Commission Implementing Decision (EU) 2019/417 of 8 November 2018 laying down gui... (32019D0417)
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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)
- 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)
- Article 1
- Article 2
- Article 3
- 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 I
- SCOPE AND ADDRESSEES OF THE GUIDELINES
- 1.
- Scope, objectives and update
- 1.1.
- Scope
- 1.2.
- Objectives
- 1.3.
- Update
- 2.
- Addressees of the Guidelines
- 3.
- Products
- 3.1.
- Products covered by these Guidelines
- 3.1.1.
- Products covered by the GPSD
- 3.1.2.
- Products covered by Regulation (EC) No 765/2008
- 3.2.
- Products not covered by these Guidelines
- 4.
- Measures
- 4.1.
- Types of measures
- 4.2.
- Categories of measures
- 4.3.
- Requirements of the measures
- 4.4.
- Exclusion of generally applicable compulsory measures
- 5.
- Risk Levels
- 5.1.
- Serious risk
- 5.2.
- Less than serious risk
- 5.3.
- Risk assessment method
- 5.4.
- Assessing authority
- 6.
- Cross-border effects
- 6.1.
- International event
- 6.2.
- Local event
- PART II
- EU RAPID INFORMATION SYSTEM ‘RAPEX’ ESTABLISHED UNDER ARTICLE 12 OF THE GENERAL PRODUCT SAFETY DIRECTIVE
- 1.
- Introduction
- 1.1.
- Objectives of RAPEX
- 1.2.
- Components of RAPEX
- 2.
- Notification criteria
- 2.1.
- Mandatory participation in RAPEX: Article 12 of the GPSD and Article 22 of Regulation (EC) No 765/2008
- 2.2.
- Non-mandatory participation in RAPEX: Article 11 of the GPSD and Article 23 of Regulation (EC) No 765/2008
- 3.
- Notifications
- 3.1.
- Types of notification
- 3.1.1.
- Notifications
- 3.1.2.
- Notifications for information
- 3.2.
- Content of notifications
- 3.2.1.
- Scope of data
- 3.2.2.
- Completeness of data
- 3.2.3.
- Updating of data
- 3.2.4.
- Responsibility for the information transmitted
- 3.3.
- Actors and roles involved in the notification process
- 3.3.1.
- Economic operators
- 3.3.2.
- Member States authorities
- 3.3.3.
- Authorities in charge of external border controls
- 3.3.4.
- European Commission
- 3.4.
- Workflow
- 3.4.1.
- Creation of a notification
- 3.4.1.1.
- By a national authority
- 3.4.1.2.
- By the Commission
- 3.4.2.
- Submission of notifications to the Commission
- 3.4.3.
- Examination of notifications by the Commission
- 3.4.3.1.
- Correctness
- 3.4.3.2.
- Completeness
- 3.4.3.3.
- Validation of notifications without a detailed risk assessment
- (a) Notifications of products posing chemical risks
- (b) Notifications of cosmetic products
- (c) Notification of other products
- 3.4.3.4.
- Requests for additional information
- 3.4.3.5.
- Investigation
- 3.4.4.
- Validation and distribution of notifications
- 3.4.5.
- Publication of notifications
- 3.4.5.1.
- Disclosure of information as a general rule
- 3.4.5.2.
- Exceptions to the general rule
- 3.4.5.3.
- Requests for confidentiality
- 3.4.5.4.
- Handling of notifications covered by confidentiality
- 3.4.5.5.
- Withdrawal of request for confidentiality
- 3.4.6.
- Follow-up to notifications
- 3.4.6.1.
- Follow-up to the different types of notification
- 3.4.6.2.
- Objectives of the follow-up activities
- 3.4.6.3.
- Follow-up techniques
- (a) Checks on the market
- (b) Cooperation with business associations
- (c) Publication of RAPEX data via the internet or other electronic and paper media
- (d) Online checks
- 3.4.7.
- Withdrawal/removal of notifications
- 3.4.7.1.
- Permanent withdrawal of a notification from RAPEX
- 3.4.7.1.1. Situations where withdrawal of a submitted or validated notification is possible
- 3.4.7.1.2. Request for permanent or temporary withdrawal by Member States
- 3.4.7.1.3. Content of the request for permanent or temporary withdrawal
- 3.4.7.1.4. Decision to withdraw
- 3.4.7.2.
