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(1)

Directive 2001/95/EC of the European Parliament and of the Council (3) requires that consumer products must be safe and that the market surveillance authorities of the Member States must act against dangerous products and exchange information on them via the Union Rapid Information System (RAPEX).

(2)

Directive 2001/95/EC needs to be revised and updated in the light of developments related to new technologies and online sales in order to ensure coherence with developments in Union harmonization and standardization legislation, a better functioning of product safety recalls and a clearer framework for the counterfeiting of foodstuffs previously regulated by Council Directive 87/357/EEC (4). In the interests of clarity, Directives 2001/95/EC and 87/357/EEC should be repealed and replaced by this Regulation.

(3)

A Regulation is the appropriate legal instrument as it contains clear and detailed rules that leave no room for divergent transposition by Member States. By opting for a regulation instead of a directive, better results can also be achieved with regard to the objective of consistency with the legal framework for market surveillance of products falling within the scope of Union harmonization legislation, where the applicable legal instrument is also a regulation, namely Regulation (EU) 2019/1020 of the European Parliament and of the Council (5). Ultimately, this Decision and the resulting uniform application of product safety rules across the Union will further reduce the regulatory burden.

(4)

The purpose of this Regulation is to contribute to the achievement of the objectives set out in Article 169 of the Treaty on the Functioning of the European Union (TFEU). In particular, it aims to ensure the health and safety of consumers and the functioning of the internal market with regard to products intended for consumers.

(5)

This Regulation should aim to protect consumers and their safety as one of the fundamental principles of the Union legal framework enshrined in the Charter of Fundamental Rights of the European Union ('the Charter'). Dangerous products can have a significant negative impact on consumers and citizens. All consumers, including vulnerable groups such as children, the elderly and people with disabilities, have the right to safe products. Consumers should have sufficient means at their disposal to enforce this right, just as Member States should have appropriate tools and measures at their disposal to enforce this Regulation.

(6)

While the Union has developed sector-specific harmonization legislation dealing with the safety aspects of certain products or categories of products, it is practically impossible to adopt Union legislation for all existing or potentially developing consumer products. A broad cross-cutting legal framework is therefore needed to fill gaps and complement provisions in existing or future sector-specific Union harmonization legislation and to ensure consumer protection that is otherwise not provided by such legislation, in particular with a view to achieving the high level of consumer health and safety protection required by Articles 114 and 169 TFEU.

(7)

At the same time, with regard to products covered by sectoral Union harmonization legislation, the scope of the different parts of this Regulation should be clearly defined in order to avoid overlaps and to ensure a clear legal framework.

(8)

While some provisions of this Regulation, such as most of the obligations of economic operators, should not apply to products covered by Union harmonization legislation, certain other provisions of this Regulation are complementary to Union harmonization legislation and should therefore apply to such products. In particular, the general product safety requirement and related provisions should apply to consumer products covered by Union harmonization legislation where certain types of risks are not covered by the Union harmonization legislation concerned. The provisions of this Regulation concerning the obligations of online marketplace providers, the obligations of economic operators in the event of accidents, the right of access and redress for consumers and product safety recalls should apply to products covered by Union harmonization legislation where that Union harmonization legislation does not contain specific provisions with the same purpose. Similarly, in accordance with Article 20 of Regulation (EU) 2019/1020, RAPEX is already used for the purposes of Union harmonization legislation: The provisions of this Regulation governing the safety gate and its functioning should therefore apply to products covered by Union harmonization legislation.

(9)

This Regulation should also apply to products which are designed for professional use only but which have subsequently entered the consumer market, as they could endanger the health and safety of consumers under reasonably foreseeable conditions.

(10)

Medicinal products must be assessed before being placed on the market, including a specific risk-benefit analysis. These products should therefore be excluded from the scope of this Regulation.

(11)

Union legislation on food and feed and related matters establishes a specific system to ensure the safety of the products they cover. Indeed, food and feed have their own legal framework, established in particular by Regulation (EC) No 178/2002 of the European Parliament and of the Council (6). In addition, food and feed are also regulated by Regulation (EU) 2017/625 of the European Parliament and of the Council (7), which ensures a harmonized approach to official controls to verify compliance with food and feed law, animal health and animal welfare rules. Food and feed products should therefore not fall within the scope of this Regulation, with the exception of materials and articles intended to come into contact with food, as far as risks not covered by Regulation (EC) No 1935/2004 of the European Parliament and of the Council (8) or other legislation specifically applicable to food and concerning only chemical and biological food risks are concerned.

(12)

Live plants are subject to a specific legal framework, laid down in particular in Regulation (EU) 2016/2031 of the European Parliament and of the Council (9), which takes into account the specificities of these products in order to ensure consumer safety.

(13)

Animal by-products are materials of animal origin that are not consumed by humans. A separate legal framework applies to such products, such as animal feed, which is laid down in particular in Regulation (EC) No 1069/2009 of the European Parliament and of the Council (10).

(14)

Plant protection products (also known as pesticides) are subject to specific provisions for their authorization at national level on the basis of Regulation (EC) No 1107/2009 of the European Parliament and of the Council (11) and should therefore also be excluded from the scope of this Regulation.

(15)

Aircraft referred to in point (d) of Article 2(3) of Regulation (EU) 2018/1139 of the European Parliament and of the Council (12) are subject to regulatory control by Member States due to their limited risk to civil aviation safety. Those aircraft should therefore be excluded from the scope of this Regulation.

(16)

The requirements laid down in this Regulation should apply to used products or products that have been repaired, remanufactured or recycled and re-enter the supply chain in the course of a commercial activity, with the exception of those products that consumers cannot reasonably expect to meet current safety standards, such as products explicitly presented as products in need of repair or remanufacturing or made available on the market as collectors' items of historical importance.

(17)

Services should not be covered by this Regulation. However, in order to protect the health and safety of consumers, products supplied or made available to consumers in the context of the provision of services or to which consumers are directly exposed during the provision of a service should fall within the scope of this Regulation. However, means of transport by which consumers move or travel should not be covered by this Regulation where such means of transport are operated directly by service providers in the context of a transport service, as they should be treated in relation to the safety of the service provided.

