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Commission Implementing Decision (EU) 2019/417 of 8 November 2018 laying down guidelines for the management of the European Union Rapid Information System ‘RAPEX’ established under Article 12 of Directive 2001/95/EC on general product safety and its notification system (notified under document C(2018) 7334)

EU Decision 2019/417 · Adopted 8 November 2018 · Extends to United Kingdom

Original text. legislation.gov.uk does not revise this item, so later amendments are not shown here. Changes made to it are listed under each provision when known.

Commission Implementing Decision (EU) 2019/417

of 8 November 2018

laying down guidelines for the management of the European Union Rapid Information System ‘RAPEX’ established under Article 12 of Directive 2001/95/EC on general product safety and its notification system

(notified under document C(2018) 7334)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safetyf1, and in particular the third subparagraph of Article 11(1) and point 8 of Annex II thereof,

Having regard to Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008, setting out the requirements for accreditation and market surveillance on the marketing of products and repealing Regulation (EEC) No 339/93f2,

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

Whereas:

(1)

Article 12 of Directive 2001/95/EC establishes a European Union Rapid Information System (‘RAPEX’) for the rapid exchange of information between the Member States and the Commission on measures and action taken on products posing a serious risk to the health and safety of consumers.

(2)

Point 8 of Annex II to Directive 2001/95/EC requires the guidelines to be regularly updated in the light of new developments and experience. Commission Decision 2010/15/EUf3 was the first and only update of the guidelines.

(3)

In view of new developments and in order to ensure more efficient and effective notification procedures in line with best practice, a further update of the guidelines is required.

(4)

Terminology and references have become obsolete as has the means of communication between the Commission and the Member States authorities and between the authorities themselves.

(5)

New tools that have been developed over the last years for the proper functioning of RAPEX (wiki's, interface between RAPEX and other market surveillance systems) have to be taken into consideration in the guidelines.

(6)

Criteria for the RAPEX notification, following the new developments, have become unclear and need to be clarified.

(7)

Cross-border online sales of goods have increased. This development needs to be reflected in the notification techniques as well as in the follow-up instruments to be used.

(8)

Regulation (EC) No 765/2008 extends the application of RAPEX provided for in Article 12 of Directive 2001/95/EC also to products covered by that legislation. Extending the application of RAPEX raises some issues that need to be clarified in the guidelines.

(9)

Regulation (EC) No 765/2008 applies to consumer products and to professional products such as some medical devices. That Regulation covers a broader scope of risks, other than those related to the health and safety of consumers, such as security and environmental risks. Therefore, a risk can concern not only consumers but also an indeterminate group of people referred to as ‘end-users’.

(10)

Article 22 of Regulation (EC) No 765/2008 provides therefore that measures taken against products presenting a serious risk to health and safety or other relevant public interests should be notified via RAPEX.

(11)

Directive 2001/95/EC and Regulation (EC) No 765/2008 are complementary and provide a system to improve the safety of non-food products.

(12)

RAPEX helps to prevent and restrict the supply of products posing a serious risk to health and safety or, in the case of products covered by Regulation (EC) No 765/2008, also to other relevant public interests. It enables the Commission to monitor the effectiveness and consistency of market surveillance and enforcement activities in the Member States.

(13)

RAPEX provides a basis for identifying the need for action at EU level and makes for consistent enforcement of EU product safety requirements and therefore contributes to the smooth functioning of the single market.

(14)

The notification procedure established under Article 11 of Directive 2001/95/EC provides for an exchange of information between the Member States and the Commission on measures adopted on products posing a less than serious risk to the health and safety of consumers. It helps to ensure a consistent, high level of consumer health and to preserve the single market.

(15)

Article 23 of Regulation (EC) No 765/2008 provides for an information support system where Member States make available to the Commission the information required by the same Article on products presenting a less than serious risk.

(16)

According to the applicable legislation, Member States are not obliged to provide such information in the RAPEX system.

(17)

Article 16 of the GPSD provides an obligation for Member States and the Commission to make available to the public information relating to risks to consumer health and safety posed by products.

(18)

To ensure a coherent system of information for products posing a risk to the health and safety of consumers or, in case of products covered by Regulation (EC) No 765/2008, also to other relevant public interests, it would be desirable that available information concerning dangerous products covered by Article 23 of Regulation (EC) No 765/2008 could also be made available in the RAPEX system.

(19)

In order to enable the functioning of the RAPEX system, guidelines should be drawn up on the various aspects of these notification procedures and, in particular, to establish the content of notifications. These should include the information to be contained in the notification, criteria for notifications involving risks that do not or cannot go beyond the territory of the Member State and criteria for the classification of notifications according to the degree of urgency. The guidelines should also lay down operating arrangements, including deadlines for the various steps of the notification and follow-up notification procedures as well as confidentiality rules.

(20)

To ensure that notification procedures are properly applied, the guidelines should also set out risk assessment methods with criteria for identifying risks taking into consideration also the management of risks.

