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Market surveillance group (SOGS - UNECE

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Market surveillance group (SOGS - UNECE

    EUROPEAN COMMISSION

    ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Regulatory policy Regulatory approach for the free circulation of goods

    NOTE TO THE SENIOR OFFICIALS GROUP ON

    STANDARDISATION AND CONFORMITY ASSESSMENT POLICY MARKET

    SURVEILLANCE GROUP (SOGS-MSG)

    Draft CERTIF 2008-001 - Application of the RAPEX system to the Title:

    Community harmonisation legislation as in the Regulation (EC) No

    765/2008

    Rita L’Abbate - Unit C1 Author:

    SOGS-MSG N002 EN 23-09-2008 Doc. N.: Issue Date:

    st0.0 1 October 2008 Version: Meeting:

    For discussion Status:

    Abstract:

    The objectives of this paper are:

    -to inform on how the RAPEX system currently operates;

    -to outline and evaluate the needs of a rapid exchange of information mechanism to be established under the Regulation 765/2008 setting out the requirements for accreditation

    and market surveillance;

    -to identify the necessary measures to ensure that from 1 January 2010 onwards all

    notification procedures required by the Regulation are established and effectively implemented.

    A plan/flow of the rapid exchange of information currently requested into the above Regulation and the Decision 768/2008/EC is attached.

    Market surveillance, rapid exchange of information system, notification, Keywords:

    serious risk, market surveillance authorities

    Regulation 765/2008; 2001/98/EC Directive (GPSD); RAPEX system; References:

    RAPEX Guidelines; Decision 768/2008/EC

    EUROPEAN COMMISSION

    ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Regulatory policy Regulatory approach for the free circulation of goods

     CERTIF doc. 2008-001

    Subject: Application of the RAPEX system to the Community harmonisation 1legislation as in the Regulation (EC) No 765/2008

I. CURRENT SITUATION

    1. INTRODUCTION

    2RAPEX is the European rapid alert system for non-food consumer products

    presenting a serious risk to the health and safety of consumers. It is set up under 3Article 12 of the General Product Safety Directive (2001/95/EC, GPSD).

    The new Regulation (EC) No 765/2008 foresees the establishment of a Community

    Rapid Information System (see Article 22) for products presenting a serious risk

    and for any voluntary measure taken and communicated by an economic operator.

    Moreover, this rapid information system will cover the scope of the regulation i.e.

    all products covered by Community harmonisation legislation which includes

    consumer products and other categories of products (e.g. for professional and

    industrial use) and risks (e.g. environmental).

    The objective of this paper is to outline how the RAPEX system currently operates,

    to evaluate the needs of a rapid exchange of information mechanism to be

    established under the Regulation and to identify the necessary measures to ensure

    that from 1 January 2010 onwards all notification procedures required by the

    Regulation are established and effectively implemented.

2. ABOUT RAPEX TODAY

    RAPEX ensures that information about restrictive measures (preventing or

    restricting marketing or use), whether ordered by national authorities or taken

    'voluntarily' by businesses in relation to consumer products posing serious risks to

    the health and safety of consumers is circulated between national authorities and

    the Commission, with the aim of preventing or restricting the circulation of such

    1 OJEU L 218, 13.8.2008, p. 30 - Regulation of 9 July 2008 setting out the requirements for accreditation

    and market surveillance relating to the marketing of products 2 RAPEX Members: EU Member States and EFTA/EEA countries 3 OJEU L 11, 15.1.2002, p. 4

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    4products in all Member States.In other words, RAPEX is a general and horizontal

    rapid warning and monitoring system for consumer products. It is designed for handling situations caused by products presenting a serious risk to the health and safety of consumers.

    2.1. Legal basis

    The RAPEX system was created to support consumer product safety enforcement. The RAPEX system in the current form became operational in 2004 when the revised GPSD (2001/95/EC) came into force. To ensure the effectiveness and proper functioning of the system, the Commission adopted (also in 2004) with its Decision the "Guidelines for the management of the Community Rapid Information System (RAPEX) and for notifications presented in accordance with Article 11 of 5Directive 2001/95/EC" (RAPEX Guidelines) .

