CELEX: 32004D0418
Language: en
Date: 2004-04-29 00:00:00
Title: 2004/418/EC:Commission Decision of 29 April 2004 laying down guidelines for the management of the Community Rapid Information System (RAPEX) and for notifications presented in accordance with Article 11 of Directive 2001/95/EC

30.4.2004                   EN                Official Journal of the European Union        L 151/83
                                         COMMISSION DECISION
                                               of 29 April 2004
laying down guidelines for the management of the Community Rapid Information System
     (RAPEX) and for notifications presented in accordance with Article 11 of Directive
                                                  2001/95/EC
                               (notified under document number C(2004) 1676)
                                         (Text with EEA relevance)
                                                (2004/418/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Directive 2001/95/EC of the European Parliament and of the Council of 3
December 2001 on general product safety (1), and in particular the third subparagraph of
paragraph 1 of Article 11 thereof,
After consulting the Committee set up by Article 15 of Directive 2001/95/EC,
Whereas:
(1)      Directive 2001/95/EC establishes a Community Rapid Information System (RAPEX) for
         the rapid exchange of information between the Member States and the Commission on
         measures and actions relating to products posing a serious risk to the health and safety of
         consumers.
(2)      The RAPEX helps to prevent the supply to consumers of products which pose a serious
         risk to their health and safety, facilitates the monitoring of the effectiveness and
         consistency of market surveillance and enforcement activities in the Member States, and
         provides a basis for identifying needs for action at Community level.
(3)      The notification procedure under Article 11 of Directive 2001/95/EC provides for an
         exchange of information between the Member States and the Commission on measures
         and actions relating to dangerous products which do not present a serious risk to the
         health and safety of consumers.
1
  OJ L 11, 15.1.2002, p. 4.
 ---pagebreak--- L 151/84                 EN                Official Journal of the European Union           30.4.2004
(4)     The effective operation of the notification procedures under Directive 2001/95/EC by the
        Commission and the competent authorities of the Member States requires consistent
        implementation of the relevant provisions of that Directive, in particular of the concept of
        serious risk and of risks the effects of which do not, or cannot, go beyond the territory of
        one Member State but which can be of interest for all Member States.
(5)     In order to facilitate the operation of RAPEX and of the Article 11 notification procedure,
        the guidelines should include a standard notification form and criteria for the classification
        of notifications according to the degree of urgency. The guidelines should also define the
        operating arrangements including deadlines for the various steps of the notification
        procedures.
(6)     The guidelines should be addressed to the national authorities designated as contact points
        in the RAPEX and in charge of the notification procedure under Article 11 of Directive
        2001/95/EC. The Commission should use the guidelines as the reference document for
        managing RAPEX and the Article 11 notification procedure,
HAS ADOPTED THIS DECISION:
                                                Article 1
The Commission hereby adopts guidelines to supplement Directive 2001/95/EC for the
management of the Community Rapid Information System (RAPEX) and for notifications
presented in accordance with Article 11 of that Directive.
The guidelines are set out in the Annex to this Decision.
                                                Article 2
This Decision is addressed to the Member States.
Done at Brussels, 29 April 2004.
                                                    For the Commission
                                                       David BYRNE
                                                  Member of the Commission
 ---pagebreak--- 30.4.2004       EN         Official Journal of the European Union L 151/85
                                     ANNEX
                          GUIDELINES
   for the management of the Community Rapid Information System
  (RAPEX) and for notifications presented in accordance with Article
                    11 of Directive 2001/95/EC
 ---pagebreak--- L 151/86                 EN                Official Journal of the European Union 30.4.2004
                                    TABLE OF CONTENTS
    1. Introduction
    2. General scope of RAPEX
    3. Criteria for identifying serious risk
    4. Contents of RAPEX notifications
    5. Deadlines for submission and circulation of RAPEX notifications
    6. Follow-up to RAPEX notifications
    7. Examination by the Commission of notifications
    8. Network for exchanges under RAPEX
    9. Coordination between RAPEX and other notification mechanisms
    10. Notifications under Article 11 of the GPSD
    ANNEXES:
    I: Notification form
    II: Reaction form
    III: Notification form for toys
    IV: Deadlines for national contact points
    V: Deadlines for Commission contact point
 ---pagebreak--- 30.4.2004                   EN            Official Journal of the European Union               L 151/87
1. INTRODUCTION
     1.1 Background and Objectives of the guidelines
     Directive 2001/95/CE1 on general product safety (GPSD) establishes a Community Rapid
     Information System (RAPEX) for the rapid exchange of information between the Member States
     and the Commission on measures and actions in relation to consumer products posing a serious
     risk for the health and safety of consumers in so far as there are no specific provisions in
     Community law with the same objective.
     Furthermore, the notification procedure in Article 11 of the GPSD is intended for exchange of
     information between the Member States and the Commission on measures and actions in
     relation to consumer products that do not present a serious risk to the health and safety of
     consumers.
     These procedures are part of the provisions of the GPSD aimed at ensuring an effective and
     consistent enforcement of the applicable safety requirements.
     The objectives of the RAPEX system are:
     a) to provide a rapid exchange of information between Member States and the Commission
          about measures and actions taken in relation to consumer products because of a serious risk
          to the health and safety of consumers;
     b) to inform Member States and the Commission about the existence of a serious risk even
          before measures are adopted or actions taken;
     c) to obtain and circulate to all Member States information on the follow-up given to the
          information exchanged by the Member States receiving it;
     with the aim of:
     a) preventing the supply to consumers of products which pose a serious risk to their health and
          safety, and where necessary withdrawing them from the market or recalling them from
          consumers;
     b) facilitating the monitoring of the effectiveness and consistency of market surveillance and
          enforcement activities in the Member States;
     c) identifying the need and providing a basis for action at Community level, where necessary;
     d) contributing to the consistent enforcement of Community product safety requirements and
          to the proper functioning of the internal market.
     The notification mechanism of Article 11 of the GPSD also facilitates prevention of the supply to
     consumers of dangerous products (not presenting a serious risk) and monitoring of market
     surveillance activities in the Member States.
1
  OJ L 11, 15.1.2002, p. 4.
 ---pagebreak--- L 151/88                    EN                    Official Journal of the European Union             30.4.2004
     The GPSD provides for the “establishment of non-binding guidelines aimed at indicating simple
     and clear criteria and practical rules, which may change in order to be completed, improved or
     adapted in the light of the experience and new developments, to facilitate the effective operation
     of RAPEX by the Commission and the competent authorities of the Member States2”, in other
     words these guidelines are intended to facilitate the effective and consistent application of the
     provisions of the GPSD related to notification procedures.
     The objectives of these guidelines are:
     a) to clarify the scope of RAPEX from the operational point of view, by
      -    setting a conceptual framework for the provisions of the Directive related to products posing
           serious risks and in particular criteria for applying the concept of “serious risk”;
      -    giving guidance on the types of measures, action and situations that need to be notified;
      -    providing guidance on how to notify the Commission of measures taken by producers or
           distributors on a voluntary basis, in agreement with the authorities or when required by
           these authorities;
      -    providing criteria for identifying “local events” (cases where the effects of the risk in question
           do not, or cannot, go beyond the territory of one Member State) that could be of interest for
           all Member States, in which case they would have to be notified;
      -    setting criteria for notifying information on dangerous products to the Commission before a
           Member State decides to adopt measures or take actions;
      -    identifying the products covered by a specific equivalent exchange of information systems,
           therefore excluded from the scope of RAPEX;
      -    classifying and indexing notifications according to the degree of urgency.
     b) to define the contents of the notifications, in particular the information and data required,
          and the forms to be used for the RAPEX system;
     c) to define the follow-up action to be taken by the Member States receiving a notification and
          the information to be provided on such follow-up;
     d) to describe the treatment of the notifications and of the follow-up information by the
          Commission;
     e) to set the deadlines for the various steps of the RAPEX processes;
     f) to define and document the practical arrangements at Commission and Member States level
          for the operation of RAPEX and all the relevant technical details.
