European Commission

REGULATORY MODEL OFTHE

EUROPEAN UNION

Norbert ANSELMANN(norbert.anselmann@cec.eu.int)

Head of Unit, ENTR G2, Standardisation

Directorate General EnterpriseEuropean Commission

REGULATORY MODEL OF THE EUREGULATORY MODEL OF THE EU

To remove technical barriers to internal EU trade deriving from divergent national technical regulations, standards,tests and certification/approval procedures

Solutions to ensure free movement of goodsSolutions to ensure free movement of goods :

- mutual recognition- EU-wide technical harmonisation

ObjectiveObjective

COUNCIL RESOLUTION OF MAY 1985 LAYING DOWN THE NEW APPROACH CONCEPT ON TECHNICAL HARMONISATION AND STANDARDISATION

REGULATORY MODEL OF THE EUREGULATORY MODEL OF THE EU

DRIVING FORCESDRIVING FORCES

* Jurisprudence “Cassis de Dijon” : any product legally manufactured and placed on the market in one Member State shall in principle be accepted also in the other Member States, unless the country of destination can claim the existence of imperative imperative requirements requirements to be complied with for reasons of

public health, safety, consumer protection, …

* Legislative harmonisation of detailed technical legal requirements on product safety proved not to be successfully in major product

areas.

DRIVING FORCESDRIVING FORCES

* European legislation on safety of electrical equipment – the so-called Low Voltage Directive (73/23/EEC) – making general

reference to standards appeared to be a more appropriate solution.

* Favourable political framework conditions and commitments : Internal Market programme ‘92.

* Commitment of stakeholders.

TECHNICAL HARMONISATIONTECHNICAL HARMONISATION

* SOLUTION = EU-DIRECTIVES

= adopted by the EU legislator= transposed and implemented by Member

States

* In given sectors (e.g. automotive, pharmaceutical, food safety) other solutions than the New Approach concept have been applied

NEW APPROACHNEW APPROACH

CONTENT OF THE DIRECTIVES

* Definition of the scope,

* Essential requirements aiming at ensuring protection of public interests(health, safety, consumer protection, …)

* Reference to harmonised standards

* Conformity assessment procedures, affixing of the CE marking

* Market surveillance

* EU-wide mechanisms to ensure uniform application throughout EU

THE NEW APPROACHTHE NEW APPROACH

* First “New Approach” Directive in 1987* Since then more than 22 products or risks areas

have been covered by specific directives, including:= Machines, Lifts, Pressure equipment, Pleasure boats

= Medical Devices, in vitro diagnostic equipment

= Personal Protection Equipment, Toys, RTT equipment, measurement equipment

= Gas appliances, Low Voltage Equipment, construction products

* New proposal

=Eco-design of energy using equipment (proposal)

THE NEW APPROACHTHE NEW APPROACH

• Harmonised European standards give a presumption of conformity with essential requirements

… but remain voluntary!

* European standardisation Bodies CEN / CENELEC / ETSI elaborate European Standards on the basis of requests “mandates” from the Commission; international standards should be transposed uniformingly at European level, wherever they are in line with relevant directives

STANDARDS ARE VOLUNTARY …

and standardisation is independentand standardisation is independent

• Standards are not defined by public authorities• Standards are adopted by a transparent consensus

procedure• The standardisation bodies cover a very broad

range of interests including industry, users, certifiers, consumer and environmental NGOs

• Publication of references of harmonised standards in the Official Journal of the EC

NEW APPROACHNEW APPROACHCONFORMITY ASSESSMENTCONFORMITY ASSESSMENT

Manufacturer is responsible to establish conformity with the requirements of the Directive :– Shall use defined procedures (“modules”)– Must in many modules be aided by independent

certification bodies (“Notified bodies”)– Is free to choose, where required, any suitable Notified

body designated by national authorities for the directive in question.

