Legal provisions of COM(2021)346 - General product safety - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
dossier | COM(2021)346 - General product safety. |
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document | COM(2021)346 ![]() |
date | May 10, 2023 |
CHAPTER I
General provisions
Contents
- Article 1 - Subject matter
- Article 2 - Scope
- Article 3 - Definitions
- Article 4 - Distance sales
- Article 5 - General safety requirement
- Article 6 - Presumption of safety
- Article 7 - Aspects for assessing the safety of products
- Article 8 - Obligations of manufacturers
- Article 9 - Obligations of authorised representatives
- Article 10 - Obligations of importers
- Article 11 - Obligations of distributors
- Article 12 - Cases in which obligations of manufacturers apply to other economic operators
- Article 13 - Internal processes for product safety
- Article 14 - Cooperation of economic operators with market surveillance authorities
- Article 15 - Responsible person for products placed on the Union market
- Article 16 - Information to economic operators
- Article 17 - Traceability of products
- Article 18 - Obligations of economic operators in case of distance sales
- Article 19 - Obligations of economic operators in case of accidents or safety issues related to products
- Article 20 - Specific obligations of online marketplaces related to product safety
- Article 21 - Market Surveillance
- Article 22 - Implementation
- Article 23 - Safety Gate
- Article 24 - Notification through the Safety Gate of products presenting a risk
- Article 25 - Safety Business Gateway
- Article 26 - Union action against products presenting a serious risk
- Article 27 - Arbitration mechanism
- Article 28 - Consumer Safety Network
- Article 29 - Joint activities on product safety
- Article 30 - Sweeps
- Article 31 - Information between public authorities and consumers
- Article 32 - Safety Gate portal
- Article 33 - Information from economic operators to consumers
- Article 34 - Recall notice
- Article 35 - Right to remedy
- Article 37 - Financing activities
- Article 38 - Protection of the Union's financial interests
- Article 39 - Liability
- Article 40 - Penalties
- Article 41 - Exercise of the delegation
- Article 42 - Committee procedure
- Article 43 - Evaluation
- Article 44 - Amendments to Regulation (EU) No 1025/2012
- Article 45 - Repeal
- Article 46 - Transitional provisions
- Article 47 - Entry into force and application
Article 1 - Subject matter
Article 2 - Scope
Where products are subject to specific safety requirements imposed by Union legislation, this Regulation shall apply only to the aspects and risks or categories of risks not covered by those requirements.
In particular, as regards products subject to specific requirements imposed by Union harmonisation legislation as defined in Article 3(25),
(a)Chapter II shall not apply insofar as the risks or categories of risks covered by Union harmonisation legislation are concerned;
(b)Chapter III, Section 1, Chapters V and VII, Chapters IX to XI shall not apply.
2. This Regulation shall not apply to:
(a)medicinal products for human or veterinary use;
(b)food;
(c)feed;
(d)living plants and animals, genetically modified organisms and genetically modified microorganisms in contained use, as well as products of plants and animals relating directly to their future reproduction;
(e)animal by-products and derived products;
(f)plant protection products;
(g)equipment on which consumers ride or travel which is operated by a service provider within the context of a service provided to consumers;
(h)aircraft referred to in point (d) of Article 2(3) of Regulation 2018/1139;
(i)antiques.
3. This Regulation shall apply to products placed or made available on the market whether new, used, repaired or reconditioned. It shall not apply to products to be repaired or reconditioned prior to being used where those products are made available on the market as such.
4. This Regulation is without prejudice to the rules laid down by Union law on consumer protection.
5. This Regulation shall be applied taking due account of the precautionary principle.
Article 3 - Definitions
1.‘product’ means any item, interconnected or not to other items, supplied or made available, whether for consideration or not, in the course of a commercial activity including in the context of providing a service – which is intended for consumers or can, under reasonably foreseeable conditions, be used by consumers even if not intended for them;
2. ‘safe product’ means any product which, under normal or reasonably foreseeable conditions of use or misuse, including the actual duration of use, does not present any risk or only the minimum risks compatible with the product's use, considered acceptable and consistent with a high level of protection of health and safety of consumers;
3.‘dangerous product’ means any product which does not conform to the definition of ‘safe product’;
4.‘risk’ means the combination of the probability of an occurrence of a hazard causing harm and the degree of severity of that harm;
5.‘serious risk’ means a risk for which, based on a risk assessment and taking into account the normal and foreseeable use of the product, the combination of the probability of occurrence of a hazard causing harm and the degree of severity of the harm is considered to require rapid intervention by the market surveillance authorities, including cases where the effects of the risk are not immediate;
6.‘making available on the market’ means any supply of a product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
7.‘placing on the market’ means the first making available of a product on the Union market;
8. ‘manufacturer’ means any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under its name or trademark;
9.‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his or her behalf in relation to specified tasks;
10.‘importer’ means any natural or legal person established within the Union who places a product from a third country on the Union market;
11.‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market;
12.‘fulfilment service provider’ means any natural or legal person offering, in the course of commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching, without having ownership of the products involved, excluding postal services as defined in Article 2, point 1 of Directive 97/67/EC of the European Parliament and of the Council 39 , parcel delivery services as defined in Article 2, point 2 of Regulation (EU) 2018/644 of the European Parliament and of the Council 40 , and any other postal services or freight transport services;
13.‘economic operator’ means the manufacturer, the authorized representative, the importer, the distributor, the fulfilment service provider or any other natural or legal person who is subject to obligations in relation to the manufacture of products, making them available on the market in accordance with this Regulation;
14.‘online marketplace’ means a provider of an intermediary service using software, including a website, part of a website or an application, operated by or on behalf of a trader, which allows consumers to conclude distance contracts with other traders or consumers for the sale of products covered by this Regulation;
15.‘online interface’ means any software, including a website, part of a website or an application, that is operated by or on behalf of an economic operator, and which serves to give end users access to the economic operator's products;
16.‘end user’ means any natural or legal person residing or established in the Union, to whom a product has been made available either as a consumer outside of any trade, business, craft or profession or as a professional end user in the course of its industrial or professional activities;
17.‘European standard’ means a European standard as defined in Article 2(1), point (b) of Regulation (EU) No 1025/2012;
18.‘International standard’ means an international standard as defined in Article 2(1), point (a) of Regulation (EU) No 1025/2012;
19.‘National standard’ means a national standard as defined in Article 2(1), point (d) of Regulation (EU) No 1025/2012;
20.‘European standardisation organisation’ means a European standardisation organisation as listed in Annex 1 to Regulation (EU) No 1025/2012;
21.‘market surveillance’ means the activities carried out and measures taken by market surveillance authorities to ensure that products comply with the requirements set out in this Regulation;
22.‘market surveillance authority’ means an authority designated by a Member State under Article 10 of Regulation (EU) 2019/1020 as responsible for organising and carrying out market surveillance in the territory of that Member State;
23.‘recall’ means any measure aimed at achieving the return of a product that has already been made available to the consumer;
24.‘withdrawal’ means any measure aimed at preventing a product in the supply chain from being made available on the market;
25.‘Union harmonisation legislation’ means Union legislation listed in Annex I to Regulation (EU) 2019/1020 and any other Union legislation harmonising the conditions for the marketing of products to which that Regulation applies.