     These guidelines provide also guidance on the notification procedure of Article 11 of the GPSD
     by clarifying the scope of the procedure, detailing the contents of notifications and establishing
     arrangements for treatment and transmission of notifications.
2
  In the context of this document the term "Member States" means all States which belong to the European Union and
  also those States which are parties to the EEA Agreement.
 ---pagebreak--- 30.4.2004                 EN                Official Journal of the European Union                      L 151/89
    1.2 Status and further developments of the guidelines
    Status:
    These are operational guidelines. These guidelines are adopted by the Commission, after
    consultation of the Member States within the GPSD Committee acting in accordance with the
    advisory procedure.
    They therefore represent the reference document for the application of the provisions of the
    GPSD concerning RAPEX as well as for notifications presented according to Article 11 of the
    GPSD.
    Further developments:
    These guidelines will need to be adapted in the light of experience and of new developments. The
    Commission will update or amend them as necessary in consultation with the Committee
    referred to in Article 15 GPSD.
    1.3 To whom are the guidelines addressed
    These guidelines are addressed to the Member States’ national authorities designated to
    participate in the RAPEX network as contact points and in charge of the notification procedure
    under Article 11 of the Directive. The Commission will use these guidelines as the reference
    document for managing RAPEX and the notification procedure under Article 11 of the Directive.
2. GENERAL SCOPE OF RAPEX
    2.1 Definition of the products covered by the GPSD and criteria for applying this definition
    for the aims of RAPEX
    The provisions of the GPSD, and in particular the RAPEX procedure, apply to consumer products
    that pose a serious risk to consumers in so far as there are no specific provisions in Community
    law with the same objective. Examples of products covered by RAPEX are toys, domestic
    electrical appliances, lighters, childcare articles, cars and tyres, etc.
    The products covered by the GPSD are defined in its Article 2(a):
    "product" shall mean any product – including in the context of providing a service – which is intended for
    consumers or likely, under reasonably foreseeable conditions, to be used by consumers even if not intended
    for them, and is supplied or made available, whether for consideration or not, in the course of a commercial
    activity, and whether new, used or reconditioned."
    The following elements are particularly relevant:
    -    products must be intended for and supplied or made available to consumers; or
    -    likely, under reasonably foreseeable conditions, to be used by consumers even if not intended
         for consumers. Products "migrating" from professional use to the consumer market should
         also be covered. In other words, products that had been originally developed for professional
         use and allowed on the market as intended for professionals, which have subsequently also
         been marketed to consumers;
 ---pagebreak--- L 151/90                    EN                    Official Journal of the European Union                 30.4.2004
     -    products provided in the context of a service: the GPSD also covers products supplied or
          made available to consumers in the course of a service provided to them. Consumer products
          are often made available in connection with certain services (for example renting of
          machines). The equipment used by the service provider to supply a service is beyond the
          scope of the GPSD, in particular, equipment on which consumers ride or travel operated by a
          service provider.
     2.2 Products excluded from RAPEX because covered by specific and equivalent requirements
     for the rapid exchange of information
     The following products are excluded from RAPEX because they are covered by equivalent
     notification mechanisms established by Community legislation:
     -    pharmaceuticals covered by Directives 75/319/EEC3 and 81/851/EEC4;
     -    active implantable medical devices covered by Directive 90/385/EEC5, medical devices
          covered by Directive 93/42/EEC6, and in vitro diagnostic medical devices covered by
          Directive 98/79/EC7;
     -    food and feed covered by Regulation (EC) No 178/20028.
     Further information on the relationship between the different notification procedures established
     by Community law can be found in chapter 9.1 and in the separate “Guidance Document on the
     Relationship between the GPSD and Certain Sector Directives9”.
     2.3 Measures, decisions and actions to be notified under RAPEX
     An indicative list of the different types of measures and actions of the competent authorities of
     the Member States that should be notified under RAPEX, can be found in Article 8 GPSD. These
     measures and actions are aimed at:
     -    imposing conditions prior to the marketing of a product;
     -    requiring that a product be marked with warnings concerning any risks;
     -    alerting consumers about a risk related to a product;
     -    banning temporarily or definitively the supply, the offer to supply or the display of a product;
     -    organising the withdrawal or the recall of a product;
     -    ordering producers and distributors to withdraw a product, recall it from consumers, and
          destroy it.
     Other measures and actions that authorities can adopt or take and should notify are:
3
  OJ L 147, 9.6.1975, p. 13. Directive as last amended by Directive 2000/38/EC (OJ L 139, 10.6.2000, p. 28).
4
  OJ L 317, 6.11.1981, p. 1. Directive as last amended by Directive 2000/37/EC (OJ L 139, 10.6.2000, p. 25).
5
  OJ L 189, 20.7.1990, p.17
6
  OJ L 169, 12.7.1993, p.1
7
  OJ L 331, 7.12.1998, p.1
8
  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. OJ L 031, 01/02/2002 p. 1.
9
  http://europa.eu.int/comm/consumers/cons_safe/prod_safe/gpsd/revisedGPSD_en.htm
 ---pagebreak--- 30.4.2004                 EN              Official Journal of the European Union                L 151/91
    -   agreements with producers and distributors to take actions necessary to avoid the risks posed
        by products;
    -   agreements with producers and distributors to organise jointly the withdrawal, the recall of
        products from consumers and their destruction or any other relevant action;
    -   agreements with producers and distributors to coordinate the recall of a product from
        consumers and its destruction.
    Member States should notify all such measures even if an appeal against them is likely or they are
    under appeal at national level or subject to publication requirements. Member States should
    indicate in the notification whether the measure is of a definitive nature (because it has not been
    contested by the manufacturer or importer, or because it has been finally confirmed) or if it is still
    likely to be, or is currently, under appeal. In any case, any subsequent change in the status of the
    measure should be communicated to the Commission.
    Under Article 5 producers and distributors are obliged to inform the national authorities of
    voluntary actions or measures taken to prevent risk to the consumer. The authorities must notify
    these voluntary measures to the Commission when the product poses a serious risk (see chapter
    4.3).
    2.4 Other information on serious risks that may be exchanged under RAPEX
    Member States may inform the Commission of:
    -   any information regarding the existence of a serious risk at the stage before deciding to adopt
        measures or to take action (Article 12.1, third subparagraph). In such cases RAPEX contact
        points should also inform the Commission about the final decision;
    -   measures on a specific production batch which has been withdrawn from the market by a
        Member State due a serious risk and when all items in this batch have been withdrawn from
        the market by the Member State;
    -   customs authority decisions to block or to reject products at the EU borders if the consumer
        product blocked or rejected presents a serious risk. Contact points should circulate this
        information to their customs authorities (see details in chapter 8.3).
    The Commission may receive information relating to products that present a serious risk to the
    health of the consumer from Third Countries or through equivalent information systems
    established by other organisations including non-EU countries. The Commission will evaluate the
    information and may transmit it to the Member States.
    These types of additional information on serious risks that may be exchanged under RAPEX do
    not require a formal reaction from the rest of Member States and the use of a standard form is not
    required.
    2.5 Criteria for notifying measures related to risks not going beyond the territory of a
    Member State
    Measures and actions related to risks where the effects do not or cannot go beyond the territory
    of a Member State are excluded from the scope of RAPEX.
