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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 Eu ropean 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 enforc ement activities in the Member States, and 
provides a basis for identifying need s for action at Community level. 
(3) The notification procedure under Articl e 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 wh ich do not present a serious risk to the 
health and safety of consumers. 
                                                
 
1 OJ L 11, 15.1.2002 , p. 4. 
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(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 th at 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 RAPE X 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 fo r the various steps of the notification 
procedures. 
(6) The guidelines should be addressed to the na tional authorities designated as contact points 
in the RAPEX and in charge of the notifica tion procedure under Article 11 of Directive 
2001/95/EC. The Commission should use the gu idelines 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 Inform ation 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 
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ANNEX  
 
   
 
 
GUIDELINES 
 
for the management of the Community Rapid Information System 
(RAPEX) and for notifications presen ted in accordance with Article 
11 of Directive 2001/95/EC 
 
 
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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 an d 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 
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1. INTRODUCTION 
1.1 Background and Object ives of the guidelines 
Directive 2001/95/CE1 on general product safety (GPS D) 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 re lation 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 Articl e 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 presen t 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 informat ion 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 exi stence of a serious risk even 
before measures are adopted or actions taken; 
c) to obtain and circulate to all Member Stat es 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 consum ers of products which pose a se rious 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 effectiv eness and consistency of market surveillance and 
enforcement activities in the Member States; 
c) identifying the need and providing a basis fo r action at Community level, where necessary; 
d) contributing to the consistent enforcemen t 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. 
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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 de velopments, to facilitate the effective operation 
of RAPEX by the Commission and the comp etent authorities of the Member States2”, in other 
words these guidelines are intended to facilitate  the effective and consi stent 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, acti on and situations that need to be notified; 
- providing guidance on how to notify the Co mmission of measures taken by producers or 
distributors on a voluntary basis, in agreemen t with the authorities or when required by 
these authorities; 
- providing criteria for identifyin g “local events” (cases where the effects of the risk in question 
do not, or cannot, go beyond the territory of on e 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 notification s 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 notifica tions 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 arra ngements at Commission and Member States level 
for the operation of RAPEX and all the relevant technical details. 
These guidelines provide also gu idance on the notification procedure of Article 11 of the GPSD 
by clarifying the scope of the procedure, detailin g 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. 
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1.2 Status and further developments of the guidelines 
Status :  
These are operational guidelines. These guid elines 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 notificati ons presented according to Article 11 of the 
GPSD. 
Further developments : 
These guidelines will need to be adapted in the light of experien ce and of new developments. The 
Commission will update or amend them as nece ssary 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 poin ts and in charge of the notification procedure 
under Article 11 of the Directive. The Commissio n 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 GP SD and criteria for applying this definition 
for the aims of RAPEX 
The provisions of the GPSD, and in particular th e 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 co ntext of providing a service – which is intended for 
consumers or likely, under reasonably foreseeable condit ions, to be used by consumers even if not intended 
for them, and is supplied or made avai lable, 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 profe ssional 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 ha ve subsequently also 
been marketed to consumers; 
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- products provided in the context of a servic e: 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 cove red by specific and equivalent requirements 
for the rapid exchange of information 
The following products are excluded from RA PEX 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 device s covered by Directive 90/385/EEC5, medical devices 
covered by Directive 93/42/EEC6, and in vitro diagnostic me dical devices covered by 
Directive 98/79/EC7; 
- food and feed covered by Regulation (EC) No 178/20028. 
Further information on the relationship between th e different notification procedures established 
by Community law can be found in chapter 9.1 an d in the separate “Guidance Document on the 
Relationship between the GPSD and Certain Sector Directives9”. 
2.3 Measures, decisions and action s to be notified under RAPEX 
An indicative list of the different types of meas ures and actions of the competent authorities of 
the Member States that should be notified unde r 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 amen ded 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 amende d 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, establis hing 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 
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- 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 an y case, any subsequent change in the status of the 
measure should be communicated to the Commission. 
Under Article 5 producers and distributors are ob liged to inform the national authorities of 
voluntary actions or measures taken to prevent ri sk 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 risk s that may be exchanged under RAPEX 
Member States may inform the Commission of: 
- any information regarding the existence of a seri ous risk at the stage before deciding to adopt 
measures or to take action (Article 12.1, th ird subparagraph). In such cases RAPEX contact 
points should also inform the Comm ission about the final decision; 
- measures on a specific production batch wh ich has been withdrawn from the market by a 
Member State due a serious risk and when all it ems in this batch have been withdrawn from 
the market by the Member State; 
- customs authority decisions to block or to reje ct products at the EU borders if the consumer 
product blocked or rejected presents a seriou s 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 Countrie s or through equivalent  information systems 
established by other organisation s including non-EU countries. The Commission will evaluate the 
information and may transmit it to the Member States. 
These types of additional information on seriou s risks that may be exchanged under RAPEX do 
not require a formal reaction from the rest of Memb er 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 ef fects 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 
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local effect involves information on product safety  likely to be of interest for the other Member 
States, the authority should take into accoun t 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 combin ation 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 th e scope of RAPEX if the Member State which took 
the measure can conclude from the existing info rmation that the product could not be found in 
another Member State. 
Taking into account the free circulation of pr oducts at European level, the openness of the 
European economy and the fact th at consumers buy products not on ly in their home market but 
also during holidays abroad or by Internet, cont act 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 an d 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 ar e 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 rapi d 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 ju dge each individual case on its merits taking 
into account the criteria set out in these guidelin es 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 in trinsic hazard. The hazard may be of various 
types (chemical, mechanical, electrical, heat, radi ation etc.). The hazard represents the intrinsic 
potential of the product to damage the health and safety of users under certain conditions.  
The  se v e r ity  of  e ach ty pe of  hazar d m ay  b e gi ven 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 pres ent the hazard in question, but only some of 
the items placed on the ma rket. 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 ex posed to it when using the product as intended 
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or as could reasonably be expected during its life time. 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 cons umer who may be exposed. 
Taking into account the above considerations, the following conceptual approach may assist 
enforcement officers to decide whether a specif ic 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 determin e the gravity of the outcome of a hazard, 
depending on both its severity and probabilit y 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 a ssess 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 sufficien tly 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 factor s affecting the risk estimation , namely the severity and the 
probability of health/safety damage, are combin ed. 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 considerat ion 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 follow ing 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  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 
 
