Decision 2010/15 - 2010/15/: Commission Decision of 16 December 2009 laying down guidelines for the management of the EC Rapid Information System RAPEX established under Article 12 and of the notification procedure established under Article 11 of Directive 2001/95/EC (the General Product Safety Directive) (notified under document C(2009) 9843) - Main contents

COMMISSION DECISION

of 16 December 2009

laying down guidelines for the management of the Community Rapid Information System ‘RAPEX’ established under Article 12 and of the notification procedure established under Article 11 of Directive 2001/95/EC (the General Product Safety Directive)

(notified under document C(2009) 9843)

(2010/15/EU)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on European Union and to the Treaty on the Functioning of the European Union,

Having regard to Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (1), and in particular the third subparagraph of Article 11(1) and point 8 of Annex II thereof,

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

Whereas:

HAS ADOPTED THIS DECISION:

Article 1

The guidelines for the management of the Community Rapid Information System ‘RAPEX’ established under Article 12 and of the notification procedure established under Article 11 of Directive 2001/95/EC are set out in the Annex to this Decision.

Article 2

Decision 2004/418/EC is repealed.

Article 3

This Decision is addressed to the Member States.

Done at Brussels, 16 December 2009.

For the Commission

Meglena KUNEVA

Member of the Commission

• (1) 

  OJ L 11, 15.1.2002, p. 4.

• (2) 

  OJ L 151, 30.4.2004, p. 83.

• (3) 

  OJ L 218, 13.8.2008, p. 30.

ANNEX

Guidelines for the management of the Community Rapid Information System ‘RAPEX’ established under Article 12 and of the notification procedure established under Article 11 of Directive 2001/95/EC (the General Product Safety Directive)

TABLE OF CONTENTS

PART I — Status and addressees of the Guidelines

PART II — Community Rapid Information System ‘RAPEX’ established under Article 12 of the General Product Safety Directive

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

PART IV — Appendices

PART I

STATUS AND ADDRESSEES OF THE GUIDELINES

• 1. 

  Status, objectives and updating of the Guidelines

1.1.   Status

The ‘Guidelines for the management of the Community Rapid Information System “RAPEX” established under Article 12 and of the notification procedure established under Article 11 of Directive 2001/95/EC (the General Product Safety Directive)’ (the ‘Guidelines’) are adopted by the Commission (1) pursuant to Article 11(1) and Annex II, point 8, of Directive 2001/95/EC (2) of the European Parliament and of the Council of 3 December 2001 on general product safety (the ‘GPSD’), which is assisted by an advisory committee composed of the representatives of Member States and established under Article 15(3) of the GPSD.

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

The Guidelines form a self-standing document that governs the RAPEX notification procedure established under Article 12 of the GPSD. This procedure applies to preventive and restrictive measures taken in relation to consumer products posing a serious risk to the health and safety of consumers. However, the structure and content of the Guidelines allow them to be adapted, if and as appropriate, to include provisions relating to the notification procedure established under Article 22 of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (3).

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

1.2.   Objectives

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

1.3.   Updating

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

• 2. 

  Addressees of the Guidelines

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

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

PART II

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

• 1. 

  Introduction

1.1.   Objectives of RAPEX

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

RAPEX was established in order to:

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

RAPEX data help to:

1.2.   Components of RAPEX

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

• 2. 

  RAPEX notification criteria

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

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

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:

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

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

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

2.1.2.   Products which are not covered by RAPEX

RAPEX does not cover:

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:

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

2.2.2.   Type of measures

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

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

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

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

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

2.2.4.   Exclusion of generally applicable obligatory measures

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

2.2.5.   Timing of the notification

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

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

2.2.6.   Notifying authorities

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

2.2.7.   RAPEX notification concerning business notifications

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

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

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

2.3.   Serious risk

2.3.1.   Serious risk

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

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

2.3.2.   Risk assessment method

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

2.3.3.   Assessing authority

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

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

2.3.4.   Risk assessment in business notifications

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

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

2.4.   Cross-border effects

2.4.1.   International event

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

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

2.4.2.   Local event

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

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

• 3. 

  Notifications

3.1.   Types of notifications

3.1.1.   RAPEX notifications

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

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

3.1.2.   Notifications for information

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

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

3.2.   Content of notifications

3.2.1.   Completeness of data

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

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

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

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

3.2.2.   Scope of data

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

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

3.2.3.   Updating of data

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

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

3.2.4.   Responsibility for the information transmitted

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

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

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

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

3.3.   Confidentiality

3.3.1.   Disclosure of information as a general rule

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

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

3.3.2.   Exceptions to the general rule

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

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

3.3.3.   Request for confidentiality

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

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

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

3.3.4.   Handling of notifications covered by confidentiality

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

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

3.3.5.   Withdrawal of request for confidentiality

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

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

3.4.   Examination of notifications by the Commission

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

3.4.1.   Correctness

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

3.4.2.   Completeness

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

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

3.4.3.   Requests for additional information

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

3.4.4.   Investigation

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

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

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

The Commission informs all Member States of:

3.5.   Validation and distribution of notifications

3.5.1.   Validation and distribution of notifications

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

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

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

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

3.6.   Information on dangerous products sent by the Commission

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

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

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

3.7.   Follow-up to notifications

3.7.1.   Follow-up to the different types of notification

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

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

3.7.2.   Objectives of the follow-up

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

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:

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

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

3.8.   Permanent withdrawal of a notification from the RAPEX application

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

3.8.1.   Situations where withdrawal is possible

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

3.8.2.   Requesting Member State

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

3.8.3.   Content of the request

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

3.8.4.   Decision to withdraw

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

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

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

3.9.1.   Situations where temporary removal is possible

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

3.9.2.   Requesting Member State

The provisions of Chapter 3.8.2 apply.

