EUROPEAN COMMISSION Brussels, 30.6.2021 COM(2021) 346 final 2021/0170(COD) Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT 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





(Text with EEA relevance) {SEC(2021) 280 final} - {SWD(2021) 168 final} - {SWD(2021) 169 final}



TABLE OF CONTENTS EXPLANATORY MEMORANDUM 3 1. CONTEXT OF THE PROPOSAL3 •Reasons for and objectives of the proposal3 •Consistency with other EU policies5 2.LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY6 •Legal basis6 •Subsidiarity (for non-exclusive competence)7 •Proportionality8 •Choice of the instrument8 3.RESULTS OF EX POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS8 •Ex post evaluations/fitness checks of existing legislation8 •Stakeholder consultations9 •Collection and use of expertise11 •Impact assessment11 •Regulatory fitness and simplification13 •Fundamental rights14 4.BUDGETARY IMPLICATIONS15 5.OTHER ELEMENTS15

•Implementation plans and monitoring, evaluation and reporting arrangements15 •Detailed explanation of the specific provisions of the proposal15 REGULATION OF THE EUROPEAN PARLIAMENT 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 CHAPTER 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 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 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 aiming to: (i) update and modernise 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 businesses. While the proposal will replace the Directive 2001/95/EC on general product safety (‘GPSD’), it will continue applying to manufactured non-food consumer products. The proposed Regulation will also provide continuity with the GPSD by: (i) requiring that consumer products be ‘safe’; (ii) setting certain obligations for economic 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 products falling outside the scope of the EU harmonisation legislation (‘non-harmonised products’) with those applying to products falling under the scope of the EU harmonisation legislation (‘harmonised products’) as set out in Regulation (EU) 2019/1020. The 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-harmonised products. Already in 2011, the Single Market Act identified the revision of the GPSD and of Regulation (EC) No 765/2008 as key actions ‘to improve the safety of products circulating in the EU through better coherence and enforcement of product safety and market surveillance rules’. Such revision was proposed in 2013 in a package including the revision of both legal 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 operators 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 Upgrading the Single Market: more opportunities for people and business, the Commission adopted a proposal to revise Regulation (EC) 765/2008 to strengthen product compliance and enforcement of EU harmonisation legislation on products, as part of the ‘goods package’, e.g. a package of initiatives to ensure a better functioning of the single market for goods. This led to the adoption, in 2019, of Regulation (EU) 2019/1020 • Consistency with existing policy provisions in the policy area Regulation (EU) 2019/1020 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 market surveillance of non-food products (‘industrial products’) whose placement on the single market is subject to EU 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. Decision 768/2008/EC 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/EC, such as those on traceability requirements and the obligations of economic operators.

Regulation (EU) 1025/2012 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. To ensure consistency with the general regime 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 assimilated to harmonised standards and are indicated therefore as “European standards”. Directive (EU) 2019/771 Directive 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 are recalled. Therefore they do not amend Directive 2019/771 but only add additional protection in the case of recall. Regulation (EU) 2019/881 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 Regulation. •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, 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 diligence obligations for online platforms relevant for the proposed regulation, including the introduction of the ‘traceability of traders’ principle and the obligation to take into consideration product safety 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 content. The DSA also sets out the framework for the notice and action procedure (Article 14). The proposed regulation specifies certain obligations for online marketplaces in the product safety field. The legislative proposal on artificial intelligence (AI) lays down harmonised rules for the placing on the market, putting into service and use of artificial intelligence systems in the EU. The rules need to ensure a high level of protection of the public interests, in particular on health and safety, and people’s fundamental rights and freedoms. It lays down specific requirements with which high-risk AI systems must comply and imposes obligations on providers and users of such systems. This proposal takes into consideration these provisions and provides a safety net for products and risks to health and safety of consumers that do not enter into the scope of application of the AI proposal. The chemicals strategy adopted in October 2020 points to the fact that the already widespread use of chemicals will increase, including in consumer products, and that it is necessary to ban the most harmful chemicals in consumer products to ensure their safety. The REACH Regulation has introduced obligations for the industry to assess and manage the risks posed by chemicals and provide appropriate safety information for their users. It also provides for restrictions to protect human health and the environment from unacceptable risks posed by chemicals. This proposal maintains a safety net for chemical risks in products not covered by specific legislation. The Circular economy action plan adopted in March 2020aims to reduce waste through reuse, repair, remanufacturing and high-quality recycling - in particular concerning secondary raw materials where dangerous substances can persist - and states that the safety of products must be taken into consideration as a primary objective. This proposal acknowledges that, when economic operators or authorities face a choice of corrective actions, the most sustainable action (i.e. the one with the lowest environmental impact) should be preferred, provided that it does not result in a lower level of safety.” 2.LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY •Legal basis The legal basis for the proposed Regulation is Article 114 TFEU, with due regard to Article 169. Its objective is to ensure product safety and improve the functioning of the internal market. At the same time, it aims to ensure a high level of consumer protection, by contributing to protect the health and safety of European consumers and promoting their right to information. •Subsidiarity (for non-exclusive competence) The proposal harmonises the general product safety requirement in the EU. Ensuring 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 very 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 safety 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 surveillance is ‘softer’ in some parts of the EU, weak spots are created. These threaten the public interest, create unfair trading conditions and encourage ‘forum shopping’. 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 benefits 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 surveillance 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 businesses, 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 dangerous products across the EU and a level playing field. –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 This proposal strikes a careful balance between, on the one hand, EU countries’ regulatory autonomy in setting the level of consumer protection and market 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 foreseen 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 jurisdictional 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 legislative 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, conducted as a ‘back-to-back’ evaluation with the impact assessment 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 field 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. The GPSD’s role as a ‘safety net’ remains essential for consumer protection, as it provides a legal basis aimed to ensure that no dangerous products end up in consumers’ hands. The establishment of the rapid alert system for dangerous non-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 decreased 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 whether 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 actions 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 market 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 inception 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 incorporated 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 protect 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, consumer representatives and several Member State authorities expressed support for expanding the definition of ‘safety’ to include (cyber)security aspects that have an impact on safety. However, in the consultation on the roadmap/inception impact assessment, technology-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 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. Addressing safety 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 countries and to take enforcement action against economic operators outside the EU. Views diverged between stakeholders regarding the obligations of online marketplaces: –Online marketplaces providing their feedback on the roadmap indicated that they would accept some of the obligations under the current voluntary Product Safety Pledge being binding, but would not be in favour of further obligations. Retailers argued that online marketplaces play a key role in the supply chain, and therefore they should have corresponding 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 proposal. Regarding the introduction of a ‘responsible person’ in the revised GPSD, a large 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). Revision 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 should 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 reflected 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 recalls 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 proposed regulation. Several stakeholders mentioned the need to make recall participation less burdensome and more attractive to consumers. Improving traceability along the supply chain: A large majority of stakeholders agreed that the system of product traceability should be strengthened in the GPSD (82% in favour in the OPC). Moreover, the role of online marketplaces in improving product traceability was also stressed, with respondents notably arguing that marketplaces should check that traceability information is available before listing a product. Addressing counterfeit products: Brand owner organisations stressed that the GPSD should be amended to tackle counterfeit unsafe products. This issue was duly taken into consideration but not included in this proposal, as counterfeit products are already addressed by EU legislation, and unsafe products are covered in the GPSD and in this proposal regardless of their authenticity. Even though counterfeit products can pose safety risks, the safety of a given product has to be analysed based on a risk assessment. •Collection and use of expertise The preparatory steps for this proposal rest on expert advice and a number of studies. This includes studies with a focus on the GPSD’s implementation, to support the evaluation and impact assessment, as well as on the effectiveness of product recalls. The Commission also gathered expertise and views through targeted consultations and engagement activities, including a series of workshops, conferences, interviews with experts and authorities, and the opinion of the Sub-group of the Consumer Safety Network on artificial intelligence, connected products and other new challenges on product safety. The Commission held numerous bilateral meetings and carried out an analysis of ad-hoc position papers from consumer organisations, industry representatives and academia. •Impact assessment This proposal is supported by an impact assessment report (SWD (2021) 169, SWD (2021) 168). The impact assessment report has been scrutinised by the Regulatory Scrutiny Board and received a positive opinion (SEC 280 (avis du RSB)

