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

The European Union (EU) 28 Member States with different languages 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 Internal market guiding principles: Effective market access to the whole EU market, while Achieving a high level of health, 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 Ensure that Member States comply with their obligations Co-ordinate co-operation between Member States; RAPEX Responsiblities do not include: Market surveillance Enforcement of rules against market operators (except under competition law)

Who does market surveillance in the EU? Core principles The 28 EU Member States Each in its own territory and at its own borders / 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 products inside the EU and for products entering the EU In co-operation with customs 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 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 surveillance What 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 search function and weekly reports

RAPEX – Just some illustrative "statistics" First quarter of 2014 – informal check: 1) Toys: Phthalates 68 notifications Small parts 47 notifications (incl. 5 suction cups) Button cells 15 (some double counting w/ above) Microbiological risk 5 notifications 2) Electrical appliances: Electric shock / burns 69 notifications 3) Clothing: Cords and drawstrings 56 notifications Swallowing risk buttons 6 notifications Chemical risks 4 notifications

AQSIQ and CIQs follow up on these notifications RAPEX-China system AQSIQ receives all details about RAPEX notifications where the product originates from China AQSIQ and CIQs follow 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?