(18)

Antiques, such as works of art or collectors' items, are special categories of products which cannot be expected to meet the safety requirements laid down in this Regulation and should therefore be excluded from the scope of this Regulation. However, in order to prevent other products from being wrongly assigned to those categories, it is necessary to take into account that works of art are products created exclusively for artistic purposes, that collectors' items are of sufficient rarity and historical or scientific interest to justify their collection and preservation, and that antiques, if they are not already works of art or collectors' items or both, are of exceptional age. Annex IX of Council Directive 2006/112/EC (13) could be used to assess whether a product is an antique such as an object of art or a collector's item.

(19)

The World Health Organization defines the term "health" as a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.

(20)

This Regulation should also apply to distance selling, including online sales. Online sales are showing constant and steady growth, creating new business models, new challenges in terms of product safety and new market players such as online marketplace providers.

(21)

Where a product is offered for sale online or by any other means of distance selling, the product should be deemed to be made available on the market if the offer for sale is addressed to consumers in the Union. In accordance with the applicable Union rules in the field of private international law, it should be determined on a case-by-case basis whether an offer is made to consumers in the Union. An offer for sale should be considered to be addressed to consumers in the Union if the economic operator concerned directs its activities in any way to a Member State. The case-by-case assessments should take into account relevant factors such as the geographical areas to which dispatch is possible, the available languages used for the offer or order, the means of payment, the use of the currency of the Member State or a domain name registered in one of the Member States. The mere accessibility of the economic operators' or online marketplace providers' website in the Member State where the consumer is established or resident is not sufficient as a criterion for online sales.

(22)

In accordance with the general safety requirement laid down in this Regulation, economic operators should be obliged to place only safe products on the market. Such a high level of safety should be achieved primarily through the design and characteristics of the device, taking into account the intended and foreseeable use and the intended and foreseeable conditions of use of the device. Any residual risks should be reduced by specific safety precautions, such as warnings and instructions.

(23)

The safety of a product should be assessed taking into account all relevant aspects of the product, including in particular its characteristics, such as physical, mechanical and chemical properties, and its presentation, as well as the specific needs and risks posed by the product to certain categories of consumers who are likely to use the products, in particular children, the elderly and people with disabilities. These risks may also include environmental risks if they pose a risk to the health and safety of consumers. This assessment should take into account the health risk posed by digitally connected products, including the risk to mental health, in particular for vulnerable consumers, especially children. Therefore, when assessing the safety of digitally connected products that may have an impact on children, manufacturers should ensure that the products they make available on the market are designed to meet the highest standards of protection, safety and privacy in the interest of children. Where specific information is required to make a product safe for a particular category of person, the availability and accessibility of that information should also be taken into account when assessing the safety of those products. When assessing the safety of all products, it should be taken into account that the product must be safe throughout its life cycle.

(24)

Objects that are connected to other objects or non-embedded objects that affect how another object functions can pose a risk to the safety of the product. This aspect should be duly considered as a potential risk. The connections and interactions of an object with external objects should not affect its safety.

(25)

New technologies could introduce new risks to the health and safety of consumers or change the way in which existing risks could occur, for example in the case of an external intervention that hacks a product or changes its characteristics. New technologies could significantly change the original product, for example through software updates, so that it should subsequently be subject to a new risk assessment if this significant change affects the safety of the product.

(26)

Certain cybersecurity risks affecting consumer safety, protocols and certifications may be addressed in sector-specific legislation. However, in cases where such sector-specific legislation does not apply, it should be ensured that the relevant economic operators and national authorities take into account risks related to new technologies when designing or assessing the products in order to ensure that changes made to the product do not compromise its safety.

(27)

In order to promote an effective and consistent application of the general safety requirement laid down in this Regulation, it is important that European standards covering specific products and risks be used. European standards the references of which are published in accordance with Directive 2001/95/EC should continue to serve as a basis for presumption of conformity with the general safety requirement laid down in this Regulation. Standardization mandates issued by the Commission in accordance with Directive 2001/95/EC should be considered as standardization mandates for the purposes of this Regulation. Where different risks or categories of risk are covered by the same standard, compliance of a product with the part of the standard covering the risk or category of risk in question also confers a presumption of safety on the product itself with regard to that risk or category of risk.

(28)

Where the Commission considers that a European standard is necessary to ensure that certain products comply with the general safety requirement laid down in this Regulation, the Commission should, with reference to the relevant provisions of Regulation (EU) No 1025/2012 of the European Parliament and of the Council (14), mandate one or more European standardization bodies to develop or designate a standard to ensure that products that comply with the standard are considered safe.

(29)

Products may pose different risks to different genders and standardization should take this into account to avoid discrepancies in safety and thus a safety gap between genders. The United Nations Economic Commission for Europe's Declaration on Gender-Responsive Standards sets out several actions that national standards bodies and standardization organizations should include in their action plan for gender-sensitive standards and standards development to achieve gender-responsive, representative and inclusive standards.

(30)

Together with the amendment of Regulation (EU) No 1025/2012, a specific procedure for the adoption of specific safety requirements should be introduced with the support of the special committee provided for in this Regulation.

(31)

In the absence of European standards, the national law of the Member State in which the product is made available on the market should comply with Union law, in particular Articles 34 and 36 TFEU, in order to establish health and safety requirements.

(32)

Depending on their role in the supply chain, economic operators should have proportionate obligations in relation to the safety of products so as to ensure a high level of protection of the health and safety of consumers, while ensuring the efficient functioning of the internal market. All economic operators that are part of the supply and distribution chain should take appropriate measures to ensure that they only make available on the market products that are safe and in conformity with this Regulation. It is necessary to ensure a clear and proportionate distribution of obligations corresponding to the role of each actor in the supply and distribution process. For example, as regards the verification that the manufacturer and, where applicable, the importer have fulfilled their obligations, the distributor should only be obliged to carry out factual verifications and not to assess the information they provide. The information on the identification of the product and the economic operators as well as instructions and safety information could additionally be provided by the economic operators in digital form by means of electronic solutions, such as a QR code or a data matrix code.

