Training on standardisation

Support to the Modernisation of the Mongolia’s Standardisation System (SMMSS) Training on standardisation THE NEW APPROACH TO EU TECHNICAL HARMONIZATION

Reasons for the New Approach • Old Approach Directives: • Take a very long time to negotiate because they are full of technical detail • Get out of date quickly because science & technology always develop rapidly and the Directives need frequent amendment • Are comparatively narrow in scope because of the need to include the technical specifications in the legislation – one needs hundreds of them to achieve worthwhile harmonization. • They are therefore not a very effective basis for harmonization across the EU Internal Market

The New Approach and the Global Approach • As said in the introduction: • The New Approach Resolution of 1985 and • The Global Approach Resolution of 1989 • between them have established a basis for a much more efficient approach to harmonization based on a legislation with a system of Essential Requirements for public protection and the means to assess whether they are being conformed with. In a separate presentation we will look at Conformity Assessment.

The four main New Approach principles – 1 and 2 • There are four principles that act as the basis for New Approach legislation. • In the legislation itself, principles for public protection – health, safety, certain environmental requirements, public (consumer) protection - should be expressed as goal-setting Essential Requirements not the technical specifications for achieving them. • Technical Specifications should, instead, be included in harmonized Standards produced by the three European Standards organizations (ESO) under Mandates (contracts) from the European Commission to produce Standards in support of EU product Directives or Regulations.

The four main New Approach Principles – 3 and 4 • 3. The use of those Standards by manufacturers is voluntary but: • once the standards have been accepted by the Commission and their titles have been published in the Official Journal of the EU and the standards have been published by at least one national standards body in the EU: • 4. Products made in accordance with those standards gain the Presumption of Conformity with the Essential Requirements (ERs of the relevant legislation – at least to the extent that the Standards cover those ERs.

Commentary • There will be more later about this but a few comments to note here: • The use of standards is voluntary but it is the most straight forward way to comply with the Essential Requirements of product Directives • If manufacturers wish to use their own distinctive non-Standard or non-EU standard way of manufacturing, that does not make the product non-compliant with the Directives but: • They may need to demonstrate to the EU Market Surveillance Authorities how they have achieved compliance • It may – depending on the conformity assessment provisions of the Directive – limit their choices of conformity assessment procedure

Key Component of a New Approach Directive - 1 • There will be Recitals explaining the purpose of the legislation and helping to interpret the Articles and Annexes that follow them. • The Articles and Annexes are binding on those to whom they are addressed. Member States must turn the relevant ones into national law so that they become binding on Economic Operators – manufacturers, their authorised representatives, importers, distributors – and upon other such as Notified Bodies and Market Surveillance Authorities

Key Components of a New Approach Directive - 2 • The Directive will lay down the scope of the products covers and have key definitions • It will lay down a fundamental requirement to trade only in compliant products • It will confer a right to the free circulation of compliant products throughout the EU • It will specify the need for a Declaration of Conformity – a document in which information about the product, the manufacturer and other key matters is contained

Key Components of a New Approach Directive - 3 • It will specify the need for the product to be accompanied by satisfactory instructions for users including provisions on the languages in which those instructions are to be written • It will specify that the product or its packaging needs to bear the CE marking • It will stipulate the need for a manufacturer to keep a technical file for a specified period of time (often for 10 years after the last individual product of that type is placed on the market in the EU)

Key Components of a New Approach Directive - 4 • It will stipulate the Essential Requirements of the legislation • It will stipulate the choice of Conformity Assessment Procedures for that legislation • There will probably be provisions on the appointment of Notified Bodies to administer those conformity assessment provisions

Some commentary – CE marking

CE marking (continued) • The CE marking is the manufacturer’s claim that his product complies with all the Directives (CE marking/ New Approach Directives) that apply to his product • CE-marked products should be allowed free circulation in the EU Internal Market unless Market Surveillance Authorities have good reason to believe that the product is, in fact, non-compliant. • Depending on the precise terms of the applicable legislation, the CE marking must be applied to the product or its packaging • It is NOT a Quality Mark – it is a manufacturer’s claim to compliance

Commentary on the Technical File - 1 • What is a Technical File/ Technical Construction file? • It is the sum total of all the information that a manufacturer needs to demonstrate that his product meets all applicable Essential health, Safety and other Requirements of the applicable legislation • What is it for? • It does not circulate with the product but is kept should the Market Surveillance Authorities need to see it or part of it for some reasonable purpose, e.g. if the product has been involved in an accident

The Technical File - 2 • If product is being exported to the EU from elsewhere, the importer in the EU must have reliable arrangements with the non-EU manufacturer to ensure that information from the Technical File can be made available to the competent authorities in the EU – and made available promptly

Some commentary on Essential Requirements • Essential Health Safety or other (e.g. Environmental) Requirements are usually contained in an Annex to the Directive. How are they laid out? Let us take the Machinery Directive 2006/42/EC (as amended) as an example

Machinery Directive • Its Annex 1 on Essential Health and Safety Requirements (EHSRs) has six main parts • General principles (i.e. ones applicable to all machines) • Supplementary EHSRs for certain categories of Machinery • Supplementary EHSRs to offset hazards due to the mobility of Machinery • Supplementary EHSRs to offset hazards due to lifting operations • Supplementary EHSRs to offset hazards due for machinery intended for underground work • Supplementary EHSRs to offset hazards due to the lifting of persons

Support to the Modernisation of the Mongolian Standardisation System (SMMSS) Thank you for your kind attention Richard Lawson richardandrosemary@btinternet.com This project is supported by the European Union

Training on standardisation