EFTA SURVEILLANCE AUTHORITY DECISION

No 447/14/COL

of 5 November 2014

adopting guidelines for the management of the Rapid Information System ‘RAPEX’ as established under Articles 11 and 12 of Directive 2001/95/EC (the General Product Safety Directive) [2016/487]

THE EFTA SURVEILLANCE AUTHORITY

Having regard to Articles 5(3), 12(3), point 2 of Annex I and point 8 of Annex II to the Act referred to at point 3h of Chapter XIX of Annex II to the Agreement on the European Economic Area (‘the EEA Agreement’), Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (1), as adapted to the EEA Agreement by Protocol 1 thereto,

Having regard to Article 5(2)(d) of the Agreement between the EFTA States on the Establishment of a Surveillance Authority and a Court of Justice (‘the SCA’), according to which the EFTA Surveillance Authority (‘the Authority’) shall carry out the functions which, through the application of Protocol 1 to the EEA Agreement, follow from the acts referred to in the Annexes to that Agreement, as specified in Protocol 1 to the SCA,

Having regard to Article 1(2) of Protocol 1 to the SCA, according to which the Authority shall carry out certain functions corresponding to the functions of the European Commission,

Having regard to College Decision No 198/10/COL empowering the College Member with special responsibility for general product safety to (1) submit draft Guidelines to the responsible EFTA Committee on Technical Regulations, Standards, Testing and Certification (‘the Committee’) (2) and to (2) adopt Guidelines concerning the management of the Rapid Information System ‘RAPEX’ after having consulted the Committee (3) on the matter (‘the RAPEX Guidelines’),

Whereas:

In accordance with Article 12(3) and point 8 of Annex II to Directive 2001/95/EC, the European Commission shall prepare and regularly update the RAPEX Guidelines.

By Decision 2010/15/EU (4), the European Commission adopted amended RAPEX Guidelines thereby repealing those adopted by Commission Decision 2004/418/EC (5). By Decision 396/10/COL of 19 October 2010, the Authority thus adopted equivalent RAPEX Guidelines.

Following a request from the EFTA States by intermediary of the EFTA Secretariat dated 14 April 2014, the Authority amended and prepared draft amended RAPEX Guidelines to reflect the new procedure and foreseen future validator tasks of the national RAPEX contact points of the EEA EFTA States, as outlined and described in greater detail in Appendix 6 to the draft amended RAPEX Guidelines.

In accordance with the written procedure provided for in Article 8 of its rules of procedure, the Committee was consulted on the draft amended RAPEX Guidelines (6).

The RAPEX Guidelines should be addressed to the national authorities of the EFTA States designated as contact points in the RAPEX system, and in charge of the notification procedures under Article 11 of Directive 2001/95/EC.

The Authority will use the RAPEX Guidelines as the reference document for managing RAPEX and the notification procedure under Directive 2001/95/EC,

HAS ADOPTED THIS DECISION:

After having consulted the EFTA Committee on Technical Regulations, Standards, Testing and Certification on the matter, the Authority hereby adopts amended guidelines to supplement the Act referred to at point 3h of Chapter XIX of Annex II to the Agreement on the European Economic Area for the management of the Rapid Information System ‘RAPEX’ established under Article 12 and of the notification procedure established under Article 11 of the Act.

The Decision, including the amended guidelines set out in the Annex, shall be published in the EEA Section of, and the EEA Supplement to, the Official Journal of the European Union.

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

(2) The EFTA Committee on Technical Regulations, Standards, Testing and Certification, as designated by Decision No 4/2012/SC of the Standing Committee of the EFTA States of 26 October 2012.

(3) Ibid.

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

(5) Commission Decision 2004/418/EC of 29 April 2004 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 (OJ L 151, 30.4.2004, p. 83).

(6) See letters of 8 July 2014 (Events No 714776, 714853, and 714857).

