ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Regulatory policy Regulatory approach for the free circulation of goods
NOTE TO THE SENIOR OFFICIALS GROUP ON
STANDARDISATION AND CONFORMITY ASSESSMENT POLICY – MARKET
SURVEILLANCE GROUP (SOGS-MSG)
Draft CERTIF 2008-001 - Application of the RAPEX system to the Title:
Community harmonisation legislation as in the Regulation (EC) No
Rita L’Abbate - Unit C1 Author:
SOGS-MSG N002 EN 23-09-2008 Doc. N.: Issue Date:
st0.0 1 October 2008 Version: Meeting:
For discussion Status:
The objectives of this paper are:
-to inform on how the RAPEX system currently operates;
-to outline and evaluate the needs of a rapid exchange of information mechanism to be established under the Regulation 765/2008 setting out the requirements for accreditation
and market surveillance;
-to identify the necessary measures to ensure that from 1 January 2010 onwards all
notification procedures required by the Regulation are established and effectively implemented.
A plan/flow of the rapid exchange of information currently requested into the above Regulation and the Decision 768/2008/EC is attached.
Market surveillance, rapid exchange of information system, notification, Keywords:
serious risk, market surveillance authorities
Regulation 765/2008; 2001/98/EC Directive (GPSD); RAPEX system; References:
RAPEX Guidelines; Decision 768/2008/EC
ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Regulatory policy Regulatory approach for the free circulation of goods
CERTIF doc. 2008-001
Subject: Application of the RAPEX system to the Community harmonisation 1legislation as in the Regulation (EC) No 765/2008
I. CURRENT SITUATION
2RAPEX is the European rapid alert system for non-food consumer products
presenting a serious risk to the health and safety of consumers. It is set up under 3Article 12 of the General Product Safety Directive (2001/95/EC, GPSD).
The new Regulation (EC) No 765/2008 foresees the establishment of a Community
Rapid Information System (see Article 22) for products presenting a serious risk
and for any voluntary measure taken and communicated by an economic operator.
Moreover, this rapid information system will cover the scope of the regulation i.e.
all products covered by Community harmonisation legislation which includes
consumer products and other categories of products (e.g. for professional and
industrial use) and risks (e.g. environmental).
The objective of this paper is to outline how the RAPEX system currently operates,
to evaluate the needs of a rapid exchange of information mechanism to be
established under the Regulation and to identify the necessary measures to ensure
that from 1 January 2010 onwards all notification procedures required by the
Regulation are established and effectively implemented.
2. ABOUT RAPEX TODAY
RAPEX ensures that information about restrictive measures (preventing or
restricting marketing or use), whether ordered by national authorities or taken
'voluntarily' by businesses in relation to consumer products posing serious risks to
the health and safety of consumers is circulated between national authorities and
the Commission, with the aim of preventing or restricting the circulation of such
1 OJEU L 218, 13.8.2008, p. 30 - Regulation of 9 July 2008 setting out the requirements for accreditation
and market surveillance relating to the marketing of products 2 RAPEX Members: EU Member States and EFTA/EEA countries 3 OJEU L 11, 15.1.2002, p. 4
4products in all Member States.In other words, RAPEX is a general and horizontal
rapid warning and monitoring system for consumer products. It is designed for handling situations caused by products presenting a serious risk to the health and safety of consumers.
2.1. Legal basis
The RAPEX system was created to support consumer product safety enforcement. The RAPEX system in the current form became operational in 2004 when the revised GPSD (2001/95/EC) came into force. To ensure the effectiveness and proper functioning of the system, the Commission adopted (also in 2004) with its Decision the "Guidelines for the management of the Community Rapid Information System (RAPEX) and for notifications presented in accordance with Article 11 of 5Directive 2001/95/EC" (RAPEX Guidelines) .
2.2. Scope of RAPEX
RAPEX covers all consumer products, i.e. products intended for consumers and products likely, under reasonably foreseeable conditions, to be used by consumers (even if not intended for them), including products provided in the context of a service. There are, however, some categories of products for which sector specific alert systems are in place and thus RAPEX does not apply to them i.e. food and feed, where Rapid Alert System for Food and Feed (RASFF) is used, medical devices (with so-called medico-vigilance procedure) and pharmaceuticals (with the pharmaco-vigilance database managed by the European Medicines Agency 'EMEA'). RAPEX is intended for notifications on 'obligatory' measures ordered by national authorities, as well as on 'voluntary' actions taken by businesses, which restrict or prevent the distribution or use of non-food consumer products posing serious risks to their health and safety, which are sent to the Commission by 6Member States under Article 12 of the GPSD.