    However, in certain cases such measures and actions are likely to interest the enforcement
    authorities of the other Member States. In order to assess whether a measure dealing with a risk of
 ---pagebreak--- L 151/92                 EN                 Official Journal of the European Union          30.4.2004
    local effect involves information on product safety likely to be of interest for the other Member
    States, the authority should take into account for example whether the measure is taken in
    response to a new type of risk which has not yet been reported in other notifications, or whether
    it is related to a new risk arising from a combination of products or whether it is a new type or
    category of product that is dangerous.
    Measures related to second-hand products sold by private individuals and custom-made products
    that present a serious risk are excluded from the scope of RAPEX if the Member State which took
    the measure can conclude from the existing information that the product could not be found in
    another Member State.
    Taking into account the free circulation of products at European level, the openness of the
    European economy and the fact that consumers buy products not only in their home market but
    also during holidays abroad or by Internet, contact points are encouraged to report actions taken
    when there is uncertainty whether the risk could be relevant or of interest for another Member
    States.
3. CRITERIA FOR IDENTIFYING SERIOUS RISKS
    3.1 Definition of serious risk in the GPSD and objectives of the guidance on serious risks
    Serious risk is defined in Article 2(d) of the GPSD as follows: “serious risk shall mean any serious
    risk, including those the effects of which are not immediate, requiring rapid intervention by the
    public authorities”.
    This definition of serious risk is characterised by two key elements. First, it includes all types of
    serious risk to consumers created by a product (immediate threats as well as possible long-term
    risks); second, the risks considered are those requiring a rapid intervention.
    The following subchapters give general guidance to assist the authorities in assessing the level of
    seriousness of the risk and deciding whether a rapid intervention is necessary. The objective is to
    help the authorities in identifying the cases to which the concept of serious risk under the GPSD
    applies. The guidelines in this chapter are not exhaustive and do not try take account of all
    possible factors. The national authorities should judge each individual case on its merits taking
    into account the criteria set out in these guidelines as well as their own experience and practice,
    other relevant considerations and appropriate methods.
    3.2 Criteria on the level of gravity of risks
    A consumer product may present one or more intrinsic hazard. The hazard may be of various
    types (chemical, mechanical, electrical, heat, radiation etc.). The hazard represents the intrinsic
    potential of the product to damage the health and safety of users under certain conditions.
    The severity of each type of hazard may be given a rating, based on qualitative and sometimes
    quantitative criteria related to the type of damage that they are liable to produce.
    It may happen that not all individual products present the hazard in question, but only some of
    the items placed on the market. The hazard may in particular be related to a defect that appears
    only in some of the products of a certain type (brand, model…) placed on the market. In such
    cases the probability of the defect/hazard being present in the product should be considered.
    The potential of a hazard to materialise as an actual negative effect on the health/safety will
    depend on the degree to which the consumer is exposed to it when using the product as intended
 ---pagebreak--- 30.4.2004                    EN            Official Journal of the European Union                            L 151/93
    or as could reasonably be expected during its lifetime. In addition the exposure to certain hazards
    may in some cases involve more than one person at a time. Finally when determining the level of
    the risk presented by a product by combining the severity of the hazard with the exposure,
    consideration should be given also to the ability of the exposed consumer to prevent or react to
    the hazardous situation. This will depend on the evidence of the hazard, the warnings given and
    the vulnerability of the consumer who may be exposed.
    Taking into account the above considerations, the following conceptual approach may assist
    enforcement officers to decide whether a specific hazardous situation caused by a consumer
    product constitutes a serious risk under the GPSD.
    The officer should:
         -    As a first step, use Table A to determine the gravity of the outcome of a hazard,
              depending on both its severity and probability to materialise under the conditions of use
              considered, and of the possible health/safety effect related to the intrinsic hazardous
              characteristics of the product;
         -    As a second step, use Table B to further assess the gravity of the outcome depending on
              the type of consumer and, for normal adults, whether the product has adequate warnings
              and guards and whether the hazard is sufficiently obvious to make it possible to grade the
              risk level qualitatively.
    Table B indicates the gravity of the outcome from Table A for which a serious risk situation exists
    and for which rapid action is to be adopted by the enforcement authorities.
    Table A:      Risk Estimation: severity and probability of health/safety damage
    In Table A the two main factors affecting the risk estimation, namely the severity and the
    probability of health/safety damage, are combined. The following definitions of severity and
    probability have been drawn up to assist the selection of appropriate values.
    Severity
    The assessment of severity is based on consideration of the potential health/safety consequences
    of the hazards presented by the product considered. A grading should be established specifically
    for each type of hazard10.
    10
       As an example, for certain mechanical risks the following definitions of the severity classifications may be
    proposed, with their typical injuries:
                      Slight                           Serious                                Very Serious
       <2% incapacity                      2 – 15% incapacity
       usually reversible and not          usually irreversible requiring         >15% incapacity
       requiring hospital treatment.       hospital treatment                     usually irreversible
       Minor cuts                          Serious cuts                           Serious injury to internal organs
       Minor fractures                     Loss of finger or toe                  Loss of limbs
                                           Damage to sight                        Loss of sight
                                           Damage to hearing                      Loss of hearing
 ---pagebreak--- L 151/94                  EN                Official Journal of the European Union               30.4.2004
    The assessment of severity should also take into account the number of people who could be
    affected by a dangerous product. This means that the risk from a product which could pose a risk
    to more than one person at a time (e.g. fire or gas poisoning from a gas appliance) should be
    classified as more severe than a hazard which can only affect one person.
    The initial risk estimation should refer to the risk to any person exposed to the product and
    should not be influenced by the size of the population at risk. However, it may be legitimate for
    the authorities to take account of the total number of people exposed to a product in deciding on
    the action to be taken.
    For many hazards it is possible to envisage unlikely circumstances which could lead to very
    serious effects, e.g. tripping over cable, falling and banging head leading to death, although a less
    serious outcome is more likely. The assessment of the severity of the hazard should be based on
    reasonable evidence that the effects selected for characterizing the hazard could occur during
    foreseeable use. This could be worst case experience involving similar products.
    Overall Probability
    This refers to the probability of negative health/safety effects to a person exposed to the hazard. It
    does not take into account the total number of people at risk. Where the guide refers to the
    probability of a product being defective, this should not be applied if it is possible to identify each
    one of the defective samples. In this situation, the users of the defective products are exposed to
    the full risk and the users of the other products to no risk.
    The overall probability is the combination of all the contributing probabilities such as:
             -    the probability of the product being or becoming defective (if all products carry the
                  defect then this probability would be 100%)
             -    the probability of the negative effect materialising for a normal user who has an
                  exposure corresponding to the intended or reasonably expected use of the defective
                  product.
    These two probabilities are combined in the following table to give an overall probability which
    is entered into table A.
            Overall Probability of Health/Safety Damage                   Probability of hazardous product
                                                                      1%              10%          100%
                                                                                                   (All)
       Probability of       Hazard is always present and              Medium            High         Very
       health/safety        health/safety damage is likely to                                        High
       damage from          occur in foreseeable use
       regular              Hazard may occur under one                Low             Medium       High
       exposure to          improbable or two possible
       hazardous            conditions
       product              Hazard only occurs if several             Very Low        Low          Medium
                            improbable conditions are met
 ---pagebreak--- 30.4.2004                EN                Official Journal of the European Union                    L 151/95
    Combining the severity and overall probability in Table A gives an estimation of the gravity of the
    risk. The accuracy of this assessment will depend upon the quality of the information available to
    the enforcement officer. However, this assessment needs to be modified to take account of the
    society’s perception of the acceptability of the risk. Society accepts much higher risks in some
    circumstances such as motoring, than in others, such as children’s toys. Table B is used to input
    this factor.