3.9.3.   Content of the request

The provisions of Chapter 3.8.3 apply.

3.9.4.   Decision to remove

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

3.9.5.   Re-publishing of a notification

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

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

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

3.10.   Deadlines for submitting RAPEX notifications

3.10.1.   Deadlines (21)

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

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

3.10.2.   Emergency situations

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

• 4. 

  Reactions

4.1.   Communication of follow-up action

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

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

4.2.   Content of reactions

4.2.1.   Data provided

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

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

4.2.2.   Completeness of reactions

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

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

4.2.3.   Updating of validated reactions

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

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

4.2.4.   Responsibility for reactions

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

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

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

4.3.   Confidentiality

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

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

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

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

4.4.   Examination of reactions by the Commission

4.4.1.   Correctness and completeness

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

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

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

4.4.2.   Request for additional information

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

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

4.5.   Validation and distribution of reactions

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

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

4.6.   Permanent withdrawal of a reaction from the RAPEX application

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

The provisions of Chapters 3.8.2 and 3.8.3 apply.

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

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

4.7.   Deadlines for submitting reactions

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

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

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

• 5. 

  Operation of the RAPEX networks

5.1.   RAPEX Contact Points

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

5.1.1.   Organisation

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

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

5.1.2.   Tasks

The main tasks of a RAPEX Contact Point are to:

5.2.   RAPEX networks established at EU and national levels

5.2.1.   RAPEX Contact Points Network

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

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

5.2.2.   RAPEX networks established at national level

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

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

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

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

5.3.1.   Languages

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

5.3.2.   Online application for RAPEX

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

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

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

5.3.3.   Operation of RAPEX outside regular working hours

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

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

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

PART III

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

• 1. 

  Background and objectives

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

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

The Article 11 notification procedure has two main objectives:

• 2. 

  Notification criteria

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

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

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

• 3. 

  Notifications

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

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

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

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

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

• 4. 

  Reactions

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

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

• 5. 

  Practical and technical arrangements

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

PART IV

APPENDICES

• 1. 

  Standard notification form

• 2. 

  Reaction form

• 3. 

  Deadlines for Member States

• 4. 

  Deadlines for the Commission

• 5. 

  Risk Assessment Guidelines for Consumer Products

TABLE OF CONTENTS

Table 1 — Consumers

Table 2 — Hazards, Typical Injury Scenarios And Typical Injuries

Table 3 — Severity Of Injury

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

Glossary of terms

• 1. 

  Introduction

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

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

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

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

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

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

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

Nor are these guidelines to be used by manufacturers ‘just to avoid serious risks’ when designing and manufacturing products. Consumer products have to be safe, and these guidelines aim at helping authorities to identify serious risks when, despite the best efforts of the manufacturer, a product is not safe.

• 2. 

  Risk assessment – an overview

2.1.   Risk – Combination of hazard and probability

Risk is generally understood as something that threatens the health or even the lives of people, or that may cause considerable material damage. Nevertheless, people take risks while being aware of the possible damage, because the damage does not always happen. For example:

Risk is thus the combination of the severity of possible damage to the consumer and the probability that this damage should occur.

2.2.   A risk assessment in three steps

It takes three steps to determine the risk:

Where different injury scenarios are foreseeable, the risk for each of those scenarios should be determined the highest risk being labelled as ‘the risk’ of the product. The highest risk is normally crucial because only action on the highest risk can effectively provide a high level of protection.

On the other hand, an identified risk may be lower than the highest risk, but require specific risk reduction action. It is then important also to take measures against that risk so that all risks are effectively reduced.

Once the above steps have been carried out, the risk assessment is basically complete.

A flow chart on building a risk assessment is at the end of section 5.

2.3.   Some useful tips

Seek information

As can be seen from the above examples, each of the above steps of a risk assessment requires anticipation of what might happen and how likely it is to happen, since the product under consideration will normally not have caused an accident, and thus the risk will not have materialised (yet). Previous experience with similar products will help in this exercise, as will any other information about the product, such as design, mechanical stability, chemical composition, operation, instructions for use, including possible risk management advice, type of consumers it is intended for (and those for which it is not), test reports, accident statistics, the EU Injury Database (IDB) (27), information about consumer complaints, about the behaviour of different consumers when they are using the product, and about product recalls. Product requirements laid down in legislation, in product standards or in checklists (such as in ISO 14121: Safety of machinery – Risk assessment) can also be useful sources of information.

Nevertheless, the products to be assessed may be quite specific and thus these sources may not contain the information required. The information collected may also be incomplete, inconsistent, or not fully plausible. This may be the case in particular for accident statistics, when only the product category is registered. The absence of an accident history, a small number of accidents or low severity of accidents should not be taken as a presumption of low risk. Product-specific statistics also have to be viewed with great care, since the product may have changed over time, be it in design or composition. The information must always be critically assessed.

Feedback from expert colleagues can be particularly useful, since they can draw from their real-life experience and provide suggestions that are not immediately obvious when assessing a product risk. They may also give advice when assessing the risk for different types of consumers, including vulnerable consumers such as children (see table 1), since the latter may handle a product differently. They may also help to assess the risk for different injuries that a product may cause, and the way in which those injuries emerge through the use of the product. They can also judge whether an injury scenario is ‘totally unperceived’, too unlikely, and then guide the risk assessor towards more realistic assumptions.

Thus, feedback from experienced colleagues, although not an obligation, can be helpful in several aspects. A risk assessor from an authority could seek advice from colleagues in that same authority, in other authorities, in industry, in other countries, in scientific groupings, and elsewhere. Conversely, any risk assessor in industry could use his contacts with authorities and others when a new or improved product is to be assessed before it is placed on the market.