(33)

Manufacturers should draw up technical documentation for the products they place on the market, which should contain the information necessary to demonstrate the safety of these products. The technical documentation should be based on an internal risk analysis carried out by the manufacturer. The amount of information to be provided in the technical documentation should be proportionate to the complexity of the device and the potential risks identified by the manufacturer. In particular, manufacturers should provide a general description of the device and the elements necessary for the assessment of its safety. In the case of complex devices or devices presenting potential risks, a more detailed description of the device may be required as part of the information to be provided. In such cases, an analysis of these risks and the technical means used to reduce or eliminate the risks should also be included. Where the product complies with European standards or other elements applied to meet the general safety requirement laid down in this Regulation, the list of relevant European standards and other elements should also be provided.

(34)

Any natural or legal person who places a device on the market under his own name or trademark or significantly modifies a device in such a way that compliance with the requirements of this Regulation could be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer.

(35)

A physical or digital modification of a product could affect the nature and characteristics of the product in a way that was not foreseen in the original risk assessment of the product and that could jeopardize the safety of the product. Such a change should therefore be considered as a substantial modification and, if not made by or on behalf of the consumer, should result in the product being considered as a new product from another manufacturer. In order to ensure compliance with the general safety requirement laid down in this Regulation, the person making the substantial modification should be considered to be the manufacturer and should be subject to the same obligations. This requirement should only apply to the modified part of the device, provided that the modification does not affect the device as a whole. In order to avoid an unnecessary and disproportionate burden, the person making the substantial modification should not be obliged to repeat tests and draw up new documentation in relation to aspects of the product that are not affected by the modification. It should be for the person making the substantial modification to demonstrate that the modification has no impact on the device as a whole.

(36)

Internal compliance procedures enabling economic operators to ensure internally the effective and rapid fulfillment of their obligations, as well as the conditions for a timely response in the event of a dangerous product, should be established by the economic operators themselves.

(37)

In order to prevent the placing on the market of dangerous products, economic operators should be required to include in their production or marketing activities internal procedures ensuring compliance with the relevant requirements of this Regulation. Such internal procedures should be defined by the economic operators themselves in relation to their role in the supply chain and the nature of the products concerned and may be based, for example, on organizational procedures, guidelines, standards or the appointment of an ad hoc administrator. The establishment and format of these internal procedures should remain the sole responsibility of the economic operators concerned.

(38)

It is essential that all economic operators and online marketplace providers cooperate with market surveillance authorities to eliminate or mitigate risks posed by products made available on the market. However, the requests addressed to them by market surveillance authorities should be tailored to their role in the supply chain and to their respective legal obligations.

(39)

Direct sales through online channels by economic operators established outside the Union hamper the action of market surveillance authorities against dangerous products in the Union, as in many cases economic operators have neither an establishment nor a legal representative in the Union. It is therefore necessary that market surveillance authorities have adequate powers and resources to address the online sale of dangerous products in an effective manner. In order to ensure the effective enforcement of this Regulation, the obligation laid down in Article 4(1), (2) and (3) of Regulation (EU) 2019/1020 should be extended to products that are not subject to Union harmonization legislation to ensure that there is a responsible economic operator established in the Union entrusted with the tasks in relation to such products so that market surveillance authorities have a point of contact and, where appropriate given the risks that a product may present, certain tasks are carried out in a timely manner to ensure the safety of the products. These specific tasks should include regular checks for compliance with the technical documentation, product and manufacturer information, instructions and safety information.

(40)

In order to facilitate verifications throughout the supply chain, the contact details of economic operators established in the Union and responsible for devices falling within the scope of this Regulation should be provided together with the device.

(41)

In order to enable economic operators that are small and medium-sized enterprises (SMEs), including microenterprises, to cope with the new obligations imposed by this Regulation, the Commission should provide them with practical guidance and tailored advice, such as a direct channel through which experts can be contacted in case of questions, taking into account the need for simplification and the need to limit the administrative burden.

(42)

The reliable identification of products and the provision of information on the manufacturer and other relevant economic operators throughout the supply chain helps to identify the economic operators involved and, where appropriate, to respond to dangerous products with effective and proportionate corrective actions, such as targeted recalls. The identification of products and the provision of information on the manufacturer and other relevant economic operators thus ensures that consumers, including persons with disabilities, and market surveillance authorities receive accurate information on dangerous products, thereby increasing confidence in the market and avoiding unnecessary trade disruption. Products should therefore bear information allowing the identification of the product itself and the identification of the manufacturer and, where applicable, the importer and other relevant economic operators. These requirements could be reinforced for certain types of products that are likely to pose a serious risk to the health and safety of consumers by a system for the collection and storage of data which, in addition to identifying the product, allows the identification of its components or the economic operators involved in its supply chain. This is without prejudice to the information requirements under Directive 2011/83/EU of the European Parliament and of the Council (15) in relation to the essential characteristics of the goods, to the extent appropriate to the medium and the nature of the goods. An image should be considered as a photograph, illustration or other pictographic element that enables the easy identification of a product or potential product.

(43)

Ensuring that manufacturers report accidents caused by a product they have made available on the market will provide market surveillance authorities with better information and will allow better identification of potentially dangerous product categories. Rules on product liability of economic operators for defective products are laid down in specific Union law and such reporting and collection of data should therefore not be considered as an admission of liability for a defective product or as an acknowledgement of liability under the relevant Union or national law.

(44)

In order to identify emerging risks and other market developments relevant to product safety at an early stage, all interested parties, including consumer or business organizations, should be encouraged to provide the market surveillance authorities and the Commission with information available to them for the purpose of detecting and investigating infringements of this Regulation.

(45)

As they allow economic operators to reach a larger number of consumers, online marketplace providers play a crucial role in the supply chain and therefore also for the product safety system.

(46)

Under the new complex business models related to online sales, the same company may offer a variety of services. Depending on the nature of the services provided for a given product, the same undertaking may fall under different categories of business models under this Regulation. If an undertaking only provides online intermediation services for a specific product, it would only be considered as a provider of an online marketplace for that product. If the same undertaking provides online marketplace services for the sale of a specific product under this Regulation and also acts as an economic operator, it would also be considered as the economic operator concerned. In such a case, the company concerned would therefore have to comply with the obligations applicable to the economic operator concerned. For example, if the provider of the online marketplace also distributes a product, it would be considered a trader in relation to the sale of the distributed product. Similarly, if the company in question sells its own branded products, it would act as a manufacturer and would therefore have to comply with the requirements applicable to manufacturers. Some companies may also be considered fulfillment service providers if they offer fulfillment services. The cases in question would therefore have to be assessed on a case-by-case basis.