In the context of this initiative, the Commission examined several policy alternatives as presented in the impact assessment report. The range of policy alternatives analysed included both non-legislative and legislative actions to address the different specific objectives as presented in the report: (i) ensure the EU legal framework provides general safety rules for all consumer products and risks, including products and risks linked to new technologies; (ii) address product safety challenges in the online sales channels; (iii) make product recalls more effective and efficient to keep unsafe products away from consumers; (iv) enhance market surveillance and ensure better alignment of rules for harmonised and non-harmonised consumer products; and finally (v) address safety issues related to food-imitating products. A number of options were assessed. First, the Commission considered how it could respond to the specific objectives without revising the GPSD (Option 1). Several non-legislative measures have been considered, in particular: (i) issuing guidance documents on the applicability of the GPSD to new technologies and on recalls and; (ii) exploring expansion of the voluntary measures under the Product Safety Pledge for online sales. However, the different consultations showed that such non-legally binding measures would not tackle the identified shortcomings. The Commission considered several legislative options to tackle the specific objectives: a targeted legislative revision of the GPSD (Option 2) focusing on a limited number of changes and a full revision of the GPSD proposing a comprehensive action on all objectives (Option 3). The impact assessment shows that Option 3, which is more ambitious than Option 2, also better addresses the identified shortcomings and better meets the specific objectives to be addressed, while keeping the economic impacts still limited. Option 4 considered a full integration of market surveillance instruments, as proposed in the 2013 product safety and market surveillance package, to analyse whether this option would still be valid after the recent adoption of Regulation (EU) 2019/1020. The impact assessment showed that Option 4, although similar on substance to Option 3, might generate higher costs for EU businesses. Therefore, the Commission chose Option 3 (full revision of the GPSD including change to a regulation) as the best policy choice for the current proposal since it addresses best the policy objectives while limiting the costs for businesses and market surveillance authorities. Different options have also been considered regarding the safety of food-imitating products. These were: (i) to maintain a separate regime for these products under a separate directive (revising Directive 87/357/EEC); (ii) to integrate the specific provisions of the current Directive 87/357/EEC into the new GPSD with a specific legal regime; (iii) to abandon targeted provisions on food-imitating products and use the general provisions to ensure safety of such products based on the case-by-case risk assessment instead. For the first two options, the Commission also considered developing guidance to overcome the issue of different interpretation by Member States; however, consulting the Member States showed that the divergences in interpretation of the Food-Imitating Products Directive were so great that a legal revision of the rules was necessary to ensure its even application. The Commission chose as the best policy option discontinuing the specific regime for food-imitating products and assessing their safety according to the same risk assessment principles as for the other non-harmonised consumer products (the food-imitating aspect will be taken into account in the risk assessment of the given product). The preferred option, which includes: a) clarification on how this legislation would apply to risks posed by new technologies and online selling, b) provisions enhancing the effectiveness of product recalls, c) alignment with harmonised market surveillance rules and ensuring better responsibilities related to products safety of economic operators and online marketplaces, d) simplification of standardisation procedures and e) integration of the provisions of the Food Imitating Products Directive, is expected to have the following impacts: On economic impacts, the preferred option is expected to lead to major benefits for consumers and society. The estimated consumer detriment should decrease by approximately EUR 1.0 billion in the first year of implementation of the preferred option and by approximately EUR 5.5 billion over the next decade. This option should also reduce consumer detriment related to ineffective recalls by more than EUR 400 million per year. Moreover, by reducing the number of unsafe products, the proposed measures should also reduce the current detriment suffered by EU consumers and society due to preventable product-related accidents (estimated today at EUR 11.5 billion per year) and the current cost of healthcare for product-related injuries (current estimate EUR 6.7 billion per year). The precise impact could not been quantified due to lack of injury data to estimate trends. Estimated cost savings caused by reducing the differences in national implementation and legal fragmentation are estimated at EUR 59 million annually for businesses and EUR 0.7 million per year for market surveillance authorities. Total costs for businesses in the EU (active in manufacturing, wholesale and retail of non-harmonised products) are estimated at EUR 196.6 million, equivalent to 0.02% of their turnover in the first year of implementation. In the following years, the recurrent costs would amount to EUR 177.8 million for EU businesses. These costs are linked to the increased obligations for businesses mainly for online sales, sales of new technology products and recalls of unsafe products, and to the alignment of market surveillance rules with those for harmonised products. Market surveillance authorities in Member States would face total additional recurrent costs under this proposal of approximatively EUR 6.7 million annually due to their increased powers in the market surveillance of unsafe products, and only relatively moderate one-off adaptation and implementation costs. •Regulatory fitness and simplification This proposal envisages revising two existing legislative instruments: the General Product Safety Directive and the Food-Imitating Product Directive. To simplify the legislation, the Commission proposes to repeal the Food-Imitating Product Directive and assess the safety of food-imitating products under the current proposal for a new general product safety regulation. The Commission also identified several areas where the administrative burden and related costs could be reduced. First, this proposal would reduce regulatory costs and burdens for businesses, since the legally binding clarifications and the choice of a regulation as instrument will reduce regulatory uncertainty and ensure more even implementation of the product safety legislation compared to today under the GPSD. Also, aligning the general market surveillance and safety requirements for harmonised and non-harmonised products will reduce implementation differences and improve the traceability of the supply chain. Cost reductions will occur for all businesses, and in particular for the 42% of businesses who reported additional costs related to the uneven implementation of the GPSD. Cost savings for businesses through more harmonised implementation are estimated at around EUR 59 million annually (EUR 34 million saved by EU SMEs and EUR 26 million saved by EU large businesses respectively). Second, this proposal will bring efficiency gains in market surveillance and enforcement to Member States. This is due to aligning market surveillance provisions between harmonised and non-harmonised products, more aligned enforcement powers, increased deterrent effect and a new arbitration mechanism. Therefore, this proposal brings cost reductions for all market surveillance authorities in Member States, and in particular for the 16% of them who reported related additional costs due to the different legal frameworks between harmonised and non-harmonised products. These cost savings for Member States are estimated at EUR 0.7 million per year across the EU. Finally, the proposed simplification of the standardisation process will reduce the administrative burden for Member States and the Commission. Such streamlining of the standardisation EU process will accelerate standardisation work and thus increase legal certainty and help companies to comply with the general product safety requirement. This proposal does not exempt micro-enterprises and SMEs from any of the obligations. EU product safety legislation does not allow for ‘lighter’ regimes for SMEs since any consumer product must be safe whatever the characteristics of its supply chain in order to meet the general objective of product safety and consumer protection. The Commission estimates the total compliance costs of this proposal for EU SMEs at EUR 111.1 million (one-off and recurrent costs) in the first year of implementation. In the subsequent years, the recurrent costs would amount to around EUR 100 million for EU SMEs. Estimated savings caused by reduced differences in national implementation and legal fragmentation would amount to EUR 34 million for EU SMEs. This proposal will have practical implications both on the economic operators handling products covered by the GPSD and on market surveillance authorities in the Member States. Businesses will have to comply with additional requirements regarding traceability and transparency. Additional requirements on recalls will apply for businesses that have actually brought unsafe products onto the market. Online marketplaces will also have to make sure they set up internal mechanisms to comply with their new obligations relating to product safety. In addition, companies selling in the single market from outside the EU will have to set up arrangements to ensure that the products sold in the EU have a responsible economic operator. Member States’ market surveillance authorities might require additional resources to cope with the broadening of market surveillance responsibilities and the new competences they would be given. For example, the new tools for market surveillance online broaden the possibilities for national authorities and may require additional resources and skills. However, with these new powers being largely aligned with the existing market surveillance provisions applicable to harmonised products under Regulation (EU) 2019/1020, market surveillance authorities are often familiar with them, in particular in those Member States where the same national market surveillance authorities handle already both harmonised and non-harmonised products. The practical implications for Member States are therefore rather better synergies and better use of existing structures and resources than new additional needs. The extended coverage of risks from new technologies (e.g. cybersecurity risks that have an impact on safety) would be expected to increase the need for professional staff and external expertise in Member States to check the safety of new technology products. The most affected business sectors would be online sales and producers in some new technology sectors. However, thanks to harmonised EU requirements this should not have a major impact on their competitiveness. This proposal operates effectively in both the digital and physical worlds and takes into account digital developments, in particular the development of online sales and new technology products. Addressing the digital challenges for product safety is one of the main objectives of this proposal. It improves market surveillance rules for online sales and sets product safety obligations for online marketplaces and online retailers to improve the safety of products sold online. This proposal also addresses new safety risks brought by new technologies and clarifies the application of product safety rules to software. This proposal is fully consistent with the EU’s digital policies in place and in particular with the proposal for the Digital Services Act and with the legislative work on artificial intelligence and the internet of things. This initiative is supported by existing ICT solutions, namely the EU Rapid Alert System for dangerous non-food products (‘Safety Gate’) and the related Business Gateway. •Fundamental rights