    2.2. Scope of RAPEX

    RAPEX covers all consumer products, i.e. products intended for consumers and products likely, under reasonably foreseeable conditions, to be used by consumers (even if not intended for them), including products provided in the context of a service. There are, however, some categories of products for which sector specific alert systems are in place and thus RAPEX does not apply to them i.e. food and feed, where Rapid Alert System for Food and Feed (RASFF) is used, medical devices (with so-called medico-vigilance procedure) and pharmaceuticals (with the pharmaco-vigilance database managed by the European Medicines Agency 'EMEA'). RAPEX is intended for notifications on 'obligatory' measures ordered by national authorities, as well as on 'voluntary' actions taken by businesses, which restrict or prevent the distribution or use of non-food consumer products posing serious risks to their health and safety, which are sent to the Commission by 6Member States under Article 12 of the GPSD.

    In addition, the RAPEX system is also used for the exchange of information on measures taken by national authorities in relation to consumer products posing a non-serious risk to consumers (notifications sent under Article 11 of the GPSD).

2.3. How does RAPEX operate?

    RAPEX is used by Member States to inform the Commission, of the adoption of (i) measures to prevent, restrict or impose specific conditions on the marketing or use of (ii) a consumer product posing (iii) a serious risk to consumers, the effects of which (iv) go beyond the territory of that state. When the above notification criteria are met, Member States have a legal obligation to send a RAPEX notification to the Commission.

    To guarantee as much as possible the preventive nature of the system, Member States are also entitled (and not obliged as above) to pass on to the Commission

    4 The term ? MS ? means EU Member States and States which are parties to the EEA Agreement. 5 OJEU L 151, 30.04.2004, p. 83 - 117 6 Certain RAPEX notifications are distributed through the system "For information" purpose only (e.g. notifications with insufficient product identification).

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    information about a consumer product posing a serious risk before taking any measures or actions. The existence of a serious risk, however, should be established and proved before information is sent to the Commission. It allows Member States to exchange information about products posing serious or life threatening risks in very complex situations where adoption of measures may require more time. It should, however, be noted that on average only 5 such notifications are sent through RAPEX every year, while over 1,600 notifications were submitted through the system in 2007.

    The RAPEX system relies on co-operation between the Commission and the national market surveillance and customs authorities. Each Member State 7appointed a single RAPEX Contact Point which is responsible for the operation of

    the system at the national level and which transmits RAPEX data to/from competent authorities. The “Contact Points Network”, established and developed

    over the years with considerable investments meets regularly to discuss the operation and organisation of RAPEX.

    Member States submit RAPEX notifications to the Commission through the RAPEX online system ('REIS') using a common notification form (see Annex I to the RAPEX Guidelines). The information required includes notably product identification (including information about its origin), risk analysis (including risk assessment and conclusions of any tests performed), information about distribution channels and information about measures adopted to prevent risks. Further, the Commission (DG SANCO) examines the correctness and 8completeness of a submitted notification, validates it and has it translated and

    distributes it through the system to all national RAPEX contact points, unless a notification is not justified (as it does not meet all notification criteria) or is incomplete and thus requires suspension.

    After distribution, the receiving authorities are required to carry out the necessary follow up activities and to inform the Commission about their conclusions (e.g. any consequential measures taken). For that purpose contact points complete in the system the 'Reaction form' (see Annex II to the RAPEX Guidelines) and submit it to the Commission.

    The RAPEX system is intended exclusively for public authorities of the Member States and access to its online application is restricted to these authorities. Consumers, consumer organisations or businesses do not have access to the RAPEX database. However, in order to inform consumers and businesses about consumer products posing serious risks withdrawn from the EU market, the 9Commission publishes on the RAPEX website weekly overviews of RAPEX

    notifications. These overviews provide notably information on: the product identification, the risks it poses and the measures that were taken to prevent these risks.

    7 A list of the national contact points can be found at: http://ec.europa.eu/consumers/safety/rapex/

    contact_points.pdf

    8 RAPEX operates in DE, EN, ES, FR, IT

    9 http://ec.europa.eu/rapex

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    2.4. RAPEX online systems ('REIS' and 'GRAS-RAPEX')

    To ensure a smooth and rapid exchange of information through RAPEX, the

    Commission established in 2004 the online system called "REIS" which is still in

    operation today. Currently, DG SANCO prepares a new online system for RAPEX