DIRECTORATE-GENERAL
ENVIRONMENT
Directorate D - Water, Chemicals and Biotechnology
ENV.D.3 – Chemicals and Nanomaterials
Brussels, 9 November 2010
POP-CA7/2010/05
Seventh Meeting of the Competent Authorities
for the implementation of Regulation (EC) Nr 850/2004 of the European Parliament and of the Council on
Persistent Organic Pollutants
Centre de Conférence A. Borschette, room 1D, rue Froissart 36, Brussels
12 November 2010 (10:00 – 18:00)
Concerns: Market Surveillance Regulation (765/2008) and POPs Regulation
Agenda Point: 6
Action Requested: This document contains brief summary of obligations under Market Surveillance Regulation relevant to POPs Regulation
The POP-CA is invited to:
- take note of this document
(1) General information
The aim of this paper is to provide a brief summary of obligations under Regulation (EC) No 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products (hereinafter referred to as “AMS Regulation”) relevant to POP Regulation. This document is prepared based on the document CA/95/2009 rev.1 prepared for the 3rd CARACAL meeting in 2009.
(2) Overview of the AMS Regulation
The AMS Regulation entered into force in September 2008 and started to apply from 1 January 2010. The main aim of the AMS Regulation is to establish an overall framework of rules and principles in relation to accreditation and market surveillance, which should not affect the substantive rules of existing legislation, but aim at enhancing their operation.
The AMS Regulation has a horizontal scope of application across the entire internal market for goods. The AMS Regulation consists of four main parts: accreditation, market surveillance framework, CE marking and Community financing.
The market surveillance provisions (Chapter III) are the most relevant provisions as regards application of the POP Regulation. Therefore, in section 3 of this document, the market surveillance provisions of the AMS Regulation are addressed.
(3) Market Surveillance Framework
3.1. The aim and scope of the framework
“Market surveillance”, as defined in Article 2(17) of the AMS Regulation, means the activities carried out and measures taken by public authorities to ensure that products comply with the requirements set out in the relevant Community harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection. The market surveillance provisions within the Community (Sections 1 and 2 of Chapter III of the AMS Regulation, Articles 16 to 26) apply to products covered by Community harmonisation legislation. The provisions on controls of imported products apply to all products from third countries (Section 3 of Chapter III of the AMS Regulation, Articles 27 to 29). The whole Chapter III applies both to industrial products and to consumer products.
The framework for market surveillance established by the AMS Regulation should complement and strengthen existing provisions in Community harmonisation legislation relating to market surveillance and their enforcement. The objective is to ensure equivalent and consistent enforcement of Community harmonisation legislation throughout all Member States.
Market surveillance under the AMS Regulation aims to ensure that products that do not conform to applicable harmonisation legislation (POP Regulation) are withdrawn or their being made available on the market[1] is prohibited or restricted and that the public, the Commission and other Member States are informed accordingly (Art. 16).
3.2. Market surveillance obligations for Community products
For the purpose of this document, we may distinguish three basic types of obligations for Member States and corresponding powers for market surveillance authorities, which flow directly from the AMS Regulation (organisation obligations, market surveillance obligations and restrictive measures). The list of obligations below (3.3.1 to 3.3.3) is not supposed to be exhaustive in this paper, but aims to illustrate the most important obligations/powers for market surveillance authorities.
3.2.1. General organisation obligations
The general organisation obligations for Member States, provided for in the AMS Regulation, include, in particular, the following ones:
Ø general obligation to organize and carry out market surveillance activities as provided for in the Regulation (Art. 16(1)),
Ø obligation to inform the Commission of the market surveillance authorities and their areas of competence (Art. 17(1)),
Ø obligation to establish appropriate communication and coordination mechanisms between market surveillance authorities (Art. 18(1)),
Ø obligation to entrust the authorities with the necessary powers, resources and knowledge for the proper performance of tasks (Art. 18(4)),
Ø obligation to establish, implement and periodically update their market surveillance programmes (either general or sector specific (e.g. POP Regulation)), these programmes must be communicated to other Member States and the Commission and be made publicly available (Art. 18(5)),
In this respect, note that pursuant to Article 18(5) the first market surveillance programmes had to be communicated to the Commission by 1 January 2010.
Ø obligation to periodically review and assess the functioning of surveillance activities, at least every fourth year and to communicate the results to the other Member States and the Commission and make it available to the public (Art. 18(6))
Ø obligation to give the market surveillance authority of other Member States assistance on adequate scale by supplying information or documentation, by carrying out appropriate investigations or any other appropriate measures and by participating in investigations initiated in other Member States (Art. 24(2))
3.2.2. Surveillance measures
The obligations regarding the actual market surveillance stemming from the AMS Regulation may be briefly summarized as follows:
Ø obligation to perform appropriate checks (documentary checks, and where appropriate physical and laboratory checks) on an adequate scale (Art. 19(1))
This obligation entails the power:
· to require documentation and information,
· to enter the premises of economic operators and take the necessary samples of products,
· to destroy or render inoperable products presenting a serious risk.
