Commission Decision 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11 of Directive 2001/95/EC (the General Product Safety Directive) (notified under document C(2009) 9843) (2010/15/EU) (repealed)

1. Introductory Text

2. Article 1. The guidelines for the management of the Community Rapid Information...

3. Article 2. Decision 2004/418/EC is repealed.

4. Article 3. This Decision is addressed to the Member States.

5. Signature

6. 1. ANNEX

      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)

      1. PART I STATUS AND ADDRESSEES OF THE GUIDELINES

         1. 1. Status, objectives and updating of the Guidelines

            1. 1.1. Status

            2. 1.2. Objectives

            3. 1.3. Updating

         2. 2. Addressees of the Guidelines

      2. PART II COMMUNITY RAPID INFORMATION SYSTEM ‘RAPEX’ ESTABLISHED UNDER ARTICLE 12 OF THE GENERAL PRODUCT SAFETY DIRECTIVE

         1. 1. Introduction

            1. 1.1. Objectives of RAPEX

            2. 1.2. Components of RAPEX

         2. 2. RAPEX notification criteria

            2. 2.1. Consumer products

               1. 2.1.1. Products covered by RAPEX

               2. 2.1.2. Products which are not covered by RAPEX

            3. 2.2. Measures

               1. 2.2.1. Categories of measures

               2. 2.2.2. Type of measures

               3. 2.2.3. Obligatory measures initiated by authorities in charge of external border...

               4. 2.2.4. Exclusion of generally applicable obligatory measures

               5. 2.2.5. Timing of the notification

               6. 2.2.6. Notifying authorities

               7. 2.2.7. RAPEX notification concerning business notifications

            4. 2.3. Serious risk

               1. 2.3.1. Serious risk

               2. 2.3.2. Risk assessment method

               3. 2.3.3. Assessing authority

               4. 2.3.4. Risk assessment in business notifications

            5. 2.4. Cross-border effects

               1. 2.4.1. International event

               2. 2.4.2. Local event

         3. 3. Notifications

            1. 3.1. Types of notifications

               1. 3.1.1. RAPEX notifications

               2. 3.1.2. Notifications for information

            2. 3.2. Content of notifications

               1. 3.2.1. Completeness of data

               2. 3.2.2. Scope of data

               3. 3.2.3. Updating of data

               4. 3.2.4. Responsibility for the information transmitted

            3. 3.3. Confidentiality

               1. 3.3.1. Disclosure of information as a general rule

               2. 3.3.2. Exceptions to the general rule

               3. 3.3.3. Request for confidentiality

               4. 3.3.4. Handling of notifications covered by confidentiality

               5. 3.3.5. Withdrawal of request for confidentiality

            4. 3.4. Examination of notifications by the Commission

               2. 3.4.1. Correctness

               3. 3.4.2. Completeness

               4. 3.4.3. Requests for additional information

               5. 3.4.4. Investigation

            5. 3.5. Validation and distribution of notifications

               1. 3.5.1. Validation and distribution of notifications

               2. 3.5.2. Validation of notifications on safety aspects subject to discussions at...

            6. 3.6. Information on dangerous products sent by the Commission

            7. 3.7. Follow-up to notifications

               1. 3.7.1. Follow-up to the different types of notification

               2. 3.7.2. Objectives of the follow-up

               3. 3.7.3. Follow-up techniques

            8. 3.8. Permanent withdrawal of a notification from the RAPEX application

               2. 3.8.1. Situations where withdrawal is possible

               3. 3.8.2. Requesting Member State

               4. 3.8.3. Content of the request

               5. 3.8.4. Decision to withdraw

            9. 3.9. Temporary removal of a RAPEX notification from the RAPEX website...

               1. 3.9.1. Situations where temporary removal is possible

               2. 3.9.2. Requesting Member State

               3. 3.9.3. Content of the request

               4. 3.9.4. Decision to remove

               5. 3.9.5. Re-publishing of a notification

            10. 3.10. Deadlines for submitting RAPEX notifications

                1. 3.10.1. Deadlines

                2. 3.10.2. Emergency situations

         4. 4. Reactions

            1. 4.1. Communication of follow-up action

            2. 4.2. Content of reactions

               1. 4.2.1. Data provided

               2. 4.2.2. Completeness of reactions

               3. 4.2.3. Updating of validated reactions

               4. 4.2.4. Responsibility for reactions

            3. 4.3. Confidentiality

            4. 4.4. Examination of reactions by the Commission

               1. 4.4.1. Correctness and completeness

               2. 4.4.2. Request for additional information

            5. 4.5. Validation and distribution of reactions

            6. 4.6. Permanent withdrawal of a reaction from the RAPEX application

            7. 4.7. Deadlines for submitting reactions

         5. 5. Operation of the RAPEX networks

            1. 5.1. RAPEX Contact Points

               2. 5.1.1. Organisation

               3. 5.1.2. Tasks

            2. 5.2. RAPEX networks established at EU and national levels

               1. 5.2.1. RAPEX Contact Points Network

               2. 5.2.2. RAPEX networks established at national level

            3. 5.3. Means of communication, practical and technical arrangements for RAPEX

               1. 5.3.1. Languages

               2. 5.3.2. Online application for RAPEX

               3. 5.3.3. Operation of RAPEX outside regular working hours

      3. PART III NOTIFICATION PROCEDURE ESTABLISHED UNDER ARTICLE 11 OF THE GENERAL PRODUCT SAFETY DIRECTIVE

         1. 1. Background and objectives

         2. 2. Notification criteria

         3. 3. Notifications

         4. 4. Reactions

         5. 5. Practical and technical arrangements

      4. PART IV APPENDICES

         1. 1. Standard notification form

         2. 2. Reaction form

         3. 3. Deadlines for Member States

         4. 4. Deadlines for the Commission

         5. 5. Risk Assessment Guidelines for Consumer Products

         6. 1. Introduction

         7. 2. Risk assessment – an overview

            1. 2.1. Risk – Combination of hazard and probability

            2. 2.2. A risk assessment in three steps

            3. 2.3. Some useful tips

               1. Seek information

               2. Make a sensitivity analysis of your risk assessment

               3. Let others check your risk assessment

               4. Document your risk assessment

               5. Several hazards, several injuries – but only one risk

               6. Can risks cumulate?

               7. Compliance with limit values in legislation and standards

               8. Specific risk assessment guidelines in specific cases

         8. 3. Building a risk assessment step by step

            2. 3.1. The product

            3. 3.2. The product hazard

               2. Hazard identification by tests and standards

               3. Products may still present a risk even though they do...

            4. 3.3. The consumer

            5. 3.4. Injury scenario: Steps leading to injury(ies)

            6. 3.5. Severity of injury

            7. 3.6. Probability of injury

            8. 3.7. Determination of risk

         9. 4. From risk to action

         10. 5. How to prepare a risk assessment – in brief

             1. 1. Describe the product and its hazard.

             2. 2. Identify the type of consumer you want to include in...

             3. 3. Describe an injury scenario in which the product hazard(s) you...

             4. 4. Determine the severity of the injury.

             5. 5. Determine the probability of the injury scenario.

             6. 6. Determine the risk level.

             7. 7. Check whether the risk level is plausible.

             8. 8. Develop several injury scenarios to identify the highest risk of...

             9. 9. Document and pass on your risk assessment.

         11. 6. Examples

             1. 6.1. Folding chair

             2. 6.2. Socket protectors

             3. 6.3. Sensitivity analysis