Article 4 - Distance sales
2. For the purpose of determining whether an offer is targeted at consumers in the Union, the following non-exhaustive criteria shall be taken into account:
(a)the use of an official language or currency of the Member States,
(b)a domain name registered in one of the Member States,
(c)the geographical areas to which the products can be dispatched.
CHAPTER II
Safety requirements
Article 5 - General safety requirement
Article 6 - Presumption of safety
(a)if it conforms to relevant European standards or parts thereof as far as the risks and risk categories covered are concerned, the references of which have been published in the Official Journal of the European Union in accordance with Article 10(7) of Regulation (EU) 1025/2012;
(b)in the absence of European standards referred to in point (a), as regards the risks covered by health and safety requirements laid down in the law of the Member State where the product is made available on the market, if it conforms to such national requirements.
2. The Commission shall adopt implementing acts determining the specific safety requirements necessary to ensure that products which conform to the European standards satisfy the general safety requirement laid down in Article 5. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 42(3).
3. However, presumption of safety under paragraph 1 shall not prevent market surveillance authorities from taking action under this Regulation where there is evidence that, despite such conformity, the product is dangerous.
Article 7 - Aspects for assessing the safety of products
(a)the characteristics of the product, including its design, technical features, composition, packaging, instructions for assembly and, where applicable, for installation and maintenance;
(b)the effect on other products, where it is reasonably foreseeable that it will be used with other products, including the interconnection of products among them;
(c)the effect that other products might have on the product to be assessed, including the effect of non-embedded items that are meant to determine, change or complete the way another product falling under the scope of this Regulation works, which have to be taken into consideration in assessing the safety of that other product;
(d)the presentation of the product, the labelling, any warnings and instructions for its safe use and disposal, and any other indication or information regarding the product;
(e)the categories of consumers at risk when using the product, in particular vulnerable consumers such as children, older people and persons with disabilities;
(f)the appearance of the product and in particular where a product, although not foodstuff, resembles foodstuff and is likely to be confused with foodstuff due to its form, odour, colour, appearance, packaging, labelling, volume, size or other characteristics;
(g)the fact that although not designed or not intended for use by children, the product resembles an object commonly recognized as appealing to or intended for use by children, because of its design, packaging and characteristics;
(h)the appropriate cybersecurity features necessary to protect the product against external influences, including malicious third parties, when such an influence might have an impact on the safety of the product;
(i)the evolving, learning and predictive functionalities of a product.
2. The feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering a product not to be safe.
3. For the purpose of paragraph 1, when assessing whether a product is safe, the following elements, when available, shall be taken into account, in particular:
(a)European standards other than those the references of which have been published in the Official Journal of the European Union in accordance with Article 10(7) of Regulation (EU) 1025/2012;
(b)international standards;
(c)international agreements;
(d)voluntary certification schemes or similar third-party conformity assessment frameworks, in particular those conceived to support Union legislation;
(e)Commission recommendations or guidelines on product safety assessment;
(f)national standards drawn up in the Member State in which the product is made available;
(g)the state of the art and technology, including the opinion of recognized scientific bodies and expert committees;
(h)product safety codes of good practice in force in the sector concerned;
(i)reasonable consumer expectations concerning safety;
(j)safety requirements adopted in accordance with Article 6(2).
CHAPTER III
Obligations of economic operators
Section 1
Article 8 - Obligations of manufacturers
2. Manufacturers shall investigate the complaints received that concern products they made available on the market, and which have been identified as dangerous by the complainant, and shall keep a register of these complaints as well as of product recalls.
Manufacturers shall make publicly available to consumers, communication channels such as telephone number, electronic address or dedicated section of their website, allowing the consumers to file complaints and to inform them of any accident or safety issue they have experienced with the product.
Personal data stored in the register of complaints shall only be those personal data that are necessary for the manufacturer to investigate the complaint about an alleged dangerous product. Such data shall only be kept as long as it is necessary for the purpose of investigation and no longer than five years after they have been encoded.
3. Manufacturers shall keep distributors, importers and online marketplaces in the concerned supply chain informed of any safety issue that they have identified.
4. Manufacturers shall draw up technical documentation of the product. The technical documentation shall contain, as appropriate:
(a)a general description of the product and its essential properties relevant for assessing the product's safety;
(b)an analysis of the possible risks related to the product and the solutions adopted to eliminate or mitigate such risks, including the outcome of any tests conducted by the manufacturer or by another party on their behalf;
(c)the list of the European standards referred to in Article 6(1) point a, or the other elements referred to in Article 7(3), applied to meet the general safety requirement laid down in Article 5.
Where any of the European standards, health and safety requirements or elements referred to in Article 7(3) have been only partly applied, the parts which have been applied shall be identified.
5. Manufacturers shall keep the technical documentation, for a period of ten years after the product has been placed on the market and make it available to the market surveillance authorities, upon request.