(47)

Given the important role played by online marketplace providers in facilitating the sale of products between traders and consumers, those actors should bear more responsibility in relation to the prevention of the online sale of dangerous products. Directive 2000/31/EC of the European Parliament and of the Council (16) sets out the general framework for electronic commerce and lays down certain obligations for online platforms. Regulation (EU) 2022/2065 of the European Parliament and of the Council (17) regulates the responsibility and accountability of online intermediary service providers with regard to illegal content, including dangerous products. That Regulation applies without prejudice to the rules laid down in Union law in the field of consumer protection and product safety. Building on the horizontal legal framework established by that Regulation, specific requirements necessary to effectively prevent the online sale of dangerous products should be introduced in accordance with Article 2(4)(f) of that Regulation. To the extent that this Regulation sets out the product safety requirements that online marketplace providers need to comply with in order to ensure compliance with certain provisions of Regulation (EU) 2022/2065, those requirements should be without prejudice to the application of Regulation (EU) 2022/2065, which continues to apply to those online marketplace providers.

(48)

The Product Safety Pledge, which was first signed in 2018 and has since been joined by a number of online marketplace providers, includes a number of voluntary commitments on product safety. The Product Safety Pledge has proven to be useful in terms of increasing consumer protection against dangerous products sold online. To strengthen consumer protection by preventing harm to life, limb, health and safety and to ensure fair competition in the internal market, online marketplace providers are encouraged to make these voluntary commitments to ensure that dangerous products already withdrawn from the market are not re-listed. The use of technology and digital processes and improvements to alert systems, in particular the safety gate portal, can enable the automatic identification and transmission of notified dangerous products and the performance of automatic spot checks using the safety gate portal.

(49)

Online marketplace providers should act with due care in relation to the product safety content provided on their online interfaces in accordance with the specific obligations laid down in this Regulation. Accordingly, this Regulation should impose due diligence obligations on all online marketplace providers in relation to the product safety content made available on their online interfaces.

(50)

Furthermore, for the purpose of effective market surveillance, providers of online marketplaces should register on the Safety Gate Portal and indicate their single point of contact on the Safety Gate Portal in order to facilitate communication on product safety issues. The Commission should ensure that registration is simple and user-friendly. The single point of contact under this Regulation may be the contact point referred to in Article 11 of Regulation (EU) 2022/2065, without prejudice to the objective of addressing product safety issues quickly and in a targeted manner.

(51)

Providers of online marketplaces should designate a single point of contact for consumers. This single point of contact should serve as a central point of contact for communication with consumers on product safety issues, which can then be forwarded to the relevant service point of an online marketplace. This should not prevent consumers from being provided with additional contact points for specific services. The single point of contact under this Regulation may be the contact point referred to in Article 12 of Regulation (EU) 2022/2065.

(52)

Online marketplace providers should have an internal mechanism for dealing with product safety-related issues in order to comply with their obligations under this Regulation, in particular with regard to the timely and effective compliance with orders from public authorities, the processing of notifications by third parties and, upon request, cooperation with market surveillance authorities in the context of corrective action.

(53)

In accordance with Article 14(4) of Regulation (EU) 2019/1020, market surveillance authorities have the power to require the removal of content from an online interface referring to the products concerned or to require the explicit display of a warning to end-users accessing the online interface, unless there are other effective means to address a serious risk. The powers conferred on market surveillance authorities by Article 14(4) of Regulation (EU) 2019/1020 should also apply to this Regulation. In order to ensure effective market surveillance under this Regulation and to prevent the presence of dangerous products on the Union market, those powers should apply in all cases where necessary and appropriate, including to products that do not present a serious risk. It is essential that providers of online marketplaces comply with such orders without undue delay. This Regulation should therefore introduce binding deadlines in this respect. Those powers should be exercised in accordance with Article 9 of Regulation (EU) 2022/2065.

(54)

Orders that also require the online marketplace provider to remove from its online interface any identical content relating to the offering of a dangerous product referred to in the order should identify, on the basis of the information displayed by traders, the elements that constitute identical offers and allow the online marketplace provider to remove identical offers to the extent that the online marketplace provider is not required to carry out an independent assessment of such content.

(55)

Where the Safety Gate rapid alert system does not contain a precise Uniform Resource Locator (URL) address and, where necessary, other information to identify the content relating to an offer of a dangerous product, online marketplace providers should nevertheless take into account, where appropriate, the information submitted, such as product identifiers (where available) and other traceability information, when taking any action on their own initiative to detect, identify, remove or disable access to such dangerous products offered on their online marketplaces. However, the safety gate portal should be modernized and updated to enable online marketplace providers to identify unsafe products more easily, including by allowing the provisions of this Regulation on the removal of content relating to an offer of a dangerous product from online interfaces to be implemented through a reporting system designed and developed under the safety gate portal.

(56)

The obligations imposed on online marketplace providers by this Regulation should not amount to a general obligation to monitor the information that they transmit or store or to impose on online marketplace providers the obligation to actively investigate circumstances indicating illegal activity, such as the online sale of dangerous products. In order to benefit from the exemption from liability for hosting services under Directive 2000/31/EC and Regulation (EU) 2022/2065, online marketplace providers should nevertheless remove content relating to an offer of a dangerous product from their online interfaces as soon as they become aware of the content, content relating to an offer of a dangerous product actually becomes known to them or, in the case of claims for damages, becomes known to them, in particular in cases where the online marketplace provider has been made aware of facts or circumstances on the basis of which a diligent economic operator should have established the illegality. Online marketplace providers should, in accordance with Article 16 of Regulation (EU) 2022/2065, process notifications received regarding content relating to an offer of a dangerous product within the additional time limits set out in this Regulation. In addition, online marketplace providers are encouraged to check products against the Safety Gate Portal before placing them on their interface.

