2004/418/EC:Commission Decision of 29 April 2004 laying down guidelines for the management of the Community Rapid Information System (RAPEX) and for notifications presented in accordance with Article 11 of Directive 2001/95/EC
Date: 2004-04-29
Institutions: European Commission
Subjects: access to EU information, consumer protection, information system, product safety, public health

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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  European  Parliament  and  of  the  Council  of  3 
December  2001  on  general  product  safety  (1),  and  in  particular  the  third  subparagraph  of 
paragraph 1 of Article 11 thereof, 

After consulting the Committee set up by Article 15 of Directive 2001/95/EC, 

Whereas: 

(1) 

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

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. 

1 OJ L 11, 15.1.2002, p. 4. 

 
 
 
 
 
                                                 
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(4) 

(5) 

(6) 

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. 

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 
managing RAPEX and the Article 11 notification procedure, 

HAS ADOPTED THIS DECISION:  

Article 1 

The  Commission  hereby  adopts  guidelines  to  supplement  Directive  2001/95/EC  for  the 
management  of  the  Community  Rapid  Information  System  (RAPEX)  and  for  notifications 
presented in accordance with Article 11 of that Directive. 

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

Article 2 

This Decision is addressed to the Member States. 

Done at Brussels, 29 April 2004. 

   For the Commission 
       David BYRNE 
Member of the Commission 

 
 
 
 
 
 
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ANNEX  

GUIDELINES 

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

 
 
 
 
 
 
 
 
 
 
 
 
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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 and other notification mechanisms 

10. Notifications under Article 11 of the GPSD 

ANNEXES: 

I: Notification form 

II: Reaction form 

III: Notification form for toys 

IV: Deadlines for national contact points 

V: Deadlines for Commission contact point 

 
 
 
 
 
  
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1.  INTRODUCTION 

1.1 Background and Objectives of the guidelines 
Directive  2001/95/CE1  on  general  product  safety  (GPSD)  establishes  a  Community  Rapid 
Information System (RAPEX) for the rapid exchange of information between the Member States 
and the Commission on measures and actions in relation to consumer products posing a serious 
risk  for  the  health  and  safety  of  consumers  in  so  far  as  there  are  no  specific  provisions  in 
Community law with the same objective.  

Furthermore,  the  notification  procedure  in  Article  11  of  the  GPSD  is  intended  for  exchange  of 
information  between  the  Member  States  and  the  Commission  on  measures  and  actions  in 
relation  to  consumer  products  that  do  not  present  a  serious  risk  to  the  health  and  safety  of 
consumers. 

These  procedures  are  part  of  the  provisions  of  the  GPSD  aimed  at  ensuring  an  effective  and 
consistent enforcement of the applicable safety requirements. 

The objectives of the RAPEX system are: 

a) 

to  provide  a  rapid  exchange  of  information  between  Member  States  and  the  Commission 
about measures and actions taken in relation to consumer products because of a serious risk 
to the health and safety of consumers; 

b)  to  inform  Member  States  and  the  Commission  about  the  existence  of  a  serious  risk  even 

before measures are adopted or actions taken; 

c) 

to  obtain  and  circulate  to  all  Member  States  information  on  the  follow-up  given  to  the 
information exchanged by the Member States receiving it; 

with the aim of: 

a)  preventing the supply to consumers of products which pose a serious risk to their health and 
safety,  and  where  necessary  withdrawing  them  from  the  market  or  recalling  them  from 
consumers; 

b)  facilitating  the  monitoring  of  the  effectiveness  and  consistency  of  market  surveillance  and 

enforcement activities in the Member States; 

c) 

identifying the need and providing a basis for action at Community level, where necessary; 

d)  contributing to the consistent enforcement of Community product safety requirements and 

to the proper functioning of the internal market. 

The notification mechanism of Article 11 of the GPSD also facilitates prevention of the supply to 
consumers  of  dangerous  products  (not  presenting  a  serious  risk)  and  monitoring  of  market 
surveillance activities in the Member States. 

1 OJ L 11, 15.1.2002, p. 4. 

 
 
 
 
                                                           
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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 developments, to facilitate the effective operation 
of  RAPEX  by  the  Commission  and  the  competent  authorities  of  the  Member  States2”,  in  other 
words  these  guidelines  are  intended  to  facilitate  the  effective  and  consistent  application  of  the 
provisions of the GPSD related to notification procedures. 

The objectives of these guidelines are: 

a) 

to clarify the scope of RAPEX from the operational point of view, by 

- 

setting a conceptual framework for the provisions of the Directive related to products posing 
serious risks and in particular criteria for applying the concept of  “serious risk”; 

- 

giving guidance on the types of measures, action and situations that need to be notified; 

-  providing  guidance  on  how  to  notify  the  Commission  of  measures  taken  by  producers  or 
distributors  on  a  voluntary  basis,  in  agreement  with  the  authorities  or  when  required  by 
these authorities; 

-  providing criteria for identifying “local events” (cases where the effects of the risk in question 
do not, or cannot, go beyond the territory of one Member State) that could be of interest for 
all Member States, in which case they would have to be notified; 

- 

- 

setting criteria for notifying information on dangerous products to the Commission before a 
Member State decides to adopt measures or take actions; 

identifying the products covered by a specific equivalent exchange of information systems, 
therefore excluded from the scope of RAPEX; 

- 

classifying and indexing notifications according to the degree of urgency. 

b)  to  define  the  contents  of  the  notifications,  in  particular  the  information  and  data  required, 

and the forms to be used for the RAPEX system; 

c) 

to define the follow-up action to be taken by the Member States receiving a notification and 
the information to be provided on such follow-up; 

d)  to  describe  the  treatment  of  the  notifications  and  of  the  follow-up  information  by  the 

Commission; 

e) 

to set the deadlines for the various steps of the RAPEX processes; 

f) 

to define and document the practical arrangements at Commission and Member States level 
for the operation of RAPEX and all the relevant technical details. 

These guidelines provide also guidance on the notification procedure of Article 11 of the GPSD 
by clarifying the scope of the procedure, detailing the contents of notifications and establishing 
arrangements for treatment and transmission of notifications. 

2 In the context of this document the term "Member States" means all States which belong to the European Union and 

also those States which are parties to the EEA Agreement. 

 
 
 
                                                           
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1.2 Status and further developments of the guidelines 

Status:  

These  are  operational  guidelines.  These  guidelines  are  adopted  by  the  Commission,  after 
consultation  of  the  Member  States  within  the  GPSD  Committee  acting  in  accordance  with  the 
advisory procedure. 

They  therefore  represent  the  reference  document  for  the  application  of  the  provisions  of  the 
GPSD  concerning  RAPEX  as  well  as  for  notifications  presented  according  to  Article  11  of  the 
GPSD. 

Further developments: 

These guidelines will need to be adapted in the light of experience and of new developments. The 
Commission  will  update  or  amend  them  as  necessary  in  consultation  with  the  Committee 
referred to in Article 15 GPSD. 

