New concept for product conformity in the European Union

from Wikipedia, the free encyclopedia

The new concept (Engl. New Approach ) for the product regulation and the overall concept for the conformity assessment of the European Union are since 1985 the technical harmonization of national regulations for certain product groups and the removal of trade barriers within the European single market .

What these complementary concepts have in common is that they limit state intervention to an indispensable minimum and thus give industry the greatest possible scope for action in fulfilling its obligations to the public in order to promote technical progress. The yardstick for the severity of the required measures is the risk potential of the products concerned.

Since 1987, over 25 guidelines have gradually come into force based on the new concept and the overall concept. Basically, a distinction is made between products for which a CE mark is required, for which another conformity mark must be affixed, and products on which no conformity mark may be affixed.

A guideline for the implementation of the guidelines drawn up according to the New Concept is the so-called “Blue Guide” of the European Commission .

After more than 20 years, the New Approach has been revised and updated; the so-called New Legislative Framework (NLF) was adopted in 2008 . It came into force in January 2010.

A guideline for the implementation of the guidelines drawn up according to the New Concept is the so-called “Blue Guide” of the European Commission . The current edition also takes into account the changes / additions made by the New Legislative Framework.

Regulatory basics

New concept

The new concept was developed to simplify and standardize the EU's regulatory system. It is based on the following legal acts of the Commission:

  • the resolution of 7 May 1985 on a new approach to technical harmonization and standardization,
  • the resolution of December 21, 1989 on an overall concept for conformity assessment,
  • the decision of July 22, 1993 (93/465 / EEC) on the modules to be used in the technical harmonization guidelines for the various phases of the conformity assessment procedure and the rules for affixing and using the CE conformity marking,
  • the resolution of October 28, 1999 on the role of standardization in Europe and
  • its conclusions of March 1, 2002 on standardization .
  • According to a Council decision of the European Commission of 10 November 2003, the new concept, in particular its implementation, is to be further improved.

The principles of the New Concept essentially continue to apply.

Main elements of the new concept

The New Approach guidelines are based on the following principles:

  • The harmonization is limited to the definition of the so-called essential requirements . Only these are binding;
  • Only products that meet the essential requirements can be placed on the market or put into operation;
  • In the full application of harmonized standards , the references of which have been published in the Official Journal and which have been implemented in national standards, compliance with the corresponding essential requirements must be assumed ("presumption of conformity");
  • However, the application of harmonized standards or other technical specifications remains voluntary, and manufacturers are free to choose any technical solution with which they want to achieve conformity with the essential requirements. However, the technical benchmark for authorities always remains the harmonized standards;
  • Manufacturers usually have the choice between various conformity assessment procedures, which are specified in the respective applicable guidelines (depending on the risk potential of the product).

The New Legislative Framework

In 2008, the New Legislative Framework ("new legal framework") was adopted to supplement and expand the new concept . It consists of

  • Regulation (EC) 765/2008 laying down the requirements for the accreditation of conformity assessment bodies and market surveillance of products. This regulation is aimed at the member states and applies directly.
  • Decision 768/2008 on a common framework for the marketing of products, which contains reference provisions to be included in every revision of the product legislation. It is a template for future product harmonization regulations and is therefore aimed at the Commission itself.
  • Regulation (EC) 764/2008 laying down procedures in connection with the application of certain national technical regulations for products that are lawfully placed on the market in another EU country

Resolution 768/2008 is of particular importance for the design of the product guidelines . It standardizes, specifies and expands the requirements of the New Concept, which must be implemented in the guidelines:

  • Standardization of term definitions;
  • additional requirements for manufacturers e.g. B.:
    • Risk analysis now for all guidelines;
    • Obligation to observe the market; Carry out risk-dependent market samples, set up recall management;
    • Immediate corrective measures, including withdrawal or recall, in the event of a justified suspicion of a lack of conformity;
    • In case of danger: obligation to report and cooperation with the responsible authorities.
  • Introduction of the so-called " economic actors ". In addition to the manufacturers, authorized representatives of the manufacturer and importers, these are now also dealers;
  • all economic actors are subject to additional administrative requirements. These requirements apply beyond the date of placing on the market.

Principles of the guidelines

Placing on the market

Placing on the market denotes the first time a product is made available on the Community market for sale or use in the territory of the Community as part of a business activity, whether in return for payment or free of charge. At this point an affected product must comply with the applicable directive (s).

If a product is placed on the Community market or put into operation for the first time, it must comply with all EC directives that apply to the product .

The Member States must ensure through appropriate market surveillance measures that only compliant products are placed on the market and put into service.

Essential requirements

The essential requirements (or essential requirements) are set out in the annexes to the guidelines and contain everything necessary to achieve the objective of the guidelines. Products may only be placed on the market and put into operation if they meet the essential requirements.

CE marking

The CE marking may only be attached to products that meet all the provisions of the applicable directives in which this marking is provided. In particular, the CE marking indicates that the products meet the essential requirements of the applicable directives and have been subjected to a conformity assessment procedure provided for in the directives .

Products without CE marking

For the following product groups there are European directives based on the principles of the new concept or the overall concept , according to which no CE marking is provided or other conformity marks must be attached:

  • Packaging and packaging waste (94/62 / EC),
  • High-speed rail system (96/48 / EG),
  • Marine equipment (96/98 / EC); Conformity mark: rowing wheel
  • Interoperability of the rail system in the Community ( 2008/57 / EC (PDF) ).
  • Components for intended use in potentially explosive areas (94/9 / EC)

Products that are not subject to European directives are subject to the respective national legislation of the country in which they are placed on the market. Regulation (EC) 764/2008 (see above) applies to these products within the European Economic Area .

EU / EC directives

Directives with CE marking

CE marking in accordance with the relevant guidelines is provided for the following products:

Further guidelines

There are other guidelines based on the principles of the new concept or the overall concept :

  • Electric household refrigerators and freezers (96/57 / EG),
  • Transportable pressure equipment (1999/36 / EG),
  • Environmentally harmful noise emissions from devices and machines intended for use outdoors (2000/14 / EC; in short: Outdoor Directive)
  • Energy efficiency requirements for ballasts for fluorescent lamps (2000/55 / ​​EG)

Other guidelines

The following directives, regulations and decisions of the Commission are related to the new concept or the overall concept :

  • Seamless steel cylinders (84/525 / EEC),
  • Seamless aluminum bottles (84/526 / EEC),
  • Welded steel cylinders (84/527 / EEC),
  • Liability for defective products (85/374 / EEC and 1999/34 / EEC),
  • General product safety (2001/95 / EC) for consumer products.

Individual evidence

  1. European Commission: Guide for the implementation of EU product regulations 2016 ("Blue Guide") (PDF; 2538 kB)
  2. a b European Commission: "New legislative framework" . Retrieved April 2, 2020
  3. European Commission: Federal Ministry of Economics and Technology, Section VIIA3 of March 14, 2008, The Accreditation System in Germany ... , (PDF, 125 kB), in particular pages 2 and 5, accessed at | Inst. For Sanitary Engineering and Waste Management at the University of Stuttgart on May 21, 2019.
  4. European Commission: Guide for the implementation of EU product regulations 2016 ("Blue Guide") (PDF; 2538 kB)

Web links