    Table B Grading of Risk: type of person, knowledge of the risk and precautions
    Society accepts higher risks in some circumstances than in others. It is considered that the main
    factors affecting the level of risk that is considered to be serious are the vulnerability of the type of
    person affected and for normal adults, the knowledge of the risk and the possibility of taking
    precautions against it.
    Vulnerable people
    The type of person using a product should be taken into account. If the product is likely to be
    used by vulnerable people, the level of risk which is serious should be set at a lower level. Two
    categories of vulnerable people are proposed below, with examples:
                           Very vulnerable                                  Vulnerable
                   Blind                                        Partially sighted
                   Severely disabled                            Partially disabled
                   Very old                                     Elderly
                   Very young (<3yrs)                           Young (3 – 11yrs)
    Normal adults
    The adjustment of the seriousness of risk for normal adults should only apply if the hazard is
    obvious and necessary for the function of the product. For normal adults the level of risk which is
    serious should be dependent on whether the hazard is obvious and whether the manufacturer has
    taken adequate care to make the product safe and to provide safeguards and warnings, especially
    if the hazard is not obvious. For example, if a product has adequate warnings and safeguards and
    the hazard is obvious, a high gravity of outcome may not be serious in terms of grading the risk
    (Table B), although some action may be needed to improve the safety of the product. Conversely,
    if the product does not have adequate safeguards and warnings, and the hazard is not obvious, a
    moderate gravity of outcome is serious in terms of grading the risk (Table B).
 ---pagebreak--- L 151/96                                      EN                             Official Journal of the European Union                                                       30.4.2004
                                 Risk Assessment of consumer products for the GPSD
                                 This procedure is proposed to assist enforcement officers when deciding whether a specific hazardous situation caused by a
                                 consumer product is intolerable and constitutes a serious risk under the General Product Safety Directive.
                                 Table A - Risk Estimation                               Table B – Grading of Risk
                                 Severity of Health/Safety Damage                             Vulnerable people                  Normal adults
                                                                        Overall                                                                               Adequate warnings
                                                                       Gravity of             Very                        No      Yes        No         Yes      and safeguards?
                                   Slight    Serious   Very Serious    Outcome             vulnerable      Vulnerable     No      No         Yes        Yes    obvious hazard?
                                            Very High High             Very High         SERIOUS RISK - RAPID ACTION REQUIRED
                                 Very High High        Medium          High
  Probability of Health/Safety
                                 High       Medium     Low             Moderate
                                                                                                          Moderate risk - Some action required
                                 Medium     Low        Very Low        Low
                                                                                                                                 Low risk - Action unlikely
  Damage
                                 Low        Very Low                   Very low
  Table A is used to determine the gravity of the outcome of a hazard, depending on the severity and probability of the possible health/safety
  damage (see tables in notes)
  Table B is used to determine the rating of the gravity of risk depending on the type of user and, for normal adults, whether the
  product has adequate warnings and safeguards and whether the hazard is sufficiently obvious, and to decide whether
  a serious risk situation exists and rapid action is required
  Example (indicated by the arrows above)
  A chain saw user has suffered a badly cut hand and it is found that the chain saw has an inadequately designed guard which
  allowed the user's hand to slip forward and touch the chain. The enforcement officer makes the following risk assessment.
  Table A - The assessment of probability is High because the hazard is present on all products and may occur under certain conditions. The
                                                                       .
  assessment of severity is Serious so the overall gravity rating is High.
  Table B – The chain saw is for use by normal adults, has an obvious hazard but inadequate guards, so the risk rating would be
  Moderate.
  The High gravity is therefore intolerable so a serious risk situation exists and rapid action is required.
 ---pagebreak--- 30.4.2004                EN               Official Journal of the European Union      L 151/97
4. CONTENTS OF RAPEX NOTIFICATIONS
    4.1 Information to be entered on the notification form
    Information should be as complete as possible: contact points should fill in all the
    fields in the notification form (Annex I of the Guidelines). If information is not
    available, this should be indicated and explained. A timetable for providing the missing
    information should be transmitted.
    Responsibility for the information provided lies with the notifying Member State
    (GPSD Annex II.10).
    In order to be useful to the authorities of the other Member States in their market
    surveillance activities, the notification must include all the data needed to identify the
    dangerous product, trace its origin, identify the marketing and distribution channels,
    determine the related risks, etc.
    Confidentiality could be requested if disclosure of the information would undermine
    the protection of court proceedings, monitoring and investigation activities or
    professional secrecy, unless there were an overriding public interest in disclosure of the
    information to protect the health and safety of consumers.
    The notifying Member State could also require confidentiality for annexes to the
    notification, such as legal proceedings, that do not contain information relevant for
    consumer protection and need to be protected.
    According to the GPSD, the public must have access to information relating to the
    safety properties of products, the nature of the risk, product identification and the
    measure taken.
    Contact points should pay special attention to checking that the following items of
    essential information appear in the notification:
    -    a detailed description of the product (including if possible the customs code of the
         product) together with a photograph in order to facilitate its identification by
         enforcement authorities. The identification and description of the product should
         be accurate in order to avoid any confusion with similar products in the same
         category that are safe;
    -    the risk assessment including, in particular, results of tests carried out by the
         authority;
    -    the scope and the nature of the measure taken in order to avoid the risk, its
         duration and the follow-up. The notifying Member State should inform the
         Commission of any amendment to the measure taken and of the final decision
         taken on the product in question. The Member State should indicate in the
         notification whether the measure has a definitive character (i.e. it has not been
         contested by the manufacturer or importer, or has been confirmed by an instance
         that does not admit appeal) or could be, or is currently, subject to appeal. In any
         case, any change in the status of the measure should be communicated to the
         Commission;
 ---pagebreak--- L 151/98                    EN                   Official Journal of the European Union    30.4.2004
     -    the information needed to identify the product’s distribution channels and its
          origin, in particular its producer, importer or exporter, as well as other information
          related to its traceability.
     In the case of products imported from Third Countries, and in order to facilitate
     investigation by the authorities of the Third Country of origin of the product, the
     following documents and information should also be communicated (if available):
     copies of Sales Contract, Letter of Credit, date and port of export and batch number of
     the products.
     4.2 Information to provide in relation to measures concerning use of chemicals
     When the measure notified pursuant to Article 11 or Article 12 seeks to limit the
     marketing or use of a chemical substance or preparation, the Member States must
     provide as soon as possible either a summary or the references of the relevant data
     relating to the substance or preparation considered and to known and available
     substitutes, where such information is available.
     They will also communicate the anticipated effects of the measure on consumer health
     and safety together with the assessment of the risk carried out in accordance with the
     general principles for the risk evaluation of chemical substances as referred to in
     Article 10(4) of Regulation (EEC) No 793/9311 in the case of an existing substance or in
     Article 3(2) of Directive 67/548/EEC12 in the case of a new substance.
     4.3 Notification of the voluntary measures taken by producers and distributors
     Article 5(3) of the GPSD obliges producers and distributors to inform the national
     authorities of any voluntary action or measure taken to prevent risk to the consumer.
     Article 12(1) fourth subparagraph requires Member States to notify the Commission of
     the voluntary measures taken by producers and distributors in the case of a serious
     risk.
     When the authorities receive information from producers and distributors concerning
     a risk and the voluntary actions taken to avoid it, they should examine this information
     in order to assess whether a notification to the Commission is justified due to the
     involvement of a serious risk, taking into account the criteria outlined in chapter 3.
     Such notification at Community level is required in the case of a serious risk the effects
     of which can go beyond the territory of a Member State (taking into account the
     criteria for notifying local events: see chapter 2.5).