1.3 To whom are the guidelines addressed 

These  guidelines  are  addressed  to  the  Member  States’  national  authorities  designated  to 
participate in the RAPEX network as contact points and in charge of the notification procedure 
under  Article  11  of  the  Directive.  The  Commission  will  use  these  guidelines  as  the  reference 
document for managing RAPEX and the notification procedure under Article 11 of the Directive. 

2.  GENERAL SCOPE OF RAPEX 

2.1 Definition of the products covered by the GPSD and criteria for applying this definition 
for the aims of RAPEX 

The provisions of the GPSD, and in particular the RAPEX procedure, apply to consumer products 
that pose a serious risk to consumers in so far as there are no specific provisions in Community 
law  with  the  same  objective.  Examples  of  products  covered  by  RAPEX  are  toys,  domestic 
electrical appliances, lighters, childcare articles, cars and tyres, etc. 

The products covered by the GPSD are defined in its Article 2(a): 

"product" shall mean any product – including in the context of providing a service – which is intended for 
consumers or likely, under reasonably foreseeable conditions, to be used by consumers even if not intended 
for them, and is supplied or made available, whether for consideration or not, in the course of a commercial 
activity, and whether new, used or reconditioned." 

The following elements are particularly relevant: 

-  products must be intended for and supplied or made available to consumers; or 

- 

likely, under reasonably foreseeable conditions, to be used by consumers even if not intended 
for  consumers.  Products  "migrating"  from  professional  use  to  the  consumer  market  should 
also be covered. In other words, products that had been originally developed for professional 
use and allowed on the market as intended for professionals,  which have subsequently also 
been marketed to consumers; 

 
 
 
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-  products  provided  in  the  context  of  a  service:  the  GPSD  also  covers  products  supplied  or 
made available to consumers in the course of a service provided to them. Consumer products 
are  often  made  available  in  connection  with  certain  services  (for  example  renting  of 
machines).  The  equipment  used  by  the  service  provider  to  supply  a  service  is  beyond  the 
scope of the GPSD, in particular, equipment on which consumers ride or travel operated by a 
service provider. 

2.2 Products excluded from RAPEX because covered by specific and equivalent requirements 
for the rapid exchange of information 

The  following  products  are  excluded  from  RAPEX  because  they  are  covered  by  equivalent 
notification mechanisms established by Community legislation: 

-  pharmaceuticals covered by Directives 75/319/EEC3 and 81/851/EEC4; 

- 

active  implantable  medical  devices  covered  by  Directive  90/385/EEC5,  medical  devices 
covered  by  Directive  93/42/EEC6,  and  in  vitro  diagnostic  medical  devices  covered  by 
Directive 98/79/EC7; 

- 

food and feed covered by Regulation (EC) No 178/20028. 

Further information on the relationship between the different notification procedures established 
by Community law can be found in chapter 9.1 and in the separate “Guidance Document on the 
Relationship between the GPSD and Certain Sector Directives9”. 

2.3 Measures, decisions and actions to be notified under RAPEX 

An indicative list of the different types of measures and actions of the competent authorities of 
the Member States that should be notified under RAPEX, can be found in Article 8 GPSD. These 
measures and actions are aimed at: 

- 

- 

- 

imposing conditions prior to the marketing of a product; 

requiring that a product be marked with warnings concerning any risks; 

alerting consumers about a risk related to a product; 

-  banning temporarily or definitively the supply, the offer to supply or the display of a product; 

-  organising the withdrawal or the recall of a product; 

-  ordering  producers  and  distributors  to  withdraw  a  product,  recall  it  from  consumers,  and 

destroy it. 

Other measures and actions that authorities can adopt or take and should notify are: 

3 OJ L 147, 9.6.1975, p. 13. Directive as last amended by Directive 2000/38/EC (OJ L 139, 10.6.2000, p. 28). 
4 OJ L 317, 6.11.1981, p. 1. Directive as last amended by Directive 2000/37/EC (OJ L 139, 10.6.2000, p. 25). 
5 OJ L 189, 20.7.1990, p.17 
6 OJ L 169, 12.7.1993, p.1 
7 OJ L 331, 7.12.1998, p.1 
8  Regulation  (EC)  No  178/2002  of  the  European  Parliament  and  of  the  Council  of  28  January  2002  laying  down  the 
general  principles  and  requirements  of  food  law,  establishing  the  European  Food  Safety  Authority  and  laying  down 
procedures in matters of food safety. OJ L 031, 01/02/2002 p. 1. 
9 http://europa.eu.int/comm/consumers/cons_safe/prod_safe/gpsd/revisedGPSD_en.htm 

 
 
 
                                                           
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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 any case, any subsequent change in the status of the 
measure should be communicated to the Commission. 

Under  Article  5  producers  and  distributors  are  obliged  to  inform  the  national  authorities  of 
voluntary actions or measures taken to prevent risk to the consumer. The authorities must notify 
these voluntary measures to the Commission when the product poses a serious risk (see chapter 
4.3). 

2.4 Other information on serious risks that may be exchanged under RAPEX 

Member States may inform the Commission of: 

- 

any information regarding the existence of a serious risk at the stage before deciding to adopt 
measures or to take action (Article 12.1, third subparagraph). In such cases RAPEX contact 
points should also inform the Commission about the final decision; 

-  measures  on  a  specific  production  batch  which  has  been  withdrawn  from  the  market  by  a 
Member State due a serious risk and when all items in this batch have been withdrawn from 
the market by the Member State; 

- 

customs authority decisions to block or to reject products at the EU borders if the consumer 
product  blocked  or  rejected  presents  a  serious  risk.  Contact  points  should  circulate  this 
information to their customs authorities (see details in chapter 8.3). 

The Commission may receive information relating to products that present a serious risk to the 
health  of  the  consumer  from  Third  Countries  or  through  equivalent  information  systems 
established by other organisations including non-EU countries. The Commission will evaluate the 
information and may transmit it to the Member States. 

These types of additional information on serious risks that may be exchanged under RAPEX do 
not require a formal reaction from the rest of Member States and the use of a standard form is not 
required. 

2.5  Criteria  for  notifying  measures  related  to  risks  not  going  beyond  the  territory  of  a 
Member State 

Measures and actions related to risks where the effects do not or cannot go beyond the territory 
of a Member State are excluded from the scope of RAPEX.  

However,  in  certain  cases  such  measures  and  actions  are  likely  to  interest  the  enforcement 
authorities of the other Member States. In order to assess whether a measure dealing with a risk of 

 
 
 
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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  account  for  example  whether  the  measure  is  taken  in 
response to a new type of risk which has not yet been reported in other notifications, or whether 
it is related to a new risk arising from a combination of products or whether it is a new type or 
category of product that is dangerous. 

