Mr Henk de Pauw , Eurochambres expert henk.depauw@certif.be Ankara, 18 June 2009

1. The EU Training Programmefor Turkish Chamber ExecutivesFree Movement of GoodsProduct legislation in the EU Mr Henk de Pauw, Eurochambres expert henk.depauw@certif.be Ankara, 18 June 2009 Istanbul, 19 June 2009

2. Harmonisation and standardisation for SMEs • Purpose of product regulations • Barriers to trade • Removal of non-tariff barriers to trade: The EU way • New approach directives: Principles of harmonisation and standardisation

3. Purpose of product regulations • Protection of men, animals, plants, other products, environment in general • Securing the functionality of a product • Barrier against competitive products from abroad

4. Barriers to trade • Tariff barriers • Direct tariff barriers: Duties, quotas, licences, import bans • Indirect tariff barriers: By local regulations • Non-tariff barriers • Technical barriers (TBTs): Technical product regulations • Administrative barriers: Rules for certification and marking

5. Decline of tariff barriers Weighted average of duties in % in industrial countries since 1947 (Source: WTO 1997)

6. Rise of non-tariff barriers • Rising product complexity • Ever keener competition • Increased awareness of quality and safety • User demands for proof of conformity

7. Effect of non-tariff barriers • Higher costs for manufacturer • Slower introduction to the market of new products • Smaller choice for consumers • Higher prices for consumers

8. Removal of non-tariff barriers: The EU way • Mutual recognition Principle • Cassis de Dijon-principle • Exception: public policy • Exception: Public security • Exeption: public morality • Case 121/85, Conegate Ltd v Customs and Excise Commissioners • Exception: Protection of the health and life of humans, animals and plants

9. Product legislation in the EU • Non-Harmonised • Ex. Furniture • (-)Need to find the legislation of all Member States • Harmonised • Old Approach • Ex. chemicals, medicinal products, foodstuffs • SCAD database • (+) Technical details in directive • (-) Directives underwent several changes • (ex. http://europa.eu.int/scadplus/leg/en/lvb/l21276.htm • New Approach • 20 directives • Roughly 20% of trade

10. Principles of the New Approach New Approach principles: • Legislative harmonization - only essential requirements to be met • “(c) Toys must be so designed and constructed as to minimize the risk of physical injury which could be caused by the movement of their parts.“ • Technical specifications are to be found in harmonized standards • EN 71-1 Safety of toys-Part 1: Mechanical and physical properties - Application of standards, including harmonized standards is voluntary - Essential requirements are presumed to be met if product is manufactured in compliance with harmonized standards

11. Where CE

12. Where CE - EU (not mandatory in UK, Ireland and Sweden) • EEA (EU+Lichtenstein, Norway and Iceland) • Switserland • Turkey • Croatia • Soon: Kosovo, Morocco, Albania - Future: MEDA and ENP countries

13. Principles of the Global Approach Global Approach principles: - Modules for various phases of conformity assessment procedures - CE-marking - Quality assurance (EN/ISO 9000 series standards) - Conformity Assessment bodies (EN 45000 series standards) - Setting up accreditation systems - Mutual recognition agreements for testing and certification in the non-regulatory sectors - Programs to reduce differences in the quality of testing inspection, certification, accreditation

14. Questions • Who is responsible? • Is my product covered by the directive(s)? • Does my product meet the Essential Requirements? • Do I apply Standards? • Do I need a Notified Body?

15. Actions • Draft a Technical Construction File • Gather Information • Draft a Manual • Draft a Declaration of Conformity • Apply the CE-mark • Adaptations and New Developments

16. Who is responsible Compare with Product Liability 1. The manufacturer • the person who is responsible for designing and manufacturing a product with a view of placing it on the Community market on his own behalf. • In practice: under his own name 2. Authorised Representative • If manufacturer is not established in the EU, though not mandatory 3. Importer 4. Distributor 5. Assembler and Installer 6. User (Employer)

17. Not always clear The manufacturer is any natural or legal person who is responsible for designing and manufacturing a product with a view of placing it on the Community market under his own name. Whoever is on the label Whoever retains the overallcontrol The Manufacturer

18. The manufacturer may appoint any natural or legal person to act on his behalf as an authorised representative. Authorised Representative must be established inside the Community. The Authorised Representative • The authorised representative is the contact point in the EU for the Marker Authorities • The manufacturer remains generally responsible for actions carried out by an authorised representative on his behalf.

