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“New Approach” legislation

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Free movement of goods is a fundamental objective of the single European market. The mechanisms in place to achieve this aim are based on the prevention of new barriers to trade, mutual recognition and technical harmonization. ‘New Approach’ directives are in effect Community laws that must be transposed into the national law of each member state. This process should allow products legally manufactured or marketed in one country to move freely throughout all member states of the European Union.The “New Approach” and European standardization have contributed significantly to the development of the Single Market. The success of the European standardization system in removing technical barriers to trade has played a vital role in ensuring the free movement of goods between Member States. “New Approach” was conceived in the early 1980s and laid down in a “Council Resolution of 7 May 1985 on a New Approach to technical harmonization and standards”.

The European Commission directives define the “essential requirements”, e.g., protection of health and safety that goods must meet when they are placed on the market. The European standards bodies have the task of drawing up the corresponding technical specifications meeting the essential requirements of the directives, compliance with which will provide apresumption of conformity with the essential requirements.

The “New Approach” is based on a few key principles:

  • There is a clear separation between the EU legislation and European standardization;

  • EU legislative harmonization is limited to the essential requirements (safety requirements of general interest) needed to ensure the free movement of products throughout the Community;

  • the task of drawing up the corresponding technical specifications is entrusted to the standardization bodies;

  • products manufactured in conformity with harmonized standards are presumed to be conformant to the essential requirements;

  • standards are not mandatory, they remain voluntary. Alternate paths are possible but producers of goods that are subject to essential requirements of the directives have an obligation to prove that his products comply with the essential requirements of the directives;

  • standards must offer a guarantee of quality with regard to the essential requirements of the directives;

  • public authorities are still responsible for the protection requirements on their territory (e.g. market surveillance);

  • safeguard clauses require the Member States to take all appropriate measures to withdraw unsafe products from the market.

In comparison with the former directives, some improvements have to be noted since the “New approach”:

  • Deals with large families of products (e.g. machinery, toys, etc.);

  • covers horizontal risks and not specific products;

  • establishes a close co-operation between public authorities and market operators;

  • is based on total harmonization (replacing diverging national legislation) as compared to optional harmonization (dual regime).

A summary of the key features of the “New Approach” would not be complete without mentioning the degree of flexibility which is allowed in most of the directives. The flexibility of the “New Approach” is linked to the following features:

  • It indicates what has to be achieved but not the details of the corresponding technical solutions;

  • It presents different options for conformity assessment;

  • It does not necessitate regular adaptation to technical progress.

The New Legislative Framework, the modernization of the New Approach for marketing of products, was adopted in Council on 9 July 2008 and finally published in the Official Journal on 13 August 2008. This broad package of measures which has the objective of removing the remaining obstacles to free circulation of products represents a major boost for trade in goods between EU Member States.

For more information on the new approach: Visit

 

CE marking

The Directives also state how producers should demonstrate that products meet the ‘Essential Requirements’. The CE marking is an indication that the marked products comply with the essential requirements of all applicable directives and that the products have been subject to a conformity assessment procedure provided for in the directives. The CE marking is mandatory and must be affixed before any product subject to it is placed on the market and put into service, except where specific directives require otherwise. Where products are subject to several directives, which all provide for the affixing of the CE marking, the marking indicates that the products have been built according to regulation applicable.

The CE marking must be visible, readable and  indelible on the product or on its data plate. However, where this is not possible or not warranted on account of the nature of the product, it must be affixed to the packaging, if any, and to the accompanying documents, where the directive concerned provides for such documents. Where a notified body is involved in the production control phase according to the applicable directives, its identification number must follow the CE marking. The manufacturer or the authorised representative established in the Community affixes the identification number, under the responsibility of the notified body.

ce mark

 

European Safety Marks

Besides the CE marking, there can be other marks affixed next to it, either at national, regional or European level. Among the most popular or used are: GS mark from Germany, Kitemark from the United Kingdom, the ENEC scheme for luminaries and the HAR scheme for electric cables.