Measures related to second-hand products sold by private individuals and custom-made products 
that present a serious risk are excluded from the scope of RAPEX if the Member State which took 
the measure can conclude from the existing information that the product could not be found in 
another Member State. 

Taking  into  account  the  free  circulation  of  products  at  European  level,  the  openness  of  the 
European economy and the fact that consumers buy products not only in their home market but 
also during holidays abroad or by Internet, contact points are encouraged to report actions taken 
when there is uncertainty whether the risk could  be relevant or of interest for another Member 
States.  

3.  CRITERIA FOR IDENTIFYING SERIOUS RISKS 

3.1 Definition of serious risk in the GPSD and objectives of the guidance on serious risks 

Serious risk is defined in Article 2(d) of the GPSD as follows: “serious risk shall mean any serious 
risk, including those the effects of which are not immediate, requiring rapid intervention by the 
public authorities”. 

This definition of serious risk is characterised by two key elements. First, it includes all types of 
serious risk to consumers created by a product (immediate threats as well as possible long-term 
risks); second, the risks considered are those requiring a rapid intervention. 

The following subchapters give general guidance to assist the authorities in assessing the level of 
seriousness of the risk and deciding whether a rapid intervention is necessary. The objective is to 
help the authorities in identifying the cases to which the concept of serious risk under the GPSD 
applies.  The  guidelines  in  this  chapter  are  not  exhaustive  and  do  not  try  take  account  of  all 
possible factors. The national authorities should judge each individual case on its merits taking 
into account the criteria set out in these guidelines as well as their own experience and practice, 
other relevant considerations and appropriate methods. 

3.2 Criteria on the level of gravity of risks 

A  consumer  product  may  present  one  or  more  intrinsic  hazard.  The  hazard  may  be  of  various 
types  (chemical,  mechanical,  electrical,  heat,  radiation  etc.).  The  hazard  represents  the  intrinsic 
potential of the product to damage the health and safety of users under certain conditions.  

The severity of each type of hazard may be given a rating, based on qualitative and sometimes 
quantitative criteria related to the type of damage that they are liable to produce.  

It may happen that not all individual products present the hazard in question, but only some of 
the items placed on the market. The hazard may in particular be related to a defect that appears 
only in some of the products of a certain type  (brand, model…) placed on the market. In such 
cases the probability of the defect/hazard being present in the product should be considered.  

The  potential  of  a  hazard  to  materialise  as  an  actual  negative  effect  on  the  health/safety  will 
depend on the degree to which the consumer is exposed to it when using the product as intended 

 
 
 
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or as could reasonably be expected during its lifetime. In addition the exposure to certain hazards 
may in some cases involve more than one person at a time. Finally when determining the level of 
the  risk  presented  by  a  product  by  combining  the  severity  of  the  hazard  with  the  exposure, 
consideration should be given also to the ability of the exposed consumer to prevent or react to 
the hazardous situation. This will depend on the evidence of the hazard, the warnings given and 
the vulnerability of the consumer who may be exposed. 

Taking  into  account  the  above  considerations,  the  following  conceptual  approach  may  assist 
enforcement  officers  to  decide  whether  a  specific  hazardous  situation  caused  by  a  consumer 
product constitutes a serious risk under the GPSD.  

The officer should: 

-  As  a  first  step,  use  Table  A  to  determine  the  gravity  of  the  outcome  of  a  hazard, 
depending on both its severity and probability to materialise under the conditions of use 
considered,  and  of  the  possible  health/safety  effect  related  to  the  intrinsic  hazardous 
characteristics of the product; 

-  As a second step, use Table B to further assess the gravity of the outcome depending on 
the type of consumer and, for normal adults, whether the product has adequate warnings 
and guards and whether the hazard is sufficiently obvious to make it possible to grade the 
risk level qualitatively. 

Table B indicates the gravity of the outcome from Table A for which a serious risk situation exists 
and for which rapid action is to be adopted by the enforcement authorities. 

Table A:  Risk Estimation: severity and probability of health/safety damage 

In  Table  A  the  two  main  factors  affecting  the  risk  estimation,  namely  the  severity  and  the 
probability  of  health/safety  damage,  are  combined.  The  following  definitions  of  severity  and 
probability have been drawn up to assist the selection of appropriate values.   

Severity 

The assessment of severity is based on consideration of the potential health/safety consequences 
of the hazards presented by the product considered. A grading should be established specifically 
for each type of hazard10. 

10  As  an  example,  for  certain  mechanical  risks  the  following  definitions  of  the  severity  classifications  may  be 
proposed, with their typical injuries: 

Slight 

<2% incapacity 
usually reversible and not 
requiring hospital treatment. 

Serious 
2 – 15% incapacity 
usually irreversible requiring 
hospital treatment 

Minor cuts  

Minor fractures 

Serious cuts 

Loss of finger or toe 

Damage to sight 

Damage to hearing 

Very Serious 

>15% incapacity  
usually irreversible  

Serious injury to internal organs 

Loss of limbs 

Loss of sight 

Loss of hearing 

 
 
 
                                                           
 
 
 
 
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The  assessment  of  severity  should  also  take  into  account  the  number  of  people  who  could  be 
affected by a dangerous product. This means that the risk from a product which could pose a risk 
to  more  than  one  person  at  a  time  (e.g.  fire  or  gas  poisoning  from  a  gas  appliance)  should  be 
classified as more severe than a hazard which can only affect one person. 

The  initial  risk  estimation  should  refer  to  the  risk  to  any  person  exposed  to  the  product  and 
should not be influenced by the size of the population at risk. However, it may be legitimate for 
the authorities to take account of the total number of people exposed to a product in deciding on 
the action to be taken. 

For  many  hazards  it  is  possible  to  envisage  unlikely  circumstances  which  could  lead  to  very 
serious effects, e.g. tripping over cable, falling and banging head leading to death, although a less 
serious outcome is more likely. The assessment of the severity of the hazard should be based on 
reasonable  evidence  that  the  effects  selected  for  characterizing  the  hazard  could  occur  during 
foreseeable use. This could be worst case experience involving similar products. 

Overall Probability 

This refers to the probability of negative health/safety effects to a person exposed to the hazard. It 
does  not  take  into  account  the  total  number  of  people  at  risk.  Where  the  guide  refers  to  the 
probability of a product being defective, this should not be applied if it is possible to identify each 
one of the defective samples. In this situation, the users of the defective products are exposed to 
the full risk and the users of the other products to no risk. 

The overall probability is the combination of all the contributing probabilities such as: 

- 

- 

the probability of the product being or becoming defective (if all products carry the 
defect then this probability would be 100%) 

the  probability  of  the  negative  effect  materialising  for  a  normal  user  who  has  an 
exposure corresponding to the intended or reasonably expected use of the defective 
product. 

These two probabilities are combined in the following table to give an overall probability which 
is entered into table A. 

