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)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on European Union and 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 safety (1), and in particular the third subparagraph of Article 11(1) and point 8 of Annex II thereof,

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

Whereas:

Article 12 of 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 action taken in relation to products posing a serious risk to the health and safety of consumers.

RAPEX helps to prevent and restrict the supply of products posing a serious risk to consumer health and safety, and facilitates the monitoring of the effectiveness and consistency of market surveillance and enforcement activities in the Member States. It provides a basis for identifying the need for action at Community level and makes for consistent enforcement of EC product safety requirements and hence the smooth functioning of the internal market.

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 in relation to products posing a non-serious risk to the health and safety of consumers.

Notifications submitted under Article 11 of Directive 2001/95/EC help to ensure a consistent, high level of consumer health and to preserve the unity of the internal market.

In order to facilitate the operation of RAPEX and the notification procedure under Article 11 of Directive 2001/95/EC, the Commission should draw up guidelines to regulate various aspects of these notification procedures and, in particular, to establish the content of notifications. These should include a standard notification form, 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 procedures.

To ensure that RAPEX and notification procedure under Article 11 of Directive 2001/95/EC are properly applied, the guidelines should also set out a risk assessment method and, in particular, specific criteria for identifying serious risks.

On 29 April 2004, the Commission adopted Decision 2004/418/EC 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 (2) . Point 8 of Annex II to Directive 2001/95/EC and Chapter 1.2 of the guidelines set out in the Annex to Decision 2004/418/EC require the guidelines to be regularly updated in the light of new developments and experience.

In the fifth year since the adoption of Decision 2004/418/EC, the total number of notifications submitted under RAPEX and the notification procedure under Article 11 of Directive 2001/95/EC has quadrupled and is still growing. Market surveillance authorities have enhanced their enforcement actions (including their participation in joint market surveillance projects) and national authorities in charge of external border controls have became more actively involved in product safety activities.

In view of these developments, and in order to ensure more efficient and effective notification procedures in line with best practice, it is necessary to update the guidelines.

The main objective of this Decision is to lay down new guidelines that establish the scope of RAPEX and of the notification procedure under Article 11 of Directive 2001/95/EC more clearly, identify the notification criteria and regulate various aspects of the notification and reaction procedures, such as the scope of data provided by the Member States, confidentiality rules, withdrawal of notifications, follow-up action to notifications and organisational aspects.

In the light of the provisions of point 2 in Annex II to Directive 2001/95/EC, the new guidelines include improved risk assessment guidelines for consumer products which specify the criteria for identifying serious risks.

The structure and content of the new guidelines allow them to be adapted, if and as appropriate, to include provisions relating to the notification procedure established under Article 22 of 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 relating to the marketing of products and repealing Regulation (EEC) No 339/93 (3) which will use RAPEX to exchange information and to the safeguard procedure notifications, for example regarding toys.

The guidelines are addressed to all authorities of the Member States acting in the consumer product safety area and participating in the RAPEX network pursuant to Directive 2001/95/EC, including market surveillance authorities responsible for monitoring the compliance of consumer products with safety requirements and authorities in charge of external border controls. The Commission should use the guidelines as a reference for managing RAPEX and the notification procedure under Article 11 of Directive 2001/95/EC,

HAS ADOPTED THIS DECISION:

Article 1

The 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 are set out in the Annex to this Decision.

Article 2

Decision 2004/418/EC is repealed.

Article 3

This Decision is addressed to the Member States.

(1) OJ L 11, 15.1.2002, p. 4.

(2) OJ L 151, 30.4.2004, p. 83.

(3) OJ L 218, 13.8.2008, p. 30.

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)

TABLE OF CONTENTS

PART I — Status and addressees of the Guidelines

1. Status, objectives and updating of the Guidelines

1.1. Status

1.2. Objectives

1.3. Updating

2. Addressees of the Guidelines

PART II — Community 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. RAPEX notification criteria

2.1. Consumer products

2.1.1. Products covered by RAPEX

2.1.2. Products which are not covered by RAPEX

2.2. Measures

2.2.1. Categories of measures

2.2.2. Type of measures

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

2.2.4. Exclusion of generally applicable obligatory measures

2.2.5. Timing of the notification

2.2.6. Notifying authorities

2.2.7. RAPEX notification concerning business notifications

2.3. Serious risk

2.3.1. Serious risk

2.3.2. Risk assessment method

2.3.3. Assessing authority

2.3.4. Risk assessment in business notifications

2.4. Cross-border effects

2.4.1. International event

2.4.2. Local event

3. Notifications

3.1. Type of notifications

3.1.1. RAPEX notifications

3.1.2. Notifications for information

3.2. Content of notifications

3.2.1. Completeness of data

3.2.2. Scope of data

3.2.3. Updating of data

3.2.4. Responsibility for the information transmitted

3.3. Confidentiality

3.3.1. Disclosure of information as a general rule

3.3.2. Exceptions to the general rule

3.3.3. Request for confidentiality

3.3.4. Handling of notifications covered by confidentiality

3.3.5. Withdrawal of request for confidentiality

3.4. Examination of notifications by the Commission

3.4.1. Correctness

3.4.2. Completeness

3.4.3. Requests for additional information

3.4.4. Investigation

3.5. Validation and distribution of notifications

3.5.1. Validation and distribution of notifications

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

3.6. Information on dangerous products sent by the Commission

3.7. Follow-up to notifications

3.7.1. Follow-up to the different types of notification

3.7.2. Objectives of the follow-up

3.7.3. Follow-up techniques

3.8. Permanent withdrawal of a notification from the RAPEX application

3.8.1. Situations where withdrawal is possible

3.8.2. Requesting MemberState

3.8.3. Content of the request

3.8.4. Decision to withdraw

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

3.9.1. Situations where temporary removal is possible

3.9.2. Requesting Member State

3.9.3. Content of the request

3.9.4. Decision to remove

3.9.5. Re-publishing of a notification

3.10. Deadlines for submitting RAPEX notifications

3.10.1. Deadlines

3.10.2. Emergency situations

4. Reactions

4.1. Communication of follow-up action

4.2. Content of reactions

4.2.1. Data provided

4.2.2. Completeness of reactions

4.2.3. Updating of validated reactions

4.2.4. Responsibility for reactions

4.3. Confidentiality

4.4. Examination of reactions by the Commission

4.4.1. Correctness and completeness

4.4.2. Request for additional information

4.5. Validation and distribution of reactions

4.6. Permanent withdrawal of a reaction from the RAPEX application

4.7. Deadlines for submitting reactions

5. Operation of the RAPEX networks

5.1. RAPEX Contact Points

5.1.1. Organisation

5.1.2. Tasks

5.2. RAPEX networks established at EU and national levels

5.2.1. RAPEX Contact Points Network

5.2.2. RAPEX networks established at national level

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

5.3.1. Languages

5.3.2. Online application for RAPEX

5.3.3. Operation of RAPEX outside regular working hours

PART III — Notification procedure established under Article 11 of the General Product Safety Directive

1. Background and objectives

2. Notification criteria

3. Notifications

4. Reactions

5. Practical and technical arrangements

PART IV — Appendices

1. Standard notification form

2. Reaction form

3. Deadlines for Member States

4. Deadlines for the Commission

5. Risk Assessment Guidelines for Consumer Products

PART I

STATUS AND ADDRESSEES OF THE GUIDELINES

1. Status, objectives and updating of the Guidelines

1.1. Status

The ‘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)’ (the ‘Guidelines’) are adopted by the Commission (1) pursuant to Article 11(1) and Annex II, point 8, of Directive 2001/95/EC (2) of the European Parliament and of the Council of 3 December 2001 on general product safety (the ‘GPSD’), which is assisted by an advisory committee composed of the representatives of Member States and established under Article 15(3) of the GPSD.

Point 8 of Annex II to the GPSD reads as follows: ‘The Commission shall prepare and regularly update, in accordance with the procedure laid down in Article 15(3), guidelines concerning the management of RAPEX by the Commission and Member States’. Furthermore, Article 11(1) of the GPSD states that the guidelines drafted for the purpose of the RAPEX notification procedure should also regulate various aspects of the notification procedure established under Article 11 of the GPSD. Therefore, the Guidelines regulate the operation and management of the RAPEX notification procedure established under Article 12 of the GPSD, as well as the notification procedure established under Article 11 of the GPSD.

The Guidelines form a self-standing document that governs the RAPEX notification procedure established under Article 12 of the GPSD. This procedure applies to preventive and restrictive measures taken in relation to consumer products posing a serious risk to the health and safety of consumers. However, the structure and content of the Guidelines allow them to be adapted, if and as appropriate, to include provisions relating to the notification procedure established under Article 22 of 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 relating to the marketing of products and repealing Regulation (EEC) No 339/93 (3).

Member States (4), applicant countries, as well as third countries and international organisations which are granted access to RAPEX (on the conditions defined in Article 12(4) of the GPSD), participate in the system according to the rules provided for in the GPSD and the Guidelines.