ANNEX

EFTA Surveillance Authority Guidelines for the management of the 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

Preface

Part I

Status and addresses 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

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. Types 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 EFTA Surveillance Authority

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 EEA level

3.6. Information on dangerous products sent by the Commission

3.7. Follow-up to notifications

3.8. Permanent withdrawal of a notification by EEA States from the RAPEX application

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

3.10. Deadlines for submitting RAPEX notifications

4. Reactions

4.1. Communication of follow-up action

4.2. Content of reactions

4.3. Confidentiality

4.4. Examination of reactions from EFTA States by the EFTA Surveillance Authority

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 EEA 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

6. Tasks and role of the national RAPEX contact points of the EFTA States

PREFACE

The revised General Product Safety Directive, as adapted to the Agreement on European Economic Area by Protocol 1 thereto, entered into force in the EFTA States on 1 March 2004.

In accordance with Article 12(3) of the Directive and point 8 of Annex II to the Directive, the European Commission (hereafter referred to as ‘the Commission’ or ‘the EC’) shall prepare and regularly update guidelines concerning the management of the Community Rapid Information System (RAPEX). By Decision 2004/418/EC, the Commission adopted, for the first time, guidelines to supplement Directive 2001/95/EC for the management of the Community Rapid Information System (RAPEX) and for notifications presented in accordance with Article 11 of that Directive. By its Decision 2010/15/EU, the Commission adopted new guidelines, thereby repealing Decision 2004/418/EC.

According to Article 5(2)(d) of the Agreement between the EFTA States on the Establishment of a Surveillance Authority and a Court of Justice, the EFTA Surveillance Authority (referred to also as ‘ESA’ or ‘the Authority’ in these guidelines) shall carry out the functions which, through the application of Protocol 1 to the EEA Agreement, follow from the acts referred to in the Annexes to that Agreement, as specified in Protocol 1 to the Surveillance and Court Agreement. Furthermore, pursuant to Article 1(2) of Protocol 1 to the Surveillance and Court Agreement, the EFTA Surveillance Authority shall carry out certain functions corresponding to the functions of the European Commission. The EFTA Surveillance Authority therefore considers it necessary to adopt and issue guidelines equivalent to, and serving a similar purpose as, the new Commission guidelines.

These guidelines are addressed to the national authorities in the EFTA States designated as contact points in the RAPEX and in charge of the notification procedure under Article 11 of Directive 2001/95/EC. The EFTA Surveillance Authority shall use these guidelines as the reference document in operating RAPEX and the Article 11 notification procedure.

It should be noted that in these guidelines, the term ‘EFTA States’ shall read ‘EFTA States contracting parties to the EEA Agreement in respect of which the Agreement has entered into force’. Also, in the context of these guidelines, the term ‘EEA States’ shall mean all States which belong to the European Union and those EFTA States which are contracting parties to the EEA Agreement.

These guidelines may be amended or supplemented by the EFTA Surveillance Authority where necessary or to accord with the guidelines issued by the Commission.

These guidelines and future amendments and additions thereto will be published in the EEA Section of the Official Journal of the European Union and the EEA Supplement thereto in accordance with the Arrangement with regard to Publication of EEA Relevant Information, referred to in the Final Act of the EEA Agreement.

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 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 EFTA Surveillance Authority pursuant to Article 11(1) and Annex II, point 8, to the Act referred to at point 3h of Chapter XIX of Annex II to the Agreement on the European Economic Area, Directive 2001/95/EC, as adapted to the EEA Agreement by Protocol 1 thereto. In carrying out this task, the Authority is assisted by an advisory committee composed of the representatives of the EFTA States acting in accordance with the advisory procedure (1).

It follows from point 8 of Annex II to the GPSD that the EFTA Surveillance Authority shall prepare and regularly update, in accordance with the applicable advisory procedure, guidelines concerning the management of RAPEX by the EFTA Surveillance Authority and the EFTA 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 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 (2).

EEA States, 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 EFTA States upon receipt of a notification and the type of information to be provided,

— describe the handling of notifications and reactions by the EFTA Surveillance Authority,

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

— set out the practical and technical arrangements needed at the level of the EFTA Surveillance Authority and the EFTA States 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 EFTA Surveillance Authority in accordance with the updates adopted by the Commission in the light of experience and new developments in the product safety area and in accordance with the advisory procedure referred to in point 1.1.