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The assessment of severity should also take in to 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 
t o  m o r e  t h a n  o n e  p e r s o n  a t  a  t i m e  ( e . g .  f i r e  o r  g a s  p o i s o n i n g  f r o m  a  g a s  a p p l i a n c e )  s h o u l d  b e  classified as more severe than a haza rd 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 popula tion 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 un likely circumstances which could lead to very 
serious effects, e.g. tripping over  cable, falling and banging head le ading 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 fo r 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/s afety 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 be coming 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 follow ing 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) 
Hazard is always present and health/safety damage is likely to occur in foreseeable use Medium 
 High 
 Very 
High  
Hazard may occur under one improbable or two possible conditions Low 
 Medium 
 High Probability of 
health/safety damage from regular exposure to hazardous product Hazard only occurs if several 
improbable conditions are met Very Low Low Medium 
 
 
                                                                                                                                                                                           
 
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Combining the severity and overall probability in Table A gives an e stimation 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, su ch as children’s toys. Ta ble 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 th at is considered to be serious are the vulnerability of the type of 
person affected and for normal adults, the knowle dge of the risk and the possibility of taking 
precautions against it. 
Vulnerable people 
The type of person using a product should be take n into account. If the product is likely to be 
used by vulnerable people, the level of risk whic h is serious should be se t 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 produc t. For normal adults the level of risk which is 
serious should be dependent on whether the haza rd is obvious and whether the manufacturer has 
taken adequate care to make the product safe an d 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). 
 