     The information transmitted to the Commission should include details of the
     voluntary action taken by the producers or distributors. All relevant information on
     the risk should also be notified. In particular:
     -    information to identify and trace the product or batch of products;
11
   OJ L 84, 5.4.1993, p. 1.
12
   OJ 196, 16.8.1967, p. 1/67. Directive as last amended by Commission Directive 2000/33/EC (OJ L 136,
8.6.2000, p. 90).
 ---pagebreak--- 30.4.2004                   EN                  Official Journal of the European Union      L 151/99
     -    description of the risk;
     -    identification of the producers and distributors participating in the application of
          the measure;
     -    description of the action taken by producers and distributors to avoid risks to
          consumers (scope, countries covered, monitoring);
     -    final destination of the dangerous product (destruction, recondition);
     -    follow-up actions that national authorities would take in order to monitor the
          effectiveness of the voluntary measures taken by producers and distributors;
     -    actions provided for in other Member States by the producers or distributors.
5. DEADLINES FOR SUBMISSION AND CIRCULATION OF RAPEX
     NOTIFICATIONS
     5.1 Deadlines for submitting notifications to the Commission by the Member
     States
     National contact points are required to notify the Commission as soon as possible and
     at the latest 10 days13 after the competent authorities have taken the decision or have
     decided to adopt measures14 relating to products presenting a serious risk.
     Measures or action taken in agreement between authorities and producers and/or
     distributors should be notified to the Commission as soon as possible and at the latest
     10 days after the agreement has been concluded.
     Contact points are required to transmit information to the Commission on voluntary
     measures taken by producers and distributors which have been notified to the
     authorities by reason of a serious risk and which go beyond the territory of a Member
     State. This should be done as soon as possible and at the latest 10 days after the
     producer and/or distributor have informed the national authority.
     In the case of notifications requiring emergency action from Member States (as defined
     in Chapter 7.1), the notifying national contact point is required to inform the
     Commission as soon as possible and at the latest three days after the measure has been
     adopted. This type of notification should always be preceded by a phone call to the
     Commission RAPEX mobile phone number (in particular during week-ends and
     holiday periods).
     Information on serious risks to be exchanged under RAPEX as described in point 2.4 is
     to be transmitted to the Commission as soon as possible and at the latest 10 days after
     the contact point was informed.
13
   All deadlines mentioned in the text are expressed in calendar days.
14
   The measures, decisions and actions to be notified under RAPEX are described in point 2.3 of these
guidelines.
 ---pagebreak--- L 151/100                 EN                Official Journal of the European Union   30.4.2004
    National contact points are required to notify the Commission as soon as possible and
    at the latest 15 days after the competent authorities have taken the decision or have
    decided to adopt measures restricting the marketing or use of products by reason of a
    risk that is not serious.
    These deadlines apply to the exchange of information between national contact points
    and the Commission. They do not take into account national deadlines applicable
    internally in the Member States (for instance between local and central authorities).
    Appropriate arrangements should be put in place at national level in order to ensure
    rapid transmission of the information between the different national authorities in
    charge of product safety.
    These deadlines apply irrespective of any appeal procedure entered into by the
    producer or distributor or official publication requirements.
    5.2 Commission deadlines for the transmission of notifications to all the Member
    States
    The Commission will transmit the notification to the contact points only if the
    notifying Member State has provided the essential information described in chapter
    4.1. Any follow-up by other Member States would not be feasible if such essential
    information were missing.
    The Commission will treat the information received in accordance with the following
    degrees of urgency:
    -   Notifications requiring emergency action from Member States will be treated as
        priority by the Commission and transmitted to Member States as soon as possible
        and at the latest three days after reception;
    -   Alert notifications (Article 12 of the GPSD) will be transmitted to Member States
        within five days of reception. This category includes measures or action taken by
        authorities, agreements for action between authorities and producers and
        distributors, and voluntary measures taken by producers and distributors relating
        to products that present a serious risk;
    -   Other information on serious risks to be exchanged under RAPEX will be
        transmitted within five days of reception;
    -   Notifications presented in accordance with Article 11 of the GPSD will be sent by
        the Commission within 15 days of reception. These notifications relate to
        measures taken by the authorities which restrict the placing on the market or
        require the withdrawal or recall of products that do not create a serious risk.
    5.3 Deadlines for updating the information provided by the Member States
    Member States are required to notify the Commission of any modification or lifting of
    measures or actions at the latest five days after the competent authorities have taken
    the decision to modify or lift the measure.
 ---pagebreak--- 30.4.2004                 EN              Official Journal of the European Union    L 151/101
    Member States may provide information to the Commission at the stage preceding the
    decision on the measures to be taken, as provided for in GPSD Article 12(1) third
    subparagraph. The Member State will confirm or modify this information within 45
    days of the first communication (GPSD Annex II.4).
6. FOLLOW-UP TO THE RAPEX NOTIFICATIONS
    6.1 Action by the Member States to follow up the notifications
    Upon receipt of a notification Member States are required to examine all the
    information supplied in order to:
    -    find out whether the product has been marketed in their territory;
    -    enquire in order to collect any relevant information;
    -    perform any additional assessment of the risk (if needed);
    -    evaluate whether national measures should be adopted in the light of their own
         circumstances.
    6.2 Contents of the reaction to be communicated to the Commission
    Only notifications requiring emergency action from Member States and Alert
    notifications (Article 12) require a reaction from the Member States informing the
    Commission of their follow-up activities and conclusions. On the other hand,
    notifications presented according Article 11 and as “Other information on serious risks
    that may be exchanged under RAPEX” do not require Member States to inform the
    Commission of the follow-up given to the information received.
    After receiving a notification requiring emergency action from Member States or an
    Alert notification (Article 12) all Member States are required to inform the
    Commission, using the Reaction form in Annex II, of the conclusions of their market
    surveillance activities and in particular:
    -    whether or not the product has been found;
    -    any differing assessment of the risk notified;
    -    the measures taken or decided on and the reasons justifying a different measure;
    -    the special circumstances justifying lack of action or follow-up.
    If the product is manufactured in the EU and the notifying Member State is not the
    country of origin of the product, the authorities of the Member State where the
    product is manufactured should inform the Commission about:
    -    any contacts with the manufacturer;
    -    the measures adopted to ensure that the manufacturer solves the problem at
         source, where appropriate;
 ---pagebreak--- L 151/102                 EN                 Official Journal of the European Union  30.4.2004
    -    the distributors or retailers of the product in other Member States.
    If the product is not manufactured in the EU and the notifying Member State is not the
    country where the product was first marketed in the EU, the authorities of this country
    should inform the Commission about:
    -    any contacts with the manufacturer’s representative or with the importer of the
         product;
    -    the measures adopted by the manufacturer’s representative or by the importer to
         ensure that the problem is solved at source;
    -    the distributors or clients of the product in other Member States.
    6.3 Circulation by the Commission to the Member States of the reactions received
    The Commission will circulate as a priority case-by-case reactions:
    -    to notifications requiring emergency follow-up from Member States;
    -    containing a different assessment of the risk;
    -    containing a different measure to deal with the risk.
    The Commission will circulate in the form of weekly reports reactions received after
    the deadlines and reactions informing it:
    -    that the product has been found and similar actions taken;
    -    of a lack of action or of follow-up by Member States;
    -    that the product has not been found on the national market.
    6.4 Deadlines for submitting reactions to the Commission by the Member States
    Adequate follow-up by the Commission will not be possible if Member States do not
    fulfil their obligation to react to the notifications received.
