Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) The EU Training Programme for Turkish Chamber Executives Free Movement of Goods Product legislation in the EU Mr Henk de Pauw, Eurochambres expert Ankara, 18 June 2009 Istanbul, 19 June 2009

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) 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

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) Protection of men, animals, plants, other products, environment in general Securing the functionality of a product Barrier against competitive products from abroad Purpose of product regulations

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) 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 Barriers to trade

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) Weighted average of duties in % in industrial countries since 1947 (Source: WTO 1997) Decline of tariff barriers

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) Rising product complexity Ever keener competition Increased awareness of quality and safety User demands for proof of conformity Rise of non-tariff barriers

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) Higher costs for manufacturer Slower introduction to the market of new products Smaller choice for consumers Higher prices for consumers Effect of non-tariff barriers

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) 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 Removal of non-tariff barriers: The EU way

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) 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. –New Approach 20 directives Roughly 20% of trade

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) 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

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) Where CE

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) 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

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) 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 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

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) Questions 1.Who is responsible? 2.Is my product covered by the directive(s)? 3.Does my product meet the Essential Requirements? 4.Do I apply Standards? 5.Do I need a Notified Body?

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) Actions 1.Draft a Technical Construction File 2.Gather Information 3.Draft a Manual 4.Draft a Declaration of Conformity 5.Apply the CE-mark 6.Adaptations and New Developments

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) 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)

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) 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 overall control The Manufacturer

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) 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.

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) Is considered as the representative of the manufacturer if there is no Authorised Representative The importer

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) 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

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) 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

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) 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

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) The ultimate decision: no more grey areas No technical expert Very few cases The court

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) Which products -Low voltage equipment -Simple pressure vessels -Toys -Construction products -Machinery -Personal protective equipment -Weighing instruments -Active implantable medical devices -Gas appliances

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) Which products (cont.) -Hot water boilers -Civil explosives -Medical devices -Products for potentially explosive atmospheres -Recreational craft -Lifts -Refrigeration appliances -Pressure equipment

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) 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...

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) Paperwork under the NA Technical Construction File Manual Declaration of Conformity

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) The Technical Construction File Part A & B Part A should be at hand at all times

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) 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

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) 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 –…–…

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) The Manual From start to finish Essential for limiting product liability Language! Ingredients in each directive

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) The Declaration of Conformity Need a model: PPE Ingredients in each directive

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) Labelling The most visible part of CE-marking. Name & Adress. N° of notified body. Others, specified per directive.

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) 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

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) Sources of information –CEN site, source for standards, text of directives and link to standard bodies –Introduction to the New Approach dex.htm –DG ENTR site on the NA, source for guides, such as the “Blue Guide” –DG ENTR site on different industry sectors, if you want to know more about the product-specific directives. –DG ENTR database on notified bodies

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) Sources of information –Communication tool for market surveillance authorities on products to be taken off the market –Sharing of experience on market surveillance

Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0) Thank you… Please feel free to contact us Free Movement of Goods With the support of the European Commission Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium Tel: +32 (0) Fax +32 (0)