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 Risk Assessment of consumer products for the GPSD
Table A - Risk Estimation Table B – Grading of  Risk
No Yes No YesAdequate warnings 
and safeguards? 
No No Yes Yes obvious hazard? 
Very High High Very High
Very High High Medium High
High Medium Low Moderate
Medium Low Very Low Low
Low Very Low Very low
a serious risk situation exists and rapid action is required
The High   gravity is therefore intolerable so a serious risk   situation exists and rapid action is required. 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  . 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 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)  
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.
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.SERIOUS RISK - RAPID ACTION REQUIREDSeverity of Health/Safety Damage
Overall 
Gravity of 
OutcomeVulnerable people Normal adults
Slight Serious Very SeriousVery 
vulnerable Vulnerable Probability of Health/Safety 
 Dama ge 
Low risk - Action unlikely Moderate risk - Some action required
 
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4. CONTENTS OF RAPEX NOTIFICATIONS 
4.1 Information to be entere d on the notification form 
Information should be as complete as possibl e: 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 expl ained. 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 in clude all the data need ed to identify the 
dangerous product, trace its origin, identi fy the marketing and distribution channels, 
determine the related risks, etc. 
Confidentiality could be requested if disc losure of the information would undermine 
the protection of court proceedings, monitoring and investigation activities or professional secrecy, unless ther e were an overriding public interest in disclosure of the 
information to protect the heal th and safety of consumers. 
The notifying Member State could also re quire 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 th e 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 partic ular, results of tests carried out by the 
authority; 
- the scope and the nature of the measur e 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 meas ure 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; 
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- the information needed to  identify the product’s di stribution 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 Th ird 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, da te 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 e ffects 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
11 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 measure s taken by producers and distributors 
Article 5(3) of the GPSD obliges producer s and distributors to inform the national 
authorities of any voluntary action or meas ure 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 fr om producers and distributors concerning 
a risk and the voluntary actions taken to avoi d 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 a ccount the criteria outlined in chapter 3. 
Such notification at Community level is requir ed 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 am ended by Commission Directive 2000/33/EC (OJ L 136, 
8.6.2000, p. 90). 
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- 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 authorit ies would take in order to monitor the 
effectiveness of the voluntary measures  taken by producers and distributors; 
- actions provided for in other Member St ates by the producers or distributors. 
5. DEADLINES FOR SUBMISSION AND CIRCULATION OF RAPEX 
NOTIFICATIONS 
5.1 Deadlines for submitting notificati ons to the Commission by the Member 
States 
National contact points are required to noti fy the Commission as soon as possible and 
at the latest 10 days13 after the competent authorities ha ve 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 distribut ors which have been notified to the 
authorities by reason of a serious risk and which go beyond the te rritory 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 emerge ncy action from Member States (as defined 
in Chapter 7.1), the notifying national co ntact 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 exchange d 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.  
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National contact points are required to noti fy the Commission as soon as possible and 
at the latest 15 days after the competent auth orities have taken the decision or have 
decided to adopt measures restricting the ma rketing 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 insta nce between local and central authorities). 
Appropriate arrangements should be put in pl ace at national level in order to ensure 
rapid transmission of the information betw een the different national authorities in 
charge of product safety. 
These deadlines apply irrespective of an y appeal procedure entered into by the 
producer or distributor or official publication requirements. 
5.2 Commission deadlines for the transmissi on of notifications to all the Member 
States 
The Commission will transmit the notificati on to the contact points only if the 
notifying Member State has provided the e ssential 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 GP SD) 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 take n 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 Co mmission 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. 
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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 confir m 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 assessm ent of the risk (if needed); 
- evaluate whether national measures shou ld 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 reacti on 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 no t require Member States to inform the 
Commission of the follow-up given to the information received. 
After receiving a notification requiring emer gency action from Member States or an 
Alert notification (Article 12) all Memb er States are required to inform the 
Commission, using the Reaction form in Anne x 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 th e reasons justifying a different measure; 
- the special circumstances justifyin g 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 au thorities 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; 
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- 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 authorit ies of this country 
should inform the Commission about: 
- any contacts with the manufacturer’s repr esentative 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 th e 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 no t 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 late r 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 author ities, 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 au thorities of the Member State where the 
product is manufactured should react to th e notification within 15 days, providing 
information about the contacts with the ma nufacturer and the measures adopted to 
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ensure that the manufacturer will solve the problem at source. The same deadline is 
applicable to the Member State where th e 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 wh ere 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 noti fication 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 late r than three days if th e reaction relates to 
a notification requiring emergency follow-up from Member States; 
- as soon as possible and in any case not la ter than five days for other reactions to 
notifications on national measures, agr eements 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 examinatio n of the notifications by the Commission 