19. Is considered as the representative of the manufacturer if there is no Authorised Representative The importer

20. Installer Has to follow the guidelines laid out by the manufacturer Repair/Service Can be held responsible for re-marking the product, if he implements major changes (increased risk) Others

21. For a large part under the jurisdiction of the Member States Cannot exercise any pre-market inspections Must be entitled to obtain access to places of manufacture or storage, to receive information, and to select a sample and take it away for examination and testing Requests need to be motivated and specific Market Surveillance Authorities

22. have the right to stop products coming in the Community from third countries, if they find products that display certain characteristics which would give rise to a serious doubt as to the existence of a serious and immediate risk to health and safety, or if they find products which are not accompanied by a document or marked in accordance with applicable rules on product safety. especially concerned with toys; as in most other cases in the New Approach products, the customer is not a consumer, but a rather more informed client. Custom officials

23. The ultimate decision: no more grey areas No technical expert Very few cases The court

24. Which products - Low voltage equipment - Simple pressure vessels - Toys - Construction products - Machinery - Personal protective equipment - Weighing instruments - Active implantable medical devices - Gas appliances

25. Which products (cont.) - Hot water boilers - Civil explosives - Medical devices - Products for potentially explosive atmospheres - Recreational craft - Lifts - Refrigeration appliances - Pressure equipment

26. Which products (cont.) - Telecommunications terminal Equipment - Electromagnetic compatibility - Noise emissions - Cableway installations - Marine equipment - High speed rail systems - Packaging and packaging waste and the list will be continued...

27. Paperwork under the NA • Technical Construction File • Manual • Declaration of Conformity

28. The Technical Construction File • Part A & B • Part A should be at hand at all times

29. The Technical Construction File: part A • First aid kit • Name(s) and adress of mft. • ID of product • Description (prospectus) • Manual • Declaration of conformity • List of standards & directives • Content of part B

30. The Technical Construction File: part B • Start with the Essential Requirement at top of page • Identify the hazards • Proof of remedy: • Application of standard • Drawings • Testresults • …

31. The Manual • From start to finish • Essential for limiting product liability • Language! • Ingredients in each directive

32. The Declaration of Conformity • Need a model: PPE • Ingredients in each directive

33. Labelling • The most visible part of CE-marking. • Name & Adress. • N° of notified body. • Others, specified per directive.

34. Mutual Recognition Agreements (MRA) • Mutual recognition agreements between the EU and third countries • conformity assessment can be performed by bodies of the partner countries, eliminating double testing and certification • mutual acceptance of conformity assessment results (testing, inspection, certification) • Partners: Australia, New Zealand, Switzerland, United States, Canada, Israel, Japan, partly not yet concluded

35. Sources of information • www.newapproach.org • CEN site, source for standards, text of directives and link to standard bodies • http://www.eotc.be/newapproach/cdrom/index.htm • Introduction to the New Approach • http://europa.eu.int/comm/enterprise/newapproach/index.htm • DG ENTR site on the NA, source for guides, such as the “Blue Guide” • http://europa.eu.int/comm/enterprise/sectors_en.htm • DG ENTR site on different industry sectors, if you want to know more about the product-specific directives. • http://ec.europa.eu/enterprise/newapproach/nando • DG ENTR database on notified bodies

36. Sources of information • www.icsms.org • Communication tool for market surveillance authorities on products to be taken off the market • http://www.emars.eu/ • Sharing of experience on market surveillance

37. Thank you… Please feel free to contact us eurochambres@eurochambres.eu Free Movement of Goods Withthesupport of the European Commission www.eurochambres.eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres.eu