This proposal aims to strengthen the protection of European consumers’ health and safety and promote their right to information. Thanks to clearer obligations and better product safety enforcement, this proposal is expected to have a positive impact on, and ensure a higher level of, consumer protection and environmental protection, in line with Articles 37 and 38 of the Charter of Fundamental Rights of the European Union. The proposal imposes additional requirements on businesses that are necessary to pursue the general EU interest of increasing consumer protection. The resulting compliance costs are estimated to be comparatively low compared to businesses’ turnover. As such, these requirements do not affect the fundamental freedom to conduct a business and its proportionality under Article 52 of the Charter. 4.BUDGETARY IMPLICATIONS The proposed regulation requires the Commission to support and facilitate the cooperation of market surveillance enforcement authorities, including coordinated market surveillance activities, the new arbitration mechanism and peer reviews. Furthermore, this proposal allows for enhanced cooperation and exchange of information with EU international partners in the product safety field. Finally, this proposal provides for the adoption of implementing acts and delegated acts (related to traceability and recalls) and possible higher standardisation activity through a simplified standardisation procedure. This will trigger additional workload for the Commission, estimated at four extra full-time officials (three administrators and one assistant). These resources will be obtained through the redistribution and refocusing of the existing personnel’s tasks. The Commission will also finance electronic interfaces, namely the Safety Gate webpage, the Safety Gate portal (which provides notifications of dangerous products) and the Safety Business Gateway collecting notifications from economic operators to market surveillance authorities. Additional costs for these coordination activities and electronic interfaces can be covered by the single market programme under the current multiannual financial framework 2021-2027. Similar financing possibilities may also be included under the successor programmes under future multiannual financial frameworks. The details are set out in the financial statement attached to this proposal. 5.OTHER ELEMENTS •Implementation plans and monitoring, evaluation and reporting arrangements The implementation of the proposal will be accompanied by monitoring based on predefined core enforcement indicators. The Commission is carrying out a study to define a common set of feasible and relevant enforcement indicators in the product safety field, to be agreed with Member States. In addition to the regular monitoring and reporting, an evaluation of the effectiveness, efficiency, relevance, coherence and EU added value of this legislative intervention is proposed after 5 years of implementation by Member States. The Commission will support the implementation of the proposal by coordination actions, both in the context of the Consumer Safety Network (follow-up of implementation, exchange of best practices between Member States, etc.) and the market surveillance coordinated activities (CASPs). •Detailed explanation of the specific provisions of the proposal The proposed regulation consists of 11 chapters comprising 47 articles. Chapter I – General provisions This chapter sets out the scope and the main terms used in the proposed regulation. It provides a ‘safety net’ for all products falling under its scope of application establishing requirements to ensure the safety of consumer products and therefore the safety of consumers. It provides rules on the application of this Regulation to the non-harmonised legislation. It updates the definitions used in Directive 2001/95/EC, in particular to take into account the different scope of the definition of product, and introduces a specific definition of ‘online marketplace’ Chapter II – Safety requirements It introduces the general safety requirement, confirms the importance of standards published in the EU Official Journal as providing presumption of safety and updates aspects for assessing the safety of products to take into consideration food-imitating products in the risk evaluation, following the repeal of Directive 87/357/EEC. New aspects for assessing product safety also include the possible risks related to products based on new technologies. Chapter III – Obligations of economic operators Section 1 This Section set outs the obligations of the economic operators except those economic operators which fall under the scope of application of Regulation (EU) 2019/1020. This is to avoid that obligations contained in this Chapter could conflict with similar obligations contained in the harmonised legislation. Apart of the more general obligations of economic operators to ensure the safety of products, it introduces the concept of substantial modification, in which case responsibility for the safety of the product shifts to the person making the modification. Furthermore, it extends the concept of person responsible contained in Article 4 of Regulation (EU) 2019/1020 to non-harmonised products. This is a necessary condition for making the products available on the market to tackle the issues of direct imports from third countries. This chapter also contains the basic provisions on traceability, mostly taken from Decision 768/2008/EC, and the possibility, in the case of products susceptible to pose a serious risk to people’s health and safety, to adopt a more stringent system of traceability, to be adopted by a delegated act.