(57)

For the purposes of Article 22 of Regulation (EU) 2022/2065 and with regard to the safety of products sold online, the Digital Services Coordinator should consider consumer organizations and associations representing the interests of consumers and other relevant stakeholders as trusted flaggers upon their request, provided that the conditions set out in that Article are met.

(58)

Traceability of products is essential for effective market surveillance of dangerous products and for corrective action. In addition, consumers should be equally protected from dangerous products through offline and online distribution channels, including when purchasing products through online marketplaces. Building on the provisions of Regulation (EU) 2022/2065 on traceability of traders, online marketplace providers should not allow listings of a given product offer on their platforms unless the trader has provided all the product safety and traceability information described in this Regulation. This information should be displayed together with the product listing so that consumers can receive the same information through online and offline channels. However, online marketplace providers should not be responsible for verifying the completeness, correctness and accuracy of the information themselves, as the obligation to ensure the traceability of products remains with the trader concerned.

(59)

It is also important that online marketplace providers cooperate closely with market surveillance authorities, traders and relevant economic operators in relation to the safety of products. Article 7(2) of Regulation (EU) 2019/1020 imposes an obligation on information society service providers to cooperate with market surveillance authorities in relation to products covered by that Regulation. This obligation should therefore be extended to all consumer products. For example, market surveillance authorities are constantly improving the technological tools they use for online market surveillance to identify dangerous products sold online. For these tools to be functional, online marketplace providers should provide access to their interfaces. Furthermore, for the purpose of product safety, market surveillance authorities should also have the possibility to extract data from an online interface upon reasoned request where online marketplace providers or online sellers have created technical barriers. Online marketplace providers should also cooperate on product recalls and accident reports.

(60)

There should be maximum coherence between the legal framework for market surveillance of products covered by Union harmonization legislation under Regulation (EU) 2019/1020 and the legal framework for market surveillance of products covered by this Regulation. It is therefore necessary to align the provisions of the two legal frameworks with regard to market surveillance activities, obligations, powers, measures and cooperation between market surveillance authorities. To this end, Article 10, Article 11(1) to (7), Articles 12 to 15, Article 16(1) to (5), Articles 18 and 19 and Articles 21 to 24 of Regulation (EU) 2019/1020 should also apply to products covered by this Regulation.

(61)

In accordance with Regulation (EU) No 952/2013 of the European Parliament and of the Council (18) (Union Customs Code), products from third countries which are intended to be made available on the Union market or which are intended for private use or consumption in the customs territory of the Union are placed under the customs procedure 'release for free circulation'. This procedure aims at completing the formalities required for the importation of the goods, including the enforcement of the applicable provisions of Union law, so that these goods can be made available on the market like all goods produced in the Union. As regards consumer safety, those products shall comply with this Regulation and, in particular, with the general safety requirement laid down in this Regulation.

(62)

Chapter VII of Regulation (EU) 2019/1020 laying down rules for controls on products entering the Union market is already directly applicable to products covered by this Regulation. The authorities responsible for those controls should carry them out on the basis of risk analysis in accordance with Articles 46 and 47 of Regulation (EU) No 952/2013, the implementing acts and related guidance. Therefore, this Regulation does not amend in any way Chapter VII of Regulation (EU) 2019/1020 or the way in which the authorities responsible for controls on products entering the Union market organize themselves and carry out their activities.

(63)

Member States should ensure that all measures taken by their competent authorities under this Regulation are subject to effective judicial remedies in accordance with Article 47 of the Charter.

(64)

National authorities should be enabled to complement traditional market surveillance activities focused on the safety of products with market surveillance activities focused on internal compliance procedures used 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 process or containing the same components that are considered to be at risk or belonging to the same production batch - are affected by the same risk.

(65)

Member States should also ensure that market surveillance authorities have sufficient expertise and resources for all their enforcement activities.

(66)

An exchange of information on the application of this Regulation should be established between the Member States and the Commission on the basis of output indicators which make it possible to measure the effectiveness of Union legislation on product safety.

(67)

There should be an effective, rapid and accurate exchange of information on dangerous products to ensure that appropriate measures are taken in relation to these products and thus to protect the health and safety of consumers.

(68)

RAPEX should be modernized to enable more efficient corrective action to be taken throughout the Union in relation to products posing a risk beyond the territory of a single Member State. It is appropriate to change the acronym of the system from 'RAPEX' to 'Safety-Gate' in order to give it a clearer name and make it easier to reach consumers. The Safety Gate comprises three elements: firstly, a rapid alert system for dangerous non-food products, through which national authorities and the Commission can exchange information on these products (Safety Gate rapid alert system); secondly, a web portal to inform the public, including the possibility of submitting complaints (Safety Gate portal); and thirdly, a web portal that enables companies to fulfill their obligation to report dangerous products and accidents to the authorities and consumers (Safety Business Gateway). There should be interfaces between the various Safety Gate elements. The Safety Gate rapid alert system is the internal system through which authorities and the Commission exchange information on measures relating to dangerous products and which may contain confidential information. An extract of alerts should be published on the Safety Gate portal to inform the public about dangerous products. The Safety Business Gateway is the web portal through which companies inform the market surveillance authorities of the Member States about dangerous products and accidents. The Commission should develop a technical solution to ensure that the information entered by companies into the Safety Business Gateway, which is intended to alert consumers, can be made available to consumers on the Safety Gate portal without delay. In addition, the Commission should develop an interoperable interface so that online marketplace providers can easily, quickly and reliably link their interfaces to the safety gateway.

(69)

Member States should report through the rapid alert system Safety Gate both mandatory and voluntary corrective actions that prevent, restrict or impose specific conditions on the possible marketing of a product because it poses a serious risk to the health and safety of consumers or, for products covered by Regulation (EU) 2019/1020, to relevant public interests of end-users.

