1. CONTEXT OF THE PROPOSAL. •. Reasons for and objectives of the proposal. This proposal for a Regulation on consumer product safety is in line with the New
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EN 1 EN TABLE OF CONTENTS EXPLANATORY MEMORANDUM .. .. .. 3 1. CONTEXT OF THE PROPOSAL .. .. . 3 Reasons for and objectives of the proposal .. .. .. 3 Consistency with other EU policies .. .. . 5 2. LEGAL BAS IS, SUBSIDIARITY AND PROPORTIONALITY . 6 Legal basis .. .. .. .. 6 Subsidiarity (for non – exclusive competence) .. . 7 Proportionality .. .. .. .. 8 Choice of the instrument .. .. 8 3. RESULTS OF EX POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS .. .. . 8 Ex post evaluations/fitness checks of existing legislation .. .. 8 Stakeholder consultations .. .. .. 9 Collection and use of expertise .. .. 11 Impact assessment .. .. .. 11 Regulatory fitness and simplification .. .. 13 Fundamental rights .. .. .. .. 14 4. BUDGETARY IMPLICATIONS .. .. .. 15 5. OTHER ELEMENTS .. .. .. . 15 Implementation plans and monitoring, evaluation and reporting arrangements .. 15 Detailed explanation of the specific provisions of the proposal .. 15 REGULATION OF THE EUROPEAN PARLI AMENT AND OF THE COUNCIL on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council, and repealing Council Directive 87/357/EEC and Directive 2001/95/EC of the European Parliament and of the Council .. .. . CHAP TER I .. .. .. .. 32 General provisions .. .. .. .. 32 CHAPTER II .. .. .. . 35 Safety requirements .. .. .. 35 CHAPTER III .. .. .. 37 Obligations of economic operators .. .. 37 Section 1 .. .. .. .. 37 Section 2 .. .. .. .. 43
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EN 2 EN CHAPTER IV .. .. .. 44 Online marketplaces .. .. .. .. 44 CHAPTER V .. .. .. . 46 Market surveillance and implementation .. .. .. 46 CHAPTER VI .. .. .. 47 Safety Gate rapid alert system .. .. .. .. 47 CHAPTER VII .. .. .. . 48 Commission role and enforcement coordination .. .. 48 CHAPTER VIII .. .. .. 51 Right to information and remedy .. .. .. 51 CHAPTER IX .. .. .. 53 International cooperation .. .. .. . 53 CHAPTER X .. .. .. . 54 Financial provisions .. .. .. .. 54 CHAPTER XI .. .. .. 57 Final provisions .. .. .. 57 LEGISLATIVE FINANCIAL STATEMENT .. .. 62
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EN 3 EN EXPLANATORY MEMORANDUM 1 . CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal This proposal for a Regulation on consumer product safety is in line with the New Consumer Agenda of 2020 1 aiming to: (i) update and modern ise the general framework for the safety of non – food consumer products; (ii) preserve its role as a safety net for consumers; (iii) adapt the provisions to challenges posed by new technologies and online selling; and (iv) ensure a level playing field for b usinesses. While the proposal will replace the Directive 2001/95/EC on general product safety 2 – food consumer products. The proposed Regulation will also provide continuity with the GPSD by: (i) requir operators; and (iii) containing provisions for the development of standards in support of the general safety requirement. It also aligns the market surveillance rules for p roducts falling – T he proposed Regulation aims therefore both to update the rules currently set out in Directive 2001/95/EC to ensure a safety net for all products, and, at the same time, to ensure that the regime provides greater consistency between harmonised and non – harmo nised products. Already in 2011, the Single Market Act 3 identified the revision of the GPSD and of Regulation (EC) No 765/2008 4 the EU through better coherence and enforcement of product safe ty and market surveillance instruments, the purpose being to introduce a single legislative framework for harmonised and non – harmonised products. It was considered that overlaps in market surveillance rules and obligations of economic operators laid down in various pieces of EU legislation (GPSD, Regulation (EC) No 765/2008 and sector – specific EU harmonisation legislation) have led to confusion among