1.2. Objectives

The GPSD provides for the establishment of guidelines to lay down simple and clear criteria and practical rules to facilitate the operation of the notification mechanisms established under Articles 11 and 12 of the GPSD. The objectives of the Guidelines are to:

— clarify the scope of the two notification mechanisms;

— set out the notification criteria for the two notification mechanisms;

— define the content of notifications and reactions sent under the two notification mechanisms, in particular what data are required and forms to be used;

— establish follow-up action to be taken by Member States upon receipt of a notification and the type of information to be provided;

— describe the handling of notifications and reactions by the Commission;

— set deadlines for the various types of action taken under the two notification mechanisms;

— set out the practical and technical arrangements needed at Commission and Member State levels for the notification mechanisms to be employed effectively and efficiently;

— establish a risk assessment method and, in particular, criteria for identifying serious risks.

1.3. Updating

The Guidelines will be regularly updated by the Commission in accordance with the advisory procedure in the light of experience and new developments in the product safety area.

2. Addressees of the Guidelines

The Guidelines are addressed to all the authorities of Member States acting in the consumer product safety area and participating in the RAPEX network, including market surveillance authorities responsible for monitoring the compliance of consumer products with safety requirements, and authorities in charge of external border controls.

The Commission should use the Guidelines as a reference for managing the RAPEX system established under Article 12 of the GPSD and the notification procedure under Article 11 of the GPSD.

PART II

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

1. Introduction

1.1. Objectives of RAPEX

Article 12 of the GPSD establishes a Community Rapid Information System (‘RAPEX’).

RAPEX was established in order to:

— provide a rapid information exchange mechanism between Member States and the Commission on preventive and restrictive measures taken in relation to consumer products posing a serious risk to the health and safety of consumers;

— inform Member States and the Commission of the conclusions of follow-up action taken by national authorities with regard to information exchanged through RAPEX.

RAPEX plays an important role in the area of product safety; it complements other action taken both at national and at European level to ensure a high level of consumer safety in the EU.

RAPEX data help to:

— prevent and restrict the supply to consumers of dangerous products;

— monitor the effectiveness and consistency of market surveillance and enforcement activities carried out by Member State authorities;

— identify needs and provide a basis for action at EU level;

— make for consistent enforcement of the EU product safety requirements and thus the smooth functioning of the internal market.

1.2. Components of RAPEX

RAPEX consists of several complementary components, which are crucial for effective and efficient operation. The most important are:

— the legal framework, which regulates how the system operates (i.e. the GPSD and the Guidelines);

— the on-line application (‘RAPEX application’), which allows Member States and the Commission to exchange information rapidly via a web-based platform;

— the RAPEX Contact Points network, which consists of the single RAPEX Contact Points responsible for operating RAPEX in all the Member States;

— the national RAPEX networks established in all Member States, which include the RAPEX Contact Point and all the authorities involved in ensuring consumer product safety;

— the Commission RAPEX Team in the department responsible for the GPSD, which examines and validates documents submitted through RAPEX, and maintains and ensures correct operation of the RAPEX system;

— the RAPEX website (5), which provides summaries of RAPEX notifications in application of Article 16(1) of the GPSD;

— RAPEX publications, such as RAPEX statistics, RAPEX annual reports and other promotional materials.

2. RAPEX notification criteria

RAPEX, which is established under Article 12 of the GPSD, applies to measures which prevent, restrict or impose specific conditions on the marketing and use of consumer products posing a serious risk to the health and safety of consumers.

Under the GPSD, the participation of Member States in RAPEX is mandatory, and thus Member States have a legal obligation to notify the Commission when the following four notification criteria are met:

— the product is a consumer product,

— the product is subject to measures that prevent, restrict or impose specific conditions on its possible marketing or use (‘preventive and restrictive measures’),

— the product poses a serious risk to the health and safety of consumers,

— the serious risk has a cross-border effect.

2.1. Consumer products

2.1.1. Products covered by RAPEX

Under Article 2(a) of the GPSD, consumer products for the purpose of RAPEX are:

— ‘products intended for consumers’ – products that are designed and manufactured for and made available to consumers;

— ‘migrating products’ – products that are designed and manufactured for professionals, which are likely, however, under reasonably foreseeable conditions, to be used by consumers. These are products manufactured for professionals that are made available to consumers, who can purchase and operate them without any special knowledge or training, e.g. a power drill, an angle grinder and a table saw designed and manufactured for professionals, but also supplied on the consumer market (i.e. consumers can readily purchase them in shops and operate them on their own without any special training).

Both products intended for consumers and migrating products can be given to consumers free of charge, can be purchased by consumers and can be provided to consumers in the context of a service. All three situations are covered by RAPEX.

Products provided to consumers in the context of a service include:

— products supplied to consumers that are taken away and used outside the premises of a service provider, such as cars and lawn-mowing machines rented or leased in rental salons, and tattoo inks and implants (that are not classified as medical devices) implanted beneath the skin of a consumer by a service provider;

— products used on the premises of a service provider, provided that consumers themselves actively operate a product (e.g. start the machine, have the option of stopping it, affect its operation by changing its position or intensity during use). Sun-beds used in tanning salons and fitness centres are examples of such products. Use of the products by consumers must be active, and involve an significant degree of control. Merely passive use, such as the use of shampoo by a person whose hair is washed by a hairdresser, or the use of a bus by its passengers, does not qualify as use by consumers.

By contrast, equipment used or operated by a service provider to supply a service is beyond the scope of RAPEX and therefore such products cannot be notified through the system, e.g. equipment on which consumers ride or travel and is operated by a service provider.

2.1.2. Products which are not covered by RAPEX

RAPEX does not cover:

1. Products that are not covered by the definition of a ‘product’ laid down in Article 2(a) of the GPSD: — products that were designed and manufactured for and made available only to professionals and are not likely, under reasonably foreseeable conditions, to be used by consumers (‘professional products’); — second-hand products supplied as antiques or as products to be repaired or reconditioned prior to being used, provided that a supplier clearly informs the person to whom he supplies the product to that effect.

2. Products that are covered by specific and equivalent notification mechanisms established by other EU legislation: — food and feed covered by 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 (6); — medicinal products covered by Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (7), and Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (8); — medical devices covered by Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (9); — in vitro diagnostic medical devices covered by Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (10); — active implantable medical devices covered by Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (11).

2.2. Measures

2.2.1. Categories of measures

All categories of preventive and restrictive measures taken in relation to the marketing and use of consumer products posing a serious risk to the health and safety of consumers are subject to the notification obligation under RAPEX. Article 8(1)(b) to (f) of the GPSD provides a list of the different categories of measures that are notifiable under RAPEX, including measures:

— marking a product with appropriate warnings on the risks it may present;

— making the marketing of a product subject to prior conditions;

— warning consumers of the risks that could be posed by a product for certain persons;

— temporary ban on the supply, offer to supply and display of a product;

— ban on the marketing of a product and any accompanying measures;

— withdrawal of a product from the market;

— recall of a product from consumers;

— destruction of a withdrawn or recalled product.

For the purpose of RAPEX, the term ‘withdrawal’ is used exclusively for measures aimed at preventing the distribution, display and offer of a dangerous product to consumers, while the term ‘recall’ is used only for measures aimed at achieving the return of a dangerous product that has already been made available to consumers by a producer or distributor.

2.2.2. Type of measures

Preventive and restrictive measures can be taken in relation to dangerous products either on the initiative of a producer or a distributor who placed and/or distributed it on the market (‘voluntary measures’) or as ordered by an authority of a Member State competent to monitor the compliance of products with the safety requirements (‘obligatory measures’).

For the purpose of RAPEX, the obligatory measures and voluntary measures are defined as follows:

— Obligatory measures: Measures adopted or decided to be adopted by Member State authorities, often in the form of an administrative decision, which oblige a producer or a distributor to take preventive or restrictive action in relation to a specific product that they made available on the market.

— Voluntary measures: — Preventive and restrictive measures adopted on a voluntary basis by a producer or a distributor, i.e. without any intervention of an authority of a Member State. Products posing a serious risk and the related preventive or restrictive measures initiated by a producer or a distributor should be immediately notified to the competent authorities of Member States under the notification mechanism provided for in Article 5(3) of the GPSD. — Recommendations and agreements with producers and distributors concluded by Member State authorities. This includes agreements which are not in written form and result in preventive or restrictive action taken by producers or distributors in relation to products posing a serious risk that they made available on the market.

Under Article 12(1) of the GPSD, both obligatory and voluntary measures are to be notified through RAPEX.

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

Measures adopted by the authorities in charge of external border controls that prevent the marketing in the EU of a consumer product posing a serious risk to the health and safety of consumers (e.g. decisions to stop the import at the EU border) should be notified to the Commission through RAPEX in the same manner as measures adopted by market surveillance authorities that restrict the marketing or use of a product.