Section 2 This Section contains the obligations of economic operators which are applicable also to economic operators falling under the scope of Regulation (EU) 2019/1020. These are obligations which do not have correspondence in the harmonised sectors and therefore their applicability also to this sector would not create conflict. It concerned the obligation of economic operators in case of distance sales and in case of accidents with a product. Chapter IV – Online marketplaces This Chapter examines the role played by online marketplaces and lays down specific obligations applicable to them. Chapter V– Market surveillance and implementation This chapter takes up and adapts the entire Chapters IV, V and VI of Regulation (EU) 2019/1020 on market surveillance. The aim is to create, as far as possible, a single regime for both harmonised and non-harmonised products. Chapter VI – Safety Gate rapid alert system This chapter lays down the principle for exchanging information in the case of a dangerous product and changes the name of the RAPEX system to Safety Gate, while maintaining the same characteristics of the system. The proposal adds more specific deadlines. The relation between Safety Gate and the Information and Communication System on Market Surveillance (ICSMS) is made clearer; the chapter also clarifies that Member State authorities can decide to entrust the task of single liaison officer to the Safety Gate National contact point. Chapter VII – Commission role and enforcement coordination This chapter provides the possibility for the Commission to adopt measures, through implementing acts, in case of a serious risk which cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned or by any other procedure under EU legislation. This possibility already exists in the GPSD: the proposed regulation makes its scope of application more precise. Chapter V also introduces a voluntary arbitration mechanism where Member States can submit to the Commission questions concerning the identification or the level of a risk linked to a product in case of diverging risk assessments. This will make it possible to take more uniform action at EU level against dangerous products. Chapter VIII – Right to information and remedy This chapter provides provisions on information for consumers. It confirms the obligation for the Commission and Member States to make available to consumers information relating to risks to health and safety posed by products. It also sets the obligation for Member States to give consumers the opportunity to submit complaints to the competent national authorities. It confirms and further enhances the scope of the Safety Gate web portal, which already exists, adding a new section where consumers can consult warnings and recalls issued directly by economic operators. On recalls, the new provisions try to improve their effectiveness, thus ensuring a more complete and widespread provision of information for consumers, as well as an enhanced system of remedies available to consumers. Chapter IX– International cooperation This Chapter provides the legal basis for the Commission to establish forms of cooperation to improve product safety. These include common enforcement actions, technical support, exchange of officials, and the exchange of information on dangerous products and in particular information contained in the Safety Gate. In this respect, the provision allows either fully fledged participation in Safety Gate or an exchange of selected information. Chapter X – Financial provisions The proposed Regulation provides for the financing by the Commission of activities in all matters falling under its scope of application. The proposed Regulation includes general clauses on protecting the financial interests of the EU. Chapter XI - Final provisions This chapter provides in particular for a system of penalties: while recognising that establishing penalties is a national competence, it sets out guiding principle for penalties, in particular criteria for setting penalties, the types of infringements to be penalised, criteria on maximum ceilings, as well as the possibility to impose periodic penalty payments. 2021/0170 (COD)

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT 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





(Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee, Acting in accordance with the ordinary legislative procedure, Whereas: (1)Directive 2001/95/EC of the European Parliament and of the Council lays down the requirement that consumer products must be safe and that Member States' market surveillance authorities must take action against dangerous products as well as exchange information to that effect through the “Union rapid information exchange system”, RAPEX. (2)Directive 2001/95/EC needs to be revised and updated in light of the developments related to new technologies and online selling, to ensure consistency with developments in the Union harmonisation legislation and in the standardisation legislation, to ensure a better functioning of the product recalls as well as to ensure a clearer framework for food-imitating products so far regulated by Council Directive 87/357/EEC. In the interest of clarity, Directive 2001/95/EC, as well as Directive 87/357/EEC, should be repealed and replaced by this Regulation. (3)A Regulation is the appropriate legal instrument as it imposes clear and detailed rules which do not give room for divergent transposition by Member States. The choice of Regulation instead of Directive also allows to better deliver on the objective to ensure coherence with the market surveillance legislative framework for products falling under the scope of Union harmonisation legislation as set out in Regulation (EU) 2019/1020, where the applicable legal instrument is also of the same type, namely Regulation (EU) 2019/1020 of the European Parliament and of the Council. Finally, such a choice will further reduce the regulatory burden through a consistent application of product safety rules across the Union. (4)The aim of this instrument is to contribute to the attainment of the objectives referred to in Article 169 of the Treaty. In particular, it should aim at ensuring health and safety of consumers and the functioning of the internal market as regards products intended for consumers. (5)This Regulation should aim at protecting consumers and their safety as one of the fundamental principle of the EU legal framework, enshrined in the EU Charter of fundamental rights. Dangerous products can have very negative consequences on consumers and citizens. All consumers, including the most vulnerable, such as children, older persons or persons with disabilities, have the right to safe products. Consumers should have at their disposal sufficient means to enforce such rights, and Member States adequate instruments and measures at their disposal to enforce this Regulation. (6)Despite the development of sector-specific Union harmonisation legislation that addresses safety aspects of specific products or categories of products, it is practically impossible to adopt Union legislation for all consumer products that exist or may be developed. There is therefore still a need for a legislative framework of a horizontal nature to fill gaps and ensure consumer protection not otherwise ensured, in particular with a view to achieving a high level of protection of safety and health of consumers, as required by Article 114 and Article 169 of the Treaty. (7)At the same time, in respect of products subject to sector-specific Union harmonisation legislation, the scope of application of the different parts of this Regulation should be clearly set out to avoid overlapping provisions and an unclear legal framework. (8)Whilst some of the provisions such as those concerning most of the obligations of economic operators should not apply to products covered by Union harmonisation legislation since already covered in such legislation, a certain number of other provisions should apply in order to complement Union harmonisation legislation. In particular the general product safety requirement and related provisions should be applicable to consumer products covered by Union harmonisation legislation when certain types of risks are not covered by that legislation. The provisions of this Regulation concerning the obligations of online marketplaces, the obligations of economic operators in case of accidents, the right of information for consumers as well as the recalls of consumer products should apply to products covered by Union harmonisation legislation when there are not specific provisions with the same objective in such legislation. Likewise RAPEX is already used for the purposes of Union harmonisation legislation, as referred to in Article 20 of Regulation (EU) 2019/1020 of the European Parliament and of the Council, therefore the provisions regulating the Safety Gate and its functioning contained in this Regulation should be applicable to Union harmonisation legislation. (9)The provisions of Chapter VII of Regulation (EU) 2019/1020, setting up the rules of controls on products entering the Union market, are already directly applicable to products covered by this Regulation and it is not the intention of this Regulation to modify such provisions. The stability of the former is particularly important taking into account the fact that the authorities in charge of these controls (which in almost all Member States are the customs authorities) shall perform them on the basis of risk analysis as referred to in Articles 46 and 47 of Regulation (EU) No 952/2013 (the Union Customs Code), the implementing legislation and corresponding guidance. This risk-based approach is pivotal to customs controls given the substantial volumes of goods coming into and leaving the customs territory and results in application of concrete control measures depending on identified priorities. The fact that the Regulation does not modify in any way Chapter VII of Regulation 2019/1020, directly referring to the risk based approach laid down in the customs legislation, means in practice that the authorities in charge of controls on products entering the Union market (including customs authorities) should limit their controls to the most risky products, depending on the likelihood and impact of the risk, thereby ensuring effectiveness and efficiency of their activities as well as protection of their capacity to perform such controls.