Overall Probability of Health/Safety Damage 

Probability of hazardous product 

Probability  of 
health/safety 
damage  from 
regular 
exposure 
hazardous 
product 

to 

Hazard  is  always  present  and 
health/safety damage is likely to 
occur in foreseeable use 
Hazard  may  occur  under  one 
improbable  or 
two  possible 
conditions 
Hazard  only  occurs  if  several 
improbable conditions are met 

1% 

10% 

Medium 

High 

100% 
(All) 

Very 
High 

Low 

Medium 

High 

Very Low 

Low 

Medium 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                                                                                                                                                           
 
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Combining the severity and overall probability in Table A gives an estimation of the gravity of the 
risk. The accuracy of this assessment will depend upon the quality of the information available to 
the enforcement officer. However, this assessment  needs  to  be  modified  to  take  account  of  the 
society’s  perception  of  the  acceptability  of  the  risk.  Society  accepts  much  higher  risks  in  some 
circumstances such as motoring, than in others, such as children’s toys. Table B is used to input 
this factor. 

Table B Grading of Risk: type of person, knowledge of the risk and precautions 

Society accepts higher risks in some circumstances than in others. It is considered that the main 
factors affecting the level of risk that is considered to be serious are the vulnerability of the type of 
person  affected  and  for  normal  adults,  the  knowledge  of  the  risk  and  the  possibility  of  taking 
precautions against it. 

Vulnerable people 

The type of person using a product should be taken into account. If the product is likely to be 
used by vulnerable people, the level of risk which is serious should be set at a lower level. Two 
categories of vulnerable people are proposed below, with examples: 

Very vulnerable 

Vulnerable 

Blind 

Partially sighted 

Severely disabled 

Partially disabled 

Very old 

Elderly 

Very young (<3yrs) 

Young (3 – 11yrs) 

Normal adults 

The  adjustment  of  the  seriousness  of  risk  for  normal  adults  should  only  apply  if  the  hazard  is 
obvious and necessary for the function of the product. For normal adults the level of risk which is 
serious should be dependent on whether the hazard is obvious and whether the manufacturer has 
taken adequate care to make the product safe and to provide safeguards and warnings, especially 
if the hazard is not obvious. For example, if a product has adequate warnings and safeguards and 
the hazard is obvious, a high gravity of outcome may not be serious in terms of grading the risk 
(Table B), although some action may be needed to improve the safety of the product. Conversely, 
if the product does not have adequate safeguards and warnings, and the hazard is not obvious, a 
moderate gravity of outcome is serious in terms of grading the risk (Table B). 

 
 
 
 
 
 
 
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E

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
30.4.2004 

EN 

Official Journal of the European Union 

L 151/97

4.  CONTENTS OF RAPEX NOTIFICATIONS 

4.1 Information to be entered on the notification form 

Information  should  be  as  complete  as  possible:  contact  points  should  fill  in  all  the 
fields  in  the  notification  form  (Annex  I  of  the  Guidelines).  If  information  is  not 
available, this should be indicated and explained. A timetable for providing the missing 
information should be transmitted. 

Responsibility  for  the  information  provided  lies  with  the  notifying  Member  State 
(GPSD Annex II.10). 

In  order  to  be  useful  to  the  authorities  of  the  other  Member  States  in  their  market 
surveillance activities, the notification must include all the data needed to identify the 
dangerous  product,  trace  its  origin,  identify  the  marketing  and  distribution  channels, 
determine the related risks, etc. 

Confidentiality  could  be  requested  if  disclosure  of  the  information  would  undermine 
the  protection  of  court  proceedings,  monitoring  and  investigation  activities  or 
professional secrecy, unless there were an overriding public interest in disclosure of the 
information to protect the health and safety of consumers. 

The  notifying  Member  State  could  also  require  confidentiality  for  annexes  to  the 
notification,  such  as  legal  proceedings,  that  do  not  contain  information  relevant  for 
consumer protection and need to be protected. 

According  to  the  GPSD,  the  public  must  have  access  to  information  relating  to  the 
safety  properties  of  products,  the  nature  of  the  risk,  product  identification  and  the 
measure taken. 

Contact  points  should  pay  special  attention  to  checking  that  the  following  items  of 
essential information appear in the notification: 

- 

- 

- 

a detailed description of the product (including if possible the customs code of the 
product)  together  with  a  photograph  in  order  to  facilitate  its  identification  by 
enforcement authorities. The identification and description of the product should 
be  accurate  in  order  to  avoid  any  confusion  with  similar  products  in  the  same 
category that are safe; 

the  risk  assessment  including,  in  particular,  results  of  tests  carried  out  by  the 
authority; 

the  scope  and  the  nature  of  the  measure  taken  in  order  to  avoid  the  risk,  its 
duration  and  the  follow-up.  The  notifying  Member  State  should  inform  the 
Commission  of  any  amendment  to  the  measure  taken  and  of  the  final  decision 
taken  on  the  product  in  question.  The  Member  State  should  indicate  in  the 
notification  whether  the  measure  has  a  definitive  character  (i.e.  it  has  not  been 
contested by the manufacturer or importer, or has been confirmed by an instance 
that does not admit appeal) or could be, or is currently, subject to appeal. In any 
case,  any  change  in  the  status  of  the  measure  should  be  communicated  to  the 
Commission; 

 
 
 
L 151/98

EN 

Official Journal of the European Union 

30.4.2004 

- 

the  information  needed  to  identify  the  product’s  distribution  channels  and  its 
origin, in particular its producer, importer or exporter, as well as other information 
related to its traceability. 

In  the  case  of  products  imported  from  Third  Countries,  and  in  order  to  facilitate 
investigation  by  the  authorities  of  the  Third  Country  of  origin  of  the  product,  the 
following  documents  and  information  should  also  be  communicated  (if  available): 
copies of Sales Contract, Letter of Credit, date and port of export and batch number of 
the products. 

4.2 Information to provide in relation to measures concerning use of chemicals 

When  the  measure  notified  pursuant  to  Article 11  or  Article  12  seeks  to  limit  the 
marketing  or  use  of  a  chemical  substance  or  preparation,  the  Member  States  must 
provide  as  soon  as  possible  either  a  summary  or  the  references  of  the  relevant  data 
relating  to  the  substance  or  preparation  considered  and  to  known  and  available 
substitutes, where such information is available. 

They will also communicate the anticipated effects of the measure on consumer health 
and safety together with the assessment of the risk carried out in accordance with the 
general  principles  for  the  risk  evaluation  of  chemical  substances  as  referred  to  in 
Article 10(4) of Regulation (EEC) No 793/9311 in the case of an existing substance or in 
Article 3(2) of Directive 67/548/EEC12 in the case of a new substance. 

4.3 Notification of the voluntary measures taken by producers and distributors 

Article  5(3)  of  the  GPSD  obliges  producers  and  distributors  to  inform  the  national 
authorities of any voluntary action or measure taken to prevent risk to the consumer. 

Article 12(1) fourth subparagraph requires Member States to notify the Commission of 
the  voluntary  measures  taken  by  producers  and  distributors  in  the  case  of  a  serious 
risk. 