(21)

In the light of point 2 in Annex II to Directive 2001/95/EC, the new guidelines include a set of risk assessment guidelines for consumer products and refer also to professional products, which specify the criteria for identifying serious risks.

(22)

The guidelines should be addressed to all Member States authorities participating in the RAPEX network pursuant to Directive 2001/95/EC and Regulation EC No 765/2008, including market surveillance authorities responsible for monitoring the compliance of products with safety requirements and authorities in charge of external border controls,

HAS ADOPTED THIS DECISION:

Annotations to the whole text

Footnotes

f1

OJ L 11, 15.1.2002, p. 4.

f2

OJ L 218, 13.8.2008, p. 30.

f3

Commission Decision 2010/15/EU of 16 December 2009 laying down guidelines for the management of the Community Rapid Information System ‘RAPEX’ established under Article 12 and of the notification procedure established under Article 11 of Directive 2001/95/EC (the General Product Safety Directive) (OJ L 22, 26.1.2010, p. 1).

Contents

  1. 1Article 1
  2. 2Article 2
  3. 3Article 3
  4. Signature
  5. Annex
  6. GUIDELINES FOR THE MANAGEMENT OF THE EUROPEAN UNION RAPID INFORMATION SYSTEM ‘RAPEX’ ESTABLISHED UNDER ARTICLE 12 OF DIRECTIVE 2001/95/EC (THE GENERAL PRODUCT SAFETY DIRECTIVE) AND ITS NOTIFICATION SYSTEM
  7. SCOPE AND ADDRESSEES OF THE GUIDELINES
  8. Scope, objectives and update
  9. 1.1Scope
  10. 1.2Objectives
  11. 1.3Update
  12. 2Addressees of the Guidelines
  13. Products
  14. 3.1Products covered by these Guidelines
  15. 3.1.1Products covered by the GPSD
  16. 3.1.2Products covered by Regulation (EC) No 765/2008
  17. 3.2Products not covered by these Guidelines
  18. Measures
  19. 4.1Types of measures
  20. 4.2Categories of measures
  21. 4.3Requirements of the measures
  22. 4.4Exclusion of generally applicable compulsory measures
  23. Risk Levels
  24. 5.1Serious risk
  25. 5.2Less than serious risk
  26. 5.3Risk assessment method
  27. 5.4Assessing authority
  28. Cross-border effects
  29. 6.1International event
  30. 6.2Local event
  31. EU RAPID INFORMATION SYSTEM ‘RAPEX’ ESTABLISHED UNDER ARTICLE 12 OF THE GENERAL PRODUCT SAFETY DIRECTIVE
  32. Introduction
  33. 1.1Objectives of RAPEX
  34. 1.2Components of RAPEX
  35. 2Notification criteria
  36. 2.1Mandatory participation in RAPEX: Article 12 of the GPSD and Article 22 of Regulation (EC) No 765/2008
  37. 2.2Non-mandatory participation in RAPEX: Article 11 of the GPSD and Article 23 of Regulation (EC) No 765/2008
  38. Notifications
  39. Types of notification
  40. 3.1.1Notifications
  41. 3.1.2Notifications for information
  42. Content of notifications
  43. 3.2.1Scope of data
  44. 3.2.2Completeness of data
  45. 3.2.3Updating of data
  46. 3.2.4Responsibility for the information transmitted
  47. 3.3Actors and roles involved in the notification process
  48. 3.3.1Economic operators
  49. 3.3.2Member States authorities
  50. 3.3.3Authorities in charge of external border controls
  51. 3.3.4European Commission
  52. Workflow
  53. Creation of a notification
  54. 3.4.1.1By a national authority
  55. 3.4.1.2By the Commission
  56. 3.4.2Submission of notifications to the Commission
  57. 3.4.3Examination of notifications by the Commission
  58. 3.4.3.1Correctness
  59. 3.4.3.2Completeness
  60. 3.4.3.3Validation of notifications without a detailed risk assessment
  61. (a)Notifications of products posing chemical risks
  62. (b)Notifications of cosmetic products
  63. (c)Notification of other products
  64. 3.4.3.4Requests for additional information
  65. 3.4.3.5Investigation
  66. 3.4.4Validation and distribution of notifications
  67. Publication of notifications
  68. 3.4.5.1Disclosure of information as a general rule
  69. 3.4.5.2Exceptions to the general rule
  70. 3.4.5.3Requests for confidentiality
  71. 3.4.5.4Handling of notifications covered by confidentiality
  72. 3.4.5.5Withdrawal of request for confidentiality
  73. Follow-up to notifications
  74. 3.4.6.1Follow-up to the different types of notification
  75. 3.4.6.2Objectives of the follow-up activities
  76. 3.4.6.3Follow-up techniques
  77. (a)Checks on the market
  78. (b)Cooperation with business associations
  79. (c)Publication of RAPEX data via the internet or other electronic and paper media
  80. (d)Online checks
  81. Withdrawal/removal of notifications
  82. 3.4.7.1Permanent withdrawal of a notification from RAPEX
  83. 3.4.7.1.1Situations where withdrawal of a submitted or validated notification is possible
  84. 3.4.7.1.2Request for permanent or temporary withdrawal by Member States