- Temporary removal of a notification from the RAPEX website
- 3.4.7.2.1. Situations where temporary removal is possible
- 3.4.7.2.2. Request for temporary removal by Member States
- 3.4.7.2.3. Content of the request for temporary removal
- 3.4.7.2.4. Decision to remove
- 3.4.7.2.5. Re-publishing of a notification temporarily removed
- 3.4.8.
- Notifications older than ten years
- 3.5.
- Timing and deadlines for notifications
- 3.5.1.
- Timing of the notification
- (a) Compulsory measures
- (b) Voluntary measures
- 3.5.2.
- Deadlines
- (33)
- 3.5.3.
- Emergency situations
- 4.
- Follow-up activities
- 4.1.
- Communication of follow-up activities
- 4.2.
- Content of follow-up notifications
- 4.2.1.
- Scope of data
- (a) A notified product has been found on the market
- (b) Different risk assessment
- (c) Additional information
- 4.2.2.
- Completeness of follow-up notifications
- 4.2.3.
- Updating of validated follow-up notifications
- 4.2.4.
- Responsibility for follow-up notifications
- 4.2.5.
- Response to follow-up notifications
- 4.3.
- Actors and roles involved in follow-up activities
- 4.3.1.
- Economic operators
- (35)
- 4.3.2.
- Market surveillance authorities
- 4.3.3.
- European Commission
- 4.4.
- Workflow
- 4.4.1.
- Creation and submission of a follow-up notification by a Member State
- 4.4.2.
- Examination of follow-up notifications by the Commission
- 4.4.2.1.
- Correctness and completeness
- 4.4.2.2.
- Requests for additional information
- 4.4.3.
- Validation and distribution of follow-up notifications
- 4.4.4.
- Permanent withdrawal of a follow-up notification from RAPEX
- 4.5.
- Deadlines for submitting follow-up notifications
- 4.6.
- Requests for confidentiality
- 5.
- RAPEX networks
- 5.1.
- RAPEX National Contact Points
- 5.1.1.
- Organisation
- 5.1.2.
- Tasks
- 5.2.
- RAPEX networks established at EU and national levels
- 5.2.1.
- The RAPEX Contact Point Network
- 5.2.2.
- RAPEX networks established at national level
- 5.3.
- RAPEX internal communication tools, practical and technical arrangements for RAPEX and best practice
- 5.3.1.
- Languages
- 5.3.2.
- RAPEX online tools
- (a) RAPEX system
- (b) ‘Product Safety Business Alert Gateway’
- (c) Collaborative space
- (d) ‘RAG tool’ (38)
- 5.3.3.
- Contact details
- 5.3.4.
- Operation of RAPEX outside regular working hours
- PART III
- APPENDICES
- 1.
- Fields and information included in notifications
- (39)
- 2.
- Fields and information included in follow-up notifications
- (40)
- 3.
- Notification scheme
- 4.
- Deadlines for member states
- 5.
- Deadlines for the Commission
- RISK ASSESSMENT GUIDELINES FOR CONSUMER PRODUCTS
- (41)
- 1.
- Introduction
- 2.
- Risk assessment — an overview
- 2.1.
- Risk — Combination of hazard and probability
- 2.2.
- A risk assessment in three steps
- 2.3.
- Some useful tips
- Seek information
- Make a sensitivity analysis of your risk assessment
- Let others check your risk assessment
- Document your risk assessment
- Several hazards, several injuries — but only one risk
- Can risks cumulate?
- Compliance with limit values in legislation and standards
- Specific risk assessment guidelines in specific cases
- 3.
- Building a risk assessment step by step
- 3.1.
- The product
- 3.2.
- The product hazard
- Hazard identification by tests and standards
- Products may still present a risk even though they do not cause injuries
- 3.3.
- The consumer
- 3.4.
- Injury scenario: Steps leading to injury(ies)
- 3.5.
- Severity of injury
- 3.6.
- Probability of injury
- 3.7.
- Determination of risk
- 4.
- From risk to action: how to manage risk responsibly
- 5.
- How to prepare a risk assessment — in brief
- 1. Describe the product and its hazard.
- 2. Identify the type of consumer you want to include in your injury scenario with the hazardous product.
- 3. Describe 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.
- 4. Determine the severity of the injury.
- 5. Determine the probability of the injury scenario.
- 6. Determine the risk level.
- 7. Check whether the risk level is plausible.
- 8. Develop several injury scenarios to identify the highest risk of the product.
- 9. Document and pass on your risk assessment.
- 6.
- Examples
- 6.1.
- Folding chair
- 6.2.
- Socket protectors
- 6.3.
- Sensitivity analysis
- Table 3
- Severity of injury
- Introduction
- Glossary of terms
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