economic operat ors and national authorities and have hampered the effectiveness of market surveillance activity in the EU. The proposed package stalled in negotiations for its adoption and was withdrawn. In the meantime, in 2017, following up on the 2015 Communication Up grading the Single Market: more opportunities for people and business 5 , the Commission adopted a proposal to revise Regulation (EC) 765/2008 to strengthen product compliance and enforcement of EU harmonisation legislation on products, 1 Communication from the Commission to the European Parliament and the Council, New Consumer Agenda Strengthening consumer resilience for sustainable recovery , COM(2020) 696 final. 2 Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (Text with EEA relevance),) OJ L 11, 15.1.2002, p. 4 . 3 Communication from the Commission to the European Parliament and the Council, the European Economic and Social Committee and the Committee of the Regions, Single Market Act Twelve levers to boost growth and strengthen confidence Working together to cre ate new growth/* COM/2011/0206 final. 4 Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regu lation (EEC) No 339/93 (Text with EEA relevance), )OJ L 218, 13.8.2008, p. 30. 5 Communication from the Commission to the European Parliament and the Council, the European Economic and Social Committee and the Committee of the Regions, Upgrading the Single Market: more opportunities for people and business, COM/2015/0550 final.
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EN 4 EN the single market for goods. This led to the adoption, in 2019 , of Regulation (EU) 2019/1020 6 . Consistency with existing policy provisions in the policy area Regulation (EU) 2019 /1020 7 Regulation (EU) 2019/1020 lays down rules and procedures for compliance with, and enforcement of, EU harmonisation legislation on products. The proposal seeks to enable better cooperation among national market surveillance authorities. To that end, it aims to clarify the procedures for the mutual assistance mechanism between them, and, for some product categories, it will require non – EU manufacturers to designate a natural or legal person responsible for compliance information. The proposal covers ma rket surveillance of non – food harmonising acts. It is applicable, except for Chapter VII, to harmonised products only. To ensure coherence and consistency between the regimes for harmonised and non – harmonised products, this proposal takes up and adapts a number of provisions of Regulation 2019/1020, such as Chapters IV, V and VI on market surveillance and Article 4. Decis ion 768/2008/EC 8 Decision 768/2008/EC sets out common principles and procedures that EU legislation must follow when harmonising conditions for marketing products in the EU and the EEA. It includes reference requirements to be incorporated whenever product legislation is revised. As such, it is a template for future product harmonisation legislation. To ensure consistency between the legislation for harmonised and non – harmonised products, this proposal takes up some of the provisions of Decision 768/2008/E C, such as those on traceability requirements and the obligations of economic operators. Regulation (EU) 1025/2012 9 Regulation (EU) 1025/2012 provides a legal basis to use European standards for products and services, identify ICT technical specifications, and finance the European standardisation process. It also sets an obligation for European standardisation organisations (CEN, CENELEC, ETSI) and national standardisation bodies on transparency and participation. 6 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 Regu lations (EC) No 765/2008 and (EU) No 305/2011, OJ L 169, 25.6.2019, p. 1. 7 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 Regu lations (EC) No 765/2008 and (EU) No 305/2011, OJ L 169, 25.6.2019, p. 1. 8 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 (Text with EEA relevance),) OJ L 218, 13.8.2008, p. 82. 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 , L 316, 14.11.2012, p. 12 .
