Commission Decision of 16 December 2009 laying down guidelines for the management of the Community Rapid Information System ‘RAPEX’ established under Article 12 and of the notification procedure established under Article 11 of Directive 2001/95/EC (the General Product Safety Directive) (notified under document C(2009) 9843) (2010/15/EU) (repealed)

2.1. Consumer products

2.1.1. Products covered by RAPEX

Under Article 2(a) of the GPSD, consumer products for the purpose of RAPEX are:

• ‘products intended for consumers’ – products that are designed and manufactured for and made available to consumers;

• ‘migrating products’ – products that are designed and manufactured for professionals, which are likely, however, under reasonably foreseeable conditions, to be used by consumers. These are products manufactured for professionals that are made available to consumers, who can purchase and operate them without any special knowledge or training, e.g. a power drill, an angle grinder and a table saw designed and manufactured for professionals, but also supplied on the consumer market (i.e. consumers can readily purchase them in shops and operate them on their own without any special training).

Both products intended for consumers and migrating products can be given to consumers free of charge, can be purchased by consumers and can be provided to consumers in the context of a service. All three situations are covered by RAPEX.

Products provided to consumers in the context of a service include:

• products supplied to consumers that are taken away and used outside the premises of a service provider, such as cars and lawn-mowing machines rented or leased in rental salons, and tattoo inks and implants (that are not classified as medical devices) implanted beneath the skin of a consumer by a service provider;

• products used on the premises of a service provider, provided that consumers themselves actively operate a product (e.g. start the machine, have the option of stopping it, affect its operation by changing its position or intensity during use). Sun-beds used in tanning salons and fitness centres are examples of such products. Use of the products by consumers must be active, and involve an significant degree of control. Merely passive use, such as the use of shampoo by a person whose hair is washed by a hairdresser, or the use of a bus by its passengers, does not qualify as use by consumers.

By contrast, equipment used or operated by a service provider to supply a service is beyond the scope of RAPEX and therefore such products cannot be notified through the system, e.g. equipment on which consumers ride or travel and is operated by a service provider.

2.1.2. Products which are not covered by RAPEX

RAPEX does not cover:

1.

Products that are not covered by the definition of a ‘product’ laid down in Article 2(a) of the GPSD:

• products that were designed and manufactured for and made available only to professionals and are not likely, under reasonably foreseeable conditions, to be used by consumers (‘professional products’);

• second-hand products supplied as antiques or as products to be repaired or reconditioned prior to being used, provided that a supplier clearly informs the person to whom he supplies the product to that effect.

2.

Products that are covered by specific and equivalent notification mechanisms established by other EU legislation:

• food and feed covered by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(1);

• medicinal products covered by Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(2), and Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products(3);

• medical devices covered by Council Directive 93/42/EEC of 14 June 1993 concerning medical devices(4);

• in vitro diagnostic medical devices covered by Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices(5);

• active implantable medical devices covered by Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices(6).

(1)

OJ L 31, 1.2.2002, p. 1.

(2)

OJ L 311, 28.11.2001, p. 67.

(3)

OJ L 311, 28.11.2001, p. 1.

(4)

OJ L 169, 12.7.1993, p. 1.

(5)

OJ L 331, 7.12.1998, p. 1.

(6)

OJ L 189, 20.7.1990, p. 17.