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11 of Directive 2001/95/EC (the General Product Safety Directive) (notified under document C(2009) 9843) (2010/15/EU) (repealed)

PART III NOTIFICATION PROCEDURE ESTABLISHED UNDER ARTICLE 11 OF THE GENERAL PRODUCT SAFETY DIRECTIVE

1. Background and objectives

Article 11 of the General Product Safety Directive establishes a notification procedure for the exchange of information between Member States and the Commission on measures taken in relation to consumer products posing a non-serious risk to the health and safety of consumers.

The Article 11 notification mechanism (despite similarities and links) should be treated as an independent procedure that is separate from the notification procedure established under Article 12 of the GPSD (‘RAPEX’).

The Article 11 notification procedure has two main objectives:

• To help the internal market to operate

  The first objective of the Article 11 notification procedure is to ensure that the Commission is informed about measures adopted by national authorities that restrict the marketing on the EU market of products posing a non-serious risk to the health and safety of consumers.

  This objective is similar to the objective of the safeguard clause procedure established under sectoral directives, which aims to ensure that the Commission is kept informed of preventive and restrictive measures adopted by national authorities and can assess whether the restriction to the free movement of the notified product complies with EU legislation and does not unduly infringe the free movement of goods. The Article 11 notification procedure complements the safeguard clause procedure and ensures that the Commission is kept informed of preventive and restrictive measures adopted by national authorities that are not subject to the latter procedure.

• To prevent the marketing and use by consumers of dangerous products (not posing a serious risk)

  The second objective of the Article 11 notification procedure is to ensure that Member States can rapidly exchange information about products posing a non-serious risk to the health and safety of consumers and to prevent or restrict them from being marketed and used in the EU. This is similar to the objective of RAPEX, although RAPEX only covers products posing a serious risk to the health and safety of consumers.

2. Notification criteria

The Article 11 notification procedure applies only to measures adopted by national authorities to restrict the placing on the market, to withdraw from the market or to recall from consumers products posing a non-serious risk to the health and safety of consumers. This excludes notifications of voluntary measures under this procedure.

Where the following five notification criteria are met, Member States have a legal obligation to notify the Commission under Article 11 of the GPSD:

• the product concerned is a consumer product,

• it is subject to restrictive measures adopted by national authorities (obligatory measures),

• it poses a non-serious risk to the health and safety of consumers,

• the effects of the risk can or do go beyond the territory of one Member State or do not or cannot go beyond its territory, but measures involve information likely to be of interest to other Member States from a product safety standpoint,

• the measures adopted do not have to be notified under any other notification procedure established by EU law (e.g. under RAPEX established under Article 12 of the GPSD or under the safeguard clause procedure established by sectoral directives).

The following Chapters in Part II of the Guidelines are relevant to the Article 11 notification procedure:

• Chapter 2.1 on consumer product (definition of consumer product),

• Chapter 2.2 on restrictive measures (categories of restrictive measures, definition of obligatory measures, timing of the notification and notifying authorities),

• Chapter 2.3 on risk assessment (risk assessment method, assessing authority),

• Chapter 2.4 on cross-border effects (international event, local event).

3. Notifications

Where all notification criteria are met, a Member State prepares a notification and sends it to the Commission using the RAPEX application. The standard notification form is provided in Appendix 1 to the Guidelines.

All notifications sent through the RAPEX application under Article 11 of the GPSD are classified in the system as ‘Article 11 notifications’.

The RAPEX Contact Point of the notifying Member State ensures that all notifications meet all the notification requirements provided for in Article 11 of the GPSD.

The following Chapters in Part II of the Guidelines are relevant to the Article 11 notification procedure:

• Chapter 3.2 on the content of notifications (completeness, scope, updating of data, responsibility for the information transmitted),

• Chapter 3.3 on confidentiality (disclosure of information, exceptions to the general rule, requests for confidentiality, treatment of notifications covered by confidentiality and withdrawal of the confidentiality request),

• Chapter 3.4 on the examination of notifications by the Commission (correctness, completeness, requests for additional information, investigation),

• Chapter 3.5 on the validation of notifications,

• Chapter 3.8 on the permanent withdrawal of a notification from the RAPEX application (withdrawal situations, requesting Member State, content of the request, withdrawal decision).

Member States submit an ‘Article 11 notification’ as soon as possible and by the deadlines specified in Appendix 3 to the Guidelines at the latest. Chapter 3.10 of Part II of the Guidelines on deadlines applies.

4. Reactions

Member States are encouraged to ensure follow-up to ‘Article 11 notifications’ if product identification is likely to allow preventive and restrictive measures to be adopted. Member States are also encouraged to notify to the Commission the conclusions of follow-up activities taken with regard to ‘Article 11 notifications’.

The following Chapters in Part II of the Guidelines are relevant to the Article 11 notification procedure:

• Chapter 3.7 on follow-up activities (objectives, follow up action),

• Chapter 4.2 on the content of reactions (data provided, completeness, updating, responsibility for reactions),

• Chapter 4.3 on confidentiality,

• Chapter 4.4 on the examination of reactions by the Commission (correctness and completeness, request for additional information),

• Chapter 4.5 on the validation of reactions,

• Chapter 4.6 on the permanent withdrawal of reactions from the RAPEX application.

5. Practical and technical arrangements

‘Article 11 notifications’ and reactions to them are prepared and sent to the Commission by the RAPEX Contact Points using the RAPEX application. Chapters 5.1 to 5.3 in Part II of the Guidelines concerning the operation of RAPEX networks (established at EU and national levels) and on practical and technical arrangements (languages, on-line application, and operation outside normal working hours) are relevant to the Article 11 notification procedure.