The new concept (English new Approach) for the product adjustment and the total concept for the conformity evaluation of the European union serve the technical harmonization of certain product groups and the dismantling of barriers to trade within the European domestic market.

Together these each other supplementing concepts have the fact that they limit an intervening of the state to an indispensable minimum and thus with the fulfilment of its obligations in relation to the public a greatest possible scope of action to the industry grants.

Since 1987 gradually over 20 guidelines into force, those stepped on the new concept and the total concept being based. In principle one differentiates between products, for which a CE-marking is necessary, as well as another to be attached must products, at which no may be attached.

A manual for the conversion that of the guidelines written after the new concept is the Blue in such a way specified Guide of the European commission.

Regulatori bases

Regulatori bases of the European commission in this connection are:

• the resolution of 7. May 1985 over a new conception in the area of the technical harmonization and the standardization,
• the resolution from 21 December 1989 to a total concept for the conformity evaluation,
• the resolution from 22 July 1993 (93/465/EWG) over the modules for the different phases of the conformity appraisal procedures, which can be used in the technical harmonization guidelines, and the rules for mounting and use of the
• the resolution from 28 October 1999 for the function of the standardization in Europe and
• those its conclusions of the 1. March 2002 to the topic "standardization ".
• The new concept, in particular its conversion, is to be further improved in accordance with a council decision of the European commission from 10 November 2003

Main elements of the new concept

The guidelines of the new concept are based on the following principles:

• The harmonization is limited to the substantial requirements.
• Only products, which correspond to the substantial requirements, can be brought into traffic or taken in enterprise.
• With harmonized standards, whose places of discovery in the Official Journal published and which were converted into national standards, an agreement with the appropriate substantial requirements is to assume.
• The application of harmonized standards or other technical specifications remains voluntary, and the choice of each technical solution is open the manufacturers, as long as the conformity with the substantial requirements is ensured.
• Manufacturers have the choice between different conformity appraisal procedures, which are intended in the applicable guidelines.

Inverkehrbringen

Inverkehrbringen designates the first entgeltliche or free supply of a product on the community market for the selling or the use in the area of the community.

If a product is brought for the first time on the community market into traffic and taken in enterprise, it must correspond to the applicable EEC guidelines written after the "new concept".

The member states must ensure by appropriate market monitoring measures that only safe products are brought into traffic and taken in enterprise.

Substantial requirements

The substantial requirements (or fundamental requirements) in the appendices on the guidelines festgelegtund contain everything that for the reaching of the goal of the guideline is necessary. Products may be brought only into traffic and taken in enterprise, if they fulfill the substantial requirements.

CE-marking

The CE-marking may be appropriate only at products, which fulfill all regulations of the applicable guidelines, in which this marking is intended. In particular the CE-marking indicates the fact that the products correspond to the substantial requirements of the applicable guidelines and was submitted to a conformity appraisal procedure planned in the guidelines.

Products without CE-marking

For the following product groups there are European guidelines after the principles of the "new concept" or the "total concept", after which no CE-marking is intended or must other be attached:

• Packing and packing wastes (94/62/EG),
• High-speed course system (96/48/EG),
• Marine equipment (96/98/EG); Rudder wheel
• Interoperability of the conventional railway system (2001/16/EG).

EEC guidelines

Guidelines to the CE-marking

For the following products a CE-marking is before-seen after the appropriate guidelines:

• Electrical operational funds, for use with tensions between 50 and 1000 V (73/23/EWG; briefly: Low-voltage guideline),
• Simple receivers (87/404/EWG),
• Toy (88/378/EWG),
• Building products (89/106/EWG),
• Electromagnetic compatibility (of electrical and electronics products) (89/336/EWG, 2004/109/EG),
• Personal protection equipment (89/686/EWG),
• balances (90/384/EWG),
• Active implantierbare medical instruments (90/385/EWG; Abk. "AIMD"),
• Gas consumption equipments (90/396/EWG),
• With liquid or gaseous fuels new warm water boilers (92/42/EWG) fed,
• Explosives for civilian purposes (93/15/EWG),
• Medicine products (93/42/EWG; briefly medicine product guideline, Abk. "MDD"),
• Devices and protective systems for intended use within highly combustible ranges (94/9/EG),
• Sport boats (2003/44/EG (the 94/25/EG replaces) - see also: CE-Seetauglichkeitseinstufung),
• Elevators (95/16/EG),
• Printing devices (97/23/EG),
• Machines (98/37/EG; briefly: Machine guideline),
• In-vitro-Diagnostika (98/79/EG; briefly: IVD guideline, Abk. "IVDD"),
• Radio communication systems and Telekommunikatiosendeinrichtungen and (98/5/EG),
• Aerial ropeways for the passenger traffic (2000/9/EG) and
• Measuring instruments (2004/22/EG).

Suggestions for guidelines

The following suggestions for new or fundamental changes of existing EEC guidelines are treated by the commission:

• Work from precious metals (COM (1993) 322),
• Marking of packing and introduction of a conformity appraisal procedure for packing (COM (1996) 191) and
• Machines and change of the guideline 95/16/EC (COM (2000) 899).

Further guidelines

There are still further guidelines after the principles of the "new concept" or the "total concept":

• Electrical household cool and - freezing devices (96/57/EG),
• Transportable printing devices (1999/36/EG),
• Polluting noise emissions of for use in the free one planned devices and machines (2000/14/EG; briefly: Outdoor guideline)
• Energy efficiency requirements of fluorescent lamp ballasts for fluorescent lamps (2000/55/EG)

Other guidelines

Following guidelines, regulations and resolutions of the commission stand in connection with the "new concept" or the "total concept":

• Smooth steel bottles (84/525/EWG),
• Smooth aluminum bottles (84/526/EWG),
• Welded steel bottles (84/527/EWG),
• Adhesion for incorrect products (85/374/EWG),
• General product security (2001/95/EG) and.

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