administrative burden on the economic operators. It is therefore necessary to update and align legal obligations of economic operators with those provided for in other Union legislation, as well as to add new provisions including as regards market surveillance, so that legal certainty is increased and that diverging interpretations are avoided. |
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(4) |
It is necessary to establish well-functioning information flows, including via electronic means and using a machine-readable format, to ensure that coherent and transparent information about construction products performances is available along the supply chain. This is expected to increase transparency and to improve efficiency in terms of information transfer. Ensuring digital access to comprehensive information about construction products would contribute to the digitalisation of the construction sector altogether, making the framework fit for the digital age. Moreover, providing access to reliable and durable information would also mean that economic operators and other actors would not contribute to each other’s non-compliance with requirements. |
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(5) |
The European Parliament resolution of 10 March 2021 on the implementation of Regulation (EU) No 305/2011 laying down harmonised conditions for the marketing of construction products (the Construction Products Regulation) (4) welcomed the Commission’s objective to make the construction sector more sustainable by addressing the sustainability performance of construction products in the revision of Regulation (EU) No 305/2011, as announced in Commission’s communication of 11 March 2020 entitled ‘A new Circular Economy Action Plan. For a cleaner and more competitive Europe’. The Council Conclusions on the Circular Economy in the Construction Sector of 28 November 2019 urged the Commission to facilitate the circularity of construction products when revising Regulation (EU) No 305/2011. In its Communication of 10 March 2020 entitled ‘A New Industrial Strategy for Europe’ the Commission emphasised the need to address the sustainability of construction products and highlighted a more sustainable built environment as essential for Europe’s transition towards climate-neutrality. In its Communication of 5 May 2021 entitled ‘Updating the 2020 New Industrial Strategy: Building a stronger Single Market for Europe’s recovery’ the Commission identified construction as one of the priority ecosystems that face the most important challenges meeting climate and sustainability goals and embracing the digital transformation, and on which the competitiveness of the construction sector depends. It is therefore appropriate to lay down rules for declaring environmental sustainability performance of construction products, including the possibility of establishing relevant threshold levels and classes. Classes of performance for the environmental performance of products should accurately reflect the diversity of products and their state of the art and should allow for the most environmentally friendly products to be accurately identified. Moreover, when referring to environmental impacts, such classes of performance should be understandable, should not be misleading, nor allow for burden shifting. |
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(6) |
Similarly, the 2022 EU Strategy on Standardisation set out in the Commission Communication of 2 February 2022, entitled ‘An EU Strategy on Standardisation – Setting global standards in support of a resilient, green and digital EU single market’ identified construction as one of the most pertinent areas where harmonised standards could improve competitiveness and reduce market barriers. |
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(7) |
Pursuing the environmental goals, including the fight against climate change and the transition towards a circular economy, makes it necessary to establish, without increasing disproportionately bureaucracy and costs for economic operators, especially for small and medium-sized enterprises (‘SMEs’), new environmental obligations and to lay the ground for the development and the application of an assessment method for the calculation of the environmental sustainability of construction products. The calculations should cover the life cycle of the product using the methods established through standardisation. For new products the calculated life cycles should include all stages of a product’s life, from raw material acquisition or generation from natural resources, to its final disposal, including potential benefits and loads outside the boundary limits. For used and remanufactured products, the calculated life cycle should start with the deinstallation from a construction work and should include all following stages until final disposal. The Commission should make available software to perform the calculation, in particular the characterisation factors applicable in accordance with European standard EN 15804 or future applicable standards. Any update of this software should be communicated and should trigger the update to the relevant calculations within one year. |
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(8) |
To ensure safety and functionality of construction products and, by extension, of construction works as well as safety of workers and users, it is necessary to ensure that certain service providers, such as fulfilment service providers, online marketplaces and actors providing intermediary services, do not contribute to the non-compliance of other actors. It is therefore necessary to render relevant provisions applicable also to these services and their providers. |
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(9) |
To create the necessary link between construction products and the construction works, including buildings, into which they might be incorporated, the notion of construction works should be defined only for the purposes of this Regulation and without prejudice to Member States’ competences to define and regulate construction works and buildings. |
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(10) |
In order to avoid innovative distribution models being used to circumvent the obligations under this Regulation, it should be clarified that any supply of a product in the course of a commercial activity, including when ownership or possession of the products is transferred as part of the provision of a service, would be considered as the product being made available on the market. |
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(11) |
Ensuring the free movement of kits for construction products on the internal market would support industry competitiveness. This approach would expand market reach, streamline production processes for companies, and improve convenience for both consumers and businesses. |
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(12) |
The compliance of construction products with Union legislation often depends on the compliance of their key parts with that legislation. However, since key parts are often integrated into various construction products, ensuring safety and the protection of the environment, including climate, would be better achieved if those key parts were assessed upstream, that is if their performance and conformity were assessed beforehand and independently from the assessment of the final construction product into which they are integrated. Similarly, market surveillance would be more efficient if non-compliant key parts could be identified and targeted. Therefore, it is necessary to lay down mandatory rules applicable to key parts of construction products. The same approach should be used for parts or materials intended to be used for construction products which would benefit from the voluntary application of the Regulation. |
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(13) |
Items, such as construction products, their key parts or other parts or materials, can be placed on the market as such or as a set of separate components intended to be used together and should be subject to dedicated harmonised technical specifications. To simplify the application of this Regulation, the items and components falling under its scope should be clearly identified. However, such identification should not preclude the possibility to market the components as construction products when these components are placed on the market separately, as key parts or otherwise. |
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(14) |
While keeping a broad scope for the possible application of this Regulation, its application to certain products already harmonised by other Union legal acts should be excluded to avoid regulatory overlap. For the same purpose, it is also important to distinguish between those aspects of the same products which are covered by this Regulation and those aspects which are regulated by other sectorial legislation. This would be the case, for example, for lighting products and electrical and electronic products, which are subject to Directives 2014/35/EU (5), 2014/30/EU (6), 2014/53/EU (7) and 2001/95/EC (8) of the European Parliament and of the Council. The broad scope of this Regulation should however not be interpreted as an intention to harmonise all products which can be placed on the market for incorporation into construction works. Products which are not suitable for harmonisation, for instance due to their relation to cultural heritage, their usage of specific materials which can only be sourced in certain localities or to heterogeneous conditions between Member States, should not be subject to the harmonising effect of this Regulation. This could be achieved through the active choice of not pursuing their coverage through harmonised technical specifications. |
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(15) |
Used products subject to this Regulation imported from third countries, should, in the absence of dedicated rules for used products, be subject to the same rules as new construction products. |
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(16) |
Construction products placed on the market in the outermost regions of the Union are often imported from neighbouring countries, and are therefore not subject to requirements laid down in Union law. Subjecting those construction products to such requirements would be disproportionately costly. At the same time, construction products manufactured in the outermost regions hardly circulate in other Member States. Therefore, Member States should have the possibility to exempt construction products placed on the market in the outermost regions of the Union from those requirements. |
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(17) |
To ensure that a strong link between standards and the regulatory needs of the Member States is maintained, an expert group should support the Commission in the preparation of standardisation requests and other harmonised technical specifications. The work of the expert group should follow a working plan established on the basis of inputs from Member States in addition to overall Union priorities such as EU climate and circular economy goals. In establishing the priorities of the working plan, the Commission should pay particular attention to the replacement of harmonised technical specifications adopted under Regulation (EU) No 305/2011. The Commission should inform the Member States and the European Parliament on a yearly basis about progress in implementing the working plan, including information on the standardisation requests issued, the number of standards proposed by the European standardisation organisations, the average time needed for the assessment of standards by the Commission, and the ratio between standards accepted and rejected by the Commission. |
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(18) |
In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objective of harmonising the internal market for construction products to address the regulatory needs of Member States by defining only the necessary essential characteristics to assess the product performance. The definition of these essential characteristics and the assessment methods applicable to them should provide the less onerous approach with sufficient reliability and avoid duplications and inconsistencies. This Regulation does not go beyond what is necessary in order to achieve this objective, in accordance with Article 5(4) of the Treaty on European Union (TEU). |
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(19) |
In order to strive for a maximum of regulatory coherence, this Regulation should to the extent possible build on the horizontal legal framework, in this case namely on Regulation (EU) No 1025/2012 of the European Parliament and of the Council (9). It follows the recent trend in product legislation to develop a fall-back solution where the European standardisation organisations do not deliver valid harmonised standards. When a European standardisation organisation delivers a harmonised standard in accordance with the standardisation request which includes elements that do not satisfy the regulatory needs of Member States, or are not aligned with the Union safety, environmental, circularity and climate objectives, the Commission should revise the standardisation request or make the harmonised standard mandatory with restrictions. A fall-back solution should be possible to apply to harmonised standards which are not compliant with the standardisation request and address a product family or product category which is either not previously covered by a harmonised standard, or is already covered by a harmonised standard applicable for more than 5 years, or is covered by a harmonised standard applicable with restrictions. |
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(20) |
Where harmonised standards lay down the rules for the assessment of performance with regard to essential characteristics relevant for the construction codes of Member States, those standards should be made mandatory for the purposes of application of this Regulation as performance harmonised standards, as only such mandatory standards reach the goal of permitting the free circulation of products, whilst ensuring the Member States’ ability to request product characteristics related to the basic requirements for construction works in view of their specific national situation such as differences in climate, geology and geography and other conditions. When pursued together, these two goals require that products are assessed by a single assessment method, therefore the method needs to be mandatory. However, voluntary standards can be used to make product requirements, specified for the relevant product family or product category by delegated acts, even more concrete, following the path of Decision No 768/2008/EC of the European Parliament and of the Council (10). In line with Decision No 768/2008/EC, those voluntary standards should be able to provide a presumption of conformity with the requirements covered by them. |
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(21) |
The assessment of performance with regard to essential characteristics may require the establishment of threshold levels. Voluntary threshold levels have to be fulfilled in relation to certain applications. Mandatory threshold levels have to be fulfilled as a condition for placing the product on the internal market irrespective of its application. |
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(22) |
In order to contribute to the objectives of the European Green Deal set out in Commission’s communication of 11 December 2019 entitled ‘The European Green Deal’, the Circular Economy Action Plan and the Zero Pollution Action Plan set out in Commission’s communication of 12 May 2021 entitled ‘Pathway to a Healthy Planet for All. EU Action Plan: “Towards Zero Pollution for Air, Water and Soil”’, and to ensure safe construction products, safety being one of the goals to be pursued in the legislation based on Article 114 of the Treaty on the Functioning of the European Union (TFEU), product requirements related to functionality, safety, and protection of environment, including climate, are necessary. When setting these requirements, the Commission should address the safety risks and take into account the product’s potential contribution to achieving Union climate, environmental and energy efficiency objectives over the course of their life cycle. Those requirements do not relate to the performance of construction products. Contrary to its predecessor Council Directive 89/106/EEC (11), Regulation (EU) No 305/2011 does not provide for the possibility to establish such product requirements. However, certain harmonised standards for construction products contain such product requirements. Those standards demonstrate that there is a practical need for such requirements on functionality, safety, and protection of environment. Article 114 TFEU as the legal basis of this Regulation also imposes the pursuit of a high level of health, safety and protection of the environment. Thus, this Regulation should reintroduce or validate product requirements. Hence, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to specify those requirements for the respective product family or product category. |
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(23) |
Manufacturing and distribution of construction products becomes ever more complex, leading to the emergence of new specialised operators, such as fulfilment service providers. For reasons of clarity, certain generic obligations, including on cooperation with authorities, should be applicable to all those involved in the supply chain. |
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(24) |
In order to foster harmonised practices amongst Member States even where a consensus about these practices could not be found, the Commission should be empowered to adopt, with regard to a limited range of issues, implementing acts on the implementation of this Regulation. The respective empowerments should concern the obligations and rights of economic operators and the obligations of notified bodies. |
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(25) |
In order to improve the legal certainty and to mitigate the fragmentation of the Union market for construction products it is necessary to clearly define the area regulated at Union level, the so-called ‘harmonised zone’, as opposed to the elements remaining within the competence of Member States. Member States remain competent to lay down provisions on construction works, including on their design and dimensioning. The establishment of the harmonised zone should not affect the right of Member States to specify national requirements on construction works and should not reduce the level of protection already existing and justified in the Member States. National environmental policies applicable to construction works should not be considered as prohibitions or barriers to the making available of products on the market as long as they respect the harmonised zone. |
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(26) |
Member States set the safety level for construction works on the basis of their responsibilities towards their citizens, while the Union determines the framework conditions for the internal market. The competence to adopt provisions on construction works remains with the Member States. The basic requirements for construction works set out in this Regulation should establish the links to construction products that are technically necessary, and serve as a basis for issuing standardisation requests to the European standardisation organisations for the development of harmonised standards for construction products, corresponding delegated acts as well as for the development of European assessment documents. |
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(27) |
The harmonised zone should also apply to public contracts, grants or other positive incentives with the exception of fiscal incentives. |
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(28) |
In order to strike a balance between mitigating the fragmentation of the market and the legitimate interests of Member States to regulate construction works, it is necessary to provide for a mechanism to better reflect the needs of the Member States in the development of harmonised technical specifications. For the same reason, an additional mechanism of prior authorisation should be established, allowing Member States to set, based on imperative grounds of health and safety of persons or of protection of the environment, requirements other than those laid down in the harmonised technical specifications for products covered by the harmonised zone. This mechanism should give Member States the possibility, while awaiting updated harmonised technical specifications addressing their regulatory needs, to notify and seek authorisation for national measures affecting the performance of an essential characteristic not addressed by the harmonised technical specification. This mechanism should be complementary to a Member State’s possibility to notify the Commission, in accordance with Article 114 TFEU, when it deems it necessary to introduce national provisions based on new scientific evidence relating to the protection of the environment or the working environment on grounds of a problem specific to that Member State in contradiction with harmonised technical specifications. In order to ensure that authorised national measures only remain as temporary deviations from the harmonised zone, it is important to enable swift consultations on the need to update harmonised technical specifications in light of those regulatory needs, including, where appropriate, through standardisation requests with deadlines specifically set to address the urgency at hand. |
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(29) |
A circular economy, the key element of the Circular Economy Action Plan, can be promoted by mandatory deposit-refund systems and the obligation of manufacturers to regain ownership of new, surplus or unsold non-custom made products. Member States should therefore be allowed to take such measures and to establish obligations regarding the collection and the treatment of products for waste. The owner of the product should be in charge of the transport back to the distributor, importer or manufacturer. |
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(30) |
In order to enhance legal clarity and reduce the administrative burden for the economic operators, it is necessary to avoid that construction products are subject to multiple assessments regarding the same aspect of health and safety of persons or protection of the environment, including climate, under different Union legal acts. This was confirmed by the REFIT platform, established by Commission Decision C(2015) 3261, recommending that the Commission gives priority to addressing the problems of overlapping and repetitive requirements. While not reducing or encroaching on the level of protection already existing and justified in Member States at construction level, the Commission should thus be able to determine the conditions under which the fulfilment of obligations provided for in other Union legal acts also fulfils certain obligations of this Regulation, where otherwise the same aspect of health and safety of persons or protection of the environment, including climate, would be assessed in parallel under this Regulation and other Union law. |
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(31) |
Moreover, in order to avoid diverging practices of Member States and economic operators, the power to adopt implementing acts in accordance with Article 291 TFEU should be granted to the Commission to determine whether certain items fall within the definition of product. |
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(32) |
As this Regulation is developed in line with the framework of Regulation (EU) 2024/1781 of the European Parliament and of the Council (12) but with its provisions adapted to the sectorial specificities of construction products, it will be, with limited exceptions, the legal act used for harmonising all relevant aspects of construction products, including sustainability aspects even though these might also be addressed through Regulation (EU) 2024/1781. If a policy need is identified horizontally within the framework of Regulation (EU) 2024/1781, the Commission should primarily use this Regulation for addressing this need in regard to construction products. Only in exceptional cases where requirements under this Regulation are insufficient and cannot be amended or complemented in a reasonable time, it should be possible to apply Regulation (EU) 2024/1781 in a complementary manner to construction products, provided the administrative cost entailed, including as a result of economic operators potentially becoming subject to two conformity assessment procedures, is shown to be reasonable. As an exception, in the case of energy-related products included in ecodesign working plans which are also construction products and for intermediate products within the meaning of Regulation (EU) 2024/1781, with the exception of cement, priority for the setting of sustainability requirements will be given to that Regulation. This will be the case for instance for heaters, boilers, heat pumps, water and space heating appliances, fans, cooling and ventilating systems and photovoltaic products, excluding building-integrated photovoltaic panels. This Regulation would still apply in a complementary manner where needed, mainly in relation to safety aspects also taking account of other Union legislation on products such as on gas appliances, low voltage, and machinery. In the case of a conflict with Regulation (EU) 2024/1781, the relevant provisions of this Regulation should prevail. For other products, in order to avoid unnecessary burden for economic operators, the need may arise to determine the conditions under which the fulfilment of obligations under other Union law also fulfils certain obligations under this Regulation. Therefore the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to determine such conditions. |
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(33) |
In order to create an incentive for compliance, the manufacturer of construction products should be liable for incorrect declarations of performance and conformity. |
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(34) |
The increased reuse of construction products is part of a shift towards a more circular economy and a reduction of the environmental and carbon footprint of construction. The second-hand market for construction products is currently not very developed and requirements for construction products which have previously been used vary widely amongst Member States. Therefore, used construction products, including other used items subject to this Regulation, should be subject to long-term harmonisation by establishing the possibility to develop dedicated harmonised technical specifications under this Regulation. Such harmonised technical specifications should be applicable to used products and as long as the used product is not waste or has ceased to be waste. The adoption of dedicated harmonised technical specifications for used products should not prejudice the scope and definition of waste under Directive 2008/98/EC of the European Parliament and of the Council (13). However, products directly reused in a construction work should not be considered as placed on the market again and therefore not be subject to any measures under this Regulation. |
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(35) |
In order to provide clarity about the extent of the harmonised zone, it is important that all harmonised technical specifications are explicit in whether they cover or exclude used products from their scope. The exclusion of used products from the scope of a harmonised technical specification should however not prevent economic operators from opting for the application of this Regulation as if the used product was new. |
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(36) |
According to the definition of used products, harmonised technical specifications explicitly including used products within their scope should also apply to used products which have undergone a transformative process going beyond checking, cleaning or repairing recovery operations defined by the harmonised technical specification as non-essential transformative processes to the product’s performance. Remanufactured products should, regardless of the harmonised technical specification, benefit from not having to include events before the product’s last deinstallation when calculating its environmental impact over its life cycle. Remanufactured products should also benefit from requirements or incentives that promote a high recycled content. |
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(37) |
To enhance access to easily available and comprehensive information on construction products, thereby contributing to their safety, functionality and sustainability, it should be ensured that the declaration of performance and conformity provides all information necessary for users and authorities. In view of its utility for users, manufacturers should be able to include into that declaration additional information, provided that the declarations of performance and conformity remain uniform and easily readable and that they are not abused as advertisement. |
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(38) |
In order to reduce the burden for economic operators, and in particular manufacturers, economic operators issuing declarations of performance and conformity should be allowed to provide copies of those declarations by electronic means, and be authorised to make them available on websites on the conditions that they are unamendable, human and machine readable, available, accessible and unequivocally linked to the product. In order to simplify supply chain communication, declarations of performance and conformity should allow the user – by means of an IT application – to check conformity with the application rules of the Member State where the product is used. An important prerequisite for machine-readable declarations is a standardised IT format, which is required for each harmonised technical specification. |
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(39) |
In order for the manufacturers to demonstrate that the construction products benefitting from the free movement of goods fulfil relevant Union requirements, it is necessary to require a declaration of conformity complementing the declaration of performance, thus also bringing the regulatory system for construction products closer to Regulation (EC) No 765/2008 of the European Parliament and of the Council (14). However, in order to minimise the potential administrative burden, the declaration of conformity and the declaration of performance should be combined. The administrative burden on SMEs should be further minimised through targeted simplification provisions, including sharing test results, recognition of certificates, cascading of technical documentation and declaration without assessment, permitting micro-enterprises to use the more lenient assessment and verification system and reducing the requirements for custom-made non-series products. When such products are installed in an identified single construction work exemptions from the obligation to draw up a declaration of performance and conformity should be possible. In cases where a manufacturer fulfils the criteria for both the application of a simplified procedure and an exemption from the obligation to draw up a declaration of performance and conformity, it should be given the opportunity to choose one of them, or to provide a declaration of performance and conformity without applying the simplified procedure, so as to better adapt its offer to the needs of potential customers. |
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(40) |
In order to reach alignment with other product legislation and subject to the general principles of Regulation (EC) No 765/2008, the CE marking should be affixed only to construction products for which the manufacturer has drawn up a declaration of performance and conformity. The manufacturer thereby assumes the responsibility for the conformity of the product with the declared performance and the applicable product requirements. |
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(41) |
The procedural rights of all economic operators and natural or legal persons acting on their behalf in relation to measures, decisions or orders taken by market surveillance authorities and other competent national authorities need to be ensured in line with Regulation (EU) 2019/1020 of the European Parliament and of the Council (15). It is necessary that Member States ensure that adequate appeal procedures against such measures, decisions or orders are in place. |
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(42) |
To ensure functionality, safety and sustainability of construction products, and by extension of construction works, all economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that they place, make available, or support making available on the market only construction products which are in compliance with the binding Union requirements. In order to improve the legal clarity, it is necessary to set explicitly the obligations of economic operators. |
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(43) |
It is necessary for manufacturers of construction products to determine the product type in a precise and unequivocal manner in order to ensure a precise basis for assessing the compliance of such product with Union requirements. At the same time, in order to avoid circumvention of the applicable requirements, manufacturers should be prohibited from creating ever new product types where the products in question are, in view of the crucial characteristics, identical. |
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(44) |
On the internal market, the CE marking should be the only marking demonstrating compliance with assessment methods in relation to essential characteristics covered by harmonised technical specifications. In order to avoid market fragmentation and misleading claims resulting from the application of different assessment methods, the CE marking should be the only marking allowed on products covered by harmonised technical specification indicating that the product in question has been assessed in relation to the essential characteristics covered by harmonised technical specifications and is compliant with the applicable product requirements. The market for construction products faces a proliferation of markings which often create confusion and distrust among market players but also mislead consumers. The use of additional markings negatively impacts the probative value of the CE marking when based on assessment methods which are different than those defined in the relevant harmonised technical specifications. In addition, SMEs cannot always benefit from such markings, creating a distortion among market players and potentially hindering market access. Those additional markings should therefore not be affixed to the products in combination with the CE marking. However, this prohibition does not prevent products which bear other markings from being placed on the single market, providing such markings do not mislead the consumer or create confusion with the CE marking. In addition, the markings should not impair the visibility, legibility or meaning of the CE marking. As such, these markings should not display any information, text or claims in relation to the product’s performance. |
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(45) |
To avoid misleading claims, any claims made by manufacturers of construction products should be based on an assessment method contained in harmonised technical specifications where available. |
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(46) |
Technical documentation about construction products, drawn up by the manufacturer, facilitates the verification of those products by competent national authorities and notified bodies against the Union requirements. To enhance access to comprehensive information, that technical documentation should include the necessary information to validate the calculation substantiating the assessment of the environmental sustainability of the construction product. |
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(47) |
To create transparency for users of construction products and to avoid inappropriate use of those products, construction products and their intended use should be precisely identified by the manufacturer. For the same reason, the manufacturer should make clear whether the construction products are intended for professional use. To ensure that construction products can be traced back, manufacturers should indicate manufacturer-specific unique identification code of the product type on the product or, where this is not possible e.g. due to the product’s size or surface, on an affixed label, on the packaging or, where that is not possible either, in a document accompanying the product. |
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(48) |
To ensure that requirements of this Regulation are fulfilled, manufacturers should actively search, store and evaluate information and take appropriate measures where non-conformity or under-performance has been confirmed or where there is a risk. |
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(49) |
To achieve the goals of the European Green Deal and of the Circular Economy Action Plan, the Commission should have the possibility to specify minimum threshold levels for the environmental performance of construction products and product environmental requirements preventing and reducing the impact that construction products have on the environment. However, the ‘safety first’ principle, applicable both for the construction product and the construction works, should in all instances be respected, and should encompass the protection of health. |
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(50) |
With the goals of ensuring sustainability and durability of construction products, manufacturers should ensure that products can be used for as long as possible. Such long use requires adequate design, use of reliable parts, reparability of products, availability of information on repair and access to spare parts. In the event that the spare parts are not commonly available in the market, the Commission should be empowered to require from the manufacturer to ensure the availability of these spare parts at a reasonable and non-discriminatory price for a period of 10 years which may be extended if the availability for a longer period of time is expected to increase the life span of the product. |
|
(51) |
In view of enhancing the circularity of construction products, in line with the goals of the Circular Economy Action Plan and the waste hierarchy, product requirements should also be able to improve resource efficiency, prevent waste generation, prioritise repair, reuse and remanufacturing, favour the use of secondary materials and address the recyclability of the product and the production of by-products. Preparing for reuse, reuse, remanufacturing and recycling require certain design, namely by facilitating the separation of products, components and materials at deinstallation, deconstruction and demolition and at the later stage of recycling and, when possible, avoiding mixed, blended or intricate materials and substances of concern. As the usual instructions for use and safety information will not necessarily reach the economic operators in charge of preparing for reuse, reuse, remanufacturing and recycling, the necessary information in this regard should be made available in digital product passports accessible through data carriers and in manufacturer’s websites. |
|
(52) |
General product information, instructions for use and safety information are a vital tool to provide information that is sufficient to make knowledgeable decisions on purchase, installation, use, maintenance, dismantling, reuse and recycling of the product to a wide group in potential need of the information. Elements to be covered by the general product information, instructions for use and safety information should therefore be specified in this Regulation and guidance on how to typically cover these elements in relation to a certain product should be possible to include in performance harmonised standards. Such guidance should however not expand or restrict the responsibility for the manufacturer to provide information as set out in the Regulation. The Commission should be empowered to adopt delegated acts to ensure adequate and homogeneous implementation of the obligation to provide the general product information, instructions for use and safety information for specific product families or product categories when performance harmonised standards are not able to do it. |
|
(53) |
Some construction products become waste though they were never used. To avoid this waste of resources, the Regulation should not affect the possibility for Member States to oblige manufacturers to accept to regain, directly or via their importers and distributors, ownership of products that, after delivery onto a construction site or to the user, have not been used and are in a state equivalent to the one in which they were placed on the market. |
|
(54) |
In order to be able to make informed choices, users of construction products should be sufficiently well informed about the environmental performances of products, about their conformity with environmental requirements and of the degree of fulfilment of manufacturer’s environmental obligations in this regard. Therefore, the Commission is empowered to adopt delegated acts to establish specific labelling requirements. |
|
(55) |
The authorised representatives are often the only reachable persons in the case of imported products whilst manufacturers often attribute to them very limited tasks and do not provide them with all the necessary information to effectively represent the manufacturers. Hence, the role and responsibilities of authorised representatives should be strengthened and clearly set out in this Regulation, such as the tasks to be included in the mandate of the manufacturer. The mandate of the authorised representative should not include the drawing up of technical documentation. Nevertheless, manufacturers should be allowed to establish a separate contract with its authorised representative for this purpose, outside the scope of the mandate. |
|
(56) |
There should be always a manufacturer when the Regulation establishes obligations as regards the placing of a product on the market. When there is otherwise no manufacturer in the meaning of this Regulation, the distributor or importer should act as manufacturer and assume its responsibilities. |
|
(57) |
An economic operator who modifies a product or stores it in such a way that its performance or safety might be affected should be subject to the obligations of manufacturers, to ensure the verification whether performance or safety of the product are still the same. However, this obligation should not be imposed on an economic operator who repackages products, as otherwise secondary trade and thus free circulation of products would be hampered and repackaging in principle should not affect the performance or safety of the construction product. Still, and with the aim to preserve the performance and safety of products, the economic operator undertaking the repackaging should be responsible for the correct execution of these operations to ensure that the product is not damaged and that the users are still correctly informed in the language set out by the Member State where the products are made available. |
|
(58) |
Given its environmental effects, the calculation of the environmental sustainability of a construction product should also cover the packaging used or most likely to be used. The packaging of a product can also be vital to preserve its performance through the distribution chain to the user. Even though the packaging in itself is not included in other assessments of a product’s performance, all economic operators should, as part of their obligation to take necessary measures to ensure continued compliance of products with this Regulation, be responsible for using packaging suitable for preserving the performance and the compliance with the products’ requirements. The packaging could in itself pose a risk for users and the obligation to provide information on risks relating to the use of the product should take this into account. |
|
(59) |
In order to increase compliance of manufacturers with the obligations under this Regulation and to contribute to addressing the identified shortcomings and improve the market surveillance, fulfilment service providers, online market places and other market actors should actively contribute to ensuring that only compliant products reach the users. |
|
(60) |
To avoid circumvention of the obligations under this Regulation when the production technology involves several different actors who contribute to the design and manufacture of a construction product, it is necessary to establish a clearly defined manufacturer’s role where the natural or legal person who does the actual production of a construction product assumes the responsibilities under this Regulation in respect of the entire product, unless there is another person who either places the product on the market under his or her name or trademark, or assumes responsibility for the product by drawing up a declaration of performance and conformity. This is of particular importance in relation to 3D-printing, whereby a natural or legal person 3D-prints construction products and places them on the market. That person should fulfil the obligations incumbent on manufacturers including as regards the use of appropriate 3D-datasets and of materials which have undergone the procedures applicable to products as well as with regard to the correspondence of the information to be provided by the manufacturer of the 3D-dataset with the information to be provided by the manufacturer of the printing material. |
|
(61) |
In cases when the product is not intended to be used for construction but its appearance is likely to lead consumers to use the product in construction, the product is accompanied by instructions for use and safety information pursuant to Regulation (EU) 2023/988 of the European Parliament and of the Council (16) or another applicable regulation indicating that despite its appearance it was not designed as a construction product. Market surveillance authorities are to take the appropriate measures, including the possibility to withdraw the product from the market, if its appearance could lead to confusion for the consumer or to misuse. |
|
(62) |
To clarify the applicability of this Regulation to online and other distance sales, it should be defined under which conditions a certain product is deemed to be offered to clients in the Union. As online trade has a higher likelihood of non-compliance, Member States should make a special effort to designate a single market surveillance authority for detecting distance sales offers targeting clients on their territory, so that the responsible market surveillance authorities can take appropriate measures. Offers using the currency of the Member States, available through an internet domain name which is registered in one of the Member States or which refers to the Union or one of the Member States, and dispatched to any Member State, should be considered targeted at customers in the Union. Other elements such as using an official language of a Member State may also be considered as an indication by market surveillance authorities as to whether the offer targets customers in the Union. |
|
(63) |
Digital technologies, which provide a significant potential for reducing administrative burden and costs for economic operators and authorities, while also fostering innovative and new business opportunities and models, are evolving at rapid pace. The uptake of digital technologies will also contribute significantly towards achieving the objectives of the Renovation Wave, including energy efficiency, life cycle assessments and monitoring and of the building stock. |
|
(64) |
In order to ensure a timely adoption of harmonised standards and European assessment documents, the Commission should have the possibility to make them mandatory with restrictions of their legal effects under this Regulation. It should be possible for such restrictions to cover, for example, outdated references to other standards or documents, provisions which contradict this Regulation or other Union law, provisions which contradict other harmonised standards, or provisions which are not in conformity with the demands to be met in relation to the basic principles and reference points set out in a standardisation request. |
|
(65) |
To ensure the coherence of the system, this Regulation should build on the horizontal legal framework for standardisation. Hence, Regulation (EU) No 1025/2012 should also apply to the extent possible to standards made mandatory in accordance with this Regulation. Regulation (EU) No 1025/2012 is thus to provide, among others, for a procedure for objections to harmonised standards where those standards do not entirely conform with applicable legal requirements or satisfy the requirements set out in the relevant standardisation request or other requirements of this Regulation. |
|
(66) |
The Commission should support European standardisation organisations in developing guidelines laying down a set of clear and stable rules for the whole standardisation process, including roles, responsibilities, competences and the general procedural deadlines for all stakeholders involved, as well as templates to be used. The Commission should also provide support to ensure the coherence and compliance of standards with legal requirements and should participate in the informal and formal discussions of European standardisation organisations developing the requested European standardisation deliverables, in particular on matters concerning the compliance of the standardisation deliverables with this Regulation and with other Union law. Those activities should benefit from the horizontal work developed in the context of the implementation of Regulation (EU) No 1025/2012. |
|
(67) |
When the Commission endorses by means of delegated acts proposals of European standardisation organisations related to voluntary or mandatory threshold levels and classes of performance in relation to the essential characteristics and those essential characteristics which always have to be declared by manufacturers, they should be accompanied by an impact assessment where required in accordance with the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (17). |
|
(68) |
As they are not acts of general applicability but the first step of a two-step administrative procedure leading to the CE marking, European assessment documents should not qualify as harmonised technical specifications. However, basic principles of the elaboration of harmonised standards, such as transparency for competitors, can and should also apply to European assessment documents. Moreover, the European assessment documents should be referred to in the process of assessment and verification in the same way as harmonised standards. To create transparency for competitors, European assessment documents should be made publicly available and the references of all European assessment documents should be published in the Official Journal of the European Union. |
|
(69) |
Currently, the increasing number of hardly distinguishable European assessment documents which often have little added value when compared to others or existing harmonised standards, risks to slow down their publication. In order to deal with this risk in a cost-effective way, certain principles for the development and adoption of European assessment documents should be established or be made more concrete. Moreover, the control by the Commission should be enhanced. |
|
(70) |
Where the organisation of technical assessment bodies (TABs) considers the development of a European assessment document to be useful even without any demand from a manufacturer, the organisation of TABs should bring the issue to the attention of the Commission who should decide on requesting the development of the European assessment document taking into consideration the justification provided by the organisation of TABs and the market needs. |
|
(71) |
The requirements applicable to designating authorities of TABs should not fall behind those applicable to notifying authorities given the similarities between their respective roles. For the same reason, TABs should have the same degree of independence and control of decision-making as notified bodies. |
|
(72) |
In order to respond to a noteworthy percentage of notifications which were based on incomplete or erroneous assessments, in particular where legal bodies without own in-house technical competence were notified, it is necessary to make requirements for notified bodies more precise, namely with regard to their independence, delegation to other legal entities and own ability to perform; to require sufficient adequate qualified staffing of notified bodies and to verify the adequacy of the staffing, for which a qualification matrix can be an efficient tool; to ensure and verify that the notified body is effectively in control of staffing, attribution of external experts, procedures, criteria and decision-making, and not a subcontractor, subsidiary or another company belonging to the same family of companies; and to enlarge the documentation to be provided by bodies when applying for designation as notified body so as to provide a deeper and comparatively fairer basis for decision to notifying authorities. |
|
(73) |
In order to ensure the correct implementation of this Regulation, it is necessary to ensure that accreditation bodies take as a basis for accreditation this Regulation and not deviating standards. It is also important to ensure that the accreditation bodies assess the ability of the applicant body and not of a group of companies, as it is the applicant body itself that must be in control of future certification. |
|
(74) |
To reach a level playing field and to avoid legal uncertainty, the obligations of notified bodies should be more clearly defined and rendered explicit, and this both for their assessment and verification activities and the related aspects. |
|
(75) |
In order to avoid involvement between notified bodies’ staff and the manufacturers, it should be possible for the notified bodies to allow rotation between the personnel carrying out different conformity assessment tasks. |
|
(76) |
Authorities of Member States might have questions that only a certain notified body can answer. Notified bodies should thus respond also to the questions authorities of other Member States may have. |
|
(77) |
To enable authorities to more easily identify instances of non-compliance by notified bodies, manufacturers and products, and to ensure a level playing field, notified bodies should be empowered, and where the non-compliance can be clearly demonstrated even obliged to, proactively forward information on instances of non-compliance to relevant competent national authorities or notifying authorities. Notified bodies should however not trespass the information obligation by investigating other operators than their own clients or peers. |
|
(78) |
With a view to creating a level playing field for notified bodies and manufacturers, the coordination amongst notified bodies should be enhanced. As only half of the current notified bodies participate on their own initiative in the activities of the already currently existing notified body coordination group, direct participation or by means of designated representatives thereto should thus become mandatory. |
|
(79) |
The attempts of establishing simplified procedures for small and medium-sized enterprises in Regulation (EU) No 305/2011 and thus reducing the burden and costs on SMEs and microenterprises have not been entirely effective and have often remained misunderstood or not used due to the lack of awareness or the lack of clarity regarding their application. By addressing the identified shortcomings while building on the previously established rules, it is necessary to clarify and facilitate their application and hence achieve the objective of supporting SMEs while ensuring performance, safety and environmental sustainability of construction products. |
|
(80) |
The recognition of test results obtained by another manufacturer, provided for in Article 36(1), point (b), of Regulation (EU) No 305/2011, should be generalised, in order to generally reduce the burden of economic operators and namely manufacturers. Such recognition mechanism is particularly needed to avoid multiple assessment of environmental sustainability of raw materials, interim products and final products. |
|
(81) |
To ensure legal certainty in the event of safety or performance problems, such recognition should only be permitted where the assessed and verified economic operators agree to cooperate between themselves and with the notified bodies involved, including the necessary sharing of data. |
|
(82) |
The evaluation of Regulation (EU) No 305/2011 showed that market surveillance activities carried out at national level, widely vary in quality and effectiveness. In addition to measures set out in this Regulation and under relevant Union law in favour of better market surveillance, the compliance of economic operators, bodies and products with this Regulation should be facilitated by also involving third parties such as by the possibility of any natural or legal person to submit information on instances of non-compliance through a complaint portal established and maintained by the Commission. The handling of complaints adheres to the right to good administration, as outlined in Article 41 of the Charter of Fundamental Rights of the European Union. In handling the complaints the Commission should take into account the relevance and substantiation of the complaint by prioritising those complaints raising issues having particularly far-reaching negative impacts for citizens or the internal market. For a complaint to be considered substantiated the Commission should particularly check if the complaint manages to set out a grievance or if the grievance sets out an issue where the Commission has adopted a clear, public and consistent position which has been communicated to the complainant. The Commission should reply to the complainant without undue delay and efficiently transmit the complaints to the relevant Member States who should handle these complaints promptly and effectively in accordance with their legal frameworks and obligations. |
|
(83) |
To address the identified shortcomings with regards to the market surveillance under Regulation (EU) No 305/2011, this Regulation should contain more justified empowerments for market surveillance authorities and for the Commission that should enable authorities to act under all potential problematic circumstances. |
|
(84) |
Market surveillance practice has proved that when evaluating products, at a certain point in time, there is a risk of non-compliance but no non-compliance incidence whereas, at a later point in time, the opposite is to be stated. Moreover, there are situations where there is a non-compliance other than a formal one that does not trigger a risk. For these reasons, Member States should be empowered to act in all cases of suspected non-compliance or risk, whilst the definition of ‘product presenting a risk’ has to be extended to include risk for the environment. It is necessary to offer Member States enough procedural flexibility to distinguish between high and low priority cases of non-compliance, whilst all Member States should also be informed about less important cases. |
|
(85) |
To ensure effective enforcement of the requirements and to strengthen market surveillance in Member States the Commission should issue guidelines for the application of this Regulation, as well as common practices and methodologies for effective market surveillance, including, for example, elements such as a recommended number and type of checks to be performed by the market surveillance authorities on specific product category or family or in relation to specific requirements. It is appropriate that such recommendations be based on good practices developed in the framework of market surveillance. |
|
(86) |
In addition, to strengthen the on average weak capacities of market surveillance authorities in terms of market surveillance and to further align with Regulation (EU) 2024/1781, it is necessary to provide more detailed administrative coordination support and to provide them with the right to retrieve costs of inspections and testing from economic operators in relation to non-compliant products. |
|
(87) |
To create an incentive for increasing the capacities of market surveillance authorities in terms of market surveillance and to reach alignment with Regulation (EU) 2024/1781, Member States should report on their market surveillance activities regarding products covered by this Regulation, including regarding the penalties imposed. |
|
(88) |
To better serve economic operators, product contact points for construction should become more effective and therefore should obtain more resources. In order to facilitate the work of economic operators, the tasks of product contact points for construction should be fine-tuned and extended so as to include information on product related provisions of this Regulation and on acts adopted in accordance with it. Member States should also raise economic operators’ awareness of the product contact points for construction within their territory. |
|
(89) |
It is necessary to establish an appropriate, efficient and cost-effective coordination mechanism to ensure a consistent application of the obligations and requirements set and to strengthen the overall system, also taking into consideration the fact that new interpretative questions may arise in relation to safety and sustainability of products and construction works. As diverging decisions create an uneven playing field, contribute to rendering the legal framework more complex, create barriers to the free movement of the internal market and additional administrative burden and costs on economic operators, such diverging decisions should be prevented by that coordination mechanism. |
|
(90) |
In particular, an information and communication system should therefore be established to collect questions related to interpretation, to find appropriate common solutions and to improve the sharing of information in this regard. To facilitate information sharing, such a system should rely on national systems. Those national systems should also identify cases of uneven application of this Regulation, to ensure that diverging practices do not become a common practice and permanent. The information and communication system should also deal with issues raised related to the emergence of new products or business models, unforeseen situations and to situations in which other provisions of Union law also apply. |
|
(91) |
Digitalisation and availability of product information increases transparency to the benefit of safety of products and the protection of the environment and health of persons while also reducing administrative burden and costs for economic operators. Accordingly, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to establish a construction digital product passport system aligned to the extent possible to the digital product passport under Regulation (EU) 2024/1781. |
|
(92) |
To improve machine readability, it is necessary to establish a common data dictionary based on European standards, a tool to govern and publish the data structure and their meaningful definitions and descriptions for all relevant construction products. For each product family or product category, the data dictionary should include all the essential characteristics and other properties as set out in the harmonised technical specifications as well as other information required by this Regulation. A data dictionary harmonised at the Union level allows for the classification and use of structured definitions by both competent national authorities and in the further digitalisation of the construction sector, in particular in Building Information Modelling, building logbooks, digital passports and registries. |
|
(93) |
To improve their level of competence, harmonise their decision-making and create a level playing field for economic operators, trainings should be organised for market surveillance authorities, product contact points for construction, designating authorities, notifying authorities, and representatives of notified bodies and TABs. The same goals should also be pursued by exchanges of staff between the market surveillance authorities, notifying authorities and notified bodies of two or more Member States. |
|
(94) |
Member States do not always have the technical competence to fulfil all obligations incumbent on them in accordance with Union legislation cumulatively for all product sectors. They therefore obtain informal support, from other Member States. Since such support is unavoidable in some cases, this Regulation should set out the basic rules for such support, namely to clarify responsibilities. |
|
(95) |
Business on construction products becomes slowly but steadily more and more international. Hence, situations arise where non-compliance by economic operators based outside the Union need to be countered as well. Provisions on international cooperation should therefore be provided for in this Regulation. |
|
(96) |
A certain number of third countries applies Union product legislation or at least recognises certificates issued in accordance with it, be it on the basis of international agreements or unilaterally, both being in the interest of the Union. In order to give these third countries an incentive to continue this practice and other third countries to do the same, certain additional possibilities should be provided, on a case-by-case basis, to third countries applying Union product legislation or recognising certificates issued in accordance with it. For this reason, it should be possible, after consultation with Member States, to support these particularly cooperative third countries by allowing them to participate in certain trainings and to participate in the construction digital product passport system, to the information system for harmonised decision-making and to the information exchange amongst authorities. Moreover, for the same reason, it should be possible to inform these particularly cooperative third countries about non-compliant or risky products. |
|
(97) |
In order to incentivise the use of sustainable construction products whilst avoiding market distortions and to remain in line with Regulation (EU) 2024/1781, incentives for the use of sustainable construction products provided by Member States should target the most sustainable products. The Commission should furthermore have the possibility to coordinate Member States incentives in order to boost the demand of certain environmentally sustainable products. Member States might also provide incentives to promote environmentally friendly and sustainable construction products that are not covered by harmonised technical specifications in line with State aid rules. |
|
(98) |
Public procurement amounts to 14 % of Union’s GDP. In order to enhance the use of sustainable construction products, which would contribute to the objective of reaching climate neutrality, improve energy and resource efficiency and in the transition to a circular economy that protects public health and biodiversity and to reach alignment with Regulation (EU) 2024/1781, the public procurement practices of the Member States should comply with mandatory minimum performance requirements on environmental sustainability for construction products set out by delegated acts. The Commission should decide the essential characteristics to be addressed and its implementation in the form of one or more of the following: technical specifications, selection criteria, contract performance clauses or contract award criteria. The mandatory minimum performance requirements on environmental sustainability deal with essential characteristics only and do not pre-empt the possibility for Member States to be more ambitious in their contracts by requesting better performances for the relevant essential characteristics while respecting the harmonised zone. |
|
(99) |
Contracting authorities and contracting entities should, where appropriate, be required to align their procurement with specific green public procurement criteria, to be set out in the delegated acts referred to in this Regulation. The criteria for specific product families or product categories should be complied with where contracts require mandatory minimum environmental sustainability performance for construction products as regards their essential characteristics covered by harmonised technical specifications. Those minimum requirements should be established in accordance with transparent, objective and non-discriminatory criteria. When developing delegated acts related to green public procurement, the Commission should take due account of the Member States different geographical, social and economic circumstances. When considering the effect on the market situation, the Commission should take into account, among others, the effects of the requirements on competition, SMEs and the best environmental products and solutions available on the market. When considering the economic feasibility for contracting authorities and contracting entities, the Commission should take into account that different contracting authorities in different Member States might have different budgetary capacities. In duly justified cases, contracting authorities should be able to derogate from the requirements such as when there is only one supplier, there are no suitable tenders or its application would lead to a disproportionate cost. |
|
(100) |
In order to ensure the proper functioning of the internal market in the event of an internal market emergency as referred to in Regulation (EU) 2024/2748 of the European Parliament and of the Council (18), for the reasons set out in that Regulation, it is necessary to provide for rules on construction products designated as crisis-relevant goods, prioritisation of the assessment and verification of those products, assessment and declaration of performance based on standards and common specifications as well as on prioritisation of market surveillance activities and mutual assistance among authorities, in the case of an active internal market emergency mode under that Regulation. |
|
(101) |
In order to take into account technical progress and knowledge of new scientific evidence, ensure proper functioning of the internal market, facilitate access to information and ensure homogeneous implementation of rules, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending Annexes II, III, IV, V, VI, VII, IX and X and amending this Regulation to further specify, add and remove certain functionalities and revise certain provisions with a view to ensuring compatibility and interoperability with Regulation (EU) 2024/1781. For the same reasons the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to supplement this Regulation by: determining voluntary or mandatory threshold levels in relation to the essential characteristics, classes of performance in relation to the essential characteristics, and the essential characteristics which always have to be declared by manufacturers; determining elements of standardisation requests and conditions under which a product is to be deemed to satisfy a certain level or threshold level or to qualify for a class of performance without testing or without further testing; establishing product requirements in accordance with Annex III; establishing rules on the provision of general product information, instructions for use and safety information for the respective product family or product category; determining, for each product family or product category, the applicable assessment and verification system among those set out in Annex IX; laying down conditions under which obligations relating to the assessment of a product’s performance or the fulfilment of certain product requirements can be satisfied by the fulfilment of obligations under other Union legal acts; imposing in respect of certain product families and product categories an obligation on manufacturers to make available on the market specific spare parts not commonly available for the products they place on the market; establishing specific environmental sustainability labelling requirements for particular product families and product categories; setting up a construction digital product passport system; and by specifying mandatory minimum environmental sustainability requirements for construction products. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. When developing those acts, the Commission should aim at reducing the administrative burden for companies and take into account the needs of SMEs. |
|
(102) |
In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (19). |
|
(103) |
The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to health and safety of persons or the protection of the environment, imperative grounds of urgency so require. |
|
(104) |
Regulation (EU) 2019/1020 lays down rules on a horizontal framework for market surveillance and control of products entering the Union market. In order to ensure that products under this Regulation, which are benefiting from the free movement of goods within the Union, fulfil requirements providing a high level of protection of public interests, such as the protection of health and safety of persons and the protection of the environment, that Regulation should apply also to products covered by this Regulation, in so far as there are no specific provisions with the same objective, nature or effect in this Regulation. |
|
(105) |
To render the implementation of this Regulation more efficient and to reduce the burden for economic operators, it should be possible to make applications and decisions on paper or in a commonly used electronic format. To obtain legal certainty, applications and decisions should only be valid where the electronic signature fulfils the requirements of Regulation (EU) No 910/2014 of the European Parliament and of the Council (20) and where the signing person is entrusted to represent the body or economic operator, in accordance with the law of the Member States or Union law respectively. |
|
(106) |
To further reduce the burden on economic operators, it should be possible to provide documentation in a commonly used electronic format, and to fulfil information requirements electronically by default. |
|
(107) |
In order to ensure a high level of compliance with this Regulation, Member States should lay down rules on penalties applicable to instances of non-compliance and ensure that those rules are enforced. The penalties provided for should be effective, proportionate and dissuasive. |
|
(108) |
In order to create legal certainty, it should be specified whether and for how long designations of product contact points for construction, TABs, or notified bodies and harmonised standards, European assessment documents, European technical assessments and notified bodies certificates or test reports adopted or issued under Regulation (EU) No 305/2011 maintain legal effects under this Regulation. The respective transitional periods should be long enough to avoid bottlenecks in respect of notified bodies and TABs designation and of the adoption or issuing of European assessment documents, European technical assessments, and notified body certificates or test reports. |
|
(109) |
To create legal certainty, it should be clarified for how long products placed on the market on the basis of European technical assessments issued in accordance with European assessment documents adopted under Regulation (EU) No 305/2011 may be placed on the market. |
|
(110) |
Both the essential characteristics of construction products and their assessment methods can only be determined by harmonised technical specifications to be developed for the various product families and product categories, or by European assessment documents. Accordingly, requirements and obligations incumbent on economic operators with regard to a certain product family or product category should only apply mandatorily as of 12 months after the entry into force of harmonised technical specification covering the respective product family or product category unless a later application date has been specified in the publication in the Official Journal of the European Union. |
|
(111) |
To facilitate a smooth phasing-in of future harmonised technical specifications and taking into consideration the time needed for drawing up the declaration of performance and conformity, economic operators should be permitted to opt for the voluntary application of this Regulation as from the entry into force of these harmonised technical specifications. |
|
(112) |
It is necessary to avoid that economic operators can permanently circumvent the application of this Regulation by applying the harmonised technical specifications adopted under Regulation (EU) No 305/2011. For this reason, the Commission should withdraw from the Official Journal of the European Union the references to harmonised standards and European assessment documents published in support of Regulation (EU) No 305/2011 and covering a certain product family or product category by the entry into application of harmonised technical specification adopted under this Regulation covering that respective product family or product category. |
|
(113) |
While the concept of basic requirements for construction works is kept as the technically necessary link between construction works and construction products, it should be made explicit that they do not constitute obligations incumbent upon economic operators or Member States seeing as the right to regulate construction works is a competence of Member States. In order to cover the environmental assessment of construction products as well as product requirements which exist even in current harmonised technical specifications, a more comprehensive Annex I should be developed, including also a detailed list of predetermined environmental essential characteristics related to life cycle assessment and a framework for the product requirements. On that occasion, overlaps between basic requirements for construction works should be eliminated and clarifications should be brought forward. |
|
(114) |
In order to reach a minimum control intensity of the assessment and verification of manufacturers by notified bodies and to create a level playing field both for manufacturers and notified bodies, Annex IX on assessment and verification systems should more precisely and comprehensively determine the tasks of manufacturers and notified bodies under different possible assessment and verification systems. Moreover, that Annex should determine the assessments and verifications to be undertaken to verify the environmental sustainability of products, in terms of product performance and product requirements. When the Commission defines the applicable assessment and verification system for a product family or product category, continuity with Regulation (EU) No 305/2011 and coherence across product families should be the guiding principles. |
|
(115) |
Since the objectives of this Regulation, namely to ensure the free movement of safe and sustainable construction products in the internal market, to contribute to the green and digital transition and to protect health and safety of persons and the environment, cannot be sufficiently achieved by the Member States, as Member States tend to establish very diverging requirements for construction products, with an uneven level of protection of health and safety of persons and of the environment, but can rather be better achieved at Union level by establishing a harmonised assessment framework for the performance of construction products and certain product requirements for the protection of health and safety of persons and of the environment, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives, |
HAVE ADOPTED THIS REGULATION:
已通过本条例:
CHAPTER I 第一章
GENERAL PROVISIONS 一般规定
Article 1 第 1 条
Subject matter and objectives
主题和目标
1. This Regulation lays down harmonised rules for the placing and making available on the market of construction products, regardless of whether undertaken in the framework of a service or not, by establishing:
1. 本条例规定了建筑产品投放和提供市场的统一规则,无论是否在服务框架内进行,具体包括:
|
(a) |
harmonised rules on how to express the environmental and safety performance of construction products in relation to their essential characteristics, including on life cycle assessment; |
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(b) |
environmental, functional and safety product requirements for construction products. |
2. This Regulation also establishes:
2. 本条例还规定:
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(a) |
rights and obligations for economic operators dealing with construction products or their components; and |
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(b) |
obligations for other actors providing services linked to the manufacturing and commercialisation of products covered by this Regulation. |
3. This Regulation aims to contribute to the efficient functioning of the internal market by ensuring the free movement of safe and sustainable construction products in the Union. It also aims to contribute to the objectives of a green and digital transition by preventing and reducing the impact that construction products have on the environment and on the health and safety of persons.