New information obtained should of course be used to update any existing risk assessment.

Make a sensitivity analysis of your risk assessment

If all information searches and queries to expert colleagues do not provide the required, very specific data, a so-called sensitivity analysis might help. In this analysis a lower and a higher value than previously chosen is assumed for each parameter of the risk assessment, and taken through the entire risk assessment procedure. The resulting risk levels will show how sensitive the risk level reacts to the input of lower and higher values. In this way the range in which the real risk of the product will be can be estimated.

If the most likely value of each parameter can be estimated, then those most likely values should be taken through the procedure, and the resulting risk level will be the most likely risk.

An example of a sensitivity analysis is illustrated in section 6 below.

Let others check your risk assessment

Feedback from colleagues will also help when finalising the risk assessment. They will be able to provide advice on the assumptions and estimations made during the three steps above. They will feed in their experience and thus help to generate a more robust, more solid, more transparent and ultimately more acceptable risk assessment. It is therefore recommended that, ideally, advice be sought from expert colleagues, possibly in the form of a group discussion, before concluding a risk assessment. These groups, of perhaps 3 to 5 members, should include a combination of expertise appropriate to the product under assessment: engineers, chemists, (micro-)biologists, statisticians, product safety managers, and others. Group discussion will be particularly useful when a product is new on the market and has never been assessed before.

Risk assessments should be solid and realistic. However, since they require a number of assumptions, different risk assessors may come to different conclusions in view of the data and other evidence they have been able to find or because of their diverging experience. It is thus necessary for risk assessors to talk to one another in order to reach agreement or, at least, consensus. The step-by-step risk assessment described in these guidelines, however, should make such discussions more productive. Each step in a risk assessment must be clearly described in detail. Thus, any point of disagreement can be quickly identified, and consensus can more easily be reached. This will make risk assessments more acceptable.

Document your risk assessment

It is important to document your risk assessment, describing the product and all the parameters that you chose while developing it, such as test results, the type(s) of consumers you chose for your injury scenario(s), and the probabilities with the underlying data and assumptions. This will enable you to demonstrate unambiguously how you estimated the level of risk, and it will also help you to update your assessment while keeping track of all changes.

Several hazards, several injuries – but only one risk

When several hazards, several injury scenarios or differing severities of injuries or probabilities have been identified, each of those should be carried through the entire risk assessment procedure in order to determine the risk for each. As a result, the product may have several risk levels. The overall risk of the product is then the highest risk level identified, because action on the highest risk level is normally the most effective way of risk reduction. Only in special cases may a less-than-highest risk be considered particularly important, since it may require specific risk management measures.

As an example of several risks, a hammer may have a weak head and a weak grip, each of which may break when the hammer is used, and the consumer may be injured. If the relevant scenarios lead to different risk levels, the highest risk should be reported as ‘the risk’ of the hammer.

It could be argued that

However, this would not consider the seriousness of eye injuries that the hammer head breaking could cause. Looking at probability alone would not therefore give the whole picture.

In conclusion, risk is a balanced combination of both the hazard and the probability of the injury that the hazard can cause. Risk describes neither the hazard, nor the probability, but both at the same time. Taking the highest risk as ‘the risk’ of the product will ensure the most effective product safety (apart from specific risks requiring specific risk management, as mentioned above).

Can risks cumulate?

Several injury scenarios leading to several risks can be developed for virtually every product. For example, an angle grinder may present the risk of an electric shock, because electrical wires may be too exposed, and the risk of fire, because the machine may overheat and ignite during normal use. If both risks are considered to be ‘high’, do they add up to the grinder posing an overall ‘serious risk’?

Where several risks are linked to the same product, one of them is obviously more likely to materialise and causes an injury. The overall likelihood of an injury is therefore greater. This does not mean that the overall risk is automatically higher, however:

Thus, risks are not simply cumulated. However, if more than one relevant risk exists, action to manage the risks may need to be taken more rapidly or may need to be more pronounced. For example, with two risks, a product may need to be immediately taken off the market and recalled, whereas, with a single risk, halting sales could be sufficient.

Risk management depends on many factors, not only on the number of risks that a product may present at one and the same time. Thus, consideration is given below to the link between risk and risk management (section 4).

Compliance with limit values in legislation and standards

In market surveillance, consumer products are often tested against limit values or requirements laid down in legislation and in product safety standards. A product that complies with the limit value(s) or requirement(s) (28) is presumed to be safe in terms of the safety characteristics covered by those value(s) or requirement(s). This assumption can be made because the risks of a product from its intended and reasonably foreseeable use are taken into account when establishing the limit value(s) or requirement(s). Manufacturers thus need their products to comply with these values or requirements, because they then only have to look at risks with their products that are not be covered by those limit value(s) or requirement(s).

An example of a limit value in

The product is presumed not to be safe where it fails to comply with established limit values. For limit values laid down in

Non-compliance with limit values does not automatically mean that the product presents a ‘serious risk’ (which is the highest risk level covered by these guidelines). Therefore, to ensure appropriate risk reduction measures, a risk assessment will be required for those parts of a product that do not comply with or are not covered by legislation or a standard.

Furthermore, some products, such as cosmetics, require a risk assessment even when they are compliant with the limit values laid down in legislation. This risk assessment should provide evidence of the safety of the whole product (32).

In conclusion, compliance with limit values in legislation or in standards provides presumption of safety, but such compliance may not be sufficient.

Specific risk assessment guidelines in specific cases

For chemicals there are specific instructions on how to prepare a risk assessment (33), and therefore they are not dealt with in detail in these guidelines. Nevertheless, they follow the same principles as for ‘normal’ consumer products:

Since a chemical may possess several hazards, risk is normally determined for the ‘leading health effect’, which is the health effect (or ‘endpoint’ such as acute toxicity, irritation, sensitisation, carcinogenicity, mutagenicity, toxicity for reproduction) considered to be the most important.