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EN 5 EN To ensure consistency with the general regi me for standardisation as provided for by Regulation (EU) 1025/2012, this proposal provides for a number of amendments to Regulation (EU) 1025/2012 to adapt it to the specific characteristics of the proposed regulation, in particular to the fact that this Regulation requires the adoption of specific safety requirements and to the fact that the standards adopted under this regulation cannot be Directive (EU) 2019/771 10 Di rective 2019/771 introduces rules on the conformity of goods, remedies in the event of a lack of conformity and how to make use of those remedies. The proposal provides remedies specifically for dangerous products that have been recalled from the market. This particular situation justifies having a set of rules that are partially different and easier to activate, in particular because the consumer does not need to demonstrate the non – conformity of the product. These rules are applicable only if products ar e recalled. Therefore they do not amend Directive 2019/771 but only add additional protection in the case of recall. Regulation (EU) 2019/881 11 The Cybersecurity Act introduces an EU – wide cybersecurity certification framework for ICT products, services and processes. However, it does not include minimum cybersecurity legal requirements for ICT products. This proposal clarifies that cybersecurity risks that have an impact on the safety of consumers are covered by the concept of safety under the proposed Regul ation. Consistency with other EU policies The following ongoing or planned initiatives at EU level play an important role for product safety: The Digital Services Act (DSA), adopted by the Commission on 15 December 2020 12 , aims to regulate the responsibilities of providers of intermediary services online, including online platforms such as social media and online marketplaces, with regard to illegal content, goods or services offered by their users. That proposal sets out a number of due diligen ce obligations for online platforms relevant for the proposed regulation, including the introduction of the law in structuring the interface (Article 22). The DSA covers all types of illegal content, as defined by national or EU law, including the sale of dangerous products online. As the DSA is a legislative instrument of general application, it does not include specific provisions addressing such type of conte nt. The DSA also sets out the framework for the notice and 10 Directive (EU) 2019/771 of the European Parliament and of the Council of 20 May 2019 on certain aspects concerning contracts for the sale of goods, amending Regulation (EU) 2017/2394 and Directive 2009/22/EC, and repealing Direc tive 1999/44/EC (Text with EEA relevance),.) OJ L 136, 22.5.2019, p. 28. 11 Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (the European Union Agency for Cybersecurity) and on information and communications technology cybersecurity certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act), OJ L 151, 7.6.2019, p. 15. 12 Proposal for a regulation of the European Parliament and of the Council on a Single Market For Digital Services (Digital Ser vices Act) and amending Directive 2000/31/EC, COM/2020/825 final.
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EN 7 EN contributing to protect the health and safety of European consumers and promoting their right to information 17 . Subsidiarity (for non – exclusive competence) The proposal harmonises the general product safety requirement in the EU. Ensuri ng the safety of products in the single market cannot be achieved sufficiently by Member States acting alone for the following reasons: Products circulate freely across the single market. When a dangerous product is identified in a certain country it is ve ry likely that the same product could be found in other Member States too, not least because of the exponential growth of online selling. Different rules on product safety at national level can create uneven costs for businesses to comply with product saf ety legislation, and therefore can cause distortions in the level playing field on the internal market. To ensure a high level of consumer protection, the EU must contribute to protecting the health and safety of consumers. If different countries have different rules, consumers will not be protected against dangerous products in the same way across the EU. To be effective, market surveillance must be uniform across the EU. If market 18 . EU – level action on product safety for non – harmonised products has the following added value: Common rules and standards for product safety at EU level mean that businesses no longer have to comply with heterogeneous sets of national rules. This generates ben efits in terms of costs savings, a lower administrative burden and a less complex legal regime for businesses. This also enables free circulation of goods in the EU and allows for closer cooperation between Member States. Common EU rules allow economies of scale in market surveillance, particularly important with the exponential development of online selling, which intensifies cross – border sales and direct imports from outside the EU. The costs of market surveillance are also shared through joint market sur veillance actions and the exchange of information among EU countries. The functioning of the single market will be improved by EU – level action. Common product safety and market surveillance rules across the EU will ensure a more even treatment of businesse s, and therefore will be less likely to distort the level playing field on the EU single market. EU action allows for faster and more efficient circulation of information, in particular via the Safety Gate/RAPEX system, thus ensuring fast action against da ngerous products across the EU and a level playing field. 17 Also, product safety is part of the high level of consumer protection ensured by EU policies (see Article 38 of the Charter of Fundamental Rig hts of the European Union) and is therefore one of the pillars of EU consumer protection policy. 18 Traders trying different entry points to the EU.