3. 本条例旨在通过确保安全且可持续的建筑产品在欧盟内部自由流通,促进内部市场的高效运作。它还旨在通过防止和减少建筑产品对环境以及人员健康和安全的影响,助力绿色和数字转型的目标。
Article 2 第 2 条
Scope 范围
1. This Regulation applies to construction products, including used products, and to the following items:
1. 本条例适用于建筑产品,包括二手产品,以及以下项目:
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(a) |
key parts of products; and |
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(b) |
parts or materials intended to be used for products covered by this Regulation, if the manufacturer of those parts or materials so requests. |
2. This Regulation does not apply to:
2. 本条例不适用于:
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(a) |
lifts subject to Directive 2014/33/EU of the European Parliament and of the Council (21), escalators or their components; |
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(b) |
requirements or performance assessment subject to Directive (EU) 2020/2184 of the European Parliament and of the Council (22) and covered by the delegated acts of the Commission referred to in Article 11(8) of that Directive. |
3. Member States may exempt from the application of this Regulation products falling within its scope that are placed on the market in the outermost regions of the Union within the meaning of Article 349 TFEU. Member States shall notify to the Commission and to the other Member States the national laws, regulations and administrative provisions providing such exemptions. They shall ensure that exempted products do not bear the CE marking referred to in Article 17. Products placed on the market on the basis of that exemption shall not be deemed to have been placed on the market in the Union within the meaning of this Regulation.
3. 成员国可对在《欧盟运行条约》第 349 条意义上的欧盟最外围地区投放市场的、属于本条例范围内的产品免于适用本条例。成员国应将提供此类豁免的国家法律、法规和行政规定通知委员会及其他成员国。成员国应确保被豁免的产品不带有第 17 条所述的 CE 标志。基于该豁免投放市场的产品,不应视为根据本条例意义上的在欧盟市场投放的产品。
Article 3 第 3 条
Definitions 定义
For the purposes of this Regulation, the following definitions shall apply:
为本条例之目的,适用以下定义:
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(1) |
‘construction product’ means any formed or formless physical item, including 3D-printed products, or a kit that is placed on the market, including by means of supply to the construction site, for incorporation in a permanent manner into construction works or parts thereof with the exception of items that need first to be integrated into a kit or another construction product prior to being incorporated in a permanent manner into construction works; |
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(2) |
‘product’ means a construction product or other item falling within the scope of this Regulation as set out in Article 2; |
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(3) |
‘permanent’ means intended to remain in the construction work, or in parts thereof, after the completion of the construction or renovation process; |
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(4) |
‘making available on the market’ means any supply of a product for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge, regardless whether in the framework of providing a service or not; |
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(5) |
‘placing on the market’ means the first making available of a product on the Union market, or the first making available on the Union market of a used product after a deinstallation of such a product; |
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(6) |
‘performance’ means the degree to which a product has certain scalable essential characteristics; |
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(7) |
‘essential characteristics’ means those characteristics of the product which relate to the basic requirements for construction works set out in Annex I, and those which are listed as predetermined environmental essential characteristics in Annex II; |
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(8) |
‘product requirement’ means a characteristic, as set out in Annex III, which a product must have before it can be placed on the market; |
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(9) |
‘economic operator’ means the manufacturer, the authorised representative, the importer, the distributor, the fulfilment service provider or any other natural or legal person who is subject to this Regulation in relation to the manufacturing or remanufacturing of products, including products to be reused, or to making those products available on the market, in accordance with this Regulation; |
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(10) |
‘manufacturer’ means a ‘manufacturer’ as defined in Article 3, point (8), of Regulation (EU) 2019/1020; |
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(11) |
‘3D-dataset’ means a set of numerical data describing the shape of an object by its outer dimensions and its cavities; |
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(12) |
‘construction works’ means buildings and civil engineering works whether over or in the ground or water, including but not limited to roads, bridges, tunnels, pylons and other facilities for transport of electricity, communication cables, pipelines, aqueducts, dams, airports, ports, waterways, and installations which are the bases for the rails of railways; |
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(13) |
‘level’ means the result of the assessment of the performance of a product in relation to its essential characteristics, expressed as a numerical value; |
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(14) |
‘class’ means a range of levels, delimited by a minimum and a maximum value, of performance of a product; |
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(15) |
‘threshold level’ means a minimum or maximum performance level of a product with regard to a certain essential characteristic; |
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(16) |
‘key part’ means a part which is used as a component or spare part for a product and which has been specified by a harmonised technical specification as essential for the characterisation, safety or performance of a product; |
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(17) |
‘kit’ means a product placed on the market by a single economic operator as a set of at least two separate items, none of which needs to be a product itself, intended to be incorporated together into construction works; |
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(18) |
‘European assessment document’ or ‘EAD’ means a document adopted by the organisation of technical assessment bodies for the purposes of issuing European technical assessments; |
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(19) |
‘European technical assessment’ or ‘ETA’ means the documented assessment of the performance of a product, in relation to its essential characteristics, in accordance with the respective European assessment document; |
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(20) |
‘used product’ means a product that is not waste or has ceased to be waste in accordance with Directive 2008/98/EC, and which has been installed at least once into a construction work, and that:
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(21) |
‘intended use’ means the purpose of a product as set out in the applicable harmonised technical specifications or European assessment documents; |
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(22) |
‘declared use’ means the use intended by the manufacturer, including the conditions for usage, as set out in technical documentation, on labels, in general product information, in instructions for use, in safety information, or in publicity material; |
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(23) |
‘repair’ means the process of fixing a faulty product or replacing its defective components, in order to return the product to a condition where it can fulfil its declared use; |
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(24) |
‘maintenance’ means an action carried out to keep a product in a condition where it is able to function as specified; |
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(25) |
‘remanufactured product’ means a product that is not waste, or has ceased to be waste in accordance with Directive 2008/98/EC, which has been installed at least once into a construction work, and that has been subject to a transformative process going beyond checking, cleaning and repairing recovery operations which, according to the applicable harmonised technical specification, are qualified as essential to the product’s performance; |
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(26) |
‘risk’ means ‘risk’ as defined in Article 3, point (18), of Regulation (EU) 2019/1020; |
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(27) |
‘product type’ means the abstract model of individual products, determined by the intended use and a set of characteristics which exclude any variation with regard to performance or to the fulfilment of product requirements set out in or in accordance with this Regulation, whilst identical products of different manufacturers belong to different product types; |
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(28) |
‘state of the art’ means a way of achieving a certain goal which is either the most effective and advanced or close to it, or a way which is currently possible by applying common technologies, whether or not it is the most technologically advanced solution; |
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(29) |
‘recycling’ means ‘recycling’ as defined in Article 3, point (17), of Directive 2008/98/EC; |
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(30) |
‘fulfilment service provider’ means a ‘fulfilment service provider’ as defined in Article 3, point (11), of Regulation (EU) 2019/1020; |
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(31) |
‘product family’ means all product types belonging to one of the families listed in Annex VII; |
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(32) |
‘product category’ means a subset of the product types of a certain product family encompassing those product types which have in common a certain intended use as specified in harmonised technical specifications or European assessment documents; |
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(33) |
‘factory production control’ means the documented, continuous and internal production control in a manufacturing plant with regard to certain parameters or quality aspects, reflecting the specificities of a respective product family or product category and manufacturing processes, and which aims at the constancy of performance or at the continuous fulfilment of product requirements, executed in accordance with Annex IX; |
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(34) |
‘importer’ means an ‘importer’ as defined in Article 3, point (9), of Regulation (EU) 2019/1020; |
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(35) |
‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market, including by offering products for sale, hire or hire purchase, or displaying products to customers or installers in the course of a commercial activity, and including through distance selling, whether or not in return for payment; |
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(36) |
‘authorised representative’ means any natural or legal person established in the Union who has received a written mandate from a manufacturer to act on that manufacturer’s behalf in relation to specified tasks with regard to the manufacturer’s obligations under this Regulation; |
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(37) |
‘individually manufactured’ means that, due to the specifications of the client, there is a need for readjustment of the production process for manufacture when compared with all other products produced for other clients by the economic operator in question; |
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(38) |
‘micro-enterprise’ means a ‘micro-enterprise’ as defined in Article 2(3) of the Annex to Commission Recommendation 2003/361/EC (23); |
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(39) |
‘custom-made’ means that, due to the specifications of the client, there is a variation in terms of size or material when compared with all other products produced for other clients by the economic operator in question; |
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(40) |
‘permalink’ means an internet link to a website which is stable both for its content and the address (‘URL’); |
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(41) |
‘data carrier’ means a linear bar code symbol, a two-dimensional symbol, or other automatic identification data capture medium that can be read by a device; |
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(42) |
‘harmonised technical specifications’ means the performance harmonised standards which have been made mandatory for the purposes of the application of this Regulation in accordance with Article 5(8), the implementing acts referred to in Article 6(1) and the delegated acts referred to in Article 7(1), Article 9(3) and Article 10(2); |
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(43) |
‘European standardisation organisation’ means a ‘European standardisation organisation’ as defined in Article 2, point (8) of Regulation (EU) No 1025/2012; |
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(44) |
‘non-series process’ means a process that is neither predominantly automated or predominantly carried out using assembly-line techniques, nor repeated very often in relation to the volume of production by the economic operator concerned or the economic operators belonging to the same group of companies, determined by a common controlling natural or legal person, or the same organisational structure; |
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(45) |
‘withdrawal’ means ‘withdrawal’ as defined in Article 3, point (23), of Regulation (EU) 2019/1020; |
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(46) |
‘recall’ means ‘recall’ as defined in Article 3, point (22), of Regulation (EU) 2019/1020; |
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(47) |
‘online marketplace’ means a provider of an intermediary service using an online interface which enables customers to conclude distance contracts with economic operators for the sale of products; |
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(48) |
‘online interface’ means an ‘online interface’ as defined in Article 3, point (15), of Regulation (EU) 2019/1020; |
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(49) |
‘supplier’ means any natural or legal person providing raw materials, intermediate products, or used products to manufacturers or to other persons providing raw materials, intermediate products, or used products to manufacturers; |
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(50) |
‘service provider’ means any natural or legal person providing a service to a manufacturer or to a supplier of a key part, provided that the service is relevant for the manufacturing of products, including to their design, or to their deinstallation in the case of used products; |
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(51) |
‘accreditation’ means ‘accreditation’ as defined in Article 2, point (10), of Regulation (EC) No 765/2008; |
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(52) |
‘market surveillance authority’ means a ‘market surveillance authority’ as defined in Article 3, point (4), of Regulation (EU) 2019/1020; |
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(53) |
‘life cycle’ means the consecutive and interlinked stages of a product’s life, from raw material acquisition or generation from natural resources, or in the case of products which have previously been incorporated into construction works, from the latest deinstallation from the construction work, to final disposal; |
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(54) |
‘single liaison point’ means the authority designated as the focal point for contacts with the Commission and other Member States on construction product related issues; |
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(55) |
‘notified body’ means a conformity assessment body authorised to carry out third-party assessment and verification tasks under this Regulation that has been duly notified; |
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(56) |
‘notifying authority’ means the single public administration body, designated in accordance with this Regulation, in charge of the notification and monitoring of notified bodies; |
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(57) |
‘technical assessment body’ or ‘TAB’ means a body, designated in accordance with this Regulation, that issues European technical assessments on the basis of European assessment documents; |
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(58) |
‘designating authority’ means the single public administration body, designated in accordance with this Regulation, in charge of the designation and monitoring of TABs in a Member State; |
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(59) |
‘product presenting a risk’ means a product that, whenever during its entire life cycle, has an inherent potential to affect adversely the health and safety of persons, the environment or the fulfilment of basic requirements for construction works when incorporated in those works, to a degree which, taking account of the state-of-the-art, goes beyond what is considered reasonable and acceptable in relation to its intended use and under normal or reasonably foreseeable conditions of use; |
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(60) |
‘product presenting a serious risk’ means a ‘product presenting a serious risk’ as defined in Article 3, point (20), of Regulation (EU) 2019/1020; |
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(61) |
‘by-product’ means a ‘by-product’ within the meaning of Article 5 of Directive 2008/98/EC; |
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(62) |
‘recyclability’ means the capability of a material or product to be effectively and efficiently separated, collected, sorted and aggregated in specific waste streams for the purpose of being recycled into secondary raw materials while minimising the loss of quality or functionality compared to the relevant primary raw material; |
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(63) |
‘crisis-relevant goods’ means ‘crisis-relevant goods’ as defined in Article 3, point (6), of Regulation (EU) 2024/2747 of the European Parliament and of the Council (24); |
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(64) |
‘internal market emergency mode’ means ‘internal market emergency mode’ as defined in Article 3, point (3), of Regulation (EU) 2024/2747. |
Article 4 第 4 条
Working plan and preparatory phase for the development of harmonised technical specifications
制定统一技术规范的发展工作计划和准备阶段
1. The Commission shall be supported by an expert group (‘the Construction Products Regulation Acquis Expert Group’ or ‘CPR Acquis Expert Group’). The CPR Acquis Expert Group shall be composed at least of experts designated by the Member States, representatives of European standardisation organisations and of relevant European stakeholder organisations receiving Union financing under Regulation (EU) No 1025/2012. The CPR Acquis Expert Group shall support the Commission in processing Member States’ requests for Union harmonisation through harmonised technical specifications. In particular, the CPR Acquis Expert Group shall assist the Commission in establishing and updating a working plan for the development of harmonised technical specifications, in preparing the technical content related to harmonised technical specifications, in deciding on the need to launch the procedures in relation to harmonised technical specifications that present deficiencies, are unavailable, or not able to cover immediate regulatory needs, and in determining the inclusion of used products in harmonised technical specifications.
1. 委员会应由一个专家组支持(“建筑产品法规专家组”或“CPR 法规专家组”)。CPR 法规专家组应至少由成员国指定的专家、欧洲标准化组织的代表以及根据条例(欧盟)第 1025/2012 号获得欧盟资助的相关欧洲利益相关方组织的代表组成。CPR 法规专家组应协助委员会处理成员国关于通过协调技术规范实现欧盟统一的请求。具体而言,CPR 法规专家组应协助委员会制定和更新协调技术规范开发的工作计划,准备与协调技术规范相关的技术内容,决定是否启动针对存在缺陷、不可用或无法满足紧迫监管需求的协调技术规范的程序,以及确定是否将二手产品纳入协调技术规范。
2. After consulting the CPR Acquis Expert Group, the Commission shall establish a working plan for the development of harmonised technical specifications for product families listed in Annex VII, including product requirements as well as general product information, instructions for use and safety information, covering at least the following three-year period. The Commission shall set the priorities of the working plan using a transparent and balanced methodology, which shall be published together with the working plan. That methodology shall at least reflect the regulatory needs of the Member States, the safety issues related to construction works and products and the climate and circular economy goals of the Union.
2. 在咨询 CPR 法规专家组后,委员会应制定一项工作计划,用于开发附录 VII 中列出的产品系列的统一技术规范,包括产品要求以及一般产品信息、使用说明和安全信息,涵盖至少以下三年期限。委员会应采用透明且平衡的方法确定工作计划的优先事项,该方法应与工作计划一同公布。该方法至少应反映成员国的监管需求、与建筑工程和产品相关的安全问题以及欧盟的气候和循环经济目标。
The Commission shall publish the first working plan no later than 8 January 2026.
委员会应于 2026 年 1 月 8 日之前公布第一份工作计划。
The Commission shall renew and update the working plan at least every three years. It shall publish the working plan for the following three-year period one year before the expiration of the working plan in force.
委员会应至少每三年更新和修订工作计划。应在现行工作计划到期前一年公布下一三年期间的工作计划。
The Commission shall inform the European Parliament and the Member States annually about progress in implementing the working plan.
委员会应每年向欧洲议会和成员国通报工作计划的实施进展情况。
If the Commission considers that it cannot achieve the goals set out in the working plan, it shall amend it accordingly without undue delay, and shall inform the European Parliament and the Member States about the reasons thereof.
如果委员会认为无法实现工作计划中设定的目标,应及时相应修订工作计划,并将原因通知欧洲议会和成员国。
3. Following the working plan established under paragraph 2, Member States shall communicate to the Commission and the CPR Acquis Expert Group the essential characteristics they require for a product family or product category, and the assessment methods, threshold levels or classes of performance, as well as the product requirements, that they deem necessary.
3. 根据第 2 款制定的工作计划,成员国应向委员会和 CPR 法规专家组通报其对产品系列或产品类别所需的基本特征,以及其认为必要的评估方法、阈值水平或性能等级,以及产品要求。
When Member States communicate their regulatory needs to the Commission pursuant to the first subparagraph, the Commission shall integrate them or shall provide a statement of reasons why it is not possible to do so.
当成员国根据第一款向委员会通报其监管需求时,委员会应将其纳入工作计划,或提供无法纳入的理由说明。
4. On the basis of the basic requirements for construction works set out in Annex I and taking into account the regulatory needs communicated by Member States in accordance with paragraph 3 of this Article, as well as the safety, environmental, circularity and climate objectives of the Union, the Commission, with the support of the CPR Acquis Expert Group, shall identify the technical aspects needed to prepare standardisation requests, including the relevant essential characteristics. Those essential characteristics and the list of predetermined environmental essential characteristics set out in Annex II shall constitute the basis for the preparation of the standardisation requests referred to in Article 5(2) and of the implementing acts referred to in Article 6(1).
4. 根据附件 I 中规定的建筑工程基本要求,并考虑成员国根据本条第 3 款通报的监管需求,以及欧盟的安全、环境、循环利用和气候目标,委员会在 CPR 法规专家组的支持下,应确定准备标准化请求所需的技术方面,包括相关的基本特性。该等基本特性及附件 II 中列出的预定环境基本特性清单,应构成第 5 条第 2 款所述标准化请求和第 6 条第 1 款所述实施法案准备的基础。
5. The Commission shall ensure that essential characteristics are covered by harmonised technical specifications to the extent that the development of such specifications is technically and economically proportionate.
5. 委员会应确保通过协调的技术规范涵盖基本特征,前提是制定此类规范在技术和经济上是相称的。
6. The Commission, with the support of the CPR Acquis Expert Group, shall identify the product requirements referred to in Article 7, as well as other harmonised technical specifications, and shall determine whether used products are to be covered by or excluded from a standardisation request or a harmonised technical specification. The CPR Acquis Expert Group shall, as a matter of urgency, be consulted on notifications from Member States made in accordance with Article 11(5).
6. 委员会在 CPR 法规专家组的支持下,应确定第 7 条所述的产品要求,以及其他协调的技术规范,并应确定二手产品是否应包含在标准化请求或协调技术规范中,或应被排除在外。CPR 法规专家组应紧急就根据第 11 条第 5 款由成员国作出的通知进行咨询。
7. The Commission is empowered to adopt delegated acts in accordance with Article 89 to amend:
7. 委员会有权根据第 89 条通过授权法案修订:
|
(a) |
the list of predetermined environmental essential characteristics set out in Annex II in order to adapt it to technical progress and new environmental risks and to comply with the priorities established pursuant to paragraph 2 of this Article based on the regulatory needs of the Member States; |
|
(b) |
the product families listed in Annex VII, to adapt them to technical progress and to the regulatory needs of the Member States. |
Article 5 第 5 条
Harmonised standards laying down essential characteristics dealing with performance
规定性能基本特征的协调标准
1. The methods and the criteria for assessing the performance of a product in relation to its essential characteristics shall be laid down in harmonised standards made mandatory by means of the implementing acts referred to in paragraph 8 (‘performance harmonised standards’). Performance harmonised standards shall, where appropriate and without endangering the accuracy, reliability or stability of the results, provide methods for assessing the performance of the products in relation to their essential characteristics that are less onerous than testing.
1. 产品与其基本特征相关的性能评估方法和标准,应通过第 8 款所述的实施法令强制采用的协调标准予以规定(“性能协调标准”)。性能协调标准应在适当且不危及结果的准确性、可靠性或稳定性的前提下,提供比测试更简便的产品性能评估方法。
2. The Commission shall, in accordance with Article 10 of Regulation (EU) No 1025/2012, request one or more European standardisation organisations to draft harmonised standards laying down essential characteristics and their assessment methods for one or more product families, or for one or more product categories within a family. The standardisation request shall set out the basic principles and reference points for the establishment of those essential characteristics and their assessment methods. The standardisation request shall explicitly state whether it covers or excludes used products from the scope of the request.
2. 委员会应根据《条例》(EU)第 1025/2012 号第 10 条的规定,要求一个或多个欧洲标准化组织起草协调标准,规定一个或多个产品系列,或一个系列内一个或多个产品类别的基本特性及其评估方法。标准化请求应阐明制定这些基本特性及其评估方法的基本原则和参考点。标准化请求应明确说明是否涵盖或排除二手产品在请求范围内。
3. As part of the standardisation requests referred to in paragraph 2 of this Article, the Commission may also request the European standardisation organisations to provide the technical details necessary for the implementation of the assessment and verification system that is to be applied in accordance with the delegated acts referred to in Article 10(2).
3. 作为本条第 2 款所述标准化请求的一部分,委员会还可以要求欧洲标准化组织提供实施根据第 10 条第 2 款所述授权法案应适用的评估和验证体系所需的技术细节。
4. The standardisation requests referred to in paragraph 2 may include a request to propose one or more of the following elements:
4. 第 2 款所述的标准化请求可包括提出以下一项或多项内容的请求:
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(a) |
voluntary or mandatory threshold levels in relation to the essential characteristics; |
|
(b) |
classes of performance in relation to the essential characteristics; |
|
(c) |
those essential characteristics which always have to be declared by manufacturers. |
Such standardisation requests shall set out the basic principles and reference points for the establishment of the elements requested.
此类标准化请求应规定建立所请求元素的基本原则和参考点。
5. Where it has included with its standardisation request a request for a proposal in accordance with paragraph 4 of this Article, the Commission is empowered to adopt delegated acts in accordance with Article 89 to supplement this Regulation by determining, for the product families or product categories and for the elements covered by that request, the elements referred to in paragraph 4, first subparagraph of this Article.
5. 如果委员会在其标准化请求中包含了根据本条第 4 款提出建议的请求,则委员会有权根据第 89 条通过授权法案补充本条例,确定针对该请求所涵盖的产品系列或产品类别及元素,本条第 4 款第一段所指的元素。
After consulting the CPR Acquis Expert Group, the Commission may deviate from the proposals of the European standardisation organisation.
在咨询 CPR 法规专家组后,委员会可偏离欧洲标准化组织的提案。
The Commission is empowered to adopt delegated acts, irrespective of any prior standardisation request but on the advice of the CPR Acquis Expert Group, in accordance with Article 89 to supplement this Regulation by determining the elements set out in paragraph 4, first subparagraph of this Article in relation to any of the groupings of essential characteristics of a horizontal nature listed in Annex X.
委员会有权根据第 89 条,在不考虑任何先前标准化请求的情况下,但须听取 CPR 法规专家组的意见,通过制定本条第 4 款第一段所列的要素,补充本条例,涉及附录 X 中列出的任何具有横向性质的基本特征分组。
6. In cases where, on the basis of the nature or technical characteristics of a product, it is apparent that testing would be unnecessary or redundant, the Commission is empowered to adopt delegated acts in accordance with Article 89 to supplement this Regulation by laying down conditions under which a product is to be deemed to satisfy a certain level, threshold level or to qualify for a class of performance without testing, or without further testing.
6. 在基于产品的性质或技术特性明显表明测试是不必要或多余的情况下,委员会有权根据第 89 条,通过制定补充本条例的授权法案,规定在何种条件下产品可被视为满足某一水平、阈值水平或符合某一性能等级,无需测试或无需进一步测试。
7. The Commission shall assess the compliance of harmonised standards with the relevant standardisation requests, with this Regulation and with other Union law, including general principles of law. The Commission may assess whether harmonised standards comply with other harmonised standards under this Regulation or with other harmonised standards the references of which have been published in the Official Journal of the European Union.
7. 委员会应评估协调标准是否符合相关标准化请求、本条例及其他欧盟法律,包括法律的一般原则。委员会可评估协调标准是否符合本条例下的其他协调标准,或符合其引用已在《欧盟官方公报》上公布的其他协调标准。
The Commission shall carry out the assessment referred to in the first subparagraph of this paragraph and present its reasons in writing to the relevant European standardisation organisation and to the CPR Acquis Expert Group within six months after the relevant harmonised standard has been transmitted to it. Where the Commission considers that a standard, or a part thereof, is unsatisfactory, it shall specify the deficiencies. In order for the Commission to fulfil that obligation within that timeframe, the European standardisation organisations shall regularly inform the Commission of the progress and content of the European standardisation deliverable in accordance with Article 10(5) of Regulation (EU) No 1025/2012.
委员会应在相关协调标准传送给其后的六个月内,进行本段第一款所述的评估,并以书面形式向相关欧洲标准化组织及 CPR 法规专家组说明其理由。若委员会认为某项标准或其部分内容不令人满意,应具体说明其缺陷。为使委员会能在该期限内履行该义务,欧洲标准化组织应根据欧盟条例(EU)第 1025/2012 号第 10 条第 5 款的规定,定期向委员会通报欧洲标准化成果的进展和内容。
8. Where a harmonised standard is in conformity with applicable legal requirements and satisfies the requirements to be met in relation to the basic principles and reference points set out in the standardisation request, as well as in relation to the essential characteristics to be covered in view of the basic requirements for construction works, the Commission shall without delay adopt an implementing act making that standard mandatory. One year after such adoption the performance harmonised standard shall become mandatory for the purposes of this Regulation unless a later application date has been specified in the implementing act. A later application date shall be specified only in exceptional cases and its use shall be duly justified. A performance harmonised standard may be voluntarily applied from the date of the adoption of the implementing act.
8. 当一项协调标准符合适用的法律要求,并满足标准化请求中规定的基本原则和参考点以及针对建筑工程基本要求所涵盖的基本特征的要求时,委员会应立即通过实施法令使该标准具有强制性。自该实施法令通过之日起一年后,除非实施法令中另有规定的较晚适用日期,否则该性能协调标准应成为本条例的强制性标准。较晚的适用日期仅在特殊情况下指定,且其使用须有充分理由。性能协调标准可自实施法令通过之日起自愿适用。
Where the Commission considers a harmonised standard or a part thereof to be unsatisfactory, it may adopt an implementing act making that harmonised standard mandatory with restrictions.
如果委员会认为某项协调标准或其部分内容不令人满意,可以通过实施法令使该协调标准在附加限制的情况下成为强制性标准。
The implementing acts referred to in the first and second subparagraph shall be adopted in accordance with the advisory procedure referred to in Article 90(2).
第一款和第二款所指的实施法案应按照第 90 条第 2 款所述的咨询程序予以通过。
Where it is not possible to make a harmonised standard mandatory with restrictions, the Commission may adopt an implementing act in accordance with Article 6.
当无法通过限制使协调标准具有强制性时,委员会可根据第 6 条采纳实施法案。
9. When a Member State, the European Parliament or the Commission, the last with the support of the CPR Acquis Expert Group, considers that a performance harmonised standard does not entirely fulfil the applicable legal requirements or satisfy the demands to be met in relation to the essential characteristics to be covered in view of the basic requirements for construction works, the procedure for formal objections to harmonised standards as set out in Article 11 of Regulation (EU) No 1025/2012 shall apply.
9. 当成员国、欧洲议会或委员会(后者在 CPR 法规专家组的支持下)认为某项性能协调标准未能完全满足适用的法律要求或未能满足关于建筑工程基本要求所涵盖的基本特性的相关需求时,应适用《欧盟条例》第 1025/2012 号第 11 条中规定的对协调标准提出正式异议的程序。
10. The Commission is empowered to adopt delegated acts in accordance with Article 89 to amend Annex X by adding additional groupings of essential characteristics of a horizontal nature.
10. 委员会有权根据第 89 条通过授权法案修订附件 X,增加具有横向性质的基本特征的额外分组。
Article 6 第 6 条
Other harmonised technical specifications laying down essential characteristics
其他规定基本特征的协调技术规范
1. While priority shall be given to the elaboration of standards, by way of derogation from Article 5(1) to (4) of this Regulation, in order to cover the regulatory needs of Member States and to pursue the goals of Article 114 TFEU, the Commission may adopt implementing acts laying down essential characteristics, their assessment methods and technical details pursuant to Article 5 of this Regulation for one or more product families or for one or more product categories within a family.
1. 虽然应优先制定标准,但根据本条例第 5 条第 1 款至第 4 款的例外规定,为满足成员国的监管需求并实现《欧盟运行条约》第 114 条的目标,委员会可根据本条例第 5 条,采用实施措施,规定一个或多个产品系列或一个系列内一个或多个产品类别的基本特征、其评估方法及技术细节。
Those implementing acts shall be adopted only if the following conditions are fulfilled:
仅当满足以下条件时,方可通过该等实施措施:
|
(a) |
the Commission has requested, pursuant to Article 5(2), one or more European standardisation organisations to draft a harmonised standard and:
|
|
(b) |
no implementing act, as referred to in Article 5(8), first subparagraph, making mandatory a harmonised standard covering the essential characteristics, their assessment methods and technical details pursuant to Article 5 was adopted in the last 5 years, or such an implementing act was adopted within the last five years, but with restrictions, as referred to in Article 5(8), second subparagraph. |
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 90(3).
这些实施法令应按照第 90 条第 3 款所述的审查程序予以采纳。
2. Before preparing a draft implementing act referred to in paragraph 1 of this Article, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in paragraph 1 of this Article are fulfilled.
2. 在起草本条第 1 款所述的实施法案草案之前,委员会应通知《欧盟条例》第 1025/2012 号第 22 条所述的委员会,表明其认为本条第 1 款中的条件已得到满足。
3. When preparing the draft implementing act, the Commission shall take into account the views of relevant bodies and of the CPR Acquis Expert Group and shall duly consult all relevant stakeholder organisations receiving Union financing under Regulation (EU) No 1025/2012.
3. 在起草实施条例草案时,委员会应考虑相关机构和 CPR 法规专家组的意见,并应适当咨询根据欧盟条例(EU)第 1025/2012 号获得欧盟资助的所有相关利益相关方组织。
4. Where an implementing act referred to in paragraph 1 of this Article covers the same essential characteristics or assessment methods in relation to a specific product family or product category as a harmonised standard the reference of which has been published in the Official Journal of the European Union or in respect of which an implementing act referred to in Article 5(8) has been adopted, the Commission shall withdraw from the Official Journal of the European Union the reference of that harmonised standard or repeal that implementing act. Where the implementing act referred to in paragraph 1 of this Article only partially covers the harmonised standard, the Commission shall retain the implementing act laying down a harmonised standard that is subject to restrictions.
4. 当本条第 1 款所述的实施法案涵盖与某一特定产品系列或产品类别相关的相同基本特征或评估方法,而该产品系列或类别的协调标准的引用已在《欧盟官方公报》上发布,或已通过第 5 条第 8 款所述的实施法案时,委员会应从《欧盟官方公报》撤销该协调标准的引用或废止该实施法案。若本条第 1 款所述的实施法案仅部分涵盖该协调标准,委员会应保留规定受限制协调标准的实施法案。
5. When a Member State or the European Parliament considers that an implementing act adopted in accordance with paragraph 1 does not entirely satisfy the requirements to be met in relation to the essential characteristics to be covered in view of the basic requirements for construction works, it shall inform the Commission thereof, by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend the implementing act in question.
5. 当成员国或欧洲议会认为根据第 1 款通过的实施法案未能完全满足关于建筑工程基本要求所涵盖的基本特征的相关要求时,应向委员会通报,并提交详细说明。委员会应对该详细说明进行评估,并可在适当情况下修改相关实施法案。
6. The Commission shall follow the procedure in Article 5 to request any revision or update of the essential characteristics or assessment methods in relation to the same product families or product categories as those covered by the implementing act referred to in paragraph 1 of this Article. Where the harmonised standard delivered by the European standardisation organisation is suitable to be adopted in accordance with Article 5(8), the Commission shall repeal the implementing act adopted in accordance with paragraph 1 of this Article, or the parts thereof which cover the same essential characteristics or assessment methods in relation to the same product families or product categories as those covered by the harmonised standard.
6. 委员会应按照第 5 条的程序,要求对与本条第 1 款所述实施法案涵盖的相同产品系列或产品类别相关的基本特性或评估方法进行任何修订或更新。若欧洲标准化组织发布的协调标准适合根据第 5 条第 8 款予以采纳,委员会应废止根据本条第 1 款采纳的实施法案,或废止其中涵盖与该协调标准所涵盖的相同产品系列或产品类别相关的相同基本特性或评估方法的部分。
Article 7 第 7 条
Product requirements and harmonised standards conferring a presumption of conformity
赋予符合性推定的产品要求和协调标准
1. Where a product family, or one or more product categories within a product family, is covered either by a performance harmonised standard or by an implementing act referred to in Article 6(1), the Commission is empowered to adopt delegated acts in accordance with Article 89 to supplement this Regulation, by establishing product requirements in accordance with Annex III for that product family or product category, or for parts thereof.
1. 当某一产品系列或该产品系列内的一个或多个产品类别被性能协调标准或第 6 条第 1 款所指的实施法案涵盖时,委员会有权根据第 89 条通过授权法案补充本条例,依据附件 III 为该产品系列或产品类别或其部分制定产品要求。
2. Prior to their placing on the market, products covered by this Regulation shall satisfy the applicable product requirements.
2. 根据本条例涵盖的产品在投放市场前,应满足适用的产品要求。
3. The Commission may, in accordance with Article 10(1) of Regulation (EU) No 1025/2012, request one or more European standardisation organisations to draft harmonised standards conferring the presumption of conformity (‘voluntary harmonised standards’) for the product requirements established by delegated acts referred to in paragraph 1 of this Article.
3. 委员会可根据(欧盟)第 1025/2012 号条例第 10 条第 1 款,要求一个或多个欧洲标准化组织起草赋予符合性推定的协调标准(“自愿协调标准”),以满足第 1 款所述授权法案制定的产品要求。
4. Where a voluntary harmonised standard requested in accordance with paragraph 3 is adopted by a European standardisation organisation and proposed to the Commission for the purpose of publishing its reference in the Official Journal of the European Union, the Commission shall assess the voluntary harmonised standard in accordance with Regulation (EU) No 1025/2012.
4. 当根据第 3 款请求的自愿协调标准被欧洲标准化组织采纳并提议委员会将其参考文献刊登于《欧盟官方公报》时,委员会应根据《欧盟条例》第 1025/2012 号对该自愿协调标准进行评估。
5. Where a voluntary harmonised standard is in conformity with the applicable legal requirements and satisfies the requirements in relation to the product requirements set out in the standardisation request, the Commission shall without delay publish the reference of that standard in the Official Journal of the European Union.
5. 当自愿协调标准符合适用的法律要求并满足标准化请求中规定的产品要求时,委员会应立即在《欧盟官方公报》上发布该标准的参考文献。
6. Where the reference of a voluntary harmonised standard cannot be published in the Official Journal of the European Union, the Commission may publish such a reference with restrictions. Where a reference of a voluntary harmonised standard cannot be published in the Official Journal of the European Union and cannot be published as a reference with restrictions, the Commission shall bring the issue to the attention of the committee referred to in Article 22 of Regulation (EU) No 1025/2012 and of the CPR Acquis Expert Group.
6. 当自愿协调标准的参考文献无法在《欧盟官方公报》上发布时,委员会可以有限制地发布该参考文献。若自愿协调标准的参考文献既无法在《欧盟官方公报》上发布,也无法作为有限制的参考文献发布,委员会应将该问题提交给《欧盟条例》第 1025/2012 号第 22 条所指的委员会及 CPR 法规专家组关注。
7. A product subject to product requirements which is in conformity with voluntary harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the product requirements covered by those standards or parts thereof.
7. 受产品要求约束且符合已在《欧盟官方公报》上发布参考文献的自愿协调标准或其部分内容的产品,应被推定符合该标准或其部分内容所涵盖的产品要求。
8. The Commission is empowered to adopt delegated acts in accordance with Article 89 to amend Annex III in order to adapt it to technical progress and to cover new risks and environmental aspects and to comply with the priorities established in Article 4, based on the regulatory needs of the Member States.
8. 委员会有权根据第 89 条通过授权法案修改附录 III,以使其适应技术进步,涵盖新的风险和环境方面,并根据成员国的监管需求,遵守第 4 条确立的优先事项。
Article 8 第 8 条
Common specifications conferring a presumption of conformity
赋予符合性推定的共同规范
1. The Commission may adopt implementing acts establishing common specifications that provide an alternative means to comply with the product requirements established in accordance with Article 7(1).
1. 委员会可通过实施法案制定共同规范,作为符合第 7 条第 1 款规定的产品要求的替代方式。
Those implementing acts shall be adopted only where the following conditions are fulfilled:
仅当满足以下条件时,方可通过实施法案:
|
(a) |
the Commission has requested, pursuant to Article 7(3), one or more European standardisation organisations to draft a voluntary harmonised standard for the product requirements and:
|
|
(b) |
no reference of voluntary harmonised standards covering the product requirements has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable period. |
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 90(3).
这些实施法令应按照第 90 条第 3 款所述的审查程序予以采纳。
2. Before preparing a draft implementing act referred to in paragraph 1 of this Article, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in paragraph 1 of this Article have been fulfilled.
2. 在准备本条第 1 款所述的拟议实施法案之前,委员会应通知欧盟条例(EU)第 1025/2012 号第 22 条所述的委员会,表明其认为本条第 1 款中的条件已得到满足。
3. When preparing the draft implementing act referred to in paragraph 1 of this Article, the Commission shall take into account the views of the relevant bodies and of the CPR Acquis Expert Group and shall duly consult all relevant stakeholder organisations receiving Union financing under Regulation (EU) No 1025/2012.
3. 在准备本条第 1 款所述的拟议实施法案时,委员会应考虑相关机构和 CPR 法规专家组的意见,并应适当咨询根据欧盟条例(EU)第 1025/2012 号获得欧盟资助的所有相关利益相关者组织。
4. A product which is in conformity with the common specifications established by implementing acts referred to in paragraph 1 of this Article, or parts thereof, shall be presumed to be in conformity with the product requirements established by delegated acts referred to in Article 7(1) covered by those common specifications or parts thereof.
4. 符合本条第 1 款所述实施法令所确立的共同规范或其部分内容的产品,应被推定为符合第 7 条第 1 款所述授权法令所确立的、涵盖该共同规范或其部分内容的产品要求。
5. The Commission shall repeal the implementing acts referred to in paragraph 1 of this Article, or parts thereof which cover the same product requirements as those covered by a voluntary harmonised standard the reference of which is published in the Official Journal of the European Union in accordance with Article 7(5) or (6).
5. 对于与根据第 7 条第 5 款或第 6 款在《欧盟官方公报》上公布参考文献的自愿协调标准涵盖的相同产品要求相同的,本条第 1 款所述的实施法令或其部分内容,委员会应予以废止。
6. When a Member State or the European Parliament considers that a common specification does not entirely satisfy the product requirements established by delegated acts referred to in Article 7(1), it shall inform the Commission thereof, by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend the implementing act establishing the common specification in question.