6. Manufacturers shall ensure that their products bear a type, batch or serial number or other element allowing the identification of the product which is easily visible and legible for consumers, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document accompanying the product.
7. Manufacturers shall indicate their name, registered trade name or registered trade mark and the postal and electronic address at which they can be contacted on the product or, where that is not possible, on its packaging or in a document accompanying the product. The address shall indicate a single contact point at which the manufacturer can be contacted.
8. Manufacturers shall ensure that their product is accompanied by instructions and safety information in a language which can be easily understood by consumers, as determined by the Member State in which the product is made available. This requirement shall not apply where the product can be used safely and as intended by the manufacturer without such instructions and safety information.
9. Manufacturers shall ensure that procedures are in place for series production to remain in conformity with the general safety requirement laid down in Article 5.
10. Manufacturers who consider or have reason to believe, on the basis of the information in their possession, that a product which they have placed on the market is not safe, shall immediately take the corrective measures necessary to bring the product into conformity, including a withdrawal or recall, as appropriate.
11. Manufacturers shall, via the Safety Business Gateway referred to in Article 25, immediately alert consumers of the risk to their health and safety presented by a product they manufacture and immediately inform the market surveillance authorities of the Member States in which the product has been made available to that effect, giving details, in particular, of the risk to health and safety of consumers and of any corrective measure already taken.
Article 9 - Obligations of authorised representatives
2. An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to perform at least the following tasks:
(a)provide a market surveillance authority, upon its reasoned request, with all information and documentation necessary to demonstrate the safety of the product in an official language which can be understood by that authority;
(b)where they have a reason to believe that a product in question presents a risk, inform the manufacturer;
(c)cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by products covered by their mandate.
Article 10 - Obligations of importers
2. Where an importer considers or has reason to believe that a product is not in conformity with Article 5 and Article 8(4), (6) and (7), he or she shall not place the product on the market until it has been brought into conformity. Furthermore, where the product is not safe, the importer shall inform the manufacturer and ensure that the market surveillance authorities are informed.
3. Importers shall indicate their name, registered trade name or registered trade mark, the postal and electronic address at which they can be contacted on the product or, where that is not possible, on its packaging or in a document accompanying the product. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer.
4. Importers shall ensure that the product they imported is accompanied by instructions and safety information in a language which can be easily understood by consumers, as determined by the Member State in which the product is made available, except where the product can be used safely and as intended by the manufacturer without such instructions and safety information.
5. Importers shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardize its conformity with the general safety requirement laid down in Article 5 and its conformity with Article 8 (6) and (7).
6. Importers shall investigate complaints related to products they made available on the market and file these complaints, as well as products recalls, in the register referred to in Article 8(2), first subparagraph, or in their own register. Importers shall keep the manufacturer and distributors informed of the investigation performed and of the results of the investigation.
Importers shall ensure that the communication channels referred to in Article 8(2), second subparagraph, are available to consumers allowing them to present complaints and communicate any accident or safety issue they have experienced with the product. If such channels are not available the importer shall provide for them.
Personal data stored in the register of complaints shall only be those personal data that are necessary for the importer to investigate the complaint about an alleged dangerous product. Such data shall only be kept as long as it is necessary for the purpose of investigation and no longer than five years after they have been encoded.
7. Importers shall cooperate with market surveillance authorities and the manufacturer to ensure that a product is safe.
8. Importers who consider or have reason to believe, on the basis of the information in their possession, that a product which they have placed on the market is not safe shall immediately inform the manufacturer and ensure that the corrective measures necessary to bring the product into conformity are adopted including withdrawal or recall, as appropriate. In case such measures have not been adopted, the importer shall adopt them. Importers shall ensure that, through the Safety Business Gateway referred to in Article 25, consumers are immediately and effectively alerted of the risk where applicable and that market surveillance authorities of the Member States in which they made the product available to that effect be immediately informed, giving details, in particular, of the risk to health and safety of consumers and of any corrective measure already taken.
9. Importers shall keep the technical documentation referred to in Article 8(4) for a period of 10 years after they have placed the product on the market and make it available to the market surveillance authorities, upon request.
Article 11 - Obligations of distributors
2. Distributors shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardize its conformity with the general safety requirement laid down in Article 5 and its conformity with Article 8(6), (7) and (8) and Article 10(3) and (4), as applicable.
3. Distributors who consider or have reason to believe, on the basis of the information in their possession, that a product is not in conformity with the provisions referred to in paragraph 2, shall not make the product available on the market until it has been brought into conformity. Furthermore, where the product is not safe, the distributor shall immediately inform the manufacturer or the importer, as applicable, to that effect and shall make sure that, through the Safety Business Gateway referred to in Article 25, the market surveillance authorities are informed.
4. Distributors who consider or have reason to believe, on the basis of the information in their possession, that a product which they have made available on the market is not safe or is not in conformity with Article 8(6), (7) and (8) and Article 10(3) and (4), as applicable, shall ensure that the corrective measures necessary to bring the product into conformity are adopted, including withdrawal or recall, as appropriate. Furthermore, where the product is not safe, distributors shall immediately inform the manufacturer or the importer, as applicable, to that effect and shall make sure that, through the Safety Business Gateway referred to in Article 25, the market surveillance authorities of the Member State in which they made the product available to that effect are informed giving details, in particular, of the risk to health and safety and of any corrective measure taken.
Article 12 - Cases in which obligations of manufacturers apply to other economic operators
2. A modification shall be deemed to be substantial where the three following criteria are met:
(a)the modification changes the intended functions, type or performance of the product in a manner which was not foreseen in the initial risk assessment of the product;
(b)the nature of the hazard has changed or the level of risk has increased because of the modification;
(c) the changes have not been made by the consumer for their own use.
Article 13 - Internal processes for product safety
Article 14 - Cooperation of economic operators with market surveillance authorities
2. On request of a market surveillance authority, the economic operator shall provide all necessary information, and in particular:
(a)a full description of the risk presented by the product;
(b) a description of any corrective measure undertaken to address the risk.