2. ADDRESSEES OF THE GUIDELINES

The Guidelines are addressed to all the authorities of the EFTA 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 EFTA Surveillance Authority should use the Guidelines as a reference for managing, in cooperation with the Commission, the RAPEX system established under Article 12 of the GPSD and the notification procedure under Article 11 of the GPSD.

PART II

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 Rapid Information System (‘RAPEX’). RAPEX was established in order to:

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

— inform the EEA States, the Commission and the EFTA Surveillance Authority 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 EEA.

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 EEA States' authorities,

— identify needs and provide a basis for action at EEA level,

— make for consistent enforcement of the EEA 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 online application (‘RAPEX application’), which allows EEA States, the Commission and the EFTA Surveillance Authority 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 EEA States,

— the national RAPEX networks established in all EEA States, which include the RAPEX contact points 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 by EU Member States, and maintains and ensures correct operation of the RAPEX system with regard to these states,

— the EFTA Surveillance Authority's RAPEX Team which examines documents submitted by EFTA States, prior to the validation by the EFTA States thereof in the RAPEX database, in view of transmission to the Commission, and which maintains and ensures correct operation of the RAPEX system with regard to these States,

— the RAPEX website (3), 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 the EFTA States in RAPEX is mandatory, and thus the EFTA States have a legal obligation to notify the EFTA Surveillance Authority 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 or 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 a 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 which are 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 EEA legislation: — food and feed covered by Regulation (EC) No 178/2002 of the European Parliament and of the Council (4), — medicinal products covered by Directive 2001/83/EC of the European Parliament and of the Council (5), and Directive 2001/82/EC of the European Parliament and of the Council (6), — medical devices covered by Council Directive 93/42/EEC (7), — in vitro diagnostic medical devices covered by Directive 98/79/EC of the European Parliament and of the Council (8), — active implantable medical devices covered by Council Directive 90/385/EEC (9).

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 an EEA 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 EFTA 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 an EFTA 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 EEA States under the notification mechanism provided for in Article 5(3) of the GPSD. — Recommendations and agreements with producers and distributors concluded by EFTA 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 EEA of a consumer product posing a serious risk to the health and safety of consumers (e.g. decisions to stop the import at the national border) should be notified to the EFTA Surveillance Authority 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 EFTA Surveillance Authority 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 EFTA Surveillance Authority under Directive 98/34/EC of the European Parliament and of the Council (10).

2.2.5. Timing of the notification

Article 12(1) of the GPSD requires EFTA States immediately to notify the EFTA Surveillance Authority 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 EEA States, the EFTA Surveillance Authority 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 EFTA 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 an EFTA 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 an EFTA 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 EFTA Surveillance Authority via RAPEX (11).

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 (12).

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 EEA 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 EEA 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 the EEA States that a RAPEX notification should be submitted only by the EEA State where the notifying producer/distributor is established (‘main EEA State’). Once a RAPEX notification has been validated and distributed through the system by the EFTA Surveillance Authority, the EFTA States and the Commission, other EEA States (especially the ones that also received the same business notification) should submit reactions to this RAPEX notification.

Where a main EFTA State does not submit a RAPEX notification by the deadline specified in Appendix 3 to the Guidelines and does not inform the EFTA Surveillance Authority of the reasons for the delay, any other EEA 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 an EFTA 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 EFTA 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 an EFTA 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 EFTA Surveillance Authority, the risk assessment performed by an authority of an EFTA 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 EFTA 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 an EFTA 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 EFTA Surveillance Authority (the fourth subparagraph of Article 12(1)of the GPSD).

Risk assessments carried out by producers and distributors are not binding on EFTA State authorities. It is therefore possible for an authority of an EFTA 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, an EFTA 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 EEA 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 EEA 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 EEA 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 an EFTA State has reason to believe that a product has not been and will not be made available (by any means) to consumers in other EEA States, e.g. measures taken with regard to a local product manufactured and distributed only in one EEA State.

