The EU Training Programme for Turkish Chamber Executives Free Movement of Goods Product legislation in the EU Mr Henk de Pauw, Eurochambres expert henk. depauw@certif. be Ankara, 18 June 2009 Istanbul, 19 June 2009 www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
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 www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
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 www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
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 www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
Decline of tariff barriers Weighted average of duties in % in industrial countries since 1947 (Source: WTO 1997) www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
Rise of non-tariff barriers • Rising product complexity • Ever keener competition • Increased awareness of quality and safety • User demands for proof of conformity www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
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 www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
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 www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
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/l 21276. htm – New Approach • 20 directives • Roughly 20% of trade www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
Principles of the 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 www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
Where CE www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
Where CE - EU (not mandatory in UK, Ireland Sweden) - EEA (EU+Lichtenstein, Norway and Iceland) - Switserland - Turkey - Croatia - Soon: Kosovo, Morocco, Albania - Future: MEDA and ENP countries www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
Principles of the 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 www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
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? www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
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 www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
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) www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
The Manufacturer • 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 www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
The Authorised Representative • 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 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. www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
The importer • Is considered as the representative of the manufacturer if there is no Authorised Representative www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
Others • 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) www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
Market Surveillance Authorities • 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 www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
Custom officials • 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. www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
The court • The ultimate decision: no more grey areas • No technical expert • Very few cases www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
Which products - Low voltage equipment - Simple pressure vessels - Toys - Construction products - Machinery - Personal protective equipment - Weighing instruments - Active implantable medical devices - Gas appliances www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
Which products (cont. ) - Hot water boilers - Civil explosives - Medical devices - Products for potentially explosive atmospheres - Recreational craft - Lifts - Refrigeration appliances - Pressure equipment www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
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. . . www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
Paperwork under the NA • Technical Construction File • Manual • Declaration of Conformity www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
The Technical Construction File • Part A & B • Part A should be at hand at all times www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
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 www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
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 –… www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
The Manual • From start to finish • Essential for limiting product liability • Language! • Ingredients in each directive www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
The Declaration of Conformity • Need a model: PPE • Ingredients in each directive www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
Labelling • The most visible part of CE-marking. • Name & Adress. • N° of notified body. • Others, specified per directive. www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
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 www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
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/in dex. 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 www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
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 www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
Thank you… Please feel free to contact us eurochambres@eurochambres. eu Free Movement of Goods With the support of the European Commission www. eurochambres. eu Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: eurochambres@eurochambres. eu
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