    Member States are required to react:
    -    as soon as possible and in any case not later than 20 days if the reaction relates to a
         notification requiring emergency action from Member States;
    -    as soon as possible and in any case not later than 45 days in the case of alert
         notifications on measures taken by authorities, actions agreed between authorities
         and producers and distributors, or voluntary actions notified at Community level
         concerning products presenting a serious risk.
     If the product is manufactured in the EU and the notifying Member State is not the
     country of origin of the product, the authorities of the Member State where the
     product is manufactured should react to the notification within 15 days, providing
     information about the contacts with the manufacturer and the measures adopted to
 ---pagebreak--- 30.4.2004                 EN             Official Journal of the European Union        L 151/103
     ensure that the manufacturer will solve the problem at source. The same deadline is
     applicable to the Member State where the manufacturer’s representative or the
     importer of the product is established in cases where the product is not manufactured
     in the EU and the notifying Member State is not the country where the product was
     first marketed in the EU.
     A reminder will be sent to the Member States that have not reacted to the notifications
     after 45 days from the date when the notification was sent. The GPSD Committee will
     also be informed about any missing reactions.
    The Commission will circulate the reactions as follows:
    -    as soon as possible and in any case not later than three days if the reaction relates to
         a notification requiring emergency follow-up from Member States;
    -    as soon as possible and in any case not later than five days for other reactions to
         notifications on national measures, agreements between authorities and producers,
         or voluntary actions.
7. EXAMINATION BY THE COMMISSION OF NOTIFICATIONS
    7.1 Examination of the completeness and correctness of the notifications
    The Commission contact point checks all information received through the system
    before further transmission. The examination of the notifications by the Commission
    does not imply any assumption of responsibility for the information transmitted which
    remains with the notifying Member State.
    Specific internal arrangements have been put in place in order to circulate information
    to the Commission services concerned.
    The examination includes the following steps to check and complete the information,
    if necessary:
    Completeness check:
    If the information is incomplete, additional details are requested from the contact point
    of origin.
    If the product is manufactured in the EU and the notifying Member State is not the
    country of origin of the product and has not obtained the essential information for the
    notification, the Commission will contact the authorities of the Member State where
    the product is manufactured in order to complete the information on the distribution
    channels and destinations of the product. The authorities of the Member State of origin
    will be requested to obtain this information by contacting the producer or distributors.
    If the product is not manufactured in the EU and the notifying Member State is not the
    country where the product was first marketed in the EU and has not obtained the
    essential information of the notification, the Commission will contact the authorities
 ---pagebreak--- L 151/104                  EN                 Official Journal of the European Union 30.4.2004
    of the Member State where the product was first marketed in order to obtain
    information on the possible distribution of the product to other Member States.
    To check the notifications received, the Commission will:
    -    verify in general whether the information received is in conformity with EU
         legislation and with the provisions applicable to the functioning of RAPEX as
         defined in these guidelines;
    -    contact the notifying country, if necessary, in order to obtain extra information.
    Classification:
    Notifications will be classified according to the degree of urgency (GPSD Annex II. 11)
    in:
    a) Notifications requiring emergency action from Member States (serious risk,
         foreseeable need for measures to be agreed at Community level and/or likely
         political visibility of the issue and/or mass-media coverage);
    b) Alert notifications (Article 12 of the GPSD): measures or actions taken on products
         presenting a serious risk;
    c) Notifications under Article 11 of the GPSD: measures or actions taken by the
         competent authorities on products not posing a serious risk;
    d) For Information Only: information on serious risks to be exchanged under RAPEX
         as described in chapter 2.4.
    Consultations:
    When the product notified falls under the scope of specific sector legislation, the
    Commission contact point will ask for expert advice from other Commission services,
    if necessary. The Commission may, whenever it considers it to be necessary, carry out
    an investigation on its own initiative or ask for scientific advice.
    Database research:
    The Member States and the Commission should avoid any unnecessary duplication of
    notifications by checking previous notifications in the available database used by
    national authorities or by the Commission.
    7.2 Examination in relation to the scope of RAPEX
    The Commission will check whether the product notified is a consumer product falling
    under the scope of the GPSD as far as RAPEX provisions are concerned and whether it
    is covered by equivalent alert system.
    The Commission will also verify that the notification complies with the GPSD and with
    the provisions applicable to the functioning of RAPEX.
 ---pagebreak--- 30.4.2004                 EN              Official Journal of the European Union      L 151/105
    The Commission will not make a risk assessment of the product. Therefore, Member
    States should include in all notifications a complete summary of their risk evaluation
    and the results of any tests or analyses carried out to assess the level of risk.
    In the first instance, the Commission will base its conclusions on the classification of
    the notification on the information provided by the notifying Member State.
    After examination the Commission will forward the notification to the other Member
    States or ask for clarification or additional information from the notifying Member
    State.
    7.3 Examination of the follow-up reactions
    On the basis of the examination of the information obtained from the notifications and
    reactions, the Commission will decide on the appropriate action, such as to:
    -   convene the GPSD Committee to discuss the information received and the results
        obtained and to evaluate the measures taken or to adopt;
    -   request an independent risk assessment;
    -   institute an investigation in cooperation with Member States;
    -   consult a Commission Scientific Committee;
    -   mandate the standardisation bodies to draft new standards or amend existing ones
        if clear and consistent safety specifications are not available for a category of
        products;
    -   inform Third countries;
    -   prepare proposals for new or modified legislation;
    -   launch the procedure for a Commission Decision based on Article 13 of the GPSD
        in urgent cases.
    15 days after the date on which the reaction period has expired (45 days after the
    notification was sent), the Commission will send the national contact points a report
    with:
    -   the final conclusion on the notification taking into account the information
        received as reactions from Member States. If no further follow-up is required the
        file will be closed. If new developments concerning the notification occur later, the
        Commission will reopen the file;
    -   the follow-up actions to be taken by the Member States if any reactions are still
        outstanding or if there are different national approaches.
    The GPSD Committee will be periodically informed of all the notifications received and
    of the follow-up.
 ---pagebreak--- L 151/106               EN                Official Journal of the European Union  30.4.2004
8. NETWORK FOR THE EXCHANGES UNDER RAPEX
    8.1 Setting up of two-way internal networks by the Member States to collect and
    to distribute the relevant information
    Member States should ensure that there are systems at national level so that their
    national, regional or local authorities are aware of their responsibilities and of the
    action they should take to inform other services if a problem comes to light in their
    area.
    Member States should establish a two-level internal structure consisting of:
    -   a single contact point with the Commission. This contact point will send the
        Commission and receive from the Commission all information exchanged through
        RAPEX; and
    -   a national network involving all the authorities responsible for product safety.
        These authorities send to and receive from the contact point the notifications and
        reactions. The composition of the network should be communicated to the
        Commission.
    8.2 Designation of the authorities in charge of notifying the Commission and to
    whom the Commission communicates notifications
    The main tasks of the national contact points are:
    a) before sending a notification to the Commission
        -   to verify the information received from the national, regional or local
            authorities in order to decide whether use of the RAPEX system is required
            (based on the Directive, the guidelines and previous experience);
        -   to check if the product has already been notified or information related to it
            exchanged in order to avoid any unnecessary duplication;
        -   to check that the notification form and the information are complete;
        -   to classify the information into one of the predefined categories of
            notifications.
    b) after receiving information from the Commission
        -   to transmit the information to the national, regional or local authorities
            responsible for product safety at the various different levels;
        -   to ensure follow-up of the information;
        -   to inform the Commission of their conclusions.
    National contact points should also:
 ---pagebreak--- 30.4.2004                  EN               Official Journal of the European Union   L 151/107
          -   help explain the obligations and requirements created by Community and
              national legislation for producers and distributors concerning the notification
              of dangerous products;
          -   assist in the creation of a network culture among the different national
              authorities at the various different levels;
          -   assist these authorities in the use of RAPEX;
          -   ensure that the internal procedures for information exchange work properly.