There are also efforts to develop a unified European safety mark under the name Keymark, which is a voluntary quality mark for products and services and is owned by CEN and CENELC. At the moment 29 certification bodies located in 16 different European countries can issue Keymark licenses on the basis of more than 160 European Standards. The most important today is the CEN Solar Keymark – the quality label for solar thermal products in Europe.

The “EFTA study on Certification and Marks in Europe” offers an in depth study of when and how the marks are being used in Europe as well as what purpose they serve. The study’s purpose is to “create a better understanding of crucial parts of the market for marks in Europe” and it provides useful insights in the current situation as well as interesting findings. The full text of the study can be found here: Visit

cen solar keymark

 

Essential Requirements

Essential requirements are mandatory requirements that products must meet to be placed on the market in order to protect the public interest. These requirements define the results to be attained, or the risks to be dealt with, but do not specify the technical solutions for doing so; suppliers are free to choose how the requirements are to be met. Essential requirements are therefore written in such a way that they remain valid over time, and do not become obsolete with technical progress. Assessment of whether requirements have been met should be based on the state of technical know-how at a given moment. This does not mean that essential requirements are vague. They have to be drafted in such a way as to give sufficient information to enable assessment of whether products meet them.

Compliance with essential requirements can be achieved through construction of products according to the harmonized standards, if such standards are available and are covering all essential requirements of the products.

 

Harmonized Standards

According to the European Commission, a “harmonized standard” issued within the context of the “New Approach” is a standard for which the European Commission (and/or EFTA) has issued a standardization mandate to CEN, CENELEC or ETSI, and for which a reference has been published in the Official Journal of the EU. Harmonized standards provide a method for a product to comply with the relative Directive’s essential requirements, and therefore provide a path for CE marking.

 

Declaration of Conformity

The declaration of conformity is a procedure, in which the manufacturer or his authorized representative established in the Community declares that the product placed on the market complies with all the relevant safety requirements of the appropriated directive. It is a form that is to be provided with every product and must be completed in the user’s language. The Declaration must include: the manufacturer’s details (name and address etc); the essential characteristics that the product complies with; any European standards and performance data; if relevant the identification number of the Notified Body; and a legally binding signature on behalf of the organization.

The EC declaration of conformity must be kept for at least 10 years from the last date of manufacture of the product, unless the directive expressly provides for any other duration. This is the responsibility of the manufacturer or the authorized representative established within the Community. The EC declaration of conformity and other technical documentation are intended to provide the surveillance authorities with necessary information about the product.

 

Market surveillance

Market surveillance is an essential tool for the enforcement of “New Approach” directives. The purpose of market surveillance is to ensure that the provisions of applicable directives are complied with across the EU. Citizens are entitled to an equivalent level of protection throughout the single market, regardless of the origin of the product. Market surveillance is important for economic operators, because it aims at eliminating unfair competition. Member States must nominate or establish public authorities to be responsible for market surveillance. The nominated authorities need to have the necessary resources and powers for their surveillance activities, ensure technical competence and professional integrity of their personnel, and act in an independent and non-discriminatory way respecting the principle of proportionality.

Although market surveillance operations cannot take place during the design and production stages, efficient enforcement usually requires that market surveillance authorities act in collaboration with manufacturers and suppliers in order to prevent the placing on the market of noncompliant products. Market surveillance authorities control the market by regularly visiting commercial, industrial and storage premises in an annual program of random and spot checks to examine products and take samples of suspect products for additional testing. They have the legal powers to require all necessary information.

 

Information Exchange Systems

The rapid information exchange system RAPEX has been set up by the EU Commission on general product safety to handle emergency situations caused by consumer products that present a serious and immediate danger. It is designed to handle urgent situations caused by new, used or repaired products that present a serious and immediate risk to the health and safety of consumers. Its essential aim is to provide information in order to allow market surveillance authorities of all Member States to take immediate and appropriate action when a serious risk arising from a product has been detected.

Sources of the information:

CEN: www.cen.eu

CENELEC: www.cenelec.eu

ETSI: www.etsi.org

DG ENTR: ec.europa.eu/enterprise/index_en.htm

Website of “New Approach”: http://www.newapproach.org/