2.2.4. Exclusion of generally applicable obligatory measures

Generally applicable acts adopted at national level and aimed at preventing or restricting the marketing and use of (a) generally described category(ies) of consumer products due to the serious risk they pose to the health and safety of consumers should not be notified to the Commission through the RAPEX system. All such national measures that apply to only generally defined categories of products, such as all products in general or all products serving the same purpose – and not to (categories of) products specifically identified by their brand, specific look, producer, trader, model name or number, etc. – are notified to the Commission under Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (12).

2.2.5. Timing of the notification

Article 12(1) of the GPSD requires Member States immediately to notify the Commission through RAPEX of preventive and restrictive measures. This provision applies to both obligatory and voluntary measures, although the timing of the notification is different.

— Obligatory measures These measures are notified through RAPEX immediately after being adopted or the decision to adopt them, even if an appeal against them at national level is likely, they are already under appeal or subject to publication requirements. This approach is consistent with the objective of RAPEX, i.e. to ensure the rapid exchange of information between Member States and the Commission in order to prevent the supply and use of products that pose a serious health or safety risk to consumers.

— Voluntary measures Under Article 5(3) of the GPSD, producers and distributors are obliged to notify the competent Member State authorities of voluntary action and measures taken to prevent risks to consumers posed by products they have made available on the market (‘business notification’). The authority of a Member State receiving this kind of business notification uses this information as the basis for a RAPEX notification (when all the RAPEX notification criteria provided for in Article 12(1) are met) and sends it immediately after receipt of the business notification. Where voluntary measures are adopted in the form of an agreement between a producer or a distributor and an authority of a Member State or on the basis of a recommendation from an authority to a producer or distributor, a RAPEX notification is submitted immediately after the conclusion of such an agreement or the adoption of such a recommendation.

To ensure common application of the RAPEX notification obligation, Appendix 3 to the Guidelines lays down specific deadlines for submitting notifications to the Commission via RAPEX (13).

2.2.6. Notifying authorities

Both obligatory and voluntary measures are notified through RAPEX by the national RAPEX Contact Point, which is responsible for all information transmitted through the system by its country (14).

2.2.7. RAPEX notification concerning business notifications

Article 5(3) of the GPSD requires producers and distributors to notify information concerning a dangerous product (at the same time) to the competent authorities in all Member States where the dangerous product was made available. The conditions and details for this notification are laid down in Annex I to the GPSD.

In these situations, the RAPEX notification obligation applies to all Member States that received a business notification. However, in order to simplify the practical application of Article 12(1) of the GPSD and to avoid unnecessary duplication of RAPEX notifications, it has been agreed with Member States that a RAPEX notification should be submitted only by the Member State where the notifying producer/distributor is established (‘Main Member State’). Once a RAPEX notification has been validated and distributed through the system by the Commission, other Member States (especially the ones that also received the same business notification) should submit reactions to this RAPEX notification.

Where a main Member State does not submit a RAPEX notification by the deadlines specified in Appendix 3 to the Guidelines and does not inform the Commission and other Member States of the reasons for the delay, any other Member State that received the same business notification can submit a notification through RAPEX.

2.3. Serious risk

2.3.1. Serious risk

Before an authority of a Member State decides to submit a RAPEX notification, it always performs the appropriate risk assessment in order to assess whether a product to be notified poses a serious risk to the health and safety of consumers and thus whether one of the RAPEX notification criteria is met.

As RAPEX is not intended for the exchange of information on products posing non-serious risks, notifications on measures taken with regard to such products cannot be sent through RAPEX under Article 12 of the GPSD.

2.3.2. Risk assessment method

Appendix 5 to the Guidelines sets out the risk assessment method to be used by Member State authorities to assess the level of risks posed by consumer products to the health and safety of consumers and to decide whether a RAPEX notification is necessary.

2.3.3. Assessing authority

The risk assessment is always performed by an authority of a Member State that either carried out the investigation and took appropriate measures or monitored voluntary action taken with regard to a dangerous product by a producer or a distributor.

Before a RAPEX notification is sent to the Commission, the risk assessment performed by an authority of a Member State (to be included in the notification) is always verified by the RAPEX Contact Point. Any unclear issues are resolved by the Contact Point with the authority responsible before a notification is transmitted through RAPEX.

2.3.4. Risk assessment in business notifications

Notifications on dangerous consumer products submitted by producers and distributors under Article 5(3) of the GPSD to the competent authorities of Member States should include a detailed description of the risk. National authorities receiving such notifications examine their content and analyse the risk assessments provided. If, on the basis of the information provided and an independent risk assessment, an authority of a Member State decides that the notified product poses a serious risk to the health and safety of consumers, a RAPEX notification concerning this product is immediately transmitted to the Commission (the fourth subparagraph of Article 12(1)of the GPSD).

Risk assessments carried out by producers and distributors are not binding on Member State authorities. It is therefore possible for an authority of a Member State to come to a different conclusion regarding the risk assessment from a conclusion drawn in a business notification.

2.4. Cross-border effects

2.4.1. International event

Under Article 12 of the GPSD, a Member State submits a RAPEX notification only if it considers that the effects of the risks posed by a dangerous product go or can go beyond its territory (‘cross-border effects’ or ‘international event’).

In the light of the free movement of products in the internal market, and the fact that products are imported into the EU through different distribution channels and that consumers buy products during stays abroad and via the internet, national authorities are encouraged to interpret the cross-border effects criterion in a fairly broad sense. A RAPEX notification, therefore, is submitted where:

— it cannot be excluded that a dangerous product has been sold to consumers in more than one EU Member State, or

— it cannot be excluded that a dangerous product has been sold to consumers via the internet, or

— the product originates from a third country and is likely to have been imported into the EU through multiple distribution channels.

2.4.2. Local event

Measures adopted in relation to a product posing a serious risk that can only have local effects (‘Local event’) are not notified through RAPEX. This applies to situations where an authority of a Member State has reason to believe that a product has not been and will not be made available (by any means) to consumers in other Member States, e.g. measures taken with regard to a local product manufactured and distributed only in one Member State.

A notification involving a local event should still be submitted to the Commission but under Article 11 of the GPSD and only where it involves information on product safety likely to be of interest to other Member States, especially information on measures adopted in response to a new type of risk which has not yet been notified, a new type of risk arising from a combination of products or a new type or category of dangerous products (the second subparagraph of Article 12(1) of the GPSD).

3. Notifications

3.1. Types of notifications

3.1.1. RAPEX notifications

There are two types of RAPEX notifications, namely ‘Article 12 notification’ and ‘Article 12 notification requiring emergency action’.

— Where all the RAPEX notification criteria laid down in Article 12 of the GPSD (see Chapter 2 of Part II of the Guidelines) are met, a Member State prepares and submits to the Commission a RAPEX notification classified in the RAPEX application as ‘Article 12 notification’.

— Where all the RAPEX notification criteria are met and, in addition, a product poses a life-threatening risk and/or there have been fatal accidents and in other cases where a RAPEX notification requires emergency action by all Member States, the notifying Member State prepares and submits to the Commission a RAPEX notification classified in the RAPEX application as ‘Article 12 notification requiring emergency action’.

Before sending a RAPEX notification to the Commission, the RAPEX Contact Point of the notifying Member State checks that all RAPEX notification criteria are met and that it should be sent through the RAPEX application as an ‘Article 12 notification’ or an ‘Article 12 notification requiring emergency action’.

3.1.2. Notifications for information

If a notification cannot be sent through the system as a RAPEX notification, the Contact Point may choose to use the RAPEX application to send the information concerned for information. Such notifications are classified in the RAPEX application as ‘Notifications for information’ and they may be sent in the following situations:

(a) Where all the RAPEX notification criteria laid down in Article 12 of the GPSD are met but a notification does not contain all the information (mainly on product identification and distribution channels) necessary for other Member States to ensure follow-up (15) to such a notification. A notification where the product name, brand and picture are missing and thus the notified product cannot be correctly identified and it cannot be distinguished from other products of the same category or type that are available on the market, is an example of a notification that can be distributed through the RAPEX application as ‘Notification for information’. Assessment as to whether a notification contains sufficient information for other Member States to ensure follow-up is always on a case-by-case basis.

(b) Where a Member State is aware of the fact that a consumer product that is available on the EU market poses a serious risk to the health and safety of consumers, but preventive and restrictive measures have not yet been taken by the producer or distributor or adopted or decided to be adopted by an authority of a Member State (the fourth subparagraph of Article 12(1) of the GPSD). If information on such a product is distributed through the RAPEX application before measures are taken, the notifying Member State subsequently informs the Commission (as soon as possible and not later than the deadlines specified in Appendix 3 to the Guidelines) of the final decision taken with regard to the notified product (mainly, what type of preventive or restrictive measures were taken or why such measures were not taken).

(c) Where a Member State decides to notify preventive and restrictive measures taken in relation to a consumer product posing a serious risk to the health and safety of consumers which has only local effects (‘local event’). If, however, as explained in Chapter 2.4.2, a notification by ‘local event’ involves information on product safety likely to be of interest for other Member States, it should be sent under Article 11 of the GPSD.