(70)

In accordance with Article 34 of Regulation (EU) 2019/1020, Member State authorities shall notify through the information and communication system referred to in that Article when they take action in relation to products covered by that Regulation which do not present a serious risk, whereas corrective action in relation to products covered by this Regulation which do not present a serious risk could also be notified through the Safety Gate rapid alert system. Member States and the Commission should provide the public with information on health and safety risks posed to consumers by products. It is advisable for consumers and businesses that all information on corrective actions taken in relation to products posing a serious risk is included in the Safety Gate rapid alert system, so that relevant information on dangerous products can be made available to the public via the Safety Gate portal. It is important to ensure that all such information is available in the official language(s) of the Member State in which the consumer resides and that it is drafted in a clear and comprehensible manner. Member States are therefore encouraged to report all corrective actions in relation to products that pose a risk to the health and safety of consumers via the Safety Gate rapid alert system.

(71)

If the information is to be reported through the information and communication system referred to in Regulation (EU) 2019/1020, it is possible for those reports to be transmitted directly in the rapid alert system Safety Gate or to be generated from the information and communication system for market surveillance referred to in Article 34 of Regulation (EU) 2019/1020. To that end, the Commission should maintain and further develop the interface established for the transmission of information between that information and communication system and the Safety Gate rapid alert system in order to avoid duplication of data entries and to facilitate such transmission.

(72)

The Commission should maintain and further develop the Safety Business Gateway web portal to enable economic operators to fulfill their obligations to notify market surveillance authorities and consumers of dangerous products that they have made available on the market. It should enable a fast and efficient exchange of information between economic operators and national authorities and facilitate the transmission of information from economic operators to consumers.

(73)

There might be cases where a serious risk needs to be addressed at Union level and the risk cannot be contained satisfactorily by measures taken by the Member State concerned or by other procedures under Union law. This could be the case in particular with regard to emerging risks or risks affecting vulnerable consumers. For this reason, the Commission should be able to adopt measures on its own initiative or at the request of a Member State. These measures should be adapted to the gravity and urgency of the situation. It is also necessary to provide for an appropriate mechanism by which the Commission could adopt immediately applicable provisional measures.

(74)

The determination of the risk for a product and its level is based on a risk assessment carried out by the relevant stakeholders. In the course of such a risk assessment, Member States may come to different conclusions as to whether a risk exists and at what level. This could jeopardize the proper functioning of the internal market and the level playing field for consumers and economic operators. A mechanism should therefore be established through which the Commission could issue an opinion on the subject matter of the dispute.

(75)

The Commission should draw up a regular report on the application of the mechanism referred to in Article 29, which should be submitted to the European network of Member States' authorities responsible for product safety under this Regulation ('the Consumer Safety Network'). That report should identify the main risk assessment criteria applied by Member States and their impact on the internal market and on an equal level of consumer protection, in order to allow Member States and the Commission to harmonize approaches and criteria for risk assessment.

(76)

The Consumer Safety Network promotes cooperation between Member States in the enforcement of product safety. In particular, it facilitates the exchange of information, the organization of joint market surveillance activities and the exchange of expertise and best practices. It should also contribute to the harmonization of methodologies for the collection of product safety data and to the improvement of interoperability between regional, sectoral, national and European product safety information systems. The Consumer Safety Network should be duly represented and participate in coordination and cooperation activities of the Union Network for Product Conformity under Regulation (EU) 2019/1020 whenever coordination of activities falling within the scope of both Regulations is necessary to ensure their effectiveness.

(77)

In order to maintain the coherence of the legal framework for market surveillance while ensuring effective cooperation between the Consumer Safety Network and the Union Product Compliance Network, which aims at structured coordination and cooperation between the enforcement authorities of the Member States and the Commission in accordance with Regulation (EU) 2019/1020, it is necessary to link the Consumer Safety Network with the Union Product Compliance Network with regard to the activities referred to in Articles 11, 12, 13 and 21 of Regulation (EU) 2019/1020.

(78)

Market surveillance authorities should carry out joint activities with other authorities or with organizations representing economic operators or consumers in order to promote the safety of products and to identify dangerous products, including products offered for sale online. In doing so, market surveillance authorities and, where appropriate, the Commission should ensure that the choice of products and manufacturers and the activities carried out do not lead to situations which could distort competition or compromise the objectivity, independence and impartiality of the parties. Market surveillance authorities should make the agreements on joint activities available to the public as soon as possible, provided that publication does not compromise the effectiveness of the activities to be carried out.

(79)

The Commission should periodically organize a joint activity in which market surveillance authorities should check products purchased online or offline using a concealed identity, in particular those products that are most frequently reported through the safety gate.

(80)

Concurrent coordinated control measures (hereinafter "sweeps") are specific enforcement actions that could further improve product safety and should therefore be carried out to detect infringements of this Regulation, both online and offline. Sweeps should be carried out in particular when market developments, consumer complaints or other indications suggest that certain products or product categories frequently pose a serious risk.

(81)

It should in principle be ensured that information on product safety available to the authorities is publicly available. However, when making product safety information available to the public, professional secrecy as referred to in Article 339 TFEU should be respected in a way that is compatible with the need to ensure the effectiveness of market surveillance activities and safeguard measures.

(82)

Complaints are important to raise awareness among national authorities about the safety and effectiveness of monitoring and control activities related to dangerous products. Member States should therefore give consumers and other interested parties such as consumer associations and economic operators the possibility to lodge complaints.

(83)

The public interface of the Safety Gate rapid alert system, the Safety Gate portal, allows the public, including consumers, economic operators and online marketplace providers, to find out about corrective actions taken in relation to dangerous products present on the Union market. A dedicated section of the Safety Gate portal allows consumers to inform the Commission about products on the market that pose a risk to the health and safety of consumers. Where appropriate, the Commission should take appropriate follow-up action, in particular by transmitting this information to the national authorities concerned. The Safety Gate database and website should be easily accessible to persons with disabilities.

(84)

After verifying the accuracy of the information provided by consumers and other interested parties, the Commission should ensure appropriate follow-up. In particular, the Commission should forward the information to the Member States concerned so that the competent market surveillance authority can act as required. It is important that consumers and other interested parties are properly informed of the Commission's action.