3. On request, the economic operators shall also identify and communicate the following information:
(a)any economic operator who has supplied them with the product;
(b)any economic operator to whom they have supplied the product.
4. Economic operators shall be able to present the information referred to in paragraph 2 for a period of ten years after they have been supplied with the product and for a period of ten years after they have supplied the product, where relevant.
5. Economic operators shall ensure that the corrective measure undertaken is effective in eliminating or mitigating the risks. Market surveillance authorities may request the economic operators to submit regular progress reports and decide whether or when the corrective measure can be considered completed.
Article 15 - Responsible person for products placed on the Union market
2. In addition to the tasks referred to in Article 4(3) of Regulation (EU) 2019/1020, the economic operator referred to in Article 4(1) of Regulation (EU) 2019/1020 shall periodically carry out sample testing of randomly chosen products made available on the market. When the products made available on the market have been subject to a Commission decision adopted under Article 26(1) of this Regulation, the economic operator referred to in Article 4(1) of Regulation (EU) 2019/1020 shall carry out, at least once a year, for the entire duration of the decision, representative sample testing of products made available on the market chosen under the control of a judicial officer or any qualified person designated by the Member State where the economic operator is situated.
3. The name, registered trade name or registered trade mark, and contact details, including the postal and electronic address, of the economic operator referred to in Article 4(1) of Regulation (EU) 2019/1020 shall be indicated on the product or on its packaging, the parcel or an accompanying document.
Article 16 - Information to economic operators
Article 17 - Traceability of products
2. The system of traceability shall consist in the collection and storage of data, including by electronic means, enabling the identification of the product, its components or of the economic operators involved in its supply chain, as well as in modalities to display and to access that data, including placement of a data carrier on the product, its packaging or accompanying documents.
3. The Commission is empowered to adopt delegated acts in accordance with Article 41 to supplement this Regulation by:
(a)determining the products, categories or groups of products or components susceptible to bear a serious risk to health and safety of persons as referred to in paragraph 1. The Commission shall state in the delegated acts concerned if it has used the risk analysis methodology provided for in Commission Decision (EU) 2019/417 41 or, if that methodology is not appropriate for the product concerned, it shall give a detailed description of the methodology used;
(b)specifying the type of data, which economic operators shall collect and store by means of the traceability system referred to in paragraph 2;
(c)the modalities to display and to access data, including placement of a data carrier on the product, its packaging or accompanying documents as referred to in paragraph 2.
4. When adopting the measures referred to in paragraph 3, the Commission shall take into account:
(a)the cost-effectiveness of the measures, including their impact on businesses, in particular small and medium-sized enterprises;
(b)the compatibility with traceability systems available at Union or at international level.
Section 2
Article 18 - Obligations of economic operators in case of distance sales
(a)name, registered trade name or registered trade mark of the manufacturer, as well as the postal or electronic address at which they can be contacted;
(b)in case the manufacturer is not established in the Union, the name, address, telephone number and electronic address of the responsible person within the meaning of Article 15(1);
(c)information to identify the product, including its type and, when available, batch or serial number and any other product identifier;
(d)any warning or safety information that is to be affixed on the product or to accompany it in accordance with this Regulation or the applicable Union harmonisation legislation in a language which can be easily understood by consumers.
Article 19 - Obligations of economic operators in case of accidents or safety issues related to products
2. The importers and the distributors which have knowledge of an accident caused by a product that they placed or made available on the market shall inform the manufacturer, which can instruct the importer or one of the distributors to proceed to the notification.
CHAPTER IV
Online marketplaces
Article 20 - Specific obligations of online marketplaces related to product safety
Online marketplaces shall register with the Safety Gate portal and indicate on the portal the information concerning their single contact point.
2. As far as powers conferred by Member States in accordance to Article 14 of Regulation (EU) 2019/1020 are concerned, Member States shall confer on their market surveillance authorities the power, for all products covered by this Regulation, to order an online marketplace to remove specific illegal content referring to a dangerous product from its online interface, to disable access to it or to display an explicit warning to end users when they access it. Such orders shall contain a statement of reasons and specify one or more exact uniform resource locators and, where necessary, additional information enabling the identification of the illegal content concerned. They may be transmitted by means of the Safety Gate portal.
Online marketplaces shall take the necessary measures to receive and process the orders issued in accordance with this paragraph. They shall act upon receipt of the order issued without undue delay, and in any event within two working days in the Member State where the online marketplace operates, from receipt of the order. They shall inform the issuing market surveillance authority of the effect given to the order by using the contacts of the market surveillance authority published in the Safety Gate.
3. Online marketplaces shall take into account regular information on dangerous products notified by the market surveillance authorities in line with Article 24, received via the Safety Gate portal, for the purpose of applying their voluntary measures aimed at detecting, identifying, removing or disabling access to the illegal content referring to dangerous products offered on their marketplace, where applicable. They shall inform the authority that made the notification to the Safety Gate of any action taken by using the contacts of the market surveillance authority published in the Safety Gate.
4. Online marketplaces shall give an appropriate answer without undue delay, and in any event within five working days, in the Member State where the online marketplace operates, to notices related to product safety issues and dangerous products received in accordance with [Article 14] of Regulation (EU) […/…] on a Single Market for Digital Services (Digital Service Act) and amending Directive 2000/31/EC.
5. For the purpose of the requirements of Article 22(7) of Regulation (EU) […/…] on a Single Market for Digital Services (Digital Services Act) and amending Directive 2000/31/EC, online marketplaces shall design and organise their online interface in a way that enables traders to provide the following information for each product offered and ensures that it is displayed or otherwise made easily accessible by consumers on the product listing:
(a)name, registered trade name or registered trade mark of the manufacturer, as well as the postal or electronic address at which they can be contacted;
(b)where the manufacturer is not established in the Union, the name, address, telephone number and electronic address of the responsible person within the meaning of Article 15 (1);
(c)information to identify the product, including its type and, when available, batch or serial number and any other product identifier;
(d)any warning or safety information that is to be affixed on the product or to accompany it in accordance with this Regulation or the applicable Union harmonisation legislation in a language which can be easily understood by consumers.