(d) Where a notification concerns a consumer product whose safety aspects (especially the level of risk posed to the health and safety of consumers) are subject to discussion at EU level to ensure a common approach between Member States to risk assessment and/or enforcement action (16).

(e) Where a decision cannot be taken with certainty that one or more of the RAPEX notification criteria are met but a notification involves information on product safety likely to be of interest for other Member States. A notification on a product that cannot be indisputably classified as a consumer product, which however provides information on a new type of risk to the health and safety of consumers, is an example of a notification that can be distributed through the RAPEX application as a ‘Notification for information’.

When sending a ‘Notification for information’, the RAPEX Contact Point clearly states the reasons for so doing.

3.2. Content of notifications

3.2.1. Completeness of data

Notifications should be as complete as possible. The standard notification form is provided in Appendix 1 to the Guidelines. All fields of the notification form should be completed with the required data. Where the required information is not available when a notification is submitted, this is clearly indicated and explained on the form by the notifying Member State. Once the missing information becomes available, the notifying Member State updates its notification. The updated notification is examined by the Commission before being validated and distributed through the system.

RAPEX Contact Points provide all national authorities that participate in the RAPEX network with instructions on the scope of data required to complete the standard notification form. This helps to ensure that the information provided by these authorities to the RAPEX Contact Point is correct and complete.

Member States should observe the established deadlines and not delay a RAPEX notification on a product posing a very serious or life-threatening risk to the health and safety of consumers because part of the information required by the Guidelines is not yet available.

Before submitting a notification, the Contact Point checks (to avoid any unnecessary duplication) that the product concerned has not already been notified through the application by another Member State. If the product has already been notified, rather than creating a new notification, the Contact Point submits a reaction to the existing notification and provides any additional information that may be relevant for authorities in other Member States, such as additional vehicle identification numbers, a detailed list of importers and distributors, additional test reports, etc.

3.2.2. Scope of data

Notifications sent to the Commission through RAPEX include the following types of data:

— Information enabling the notified product to be identified, i.e. product category, product name, brand, model and/or type number, barcode, batch or serial number, customs code, description of the product and its packaging accompanied by pictures showing the product, its packaging and labels. Detailed and accurate product identification is a key element for market surveillance and enforcement, as it allows national authorities to identify the notified product, to distinguish it from other products of the same or similar type or category that are available on the market and to find it on the market and take or agree on appropriate measures.

— Information establishing the product’s origin, i.e. country of origin, name, address and contact details, such as telephone number and e-mail address, of a manufacturer and exporters. In particular, Member States provide all available information on manufacturers and exporters located in third countries that cooperate closely with the EU on product safety. The Commission thus regularly informs the RAPEX Contact Points of recent developments in this area. The following documents also are to be attached to the form where available: copies of orders, sales contracts, invoices, shipping documents, customs declarations, etc. Detailed information on third country producers allows the Commission to promote more effective enforcement in those countries and helps to reduce the number of dangerous consumer products exported into the EU.

— Information on the safety requirements applicable to the notified product, including the reference number and name of the applicable legislation and standards.

— A risk description of the notified product, including a description of the results of laboratory or visual tests, test reports and certificates proving non-compliance of the notified product with the safety requirements, a complete risk assessment with conclusions and information on known accidents or incidents.

— Information on the supply chains of the notified product in the Member States, and, in particular, information on the countries of destination, plus information on importers, and also, if available, on distributors of the notified product.

— Information on measures taken, in particular, the type (obligatory or voluntary), category (e.g. withdrawal from the market, recall from consumers), scope (e.g. country-wide, local), date of entry into force and duration (e.g. unlimited, temporary).

— Indication of whether a notification, part of it and/or attachment(s) are covered by confidentiality. Requests for confidentiality are always accompanied by a justification clearly stating the reasons for such a request.

Member States are encouraged to obtain and provide information on the supply chains of the notified product in non-EU countries that cooperate closely with the EU on product safety.

3.2.3. Updating of data

The notifying Member State informs the Commission (as soon as possible and not later than by the deadlines specified in Appendix 3 to the Guidelines) of any developments that require changes to a notification transmitted through the RAPEX application. In particular, Member States inform the Commission of any changes (e.g. following a ruling by a court during an appeal procedure) to the status of the notified measures, to the risk assessment and to new decisions regarding confidentiality.

The Commission examines the information provided by the notifying Member State and updates the information concerned in the RAPEX application and on the RAPEX website, where necessary.

3.2.4. Responsibility for the information transmitted

Point 10 of Annex II to the GPSD states that ‘Responsibility for the information provided lies with the notifying Member State’.

The RAPEX Contact Point of the notifying Member State and the national authority responsible ensure that the data provided through RAPEX, especially product and risk descriptions, are accurate so as to avoid any confusion with similar products of the same category or type that are available on the EU market.

The RAPEX Contact Point and the authority involved in the notification procedure (e.g. by performing the risk assessment of the notified product or by providing information on distribution channels) take responsibility for the information provided through RAPEX. The RAPEX Contact Point checks and validates all notifications received from the authorities responsible before transmitting them to the Commission.

Any action taken by the Commission, such as examining notifications, validating and distributing them through the RAPEX application and publishing them on the RAPEX website, does not imply any assumption of responsibility for the information transmitted, which remains with the notifying Member State.

3.3. Confidentiality

3.3.1. Disclosure of information as a general rule

Under Article 16(1) of the GPSD, the public has the right to be informed about dangerous products posing a risk to their health and safety. To meet this obligation, the Commission publishes overviews on the RAPEX website of new RAPEX notifications (i.e. ‘Article 12 notifications’ and ‘Article 12 notifications requiring emergency action’). Member States do the same and provide the public with information in the national languages on products posing a serious risk to consumers and on measures taken to address this risk. Such information can be distributed via the internet, on paper and by electronic media, etc.

The information made available to the public is a summary of a RAPEX notification and includes only the details specified in Article 16 of the GPSD, i.e. product identification and information about the risks and measures taken to prevent or restrict those risks. The Commission and the Member States do not disclose whole notifications to the public, especially not detailed risk descriptions with test reports and certificates or detailed lists of distribution channels, as some of this information, due to its nature, is confidential (professional secrets) and needs to be protected.

3.3.2. Exceptions to the general rule

Paragraph 1 of Article 16(1) of the GPSD states that the information should be disclosed to the public ‘without prejudice to the restrictions required for monitoring and investigation activities’ while paragraph 2 stipulates that the Commission and the Member States should not ‘disclose information […] which, by its nature, is covered by professional secrecy in duly justified cases, except for information relating to the safety properties of products which must be made public if circumstances so require, in order to protect the health and safety of consumers’.

In the light of these provisions, Member States and the Commission should not disclose to the public any information about a dangerous product notified through the RAPEX application if such disclosure undermines the protection of court proceedings, monitoring and investigation activities or professional secrecy, except for information relating to the safety properties of products which must be made public if circumstances so require to protect the health and safety of consumers.

3.3.3. Request for confidentiality

A notifying Member State may request confidentiality in a notification. Such a request clearly indicates the part(s) of the notification that should be kept confidential.

Furthermore, each request for confidentiality is accompanied by a justification clearly stating the reasons, as provided for in Article 16(1) and (2) of the GPSD.

Requests for confidentiality are subject to examination by the Commission. The Commission checks that the request is complete (i.e. that it states which parts of the form are covered by confidentiality and that it contains a justification) and justified (i.e. the it is in line with the provisions of the GPSD and the Guidelines). A decision as to the validity of the request is taken by the Commission after consulting the respective RAPEX Contact Point.

3.3.4. Handling of notifications covered by confidentiality

Article 16(2) of the GPSD states that ‘Protection of professional secrecy shall not prevent the dissemination to the competent authorities of information relevant for ensuring the effectiveness of market monitoring and surveillance activities’. Notifications covered partially or fully by confidentiality are examined by the Commission and, after being validated and distributed through the RAPEX application, they are subject to the usual follow-up by the Member States. The confidentiality of a notification or parts of it does not prevent it from being handled and distributed through RAPEX to the competent national authorities.

The only significant difference in the handling and follow-up procedures is that the Commission and Member States should not disclose any parts of a notification that are confidential to the public. These parts have to remain confidential and thus they should not be published in any shape or form. Member State authorities that receive confidential information through RAPEX ensure that it is protected when performing their activities.

3.3.5. Withdrawal of request for confidentiality

The notifying Member State withdraws its request for confidentiality immediately after the authority in that Member State becomes aware that the justification for such a request is no longer valid. The Commission informs all Member States of the withdrawal of confidentiality on receipt of such a request from the notifying Member State.

A RAPEX notification that is no longer covered by full or partial confidentiality is made available to the public in line with the ‘general rules’ applying to RAPEX notifications.

3.4. Examination of notifications by the Commission

The Commission checks all notifications received through the RAPEX application before transmitting them to Member States to ensure that they are correct and complete.

