ANNEX
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
PART IIIAPPENDICES
1.Fields and information included in notifications42
Fields that will be published on the web are shaded.
Notification Form | |
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Section 1: General information | |
Case number | |
Creation date | |
Validation/distribution date | |
Notification type * | |
Notifying country | |
Full Contact details of the Notifying Authority * | |
Section 2: Product | |
Professional / Consumer Product | |
Product category * | |
OECD Portal category (if known) | |
Product (what the product is) * | |
Name * | |
Brand * | |
Type/number of model: * | |
Batch number/Bar code * | |
Customs code * | |
Product and packaging description * | |
Total number of items covered by the notification (if known) * | |
Photos: | |
Section 3: Regulations and standards applicable | |
Legal provisions (directive, decision, regulation, etc.) * | |
Standards * | |
Proof of conformity * | |
Is the product counterfeit? * | |
Certificates | |
Section 4: Traceability | |
Country of origin (where the product manufactured) * | |
Countries of destination * | |
Full Contact details of the manufacturer or its representative(s) * | |
Full Contact details of the exporter(s) * | |
Full Contact details of the importer(s) * | |
Full Contact details of the distributor(s) * | |
Full Contact details of the retailer(s) * | |
Is the product (also) sold online? | |
Please give details: URL | |
Section 5: Risk assessment | |
Risk category * | |
Risk level | |
Summary of test results * | |
Description of the technical issue that leads to the highest risk level | |
Risk description (how the technical defect leads to the risk) * | |
EU Legal provisions and /or Standards against which the product was tested and did not comply with * | |
Information on known incidents and accidents * | |
Section 6: Measures | |
Type of measures adopted * | |
If Voluntary: | Type of economic operator taking notified measure(s) * |
Name of economic operator taking notified measure(s) * | |
If Compulsory: | Name of authority ordering the notified measure(s) * |
Type of economic operator to whom the measure(s) were ordered * | |
Category of measures * | |
Date of entry into force * | |
Duration * | |
Scope * | |
Has the notification been sent by a producer or a distributor under Article 5(3) of the GPSD? * | |
URL link to company recall page (if available) | |
Section 7: Confidentiality | |
Is the notification confidential? * | |
Scope of confidentiality | |
Justification | |
Section 8: Other | |
Additional information | |
Justification for sending ‘Notification for information’ | |
Annexes | |
Photos (products, packaging and label) | |
Certificates | |
Test report and risk assessment | |
Notification sent by an economic operator through ‘Business Gateway’ | |
Adopted measures | |
* Indicates a mandatory field. |
2.Fields and information included in follow-up notifications44
Fields that will be published on the web are shaded.
Section 1: General information | |
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Case number | |
Validated notification type | |
Notifying country | |
Creation date | |
Validation/distribution date | |
Submission number | |
Follow up notification number | |
Reacting country | |
Full contact details of the notifying authority | |
Validated notification product category | |
Notified product | |
Notified name | |
Product (what the product is) | |
Name (on the product or the packaging) | |
Brand (on the product or the packaging) | |
Type/number of model | |
Batch number/Bar code (or other information to identify which products are affected) | |
Photos (products, packaging and label) | |
Section 2: Type of follow-up notification | |
Product found * | |
Total number of items found (if known) * | |
Measures adopted / Measures not adopted | |
Type of measures adopted * | |
If Voluntary: | Type of economic operator taking notified measure(s) * |
Name of economic operator taking notified measure(s) * | |
If Compulsory: | Name of authority ordering the notified measure(s) * |
Type of economic operator to whom the measure(s) were ordered * | |
Category of measures * | |
Date of entry into force * | |
Duration * | |
Scope * | |
Adopted measures | |
URL link to company recall page (if available): | |
Different risk assessment * | |
Risk category * | |
Summary of the test results (description of technical defects) * | |
Indication of legal provisions and standards (with clauses) against which the product was tested * | |
Different risk assessment * | |
Information on known incidents and accidents * | |
Attachments (certificates, test report and risk assessment …) | |
Additional information * | |
Complementary information on distribution channels and/or product's origin | |
Complementary information on the risk assessment | |
Other complementary information | |
Section 3: Confidentiality | |
Is the follow-up confidential? * | |
Scope of confidentiality | |
Justification | |
Annexes | |
Photos (product, packaging and label) | |
Test reports and risk assessments | |
Certificates | |
Adopted measures | |
* Indicates a mandatory field |
3.Notification scheme
4.Deadlines for member states
Member States are required to act within the deadlines indicated unless duly justified
Notification procedure | Action | Deadline | ||
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Notifications | Send ‘Article 12 notification requiring emergency action’ | Within 3 days after:
| ||
Send ‘Article 12 notification’ or Article 22 Regulation (EC) No 765/2008 notification | Within 10 days after:
| |||
Confirm measures if the notification was sent before deciding to adopt measures | Within 45 days after submission of the notification | |||
Update to a notification | Within 5 days after receipt of the information on developments requiring changes to a notification | |||
Follow-up notifications | Ensure follow-up activities to: | ‘Article 12 notification requiring emergency action’ | Within 20 days after receipt of a notification | |
‘Article 12 notification’ and to ‘Notification sent by the European Commission’ as well as Article 22 of Regulation (EC) No 765/2008 notification | Within 45 days after receipt of a notification | |||
Send follow-up notification to: | ‘Article 12 notification requiring emergency action’ | Within 3 days after:
| ||
‘Article 12 notification’ and to ‘Notification sent by the European Commission’ as well as Article 22 of Regulation (EC) No 765/2008 notification | Within 5 days after:
| |||
Update to a follow-up notification | Within 5 days after receipt of information or developments requiring changes to a follow-up notification | |||
Notification procedure established under Article 11 of the GPSD | Notifications | Send ‘Article 11 notification’ | Within 10 days after adoption of ‘Compulsory measures’ | |
Update to the notification | Within 5 days after receipt of information on developments requiring changes to the notification |
5.Deadlines for the Commission
Notification procedure | Action | Deadline | |
---|---|---|---|
EU Rapid Information System ‘RAPEX’ established under Article 12 of the GPSD | Notifications | Validate ‘Article 12 notification requiring emergency action’ | Within 3 days after receipt of a notification |
Validate ‘Article 12 notification’ as well as Article 22 of Regulation (EC) No 765/2008 notification | Within 5 days after receipt of a notification | ||
Validate ‘Notification for information’ | Within 10 days after receipt of a notification | ||
Follow-up notifications | Validate follow-up notification sent to ‘Article 12 notification requiring emergency action’ | Within 3 days after receipt of a follow-up notification | |
Validate follow-up notification sent to ‘Article 12 notification’ and to ‘Notification sent by the European Commission’ as well as Article 22 of Regulation (EC) No 765/2008 notification | Within 5 days after receipt of a follow-up notification | ||
Validate follow-up notification sent to ‘Notification for information’ | Within 10 days after receipt of a follow-up notification | ||
Notification procedure established under Article 11 of the GPSD | Notifications | Validate ‘Article 11 notification’ | Within 10 days after receipt of a notification |
Follow-up notifications | Validate follow-up notifications sent to ‘Article 11 notification’ | Within 10 days after receipt of a follow-up notification |