A notification involving a local event should still be submitted to the EFTA Surveillance Authority but under Article 11 of the GPSD and only where it involves information on product safety likely to be of interest to other EEA 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, an EFTA State prepares and submits to the EFTA Surveillance Authority 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 EEA States, the notifying EFTA State prepares and submits to the EFTA Surveillance Authority a RAPEX notification classified in the RAPEX application as ‘Article 12 notification requiring emergency action’.

Before sending a RAPEX notification to the EFTA Surveillance Authority, the RAPEX contact point of the notifying EFTA 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 EEA States to ensure follow-up (13) 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 EEA States to ensure follow-up is always on a case-by-case basis.

(b) Where an EFTA State is aware of the fact that a consumer product that is available on the EEA 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 an EEA 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 EFTA State subsequently informs the EFTA Surveillance Authority (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 an EFTA 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 EEA 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 EEA level to ensure a common approach between EEA States to risk assessment and/or enforcement action (14).

(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 EEA 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 doing so.

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 EFTA State. Once the missing information becomes available, the notifying EFTA State updates its notification. The updated notification is examined by the EFTA Surveillance Authority before being transmitted to the Commission for validation and distribution 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.

EFTA 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 EEA 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 EEA 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 EFTA Surveillance Authority for uploading and distribution in 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 email address, of a manufacturer and exporters. In particular, EFTA States provide all available information on manufacturers and exporters located in third countries that cooperate closely with the EU/EEA on product safety. The EFTA Surveillance Authority and the Commission thus regularly inform 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 EEA.

— 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 EEA 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.

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

3.2.3. Updating of data

The notifying EFTA State informs the EFTA Surveillance Authority (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, EFTA States inform the EFTA Surveillance Authority 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 EFTA Surveillance Authority examines the information provided by the notifying EFTA State, which shall be forwarded to the Commission in view of updating 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 EFTA 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 EEA 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 EFTA Surveillance Authority.

Any action taken by the EFTA Surveillance Authority or 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 EFTA 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’). EFTA 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 EFTA Surveillance Authority, the Commission and the EEA 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 EEA 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, the EFTA States and the EFTA Surveillance Authority 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 EFTA 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 EFTA Surveillance Authority. The EFTA Surveillance Authority 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. that 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 EFTA Surveillance Authority after consulting the respective RAPEX contact point and in cooperation with the Commission.

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 EFTA Surveillance Authority and, after being validated and distributed through the RAPEX application, they are subject to the usual follow-up by the EEA 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 EFTA Surveillance Authority and the EFTA 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. EFTA 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 EFTA State withdraws its request for confidentiality immediately after the authority in that State becomes aware that the justification for such a request is no longer valid. The EFTA Surveillance Authority shall notify the Commission thereof, which in turn, informs all EEA States of the withdrawal of confidentiality.

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 EFTA Surveillance Authority

The EFTA Surveillance Authority checks all notifications received from EFTA States to be transmitted through the RAPEX application to ensure that they are correct and complete, before they are sent to the Commission. The Commission will, in turn, transmit the notifications to all EEA States.

3.4.1. Correctness

When assessing the correctness of a notification, the EFTA Surveillance Authority 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 EFTA 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 EFTA Surveillance Authority 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 EFTA Surveillance Authority 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 EFTA 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 EFTA Surveillance Authority have questions regarding a notification by one of the EFTA States, it may suspend validation of the notification and ask the notifying EFTA State for additional information or clarification. This additional information is provided by the notifying EFTA State by the deadline specified in the EFTA Surveillance Authority's request for information.

3.4.4. Investigation

Where necessary, the EFTA Surveillance Authority may carry out an investigation to assess the safety of a product notified by an EFTA State. 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 EFTA Surveillance Authority or be brought to the attention of the EFTA Surveillance Authority by an EEA State (e.g. through a reaction), by the Commission or by a third party (e.g. a producer).