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EN 8 EN At international level, the common set of provisions established under the GPSD has also enabled the EU to be stronger in promoting a high level of safety both bilaterally and multilaterally, thus tackling the increasing circulation of goods from third countries via online selling. Proportionality autonomy in setting the level of consumer protection and mar ket surveillance they consider necessary, and, on the other hand, the need to address product safety issues that have to be tackled centrally. As underlined in Chapter 7 of the impact assessment, the challenges remain considerable, with a high presence of unsafe consumer products on the EU market. The costs and regulatory burdens associated with this proposal have been kept as limited as possible. Total costs for businesses in the EU27 in the first year of implementation of this Regulation is estimated at 0 .02% of turnover of EU companies for manufacturing, wholesale and retail of non – harmonised products. The measures included in this proposal do not extend beyond what is necessary to solve the identified problems and to achieve the objectives set. The fores een costs for the Commission and Member States are considered as acceptable, and will be compensated by the savings incurred by businesses, and benefits for businesses, consumers and Member States alike. Choice of the instrument A regulation is the only suitable instrument to achieve the objective of improving enforcement of, and compliance with EU legislation on product safety ensuring coherence in the implementation of its legal framework. A directive would not sufficiently achieve the objectives, as j urisdictional boundaries and potential jurisdictional conflicts would persist following its transposition. The choice of Regulation instead of Directive also allows to better deliver on the objective to ensure coherence with the market surveillance legisla tive framework for harmonised products, where the applicable legal instrument is also a Regulation (Regulation (EU) 2019/1020). Finally, such a choice will further reduce the regulatory burden through a consistent application of product safety rules across the EU. 3. RESULTS OF EX POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS Ex post evaluations/fitness checks of existing legislation This proposal for a regulation builds on the evaluation of the General Product Safety Directive, con – to – accompanying the proposal. The GPSD has a twofold objective. It pursues the aim of improving the functioning of the single market , by introducing a common legislative framework to avoid disparities between Member States that could have emerged in the absence of EU law. At the same time, the GPSD intends to achieve a high level of consumer protection by introducing a general product safety requirement and other measures. Both aims are interrelated: the harmonised safety requirement for consumer products envisaged by the GPSD prevents disparities that would lead to the creation of barriers to trade and distortion of the level playing f ield within the single market. The evaluation concluded that the role of the GPSD as a cornerstone of consumer safety and the functioning of the single market is uncontested. Its objectives remain fully relevant, and its EU added value cannot be denied. Th consumer protection, as it provides a legal basis aimed to ensure that no dangerous products –
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EN 9 EN food products under the GPSD has proven to be a success. However, the evaluation has exposed a number of factors that question how far some provisions of the GPSD still contribute to the proper achievement of its goals. In the first place, the growth of e – commerce has decrea sed the effectiveness of the GPSD. The GPSD applies to all consumer products, regardless of whether they are sold in bricks – and – mortar shops or online. However, the lack of explicit provisions in the GPSD to address the specificities of online selling, in particular the appearance of new actors in the online supply chain, has negatively affected the safety of EU consumers and the level playing field for compliant EU businesses. The rapid development of new technologies also raises questions about the scope of some of the key concepts of the GPSD. The appearance of some new risks linked to connectivity, the applicability of the Directive to software updates and downloads as well as the evolving functionalities of AI – powered products raise the question whethe r the GPSD is clear enough to provide legal certainty for businesses and protection to consumers. The evaluation has also identified a lack of internal coherence in the EU legal framework, with the existence of two different sets of rules on market surveillance for harmonised and non – harmonised products. Finally, it is apparent from the evaluation that it would be necessary to fine – tune some of the provisions to improve the effectiveness of the GPSD. In particular, legislative changes or further act ions are needed to improve the effectiveness of product recalls . There is also a need for a mechanism to arbitrate disputes between Member States regarding risk assessments. The traceability system under the Directive and the resources constraints of marke t surveillance authorities make it difficult to effectively control the safety of products, and consequently need to be tackled to ensure the proper protection of consumers and functioning of the Single market. Also, the Food – Imitating