3.4.1. Correctness

When assessing the correctness of a notification, the Commission checks in particular that:

— a notification meets all the relevant requirements set out in the GPSD and in the Guidelines,

— the notified product has not already been notified (to avoid any unnecessary duplication),

— a notification made by the RAPEX Contact Point of the notifying Member State is classified in accordance with the criteria set out in Chapter 3.1 of the Guidelines,

— the information provided (in particular the risk description) is in line with the applicable product safety legislation and the relevant standards,

— the correct notification procedure has been used.

3.4.2. Completeness

Once a notification is confirmed as correct, the Commission checks that it is complete. Chapters 3.2.1 and 3.2.2 of the Guidelines act as a point of reference. Special attention is given to the parts of a notification concerning product identification, risk description, measures, traceability and distribution channels.

As the Commission is not empowered to perform a risk assessment of the notified product, checking only that the assessment is included in a notification submitted, the notifying Member State always provides an exhaustive risk description containing all the elements listed in Chapter 3.2.2 of the Guidelines.

3.4.3. Requests for additional information

Should, during examination, the Commission have questions regarding a notification, it may suspend validation of the notification and ask the notifying Member State for additional information or clarification. This additional information is provided by the notifying Member State by the deadline specified in the Commission’s request for information.

3.4.4. Investigation

Where necessary, the Commission may carry out an investigation to assess the safety of a product. This investigation may be conducted in particular where there are serious doubts as to the risks posed by the product notified via the RAPEX application. These doubts can either arise during the examination of a notification by the Commission or be brought to the attention of the Commission by a Member State (e.g. through a reaction) or by a third party (e.g. a producer).

As part of such investigations the Commission may, in particular:

— ask any Member State to provide information or clarification,

— ask for an independent risk assessment and independent testing (laboratory or visual) of the product under investigation,

— consult the Scientific Committees, the Joint Research Centre or any other institution specialising in the safety of consumer products,

— convene the GPSD Committee, Consumer Safety Network and/or RAPEX Contact Points meetings, as well as consult the relevant Working Groups to discuss developments in an investigation.

Where an investigation concerns a product notified through the RAPEX application, the Commission may suspend validation of a notification or, where such a notification has already been validated and distributed through the RAPEX application, temporarily remove the overview published on the RAPEX website. After an investigation, and depending on the outcome, the Commission (after consulting the notifying Member State, where necessary) may in particular validate and distribute through RAPEX the previously suspended notification, uphold the validated notification in the RAPEX application (with any changes) or permanently withdraw the notification from the RAPEX application.

The Commission informs all Member States of:

— its decision to launch an investigation, clearly stating the reasons for its decision,

— its decision to close an investigation, presenting its conclusions and changes to the investigated notification(s) (if any), and

— all the relevant developments during an investigation.

3.5. Validation and distribution of notifications

3.5.1. Validation and distribution of notifications

The Commission validates and distributes (‘validation’) through the RAPEX application, by the deadlines specified in Appendix 4 to the Guidelines, all notifications assessed as correct and complete during the examination.

Where, during an examination, a request for additional information or clarification was sent to the notifying Member State (followed by a reminder, if necessary), the Commission may take the following decisions:

— where the additional information or clarification requested has been provided, the Commission re-examines the notification and validates it with the changed classification where necessary (e.g. from ‘Notification for information’ to ‘Article 12 notification’);

— where the additional information or clarification requested has not been provided within a specified deadline or it is insufficient, the Commission takes a decision on the basis of the information provided and, depending on the circumstances, may either validate it after changing the classification (e.g. from ‘Article 12 notification’ to ‘Notification for information’) or decide not to validate it.

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

Once a common approach to risk assessment and/or enforcement has been agreed between Member States, depending on the circumstances and the views of the Member States, the Commission may, in particular:

— keep the notifications concerned in the RAPEX application, or

— change the classification of the notifications stored in the RAPEX application, or

— withdraw notifications from the RAPEX application (17).

3.6. Information on dangerous products sent by the Commission

Point 9 of Annex II to the GPSD reads as follows: ‘The Commission may inform the national contact points regarding products posing serious risks, imported into or exported from the Community and the European Economic Area’.

The Commission may transmit information to the Member States about dangerous non-food consumer products of EU and non-EU origin that, according to the information available, are likely to be on the EU market. This mainly concerns information that the Commission receives from third countries, international organisations, businesses or other rapid alert systems.

As far as possible, the Commission assesses the correctness and completeness of the data before transmission to the Member States. However, the Commission can only carry out preliminary checks and cannot take legal responsibility for the validity of the information it transmits, as it cannot legally or technically perform a complete risk assessment or take enforcement action.

3.7. Follow-up to notifications

3.7.1. Follow-up to the different types of notification

Member States ensure appropriate follow-up to RAPEX notifications (i.e. ‘Article 12 notifications’ and ‘Article 12 notifications requiring emergency action’) and to information on dangerous products sent by the Commission (Chapter 3.6) as soon as possible and by the deadlines specified in Appendix 3 to the Guidelines at the latest.

Notifications for information do not require any specific follow-up. These notifications often do not contain the data needed for effective and efficient enforcement regarding the notified product (e.g. the notified product and/or measures are not sufficiently identified). However, Member States are encouraged to ensure follow-up to such notifications where the notified product is likely to have been made available to consumers on their market and product identification allows measures to be taken.

3.7.2. Objectives of the follow-up

On receipt of a notification, a Member State examines the information provided in the notification and takes appropriate action in order to:

— establish whether the product was marketed on its territory,

— assess what preventive or restrictive measures should be taken with regard to the notified product found on its market, taking into account the measures taken by the notifying Member State and any special circumstances that could justify different types of measures or no action being taken,

— perform additional risk assessment and testing of the notified product, if necessary,

— collect any additional information that may be relevant for other Member States (e.g. information on distribution channels of the notified product in other Member States).

3.7.3. Follow-up techniques

To ensure efficient and effective follow-up, best practice follow-up techniques should be employed by national authorities, including:

— Checks on the market National authorities organise regular (planned and random) checks on the market in order to establish whether consumer products notified through the RAPEX application are made available to consumers.

— Cooperation with business associations National authorities regularly provide business associations with overviews of the most recent notifications and enquire whether any of the notified products were produced or distributed by their members. National authorities provide businesses only with summaries of notifications, such as the weekly overviews published on the RAPEX website. Whole notifications should not be transmitted to third parties, as certain information (e.g. details of the risk description or information on distribution channels) is often confidential and should be protected.

— Publication of RAPEX data via the internet or electronic and paper media National authorities regularly alert consumers and businesses about consumer products notified through RAPEX via their websites and/or other media. Information published in this way allows consumers to check whether they have and use dangerous products and often provides the authority with useful feedback.

National authorities should apply various follow-up techniques in parallel and should not limit their activities to only one of them.

Especially a Member State in which a manufacturer, a representative or an importer of the notified product is established (‘Main Member State’) ensures appropriate follow-up to notifications distributed through the RAPEX application. The ‘Main Member State’ often has better legal and technical means of obtaining information on the notified case, which will help other Member States to undertake effective follow-up.

3.8. Permanent withdrawal of a notification from the RAPEX application

Notifications distributed through the RAPEX application are kept in the system for an unlimited period of time. The Commission may, however, in the situations presented in this Chapter, permanently withdraw a notification from the application.

3.8.1. Situations where withdrawal is possible

— There is proof that one or more of the RAPEX notification criteria (18) are not met and thus a RAPEX notification is not justified. This concerns cases in particular where it is established that the original risk assessment was performed incorrectly and that the notified product does not pose a serious risk to the health and safety of consumers. It also covers situations where the notified measures were successfully challenged in court or in other proceedings and they are no longer valid.

— No measures have been taken with regard to a product notified through the RAPEX application (for information) before it was decided to adopt measures or take action (19).

— After a discussion held at EU level, Member States agree that it is not useful to exchange information on certain safety aspects that have been notified through the RAPEX application (20).

— There is proof that products covered by a notification are no longer marketed and that all items that had been made available to consumers have already been withdrawn from the market and recalled from consumers in all Member States.

Withdrawal of a notification cannot be requested on the basis of the fact that the notified product has been subject to changes needed for it to comply with all the applicable safety requirements, unless proof is provided that all the dangerous products (items) that had been made available to consumers have been withdrawn and recalled in all Member States and that they are no longer marketed.

3.8.2. Requesting Member State

The Commission may withdraw notifications from the RAPEX application only at the request of the notifying Member State, as the latter takes full responsibility for the information transmitted through the system. Other Member States, however, are encouraged to inform the Commission of any facts that may justify withdrawal.

3.8.3. Content of the request

Every request for withdrawal is accompanied by justification stating the reasons and by all available documents supporting those reasons. The Commission examines each request and checks the justification and the supporting documents in particular. The Commission may request additional information, clarification or the opinion of the notifying Member State and/or other Member States before taking any decision.