• The New Approach establishes eight basic conformity assessment modules to cover different risk-related situations

• Each Directive specifies which modules can be used

• There are modules for both the product’s design and production phase

• Most modules require use of Notified Bodies

CONFORMITY ASSESSMENT - MODULESCONFORMITY ASSESSMENT - MODULES

A Internal control of production (design&production)B EC type examination (design) (notified body)C Conformity to type (production)D Production quality assurance (prod.) (notified body)E Product quality assurance (production) (notified body) F Product verification (production) (notified body)G Unit verification (design&production) (notified body)H Full quality assurance (design&prod.) (notified body)

… … THE BASIC MODULESTHE BASIC MODULES

NOTIFIED BODIES’ RESPONSIBILITIESNOTIFIED BODIES’ RESPONSIBILITIES

* Provide conformity assessment services on the conditions set out in Directives

* Operate impartially, independent of clients * Provide relevant information to notifying

authority, market surveillance authorities, other notified bodies

* Ensure confidentiality of information as necessary* Take part in European standardisation information

exchange

CE MARKINGCE MARKING

Affixed by manufacturer on his own responsibility meaning that:

– the product meets the legal requirements– the manufacturer has carried out the necessary conformity

assessment (industry involvement of a Notified Body, where required)

CE-marked products shall be allowed to circulate freely throughout the European Economic Area without any further additional national approval with regard to aspects covered by the relevant Directive(s)

TECHNICAL FILE (TECHNICAL TECHNICAL FILE (TECHNICAL DOCUMENTATION)DOCUMENTATION)

• Prepared by manufacturer

• Kept by him

• Provides information on the design, manufacture and operation of the product and on the compliance with the requirements defined in the relevant directive

• Must be available to authorities on request

… … MARKET SURVEILLANCEMARKET SURVEILLANCE

• Market surveillance is a national responsibility and national responsibility and obligationobligation

• It is carried out by government officialscarried out by government officials in the market place

• Directives provide for EU-wide procedures and information exchange in cases where the CE-marking has been unduly affixed

• RAPEX communication systemRAPEX communication system between the Commission and Member States

DEVELOPMENT …DEVELOPMENT …

• The New Approach is working properly and has proven to be successful

• Improvements and expansions take place

Commission’s Communication on enhancing the Implementation of the New Approach COM(2003) 240 final

… … DEVELOPMENTDEVELOPMENT

Example of activity areas:

* Co-operation in market surveillance between Member States

* Co-operation with regard to designation and continuous surveillance of Notified bodies

* The use of the New approach principles in other legislation (e.g. in the area of environmental protection, transport, ICT)

• Conduct of sound impact assessment in preparationof the legislative process

ADVANTAGES OF THE NEW APPROACH ADVANTAGES OF THE NEW APPROACH CONCEPTCONCEPT

* Effective approach in terms of protection of public interests (protection of consumers, health and safety, environment, …)* Reduces the regulatory burden to the extent necessary

and relies on the active contribution from stakeholders* Flexible, favourable to innovation, because the use of

voluntary standards allows to rely on most competent experts of stakeholders and to adapt standards easily in accordance with technical progress* In favour of international harmonisation because reference to international standards can be made

AREA OF APPLICATION OF EU LEGISLATION ANDAREA OF APPLICATION OF EU LEGISLATION ANDEUROPEAN STANDARDSEUROPEAN STANDARDS

European Union : 15 Member States 380 Mio citizens

European Economic Area(EEA) 15 + 3 (Norway, Island, Liechtenstein)

385 Mio citizens

European Union : 25 Member States1st wave of enlargement

European Union : 25 Member States+ further enlargement + 100 Mio citizens

+ 75 Mio citizens

FOR MORE INFORMATIONFOR MORE INFORMATION

Guide to the implementation of directives based on the New Approach and the Global Approach (11 EU languages) on Internet

(http//europa.eu.int/comm/enterprise/newapproach/index.htm)

IMPORTANT INTERNET-ADDRESSESIMPORTANT INTERNET-ADDRESSES

www.cenelec.org

www.cenorm.be

www.etsi.org

DG Enterprise …..http://europa.eu.int/comm/enterprise/regulation/index.htm

List of harmonised …... standards

http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/index.html

New Approach ...http://www.newapproach.org