does not imply any assumption of responsibi lity for the information transmitted which 
remains with the notifying Member State. 
Specific internal arrangements have been put in place in or der 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 no t obtained the essential information for the 
notification, the Commission will contact th e authorities of the Member State where 
the product is manufactured in order to co mplete 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 wa s first marketed in the EU  and has not obtained the 
essential information of the notification, the Commission will contact the authorities 
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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 informatio n received is in conformity with EU 
legislation and with the provisions appl icable 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 acti on from Member States (serious risk, 
foreseeable need for measures to be ag reed 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 se rious 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 shou ld 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 RAPE X provisions are concerned and whether it 
is covered by equivalent alert system. 
The Commission will also verify that the noti fication complies with the GPSD and with 
the provisions applicable to the functioning of RAPEX. 
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The Commission will not make a risk assessm ent 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 prov ided by the notifying Member State. 
After examination the Commission will forwar d the notification to the other Member 
States or ask for clarification or addition al information from the notifying Member 
State. 
7.3 Examination of the follow-up reactions 
On the basis of the examination of the info rmation 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 Dec ision 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 co ncerning 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 di fferent national approaches. 
The GPSD Committee will be periodically inform ed of all the notifications received and 
of the follow-up. 
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8. NETWORK FOR THE EXCHANGES UNDER RAPEX 
8.1 Setting up of two-way internal networ ks 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 se rvices if a problem comes to light in their 
area. 
Member States should establish a two-le vel internal structure consisting of: 
- a single contact point with the Commission. This contact point will send the 
Commission and receive from the Commissi on all information exchanged through 
RAPEX; and 
- a national network involving all the au thorities 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 char ge 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 fr om the national, regional or local  
authorities in order to decide whether use of the RAPEX system is required (based on the Directive, the guid elines 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 fo rm and the information are complete; 
- to classify the information into on e of the predefined categories of 
notifications. 
b) after receiving information from the Commission 
- to transmit the information to the na tional, 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: 
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- help explain the obligations and re quirements 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 competen t 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 su rveillance 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-exhau stive 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 informatio n to the contact points and they should 
circulate this information to customs official s 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 notification s 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 
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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 si te, contact points may send notifications and 
reactions by e-mail (mail box: Sanco-Reis@cec.e u . in t )  o r  b y  f a x  i f  ( a n d  o n l y  i f )  e - m a i l 
transmission is not possible (+32.2.296.43.23). 
Out-of-hours service and permanent st affing during periods of closure: 
As emergencies may arise out of working ho urs, Member States should ensure that 
their national, regional or local authorities can be contacted in urgent cases such as for notifications requiring emergenc y action by Member States. 
Changes at national contact point level ar e to be communicated immediately to the 
Commission, which will forward them  to the other Member States. 
The Commission will ensure the proper fu nctioning 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 co ntact 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 th e 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 provid e 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 un der RAPEX must also be notified under 
another mechanism 
Whenever a measure with binding legal effe cts relates to consumer products covered 
by specific community legislation such as toys , electrical appliances, etc., it should also 
be considered under the sector specific no tification mechanism applicable (safeguard 
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clause). The RAPEX system and the sector sp ecific 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 su bmission of notifications due under 
different mechanisms 
When products are covered by other Commu nity legislation with a notification 
procedure for national measures (safeguard clause), the Commission will, through its 
internal procedures, ensure that a single no tification 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 co vers the exchange of information between 
the Member States and the Commission fo r 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 specifyi ng 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 meas ures concerned insofar as they involve 
information likely to be of interest to othe r Member States as defined in chapter 2.5. 
10.2 Contents of the notifications 
The notifying Member State has to includ e 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 
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- the scope, nature, duration and follow-u p of the measure taken in order to avoid 
the risk;  
- information enabling the product’s di stribution 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 circ ulation of Article 11 notifications 
National contact points are required to no tify 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 Co mmunity law and with the guidelines. If 
necessary it will contact the notifying coun try to obtain additional information.  
The Commission will circulate the notificati on 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 tran smission 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 notifi cations. The standard form for Article 11 
notifications and the User’s Guide for the Inte rnet 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). 
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(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 regu lations applicable: 
08. Proof of conformity:  
PRODUCER 
09. Name, address and contact information for the manufactur er or its representative: 
10. Name, address and co ntact information of th e exporter/importer:  
DISTRIBUTOR and RETAILER 
11. Name, address and contact in formation for the distributors or their representatives: 
12. Supplier (shop, supermar ket, by mail, Internet) and countries of destination: 
DANGER 
13. Type of risk :  14. Summary of the results of te sts/analyses and conclusions:  
15. Description of accident s which have occurred:  
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MEASURES ADOPTED 
16. Voluntary measures (scope , nature and duration):  
17. Compulsory measures (sco pe, nature and duration):  
OTHER INFORMATION 
18. Additional information:  
 
