Transcript Market Surveillance: The implementation of Regulation 765/2008 in the EU Bratislava, 13 September 2011 Rita L’Abbate Unit C1: Regulatory approach for the free movement of.

Market Surveillance: The
implementation of Regulation
765/2008 in the EU
Bratislava, 13 September 2011
Rita L’Abbate
Unit 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 texts
REGULATION 765/2008
 Accreditation
 Market Surveillance
• Internal
• Imported products

General
principles
 Financing elements
DECISION 768/2008
 Definitions
 Obligations for economic
operators
 Conformity Assessment
Procedures

marking
 Notified bodies
 Safeguard mechanisms
Applicable 1 Jan 2010
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 process
• 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
on MSA (art. 17 NLF Regulation)
• 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/regulatorypolicies-common-rules-for-products/index_en.htm
National Market Surveillance Programmes
• Obligation to establish NMSP (art 18(5) NLF Regulation)
• Purpose
• 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-p92new-legislative-framework-general-national-market-surveillance-2011
•
http://www.uvzsr.sk/en/docs/info/SK_NATIONAL_MARKET_SURVEIL
LANCE_PROGRAMME_2010.pdf
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
Exchange of information tools: RAPEX
• RAPEX - 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)
Members
-- 27 MS of the EU
-- 3 EFTA/EEA
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/blankAboutIcs
ms.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/singlemarket-goods/regulatory-policies-commonrules-for-products/index_en.htm
Thank you for your attention