     8.3 Setting up of cooperation arrangements between the competent authorities, in
     particular with customs.
     Customs officials’ decisions to block or to reject products at the EU borders for safety
     reasons are also of interest to market surveillance authorities and the Commission. The
     legal basis for such decisions is Council Regulation (EEC) No 339/93 of 8 February
     199315 on checks for conformity with the rules on product safety in the case of
     products imported from Third countries and Commission Decision 93/583/EEC of 28
     July 199316 drawing up a priority and non-exhaustive list of products as provided for
     in Article 8 of Regulation 339/93/EEC.
     Contact points should inform the Commission about these decisions. This information
     is only pertinent if the consumer product blocked or rejected presents a serious risk.
     The Commission will transmit the information to the contact points and they should
     circulate this information to customs officials in their country in order to prevent the
     entry of these products within the European market.
     The reasons for prohibiting entry into the EU should be mentioned in the documents
     accompanying the dangerous products.
     Contact points should also inform their customs authorities of the measures and
     actions taken by market surveillance authorities relating to imported products
     presenting a serious risk in order to avoid further imports of the same product into the
     EU market.
     8.4 Means of communication, practical and technical arrangements applicable
     Languages:
     The contact points in the Member States may issue the notification in their national
     language and/or in English. The notifications will be translated into English, French,
     German, Italian and Spanish by the Commission.
     Transmission via Internet
     The RAPEX system uses an Internet-based software application as a communication
     tool between the contact points linked to a database containing all the information
15
   OJ L 040, 17/02/1993 p. 1
16
   OJ L 279, 12/11/1993 p. 0039
 ---pagebreak--- L 151/108                 EN                 Official Journal of the European Union   30.4.2004
    from the notifications and reactions. This system, which is accessible via
    https://reis.cec.eu.int/reis, includes all the forms and a User’s Guide.
    If there are technical problems with this site, contact points may send notifications and
    reactions by e-mail (mail box: Sanco-Reis@cec.eu.int) or by fax if (and only if) e-mail
    transmission is not possible (+32.2.296.43.23).
    Out-of-hours service and permanent staffing during periods of closure:
    As emergencies may arise out of working hours, Member States should ensure that
    their national, regional or local authorities can be contacted in urgent cases such as for
    notifications requiring emergency action by Member States.
    Changes at national contact point level are to be communicated immediately to the
    Commission, which will forward them to the other Member States.
    The Commission will ensure the proper functioning of the RAPEX system during
    weekends, periods of closure and holidays.
    Weekends:
    The contact points can reach the officials in charge of RAPEX operations by telephone
    (mobile phone) in case of an emergency. This will allow rapid organisation of an early
    warning.
    Longer periods of closure:
    It should be noted that the Commission contact point ensures holiday coverage by
    using a mobile phone and a laptop computer that can be linked into the system via the
    Internet. In emergencies, before sending the notification to the Commission, national
    contact points should contact the Commission official in charge of the permanent
    staffing, using a mobile phone number which will be communicated to contact points
    before the holiday period starts.
    Contact points are also requested to provide similar coverage during weekends, short
    periods of closure and holiday periods. A list of emergency phone numbers, e-mails
    and faxes for the RAPEX contact points is established by the Commission to ensure
    that RAPEX members can be reached without delay. Any subsequent change should be
    communicated to the Commission.
9. COORDINATION                      BETWEEN                RAPEX              AND   OTHER
    NOTIFICATION MECHANISMS
    9.1 Cases in which a measure notified under RAPEX must also be notified under
    another mechanism
    Whenever a measure with binding legal effects relates to consumer products covered
    by specific community legislation such as toys, electrical appliances, etc., it should also
    be considered under the sector specific notification mechanism applicable (safeguard
 ---pagebreak--- 30.4.2004                  EN              Official Journal of the European Union     L 151/109
     clause). The RAPEX system and the sector specific safeguard clauses involve separate
     legal obligations to notify because they serve different purposes.
     For further information on the relationship between the notification procedures and
     their purposes, please see the separate “Guidance Document on the Relationship between the
     GPSD and Certain Sector Directives17”.
     9.2 Arrangements for simplifying the submission of notifications due under
     different mechanisms
     When products are covered by other Community legislation with a notification
     procedure for national measures (safeguard clause), the Commission will, through its
     internal procedures, ensure that a single notification from national authorities fulfils
     the different obligations to inform the Commission under Community legislation.
     A common notification form covering both the safeguard clause of Directive
     88/378/EEC on Safety of Toys18 and RAPEX is given in Annex III.
10.NOTIFICATIONS UNDER ARTICLE 11 OF THE GPSD
     10.1 Scope of these notifications
     The procedure in Article 11 of the GPSD covers the exchange of information between
     the Member States and the Commission for consumer products (as described in
     chapter 2.1) that do not present a serious risk to the health and safety of consumers
     (taking into account the criteria on serious risk outlined in chapter 3).
     Measures that Member States adopt, such as those described in chapter 2.3, which
     restrict the placing on the market of products that do not pose a serious risk, have to be
     notified to the Commission specifying the reasons for adopting them.
     The notifying Member State should inform the Commission of any amendment to the
     measure taken and of the final decision taken on the product in question.
     If the Member State considers that the effects of the risk do not, or cannot, go beyond
     its territory, it should notify the measures concerned insofar as they involve
     information likely to be of interest to other Member States as defined in chapter 2.5.
     10.2 Contents of the notifications
     The notifying Member State has to include in the Notification Form (Annex I):
     -     a detailed description and photograph of the product in order to facilitate its
           identification by the enforcement authorities;
     -     the results of the risk assessment carried out by the authority that justify the
           measure adopted;
17
   http://europa.eu.int/comm/consumers/cons_safe/prod_safe/gpsd/revisedGPSD_en.htm
18
   OJ L 187, 16/07/1988 p. 1
 ---pagebreak--- L 151/110                 EN               Official Journal of the European Union   30.4.2004
    -    the scope, nature, duration and follow-up of the measure taken in order to avoid
         the risk;
    -    information enabling the product’s distribution channels and origin to be
         identified, and other information relating to its traceability.
    If all the information is not available, this should be indicated and justified together
    with a timetable for providing the missing information.
    10.3 Processing and deadlines for circulation of Article 11 notifications
    National contact points are required to notify the Commission of the measures and
    actions taken as soon as possible and in any case not later than 15 days after the
    competent authorities have taken the decision restricting the marketing or use of
    products by reason of a risk.
    This deadline is irrespective of any appeal procedure entered into by the producer or
    distributor and of official publication requirements.
    The Commission will assess, on the basis of the information contained in the
    notification, whether it complies with Community law and with the guidelines. If
    necessary it will contact the notifying country to obtain additional information.
    The Commission will circulate the notification to the other Member States within 15
    days of its reception unless it concludes that the measure does not comply with the
    requirements. In this case the Commission will inform the Member State which
    initiated the action, explaining the reasons for its conclusion.
    The Member State which initiated the action may resubmit the notification taking into
    account the comments from the Commission.
    Under this procedure the other Member States receiving a new Article 11 notification
    are not required to inform the Commission about the follow-up given to the
    notification.
    10.4 Practical arrangements for the transmission of Article 11 notifications
    Contact points and the Commission will use the Internet site https://reis.cec.eu.int/reis
    for the transmission of Article 11 notifications. The standard form for Article 11
    notifications and the User’s Guide for the Internet application are available on this site.