When the authorities receive information from producers and distributors concerning 
a risk and the voluntary actions taken to avoid it, they should examine this information 
in  order  to  assess  whether  a  notification  to  the  Commission  is  justified  due  to  the 
involvement of a serious risk, taking into account the criteria outlined in chapter 3. 

Such notification at Community level is required in the case of a serious risk the effects 
of  which  can  go  beyond  the  territory  of  a  Member  State  (taking  into  account  the 
criteria for notifying local events: see chapter 2.5). 

The  information  transmitted  to  the  Commission  should  include  details  of  the 
voluntary  action  taken  by  the  producers  or  distributors.  All  relevant  information  on 
the risk should also be notified. In particular: 

- 

information to identify and trace the product or batch of products; 

11 OJ L 84, 5.4.1993, p. 1. 
12 OJ 196, 16.8.1967, p. 1/67. Directive as last amended by Commission Directive 2000/33/EC (OJ L 136, 
8.6.2000, p. 90). 

 
 
 
 
                                                           
30.4.2004 

EN 

Official Journal of the European Union 

L 151/99

- 

- 

- 

- 

- 

description of the risk; 

identification of the producers and distributors participating in the application of 
the measure; 

description  of  the  action  taken  by  producers  and  distributors  to  avoid  risks  to 
consumers (scope, countries covered, monitoring); 

final destination of the dangerous product (destruction, recondition); 

follow-up  actions  that  national  authorities  would  take  in  order  to  monitor  the 
effectiveness of the voluntary measures taken by producers and distributors; 

- 

actions provided for in other Member States by the producers or distributors. 

5.  DEADLINES  FOR  SUBMISSION  AND  CIRCULATION  OF  RAPEX 

NOTIFICATIONS 
5.1  Deadlines  for  submitting  notifications  to  the  Commission  by  the  Member 
States 

National contact points are required to notify the Commission as soon as possible and 
at the latest 10 days13 after the competent authorities have taken the decision or have 
decided to adopt measures14 relating to products presenting a serious risk. 

Measures  or  action  taken  in  agreement  between  authorities  and  producers  and/or 
distributors should be notified to the Commission as soon as possible and at the latest 
10 days after the agreement has been concluded. 

Contact points are required to transmit information to the Commission on voluntary 
measures  taken  by  producers  and  distributors  which  have  been  notified  to  the 
authorities by reason of a serious risk and which go beyond the territory of a Member 
State.  This  should  be  done  as  soon  as  possible  and  at  the  latest  10  days  after  the 
producer and/or distributor have informed the national authority. 

In the case of notifications requiring emergency action from Member States (as defined 
in  Chapter  7.1),  the  notifying  national  contact  point  is  required  to  inform  the 
Commission as soon as possible and at the latest three days after the measure has been 
adopted.  This  type  of  notification  should  always  be  preceded  by  a  phone  call  to  the 
Commission  RAPEX  mobile  phone  number  (in  particular  during  week-ends  and 
holiday periods). 

Information on serious risks to be exchanged under RAPEX as described in point 2.4 is 
to be transmitted to the Commission as soon as possible and at the latest 10 days after 
the contact point was informed. 

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

 
 
 
                                                           
 
L 151/100

EN 

Official Journal of the European Union 

30.4.2004 

National contact points are required to notify the Commission as soon as possible and 
at  the  latest  15  days  after  the  competent  authorities  have  taken  the  decision  or  have 
decided to adopt measures restricting the marketing or use of products by reason of a 
risk that is not serious. 

These deadlines apply to the exchange of information between national contact points 
and  the  Commission.  They  do  not  take  into  account  national  deadlines  applicable 
internally  in  the  Member  States  (for  instance  between  local  and  central  authorities). 
Appropriate arrangements should be put in place at national level in order to ensure 
rapid  transmission  of  the  information  between  the  different  national  authorities  in 
charge of product safety. 

These  deadlines  apply  irrespective  of  any  appeal  procedure  entered  into  by  the 
producer or distributor or official publication requirements. 

5.2 Commission deadlines for the transmission of notifications to all the Member 
States 

The  Commission  will  transmit  the  notification  to  the  contact  points  only  if  the 
notifying  Member  State  has  provided  the  essential  information  described  in  chapter 
4.1.  Any  follow-up  by  other  Member  States  would  not  be  feasible  if  such  essential 
information were missing. 

The Commission will treat the information received in accordance with the following 
degrees of urgency: 

-  Notifications  requiring  emergency  action  from  Member  States  will  be  treated  as 
priority by the Commission and transmitted to Member States as soon as possible 
and at the latest three days after reception; 

-  Alert notifications (Article 12 of the GPSD) will be transmitted to Member States 
within five days of reception. This category includes measures or action taken by 
authorities,  agreements  for  action  between  authorities  and  producers  and 
distributors, and voluntary measures taken by producers and distributors relating 
to products that present a serious risk; 

-  Other  information  on  serious  risks  to  be  exchanged  under  RAPEX  will  be 

transmitted within five days of reception; 

-  Notifications presented in accordance with Article 11 of the GPSD will be sent by 
the  Commission  within  15  days  of  reception.  These  notifications  relate  to 
measures  taken  by  the  authorities  which  restrict  the  placing  on  the  market  or 
require the withdrawal or recall of products that do not create a serious risk. 

5.3 Deadlines for updating the information provided by the Member States 

Member States are required to notify the Commission of any modification or lifting of 
measures  or  actions  at  the  latest  five  days after the competent authorities have taken 
the decision to modify or lift the measure. 

 
 
 
 
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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  confirm  or  modify  this  information  within  45 
days of the first communication (GPSD Annex II.4). 

6.  FOLLOW-UP TO THE RAPEX NOTIFICATIONS 

6.1 Action by the Member States to follow up the notifications 

Upon  receipt  of  a  notification  Member  States  are  required  to  examine  all  the 
information supplied in order to: 

- 

- 

find out whether the product has been marketed in their territory; 

enquire in order to collect any relevant information; 

-  perform any additional assessment of the risk (if needed); 

- 

evaluate  whether  national  measures  should  be  adopted  in  the  light  of  their  own 
circumstances. 

6.2 Contents of the reaction to be communicated to the Commission 

Only  notifications  requiring  emergency  action  from  Member  States  and  Alert 
notifications  (Article  12)  require  a  reaction  from  the  Member  States  informing  the 
Commission  of  their  follow-up  activities  and  conclusions.  On  the  other  hand, 
notifications presented according Article 11 and as “Other information on serious risks 
that  may  be  exchanged  under  RAPEX”  do  not  require  Member  States  to  inform  the 
Commission of the follow-up given to the information received. 