 
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(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:  
 
 
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(Annex III) 
NOTIFICATION FORM FOR TOYS 
 
Please tick the appropriate box below:  
[ ] Notification under Article 7 of Directive 
88/378/EEC of 3 May 1988 on Safety of Toys – Safeguard clause 
 Use Parts 1  and
 2 of the form 
To be sent via the Permanent Representation to the 
EU to the Secretary Genera l of the Commission with 
electronic copy to Entr-Textile-Leather-Toys@cec.eu.int 
[ ] Notification under Article 12 of Directive 
2001/95/EC on General Product Safety and  
under Article 7 of Directive 88/378/EEC on Safety of Toys Use Parts 1  and
 2 of the form  
To be sent via https://reis.cec.eu.int/reis and to 
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  
30.4.2004 EN Official Journal of the European Union 
 
 
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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 regu lations applicable: 
08. Proof of conformity: 
PRODUCER 
09. Name, address and contact information for the manufactur er or its representative: 
10. Name, address and co ntact information of th e exporter/importer:  
DISTRIBUTOR and RETAILER 
11. Name, address and contact in formation for the distributors or their representatives: 
12. Supplier (shop, supermar ket, by mail, Internet) and countries of destination: 
DANGER 
13. Type of risk:  
14. Summary of the results of te sts/analyses and conclusions:  
15. Description of  accide nts which have occurred:  
MEASURES ADOPTED 
16. Compulsory measures (sco pe, nature and duration):  
OTHER INFORMATION 
17. Additional information:  
 EN Official Journal of the European Union 30.4.2004 
 
 
 L 151/116
(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 
distributors. ASAP or maximum 10 
days 
Notify the Commission of voluntary measures by producers 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 
 
30.4.2004 EN Official Journal of the European Union 
 
 
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(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 ri sks 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 to notifications requiring emergency follow-up by the national contact points  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