For cosmetics, there is also specific guidance (34), and there may be specific guidance for other products or purposes.

It is highly recommended to use such specific guidance, since it is tailored to the specific cases in question. Nevertheless, where the data required by the specific guidance do not exist or cannot be estimated the present guidelines may be used for a preliminary risk assessment. This risk assessment will have to be carried out with due care and attention in order to avoid any misinterpretation.

• 3. 

  Building a risk assessment step by step

This section describes in detail what points have to be taken into account and what questions have to be asked when preparing a risk assessment.

3.1.   The product

The product should be identified unambiguously. This includes the product name, the brand, the model name, the type number, a possible production lot number, any certificate that may come with the product, a child-resistant fastening if there is one, the identity of the person who placed it on the market, and the country of origin. A picture of the product, the packaging and the marking plate (if appropriate) and a test report(s) identifying the product hazard(s) can also be considered to be part of the product description.

In particular cases, the hazard may be limited to a distinct part of the product, which can be separate from it and also separately available to consumers. In such cases, it is sufficient only to assess the distinct part of the product. Rechargeable batteries of notebook computers which may overheat are an example of this.

The description of the product includes any label that may be relevant for risk assessment, in particular warning labels. Instructions for use may also contain relevant information on the risk of the product and how to keep it as low as possible, for example by using personal protective equipment or by excluding children from using the product. An example of this is a chain saw.

Products may also need to be self-assembled by consumers before use, such as self-assembled furniture. Are the assembly instructions clear enough for the ready-to-use product to meet all the relevant safety requirements? Or could consumers make mistakes when putting the product together that could lead to unforeseen risks?

A risk assessment should always consider the entire life time of a product. This is particularly important when a new product has been developed and its risks are assessed. Will age and usage change the type or the extent of the hazard? Will new hazards appear with increasing product age or perhaps through reasonably foreseeable inappropriate use? How long is the ‘time to product failure’? What is the product’s lifetime, including shelf life? How long is the product used in practice by the consumer before it becomes waste?

Additional considerations may need to be taken into account when a product becomes unusable after a certain time period, even though it has never been used. Examples are electric blankets or heating pads. The electric cords in the products are usually thin and become fragile after ten years, even if the product has never been used. The heating cords can come into contact with each other, can cause a short-circuit and set the bedclothes on fire.

Finally, the packaging of the product should also be included in any risk assessment.

3.2.   The product hazard

Hazard is the intrinsic property of the product that may cause an injury to the consumer who uses the product. It can appear in different forms:

For the purpose of these guidelines, hazards have been grouped, linked to the size, shape and surface of a product, to potential, kinetic or electric energy, to extreme temperatures, and others, as shown in table 2. The table is for guidance only, and any risk assessor should adapt the scenario to the product under consideration. Of course not every type of hazard applies to every product.

Nevertheless, table 2 should help risk assessors to look for and identify all possible hazards in consumer products that are being assessed. Where a product has several hazards, each hazard should be taken separately with its own risk assessment and the highest risk identified as ‘the risk’ of the product. Of course, risks requiring specific risk management measures should also be reported, to ensure that all risks can be reduced.

Note that a single hazard may lead to several injuries in the same scenario. For example, malfunctioning brakes on a motor cycle could cause an accident and result in damage to the driver’s head, hands and legs, and could even cause burns if the petrol bursts into flames in the accident. In this case, all injuries would belong to the same injury scenario, and the severity of all injuries together would have to be estimated. Of course, these injuries together are very serious. Several injuries in different scenarios should, however, not be added.

In the daily practice of market surveillance, it may be sufficient to assess the risk from even a single hazard. If the risk from that hazard provides for risk management action, that action can be taken without further ado. Nevertheless, the risk assessor should be sure that the risk identified is (one of) the highest risk(s), to ensure that the risk management action is sufficiently effective. This is always the case when the risk is serious, since this is the highest possible risk level proposed in these guidelines. In cases of less than serious risk, however, further risk assessments might be necessary and possibly specific risk management at a later stage. In conclusion, experience with risk assessment in market surveillance practice will limit the number of required risk assessments to a minimum.

Hazard identification by tests and standards

Hazards are often identified and quantified by tests. These tests and how to carry them out may be laid down in European or international product standards. Compliance of a product with a ‘harmonised’ European standard (‘EN …’), of which the references have been published in the Official Journal, provides presumption of safety (albeit only for the safety characteristics covered by the value(s) or standard(s)). It can be presumed in such cases that the product presents only a minimum risk and a high level of protection with regard to the specific hazard tested.

Nevertheless, there may be instances where presumption of safety is not the case, and in such cases a particularly well-documented risk assessment will have to be prepared, including a call for amendment to the harmonised standard.

On the other hand, if a product fails the test, a risk can normally be assumed, unless the manufacturer can provide evidence that the product is safe.

Products may still present a risk even though they do not cause injuries

Products may not be hazardous but can nevertheless cause a risk, due to not being fit for their intended use. Examples of this can be observed in the area of personal protective equipment or life saving equipment, such as reflective jackets that car drivers put on after an accident. These jackets are meant to get the attention of oncoming drivers and traffic participants to warn them of the accident, in particular at night. However, they might not be seen if the reflector stripes are too small or do not reflect sufficiently, and do not therefore protect users as they should. These jackets therefore pose a risk even though they are not hazardous in themselves. Another example is a sunscreen product which displays ‘high protection’ (sun protection factor of 30) on the label but provides only ‘low protection’ (factor of 6). This can lead to severe sunburn.