After  receiving  a  notification  requiring  emergency  action  from  Member  States  or  an 
Alert  notification  (Article  12)  all  Member  States  are  required  to  inform  the 
Commission, using the Reaction form in Annex II, of the conclusions of their market 
surveillance activities and in particular: 

-  whether or not the product has been found; 

- 

- 

- 

any differing assessment of the risk notified; 

the measures taken or decided on and the reasons justifying a different measure; 

the special circumstances justifying lack of action or follow-up. 

If  the  product  is  manufactured  in  the  EU  and  the  notifying  Member  State  is  not  the 
country  of  origin  of  the  product,  the  authorities  of  the  Member  State  where  the 
product is manufactured should inform the Commission about:  

- 

- 

any contacts with the manufacturer; 

the  measures  adopted  to  ensure  that  the  manufacturer  solves  the  problem  at 
source, where appropriate; 

 
 
 
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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 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 

 
 
 
 
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ensure that the manufacturer will solve the problem at source. The same deadline is 
applicable  to  the  Member  State  where  the  manufacturer’s  representative  or  the 
importer of the product is established in cases where the product is not manufactured 
in the EU and the notifying Member State  is not the country where the product was 
first marketed in the EU. 

A reminder will be sent to the Member States that have not reacted to the notifications 
after 45 days from the date when the notification was sent. The GPSD Committee will 
also be informed about any missing reactions. 

The Commission will circulate the reactions as follows: 

- 

- 

as soon as possible and in any case not later than three days if the reaction relates to 
a notification requiring emergency follow-up from Member States; 

as soon as possible and in any case not later than five days for other reactions to 
notifications on national measures, agreements between authorities and producers, 
or voluntary actions. 

7.  EXAMINATION BY THE COMMISSION OF NOTIFICATIONS 
7.1 Examination of the completeness and correctness of the notifications 

The  Commission  contact  point  checks  all  information  received  through  the  system 
before further transmission. The examination of the notifications by the Commission 
does not imply any assumption of responsibility for the information transmitted which 
remains with the notifying Member State. 

Specific internal arrangements have been put in place in order to circulate information 
to the Commission services concerned. 

The examination includes the following steps to check and complete the information, 
if necessary: 

Completeness check: 

If the information is incomplete, additional details are requested from the contact point 
of origin. 

If  the  product  is  manufactured  in  the  EU  and  the  notifying  Member  State  is  not  the 
country of origin of the product and has not obtained the essential information for the 
notification,  the  Commission  will  contact  the  authorities  of  the  Member  State  where 
the product is manufactured in order to complete the information on the distribution 
channels and destinations of the product. The authorities of the Member State of origin 
will be requested to obtain this information by contacting the producer or distributors. 

If the product is not manufactured in the EU and the notifying Member State is not the 
country  where  the  product  was  first  marketed  in  the  EU  and  has  not  obtained  the 
essential information of the notification,  the Commission will contact the authorities 

 
 
 
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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  information  received  is  in  conformity  with  EU 
legislation  and  with  the  provisions  applicable  to  the  functioning  of  RAPEX  as 
defined in these guidelines; 

- 

contact the notifying country, if necessary, in order to obtain extra information. 

Classification: 

Notifications will be classified according to the degree of urgency (GPSD Annex II. 11) 
in: 

a)  Notifications  requiring  emergency  action  from  Member  States  (serious  risk, 
foreseeable  need  for  measures  to  be  agreed  at  Community  level  and/or  likely 
political visibility of the issue and/or mass-media coverage); 

b)  Alert notifications (Article 12 of the GPSD): measures or actions taken on products 

presenting a serious risk; 

c)  Notifications  under  Article  11  of  the  GPSD:  measures  or  actions  taken  by  the 

competent authorities on products not posing a serious risk; 

d)  For Information Only: information on serious risks to be exchanged under RAPEX 

as described in chapter 2.4. 

Consultations: 

When  the  product  notified  falls  under  the  scope  of  specific  sector  legislation,  the 
Commission contact point will ask for expert advice from other Commission services, 
if necessary. The Commission may, whenever it considers it to be necessary, carry out 
an investigation on its own initiative or ask for scientific advice. 

Database research: 

The Member States and the Commission should avoid any unnecessary duplication of 
notifications  by  checking  previous  notifications  in  the  available  database  used  by 
national authorities or by the Commission. 

7.2 Examination in relation to the scope of RAPEX 

The Commission will check whether the product notified is a consumer product falling 
under the scope of the GPSD as far as RAPEX provisions are concerned and whether it 
is covered by equivalent alert system. 

The Commission will also verify that the notification complies with the GPSD and with 
the provisions applicable to the functioning of RAPEX. 

 
 
 
 
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The Commission will not make a risk assessment of the product. Therefore, Member 
States should include in all notifications a complete summary of their risk evaluation 
and the results of any tests or analyses carried out to assess the level of risk. 

In the first instance, the Commission will base its conclusions on the classification of 
the notification on the information provided by the notifying Member State. 

After examination the Commission will forward the notification to the other Member 
States  or  ask  for  clarification  or  additional  information  from  the  notifying  Member 
State. 

7.3 Examination of the follow-up reactions 

On the basis of the examination of the information obtained from the notifications and 
reactions, the Commission will decide on the appropriate action, such as to: 

- 

- 

- 

- 

convene the GPSD Committee to discuss the information received and the results 
obtained and to evaluate the measures taken or to adopt; 

request an independent risk assessment; 

institute an investigation in cooperation with Member States; 

consult a Commission Scientific Committee; 

-  mandate the standardisation bodies to draft new standards or amend existing ones 
if  clear  and  consistent  safety  specifications  are  not  available  for  a  category  of 
products; 

- 

inform Third countries; 

-  prepare proposals for new or modified legislation; 

- 

launch the procedure for a Commission Decision based on Article 13 of the GPSD 
in urgent cases. 

15  days  after  the  date  on  which  the  reaction  period  has  expired  (45  days  after  the 
notification was sent), the Commission will send the national contact points a report 
with: 

- 

- 

the  final  conclusion  on  the  notification  taking  into  account  the  information 
received  as  reactions  from  Member  States.  If  no  further  follow-up  is  required  the 
file will be closed. If new developments concerning the notification occur later, the 
Commission will reopen the file; 

the  follow-up  actions  to  be  taken  by  the  Member  States  if  any  reactions  are  still 
outstanding or if there are different national approaches. 

The GPSD Committee will be periodically informed of all the notifications received and 
of the follow-up. 

 
 
 
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8.  NETWORK FOR THE EXCHANGES UNDER RAPEX 

8.1 Setting up of two-way internal networks by the Member States to collect and 
to distribute the relevant information 

Member  States  should  ensure  that  there  are  systems  at  national  level  so  that  their 
national,  regional  or  local  authorities  are  aware  of  their  responsibilities  and  of  the 
action  they  should  take  to  inform  other  services  if  a  problem  comes  to  light  in  their 
area. 