6. 当成员国或欧洲议会认为某项共同规范未能完全满足第 7 条第 1 款所述授权法令确立的产品要求时,应向委员会通报,并提交详细说明。委员会应对该详细说明进行评估,并可在适当情况下修订确立该共同规范的实施法令。
Article 9 第 9 条
General product information, instructions for use and safety information
一般产品信息、使用说明及安全信息
1. General product information, instructions for use and safety information shall be provided in relation to construction products covered by a harmonised technical specification or a European technical assessment. The content of the general product information, instructions for use and safety information is set out in Annex IV.
1. 关于受协调技术规范或欧洲技术评估涵盖的建筑产品,应提供一般产品信息、使用说明及安全信息。一般产品信息、使用说明及安全信息的内容载于附件 IV。
2. As part of the standardisation request referred to in Article 5(2), the Commission may also request the European standardisation organisation to issue guidelines, including technical details, necessary for drawing up general product information, instructions for use and safety information in accordance with Annex IV.
2. 作为第 5 条第 2 款所述标准化请求的一部分,委员会还可要求欧洲标准化组织发布指南,包括制定符合附件 IV 的一般产品信息、使用说明及安全信息所需的技术细节。
3. If the Commission considers that the guidelines issued by the European standardisation organisation pursuant to paragraph 2 of this Article for a specific product family or product category do not ensure adequate and homogeneous implementation of paragraph 1 of this Article, the Commission is empowered to adopt delegated acts in accordance with Article 89 to supplement this Regulation by establishing rules on the provision of general product information, instructions for use and safety information for the respective product family or product category.
3. 如果委员会认为欧洲标准化组织根据本条第 2 款发布的针对特定产品系列或产品类别的指南未能确保本条第 1 款的充分且统一的实施,委员会有权根据第 89 条通过授权法案补充本条例,制定关于相应产品系列或产品类别的一般产品信息、使用说明和安全信息的提供规则。
4. The Commission is empowered to adopt delegated acts in accordance with Article 89 to amend Annex IV in order to adapt it to technical progress and new information needs.
4. 委员会有权根据第 89 条通过授权法案修改附件 IV,以使其适应技术进步和新的信息需求。
Article 10 第 10 条
Assessment and verification systems
评估和验证体系
1. The assessment and verification of a product’s performance in relation to its essential characteristics, as set out in harmonised technical specifications adopted in accordance with Articles 5 and 6 or in European assessment documents referred to in Article 31, or of the product’s conformity with product requirements adopted in accordance with Article 7, shall be carried out in accordance with one or more of the systems set out in Annex IX.
1. 根据第 5 条和第 6 条通过的协调技术规范或第 31 条提及的欧洲评估文件中规定的基本特性,对产品性能的评估和验证,或根据第 7 条通过的产品要求对产品合规性的评估和验证,应按照附录 IX 中列明的一种或多种体系进行。
2. The Commission is empowered to adopt delegated acts in accordance with Article 89 to supplement this Regulation, by determining, for each product family or product category, the applicable assessment and verification system among those referred to in Annex IX. Those delegated acts may determine different assessment and verification systems within the same product family or product category, differentiating by essential characteristic or product requirement. The assessment and verification systems shall be determined before the harmonised technical specifications or European assessment documents become applicable.
2. 委员会有权根据第 89 条通过授权法案,补充本条例,确定每个产品系列或产品类别适用的附录 IX 中所述的评估和验证体系。该等授权法案可在同一产品系列或产品类别内,根据基本特性或产品要求,确定不同的评估和验证体系。评估和验证体系应在协调技术规范或欧洲评估文件生效前确定。
3. The delegated acts adopted in accordance with paragraph 2 shall take into account the intended uses, the potential damage resulting from product deficiencies, the product’s sensitivity to performance variations under production conditions, the likelihood of errors during its manufacturing and the possibility of easily detecting manufacturing errors. Those delegated acts shall be tailored to the respective product families or product categories and shall minimise the burden on manufacturers, whilst ensuring a high level of protection of health and safety of persons and of the environment.
3. 根据第 2 款通过的授权法案应考虑预期用途、产品缺陷可能造成的损害、产品在生产条件下对性能变化的敏感性、制造过程中发生错误的可能性以及制造错误的易于检测性。该等授权法案应针对各自的产品系列或产品类别进行定制,最大限度地减轻制造商的负担,同时确保对人员健康与安全及环境的高度保护。
4. The Commission is empowered to adopt delegated acts in accordance with Article 89 in order to amend Annex IX to:
4. 委员会有权根据第 89 条通过授权法案,以修订附件 IX:
|
(a) |
introduce additional assessment and verification systems when necessary to adapt to technical progress; or |
|
(b) |
amend the existing assessment and verification systems to counter systematic non-compliance by notified bodies or manufacturers and to harmonise the application of the requirements or obligations contained in them, without such amendments adding or removing any task defined in a system. |
When adopting delegated acts under point (a), the Commission may not introduce additional systems that set more demanding obligations for economic operators than those provided for in System 1+. In addition, the Commission may introduce such additional systems only when it is evident that guidance on the application of existing systems has proved to be insufficient.
在根据第(a)点采纳授权法案时,委员会不得引入对经济运营者设定比系统 1+规定更严格义务的额外系统。此外,只有在明显现有系统的应用指导被证明不足时,委员会才可引入此类额外系统。
Article 11 第 11 条
Harmonised zone and national measures
统一区域和国家措施
1. This Regulation, and the harmonised technical specifications adopted in accordance with it, together, establish a ‘harmonised zone’.
1. 本条例及根据其采纳的统一技术规范,共同构成“统一区域”。
The harmonised zone covers all products subject to harmonised technical specifications.
统一区域涵盖所有受统一技术规范约束的产品。
Harmonised technical specifications shall be presumed to be comprehensive, in the following respects:
统一技术规范应被推定为在以下方面是全面的:
|
(a) |
laying down all essential characteristics and their assessment methods; |
|
(b) |
specifying all product requirements other than those covered by other Union law; and |
|
(c) |
determining the applicable assessment and verification systems. |
Harmonised technical specifications for new products shall apply to used products from third countries unless the harmonised technical specification explicitly provides rules for used products.
除非协调技术规范明确规定了二手产品的规则,否则新产品的协调技术规范应适用于来自第三国的二手产品。
2. Member States shall respect the harmonised zone in their national laws, regulations and administrative measures, and shall neither prohibit nor impede the making available on the market of products covered by it when those products are in compliance with this Regulation. Member States shall not lay down essential characteristics and their assessment methods or product requirements other than those set out in the harmonised technical specifications.
2. 成员国应在其国家法律、法规和行政措施中尊重协调区,并且当产品符合本条例时,不得禁止或阻碍该协调区涵盖的产品在市场上的供应。成员国不得制定除协调技术规范中规定的以外的基本特性及其评估方法或产品要求。
The harmonised zone does not affect the right of Member States to specify national requirements for the use of products that are subject to harmonised technical specifications. Any assessment methods and systems for assessment and verification set out in such national requirements shall be in accordance with the applicable harmonised technical specifications.
协调区不影响成员国为使用受协调技术规范约束的产品规定国家要求的权利。此类国家要求中规定的任何评估方法及评估和验证体系应符合适用的协调技术规范。
Member States shall ensure that the making available on the market of products within the harmonised zone which are in compliance with this Regulation shall not be impeded by rules or conditions imposed by public bodies or by private bodies acting as a public undertaking or private bodies acting as a public body on the basis of a monopoly position or under a public mandate.
成员国应确保,符合本条例的协调区内产品在市场上的供应不受公共机构或以垄断地位或公共授权为基础行使公共职能的私人机构所施加的规则或条件的阻碍。
3. When complying with the obligations provided for in paragraph 2, Member States shall in particular apply the following rules:
3. 在履行第 2 款规定的义务时,成员国应特别适用以下规则:
|
(a) |
no requirements for information or registration related to the placing on the market of the product other than those laid down in the harmonised zone shall be established; |
|
(b) |
no assessments of the product other than those set out in the harmonised zone shall be made mandatory; |
|
(c) |
no markings attesting to conformity with requirements or declared performances in relation to essential characteristics covered by the harmonised zone shall be required other than the CE marking, and any existing provisions in national measures requiring such markings shall be withdrawn; |
|
(d) |
national laws, regulations and administrative measures shall respect the threshold levels established in accordance with Article 5(5); |
|
(e) |
national laws, regulations and administrative measures shall not be based on classes, sub-classes or additional classes other than those established in accordance with Article 5; |
|
(f) |
national laws, regulations and administrative measures shall not require more assessments and verifications than those established in accordance with Article 10(1). |
4. Member States shall register in the Single Digital Gateway established by Regulation (EU) 2018/1724 of the European Parliament and of the Council (25) all their national laws, regulations and administrative measures related to construction products on their territory covered by the harmonised zone.
4. 成员国应在欧洲议会和理事会第(EU)2018/1724 号条例(25)设立的单一数字门户中登记其境内涵盖协调区的所有与建筑产品相关的国家法律、法规和行政措施。
5. Where a Member State deems it necessary on imperative grounds of health and safety of persons or protection of the environment and in order to address immediate regulatory needs, to take measures applicable to products within the harmonised zone in relation to characteristics not laid down in harmonised technical specifications, it shall notify the Commission thereof, justifying the need for the measures taken and explaining the regulatory need it aims to address.
5. 如果成员国基于对人员健康和安全或环境保护的紧迫理由,且为应对紧急监管需求,认为有必要对协调区内产品采取涉及协调技术规范未规定特性的措施,应将此情况通知委员会,说明采取该措施的必要性并解释其旨在解决的监管需求。
To that end, Member States shall use the procedure set up by Directive (EU) 2015/1535 of the European Parliament and of the Council (26). When doing so, Member States shall make reference to this paragraph and specify which elements are part of the measure.
为此,成员国应使用欧洲议会和理事会第(EU)2015/1535 号指令(26)设立的程序。在此过程中,成员国应提及本款内容,并具体说明措施包含的要素。
The Commission shall reply to the notification within the time limits established in the procedure set up by Directive (EU) 2015/1535. The Commission shall within six months of the notification either put forward a proposal for authorisation in accordance with paragraph 6 of this Article or communicate its grounds for rejecting the national measure.
委员会应在《指令(欧盟)2015/1535》设定的程序时间限制内对通知作出回复。委员会应在收到通知后六个月内,依据本条第 6 款提出授权建议,或说明拒绝该国家措施的理由。
Upon receipt of a notification as referred to in the first subparagraph, the Commission shall, irrespective of whether it intends to authorise the measure, without delay submit the matter to the CPR Acquis Expert Group for consultations on whether updates to existing performance harmonised standards need to be requested as a priority.
收到第一款所述通知后,委员会无论是否打算授权该措施,应立即将该事项提交给 CPR 法规专家组,协商是否需要优先请求更新现有的性能协调标准。
6. The Commission shall adopt an implementing act, authorising the national measure notified under paragraph 5 where:
6. 委员会应当通过实施条例,授权根据第 5 款通报的国家措施,条件如下:
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(a) |
the notified measure appears duly justified in the light of imperative grounds of health and safety of persons or protection of the environment, including the climate; |
|
(b) |
the regulatory need is not covered by harmonised technical specifications or by other Union law; |
|
(c) |
the notified measure does not discriminate against economic operators of other Member States; |
|
(d) |
the notified measure is able to cover the respective regulatory need; |
|
(e) |
the notified measure does not constitute a serious obstacle to the functioning of the internal market; and |
|
(f) |
the notified measure is not expected to be covered by a harmonised standard which is to be delivered within one year from the date of the notification referred to in paragraph 5 of this Article, following a standardisation request issued pursuant to Article 5(2), or, at the moment of that notification, no implementing act referred to in Article 6(1) has been presented to the committee referred to in Article 90(1). |
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 90(3). They shall be withdrawn once the regulatory need is covered by harmonised technical specifications or by other Union law.
这些实施法案应按照第 90 条第 3 款所述的审查程序通过。一旦通过统一技术规范或其他欧盟法律涵盖了监管需求,应予以撤销。
On duly justified imperative grounds of urgency relating to health and safety of persons or the protection of the environment, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 90(4).
基于与人员健康安全或环境保护相关的正当紧急理由,委员会应根据第 90 条第 4 款所述程序,立即通过具有直接适用性的实施法案。
7. This Regulation does not affect the possibility for Member States to introduce mandatory deposit-refund systems or to oblige manufacturers to accept to regain, directly or via their importers and distributors, ownership of their new, surplus or unsold non-custom-made products that are in a state equivalent to that in which they were placed on the market, provided that the measure does not directly or indirectly discriminate against economic operators in other Member States.
7. 本条例不影响成员国引入强制性押金返还制度的可能性,或要求制造商直接或通过其进口商和分销商接受回收其新的、过剩的或未售出的非定制产品所有权的权利,前提是该措施不直接或间接歧视其他成员国的经济运营者。
8. This Regulation does not affect the possibility for Member States to ban the destruction of surplus or unsold products, or to make their destruction conditional upon their previously having been made available on a national brokering platform for non-commercial use of products.
8. 本条例不影响成员国禁止销毁过剩或未售出产品的可能性,或将其销毁条件设定为必须先在国家非商业用途产品中介平台上提供。
Article 12 第 12 条
Relationship with other Union law
与其他欧盟法律的关系
1. To avoid double assessment of the same aspects of health and safety of persons or protection of the environment in respect of products, the Commission is empowered to adopt delegated acts in accordance with Article 89 to supplement this Regulation by laying down the conditions under which obligations relating to the assessment of a product’s performance or the fulfilment of certain product requirements, including the equivalence of assessment and verification systems required under this Regulation and obligations as regards general product information, instructions for use and safety information requirements, can be satisfied by the fulfilment of obligations provided for under other Union law.
1. 为避免对产品的人员健康安全或环境保护的相同方面进行重复评估,委员会有权根据第 89 条通过授权法案补充本条例,规定在何种条件下,通过履行其他欧盟法律规定的义务,可以满足与产品性能评估或某些产品要求的履行相关的义务,包括本条例要求的评估和验证体系的等效性义务,以及关于一般产品信息、使用说明和安全信息要求的义务。
The conditions referred to in the first subparagraph shall not allow for product safety levels which are less strict than those established in accordance with this Regulation.
第一款所述的条件不得允许产品安全水平低于根据本条例确定的标准。
2. Where conflicts arise between this Regulation and Regulation (EU) 2024/1781 as well as Regulation (EU) No 1025/2012, the relevant provisions of this Regulation shall prevail.
2. 若本条例与条例(欧盟)2024/1781 及条例(欧盟)第 1025/2012 号之间发生冲突,应以本条例的相关规定为准。
CHAPTER II 第二章
PROCEDURE, DECLARATIONS AND MARKINGS
程序、声明和标识
Article 13 第 13 条
Declaration of performance and conformity
性能和合格声明
1. Where a product is covered by a harmonised technical specification adopted in accordance with Articles 5 or 6, the manufacturer shall undergo the applicable assessment and verification system set out in Annex IX and draw up a declaration of performance and conformity before such a product is placed on the market. Where a product is covered by a harmonised technical specification adopted in accordance with Article 7, the manufacturer shall also verify the product’s compliance with applicable product requirements that have been specified by delegated acts. The manufacturer of a product which is not covered by any harmonised technical specification may issue a declaration of performance and conformity in accordance with the relevant European assessment document and European technical assessment.
1. 当产品受第 5 条或第 6 条所采纳的协调技术规范覆盖时,制造商应按照附件 IX 中规定的适用评估和验证体系进行,并在该产品投放市场前编制性能和合格声明。 当产品受第 7 条所采纳的协调技术规范覆盖时,制造商还应验证产品是否符合由授权法案规定的适用产品要求。 对于不受任何协调技术规范覆盖的产品制造商,可根据相关欧洲评估文件和欧洲技术评估发布性能和合格声明。
2. By drawing up the declaration of performance and conformity, the manufacturer assumes responsibility for the conformity of the product with its declared performance and any applicable product requirements, and becomes liable in accordance with Union and national laws on contractual and extra-contractual liability. In the absence of objective indications to the contrary, Member States shall presume the declaration of performance and conformity drawn up by the manufacturer to be accurate and reliable.
2. 制造商通过编制性能和合格声明,承担产品符合其声明性能及任何适用产品要求的责任,并根据欧盟和国家关于合同责任和非合同责任的法律承担责任。在没有客观相反迹象的情况下,成员国应推定制造商编制的性能和合格声明是准确且可靠的。
In the event of non-compliance, or in the absence of a declaration of performance and conformity when such a declaration is required, the product may not be made available on the market.
在不符合规定的情况下,或者在需要性能和合格声明时未提供该声明,产品不得投放市场。
Article 14 第 14 条
Exemptions from drawing up a declaration of performance and conformity
免于编制性能和合格声明
By way of derogation from Article 13(1), a manufacturer may decide not to undergo the applicable assessment and verification of the product’s compliance with applicable product requirements and not to draw up a declaration of performance and conformity when any of the following applies:
根据第 13 条第 1 款的例外规定,制造商可以决定不进行适用的产品符合性评估和验证,也不编制性能和合格声明,前提是符合以下任一情况:
|
(a) |
the product is individually manufactured or custom-made and fulfils all of the following conditions:
|
|
(b) |
the product is manufactured in a manner exclusively appropriate to heritage conservation and in a non-series process for adequately renovating construction works officially protected as part of a designated environment or because of their special architectural or historic merit, in compliance with the applicable national rules. |
Article 15 第 15 条
Content of the declaration of performance and conformity
性能和合格声明的内容
1. The declaration of performance and conformity shall be drawn up using the model set out in Annex V. The declaration of performance and conformity shall express the performance of products in relation to the essential characteristics of those products in accordance with the relevant harmonised technical specifications or European assessment document.
1. 性能和合格声明应使用附件 V 中规定的模型编制。性能和合格声明应根据相关的协调技术规范或欧洲评估文件,表达产品在其基本特性方面的性能。
Where product requirements specified in accordance with Article 7 are applicable, the declaration of performance and conformity shall state that the fulfilment of those requirements has been demonstrated.
当根据第 7 条规定的产品要求适用时,性能和合格声明应说明已证明满足这些要求。
2. The declaration of performance and conformity shall include the product’s environmental sustainability performance over its life cycle in respect of the predetermined environmental essential characteristics listed in Annex II for those characteristics that are declared. The performance shall include the packaging used or most likely to be used and shall be calculated using the latest version of software made available free of charge on the website of the Commission.
2. 性能和合格声明应包括产品在其生命周期内针对附件 II 中列出的预定环境基本特性(对于已声明的特性)的环境可持续性表现。该表现应包括所使用或最可能使用的包装,并应使用欧盟委员会网站上免费提供的最新版软件进行计算。
Updates of the software referred to in the first subparagraph shall become mandatory for the purposes of this Regulation one year after their publication. Such software updates may be voluntarily applied from their date of publication.
上述第一款所述软件的更新,自发布之日起一年后,成为本条例目的下的强制性要求。此类软件更新可自发布之日起自愿应用。
3. The declaration of performance and conformity shall cover at least a product’s performance over its life cycle with regard to the following essential characteristics:
3. 性能和合格声明应至少涵盖产品在其生命周期内关于以下基本特性的表现:
|
(a) |
essential characteristics listed in points (a) to (d) of Annex II, from 8 January 2026; |
|
(b) |
essential characteristics listed in points (e) to (m), of Annex II, from 9 January 2030; |
|
(c) |
essential characteristics listed in points (n) to (s), of Annex II, from 9 January 2032. |
The declaration of performance and conformity shall also cover those essential characteristics which always have to be declared, as determined in delegated acts adopted in accordance with Article 5(5).
性能和合格声明还应涵盖根据第 5 条第 5 款通过的授权法案确定的必须始终声明的那些基本特性。
4. No marking other than the CE marking may be placed on the declaration of performance and conformity.
4. 性能和合格声明上不得标注除 CE 标志以外的任何标记。
5. The Commission is empowered to adopt delegated acts in accordance with Article 89 to amend the model set out in Annex V to adapt it to reflect technical progress as regards new information needs, to facilitate the fulfilment of digital product passport requirements set out in Articles 76 and 77, and to ensure interoperability and correct integration with the construction digital product passport system in accordance with Article 75.
5. 委员会有权根据第 89 条通过授权法案修改附件 V 中规定的样本,以适应技术进步,满足新的信息需求,促进履行第 76 条和第 77 条规定的数字产品护照要求,并确保根据第 75 条与建筑数字产品护照系统的互操作性和正确整合。
6. The information referred to in Article 31 or, as the case may be, in Article 33 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (27) shall be provided together with the declaration of performance and conformity.
6. 应当随性能和合格声明一并提供欧洲议会和理事会第 1907/2006 号条例(27)第 31 条或(视情况而定)第 33 条所述的信息。
Article 16 第 16 条
Supply of the declaration of performance and conformity
性能和合格声明的提供
1. The manufacturer shall supply by electronic means a copy of the declaration of performance and conformity of each product which is made available on the market, unless the declaration is included in a digital product passport that fulfils the conditions set out in Article 76 and is available through the construction digital product passport system established in accordance with Article 75.
1. 制造商应通过电子方式提供每个投放市场产品的性能和合格声明副本,除非该声明包含在符合第 76 条规定条件的数字产品护照中,并且可通过根据第 75 条建立的建筑数字产品护照系统获得。
However, where a batch of the same product is supplied to a single user, it may be accompanied by a single copy of the declaration of performance and conformity.
但是,如果同一批次的产品供应给单一用户,则可附带一份性能和合格声明的副本。
2. By way of derogation from paragraph 1 of this Article, a manufacturer may make the declaration of performance and conformity referred to in Article 13(1) available on a website, provided that the manufacturer complies with all of the following conditions:
2. 根据本条第 1 款的例外规定,制造商可将第 13 条第 1 款所述的性能和合格声明放置于网站上,前提是制造商符合以下所有条件:
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(a) |
ensures that the content of the declaration of performance and conformity is made available in an unamendable electronic format on the website; |
|
(b) |
provides the declaration of performance and conformity in a human- and machine-readable format and offers the possibility to download a copy in a commonly readable format; |
|
(c) |
ensures that the website where the declaration of performance and conformity has been made available is monitored and maintained so that the website and the declarations of performance and conformity are continuously available to recipients of the construction product; |
|
(d) |
ensures that the recipients of construction products are able to access the declaration of performance and conformity free of charge; |
|
(e) |
provides instructions to the recipients of construction products on how to access the website and the declarations of performance and conformity drawn up for such products available on that website; |
|
(f) |
provides a link between the product and the declaration of performance and conformity related to it through the unique identification code of the product type; manufacturers may use a data carrier, including a permalink, to provide the link, provided that point (a) is complied with. |
3. As part of the standardisation request referred to in Article 5(2), the Commission may also request the European standardisation organisation to issue guidelines to ensure interoperability of the human- and machine readable formats referred to in paragraph 2, point (b) of this Article.
3. 作为第 5 条第 2 款所述标准化请求的一部分,委员会还可以要求欧洲标准化组织发布指南,以确保本条第 2 款第(b)点所述的人类可读和机器可读格式的互操作性。
4. The manufacturer shall supply or make available in a digital product passport in accordance with paragraph 1, or on a website in accordance with paragraph 2, the declaration of performance and conformity in the language or languages required by each of the Member States in which the manufacturer intends to make the product available. Another economic operator who makes that manufacturer’s product available in any additional Member State shall make a translation or translations of the declaration of performance and conformity available in the languages required by the additional Member State, together with the respective original version.
4. 制造商应根据第 1 款的规定,在数字产品护照中,或根据第 2 款的规定,在网站上,提供性能和合格声明,且该声明应使用制造商拟在其销售产品的各成员国要求的语言。任何其他经济运营者若在额外的成员国销售该制造商的产品,应提供性能和合格声明的翻译版本,使用该额外成员国要求的语言,并附上相应的原始版本。
Article 17 第 17 条
General principles and use of CE marking
CE 标志的一般原则及使用
1. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
1. CE 标志应遵守《条例(EC)第 765/2008 号》第 30 条规定的一般原则。
2. The CE marking shall be affixed only to those products for which the manufacturer has drawn up a declaration of performance and conformity in accordance with Articles 13 and 15. The CE marking shall be affixed to key parts.
2. 只有制造商根据第 13 条和第 15 条制定了性能和合格声明的产品,方可贴附 CE 标志。CE 标志应贴附于关键部件。
3. By affixing the CE marking to the product, or having it affixed, the economic operator indicates that it has assumed responsibility for the conformity of the product with the declared performance and applicable product requirements laid down in accordance with this Regulation. By affixing the CE marking, the economic operator becomes liable for the declared performance and the fulfilment of those requirements in accordance with national law on contractual and extra-contractual liability.
3. 通过在产品上加贴 CE 标志,或使其被加贴,经济运营者表明其已承担产品符合所声明性能及根据本条例规定的适用产品要求的责任。通过加贴 CE 标志,经济运营者根据国家合同及非合同责任法,对所声明的性能及这些要求的履行承担责任。
4. The CE marking shall be the only marking attesting to the performance of the product with regard to assessed essential characteristics in accordance with this Regulation, as well as to the conformity of the product with this Regulation.
4. CE 标志应当是唯一证明产品在本条例规定的评估基本特性方面性能,以及产品符合本条例的标志。
Article 18 第 18 条
Rules and conditions for the affixing of CE marking
CE 标志的粘贴规则和条件
1. The CE marking shall be affixed visibly, legibly and indelibly to the product. Where this is not possible or not warranted on account of the nature of the product, the CE marking shall be affixed to a label attached to the product or to the packaging or, where that is also not possible, to the accompanying documents.
1. CE 标志应当明显、清晰且不可擦除地粘贴在产品上。如因产品性质原因无法或不适宜粘贴,则应粘贴在附着于产品或包装的标签上;如仍无法粘贴,则应粘贴在随附文件上。
2. The CE marking shall be followed by:
2. CE 标志后应跟随:
|
(a) |
the last two digits of the year in which the CE marking was first affixed; or, in the case of used products, the last two digits of the year when the product was deinstalled followed by the last two digits of the year in which the CE marking was affixed to the used product; |
|
(b) |
the name and the registered address, or the identifying mark allowing easy and unambiguous identification of the name and address, of the manufacturer; |
|
(c) |
the name and the registered address of the authorised representative, or the identifying mark allowing easy and unambiguous identification of the name and address of the authorised representative where the manufacturer does not have a place of business in the Union or where the manufacturer chooses to have an authorised representative; |
|
(d) |
the unique identification code of the product-type; |
|
(e) |
the declaration code of the declaration of performance and conformity; |
|
(f) |
the identification number of the notified body or bodies verifying the product type and assessing the factory production control, if applicable; and |
|
(g) (g) |
a data carrier connected to the digital product passport referred to in Article 76 if such a digital product passport is available through the construction digital product passport system established pursuant to Article 75. |
The information listed in points (d) and (e) of the first subparagraph of this paragraph may be replaced by a data carrier, including permalink connected to the declaration of performance and conformity pursuant to Article 16(2), point (e), if the declaration of performance and conformity is available on a website. The information listed in points (d) and (e) of the first subparagraph of this paragraph may be omitted if a data carrier referred to in point (g) of the first subparagraph of this paragraph is provided.
本款第一段中第(d)和(e)点所列信息可由数据载体替代,包括连接至根据第 16 条第 2 款(e)点的性能和合格声明的永久链接,前提是性能和合格声明可在网站上获得。如果提供了本款第一段第(g)点所述的数据载体,则可省略本款第一段第(d)和(e)点所列信息。
3. The CE marking shall be affixed before the product is placed on the market. It may be followed by a pictogram or any other mark indicating a special risk or use.
3. CE 标志应在产品投放市场前贴附。其后可附加表示特殊风险或用途的图标或其他标记。
Article 19 第 19 条
Other markings and performance claims
其他标识和性能声明
1. Markings other than the CE marking, including private ones, may be affixed to a product only if they do not indicate that the product’s performance in relation to essential characteristics covered by applicable harmonised technical specifications had to be assessed in a way different from that laid down by this Regulation.
1. 除 CE 标志外的其他标识,包括私人标识,仅可贴附于产品上,前提是这些标识不表明产品在适用的协调技术规范涵盖的基本特性方面的性能必须以本条例规定的不同方式进行评估。
Officially recognised EN ISO 14024 type I ecolabels may be affixed to a product if they fulfil the requirement in the first subparagraph.
经官方认可的 EN ISO 14024 型 I 生态标签,如符合第一款的要求,可贴附于产品上。
2. Markings allowed in accordance with paragraph 1 and other markings set out by Union legislation may be affixed to a product provided that they do not impair the visibility, legibility and meaning of the CE marking.
2. 根据第 1 款允许的标识及欧盟立法规定的其他标识,可贴附于产品上,前提是它们不妨碍 CE 标志的可见性、清晰度和含义。
3. Where a product is covered by a harmonised technical specification, a claim made by an economic operator about the product’s performance, which concerns an essential characteristic covered by that harmonised technical specification, shall comply with the assessment method for that particular essential characteristic as laid down in the harmonised technical specifications.
3. 当产品受统一技术规范覆盖时,经济运营者对该产品性能所作的声明,若涉及该统一技术规范涵盖的基本特性,应符合该统一技术规范中规定的该基本特性的评估方法。
4. Where a product is covered by harmonised technical specifications, claims about its performance in relation to the essential characteristics laid down in those harmonised technical specifications may be additionally provided in a place other than in the declaration of performance and conformity only if they are already provided in the declaration of performance and conformity.
4. 当产品符合统一技术规范时,关于其与该统一技术规范中规定的基本特性相关的性能声明,只有在性能和合格声明中已有提供的情况下,才可额外在性能和合格声明以外的其他地方提供。
The first subparagraph shall not apply to situations where, in accordance with Article 14, no declaration of performance and conformity has been drawn up.
第一款不适用于根据第 14 条未编制性能和合格声明的情况。
CHAPTER III 第三章
OBLIGATIONS AND RIGHTS OF ECONOMIC OPERATORS
经济运营者的义务和权利
Article 20 第 20 条
Obligations of all economic operators
所有经济运营者的义务
1. The obligations of economic operators under this Chapter are applicable only in relation to products covered by a harmonised technical specification, or to products that have been CE-marked on the basis of a European technical assessment.
1. 本章规定的经济经营者义务仅适用于涵盖在协调技术规范内的产品,或基于欧洲技术评估已加贴 CE 标志的产品。
2. An economic operator shall take all necessary measures to ensure continued compliance with this Regulation. Where non-compliance of the economic operator or of a product has been stated and corrective action has been requested by a market surveillance authority in accordance with Article 65(1), the economic operator shall submit progress reports to that authority until that authority decides that the corrective action can be closed.
2. 经济经营者应采取一切必要措施,确保持续符合本条例的要求。若市场监管机构根据第 65 条第 1 款确认经济经营者或产品存在不合规情况并要求采取纠正措施,经济经营者应向该机构提交进展报告,直至该机构决定纠正措施可以结束。
3. An economic operator shall, on request of a competent national authority, identify to that authority any economic operator or other actor:
3. 经济经营者应根据主管国家当局的要求,向该当局识别任何经济经营者或其他行为者:
|
(a) |
who has supplied that economic operator with a product, including components or spare parts of products, and the quantity of that supply, or who has supplied it with a service covered by this Regulation; |
|
(b) |
to whom that economic operator has supplied a product, including components or spare parts of products, and the quantity of that supply, or to whom it has supplied a service covered by this Regulation. |
When identifying the economic operators or other actors referred to in the first subparagraph, an economic operator shall inform the competent national authority of, at least, the following:
在识别第一款所述的经济运营者或其他行为者时,经济运营者应至少向主管国家当局提供以下信息:
|
(a) |
the contact details, including addresses and email addresses of those economic operators or actors; |
|
(b) |
the tax and company registration numbers of those economic operators or actors. |
4. An economic operator shall keep all documents and all information referred to in this Chapter at the disposal of competent national authorities for a period of 10 years after the economic operator supplied or was supplied with the product or service in question, unless the documents or the information have been made available through the digital product passport referred to in Article 76. An economic operator shall present the documentation and information within 10 days of receipt of a request by a competent national authority.
4. 经济运营者应将本章所述的所有文件和所有信息保存,并在经济运营者供应或被供应相关产品或服务后 10 年内,向主管国家当局提供,除非这些文件或信息已通过第 76 条所述的数字产品护照提供。经济运营者应在收到主管国家当局请求后的 10 天内提交相关文件和信息。
5. An economic operator may register itself in its respective national system established in accordance with Article 71(5).
5. 经济运营者可在根据第 71 条第 5 款设立的各自国家系统中进行注册。
An economic operator shall make available to consumers and users communication channels, including telephone numbers, email addresses or dedicated sections of its website, allowing them to communicate any accident, other incident or safety issue they have experienced with the product.
经济运营者应向消费者和用户提供沟通渠道,包括电话号码、电子邮件地址或其网站的专门栏目,使其能够报告他们在使用产品过程中遇到的任何事故、其他事件或安全问题。
6. Where an economic operator considers that a non-conforming product presents a risk to health and safety of persons or to the environment, it shall immediately inform thereof the competent national authorities of the Member States in which it made the product available, giving details, in particular, of the non-compliance and of any corrective measures taken. An economic operator may inform the competent national authorities of any other likely infringement of this Regulation of which it becomes aware, of the non-compliance and of any corrective measures taken.
6. 当经济运营者认为不合格产品对人员健康安全或环境构成风险时,应立即将该情况通知其将产品投放市场的成员国主管国家当局,特别说明不合格情况及所采取的任何纠正措施。经济运营者也可将其知悉的本条例的任何其他可能违规行为、不合格情况及所采取的纠正措施通知主管国家当局。
7. An economic operator shall be liable for infringements of this Article or of the Articles in this Chapter related to its activities, in accordance with national law on contractual and extra-contractual liability.
7. 经济经营者应根据国家关于合同责任和非合同责任的法律,对其活动相关的本条款或本章条款的违反行为承担责任。
Article 21 第 21 条
Rights of manufacturers 制造商的权利
1. A manufacturer shall have the right to request from its suppliers and service providers the information necessary in relation to their products to fulfil its obligations under this Regulation.
1. 制造商有权向其供应商和服务提供者请求与其产品相关的必要信息,以履行本条例规定的义务。
2. If the manufacturer is subject to third-party tasks carried out by a notified body, the manufacturer shall have the right to request from its suppliers or service providers that they permit that notified body to have access to their documentation and to their premises to the extent that the notified body requires such access in order to carry out its tasks.
2. 如果制造商需接受由公告机构执行的第三方任务,制造商有权要求其供应商或服务提供者允许该公告机构在其执行任务所需范围内,访问其文件和场所。
3. The rights established in paragraph 1 also apply to a manufacturer placing a used or remanufactured product on the market in relation to the supplier of the used product, including the deinstaller where applicable. The information required may include, but is not limited to, information about the previous use of the product and about the process of deinstalling it.
3. 第 1 款规定的权利同样适用于制造商在将二手或再制造产品投放市场时,针对二手产品的供应商,包括适用时的拆卸者。所需信息可能包括但不限于有关产品先前使用情况及拆卸过程的信息。
4. A manufacturer shall have the right to request from its suppliers and service providers the data and calculations required under Article 15(2) in relation to the supplies or services provided, including the necessary validation reports issued by a notified body.
4. 制造商有权向其供应商和服务提供者请求与所提供的供应或服务相关的第 15 条第 2 款所要求的数据和计算,包括由公告机构出具的必要验证报告。
Article 22 第 22 条
Obligations of manufacturers
制造商的义务
1. When placing a product on the market, the manufacturer shall determine the product type, respecting the boundaries set up therefor by the definition provided in Article 3, point (27). The manufacturer shall ensure that the product’s performance is assessed in relation to both mandatory essential characteristics and those essential characteristics intended to be declared. If the product is covered by product requirements established by delegated acts referred to in Article 7(1), the manufacturer shall ensure that the product has also been designed and constructed in accordance with those requirements.
1. 制造商在将产品投放市场时,应确定产品类型,遵守第 3 条第(27)点所提供定义中设定的界限。制造商应确保产品的性能既符合强制性基本特性,也符合拟声明的基本特性。如果产品受第 7 条第(1)款所指的授权法案中规定的产品要求的约束,制造商还应确保产品的设计和制造符合这些要求。
A natural or legal person that manufactures a product using 3-D printing shall satisfy the obligations incumbent on manufacturers when placing it on the market. The obligations shall include, but are not limited to, the use of appropriate 3-D datasets, the use of materials compliant with the applicable procedures under this Regulation, and the verification of the compatibility of 3-D datasets, printing material and the printing technology used.
使用 3D 打印制造产品的自然人或法人在将产品投放市场时,应履行制造商应承担的义务。该义务包括但不限于使用适当的 3D 数据集、使用符合本条例适用程序的材料,以及验证 3D 数据集、打印材料和所用打印技术的兼容性。
2. Where a product’s compliance with applicable requirements and its performance in relation to essential characteristics referred to in paragraph 1 of this Article have been demonstrated in accordance with the applicable assessment and verification system or systems set out in Annex IX, the manufacturer shall draw up a declaration of performance and conformity in accordance with Articles 13 to 15, affix the CE marking in accordance with Articles 17 and 18 and, when applicable, ensure the availability of spare parts not commonly available in the market, as referred to in paragraph 8 of this Article, and affix the labelling pursuant to paragraph 9 of this Article.
2. 当产品已根据附件 IX 中规定的适用评估和验证体系,证明符合适用要求及本条第 1 款所述基本特性的性能时,制造商应按照第 13 至 15 条制定性能和合格声明,按照第 17 和 18 条贴附 CE 标志,并在适用情况下,确保本条第 8 款所述市场上不常见的备件的供应,并按照本条第 9 款贴附标签。
3. The manufacturer shall, as the basis for the declaration of performance and conformity, draw up a technical documentation in which he shall indicate:
3. 制造商应作为性能和合格声明的依据,编制技术文件,其中应注明:
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(a) |
the declared use, which shall fall within the scope of the applicable intended use; |
|
(b) |
all the relevant elements necessary to demonstrate performance and conformity; |
|
(c) |
information on the procedures in place referred to in paragraph 4 of this Article; |
|
(d) |
information on the applicable system or systems set out in Annex IX; |
|
(e) |
where relevant, information on the application of simplified procedures applied in accordance with Articles 59 to 61; and |
|
(f) |
the calculation of the performance of environmental sustainability in respect of essential characteristics as referred to in Article 15(2). |
4. The manufacturer shall ensure that procedures are in place to ensure that products fulfil their declared performance and remain in conformity with this Regulation. Product design, including 3-D datasets, production processes and material used shall be appropriate. Where the product is manufactured in series production, the manufacturer shall ensure that procedures are in place to ensure that it maintains its declared performance and remains in conformity with this Regulation. Changes in the product design, including 3-D datasets, production process and material used shall be appropriate. Changes in the applicable harmonised technical specifications shall be adequately taken into account and, where the performance or conformity of the product is affected, shall trigger a re-assessment in accordance with the relevant assessment procedure.
4. 生产者应确保建立程序,以保证产品达到其声明的性能并持续符合本条例的要求。产品设计,包括三维数据集、生产工艺和所用材料,应当适当。对于批量生产的产品,生产者应确保建立程序,以保证产品维持其声明的性能并持续符合本条例的要求。产品设计的变更,包括三维数据集、生产工艺和所用材料的变更,应当适当。应充分考虑适用的协调技术规范的变更,且当产品的性能或合规性受到影响时,应根据相关评估程序触发重新评估。
The manufacturer shall, where deemed appropriate with regard to ensuring the accuracy, reliability and stability of the declared performance and of the conformity of a product, carry out sample testing of products placed or made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming products and product recalls, and shall keep importers and distributors informed thereof.
制造商应在确保所声明性能的准确性、可靠性和稳定性以及产品合格性方面认为适当时,对投放或提供于市场的产品进行抽样检测,进行调查,并在必要时建立投诉、不合格产品和产品召回的登记册,并应将相关情况通知进口商和分销商。
5. The manufacturer shall ensure that its products bear a manufacturer-specific unique identification code of the product type and, where available, a batch or serial number which is easily visible and legible for users. Where that is not possible on account of the nature of the product, the required information shall be provided on an affixed label, on the packaging or, where that is also not possible, in a document accompanying the product.
5. 制造商应确保其产品标有制造商特定的产品类型唯一识别代码,以及(如有)批次号或序列号,且该标识对用户来说易于识别和阅读。若因产品性质无法直接标注,应在附着的标签、包装上提供所需信息;若包装上也无法标注,则应在随产品附带的文件中提供该信息。
The manufacturer shall, in the same way as set out in the first subparagraph, label a product as ‘Only for professional use’ if expertise is needed in order to use it and shall display the label to customers before they are bound by a sales contract, including in the case of distance selling. Products not labelled ‘Only for professional use’ shall be deemed to also be intended for non-professional users and consumers within the meaning of this Regulation and of Regulation (EU) 2023/988.
制造商应按照第一款规定的相同方式,将产品标注为“仅限专业使用”,如果使用该产品需要专业知识,并应在客户受销售合同约束之前向其展示该标签,包括远程销售的情况。未标注“仅限专业使用”的产品,应视为也面向本条例及欧盟条例(EU)2023/988 所指的非专业用户和消费者。
The manufacturer shall display to customers, in a visible manner, before they are bound by a sales contract, including in the case of distance selling, the information which must be provided pursuant to this Regulation.
制造商应在客户受销售合同约束之前,以显著方式向其展示本条例规定必须提供的信息,包括远程销售的情况。
6. When making a product available on the market, the manufacturer shall ensure that it is accompanied by general product information, instructions for use and safety information, as set out in Annex IV in a language to be determined by the Member State concerned or, in absence of such determination, in a language which can be easily understood by users.
6. 制造商在将产品投放市场时,应确保产品附有一般产品信息、使用说明和安全信息,如附件 IV 所述,语言由相关成员国确定;若无此类确定,则应使用用户易于理解的语言。
7. By 18 months after the entry into force of the delegated act referred to in Article 75(1) the manufacturer shall make available a digital product passport referred to in Article 76, through the construction digital product passport system referred to in Article 75, connected to a data carrier referred to in Article 18(2), point (g).
7. 在第 75 条第 1 款所述的授权法案生效后 18 个月内,制造商应通过第 75 条所述的建筑数字产品护照系统,提供第 76 条所述的数字产品护照,该系统应连接至第 18 条第 2 款(g)项所述的数据载体。
8. In order to ensure the availability of spare parts not commonly available on the market, the Commission is empowered to adopt delegated acts in accordance with Article 89 to supplement this Regulation, by imposing in respect of certain product families and product categories an obligation on manufacturers to make available on the market specific spare parts not commonly available for the products they place on the market.
8. 为确保市场上不常见的备件的可用性,委员会有权根据第 89 条通过授权法案补充本条例,规定制造商对其投放市场的某些产品系列和产品类别,必须提供市场上不常见的特定备件。
The obligation established by the delegated acts referred to in the first subparagraph of this paragraph shall apply for a period of 10 years after the last product of the respective type has been placed on the market, unless the delegated act sets a different period.
本款第一段所述的授权法案所确立的义务,应适用于相应类型的最后一件产品投放市场后 10 年内,除非授权法案另有规定期限。
Manufacturers subject to the obligation laid down in the first paragraph shall offer the spare parts within a reasonably short delivery period, at a reasonable and non-discriminatory price, and shall inform the public thereof.
受第一段规定义务约束的制造商应在合理短的交货期内提供备件,价格合理且不歧视,并应向公众通报此事。
9. In order to ensure transparency for users and to promote sustainable products, the Commission is empowered to adopt delegated acts in accordance with Article 89 to supplement this Regulation, by establishing specific environmental sustainability labelling requirements for particular product families and product categories when the following conditions are fulfilled:
9. 为确保用户的透明度并促进可持续产品,委员会有权根据第 89 条通过授权法案补充本条例,建立特定产品系列和产品类别的环境可持续性标签要求,前提是满足以下条件:
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(a) |
the product is typically chosen or purchased by consumers; and |
|
(b) |
the product does not have a significantly different overall environmental performance over its life cycle depending on its installation. |
The labelling shall be based on the performance of the product, as assessed in accordance with Article 5(1) or Article 6(1), and shall provide consumer-friendly information understandable by non-experts.
标签应基于根据第 5 条第 1 款或第 6 条第 1 款评估的产品性能,并应提供非专业人士易于理解的消费者友好信息。
10. The delegated acts referred to in paragraph 9 shall determine the way in which the manufacturer is to affix the label, by specifying the following:
10. 第 9 款提及的授权法案应确定制造商贴标签的方式,具体包括:
|
(a) |
the content of the label; |
|
(b) |
the layout of the label, taking into account its visibility and legibility; |
|
(c) |
the manner in which the label is to be displayed to customers, including in the case of distance selling; |
|
(d) |
where appropriate, the electronic means to be used for generating labels. |
11. A manufacturer who considers or has reason to believe that a product which it has placed on the market does not conform to its declared performance or does not comply with this Regulation shall immediately take the necessary corrective measures to bring that product into conformity or compliance, or, if appropriate, to withdraw or recall it. If the issue is linked to a supplied component or an externally provided service, the manufacturer shall inform the supplier or service provider and the manufacturer’s competent national authority.
11. 制造商如果认为或有理由相信其投放市场的产品不符合其声明的性能或不符合本条例,应立即采取必要的纠正措施,使该产品符合要求,或者在适当情况下,撤回或召回该产品。如果问题与所供应的组件或外部提供的服务有关,制造商应通知供应商或服务提供者及制造商所属的主管国家当局。
12. Where the product presents a risk, the manufacturer shall, without undue delay and at the latest within three working days, inform all the authorised representatives, importers, distributors, fulfilment service providers, and online market places involved in its distribution, as well as the competent national authorities of the Member States in which the manufacturer or, to its knowledge, other economic operators made the product available. The manufacturer shall, to that effect, provide all useful details and, in particular, specify the type of the non-compliance, the frequency of accidents or incidents, and the corrective measures taken or recommended. In the case of risks caused by products which have already reached an end user or consumer who cannot be identified or contacted directly, the manufacturer shall, through the media and other appropriate channels, ensuring the widest possible reach, disseminate information about appropriate measures to eliminate or, if not possible, to reduce the risks. Where there is a serious risk the manufacturer shall withdraw and recall the product at its own cost.