3.3.   The consumer

The abilities and behaviour of the consumer using the product may greatly influence the level of risk. It is therefore of prime importance to have a clear idea of the type of consumer pictured in the injury scenario.

It may be necessary to generate injury scenarios with different types of consumers in order to identify the highest risk and thus ‘the risk’ of the product. It is not enough, for example, to consider only the most vulnerable consumers, because the probability of their suffering adverse effects in the scenario may be so low that the risk is lower than in an injury scenario with a non-vulnerable consumer.

Consideration should also be given to people who are not actually using the product, but who may be in the vicinity of the user. For example, a chain saw may cause splinters to fly around and hit a bystander in the eye. Thus, although the risk from the chain saw may be effectively managed by the user him- or herself wearing protective equipment and complying with any other risk management measures specified by the manufacturer, bystanders may be under serious threat. Consequently, warnings should be given, for example in the chain saw instructions for use, about the risks to bystanders and how to minimise such risks.

Thus, when developing an injury scenario, the following aspects should be taken into account regarding the type of consumer and how they use the product. This is not a complete list, but it should encourage risk assessors to describe their injury scenarios with the necessary level of detail. It should be noted that ‘consumer’ also means people who are not actually using the product, but who may be affected by virtue of being nearby:

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

Most injury scenarios consist of the following three main steps:

These three main steps can be divided into further steps to show how the product hazard can lead to injury and the like. Nevertheless, these ‘steps to injury’ have to be clear and concise, and not exaggerate the detail or the number of steps. With experience, it will be increasingly easier to identify the conditions for the occurrence of any given injury and the ‘shortest path to injury’ (or ‘critical path to injury’).

It is probably easiest to start with a scenario with the consumer for whom the product is intended where the consumer uses the product as per the instructions or, if there are none, according to normal handling and use. If this assessment produces the highest risk level, there is normally no need to carry out further assessments, and appropriate risk reduction measures can be taken. Similarly, where an incident is reported in a specific consumer complaint, a single injury scenario may be sufficient to conclude as to appropriate risk reduction measures.

Otherwise, further scenarios could be developed to include vulnerable consumers, in particular children (see table 1), slight or more pronounced deviations from normal use, use under different climate conditions, such as very cold or very hot, unfavourable conditions of use, such as without proper daylight or illumination, use as suggested when the product was sold (for instance, a lamp sold in a toy shop should also be assessed for its risk when used by a child), use over the entire life-time (including wear and tear), etc. Each scenario should be considered through the entire risk assessment procedure.

Where the product displays several hazards, injury and thus risk scenarios should be developed for each of them. Nevertheless, a plausibility check as to whether an injury scenario might lead to a risk requiring action can limit the number of injury scenarios.

From all the scenarios generated, the scenario providing the highest risk (= ‘the risk’ of the product) will normally be decisive for the risk reduction measures to be taken, because action on the highest risk reduces the risk most effectively. An exception to the rule might be a specific, less-than-highest risk stemming from a different hazard, which could be managed by specific measures and should, of course, also cover the highest risk.

As a rule of thumb, injury scenarios can lead to the highest risk level when

Table 4 provides further guidance in this respect. This might help to limit the number of scenarios.

Of course, the number of injury scenarios remains the responsibility of the risk assessor, and it depends on the number of factors that need to be taken into account when determining 'the risk' of the product. It is therefore impossible to give a specific number of injury scenarios that may be necessary in a specific case.

To help develop a suitable number of scenarios, these guidelines provide a table with typical injury scenarios (table 2). These should be adapted to the specific product, consumer type and other circumstances.

3.5.   Severity of injury

The injury that a hazard can cause to the consumer can have different degrees of severity. The severity of the injury thus reflects the effect the hazard has on the consumer under the conditions described in the injury scenario.

The severity of the injury can depend on:

To quantify the severity of injury(ies), table 3 in these guidelines shows how to classify injuries into four categories, depending on the reversibility of an injury, i.e. whether recovery from an injury is possible and to what extent. This categorisation is for guidance only, and a risk assessor should change the category if necessary, and report it in the risk assessment.

Where several injury scenarios are considered in the risk assessment, the severity of each injury should be classified separately, and considered throughout the entire risk assessment process.

An example: A consumer uses a hammer to knock a nail into a wall. The hammer head is too weak (due to incorrect material) and it breaks, one of the pieces flying into the eye of the consumer so hard that it causes blindness. The injury is thus an ‘eye injury, foreign body in eye: permanent loss of sight (one eye)’, which is a level 3 injury in table 3.

3.6.   Probability of injury

The ‘probability of injury’ is the probability that injury scenario may indeed materialise during the expected lifetime of the product.

This probability is not easy to estimate; but when a scenario is described in distinct steps, each step can be given a certain probability, and multiplying these partial probabilities together gives the overall probability of the scenario. This stepwise approach should make it easier to estimate the overall probability. Of course, where several scenarios are developed, each scenario requires its own overall probability.

Where an injury scenario is nevertheless described in a single step, the probability of the scenario can also only be determined in a single overall step. This would only be a ‘guesstimate’, however, which could be severely criticised and thus call the entire risk assessment into question. A more transparent assignment of probabilities to a several-steps-scenario is therefore preferable, especially as the partial probabilities can be built on undisputable evidence.

These guidelines distinguish between 8 levels of probability to classify overall probability: from < 1/1 000 000 to > 50 % (see left-hand side of table 4). The following example of a hammer head that breaks when the user knocks a nail into a wall should illustrate how to assign a probability to each step, and how to classify overall probability:

Multiplying the probabilities of the above steps together gives an overall probability for the scenario of 1/10 * 1/10 * 1/3 * 1/20 = 1/6 000. This translates into > 1/10 000 (see left-hand side of table 4).