In addition, the RAPEX system is also used for the exchange of information on measures taken by national authorities in relation to consumer products posing a non-serious risk to consumers (notifications sent under Article 11 of the GPSD).
2.3. How does RAPEX operate?
RAPEX is used by Member States to inform the Commission, of the adoption of (i) measures to prevent, restrict or impose specific conditions on the marketing or use of (ii) a consumer product posing (iii) a serious risk to consumers, the effects of which (iv) go beyond the territory of that state. When the above notification criteria are met, Member States have a legal obligation to send a RAPEX notification to the Commission.
To guarantee as much as possible the preventive nature of the system, Member States are also entitled (and not obliged as above) to pass on to the Commission
4 The term ? MS ? means EU Member States and States which are parties to the EEA Agreement. 5 OJEU L 151, 30.04.2004, p. 83 - 117 6 Certain RAPEX notifications are distributed through the system "For information" purpose only (e.g. notifications with insufficient product identification).
information about a consumer product posing a serious risk before taking any measures or actions. The existence of a serious risk, however, should be established and proved before information is sent to the Commission. It allows Member States to exchange information about products posing serious or life threatening risks in very complex situations where adoption of measures may require more time. It should, however, be noted that on average only 5 such notifications are sent through RAPEX every year, while over 1,600 notifications were submitted through the system in 2007.
The RAPEX system relies on co-operation between the Commission and the national market surveillance and customs authorities. Each Member State 7appointed a single RAPEX Contact Point which is responsible for the operation of
the system at the national level and which transmits RAPEX data to/from competent authorities. The “Contact Points Network”, established and developed
over the years with considerable investments meets regularly to discuss the operation and organisation of RAPEX.
Member States submit RAPEX notifications to the Commission through the RAPEX online system ('REIS') using a common notification form (see Annex I to the RAPEX Guidelines). The information required includes notably product identification (including information about its origin), risk analysis (including risk assessment and conclusions of any tests performed), information about distribution channels and information about measures adopted to prevent risks. Further, the Commission (DG SANCO) examines the correctness and 8completeness of a submitted notification, validates it and has it translated and
distributes it through the system to all national RAPEX contact points, unless a notification is not justified (as it does not meet all notification criteria) or is incomplete and thus requires suspension.
After distribution, the receiving authorities are required to carry out the necessary follow up activities and to inform the Commission about their conclusions (e.g. any consequential measures taken). For that purpose contact points complete in the system the 'Reaction form' (see Annex II to the RAPEX Guidelines) and submit it to the Commission.
The RAPEX system is intended exclusively for public authorities of the Member States and access to its online application is restricted to these authorities. Consumers, consumer organisations or businesses do not have access to the RAPEX database. However, in order to inform consumers and businesses about consumer products posing serious risks withdrawn from the EU market, the 9Commission publishes on the RAPEX website weekly overviews of RAPEX
notifications. These overviews provide notably information on: the product identification, the risks it poses and the measures that were taken to prevent these risks.
7 A list of the national contact points can be found at: http://ec.europa.eu/consumers/safety/rapex/
8 RAPEX operates in DE, EN, ES, FR, IT
2.4. RAPEX online systems ('REIS' and 'GRAS-RAPEX')
To ensure a smooth and rapid exchange of information through RAPEX, the
Commission established in 2004 the online system called "REIS" which is still in
operation today. Currently, DG SANCO prepares a new online system for RAPEX
called "GRAS-RAPEX" which will replace the "REIS" system. The new RAPEX
application will be established on the IT platform called "GRAS", which will serve
as a common online platform for four rapid alert systems managed by DG SANCO,
including in addition to RAPEX, Rapid Alert system for Food and Feed ("RASFF"),
Rapid Alert System for –Chemical agents ("RAS-CHEM") and Rapid Alert System
for-Biological and Chemical Attacks and Threats ("RAS-BICHAT").
It should be noted that four mentioned above alert systems, though established on a
common IT platform will not be inter-connected in any way and will operate
independently from each other. The "GRAS-RAPEX" application should ensure a
more rapid and efficient operation of RAPEX compared to "REIS", which is
currently under severe strain, and will simplify the work of the Contact Points
Network and the Commission RAPEX Team.
In conclusion, it should be stressed that RAPEX has not been designed to cover the needs of the Regulation. Therefore, the currently operational RAPEX system and Contact Points Network cannot be used for the purpose of notifications distributed under the Regulation.