3.8.4. Decision to withdraw

Should, on the basis of the justification provided, the Commission decide to withdraw a notification from the RAPEX application, it removes it from:

— the RAPEX application (or makes it otherwise invisible to all users of the system),

— the RAPEX website (if necessary).

The Commission informs all Member States of the withdrawal of a notification by e-mail or through other equally effective means and, if necessary, also the public by publishing a corrigendum on the RAPEX website.

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

3.9.1. Situations where temporary removal is possible

Where justified, the Commission may temporarily remove a RAPEX notification from the RAPEX website, especially where the notifying Member State suspects that a risk assessment submitted in a notification has been performed incorrectly and thus the notified product may not pose a serious risk to the health and safety of consumers. A notification can be temporarily removed from the RAPEX website until the suspect risk assessment of the notified product has been clarified.

3.9.2. Requesting Member State

The provisions of Chapter 3.8.2 apply.

3.9.3. Content of the request

The provisions of Chapter 3.8.3 apply.

3.9.4. Decision to remove

Should, on the basis of the justification provided, the Commission decide to remove a RAPEX notification from the RAPEX website, it informs all Member States by e-mail or by other equally effective means and, if necessary, also the public by publishing a corrigendum on the RAPEX website.

3.9.5. Re-publishing of a notification

The notifying Member State immediately informs the Commission when the reasons for the removal of a notification from the RAPEX website are no longer valid. In particular, it informs the Commission of the results of any new risk assessment to enable the Commission to determine whether to maintain a notification in the RAPEX application and to re-publish it on the RAPEX website or to withdraw it permanently from the RAPEX application (following a request from the notifying Member State).

The Commission may re-publish a RAPEX notification on the RAPEX website following a justified request from the notifying Member State after the risk assessment has been clarified.

The Commission informs the other Member States of the re-publishing of a RAPEX notification on the RAPEX website by e-mail or by other equally effective means and also the public by replacing the corrigendum with a new one on the RAPEX website.

3.10. Deadlines for submitting RAPEX notifications

3.10.1. Deadlines (21)

Member States notify the Commission of preventive and restrictive measures adopted in relation to consumer products posing a serious risk to the health and safety of consumers as soon as possible and by the deadlines specified in Appendix 3 to the Guidelines at the latest. Appropriate arrangements are in place at national level concerning the transmission of information between national authorities in charge of product safety and the RAPEX Contact Point to ensure that the deadlines are met.

The deadlines provided apply irrespective of any appeal procedure or official publication requirement.

3.10.2. Emergency situations

All ‘Article 12 notifications requiring emergency action’ are preceded by a telephone call by the RAPEX Contact Point to the Commission RAPEX Team mobile telephone number to ensure immediate validation and follow-up. This rule applies in particular to notifications transmitted at weekends or in holiday periods.

4. Reactions

4.1. Communication of follow-up action

Member States notify the Commission of any follow-up regarding RAPEX notifications (i.e. ‘Article 12 notifications’ and ‘Article 12 notifications requiring emergency action’) and information on dangerous products sent by the Commission (Chapter 3.6).

Member States are encouraged to notify the Commission of any follow-up regarding notifications distributed for information.

4.2. Content of reactions

4.2.1. Data provided

Results of follow-up activities are communicated to the Commission in the form of reactions to notifications. To harmonise the type of information and to keep the work load to a minimum, Member States submit reactions in particular in the following situations:

— Product found A reaction is sent when national authorities find the notified product on the market or at the external border. This reaction contains the full details of the product in question (e.g. name, brand, model number, bar code, batch number) plus information on the total number of items found. Furthermore, the following details of the measures taken are communicated: type (obligatory or voluntary), category (e.g. withdrawal from the market, recall from consumers), scope (e.g. country-wide, local), date of entry into force and duration (e.g. unlimited, temporary). If the notified product was found on the market but no measures were adopted, specific reasons justifying no measures being taken should be given in the reaction. Member States do not inform the Commission (unless the Commission asks to be informed) of the conclusions of follow-up activities where the notified product was not found on the market.

— Different risk assessment A reaction is sent when the conclusions of a risk assessment performed by an authority of the reacting Member State differ from the conclusions set out in a notification. This reaction contains a detailed risk description (including the results of tests, a risk assessment and information on known accidents and incidents) accompanied by supporting documents (test reports, certificates, etc.). Furthermore, the reacting Member State proves that the risk assessment submitted with a reaction was performed on the same product as the one notified, i.e. with the same brand, name, model number, production dates, origin, etc.

— Additional information A reaction is sent when national authorities collect additional information (during follow-up activities) that may be useful for market surveillance and enforcement in other Member States. Member States are encouraged to collect additional information that may be relevant for authorities both in other Member States and in third countries that cooperate closely with the EU on product safety. Details include product origin (e.g. information on the country of origin, manufacturer and/or exporters) and information on the supply chains (e.g. information on the countries of destination, importers and distributors). The reacting country attaches all available supporting documents to the reaction, such as copies of orders, sales contracts, invoices, customs declarations, etc.

The Contact Point of the reacting Member State together with the responsible authority ensure that all data provided in a reaction is accurate and complete and that there is no confusion with similar products of the same or similar category or type that are available on the EU market.

4.2.2. Completeness of reactions

Information provided in reactions should be as complete as possible. The standard reaction form is provided in Appendix 2 to the Guidelines. Should certain relevant information not be available when a reaction is submitted, the reacting Member State indicates this on the reaction form. Once this information becomes available, the reacting Member State updates its reaction. The updated reaction is examined by the Commission before it is validated and distributed through the system.

The RAPEX Contact Point provides all authorities in its own Member State that participate in the RAPEX network with instructions on the scope of the data required to complete the reaction form correctly. This will help to ensure that information provided by these authorities to the Contact Point is correct and complete.

4.2.3. Updating of validated reactions

The reacting Member State informs the Commission (as soon as possible and by the deadlines specified in Appendix 3 to the Guidelines at the latest) of any developments that may require changes to a reaction distributed through the RAPEX application. In particular, Member States inform the Commission of changes in the status of the measures taken and in the risk assessment submitted with a reaction.

The Commission examines the information provided by the reacting Member State and if necessary updates the information concerned.

4.2.4. Responsibility for reactions

Point 10 of Annex II to the GPSD reads as follows: ‘Responsibility for the information provided lies with the notifying Member State’.

The RAPEX Contact Point and the respective authority involved in the reaction procedure (e.g. by carrying out the risk assessment or by adopting restrictive measures) take responsibility for the information provided in reactions. The RAPEX Contact Point checks and validates all reactions prepared by the respective authorities before transmitting them to the Commission.

Any action taken by the Commission, such as examining and validating reactions, does not imply any assumption of responsibility for the information transmitted, which remains with the reacting Member State.

4.3. Confidentiality

A reacting Member State may request confidentiality in a reaction. Such requests clearly state which part(s) of a reaction should be kept confidential. Furthermore, all requests for confidentiality are accompanied by justification clearly stating the reasons.

Requests for confidentiality are examined by the Commission to determine that they are justified (i.e. in line with the provisions of the GPSD and the Guidelines) and complete (i.e. it states which parts of the form that it covers and if it contains a justification). The final decision on confidentiality is taken by the Commission after consultation of the responsible RAPEX Contact Point.

The Commission and the Member States treat reactions with requests for confidentiality in the same way as other reactions. The confidentiality of a reaction or parts of it does not prevent it from being distributed through the RAPEX system to the competent national authorities. However, neither the Commission nor the Member States should disclose any parts of a reaction that are confidential to the public. This information is confidential and therefore cannot be published in any shape or form.

The reacting Member State withdraws its confidentiality request immediately after that Member State’s authority becomes aware that the reasons for such a request are no longer valid. The Commission informs all Member States of the withdrawal of the confidentiality after the receipt of such a request from the reacting Member State.

4.4. Examination of reactions by the Commission

4.4.1. Correctness and completeness

The Commission checks all reactions received through the RAPEX application before they are validated and transmitted to the Member States. These checks focus on the correctness and completeness of the information provided.

The Commission checks if a reaction received meets all the relevant requirements set out in the GPSD and in the Guidelines and if the correct reaction procedure was applied. Once the correctness of a reaction is confirmed, the Commission checks its completeness. Chapter 4.2.2 of the Guidelines is to be used as a point of reference for this examination.

The Commission pays special attention to reactions with risk assessments. It verifies, in particular, that the risk description is complete, clearly presented and well documented, and that the risk assessment clearly relates to the product covered by a notification.

4.4.2. Request for additional information

Before validating a reaction, the Commission may request the reacting Member State to provide additional information or clarification within a given deadline. Validation of a reaction may be conditional on receipt of the data requested.

The Commission may request the opinion of any Member State and, in particular, the notifying Member State on a validated reaction. The Member State submits its opinion to the Commission within a deadline specified by the latter. Furthermore, the notifying Member State informs the Commission whether any changes to the notification (e.g. to the risk assessment) or to its status (e.g. permanent withdrawal from the system) are necessary.