6. Online marketplaces shall cooperate with the market surveillance authorities and with relevant economic operators to facilitate any action taken to eliminate or, if that is not possible, to mitigate the risks presented by a product that is or was offered for sale online through their services. That cooperation shall include in particular:
(a)cooperating to ensure effective product recalls, including by abstaining from putting obstacles to product recalls;
(b)informing the market surveillance authorities of any action taken;
(c)cooperating with law enforcement agencies at national and Union level, including the European Anti-Fraud Office, through regular and structured exchange of information on offers that have been removed on the basis of this Article by online marketplaces;
(d)allowing access to their interfaces for the online tools operated by market surveillance authorities to identify dangerous products;
(e)upon request of the market surveillance authorities, when online marketplaces or online sellers have put in place technical obstacles to the extraction of data from their online interfaces (data scraping), allowing to scrape such data for product safety purposes based on the identification parameters provided by the requesting market surveillance authorities.
CHAPTER V
Market surveillance and implementation
Article 21 - Market Surveillance
2. For the purpose of this Regulation, Regulation (EU) 2019/1020 shall be applied as follows:
(a)references to ‘Union harmonisation legislation’ in Articles 10 to 16, Articles 18 and 19 and Articles 21 to 24 of Regulation (EU) 2019/1020 shall be read as references to ‘this Regulation’;
(b)reference to ‘that legislation and this Regulation’ in Article 11(1) point b of Regulation (EU) 2019/1020 shall be read as ‘Regulation […]’;
(c)references to ‘Network’ in Articles 10 to 16, Articles 18 and 19 and Articles 21 to 24 of Regulation (EU) 2019/1020 shall be read as references to ‘Network and Consumer Safety Network referred to in Article 28 of this Regulation’;
(d)references to ‘non-compliance’ in Articles 10 to 16, Articles 18 and 19 and Articles 21 to 24 of Regulation (EU) 2019/1020 shall be read as reference to ‘failure to comply with this Regulation’;
(e)the reference to ‘Article 41’ in Article 14(4), point (i) of Regulation (EU) 2019/1020 shall be read as reference to ‘Article 40 of this Regulation’:
(f)the reference to ‘Article 20’ in Article 19(1) of Regulation (EU) 2019/1020 shall be read as reference to ‘Article 24 of this Regulation’.
3. Where a dangerous product has been identified, the manufacturer shall indicate, upon request by market surveillance authorities, which other products, produced with the same procedure, containing the same components or being part of the same production batch, are affected by the same risk.
4. Market surveillance authorities may set up schemes focusing on control of internal processes for product safety set up by economic operators according to Article 13.
Article 22 - Implementation
2. The Commission, by means of implementing acts, shall determine the output indicators on the basis of which Member States have to communicate this data. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 42(3).
CHAPTER VI
Safety Gate rapid alert system
Article 23 - Safety Gate
2. The Commission and the Member States shall have access to the Safety Gate. For that purpose, each Member State shall designate a single national contact point which shall perform the tasks provided for in Article 24(1) to (6).
Article 24 - Notification through the Safety Gate of products presenting a risk
(a)on the basis of provisions of this Regulation in relation to products presenting a risk to the health and safety of consumers;
(b)on the basis of Regulation (EU) 2019/1020 in relation to products presenting a serious risk, in accordance with Article 20 of Regulation (EU) 2019/1020.
2. Member States may notify in the Safety Gate corrective measures taken by their authorities or by economic operators on the basis of provisions of Union harmonisation legislation and Regulation (EU) 2019/1020 in relation to products presenting a less than serious risk.
The notification shall be submitted in the Safety Gate within two working days from the adoption of the corrective measure.
3. On receiving a notification, the Commission shall check whether it complies with this Article and with the requirements related to the operation of Safety Gate defined by the Commission on the basis of paragraph 7, and shall transmit it to the other Member States if the requirements are complied with.
4. Member States shall notify in the Safety Gate without delay any update, modification or withdrawal of the corrective measures referred in paragraph 1.
5. Where a Member State notifies corrective measures taken in relation to products presenting a serious risk, the other Member States shall notify in the Safety Gate the measures and actions taken subsequently in relation to the same products and any other relevant information, including the results of any tests or analyses carried out, within two working days from the adoption of the measures or actions.
6. If the Commission identifies products which are likely to present a serious risk and for which Member States have not submitted a notification in the Safety Gate, it shall inform the Member States. Member States shall undertake the appropriate verifications and, if they adopt measures, notify them in the Safety Gate in accordance with paragraph 1.
7. The Commission shall develop an interface between the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020 and the Safety Gate, in order to avoid double data entry and enable a draft Safety Gate notification to be triggered from that information and communication system.
8. The Commission shall adopt implementing acts specifying the implementation of this Article, and in particular the access to the system, the operation of the system, the information to be entered in the system, the requirements notifications must meet, and criteria to assess the level of risk. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 42(3).
Article 25 - Safety Business Gateway
2. The Commission shall draw up guidelines for the practical implementation of the Safety Business Gateway.
CHAPTER VII
Commission role and enforcement coordination
Article 26 - Union action against products presenting a serious risk
(a)it emerges from prior consultations with the Member States that they differ significantly on the approach adopted or to be adopted to deal with the risk; and;
(b)the risk cannot be dealt with, in view of the nature of the safety issue posed by the product, category or group of products, in a manner compatible with the degree of gravity or urgency of the case, under other procedures laid down by the specific Union legislation applicable to the products concerned; and
(c)the risk can be eliminated effectively only by adopting appropriate measures applicable at Union level, in order to ensure a consistent and high level of protection of the health and safety of consumers and the proper functioning of the internal market.
Those measures may include measures prohibiting, suspending or restricting the placing or making available on the market of such products or laying down special conditions for their marketing, in order to ensure a high level of consumer safety protection.
In those implementing acts, the Commission shall lay down the appropriate control measures to be taken by Member States to ensure their effective implementation.