(85)

If a product that has already been sold to consumers is found to be dangerous, it may need to be recalled to protect consumers in the Union. Consumers may not be aware that they are the owners of a recalled product. To improve the effectiveness of recalls, it is therefore important to better reach the consumers concerned. Direct contact is the most effective way to increase consumer awareness of recalls and encourage them to take action. It is also the preferred method of communication for all consumer groups. To ensure the safety of consumers, it is important that they are informed quickly and reliably. Economic operators and, where applicable, online marketplace providers should therefore use any customer data available to them to inform consumers about recalls and safety alerts related to the products they have purchased. It is therefore necessary to impose a legal obligation on economic operators and online marketplace providers to use any customer data they already hold to inform consumers about recalls and safety alerts. In this respect, economic operators and online marketplace providers should ensure that the possibility to contact customers directly in case of recalls or safety alerts concerning them is included in existing customer loyalty programs and product registration systems, where customers are asked to provide the manufacturer with some information such as their name, contact details, product model or serial number on a voluntary basis after purchasing a product. The mere fact that recalls are addressed to consumers should not prevent economic operators and online marketplace providers from making all customers aware of a product recall notice, nor from offering remedies to other end-users. Economic operators and online marketplace providers should be encouraged to take such measures, in particular in the case of micro and small enterprises acting as consumers.

(86)

Consumers should be encouraged to register products in order to receive information on recalls and safety alerts. The power to adopt implementing acts should be delegated to the Commission in respect of specifying that, for certain products or categories of products, consumers should always have the possibility to register a product they have purchased in order to be directly informed of a recall or a safety alert related to the product. When determining the products or categories of products to which that requirement applies, due account should be taken of the life cycle of the products or categories of products concerned, the risks posed by the products, the frequency of recalls and the category of users of the products, in particular vulnerable consumers.

(87)

One third of consumers continue to use dangerous products after seeing a recall notice, in particular because recall notices are complicated or present the existing risk as low. Recall notices should therefore be clear and transparent and clearly describe the existing risk, avoiding terms, expressions and other elements that could affect consumers' perception of risk. Consumers should also have the possibility to obtain further information via a toll-free number or another interactive tool if necessary.

(88)

In order to encourage consumers to respond to recalls, it is important that the action required of consumers is as simple as possible and that the remedies offered are effective, free of charge and timely. Directive (EU) 2019/771 of the European Parliament and of the Council (19) provides for contractual remedies for consumers in the event of lack of conformity of physical goods which exists at the time of delivery and becomes apparent within the liability period set by Member States in accordance with Article 10(3) of that Directive. Article 14 of Directive (EU) 2019/770 of the European Parliament and of the Council (20) also applies to tangible media such as DVDs, CDs, USB sticks and memory cards used as carriers of digital content. However, situations where dangerous products are recalled from the market justify a specific set of rules that should be applied without prejudice to contractual remedies, as they pursue different objectives. While contractual remedies serve the purpose of remedying the non-conformity of the goods, recall remedies serve both to remove dangerous products from the market and to provide adequate redress to the consumer. Consequently, there are major differences between the two types of possible remedies: First, in the case of a product recall under this Regulation, there should be no time limit for seeking redress; second, consumers should have the right to seek redress from the economic operator concerned, but not necessarily from the trader. Furthermore, in the event of a recall, consumers should not have to prove that the product is dangerous.

(89)

As the remedies for the recall of a dangerous product and the remedies for non-conformity of goods have different objectives, consumers should use the system that is appropriate to the situation. For example, if consumers receive a recall notice with a description of the remedies available to them, they should act in accordance with the instructions in the recall notice. However, they should not be deprived of the possibility to seek redress from the seller due to the lack of conformity of the dangerous goods.

(90)

Once consumers have received a remedy following a recall, they shall not be entitled to a remedy for lack of conformity of the goods on grounds relating to the fact that the goods were dangerous, as the lack of conformity no longer exists. Also, where consumers exercise their right to a remedy under Directive (EU) 2019/770 or Directive (EU) 2019/771, they are not entitled to a remedy under this Regulation for the same safety problem. However, if other conformity requirements for the same product are not met, the seller remains liable for that lack of conformity of the product even if the consumer has been granted a remedy following a recall of a dangerous product.

(91)

Economic operators initiating a product recall should offer consumers at least two of the options of repair, replacement or adequate reimbursement of the value of the recalled product, unless this is not possible or disproportionate. Offering consumers a choice of remedies can improve the effectiveness of a recall. In addition, incentives such as rebates or vouchers should be encouraged to motivate consumers to participate in a recall in order to improve the effectiveness of recalls. The repair of the product should only be considered as a possible remedy if the safety of the repaired product can be ensured. The amount of reimbursement should be at least equal to the price paid by the consumer, without prejudice to further compensation under national law. If no proof of the price paid is available, an appropriate reimbursement of the value of the recalled product should nevertheless be granted. In the case of recall of the tangible medium for digital content within the meaning of Article 2(1) of Directive (EU) 2019/770, the refund should cover all amounts paid by the consumer under the contract, as provided for in Article 16(1) of that Directive. Any remedy should be without prejudice to the consumer's right to compensation under national law.

(92)

Remedies offered in the event of a product safety recall should not result in undue burden on, or risk to, consumers. Where the remedy includes the disposal of the recalled product, such disposal should be carried out with due regard to the environmental and sustainability objectives set at Union and national level. In addition, consumer repair should only be considered as a possible remedy if it can be easily and safely carried out by the consumer, for example by replacing a battery or by cutting off excessively long drawstrings on a child's garment, if provided for in the recall notice. Furthermore, the repair by the consumer should be without prejudice to the rights of consumers under Directives (EU) 2019/770 and (EU) 2019/771. Therefore, in such cases, economic operators should not oblige consumers to repair a dangerous product.

(93)

This Regulation should also encourage economic operators and online marketplace providers to conclude voluntary agreements with the competent authorities, the Commission or organizations representing consumers or economic operators to enter into voluntary commitments in relation to product safety that go beyond the legal obligations laid down in Union law.

