1. 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

2. 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

3. 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)

4. 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

5. 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

6. 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

7. 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

8. 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!

9. 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

10. 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 ( ) includes toys, kick scooters, chemical risks of clothing

11. 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.)

12. RAPEX (continued) RAPEX participants 31 European countries
28 EU Member States
3 EFTA-EEA countries: Iceland, Liechtenstein, Norway
1 National Contact Point per country

13. 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

14. RAPEX report for 2013
Total number of notifications: 10-year trend

15. RAPEX report for 2013 (continued)
Top five notified product categories in 2013, compared to 2012 (% of total notifications)

16. RAPEX report for 2013 (continued)
Notifications by country of origin of the notified product (% of total notifications)

17. RAPEX report for 2013 (continued)
Top five notified types of risk in 2013, compared to 2012 (% of total notifications)

18. RAPEX search function and weekly reports

19. 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

20. 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

21. More information
"Blue Guide" on the implementation of EU product rules
Market Surveillance homepage
RAPEX homepage
Joint Actions

22. Thank you for your attention!
Any Questions?