2. The implementing acts referred to in the paragraph 1 shall be adopted in accordance with the examination procedure referred to in Article 42(3). The implementing act shall determine the date, on which it will cease to apply.
3. On duly justified imperative grounds of urgency relating to the health and safety of consumers the Commission may adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 42(4).
4. The export from the Union of a product that has been prohibited to be placed or made available on the Union market pursuant to a measure adopted in accordance with paragraph 1 or 3 shall be prohibited, unless the measure expressly so permits.
5. Any Member State may submit a substantiated request to the Commission to examine the need for the adoption of a measure referred to in paragraph 1 or 3.
Article 27 - Arbitration mechanism
2. Where market surveillance authorities in other Member States reach a different conclusion in terms of identification or level of the risk on the basis of their own investigation and risk assessment, the Member States concerned may request the Commission to arbitrate. In that case, the Commission shall invite all Member States to express a recommendation.
3. Taking into account the recommendations referred to in paragraph 2, the Commission shall adopt an opinion on the identification or on the level of the risk of the relevant product as appropriate
4. The opinion shall be taken into due account by the Member States.
5. The Commission shall draw up guidelines for the practical implementation of this Article.
Article 28 - Consumer Safety Network
2. The Commission shall promote and take part in the operation of the Consumer Safety Network, in particular in the form of administrative cooperation.
3. The objective of that Consumer Safety Network shall be, in particular, to facilitate:
(a)the exchange of information on risk assessments, dangerous products, test methods and results, recent scientific developments as well as other aspects relevant for control activities;
(b)the establishment and execution of joint surveillance and testing projects;
(c)the exchange of expertise and best practices and cooperation in training activities;
(d)improved cooperation at EU level with regard to the tracing, withdrawal and recall of dangerous products;
(e)enhanced cooperation on product safety enforcement between Member States, in particular to facilitate the activities referred to in Article 30.
4. The Consumer Safety Network shall coordinate its action with the other existing Union activities.
5. The Consumer Safety Network shall be duly represented and participate in the activities of in the Union Product Compliance Network established under Article 29 of Regulation (EU) 2019/1020 and shall contribute to its activities in relation to product safety to ensure adequate coordination of market surveillance activities in both harmonised and non-harmonised areas.
Article 29 - Joint activities on product safety
2. The market surveillance authorities and the Commission, where applicable, shall ensure that the agreement to carry out activities does not lead to unfair competition between economic operators and does not affect the objectivity, independence and impartiality of the parties to the agreement.
3. A market surveillance authority may use any information resulting from the activities carried out as part of any investigation regarding the safety of products that it undertakes.
4. The market surveillance authority concerned and the Commission where applicable shall make the agreement on joint activities, including the names of the parties involved, available to the public.
Article 30 - Sweeps
2. Unless otherwise agreed upon by the market surveillance authorities concerned, sweeps shall be coordinated by the Commission. The coordinator of the sweep may, where appropriate, make the aggregated results publicly available.
3. When conducting sweeps, the market surveillance authorities involved may use the investigation powers set out in Chapter V and any other powers conferred upon them by national law.
4. Market surveillance authorities may invite Commission officials, and other accompanying persons authorised by the Commission, to participate in sweeps.
CHAPTER VIII
Right to information and remedy
Article 31 - Information between public authorities and consumers
2. Member States and the Commission shall take the necessary steps to ensure that their officials and agents are required not to disclose information obtained for the purposes of this Regulation which, by its nature, is covered by professional secrecy in duly justified cases, except for information relating to the safety properties of products which must be made public in order to protect consumers.
3. Protection of professional secrecy shall not prevent the dissemination to the competent authorities of Member States of information relevant for ensuring the effectiveness of market monitoring and surveillance activities. The authorities receiving information covered by professional secrecy shall ensure its protection.
4. Member States shall give consumers and other interested parties the opportunity to submit complaints to the competent authorities on product safety and on surveillance and control activities and these complaints shall be followed up as appropriate.
Article 32 - Safety Gate portal
2. Consumers shall have the possibility to inform the Commission of products presenting a risk to consumer health and safety through a separate section of the Safety Gate portal. The Commission shall take in due consideration the information received and ensure follow up, where appropriate.
3. The Commission, by means of an implementing act, shall adopt the modalities for the sending of information by consumers in accordance with paragraph 2, as well as for the transmission of such information to the concerned national authorities for possible follow up. This implementing act shall be adopted in accordance with the examination procedure referred to in Article 42(3).
Article 33 - Information from economic operators to consumers
2. Where economic operators have product registration systems or customer loyalty programs in place for purposes other than contacting their customers with safety information, they shall offer the possibility to their customers to provide separate contact details only for safety purposes. The personal data collected for that purpose shall be limited to the necessary minimum and may only be used to contact consumers in case of a recall or safety warning.
3. The Commission, by means of implementing acts, shall set out requirements for registration of products or specific categories of products. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 42(3).
4. If not all affected consumers can be contacted directly, economic operators, in accordance with their respective responsibilities, shall disseminate a recall notice or safety warning through other appropriate channels, ensuring the widest possible reach including, where available: the company’s website, social media channels, newsletters and retail outlets and, as appropriate, announcements in mass media and other communication channels. Information shall be accessible to consumers with disabilities.
Article 34 - Recall notice
2. A recall notice shall be available in the language(s) of the Member State(s) where the product has been put on the market and include the following elements:
(a)headline ‘Product safety recall’;
(b)clear description of the recalled product, including:
(i)photograph, name and brand of the product;
(ii)product identification numbers, such as batch or serial number, and, if applicable, graphical indication of where to find them on the product;
(iii)information on when and where the product was sold, if available.
(c)clear description of the hazard associated with the recalled product, avoiding any elements that may decrease consumers’ perception of risk, including terms and expressions such as “voluntary”, “precautionary”, “discretionary”, “in rare/specific situations” as well as indicating that there have been no reported accidents;
(d)clear description of the action consumers should take, including an instruction to immediately stop using the recalled product;
(e)clear description of the remedy available to consumers if appropriate;
(f)free phone number or interactive online service, where consumers can get more information in relevant official language(s) of the Union;
(g)an encouragement to further share information about the recall, if appropriate.