(94)

Consumers should be entitled to enforce their rights in relation to the obligations imposed on economic operators or online marketplace providers under this Regulation through representative actions in accordance with Directive (EU) 2020/1828 of the European Parliament and of the Council (21). To that end, this Regulation should provide that Directive (EU) 2020/1828 applies to representative actions for infringements of this Regulation that harm or are likely to harm the collective interests of consumers. Consequently, Annex I to that Directive should be amended accordingly. It is for Member States to ensure that this amendment is reflected in the transposition measures they adopt pursuant to that Directive, although the adoption of national transposition measures in this respect is not a precondition for the application of that Directive to such representative actions. That Directive should apply from the date of application of this Regulation to representative actions brought against infringements by economic operators or online marketplace providers of the provisions of this Regulation where the infringements harm or are likely to harm the collective interests of consumers. Until that date, consumers should be able to rely on the applicability of Directive (EU) 2020/1828 in accordance with point 8 of Annex I to that Directive.

(95)

The Union should be able to cooperate with third countries or international organizations in the framework of agreements concluded between the Union and third countries or international organizations, or agreements concluded between the Commission and authorities of third countries or international organizations, and to exchange product safety-related information with regulatory authorities of third countries or international organizations, including in order to prevent dangerous products from circulating on the market. Such cooperation and exchange of information should respect Union rules on confidentiality and protection of personal data. The exchange of personal data should only take place insofar as it is necessary for the sole purpose of protecting the health or safety of consumers.

(96)

The systematic exchange of information between the Commission and third countries or international organizations on the safety of consumer products and on preventive, restrictive and corrective actions should be based on reciprocity, which implies an equivalent but not necessarily identical exchange of information for mutual benefit. An exchange of information with a third country producing goods destined for the Union market could consist of the Commission transmitting selected information contained in the Rapid Alert System Safety Gate on products from that third country. In return, that third country could provide information on the follow-up measures taken on the basis of the notifications received. Such cooperation could contribute to the objective of containing dangerous products at source and preventing them from entering the Union market.

(97)

In order to ensure a strong deterrent effect on economic operators and, where applicable, online marketplace providers to prevent the placing on the market of dangerous products, penalties should be proportionate to the nature of the infringement, the potential benefit for the economic operator or online marketplace provider and the nature and gravity of the infringement suffered by the consumer. The penalties should be effective, proportionate and dissuasive.

(98)

When imposing penalties, due account should be taken of the nature, gravity and duration of the breach concerned. The imposition of penalties should be proportionate and in accordance with Union and national law, including applicable procedural safeguards and the principles of the Charter.

(99)

The power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the identification and traceability of products potentially presenting a serious risk to the health and safety of consumers, in order to maintain a high level of consumer health and safety, and in respect of the functioning of the rapid alert system Safety Gate, in particular to establish the modalities and procedures for the exchange of information on the measures notified through the rapid alert system Safety Gate and criteria for the assessment of the level of risk. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (22). 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.

(100)

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 and to establish the output indicators on the basis of which Member States are to submit data for the implementation of this Regulation, to specify the tasks and functions of the national central contact points, to adopt measures for Union action against products presenting a serious risk, to adopt the modalities for the transmission of information from consumers in the safety gate portal, to specify the implementation of the interoperable interface of the safety gate portal, to specify the requirements for the registration of products for the purposes of product safety recalls and to adopt the template for recall notifications. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (23).

(101)

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.

(102)

The Commission should carry out an evaluation of the implementation of the penalties laid down in this Regulation with regard to their effectiveness and dissuasive effect and, if appropriate, adopt a legislative proposal for their enforcement.

(103)

Certain provisions of Regulation (EU) No 1025/2012 should be amended to take into account the specificities of this Regulation, in particular the fact that specific safety requirements under this Regulation need to be established before mandating the European standardization organisations.

(104)

Directive 87/357/EEC, which covers consumer products which are not food but which resemble food and can easily be mistaken for food and therefore can be placed in the mouth, sucked or swallowed by consumers, especially children, which could lead, for example, to choking, poisoning or perforation or obstruction of the alimentary canal, has led to controversial interpretations. The Directive was also adopted at a time when the scope of the legal framework for the safety of consumer products was very limited. For those reasons, Directive 87/357/EEC should be repealed and replaced by this Regulation, in particular the provisions of this Regulation ensuring that, following a risk assessment, products which may be harmful when placed in the mouth, sucked or swallowed and which, because of their shape, smell, color, appearance, packaging, labeling, volume, size or other characteristics, may easily be mistaken for food, should be considered as dangerous. In carrying out their evaluation, market surveillance authorities should take into account, inter alia, that, as stated by the Court of Justice of the European Union, it is not necessary to demonstrate, on the basis of objective and substantiated data, that risks such as choking, poisoning, perforation or obstruction of the alimentary canal may occur when the counterfeit food product in question is brought to the mouth, sucked or swallowed. Nevertheless, the competent national authorities should assess on a case-by-case basis whether such products are dangerous and justify this assessment.

(105)

In order to allow economic operators and online marketplace providers sufficient time to adapt to the requirements of this Regulation, including the information requirements, it is necessary to provide for a sufficient transitional period after the entry into force of this Regulation during which products covered by Directive 2001/95/EC and compliant with that Directive may still be placed on the market. Member States should therefore not impede the making available on the market of such products, including offers for sale.

(106)

Since the objective of this Regulation, namely to improve the functioning of the internal market while ensuring a high level of consumer protection, cannot be sufficiently achieved by the Member States, given the high level of cooperation and coherence required between the competent authorities of the Member States and the need for a mechanism for the rapid and efficient exchange of information on dangerous products in the Union, but can rather, by reason of the Union-wide nature 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 that objective.

(107)

Where the processing of personal data is necessary for the purposes of this Regulation, such processing should be carried out in accordance with Union law on the protection of personal data. Any processing of personal data under this Regulation is subject to Regulations (EU) 2016/679 (24) and (EU) 2018/1725 (25) and Directive 2002/58/EC (26) of the European Parliament and of the Council, where applicable. When consumers notify a product on the Safety Gate portal, only the personal data necessary for the notification of the dangerous product should be stored and should be stored for a maximum period of five years from the date of entry of the data. Manufacturers and importers should keep the register of consumer complaints only for as long as necessary for the purposes of this Regulation. Where producers and importers are natural persons, they should disclose their names to ensure that consumers can identify the product for traceability purposes.

(108)

The European Data Protection Supervisor has been consulted in accordance with Article 42 of Regulation (EU) 2018/1725