II. THE NEW LEGISLATIVE ENVIRONMENT
3. OVERALL NEEDS
3.1. General considerations
The RAPEX system established under Article 12 of the GPSD has proved its
effectiveness and efficiency in the field of consumer product safety. The EU
legislator decided that: “Situations of serious risk posed by a product require rapid
intervention, which may entail the withdrawal of the product, its recall or the
prohibition of its being made available on the market. In those situations it is
necessary to have access to a system of rapid exchange of information between
Member States and the Commission. […]. To avoid unnecessary duplication, the
GPSD system should be used for the purposes of this Regulation.”
In this context one of the most important decisions to be taken quickly is how to
make the rapid information of the Regulation work.
stThe new framework for market surveillance will apply from 1 January 2010. It
should be taken into account that Community harmonisation legislation will in the
next future be adapted to the Decision No 768/2008/EC for the marketing of 10products, which contains an important aspect of market surveillance, the
safeguard clause procedures. These procedures also require an exchange of
10 see OJEU L 218, 13.08.2008
information between Member States and the Commission and outmost synergy should be achieved.
The flowchart attached to this note shows the Regulation rapid exchange of information channels and needs which are explained below.
3.2. Exchange of information - Community Rapid Information System under
Article 22 (4) of the Regulation makes reference to the GPSD (Article 12 (2), (3) and (4) mutatis mutandis) as regards the functioning and the procedural aspects of the information exchange mechanism. Various additional elements have to be taken into consideration when establishing such a mechanism under the Regulation: 3.2.1. In relation to the exchange mechanism:
; The procedure has to cover all products under Community harmonisation legislation as set out in Article 15, paragraphs 1, 2 and 4 of the Regulation regardless whether they are consumer products or products intended for professional use.
; The procedure has to cover risks in addition to health and safety aspects such as, e.g. environment, interoperability, safety of the worker at the work place, etc. ; It should be ensured that EU customs are informed of the national measures taken to impede the release for free circulation of a product coming from third countries presenting a serious risk or which does not comply with the relevant EU legislation and consequently apply the same restrictions.
3.2.2. In relation to final national decision and link to safeguard mechanisms The majority of the EU sectoral legislation foresees a safeguard clause procedure. It obliges MS to inform when they take measures restricting the free circulation of a product presenting a (serious or non-serious) risk or when they intend to take restrictive measures because they have sufficient reason to believe that the product concerned presents a (serious or non-serious) risk. This obligation exists in parallel to the RAPEX notification obligation established in Article 12 of the GPSD which applies to measures adopted in relation to consumer product (regardless of whether they are covered or not by Community harmonisation legislation) presenting a serious risk for the health and safety of consumers. Currently there is no link between the RAPEX notifications and the safeguard clause notifications sent to the Commission. It should, however, be reminded that in 2006, in order to simplify procedures and reduce burden of work for national authorities, the Commission introduced in the RAPEX application one "notification form for toys" intended to be used by national authorities for both procedures: RAPEX and Safeguard Clause (Annex III to the RAPEX Guidelines). With the entry into force of the Regulation, the information exchange mechanism established under the Regulation (Article 22) will be used for notifications concerning all products covered by Community harmonisation legislation (Article 15(1)). At the same time, Member States must follow the safeguard clause procedure in sectoral legislation (Article R31 of the Decision).
The objective would be to ensure that when, for the same product/risk, a notification is required in parallel under Article 20 (1) of the Regulation as well as under the safeguard clause provisions in sectoral EU legislation, there is only one notification form covering both notification obligations. Therefore, the inter-connection between notifications sent under the Regulation and Safeguard Clause notifications, for cases where a serious risk is present and where the relevant economic operator has not taken the appropriate corrective measures or recalled the product, should be considered in the future (taking as an example the "notification form for toys" created in the RAPEX application),
This will create an appropriate mechanism to ensure that MS are informed of the real existing emergency situation for the safety of products.
Furthermore, Article 21 (4) of the Regulation obliges authorities to withdraw measures when an economic operator has taken effective corrective action. Consequently the information exchange mechanism established under the Regulation needs to allow notifications to be withdrawn or amended by the relevant authority or at least inform the network members that corrective measures have already been taken and that there is no longer a risk.
3.2.3. Contact points network
Currently RAPEX is managed by the Commission through a “Contact Points Network” (see points 2.3 and 2.4).
How to deal with the issue of contact points under the Regulation remains to be decided.