3. The Commission, by means of implementing acts, shall set out the template for a recall notice, taking into account scientific and market developments. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 42(2).
Article 35 - Right to remedy
(a)repair of the recalled product;
(b)replacement of the recalled product with a safe one of the same type and at least the same value and quality;
(c)refund of the value of the recalled product.
2. Repair, disposal or destruction of the product by consumers shall only be considered an effective remedy where it can be carried out easily and safely by the consumer. In such cases, the economic operator responsible for the recall shall provide consumers with the necessary instructions and/or, in the case of self-repair, free replacement parts or software updates.
3. The remedy shall not entail significant inconvenience for the consumer. The consumer shall not bear the costs of shipping or otherwise returning the product. For products that by their nature are not portable, the economic operator shall arrange for the collection of the product.
CHAPTER IX
International cooperation
Article 36
International cooperation
1. The Commission may cooperate, including through the exchange of information, with third countries or international organisations in the field of application of this Regulation, such as:
(a)enforcement activities and measures related to safety, including market surveillance;
(b)risk assessment methods and product testing;
(c)coordinated product recalls and other similar actions;
(d)scientific, technical, and regulatory matters, aiming to improve product safety;
(e)emerging issues of significant health and safety relevance;
(f)standardisation-related activities;
(g)exchange of officials.
2. The Commission may provide third countries or international organisations with selected information from its Safety Gate system and receive relevant information on the safety of consumer products and on preventive, restrictive and corrective measures taken by those third countries or international organisations. The Commission shall share such information with national authorities, where relevant.
3. The information exchange referred to in paragraph 2 may take the form of either:
(a)a non-systematic exchange, in duly justified and specific cases;
(b)a systematic exchange, based on an administrative arrangement specifying the type of information to be exchanged and the modalities for the exchange.
4. Full participation in the Safety Gate system may be open to applicant countries and third countries, provided that their legislation is aligned with the relevant Union legislation and that they participate in the European Standardisation System. Such participation shall entail the same obligations as for Member States according to this Regulation, including notification and follow-up obligations. Full participation in the Safety Gate shall be based on agreements between the Union and those countries, according to arrangements defined in these agreements.
5. Any information exchange under this Article, to the extent it involves personal data, shall be carried out in accordance with Union data protection rules. Personal data shall only be transferred to the extent that such exchange is necessary for the sole purpose of the protection of consumers’ health or safety.
6. The information exchanged pursuant to this Article shall be used for the sole purpose of the protection of consumers’ health or safety and respect confidentiality rules.
CHAPTER X
Financial provisions
Article 37 - Financing activities
(a)performance of the tasks of the Consumer Safety Network referred to in Article 28;
(b)the development and operation of the Safety Gate referred to in Article 23, including the development of electronic interoperability solutions for:
–the exchange of data between the Safety Gate and the national market surveillance systems;
–the exchange of data between the Safety Gate and national customs systems;
–the exchange of data with other relevant restricted systems used by market surveillance authorities for their enforcement purposes.
(c)the development and maintenance of the Safety Gate portal referred to in Article 32 and the Safety Business Gateway, referred to in Article 25, including a public non-restricted software interface for data exchange with platforms and third parties.
2. The Union may finance the following activities in relation to the application of this Regulation:
(a)the development of instruments of international cooperation referred to in Article 36;
(b)the drawing up and updating of contributions to guidelines on market surveillance and product safety;
(c)the making available to the Commission of technical or scientific expertise for the purpose of assisting the Commission in its implementation of market surveillance administrative cooperation;
(d)the performance of preliminary or ancillary work in connection with the implementation of market surveillance activities linked to the application of this Regulation such as studies, programmes, evaluations, guidelines, comparative analyses, mutual joint visits and visit programmes, exchange of personnel, research work, the development and maintenance of databases, training activities, laboratory work, proficiency testing, inter-laboratory tests and conformity assessment work;
(e)Union market surveillance campaigns and associated activities, including resources and equipment, IT tools and training;
(f)activities carried out under programmes of technical assistance, cooperation with third countries and the promotion and enhancement of Union market surveillance policies and systems among interested parties at Union and international levels.
3. The Union's financial assistance to the activities under this Regulation shall be implemented in accordance with Regulation (EU, Euratom) No 2018/1046 of the European Parliament and of the Council 42 , either directly, or indirectly by delegating budget implementation tasks to the entities listed in Article 62(1), point (c) of that Regulation.
4. The appropriations allocated to activities referred to in this Regulation shall be determined each year by the budgetary authority within the limits of the financial framework in force.
5. The appropriations determined by the budgetary authority for the financing of market surveillance activities may also cover expenses pertaining to preparatory, monitoring, control, audit and evaluation activities which are required for the management of the activities pursuant to this Regulation and the achievement of their objectives; in particular, studies, meetings of experts, information and communication actions, including corporate communication of the political priorities of the Union as far as they are related to the general objectives of market surveillance activities, expenses linked to information technology networks focusing on information processing and exchange, together with all other technical and administrative assistance expenses incurred by the Commission for the management of the activities pursuant to this Regulation.
Article 38 - Protection of the Union's financial interests
2. The Commission or its representatives and the Court of Auditors shall have the power of audit, on the basis of documents and of on-the-spot inspections, over all grant beneficiaries, contractors and subcontractors who have received Union funds under the Single Market Programme and its successor 43 .
3. The European Anti-Fraud Office (OLAF) may carry out investigations, including on-the-spot checks and inspections, in accordance with the provisions and procedures laid down in Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council 44 and Council Regulation (Euratom, EC) No 2185/96 45 , with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union in connection with a grant agreement or grant decision or a contract funded under the programme.
4. Without prejudice to paragraphs 1, 2 and 3, cooperation agreements with third countries and with international organisations, contracts, grant agreements and grant decisions resulting from the implementation of this Regulation shall contain provisions expressly empowering the Commission, the Court of Auditors and OLAF to conduct such audits and investigations, in accordance with their respective competences.