Once the overall probability has been calculated for an injury scenario, it should be checked for plausibility. This requires rather a lot of experience, thus suggesting that the assistance of persons experienced in risk assessment should be sought (see above in section ‘Let others check your risk assessment’). As experience is gained with these guidelines estimating probability should become easier, and an increasing number of examples will become available to facilitate this task.

Assigning probabilities to different injury scenarios for the same product may lead to the following:

The ‘probability of injury’ in this instance is the probability that the injury scenario may actually happen. Probability does not therefore describe the general exposure of the population to the product, calculated, for example, by considering the millions of product items sold on the market and then considering that a few of them might fail. Considerations of this kind do, however, play a role when determining the appropriate risk reduction measures (see section 4).

Also, accident statistics, even if product-specific, have to be considered with care when used for to estimate probability. The circumstances of the accident may not be reported in sufficient detail, the product may have changed over time, or the manufacturer may be different, and so on. In addition, light accidents may not have been reported to those collecting the data for the statistics. None the less, accident statistics can shed light on injury scenarios and their probability.

3.7.   Determination of risk

Once the severity of the injury and the probability have been determined, if possible for several injury scenarios, the risk level then needs to be looked up in table 4. Table 4 combines both the severity of the injury and the probability, and the highest risk is ‘the risk’ of the product. Risks requiring specific risk management measures should also be reported, to ensure that all risks are reduced to a minimum.

These guidelines distinguish between 4 levels of risk: serious, high, medium and low. The risk level between neighbouring severities of injury or probability normally changes by 1 level. This is consistent with the general experience that risk does not increase incrementally when input factors change gradually. However, where the severity of injury increases from level 1 to level 2 (on the right-hand side of table 4), some risk levels increase by 2 levels, namely from medium to serious and from low to high. This is due to the fact that these guidelines include 4 graduations of severity of injury, whereas the original method (see Introduction) included 5. Nevertheless, 4 graduations are considered normal for consumer products, since they make for a sufficiently robust estimation of severity; 5 levels would be too sophisticated since neither the severity of the injury nor the probability can be determined with very high precision.

At the end of the risk assessment, be it for an individual injury scenario or for the overall risk of the product, the plausibility of the risk level and uncertainties in the estimates should be considered. This may mean verifying that the risk assessor has used the best information available to make his estimations and assumptions. Feedback from colleagues and other experts can also be helpful.

A sensitivity analysis can also be very valuable (see example in section 6.3). How does the risk level change when the severity of injury or probability changes by 1 level up or down? If the risk level does not change at all, it is quite plausible that it has been estimated correctly. If it changes, however, the risk level may be borderline. It is then necessary to reconsider the injury scenarios and the assigned severity of injury(ies) and probability(ies). At the end of the sensitivity analysis the risk assessor should be confident that the risk level is sufficiently plausible and that he can document it and pass the information on.

• 4. 

  From risk to action

Once the risk assessment is complete it will normally be used to decide whether action needs to be taken to reduce the risk and thus prevent harm to a consumer’s health. Although action is separate from risk assessment, some points are raised here to illustrate the possible follow-up of identified risks.

Within market surveillance, action will often be taken in contact between the authority and the manufacturer, importer or distributor. This can help the authority to determine the most effective and efficient way of managing the risk.

With a serious risk in a consumer product, measures to reduce the risk may include withdrawal from the market or recall. Lower levels of risk normally lead to less rigorous measures. It may then be sufficient to add warning labels on the product or to improve the instructions to make the product safe. Thus, whatever the level of risk, the authority should consider whether to take action, and if so, what action.

Nevertheless, there is no automatic link from risk to action. When a product shows several less-than-serious risks, and its overall risk is thus not serious, urgent action may be necessary since any of the risks may materialise quite quickly. The pattern of risks in the product may indicate a lack of quality control in production.

It is also important to take account of exposure of the population as a whole. Where there are a large number of products on the market and the product is therefore used by a large number of consumers, even a single less-than-serious risk may require quick action to avoid adverse effects to the health of consumers.

Less-than-serious risks may also require action when the product concerned could cause fatal accidents, even though such accidents may be extremely unlikely. This could be the case with a fastening on a beverage container, which could come loose and be swallowed by a child, causing the child to choke to death. A simple change of design to the lid could eliminate the risk, and no further action might be required. Even a selling-off period may be granted if the risk of a fatal accident were indeed extremely small.

Other risk-related aspects may be the public perception of risk and its likely consequences, cultural and political sensitivities and how it is portrayed in the media. These aspects may be especially relevant when the consumers concerned are vulnerable, in particular children. It will be up to the national market surveillance authority(ies) to determine what measures are required.

Taking action to counteract a risk may also depend on the product itself and the ‘minimum risks compatible with the product’s use, considered to be acceptable and consistent with a high level of protection’ (35). This minimum risk will probably be much lower for toys, where children are involved, than for a chain-saw, which is known to be so high-risk that solid protective equipment is required to keep the risk at a manageable level.

Finally, even if there is no risk, action may be necessary, for example, when a product is non-compliant with the applicable regulation/legislation (e.g. incomplete markings).

In conclusion, there is no automatic link from risk to action. Surveillance authorities will take account of a range of factors such as those indicated above. The principle of proportionality always has to be considered, and action has to be effective.

• 5. 

  How to prepare a risk assessment – in brief

• 1. 

  Describe the product and its hazard.

Describe the product unambiguously. Does the hazard concern the entire product or only a (separable) part of the product?

Is there only one hazard within the product? Are there several hazards? See table 2 for guidance.

Identify the standard(s) or legislation applicable to the product.

• 2. 

  Identify the type of consumer you want to include in your injury scenario with the hazardous product.

