Corrigendum to Commission Decision 2004/418/EC 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 (OJ L 151, 30.4.2004)
Date: 2004-06-10
Institutions: European Commission
Subjects: access to EU information, consumer protection, information system, product safety, public health

10.6.2004

EN

Official Journal of the European Union

L 208/73

Corrigendum to Commission Decision 2004/418/EC of 29 April 2004 laying down guidelines for the manage-
ment of the Community Rapid Information System (RAPEX) and for notifications presented in accordance
with Article 11 of Directive 2001/95/EC

(Official Journal of the European Union L 151 of 30 April 2004)

Decision 2004/418/EC should read as follows:

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,

(4)

Having regard to the Treaty establishing the European Com-
munity,

Having regard to Directive 2001/95/EC of the European Parlia-
ment 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 Direc-
tive 2001/95/EC,

Whereas:

(1)

(2)

(3)

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
relating to
products posing a serious risk to the health and safety of
consumers.

and actions

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.

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.

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)

(6)

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.

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 mana-
ging 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.

(1) OJ L 11, 15.1.2002, p. 4.

The guidelines are set out in the Annex to this Decision.

L 208/74

EN

Official Journal of the European Union

10.6.2004

This Decision is addressed to the Member States.

Article 2

Done at Brussels, 29 April 2004.

For the Commission

David BYRNE

Member of the Commission

10.6.2004

EN

Official Journal of the European Union

L 208/75

ANNEX

for the management of the Community Rapid Information System (RAPEX) and for notifications presented
pursuant to Article 11 of Directive 2001/95/EC

GUIDELINES

L 208/76

EN

Official Journal of the European Union

10.6.2004

TABLE OF CONTENTS

1.

2.

3.

4.

5.

6.

7.

8.

9.

Introduction

General scope of RAPEX

Criteria for identifying serious risk

Contents of RAPEX notifications

Deadlines for submission and circulation of RAPEX notifications

Follow-up to RAPEX notifications

Examination by the Commission of notifications

Network for exchanges under RAPEX

Coordination between RAPEX and other notification mechanisms

10. Notifications under Article 11 of the GPSD

ANNEXES:

I:

II:

Notification form

Reaction form

III: Notification form for toys

IV: Deadlines for national contact points

V:

Deadlines for Commission contact point

10.6.2004

EN

Official Journal of the European Union

L 208/77

1.

INTRODUCTION

1.1. Background and objectives of the guidelines

Directive 2001/95/EC (1) 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 func-

tioning 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.

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 autho-
rities of the Member States (2)’, 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;

(1) OJ L 11, 15.1.2002, p. 4.
(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.

L 208/78

EN

Official Journal of the European Union

10.6.2004

(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.

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 proce-
dure 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 consu-
mers 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,

10.6.2004

EN

Official Journal of the European Union

L 208/79

— 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 connec-
tion 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 informa-

tion

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/EEC (1) and 81/851/EEC (2),

— active implantable medical devices covered by Directive 90/385/EEC (3), medical devices covered by Directive

93/42/EEC (4), and in vitro diagnostic medical devices covered by Directive 98/79/EC (5),

— food and feed covered by Regulation (EC) No 178/2002 (6).

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 Directives (7)’.

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:

— 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.

(1) 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).
(2) 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).
(3) OJ L 189, 20.7.1990, p.17.
(4) OJ L 169, 12.7.1993, p.1; Directive as last amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).
(5) OJ L 331, 7.12.1998, p.1; Directive as last amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).
(6) OJ L 031, 01.2.2002, p. 1.Regulation as last amended by Regulation (EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4).
(7) http://europa.eu.int/comm/consumers/cons_safe/prod_safe/gpsd/revisedGPSD_en.htm

L 208/80

EN

Official Journal of the European Union

10.6.2004

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 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.

10.6.2004

EN

Official Journal of the European Union

L 208/81

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 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 vulner-
ability 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 suffi-
ciently 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 hazard (1).

(1) 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
usually reversible and not requiring
hospital treatment.

2 – 15 % incapacity
usually irreversible requiring hospital
treatment

>15 % incapacity
usually irreversible

Minor cuts

Minor fractures

Serious cuts

Serious injury to internal organs

Loss of finger or toe

Damage to sight

Loss of limbs

Loss of sight

Damage to hearing

Loss of hearing

L 208/82

EN

Official Journal of the European Union

10.6.2004

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 influ-
enced 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. trip-
ping 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 charac-
terizing 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 defec-
tive, 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
health/safety
of
damage from regular exposure
to hazardous product

Hazard is always present and
health/safety damage is likely
to occur in foreseeable use

Probability of hazardous product

1 %

10 %

100 %
(All)

Medium

High

Very High

Hazard may occur under one
improbable or
two possible
conditions

Low

Medium

High

Hazard only occurs if several
improbable conditions are met

Very Low

Low

Medium

Combining the severity and overall probability in Table A gives an estimation of the gravity of the risk. The accu-
racy 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 chil-
dren'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.

10.6.2004

EN

Official Journal of the European Union

L 208/83

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

Blind

Severely disabled

Very old

Very young (<3 yrs)

Normal adults

Vulnerable

Partially sighted

Partially disabled

Elderly

Young (3 – 11 yrs)

The adjustment of the seriousness of risk for normal adults should only apply if the hazard is obvious and neces-
sary 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).