(10)The precautionary principle is a fundamental principle for ensuring the safety of products and consumers and should therefore be taken into due account by all relevant actors when applying this Regulation. (11)Considering also the broad scope given to the concept of health, the environmental risk posed by a product should be taken into consideration in the application of this Regulation inasmuch as it can also ultimately result in a risk to the health and safety of consumers. (12)Products which are designed exclusively for professional use but which have subsequently migrated to the consumer market should be subject to this Regulation because they could pose risks to the health and safety of consumers when used under reasonably foreseeable conditions. (13)Union legislation on food, feed and related areas sets up a specific system ensuring the safety of the products covered by it. Therefore, food and feed should be excluded from the scope of this Regulation with the exception of materials and articles intended to come into contact with food insofar as risks are concerned that are not covered by Regulation (EC) No 1935/2004 of the European Parliament and of the Council or by other food specific legislation which only covers chemical and biological food-related risks. (14)Medicinal products are subject to a pre-market assessment that includes a specific risk-benefit analysis. They should therefore be excluded from the scope of this Regulation. (15)Aircraft referred to in Article 2(3) point (d) of Regulation (EU) 2018/1139 are subject to the regulatory control of the Member States, in light of their limited risk to civil aviation safety. They should therefore be excluded from the scope of this Regulation. (16)The requirements laid down in this Regulation should apply to second hand products or products that are repaired, refurbished or recycled that re-enter the supply chain in the course of a commercial activity, except for those products for which the consumer cannot reasonably expect that they fulfil state-of-the art safety standards, such as antiques or products which are presented as to be repaired or to be refurbished. (17)Directive 87/357/EEC on consumer products which, although not foodstuff, resemble foodstuff and are likely to be confused with foodstuff in a way that consumers, especially children, may place them in their mouths, suck or ingest them and which might cause, for example, suffocation, poisoning, the perforation or obstruction of the digestive tract, has given rise to controversial interpretation. Furthermore it has been adopted at a time where the legal framework for consumer product safety was very limited in scope. For these reasons, Directive 87/357/EEC should be repealed. (18)Services should not be covered by this Regulation. However, in order to secure the attainment of the protection of health and safety of consumers, products that are supplied or made available to consumers in the context of the provision of services, including products to which consumers are directly exposed during a service provision, should fall within the scope of this Regulation. Equipment on which consumers ride or travel which is operated by a service provider should be excluded from the scope of this Regulation since it has to be dealt with in conjunction with the safety of the service provided. (19)Items which connect to other items or non-embedded items which influence the way another item works can present a risk for the safety of the product. That aspect should be taken into due consideration as a potential risk. The connections and interrelation that an item might have with external items should not jeopardise its safety. (20)New technologies also cause new risks to consumers’ health and safety or change the way the existing risks could materialise, such as an external intervention hacking the product or changing its characteristics. (21)The World Health Organisation defines ‘health’ as a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity. This definition supports the fact that the development of new technologies might bring new health risks to consumers, such as psychological risk, development risks, in particular for children, mental risks, depression, loss of sleep, or altered brain function. (22)Specific cybersecurity risks affecting the safety of consumers as well as protocols and certifications can be dealt with by sectorial legislation. However, it should be ensured, in case of gaps in the sectorial legislation, that the relevant economic operators and national authorities take into consideration risks linked to new technologies, respectively when designing the products and assessing them, in order to ensure that changes introduced in the product do not jeopardise its safety. (23)The safety of products should be assessed taking into account all the relevant aspects, notably their characteristics and presentation as well as the specific needs and risks for categories of consumers who are likely to use the products, in particular children, older persons and persons with disabilities. Therefore, if specific information is necessary to make products safe toward a given category of persons, the assessment of the safety of the products should take into consideration also the presence of this information and its accessibility. The safety of products should be assessed taking into consideration the need for the product to be safe over its entire lifespan. (24)Economic operators should have obligations concerning the safety of products, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of the health and safety of consumers. All economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that they only make available on the market products, which are safe and in conformity with this Regulation. It is necessary to provide for a clear and proportionate distribution of obligations corresponding to the role of each operator in the supply and distribution process. (25)Distance selling, including online selling, should also fall within the scope of this Regulation. Online selling has grown consistently and steadily, creating new business models and new actors in the market such as the online marketplaces. (26)Online marketplaces play a crucial role in the supply chain - allowing economic operators to reach an indefinite number of consumers - and therefore also in the product safety system. (27)Given the important role played by online marketplaces when intermediating the sale of products between traders and consumers, such actors should have more responsibilities in tackling the sale of dangerous products online. Directive 2000/31/EC of the European Parliament and of the Council provides the general framework for e-commerce and lays down certain obligations for online platforms. Regulation […/…] on a Single Market for Digital Services (Digital Services Act) and amending Directive 2000/31/EC regulates the responsibility and accountability of providers of intermediary services online with regard to illegal contents, including unsafe products. That Regulation applies without prejudice to the rules laid down by Union law on consumer protection and product safety. Accordingly, building on the horizontal legal framework provided by that Regulation, specific requirements essential to effectively tackle the sale of dangerous products online should be introduced, in line with Article [1(5), point (h)] of that Regulation. (28)The Product Safety Pledge, signed in 2018 and joined by a number of marketplaces since then, provides for a number of voluntary commitments on product safety. The Product Safety Pledge has proved its rationale in enhancing the protection of consumers against dangerous products sold online. Nonetheless, its voluntary nature and the voluntary participation by a limited number of online marketplaces reduces its effectiveness and cannot ensure a level-playing field. (29)Online marketplaces should act with due care in relation to the content hosted on their online interfaces that concerns safety of products, in accordance with the specific obligations laid down in this Regulation. Accordingly, due diligence obligations for all online marketplaces should be established in relation to the content hosted on their online interfaces that concerns safety of products.