Products Directive ( FIPD) is currently not enforced in a harmonised manner among Member States, so a solution to address this issue is needed. Stakeholder consultations In preparing this proposal, the Commission consulted stakeholders via a public consultation on the incept ion impact assessment and roadmap, an open public consultation (OPC), stakeholder workshops, as well as ad hoc contributions and targeted consultations with Member States and other stakeholders. The results from the consultation activities have been incorp orated throughout the impact assessment and are reflected in this proposal. The main points raised during the consultations are the following: Preserving the safety net : The overall feedback among all stakeholder groups was that the GPSD is a useful piece of legislation and its safety net principle should be preserved. However, a large majority of respondents stated that current EU safety rules for non – food consumer products covered by the GPSD could be improved in specific areas so that they better protec t consumers (71% of answers in the OPC). Tackling the challenges posed by new technologies : While all stakeholders acknowledged that new technologies raise many challenges, they put forward divergent approaches to tackle them. In the consultations, consum er representatives and several Member State authorities that have an impact on safety. However, in the consultation on the roadmap/inception impact assessment, te chnology – oriented businesses were more reluctant to include new technologies and new risks related to them in the GPSD. They would prefer the GPSD to remain technology – neutral, with risks linked to new technologies covered in other, more specific
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EN 10 EN pieces of legislation. Nevertheless, the proposal for a regulation includes such aspects to make sure that risks posed by new technologies are in the scope of the safety net, in case they are not covered by more specific pieces of EU legislation 19 . Addressing safet y issues associated with products sold online : The issue of products coming directly or via online platforms from outside the EU was a recurrent issue mentioned in the consultations. Businesses and business representatives stressed the importance of having a level playing field and pointed out that currently many EU retailers suffer as a result of unfair competition from operators based in third countries. Member State authorities stressed that it was difficult to control products coming from third countrie s and to take enforcement action against economic operators outside the EU. Vie ws diverged between stakeholders regarding the obligations of online marketplace s : Online marketplaces providing their feedback on the roadmap indicated that they would accept s ome of the obligations under the current voluntary Product Safety Pledge being binding, but would not be in favour of further obligations. 20 Retailers argued that online marketplaces play a key role in the supply chain, and therefore they should have corres ponding responsibilities. Consumer representatives and Member States authorities were in favour of strengthening responsibilities across the supply chain. Improving market surveillance rules and enforcement: As regards market surveillance and enforcement, stakeholders from all categories were in favour of an alignment of market surveillance rules between harmonised and non – harmonised products. This is included in the e majority of respondents in the OPC considered that products covered by the GPSD should only be placed on the EU market if there is an economic operator established in the EU responsible for product safety purposes (70% of respondents in favour). Revisio n of the standardisation process: A majority of stakeholders was in favour of simplifying the standardisation process for developing new standards under the GPSD and now under this Regulation. This is provided for in this proposal. Including food – imitating products in the scope of the revised GPSD : Most stakeholders were in favour of incorporating the food – imitating legislation into the revised GPSD. A large majority of respondents to the OPC stated that products which resemble foodstuff shoul d be incorporated into the general product safety legal instrument (69% of respondents in favour). In the consultation on the inception impact assessment, respondents favoured including this element in the product safety risk assessment. This approach is r eflected in the proposal. No support was expressed for a full ban of food – imitating products. Improving the framework for product recalls : Stakeholders repeatedly stressed the crucial importance of contacting affected consumers directly in the case of rec alls whenever possible, for instance because the product was registered, bought online, or bought with the use of loyalty card. Several stakeholders mentioned that consumers should be able to choose to receive safety notifications only (when registering a product or subscribing to a loyalty scheme). There was a broad agreement that some key elements and ground rules, applicable to all recall notices, should be standardised and made compulsory, which is the case in the 19 Please see the o pinion of the Sub – group on Artificial Intelligence (AI), connected products and other new challenges in product safety to the Consumer Safety Network of December 2020. 20 Feedbacks received on the roadmap : General Product Safety Directive review (europa.eu)
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