12. 当产品存在风险时,制造商应在不延误的情况下,且最迟在三个工作日内,通知所有参与其分销的授权代表、进口商、分销商、履约服务提供者和在线市场,以及制造商所在成员国或据其所知其他经济运营商将产品投放市场的成员国主管国家当局。为此,制造商应提供所有有用的细节,特别是说明不合规的类型、事故或事件的频率,以及已采取或建议的纠正措施。对于已到达无法直接识别或联系的最终用户或消费者的产品所引起的风险,制造商应通过媒体和其他适当渠道,确保信息传播范围尽可能广泛,发布有关消除风险或在无法消除时减少风险的适当措施的信息。若存在严重风险,制造商应自费撤回并召回产品。
Article 23 第 23 条
Obligations of authorised representatives
授权代表的义务
1. A manufacturer established in the Union may appoint, by a written mandate, any natural or legal person established within the Union as a single authorised representative. A manufacturer not established in the Union shall appoint a single authorised representative.
1. 在欧盟境内设立的制造商可通过书面授权委托任何在欧盟境内设立的自然人或法人作为唯一授权代表。未在欧盟境内设立的制造商应指定唯一授权代表。
The drawing up of technical documentation shall not form part of the authorised representative’s mandate.
编制技术文件不属于授权代表的授权范围。
2. The authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:
2. 授权代表应履行制造商所授予的授权任务。授权书应至少允许授权代表执行以下事项:
|
(a) |
keep the declaration of performance and conformity and the technical documentation at the disposal of competent national authorities; |
|
(b) |
further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a product with its declared performance and its compliance with other applicable requirements in this Regulation; |
|
(c) |
terminate the contract if the manufacturer has acted contrary to its obligations under this Regulation and inform the manufacturer, the competent national authorities of the Member States where the product is placed on the market and the competent national authority of his own place of business thereof; |
|
(d) |
when there is reason to believe that a product is non-compliant or presents a risk, inform the manufacturer and the competent national authorities of the Member States where the product is placed on the market and the competent national authority of the authorised representative thereof; and |
|
(e) |
cooperate with the competent national authorities, at their request, in any action taken to eliminate risks posed by, and to remedy non-conformities of, products covered by the mandate of the authorised representative. |
3. The authorised representative shall verify at documentary level that:
3. 授权代表应在文件层面核实:
|
(a) |
the product bears the CE marking, and the labelling in accordance with Article 22(9); |
|
(b) |
the product is accompanied by a declaration of performance and conformity, or that declaration is available in accordance with Article 16(1) or (2); and |
|
(c) |
the manufacturer has complied with the requirements set out in Article 22(5), (6) and (7). |
4. Where an authorised representative identifies a case of non-compliance mentioned in paragraph 3 of this Article, it shall ask the manufacturer to act in accordance with Article 22(11) and (12).
4. 授权代表如发现本条第 3 款所述的不合规情况,应要求制造商按照第 22 条第 11 款和第 12 款采取行动。
Article 24 第 24 条
Obligations of importers
进口商的义务
1. Importers shall place on the market only products which are compliant with this Regulation.
1. 进口商仅得投放符合本条例的产品。
2. Before placing a product on the market, the importer shall ensure that the product’s compliance with applicable requirements and its performance in relation to relevant essential characteristics have been demonstrated by the manufacturer in accordance with Article 22(1) and (2).
2. 在投放产品之前,进口商应确保制造商已根据第 22 条第 1 款和第 2 款证明产品符合适用要求及其相关基本特性的性能。
The importer shall ensure that:
进口商应确保:
|
(a) |
the manufacturer has drawn up the technical documentation referred to in Article 22(3); |
|
(b) |
the product bears the CE marking, and the labelling in accordance with Article 22(9); |
|
(c) |
the product is accompanied by the declaration of performance and conformity or that the declaration is available in accordance with Article 16(1) or (2); and |
|
(d) |
the manufacturer has complied with the requirements set out in Article 22(5), (6) and (7). |
3. The importer shall verify that the use of the product has been declared by the manufacturer, and shall ensure that the product is accompanied by general product information, instructions for use and safety information as set out in Annex IV in a language determined by the Member State concerned or, in absence of such determination, in a language which can be easily understood by users. The importer shall display to customers, in a visible manner, before they are bound by a sales contract, including in the case of distance selling, the information which must be provided pursuant to this Regulation or harmonised technical specifications.
3. 进口商应核实制造商已声明产品的用途,并应确保产品附有附件 IV 中规定的一般产品信息、使用说明和安全信息,所用语言由相关成员国确定,若无此类确定,则应使用用户易于理解的语言。进口商应在客户受销售合同约束之前(包括远程销售情况)以显著方式向客户展示根据本条例或协调技术规范必须提供的信息。
4. The importer shall ensure that, while a product is under its responsibility, the conditions of its storage or transport do not jeopardise its conformity with the declaration of performance and conformity, or its compliance with other applicable requirements in this Regulation.
4. 进口商应确保,在产品处于其责任范围内时,其储存或运输条件不会危及产品与性能声明和合格声明的一致性,或其符合本条例其他适用要求。
5. Where an importer considers, or has reason to believe, that a product is not in conformity with the declaration of performance and conformity, or not in compliance with other applicable requirements in this Regulation, the importer shall not place the product on the market until it conforms to the accompanying declaration of performance and conformity and it complies with the other applicable requirements of this Regulation, or until the declaration of performance and conformity is corrected. Furthermore, where the product presents a risk, the importer shall inform the manufacturer and the responsible competent national authority thereof.
5. 如果进口商认为或有理由相信某产品不符合性能和合格声明,或不符合本条例中的其他适用要求,进口商不得将该产品投放市场,直至其符合随附的性能和合格声明并符合本条例的其他适用要求,或直至性能和合格声明被更正。此外,如果该产品存在风险,进口商应将此情况通知制造商和负责的国家主管当局。
6. The importer shall indicate its name, registered trade name or registered trade mark, its place of business, its contact address and, where available, electronic means of communication, either on the product or, where that is not possible, on its packaging, or in a document accompanying the product.
6. 进口商应在产品上,或者在无法在产品上标明的情况下,在其包装上或随产品附带的文件中,标明其名称、注册商号或注册商标、营业地点、联系地址及(如有)电子通讯方式。
7. The importer shall investigate complaints, and, if necessary, keep a register of complaints, of non-conforming products and of product withdrawals or recalls, and shall keep manufacturers and distributors informed of any such monitoring.
7. 进口商应对投诉进行调查,并在必要时建立不合格产品及产品撤回或召回的投诉登记册,并应将任何此类监控情况通知制造商和分销商。
8. Importers who consider or have reason to believe that a product, which they have placed on the market, is not in conformity with its declared performance or not in compliance with other applicable requirements in this Regulation, shall immediately take the necessary corrective measures to bring that product into conformity, or, if appropriate, to withdraw or recall it. Furthermore, where the product poses a risk, importers shall immediately inform the competent national authorities of the Member States in which they made the product available on the market to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken.
8. 进口商如果认为或有理由相信其投放市场的产品不符合其声明的性能或不符合本条例的其他适用要求,应立即采取必要的纠正措施,使该产品符合要求,或者在适当情况下,撤回或召回该产品。此外,如果该产品存在风险,进口商应立即将此情况通知其在市场上投放该产品的成员国主管国家当局,特别说明不合格情况及所采取的任何纠正措施。
9. Importers selling to end users shall also fulfil the obligations incumbent on distributors.
9. 向最终用户销售的进口商还应履行分销商应承担的义务。
Article 25 第 25 条
Obligations of distributors
分销商的义务
1. When making products available on the market, distributors shall act with due care in relation to the obligations of this Regulation.
1. 经销商在将产品投放市场时,应当谨慎履行本条例规定的义务。
2. Before making a product available on the market, the distributor shall verify that:
2. 在将产品投放市场之前,经销商应当核实:
|
(a) |
the product bears the CE marking, and the labelling in accordance with Article 22(9), where required; |
|
(b) |
the product is accompanied, where required, by a declaration of performance and conformity, or that the declaration is available in accordance with Article 16(2); |
|
(c) |
the product is accompanied by general product information, instructions for use and safety information in accordance with Article 22(6), in a language which can be easily understood by end users in the Member State in which the product is to be made available on the market; |
|
(d) |
the manufacturer and the importer have complied with the requirements set out in Article 22(5) and (7) and Article 24(6) respectively. |
3. The distributor shall display to customers, in a visible manner, before they are bound by a sales contract, including in the case of distance selling, the information which must be provided pursuant to this Regulation.
3. 分销商应在客户受销售合同约束之前,以显著方式向其展示根据本条例必须提供的信息,包括远程销售的情况。
4. Where a distributor considers or has reason to believe that a product is not in conformity with its declared performance or not in compliance with other applicable requirements in this Regulation, the distributor shall not make the product available on the market until it conforms to its accompanying declaration of performance and conformity and it complies with the other applicable requirements in this Regulation. Furthermore, where the product presents a risk, the distributor shall inform the manufacturer and the responsible competent national authorities thereof.
4. 当分销商认为或有理由相信产品不符合其声明的性能或不符合本条例中的其他适用要求时,分销商不得将该产品投放市场,直到其符合随附的性能声明和合格声明,并符合本条例中的其他适用要求。此外,当产品存在风险时,分销商应将该情况通知制造商和负责的国家主管当局。
5. The distributor shall ensure that, while a product is under its responsibility, storage or transport conditions do not jeopardise the product’s conformity with its declared performance or its compliance with other applicable requirements in this Regulation.
5. 分销商应确保,在产品处于其责任范围内时,储存或运输条件不会危及产品符合其声明的性能或符合本条例中的其他适用要求。
6. A distributor who considers or has reason to believe that a product, which it has made available on the market, is not in conformity with its declared performance or not in compliance with other applicable requirements in this Regulation shall make sure that the necessary corrective measures to bring that product into conformity or, if appropriate, to withdraw or to recall it, are taken. Furthermore, where the product poses a risk, the distributor shall immediately inform the competent national authorities of the Member States in which it has made the product available on the market to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken.
6. 分销商如果认为或有理由相信其已投放市场的产品不符合其声明的性能或不符合本条例的其他适用要求,应确保采取必要的纠正措施,使该产品符合要求,或者在适当情况下,撤回或召回该产品。此外,如果该产品存在风险,分销商应立即将此情况通知其已投放产品市场的成员国主管国家当局,特别说明不合格情况及所采取的任何纠正措施。
Article 26 第 26 条
Cases in which obligations of manufacturers apply to importers and distributors
制造商义务适用于进口商和分销商的情况
1. An importer or distributor shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations of a manufacturer pursuant to Article 22, where:
1. 进口商或分销商在以下情况下,应被视为本条例意义上的制造商,并应根据第 22 条承担制造商的义务:
|
(a) |
it places a product on the market under its own name or trademark; |
|
(b) |
it modifies a product intentionally or the product is unintentionally modified in such a way that compliance with the declaration of performance and conformity, or with the requirements set out in or adopted in accordance with this Regulation may be affected; |
|
(c) |
it makes a product available on the market with a declared use that is different from the declared use attributed by the manufacturer in the process of assessment and verification; |
|
(d) |
it claims for the product characteristics deviating from the characteristics declared by the manufacturer; or |
|
(e) |
it opts to assume the role of the manufacturer. |
2. Paragraph 1 shall also apply to an economic operator who places on the market:
2. 第 1 款同样适用于将以下产品投放市场的经济运营者:
|
(a) |
a used product covered by a harmonised technical specification laying down provisions for used products; |
|
(b) |
a used product not covered by a harmonised technical specification with provisions for used products and not placed on the Union market before; |
|
(c) |
a remanufactured product. |
3. Paragraph 1 shall not apply where the economic operator only:
3. 第 1 款不适用于经济运营者仅:
|
(a) |
adds translations of information supplied by the manufacturer; |
|
(b) |
replaces the outer packaging of a product already placed on the market, including when changing the packaging size, if the repackaging is carried out in such a way that the original condition of the product cannot be affected by it, and that any information required by this Regulation is still correctly provided. |
4. An economic operator providing the activities listed in paragraph 3 shall inform thereof the manufacturer or its authorised representative, regardless of whether that economic operator owns the products or provides services. It shall carry out the repackaging in such a way that neither the original condition of the product nor its compliance with this Regulation is affected by the repackaging, and such that any information required by this Regulation is still correctly provided. The economic operator shall act with due care in relation to the obligations of this Regulation.
4. 提供第 3 段所列活动的经济运营者应将此情况告知制造商或其授权代表,无论该经济运营者是否拥有产品或提供服务。其应以不影响产品原始状态及其符合本条例的方式进行重新包装,并确保本条例要求的任何信息仍能正确提供。经济运营者应谨慎履行本条例规定的义务。
Article 27 第 27 条
Obligations of fulfilment service providers
履约服务提供者的义务
1. When contributing to the making available on the market of a product, fulfilment service providers shall act with due care in relation to the obligations of this Regulation.
1. 当协助将产品投放市场时,履约服务提供者应当就本条例的义务谨慎行事。
2. A fulfilment service provider shall make sure that the labelling and documents provided by the manufacturer or importer are available or accompany the product, and in particular:
2. 履约服务提供者应确保制造商或进口商提供的标签和文件随产品提供或附带,特别是:
|
(a) |
the CE marking and the labelling referred to in Article 22(9); |
|
(b) |
the declaration of performance and conformity; |
|
(c) |
the general product information and the instructions for use and safety information referred to in Article 22(6). |
3. A fulfilment service provider shall ensure that the conditions during warehousing, packaging, addressing or dispatching do not jeopardise a product’s conformity with its declared performance or its compliance with other applicable requirements in this Regulation. Manufacturers or importers of construction products shall provide their fulfilment service providers with the detailed information necessary for ensuring the safe storage, packaging, addressing or dispatch, and the further functioning of the product.
3. 履约服务提供者应确保在仓储、包装、标注或发货过程中,条件不会危及产品符合其声明性能或符合本条例其他适用要求。建筑产品的制造商或进口商应向其履约服务提供者提供确保产品安全存储、包装、标注或发货及产品后续功能所需的详细信息。
4. Fulfilment service providers shall support product withdrawals or recalls, regardless of whether initiated by market surveillance authorities, manufacturers, authorised representatives or importers.
4. 履约服务提供者应支持产品的撤回或召回,无论是由市场监管机构、制造商、授权代表还是进口商发起。
5. Where a fulfilment service provider considers or has reason to believe that a product is not in conformity with the declaration of performance and conformity or not in compliance with other applicable requirements in this Regulation, it shall not support the making available of the product on the market until the product conforms to the relevant declaration of performance and conformity, and it complies with the other applicable requirements in this Regulation, or until the declaration of performance and conformity is corrected. Furthermore, where the product presents a risk, the fulfilment service provider shall inform the manufacturer and the responsible competent national authority thereof.
5. 当履约服务提供者认为或有理由相信某产品不符合性能和合格声明,或不符合本条例中的其他适用要求时,应暂停支持该产品在市场上的供应,直到该产品符合相关的性能和合格声明,并符合本条例中的其他适用要求,或直到性能和合格声明被更正。此外,若该产品存在风险,履约服务提供者应将此情况通知制造商及负责的国家主管当局。
Article 28 第 28 条
Obligations of online marketplaces
在线市场的义务
1. An online marketplace shall:
1. 在线市场应当:
|
(a) |
for the purpose of complying with Article 31(1) of Regulation (EU) 2022/2065 of the European Parliament and of the Council (28), design and organise its online interface in such a way that allows economic operators to fulfil their obligations under Article 29(2) of this Regulation; |
|
(b) |
establish a single contact point for direct communication with Member States’ competent national authorities in relation to compliance with this Regulation, which can be the same as the contact point referred to in Article 22(1) of Regulation (EU) 2023/988 or Article 11(1) of Regulation (EU) 2022/2065; |
|
(c) |
give an appropriate answer to notices related to the notification of accidents and other incidents involving products received in accordance with Article 16 of Regulation (EU) 2022/2065; |
|
(d) |
cooperate to ensure effective market surveillance measures, including by abstaining from putting in place obstacles to such measures; |
|
(e) |
inform the competent national authorities of any action taken with regard to the non-compliance or suspected non-compliance of products covered by this Regulation; |
|
(f) |
establish a regular and structured exchange of information regarding content that has been removed by online marketplaces at the request of competent national authorities; |
2. As far as powers conferred by Member States in accordance to Article 14 of Regulation (EU) 2019/1020 are concerned, Member States shall confer on their market surveillance authorities the power, in respect of all products covered by this Regulation, to order an online marketplace to remove from its online interface specific illegal content referring to a non-compliant product, to disable access to it, or to display an explicit warning to end users when they access it. Such orders shall comply with Article 9 of Regulation (EU) 2022/2065.
2. 关于成员国根据条例(欧盟)2019/1020 第 14 条赋予的权力,成员国应赋予其市场监管机构权力,针对本条例涵盖的所有产品,命令在线市场从其在线界面移除涉及不合规产品的特定非法内容,禁用对该内容的访问,或在终端用户访问时显示明确警告。此类命令应符合条例(欧盟)2022/2065 第 9 条的规定。
3. An online marketplace shall take the necessary measures to receive and process in accordance with Article 9 of Regulation (EU) 2022/2065 the orders referred to in paragraph 2 of this Article.
3. 在线市场应采取必要措施,根据欧盟条例(EU)2022/2065 第 9 条的规定接收和处理本条第 2 款所述的订单。
4. This Article shall also apply to manufacturers, importers, or distributors offering products online without the involvement of an online marketplace.
4. 本条款同样适用于制造商、进口商或分销商在未通过在线市场参与的情况下在线提供产品。
Article 29 第 29 条
Online and other distance sales
在线及其他远程销售
1. Products offered for sale online or through other means of distance sales shall be deemed to be made available on the market if the offer is targeted at customers in the Union. An offer for sale shall be considered to be targeted at customers in the Union if the relevant economic operator directs, by any means, its activities to a Member State. An offer shall, inter alia, be considered to be targeted at customers in the Union where:
1. 通过在线或其他远程销售方式提供销售的产品,如其销售对象为欧盟境内的客户,则应视为已在市场上投放。若相关经济经营者以任何方式将其活动指向某一成员国,则该销售报价应被视为针对欧盟客户。销售报价应被视为针对欧盟客户的情形包括但不限于:
|
(a) |
the economic operator uses the currency of a Member State; |
|
(b) |
the economic operator has used an internet domain name registered in one of the Member States, or uses an internet domain that refers to the Union or to one of the Member States; or |
|
(c) |
the geographical areas to which dispatch is available include a Member State. |
The conditions listed in the first subparagraph shall not apply if the economic operator explicitly and effectively excludes the Union market.
如果经济运营者明确且有效地排除欧盟市场,则第一款所列条件不适用。
2. Where an economic operator makes a product available on the market online or through other means of distance selling, the offer of that product shall, where required, clearly and visibly indicate the CE marking, the information listed in Article 18(2), the label pursuant to Article 22(9) and a data carrier connected to a digital product passport in accordance with Article 22(7).
2. 当经济运营者通过在线或其他远程销售方式将产品投放市场时,该产品的报价应在必要时清晰且明显地标示 CE 标志、第 18 条第 2 款所列信息、第 22 条第 9 款规定的标签以及根据第 22 条第 7 款连接至数字产品护照的数据载体。
3. Any natural or legal person providing an intermediary service for the placing on the market of products shall fulfil the obligations of an economic operator pursuant to paragraph 2 in relation to the services provided.
3. 任何为产品投放市场提供中介服务的自然人或法人,应就所提供的服务履行第 2 款规定的经济运营者义务。
Article 30 第 30 条
Implementing acts regarding the obligations and rights of economic operators
关于经济运营者义务和权利的实施法令
Where it is necessary, to ensure the harmonised application of this Regulation, and only to the extent necessary to prevent diverging practices fragmenting the internal market for economic operators, the Commission may adopt implementing acts providing details on how economic operators are to fulfil the obligations and exercise the rights set out in this Chapter.
在必要时,为确保本条例的统一适用,并且仅在防止不同做法导致经济运营者内部市场分裂的必要范围内,委员会可通过实施措施,详细规定经济运营者如何履行本章规定的义务和行使权利。
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 90(3).
这些实施法令应按照第 90 条第 3 款所述的审查程序予以采纳。
CHAPTER IV 第四章
EUROPEAN ASSESSMENT DOCUMENTS
欧洲评估文件
Article 31 第 31 条
European assessment documents
欧洲评估文件
1. The methods and criteria for assessing the performance of products, including used products, in relation to their essential characteristics may be laid down in European assessment documents provided that the products are not covered by:
1. 评估产品(包括二手产品)在其基本特性方面性能的方法和标准,可以在欧洲评估文件中规定,前提是这些产品不属于以下情况:
|
(a) |
a harmonised standard made mandatory by an implementing act referred to in Article 5(8); |
|
(b) |
an implementing act referred to in Article 6(1); or |
|
(c) |
a harmonised standard to be delivered in a period shorter than one year, in accordance with a standardisation request referred to in Article 5(2). |
2. A product shall not be considered to be covered by harmonised standards or implementing acts referred to in paragraph 1 where:
2. 当出现以下情况时,产品不应被视为涵盖第 1 款所述的协调标准或实施法令:
|
(a) |
the declared use of the product falls outside of the scope of the intended use set out in the harmonised standard or implementing act; |
|
(b) |
the materials used are not identical to the materials to be used in accordance with the harmonised standard or implementing act; or |
|
(c) |
the assessment method set out in the harmonised standard or implementing act is not appropriate for that product. |
3. Following a request for a European technical assessment by a manufacturer, a group of manufacturers or a manufacturers’ association, or on the initiative of the Commission, the organisation of TABs may, in agreement with the Commission, draw up and adopt a European assessment document.
3. 在制造商、制造商团体或制造商协会提出欧洲技术评估请求后,或根据委员会的倡议,经委员会同意,TAB 组织可起草并采纳欧洲评估文件。
The basic requirements for construction works set out in Annex I and the list of predetermined environmental essential characteristics set out in Annex II shall constitute the basis for the preparation of European assessment documents. The development and adoption of a European assessment document shall follow the principles and the procedure set out in Article 32.
附件 I 中规定的建筑工程基本要求以及附件 II 中列出的预定环境基本特性清单,应作为编制欧洲评估文件的基础。欧洲评估文件的制定和采纳应遵循第 32 条规定的原则和程序。
4. European assessment documents shall not be drawn up in relation to an essential characteristic of, or assessment method for, a product when there is another European assessment document covering the same essential characteristic or assessment method in relation to that specific product, the reference of which has either already been published in the Official Journal of the European Union, or which has been submitted to the Commission for assessment in accordance with Article 34(1).
4. 当已有另一份涵盖该特定产品相同基本特性或评估方法的欧洲评估文件,其参考文献已在《欧盟官方公报》上发布,或已根据第 34 条第 1 款提交委员会进行评估时,不得就该产品的基本特性或评估方法编制欧洲评估文件。
5. The organisation of TABs and the Commission may merge or reject requests for the development of a European assessment document in accordance with point 5 of Annex VI.
5. TAB 组织和委员会可根据附件 VI 第 5 点合并或拒绝制定欧洲评估文件的请求。
6. From the date of mandatory application of a harmonised technical specification adopted in accordance with Article 5(8) or Article 6(1), covering the same product and the same intended use as a European assessment document, the European assessment document shall no longer be used for the purposes of this Regulation. In that case the Commission shall withdraw the reference of the European assessment document from the Official Journal of the European Union.
6. 自根据第 5 条第 8 款或第 6 条第 1 款通过的涵盖相同产品及相同预期用途的协调技术规范强制适用之日起,欧洲评估文件不得再用于本条例的目的。在此情况下,委员会应从《欧盟官方公报》撤销该欧洲评估文件的参考文献。
7. European assessment documents shall constitute the basis for European technical assessments set out in Article 37.
7. 欧洲评估文件应构成第 37 条所述欧洲技术评估的基础。
Article 32 第 32 条
Principles and procedure for the development and adoption of European assessment documents
欧洲评估文件的制定和采纳的原则及程序
1. When developing and adopting European assessment documents, individual TABs and the organisation of TABs shall follow the procedure set out in Annex VI.
1. 在制定和采纳欧洲评估文件时,单个 TAB 及 TAB 组织应遵循附件 VI 中规定的程序。
2. When developing and adopting European assessment documents, individual TABs and the organisation of TABs shall:
2. 在制定和采纳欧洲评估文件时,单个 TAB 及 TAB 组织应:
|
(a) |
be transparent to Member States, the manufacturer concerned and to other manufacturers or stakeholders that request to be informed; |
|
(b) |
disclose confidential information to the Commission only when necessary to assess the compliance of a European assessment document with regulatory provisions and protect commercial secrecy and confidentiality; |
|
(c) |
specify appropriate mandatory time limits in order to avoid unjustified delay; |
|
(d) |
allow for adequate participation by the Member States and the Commission; |
|
(e) |
be cost-effective for the manufacturer; and |
|
(f) |
ensure sufficient collegiality and coordination amongst TABs designated for the product in question. |
The balancing of requirements laid down in points (a) and (b) of the first subparagraph shall allow at least for the disclosure of the name of the product at the stage of the approval and the communication of the work programme, as set out in point 3 of Annex VI, and for the disclosure of the detailed contents of the draft European assessment document set out in point 8 of Annex VI.
第一款第(a)和(b)点所规定要求的平衡应至少允许在批准阶段披露产品名称及工作计划的沟通,如附件 VI 第 3 点所述,并允许披露附件 VI 第 8 点所述的欧洲评估文件草案的详细内容。
3. The TABs shall, together with the organisation of TABs, bear the full costs of the development and adoption of European assessment documents, unless such development is initiated by the Commission.
3. 技术评审小组(TABs)及其组织应承担欧洲评估文件的制定和采纳的全部费用,除非该制定由委员会发起。
4. TABs and the organisation of TABs shall avoid the proliferation of European assessment documents where there is no technical justification for differentiating between products. They shall, in particular, give preference to extending the scope of existing European assessment documents over creating new European assessment documents.
4. 技术评审小组(TABs)及其组织应避免在无技术理由区分产品的情况下导致欧洲评估文件的过度增多。特别应优先考虑扩大现有欧洲评估文件的适用范围,而非创建新的欧洲评估文件。
5. The Commission is empowered to adopt, after consultations with the organisation of TABs, delegated acts in accordance with Article 89 to amend Annex VI in order to add additional procedural rules for the development and adoption of European assessment documents, where it is necessary to ensure the good functioning of the system of European assessment documents.
5. 委员会有权在与 TAB 组织协商后,根据第 89 条通过授权法案修改附件 VI,以增加制定和采纳欧洲评估文件的附加程序规则,前提是为确保欧洲评估文件体系的良好运作有必要。
Article 33 第 33 条
Obligations of the TAB receiving a request for a European technical assessment
收到欧洲技术评估请求的技术评估机构(TAB)的义务
1. When receiving a request for a European technical assessment from a manufacturer, a group of manufacturers or a manufacturers’ association, the TAB shall comply with the following requirements:
1. 当技术评估机构收到制造商、制造商集团或制造商协会提出的欧洲技术评估请求时,应遵守以下要求:
|
(a) |
where the product is covered by a harmonised technical specification or a European assessment document cannot be drawn up in accordance with Article 31, the TAB shall inform the applicant that a European technical assessment cannot be issued; |
|
(b) |
where the product is fully covered by a European assessment document the reference of which has been published in the Official Journal of the European Union, the TAB shall inform the applicant that the referenced European assessment document will be used as the basis for the European technical assessment to be issued; |
|
(c) |
where the product is eligible for a European assessment document referred to in Article 31, and no such document is in the process of being developed, the TAB shall inform the applicant that the procedures set out in Annex VI will be initiated. |
In the cases referred to in point (c) of the first subparagraph of this Article, but where a harmonised standard covering the same product is expected to be delivered in a period longer than one year as established in a standardisation request referred to in Article 5(2), the TAB shall inform the applicant about the possibility of a European assessment document no longer being used pursuant to Article 31(6).
在本条第一款(c)点所述的情况下,但预计涵盖同一产品的协调标准将在根据第 5 条第 2 款所指的标准化请求中确定的一年以上的期限内发布时,技术评估机构应通知申请人,根据第 31 条第 6 款,欧洲评估文件可能不再被使用的可能性。
2. In the cases referred to in paragraph 1, first subparagraph, points (b) and (c) of this Article, the TAB shall inform the organisation of TABs and the Commission of the content of the request and of the reference to a relevant delegated act determining the assessment and verification system referred to in Article 10(2), which the TAB intends to apply for that product, or of the lack of such delegated act.
2. 在本条第 1 款第一段第(b)和(c)项所述的情况下,TAB 应将请求内容及其拟用于该产品的、确定第 10 条第 2 款所述评估和验证体系的相关授权法案的引用,或该授权法案的缺失情况,通知 TAB 组织和委员会。
3. If the Commission considers that an appropriate delegated act determining the assessment and verification system does not exist for the product, it may adopt a delegated act in accordance with Article 10(2).
3. 如果委员会认为不存在适用于该产品的确定评估和验证体系的适当授权法案,则可根据第 10 条第 2 款通过授权法案。
Article 34 第 34 条
Publication of references
参考文献的公布
1. The Commission shall, in accordance with point 9 of Annex VI, assess the compliance of European assessment documents with harmonised technical specifications, with this Regulation and with other Union law. Where a European assessment document is in conformity with applicable legal requirements, the Commission shall without delay publish a reference of that document in the Official Journal of the European Union. Where a reference to a European assessment documents cannot be published in the Official Journal of the European Union, the Commission may publish such a reference with restrictions.
1. 委员会应根据附件六第 9 点,评估欧洲评估文件是否符合统一技术规范、本条例及其他欧盟法律的要求。若欧洲评估文件符合适用的法律要求,委员会应立即在《欧盟官方公报》上发布该文件的参考信息。若无法在《欧盟官方公报》上发布欧洲评估文件的参考信息,委员会可有限制地发布该参考信息。
2. Following publication in accordance with paragraph 1 of this Article, a European assessment document may, in accordance with Article 37, be used as a basis for a European technical assessment for a period of 10 years, unless the reference of the European assessment document has been withdrawn from the Official Journal of the European Union or that European assessment document is no longer used pursuant to Article 31(6). The organisation of TABs may in the last year of that period decide to submit the European assessment document for renewal. The Commission shall in that case reassess the European assessment document in accordance with paragraph 1 of this Article.
2. 根据本条第 1 款的规定发布后,欧洲评估文件可根据第 37 条的规定作为欧洲技术评估的依据,期限为 10 年,除非该欧洲评估文件的参考已从《欧盟官方公报》中撤回,或根据第 31 条第 6 款该欧洲评估文件不再使用。TAB 组织可在该期限的最后一年决定提交欧洲评估文件以进行续期。委员会在此情况下应根据本条第 1 款重新评估该欧洲评估文件。
Article 35 第 35 条
Content of the European assessment document
欧洲评估文件的内容
1. A European assessment document shall contain the following elements:
1. 欧洲评估文件应包含以下要素:
|
(a) |
a description of the product or product category covered and its intended use; and |
|
(b) |
the list of essential characteristics, relevant for the intended use of the product or product category as agreed between the manufacturer and the organisation of TABs as well as predetermined environmental essential characteristics as set out in Annex II, and the methods and criteria for assessing the performance of the product or product category in relation to the essential characteristics listed. |
2. The European assessment document shall set out:
2. 欧洲评估文件应载明:
|
(a) |
the technical details necessary for the implementation of the assessment and verification systems that are to be applied in accordance with the delegated acts adopted under Article 10(2); |
|
(b) |
the guidelines, including technical details necessary for drawing up general product information, instructions for use and safety information as referred to in Annex IV; |
|
(c) |
the guidelines to ensure interoperability of the human and machine readable formats for the declaration of performance and conformity in accordance with paragraph 16(2), point (b). |
3. Where the performance of the product can appropriately be assessed by reference to its essential characteristics, including assessment methods and criteria, already established for them in harmonised technical specifications or other European assessment documents, those existing essential characteristics and their methods and criteria shall be incorporated as parts of the European assessment document, unless it is technically necessary to deviate from that rule.
3. 如果产品的性能可以通过参考其基本特性(包括已在协调技术规范或其他欧洲评估文件中为其确立的评估方法和标准)来适当评估,则应将这些现有的基本特性及其方法和标准纳入欧洲评估文件的组成部分,除非技术上有必要偏离该规则。
Where applicable, these principles shall also apply for threshold levels and classes of performance adopted in accordance with Article 5(5).
在适用的情况下,这些原则也应适用于根据第 5 条第 5 款采纳的门槛水平和性能等级。
Article 36 第 36 条
Formal objections against European assessment documents
针对欧洲评估文件的正式异议
1. A Member State shall inform the Commission of all of the following:
1. 成员国应将以下所有事项通知委员会:
|
(a) |
where it considers that a European assessment document does not entirely conform with applicable legal requirements or satisfy the demands to be met in relation to the essential characteristics to be covered in view of the basic requirements for construction works set out in Annex I and the predetermined environmental essential characteristics set out in Annex II; |
|
(b) |
where it considers that a European assessment document raises a major concern for health and safety of persons, the protection of the environment or consumer protection; |
|
(c) |
where it considers that a European assessment document does not fulfil the requirements set out in Article 31(1). |
The Member State concerned shall substantiate its viewpoints. The Commission shall consult the other Member States on the issues raised by the Member State concerned.
有关成员国应当说明其观点的理由。委员会应就有关成员国提出的问题咨询其他成员国。
2. In the light of the views of all the Member States, the Commission shall decide to publish, not to publish, to publish with restriction, to maintain, to maintain with restriction or to withdraw the references to the European assessment documents concerned in the Official Journal of the European Union.
2. 根据所有成员国的意见,委员会应决定是否在《欧盟官方公报》上发布、不发布、限制发布、维持、限制维持或撤销有关欧洲评估文件的引用。
3. The Commission shall inform the Member States and the organisation of TABs of its decision referred to in paragraph 2 and, where necessary, request the revision of the European assessment document concerned.
3. 委员会应将其在第 2 款中提及的决定通知成员国和 TAB 组织,并在必要时请求修订相关的欧洲评估文件。
Article 37 第 37 条
European technical assessment
欧洲技术评估
1. A European technical assessment shall be issued by a TAB, at the request of a manufacturer on the basis of a European assessment document the reference of which has been published in the Official Journal of the European Union in accordance with Article 34.
1. 欧洲技术评估应由 TAB 根据制造商的请求发布,依据其参考文献已根据第 34 条在《欧盟官方公报》上公布的欧洲评估文件。
Provided that there is a European assessment document the reference of which has been published in the Official Journal of the European Union in accordance with Article 34, a European technical assessment may be issued even in the case where a standardisation request has been issued. Such issuing shall be possible until the European assessment document is no longer used pursuant to Article 31(6).
只要根据第 34 条的规定,在《欧盟官方公报》上已公布了欧洲评估文件的参考编号,即使已发布标准化请求,也可以签发欧洲技术评估。该签发应在根据第 31 条第 6 款不再使用欧洲评估文件之前进行。
2. When a request for a European technical assessment is made, the procedure laid down in Annex VI shall apply.
2. 当提出欧洲技术评估请求时,应适用附件 VI 中规定的程序。
3. The European technical assessment shall include the performance to be declared, by levels or classes, or in a description, of those essential characteristics that are agreed by the manufacturer and the TAB receiving the request for the European technical assessment for the declared use, and the technical details necessary for the implementation of the assessment and verification system.
3. 欧洲技术评估应包括由制造商与接收欧洲技术评估请求的技术评估机构(TAB)就申报用途达成一致的基本特性,按等级或类别,或以描述形式声明的性能,以及实施评估和验证体系所需的技术细节。
The European technical assessment shall also include the assessment of the performance for the predetermined environmental essential characteristics listed in Article 15(3).
欧洲技术评估还应包括对第 15 条第 3 款所列预定环境基本特性的性能评估。
4. The Commission may adopt implementing acts to establish the format of the European technical assessment.
4. 委员会可通过实施法令确定欧洲技术评估的格式。
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 90(3).
这些实施法令应按照第 90 条第 3 款所述的审查程序予以采纳。
5. European technical assessments issued on the basis of a European assessment document remain valid for either five years after the end of the period set out in Article 34(2) or five years after the reference of the European assessment document is withdrawn from the Official Journal of the European Union.
5. 基于欧洲评估文件发布的欧洲技术评估,自第 34 条第 2 款规定期限届满后五年内有效,或自欧洲评估文件的参考从《欧盟官方公报》撤回后五年内有效。
When the relevant European assessment document for a product is no longer used pursuant to Article 31(6), that product may no longer be placed on the market on the basis of a European technical assessment.
当根据第 31 条第 6 款不再使用某产品的相关欧洲评估文件时,该产品不得再基于欧洲技术评估投放市场。
6. Products covered by a European assessment document for which a European technical assessment has been issued may be CE marked and thereby obtain the same status as products CE marked on the basis of harmonised technical specifications, where the manufacturer satisfies the obligations set out in this Regulation. Where these obligations refer to harmonised technical specifications, the manufacturer shall refer to the European assessment document instead or, where the harmonised technical specifications are also relevant, in addition.
6. 对于已发布欧洲技术评估的欧洲评估文件涵盖的产品,制造商满足本条例规定的义务后,该产品可加贴 CE 标志,从而获得与基于协调技术规范加贴 CE 标志的产品相同的地位。若这些义务涉及协调技术规范,制造商应改为引用欧洲评估文件,或者在协调技术规范同样适用的情况下,同时引用。
CHAPTER V 第五章
TECHNICAL ASSESSMENT BODIES
技术评估机构
Article 38 第 38 条
Designating authorities 指定当局
1. Member States wishing to designate TABs shall designate a single designating authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and designation of TABs. Designating authorities shall satisfy the requirements for notifying authorities set out in Articles 43(1) and Article 44. Member States may designate the notifying authority referred to in Article 43, as the designating authority. The designating authority shall not be eligible for designation in accordance with Article 39(1).
1. 希望指定 TAB 的成员国应指定一个单一的指定机构,负责建立和执行评估及指定 TAB 所需的程序。指定机构应满足第 43 条第 1 款和第 44 条中规定的通知机构的要求。成员国可以将第 43 条所述的通知机构指定为指定机构。根据第 39 条第 1 款,指定机构不得被指定为 TAB。
2. Unless otherwise specified in this Chapter, the provisions applicable to notifying authorities and to notification procedures apply also to designating authorities and to the designation procedures.
2. 除本章另有规定外,适用于通报机构及通报程序的规定同样适用于指定机构及指定程序。
Article 39 第 39 条
Designation, monitoring and evaluation of TABs
TAB 的指定、监测和评估
1. Member States may, through their designating authorities, designate TABs within their territories for one or several product families listed in Annex VII. Member States may also designate TABs within their territories as competent for emerging or innovative products that do not fall into already existing product families listed in Annex VII.
1. 成员国可通过其指定机构,在其境内指定 TAB,适用于附件 VII 中列出的一个或多个产品系列。成员国也可在其境内指定 TAB,作为对不属于附件 VII 中已存在产品系列的新兴或创新产品的主管机构。
Member States shall communicate the name of the TAB, its address and the product family or families it is competent for to the Commission.
成员国应向委员会通报 TAB 的名称、地址及其负责的产品系列。
2. The Commission shall assign an identification number to each TAB.
2. 委员会应为每个 TAB 分配一个识别号码。
The Commission shall make publicly available the list of TABs designated under this Regulation by electronic means and indicate their identifications numbers, the product families for which they are designated and any limitations in the most precise possible way.
委员会应通过电子方式公开根据本条例指定的 TAB 名单,并以尽可能精确的方式标明其识别号码、所指定的产品系列及任何限制。
The Commission shall ensure that that list is kept up-to-date.
委员会应确保该名单保持最新。
3. The designating authority shall monitor the activities and competence of the TABs designated in their respective Member State, and where necessary their subsidiaries and subcontractors, and evaluate them in relation to the respective requirements set out in this Chapter. The designating authority shall impose corrective measures on TABs wherever there is an infringement of this Regulation.
3. 指定机构应监督其各自成员国内指定的 TAB 的活动和能力,以及在必要时监督其子公司和分包商,并根据本章规定的相关要求对其进行评估。指定机构应对违反本条例的 TAB 采取纠正措施。
Member States shall inform the Commission of their national procedures for the designation of TABs, of the monitoring of their activity and competence, and of any changes to that information.
成员国应将其指定 TAB 的国家程序、对其活动和能力的监控情况以及该等信息的任何变更通知委员会。
4. TABs shall, without delay, and at the latest within 15 days, inform the designating authority of any changes which may affect their compliance with the requirements set out in this Chapter or their ability to satisfy their obligations under this Regulation.
4. TAB 应当毫不拖延,且最迟在 15 天内,将可能影响其符合本章规定要求或履行本条例义务能力的任何变更通知指定机构。
5. TABs shall, at the request of the relevant designating authority, supply all relevant information and documents, required to enable that authority, the Commission and the Member States to verify their compliance with the requirements under this Regulation.
5. TAB 应应相关指定机构的要求,提供所有相关信息和文件,以使该机构、委员会和成员国能够核实其是否符合本条例的要求。
6. Where a TAB no longer complies with the requirements of this Regulation, the designating authority shall restrict, suspend or withdraw the designation of that TAB for the relevant product family as appropriate, depending on the seriousness of the failure to meet those requirements. Where a TAB has repeatedly not complied with corrective measures imposed in accordance with paragraph 3 of this Article, the designating authority may restrict, suspend or withdraw the designation of that TAB. The designating authority shall inform the Commission and the other Member States of any restriction, suspension or withdrawal of a designation. Articles 53(2) and 54 shall apply.
6. 当技术评估机构(TAB)不再符合本条例的要求时,指定机构应根据未能满足这些要求的严重程度,适当限制、暂停或撤销该技术评估机构对相关产品系列的指定。若技术评估机构多次未能遵守根据本条第 3 款施加的纠正措施,指定机构可限制、暂停或撤销该技术评估机构的指定。指定机构应将任何限制、暂停或撤销指定的情况通知委员会及其他成员国。第 53 条第 2 款和第 54 条适用。
Article 40 第 40 条
Requirements for TABs TAB 的要求
1. A TAB shall be competent, and equipped, to carry out the assessment in relation to the product families for which it has been designated. The decision-making staff and at least half of the technical competent staff shall be employed by the TAB under the national law of the designating Member State.
1. TAB 应具备能力和设备,能够对其被指定的产品系列进行评估。决策人员和至少一半的技术合格人员应根据指定成员国的国家法律由 TAB 雇佣。
2. The TAB shall satisfy the requirements set out in Annex VIII, within the scope of its designation. Article 46(2) to (5), Article 46(6), points (a) and (b), Article 46(7), (8), (9) and (11) and Article 47 shall apply.
2. TAB 应在其指定范围内满足附件 VIII 中规定的要求。第 46 条第 2 款至第 5 款、第 46 条第 6 款(a)和(b)项、第 46 条第 7 款、第 8 款、第 9 款和第 11 款以及第 47 条应适用。
3. A TAB shall have made publicly available its organigram and the names of the members of its internal decision-making bodies.
3. TAB 应公开其组织结构图及其内部决策机构成员的姓名。
4. A TAB shall participate in the activities of the organisation of TABs or ensure that their assessment personnel is informed about those activities.
4. 技术评估机构(TAB)应参与技术评估机构组织的活动,或确保其评估人员了解这些活动。
Article 41 第 41 条
Coordination of TABs 技术评估机构的协调
1. The TABs shall establish an organisation for technical assessment (‘organisation of TABs’) under this Regulation.
1. 技术评估机构应根据本条例建立一个技术评估组织(“技术评估机构组织”)。
2. The organisation of TABs shall at least carry out the following tasks:
2. TAB 组织应至少执行以下任务:
|
(a) |
supply the Commission with relevant technical content relating to European assessment documents when the development of harmonised technical specifications based on the same product families is due to take place in accordance with the working plan referred to in Article 4(2). That information shall be based on close collaboration with the relevant European standardisation organisations; |
|
(b) |
organise the coordination of the TABs and, if necessary, ensure cooperation and consultation with other stakeholders; |
|
(c) |
ensure that examples of best practice are shared between TABs to promote greater efficiency and provide a better service to industry; |
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(d) |
develop and adopt European assessment documents; |
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(e) |
coordinate the application of the procedures set out in Article 59(2), Article 60(2) and in Article 61(2), as well as provide the support needed to that end; |
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(f) |
inform the Commission of any question related to the preparation of European assessment documents and of any aspects related to the interpretation of the procedures set out in Article 60(2) and in Article 61(2) and suggest improvements to the Commission based on experience gained; |
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(g) (g) |
communicate any observations concerning a TAB not satisfying its tasks in accordance with the procedures set out in Article 60(2) and in Article 61(2) to the Commission and the Member State which designated the TAB; |
|
(h) |
report annually to the Commission on:
|
|
(i) |
ensure that adopted European assessment documents and references to European technical assessments are kept publicly available. |
The organisation of TABs shall set up a secretariat in order to carry out these tasks.
TABs 的组织应设立一个秘书处以执行这些任务。
3. Member States shall ensure that the TABs contribute adequately with financial and human resources to the organisation of TABs. Organisation of TABs shall establish the contribution of each TAB which shall be proportionate taking into account the annual budget or turnover of each TAB related to its activities as TAB.
3. 成员国应确保 TABs 以充足的财力和人力资源支持 TABs 的组织。TABs 的组织应确定各 TAB 的贡献,该贡献应与各 TAB 作为 TAB 活动相关的年度预算或营业额成比例。
4. The weight in the decision-making process of the organisation of TABs shall not depend on the TABs’ financial contribution, the number of European assessment documents developed or the number of European technical assessments issued by them.
4. TABs 组织决策过程中的权重不应取决于 TABs 的财务贡献、所制定的欧洲评估文件数量或其发布的欧洲技术评估数量。
5. The Commission shall be invited to participate in all meetings of the organisation of TABs.
5. 委员会应被邀请参加 TAB 组织的所有会议。
6. Union financing may be granted to the organisation of TABs for the implementation of the tasks referred to in paragraph 2. The Commission may make the financing of the organisation of TABs, whether by way of grants or public tenders, subject to the fulfilment of certain organisational and performance requirements set out in those tasks.
