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General safety requirements EU Overview Product safety training for buyers and sourcing professionals Shanghai, Guangzhou and Shunde August-September 2014. Katleen HENDRIX European Commission, Directorate-General Enterprise and Industry Internal Market and its International Dimension.
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General safety requirementsEU OverviewProduct safety training for buyers and sourcing professionalsShanghai, Guangzhou and ShundeAugust-September 2014 Katleen HENDRIX European Commission, Directorate-General Enterprise and Industry Internal Market and its International Dimension
The European Union (EU) • 28 Member States withdifferentlanguages and different state structures • Some have been Members since the very beginning in 1958; e.g. Belgium or the Netherlands • Others joined more recently: Bulgaria and Romania in 2007, Croatia in 2013 • Common institutions • EU Internalmarketguidingprinciples: • Effective marketaccess to the whole EU market, while • Achieving a high level ofhealth, safety, environmental and consumer protection
The European Commission • One of the EU's institutions • "Government" of the EU • Responsibilities include: • Promoting the general interest of the EU • Make proposals for legislation • Adopt implementing legislation, if empowered to do so • EnsurethatMember States complywiththeir obligations • Co-ordinateco-operationbetweenMember States; RAPEX • Responsiblities do notinclude: • Market surveillance • Enforcement of rulesagainstmarketoperators(exceptundercompetitionlaw)
Who does market surveillance in the EU?Core principles • The 28 EU Member States • Each in itsownterritory and at itsownborders / points of import • Objectives: • Ensure that only compliant products are on the market = equal level of protection of consumers and users across the EU • Guarantee a level playing field for economic operators • Both for productsinside the EU and for productsentering the EU • In co-operationwithcustoms autorities
Which EU consumer product rules do EU Member States enforce? • Harmonised EU rules • Sectorial legislation lays down essential safety requirements or comprehensive rules for a wide range of products • E.g.: toys, low voltage electrical products, chemicals, cosmetics, gas appliances, machinery, pressure equipment, pyrotechnic articles, etc. • Essential safety requirements supplemented by harmonised standards
Which EU consumer product rules do EU Member States enforce? (continued) • Non-harmonised EU rules • General safety requirement in the General Product Safety Directive 2001/95/EC: "products placed on the EU market must be safe" • E.g.: clothing, childcare articles, floating leisure articles, etc. • Products complying with harmonised standards presumed safe
Market surveillanceWhat do Member States do concretely? • Pro-actively control products placed on the market or imported • Prevent placing on the market and use of non-compliant and/or unsafe products • Approach based on risk, frequent non-compliance, particular interest • Compliance includes respect of necessary procedures, marking and documentation requirements! • At different times during life-cycle => at different locations • Also checks during import control process
Market surveillance (continued)What do Member States do concretely? • During import control process: • Customs can suspend release if suspicion of serious risk to health & safety, documentation or marking requirements not fulfilled, CE marking affixed in false or misleading manner • If release suspended, market surveillance authority has 3 working days to make preliminary investigation of the products and decide to release or further detain for further checks • If product presents serious and immediate risk: prohibit • If product is non-compliant: take appropriate measures (poss. prohibit) • Can require EC Declaration of Conformity from manufacturer or importer upon reasoned request • Can require technical documentation from manufacturer upon reasoned request; importer to ensure it's available • Member State language requirements for documents!
Market surveillance (continued)What do Member States do concretely? • Duty of market operators to co-operate, procedural rights • If product liable to affect health or safety of persons, market surveillance authorities must ask economic operators to: • Take corrective action (bring product into compliance) • Withdraw the product • Recall the product • Stop or restrict supply of the product • In case of serious risk needing rapid intervention, authorities can take restrictive action without waiting for economic operator to act • Measures must be proportionate
Co-operation and exchange of information between EU Member States • RAPEX: Rapid Alert System for non-food products (see further below) • Administrative Co-operation ("ADCO") groups active for many pieces of sectorial legislation • Joint Actions co-funded by the European Commission: practical co-operation of several Member State market surveillance authorities on selected products • JA 2013 (2014-2016) includes toys, kick scooters, chemical risks of clothing
RAPEX Aim of RAPEX Rapid information exchange between EU Member States and the European Commission about … • measures taken by national authorities … • against products which present a serious risk for … • public interests (health, safety, environment, etc.)
RAPEX (continued) RAPEX participants 31 European countries • 28 EU Member States • 3 EFTA-EEA countries: Iceland, Liechtenstein, Norway • 1 National Contact Point per country
How does the RAPEX system work? National authority takes risk management measures against a product -> National Contact Point -> European Commission -> all other National Contact Points If serious risk: All other National Contact Points -> to check whether the product is present on their markets -> to take appropriate risk management measures -> to report such measures to RAPEX
RAPEX report for 2013 Total number of notifications: 10-year trend 2003-2013 http://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/reports/index_en.htm
RAPEX report for 2013 (continued) Top five notified product categories in 2013, compared to 2012 (% of total notifications)
RAPEX report for 2013 (continued) Notifications by country of origin of the notified product(% of total notifications)
RAPEX report for 2013 (continued) Top five notified types of risk in 2013, compared to 2012 (% of total notifications)
RAPEX – Just some illustrative "statistics" First quarter of 2014 – informal check: 1) Toys: • Phthalates68 notifications • Small parts 47 notifications (incl. 5 suctioncups) • Buttoncells15 (some double counting w/ above) • Microbiologicalrisk 5 notifications 2) Electricalappliances: • Electric shock / burns69 notifications 3) Clothing: • Cords and drawstrings 56 notifications • Swallowingrisk buttons 6 notifications • Chemicalrisks 4 notifications
RAPEX-China system • AQSIQ receives all details about RAPEX notifications where the productoriginatesfrom China • AQSIQ and CIQsfollow up on these notifications • Stop export • Strengthened supervision • Corrective actions • Other
More information "Blue Guide" on the implementation of EU product rules • http://ec.europa.eu/enterprise/policies/single-market-goods/documents/internal-market-for-products/new-legislative-framework/index_en.htm Market Surveillance homepage • http://ec.europa.eu/enterprise/policies/single-market-goods/internal-market-for-products/market-surveillance/index_en.htm RAPEX homepage • http://ec.europa.eu/consumers/consumers_safety/safety_products/index_en.htm Joint Actions • http://www.prosafe.org/default25d6.html?itemid=197
Thank you for your attention! Any Questions?