General safety requirementsEU Overview

Product safety training for buyers and sourcing professionals

Shanghai, 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 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

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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)

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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

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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

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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

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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

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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! 8

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

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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

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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.)

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RAPEX (continued)

RAPEX participants

31 European countries• 28 EU Member States• 3 EFTA-EEA countries: Iceland, Liechtenstein, Norway• 1 National Contact Point per country

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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 13

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

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RAPEX report for 2013 (continued)

Top five notified product categories in 2013, compared to 2012 (% of total notifications)

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RAPEX report for 2013 (continued)

Notifications by country of origin of the notified product(% of total notifications)

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RAPEX report for 2013 (continued)

Top five notified types of risk in 2013, compared to 2012 (% of total notifications)

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RAPEX search function and weekly reports

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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 19

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

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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.htmMarket 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

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Thank you for your attention!

Any Questions?

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