6. 联盟可向 TAB 组织提供资金,用于执行第 2 款所述的任务。委员会可将对 TAB 组织的资助,无论是通过补助金还是公开招标,设定为必须满足这些任务中规定的某些组织和绩效要求。
CHAPTER VI 第六章
NOTIFYING AUTHORITIES AND NOTIFIED BODIES
通知当局和公告机构
Article 42 第 42 条
Notification 通知
1. Member States shall notify the Commission and the other Member States of bodies authorised to carry out third-party tasks in the assessment and verification of performance, assessment of conformity and of the verification of environmental sustainability calculations for the purposes of this Regulation.
1. 成员国应将获授权执行本条例目的下的性能评估与验证、合格评定以及环境可持续性计算验证的第三方机构通知委员会及其他成员国。
2. Member States shall inform the Commission of their procedures for the assessment and notification of bodies to be authorised to carry out these tasks and the monitoring of notified bodies, and of any changes thereto. The Commission shall make that information publicly available.
2. 成员国应将其评估和通知被授权执行这些任务的机构的程序以及对已通知机构的监督程序及其任何变更通知委员会。委员会应将该信息公开。
Article 43 第 43 条
Notifying authorities 通知当局
1. Member States shall designate a notifying authority responsible for setting up and carrying out the necessary procedures for the assessment and notification of the bodies to be authorised to carry out third-party tasks in the assessment and verification process for the purposes of this Regulation, and the monitoring of notified bodies, including their compliance with requirements laid down in Articles 46 and 48.
1. 成员国应指定一个通知机构,负责建立和执行必要程序,以评估和通知被授权执行本条例目的下评估和验证过程中的第三方任务的机构,并监督已通知机构,包括其是否符合第 46 条和第 48 条规定的要求。
2. Member States may decide that the assessment and monitoring referred to in paragraph 1 is to be carried out by their national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.
2. 成员国可决定由其根据第(EC)号 765/2008 号条例含义设立的国家认可机构进行第 1 款所述的评估和监测。
3. Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1 of this Article to a body which is not a governmental entity that body shall be a legal person and shall comply mutatis mutandis with the requirements laid down in Article 44. In addition, it shall have arrangements to cover liabilities arising out of its activities.
3. 若通报机构将本条第 1 款所述的评估、通报或监测工作委托或转交给非政府实体,该机构应为法人,并应相应遵守第 44 条规定的要求。此外,该机构应有安排以覆盖其活动产生的责任。
4. The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraphs 2 and 3.
4. 通知机构应对第 2 款和第 3 款所述机构执行的任务承担全部责任。
Article 44 第 44 条
Requirements relating to notifying authorities
关于通知机构的要求
1. The notifying authority shall be established in such a way that no conflicts of interest with notified bodies occur.
1. 通知机构的设立应确保不会与被通知机构发生利益冲突。
2. The notifying authority shall be organised and operated so as to safeguard the objectivity and impartiality of its activities.
2. 通知机构的组织和运作应保障其活动的客观性和公正性。
3. The notifying authority shall be organised in such a way that each decision relating to notification of a body to be authorised to carry out third-party tasks in the assessment and verification process is taken by competent persons different from those who carried out the assessment.
3. 通知机构应以这样的方式组织,即每一项关于授权机构进行第三方任务评估和验证过程的通知决定,均由与执行评估的人员不同的合格人员作出。
4. The notifying authority shall not offer or provide any activities that notified bodies perform, or consultancy services on a commercial or competitive basis.
4. 通知机构不得以商业或竞争的方式提供或开展任何由通知机构执行的活动或咨询服务。
5. The notifying authority shall safeguard the confidentiality of the information obtained. However, it shall, upon request, exchange information on notified bodies with the Commission, with notifying authorities of other Member States and with other competent national authorities which shall safeguard the confidentiality of the information received.
5. 通知机构应保障所获得信息的机密性。但应要求,应与委员会、其他成员国的通知机构及其他有权的国家机构交换关于通知机构的信息,且这些机构应保障所接收信息的机密性。
6. The notifying authority, including in the cases in which the notifying authority is the national accreditation body, shall assess only the specific conformity assessment body applying for notification and not take account of the capacities or personnel of parent or sister companies. The notifying authority shall assess that body in relation to all relevant requirements and third-party assessment and verification tasks.
6. 通知机构,包括在通知机构为国家认可机构的情况下,应仅评估申请通知的特定合格评定机构,而不考虑母公司或姊妹公司的能力或人员。通知机构应针对所有相关要求以及第三方评估和验证任务对该机构进行评估。
7. The notifying authority shall have a sufficient number of competent personnel and sufficient funding at its disposal for the proper performance of its tasks.
7. 通知机构应拥有足够数量的胜任人员和充足的资金,以妥善履行其职责。
Article 45 第 45 条
Coordination of notifying and designating authorities
通知和指定当局的协调
1. The Commission shall ensure that appropriate coordination and cooperation between the Member States’ national authorities responsible for notification policy and the notifying and designating authorities is put in place and operated in the form of a coordination group of notifying and designating authorities in the field of construction products. That group shall meet on a regular basis and at least annually.
1. 委员会应确保成员国负责通知政策的国家当局与通知和指定当局之间建立并运行适当的协调与合作机制,以建设产品领域的通知和指定当局协调小组的形式进行。该小组应定期召开会议,至少每年一次。
Member States’ national authorities responsible for notification policy and the notifying and designating authorities under this Regulation shall participate in the activities of that group.
根据本条例,成员国负责通知政策的国家当局和通知及指定当局应参与该小组的活动。
2. The Commission may establish the specific arrangements for the functioning of the coordination group of the notifying and designating authorities.
2. 委员会可制定通知和指定当局协调小组运作的具体安排。
3. The Commission shall provide for the organisation of regular exchanges of experience between the Member States’ national authorities responsible for notification policy and the notifying and designating authorities.
3. 委员会应组织成员国负责通报政策的国家主管部门与通报和指定主管部门之间定期的经验交流。
Article 46 第 46 条
Requirements relating to notified bodies
关于通报机构的要求
1. For the purposes of notification, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 12.
1. 为通报之目的,合格评定机构应符合第 2 至第 12 款规定的要求。
2. A conformity assessment body shall be established under the national law of a Member State and have legal personality.
2. 合格评定机构应根据成员国的国家法律设立,并具有法人资格。
3. A conformity assessment body shall be a third-party body independent of the organisation or the product it assesses.
3. 合格评定机构应为独立于其所评定的组织或产品的第三方机构。
It shall not have any business ties with organisations that have an interest in the products it assesses, in particular with manufacturers, their trade partners and their shareholding investors.
该机构不得与对其评定的产品有利益关系的组织存在任何商业联系,特别是制造商、其贸易伙伴及其股东投资者。
However, a body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of products which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body. This shall not preclude the body from carrying out assessment and verification activities for competing manufacturers.
然而,属于代表从事产品设计、制造、提供、组装、使用或维护的企业的商业协会或专业联合会的机构,在证明其独立性和不存在任何利益冲突的前提下,可以被视为此类机构。这不妨碍该机构为竞争制造商开展评定和验证活动。
4. A conformity assessment body, its top-level management and the personnel responsible for carrying out the third-party tasks in the assessment and verification process shall not be the designer, manufacturer, supplier, importer, distributor, installer, purchaser, owner, user or maintainer of the products which it assesses, or the representative of any of those parties. This shall not preclude the use of assessed products that are necessary for the operations of the conformity assessment body or the use of products for personal purposes.
4. 合格评定机构、其最高管理层及负责执行评估和验证过程中第三方任务的人员,不得是其所评估产品的设计者、制造商、供应商、进口商、分销商、安装者、购买者、所有者、使用者或维护者,亦不得是上述任何一方的代表。但这不排除合格评定机构为其运营所必需使用的被评估产品,或为个人用途使用产品。
A conformity assessment body, its top-level management and the personnel responsible for carrying out the third-party tasks in the assessment and verification process shall not be directly involved in the design, manufacture or construction, or marketing, installation, use or maintenance of those products, nor represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement and integrity related to the activities for which they have been notified. This shall apply in particular to consultancy services in relation to product families for which they have been notified.
合格评定机构、其最高管理层及负责执行评估和验证过程中第三方任务的人员,不得直接参与该等产品的设计、制造或建造,或其营销、安装、使用或维护,也不得代表从事该等活动的各方。其不得从事可能影响其独立判断和诚信的活动,尤其是与其已获通知的产品系列相关的咨询服务。
Conformity assessment bodies shall ensure that activities of their parent or sister companies, their subsidiaries or subcontractors do not affect the confidentiality, objectivity and impartiality of their assessment or verification activities.
合格评定机构应确保其母公司或姊妹公司、子公司或分包商的活动不影响其评定或验证活动的保密性、客观性和公正性。
A conformity assessment body shall not delegate to a subcontractor or a subsidiary the establishment and the supervision of internal procedures, general policies, codes of conduct or other internal rules, the assignment of its personnel to specific tasks and the conformity assessment decisions.
合格评定机构不得将内部程序、总体政策、行为准则或其他内部规则的制定与监督、人员分配到具体任务以及合格评定决策委托给分包商或子公司。
5. Conformity assessment bodies and their personnel shall carry out the third-party tasks in the assessment and verification process with the highest degree of professional integrity and requisite technical competence in the specific field. They shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their assessment or verification activities, especially from persons or groups of persons with an interest in the results of those activities.
5. 合格评定机构及其人员应以最高的职业诚信和特定领域所需的技术能力,执行评估和验证过程中的第三方任务。其应不受任何可能影响其判断或评估、验证活动结果的压力和诱导,尤其是来自对这些活动结果有利益关系的个人或团体的财务压力。
6. A conformity assessment body shall be capable of carrying out all the third-party tasks in the assessment and verification process assigned to it in accordance with Annex IX in relation to which it has been notified, irrespective of whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.
6. 合格评定机构应能够执行根据附件 IX 分配给其的所有第三方评估和验证过程中的任务,无论这些任务是由合格评定机构自身执行,还是由其代表并在其责任下执行。
At all times and for each assessment and verification system and for each kind or category of products, essential characteristics and tasks in relation to which it has been notified, the conformity assessment body shall have the following at its disposal:
在任何时候,对于其已被通知的每个评估和验证体系以及每种或每类产品、基本特性和相关任务,合格评定机构应具备以下条件:
|
(a) |
the necessary competent personnel with technical knowledge and sufficient and appropriate experience to perform the third-party tasks in the assessment and verification process; |
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(b) |
the necessary description of the procedures in accordance with which the assessment process is carried out, ensuring the transparency and the ability of reproduction of those procedures, including a description of competence showing how relevant personnel, their status and tasks correspond to the conformity assessment tasks in relation to which the body intends to be notified; |
|
(c) |
appropriate policies and procedures to distinguish between the tasks it carries out as a conformity assessment body and its other activities; |
|
(d) |
procedures for the performance of activities, which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process. |
The conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the activities for which it intends to be notified in an appropriate manner and shall have access to all necessary equipment or facilities.
合格评定机构应具备以适当方式执行其拟通知活动相关的技术和行政任务所必需的手段,并应能够使用所有必要的设备或设施。
7. The personnel responsible for carrying out the activities in relation to which the body intends to be notified, shall have the following:
7. 负责执行与机构拟通知事项相关活动的人员,应具备以下条件:
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(a) |
sound technical and vocational training covering all the third-party tasks in the assessment and verification process within the relevant scope for which the body has been notified; |
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(b) |
satisfactory knowledge of the requirements of the assessments and verifications it carries out and adequate authority to carry out such operations, including appropriate knowledge and understanding of the applicable harmonised technical specifications, European assessment documents and of the relevant provisions of the Regulation; |
|
(c) |
the ability required to draw up the certificates, records and reports to demonstrate that the assessments and the verifications have been carried out. |
8. Personnel responsible for taking assessment decisions shall:
8. 负责作出评估决定的人员应当:
|
(a) |
be employed by the conformity assessment body under the national law of the notifying Member State; |
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(b) |
not have any potential conflict of interest, |
|
(c) |
be competent to verify the assessments made by other staff, external experts or subcontractors; |
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(d) |
be sufficient in number to ensure business continuity and a consistent approach to conformity assessments. |
9. The impartiality of the body and its top-level management and of the assessment personnel shall be guaranteed.
9. 机构及其高层管理人员和评估人员的公正性应得到保证。
The remuneration of the top-level management and assessment personnel of a body shall not depend on the number of assessments carried out or their results.
机构高层管理人员和评估人员的报酬不得依赖于所进行评估的数量或其结果。
10. A conformity assessment body shall take out liability insurance, unless liability is assumed by the Member State in accordance with national law, or the Member State itself is directly responsible for the assessment or the verification performed.
10. 合格评定机构应购买责任保险,除非根据国家法律责任由成员国承担,或成员国本身直接负责所进行的评估或核查。
11. The personnel of the conformity assessment body shall observe professional secrecy regarding all information obtained in carrying out its tasks under Annex IX, except in relation to the notifying authorities and other competent national authorities of the Member State in which its activities are carried out. Proprietary rights shall be protected.
11. 合格评定机构的人员应对其在执行附件 IX 任务过程中获得的所有信息保守职业秘密,但对其活动所在成员国的通知机构及其他主管国家机构除外。应保护专有权利。
12. Conformity assessment bodies shall participate in, or ensure that their assessment personnel are informed about the relevant standardisation activities and the activities of the notified body coordination group established under this Regulation and shall apply as general guidance the administrative decisions and documents produced as a work result of that group.
12. 合格评定机构应参与相关标准化活动,或确保其评估人员了解相关标准化活动及根据本条例设立的通知机构协调小组的活动,并应将该小组作为工作成果所制定的行政决定和文件作为一般指导原则加以应用。
Article 47 第 47 条
Presumption of conformity of notified bodies
公告机构的符合性推定
Where a conformity assessment body to be authorised to carry out third-party tasks in the assessment and verification process demonstrates its conformity with the criteria laid down in the relevant harmonised standards the references of which have been published in the Official Journal of the European Union, harmonised technical specifications referred to in Article 5, European assessment documents, voluntary harmonised standards for product requirements the references of which have been published in the Official Journal of the European Union in accordance with Article 7(5) or (6) or the common specifications referred to in Article 8(1) or parts thereof, it shall be presumed to comply with the requirements set out in Article 46 in so far as the applicable documents cover those requirements.
当拟被授权执行第三方任务的合格评定机构在评估和验证过程中,能够证明其符合相关协调标准中规定的标准,这些标准的参考文献已在《欧盟官方公报》上公布,协调技术规范如第 5 条所述,欧洲评估文件,依据第 7 条第(5)款或(6)款已在《欧盟官方公报》上公布参考文献的产品要求自愿协调标准,或第 8 条第(1)款所述的共同规范或其部分,则在适用文件涵盖这些要求的范围内,应推定其符合第 46 条规定的要求。
Article 48 第 48 条
Subsidiaries and subcontractors of notified bodies
公告机构的子公司和分包商
1. Where a notified body subcontracts specific tasks connected with the third-party tasks in the assessment and verification process or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 46, and shall inform the notifying authority accordingly.
1. 当公告机构将与第三方任务相关的特定任务分包出去,或诉诸其子公司时,应确保该分包商或子公司符合第 46 条规定的要求,并应相应地通知公告主管当局。
2. The notified body shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established and monitor their competence in relation to its own as described in Article 46(6), point (b).
2. 通知机构应对分包商或子公司所执行的任务承担全部责任,无论其设立地点如何,并应根据第 46 条第 6 款(b)点的规定,监控其与自身能力的相关性。
3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client.
3. 只有在客户同意的情况下,活动才能分包或由子公司执行。
4. The notified body shall keep at the disposal of the notifying authority the relevant documents concerning the assessment and monitoring of the qualifications of the subcontractor or the subsidiary and the work carried out by them under Annex IX.
4. 通知机构应将有关分包商或子公司资格评估和监控以及其根据附件 IX 所开展工作的相关文件,备置于通知主管当局处。
Article 49 第 49 条
Use of facilities outside the testing laboratory of the notified body
在公告机构的测试实验室之外使用设施
1. At the request of the manufacturer and where justified by technical, economic or logistic reasons related to the nature of the product or the test equipment, notified bodies may decide to carry out the tests referred to in Annex IX, for the assessment and verification systems 1+, 1 and 3 or have such tests carried out under their supervision, either in the manufacturing plants using the test equipment of the internal laboratory of the manufacturer or, with the prior consent of the manufacturer, in an external laboratory, using the test equipment of that laboratory.
1. 应制造商的请求,并且基于与产品性质或测试设备相关的技术、经济或物流原因,公告机构可决定进行附件 IX 中所述的测试,用于评估和验证体系 1+、1 和 3,或在其监督下进行此类测试,测试地点可以是在制造厂内使用制造商内部实验室的测试设备,或者在获得制造商事先同意的情况下,在外部实验室使用该实验室的测试设备进行。
Notified bodies carrying out such tests shall be specifically designated as competent to work away from their own test facilities and shall also in that regard comply with the requirements laid down in Article 46.
进行此类测试的公告机构应被特别指定为有能力在其自身测试设施之外工作的机构,并且在这方面应遵守第 46 条规定的要求。
2. Before carrying out the tests referred to in paragraph 1, notified bodies shall verify whether the requirements of the test method are satisfied and shall evaluate whether:
2. 在进行第 1 款所述测试之前,公告机构应核实测试方法的要求是否得到满足,并应评估:
|
(a) |
test equipment has an appropriate calibration system and the traceability of the measurements is guaranteed; and |
|
(b) |
the quality of the test results is ensured. |
Notified bodies shall assume full responsibility for the tests in their entirety, including the accuracy and traceability of calibration and measurements, and for the reliability of the test results.
公告机构应对测试的全部内容承担全部责任,包括校准和测量的准确性与可追溯性,以及测试结果的可靠性。
Article 50 第 50 条
Application for notification
通知申请
1. A body to be authorised to carry out third-party tasks in the assessment and verification systems shall submit an application for notification to the notifying authority of the Member State in which it is established.
1. 拟被授权执行第三方任务的机构,应向其设立所在成员国的通知机构提交通知申请。
2. The application shall be accompanied by a description of the activities to be performed, the assessment and verification processes for which the body claims to be competent, the description of competence referred to in Article 46(6), point (b), as well as an accreditation certificate, where one exists, issued by the national accreditation body, attesting that the body fulfils the requirements laid down in Article 46. The accreditation certificate shall relate only to the precise legal body applying for notification and shall be based, in addition to relevant harmonised standards, on the specific requirements and tasks provided for in this Regulation.
2. 申请应附有拟执行活动的描述、该机构声称具备能力的评估和验证流程、以及第 46 条第 6 款(b)项所述的能力描述,还应附有由国家认可机构颁发的认可证书(如有),以证明该机构符合第 46 条规定的要求。认可证书应仅针对申请通知的具体法人机构,并应基于相关的协调标准以及本条例规定的具体要求和任务。
3. Where the body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 46.
3. 如相关机构无法提供认可证书,应向通知机构提供所有必要的文件证据,以便核查、认可及定期监督其是否符合第 46 条规定的要求。
Article 51 第 51 条
Notification procedure 通报程序
1. Notifying authorities may notify only bodies which have satisfied the requirements laid down in Article 46.
1. 通知机构只能通知已满足第 46 条规定要求的机构。
2. Notifying authorities shall notify the Commission and the other Member States using the electronic notification tool developed and managed by the Commission.
2. 通知主管当局应使用由委员会开发和管理的电子通知工具,向委员会和其他成员国发送通知。
Exceptionally, for cases regarding groupings of essential characteristics set out in Annex X, for which the appropriate electronic tool is not available, a notification in other electronic form shall be accepted.
例外情况下,对于附件 X 中列出的基本特征组合,且适用的电子工具不可用的情况,可接受其他电子形式的通知。
3. The notification shall include full details of the functions to be performed, reference to the relevant harmonised technical specification or to the relevant European assessment document and, for the purposes of the system set out in Annex IX, the essential characteristics for which the body is competent and the relevant attestation of that competence.
3. 通知应包括将要执行的职能的全部详细信息,相关协调技术规范或相关欧洲评估文件的引用,以及为附件 IX 所列系统目的,该机构具备能力的基本特征及其相关能力证明。
However, reference to the relevant harmonised technical specification or to the relevant European assessment document is not required in the cases regarding groupings of essential characteristics set out in Annex X.
但是,对于附件 X 中列出的基本特征组合的情况,不要求引用相关协调技术规范或相关欧洲评估文件。
4. Where a notification is not based on an accreditation certificate as referred to in Article 50(2), the notifying authority shall provide the Commission and the other Member States with all documentary evidence which attests to the body’s competence and the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article 46.
4. 如果通知不是基于第 50 条第 2 款所述的认可证书,通知机构应向委员会和其他成员国提供所有证明该机构能力的书面证据,以及确保该机构将被定期监督并持续满足第 46 条规定要求的安排。
5. The body concerned may perform the activities of a notified body if the Commission or the other Member States do not raise any objections within two weeks of a notification, where an accreditation certificate is used, or within two months of notification, where an accreditation certificate is not used.
5. 如果委员会或其他成员国在使用认可证书的情况下自通知之日起两周内,或在未使用认可证书的情况下自通知之日起两个月内未提出异议,相关机构可执行公告机构的活动。
Only such a body shall be considered a notified body for the purpose of this Regulation.
只有此类机构才应被视为本条例所指的公告机构。
6. Valid notifications shall be included by the Commission in the list of notified bodies referred to in Article 52(2).
6. 有效的通知应由委员会纳入第 52 条第 2 款所述的通知机构名单中。
7. The Commission and the other Member States shall be notified of any subsequent relevant changes to the notification.
7. 委员会及其他成员国应被通知任何后续相关的通知变更。
Article 52 第 52 条
Identification numbers and lists of notified bodies
通知机构的识别号码和名单
1. The Commission shall assign an identification number to a notified body.
1. 委员会应当为被通知机构分配一个识别号码。
It shall assign a single such number even where the body is notified under several Union acts.
即使该机构根据多个欧盟法规被通知,委员会也应分配一个唯一的识别号码。
2. The Commission shall make publicly available the list of bodies notified under this Regulation, including the identification numbers that have been assigned to them and the activities for which they have been notified.
2. 委员会应公开本条例下被通知机构的名单,包括分配给它们的识别号码及其被通知的活动。
The Commission shall ensure that that list is kept up-to-date.
委员会应确保该名单保持最新。
Article 53 第 53 条
Changes to the notification
对通知的变更
1. Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 46, or that it is failing to fulfil its obligations, the notifying authority shall restrict, suspend or withdraw the notification as appropriate, depending on the seriousness of the failure to meet those requirements or to fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly.
1. 当通知机构确认或被告知某个公告机构不再符合第 46 条规定的要求,或未能履行其义务时,通知机构应根据未能满足这些要求或履行这些义务的严重程度,适当限制、暂停或撤销该通知。并应立即将此情况通知委员会及其他成员国。
2. In the event of a restriction, suspension or withdrawal of a notification, or where the notified body has ceased its activity, the notifying Member State shall take appropriate steps to ensure that that body’s files are either processed by another notified body or kept available for the responsible notifying and competent national authorities at their request.
2. 在限制、暂停或撤销通知的情况下,或当公告机构停止其活动时,通知成员国应采取适当措施,确保该机构的档案由另一公告机构处理,或根据负责的通知机构和主管国家当局的要求予以保存。
Article 54 第 54 条
Challenge of the competence of notified bodies
指定机构能力的挑战
1. The Commission shall investigate all cases where it doubts, or doubt is brought to its attention regarding, the competence of a notified body or the continued fulfilment by a notified body of the requirements and responsibilities to which it is subject.
1. 委员会应对所有其怀疑或被告知怀疑指定机构能力,或指定机构持续满足其所承担的要求和责任的案件进行调查。
2. The notifying Member State shall provide the Commission, on request, with all information related to the basis for notification or the maintenance of the competence of the body concerned.
2. 通知成员国应根据请求,向委员会提供与通知依据或维持相关机构能力有关的所有信息。
3. The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially.
3. 委员会应确保在调查过程中获得的所有敏感信息均予以保密处理。
4. Where the Commission ascertains that a notified body does not meet, or no longer meets, the requirements for its notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including withdrawal of notification if necessary.
4. 如果委员会确认某个公告机构不符合或不再符合其公告要求,应相应通知公告成员国,并要求其采取必要的纠正措施,包括在必要时撤销公告。
Article 55 第 55 条
Operational obligations of notified bodies
公告机构的操作义务
1. Notified bodies shall, in accordance with Annex IX carry out the following assessments and verifications:
1. 公告机构应根据附件 IX 进行以下评估和核查:
|
(a) |
assess the performance and the conformity of products; |
|
(b) |
verify the conformity of products; |
|
(c) |
verify the constancy of performance of products; |
|
(d) |
validate the environmental sustainability calculations undertaken by the manufacturer; |
|
(e) |
verify the compliance of the manufacturer with the obligations of this Regulation. |
Those tasks are hereinafter referred to as ‘assessments and verifications’.
这些任务以下统称为“评估和核查”。
2. Assessments and verifications shall be carried out with transparency as regards the manufacturer, and in a proportionate manner, avoiding an unnecessary burden for economic operators. The notified bodies shall perform their activities taking due account of the size of the undertaking, the sector in which the undertaking operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.
2. 评估和核查应以对制造商透明的方式进行,并采取相称的方式,避免对经济运营者造成不必要的负担。公告机构应在开展活动时充分考虑企业规模、企业所处行业、企业结构、相关产品技术的复杂程度以及生产过程的批量或系列性质。
In so doing, the notified bodies shall nevertheless respect the degree of rigour required for the product by this Regulation and the part played by the product for the fulfilment of all basic requirements for construction works.
在此过程中,通知机构仍应遵守本条例对产品所要求的严格程度以及该产品在满足所有建筑工程基本要求中所起的作用。
3. Where, in the course of the initial inspection of the manufacturing plant and of factory production control, a notified body finds that the manufacturer has not ensured the constancy of performance and conformity of the manufactured product, it shall require the manufacturer to take appropriate corrective measures and shall not issue a certificate or a validation report.
3. 在对制造厂和工厂生产控制进行初次检查过程中,如果公告机构发现制造商未能确保制造产品的性能稳定性和合格性,应要求制造商采取适当的纠正措施,并不得颁发证书或验证报告。
4. Where, in the course of the monitoring activity aiming at the verification of conformity and of the constancy of performance of the manufactured product, a notified body finds that a product no longer has the same performance to that of the product-type, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate or the validation report if necessary.
4. 在旨在核查制造产品合格性和性能稳定性的监督活动过程中,如果公告机构发现某产品的性能不再与产品类型相同,应要求制造商采取适当的纠正措施,并在必要时暂停或撤销证书或验证报告。
5. Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw any certificates or validation reports, as appropriate.
5. 如果未采取纠正措施或纠正措施未达到预期效果,公告机构应视情况限制、暂停或撤销任何证书或验证报告。
6. When taking assessment decisions, including when deciding on the need to suspend or withdraw a certificate or validation report in light of possible instances of non-compliance, notified bodies shall apply clear and pre-determined criteria.
6. 在作出评估决定时,包括在决定是否因可能存在的不合规情况而暂停或撤销证书或验证报告时,公告机构应适用明确且预先确定的标准。
7. When requested by a manufacturer or provider to do so, notified bodies shall cooperate and share all relevant information with notified bodies that have recognised its assessments and verifications in accordance with Article 62. Notified bodies shall establish an agreement for that purpose.
7. 当制造商或供应商提出请求时,公告机构应与根据第 62 条认可其评估和验证的公告机构合作并共享所有相关信息。公告机构应为此目的建立协议。
Article 56 第 56 条
Information obligations of notified bodies
通报机构的信息义务
1. Notified bodies shall inform the notifying authority of the following:
1. 通知机构应向通知主管当局通报以下事项:
|
(a) |
any refusal, restriction, suspension or withdrawal of certificates, validation reports or test reports; |
|
(b) |
any circumstances affecting the scope of, and conditions for, notification; |
|
(c) |
any request for information on assessment or verification activities carried out which they have received from competent national authorities; and |
|
(d) |
on request, third-party tasks in accordance with the assessment and verification systems carried out within the scope of their notification and any other activity performed, including cross-border activities and subcontracting. |
2. Notified bodies shall provide the other bodies notified under this Regulation which carry out similar third-party tasks in accordance with the assessment and verification systems and for products covered by the same harmonised technical specification or the same European assessment document with relevant information on issues relating to negative results from these assessments and verifications, in particular, any refusal, restriction, suspension, or withdrawal of certificates, validation reports or of test reports, and, upon request, positive results from those assessments.
2. 通知机构应向根据本条例通知的其他机构提供相关信息,这些机构根据评估和验证体系执行类似的第三方任务,并针对受相同协调技术规范或相同欧洲评估文件涵盖的产品,特别是关于这些评估和验证中出现的负面结果的问题,包括任何证书、验证报告或测试报告的拒绝、限制、暂停或撤销,并应要求提供这些评估的正面结果。
A notified body shall, upon request from another notified body, a competent national authority or the Commission inform the requesting party whether certificates, validation reports or test reports issued by it are valid, restricted, suspended or withdrawn.
通知机构应根据另一通知机构、主管国家当局或委员会的请求,告知请求方其签发的证书、验证报告或测试报告是否有效、受限、暂停或已撤销。
3. Where the Commission or a competent national authority of a Member State submits a request to a notified body established on the territory of another Member State relating to an assessment carried out by that notified body, it shall send a copy of that request to the notifying authority of that other Member State. The notified body concerned shall respond without delay and within 15 days at the latest to the request. The notifying authority shall ensure that such requests are resolved by the notified body unless there is a legitimate reason for not doing so.
3. 当委员会或成员国的主管国家当局向设立在另一成员国境内的公告机构提交与该公告机构进行的评估相关的请求时,应将该请求的副本发送给该另一成员国的通报当局。相关公告机构应立即且最迟在 15 天内对该请求作出回应。通报当局应确保公告机构解决此类请求,除非存在不予解决的正当理由。
4. Where notified bodies have or receive evidence that:
4. 当公告机构拥有或收到以下证据时:
|
(a) |
another notified body does not comply with the requirements laid down in Article 46 or its obligations; |
|
(b) |
a product placed on the market does not comply with this Regulation; |
|
(c) |
a product placed on the market, due to its physical condition, is likely to cause a serious risk, |
they shall alert and share such evidence with the relevant market surveillance authority or notifying authority, as appropriate.
他们应当向相关市场监管机构或公告机构(视情况而定)发出警报并共享此类证据。
Article 57 第 57 条
Implementing acts on notified bodies’ obligations
关于公告机构义务的实施措施
Where this is necessary to ensure a harmonised application of this Regulation and where the coordination group of notifying and designating authorities have not been able to resolve a dispute concerning their diverging practices, in accordance with Article 45, and only to the extent necessary to prevent diverging practices fragmenting the internal market for economic operators, the Commission may adopt implementing acts providing details on how to execute the obligations of notified bodies contained in Articles 55 and 56.
如有必要确保本条例的统一适用,且根据第 45 条,公告和指定主管当局协调小组未能解决其分歧做法的争议,且仅在防止分歧做法导致经济运营者内部市场分裂的必要范围内,委员会可通过实施措施,详细规定公告机构在第 55 条和第 56 条中所载义务的执行方式。
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 90(3).
这些实施法令应按照第 90 条第 3 款所述的审查程序予以采纳。
Article 58 第 58 条
Coordination of notified bodies
通报机构的协调
1. The Commission shall ensure that appropriate coordination and cooperation between bodies notified under this Regulation are put into place and properly operated in the form of a group of notified bodies.
1. 委员会应确保根据本条例通知的机构之间建立适当的协调与合作,并以通知机构小组的形式妥善运作。
Notified bodies shall participate in the work of that group, directly or by means of designated representatives. Notifying authorities shall ensure that notified bodies participate in the work of that group.
公告机构应直接或通过指定代表参与该小组的工作。通知当局应确保公告机构参与该小组的工作。
2. Notified bodies shall apply as general guidance any relevant documents produced as a result of the work of the group referred to in paragraph 1.
2. 公告机构应将第 1 款所述小组工作产生的任何相关文件作为一般指导原则加以应用。
3. Coordination and cooperation in the group referred to in paragraph 1 shall aim to ensure the harmonised application of this Regulation.
3. 第 1 款所述小组的协调与合作应旨在确保本条例的统一适用。
CHAPTER VII 第七章
SIMPLIFIED PROCEDURES 简化程序
Article 59 第 59 条
Replacement of type-testing and type-calculation
替代型式试验和型式计算
1. A manufacturer may replace type-testing or type-calculation with a specific section in the technical documentation referred to in Article 22(3) demonstrating that:
1. 制造商可用技术文件中第 22 条第 3 款所述的特定部分替代型式试验或型式计算,以证明:
|
(a) |
for one or several essential characteristics of the product, which the manufacturer places on the market, that product is deemed to achieve a certain level or class of performance without testing or calculation, or without further testing or calculation, in accordance with the conditions set out in the delegated acts referred to in Article 5(6); or |
|
(b) |
the product, covered by a harmonised technical specification or a European assessment document, which the manufacturer places on the market is a system made of components, which the manufacturer duly assembles following precise instructions, including compatibility criteria in the case of individual components, given by the provider of such a system or of a component thereof, who has already tested that system or that component for one or several of its essential characteristics in accordance with the relevant harmonised technical specification or European assessment document. When these conditions are satisfied and when the manufacturer has notably verified that the precise compatibility criteria of the provider are met, the manufacturer is entitled to declare performance corresponding to all or part of the test results provided to it for the system or the component; |
|
(c) |
the product, covered by a harmonised technical specification or by a European technical assessment, which the manufacturer places on the market, corresponds to a product-type of a product manufactured by another manufacturer and is already subject to type-testing or type-calculation. |
When the conditions in point (c) are satisfied, the manufacturer may declare the performance corresponding to all or part of the results of this other product. The manufacturer shall only apply this simplification after having obtained an authorisation of the other manufacturer, who remains responsible for the accuracy, reliability and stability of those test results.
当满足(c)点的条件时,制造商可以声明该其他产品全部或部分测试结果所对应的性能。制造商仅在获得另一制造商授权后方可采用此简化方法,且该另一制造商仍对这些测试结果的准确性、可靠性和稳定性负责。
2. If the assessment and verification system applicable includes a performance assessment by a notified body as set out in Annex IX, a notified body or TAB shall, in place of the assessment of the performance of the product set out in Annex IX, assess and certify the correct fulfilment of the obligations referred to in paragraph 1 of this Article.
2. 如果适用的评估和验证体系包括附件 IX 中规定的由公告机构进行的性能评估,公告机构或技术评审机构应代替附件 IX 中规定的产品性能评估,评估并认证本条第 1 款所述义务的正确履行。
Article 60 第 60 条
Use of simplified procedures by micro-enterprises
微型企业使用简化程序
1. A micro-enterprise may replace type-testing or type-calculation for an essential characteristic under assessment and verification system 3 set out in point 5 of Annex IX with a specific section in the technical documentation referred to in Article 22(3) providing data equivalent to the assessment required for this essential characteristic in accordance with the applicable harmonised technical specifications or European assessment document.
1. 微型企业可用技术文件中第 22 条第 3 款所指的特定部分,替代附件 IX 第 5 点所列的评估和验证体系 3 中对基本特性进行的型式试验或型式计算,该特定部分应提供与根据适用的协调技术规范或欧洲评估文件对该基本特性所要求的评估等效的数据。
2. A notified body or TAB shall, instead of the assessment of the performance of the product set out in Annex IX, assess and certify the correct fulfilment of the obligations referred to in paragraph 1 of this Article.
2. 通知机构或技术评估机构应代替附件 IX 中规定的产品性能评估,评估并认证本条第 1 款所述义务的正确履行。
Article 61 第 61 条
Custom-made non-series products
定制非系列产品
1. As an alternative to the exemption in Article 14, point (a), a manufacturer of a product that fulfils the conditions in Article 14, point (a), may replace the performance assessment of the product with a specific section in the technical documentation referred to in Article 22(3) demonstrating the compliance of that product with the applicable requirements and providing data equivalent to the data required by this Regulation and the applicable harmonised technical specifications or European assessment document.
1. 作为第 14 条(a)项豁免的替代方案,符合第 14 条(a)项条件的产品制造商,可以用技术文件中第 22 条第 3 款所述的特定部分替代产品性能评估,该部分证明该产品符合适用要求,并提供与本条例及适用的协调技术规范或欧洲评估文件所要求数据等效的数据。
2. If the assessment and verification system applicable includes a performance assessment by a notified body as set out in Annex IX, a notified body or TAB shall, in place of the assessment of the performance of the product set out in Annex IX, assess and certify the correct fulfilment of the obligations referred to in paragraph 1 of this Article.
2. 如果适用的评估和验证体系包括附件 IX 中规定的由公告机构进行的性能评估,公告机构或技术评审机构应代替附件 IX 中规定的产品性能评估,评估并认证本条第 1 款所述义务的正确履行。
Article 62 第 62 条
Recognition of assessment and verification by another notified body
由另一指定机构进行的评估和验证的认可
1. When a notified body is to assess and verify a certain product in accordance with Annex IX, it may refrain from the assessment and verification and recognise the assessment and verification undertaken by another notified body for the same economic operator where all of the following conditions apply:
1. 当指定机构根据附件 IX 对某一产品进行评估和验证时,若符合以下所有条件,可免于进行评估和验证,并认可另一指定机构对同一经济经营者所进行的评估和验证:
|
(a) |
the product has been correctly assessed and verified by the other notified body; |
|
(b) |
the assessed or verified economic operator agrees to share all relevant data and documents with the recognising notified body; and |
|
(c) |
the validity of the certificate is limited to the validity of the certificate issued by the other notified body. |
This paragraph shall also apply to validation reports and to assessments of calculation of the environmental sustainability undertaken under Regulation (EU) 2024/1781.
本段同样适用于根据条例(EU)2024/1781 进行的验证报告及环境可持续性计算的评估。
2. When a notified body is to assess and verify a certain product in accordance with Annex IX, it may refrain from the assessment and verification of its parts or materials and recognise the results of the assessment and verification by another notified body, if the provider of those parts or materials applied the required assessment and verification system to them and there is an agreement between the manufacturer of the product and the provider that ensures the free flow of all information between them and the notified bodies in view of ensuring compliance with this Regulation.
2. 当指定机构根据附件 IX 对某一产品进行评估和验证时,如该产品的部件或材料的提供者已对其应用了所需的评估和验证体系,且产品制造商与提供者之间存在确保双方及指定机构之间信息自由流通的协议,以确保符合本条例的要求,则该指定机构可免于对该产品部件或材料的评估和验证,并认可另一指定机构的评估和验证结果。
This paragraph shall also apply to assessments of the calculation of the environmental sustainability undertaken under Regulation (EU) 2024/1781.
本段同样适用于根据条例(EU)2024/1781 进行的环境可持续性计算的评估。
CHAPTER VIII 第八章
MARKET SURVEILLANCE AND SAFEGUARD PROCEDURES
市场监管和保障程序
Article 63 第 63 条
Complaint portal 投诉门户
1. Without prejudice to the obligations of economic operators under this Regulation and the activities of market surveillance authorities under Regulation (EU) 2019/1020, the Commission shall set up a system allowing any natural or legal person to share complaints or reports related to possible non-compliance with this Regulation.
1. 在不影响经济运营者根据本条例承担的义务及市场监管机构根据条例(欧盟)2019/1020 开展的活动的前提下,委员会应建立一套系统,允许任何自然人或法人分享与可能违反本条例相关的投诉或报告。
2. Where the Commission considers a complaint or report relevant and substantiated based on clearly defined criteria, it shall without undue delay transmit that complaint or report to the single liaison point of the Member State concerned for that single liaison point to follow-up with the relevant natural or legal person in accordance with Article 11(7), point (a) of Regulation (EU) 2019/1020.
2. 当委员会根据明确界定的标准认为某项投诉或报告具有相关性且有充分依据时,应毫不拖延地将该投诉或报告转交给相关成员国的单一联络点,由该单一联络点根据条例(欧盟)2019/1020 第 11 条第 7 款(a)项与相关自然人或法人进行后续跟进。
Article 64 第 64 条
Market surveillance authorities and single liaison point
市场监管机构和单一联络点
1. Member States shall designate, amongst their market surveillance authorities, one or more authorities that dispose of the particular knowledge needed to assess products both technically and legally.
1. 成员国应在其市场监管机构中指定一个或多个具备评估产品技术和法律所需特殊知识的机构。
2. Member States shall designate a single liaison point to act as the focal point for contacts with the Commission and single liaison points of other Member States which are competent under this Regulation, including for requests pursuant to Articles 22, 23 and 24 of Regulation (EU) 2019/1020.
2. 成员国应指定一个单一联络点,作为与委员会及其他根据本条例有权的成员国单一联络点的联系枢纽,包括根据《条例》(EU)2019/1020 第 22、23 和 24 条提出的请求。
3. Market surveillance authorities designated in accordance with paragraph 1 of this Article shall have all the powers listed in Article 14 of Regulation (EU) 2019/1020. For the purposes of this Regulation those powers shall also apply to all economic operators covered by this Regulation.
3. 根据本条第 1 款指定的市场监管机构应具备《条例》(EU)2019/1020 第 14 条列明的所有权力。为本条例之目的,这些权力亦适用于本条例涵盖的所有经济运营者。
4. For the purpose of market surveillance, investigation and enforcement, market surveillance authorities shall have the power to request from other authorities or bodies relevant information in their possession.
4. 为市场监管、调查和执法之目的,市场监管机构有权向其他当局或机构请求其所持有的相关信息。
Article 65 第 65 条
Procedure to deal with non-compliance
处理不合规行为的程序
1. Where a market surveillance authority of one Member State has sufficient reason to believe that certain products covered by a harmonised technical specification or for which a European technical assessment has been issued, or their manufacturer, are non-compliant, it shall carry out an evaluation in relation to those products and the manufacturer concerned covering the respective requirements laid down by this Regulation. The relevant economic operators shall, as necessary, cooperate with the market surveillance authorities.
1. 如果一个成员国的市场监管机构有充分理由相信某些受协调技术规范覆盖或已发布欧洲技术评估的产品,或其制造商,不符合规定,应对相关产品及制造商进行评估,涵盖本条例规定的相应要求。相关经济运营者应根据需要与市场监管机构合作。
Where, in the course of that evaluation, the market surveillance authority finds that the products or their manufacturer do not comply with the requirements and obligations laid down in this Regulation, it shall without delay require the relevant economic operator to take appropriate and proportionate corrective actions, as provided for in Article 16(3) of Regulation (EU) 2019/1020, to bring the non-compliance to an end or, if that is not possible, to withdraw the products from the market, or to recall them, all within a reasonable period which is commensurate with the nature of the non-compliance.
在评估过程中,如果市场监管机构发现产品或其制造商不符合本条例规定的要求和义务,应当立即要求相关经济运营者采取适当且相称的纠正措施,如《条例》(EU)2019/1020 第 16 条第 3 款所规定,以消除不合规情况;如果无法消除,应在合理期限内撤回产品或召回产品,该期限应与不合规性质相称。
The market surveillance authority shall inform the notified bodies accordingly, if notified bodies are involved.
如果涉及公告机构,市场监管机构应相应通知公告机构。
2. Where the market surveillance authority considers that the non-compliance is not limited to its national territory, it shall, via the single liaison point, inform the Commission and the other Member States of the results of the evaluation and of the actions which it has required the economic operator to take.
2. 当市场监管机构认为不合规情况不限于其国家领土时,应通过单一联络点,将评估结果及其要求经济经营者采取的措施通知委员会和其他成员国。
3. The economic operator shall ensure that all appropriate corrective action is taken in respect of all the products concerned that it has made available on the market throughout the Union.
3. 经济经营者应确保对其在整个联盟市场上提供的所有相关产品采取所有适当的纠正措施。
4. Where the relevant economic operator, within the period referred to in the second subparagraph of paragraph 1, does not take the corrective action referred to in paragraph 1, second subparagraph, or where the non-compliance persists, the market surveillance authority shall ensure that the product concerned is withdrawn or recalled, or that making it available on the market is prohibited or restricted.
4. 当相关经济经营者在第 1 段第二款所述期限内未采取第 1 段第二款所述的纠正措施,或不合规情况持续存在时,市场监管机构应确保有关产品被撤回或召回,或禁止或限制其在市场上的供应。
The market surveillance authority shall inform the public, and via the single liaison point the Commission and the other Member States, without delay, of those measures.
市场监管机构应立即将这些措施通知公众,并通过单一联络点通知委员会和其他成员国。
5. The information referred to in the second subparagraph of paragraph 4 shall include all available details, in particular the data necessary for the identification of the non-compliant products, the origin of those products, the nature of the non-compliance alleged and the risk involved, the nature and duration of national measures taken as well as the arguments put forward by the relevant economic operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to any of the following:
5. 第二款第 4 段所述的信息应包括所有可用的详细资料,特别是识别不合格产品所需的数据、该等产品的来源、所指称的不合格性质及所涉及的风险、采取的国家措施的性质和持续时间,以及相关经济经营者提出的理由。特别是,市场监管当局应指出不合格是否由于以下任何原因:
|
(a) |
failure of the products to achieve the declared performance; |
|
(b) |
failure of the products to meet product requirements established by delegated acts referred to in Article 7(1); |
|
(c) |
failure of the manufacturer to meet obligations; |
|
(d) |
shortcomings in the harmonised technical specifications, in a European assessment document, in the voluntary harmonised standards for product requirements the references of which have been published in the Official Journal of the European Union in accordance with Article 7(5) or (6) or in the common specifications established by implementing acts referred to in Article 8(1). |
6. Member States other than the Member State initiating the procedure shall without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the products concerned, and, in the event of disagreement with the notified national measure, of their objections.
6. 除启动程序的成员国外,其他成员国应立即将其采取的任何措施及其掌握的有关相关产品不合规的任何补充信息通知委员会和其他成员国;如对已通知的国家措施有异议,应提出反对意见。
7. Where, within two months of receipt of the information referred to in paragraph 4, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State in relation to the product concerned, that measure shall be deemed justified.
