The free movement of goods and services is an important cornerstone of a well-functioning single market. An effective market can be created when legislation stipulates general requirements and standardisation creates detail-level solutions. Standards are voluntary tools that facilitate compliance with the legislation.
The cooperation that takes place within standardisation facilitates an effective application of legislation, which enhances business competitiveness and eliminates trade barriers. The relationship between standardisation and legislation at European level has been developed in accordance with the so-called “New Approach” to technical harmonisation and standards, which was introduced in 1985. This solution means it is possible to reduce the work public authorities need to do to regulate products in detail, as detailed rules are developed by the European Standardisation Organisations CEN, CENELEC and ETSI instead.
The new method aims to avoid specific national requirements by limiting legislation to general requirements for health, safety and environment, and other aspects of public interest. Standards should provide a minimum level of protection in respect of essential requirements laid down in directives. There should also be a mechanism for disputing the conformity of a product or to be able to criticise errors or shortcomings in harmonised standards.
The new method means that:
Directives are used to harmonise legislation in the member states, primarily but not exclusively to ensure the smooth functioning of the internal market. About 20 directives have been developed for different areas, e.g. electrical safety, occupation health & safety, healthcare, etc. Directives based on the New Approach should protect public interests and prevent products that do not fulfil the relevant requirements from being placed on the market.
Depending on the directive that is applicable, the manufacturer may be forced to get their product tested and certified by a third party or get their quality management system certified. Some directives also contain additional requirements (such as the requirement that the product should be supplied with specific information).
There is an obligation for member states to take the necessary measures to ensure that products do not pose risks to people’s safety or health or threaten other public interests. Countries are also entitled to adopt additional national regulations in order to protect workers, consumers or the environment.
Harmonised standards are European standards developed in accordance with the guidelines that have been agreed between the European Commission and the European standardisation bodies, and that follow a mandate from the European Commission. The standards that are published in The Official Journal of the European Union (OJ) are considered to fulfil the essential requirements in each directive respectively (the exception is the Low Voltage Directive (LVD), which has a standing mandate to develop harmonised standards within the framework of this directive).
Essential requirements are specified in appendices to the directives and cover all aspects that are required in order to achieve the purpose of the directive. The General Product Safety Directive (2001/95/EG) aims to ensure that consumer products do not pose any risks under normal operating conditions. Manufacturers are only allowed to release safe products on to the market and should provide information about possible risks.
Each directive specifies which aspects should be included in conformity assessment. The directives also contain criteria for what the manufacturer can do when more than one possibility exists.
Conformity assessment can be carried out either by a first party (the manufacturer) or by a third party (a notified body). The assessment may relate to a product’s design or production phase or both of these. Even if a manufacturer employs sub-suppliers for design or production, the manufacturer will still be responsible for conformity assessment during both phases.
The manufacturer or their authorised representative draws up a declaration of conformity with the essential requirements in the directive when the product is released on to the market.
Some directives provide a possibility of quality assurance in accordance with the EN ISO 9000 series, which helps manufacturers to comply with the directives and meet customer needs at the same time. Under certain conditions, this also provides manufacturers with a opportunity to take advantage of their investments in quality management systems. However, it should be noted that the terms “certification” and “registration” are used in a different and broader sense in the legislation than in the ISO 9000 and ISO 14000 series standards. The bodies that issue ISO 9000 or ISO 14000 certificates are called “certification bodies” in some countries and “registration bodies” or “registrars” in others.
“Accreditation” is sometimes used as a synonymous term for “certification” or “registration”.
In a legal sense, “accreditation” is the procedure through which a public authority formally confirms that an organisation or person is competent to perform a certain task. In an ISO context, “accreditation” is connected to the accreditation body’s work to assess the competence of a certification body.
Products that fulfil the requirements of the CE Marking Directive should be CE marked. By CE marking the product, the manufacturer is declaring that the product fulfils the essential requirements of the relevant directives and that the product has undergone the conformity assessment stipulated in the directives.
Several directives contain provisions on affixing CE marking. In some cases, a marking other than CE marking may be prescribed. CE marking does not mean that a product was made in the EEA, but states that the product is assessed before being placed on the market.