The EU's Global Approach Robin Croft organised in co-operation with - - PowerPoint PPT Presentation

The EU's Global Approach

Robin Croft

• rganised in co-operation with

TAIEX

Introduction

A general overview of the Quality Framework in the EU internal market, including:

• EC Directives & Regulations
• Harmonised standards
• Accreditation and Notification
• Conformity Assessment Procedures

2

3

Interest in EU Conformity Assessment

• Compulsory for ALL new member states
• Requires harmonisation with EU Acquis
• Necessary for:
• Partnership & Co-operation Agreements
• Association Agreements
• Deep and Comprehensive Fair Trade Agreements
• Requires approximation of the EU Acquis
• Gives access to the Single Market

The Single Market

4 Free movement of persons

 No border control  Harmonisation of legislation  Free establishment and choice

• f working place

 Stronger control of EU borders

Free Movement of Services

 Liberalisation of financial services  Harmonisation of surveillance of banks and insurers  Opening of transport and telecommunications markets

Free Movement of Goods

• No border control
• Harmonisation and mutual

recognition of standards and legislation

• Tax harmonisation

Free Movement of Capital

 More free movement for money and capital  Steps towards a common markets for financial services  Liberalisation of the movement of bonds

EUROPEAN INTERNAL MARKET

Conformity Assessment – The context

• Product Safety rules cover not only rules made to prevent

accident, but also those designed to protect health, the environment and the consumer more generally.

• In the WTO, Product Safety rules and regulations are covered

by the Technical Barriers to Trade (TBT) Agreement.

• Therefore, it is an area where rules can have wide ranging

consequences for trade and trade negotiations

5

6

EU ACQUIS Approximation

• To replace a former “control system” with an EU

compatible system requires:

• Approximation of EU Directives, implemented through

the adoption of European Standards with enforcement through Market Surveillance.

• Alignment of technical regulations, standards and

systems for conformity assessment with those of the EU and a Quality Infrastructure to implement EU new and global approach directives.

Essential Elements of the EU Approach

7 Harmonised Standards

Presumption of conformity

EC Directives

Essential requirements

Conformity Assessment Procedures CE Marking Declaration of Conformity Accreditation Notification International Co-operation Quality Assurance Product Liability MARKET SURVEILLANCE

Horizontal and vertical regulations & directives

General Product Safety Directive (2001/95/EC) Directive liability defective products (85/374/EEC) Framework for the marketing of products (D - 768/2008) Standardization (1025/2012) + Information procedure (98/34/EC) New Approach Directives Optional (“old”) Approach Directives Horizontal Legislation Vertical Legislation Vertical Legislation Global Approach Accreditation and Market Surveillance (R - 765/2008)

Products lawfully marketed in another Member State (764/2008)

Liability for defective products (85/374/EEC) Safety of products (2001/95/EC General product safety) Non regulated area Regulated area Technical regulations (DECISION No 768/2008/EC on a common framework for the marketing of products) Old Approach Directives New Approach Directives Conformity Assessment REGULATION No 765/2008 setting out the requirements for accreditation National laws

The Old Approach

• Traditional approach to product legislation detailed

regulations containing all the necessary technical and administrative requirements for each type of product.

• This reflected the existing national approach to product

legislation.

• This approach is still employed for foodstuffs, biocides,

motor vehicles, chemicals, cosmetics, detergents and pharmaceutical products.

10

Old Approach in practice

11

The New Approach

• Launched in 1985 through Council Decision 85/C 136/01
• Built upon a combination of EU Directives or Regulations
• General safety objectives for a broad sector or family of

products, or type of hazard

• Detailed harmonised standards developed by the European

standards organisations, CEN, CENELEC and ETSI

• Published in the EC Official Journal and transposed without

change into the national standards.

12

Principle of “essential requirements”

• Manufacturer is not actually obliged to meet the

published European standards

• MUST meet the ‘essential requirements ’ set in the

relevant Directive or Regulation.

• But if the product conforms to harmonised standards,

then there is a presumption of conformity that the product conforms with the essential requirements

• Choice is the prerogative of the manufacturer

13

14

EU Quality Framework for Product Safety

Internal QC should guarantee safety

Assists manufacturer to design and produce safe products Protects both consumers & traders

SAFE PRODUCTS

PRINCIPLES: Manufacturers and importers are solely responsible for the safety of their products. Some products do need to be checked by a conformity assessment body – notified body BUT some specific products – toys & electrical products DO NOT need any 3rd party product certification

Manufacturer Consumers

Conformity Assessment Body Market Surveillance Authority

15

Design Production Sale, use, “in service”, end of life Technical and legal requirements Economic Operators MARKET

16 Horizontal Directives Standards (EN) Standards (EN) PRODUCT Regulator / Government Standards body Manufacturers or Importers Conformity Assessment

Supply Chain

Placed on the market

Market Surveillance Authorities

In Use

Consumers

Manufactures/Importers Product Directives Essential requirements Standards (EN)

Conformity Assessment + Risk Assessment *Customs control (if imported) Continuing Conformity Assessment Compliance Assessment + Risk Assessment

Producer Before Market After Placing

• n the

Market Producer

Importer Distributor Customs Authorities Market Surveillance Authorities

EU philosophy: Responsibilities

“Ex Ante” “Ex Post”