Considerations on COM(2021)346 - General product safety - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2021)346 - General product safety. |
|---|---|
| document | COM(2021)346  |
| date | May 10, 2023 |
(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 23 . In the interest of clarity, Directive 2001/95/EC, as well as Directive 87/357/EEC, should be repealed and replaced by this Regulation.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 24 . 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 25 , 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 26 , 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 27 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 28 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 29 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 30 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 31 , 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 32 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 33 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 34 and Regulation (EU) 2018/1725 of the European Parliament and of the Council 35 . 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 36 .
(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 37 . 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. 38