(30)Moreover, for the purposes of effective market surveillance, online marketplaces should register in the Safety Gate portal and indicate, in the same portal, the information concerning their single contact points for the facilitation of communication of information on product safety issues. The single point of contact under this Regulation might be the same as the point of contact under [Article 10] of Regulation (EU) …/…[the Digital Services Act], without endangering the objective of treating issues linked to product safety in a swift and specific manner. (31)In order to be able to comply with their obligations under this Regulation, in particular in respect of timely and effective compliance with the orders of public authorities, processing of notices of other third parties and cooperating with market surveillance authorities in the context of corrective measures upon request, online marketplaces should have in place an internal mechanism for handling product safety-related issues. (32)The obligations imposed by this Regulation on online marketplaces should neither amount to a general obligation to monitor the information which they transmit or store, nor to actively seek facts or circumstances indicating illegal activity, such as the sale of dangerous products online. Online marketplaces should, nonetheless, expeditiously remove content referring to dangerous products from their online interfaces, upon obtaining actual knowledge or, in the case of claims for damages, awareness of the illegal content, in particular in cases where the online marketplace has been made aware of facts or circumstances on the basis of which a diligent economic operator should have identified the illegality in question, in order to benefit from the exemption from liability for hosting services under the 'Directive on electronic commerce' and the [Digital Services Act]. Online marketplaces should process notices concerning content referring to unsafe products, received in accordance with [Article 14] of Regulation (EU) …/…[the Digital Services Act], within the additional timeframes established by this Regulation. (33)Article 14(4) of Regulation (EU) 2019/1020 provides market surveillance authorities with the power, where no other effective means are available to eliminate a serious risk, to require the removal of content referring to the related products from an online interface or to require the explicit display of a warning to end users when they access an online interface. The powers entrusted to market surveillance authorities by Article 14(4) of Regulation (EU) 2019/1020 should also apply to this Regulation. For effective market surveillance under this Regulation and to avoid dangerous products being present on the Union market, this power should apply in all necessary and proportionate cases and also for products presenting a less than serious risk. It is essential that online marketplaces comply with such orders as a matter of urgency. Therefore, this Regulation introduces binding time limits in this respect, without prejudice to the possibility for a shorter time limit to be laid down in the order itself. This power should be exercised in accordance with [Article 8] of the Digital Services Act. (34)Even where the information from the Safety Gate does not contain an exact uniform resource locator (URL) and, where necessary, additional information enabling the identification of the illegal content concerned, online marketplaces should nevertheless take into account the transmitted information, such as product identifiers, when available, and other traceability information, in the context of any measures adopted by online marketplaces on their own initiative aiming at detecting, identifying, removing or disabling access to dangerous products offered on their marketplace, where applicable. (35)For the purposes of [Article 19] of Regulation (EU) …/…[the Digital Services Act], and concerning the safety of products sold online, the Digital Services Coordinator should consider in particular consumer organisations and associations representing consumers’ interest, upon their request, as trusted flaggers, provided that the conditions set out in that article have been met. (36)Product traceability is fundamental for effective market surveillance of dangerous products and corrective measures. Consumers should also be protected against dangerous products in the same way in the offline and online sales channels, including when purchasing products on online marketplaces. Building on the provisions of Regulation (EU) …/…[the Digital Services Act]concerning the traceability of traders, online marketplaces should not allow listings on their platforms unless the trader provided all information related to product safety and traceability as detailed in this Regulation. Such information should be displayed together with the product listing so that consumers can benefit from the same information made available online and offline. However, the online marketplace should not be responsible for verifying the completeness, correctness and the accuracy of the information itself, as the obligation to ensure the traceability of products remains with the trader. (37)It is also important that online marketplaces closely cooperate with the market surveillance authorities, law enforcement authorities and with relevant economic operators on the safety of products. An obligation of cooperation with market surveillance authorities is imposed on information society service providers under Article 7(2) of Regulation (EU) 2019/1020 in relation to products covered by that Regulation and should therefore be extended to all consumer products. For instance, market surveillance authorities are constantly improving the technological tools they use for the online market surveillance to identify dangerous products sold online. For these tools to be operational, online marketplaces should grant access to their interfaces. Moreover, for the purpose of product safety, market surveillance authorities may also need to scrape data from the online marketplaces. (38)Direct selling by economic operators established outside the Union through online channels hinders the work of market surveillance authorities when tackling dangerous products in the Union, as in many instances economic operators may not be established nor have a legal representative in the Union. It is therefore necessary to ensure that market surveillance authorities have adequate powers and means to effectively tackle the sale of dangerous products online. In order to ensure an effective enforcement of this Regulation, the obligation set out in Article 4(1), (2) and (3) of Regulation 2019/1020 should be extended also to products falling outside the scope of the Union harmonisation legislation to ensure that there is a responsible economic operator established in the Union, which is entrusted with tasks regarding such products, providing market surveillance authorities with an interlocutor and performing specific tasks in a timely manner. (39)Contact information of the economic operator, established in the Union and responsible for products falling under the scope of application of this Regulation should be indicated with the product in order to facilitate checks throughout the supply chain. (40)Where economic operators or market surveillance authorities face a choice of various corrective measures, the most sustainable action resulting in the lowest environmental impact, such as the repair of the product, should be preferred, provided that it does not result in a lesser level of safety. (41)Any economic operator that either places a product on the market under their own name or trademark or modifies a product in such a way that conformity with the requirements of this Regulation may be affected, should be considered to be the manufacturer and should assume the obligations of the manufacturer. (42)Internal conformity procedures through which economic operators ensure, internally, the effective and swift performance of their obligation as well as the conditions to react timely in case of a dangerous product, should be put in place by the economic operators themselves. (43)When making products available on the market, economic operators should provide minimum information on product safety and traceability as part of the relevant offer. This should be without prejudice to the information requirements laid down by Directive 2011/83/EU of the European Parliament and of the Council, such as on the main characteristics of the goods, to the extent appropriate to the medium and to the goods. (44)Ensuring product identification and the traceability of products throughout the entire supply chain helps to identify economic operators and to take effective corrective measures against dangerous products, such as targeted recalls. Product identification and traceability thus ensures that consumers and economic operators obtain accurate information regarding dangerous products which enhances confidence in the market and avoids unnecessary disruption of trade. Products should therefore bear information allowing their identification and the identification of the manufacturer and, if applicable, of the importer. Such traceability requirements could be made stricter for certain kinds of products. Manufacturers should also establish technical documentations regarding their products, which should contain the necessary information to prove that their product is safe. (45)The legal framework for market surveillance of products covered by Union harmonisation legislation and set out in Regulation (EU) 2019/1020 and the legal framework for market surveillance of products covered by this Regulation should be as coherent as possible. It is therefore necessary, as far as market surveillance activities, obligations, powers, measures, and cooperation among market surveillance authorities are concerned, to close the gap between the two sets of provisions. For that purpose Articles 10 to 16, Articles 18 and 19 and Articles 21 to 24 of Regulation (EU) 2019/1020 should be applicable also to products covered by this Regulation. (46)To preserve the coherence of the market surveillance legal framework and, at the same time, ensure an effective cooperation between the European network of the Member States’ authorities competent for product safety (‘Consumer Safety Network’) provided for by this Regulation and the Union Product Compliance Network aimed at structured coordination and cooperation between Member States’ enforcement authorities and the Commission provided for by Regulation (EU) 2019/1020, it is necessary to associate the Consumer Safety Network to the Union Product Compliance Network in the activities referred to in Articles 11, 12, 13 and 21 of Regulation (EU) 2019/1020. (47)National authorities should be enabled to complement the traditional market surveillance activities focused on safety of products with market surveillance activities focusing on the internal conformity procedures set up by economic operators to ensure product safety. Market surveillance authorities should be able to require the manufacturer to indicate which other products - produced with the same procedure, or containing the same components considered to present a risk or that are part of the same production batch - are affected by the same risk. (48)An exchange of information between Member States and the Commission concerning the implementation of this Regulation should be established on the basis of output indicators which would allow measuring and comparing Member States’ effectiveness in implementing Union product safety legislation. (49)There should be effective, speedy and accurate exchange of information concerning dangerous products.