3.2.4. Need for one single entry point for market surveillance exchange tools? The Regulation requires the Commission to develop and maintain an IT tool for the purposes of general archiving and exchange of information system on issues relating, in general, to market surveillance activities (see Article 23) and requires that this database appropriately reflect notifications and information provided under Article 22.
Currently the IT system ICSMS (Information and Communication System for Market Surveillance) led by Germany attempts to ensure this role. The use of a single internet platform for the purpose of Article 23 on which market surveillance authorities, interested-stakeholders and consumers can find relevant for them information on consumer product safety as envisaged in the Regulation should be further explored.
3.3. Guidelines document
The GPSD provides for the establishment of guidelines aimed at indicating simple and clear criteria and practical rules to facilitate the effective operation of RAPEX by the Commission and the MS competent authorities. In 2004, the Commission adopted with its Decision the "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" (RAPEX Guidelines).
The RAPEX Guidelines are currently under review in order to update them and in particular to adjust the operation of the system to best practices (e.g. notification criteria, notification forms, languages, deadlines, etc.).
These guidelines also include the risk assessment method which is used by national authorities and businesses to assess whether a risk posed by a product is serious or non-serious (“risk assessment”) (see Chapter 3). This risk assessment
method is also under revision now. A public consultation on the improved method is currently open until 15.10.2008. For more information please visit: http://ec.europa.eu/yourvoice/consultations/index_en.htm or
The above RAPEX Guidelines could be taken into account (as a model) when drafting detailed guidelines document(s) for notifications presented under the Regulation, and in particular to cover issues such as those described in points 3.2.1.and 3.2.2, as well as others, e.g.:
; Risk assessment rules and notification criteria should take into account the enlarged scope covered by the Regulation i.e. the harmonised area which covers various products and risks;
; Results of checks (documentary, physical or laboratory) which have been performed in support of the notification (see Article 19 (1)); ; Take account of and inform on contacts with the relevant economic operator (Articles 19 (2) and 21 (3)).
4. FUTURE AMENDMENTS
In view of the establishment of the information exchange mechanism under the Regulation the following questions could be raised:
; Should this system be limited to informing its members of national measures concerning serious risks only (see point 2.2.)?
; Should this system be designed to be used as a tool for both national authorities and consumer information or should the general database under Article 23 ensure this information and become the only information point open to consumers?
; Are there any elements that are not present in the model RAPEX organisation which would need to be considered for the organisation of the rapid information exchange mechanism under the Regulation and if so, what?
; Does the broad scope of the system presented under the Regulation justify envisaging more than one contact point per Member State and if so, what structure would be the most workable?
; Should the notification procedure under the Regulation be organised in a different way than the model notification procedure used currently in RAPEX and if so, how?
; What supplementary information for the purpose of the notification procedure under the Regulation needs to be added to the notification forms which are currently used in RAPEX?
; How can it be ensured that notifications sent under the Regulation reflect the final decision on a specific notification? In other words, should the measures notified under the Regulation within a reasonable delay, be reviewed to update the status of the notification (e.g. deleted, withdrawn, in progress, etc.)?
How can the information flow on products between market surveillance ;
authorities and customs and between customs themselves be enhanced? ; How should the notification process at national level as requested in the Regulation be organised?
; What training and other capacity building needs do the participating authorities have?
RAPEX has proved its effectiveness and efficiency in the field of consumer products and it is generally accepted that it works well as an information exchange tool for national authorities and the Commission.
The Commission is committed to ensure that the rapid information system established under the Regulation will be ready and work at the entry into force of the Regulation i.e. 1.1.2010 whilst maintaining the effectiveness of the RAPEX instrument.
REGULATION 765/2008 Annex Market Surveillance - Rapid Information Plan / Flow
Controls at borders & internally
Only safe products on the market Art. 16
INTERNALLY AT BORDERS
Serious risks No compliance Art. 20 Restrictive
measures Art. 29 (1) Art. 24(2)(b)
Art. 21 RAPEX
Art. 22 No release
Art. 29 (1) (2) DECISION 768/2008 Customs shall be informed of /Sectoral amended product categories when serious legislation risks or non compliance have
been identified. Art. 29 (5)
SERIOUS RISK / NORMAL RISK
Art. R 31
COMMISSION MEMBER STATE
NO COMPLIANCE Corrective actions
Provisional restrictive No corrective actions measures
If objections are Follow appropriate raised SAFEGUARD CLAUSE
Art. R32 or R33 or R34