Ø obligation to take appropriate measures to alert users within their territories within an adequate timeframe of hazards they have identified relating to any product so as to reduce the risk of injury or other damage (Art. 19(2)),
Ø obligation to co-operate with economic operators regarding actions which could prevent or reduce risks (Art.19(2)),
Ø obligation to observe confidentiality (to protect commercial secrets and personal data), but to inform public to the fullest extent necessary.
3.2.3. Restrictive measures
The obligations for the restrictive measures to be taken, when considered necessary and appropriate, are as follows:
Ø obligation to ensure recall or withdrawal of product presenting a serious risk requiring rapid intervention (Art. 20(1)),
Ø corresponding procedural obligations: e.g. to hear the operator before taking the decision, to take proportionate measures, to state the grounds, to inform the operator on remedies available, to amend or withdraw the measure after operator has taken effective action etc. (Article 21).
3.3. Market surveillance obligations for imported products
The AMS Regulation imposes certain obligations on Member States authorities controlling products entering the Community market at the external border (i.e. in particular on customs authorities). The AMS Regulation has added a clear obligation to carry out controls at borders (Art. 27), the power to destroy non-compliant products(Art. 29(4)) and an obligation for information exchange between market surveillance and customs (Art. 29 (5). Main obligations of the AMS Regulation may be summarized as follows:
Ø obligation to ensure the powers and resources necessary for the performance of tasks (Art. 27(1)),
Ø obligation to carry out appropriate checks on an adequate scale before the products are released for free circulation (Art. 27(1)),
Ø obligation to suspend the release of the product for free circulation in case of certain findings (Article 27(3)) for three working days and to immediately notify the market surveillance authorities thereof.
The enumerated obligations of customs authorities are complemented by corresponding obligations of market surveillance authorities:
Ø for the product presenting a serious risk - obligation to prohibit the placing on the market of the product and subsequent follow-up with the customs authorities (Art. 29(1)),
Ø for other non-complying product - obligation to take appropriate action with regard to the product (which may also include the prohibition of the placing on the market of the product) and subsequent follow-up with the customs authorities (Art. 29(2)),
Ø power to destroy or otherwise render inoperable the products presenting a serious risk (Art. 29(4)).
3.4. Exchange of information
3.4.1. RAPEX
The AMS Regulation envisages the use of a Community Rapid Information System for the exchange of information between the market surveillance authorities and the Commission on the measures for products presenting a serious risk (Art. 22). The AMS Regulation imposes a duty to immediately notify the Commission in case a Member State takes or intends to take a measure with respect to a product presenting a serious risk requiring rapid intervention and considers that the reasons which prompted the measure or the effects of the measure go beyond its territory.
In order to avoid unnecessary duplication, the system to be used for this purpose is RAPEX in line with Art. 22(4) of the AMS Regulation. RAPEX has been established in the context of the General Product Safety Directive (Dir. 2001/95/EC) for non-food consumer products presenting serious risk to the health and safety of consumers.
3.4.2. General Exchange of Information Database
The AMS Regulation also envisages a general electronic system for archiving and exchange of information, to be developed and maintained by the Commission (Art. 23). The aim of this database is to facilitate cooperation between the market surveillance authorities. The system should cover issues relating to market surveillance activities, market surveillance programmes and related information on non-compliance. The system should also reflect RAPEX notifications. The following issues should be also covered: identification of risks, results of testing carried out, provisional restrictive measures taken, contacts with the economic operators concerned. Other type of information may include communication of statistics, information on risk analysis methodologies, analysis of accidents etc.
(4) Conclusions
The AMS Regulation has started to apply as of 1 January 2010. It confers a number of rights and duties on Member States and in particular on their enforcement authorities.
The Commission services would like to invite the POP Competent Authorities to liaise with their colleagues dealing with the implementation of the AMS Regulation and their enforcement authorities (see Annex to this document) to co-ordinate actions to implement the AMS Regulation in the area of POP Regulation.
