4.1.1.  INTERNAL MARKET RULES – TECHNICAL HARMONISATION
            (sectors harmonised according to the “New Approach” – CE-marking)

‘What is CE-marking?’
‘Which European product laws and standards, e.g. technical requirements, labelling and packaging rules, environmental rules, have to be applied for selling products in the European Union that are covered by the so-called new approach in technical harmonisation?
‘Where can we buy harmonised standards which we need for complying with the requirements of new approach directives?’

For an answer to these questions, look into the websites and publications presented below.

Information source 1: European Commission – Scadplus database (= summaries of EU legislation)
Website:                       http://ec.europa.eu/scadplus/

To find info in this website, follow the example.

Example:             Which harmonised technical requirements apply to low voltage electrical equipment in the EU?

Step 1:   login to the website of Scadplus (click on the link above)

Step 2:   select ‘Index – T – Technical harmonisation – Electrical and electronic equipment and gas appliances – Low voltage electrical equipment‘ and find the title and summary of a relevant EU law  (e.g. Dir. 73/23/EEC).

 For consultation of full texts of EU laws: consult Eur-Lex (see below)

Information source 2: European Commission – Eur-Lex database (= full texts of EU legislation)
Website:                       http://eur-lex.europa.eu/en/index.htm

To find info in this website, follow the example.

Example:             How to find the text of the Low Voltage Directive (= Dir. 73/23/EEC)?

Step 1:   login to the website of Eur-Lex (click on the link above) and click on “Simple search”

Step 2:   click on “Search by natural number”

Step 3:   Enter the year “1973” and the number “23”, select “Directive” and click on “search”

Step 4:   Click on “Bibliographic notice”

Step 5:   Click on “Repealed by 32006L0095“

Step 6:   Consult Directive 2006/95/EC (the new codified text of the Low Voltage Directive)
 

Information source 3: New Approach website (= references to laws and harmonised standards)
Website:                       http://www.newapproach.org

To find info in this website, follow the example.

Example:             How to find the list of Harmonised Standards that are available for compliance with the Medical Devices Directive (= Dir. 73/23/EEC)?

Step 1:   login to the New Approach website (click on the link above)

Step 2:   click on ‘Directives and Standards’

Step 3.:  move to the line with info about ‘93/42/EEC Medical devices: general”

Step 4:   click on ‘References Harmonised Standards’

Step 5:   select from the list relevant standards

Step 6:   go to ‘Standards sales points’ and order the texts of harmonised standards from a national standardisation institute near to your location.

Information source 4: European Commission – DG Enterprise and Industry (= EU policy on new approach in technical harmonisation)
Website:                       http://ec.europa.eu/enterprise/index_en.htm

To find info in this website, follow the example.

Example:             How to find a practical guide on the implementation of the Personal Protective Equipment Directive (= Dir. 89/686/EEC)?

Step 1:   login to the website of DG Enterprise and Industry (click on the link above)

Step 2:   select at the ‘Index A to Z’ the item ‘Mechanical Equipment’ followed by ‘Personal Protective Equipment’

Step 3.:  click on ‘How to apply the Directive 89/686EEC?’

“Guide to the Implementation of Directives Bases on New Approach and Global Approach”
http://ec.europa.eu/enterprise/newapproach/legislation/guide/index.htm

The “New/Global Approach” directives only contain essential health and safety requirements for product design and usage. The detailed technical specifications are established in the harmonised standards developed by the European standardisation bodies CEN, CENELEC or ETSI.

To become a harmonised standard, it must be accepted by the European Commission. The Commission harmonises the standard by publishing the title together with the directive in the Official Journal. Once adopted,
European Harmonised standards must be published by national members of CEN, CENELEC and ETSI and national standards must be withdrawn.

Whereas essential requirements are binding, standards are, as a rule, voluntary. Manufacturers do not have to follow harmonised standards to comply with product directives. They are free to choose any technical solution that will meet the essential requirements. However, products in conformity with harmonised standards are cobsidered to fulfil the essential requirements in the directive (presumption of conformity).

Following websites list harmonised standards for each sector covered by the new approach in technical harmonisation:

http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist.html
http://www.newapproach.org

Texts of European harmonised standards may be ordered from National Standardisation bodies which can be identified via following websites:

CEN (European Committee for Standardisation
Rue de Stassart, 36
B-1050 Brussels
Tel.: 32 2 550 08 11
Fax: 32 2 550 08 19
E-mail: infodesk@cenorm.be
http://www.cenorm.be

CEN national members
http://www.cenorm.be/cenorm/standards_drafts/index.asp

CENELEC (European Committee for Electrotechnical Standardisation)
Rue de Stassart, 35
B-1050 Brussels
Tel.: 32 2 519 68 71
Fax: 32 2 519 69 19
E-mail: general@cenelec.be
http://www.cenelec.org

CENELEC national members
http://www.cenelec.eu/Cenelec/CENELEC+in+action/Web+Store/Standards/default.htm

ETSI (European Telecommunications Standards Institute)
650, route des Lucioles
F-06921 Sophia Antipolis Cedex
Tel.: 33 4 92 94 42 00
Fax: 33 4 93 65 47 16
E-mail: infocentre@etsi.org
http://www.etsi.org

ETSI national members
http://portal.etsi.org/Portal_Common/home.asp

Lists of notified bodies, including the identification number of a notified body as well as the tasks for which it has been notified, can be found in following web sites:

http://ec.europa.eu/enterprise/newapproach/legislation/nb/notified_bodies.htm
http://ec.europa.eu/enterprise/newapproach/nando/

The EU's Directive on product liability can be consulted at:
http://eur-lex.europa.eu/Notice.do?val=115911:cs&lang=en&list=115911:cs,&pos=1&page=1&nbl=1&pgs=10&hwords=

The EU’s General product safety directive can be found at:
http://eur-lex.europa.eu/Notice.do?val=272287:cs&lang=en&list=272287:cs,258366:cs,258142:cs,&pos=1&page=1&nbl=3&pgs=10&hwords=

A list of Mutual Recognition Agreements (MRA) can be found at:
http://ec.europa.eu/enterprise/international/index_en.htm

ISO (International Organisation for Standardisation)
1, rue de Varembé
Case postale 56
CH – 1211 Geneva 20
Tel.: 41 22 749 01 11
Fax: 41 22 733 34 30
E-mail: central@iso.ch
http://www.iso.ch

EOQ (European Organisation for Quality)
PO Box 5032
CH – 3001 Bern
Tel.: 41 31 320 67 20
Fax: 41 31 320 68 28
http://www.eoq.org

EOQ national members
http://www.eoq.org/WhatIsEOQ_FmosReps.html

EFQM (Euopean Foundation for Quality Management)
Brussels Represantation Office
Avenue des Pléiades 15
B-1200 Brussels
Tel.: 32 2 775 35 11
Fax: 32 2 775 35 35
E-mail: info@efqm.org
http://www.efqm.org

EFQM national members
http://www.efqm.org/Default.aspx?tabid=71

Following institutions operate in this field:

European Co-operation for Accreditation
http://www.european-accreditation.org/default_flash.htm

International Accrediation Forum, Inc.  (accreditation institutions for certiciation institutions)
http://www.iaf.nu

International Laboratory Accreditation Cooperation (accreditation institutions for inspection institutions and laboratories)
http://www.ilac.org

The CE mark may be downloaded in different electronic formats from the following site:

http://ec.europa.eu/enterprise/faq/ce-mark.htm