(50)The Union rapid information system (RAPEX) has proved its effectiveness and efficiency. It enables corrective measures to be taken across the Union in relation to products that present a risk beyond the territory of a single Member State. It is opportune, though, to change the used abbreviated name from RAPEX to Safety Gate for greater clarity and better outreach to consumers. Safety Gate comprises a rapid alert system on dangerous non-food products whereby national authorities and the Commission can exchange information on such products, a web portal to inform the public (Safety Gate portal) and an interface to enable businesses to comply with their obligation to inform authorities and consumers of dangerous products (Safety Business Gateway). (51)Member States should notify in the Safety Gate both compulsory and voluntary corrective measures that prevent, restrict or impose specific conditions on the possible marketing of a product because of a serious risk to the health and safety of consumers or, in case of products covered by Regulation (EU) No 2019/1020, also to other relevant public interests of the end-users. (52)Under Article 34 of Regulation (EU) No 2019/1020, Member States authorities are to notify measures adopted against products covered by that Regulation, presenting a less than serious risk, through the information and communication system referred to in the same article, while corrective measures adopted against products covered by this Regulation presenting a less than serious risk should be notified in the Safety Gate. Member States and the Commission should make available to the public information relating to risks to the health and safety of consumers posed by products. It is opportune for consumers and businesses that all information on corrective measures adopted against products posing a risk are contained in the Safety Gate, allowing relevant information on dangerous products to be made available to the public through the Safety Gate portal. Member States are therefore encouraged to notify in the Safety Gate all corrective measures on products posing a risk to the health and safety of consumers. (53)In case the information has to be notified in the information and communication system according to Regulation (EU) 2019/1020, there is the possibility, for such notifications, to be submitted directly in the Safety Gate or, to be generated from within the information and communication system for market surveillance provided for in Article 34 of Regulation (EU) 2019/1020. For this purpose, the Commission should maintain and further develop the interface that has been set up for the transfer of information between the information and communication system and the Safety Gate, in order to avoid double data entry and facilitate such transfer. (54)The Commission should maintain and further develop the Safety Business Gateway web portal, enabling economic operators to comply with their obligations to inform market surveillance authorities and consumers of dangerous products they have placed or made available on the market. This tool should also enable economic operators to inform market surveillance authorities of accidents caused by products they have placed or made available on the market. It should enable quick and efficient information exchange between economic operators and national authorities, and facilitate information to consumers from economic operators. (55)There might be cases where it is necessary to deal with a serious risk at the Union level where the risk cannot be contained satisfactorily by means of measures taken by the Member State concerned or by any other procedure under Union legislation. This could notably be the case of new emerging risks or those impacting vulnerable consumers. For that reason the Commission can adopt measures either on its own initiative or upon request of the Member States. Such measures should be adapted to the gravity and urgency of the situation. It is furthermore necessary to provide for an adequate mechanism whereby the Commission could adopt immediately applicable interim measures. (56)The determination of the risk concerning a product and its level is based on a risk assessment performed by the relevant actors. Member States, in performing risk assessment, might reach different results as far as the presence of a risk or its level is concerned. This could jeopardise the correct functioning of the single market and the level playing field for both consumers and economic operators. An arbitration mechanism should therefore be made available to Member States, on a voluntary basis, which would allow the Commission, to provide an opinion on the issue in dispute. (57)The Consumer Safety Network enhances the cooperation on product safety enforcement between Member States. In particular, it facilitates the activities of exchange of information, the organisation of joint market surveillance activities, the exchange of expertise and best practices. The Consumer Safety Network should be duly represented and participate in the coordination and cooperation activities of the Union Product Compliance Network provided for in Regulation (EU) 2019/1020 whenever coordination of activities falling under the scope of application of both Regulations is necessary to ensure their effectiveness. (58)Market surveillance authorities might carry out joint activities with other authorities or organisations representing economic operators or end users, with a view to promoting safety of products and identifying dangerous products, including those that are offered for sale online. In doing so the market surveillance authorities and the Commission, as appropriate, should ensure that the choice of products and producers as well as the activities performed does not create situation which might distort competition or affect the objectivity, independence and impartiality of the parties. (59)Simultaneous coordinated control actions (‘sweeps’) are specific enforcement actions that can further enhance product safety. In particular, sweeps should be conducted where market trends, consumer complaints or other indications suggest that certain product categories are often found to present a serious risk. (60)The public interface of the Safety Gate, the Safety Gate portal, allows the general public, including consumers, economic operators and online marketplaces, to be informed about corrective measures taken against dangerous products present on the Union market. A separate section of the Safety Gate portal enables consumers to inform the Commission of products presenting a risk to consumer health and safety found in the market. Where relevant, the Commission should provide adequate follow-up, notably by transmitting such information to the concerned national authorities. (61)In making available information on product safety to the public, professional secrecy, as referred to in Article 339 of the Treaty, should be protected in a way which is compatible with the need to ensure the effectiveness of market surveillance activities and of protection measures. (62)When a product already sold to consumers turns out to be dangerous, it may need to be recalled to protect consumers in the Union. Consumers might not be aware that they own a recalled product. In order to increase recall effectiveness, it is therefore important to better reach consumers concerned. Direct contact is the most effective method to increase consumers’ awareness of recalls and encourage action. It is also the preferred communication channel across all groups of consumers. In order to ensure the safety of the consumers, it is important that they are informed in a quick and reliable way. Economic operators should therefore use the customer data at their disposal to inform consumers of recalls and safety warnings linked to products they have purchased. Therefore, a legal obligation is needed to require economic operators to use any customer data already at their disposal to inform consumers of recalls and safety warnings. In this respect, economic operators will make sure to include the possibility to directly contact customers in the case of a recall or safety warning affecting them in existing customer loyalty programmes and product registration systems, through which customers are asked, after having purchased a product, to communicate to the manufacturer on a voluntary basis some information such as their name, contact information, the product model or serial number. (63)A third of consumers continue using dangerous products despite seeing a recall notice, notably because recall notices are drafted in a complex way or minimise the risk at stake. The recall notice should therefore be clear, transparent and clearly describe the risk at stake, avoiding any terms, expressions or other elements that may decrease consumers' perception of risk. Consumers should also be able to get more information, if needed, via a toll-free telephone number or other interactive instrument. (64)To encourage consumer response to recalls it is also important that the action required from consumers be as simple as possible and that the remedies offered be effective, cost-free and timely. Directive (EU) 2019/771 of the European Parliament and of the Council provides the consumers with the contractual remedies for a lack of conformity of goods that existed at the time of delivery and became apparent within the liability period. The economic operator responsible for the recall should provide similar remedies to the consumer. (65)In order to facilitate the effective and consistent application of the general safety requirement set out in this Regulation, it is important to make use of European standards covering certain products and risks in such a way that a product which conforms to such a European standard, the reference of which is published in the Official Journal of the European Union, is presumed to be in compliance with that requirement. (66)Where the Commission identifies a need for a European standard ensuring compliance of certain products with the general safety requirement under this Regulation, it should apply the relevant provisions of Regulation (EU) No 1025/2012 of the European Parliament and of the Council to request one or several European standardisation organisations to either draft or identify a standard which is suitable to ensure that products which conform to it are presumed to be safe. (67)Certain provisions of Regulation (EU) 1025/2012 should be amended to take the specificities of this Regulation into account, and in particular the need to define the specific safety requirements under this Regulation before launching the request to the European standardisation organisation. (68)Together with the adaptation of Regulation (EU) 1025/2012, a specific procedure for the adoption of the specific safety requirements with the assistance of the specialised Committee provided for by this Regulation should be introduced. (69)European standards, the references of which have been published in accordance with Directive 2001/95/EC, should continue providing a presumption of conformity with the general safety requirement set out in this Regulation. Standardisation requests issued by the Commission in accordance with Directive 2001/95/EC should be deemed standardisation requests issued in accordance with this Regulation.