  85. 3.4.7.1.3Content of the request for permanent or temporary withdrawal
  86. 3.4.7.1.4Decision to withdraw
  87. Temporary removal of a notification from the RAPEX website
  88. 3.4.7.2.1Situations where temporary removal is possible
  89. 3.4.7.2.2Request for temporary removal by Member States
  90. 3.4.7.2.3Content of the request for temporary removal
  91. 3.4.7.2.4Decision to remove
  92. 3.4.7.2.5Re-publishing of a notification temporarily removed
  93. 3.4.8Notifications older than ten years
  94. Timing and deadlines for notifications
  95. 3.5.1Timing of the notification
  96. (a)Compulsory measures
  97. (b)Voluntary measures
  98. 3.5.2Deadlines
  99. 3.5.3Emergency situations
  100. Follow-up activities
  101. 4.1Communication of follow-up activities
  102. Content of follow-up notifications
  103. 4.2.1Scope of data
  104. (a)A notified product has been found on the market
  105. (b)Different risk assessment
  106. (c)Additional information
  107. 4.2.2Completeness of follow-up notifications
  108. 4.2.3Updating of validated follow-up notifications
  109. 4.2.4Responsibility for follow-up notifications
  110. 4.2.5Response to follow-up notifications
  111. 4.3Actors and roles involved in follow-up activities
  112. 4.3.1Economic operators
  113. 4.3.2Market surveillance authorities
  114. 4.3.3European Commission
  115. Workflow
  116. 4.4.1Creation and submission of a follow-up notification by a Member State
  117. Examination of follow-up notifications by the Commission
  118. 4.4.2.1Correctness and completeness
  119. 4.4.2.2Requests for additional information
  120. 4.4.3Validation and distribution of follow-up notifications
  121. 4.4.4Permanent withdrawal of a follow-up notification from RAPEX
  122. 4.5Deadlines for submitting follow-up notifications
  123. 4.6Requests for confidentiality
  124. RAPEX networks
  125. 5.1RAPEX National Contact Points
  126. 5.1.1Organisation
  127. 5.1.2Tasks
  128. RAPEX networks established at EU and national levels
  129. 5.2.1The RAPEX Contact Point Network
  130. 5.2.2RAPEX networks established at national level
  131. RAPEX internal communication tools, practical and technical arrangements for RAPEX and best practice
  132. 5.3.1Languages
  133. RAPEX online tools
  134. (a)RAPEX system
  135. (b)‘Product Safety Business Alert Gateway’
  136. (c)Collaborative space
  137. (d)‘RAG tool’
  138. 5.3.3Contact details
  139. 5.3.4Operation of RAPEX outside regular working hours
  140. APPENDICES
  141. 1Fields and information included in notifications
  142. 2Fields and information included in follow-up notifications
  143. 3Notification scheme
  144. 4Deadlines for member states
  145. 5Deadlines for the Commission
  146. RISK ASSESSMENT GUIDELINES FOR CONSUMER PRODUCTS
  147. 1Introduction
  148. Risk assessment — an overview
  149. 2.1Risk — Combination of hazard and probability
  150. 2.2A risk assessment in three steps
  151. Some useful tips
  152. Seek information
  153. Make a sensitivity analysis of your risk assessment
  154. Let others check your risk assessment
  155. Document your risk assessment
  156. Several hazards, several injuries — but only one risk
  157. Can risks cumulate?
  158. Compliance with limit values in legislation and standards
  159. Specific risk assessment guidelines in specific cases
  160. 3Building a risk assessment step by step
  161. 3.1The product
  162. 3.2The product hazard
  163. Hazard identification by tests and standards
  164. Products may still present a risk even though they do not cause injuries
  165. 3.3The consumer
  166. 3.4Injury scenario: Steps leading to injury(ies)
  167. 3.5Severity of injury
  168. 3.6Probability of injury
  169. 3.7Determination of risk
  170. 4From risk to action: how to manage risk responsibly
  171. 5How to prepare a risk assessment — in brief
  172. 1Describe the product and its hazard.
  173. 2Identify the type of consumer you want to include in your injury scenario with the hazardous product.
  174. 3Describe an injury scenario in which the product hazard(s) you have selected causes an injury(ies) or adverse health effect(s) to the consumer you selected.
  175. 4Determine the severity of the injury.
  176. 5Determine the probability of the injury scenario.
  177. 6Determine the risk level.
  178. 7Check whether the risk level is plausible.
  179. 8Develop several injury scenarios to identify the highest risk of the product.
  180. 9Document and pass on your risk assessment.
  181. Examples
  182. 6.1Folding chair
  183. 6.2Socket protectors
  184. 6.3Sensitivity analysis
  185. Table 3Severity of injury
  186. Introduction
  187. Division
  188. Glossary of terms