EN EN
ANNEX:
SENIOR OFFICIALS GROUP FOR STANDARDISATION AND CONFORMITY ASSESSMENT MARKET SURVEILLANCE GROUP
CONTACT POINTS
EU Member states Government Experts
Member State(protocol order) / Name / Organisation /
Austria
/ LUDWAR Gerhard / Federal Ministry of Economy, Family and Youth
Division I/14
Stubenring 1
1011 Vienna
Austria
Phone : +43 (01) 71100-8220
Fax : +43 (01) 7110093-8220
Email:
URL: http://www.bmwfj.gv.at
Belgium
/ VAN DER CRUYSSEN C. / Federal Public Service ECONOMY
Advisor – general
Koning Albert II-laan 16
B-1000 Bruxelles
Phone: +32 2 277 83 11
Fax: +32 2 277 54 39
Email:
URL: http://economie.fgov.be
Bulgaria
/ RAICHEVA Jana / Bulgarian Ministry of Economy, Energy and Tourism
Head of Department in the Technical harmonization & Consumers’policy directorate
Phone: +359 2 940 73 36
Email:
Cyprus
/ IOANNOU Antonis / Ministry of Commerce, Industry and Tourism
1421 Nicosia
Cyprus
Phone: +357 22 86 71 00
Fax: +357 22 75 41 03
Email:
Czech Republic
/ BRACH Viktor / Czech Office for Standards, Metrology and Testing
Gorazdova 24
P.O.Box 49
128 01 Praha 2
Czech Republic
Phone: +420 224 907 148
Fax: +420 224 907 152
Email:
Denmark
/ THAGAARD Maja / Danish Enterprise and Construction Authority
Erhvervs- og Byggestyrelsen
Langelinie Allé 17
DK-2100 København Ø
Phone: +45 35 46 63 97
Fax: +45 35 46 60 01
Email:
Estonia
/ KOIV Kristel / Ministry of Economic Affairs and Communications
Executive Officer
Internal Market Dapertment
Harju 11
15072 Tallinn
Estonia
Phone: +3726256474
Fax: +3726313660
Email:
URL: http://www.mkm.ee
KOMPUS Merike / Ministry of Economic Affairs and Communications
Deputy Secretary General
Harju 11
Tallinn 15072
Estonia
Phone : +372 6256 316
Email:
URL: http://www.mkm.ee
Finland
/ KERTTULA Tuiri / Safety Technology Authority
Director
P.O. Box 123
FI-00181 Helsinki, Finland
Phone: + 35810 6052643
Fax: +358 10 6052 566
Email:
URL: www.tukes.fi
LOUNEMA Tomi / Ministry of Employment and the Economy
Commercial counsellor
P.O. Box 32
FI-00023 Government, Finland
Phone: +358 10 606 2697
Fax + 358 10 604 8998
Email:
URL : www.tem.fi
VILEN Kirsti / Ministry of Employment and the Economy
Innovation Department
P.O. Box 32
FI-00023 Government, Finland
Phone: +358 10 606 4008
Email:
URL : www.tem.fi
France
/ BERGER Michel / Ministère de l'Economie, de l'Industrie et de l'Emploi
Bureau de la libre circulation des produits
Le Bervil - SQUALPI
12 rue Villiot
F-75572 Paris CEDEX 12
Phone : +33.1.53.44.97.03
Email:
LE PARCO Jean-Marc / Ministère de l'Economie, de l'Industrie et de l’Emploi
Délégué interministériel aux normes
Le Bervil - SQUALPI
12 rue Villiot
F-75572 Paris CEDEX 12
Phone: +33.1.53.44.98.26
Fax: +33.1.53.44.98.88
Email:
MISCHLER Caroline / Ministère de l'Economie, de l'Industrie et de l'Emploi
Chef du bureau de la libre circulation des produits
Le Bervil - SQUALPI
12 rue Villiot
F-75572 Paris CEDEX 12
Phone : +33.1.53.44.97.02
Email:
Germany
/ GEISS Joachim / Bundesministerium für Wirtschaft und Technologie
Villemombler Straße 76
D-53123 Bonn
GERMANY
Phone: +49 228 615 – 3556
Email:
NIEDERMEYER Hans-Georg / Bayerisches Staatsministerium für Arbeit und Sozialordnung, Familie und Frauen
Referat II 4, Technischer Verbraucherschutz, Marktaufsicht
Winzererstraße 9
D-80797 München
Phone: +49 89 1261 1768
Fax: +49 89 1261 181768
Email:
Greece
/ AKRITOPOULOS Alexandros / Ministry of Development
Quality Policy Department
Director
Messogeion av. 119
EL – 11522 Athens
Phone: +30 210 6965821
Fax: +30 210 6965829
Email:
Hungary
/ CSERTI Istvanné / Magyar Kereskedelmi Engedélyezési Hivatal (Hungarian Trade Licensing Office)
Market Surveillance Authority (on products intended for industrial use)
1024 Budapest, Margit körút 85
HUNGARY
Phone: +36 1 336 7310
Fax: +36 1 336 7446
Email:
URL: http:// www.mkeh.hu
BOLDIZS Jozsef / Ministry of Social Affairs and Labour
Deputy Head of Department