(70)The Union should be able to cooperate and to exchange information related to product safety with regulatory authorities of third countries or international organisations within the framework of agreements concluded between the Commission and third countries or international organisations. Such cooperation and exchange of information should respect confidentiality and personal data protection rules of the Union. (71)In order to play a significant deterrent effect for economic operators and online marketplaces to prevent the placing of dangerous products on the market, penalties should be adequate to the type of infringement, to the possible advantage for the economic operator or online marketplace and to the type and gravity of the injury suffered by the consumer. Furthermore an homogenous level of penalties is important to ensure a level playing field, avoiding that economic operators or online marketplaces concentrate their activities in territories where the level of penalties is lower. (72)When imposing penalties, due regard should be given to the nature, gravity and duration of the infringement in question. The imposition of penalties should be proportionate and should comply with Union and national law, including with applicable procedural safeguards and with the principles of the Charter of fundamental rights. (73)In order to facilitate the more consistent application of penalties, common non-exhaustive and indicative criteria for the application of penalties should be included. Those criteria should include the duration or temporal effects of the infringement, as well as its nature and gravity, in particular the level of risk incurred by the consumer. Repeated infringement by the same perpetrator shows a propensity to commit such infringements and is therefore a significant indication of the gravity of the conduct and, accordingly, of the need to increase the level of the penalty to achieve effective deterrence. The financial benefits gained, or losses avoided, because of the infringement should be taken into account, if the relevant data are available. Other aggravating or mitigating factors applicable to the circumstances of the case should also be taken into account. (74)In order to ensure more consistency, a list of those types of infringements that should be subject to penalties should be included. (75)The deterrent effect of penalties should be reinforced by the possibility to publish the information related to the penalties imposed by Member States. Where these penalties are issued against natural persons or include personal data, they may be published in a manner that complies with the data protection requirements as set out in Regulation (EU) 2016/679 of the European Parliament and of the Council and Regulation (EU) 2018/1725 of the European Parliament and of the Council. The annual report on the penalties imposed by the Member States should contribute to the level playing field and to prevent repeated infringements. For reasons of legal certainty and in accordance with the principle of proportionality, it should be specified in which situations a publication should not take place. As far as natural persons are concerned, personal data should only be published in exceptional circumstances justified by the seriousness of the infringement, for instance when a penalty has been imposed to an economic operator whose name identifies a natural person and such economic operator has repeatedly failed to comply with the general product safety requirement. (76)In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to adopt the specific safety requirements, to determine the output indicators on the basis of which Member States have to communicate data concerning the implementation of this Regulation, to adopt the modalities and procedures for the exchange of information regarding measures communicated through the Safety Gate and criteria to assess the level of risk, to take measures as regards the products presenting a serious risk, to adopt the modalities for the sending of information by consumers in the Safety Gate portal, to set out the requirements for registration of products for recall purposes and to adopt the template for a recall notice. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council. (77)The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to the health and safety of consumers, imperative grounds of urgency so require. (78)In order to maintain a high level of health and safety of consumers, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of the identification and traceability of products bearing a potential serious risk to health and safety. It is of particular importance that the Commission carries 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. (79)Since the objectives of this Regulation, namely to ensure a consistent, high level of consumer health and safety protection while preserving the unity of the Single market, cannot be sufficiently achieved by the Member States given the need for a high degree of collaboration and coherent action between Member States’ competent authorities and for a mechanism to quickly and efficiently exchange information on dangerous products in the Union but can rather, by reason of the Union-wide character of the problem, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. 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. (80)Any processing of personal data for the purpose of this Regulation should be in compliance with Regulations (EU) 2016/679 and (EU) 2018/1725. When consumers report a product in the Safety Gate, only those personal data will be stored that are necessary to report the dangerous product and for a period not exceeding five years after such data have been encoded. Manufacturers and importers should hold the register of consumer complaints only as long as it is necessary for the purpose of this Regulation. Manufacturers and importers, when they are natural persons should disclose their names to ensure that the consumer is able to identify the product for purpose of traceability. (81)The European Data Protection Supervisor was consulted in accordance with Article 42 of Regulation (EU) 2018/1725 and delivered an opinion on XX XXXX. HAVE ADOPTED THIS REGULATION: CHAPTER I General provisions Article 1 Subject matter This Regulation lays down essential rules on the safety of consumer products placed or made available on the market. Article 2 Scope

1.This Regulation shall apply to products defined in Article 3(1), placed or made available on the market in so far as there are no specific provisions with the same objective in rules of Union law which regulate the safety of the products concerned. Where products are subject to specific safety requirements imposed by Union legislation, this Regulation shall apply only to the aspects and risks or categories of risks not covered by those requirements. In particular, as regards products subject to specific requirements imposed by Union harmonisation legislation as defined in Article 3(25), (a)Chapter II shall not apply insofar as the risks or categories of risks covered by Union harmonisation legislation are concerned; (b)Chapter III, Section 1, Chapters V and VII, Chapters IX to XI shall not apply. 2.This Regulation shall not apply to: (a)medicinal products for human or veterinary use; (b)food; (c)feed; (d)living plants and animals, genetically modified organisms and genetically modified microorganisms in contained use, as well as products of plants and animals relating directly to their future reproduction; (e)animal by-products and derived products; (f)plant protection products; (g)equipment on which consumers ride or travel which is operated by a service provider within the context of a service provided to consumers; (h)aircraft referred to in point (d) of Article 2(3) of Regulation 2018/1139; (i)antiques. 3.This Regulation shall apply to products placed or made available on the market whether new, used, repaired or reconditioned. It shall not apply to products to be repaired or reconditioned prior to being used where those products are made available on the market as such. 4.This Regulation is without prejudice to the rules laid down by Union law on consumer protection. 5.This Regulation shall be applied taking due account of the precautionary principle. Article 3 Definitions

For the purposes of this Regulation the following definitions apply: 1.‘product’ means any item, interconnected or not to other items, supplied or made available, whether for consideration or not, in the course of a commercial activity including in the context of providing a service – which is intended for consumers or can, under reasonably foreseeable conditions, be used by consumers even if not intended for them; 2. ‘safe product’ means any product which, under normal or reasonably foreseeable conditions of use or misuse, including the actual duration of use, does not present any risk or only the minimum risks compatible with the product's use, considered acceptable and consistent with a high level of protection of health and safety of consumers; 3.‘dangerous product’ means any product which does not conform to the definition of ‘safe product’; 4.‘risk’ means the combination of the probability of an occurrence of a hazard causing harm and the degree of severity of that harm; 5.‘serious risk’ means a risk for which, based on a risk assessment and taking into account the normal and foreseeable use of the product, the combination of the probability of occurrence of a hazard causing harm and the degree of severity of the harm is considered to require rapid intervention by the market surveillance authorities, including cases where the effects of the risk are not immediate; 6.‘making avail