7. 若在收到第 4 款所述信息后两个月内,任何成员国或委员会均未对成员国针对相关产品采取的临时措施提出异议,则该措施应视为合理。
8. Member States shall ensure that appropriate restrictive measures are taken without delay in respect of the product or manufacturer concerned, such as withdrawal of the products from their market.
8. 成员国应确保对相关产品或制造商迅速采取适当的限制性措施,例如将产品从其市场撤回。
Article 66 第 66 条
Union safeguard procedure
欧盟保障程序
1. Where, on completion of the procedure set out in Article 65(4), (6) and (7), objections are raised against a measure taken by a Member State or where the Commission considers a national measure to be contrary to Union legislation, the Commission shall without delay enter into consultation with the Member States and the relevant economic operator and shall evaluate the national measure. The consultation period shall not exceed two months. On the basis of the results of that evaluation, the Commission shall endeavour to adopt implementing acts, within two additional months, after the end of consultation period, setting out its decision as to whether the measure is justified or not.
1. 在完成第 65 条第 4 款、第 6 款和第 7 款规定的程序后,如对成员国采取的措施提出异议,或委员会认为某项国家措施与欧盟立法相抵触,委员会应立即与成员国及相关经济运营者进行磋商,并对该国家措施进行评估。磋商期限不得超过两个月。根据评估结果,委员会应在磋商期结束后额外两个月内,努力通过实施法令,阐明其关于该措施是否合理的决定。
Those implementing acts shall be adopted in accordance with the advisory procedure referred in Article 90(2).
该等实施法令应按照第 90 条第 2 款所述的咨询程序予以通过。
The Commission shall address its decision to all Member States and shall immediately communicate it to them and to the relevant economic operator.
委员会应将其决定通知所有成员国,并立即将该决定传达给相关经济运营者。
2. If the national measure is considered to be justified, all Member States shall, without delay, ensure that appropriate restrictive measures, such as withdrawal, are taken in respect of the non-compliant product and shall inform the Commission accordingly. If the national measure is considered to be unjustified, the Member State concerned shall withdraw the measure.
2. 如果国家措施被认为是合理的,所有成员国应立即确保对不合规产品采取适当的限制措施,如撤回,并相应通知委员会。如果国家措施被认为是不合理的,相关成员国应撤销该措施。
3. Where the national measure is considered to be justified and the non-compliance of the product or its manufacturer is attributed to shortcomings in the harmonised technical specifications, European assessment documents, voluntary harmonised standards or common specifications established by implementing acts as referred to in Article 65(5), point (d), the Commission shall apply the procedure provided for in Article 5(9), Article 6(5), Article 7(6) or Article 36 of this Regulation or in Article 11 of Regulation (EU) No 1025/2012, as appropriate.
3. 如果国家措施被认为是合理的,且产品或其制造商的不合规归因于实施条例第 65 条第 5 款(d)项所述的协调技术规范、欧洲评估文件、自愿协调标准或共同规范的缺陷,委员会应适用本条例第 5 条第 9 款、第 6 条第 5 款、第 7 条第 6 款或第 36 条规定的程序,或适用条例(EU) No 1025/2012 第 11 条规定的程序,视情况而定。
Article 67 第 67 条
Compliant products which nevertheless present a risk
符合规定但仍存在风险的产品
1. Where, having performed an evaluation pursuant to Article 65(1), a market surveillance authority finds that, although a product is in compliance with this Regulation, it presents a risk to the health or safety of persons or, where applicable, to the environment or to other aspects of public interest protection, it shall require the relevant economic operator to take all appropriate measures to ensure that the products concerned, when placed on the market, no longer present that risk, to withdraw the products from the market or to recall them within a reasonable period, commensurate with the nature of the risk, which it may prescribe.
1. 根据第 65 条第 1 款进行评估后,市场监管机构发现尽管某产品符合本条例的规定,但其对人员健康或安全,或在适用情况下,对环境或其他公共利益保护方面构成风险的,应要求相关经济经营者采取一切适当措施,确保有关产品在投放市场时不再存在该风险,或者在其规定的合理期限内撤回或召回该产品,该期限应与风险性质相称。
2. The economic operator shall ensure that any corrective action is taken in respect of all the products concerned which that economic operator has made available on the market throughout the Union.
2. 经济经营者应确保对其在整个欧盟市场上提供的所有相关产品采取任何纠正措施。
3. The market surveillance authority shall, via the single liaison point, immediately inform the Commission and the other Member States. That information shall include all available details, in particular the data necessary for the identification of the product concerned, the origin and the supply chain of the product, the nature of the risk involved and the nature and duration of the national measures taken.
3. 市场监管机构应通过单一联络点,立即通知委员会和其他成员国。该信息应包括所有可用的详细资料,特别是识别相关产品所需的数据、产品的来源和供应链、所涉及风险的性质以及所采取的国家措施的性质和持续时间。
4. The Commission shall without delay consult the Member States and the relevant economic operators and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall adopt an implementing act setting out its decision whether the measure is justified or not and, where necessary, ordering appropriate measures.
4. 委员会应立即与成员国和相关经济运营者进行磋商,并评估所采取的国家措施。基于该评估结果,委员会应通过实施法令,阐明其是否认为该措施合理的决定,并在必要时下达适当的措施。
Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 90(2).
这些实施法案应按照第 90 条第 2 款所述的咨询程序通过。
5. The Commission shall address its decision to all Member States and shall immediately communicate it to them and to the relevant economic operator.
5. 委员会应将其决定发送给所有成员国,并应立即将其通知成员国及相关经济运营者。
Article 68 第 68 条
Market surveillance coordination and support
市场监管协调与支持
1. For the purposes of this Regulation, the administrative cooperation group set up pursuant to Article 30(2) of Regulation (EU) 2019/1020 (‘ADCO’) shall meet at regular intervals and, where necessary, at the reasoned request of the Commission or of two or more participating market surveillance authorities.
1. 为本条例之目的,根据条例(欧盟)2019/1020 第 30 条第 2 款设立的行政合作小组(“ADCO”)应定期召开会议,并在委员会或两个或多个参与市场监管机构提出有理由的请求时召开会议。
In the context of performing its tasks set out in Article 32 of Regulation (EU) 2019/1020, the ADCO shall support the implementation of this Regulation, namely by identifying common priorities for market surveillance.
在执行《欧盟条例》(EU)2019/1020 第 32 条规定的任务时,ADCO 应支持本条例的实施,具体包括确定市场监管的共同优先事项。
2. Based on priorities identified in consultation with the ADCO, the Commission shall:
2. 根据与 ADCO 协商确定的优先事项,委员会应:
|
(a) |
organise joint market surveillance and testing projects in areas of common interest; |
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(b) |
organise joint investment in market surveillance capacities, including equipment and IT tools; |
|
(c) |
organise common trainings for the staff of market surveillance authorities, notifying authorities and notified bodies, including on the correct interpretation and application of this Regulation and on methods and techniques relevant for applying or verifying compliance with it; |
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(d) |
draw up guidelines for the application and enforcement of this Regulation, including requirements and obligations set out in harmonised technical specifications adopted pursuant to this Regulation, as well as common practices and methodologies for effective market surveillance. |
The Union shall, where appropriate, finance the actions referred to in points (a), (b) and (c).
在适当情况下,联盟应资助第(a)、(b)和(c)点所述的行动。
3. The Commission shall provide technical and logistic support to ensure that the ADCO fulfils its tasks set out in this Article and in Article 32 of Regulation (EU) 2019/1020.
3. 委员会应提供技术和后勤支持,以确保 ADCO 履行本条款及《条例》(EU)2019/1020 第 32 条规定的任务。
Article 69 第 69 条
Recovery of costs 费用追偿
Where a product has been found to be non-compliant, market surveillance authorities shall have the right to recover from the economic operators who placed or made the product available on the market the costs of document inspection and physical product testing, provided that those costs are accompanied by a justification.
当产品被发现不合规时,市场监管机构有权向将该产品投放或提供于市场的经济运营者追偿文件检查和实物产品检测的费用,前提是这些费用附有合理的说明。
Article 70 第 70 条
Reporting and benchmarking
报告与基准对比
1. Market surveillance authorities shall enter into the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020 information on the nature and severity of any penalty imposed in relation to non-compliance with this Regulation.
1. 市场监管机构应将因不符合本条例而施加的任何处罚的性质和严重程度的信息录入《欧盟条例》(EU)2019/1020 第 34 条所述的信息与通信系统。
2. Every four years, by 30 June, the Commission shall, draw up a report based on the information entered by market surveillance authorities into the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020. The first of those reports shall be published by 9 January 2030.
2. 委员会应每四年一次,于 6 月 30 日前,根据市场监管机构录入《欧盟条例》(EU)2019/1020 第 34 条所述的信息与通信系统中的信息,编制一份报告。首份报告应于 2030 年 1 月 9 日前发布。
The report shall include:
报告应包括:
|
(a) |
information on the nature and number of checks performed by market surveillance authorities during the four previous calendar years pursuant to Article 34(4) and (5) of Regulation (EU) 2019/1020; |
|
(b) |
information on the levels of non-compliance identified and on the nature and severity of penalties imposed for the four previous calendar years in relation to products covered by harmonised technical specifications or CE marked based on a European technical assessment; |
|
(c) |
indicative benchmarks for market surveillance authorities in relation to the frequency of checks and the nature and severity of penalties imposed. |
3. The Commission shall publish the report referred to in paragraph 2 of this Article in the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020 and shall make public a summary of the report.
3. 委员会应在《欧盟条例》(EU)2019/1020 第 34 条所述的信息与通信系统中公布本条第 2 款提及的报告,并公开该报告的摘要。
CHAPTER IX 第九章
INFORMATION AND ADMINISTRATIVE COOPERATION
信息与行政合作
Article 71 第 71 条
Information systems for harmonised decision-making
用于统一决策的信息系统
1. The Commission shall establish and maintain an information and communication system for the collection, processing and storage of information, in a structured form, on issues relating to the interpretation or application of the rules laid down in or pursuant to this Regulation, with the aim of ensuring the harmonised application of those rules.
1. 委员会应建立并维护一个信息与通信系统,用于以结构化形式收集、处理和存储与本条例或根据本条例制定的规则的解释或适用相关的问题,旨在确保这些规则的统一适用。
In addition to the Commission and Member States, market surveillance authorities, the single liaison offices appointed under Article 10(3) of Regulation (EU) 2019/1020, the authorities designated under Article 25(1) of Regulation (EU) 2019/1020, notifying authorities, representatives of the group of notified bodies and of the organisation of TABs, and product contact points for construction shall be able to access the information and communication system.
除委员会和成员国外,市场监管机构、根据条例(EU)2019/1020 第 10 条第 3 款指定的单一联络办公室、根据条例(EU)2019/1020 第 25 条第 1 款指定的当局、通知当局、通知机构组及 TAB 组织的代表,以及建筑产品联络点均可访问该信息与通信系统。
2. The bodies listed in paragraph 1 may use the information and communication system to raise any question or issue related to the interpretation or application of the rules laid down in or pursuant to this Regulation, including their relationship to other provisions of Union law.
2. 第 1 款所列机构可使用该信息与通信系统提出与本条例或根据本条例制定的规则的解释或适用相关的任何问题或事项,包括这些规则与欧盟其他法律条款的关系。
3. For the purposes of paragraph 2, the bodies listed in paragraph 1 may raise questions or issues related to the following topics:
3. 为第 2 款之目的,第 1 款所列机构可提出与以下主题相关的问题或事项:
|
(a) |
the application or interpretation by any other body of the rules laid down in, or pursuant to, this Regulation in a way that diverges from their own practice; |
|
(b) |
questions or issues raised through the information and communication system related to the situation they are confronted with or to their own practice; |
|
(c) |
situations not foreseen by the rules laid down in or pursuant to this Regulation when first published or referred to in the Official Journal of the European Union, especially but not limited to situations brought about by the emergence of new products or business models; |
|
(d) |
whether the rules laid down in or pursuant to this Regulation apply to a situation to which other provisions of Union law also apply and the resulting question of which rules are to prevail. |
4. When raising a question or issue, the relevant body shall enter into the information and communication system information concerning:
4. 提出问题或议题时,相关机构应在信息与通信系统中录入以下信息:
|
(a) |
any decision taken in relation to the question or issue raised; |
|
(b) |
the rationale behind the approach taken; |
|
(c) |
any alternative approach it has identified and its rationale. |
5. Member States shall establish a national information system or email distribution service to inform their competent national authorities, the economic operators active on their territory, TABs and notified bodies with place of business on their territory and, on request, also other TABs and notified bodies, on all matters relevant for the correct interpretation or application of the rules laid down in or pursuant to this Regulation. In doing so, they shall take into account the information available in the information and communications system referred to in paragraph 1.
5. 成员国应建立国家信息系统或电子邮件分发服务,以便向其主管国家当局、在其境内活动的经济运营者、在其境内设有营业场所的技术评估机构(TAB)和公告机构,以及应要求向其他技术评估机构和公告机构,通报所有与正确解释或适用本条例或根据本条例制定的规则相关的事项。在此过程中,应考虑第 1 款所述信息和通信系统中可获得的信息。
6. Competent national authorities, TABs and notified bodies with a place of business in the respective Member State shall register themselves in the system or for the email distribution service and take account of all information transmitted via them. Economic operators may register themselves in the system or for the email distribution service. Member States shall take appropriate measures to bring the system or email distribution service to the attention of economic operators.
6. 具有相应成员国营业地点的主管国家当局、技术评审机构(TAB)和公告机构应在系统中或电子邮件分发服务中进行注册,并关注通过其传输的所有信息。经济运营者可在系统中或电子邮件分发服务中自行注册。成员国应采取适当措施,将系统或电子邮件分发服务告知经济运营者。
7. The national information system or email distribution service shall be able to receive complaints from any natural or legal person, including TABs and notified bodies, on the uneven application of the rules laid down in or pursuant to this Regulation. If deemed appropriate, the single liaison point shall forward such complaints to their peers in other Member States and to the Commission.
7. 国家信息系统或电子邮件分发服务应能够接收任何自然人或法人,包括技术评估机构(TABs)和公告机构,关于本条例或根据本条例制定的规则不均等适用的投诉。如认为适当,单一联络点应将此类投诉转发给其他成员国的对应机构及委员会。
Article 72 第 72 条
Product contact points for construction
建筑产品联系点
1. Member States shall support economic operators by product contact points for construction. Member States shall designate and maintain at least one product contact point for construction on their territory and shall ensure that their product contact points for construction have sufficient powers and adequate resources for the proper performance of their tasks. They shall ensure that product contact points for construction deliver their services in accordance with Regulation (EU) 2018/1724 and that they coordinate with the product contact points for mutual recognition established pursuant to Article 9(1) of Regulation (EU) 2019/515 of the European Parliament and of the Council (29).
1. 成员国应通过建筑产品联络点支持经济运营者。成员国应在其境内指定并维持至少一个建筑产品联络点,并确保其建筑产品联络点具备充分的权限和充足的资源,以妥善履行其职责。成员国应确保建筑产品联络点按照《欧盟条例》(EU)2018/1724 提供服务,并与根据欧洲议会和理事会《条例》(EU)2019/515 第 9 条第 1 款设立的相互承认产品联络点进行协调(29)。
2. Product contact points for construction shall provide, at the request of an economic operator or a competent national authority of another Member State, any useful product related information, such as:
2. 建筑产品接触点应根据经济运营者或其他成员国主管国家当局的要求,提供任何有用的产品相关信息,例如:
|
(a) |
electronic copies of, or online access to, the national technical rules and national administrative procedures applicable to products in the territory in which the product contact points for construction is established; |
|
(b) |
information on whether those products are subject to prior authorisation under national law; |
|
(c) |
rules applicable to the incorporation, assembling or installation of products. |
Product contact points for construction shall also provide information on product related provisions of this Regulation and of acts adopted in accordance with it.
建筑产品联络点还应提供有关本条例及根据本条例通过的法律文件中产品相关规定的信息。
3. Product contact points for construction shall provide information free of charge within 15 working days of receiving any request under paragraph 2.
3. 建筑产品联络点应在收到第 2 款规定的任何请求后 15 个工作日内免费提供信息。
4. Product contact points for construction shall be able to carry out their functions in a manner that avoids conflicts of interest, particularly in respect of the procedures for obtaining the CE marking.
4. 建筑产品联系点应能够以避免利益冲突的方式履行其职能,特别是在获取 CE 标志的程序方面。
5. Paragraphs 1 to 4 apply also to products which have not yet been covered by harmonised technical specifications.
5. 第 1 至 4 款同样适用于尚未涵盖在协调技术规范中的产品。
6. The Commission shall publish and keep up-to-date a list of the national product contact points for construction.
6. 委员会应公布并保持建筑产品国家联系点名单的最新状态。
Article 73 第 73 条
Training and exchange of staff
培训和人员交流
1. Market surveillance authorities, product contact points for construction, designating authorities, TABs, notifying authorities, and notified bodies shall ensure that their staff:
1. 市场监管机构、建筑产品联络点、指定机构、技术评审机构(TABs)、通报机构和公告机构应确保其工作人员:
|
(a) |
keep up-to-date in their area of competence and receive periodic additional training to that end; and |
|
(b) |
receive periodically training on the harmonised interpretation and application of the rules laid down in or pursuant to this Regulation. |
2. The Commission shall, periodically and at least once a year, organise training events jointly for the staff of market surveillance authorities, product contact points for construction, designating authorities, notifying authorities, and notified bodies. The Commission shall organise these training events in cooperation with the Member States.
2. 委员会应定期且至少每年一次,为市场监管机构工作人员、建筑产品联络点、指定机构、通知机构和公告机构联合组织培训活动。委员会应与成员国合作组织这些培训活动。
The training events shall be open to the participation of the staff of the authorities designated under Article 25(1) of Regulation (EU) 2019/1020, the single liaison offices appointed under Article 10(3) of Regulation (EU) 2019/1020 and, where appropriate, of other authorities of the Member States involved in the implementation or enforcement of this Regulation.
培训活动应向根据《条例》(EU)2019/1020 第 25 条第 1 款指定的机构工作人员、根据该条例第 10 条第 3 款任命的单一联络办公室工作人员,以及在适当情况下,参与本条例实施或执行的成员国其他机构工作人员开放。
3. The Commission may organise, in cooperation with the Member States, programmes for the exchange of staff between the market surveillance authorities, notifying authorities, and notified bodies of two or more Member States.
3. 委员会可与成员国合作,组织两个或多个成员国的市场监管机构、通报机构和公告机构之间的人员交流项目。
Article 74 第 74 条
Shared roles and joint decision-making
共享职责与联合决策
1. In order to fulfil their obligations under this Regulation with regard to market surveillance, designation and supervision of TABs, notified bodies, and product contact points for construction, Member States may designate:
1. 为履行本条例关于市场监管、TABs、公告机构及建筑产品联络点的指定和监督义务,成员国可指定:
|
(a) |
a body or authority set up in cooperation with another Member State or other Member States for the purpose of joint designation; |
|
(b) |
a body or authority already designated by another Member State for the same purpose, in cooperation with that Member State. |
The Member States concerned shall jointly ensure that the shared bodies or authorities meet all relevant requirements. They shall be jointly responsible for them, whilst decisions taken towards natural or legal persons on a certain Member State shall be legally attributable only to that Member State.
相关成员国应共同确保共享的机构或当局符合所有相关要求。它们应共同承担责任,而针对某一成员国的自然人或法人所作出的决定,仅在法律上归属于该成员国。
2. The authorities of different Member States may, without prejudice to their individual obligations under this Regulation or other legislative acts, share resources and responsibilities in order to ensure the harmonised application or effective enforcement of this Regulation.
2. 不同成员国的当局在不影响其根据本条例或其他立法行为承担的个别义务的前提下,可以共享资源和责任,以确保本条例的统一适用或有效执行。
To that end, they may also:
为此,它们还可以:
|
(a) |
take joint decisions, especially in relation to joint cross-border activities or in relation to economic operators active on the territory of the relevant Member States; |
|
(b) |
establish common projects, such as joint market surveillance or testing projects; |
|
(c) |
pool resources for specific purposes, such as building up testing capacity or for internet surveillance; |
|
(d) |
delegate the execution of tasks to a peer authority of another Member State, whilst staying formally responsible for the decisions taken by that authority; |
|
(e) |
transfer a task from one Member State to the other, provided that such transfer is clearly communicated to all concerned. |
The relevant Member States shall be jointly responsible for the actions taken in accordance with this paragraph.
相关成员国应对根据本款采取的行动共同负责。
CHAPTER X 第十章
DIGITAL PRODUCT PASSPORT
数字产品护照
Article 75 第 75 条
Construction digital product passport system
建筑数字产品护照系统
1. The Commission shall adopt delegated acts in accordance with Article 89 to supplement this Regulation by setting up a construction digital product passport system, in accordance with the conditions set out in this Chapter.
1. 委员会应根据第 89 条通过授权法案,补充本条例,建立建筑数字产品护照系统,符合本章规定的条件。
2. The construction digital product passport system shall:
2. 建筑数字产品护照系统应当:
|
(a) |
be compatible with, interoperable with and based upon the digital product passport established by Regulation (EU) 2024/1781, without compromising interoperability with Building Information Modelling (BIM), and taking into account the specific characteristics and requirements related to construction products; |
|
(b) |
have the functionalities required to implement and manage digital product passports referred to in Article 76; |
|
(c) |
determine the actors, including economic operators, clients, deinstallers, users and competent national authorities, which are to have access to information in the digital product passport and to what information they are to have access, taking into account the need to protect intellectual property rights, and sensitive commercial information, and to ensure the safety of construction works; |
|
(d) |
determine the actors, including manufacturers, authorised representatives, importers, distributors and digital product passport service providers, which are allowed to introduce or update the information in the digital product passport, including where necessary the creation of a new digital product passport, and what information they may introduce or update; |
|
(e) |
lay down detailed arrangements for updating the information in the digital product passport of an existing product; |
|
(f) |
establish procedures to ensure the availability of digital product passports after an insolvency, a liquidation or a cessation of activity in the Union of the economic operator that created the digital product passport or, if necessary, after the obligations of manufacturers to ensure its availability have expired, including the establishment of a back-up system by digital product passport service providers; |
|
(g) (g) |
establish requirements for digital product passport service providers, including, if required, a certification scheme to verify such requirements, to be based upon developments under Regulation (EU) 2024/1781 for the same purpose, as far as possible; |
|
(h) |
when required, lay down more detailed or alternative rules and procedures related to the life cycle of identifiers, data carriers, digital credentials and the digital product passport registry to those established by Regulation (EU) 2024/1781 for the same purpose; |
|
(i) |
ensure that the system is accessible for period of 25 years after the last product corresponding to its product type has been placed on the market and that the economic operator makes available the digital product passport for at least 10 years, without„ in the case of a longer period, creating a disproportionate cost and burden for the economic operators; |
|
(j) |
take into account the need to ensure the availability of information for the reuse and remanufacturing of products. |
Article 76 第 76 条
Digital product passport
数字产品护照
1. The information in the digital product passport shall be accurate, complete, and up-to-date.
1. 数字产品护照中的信息应准确、完整且保持最新。
2. A digital product passport for a product under this Regulation shall:
2. 根据本条例,产品的数字产品护照应当:
|
(a) |
include the following information:
|
|
(b) |
be connected to one or more data carriers; |
|
(c) |
be accessible by electronic means through the data carrier displayed, in accordance with Article 18(2), point (g); |
|
(d) |
correspond to the product type and its unique identification code referred to in Article 22(5); |
|
(e) |
be accessible free of charge to all economic operators, clients, users and authorities through the data carrier; |
|
(f) |
give different levels of access to the construction digital product passport system; |
|
(g) (g) |
allow actors specified in the construction digital product passport system to introduce or to update the information in the digital product passport; |
|
(h) |
be accessible for an established period after the last product corresponding to its product type has been placed on the market. |
3. The requirements referred to in paragraph 2 shall:
3. 第 2 款所述的要求应当:
|
(a) |
ensure that actors along the value chain can easily access and understand product information relevant to them; |
|
(b) |
facilitate the verification of product compliance by competent national authorities; and |
|
(c) |
improve traceability of products along the value chain. |
4. Products in respect of which the exemption established in Article 14 is applied are also exempt from the obligation to provide a digital product passport.
4. 对于适用第 14 条规定的豁免的产品,也免于提供数字产品护照的义务。
Article 77 第 77 条
General requirements for the digital product passport
数字产品护照的一般要求
1. A digital product passport shall meet the following conditions:
1. 数字产品护照应满足以下条件:
|
(a) |
it shall be connected through one or more data carriers to a persistent unique identification code of the product type; |
|
(b) |
the data carrier shall be affixed in accordance with Article 18(2), point (g); |
|
(c) |
the data carrier shall comply with Article 79(1); |
|
(d) |
all information included in the digital product passport shall be based on open standards, developed with an interoperable format and shall, as appropriate, be machine-readable, structured, searchable and transferable through an open interoperable data exchange network, without ‘vendor lock-in’, in accordance with the essential requirements set out in Article 78; documents provided together with the declaration of performance and conformity referred to in Article 76(2)(a)(i) and technical documentation referred to in Article 76(2)(a)(iii) shall be exempted from this obligation when justified for technical reasons; |
|
(e) |
personal data related to the end-user of the product shall not be stored in the digital product passport without the explicit consent of the end-user in compliance with Article 6 of Regulation (EU) 2016/679 of the European Parliament and of the Council (30); |
|
(f) |
the information in the digital product passport shall include a reference to the product type referred to in Article 76(2), point (d); |
|
(g) (g) |
the access to information included in the digital product passport shall be regulated in accordance with the essential requirements set out in Article 78 and the specific access rights shall be identified in accordance with construction digital product passport system levels of access; |
|
(h) |
the declaration of performance and conformity referred to in Article 76(2), point (a)(i), shall follow the guidelines issued in accordance with Article 16(3). |
2. Where other Union legislation requires or allows the inclusion of specific information in the digital product passport, that information may be included in the digital product passport in accordance with the delegated act referred to in Article 75(1).
2. 当其他欧盟立法要求或允许在数字产品护照中包含特定信息时,可根据第 75 条第 1 款所述的授权法案将该信息包含在数字产品护照中。
3. The manufacturer placing the product on the market shall provide actors making the products available on the market online or through other means of distance sales with a digital copy of the data carrier and the product identifier to allow them to make it accessible to customers where they cannot physically access the product. The economic operator shall provide that digital copy or a webpage link free of charge and within 5 working days of receiving the request.
3. 将产品投放市场的制造商应向通过在线或其他远程销售方式将产品提供给市场的经营者提供数据载体和产品标识符的数字副本,以便他们在客户无法实物接触产品时使其可访问。经济经营者应免费提供该数字副本或网页链接,并在收到请求后的 5 个工作日内提供。
Article 78 第 78 条
Technical design and operation of the digital product passport
数字产品护照的技术设计与运行
The technical design and operation of the digital product passport shall comply with the following essential requirements:
数字产品护照的技术设计和运行应符合以下基本要求:
|
(a) |
digital product passports shall be fully interoperable with other digital product passports as regards the technical, semantic and organisational aspects of end-to-end communication and data transfer; |
|
(b) |
a recipient of the digital product passport shall have easy access, free of charge, to it based on the recipient’s respective access rights in the construction digital product passport system; |
|
(c) |
the data included in the digital product passport shall be stored as specified in the construction digital product passport system referred to in Article 75; |
|
(d) |
if the data included in the digital product passport is stored or otherwise processed by authorised operators or digital product passport service providers, they shall not be allowed to sell, reuse or process such data, in whole or in part, beyond what is necessary for the provision of the relevant storing or processing services, unless this is specifically agreed with the economic operator placing the product on the market; |
|
(e) |
the digital product passport shall remain available for the period specified in Article 76(2), point (h), including after an insolvency, a liquidation or a cessation of activity in the Union of the economic operator that created the digital product passport, and shall fulfil the conditions established in accordance with Article 75(2), point (f), as regards the obligation to establish a back-up system; |
|
(f) |
the right to access and to introduce, modify or update information in the digital product passport shall be restricted to the access rights specified in the construction digital product passport system; |
|
(g) (g) |
protection of information that constitutes trade secrets within the meaning of Article 2(1) Directive (EU) 2016/943 of the European Parliament and of the Council (31) or intellectual property rights shall be ensured; |
|
(h) |
data authentication, reliability and integrity shall be ensured; |
|
(i) |
digital product passports shall be designed and operated so that a high level of security and privacy is ensured and fraud is avoided. |
Article 79 第 79 条
Unique identifiers and digital product passport registry
唯一标识符和数字产品护照登记册
1. Article 12 of Regulation (EU) 2024/1781 shall apply for the purposes of the implementation of this Regulation as regards unique identifiers and data carriers unless the delegated act referred to in Article 75(1) of this Regulation lays down more detailed or alternative rules related to those unique identifiers and data carriers, as referred to in Article 75(2)(h) of this Regulation.
1. 除非本条例第 75 条第 1 款所指的授权法案就本条例第 75 条第 2 款(h)项所述的唯一标识符和数据载体规定了更详细或替代的规则,否则为实施本条例有关唯一标识符和数据载体的目的,应适用《条例(欧盟)2024/1781》第 12 条的规定。
2. Article 13 of Regulation (EU) 2024/1781 shall apply for the purposes of the implementation of this Regulation as regards the digital product passport registry unless the delegated act referred to in Article 75(1) of this Regulation lays down more detailed or alternative rules related to that registry, as referred to in Article 75(2)(h) of this Regulation.
2. 对于数字产品护照登记册的实施,本条例应适用条例(欧盟)2024/1781 的第 13 条,除非本条例第 75 条第 1 款所指的授权法案就该登记册制定了更详细或替代性的规则,如本条例第 75 条第 2 款(h)项所述。
3. Article 14 of Regulation (EU) 2024/1781 shall apply for the purposes of implementation of this Regulations as regards the web portal for information in the digital product passport.
3. 根据本条例的实施,关于数字产品护照信息的网络门户,应适用《欧盟条例》(EU)2024/1781 第 14 条的规定。
Article 80 第 80 条
Mandatory use and technical adaptation
强制使用和技术适应
1. Six months after the entry into force of the delegated act referred to in Article 75(1), the system shall be fully operational and shall be fulfilling its intended objectives, including the functionalities provided for in Article 76. 18 months after the entry into force of the delegated act referred to in Article 75(1) the obligations established pursuant to Article 22(7) shall apply. The system may be used by manufacturers voluntarily in the interim period.
1. 自第 75 条第 1 款所指授权法案生效之日起六个月内,系统应全面投入运行并实现其预期目标,包括第 76 条规定的功能。自第 75 条第 1 款所指授权法案生效之日起 18 个月后,应适用根据第 22 条第 7 款确立的义务。在此过渡期间,制造商可自愿使用该系统。
2. The Commission is empowered to adopt delegated acts in accordance with Article 89 to amend this Regulation to:
2. 委员会有权根据第 89 条通过授权法案修改本条例,以:
|
(a) |
further specify, add and remove functionalities referred to in Article 75(2) in order to adapt it to technical progress or to adapt it to the once-only principle in relation to information requirements in other Union law; |
|
(b) |
revise Articles 77(1) and 78 of this Regulation to ensure compatibility and interoperability with Regulation (EU) 2024/1781. |
CHAPTER XI 第十一章
INTERNATIONAL COOPERATION
国际合作
Article 81 第 81 条
International cooperation
国际合作
1. For the purposes of the protection of health and safety of persons or of the environment, the Commission may, cooperate with authorities of third countries or international organisations in the field of application of this Regulation. Such cooperation may include:
1. 为了保护人员健康和安全或环境,委员会可与第三国当局或国际组织在本条例适用领域内进行合作。此类合作可包括:
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(a) |
the exchange of information on enforcement activities and measures related to safety and protection of the environment, including market surveillance; |
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(b) |
the exchange of data of economic operators; |
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(c) |
the exchange of information on assessment methods and product testing; |
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(d) |
the exchange of information on product recalls, requests for corrective actions and other similar actions; |
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(e) |
cooperation on scientific, technical, and regulatory matters, aiming to improve product safety or the protection of the environment and consumers; |
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(f) |
the exchange of information on emerging issues of significant environmental, health and safety relevance; |
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(g) (g) |
the exchange of information on standardisation-related activities; |
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(h) |
the exchange of officials. |
The exchange of information pursuant to this paragraph shall respect confidentiality rules and comply with applicable Union law.
根据本款进行的信息交换应遵守保密规则,并符合适用的欧盟法律。
2. The information exchange referred to in paragraph 1 may take the form of:
2. 第 1 款所述的信息交换可以采取以下形式:
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(a) |
a non-systematic exchange, in duly justified and specific cases; or |
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(b) |
a systematic exchange, based on an administrative arrangement specifying the type of information to be exchanged and the modalities for the exchange. |
The Commission shall regularly inform Member States about the cooperation activities with third countries or international organisations that it undertakes pursuant to the first subparagraph.
委员会应定期向成员国通报其根据第一款进行的与第三国或国际组织的合作活动。
3. The Commission may adopt implementing acts, giving authorities of selected third countries that voluntarily apply this Regulation, or that have regulatory systems for construction products similar to this Regulation, access to or the right to fully participate in one or more of the following:
3. 委员会可通过实施法令,赋予自愿适用本条例的选定第三国当局,或其建设产品监管体系与本条例相似的第三国当局,访问权或完全参与以下一项或多项的权利:
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(a) |
the information and communication system established in accordance with Article 71(1); |
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(b) |
the construction digital product passport system set up in accordance with Article 75; |
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(c) |
the training events organised in accordance with Article 73(2). |
Access to the systems and events referred to in the first subparagraph shall be granted on condition that the third country concerned commits to act against economic operators that infringe this Regulation from their territory, and to ensure confidentiality.
对第一款所述系统和活动的访问应以相关第三国承诺对其境内违反本条例的经济运营者采取行动并确保保密为条件。
Full participation in the systems referred to in Articles 71 and 75 may only be granted where agreements between the European Union and third countries so provide. Such participation may be offered to third countries provided that the third country’s legislation is aligned with this Regulation and third country competent national authorities recognise certificates issued by notified bodies or European technical assessments in accordance with this Regulation. Such participation shall be subject to the fulfilment of the same obligations as those which apply to Member States under this Regulation, including notification and follow-up obligations.
仅当欧盟与第三国之间的协议有此规定时,方可完全参与第 71 条和第 75 条所述的系统。只要第三国的立法与本条例保持一致,且第三国主管国家当局承认根据本条例由公告机构或欧洲技术评估机构签发的证书,即可向第三国提供此类参与。此类参与应遵守与成员国根据本条例适用的相同义务,包括通知和后续义务。
The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the advisory procedure referred to in Article 90(2).
本段第一款所述的实施法案应根据第 90 条第 2 款所述的咨询程序予以通过。
4. Any information exchange under this Article, to the extent it involves personal data, shall be carried out in accordance with Union data protection rules. If no adequacy decision pursuant to Article 45 of Regulation (EU) 2016/679 has been adopted by the Commission in respect of the third country or international organisation concerned, the information exchange shall exclude personal data. If an adequacy decision for the third country or international organisation has been adopted, the information exchange with that third country or international organisation may contain personal data falling within the scope of the adequacy decision but only to the extent that such exchange is necessary for the sole purpose of the protection of health and safety of persons or of the environment.
4. 根据本条款进行的任何信息交换,如涉及个人数据,应遵守欧盟数据保护规则。若委员会未就相关第三国或国际组织根据《条例》(EU)2016/679》第 45 条作出充分性决定,则信息交换应排除个人数据。若已对该第三国或国际组织作出充分性决定,则与该第三国或国际组织的信息交换可包含属于充分性决定范围内的个人数据,但仅限于为保护人员或环境的健康与安全的唯一目的所必需的范围内。
CHAPTER XII 第十二章
INCENTIVES AND PUBLIC PROCUREMENT
激励措施与公共采购
Article 82 第 82 条
Member State incentives for construction products
成员国对建筑产品的激励措施
Where Member States provide incentives for a product category for which the performance is expressed as a class of performance referred to in Article 5(5) or as a class included in environmental sustainability labelling referred to in Article 22(9), those incentives shall be targeted at the highest two classes of performance.
当成员国为某一产品类别提供激励措施,而该类别的性能以第 5 条第 5 款所述的性能等级或第 22 条第 9 款所述的环境可持续性标签中的等级表示时,该激励措施应针对性能最高的两个等级。
Where classes of performance are defined in relation to more than one sustainability parameter, it shall be indicated in relation to which parameter this Article should be implemented.
当绩效类别涉及多个可持续性参数时,应指明本条款应针对哪个参数实施。
When doing so, the Commission shall take into account the following criteria:
在这样做时,委员会应考虑以下标准:
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(a) |
the number of products in each class of performance; and |
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(b) |
the need to ensure the affordability of the products meeting those requirements, in order to avoid significant negative impacts on consumers. |
Article 83 第 83 条
Green public procurement
绿色公共采购
1. The Commission shall adopt delegated acts in accordance with Article 89 to supplement this Regulation by specifying mandatory minimum environmental sustainability requirements for construction products.
1. 委员会应根据第 89 条通过授权法案,补充本条例,具体规定建筑产品的强制性最低环境可持续性要求。
2. For procurement procedures falling within the scope of Directives 2014/24/EU (32) or 2014/25/EU (33) of the European Parliament and of the Council, where contracts require minimum environmental sustainability performance for construction products as regards their essential characteristics covered by harmonised technical specifications, contracting authorities and contracting entities shall apply the mandatory minimum environmental sustainability requirements laid down in the delegated acts referred to in paragraph 1.
2. 对于属于欧洲议会和理事会指令 2014/24/EU(32)或 2014/25/EU(33)范围内的采购程序,若合同要求建筑产品在其由协调技术规范涵盖的基本特性方面达到最低环境可持续性绩效,采购当局和采购实体应适用第 1 款所述授权法案中规定的强制性最低环境可持续性要求。
This shall not prevent contracting authorities and contracting entities from establishing:
这不应妨碍采购当局和采购实体建立:
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(a) |
more ambitious environmental sustainability requirements related to essential characteristics referred in the first subparagraph; or |
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(b) |
additional environmental sustainability requirements related to other essential characteristics than those referred in the first subparagraph. |
3. Member States and the Commission shall provide technical assistance and advice to contracting authorities and contracting entities in charge of public procurement on how to comply with mandatory minimum environmental sustainability requirements laid down in the delegated acts referred to in paragraph 1.
3. 成员国和委员会应向负责公共采购的采购当局和采购实体提供技术援助和建议,指导其如何遵守第 1 款所述授权法案中规定的强制性最低环境可持续性要求。
4. Mandatory minimum environmental sustainability requirements laid down in the delegated acts referred to in paragraph 1 for public contracts awarded by contracting authorities or contracting entities may, as appropriate to the product family or product category concerned, take the form of:
4. 委托法案第 1 款所述的公共合同中,授予采购当局或采购实体的强制性最低环境可持续性要求,可根据相关产品系列或产品类别的适用情况,采取以下形式:
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(a) |
‘technical specifications’ within the meaning of Article 42 of Directive 2014/24/EU and Article 60 of Directive 2014/25/EU; |
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(b) |
‘selection criteria’ within the meaning of Article 58 of Directive 2014/24/EU and Article 80 of Directive 2014/25/EU; |
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(c) |
‘conditions for performance of contracts’ within the meaning of Article 70 of Directive 2014/24/EU and Article 87 of Directive 2014/25/EU; |
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(d) |
‘contract award criteria’ within the meaning of Article 67 of Directive 2014/24/EU and of Article 82 of Directive 2014/25/EU. |
5. When establishing mandatory minimum environmental sustainability requirements pursuant to paragraph 1 for public contracts, the Commission shall, in line with paragraphs 13 and 28 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making, consult experts designated by each Member State and relevant stakeholders, carry out an impact assessment and take into account at least the following criteria:
5. 在根据第 1 款为公共合同制定强制性最低环境可持续性要求时,委员会应根据 2016 年 4 月 13 日关于更好立法的机构间协议第 13 和 28 款的规定,咨询各成员国指定的专家和相关利益相关者,进行影响评估,并至少考虑以下标准:
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(a) |
the value and volume of public contracts awarded for the product family or product category concerned; |
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(b) |
the environmental benefits resulting from the uptake of products in the highest two classes of performance; |
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(c) |
the need to ensure sufficient demand for more environmentally sustainable products; |
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(d) |
the economic feasibility, for contracting authorities or contracting entities, of buying more environmentally sustainable products, without entailing disproportionate costs, and the availability of those products on the market; |
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(e) |
the market situation at Union level of the relevant product family or product category; |
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(f) |
the effects of the requirements on competition; |
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(g) (g) |
the impact on, and needs of, SMEs; |
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(h) |
the Members States’ regulatory needs and different climate conditions. |
The first impact assessment shall be launched by the Commission by 31 December 2026.
首次影响评估应由委员会于 2026 年 12 月 31 日前启动。
6. Contracting authorities and contracting entities may on an exceptional basis decide not to apply paragraph 2 of this Article where, after preliminary market consultation in line with Article 40 of Directive 2014/24/EU and Article 58 of Directive 2014/25/EU, it was found that:
6. 订约当局和订约实体可在特殊情况下决定不适用本条第 2 款,前提是根据 2014/24/EU 指令第 40 条和 2014/25/EU 指令第 58 条进行初步市场咨询后,发现:
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(a) |
the required construction product can only be supplied by a specific economic operator, and no reasonable alternative or substitute exists; |
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(b) |
no suitable tenders or no suitable requests to participate have been submitted in response to a previous public procurement procedure; or |
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(c) |
the application of paragraph 1 or the incorporation of the required construction product in construction works would oblige that contracting authority or contracting entity to incur disproportionate costs, or would result in incompatibility or technical difficulties. |
Contracting authorities and contracting entities may presume that estimated contract value differences above 10 %, based on objective and transparent data, are disproportionate.
采购当局和采购实体可以推定,基于客观且透明的数据,估计合同价值差异超过 10%属于不相称。
When contracting authorities and contracting entities use the derogation in this paragraph, the procurement procedure cannot be considered to be environmentally sustainable in relation to the construction products to which the exceptions have been applied.
当采购主管部门和采购实体使用本段中的例外情况时,采购程序不得被视为在所适用例外的建筑产品方面具有环境可持续性。
Every three years, Member States shall report to the Commission about the use of this paragraph, in accordance with Article 83 of Directive 2014/24/EU.
每三年,成员国应根据 2014/24/EU 指令第 83 条的规定,向委员会报告本款的使用情况。
This paragraph shall be without prejudice to the possibility of excluding abnormally low tenders under Article 69 of Directive 2014/24/EU and Article 84 of Directive 2014/25/EU.
本段不影响根据 2014/24/EU 指令第 69 条和 2014/25/EU 指令第 84 条排除异常低报价的可能性。
7. The EU Ecolabel and other national or regional EN ISO 14024 type I ecolabelling schemes officially recognised in accordance with Article 11 of Regulation (EC) No 66/2010 of the European Parliament and of the Council (34) may be used to demonstrate compliance with the minimum environmental sustainability requirements where such label complies with the requirements set out in Article 19 of this Regulation.
7. 欧盟生态标签及根据欧洲议会和理事会第(EC)66/2010 号条例(34)第 11 条正式认可的其他国家或地区 EN ISO 14024 型 I 生态标签方案,可用于证明符合最低环境可持续性要求,前提是该标签符合本条例第 19 条规定的要求。
CHAPTER XIII 第十三章
REGULATORY STATUS OF PRODUCTS
产品的监管状态
Article 84 第 84 条
Regulatory status of products
产品的监管状态
Upon a duly substantiated request of a Member State or on its own initiative, the Commission may adopt implementing acts, determining whether or not a specific item, or category of items is a product within the meaning of this Regulation.
根据成员国的正式合理请求或委员会自身的主动,委员会可通过实施法案,确定某一具体物品或物品类别是否属于本条例意义上的产品。
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 90(3).
这些实施法令应按照第 90 条第 3 款所述的审查程序予以采纳。
CHAPTER XIV 第十四章
EMERGENCY PROCEDURES 紧急程序
Article 85 第 85 条
Application of emergency procedures
紧急程序的适用
1. Articles 86 to 88 of this Regulation shall apply only if the Commission has adopted an implementing act pursuant to Article 28 of Regulation (EU) 2024/2747 with respect to construction products covered by this Regulation.
1. 本条例第 86 至 88 条仅在委员会根据条例(EU) 2024/2747 第 28 条就本条例涵盖的建筑产品通过实施法案时适用。
2. Articles 86 to 88 of this Regulation shall apply only to construction products, which have been designated as crisis-relevant goods pursuant to Article 18(4) of Regulation (EU) 2024/2747.
2. 本条例第 86 至 88 条仅适用于根据条例(EU) 2024/2747 第 18 条第 4 款被指定为危机相关商品的建筑产品。
3. This Chapter, except as regards the power of the Commission referred to in Article 87(7) of this Regulation, shall apply only during the internal market emergency mode that has been activated in accordance with Article 18 of Regulation (EU) 2024/2747.
3. 本章,除本条例第 87 条第 7 款所述的委员会权力外,仅适用于根据条例(EU)2024/2747 第 18 条启动的内部市场紧急模式期间。
4. The Commission may adopt implementing acts regarding the corrective or restrictive actions to be taken, the procedures to be followed and the specific labelling and traceability requirements with respect to construction products placed on the market in accordance with Articles 86 and 87. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 90(3).
4. 委员会可就根据第 86 条和第 87 条投放市场的建筑产品所采取的纠正或限制措施、应遵循的程序以及具体的标签和可追溯性要求,采纳实施措施。该等实施措施应按照第 90 条第 3 款所述的审查程序采纳。
Article 86 第 86 条
Prioritisation of the assessment and verification of crisis-relevant construction products
危机相关建筑产品评估和验证的优先处理
1. This Article applies to construction products listed in the implementing act referred to in Article 85(1), that are subject to third-party tasks of notified bodies related to the assessment and verification of construction products, in accordance with Article 10(1).
1. 本条适用于根据第 85 条第 1 款所指的实施法令中列出的建筑产品,这些产品根据第 10 条第 1 款,须由公告机构承担与建筑产品评估和验证相关的第三方任务。
2. The notified bodies shall make best efforts to process as a matter of priority requests for third-party tasks related to the assessment and verification of construction products referred to in paragraph 1, irrespective of whether those requests have been lodged before or after the activation of the emergency procedures pursuant to Article 85.