4.5. Validation and distribution of reactions

All reactions assessed as correct and complete are validated and distributed (‘validation’) by the Commission by the deadlines specified in Appendix 4 to the Guidelines.

The Commission does not validate reactions with a risk assessment different from that of the notification they refer to, if the risk assessment is not complete, clearly presented and well documented or if it is not shown that the risk assessment was performed in relation to the product covered by a notification.

4.6. Permanent withdrawal of a reaction from the RAPEX application

Reactions distributed through the RAPEX application are kept in the system as long as the notification to which they are attached. The Commission may permanently withdraw a validated reaction from the RAPEX application if a notification to which this reaction is attached has been withdrawn from the RAPEX application (in accordance with Chapter 3.8 of the Guidelines). Furthermore, the Commission may withdraw a validated reaction where it clearly provides incorrect information, and in particular where:

— a product found on the market by the reacting Member State is different from a product covered by a notification,

— the measures adopted by the reacting Member State are successfully challenged in court or in other proceedings and subsequently withdrawn,

— the risk assessment performed by the reacting Member State is proven to be incorrect or to relate to a different product from the one covered by a notification.

The provisions of Chapters 3.8.2 and 3.8.3 apply.

Once the Commission decides to withdraw a reaction, it is removed from the RAPEX application (or otherwise made invisible to users of the system).

The Commission informs all Member States of the withdrawal of a reaction by e-mail or through other equally effective means.

4.7. Deadlines for submitting reactions

Member States submit reactions to the Commission as soon as possible and by the deadlines specified in Appendix 3 to the Guidelines at the latest.

Appropriate arrangements are established at national level concerning the transmission of information between all competent authorities and the RAPEX Contact Point to ensure that the deadlines are met.

The deadlines apply irrespective of any appeal procedure or official publication requirement.

5. Operation of the RAPEX networks

5.1. RAPEX Contact Points

Every Member State establishes a single RAPEX Contact Point to operate the RAPEX system at national level. The national authorities decide within which national authority to set up the RAPEX Contact Point. Each Member State also organises its national RAPEX network to ensure the efficient flow of information between the RAPEX Contact Point and various authorities participating in RAPEX.

5.1.1. Organisation

Each Member State gives the RAPEX Contact Point the resources and information it needs to perform its tasks and in particular to operate the system with effective backup/business continuity.

The RAPEX Contact Point has a separate e-mail account for participation in the RAPEX system, with access to all officials in that Contact Point (e.g. rapex@ …). Professional or private e-mail accounts of the officials in charge of the RAPEX Contact Point should not be used as the e-mail account of the Contact Point. The RAPEX Contact Point also has direct phone and fax numbers through which it can be reached during and outside working hours.

5.1.2. Tasks

The main tasks of a RAPEX Contact Point are to:

— organise and steer the work of the national RAPEX network, in accordance with the rules set out in the Guidelines,

— train and assist all authorities in the network in the use of RAPEX,

— ensure that all RAPEX tasks stemming from the GPSD and the Guidelines are performed properly, and in particular that all required information (i.e. notifications, reactions, additional information, etc.) is provided to the Commission without delay,

— transmit information between the Commission and the national market surveillance authorities and authorities in charge of external border controls,

— check and validate the information received from all competent authorities before transmission to the Commission through the RAPEX application,

— check before submitting a notification whether a product has already been notified or information relating to that product has been exchanged through the RAPEX application (to avoid any duplication),

— take responsibility (together with respective authority) for the information provided through the RAPEX application,

— participate in RAPEX Contact Points Working Group meetings and other events relating to the operation of RAPEX,

— suggest possible improvements to the operation of the system,

— inform the Commission immediately of any technical problems in the functioning of the RAPEX application,

— coordinate all national activities and initiatives taken in relation to RAPEX,

— explain to stakeholders how the RAPEX system operates and what their obligations are under the GPSD, especially the business notification obligation set out in Article 5(3).

5.2. RAPEX networks established at EU and national levels

5.2.1. RAPEX Contact Points Network

The Commission organises and steers the work of the RAPEX Contact Points Network. This network consists of all RAPEX Contact Points appointed in the Member States.

The Commission regularly convenes RAPEX Contact Points Network meetings in order to discuss the operation of the system (e.g. to communicate the latest developments concerning RAPEX, to exchange experience and ‘know-how’), and to improve cooperation between Contact Points.

5.2.2. RAPEX networks established at national level

The RAPEX Contact Point organises and steers the work of its own ‘RAPEX national network’. The network consists of:

— the RAPEX Contact Point,

— market surveillance authorities responsible for monitoring the safety of consumer products,

— authorities in charge of external border controls.

RAPEX Contact Points are encouraged to formally regulate the organisation and operation of the RAPEX national network so as to ensure that all authorities involved are aware of their roles and responsibilities in the operation of RAPEX. This may be binding or non-binding and should be consistent with the Guidelines.

The RAPEX Contact Point regularly holds meetings of the RAPEX national network in order to discuss with all the authorities involved how RAPEX is organised and operates and to give training courses. A RAPEX national network meeting can be linked with a RAPEX seminar where it is organised in that Member State by the Commission.

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

5.3.1. Languages

The use of languages in notifications and reactions as well as communications between the RAPEX Contact Points and the Commission must take due account of the objectives of RAPEX and must ensure a rapid exchange of information between Member States and the Commission on products posing serious risks to the health and safety of consumers.

5.3.2. Online application for RAPEX

The Commission establishes and maintains a web-based application for use as a communication tool for the purpose of RAPEX. Member States use this application to prepare and submit notifications and reactions through RAPEX and the Commission uses it to validate the documents it receives.

The Commission provides access to the application to all RAPEX Contact Points, competent national authorities and the relevant Commission departments. The Commission creates as many users in the application as possible, taking into account needs and technical limitations. The Commission lays down the rules for granting access to the application.

Where the RAPEX application is temporarily not operational (for reasons other than regular and planned maintenance work), Member States should submit only RAPEX notifications to the Commission (i.e. ‘Article 12 notifications’, ‘Article 12 notifications requiring emergency action’). The submission of notifications for information and reactions is suspended until the RAPEX application is operational again. While the application is not operational, RAPEX notifications are sent to the Commission by e-mail to: sanco-reis@ec.europa.eu or to another e-mail address communicated in advance. If e-mail transmission is not possible, RAPEX notifications are sent to the Commission by fax to the fax number communicated in advance. There is no need to send notifications via the Permanent Representation of a Member State to the EU.

5.3.3. Operation of RAPEX outside regular working hours

The RAPEX system operates non-stop. The Commission and the RAPEX Contact Points ensure that officials responsible for operating RAPEX can always be contacted (by phone, e-mail or other equally effective means) and that they can take whatever action is necessary, including in an emergency and outside regular working hours, such as weekends and holidays.

The Commission provides the RAPEX Contact Points with contact details of the Commission RAPEX Team, including the names, e-mail addresses and telephone and fax numbers of officials they can reach during and outside working hours.

The RAPEX Contact Points provide the Commission with their contact details, including the names of officials working within the Contact Point, the name and address of the authority where that Contact Point is established, and the e-mail addresses, phone and fax numbers of officials who can be contacted during and outside working hours. Any changes to the contact details are immediately communicated to the Commission by the RAPEX Contact Points. The Commission publishes the contact details of the RAPEX Contact Points on the RAPEX website.

PART III

NOTIFICATION PROCEDURE ESTABLISHED UNDER ARTICLE 11 OF THE GENERAL PRODUCT SAFETY DIRECTIVE

1. Background and objectives

Article 11 of the General Product Safety Directive establishes a notification procedure for the exchange of information between Member States and the Commission on measures taken in relation to consumer products posing a non-serious risk to the health and safety of consumers.

The Article 11 notification mechanism (despite similarities and links) should be treated as an independent procedure that is separate from the notification procedure established under Article 12 of the GPSD (‘RAPEX’).

The Article 11 notification procedure has two main objectives:

— To help the internal market to operate The first objective of the Article 11 notification procedure is to ensure that the Commission is informed about measures adopted by national authorities that restrict the marketing on the EU market of products posing a non-serious risk to the health and safety of consumers. This objective is similar to the objective of the safeguard clause procedure established under sectoral directives, which aims to ensure that the Commission is kept informed of preventive and restrictive measures adopted by national authorities and can assess whether the restriction to the free movement of the notified product complies with EU legislation and does not unduly infringe the free movement of goods. The Article 11 notification procedure complements the safeguard clause procedure and ensures that the Commission is kept informed of preventive and restrictive measures adopted by national authorities that are not subject to the latter procedure.

— To prevent the marketing and use by consumers of dangerous products (not posing a serious risk) The second objective of the Article 11 notification procedure is to ensure that Member States can rapidly exchange information about products posing a non-serious risk to the health and safety of consumers and to prevent or restrict them from being marketed and used in the EU. This is similar to the objective of RAPEX, although RAPEX only covers products posing a serious risk to the health and safety of consumers.