Member States should establish a two-level internal structure consisting of: 

- 

- 

a  single  contact  point  with  the  Commission.  This  contact  point  will  send  the 
Commission and receive from the Commission all information exchanged through 
RAPEX; and 

a  national  network  involving  all  the  authorities  responsible  for  product  safety. 
These authorities send to and receive from the contact point the notifications and 
reactions.  The  composition  of  the  network  should  be  communicated  to  the 
Commission. 

8.2 Designation of the authorities in charge of notifying the Commission and to 
whom the Commission communicates notifications 

The main tasks of the national contact points are: 

a)  before sending a notification to the Commission 

- 

- 

- 

- 

to  verify  the  information  received  from  the  national,  regional  or  local  
authorities  in  order  to  decide  whether  use  of  the  RAPEX  system  is  required 
(based on the Directive, the guidelines and previous experience); 

to  check  if  the  product  has  already  been  notified  or  information  related  to  it 
exchanged in order to avoid any unnecessary duplication; 

to check that the notification form and the information are complete; 

to  classify  the 
notifications. 

information 

into  one  of  the  predefined  categories  of 

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: 

 
 
 
 
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-  help  explain  the  obligations  and  requirements  created  by  Community  and 
national legislation for producers and distributors concerning the notification 
of dangerous products; 

- 

- 

- 

assist  in  the  creation  of  a  network  culture  among  the  different  national 
authorities at the various different levels; 

assist these authorities in the use of RAPEX; 

ensure that the internal procedures for information exchange work properly. 

8.3 Setting up of cooperation arrangements between the competent authorities, in 
particular with customs. 

Customs officials’ decisions to block or to reject products at the EU borders for safety 
reasons are also of interest to market surveillance authorities and the Commission. The 
legal  basis  for  such  decisions  is  Council  Regulation  (EEC)  No  339/93  of  8  February 
199315  on  checks  for  conformity  with  the  rules  on  product  safety  in  the  case  of 
products imported from Third countries and Commission Decision 93/583/EEC of 28 
July 199316 drawing up a priority and non-exhaustive list of products as provided for 
in Article 8 of Regulation 339/93/EEC. 

Contact points should inform the Commission about these decisions. This information 
is  only  pertinent  if  the  consumer  product  blocked  or  rejected  presents  a  serious  risk. 
The Commission will transmit the information to the contact points and they should 
circulate this information to customs officials in their country in order to prevent the 
entry of these products within the European market. 

The reasons for prohibiting entry into the EU should be mentioned in the documents 
accompanying the dangerous products. 

Contact  points  should  also  inform  their  customs  authorities  of  the  measures  and 
actions  taken  by  market  surveillance  authorities  relating  to  imported  products 
presenting a serious risk in order to avoid further imports of the same product into the 
EU market. 

8.4 Means of communication, practical and technical arrangements applicable 

Languages: 

The  contact  points  in  the  Member  States  may  issue  the  notification  in  their  national 
language  and/or  in  English.  The  notifications  will  be  translated  into  English,  French, 
German, Italian and Spanish by the Commission. 

Transmission via Internet 

The  RAPEX  system  uses  an  Internet-based  software  application  as  a  communication 
tool  between  the  contact  points  linked  to  a  database  containing  all  the  information 

15 OJ L 040, 17/02/1993 p. 1 
16 OJ L 279, 12/11/1993 p. 0039 

 
 
 
                                                           
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from  the  notifications  and  reactions.  This  system,  which 
https://reis.cec.eu.int/reis, includes all the forms and a User’s Guide. 

is  accessible  via 

If there are technical problems with this site, contact points may send notifications and 
reactions  by  e-mail  (mail  box:  Sanco-Reis@cec.eu.int)  or  by  fax  if  (and  only  if)  e-mail 
transmission is not possible (+32.2.296.43.23). 

Out-of-hours service and permanent staffing during periods of closure: 

As  emergencies  may  arise  out  of  working  hours,  Member  States  should  ensure  that 
their national, regional or local authorities can be contacted in urgent cases such as for 
notifications requiring emergency action by Member States. 

Changes  at  national  contact  point  level  are  to  be  communicated  immediately  to  the 
Commission, which will forward them to the other Member States. 

The  Commission  will  ensure  the  proper  functioning  of  the  RAPEX  system  during 
weekends, periods of closure and holidays. 

Weekends:  

The contact points can reach the officials in charge of RAPEX operations by telephone 
(mobile phone) in case of an emergency. This will allow rapid organisation of an early 
warning. 

Longer periods of closure:  

It  should  be  noted  that  the  Commission  contact  point  ensures  holiday  coverage  by 
using a mobile phone and a laptop computer that can be linked into the system via the 
Internet. In emergencies, before sending the notification to the Commission, national 
contact  points  should  contact  the  Commission  official  in  charge  of  the  permanent 
staffing, using a mobile phone number which will be communicated to contact points 
before the holiday period starts. 

Contact points are also requested to provide similar coverage during weekends, short 
periods  of  closure  and  holiday  periods.  A  list  of  emergency  phone  numbers,  e-mails 
and  faxes  for  the  RAPEX  contact  points  is  established  by  the  Commission  to  ensure 
that RAPEX members can be reached without delay. Any subsequent change should be 
communicated to the Commission. 

9.  COORDINATION 

BETWEEN 

RAPEX 

AND 

OTHER 

NOTIFICATION MECHANISMS 

9.1 Cases in which a measure notified under RAPEX must also be notified under 
another mechanism 

Whenever a measure with binding legal effects relates to consumer products covered 
by specific community legislation such as toys, electrical appliances, etc., it should also 
be  considered  under  the  sector  specific  notification  mechanism  applicable  (safeguard 

 
 
 
 
 
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clause).  The  RAPEX  system  and  the  sector  specific  safeguard  clauses  involve  separate 
legal obligations to notify because they serve different purposes. 

For  further  information  on  the  relationship  between  the  notification  procedures  and 
their purposes, please see the separate “Guidance Document on the Relationship between the 
GPSD and Certain Sector Directives17”. 

9.2  Arrangements  for  simplifying  the  submission  of  notifications  due  under 
different mechanisms 

When  products  are  covered  by  other  Community  legislation  with  a  notification 
procedure for national measures (safeguard clause), the Commission will, through its 
internal  procedures,  ensure  that  a  single  notification  from  national  authorities  fulfils 
the different obligations to inform the Commission under Community legislation. 

A  common  notification  form  covering  both  the  safeguard  clause  of  Directive 
88/378/EEC on Safety of Toys18 and RAPEX is given in Annex III. 

10. NOTIFICATIONS UNDER ARTICLE 11 OF THE GPSD 

10.1 Scope of these notifications 

The procedure in Article 11 of the GPSD covers the exchange of information between 
the  Member  States  and  the  Commission  for  consumer  products  (as  described  in 
chapter  2.1)  that  do  not  present  a  serious  risk  to  the  health  and  safety  of  consumers 
(taking into account the criteria on serious risk outlined in chapter 3). 