As part of such investigations the EFTA Surveillance Authority may, in particular:

— ask any EFTA State to provide information or clarification,

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

— inform the Commission about the investigation and invite the Commission to: — 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 by an EFTA State through the RAPEX application, the EFTA Surveillance Authority may request the Commission to suspend validation of a notification or, where such a notification has already been validated and distributed through the RAPEX application, to temporarily remove the overview published on the RAPEX website. After an investigation, and depending on the outcome, the EFTA Surveillance Authority may ask the Commission (after consulting the notifying EFTA State, where necessary) in particular to validate and distribute through RAPEX the previously suspended notification, to uphold the validated notification in the RAPEX application (with any changes) or to permanently withdraw the notification from the RAPEX application.

The EFTA Surveillance Authority informs all EFTA States and the Commission 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 EFTA Surveillance Authority examines the correctness and completeness of all notifications by EFTA States before they are transmitted to the Commission for validation and distribution in the RAPEX system (‘validation’), by the deadlines specified in Appendix 4 to the Guidelines, and following the procedure outlined in Appendix 6 to the Guidelines.

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

— where the additional information or clarification requested has been provided, the EFTA Surveillance Authority re-examines the notification and asks the Commission to validate 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 EFTA Surveillance Authority takes a decision on the basis of the information provided and, depending on the circumstances, asks the Commission either to validate the notification after changing the classification (e.g. from ‘Article 12 notification’ to ‘Notification for information’) or not to validate it.

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

Once a common approach to risk assessment and/or enforcement has been agreed between the EEA States, depending on the circumstances and the views of the EEA 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 (15).

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 EEA States about dangerous non-food consumer products of EEA and non-EEA origin that, according to the information available, are likely to be on the EEA 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 EEA 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

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

3.8. Permanent withdrawal of a notification by EEA States 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 (16) 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 (17).

— After a discussion held at EEA level, EEA States agree that it is not useful to exchange information on certain safety aspects that have been notified through the RAPEX application (18).

— 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 EEA 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 EEA States and that they are no longer marketed.

3.8.2. Requesting EEA State

The Commission may withdraw notifications from the RAPEX application only at the request of the notifying EEA State, as the latter takes full responsibility for the information transmitted through the system. A request for withdrawal by an EFTA State shall be addressed to the EFTA Surveillance Authority, which shall transmit the request to the Commission. Other EEA States are encouraged to inform the Commission or, in case of EFTA States, to inform the EFTA Surveillance Authority, 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 EEA State and/or other EEA 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 EEA States of the withdrawal of a notification by email 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 EEA 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 EEA 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 EEA States by email 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 EFTA State immediately informs the EFTA Surveillance Authority, which shall inform 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 EFTA State).

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

The Commission informs the other EEA States of the re-publishing of a RAPEX notification on the RAPEX website by email 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 (19)

EFTA States notify the EFTA Surveillance Authority 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 shall be 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’ by EFTA States are preceded by a telephone call by the RAPEX contact point to the EFTA Surveillance Authority RAPEX Team 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

EFTA States notify the EFTA Surveillance Authority 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).

EFTA States are encouraged to notify the EFTA Surveillance Authority of any follow-up regarding notifications distributed for information.

4.2. Content of reactions

4.2.1. Data provided

Results of follow-up activities by EFTA States are communicated to the EFTA Surveillance Authority in the form of reactions to notifications. To harmonise the type of information and to keep the work load to a minimum, EFTA 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. EFTA States do not inform the EFTA Surveillance Authority (unless the EFTA Surveillance Authority 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 EFTA 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 EFTA 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 EEA States. EFTA States are encouraged to collect additional information that may be relevant for authorities both in other EEA 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 EFTA 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 EEA 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 EFTA State indicates this on the reaction form. Once this information becomes available, the reacting EFTA State updates its reaction. The updated reaction is examined by the EFTA Surveillance Authority before it is transmitted to the Commission for validation and distribution through the system.

The RAPEX contact point provides all authorities in its own 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 EFTA State informs the EFTA Surveillance Authority (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, EFTA States inform the EFTA Surveillance Authority of changes in the status of the measures taken and in the risk assessment submitted with a reaction.