2. Notification criteria

The Article 11 notification procedure applies only to measures adopted by national authorities to restrict the placing on the market, to withdraw from the market or to recall from consumers products posing a non-serious risk to the health and safety of consumers. This excludes notifications of voluntary measures under this procedure.

Where the following five notification criteria are met, Member States have a legal obligation to notify the Commission under Article 11 of the GPSD:

— the product concerned is a consumer product,

— it is subject to restrictive measures adopted by national authorities (obligatory measures),

— it poses a non-serious risk to the health and safety of consumers,

— the effects of the risk can or do go beyond the territory of one Member State or do not or cannot go beyond its territory, but measures involve information likely to be of interest to other Member States from a product safety standpoint,

— the measures adopted do not have to be notified under any other notification procedure established by EU law (e.g. under RAPEX established under Article 12 of the GPSD or under the safeguard clause procedure established by sectoral directives).

The following Chapters in Part II of the Guidelines are relevant to the Article 11 notification procedure:

— Chapter 2.1 on consumer product (definition of consumer product),

— Chapter 2.2 on restrictive measures (categories of restrictive measures, definition of obligatory measures, timing of the notification and notifying authorities),

— Chapter 2.3 on risk assessment (risk assessment method, assessing authority),

— Chapter 2.4 on cross-border effects (international event, local event).

3. Notifications

Where all notification criteria are met, a Member State prepares a notification and sends it to the Commission using the RAPEX application. The standard notification form is provided in Appendix 1 to the Guidelines.

All notifications sent through the RAPEX application under Article 11 of the GPSD are classified in the system as ‘Article 11 notifications’.

The RAPEX Contact Point of the notifying Member State ensures that all notifications meet all the notification requirements provided for in Article 11 of the GPSD.

The following Chapters in Part II of the Guidelines are relevant to the Article 11 notification procedure:

— Chapter 3.2 on the content of notifications (completeness, scope, updating of data, responsibility for the information transmitted),

— Chapter 3.3 on confidentiality (disclosure of information, exceptions to the general rule, requests for confidentiality, treatment of notifications covered by confidentiality and withdrawal of the confidentiality request),

— Chapter 3.4 on the examination of notifications by the Commission (correctness, completeness, requests for additional information, investigation),

— Chapter 3.5 on the validation of notifications,

— Chapter 3.8 on the permanent withdrawal of a notification from the RAPEX application (withdrawal situations, requesting Member State, content of the request, withdrawal decision).

Member States submit an ‘Article 11 notification’ as soon as possible and by the deadlines specified in Appendix 3 to the Guidelines at the latest. Chapter 3.10 of Part II of the Guidelines on deadlines applies.

4. Reactions

Member States are encouraged to ensure follow-up to ‘Article 11 notifications’ if product identification is likely to allow preventive and restrictive measures to be adopted. Member States are also encouraged to notify to the Commission the conclusions of follow-up activities taken with regard to ‘Article 11 notifications’.

The following Chapters in Part II of the Guidelines are relevant to the Article 11 notification procedure:

— Chapter 3.7 on follow-up activities (objectives, follow up action),

— Chapter 4.2 on the content of reactions (data provided, completeness, updating, responsibility for reactions),

— Chapter 4.3 on confidentiality,

— Chapter 4.4 on the examination of reactions by the Commission (correctness and completeness, request for additional information),

— Chapter 4.5 on the validation of reactions,

— Chapter 4.6 on the permanent withdrawal of reactions from the RAPEX application.

5. Practical and technical arrangements

‘Article 11 notifications’ and reactions to them are prepared and sent to the Commission by the RAPEX Contact Points using the RAPEX application. Chapters 5.1 to 5.3 in Part II of the Guidelines concerning the operation of RAPEX networks (established at EU and national levels) and on practical and technical arrangements (languages, on-line application, and operation outside normal working hours) are relevant to the Article 11 notification procedure.

PART IV

APPENDICES

1. Standard notification form

2. Reaction form

3. Deadlines for Member States

Notification procedure Action Deadline Community Rapid Information System ‘RAPEX’ established under Article 12 of GPSD Notifications Send ‘Article 12 notification requiring emergency action’ 3 days after: — adoption or decision to adopt ‘Obligatory measures’ or — receipt of information on ‘Voluntary measures’. Send ‘Article 12 notification’ 10 days after: — adoption or decision to adopt ‘Obligatory measures’ or — receipt of information on ‘Voluntary measures’. Confirm measures if the notification was sent before deciding to adopt measures 45 days after submission of the notification Update to a notification 5 days after receipt of the information on developments requiring changes to a notification Reactions Ensure follow-up to: ‘Article 12 notification requiring emergency action’ 20 days after receipt of a notification ‘Article 12 notification’ and to ‘Notification sent by the European Commission’ 45 days after receipt of a notification Send reaction to: ‘Article 12 notification requiring emergency action’ 3 days after: — the notified product was found on the market, or — the completion of a risk assessment with different results, or — receipt of additional information ‘Article 12 notification’ and to ‘Notification sent by the European Commission’ 5 days after: — the notified product was found on the market, or — the completion of a risk assessment with different results, or — receipt of additional information Update to a reaction 5 days after receipt of information on developments requiring changes to a reaction Notification procedure established under Article 11 of GPSD Notifications Send ‘Article 11 notification’ 10 days after adoption of ‘Obligatory measures’ Update to the notification 5 days after receipt of information on developments requiring changes of the notification

4. Deadlines for the Commission

Notification procedure Action Deadline Community Rapid Information System ‘RAPEX’ established under Article 12 of GPSD Notifications Validate ‘Article 12 notification requiring emergency action’ 3 days after receipt of a notification Validate ‘Article 12 notification’ 5 days after receipt of a notification Validate ‘Notification for information’ 10 days after receipt of a notification Reactions Validate reaction sent to ‘Article 12 notification requiring emergency action’ 3 days after receipt of a reaction Validate reaction sent to ‘Article 12 notification’ and to ‘Notification sent by the European Commission’ 5 days after receipt of a reaction Validate reaction sent to ‘Notification for information’ 10 days after receipt of a reaction Notification procedure established under Article 11 of GPSD Notifications Validate ‘Article 11 notification’ 10 days after receipt of a notification Reactions Validate reaction sent to ‘Article 11 notification’ 10 days after receipt of a reaction

5. Risk Assessment Guidelines for Consumer Products

TABLE OF CONTENTS

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

3. Building a risk assessment step by step

3.1. The product

3.2. The product hazard

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

5. How to prepare a risk assessment – in brief

6. Examples

6.1. Folding chair

6.2. Socket protectors

6.3. Sensitivity analysis

Table 1 — Consumers

Table 2 — Hazards, Typical Injury Scenarios And Typical Injuries

Table 3 — Severity Of Injury

Table 4 — Risk Level From The Combination Of The Severity Of Injury And Probability

Glossary of terms

1. Introduction

Consumer products may cause harm when used, e.g. a hot flat-iron that can cause burns, scissors or knives that can cause cuts, or a household cleaner that can damage the skin. This kind of damage is not a usual occurrence because general knowledge or instructions teach how to use consumer products safely. Nevertheless, the risk of damage remains.

This risk can be assessed in different ways. A range of methods have been used to quantify risk for consumer products, such as a nomograph method (22), a matrix method (23), and the method previously recommended for the EU’s RAPEX rapid alert system (24). While the general principles for risk assessment have always been agreed, how to quantify risks has been under permanent development. This has led to diverging results and ensuing discussions, as well as to consideration of what the best possible practice might be.

The purpose of these risk assessment guidelines is therefore to improve the situation and, within the framework of the Directive on General Product Safety (25), to provide a transparent and practicable method for appropriate use by Member States’ competent authorities when they assess the risks of non-food consumer products. These guidelines are based on a risk assessment method developed for other purposes (26), adapted to the specific requirements of non-food consumer products.

A certain amount of training will of course be needed before these guidelines can be put into practice, but expertise in risk assessment will greatly facilitate this task. This will be backed by exchanges of views between risk assessors, since expertise and experience accumulated through the years is invaluable.

In building up a risk assessment method in small, manageable steps, these guidelines help to focus on the relevant issues of a product, its user(s) and its use(s), and to identify possible divergences of views between risk assessors from the onset, thus avoiding time-consuming discussions. They should thus lead to consistent and robust risk assessment results based on evidence and science, and consequently to widely acceptable consensus on the risks that the many non-food consumer products may present.

A quick overview and a flow chart on how to prepare a risk assessment pursuant to these guidelines is provided in section 5 – ‘Consumer products’ mean non-food consumer products throughout these guidelines.

These guidelines do not set out to replace other guidelines that may address very specific products or may be specifically provided for in legislation, such as in the area of chemicals, cosmetics, pharmaceuticals or medical devices. It is highly recommended to use this specific guidance, since it is tailor-made, but it will always be for the risk assessor to decide how best to assess the risks of a product.

Nor are these guidelines to be used by manufacturers ‘just to avoid serious risks’ when d