Measures  that  Member  States  adopt,  such  as  those  described  in  chapter  2.3,  which 
restrict the placing on the market of products that do not pose a serious risk, have to be 
notified to the Commission specifying the reasons for adopting them. 

The notifying Member State should inform the Commission of any amendment to the 
measure taken and of the final decision taken on the product in question. 

If the Member State considers that the effects of the risk do not, or cannot, go beyond 
its  territory,  it  should  notify  the  measures  concerned  insofar  as  they  involve 
information likely to be of interest to other Member States as defined in chapter 2.5. 

10.2 Contents of the notifications 

The notifying Member State has to include in the Notification Form (Annex I): 

- 

- 

a  detailed  description  and  photograph  of  the  product  in  order  to  facilitate  its 
identification by the enforcement authorities; 

the  results  of  the  risk  assessment  carried  out  by  the  authority  that  justify  the 
measure adopted; 

17 http://europa.eu.int/comm/consumers/cons_safe/prod_safe/gpsd/revisedGPSD_en.htm 
18 OJ L 187, 16/07/1988 p. 1 

 
 
 
                                                           
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- 

- 

the scope, nature, duration and follow-up of the measure taken in order to avoid 
the risk; 

information  enabling  the  product’s  distribution  channels  and  origin  to  be 
identified, and other information relating to its traceability. 

If  all  the  information  is  not  available,  this  should  be  indicated  and  justified  together 
with a timetable for providing the missing information. 

10.3 Processing and deadlines for circulation of Article 11 notifications 

National  contact  points  are  required  to  notify  the  Commission  of  the  measures  and 
actions  taken  as  soon  as  possible  and  in  any  case  not  later  than  15  days  after  the 
competent  authorities  have  taken  the  decision  restricting  the  marketing  or  use  of 
products by reason of a risk. 

This deadline is irrespective of any appeal procedure entered into by the producer or 
distributor and of official publication requirements. 

The  Commission  will  assess,  on  the  basis  of  the  information  contained  in  the 
notification,  whether  it  complies  with  Community  law  and  with  the  guidelines.  If 
necessary it will contact the notifying country to obtain additional information.  

The Commission will circulate the notification to the other Member States within 15 
days  of  its  reception  unless  it  concludes  that  the  measure  does  not  comply  with  the 
requirements.  In  this  case  the  Commission  will  inform  the  Member  State  which 
initiated the action, explaining the reasons for its conclusion. 

The Member State which initiated the action may resubmit the notification taking into 
account the comments from the Commission. 

Under this procedure the other Member States receiving a new Article 11 notification 
are  not  required  to  inform  the  Commission  about  the  follow-up  given  to  the 
notification. 

10.4 Practical arrangements for the transmission of Article 11 notifications 

Contact points and the Commission will use the Internet site https://reis.cec.eu.int/reis 
for  the  transmission  of  Article  11  notifications.  The  standard  form  for  Article  11 
notifications and the User’s Guide for the Internet application are available on this site. 

If there are technical problems with this site, contact points may send notifications by 
e-mail (mail box: Sanco-Reis@cec.eu.int) or by fax if (and only if) e-mail transmission is 
not possible (+32.2.296.43.23). 

 
 
 
 
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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. 

02. 

Notifying country and contact person: 

Date of notification: 

PRODUCT 

03. 

04. 

05. 

06. 

07. 

08. 

Category of products and Customs code:  

Product name, brand, price and country of origin: 

Type/Number of model/Bar Code/Batch code:   

Description/photograph (format .jpg) of the product and its packaging: 

Standards or regulations applicable: 

Proof of conformity: 

PRODUCER 

09. 

10. 

Name, address and contact information for the manufacturer or its representative: 

Name, address and contact information of the exporter/importer: 

DISTRIBUTOR and RETAILER 

11. 

12. 

Name, address and contact information for the distributors or their representatives: 

Supplier (shop, supermarket, by mail, Internet) and countries of destination: 

DANGER 

13. 

14. 

15. 

Type of risk : 

Summary of the results of tests/analyses and conclusions: 

Description of accidents which have occurred:  

 
 
 
 
 
 
 
 
 
 
 
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MEASURES ADOPTED 

16. 

17. 

Voluntary measures (scope, nature and duration): 

Compulsory measures (scope, 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. 

02. 

03. 

04. 

05. 

06. 

07. 

08. 

09. 

Reacting country and contact person: 

Date of reaction: 

Notification number, notifying country and product name: 

Product found: yes/no 

Assessment of the risk: 

Voluntary measures (scope, nature, duration and justification): 

Compulsory measures (scope, nature, duration and justification): 

Duration: 

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 

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 the Permanent Representation to the 
EU to the Secretary General of the Commission with 
electronic 
Entr-Textile-Leather-
to 
Toys@cec.eu.int 

copy 

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 
in 
Article 3, if the toy does not meet 
the standards (Article 7(1)(a)) 

referred 

to 

Incorrect  application  of 
standards (Article 7(1)(b)) 

the 

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 

L 151/115

PART 2 

(cid:31) in application of Article 12 of Directive 2001/95/EC 
(cid:31) requiring emergency action from Member States 

GENERAL INFORMATION 

01. 

02. 

Notifying country and contact person: 

Date of notification: 

PRODUCT 

03. 

04. 

05. 

06. 

07. 

08. 

Category of products and Customs code:  

Product name, brand, price and country of origin: 

Type/Number of model/Bar Code/Batch code:   

Description/photograph (format .jpg) of the product and its packaging: 

Standards or regulations applicable: 

Proof of conformity: 

PRODUCER 

09. 

10. 

Name, address and contact information for the manufacturer or its representative: 

Name, address and contact information of the exporter/importer: 

DISTRIBUTOR and RETAILER 

11. 

12. 

Name, address and contact information for the distributors or their representatives: 

Supplier (shop, supermarket, by mail, Internet) and countries of destination: 

DANGER 

13. 

14. 

15. 

Type of risk: 

Summary of the results of tests/analyses and conclusions: 

Description of  accidents which have occurred:  

MEASURES ADOPTED 

16. 

Compulsory measures (scope, nature and duration): 

OTHER INFORMATION 

17. 

Additional information: 

 
 
 
 
 
 
 
 
 
 
 
L 151/116

EN 

Official Journal of the European Union 

30.4.2004 

(Annex IV) 
DEADLINES for NATIONAL CONTACT POINTS 

ACTION 

DEADLINE 
(see chapter 5) 

Send  notifications  relating  to  emergency  situations  to  the 
Commission 

or  maximum 

ASAP 
three days 

Notify the Commission of decisions and actions taken: 

-  by the authorities in cases of serious risk; 

ASAP  or  maximum  10 
days 

- 

as  agreed  between  authorities  and  producers  and 
distributors. 

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 

L 151/117

(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 

or  maximum 

ASAP 
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  to  notifications  requiring  emergency  follow-
up by the national contact points  

or  maximum 

ASAP 
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