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11 of Directive 2001/95/EC (the General Product Safety Directive) (notified under document C(2009) 9843) (2010/15/EU) (repealed)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. RAPEX notification criteria

RAPEX, which is established under Article 12 of the GPSD, applies to measures which prevent, restrict or impose specific conditions on the marketing and use of consumer products posing a serious risk to the health and safety of consumers.

Under the GPSD, the participation of Member States in RAPEX is mandatory, and thus Member States have a legal obligation to notify the Commission when the following four notification criteria are met:

• the product is a consumer product,

• the product is subject to measures that prevent, restrict or impose specific conditions on its possible marketing or use (‘preventive and restrictive measures’),

• the product poses a serious risk to the health and safety of consumers,

• the serious risk has a cross-border effect.

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).

2.2. Measures

2.2.1. Categories of measures

All categories of preventive and restrictive measures taken in relation to the marketing and use of consumer products posing a serious risk to the health and safety of consumers are subject to the notification obligation under RAPEX. Article 8(1)(b) to (f) of the GPSD provides a list of the different categories of measures that are notifiable under RAPEX, including measures:

• marking a product with appropriate warnings on the risks it may present;

• making the marketing of a product subject to prior conditions;

• warning consumers of the risks that could be posed by a product for certain persons;

• temporary ban on the supply, offer to supply and display of a product;

• ban on the marketing of a product and any accompanying measures;

• withdrawal of a product from the market;

• recall of a product from consumers;

• destruction of a withdrawn or recalled product.

For the purpose of RAPEX, the term ‘withdrawal’ is used exclusively for measures aimed at preventing the distribution, display and offer of a dangerous product to consumers, while the term ‘recall’ is used only for measures aimed at achieving the return of a dangerous product that has already been made available to consumers by a producer or distributor.

2.2.2. Type of measures

Preventive and restrictive measures can be taken in relation to dangerous products either on the initiative of a producer or a distributor who placed and/or distributed it on the market (‘voluntary measures’) or as ordered by an authority of a Member State competent to monitor the compliance of products with the safety requirements (‘obligatory measures’).

For the purpose of RAPEX, the obligatory measures and voluntary measures are defined as follows:

• Obligatory measures:

  Measures adopted or decided to be adopted by Member State authorities, often in the form of an administrative decision, which oblige a producer or a distributor to take preventive or restrictive action in relation to a specific product that they made available on the market.

• Voluntary measures:

  • Preventive and restrictive measures adopted on a voluntary basis by a producer or a distributor, i.e. without any intervention of an authority of a Member State. Products posing a serious risk and the related preventive or restrictive measures initiated by a producer or a distributor should be immediately notified to the competent authorities of Member States under the notification mechanism provided for in Article 5(3) of the GPSD.

  • Recommendations and agreements with producers and distributors concluded by Member State authorities. This includes agreements which are not in written form and result in preventive or restrictive action taken by producers or distributors in relation to products posing a serious risk that they made available on the market.

Under Article 12(1) of the GPSD, both obligatory and voluntary measures are to be notified through RAPEX.

2.2.3. Obligatory measures initiated by authorities in charge of external border controls

Measures adopted by the authorities in charge of external border controls that prevent the marketing in the EU of a consumer product posing a serious risk to the health and safety of consumers (e.g. decisions to stop the import at the EU border) should be notified to the Commission through RAPEX in the same manner as measures adopted by market surveillance authorities that restrict the marketing or use of a product.

2.2.4. Exclusion of generally applicable obligatory measures

Generally applicable acts adopted at national level and aimed at preventing or restricting the marketing and use of (a) generally described category(ies) of consumer products due to the serious risk they pose to the health and safety of consumers should not be notified to the Commission through the RAPEX system. All such national measures that apply to only generally defined categories of products, such as all products in general or all products serving the same purpose – and not to (categories of) products specifically identified by their brand, specific look, producer, trader, model name or number, etc. – are notified to the Commission under Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services(7).

2.2.5. Timing of the notification

Article 12(1) of the GPSD requires Member States immediately to notify the Commission through RAPEX of preventive and restrictive measures. This provision applies to both obligatory and voluntary measures, although the timing of the notification is different.

• Obligatory measures

  These measures are notified through RAPEX immediately after being adopted or the decision to adopt them, even if an appeal against them at national level is likely, they are already under appeal or subject to publication requirements.

  This approach is consistent with the objective of RAPEX, i.e. to ensure the rapid exchange of information between Member States and the Commission in order to prevent the supply and use of products that pose a serious health or safety risk to consumers.

• Voluntary measures

  Under Article 5(3) of the GPSD, producers and distributors are obliged to notify the competent Member State authorities of voluntary action and measures taken to prevent risks to consumers posed by products they have made available on the market (‘business notification’). The authority of a Member State receiving this kind of business notification uses this information as the basis for a RAPEX notification (when all the RAPEX notification criteria provided for in Article 12(1) are met) and sends it immediately after receipt of the business notification.