Start with the intended user and the intended use of the product for your first injury scenario. Take other consumers (See table 1) and uses for further scenarios.

• 3. 

  Describe an injury scenario in which the product hazard(s) you have selected causes an injury(ies) or adverse health effect(s) to the consumer you selected.

Describe the steps to the injury(ies) clearly and concisely, without exaggerating the details (‘shortest path to injury’, ‘critical path to injury’). If there are several concurrent injuries in your scenario, include them all in that same scenario.

When you describe the injury scenario, consider the frequency and duration of use, hazard recognition by the consumer, whether the consumer is vulnerable (in particular children), protective equipment, the consumer’s behaviour in the case of an accident, the consumer’s cultural background, and other factors that you consider important for the risk assessment.

See section 3.3 and table 2 for guidance.

• 4. 

  Determine the severity of the injury.

Determine the level of severity (1 to 4) of the injury to the consumer. If the consumer suffers from several injuries in your injury scenario, estimate the severity of all those injuries together.

See table 3 for guidance.

• 5. 

  Determine the probability of the injury scenario.

Assign a probability to each step of your injury scenario. Multiply the probabilities to calculate the overall probability of your injury scenario.

See left-hand side of table 4 for guidance.

• 6. 

  Determine the risk level.

Combine the severity of the injury and the overall probability of the injury scenario and check the risk level in table 4.

• 7. 

  Check whether the risk level is plausible.

If the risk level does not seem plausible, or if you are uncertain about the severity of injury(ies) or about the probability(ies), move them one level up and down and recalculate the risk. This ‘sensitivity analysis’ will show you whether the risk changes when your input changes.

If the risk level remains the same, you can be quite confident of your risk assessment. If it changes easily, you may want to err on the safe side and take the higher risk level as ‘the risk’ of the consumer product.

You could also discuss the plausibility of the risk level with experienced colleagues.

• 8. 

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

If your first injury scenario identifies a risk level below the highest risk level set out in these guidelines, and if you think that the product may pose a higher risk than the one identified,

in order to determine which injury scenario puts the product at its highest risk.

The highest risk is normally ‘the risk’ of the product that allows the most effective risk management measures. In specific cases, a particular hazard may lead to a less-than-highest risk and require specific risk management measures. This has to be taken duly into account.

As a rule of thumb, injury scenarios may lead to the highest risk level set out in these guidelines where:

See table 4 for guidance.

• 9. 

  Document and pass on your risk assessment.

Be transparent and also set out all the uncertainties that you encountered when making your risk assessment.

Examples for reporting risk assessments are provided in section 6 of these guidelines.

• 6. 

  Examples

6.1.   Folding chair

A folding chair has a folding mechanism constructed in such a way that the user’s fingers can get trapped between the seat and the folding mechanism. This can lead to fractures or even loss of one or more fingers.

Determination of risk(s)

The overall risk of the folding chair is thus ‘high risk’.

6.2.   Socket protectors

This case deals with socket protectors. These are devices that users (parents) put into the electrical socket outlets to stop small children from accessing live parts by putting a long metal object into one of the holes in the outlet and getting a (fatal) electric shock.

The holes in this particular protector (where the pins of the plug go through) are so narrow that the pins can get stuck. This means that the user may pull the protector off the outlet when the plug is pulled out. The user may not notice this happening.

Determination of risk(s)

The overall risk of the socket protectors is thus ‘serious’.

6.3.   Sensitivity analysis

The factors used to calculate the risk of an injury scenario, namely the severity of the injury and the probability, often have to be estimated. This creates uncertainty. Probability in particular can be difficult to estimate, since the behaviour of consumers, for example, can be difficult to predict. Does a person perform a certain action often or only occasionally?

It is therefore important to consider the level of uncertainty of the two factors and to make a sensitivity analysis. The purpose of this analysis is to establish how much the risk level varies when the estimated factors vary. The example below only shows the variation of probability, since the severity of the injury is usually predicted with more certainty.

A practical way of performing the sensitivity analysis is to repeat the risk assessment for a certain scenario, but to use a different probability for one or more steps in the scenario. For example, a candle containing seeds could cause a fire, because the seeds can catch fire and generate high flames. Furniture or curtains can catch fire and persons not in the room could inhale toxic fumes and suffer fatal poisoning:

The probability levels for the steps in the scenario were estimated as shown in the table.

The overall probability is 0,00675, which corresponds to > 1/1 000 in table 4. This leads to the conclusion of ‘serious risk’. Note that the exact probability is closer to 1/100 than to 1/1 000, which already gives some confidence in the risk level because it is a little deeper in the serious risk area of table 4 than the > 1/1 000 row suggests.

Suppose we are uncertain about the 5 % probability that persons inhale the toxic fumes. We could put it at a much lower 0,1 % (0,001 = 1 in a thousand). If we recalculate with that assumption, the overall probability is 0,000135, which translates into > 1/10 000. Nevertheless, the risk is still serious. Even if for some reason the probability were to be a factor of 10 lower, the risk would still be high. Therefore, although the probability may vary 10- or 100-fold, we still find a serious or high risk (the latter being quite close to ‘serious’). Thus, this sensitivity analysis lets us confidently assess the risk as serious.

In general, however, risk assessment should be based on ‘reasonable worst cases’: not too pessimistic on every factor, but certainly not too optimistic.

Table 1

Consumers

Table 2

Hazards, Typical Injury Scenarios And Typical Injuries

Table 3

Severity of injury

Introduction

These risk assessment guidelines distinguish between four levels of injury severity. It is important to realise that severity should be assessed completely objectively. The aim is to compare the severity of different scenarios and to set priorities, not to judge the acceptability of a single injury at this stage. Any injury that could easily have been avoided will be difficult to accept for a consumer. However, authorities can justifiably invest more effort into avoiding irreversible consequences than into preventing temporary discomfort.

