Market Surveillance: The implementation of Regulation

765/2008 in the EU Bratislava, 13 September 2011

Rita L’AbbateUnit C1: Regulatory approach for the free movement of goods and market surveillance

Outline

Market surveillance: Brief recall of the NLF legal provisions General aim

State of play of implementation: MSA and NMSP Exchange of information tools Custom cooperation

New Legislative Framework

• TWO complementary instruments• Regulation 765/2008/EC - on accreditation and

market surveillance • Decision 768/2008/EC - a common framework for the

marketing of products

• Objective: Improve the functioning of the internal market in practice and protection of public interest

2 complementary legal textsREGULATION 765/2008 Accreditation Market Surveillance

• Internal• Imported products

General principles

Financing elements

Applicable 1 Jan 2010

DECISION 768/2008 Definitions Obligations for economic

operators Conformity Assessment

Procedures marking Notified bodies Safeguard mechanisms

Basis for future legislation

Market surveillance: scope of Reg.765

FOR WHICH PRODUCTS? All products covered by Community

harmonisation legislation… ‘Product’ means: substance, preparation or good

produced through a manufacturing process

… unless specific provisions already exist (Lex specialis principle)

Excluded: food, feed, living plants and animals, products of human origin…

Market surveillance: general aim

GENERAL PRINCIPLES General obligation to act against:

Products liable to compromise health and safety or Which otherwise do not conform to EU harmonisation

legislation

This means: Duty to perform checks of products (documentary, physical,

laboratory checks, as appropriate) on an adequate scale Cooperation with economic operators Adoption of measures restricting availability of products on

the market (e.g. withdrawals or recalls of products) Information of public, Commission and other MS

NLF Regulation: Implementation phase

• Complex processComplex process

• Many parties involved:Many parties involved:• Commission (DGs ENTR, SANCO,

TAXUD)• Member States (both sectoral and

coordination levels – customs authorities)

National Market Surveillance Authorities

• Obligation to communicate information Obligation to communicate information on MSA on MSA (art. 17 NLF Regulation)(art. 17 NLF Regulation)

• State of play: State of play: Commission has received communications from all Member States

• Information can be found on Commission website http://ec.europa.eu/enterprise/policies/single-market-goods/regulatory-policies-common-rules-for-products/index_en.htm

National Market Surveillance Programmes

• Obligation to establish NMSP Obligation to establish NMSP (art 18(5) NLF Regulation)(art 18(5) NLF Regulation)

• PurposePurpose• State of play: all MS submitted NMSP in 2010-2011. State of play: all MS submitted NMSP in 2010-2011.

The majority have published them on the national WEB sites

• Examples:• http://www.bis.gov.uk/assets/biscore/business-sectors/docs/n/10-p92-

new-legislative-framework-general-national-market-surveillance-2011• http://www.uvzsr.sk/en/docs/info/http://www.uvzsr.sk/en/docs/info/

SK_NATIONAL_MARKET_SURVEILLANCE_PROGRAMME_2010.pSK_NATIONAL_MARKET_SURVEILLANCE_PROGRAMME_2010.pdfdf

National Market Surveillance Programmes

• EU methodology for the establishment of NMSPs Elements of a general and sector specific NMSP Template common indicators

• What next : ensure NMSP are comparable and

comprehensive homogeneity, translations, publication on the

Commission WEB

Microsoft Word Document

Adobe Acrobat Document

Exchange of information tools: RAPEX

• RAPEXRAPEX - - Rapid Alert System for products presenting a serious risk

• NLF Regulation (Article 22) extends RAPEX to: Consumer and Professional goods All risks including those others than health and

safety Restrictive Measures (obligatory, voluntary)

-- 27 MS of the EU-- 3 EFTA/EEA

Members

Exchange of information tools: RAPEX

• Notification criteria• Industrial products for consumers and

professionals• Serious risk• Restrictive measures adopted by MS or

economic operator concerned

Exchange of information tools: RAPEX MAIN ELEMENTS:• RAPEX Guidelines• RAPEX Contact Points

Network at the EU level• RAPEX networks at the

MS level• RAPEX Contact Points

Working Group• Online application ‘REIS’• Commission RAPEX Team• RAPEX website

(www.ec.europa.eu/RAPEX)• RAPEX paper and electronic

publications• Seminars

Exchange of information tools: RAPEX Current main activities:

• Operation of RAPEX in relation to the Regulation needs Adaptation of IT platform

• Common basis for the assessment of risks for products Task Force is working to review the RAPEX risk

assessment method

Exchange of information tools: RAPEX

• RAPEX notifications in 2010

• Around 2000 notifications • Increase of 13% in relation to 2009• Not only quantitative improvement, but

notably qualitative

Exchange of information tools: RAPEX

• RAPEX notifications in 2010• Main notifying Member States: Germany,

Bulgaria, Hungary, Cyprus, Greece, … • Main product categories notified : clothing,

toys, motor vehicles, electrical appliances, childcare articles, …

• Main risk categories notified: injuries, chemical, strangulation choking, electrical shocks, …

Exchange of information tools: RAPEX • RAPEX notifications

• Member States must check all the notifications:

• No reaction = acceptance of the notified national restrictive measure

• Reaction = either disagreement or additional information or product not found on the market

• Reactions in 2010 - main products: motor vehicles, toys, childcare, electrical appliances, clothing,…

Exchange of information tools: RAPEX

• RAPEX Notifications in 2010• Business notifications

• 133 of the 2010 notifications received had a business origin

• All Member States have received business notifications

• Main notifying countries: FR, NL, ES, DE, BE• Main product categories notified: electrical

appliances, motor vehicles, toys, childcare, …

Exchange of information tools: RAPEX

‘new’ types of notifications (2010-2011)Goods for Professional use : Machineries for use in workplace,

Equipment for use in potentially explosive atmospheres, Motor vehicles, Chemical products: fertilisers infringing Reg 2003/2003

Risks others than health and safety (e.g. environmental risk): Plastic products and plastic packages of various consumer products containing cadmium (REACH Regulation), Fireworks infringing Reg 850/2004 (persistent organic pollutants)

Exchange of information tools: RAPEX

• INTERNATIONAL dimension • MED-RAS project - started in 2009 –

establishment in the Mediterranean region of a rapid alert system similar to RAPEX (in operation in 2012)

• RAPEX-China system – started in 2006 – informs Chinese on RAPEX notified products of Chinese origin – Reports on enforcement actions carried out

• United States–cooperation with CPSC– strengthen exchange of information, formalise the ongoing dialogue

• Japan, ICPSC, OECD, …

Exchange of information tools: ICSMS• A general market surveillance database

(Article 23 of NLF Regulation) information on general issues relating to market

surveillance information on products presenting a risk,

identification of risks, test results, provisional measures, contacts with economic operators

• State of play Discussions with ICSMS board https://www.icsms.org/icsms/App/

blankAboutIcsms.jsp?threadId=21948&callId=14&winId=1

Control of imported products• Obligation of border controls on an adequate

scale before release for free circulation (Articles 27 to 29 of NLF Regulation)

customs must suspend release for free circulation they must inform Market Surveillance Authorities

(MSA) MSA can prohibit marketing if products dangerous

• Apply to all products covered by EU legislation

• Cooperation with customs is a key factor

Control of imported products

Implementation:• General Guidelines elaborated

Support to customs and MSA Examples of practical guidance

• WG, events, further developments,..

Further information?

New internal market package:http://ec.europa.eu/enterprise/policies/single-

market-goods/regulatory-policies-common-rules-for-products/index_en.htm

Thank you for your attention