  Where voluntary measures are adopted in the form of an agreement between a producer or a distributor and an authority of a Member State or on the basis of a recommendation from an authority to a producer or distributor, a RAPEX notification is submitted immediately after the conclusion of such an agreement or the adoption of such a recommendation.

To ensure common application of the RAPEX notification obligation, Appendix 3 to the Guidelines lays down specific deadlines for submitting notifications to the Commission via RAPEX(8).

2.2.6. Notifying authorities

Both obligatory and voluntary measures are notified through RAPEX by the national RAPEX Contact Point, which is responsible for all information transmitted through the system by its country(9).

2.2.7. RAPEX notification concerning business notifications

Article 5(3) of the GPSD requires producers and distributors to notify information concerning a dangerous product (at the same time) to the competent authorities in all Member States where the dangerous product was made available. The conditions and details for this notification are laid down in Annex I to the GPSD.

In these situations, the RAPEX notification obligation applies to all Member States that received a business notification. However, in order to simplify the practical application of Article 12(1) of the GPSD and to avoid unnecessary duplication of RAPEX notifications, it has been agreed with Member States that a RAPEX notification should be submitted only by the Member State where the notifying producer/distributor is established (‘Main Member State’). Once a RAPEX notification has been validated and distributed through the system by the Commission, other Member States (especially the ones that also received the same business notification) should submit reactions to this RAPEX notification.

Where a main Member State does not submit a RAPEX notification by the deadlines specified in Appendix 3 to the Guidelines and does not inform the Commission and other Member States of the reasons for the delay, any other Member State that received the same business notification can submit a notification through RAPEX.

2.3. Serious risk

2.3.1. Serious risk

Before an authority of a Member State decides to submit a RAPEX notification, it always performs the appropriate risk assessment in order to assess whether a product to be notified poses a serious risk to the health and safety of consumers and thus whether one of the RAPEX notification criteria is met.

As RAPEX is not intended for the exchange of information on products posing non-serious risks, notifications on measures taken with regard to such products cannot be sent through RAPEX under Article 12 of the GPSD.

2.3.2. Risk assessment method

Appendix 5 to the Guidelines sets out the risk assessment method to be used by Member State authorities to assess the level of risks posed by consumer products to the health and safety of consumers and to decide whether a RAPEX notification is necessary.

2.3.3. Assessing authority

The risk assessment is always performed by an authority of a Member State that either carried out the investigation and took appropriate measures or monitored voluntary action taken with regard to a dangerous product by a producer or a distributor.

Before a RAPEX notification is sent to the Commission, the risk assessment performed by an authority of a Member State (to be included in the notification) is always verified by the RAPEX Contact Point. Any unclear issues are resolved by the Contact Point with the authority responsible before a notification is transmitted through RAPEX.

2.3.4. Risk assessment in business notifications

Notifications on dangerous consumer products submitted by producers and distributors under Article 5(3) of the GPSD to the competent authorities of Member States should include a detailed description of the risk. National authorities receiving such notifications examine their content and analyse the risk assessments provided. If, on the basis of the information provided and an independent risk assessment, an authority of a Member State decides that the notified product poses a serious risk to the health and safety of consumers, a RAPEX notification concerning this product is immediately transmitted to the Commission (the fourth subparagraph of Article 12(1)of the GPSD).

Risk assessments carried out by producers and distributors are not binding on Member State authorities. It is therefore possible for an authority of a Member State to come to a different conclusion regarding the risk assessment from a conclusion drawn in a business notification.

2.4. Cross-border effects

2.4.1. International event

Under Article 12 of the GPSD, a Member State submits a RAPEX notification only if it considers that the effects of the risks posed by a dangerous product go or can go beyond its territory (‘cross-border effects’ or ‘international event’).

In the light of the free movement of products in the internal market, and the fact that products are imported into the EU through different distribution channels and that consumers buy products during stays abroad and via the internet, national authorities are encouraged to interpret the cross-border effects criterion in a fairly broad sense. A RAPEX notification, therefore, is submitted where:

• it cannot be excluded that a dangerous product has been sold to consumers in more than one EU Member State, or

• it cannot be excluded that a dangerous product has been sold to consumers via the internet, or

• the product originates from a third country and is likely to have been imported into the EU through multiple distribution channels.

2.4.2. Local event

Measures adopted in relation to a product posing a serious risk that can only have local effects (‘Local event’) are not notified through RAPEX. This applies to situations where an authority of a Member State has reason to believe that a product has not been and will not be made available (by any means) to consumers in other Member States, e.g. measures taken with regard to a local product manufactured and distributed only in one Member State.

A notification involving a local event should still be submitted to the Commission but under Article 11 of the GPSD and only where it involves information on product safety likely to be of interest to other Member States, especially information on measures adopted in response to a new type of risk which has not yet been notified, a new type of risk arising from a combination of products or a new type or category of dangerous products (the second subparagraph of Article 12(1) of the GPSD).

(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.

(7)

OJ L 204, 21.7.1998, p. 37.

(8)

For more information about deadlines, see Chapter 3.10 of the Guidelines.

(9)

For more information about the RAPEX Contact Points and their obligations, see Chapter 5.1 of the Guidelines.