L 208/84

EN

Official Journal of the European Union

10.6.2004

10.6.2004

EN

Official Journal of the European Union

L 208/85

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 notifi-
cation 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 proceed-
ings, 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,

— 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 793/93 (1) in the case of an existing substance or
in Article 3(2) of Directive 67/548/EEC (2) in the case of a new substance.

(1) OJ L 84, 5.4.1993, p. 1.
(2) OJ 196, 16.8.1967, p. 1/67. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).

L 208/86

EN

Official Journal of the European Union

10.6.2004

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 produ-
cers 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,

— 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 days (1) after
the competent authorities have taken the decision or have decided to adopt measures (2) 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 noti-
fying 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.

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.

(1) All deadlines mentioned in the text are expressed in calendar days.
(2) The measures, decisions and actions to be notified under RAPEX are described in point 2.3 of these guidelines.

10.6.2004

EN

Official Journal of the European Union

L 208/87

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 recep-

tion,

— 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.

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.

L 208/88

EN

Official Journal of the European Union

10.6.2004

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,

— 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
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.

10.6.2004

EN

Official Journal of the European Union

L 208/89

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 infor-
mation 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 autho-
rities of the Member State where the product is manufactured in order to complete the information on the distribu-
tion 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 of the Member State where the product was first marketed in order to obtain informa-
tion 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.

L 208/90

EN

Official Journal of the European Union

10.6.2004

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.

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 infor-
mation 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.

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 authori-
ties 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.

10.6.2004

EN

Official Journal of the European Union

L 208/91

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 notifi-

cations

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:

— 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 1993 (1) 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 1993 (2) 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 surveil-
lance authorities relating to imported products presenting a serious risk in order to avoid further imports of the
same product into the EU market.

(1) OJ L 40, 17.2.1993, p. 1; Regulation as last amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).
(2) OJ L 279, 12.11.1993 p. 39.

L 208/92

EN

Official Journal of the European Union

10.6.2004

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 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 29 64 323).

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 legisla-
tion such as toys, electrical appliances, etc., it should also be considered under the sector specific notification
mechanism applicable (safeguard clause). The RAPEX system and the sector specific safeguard clauses involve sepa-
rate 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 Directives (1)'.

(1) http://europa.eu.int/comm/consumers/cons_safe/prod_safe/gpsd/revisedGPSD_en.htm

10.6.2004

EN

Official Journal of the European Union

L 208/93

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 Toys (1) 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,

— 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 infor-
mation.

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.

(1) OJ L 187, 16.7.1988 p. 1.

L 208/94

EN

Official Journal of the European Union

10.6.2004

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 applica-
tion 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 29 64 323).

10.6.2004

EN

Official Journal of the European Union

L 208/95

Annex I

L 208/96

EN

Official Journal of the European Union

10.6.2004

ANNEX II

10.6.2004

EN

Official Journal of the European Union

L 208/97

ANNEX III

L 208/98

EN

Official Journal of the European Union

10.6.2004

10.6.2004

EN

Official Journal of the European Union

L 208/99

ANNEX IV

Deadlines for national contact points

Action

Deadline
(see Chapter 5)

Send notifications relating to emergency situations to the
Commission

ASAP or maximum three days

Notify the Commission of decisions and actions taken:
— by the authorities in cases of serious risk;
— as agreed between authorities and producers and distri-

butors.

ASAP or maximum 10 days

Notify the Commission of voluntary measures by produ-
cers and distributors

ASAP or maximum 10 days

Send the Commission information on serious risks liable
to be exchanged under RAPEX

ASAP or maximum 10 days

Inform the Commission of decisions and actions taken by
the authorities in case of products not presenting a serious
risk

ASAP or maximum 15 days

Confirm or modify information already provided before
the decision on the measure was taken

ASAP or maximum 45 days

Update the Commission on any modification or lifting of
the notified measure or action

ASAP or maximum five days

React to a notification requiring emergency action from
Member States

ASAP or maximum 20 days

React to a notification of decisions and actions taken by
the authorities, of measures and actions agreed between
authorities and producers and distributors, of voluntary
measures by producers and distributors

ASAP or maximum 45 days

React to notifications related to products manufactured or
first marketed in its territory

ASAP or maximum 15 days

L 208/100

EN

Official Journal of the European Union

10.6.2004

ANNEX V

Deadlines for the Commission contact point

Action

Deadline
(from reception of the information by the Commission)

Send notifications relating to emergency situations to
national contact points

ASAP or maximum three days

Notify national contact points of decisions and actions
taken by the authorities, of measures and actions agreed
between authorities and producers and distributors, of
voluntary measures by producers and distributors

ASAP or maximum five days

Send information on serious risks liable to be exchanged
under RAPEX to the national contact points

ASAP or maximum five days

Send the national contact points notifications presented
under Article 11 of the GPSD

ASAP or maximum 15 days

Send reactions
follow-up by the national contact points

to notifications

requiring

emergency

ASAP or maximum three days

Send reactions to notifications of decisions and actions
taken by the authorities, of measures and actions agreed
between authorities and producers and distributors, of
voluntary measures by producers and distributors

ASAP or maximum five days

Send a reminder to national contact points that have not
reacted to a notification

45 days after the original notification was sent