2. 公告机构应尽最大努力优先处理与第 1 款所述建筑产品评估和验证相关的第三方任务请求,无论这些请求是在根据第 85 条启动紧急程序之前还是之后提出的。
3. The prioritisation of requests for third-party tasks related to the assessment and verification of construction products pursuant to paragraph 2 shall not result in additional disproportionate costs for the manufacturers who have lodged those requests.
3. 根据第 2 款对与建筑产品评估和验证相关的第三方任务请求的优先处理,不得导致提出请求的制造商承担额外的不合理费用。
4. The notified bodies shall make reasonable efforts to increase their respective assessment and verification capacities regarding construction products referred to in paragraph 1 in respect of which they have been notified.
4. 通知机构应合理努力提高其对第 1 款所述建筑产品的评估和验证能力,这些建筑产品是其已被通知的范围内的。
Article 87 第 87 条
Assessment and declaration of performance based on standards and common specifications
基于标准和通用规范的性能评估与声明
1. Where construction products have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts, listing appropriate standards or establishing common specifications to cover the methods and the criteria for assessing the performance of those products in relation to their essential characteristics in the following cases:
1. 当建筑产品被指定为危机相关商品时,委员会有权通过实施条例,列出适用的标准或制定通用规范,以涵盖在以下情况下评估这些产品与其基本特性相关的性能的方法和标准:
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(a) |
where there are no performance harmonised standards and no implementing acts adopted in accordance with Article 6(1) that cover the relevant methods and criteria for assessing the performance of those products in relation to their essential characteristics and no such standards or acts are expected to be adopted within a reasonable period; or |
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(b) |
where severe disruptions to the functioning of the internal market, which led to the activation of the internal market emergency mode in accordance with Article 18 of Regulation (EU) 2024/2747, significantly restrict the possibilities of manufacturers to make use of performance harmonised standards or implementing acts adopted in accordance with Article 6(1) of this Regulation that provide the relevant methods and criteria for assessing the performance of those products in relation to their essential characteristics. |
2. The implementing acts referred to in paragraph 1 shall set out the most appropriate alternative technical solution for the purposes of providing assessment and declaration of performance in accordance with paragraph 5. To that end, the references of European standards or references of relevant applicable international or national standards may be published in those implementing acts or, if there is no European standard or no relevant applicable international or national standard, common specifications may be established by those implementing acts.
2. 第 1 款所述的实施条例应规定最适当的替代技术方案,以便根据第 5 款提供性能评估和声明。为此,实施条例中可发布欧洲标准的引用或相关适用的国际或国家标准的引用;如果不存在欧洲标准或相关适用的国际或国家标准,则可由该实施条例制定通用规范。
3. The implementing acts referred to in paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 90(3) and shall apply until the last day of the period during which the internal market emergency mode is activated, unless those implementing acts are amended or repealed in accordance with paragraph 7 of this Article.
3. 本条第 1 款所述的实施行为应按照第 90 条第 3 款所述的审查程序予以采纳,并应适用于内部市场紧急模式启动期间的最后一天,除非根据本条第 7 款对该等实施行为进行修订或废止。
4. Before preparing the draft implementing act referred to in paragraph 1 of this Article, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in paragraph 1 of this Article have been fulfilled. When preparing that draft implementing act, the Commission shall take into account the views of the CPR Acquis Expert Group and shall duly consult all relevant stakeholders.
4. 在起草本条第 1 款所述的实施条例草案之前,委员会应通知《欧盟条例》第 1025/2012 号第 22 条所述的委员会,表明其认为本条第 1 款中的条件已得到满足。在起草该实施条例草案时,委员会应考虑 CPR 法规专家组的意见,并应适当咨询所有相关利益相关者。
5. Without prejudice to Articles 13 and 15, the methods and the criteria provided in the standards or common specifications referred to in paragraph 1 of this Article, or parts thereof, may be used for assessing and declaring the performance of construction products covered by those standards or common specifications in relation to their essential characteristics. From the day following the expiry or deactivation of the internal market emergency mode it shall no longer be possible to draw up declarations of performance and conformity based on the standards or the common specifications referred to in the implementing act referred to in paragraph 1 of this Article.
5. 在不影响第 13 条和第 15 条的前提下,可使用本条第 1 款所述标准或通用规范中的方法和标准,或其部分内容,来评估和声明受这些标准或通用规范涵盖的建筑产品在其基本特性方面的性能。从内部市场紧急模式到期或停用的次日起,不得再根据本条第 1 款所述实施条例中提及的标准或通用规范制定性能和合格声明。
6. By way of derogation from Article 85(3), unless there is sufficient reason to believe that construction products covered by the standards or common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons or fail to achieve the declared performance, the declarations of performance and conformity of construction products which have been placed on the market in compliance with those standards or common specifications shall remain valid after the expiry or repeal of an implementing act adopted pursuant to paragraph 3 of this Article and after the expiry or deactivation of the internal market emergency mode.
6. 根据第 85 条第 3 款的例外规定,除非有充分理由相信本条第 1 款所述标准或共同规范涵盖的建筑产品对人员的健康或安全构成风险,或未能达到声明的性能,否则符合该等标准或共同规范并已投放市场的建筑产品的性能和合格声明,在根据本条第 3 款通过的实施法案到期或废止后,以及内部市场紧急模式到期或停用后,仍应保持有效。
7. Where a Member State considers that a standard or common specification as referred to in paragraph 1 is incorrect in terms of methods and criteria for the assessment of performance in relation to essential characteristics, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and, may, where appropriate, amend or repeal the implementing act listing the standard or establishing the common specification in question.
7. 如果成员国认为第 1 款所述的标准或共同规范在与基本特性相关的性能评估方法和标准方面存在错误,应向委员会提交详细说明并告知该情况。委员会应对该详细说明进行评估,并可在适当情况下修改或废止列出该标准或制定该共同规范的实施法案。
Article 88 第 88 条
Prioritisation of market surveillance activities and mutual assistance among authorities
市场监管活动的优先排序及当局间的相互协助
1. Member States shall prioritise the market surveillance activities for construction products listed in the implementing act referred to in Article 85(1) of this Regulation. The Commission shall facilitate coordination of such prioritisation efforts through the Union Product Compliance Network established under Article 29 of Regulation (EU) 2019/1020.
1. 成员国应优先开展本条例第 85 条第 1 款所指实施法案中列明的建筑产品的市场监管活动。委员会应通过根据欧盟条例(EU)2019/1020 第 29 条设立的欧盟产品合规网络,促进此类优先排序工作的协调。
2. The market surveillance authorities of the Member States shall ensure that best efforts are made to provide assistance to other market surveillance authorities during an internal market emergency mode, including by mobilising and dispatching expert teams to temporarily reinforce the staff of market surveillance authorities requesting assistance or by providing logistical support, such as the reinforcement of the testing capacity for construction products listed in the implementing act referred to in Article 85(1).
2. 成员国的市场监管当局应确保尽最大努力在内部市场紧急状态期间为其他市场监管当局提供协助,包括动员和派遣专家团队,临时加强请求协助的市场监管当局的人员配备,或提供后勤支持,例如加强对第 85 条第 1 款所指实施法案中列明的建筑产品的检测能力。
CHAPTER XV 第十五章
FINAL PROVISIONS 最终条款
Article 89 第 89 条
Delegated acts 授权法案
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
1. 委员会被赋予通过授权法案的权力,但须遵守本条规定的条件。
2. The power to adopt delegated acts referred to in Article 4(7), Article 5(5), (6) and (10), Article 7(1), and (8), Article 9(3) and (4), Article 10(2),and (4), Article 12, Article 15(5), Article 22(8) and (9), Article 32(5), Article 75(1), Article 80(2) and Article 83(1)shall be conferred on the Commission for a period of five years from 7 January 2025. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
2. 授予委员会根据第 4 条第 7 款、第 5 条第 5 款、第 6 款和第 10 款、第 7 条第 1 款和第 8 款、第 9 条第 3 款和第 4 款、第 10 条第 2 款和第 4 款、第 12 条、第 15 条第 5 款、第 22 条第 8 款和第 9 款、第 32 条第 5 款、第 75 条第 1 款、第 80 条第 2 款及第 83 条第 1 款所述的采用授权法案的权力,自 2025 年 1 月 7 日起,期限为五年。委员会应在五年期限届满前不少于九个月提交关于授权权力的报告。除非欧洲议会或理事会在每个期限届满前三个月内反对,否则授权权力应自动延长相同期限。
3. The delegation of powers referred to in Article 4(7), Article 5(5), (6) and (10), Article 7(1) and (8), Article 9(3) and (4), Article 10(2) and (4), Article 12, Article 15(5), Article 22(8) and (9), Article 32(5), Article 75(1), Article 80(2) and Article 83(1) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
3. 第 4 条第 7 款、第 5 条第 5 款、第 6 款和第 10 款、第 7 条第 1 款和第 8 款、第 9 条第 3 款和第 4 款、第 10 条第 2 款和第 4 款、第 12 条、第 15 条第 5 款、第 22 条第 8 款和第 9 款、第 32 条第 5 款、第 75 条第 1 款、第 80 条第 2 款及第 83 条第 1 款所述的授权权力,可由欧洲议会或理事会随时撤销。撤销决定应终止该决定中指定的授权权力。该决定自欧洲联盟官方公报发布之日起次日生效,或自该决定中指定的较晚日期生效。该决定不影响任何已生效的授权法案的有效性。
4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
4. 在采纳授权法案之前,委员会应根据 2016 年 4 月 13 日关于更好立法的机构间协议中规定的原则,咨询各成员国指定的专家。
5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
5. 委员会一旦采纳授权法案,应同时将其通知欧洲议会和理事会。
6. A delegated act adopted pursuant to Article 4(7), Article 5(5), (6) or (10), Article 7(1) or (8), Article 9(3) or (4), Article 10(2) or (4), Article 12, Article 15(5), Article 22(8) or (9), Article 32(5), Article 75(1), Article 80(2) or Article 83(1) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
6. 根据第 4 条第 7 款、第 5 条第 5 款、第 6 款或第 10 款、第 7 条第 1 款或第 8 款、第 9 条第 3 款或第 4 款、第 10 条第 2 款或第 4 款、第 12 条、第 15 条第 5 款、第 22 条第 8 款或第 9 款、第 32 条第 5 款、第 75 条第 1 款、第 80 条第 2 款或第 83 条第 1 款通过的授权法案,只有在自该法案通知欧洲议会和理事会之日起两个月内,欧洲议会或理事会未表示反对,或者在该期限届满前,欧洲议会和理事会均已通知委员会不予反对的情况下,方可生效。该期限可由欧洲议会或理事会主动延长两个月。
Article 90 第 90 条
Committee procedure 委员会程序
1. The Commission shall be assisted by the Committee on Construction Products. This committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
1. 委员会应由建筑产品委员会协助。该委员会应为《欧盟条例》(EU)第 182/2011 号所指的委员会。
2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
2. 提及本款时,应适用《欧盟条例》(EU)第 182/2011 号第 4 条。
3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
3. 提及本段时,应适用第 182/2011 号欧盟条例第 5 条的规定。
4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.
4. 提及本段时,应适用《欧盟条例》第 182/2011 号第 8 条及其第 5 条的规定。
Article 91 第 91 条
Electronic applications, decisions, documentation and information
电子申请、决定、文件和信息
1. All applications from or to notified bodies or TABs and decisions made by these bodies made in accordance with this Regulation can be provided on paper or in a commonly used electronic format provided that the signature complies with the requirements of Regulation (EU) No 910/2014 and the signing person has been entrusted with the task of representing the body or economic operator, in accordance with the law of the Member States or Union law respectively.
1. 根据本条例,由通知机构或技术评审机构(TAB)提出或接收的所有申请,以及这些机构作出的决定,可以以纸质形式或常用电子格式提供,前提是签名符合欧盟条例(EU)第 910/2014 号的要求,且签署人已根据成员国法律或欧盟法律被授权代表该机构或经济运营者。
2. All information obligations under this Regulation may, unless otherwise stated, be satisfied by electronic means. Where the information is provided by electronic means, the information shall be issued in a commonly readable electronic format that enables the recipient to download and print that information.
2. 除非另有规定,本条例项下的所有信息义务均可通过电子方式履行。通过电子方式提供信息时,应以常用的可读取电子格式发布该信息,使接收方能够下载并打印该信息。
When the obligation is established in accordance with Article 22(7), economic operators shall fulfil information obligations related to documents referred to in Article 76(2) by providing the digital product passport.
当根据第 22 条第 7 款确立义务时,经济运营者应通过提供数字产品护照,履行与第 76 条第 2 款所指文件相关的信息义务。
Declaration of performance and conformity as well as general product information, instructions for use and safety information shall be provided in paper format, free of charge, if requested by the end-user at the time of purchase.
性能和合格声明以及一般产品信息、使用说明和安全信息应以纸质形式提供,若最终用户在购买时提出要求,应免费提供。
Article 92 第 92 条
Penalties 处罚措施
Member States shall lay down the rules on penalties applicable to instances of non-compliance with this Regulation and shall take all measures necessary to ensure that these rules are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, by 8 December 2026, notify the Commission of those rules and of those measures and thereafter shall notify it, without delay, of any subsequent amendment affecting them.
成员国应制定适用于违反本条例行为的处罚规则,并采取一切必要措施确保这些规则的实施。所规定的处罚应当有效、相称且具有威慑力。成员国应于 2026 年 12 月 8 日前将这些规则和措施通知委员会,此后如有任何影响这些规则和措施的修订,应立即通知委员会。
Article 93 第 93 条
Evaluation 评估
No later than 9 January 2033 and at least every six years thereafter, the Commission shall carry out an evaluation of this Regulation and of its contribution to the functioning of the internal market and the improvement of the environmental sustainability of products and construction works and built environment. That evaluation shall, inter alia, assess the correlation of this Regulation with Regulation (EU) 2024/1781 and the potential environmental and economic benefits and the impact of extended producer responsibility of manufacturers of certain construction products and of the regain of ownership of surplus and unsold products at Union level. The Commission shall also evaluate the effect of the application of this Regulation on the state of the market for different categories of used products. The Commission shall evaluate whether the penalties applied by the Member States are effective and whether they create fragmentation in the internal market. The Commission shall, if necessary, suggest how to harmonise those penalties.
最迟于 2033 年 1 月 9 日,并且此后至少每六年一次,委员会应对本条例及其对内部市场运作和产品、建筑工程及建成环境环境可持续性改善的贡献进行评估。该评估应包括但不限于评估本条例与条例(欧盟)2024/1781 的关联性,以及某些建筑产品制造商的延长生产者责任和欧盟层面对剩余及未售出产品所有权回收的潜在环境和经济效益及影响。委员会还应评估本条例实施对不同类别二手产品市场状况的影响。委员会应评估成员国施加的处罚是否有效,以及是否造成内部市场的分裂。如有必要,委员会应提出如何统一这些处罚的建议。
The Commission shall present a report on the main findings to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions. Member States shall provide the Commission with the information necessary for the preparation of that report.
委员会应向欧洲议会、理事会、欧洲经济和社会委员会以及地区委员会提交一份关于主要发现的报告。成员国应向委员会提供准备该报告所需的信息。
Where appropriate, the report shall be accompanied by a legislative proposal for the amendment of the relevant provisions of this Regulation.
在适当情况下,报告应附有修改本条例相关条款的立法提案。
Article 94 第 94 条
Repeal 废止
Regulation (EU) No 305/2011 is repealed with effect from 8 January 2026, with the exception of Article 2, Articles 4 to 9, Articles 11 to 18, Articles 27 and 28, Articles 36 to 40, Articles 47 to 49, Articles 52 and 53, Article 55, Articles 60 to 64 of that Regulation and Annexes III and V thereto which are repealed with effect from 8 January 2040.
欧盟条例(EU)第 305/2011 号自 2026 年 1 月 8 日起废止,但该条例的第 2 条、第 4 至 9 条、第 11 至 18 条、第 27 及 28 条、第 36 至 40 条、第 47 至 49 条、第 52 及 53 条、第 55 条、第 60 至 64 条以及其附录 III 和 V 自 2040 年 1 月 8 日起废止。
References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex XI to this Regulation.
对已废止的条例的引用应被解释为对本条例的引用,并应根据本条例附录 XI 中的对应表进行解读。
Article 95 第 95 条
Derogations and transitional provisions
例外情况和过渡性规定
1. Product contact points for construction designated under Regulation (EU) No 305/2011 shall be deemed to have been designated under this Regulation as well.
1. 根据欧盟条例(EU)第 305/2011 号指定的建筑产品联络点,应视为也已根据本条例指定。
2. TABs and notified bodies that are designated or notified under Regulation (EU) No 305/2011 shall be deemed to have been designated or notified under this Regulation as well. However, they shall be assessed and designated anew by the designating Member States in accordance with their periodic re-assessment cycle and at the latest by 8 January 2030. The objection procedure set out in Article 51(5) of this Regulation shall apply.
2. 根据欧盟条例(EU)第 305/2011 号被指定或通知的技术评估机构(TABs)和通知机构,应视为已根据本条例被指定或通知。然而,指定成员国应根据其定期重新评估周期对其进行重新评估和指定,最迟不得晚于 2030 年 1 月 8 日。本条例第 51 条第 5 款规定的异议程序适用。
3. Harmonised standards the references of which are included in the list published in accordance with Article 17(5) of Regulation (EU) No 305/2011 that are in force on 8 January 2026 shall remain valid under Regulation (EU) No 305/2011 until they are withdrawn by the Commission or otherwise repealed.
3. 根据欧盟条例(EU)第 305/2011 号第 17 条第 5 款发布的清单中包含其参考文献的协调标准,在 2026 年 1 月 8 日生效的,应继续根据欧盟条例(EU)第 305/2011 号有效,直至被委员会撤销或以其他方式废止。
4. European assessment documents, the references of which are included in the list published in accordance with Article 22 of Regulation (EU) No 305/2011 by 8 January 2026, shall remain valid until 9 January 2031, unless they have expired for other reasons. Products shall not be placed on the market on the basis of European technical assessments issued in accordance with these European assessment documents after 9 January 2036.
4. 根据欧盟条例(EU)第 305/2011 号第 22 条于 2026 年 1 月 8 日前发布的清单中包含其参考文献的欧洲评估文件,应保持有效至 2031 年 1 月 9 日,除非因其他原因已失效。自 2036 年 1 月 9 日起,不得基于根据这些欧洲评估文件发布的欧洲技术评估将产品投放市场。
5. When a harmonised technical specification adopted in accordance with Article 5(8) or Article 6(1) of this Regulation covers the same product and the same intended use as a European assessment document, the reference of which is included in the list published in accordance with Article 22 of Regulation (EU) No 305/2011, the European assessment document shall no longer be used for the purposes of this Regulation and products shall not be placed on the market on the basis of European technical assessments issued in accordance with this European assessment document.
5. 当根据本条例第 5 条第 8 款或第 6 条第 1 款采纳的协调技术规范涵盖与欧洲评估文件相同的产品及相同的预期用途,而该欧洲评估文件的参考编号已包含在根据欧盟条例(EU)第 305/2011 号第 22 条公布的清单中时,该欧洲评估文件不得再用于本条例的目的,且不得基于根据该欧洲评估文件发布的欧洲技术评估将产品投放市场。
6. European technical assessments issued pursuant to European assessment documents the references of which are not included in the list published in accordance with Article 22 of Regulation (EU) No 305/2011 by 8 January 2026 shall be treated as European technical assessment requests under this Regulation. The administrative transfer shall be done at no cost for the manufacturer.
6. 根据欧洲评估文件发布的欧洲技术评估,其参考文献未包含在根据《欧盟条例》(EU)第 305/2011 号第 22 条于 2026 年 1 月 8 日发布的清单中,应视为根据本条例提出的欧洲技术评估请求。行政转移应对制造商免费进行。
7. Certificates, test reports and European technical assessments issued under Regulation (EU) No 305/2011 may be used as the technical basis to demonstrate a product’s compliance with this Regulation in cases where the product type corresponds to a product type under this Regulation and the requirements and assessment methods are valid in the light of the applicable harmonised technical specification or European assessment document. The recognition of such documents shall be possible under the conditions set out in Article 62 of this Regulation, applied mutatis mutandis.
7. 根据欧盟条例(EU)第 305/2011 号颁发的证书、测试报告和欧洲技术评估,可作为证明产品符合本条例的技术依据,前提是产品类型与本条例下的产品类型相对应,且根据适用的协调技术规范或欧洲评估文件,相关要求和评估方法仍然有效。此类文件的认可应当根据本条例第 62 条规定的条件,在适用时相应执行。
8. Article 2, Articles 4 to 9, Articles 11 to 18, Articles 27 and 28, Articles 36 to 40, Articles 47 to 49, Articles 52 and 53, Article 55 and Articles 60 to 64 of Regulation (EU) No 305/2011 shall only apply to products covered by standards referred to in paragraph 3 of this Article or to products covered by European assessment documents referred to in paragraph 4 of this Article.
8. 欧盟条例(EU)第 305/2011 号的第 2 条、第 4 至 9 条、第 11 至 18 条、第 27 及 28 条、第 36 至 40 条、第 47 至 49 条、第 52 及 53 条、第 55 条以及第 60 至 64 条,仅适用于本条第 3 款所述标准涵盖的产品或本条第 4 款所述欧洲评估文件涵盖的产品。
For the purposes of Article 5(7), Article 6(1), and Article 31(2) of this Regulation, harmonised standards the references of which are included in the list published in accordance with Article 17(5) of Regulation (EU) No 305/2011 and which have not been withdrawn shall be treated as performance harmonised standards.
为本条例第 5 条第 7 款、第 6 条第 1 款和第 31 条第 2 款的目的,依据欧盟条例(EU)第 305/2011 号第 17 条第 5 款公布的清单中包含其引用且未被撤销的协调标准,应视为性能协调标准。
9. The requirements and obligations of economic operators set out in Chapters I, II and III shall only be applicable to a certain product family or product category within such a family from one year after the date of adoption of an implementing act referred to in Article 5(8) making a harmonised standard mandatory or an implementing act referred to in Article 6(1), covering that product family or product category, unless a later application date has been specified in the implementing act. However, economic operators may choose to apply those harmonised technical specifications as from their entry into force by undergoing the procedure leading to a declaration of performance and conformity.
9. 经济运营者在第 I、II 和 III 章中规定的要求和义务,仅自根据第 5 条第 8 款所述的实施法令通过之日起一年后适用于该实施法令所强制执行的协调标准所涵盖的某一产品系列或该系列内的某一产品类别,或根据第 6 条第 1 款所述的实施法令所涵盖的该产品系列或产品类别,除非实施法令中另有规定较晚的适用日期。然而,经济运营者可选择自这些协调技术规范生效之日起,通过进行性能和合格声明程序,适用这些规范。
10. Within one year following the date of application of requirements and obligations in relation to a certain product family or product category as set out in paragraph 9 of this Article, the Commission shall withdraw from the Official Journal of the European Union references of harmonised standards and European assessment documents or parts thereof published there in accordance with Articles 17(5) and 22 of Regulation (EU) No 305/2011 when they cover the same respective product family or product category.
10. 在本条第 9 款所述的某一产品系列或产品类别的要求和义务生效之日起一年内,委员会应当从《欧盟官方公报》中撤销根据《欧盟条例》第 305/2011 号第 17 条第 5 款和第 22 条发布的涵盖相同产品系列或产品类别的协调标准和欧洲评估文件或其部分内容的引用。
Article 96 第 96 条
Entry into force 生效日期
This Regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.
本条例自其在《欧盟官方公报》发布之日起第 20 天生效。
It shall apply as from 8 January 2026, with the exception of Articles 1 to 4, Article 5(1) to (7), Article 7(1), Article 9, Article 10, Article 12(1) first subparagraph, Article 16(3), Article 37(4), Article 63, Article 89 and Article 90 and Annexes I, II, III, IV, VII, IX and X, which shall apply from 7 January 2025, and of Article 92, which shall apply from 8 January 2027.
本条例自 2026 年 1 月 8 日起适用,但第 1 至 4 条、第 5 条第 1 款至第 7 款、第 7 条第 1 款、第 9 条、第 10 条、第 12 条第 1 款第一段、第 16 条第 3 款、第 37 条第 4 款、第 63 条、第 89 条和第 90 条及附件 I、II、III、IV、VII、IX 和 X 自 2025 年 1 月 7 日起适用,第 92 条自 2027 年 1 月 8 日起适用。
This Regulation shall be binding in its entirety and directly applicable in all Member States.
本条例在所有成员国具有完全约束力,并直接适用。
Done at Strasbourg, 27 November 2024.
于斯特拉斯堡,2024 年 11 月 27 日。
For the European Parliament
代表欧洲议会
The President 主席
R. METSOLA
For the Council 理事会代表
The President 主席
BÓKA J.
(1)
OJ C 75, 28.2.2023, p. 159.
(1) 欧盟官方公报 C 75,2023 年 2 月 28 日,第 159 页。
(2) Position of the European Parliament of 10 April 2024 (not yet published in the Official Journal) and decision of the Council of 5 November 2024.
(2) 欧洲议会于 2024 年 4 月 10 日的立场(尚未在《官方公报》上公布)及理事会于 2024 年 11 月 5 日的决定。
(3) Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC (OJ L 88, 4.4.2011, p. 5).
(3) 欧洲议会和理事会于 2011 年 3 月 9 日通过的第 305/2011 号条例,规定了建筑产品投放市场的统一条件,并废止了理事会第 89/106/EEC 号指令(《官方公报》L 88,2011 年 4 月 4 日,第 5 页)。
(4)
OJ C 474, 24.11.2021, p. 41.
(4) 欧盟官方公报 C 474,2021 年 11 月 24 日,第 41 页。
(5) Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 357).
(5) 欧洲议会和理事会于 2014 年 2 月 26 日通过的 2014/35/EU 号指令,关于协调成员国法律,使电气设备在特定电压范围内投放市场(《官方公报》L 96,2014 年 3 月 29 日,第 357 页)。
(6) Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014, p. 79).
(6) 欧洲议会和理事会于 2014 年 2 月 26 日通过的关于协调成员国电磁兼容性相关法律的指令 2014/30/EU(《官方公报》L 96,2014 年 3 月 29 日,第 79 页)。
(7) Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62).
(7) 欧洲议会和理事会于 2014 年 4 月 16 日通过的关于协调成员国无线电设备投放市场相关法律并废止指令 1999/5/EC 的指令 2014/53/EU(《官方公报》L 153,2014 年 5 月 22 日,第 62 页)。
(8) Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, p. 4).
(8) 2001 年 12 月 3 日欧洲议会和理事会关于一般产品安全的指令 2001/95/EC(《官方公报》L 11,2002 年 1 月 15 日,第 4 页)。
(9) Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
(9) 欧洲议会和理事会于 2012 年 10 月 25 日通过的第 1025/2012 号欧盟条例,关于欧洲标准化,修订了理事会指令 89/686/EEC 和 93/15/EEC 以及欧洲议会和理事会的指令 94/9/EC、94/25/EC、95/16/EC、97/23/EC、98/34/EC、2004/22/EC、2007/23/EC、2009/23/EC 和 2009/105/EC,并废止了理事会决定 87/95/EEC 及欧洲议会和理事会的决定 1673/2006/EC(《官方公报》L 316,2012 年 11 月 14 日,第 12 页)。
(10) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
(10) 欧洲议会和理事会于 2008 年 7 月 9 日通过的第 768/2008/EC 号决定,关于产品市场营销的共同框架,并废止了理事会决定 93/465/EEC(《官方公报》L 218,2008 年 8 月 13 日,第 82 页)。
(11) Council Directive 89/106/EEC of 21 December 1988 on the approximation of laws, regulations and administrative provisions of the Member States relating to construction products (OJ L 40, 11.2.1989, p. 12).
(11) 理事会于 1988 年 12 月 21 日通过的第 89/106/EEC 号指令,关于成员国有关建筑产品的法律、法规和行政规定的协调(《官方公报》L 40,1989 年 2 月 11 日,第 12 页)。
(12) Regulation (EU) 2024/1781 of the European Parliament and of the Council of 13 June 2024 establishing a framework for the setting of ecodesign requirements for sustainable products, amending Directive (EU) 2020/1828 and Regulation (EU) 2023/1542 and repealing Directive 2009/125/EC (OJ L, 2024/1781, 28.6.2024, ELI: http://data.europa.eu/eli/reg/2024/1781/oj).
(12) 欧洲议会和理事会于 2024 年 6 月 13 日通过的第(EU)2024/1781 号条例,建立了可持续产品生态设计要求的制定框架,修订了第(EU)2020/1828 号指令和第(EU)2023/1542 号条例,并废止了第 2009/125/EC 号指令(《官方公报》L,2024/1781,2024 年 6 月 28 日,ELI:http://data.europa.eu/eli/reg/2024/1781/oj)。
(13) Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3).
(13) 欧洲议会和理事会于 2008 年 11 月 19 日通过的第 2008/98/EC 号指令,关于废弃物并废止若干指令(《官方公报》L 312,2008 年 11 月 22 日,第 3 页)。
(14) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
(14) 欧洲议会和理事会于 2008 年 7 月 9 日通过的第 765/2008 号条例,规定了认证的要求并废止了第 339/93 号(EEC)条例(《官方公报》L 218,2008 年 8 月 13 日,第 30 页)。
(15) Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1).
(15) 欧洲议会和理事会于 2019 年 6 月 20 日通过的关于市场监管和产品合规性的第(EU)2019/1020 号条例,并修订指令 2004/42/EC 及条例(EC)第 765/2008 号和(EU)第 305/2011 号(《官方公报》L 169,2019 年 6 月 25 日,第 1 页)。
(16) Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council and Directive (EU) 2020/1828 of the European Parliament and the Council, and repealing Directive 2001/95/EC of the European Parliament and of the Council and Council Directive 87/357/EEC (OJ L 135, 23.5.2023, p. 1).
(16) 欧洲议会和理事会于 2023 年 5 月 10 日通过的关于一般产品安全的第(EU)2023/988 号条例,修订欧洲议会和理事会第(EU)1025/2012 号条例及欧洲议会和理事会指令(EU)2020/1828,并废止欧洲议会和理事会指令 2001/95/EC 及理事会指令 87/357/EEC(《官方公报》L 135,2023 年 5 月 23 日,第 1 页)。
(17)
OJ L 123, 12.5.2016, p. 1.
(17) 欧盟官方公报 L 123, 2016 年 5 月 12 日, 第 1 页。
(18) Regulation (EU) 2024/2748 of the European Parliament and of the Council of 9 October 2024 amending Regulations (EU) No 305/2011, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2023/988 and (EU) 2023/1230 as regards emergency procedures for the conformity assessment, presumption of conformity, adoption of common specifications and market surveillance due to an internal market emergency (OJ L, 2024/2748, 8.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2748/oj).
(18) 欧洲议会和理事会于 2024 年 10 月 9 日通过的第(EU) 2024/2748 号条例,修订了第(EU) 305/2011 号、第(EU) 2016/424 号、第(EU) 2016/425 号、第(EU) 2016/426 号、第(EU) 2023/988 号和第(EU) 2023/1230 号条例,涉及因内部市场紧急情况而采取的合格评定紧急程序、合格推定、共同规范的采纳及市场监管(欧盟官方公报 L, 2024/2748, 2024 年 11 月 8 日, ELI: http://data.europa.eu/eli/reg/2024/2748/oj)。
(19) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(19) 欧洲议会和理事会于 2011 年 2 月 16 日通过的第 182/2011 号欧盟条例,规定了成员国对委员会实施权力行使的控制机制的规则和一般原则(《官方公报》L 55,2011 年 2 月 28 日,第 13 页)。
(20) Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC (OJ L 257, 28.8.2014, p. 73).
(20) 欧洲议会和理事会于 2014 年 7 月 23 日通过的第 910/2014 号欧盟条例,关于内部市场电子交易的电子身份识别和信任服务,并废止了 1999/93/EC 指令(《官方公报》L 257,2014 年 8 月 28 日,第 73 页)。
(21) Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to lifts and safety components for lifts (OJ L 96, 29.3.2014, p. 251).
(21) 欧洲议会和理事会于 2014 年 2 月 26 日通过的第 2014/33/EU 号指令,关于协调成员国有关电梯及电梯安全部件的法律(《官方公报》L 96,2014 年 3 月 29 日,第 251 页)。
(22) Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (OJ L 435, 23.12.2020, p. 1).
(22) 欧洲议会和理事会于 2020 年 12 月 16 日通过的第(EU) 2020/2184 号指令,关于供人类饮用水的水质(《官方公报》L 435,2020 年 12 月 23 日,第 1 页)。
(23) Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).
(23) 2003 年 5 月 6 日欧盟委员会关于微型、小型和中型企业定义的建议 2003/361/EC(《官方公报》L 124,2003 年 5 月 20 日,第 36 页)。
(24) Regulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 establishing a framework of measures related to an internal market emergency and to the resilience of the internal market and amending Council Regulation (EC) No 2679/98 (Internal Market Emergency and Resilience Act) (OJ L, 2024/2747, 8.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2747/oj).
(24) 2024 年 10 月 9 日欧洲议会和理事会关于建立与内部市场紧急情况及内部市场韧性相关的措施框架并修订理事会条例(EC)第 2679/98 号的条例(EU)2024/2747(《官方公报》L,2024/2747,2024 年 11 月 8 日,ELI:http://data.europa.eu/eli/reg/2024/2747/oj)。
(25) Regulation (EU) 2018/1724 of the European Parliament and of the Council of 2 October 2018 establishing a single digital gateway to provide access to information, to procedures and to assistance and problem-solving services and amending Regulation (EU) No 1024/2012 (OJ L 295, 21.11.2018, p. 1).
(25) 2018 年 10 月 2 日欧洲议会和理事会关于建立单一数字门户以提供访问信息、程序及援助和问题解决服务并修订条例(EU)第 1024/2012 号的条例(EU)2018/1724(《官方公报》L 295,2018 年 11 月 21 日,第 1 页)。
(26) Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
(26) 2015 年 9 月 9 日欧洲议会和理事会关于技术法规领域及信息社会服务规则信息提供程序的指令(EU)2015/1535(《官方公报》L 241,2015 年 9 月 17 日,第 1 页)。
(27) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
(27) 欧洲议会和理事会于 2006 年 12 月 18 日通过的第 1907/2006 号条例,关于化学品的注册、评估、授权和限制(REACH),设立欧洲化学品管理局,修订指令 1999/45/EC,废止理事会条例(EEC)第 793/93 号和委员会条例(EC)第 1488/94 号,以及理事会指令 76/769/EEC 和委员会指令 91/155/EEC、93/67/EEC、93/105/EC 和 2000/21/EC(《官方公报》L 396,2006 年 12 月 30 日,第 1 页)。
(28) Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market For Digital Services and amending Directive 2000/31/EC (Digital Services Act) (OJ L 277, 27.10.2022, p. 1).
(28) 欧洲议会和理事会于 2022 年 10 月 19 日通过的第 2022/2065 号条例,关于数字服务单一市场并修订指令 2000/31/EC(数字服务法案)(《官方公报》L 277,2022 年 10 月 27 日,第 1 页)。
(29) Regulation (EU) 2019/515 of the European Parliament and of the Council of 19 March 2019 on the mutual recognition of goods lawfully marketed in another Member State and repealing Regulation (EC) No 764/2008 (OJ L 91, 29.3.2019, p. 1).
(29) 欧洲议会和理事会于 2019 年 3 月 19 日通过的第 2019/515 号欧盟条例,关于在另一成员国合法销售商品的相互承认,并废止第 764/2008 号(EC)条例(《官方公报》L 91,2019 年 3 月 29 日,第 1 页)。
(30) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).
(30) 欧洲议会和理事会于 2016 年 4 月 27 日通过的关于保护自然人在个人数据处理方面的权利及该等数据自由流动的条例(欧盟条例 2016/679),废止指令 95/46/EC(通用数据保护条例)(《官方公报》L 119,2016 年 5 月 4 日,第 1 页)。
(31) Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1).
(31) 欧洲议会和理事会于 2016 年 6 月 8 日通过的关于保护未公开的专有技术和商业信息(商业秘密)免遭非法获取、使用和披露的指令(欧盟指令 2016/943)(《官方公报》L 157,2016 年 6 月 15 日,第 1 页)。
(32) Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65).
(32) 欧洲议会和理事会于 2014 年 2 月 26 日通过的关于公共采购的指令 2014/24/EU,废止指令 2004/18/EC(《官方公报》L 94,2014 年 3 月 28 日,第 65 页)。
(33) Directive 2014/25/EU of the European Parliament and of the Council of 26 February 2014 on procurement by entities operating in the water, energy, transport and postal services sectors and repealing Directive 2004/17/EC (OJ L 94, 28.3.2014, p. 243).
(33) 欧洲议会和理事会于 2014 年 2 月 26 日通过的关于水、电力、运输和邮政服务领域运营实体采购的指令 2014/25/EU,废止指令 2004/17/EC(《官方公报》L 94,2014 年 3 月 28 日,第 243 页)。
(34) Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel (OJ L 27, 30.1.2010, p. 1).
(34) 欧洲议会和理事会于 2009 年 11 月 25 日通过的关于欧盟生态标签的第 66/2010 号条例(《官方公报》L 27,2010 年 1 月 30 日,第 1 页)。
ANNEX I 附件 I
Basic requirements for construction works
建筑工程的基本要求
The following list of basic requirements for construction works shall be taken as the basis for the identification of essential characteristics of products and for the preparation of standardisation requests, harmonised technical specifications and European assessment documents.
以下建筑工程基本要求清单应作为识别产品基本特性以及制定标准化请求、协调技术规范和欧洲评估文件的基础。
Those basic requirements for construction works do not constitute obligations incumbent upon economic operators or Member States.
这些关于建筑工程的基本要求不构成经济运营者或成员国应承担的义务。
The intended life span related to basic requirements for construction works shall take into account the likely impact of climate change.
与建筑工程基本要求相关的预期使用寿命应考虑气候变化的可能影响。
1. Structural integrity of construction works
1. 建筑工程的结构完整性
The construction works, and their relevant parts, shall be designed, constructed, used, maintained and deconstructed or demolished in such a way that all relevant loads and any combinations of them are sustained and transmitted into the ground safely and without causing deflections or deformations of any part of the construction works, or movement of the ground as to impair the durability, structural resistance, serviceability and robustness of the construction works.
建筑工程及其相关部分应以这样的方式设计、建造、使用、维护和拆除或拆毁,使所有相关荷载及其任何组合能够安全承载并传递至地基,且不会导致建筑工程任何部分的挠度或变形,或地基的移动,从而损害建筑工程的耐久性、结构承载力、适用性和稳健性。
The structure and structural elements of construction works shall be designed, manufactured, constructed, maintained and deconstructed or demolished in such a way that they meet the following requirements:
建筑工程的结构及结构构件应以这样的方式设计、制造、建造、维护和拆除或拆毁,使其满足以下要求:
|
(a) |
they are durable for their intended life span (durability requirement); |
|
(b) |
they are capable of withstanding all actions and influences likely to occur during construction, use and deconstruction or demolition with an appropriate degree of reliability and in a cost-effective way (structural resistance requirement) and it shall not:
|
|
(c) |
they remain within their specified service requirements during their intended life span with appropriate degrees of reliability and in an economic way (serviceability requirement); |
|
(d) |
they maintain their integrity appropriately when faced with adverse events, including earthquake, explosion, fire, impact or consequences of human errors, to an extent disproportionate to the original cause (robustness requirement). |
2. Fire safety of construction works
2. 建筑工程的消防安全
The construction works and the relevant parts of them shall be designed, constructed, used, maintained and deconstructed or demolished in such a way that an outbreak of fire is appropriately prevented, including through adequate usage of detectors and alarms. The fire and smoke shall be contained and controlled, and the occupants of the construction works shall be protected against fire and smoke. Appropriate arrangements shall have been made to ensure safe escape from and evacuation of the construction works for all its occupants.
建筑工程及其相关部分应以适当的方式进行设计、建造、使用、维护和拆除或拆毁,以防止火灾的发生,包括通过适当使用探测器和报警器。火灾和烟雾应被控制和限制,建筑工程的居住者应受到火灾和烟雾的保护。应采取适当措施,确保所有居住者能够安全逃生和疏散。
The construction works and any part of them shall be designed, constructed, used and maintained in such a way that they meet the following requirements in the case of a fire:
建筑工程及其任何部分应以这样的方式进行设计、建造、使用和维护,以满足火灾情况下的以下要求:
|
(a) |
the load-bearing capacity of the construction works is maintained for a specific period of time to give occupants time to leave the building; |
|
(b) |
the rescue and emergency services’ access is ensured and there are appropriate means to facilitate their work; |
|
(c) |
the generation and spread of fire and smoke is controlled and limited; |
|
(d) |
the spread of the fire and smoke to the adjacent construction works is limited; |
|
(e) |
the safety of rescue and emergency services is taken into consideration. |
3. Protection against adverse hygiene and health impacts related to construction works
3. 防护与建筑工程相关的不良卫生和健康影响
The construction works and any part of them shall be designed, constructed, used, maintained and deconstructed or demolished in such a way that they, throughout their life cycle, do not adversely affect the hygiene or health and safety of construction workers, occupants, visitors or neighbours as a result of any of the following:
建筑工程及其任何部分应以这样的方式设计、建造、使用、维护和拆除或拆毁,使其在整个生命周期内,不因以下任何原因对建筑工人、居住者、访客或邻居的卫生或健康安全产生不利影响:
|
(a) |
the emissions of hazardous substances, volatile organic compounds or hazardous particles, including microplastics, into indoor air; |
|
(b) |
the emission of hazardous radiation into the indoor environment; |
|
(c) |
the release of hazardous substances into drinking water or substances which have an otherwise negative impact on drinking water; |
|
(d) |
the passage of moisture to the interior of the building; |
|
(e) |
faulty discharge of waste water, emission of flue gases or faulty disposal of solid or liquid waste into the indoor environment. |
4. Safety and accessibility of construction works
4. 建筑工程的安全性和可达性
The construction works and any part of them shall be designed, constructed, used, maintained and deconstructed or demolished in such a way that, throughout their life cycle, they do not present unacceptable risks of accidents or damage in service or in operation, including slipping, falling, collision, burns, electrocution and injury from falling or braking parts caused by external factors like extreme weather conditions or explosions.
建筑工程及其任何部分应设计、建造、使用、维护及拆除或拆毁,确保在其整个生命周期内,不会在使用或运行过程中产生不可接受的事故风险或损害,包括滑倒、跌落、碰撞、烧伤、触电以及因极端天气条件或爆炸等外部因素导致的坠落或断裂部件造成的伤害。
In particular, construction works shall be designed and built taking into consideration accessibility and use for disabled persons and persons with limited mobility or orientation.
特别是,建筑工程的设计和建造应考虑残疾人及行动或定向能力受限者的可达性和使用便利性。
5. Resistance to the passage of sound and acoustic properties of construction works
5. 抵抗声音传播和建筑工程的声学性能
The construction works and any part of them shall be designed, constructed, used, maintained and deconstructed or demolished in such a way that they provide, throughout their life cycle, reasonable protection against adverse sound load through air or materials from other parts of the same construction work or sources outside its structure. That protection shall ensure that that sound load:
建筑工程及其任何部分应以在其整个生命周期内,通过空气或材料对来自同一建筑工程其他部分或其结构外部来源的不利声负荷提供合理保护的方式进行设计、建造、使用、维护和拆除或拆毁。该保护应确保该声负荷:
|
(a) |
does not create immediate or chronic risks for the human health; |
|
(b) |
allows occupants and people nearby to sleep, rest and engage in their normal activities in satisfactory conditions. |
The construction works and any part of them shall be designed, constructed, used and maintained in such a way that they provide sufficient sound absorption and reflection where these acoustic properties are required.
建筑工程及其任何部分的设计、建造、使用和维护应以提供足够的吸声和反射性能为目标,前提是这些声学性能是必需的。
6. Energy efficiency and thermal performance of construction works
6. 建筑工程的能源效率和热性能
The construction works, including automated processes within them, and their heating, cooling, lighting and ventilation installations shall be designed, built, and maintained in such a way that the amount of energy they require during their use phase shall be low, when account is taken of:
建筑工程,包括其中的自动化过程及其供暖、制冷、照明和通风设施,应以在使用阶段所需能量较低为目标进行设计、建造和维护,同时考虑以下因素:
|
(a) |
the target for nearly zero energy buildings and zero-emissions buildings in the Union; |
|
(b) |
the outdoor climatic conditions; |
|
(c) |
the indoor climate conditions. |
7. Emissions into the outdoor environment of construction works
7. 建筑工程对户外环境的排放
The construction works and any part of them shall be designed, constructed, used, maintained and deconstructed or demolished in such a way that, throughout their life cycle, they are not a risk to the outdoor environment, as a result of any of the following:
建筑工程及其任何部分应以这样的方式设计、建造、使用、维护和拆除或拆毁,使其在整个生命周期内不会因以下任何原因对户外环境构成风险:
|
(a) |
the release of hazardous substances, microplastics, or radiation into air, ground water, marine or surface waters or soil; |
|
(b) |
faulty discharge of waste water, emission of flue gases or faulty disposal of solid or liquid waste to the outdoor environment; |
|
(c) |
damage to the building, including damage through the transport of water-borne contaminants to the foundations of the building; |
|
(d) |
the release of greenhouse gas emissions into the atmosphere. |
8. Sustainable use of natural resources of construction works
8. 建筑工程自然资源的可持续利用
The construction works and any part of them shall be designed, constructed, used, maintained and deconstructed or demolished in such a way that, throughout their life cycle, the use of natural resources is sustainable and ensures the following:
建筑工程及其任何部分的设计、建造、使用、维护和拆除或拆毁,应以在其整个生命周期内自然资源的使用可持续为前提,并确保以下内容:
|
(a) |
the maximisation of the resource efficient use of raw and secondary materials of high environmental sustainability; |
|
(b) |
the minimisation of the overall amount of raw materials used; |
|
(c) |
the minimisation of the overall amount of embodied energy; |
|
(d) |
the minimisation of the waste generated; |
|
(e) |
the minimisation of the overall use of drinking and service water; |
|
(f) |
the maximisation of the reuse or recyclability of the construction works, in part or in whole, and of their materials after deconstruction or demolition; |
|
(g) (g) |
the ease of deconstruction. |
ANNEX II 附件 II
Predetermined environmental essential characteristics
预定的环境基本特性
Harmonised technical specifications and European assessment documents shall cover the following list of predetermined environmental essential characteristics related to the life cycle assessment of a product:
协调的技术规范和欧洲评估文件应涵盖与产品生命周期评估相关的以下预定环境基本特性清单:
|
(a) |
climate change effects – total; |
|
(b) |
climate change effects – fossil fuels; |
|
(c) |
climate change effects – biogenic; |
|
(d) |
climate change effects – land use and land use change; |
|
(e) |
ozone depletion; 臭氧消耗; |
|
(f) |
acidification potential; |
|
(g) (g) |
eutrophication aquatic freshwater; |
|
(h) |
eutrophication aquatic marine; |
|
(i) |
eutrophication terrestrial; |
|
(j) |
photochemical ozone; 光化学臭氧; |
|
(k) |
abiotic depletion – minerals, metals; |
|
(l) |
abiotic depletion – fossil fuels; |
|
(m) |
water use; 用水; |
|
(n) |
particulate matter; 颗粒物; |
|
(o) |
ionising radiation, human health; |
|
(p) |
eco-toxicity, freshwater; |
|
(q) |
human toxicity, cancer; 人体毒性,癌症; |
|
(r) |
human toxicity, non-cancer; |
|
(s) (s) |
land use related impacts. |
Harmonised technical specifications shall also cover to the extent possible the predetermined environmental essential characteristic of capability to temporarily bind carbon and of other carbon removals.