In order to assess the severity of the consequences (acute injury or other damage to health), objective criteria can be found, on the one hand, in the level of medical intervention, and, on the other hand, in the consequences to the further functioning of the victim. Both could be expressed as cost, but the costs of consequences of health damage may be difficult to quantify.

Combining these criteria, the four levels may be defined as follows:

The following table, which should be considered as a guide rather than prescriptive or complete, provides examples of injuries at all four levels. National differences may exist, either cultural or caused by different systems of health care and financial arrangements. However, deviating from the proposed classification in the table will affect uniform assessment of risks in the EU; this should be clearly stated and explained in the risk assessment report, and reasons should be given.

Table 4

Risk level from the combination of the severity of injury and probability

Glossary of terms

Hazard: Source of danger involving the chance of being injured or harmed. A means of quantifying the hazard in a risk assessment is the severity of the possible injury or harm.

Product hazard: Hazard created by the properties of a product.

Risk: Balanced combination of a hazard and the probability that damage will occur. Risk describes neither the hazard, nor the probability, but both at the same time.

Risk assessment: Procedure for identifying and assessing hazards, consisting of three steps:

Risk level: Degree of risk, which may be ‘serious’, ‘high’, ‘medium’ and ‘low’. When the (highest) level of risk has been identified, the risk assessment is complete.

Risk management: Follow-up action, which is separate from risk assessment and aims to reduce or eliminate a risk.

• (1) 

  In the Guidelines, the term ‘Commission’ generally refers to the RAPEX Team established in the Commission department responsible for the GPSD and to the relevant Commission services, where appropriate.

• (2) 

  OJ L 11, 15.1.2002, p. 4.

• (3) 

  OJ L 218, 13.8.2008, p. 30.

• (4) 

  In the context of this document, the term ‘Member States’ means all countries which belong to the European Union and also those countries which are parties to the European Economic Area (EEA) Agreement.

• (5) 

  www.ec.europa.eu/rapex

• (6) 

  OJ L 31, 1.2.2002, p. 1.

• (7) 

  OJ L 311, 28.11.2001, p. 67.

• (8) 

  OJ L 311, 28.11.2001, p. 1.

• (9) 

  OJ L 169, 12.7.1993, p. 1.

• (10) 

  OJ L 331, 7.12.1998, p. 1.

• (11) 

  OJ L 189, 20.7.1990, p. 17.

• (12) 

  OJ L 204, 21.7.1998, p. 37.

• (13) 

  For more information about deadlines, see Chapter 3.10 of the Guidelines.

• (14) 

  For more information about the RAPEX Contact Points and their obligations, see Chapter 5.1 of the Guidelines.

• (15) 

  For more information on follow-up actions, see Chapter 3.7.

• (16) 

  For more information on notifications on safety aspects subject to discussions at EU level, see Chapters 3.5.2 and 3.8.1.

• (17) 

  For more information on notifications on safety aspects subject to discussions at EU level, see Chapters 3.1.2.d and 3.8.1.

• (18) 

  For more information on the RAPEX notification criteria, see Chapter 2.

• (19) 

  For more information on notifications sent through the RAPEX application before measures are taken, see Chapter 3.1.2 b.

• (20) 

  For more information on notifications on safety aspects subject to discussions at EU level, see Chapters 3.1.2.d and 3.5.2.

• (21) 

  All deadlines mentioned in the Guidelines are expressed in calendar days.

• (22) 

  Benis HG (1990): A Product Risk Assessment Nomograph, report prepared for the New Zealand Ministry of Consumer Affairs, dated February 1990. Cited in: European Commission (2005) Establishing a Comparative Inventory of Approaches and Methods Used by Enforcement Authorities for the Assessment of the Safety of Consumer Products Covered by Directive 2001/95/EC on General Product Safety and Identification of Best Practices. Report prepared by Risk & Policy Analysts (RPA), Loddon, Norfolk, UK.

• (23) 

  Method used by the Belgian authorities. Cited in: European Commission (2005) Establishing a Comparative Inventory of Approaches and Methods Used by Enforcement Authorities for the Assessment of the Safety of Consumer Products Covered by Directive 2001/95/EC on General Product Safety and Identification of Best Practices. Report prepared by Risk & Policy Analysts (RPA), Loddon, Norfolk, UK.

• (24) 

  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).

• (25) 

  Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, p. 4).

• (26) 

  Kinney GF, Wiruth AD (1976) Practical risk analysis for safety management. China Lake, CA: NWC Technical Publication 5865, Naval Weapons Center, California, June 1976.

• (27) 

  https://webgate.ec.europa.eu/idbpa/

• (28) 

  NB: uncertainty always has to be taken into account when comparing a test result with a limit. See, for example:

• (29) 

  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

• (30) 

  OJ L 164, 26.6.2009, p. 7.

• (31) 

  Standard EN 71-1:2005, section 8.2 +A6:2008.

• (32) 

  Article 7a(1)(d) of Council Directive 76/768/EEC (OJ L 262, 27.9.1976, p. 169).

• (33) 

  REACH Regulation and guidance documents on REACH, see http://echa.europa.eu/

European Chemicals Agency (2008). The Guidance on Information Requirements and Chemical Safety Assessment: http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm

• (34) 

  Scientific Committee on Consumer Products (SCCP), The SCCP’s Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 6th revision, 19.12.2006: http://ec.europa.eu/enterprise/cosmetics/html/testing_guidance.htm

• (35) 

  This is taken from the definition of ‘safe product’ in Article 2(b) of Directive 2001/95/EC.

This summary has been adopted from EUR-Lex.