第3条 定義

For the purposes of this Regulation, the following definitions shall apply:

(1)‘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;

(2)‘placing on the market’ means the first making available of a product on the Union market;

(3)‘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 the applicable Union harmonisation legislation and to ensure protection of the public interest covered by that legislation;

(4)‘market surveillance authority’ means an authority designated by a Member State under Article 10 as responsible for carrying out market surveillance in the territory of that Member State;

(5)‘applicant authority’ means the market surveillance authority that makes a request for mutual assistance;

(6)‘requested authority’ means the market surveillance authority that receives a request for mutual assistance;

(7)‘non-compliance’ means any failure to comply with any requirement under the Union harmonisation legislation or under this Regulation;

(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)‘importer’ means any natural or legal person established within the Union who places a product from a third country on the Union market;

(10)‘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;

(11)‘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 point 1 of Article 2 of Directive 97/67/EC of the European Parliament and of the Council, parcel delivery services as defined in point 2 of Article 2 of Regulation (EU) 2018/644 of the European Parliament and of the Council, and any other postal services or freight transport services;

(12)‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks with regard to the manufacturer's obligations under the relevant Union harmonisation legislation or under the requirements of this Regulation;

(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, making them available on the market or putting them into service in accordance with the relevant Union harmonisation legislation;

(14)‘information society service provider’ means a provider of a service as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535 of the European Parliament and of the Council;

(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)‘corrective action’ means any action taken by an economic operator to bring any non-compliance to an end where required by a market surveillance authority or on the economic operator's own initiative;

(17)‘voluntary measure’ means a corrective action where not required by a market surveillance authority;

(18)‘risk’ means the combination of the probability of an occurrence of a hazard causing harm and the degree of severity of that harm;

(19)‘product presenting a risk’ means a product having the potential to affect adversely health and safety of persons in general, health and safety in the workplace, protection of consumers, the environment, public security and other public interests, protected by the applicable Union harmonisation legislation, to a degree which goes beyond that considered reasonable and acceptable in relation to its intended purpose or under the normal or reasonably foreseeable conditions of use of the product concerned, including the duration of use and, where applicable, its putting into service, installation and maintenance requirements;

(20)‘product presenting a serious risk’ means a product presenting 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;

(21)‘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;

(22)‘recall’ means any measure aimed at achieving the return of a product that has already been made available to the end user;

(23)‘withdrawal’ means any measure aimed at preventing a product in the supply chain from being made available on the market;

(24)‘customs authorities’ means customs authorities as defined in point 1 of Article 5 of Regulation (EU) No 952/2013;

(25)‘release for free circulation’ means the procedure laid down in Article 201 of Regulation (EU) No 952/2013;

(26)‘products entering the Union market’ means products from third countries intended to be placed on the Union market or intended for private use or consumption within the customs territory of the Union and placed under the customs procedure ‘release for free circulation’.