Chapter I – General provisions (Art. 1-4)

1. This Regulation applies to products that are placed or made available on the market insofar as there are no specific provisions with the same objective under Union law which regulate the safety of the products concerned.
   Where products are subject to specific safety requirements imposed by Union law, this Regulation applies only to those aspects and risks or categories of risks which are not covered by those requirements.
   With regard to products subject to specific requirements imposed by Union harmonisation legislation as defined in Article 3, point (27):
   1. Chapter II does not apply insofar as the risks or categories of risks covered by Union harmonisation legislation are concerned;
   2. Chapter III, Section 1, Chapters V and VII and Chapters IX to XI do not apply.
2. This Regulation does not apply to:
   1. medicinal products for human or veterinary use;
   2. food;
   3. feed;
   4. 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;
   5. animal by-products and derived products;
   6. plant protection products;
   7. equipment on which consumers ride or travel where that equipment is directly operated by a service provider within the context of a transport service provided to consumers and is not operated by the consumers themselves;
   8. aircraft referred to in Article 2(3), point (d) of Regulation (EU) 2018/1139;
   9. antiques.
3. This Regulation applies to products placed or made available on the market whether new, used, repaired or reconditioned. It does not apply to products to be repaired or reconditioned prior to being used where those products are placed or made available on the market and are clearly marked as such.
4. This Regulation is without prejudice to the rules laid down by Union law on consumer protection.
5. This Regulation shall be implemented taking due account of the precautionary principle.

For the purposes of this Regulation the following definitions apply:

1. ‘product’ means any item, whether or not it is interconnected to other items, supplied or made available, whether for consideration or not, including in the context of providing a service, which is intended for consumers or is likely, under reasonably foreseeable conditions, to 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, 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 the health and safety of consumers;
3. ‘dangerous product’ means any product which is not a ‘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 which, based on a risk assessment and taking into account the normal and foreseeable use of the product, 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 that person’s 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 that manufacturer’s behalf in relation to specified tasks with regard to the manufacturer’s obligations under this Regulation;
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⁽²⁷⁾, parcel delivery services as defined in Article 2, point (2) of Regulation (EU) 2018/644 of the European Parliament and of the Council⁽²⁸⁾, and any other postal services or freight transport services;
13. ‘economic operator’ means the manufacturer, the authorised 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 or making them available on the market in accordance with this Regulation;
14. ‘provider of an online marketplace’ means a provider of an intermediary service using an online interface which allows consumers to conclude distance contracts with traders for the sale of products;
15. ‘online interface’ means any software, including a website, part of a website or an application, including mobile applications;
16. ‘distance contract’ means a distance contract as defined in Article 2, point (7), of Directive 2011/83/EU;
17. ‘consumer’ means any natural person who acts for purposes which are outside that person’s trade, business, craft or profession;
18. ‘trader’ means any natural person or any legal person irrespective of whether privately or publicly owned, who is acting, including through any person acting in that natural or legal person’s name or on that natural or legal person’s behalf, for purposes relating to the natural or legal person’s trade, business, craft or profession;
19. ‘European standard’ means a European standard as defined in Article 2, point (1), point (b) of Regulation (EU) No 1025/2012;
20. ‘international standard’ means an international standard as defined in Article 2, point (1), point (a) of Regulation (EU) No 1025/2012;
21. ‘national standard’ means a national standard as defined in Article 2, point (1), point (d) of Regulation (EU) No 1025/2012;
22. ‘European standardisation organisation’ means a European standardisation organisation as listed in Annex I to Regulation (EU) No 1025/2012;
23. ‘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;
24. ‘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;
25. ‘recall’ means any measure aimed at achieving the return of a product that has already been made available to the consumer;
26. ‘withdrawal’ means any measure aimed at preventing a product in the supply chain from being made available on the market;
27. ‘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;
28. ‘antiques’ means products, such as collectors’ items or works of art, in relation to which consumers cannot reasonably expect that they fulfil state-of-the-art safety standards.

^{(27) Directive 97/67/EC of the European Parliament and of the Council of 15 December 1997 on common rules for the development of the internal market of Community postal services and the improvement of quality of service (OJ L 15, 21.1.1998, p. 14).
(28) Regulation (EU) 2018/644 of the European Parliament and of the Council of 18 April 2018 on cross-border parcel delivery services (OJ L 112, 2.5.2018, p. 19).}

Products offered for sale online or through other means of distance sales shall be deemed to be made available on the market if the offer is targeted at consumers in the Union. An offer for sale shall be considered to be targeted at consumers in the Union if the relevant economic operator directs, by any means, its activities to one or more Member States.