The EFTA Surveillance Authority examines the information provided by the reacting EFTA State and if necessary updates the information concerned before it is transmitted to the Commission.

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 EFTA Surveillance Authority.

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

4.3. Confidentiality

A reacting EFTA 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 EFTA Surveillance Authority 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 EFTA Surveillance Authority after consultation of the responsible RAPEX contact point and in cooperation with the Commission.

The EFTA Surveillance Authority and the EFTA 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 EFTA Surveillance Authority, the Commission nor the EFTA 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 EFTA State withdraws its confidentiality request immediately after that EFTA State's authority becomes aware that the reasons for such a request are no longer valid. The EFTA Surveillance Authority informs all EEA States through the Commission of the withdrawal of the confidentiality after the receipt of such a request from the reacting EFTA State.

4.4. Examination of reactions from EFTA States by the EFTA Surveillance Authority

4.4.1. Correctness and completeness

The EFTA Surveillance Authority checks all reactions from EFTA States received through the RAPEX application before they are transmitted to the Commission for validation and transmission to the EEA States. These checks focus on the correctness and completeness of the information provided.

The EFTA Surveillance Authority checks if a reaction received from an EFTA State 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 EFTA Surveillance Authority checks its completeness. Chapter 4.2.2 of the Guidelines is to be used as a point of reference for this examination.

The EFTA Surveillance Authority 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 EFTA Surveillance Authority or the Commission may request the reacting EFTA 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 EFTA Surveillance Authority may request the opinion of any EFTA State and, in particular, the notifying EFTA State on a validated reaction. The EFTA State submits its opinion to the EFTA Surveillance Authority within a deadline specified by the latter. Furthermore, the notifying EFTA State informs the EFTA Surveillance Authority 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 by EFTA States assessed as correct and complete by the EFTA Surveillance Authority are transmitted to the Commission for validation and distribution (‘validation’) by the deadlines specified in Appendix 4 to the Guidelines, and in accordance with the procedure specified in Appendix 6 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 EFTA State is different from a product covered by a notification,

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

— the risk assessment performed by the reacting EFTA 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 EEA States of the withdrawal of a reaction by email or through other equally effective means.

4.7. Deadlines for submitting reactions

EFTA States submit reactions to the EFTA Surveillance Authority 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 EFTA 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 EFTA 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 EFTA 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 email account for participation in the RAPEX system, with access to all officials in that contact point (e.g. rapex@……). 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 EFTA Surveillance Authority for distribution 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 EFTA Surveillance Authority 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 EEA 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 EEA 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 EEA State by the EFTA Surveillance Authority or 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, the EFTA Surveillance Authority and the Commission must take due account of the objectives of RAPEX and must ensure a rapid exchange of information between EEA States, the EFTA Surveillance Authority 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. The EFTA States and the EFTA Surveillance Authority use this application to submit notifications and reactions and additional information in relation thereto 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, the relevant Commission departments and the EFTA Surveillance Authority. 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), EFTA States should submit only RAPEX notifications to the EFTA Surveillance Authority (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 EFTA Surveillance Authority by email to: rapex@eftasurv.int or to another email address communicated in advance. If email transmission is not possible, RAPEX notifications are sent to the EFTA Surveillance Authority by fax to the fax number communicated in advance. There is no need to send notifications via the Permanent Representation of an EFTA State to the EU/EFTA.

5.3.3. Operation of RAPEX outside regular working hours

The RAPEX system operates non-stop. The EFTA Surveillance Authority, the Commission and the RAPEX contact points ensure that officials responsible for operating RAPEX can always be contacted (by phone, email 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 EFTA Surveillance Authority provides the RAPEX contact points of the EFTA States with contact details of the EFTA Surveillance Authority RAPEX Team, including the names, email addresses and telephone and fax numbers of officials they can reach during and outside working hours.