    If there are technical problems with this site, contact points may send notifications by
    e-mail (mail box: Sanco-Reis@cec.eu.int) or by fax if (and only if) e-mail transmission is
    not possible (+32.2.296.43.23).
 ---pagebreak--- 30.4.2004                EN              Official Journal of the European Union       L 151/111
                                        (Annex I)
                              NOTIFICATION FORM
                □ in application of Article 11 of Directive 2001/95/EC
                □ in application of Article 12 of Directive 2001/95/EC
                  □ requiring emergency action from Member States
GENERAL INFORMATION
01.       Notifying country and contact person:
02.       Date of notification:
PRODUCT
03.       Category of products and Customs code:
04.       Product name, brand, price and country of origin:
05.       Type/Number of model/Bar Code/Batch code:
06.       Description/photograph (format .jpg) of the product and its packaging:
07.       Standards or regulations applicable:
08.       Proof of conformity:
PRODUCER
09.       Name, address and contact information for the manufacturer or its representative:
10.       Name, address and contact information of the exporter/importer:
DISTRIBUTOR and RETAILER
11.       Name, address and contact information for the distributors or their representatives:
12.       Supplier (shop, supermarket, by mail, Internet) and countries of destination:
DANGER
13.       Type of risk :
14.       Summary of the results of tests/analyses and conclusions:
15.       Description of accidents which have occurred:
 ---pagebreak--- L 151/112               EN               Official Journal of the European Union 30.4.2004
MEASURES ADOPTED
16.       Voluntary measures (scope, nature and duration):
17.       Compulsory measures (scope, nature and duration):
OTHER INFORMATION
18.       Additional information:
 ---pagebreak--- 30.4.2004              EN           Official Journal of the European Union L 151/113
                                   (Annex II)
                     REACTION TO NOTIFICATION
        in application of Article 12 of Directive 2001/95/EC
01.      Reacting country and contact person:
02.      Date of reaction:
03.      Notification number, notifying country and product name:
04.      Product found: yes/no
05.      Assessment of the risk:
06.      Voluntary measures (scope, nature, duration and justification):
07.      Compulsory measures (scope, nature, duration and justification):
08.      Duration:
09.      Other information:
 ---pagebreak--- L 151/114                     EN                    Official Journal of the European Union             30.4.2004
                                                (Annex III)
                                     NOTIFICATION FORM FOR TOYS
Please tick the appropriate box below:
[]       Notification under Article 7 of Directive         Use Parts 1 and 2 of the form
         88/378/EEC of 3 May 1988 on Safety of
         Toys – Safeguard clause                           To be sent via the Permanent Representation to the
                                                           EU to the Secretary General of the Commission with
                                                           electronic      copy      to     Entr-Textile-Leather-
                                                           Toys@cec.eu.int
[]       Notification under Article 12 of Directive        Use Parts 1 and 2 of the form
         2001/95/EC on General Product Safety and
         under Article 7 of Directive 88/378/EEC on        To be sent via https://reis.cec.eu.int/reis and to
         Safety of Toys                                    ENTR-Textile-Leather-Toys@cec.eu.int
                                                           As the notification is a safeguard clause it must also
                                                           be sent via the Permanent Representation to the
                                                           Secretary-General of the Commission.
                                                      PART 1
                        SAFEGUARD CLAUSE UNDER ARTICLE 7 OF
                           DIRECTIVE 88/378/EEC ON TOY SAFETY
Please tick the appropriate box below, and state the reasons for:
                    Non-compliance is a result of:                Reasons
                    []     Failure to meet the essential
                           requirements referred to in
                           Article 3, if the toy does not meet
                           the standards (Article 7(1)(a))
                    []     Incorrect application of         the
                           standards (Article 7(1)(b))
                    []     Shortcomings in the standards
                           (Article 7(1)(c))
ADDITIONAL INFORMATION ANNEXED
                    Copy of the test reports, certificates,
                    examinations, etc.
                    Copy of the national measure
 ---pagebreak--- 30.4.2004                EN              Official Journal of the European Union       L 151/115
                                            PART 2
                    in application of Article 12 of Directive 2001/95/EC
                      requiring emergency action from Member States
GENERAL INFORMATION
01.       Notifying country and contact person:
02.       Date of notification:
PRODUCT
03.       Category of products and Customs code:
04.       Product name, brand, price and country of origin:
05.       Type/Number of model/Bar Code/Batch code:
06.       Description/photograph (format .jpg) of the product and its packaging:
07.       Standards or regulations applicable:
08.       Proof of conformity:
PRODUCER
09.       Name, address and contact information for the manufacturer or its representative:
10.       Name, address and contact information of the exporter/importer:
DISTRIBUTOR and RETAILER
11.       Name, address and contact information for the distributors or their representatives:
12.       Supplier (shop, supermarket, by mail, Internet) and countries of destination:
DANGER
13.       Type of risk:
14.       Summary of the results of tests/analyses and conclusions:
15.       Description of accidents which have occurred:
MEASURES ADOPTED
16.       Compulsory measures (scope, nature and duration):
OTHER INFORMATION
17.       Additional information:
 ---pagebreak--- L 151/116                EN                Official Journal of the European Union        30.4.2004
                                       (Annex IV)
          DEADLINES for NATIONAL CONTACT POINTS
                              ACTION                                             DEADLINE
                                                                               (see chapter 5)
 Send notifications relating to emergency situations to the ASAP or                     maximum
 Commission                                                               three days
 Notify the Commission of decisions and actions taken:                    ASAP or maximum 10
                                                                          days
       -  by the authorities in cases of serious risk;
       -  as agreed between authorities and producers and
          distributors.
 Notify the Commission of voluntary measures by producers ASAP or maximum 10
 and distributors                                                         days
 Send the Commission information on serious risks liable to ASAP or maximum 10
 be exchanged under RAPEX                                                 days
 Inform the Commission of decisions and actions taken by the ASAP or maximum 15
 authorities in case of products not presenting a serious risk            days
 Confirm or modify information already provided before the ASAP or maximum 45
 decision on the measure was taken                                        days
 Update the Commission on any modification or lifting of the ASAP or maximum five
 notified measure or action                                               days
 React to a notification requiring emergency action from ASAP or maximum 20
 Member States                                                            days
 React to a notification of decisions and actions taken by the ASAP or maximum 45
 authorities, of measures and actions agreed between days
 authorities and producers and distributors, of voluntary
 measures by producers and distributors
 React to notifications related to products manufactured or ASAP or maximum 15
 first marketed in its territory                                          days
 ---pagebreak--- 30.4.2004                EN            Official Journal of the European Union           L 151/117
                                      (Annex V)
      DEADLINES for the COMMISSION CONTACT POINT
                                                                              DEADLINE
                            ACTION                                       (from reception of the
                                                                           information by the
                                                                              Commission)
 Send notifications relating to emergency situations to ASAP or                       maximum
 national contact points                                               three days
 Notify national contact points of decisions and actions taken ASAP or maximum five
 by the authorities, of measures and actions agreed between days
 authorities and producers and distributors, of voluntary
 measures by producers and distributors
 Send information on serious risks liable to be exchanged ASAP or maximum five
 under RAPEX to the national contact points                            days
 Send the national contact points notifications presented ASAP or maximum 15
 under Article 11 of the GPSD                                          days
 Send reactions to notifications requiring emergency follow- ASAP or                  maximum
 up by the national contact points                                     three days
 Send reactions to notifications of decisions and actions taken ASAP or maximum five
 by the authorities, of measures and actions agreed between days
 authorities and producers and distributors, of voluntary
 measures by producers and distributors
 Send a reminder to national contact points that have not 45 days after the original
 reacted to a notification                                             notification was sent