CHAPTER XI
Final provisions
Article 39 - Liability
2. This Regulation shall not affect Council Directive 85/374/EEC 46 .
Article 40 - Penalties
2. Member States shall take into account at least the following indicative criteria for the imposition of penalties, where appropriate:
(a)the duration or temporal effects of the infringement, the nature and the gravity, in particular the level of risk incurred by the consumer;
(b)the number of dangerous products made available on the market or the number of consumers affected or both;
(c)the role and responsibility of the economic operator or online marketplace;
(d)any action taken by the economic operator or online marketplace to timely mitigate or remedy the damage suffered by consumers;
(e)where appropriate, the intentional or negligent character of the infringement;
(f)any previous infringements by the economic operator or online marketplace;
(g)the financial benefits gained or losses avoided directly or indirectly by the economic operator or online marketplace due to the infringement, if the relevant data are available;
(h)the size of the undertaking;
(i)the degree of cooperation with the authority;
(j)the manner in which the infringement became known to the authority, in particular whether, and if so to what extent, the economic operator or online marketplace timely notified the infringement;
(k)any other aggravating or mitigating factor applicable to the circumstances of the case.
3. The types of infringements by economic operators or online marketplaces, where applicable, subject to penalties shall be any of the following:
(a)infringement of the general product safety requirement;
(b)failure to inform the authority in a timely manner about a dangerous product they placed on the market;
(c)failure to comply with any decision, order, interim measure, economic operator’s commitment or other measure adopted pursuant to this Regulation;
(d)failure to comply with traceability and information obligations of economic operators referred to in Articles 8, 9, 10, 11 and 18 and 19;
(e)providing incorrect, incomplete or misleading information in response to a request from market surveillance authorities;
(f)failure to provide requested information within the required time-limit;
(g)refusal to submit to inspections;
(h)failure to provide the required documents or products during inspections;
(i)falsifying test results.
4. In the case of fines, the maximum amount of penalties shall be at least 4 % of the economic operator’s or, where applicable, online marketplace’s annual turnover in the Member State or Member States concerned.
5. Member States may also impose periodic penalty payments to compel economic operators or online marketplaces, where applicable:
(a)to put an end to a violation of the provisions of this Regulation;
(b)to comply with a decision ordering corrective measure;
(c)to supply complete and correct information;
(d)to submit to an inspection;
(e)to allow market surveillance authorities to perform data scraping of online interfaces.
6. By 31 March of each year, Member States shall inform the Commission of the type and the size of the penalties imposed under this Regulation, identify the actual infringements of this Regulation, and indicate the identity of economic operators or online marketplaces upon which penalties have been imposed.
7. Each year, the Commission shall elaborate and make public a report on the penalties imposed by Member States.
8. The information referred to in paragraph 6 shall not be published in the report referred to in paragraph 7 in any of the following circumstances:
(a)where it is necessary to preserve the confidentiality of an investigation or of national judicial proceedings;
(b)where publication would cause disproportionate damage to the economic operator or online marketplace;
(c)where a natural person is concerned, unless the publication of personal data is justified by exceptional circumstances, inter alia, by the seriousness of the infringement.
Article 41 - Exercise of the delegation
2. The power to adopt delegated acts referred to in Article 17(3) shall be conferred on the Commission for an indeterminate period of time from [insert date - the date of entry into force of this Regulation].
3. The delegation of power referred to in Article 17(3) may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect the day following its publication in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016 47 .
5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
6. A delegated act adopted pursuant to Article 17(3) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period may be extended by two months at the initiative of the European Parliament or of the Council.
Article 42 - Committee procedure
2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.
Article 43 - Evaluation
2. On request, Member States shall provide the Commission with information necessary for the evaluation of this Regulation.
Article 44 - Amendments to Regulation (EU) No 1025/2012
In Article 10, the following paragraph 7 is added:
‘7. Where a European standard drafted in support of Regulation (EU) …/… of the European Parliament and of the Council 48 [this Regulation (GPSR)] satisfies the general safety requirement laid down in Article 5 of that Regulation and the specific safety requirements referred to in [Article of that Regulation], the Commission shall publish a reference of such European standard without delay in the Official Journal of the European Union.’
In Article 11, paragraphs 1, 2 and 3 are replaced by the following:
‘1. When a Member State or the European Parliament considers that a harmonised standard or European standard drafted in support of Regulation (EU) …/… [this Regulation (GPSR)] does not entirely satisfy the requirements which it aims to cover and which are set out in the relevant Union harmonisation legislation or in that Regulation, it shall inform the Commission thereof with a detailed explanation. The Commission shall, after consulting the committee set up by the corresponding Union harmonisation legislation, if it exists, or the committee set up by Regulation (EU) …/… [this Regulation (GPSR)], or after other forms of consultation of sectoral experts, decide:
(a)to publish, not to publish or to publish with restriction the references to the harmonised standard or European standard drafted in support of Regulation (EU) …/… [GPSR] concerned in the Official Journal of the European Union;
(b)to maintain, to maintain with restriction or to withdraw the references to the harmonised standard or European standard drafted in support of Regulation (EU) …/… [GPSR] concerned in or from the Official Journal of the European Union.’
2. The Commission shall publish information on its website on the harmonised standards and European standards drafted in support of Regulation (EU) …/… [GPSR] that have been subject to the decision referred to in paragraph 1.
3. The Commission shall inform the European standardisation organisation concerned of the decision referred to in paragraph 1 and, if necessary, request the revision of the harmonised standards or of the European standards drafted in support of Regulation (EU) …/… [GPSR] concerned.’
Article 45 - Repeal
2. References to Directives 87/357/EEC and 2001/95/EC shall be construed as references to this Regulation and to Regulation (EU) No 1025/2012, and shall be read in accordance with the correlation table in the Annex.
Article 46 - Transitional provisions
Article 47 - Entry into force and application
It shall apply from [6 months after the entry into force of this Regulation].
This Regulation shall be binding in its entirety and directly applicable in all Member States.