统一的技术规范还应尽可能涵盖预定的环境基本特性,即暂时结合碳的能力及其他碳去除方式。
ANNEX III 附件 III
Product requirements 产品要求
1. Product requirements ensuring appropriate functioning and performance
1. 产品要求,确保适当的功能和性能
|
1.1. |
Harmonised technical specifications adopted in accordance with Article 7(1) may, as appropriate for the products that they cover, specify that products shall be designed, manufactured and packaged in such a way that, over the product’s life cycle, one or more of the following functional and performance requirements are addressed in accordance with the state of the art and to the extent not covered by other Union legal acts: 根据第 7 条第 1 款采用的协调技术规范,视其涵盖的产品适用情况,可能规定产品应以这样的方式设计、制造和包装,使得在产品生命周期内,按照技术现状并在未被其他欧盟法律法规涵盖的范围内,满足以下一项或多项功能和性能要求:
|
|
1.2. |
Voluntary harmonised standards for product requirements referred to in Article 7(3) and common specifications conferring a presumption of conformity shall set out how any requirements in accordance with point 1.1 can be fulfilled, by, for example, the following: 第 7 条第 3 款所指的产品要求的自愿协调标准和赋予符合性推定的共同规范,应规定如何满足第 1.1 点的任何要求,例如通过以下方式:
|
|
1.3. |
When specifying the functionality and performance product requirements, harmonised technical specifications may differentiate them on the basis of their classes of performance. 在规定功能性和性能产品要求时,协调的技术规范可根据性能等级对其进行区分。 |
2. Product safety requirements
2. 产品安全要求
Safety relates to professionals (workers) and non-professionals (consumers, occupants), while they transport, install, maintain, use or dismantle the product, as well as while they treat the product for its end of life phase or its reuse or recycling.
安全性涉及专业人员(工人)和非专业人员(消费者、居住者),无论是在运输、安装、维护、使用或拆卸产品时,还是在处理产品的生命周期终结阶段或其再利用或回收时。
|
2.1. |
Harmonised technical specifications established by delegated acts referred to in Article 7(1) may, as appropriate for the products they cover, specify that products shall be designed, manufactured, and packaged in such a way that one or more of the following inherent product safety risks are, over the product’s life cycle, addressed in accordance with the state of the art and to the extent they are not covered by other Union legal acts: 根据第 7 条第 1 款所述的授权法案制定的协调技术规范,视其涵盖的产品适用情况,可能规定产品应以一种或多种以下固有产品安全风险在产品生命周期内得到解决的方式进行设计、制造和包装,且应符合技术现状,并在未被其他欧盟法律法规涵盖的范围内:
|
|
2.2. |
Voluntary harmonised standards and common specifications conferring a presumption of conformity shall set out how any requirements in accordance with point 2.1 can be fulfilled, by, for example, the following: 自愿协调标准和赋予符合性推定的通用规范应规定如何满足第 2.1 点的任何要求,例如通过以下方式:
|
|
2.3. |
When specifying the product safety requirements, harmonised technical specifications may differentiate these on the basis of their classes of performance. 在规定产品安全要求时,协调的技术规范可能会根据其性能类别对这些要求进行区分。 |
3. Product environmental requirements
3. 产品环境要求
Environment relates to the extraction and manufacturing of the materials, the manufacturing of the product, the transport of materials and products, its maintenance, its potential to remain as long as possible within a circular economy and its end of life phase.
环境涉及材料的开采和制造、产品的制造、材料和产品的运输、其维护、其在循环经济中尽可能长时间存在的潜力以及其生命周期结束阶段。
|
3.1. |
Harmonised technical specifications established by delegated acts referred to in Article 7(1) may, as appropriate for the products they cover, specify that products shall be designed, manufactured, and packaged in such a way that one or more of the following inherent product environmental aspects are, over the product’s life cycle, addressed wherever possible without safety loss or by outweighing negative environmental impact, and to the extent not covered by other Union legal acts: 根据第 7 条第 1 款所指的授权法案制定的统一技术规范,视其涵盖的产品适用情况,可规定产品应以一种或多种以下固有产品环境方面在产品生命周期内尽可能得到解决的方式进行设计、制造和包装,前提是不影响安全或通过抵消负面环境影响实现,并且在未被其他欧盟法律法规涵盖的范围内:
|
|
3.2. |
Voluntary harmonised standards and common specifications conferring a presumption of conformity shall set out how any requirements in accordance with point 3.1 can be fulfilled by, for example, the following: 自愿协调标准和赋予符合性推定的共同规范应规定如何满足第 3.1 点的任何要求,例如通过以下方式:
|
|
3.3. |
When specifying the product environmental requirements, harmonised technical specifications may differentiate them on the basis of their classes of performance. 在规定产品环境要求时,协调的技术规范可根据性能等级对其进行区分。 |
ANNEX IV 附件 IV
General product information, instructions for use and safety information
一般产品信息、使用说明及安全信息
1. General product information
1. 一般产品信息
|
1.1. |
Product identification: unique identification code of the product type. 产品识别:产品类型的唯一识别代码。 |
|
1.2. |
Product description: 产品描述:
|
|
1.3. |
Contact details of the manufacturer or the authorised representative: 制造商或授权代表的联系方式:
|
|
1.4. |
Where different from point 1.3, contact details of the manufacturer or the authorised representative dealing with: 如与第 1.3 点不同,制造商或授权代表处理以下事项的联系方式:
|
|
1.5. |
Contact details of the product contact point for construction in the Member State in which the product is made available. 产品在成员国投放市场时的建筑产品联系点的联系方式。 |
2. Instructions for use and safety information
2. 使用说明和安全信息
|
2.1. |
Safety during transport, installation, deinstallation, maintenance, deconstruction and demolition: 运输、安装、拆卸、维护、拆解和拆除过程中的安全;
|
|
2.2. |
Compatibility and integration in systems or kits: 系统或套件中的兼容性和集成:
|
|
2.3. |
Maintenance needs with a view to maintaining the performance of the product during its service life span: 为维持产品在其使用寿命期间性能所需的维护需求:
|
|
2.4. |
Safety during use: 使用过程中的安全:
|
|
2.5. |
Training and other requirements necessarily to be fulfilled for safe use. 为安全使用必须完成的培训及其他要求。 |
|
2.6. |
Risk mitigation possibilities going beyond points 2.1 to 2.5. 超出第 2.1 至 2.5 点的风险缓解可能性。 |
|
2.7. |
Recommendations for a product’s: 关于产品的建议:
|
|
2.8. |
Where applicable, information on the performance of the product as measured in terms of its climate change effects – total, as referred to in point (a) of Annex II, and human toxicity, cancer, as referred to in point (q) of Annex II. 如适用,关于产品性能的信息,以其气候变化影响——总量(参见附件 II 第(a)点)和人体毒性、癌症(参见附件 II 第(q)点)为衡量标准。 |
|
3. |
The information provided on the elements listed in point 2 shall be enough, both in terms of quantity and quality, to enable potential purchasers to make informed decisions before proceeding with their purchase, including information on the necessary quantity, installation, use, maintenance, dismantling, reuse and recycling of the respective product. It may include all the drawings, diagrams, descriptions and explanations necessary for it to be understood. 所提供的关于第 2 点所列要素的信息,在数量和质量上应足够,使潜在购买者能够在购买前做出明智决定,包括关于相应产品所需数量、安装、使用、维护、拆卸、再利用和回收的信息。信息可包括所有必要的图纸、图表、描述和说明,以便理解。 The information shall, as appropriate, take into account as far as possible the needs of designers, building authorities, construction professionals, building control authorities, consumers and other users, occupant and, use managers, as well as of maintenance professionals. |
|
4. |
Guidelines and technical details issued in accordance with Article 9(2) shall also recommend where the respective information is to be provided. That location shall be one where the information is least likely to be overlooked. 根据第 9 条第 2 款发布的指南和技术细节还应建议相应信息应提供的位置。该位置应是信息最不易被忽视的地方。 |
ANNEX V 附件 V
Declaration of performance and conformity referred to in Article 15 (1)
第 15 条第 1 款所述的性能和合格声明
Name of the Manufacturer
制造商名称
Declaration Code … (2) 声明代码……(2)
Version No … (3) 版本号 … (3)
Date of that version …
该版本日期 …
1.
Product description 1. 产品描述|
(a) |
unique identification code of the product type and, where available, the batch or serial number; |
|
(b) |
product category as defined by harmonised technical specifications or European assessment documents; |
|
(c) |
declared uses of the product, within the scope of the applicable harmonised technical specification or European assessment document; |
|
(d) |
nominal dimensions or grading of the product; |
|
(e) |
key parts of the product, where applicable; |
|
(f) |
estimated average and minimum service life time for the declared use (durability); |
|
(g) (g) |
variants, if any, and their descriptions; |
|
(h) |
in cases where the product has been previously installed in a construction work, the date and place of the latest deinstallation. |
2.
Permalinks or data carriers as regards the following, unless the information is available in the digital product passport pursuant to Article 76:|
(a) |
the manufacturer’s product registrations in Union databases, if any; |
|
(b) |
information to be provided in accordance with Regulation (EC) No 1907/2006, where applicable; |
|
(c) |
general product information, instructions for use and safety information in accordance with Annex IV. |
3.
Manufacturer: 3. 制造商:|
(a) |
name; 名称; |
|
(b) |
registered trade name; 注册商号; |
|
(c) |
registered place of business; |
|
(d) |
postal address; 邮寄地址; |
|
(e) |
telephone; 电话; |
|
(f) |
email address; 电子邮件地址; |
|
(g) (g) |
website. 网站。 |
4.
Authorised representative, where applicable:|
(a) |
name; 名称; |
|
(b) |
registered trade name; 注册商号; |
|
(c) |
registered place of business; |
|
(d) |
postal address; 邮寄地址; |
|
(e) |
telephone; 电话; |
|
(f) |
email address; 电子邮件地址; |
|
(g) (g) |
website. 网站。 |
5.
Notified body or bodies, where applicable:|
(a) |
name; 名称; |
|
(b) |
identification number; 识别号码; |
|
(c) |
registered trade name, where available; |
|
(d) |
registered place of business; |
|
(e) |
postal address; 邮寄地址; |
|
(f) |
telephone; 电话; |
|
(g) (g) |
email address; 电子邮件地址; |
|
(h) |
website. 网站。 |
6.
Technical Assessment Body (‘TAB’), where applicable:|
(a) |
name; 名称; |
|
(b) |
identification number; 识别号码; |
|
(c) |
registered trade name, where available; |
|
(d) |
place of business; 营业地点; |
|
(e) |
postal address; 邮寄地址; |
|
(f) |
telephone; 电话; |
|
(g) (g) |
email address; 电子邮件地址; |
|
(h) |
website. 网站。 |
7.
Reference to certificates or validation reports issued by notified bodies and TABs.
8.
Technical reference documents:|
(a) |
harmonised technical specifications laying down essential characteristics applied (reference number and date of issue); or |
|
(b) |
European assessment document applied (reference number and date of issue) and European technical assessment issued (TAB, reference number and date of issue). |
9.
Declared performances and sustainability characteristics:|
(a) |
the complete list of essential characteristics, as determined in the harmonised technical specification or European assessment document for the respective product category for which a performance is declared and the applicable assessment and verification system applicable to them; |
|
(b) |
the performance of the product, by calculated values, levels or classes, or in a description. Respective values, levels or classes shall be reproduced in the declaration of performance itself and thus cannot be expressed solely by inserting references to other documents. For essential characteristics where no performance is declared, the word ‘NULL’ shall be inserted in the place for the declaration of the value. The performance of structural behaviour of a product may be expressed by referring to attached production documentation or structural design calculations; |
|
(c) |
the environmental sustainability expressed, for the applicable essential characteristics of the applicable life cycle modules, in accordance with Article 15(2); |
|
(d) |
reference to the version of the software used as provided by the Commission. |
10.
Applicable product requirements specified by harmonised technical specifications, the applicable assessment and verification system applicable to them and the reference to the voluntary harmonised standard or common specifications or parts thereof applied including the date.Where applicable, information on the performance of the product measured in terms of its product requirements.
如适用,产品性能信息,以其产品要求为衡量标准。
11.
Declarations: 11. 声明:|
(a) |
the performance of the product identified above is in conformity with the set of declared performances referred to in point 9; |
|
(b) |
the sustainability data of the product identified above have been correctly calculated on the basis of the product category rules applicable to it; |
|
(c) |
the product identified above is in conformity with the requirements listed under point 10. |
Signed for and on behalf of the manufacturer by:
由制造商代表签署:
[name, function (4)] [姓名,职务(4)]
At [place] 在[地点]
on [date of issue]
于[签发日期]
[signature] [签名]
(1) Where a Declaration of Performance and Conformity is issued in relation to a product not subject to product requirements established by delegated acts referred to in Article 7(1), points 10 and 11(c) are omitted.
(1) 如果针对不受第 7 条第 1 款所指委托法案规定的产品要求约束的产品发布性能和合格声明,则第 10 点和第 11(c)点应省略。
(2) Only one unique, unequivocal declaration code per product type shall be used, even where there are variants, variants being variations of the product type that do not influence performance or conformity of the product.
(2) 每种产品类型仅应使用一个唯一且明确的声明代码,即使存在变体,变体指的是不影响产品性能或合格性的产品类型的变异。
(3) Different versions may be issued, e.g. to correct mistakes or add complementary information.
(3) 可以发布不同版本,例如为纠正错误或添加补充信息。
(4) The person signing must be authorised under national law to represent the manufacturer, either on the basis of a mandate, or by virtue of his or her role as a legal representative.
(4) 签署人必须根据国家法律被授权代表制造商,授权方式可以是基于委托,也可以是其作为法定代表人的身份。
ANNEX VI 附件六
Procedure for requesting European technical assessments and for adopting a European assessment document
请求欧洲技术评估及采纳欧洲评估文件的程序
1. Request for a European technical assessment
1. 请求欧洲技术评估
|
1.1. |
When a manufacturer makes a request for a European technical assessment to any TAB for a product, and after the manufacturer and the TAB (‘responsible TAB’) have signed an agreement of commercial secrecy and confidentiality, unless the manufacturer decides otherwise, the manufacturer shall submit to the responsible TAB a technical file describing the product, its use as foreseen by the manufacturer and details of the factory production control the manufacturer intends to apply; 当制造商向任何技术评估机构(TAB)提出产品的欧洲技术评估请求,并且制造商与该技术评估机构(“负责技术评估机构”)签署了商业秘密和保密协议后,除非制造商另有决定,制造商应向负责技术评估机构提交一份技术文件,描述产品、制造商预期的使用方式以及制造商拟采用的工厂生产控制细节; |
|
1.2. |
When a group of manufacturers or a manufacturers’ association (the ‘Group’) makes a request for a European technical assessment, it shall address the request to the organisation of TABs that will propose to the Group a TAB to act as the responsible TAB. The Group can either accept the proposed TAB or ask the organisation of TABs to propose an alternative TAB. Once the Group has accepted the responsible TAB proposed by the organisation of TABs, the members of the Group shall sign a commercial secrecy and confidentiality agreement with that TAB, unless the Group decides otherwise, and the Group shall submit to the responsible TAB a technical file describing the product, its use as foreseen by the Group and details of the factory production control that the members of the Group intend to apply; 当一组制造商或制造商协会(“该组”)提出欧洲技术评估请求时,应将请求提交给 TAB 组织,该组织将向该组提议一个 TAB 作为负责的 TAB。该组可以接受所提议的 TAB,也可以要求 TAB 组织提议另一个替代的 TAB。一旦该组接受了 TAB 组织提议的负责 TAB,该组成员应与该 TAB 签署商业秘密和保密协议,除非该组另有决定,并且该组应向负责的 TAB 提交一份技术文件,描述产品、该组预期的使用方式以及该组成员打算实施的工厂生产控制的详细信息; |
|
1.3. |
In the absence of a request for a European technical assessment, when the Commission initiates the development of a European assessment document, it shall deliver to the organisation of TABs a technical file describing the product, its use and details to become applicable. The organisation of TABs shall, together with the Commission, agree on a TAB to act as the responsible TAB. 在未收到欧洲技术评估请求的情况下,当委员会启动欧洲评估文件的制定时,应向 TAB 组织提供一份描述产品、其用途及将适用细节的技术文件。TAB 组织应与委员会共同协商,确定一个 TAB 作为负责的 TAB。 |
2. Contract 2. 合同
For products referred to in Article 33(1), point (c), within 1 month from the reception of the technical file, in the cases referred to in points 1.1 and 1.2, a contract shall be concluded respectively between the manufacturer or the Group and the responsible TAB for the production of the European technical assessment, specifying the work programme for drawing up the European assessment document, including:
对于第 33 条第 1 款(c)项所指的产品,在第 1.1 和 1.2 点所述情况下,自收到技术文件之日起 1 个月内,应分别由制造商或集团与负责的 TAB 签订合同,负责制作欧洲技术评估,合同应明确制定欧洲评估文件的工作计划,包括:
|
(a) |
the organisation of work within the organisation of TABs; |
|
(b) |
the composition of the workgroup to be established within the organisation of TABs, designated for the product family in question; and |
|
(c) |
the coordination of TABs. |
In the case referred to in point 1.3, the responsible TAB shall submit to the Commission the work programme for drawing up the European assessment document with the same content and within the same deadline. Thereafter, the Commission shall have 30 working days to communicate to the responsible TAB its observations on the work programme, and the responsible TAB shall amend that work programme accordingly.
在第 1.3 点所述的情况下,负责的 TAB 应向委员会提交制定欧洲评估文件的工作计划,该计划内容相同且在相同的截止日期内。此后,委员会有 30 个工作日的时间向负责的 TAB 通报其对工作计划的意见,负责的 TAB 应相应修改该工作计划。
3. Communication of work programme
3. 工作计划的通报
In the cases referred to in points 1.1 and 1.2, after agreement with the manufacturer and the Group respectively, the organisation of TABs shall inform the Commission of the work programme for drawing up the European assessment document and the schedule for its execution, indicating the assessment programme. That communication shall take place within three months of receipt of the request for a European technical assessment by a TAB, whereupon the TAB shall initiate the procedure laid down in points 1.1 and 1.2.
在第 1.1 点和第 1.2 点所述的情况下,经与制造商和集团分别达成一致后,TAB 组织应将制定欧洲评估文件的工作计划及其执行时间表(包括评估计划)通知委员会。该通知应在 TAB 收到欧洲技术评估请求后三个月内进行,随后 TAB 应启动第 1.1 点和第 1.2 点规定的程序。
In the case referred to in point 1.3, the organisation of TABs shall submit to the Commission the work programme for drawing up the European assessment document with the same content and within the same deadline as indicated in the previous subparagraph. The Commission shall then communicate to the organisation of TABs within 30 working days its observations on the work programme. After the responsible TAB and the organisation of TABs has been given the opportunity to comment, the responsible TAB shall amend the work programme accordingly.
在第 1.3 点所述的情况下,TAB 组织应向委员会提交制定欧洲评估文件的工作计划,其内容和截止期限应与前款所述相同。委员会应在 30 个工作日内向 TAB 组织反馈对工作计划的意见。在给予负责 TAB 和 TAB 组织发表意见的机会后,负责 TAB 应相应修改工作计划。
4. The draft European assessment document
4. 欧洲评估文件草案
The organisation of TABs shall, by means of the working group coordinated by the responsible TAB, finalise a draft European assessment document which it shall communicate to the parties concerned within 6 months of the date the Commission was informed of the work programme in the cases referred to in points 1.1 and 1.2 or the date the Commission communicated to the responsible TAB its observations on the work programme in the case referred to in point 1.3.
TAB 的组织应通过由负责 TAB 协调的工作组,完成一份欧洲评估文件草案,并应在第 1.1 和 1.2 点所述情况下,自委员会获悉工作计划之日起 6 个月内,或在第 1.3 点所述情况下,自委员会向负责 TAB 通报其对工作计划的意见之日起 6 个月内,将该草案传达给相关各方。
5. Commission Participation
5. 委员会参与
A Commission representative may participate, as an observer, in all the parts of the execution of the work programme. The Commission may request the organisation of TABs at any stage to abandon or modify the development of a certain European assessment document if the development is not in line with this Regulation or if the approach is not efficient or effective in terms of resources and final applicability. The Commission may request the organisation of TABs at any stage to merge parallel processes for the development of European assessment documents, or to split a single process in two, in order to increase the clarity of, or to ensure efficiency in, the development process or in the future application of the assessment document under consideration.
委员会代表可作为观察员参与工作计划执行的所有环节。委员会可在任何阶段要求 TABs 组织放弃或修改某一欧洲评估文件的开发,若该开发不符合本条例,或在资源使用及最终适用性方面的方法效率不高。委员会亦可在任何阶段要求 TABs 组织合并平行的欧洲评估文件开发流程,或将单一流程拆分为两个,以提高开发流程的清晰度,或确保所考虑评估文件未来应用的效率。
Where the TABs involved do not agree on a European assessment document within the time limits provided, the organisation of TABs shall submit the matter to the Commission for resolution, including through instructions to the organisation of TABs on how to complete its work.
若相关 TABs 未能在规定时间内就某一欧洲评估文件达成一致,TABs 组织应将该事项提交委员会解决,包括通过向 TABs 组织发出完成工作指示。
6. Member States consultation
6. 成员国协商
In the case referred to in point 1.3, the Commission shall inform Member States on the development of the European assessment document after the finalisation of the work programme for it. When requested, Member States may, where appropriate, participate in its execution. Observations from the Member States shall be communicated to, and shall be dealt with by, the Commission. The organisation of TABs shall be informed by the Commission of any change in the work programme, required and agreed to by the Commission, within the time frame given to the Commission for commenting on the work programme before starting the development of the European assessment document.
在第 1.3 点所述的情况下,委员会应在欧洲评估文件工作计划最终确定后,通知成员国其进展情况。成员国在请求时,可在适当情况下参与其执行。成员国的意见应传达给委员会,并由委员会处理。TAB 组织应在委员会开始制定欧洲评估文件前,在委员会对工作计划发表评论的时间范围内,获知委员会要求并同意的任何工作计划变更。
7. Extension and delay
7. 延期与延误
Any delay in relation to the time limits set in points 1 to 4 of this Annex shall be reported by the working group to the organisation of TABs and to the Commission.
工作组应将与本附件第 1 至 4 点规定的时限相关的任何延误报告给 TAB 组织和委员会。
If an extension of the time limits for developing the European assessment document can be justified, notably by the absence of a Commission decision on the applicable assessment and verification system for the product or by the need to develop a new test method, an extended time limit shall be set by the Commission.
如果能够证明延长制定欧洲评估文件的时限是合理的,特别是由于委员会未就适用的产品评估和验证体系作出决定,或需要制定新的测试方法,委员会应设定延长期限。
8. Amendments and adoption of a draft European assessment document
8. 修订及采纳欧洲评估文件草案
|
8.1. |
In the cases referred to in points 1.1 and 1.2, the responsible TAB shall communicate the draft European assessment document to the manufacturer or the Group, respectively, who shall have 20 working days to react thereto. Thereafter, the organisation of TABs shall: 在第 1.1 点和第 1.2 点所述的情况下,负责的 TAB 应将欧洲评估文件草案分别传达给制造商或集团,后者应有 20 个工作日的时间对此作出回应。此后,TAB 组织应:
|
|
8.2. |
In the case referred to in point 1.3, the responsible TAB shall: 在第 1.3 点所述的情况下,负责的 TAB 应:
|
9. Commission assessment of draft European assessment documents
9. 委员会对欧洲评估文件草案的评估
The Commission shall assess the submitted draft European assessment document and, within 30 working days of receipt, communicate its observations to the organisation of TABs. The organisation of TABs, after having been given the opportunity to comment, shall amend the draft accordingly and resend copies of the amended draft European assessment document in accordance with point 8.1(c) and 8.2(b).
委员会应对提交的欧洲评估文件草案进行评估,并在收到后 30 个工作日内将其意见通知 TABs 组织。TABs 组织在获得评论机会后,应相应修改草案,并根据第 8.1(c)点和第 8.2(b)点重新发送修改后的欧洲评估文件草案副本。
10. Adoption of final European assessment document and publication
10. 最终欧洲评估文件的采纳及发布
The organisation of TABs shall adopt the final European assessment document and shall send a copy thereof to the Commission, together with a translation of its title in all the official languages of the Union, for publication of its reference in the Official Journal of the European Union without delay.
TABs 的组织机构应当采纳最终的欧洲评估文件,并将其副本连同该文件标题的所有欧盟官方语言译文一并发送给委员会,以便其在《欧盟官方公报》中及时发布其参考文献。
The organisation of TABs shall publish the European assessment document within 90 days from the date of adoption, in one or more languages of the Union and, as a minimum, ensure that it remains accessible until all European technical assessments based on it cease to be valid.
TAB 组织应在采纳之日起 90 天内,以一种或多种欧盟语言发布欧洲评估文件,并至少确保该文件在所有基于其的欧洲技术评估失效之前保持可访问。
ANNEX VII 附件七
List of product families
产品系列清单
|
CODE |
PRODUCT FAMILY 产品系列 |
|
1 |
PRECAST NORMAL/LIGHTWEIGHT/AUTOCLAVED AERATED CONCRETE PRODUCTS. |
|
2 |
DOORS, WINDOWS, SHUTTERS, GATES AND RELATED BUILDING HARDWARE. |
|
3 |
MEMBRANES, INCLUDING LIQUID APPLIED AND KITS (FOR WATER AND/OR WATER VAPOUR CONTROL). |
|
4 |
THERMAL INSULATION PRODUCTS. COMPOSITE INSULATING KITS/SYSTEMS. |
|
5 |
STRUCTURAL BEARINGS. PINS FOR STRUCTURAL JOINTS. |
|
6 |
CHIMNEYS, FLUES AND SPECIFIC PRODUCTS. |
|
7 |
GYPSUM PRODUCTS. 石膏制品。 |
|
8 |
GEOTEXTILES, GEOMEMBRANES, AND RELATED PRODUCTS. |
|
9 |
CURTAIN WALLING/CLADDING/STRUCTURAL SEALANT GLAZING. |
|
10 |
FIXED FIRE FIGHTING EQUIPMENT (FIRE ALARM/DETECTION, FIXED FIREFIGHTING, FIRE AND SMOKE CONTROL AND EXPLOSION SUPPRESSION PRODUCT). |
|
11 |
SANITARY APPLIANCES. 卫生洁具。 |
|
12 |
CIRCULATION FIXTURES: ROAD EQUIPMENT. |
|
13 |
STRUCTURAL TIMBER PRODUCTS/ELEMENTS AND ANCILLARIES. |
|
14 |
WOOD BASED PANELS AND ELEMENTS. |
|
15 |
CEMENT, BUILDING LIMES AND OTHER HYDRAULIC BINDERS. |
|
16 |
REINFORCING AND PRESTRESSING STEEL FOR CONCRETE (AND ANCILLARIES). POST TENSIONING KITS. |
|
17 |
MASONRY AND RELATED PRODUCTS. MASONRY UNITS, MORTARS, AND ANCILLARIES. |
|
18 |
WASTE WATER ENGINEERING PRODUCTS. |
|
19 |
FLOORINGS. |
|
20 |
STRUCTURAL METALLIC PRODUCTS AND ANCILLARIES. |
|
21 |
INTERNAL & EXTERNAL WALL AND CEILING FINISHES. INTERNAL PARTITION KITS. |
|
22 |
ROOF COVERINGS, ROOF LIGHTS, ROOF WINDOWS, AND ANCILLARY PRODUCTS. ROOF KITS. |
|
23 |
ROAD CONSTRUCTION PRODUCTS. |
|
24 |
AGGREGATES. |
|
25 |
CONSTRUCTION ADHESIVES. 建筑胶粘剂。 |
|
26 |
PRODUCTS RELATED TO CONCRETE, MORTAR AND GROUT. |
|
27 |
SPACE HEATING APPLIANCES. |
|
28 |
PIPES-TANKS AND ANCILLARIES NOT IN CONTACT WITH WATER INTENDED FOR HUMAN CONSUMPTION. |
|
29 |
CONSTRUCTION PRODUCTS IN CONTACT WITH WATER INTENDED FOR HUMAN CONSUMPTION. |
|
30 |
FLAT GLASS, PROFILED GLASS AND GLASS BLOCK PRODUCTS. |
|
31 |
POWER, CONTROL AND COMMUNICATION CABLES. |
|
32 |
SEALANTS FOR JOINTS. 接头密封剂。 |
|
33 |
FIXINGS. |
|
34 |
BUILDING KITS, UNITS, AND PREFABRICATED ELEMENTS. |
|
35 |
FIRE STOPPING, FIRE SEALING AND FIRE PROTECTIVE PRODUCTS. FIRE RETARDANT PRODUCTS. |
|
36 |
ATTACHED LADDERS. 附着式梯子。 |
ANNEX VIII 附件 VIII
Requirements for TABs TAB 的要求
TABs shall be able to fulfil the following tasks and requirements:
TABs 应能够完成以下任务和要求:
|
Competence 能力 |
Description of tasks 任务描述 |
Requirement 要求 |
||||||||||||||||
|
Identify the possible risks and benefits for the use of innovative products in the absence of established/consolidated technical information regarding their performance when installed in construction works. |
A TAB shall be established under national law and have legal personality. It shall be independent from the stakeholders and from any particular interests. A TAB shall have staff with:
The remuneration of the TAB personnel shall not depend on the number of the assessments carried out or on the results of such assessments. |
||||||||||||||||
|
Transform the outcome of the risk analysis into technical criteria for evaluating behaviour and performance of the products regarding the fulfilment of applicable national requirements; provide the technical information needed by those participating in the building process as potential users of the products (manufacturers, designers, contractors, installers). |
|||||||||||||||||
|
Design and validate appropriate methods (tests or calculations) to assess performance for essential characteristics of products, taking into account the current state of the art. |
|||||||||||||||||
|
Understand and evaluate the manufacturing process of the specific product in order to identify appropriate measures ensuring product constancy through the given manufacturing process. |
A TAB shall have staff with appropriate knowledge of the relationship between the manufacturing processes and product characteristics related to factory production control. |
||||||||||||||||
|
Assess the performance for essential characteristics of products on the basis of harmonised methods against harmonised criteria. |
In addition to the requirements listed in points 1, 2 and 3, a TAB shall have access to the necessary means and equipment for the assessment of the performance for essential characteristics of products within product families for which it is to be designated. |
||||||||||||||||
|
Ensure consistency, reliability, objectivity and traceability through the constant application of appropriate management methods. |
A TAB shall have:
|
ANNEX IX 附件九
Assessment and verification systems (AVS)
评估和验证系统(AVS)
The manufacturer shall, in accordance with Article 22(1), correctly determine the product type and apply the corresponding product category on the basis of the applicable harmonised technical specification or European assessment document. Where a notified body is involved in assessment and verification, the notified body shall, in accordance with Article 55(1), verify that the product type was correctly determined and the corresponding product category was correctly applied.
制造商应根据第 22 条第 1 款,依据适用的协调技术规范或欧洲评估文件,正确确定产品类型并应用相应的产品类别。若评估和验证过程中涉及公告机构,公告机构应根据第 55 条第 1 款,核实产品类型是否正确确定,且相应的产品类别是否正确应用。
1. System 1+ 1. 系统 1+
Full notified body control including audit sample testing
公告机构全面控制,包括审核抽样测试
|
(a) |
The manufacturer shall carry out:
|
|
(b) |
The notified body shall decide on the issuing, restriction, suspension, or withdrawal of the certificate of constancy of performance and of conformity of the product on the basis of:
|
2. System 1 2. 系统 1
Full notified body control without audit sample testing
完整的公告机构控制,无需审核样品测试
|
(a) |
The manufacturer shall carry out:
|
|
(b) |
The notified body shall decide on the issuing, restriction, suspension, or withdrawal of the certificate of constancy of performance and of conformity of the product on the basis of:
|
3. System 2+ 3. 系统 2+
Notified body focusing on the factory production control
专注于工厂生产控制的公告机构
|
(a) |
The manufacturer shall carry out:
|
|
(b) |
The notified body shall decide on the issuing, restriction, suspension or withdrawal of the certificate of conformity of the factory production control on the basis of:
|
4. System 3+ 4. 系统 3+
Notified body’s control of environmental sustainability assessment
公告机构对环境可持续性评估的控制
|
(a) |
The manufacturer shall carry out:
|
|
(b) |
The notified body shall decide on the issuing, restriction, suspension or withdrawal of the validation report on the basis of:
|
5. System 3 5. 系统 3
Notified body focusing on the determination of the product type
公告机构专注于产品类型的确定
|
(a) |
The manufacturer shall carry out:
|
|
(b) |
The notified body shall decide on the issuing, restriction, suspension or withdrawal of the certificate of performance and of conformity of the product on the basis of:
|
6. System 4 6. 系统 4
Manufacturer’s self-verification and self-certification
制造商的自我验证和自我认证
|
(a) |
The manufacturer shall carry out:
|
|
(b) |
There is no task for the notified body. |
|
7. |
The following horizontal rules pertaining to some or all of the systems above shall apply: 以下关于上述部分或全部系统的横向规则应予适用:
|
ANNEX X 附件 X
Essential characteristics of a horizontal nature
横向性质的基本特征
The following are groupings of essential characteristics of a horizontal nature, which have been developed on the basis of Annexes I and II, for the application of this Regulation.
以下是基于附件 I 和附件 II,为本条例的适用而制定的横向基本特征的分类。
|
1. |
Reaction to fire. 防火反应。 |
|
2. |
Resistance to fire. 耐火性能。 |
|
3. |
External fire performance. |
|
4. |
Noise absorption. 噪音吸收。 |
|
5. |
Release and content of dangerous substances. |
|
6. |
Environmental sustainability. |
ANNEX XI 附件 XI
Correlation tables 对应表
Table 1: Regulation (EU) No 305/2011 > this Regulation
表 1:条例 (EU) No 305/2011 > 本条例
|
Regulation (EU) No 305/2011 |
This Regulation 本条例 |
|
Article 1 第 1 条 |
Article 1 第 1 条 |
|
Article 2 第 2 条 |
Article 3 第 3 条 |
|
Article 3 第 3 条 |
Article 4(4) 第 4 条第 4 款 |
|
Article 4 第 4 条 |
Article 13 第 13 条 |
|
Article 5 第 5 条 |
Article 14 第 14 条 |
|
Article 6 第 6 条 |
Article 15 第 15 条 |
|
Article 7 第 7 条 |
Article 16 第 16 条 |
|
Article 8 第 8 条 |
Article 17 第 17 条 |
|
Article 9 第 9 条 |
Article 18 第 18 条 |
|
Article 10 第 10 条 |
Article 72 第 72 条 |
|
Article 11 第 11 条 |
Articles 20 and 22 第 20 条和第 22 条 |
|
Article 12 第 12 条 |
Articles 20 and 23 第 20 条和第 23 条 |
|
Article 13 第 13 条 |
Articles 20 and 24 第 20 条和第 24 条 |
|
Article 14 第 14 条 |
Articles 20 and 25 第 20 条和第 25 条 |
|
Article 15 第 15 条 |
Articles 20 and 26 第 20 条和第 26 条 |
|
Article 16 第 16 条 |
Article 20 第 20 条 |
|
Article 17 第 17 条 |
Article 5 第 5 条 |
|
Article 18 第 18 条 |
Article 5 第 5 条 |
|
Article 19 第 19 条 |
Article 31 第 31 条 |
|
Article 20 第 20 条 |
Article 32 第 32 条 |
|
Article 21 第 21 条 |
Article 33 第 33 条 |
|
Article 22 第 22 条 |
Article 34 第 34 条 |
|
Article 23 第 23 条 |
— |
|
Article 24 第 24 条 |
Article 35 第 35 条 |
|
Article 25 第 25 条 |
Article 36 第 36 条 |
|
Article 26 第 26 条 |
Article 37 第 37 条 |
|
Article 27 第 27 条 |
Article 5(5) and (6) 第 5 条第 5 款和第 6 款 |
|
Article 28 第 28 条 |
Article 10 第 10 条 |
|
Article 29 第 29 条 |
Article 39 第 39 条 |
|
Article 30 第 30 条 |
Article 40 第 40 条 |
|
Article 31 第 31 条 |
Article 41 第 41 条 |
|
Article 32 第 32 条 |
Article 41 第 41 条 |
|
Article 33 第 33 条 |
Article 41 第 41 条 |
|
Article 34 第 34 条 |
Article 41 第 41 条 |
|
Article 35 第 35 条 |
— |
|
Article 36 第 36 条 |
Article 59 第 59 条 |
|
Article 37 第 37 条 |
Article 60 第 60 条 |
|
Article 38 第 38 条 |
Article 61 第 61 条 |
|
Article 38a 第 38a 条 |
Article 85 第 85 条 |
|
Article 38b 第 38b 条 |
Article 86 第 86 条 |
|
Article 38c 第 38c 条 |
Article 87 第 87 条 |
|
Article 38d 第 38d 条 |
Article 88 第 88 条 |
|
Article 39 第 39 条 |
Article 42 第 42 条 |
|
Article 40 第 40 条 |
Article 43 第 43 条 |
|
Article 41 第 41 条 |
Article 44 第 44 条 |
|
Article 42 第 42 条 |
— |
|
Article 43 第 43 条 |
Article 46 第 46 条 |
|
Article 44 第 44 条 |
Article 47 第 47 条 |
|
Article 45 第 45 条 |
Article 48 第 48 条 |
|
Article 46 第 46 条 |
Article 49 第 49 条 |
|
Article 47 第 47 条 |
Article 50 第 50 条 |
|
Article 48 第 48 条 |
Article 51 第 51 条 |
|
Article 49 第 49 条 |
Article 52 第 52 条 |
|
Article 50 第 50 条 |
Article 53 第 53 条 |
|
Article 51 第 51 条 |
Article 54 第 54 条 |
|
Article 52 第 52 条 |
Article 55 第 55 条 |
|
Article 53 第 53 条 |
Article 56 第 56 条 |
|
Article 54 第 54 条 |
Article 45 第 45 条 |
|
Article 55 第 55 条 |
Article 58 第 58 条 |
|
Article 56 第 56 条 |
Article 65 第 65 条 |
|
Article 57 第 57 条 |
Article 66 第 66 条 |
|
Article 58 第 58 条 |
Article 67 第 67 条 |
|
Article 59 第 59 条 |
Article 65 第 65 条 |
|
Article 60 第 60 条 |
Article 89 第 89 条 |
|
Article 61 第 61 条 |
Article 89 第 89 条 |
|
Article 62 第 62 条 |
Article 89 第 89 条 |
|
Article 63 第 63 条 |
Article 89 第 89 条 |
|
Article 64 第 64 条 |
Article 90 第 90 条 |
|
Article 65 第 65 条 |
Article 94 第 94 条 |
|
Article 66 第 66 条 |
Article 95 第 95 条 |
|
Article 67 第 67 条 |
Article 93 第 93 条 |
|
Article 68 第 68 条 |
Article 96 第 96 条 |
Table 2: this Regulation > Regulation (EU) No 305/2011
表 2:本条例 > 欧盟条例第 305/2011 号
|
This Regulation 本条例 |
Regulation (EU) No 305/2011 |
|
Article 1 第 1 条 |
Article 1 第 1 条 |
|
Article 2 第 2 条 |
— |
|
Article 3 第 3 条 |
Article 2 第 2 条 |
|
Article 4 第 4 条 |
Article 3 第 3 条 |
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Article 5 第 5 条 |
Articles 17, 18 and 27 |
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Article 6 第 6 条 |
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Article 7 第 7 条 |
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Article 8 第 8 条 |
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Article 9 第 9 条 |
— |
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Article 10 第 10 条 |
Article 28 第 28 条 |
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Article 11 第 11 条 |
— |
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Article 12 第 12 条 |
— |
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Article 13 第 13 条 |
Article 4 第 4 条 |
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Article 14 第 14 条 |
Article 5 第 5 条 |
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Article 15 第 15 条 |
Article 6 第 6 条 |
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Article 16 第 16 条 |
Article 7 第 7 条 |
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Article 17 第 17 条 |
Article 8 第 8 条 |
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Article 18 第 18 条 |
Article 9 第 9 条 |
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Article 19 第 19 条 |
— |
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Article 20 第 20 条 |
Articles 11, 12, 13, 14, 15 and 16 |
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Article 21 第 21 条 |
— |
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Article 22 第 22 条 |
Article 11 第 11 条 |
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Article 23 第 23 条 |
Article 12 第 12 条 |
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Article 24 第 24 条 |
Article 13 第 13 条 |
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Article 25 第 25 条 |
Article 14 第 14 条 |
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Article 26 第 26 条 |
Article 15 第 15 条 |
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Article 27 第 27 条 |
— |
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Article 28 第 28 条 |
— |
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Article 29 第 29 条 |
— |
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Article 30 第 30 条 |
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Article 31 第 31 条 |
Article 19 第 19 条 |
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Article 32 第 32 条 |
Article 20 第 20 条 |
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Article 33 第 33 条 |
Article 21 第 21 条 |
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Article 34 第 34 条 |
Article 22 第 22 条 |
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Article 35 第 35 条 |
Article 24 第 24 条 |
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Article 36 第 36 条 |
Article 25 第 25 条 |
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Article 37 第 37 条 |
Article 26 第 26 条 |
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Article 38 第 38 条 |
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Article 39 第 39 条 |
Article 29 第 29 条 |
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Article 40 第 40 条 |
Article 30 第 30 条 |
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Article 41 第 41 条 |
Articles 31-34 第 31-34 条 |
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Article 42 第 42 条 |
Article 39 第 39 条 |
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Article 43 第 43 条 |
Article 40 第 40 条 |
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Article 44 第 44 条 |
Article 41 第 41 条 |
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Article 45 第 45 条 |
Article 54 第 54 条 |
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Article 46 第 46 条 |
Article 43 第 43 条 |
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Article 47 第 47 条 |
Article 44 第 44 条 |
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Article 48 第 48 条 |
Article 45 第 45 条 |
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Article 49 第 49 条 |
Article 46 第 46 条 |
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Article 50 第 50 条 |
Article 47 第 47 条 |
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Article 51 第 51 条 |
Article 48 第 48 条 |
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Article 52 第 52 条 |
Article 49 第 49 条 |
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Article 53 第 53 条 |
Article 50 第 50 条 |
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Article 54 第 54 条 |
Article 51 第 51 条 |
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Article 55 第 55 条 |
Article 52 第 52 条 |
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Article 56 第 56 条 |
Article 53 第 53 条 |
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Article 57 第 57 条 |
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Article 58 第 58 条 |
Article 55 第 55 条 |
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Article 59 第 59 条 |
Article 36 第 36 条 |
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Article 60 第 60 条 |
Article 37 第 37 条 |
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Article 61 第 61 条 |
Article 38 第 38 条 |
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Article 62 第 62 条 |
— |
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Article 63 第 63 条 |
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Article 64 第 64 条 |
— |
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Article 65 第 65 条 |
Articles 56 and 59 第 56 条和第 59 条 |
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Article 66 第 66 条 |
Article 57 第 57 条 |
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Article 67 第 67 条 |
Article 58 第 58 条 |
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Article 68 第 68 条 |
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Article 69 第 69 条 |
— |
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Article 70 第 70 条 |
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Article 71 第 71 条 |
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Article 72 第 72 条 |
Article 10 第 10 条 |
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Article 73 第 73 条 |
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Article 74 第 74 条 |
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Article 75 第 75 条 |
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Article 76 第 76 条 |
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Article 77 第 77 条 |
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Article 78 第 78 条 |
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Article 79 第 79 条 |
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Article 80 第 80 条 |
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Article 81 第 81 条 |
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Article 82 第 82 条 |
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Article 83 第 83 条 |
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Article 84 第 84 条 |
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Article 85 第 85 条 |
Article 38a 第 38a 条 |
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Article 86 第 86 条 |
Article 38b 第 38b 条 |
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Article 87 第 87 条 |
Article 38c 第 38c 条 |
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Article 88 第 88 条 |
Article 38d 第 38d 条 |
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Article 89 第 89 条 |
Articles 60-63 第 60-63 条 |
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Article 90 第 90 条 |
Article 64 第 64 条 |
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Article 91 第 91 条 |
— |
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Article 92 第 92 条 |
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Article 93 第 93 条 |
Article 67 第 67 条 |
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Article 94 第 94 条 |
Article 65 第 65 条 |
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Article 95 第 95 条 |
Article 66 第 66 条 |
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Article 96 第 96 条 |
Article 68 第 68 条 |
ELI: http://data.europa.eu/eli/reg/2024/3110/oj
ISSN 1977-0677 (electronic edition)
ISSN 1977-0677(电子版)