The RAPEX contact points of the EFTA States provide the EFTA Surveillance Authority 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 email 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 EFTA Surveillance Authority by the RAPEX contact points of the EFTA States. 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 EFTA Surveillance Authority is informed about measures adopted by national authorities in EFTA States that restrict the marketing on the EEA 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 EFTA Surveillance Authority is kept informed of preventive and restrictive measures adopted by national authorities in EFTA States and can assess whether the restriction to the free movement of the notified product complies with EEA 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 EFTA Surveillance Authority 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 EEA 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 EEA. 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, EFTA States have a legal obligation to notify the EFTA Surveillance Authority 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 EEA State or do not or cannot go beyond its territory, but measures involve information likely to be of interest to other EEA States from a product safety standpoint,

— the measures adopted do not have to be notified under any other notification procedure established by EEA 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, an EFTA State prepares a notification and sends it to the EFTA Surveillance Authority in accordance with the procedure outlined in Appendix 6 to the Guidelines, which will thereafter be transmitted to the Commission by 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 EFTA 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 EFTA Surveillance Authority (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 EEA State, content of the request, withdrawal decision).

EFTA 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

EFTA 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. EFTA States are also encouraged to notify to the EFTA Surveillance Authority 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 EFTA Surveillance Authority (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 by EFTA States are prepared and sent to the EFTA Surveillance Authority by the RAPEX contact points. Chapters 5.1 to 5.3 in Part II of the Guidelines concerning the operation of RAPEX networks (established at EEA and national levels) and on practical and technical arrangements (languages, online application, and operation outside normal working hours) are relevant to the Article 11 notification procedure.

PART IV

Appendices (20)

1. STANDARD NOTIFICATION FORM

Notification form General information 1. ☐ ‘Article 12 notification requiring emergency action’ ☐ ‘Article 12 notification’ ☐ ‘Notification for information’ ☐ ‘Article 11 notification’ 2. Notification number 3. Notification date 4. Notifying country 5. Contact details of the RAPEX contact point and person in charge of the notified case Product identification 6. Product category 7. Product name 8. Brand 9. Type/number of model 10. Batch number/Bar code 11. Customs code 12. Product and packaging description 13. Photos (product, packaging and label) 14. Total number of items covered by the notification Regulations and standards applicable 15. Legal provisions (directive, decision, regulation, etc.) 16. Standards 17. Proof of conformity 18. Is the product counterfeit? Traceability 19. Country of origin 20. Countries of destination 21. Contact details of the manufacturer or its representative 22. Contact details of the exporter(s) 23. Contact details of the importer(s) 24. Contact details of the distributor(s) 25. Contact details of the retailer(s) Risk description 26. Risk category 27. Summary of test results (description of technical defects) 28. Legal provisions and standards (with clauses) against which the product was tested and did not comply 29. Risk assessment and conclusions 30. Information on known incidents and accidents Measures 31. Type of measures 32. Authority/economic operator taking notified measures 33. Category of measures 34. Date of entry into force 35. Duration 36. Scope Confidentiality 37. Is the notification confidential? 38. Scope of confidentiality 39. Justification Other 40. Additional information 41. Justification for sending ‘Notification for information’ Annexes 42. Test reports 43. Certificates 44. Photographs (product, packaging and label) 45. Notification sent by a producer or a distributor under Article 5(3) of the GPSD 46. Measures adopted

2. REACTION FORM

Reaction form General information 1. Notification number 2. Notifying country 3. Notified product name 4. Reaction date 5. Reacting country 6. Contact details of the RAPEX contact point and person in charge of the reaction 7. Product name 8. Brand 9. Type/number of model 10. Batch number/Bar code Type of reaction 11. ☐ Product found ☐ Measures adopted ☐ Different risk assessment ☐ Additional information 12. Total number of items found Risk category Complementary information on distribution channels and/or product's origin 13. Type of measures adopted Summary of the test results (description of technical defects) Complementary information on the risk assessment 14. Authority/economic operator adopting notified measures Indication of legal provisions and standards (with clauses) against which the product was tested Other complementary information 15. Category of measures Risk assessment and conclusions — 16. Date of entry into force Information on known incidents and accidents 17.