Learn everything about CE marking and the New Legislative Framework (NLF) for EU product safety. Key information for manufacturers and distributors.
The new legislative framework
The New Legislative Framework (NLF) was adopted in 2008 to strengthen the European single market for goods and to create clear rules for placing products on the EU market. As a package of measures, it aims to improve market surveillance, raise the quality of conformity assessment, and clarify CE marking.
The focus of the new legal framework is on better application and enforcement of EU law:
- Improved market surveillance: Stricter surveillance rules are intended to better protect consumers and businesses from unsafe products, particularly those imported from outside the EU. A special focus is placed on products that may pose a risk to health or the environment.
- Clear accreditation rules: Accreditation rules for conformity assessment bodies are established to make their work more transparent.
- Strengthening conformity assessment: The NLF improves the requirements for the designation of conformity assessment bodies to strengthen trust and the quality of assessment procedures.
- CE marking: The meaning of CE marking is clarified and its credibility increased.
- Unified legal framework: By providing a common package of measures, the NLF offers a toolbox that can be used for future product legislation. This includes standardized definitions of terms and uniform procedures that enable consistent sectoral legislation.
The New Legislative Framework consists of the following elements:
- Regulation (EC) No 765/2008: Regulates the requirements for accreditation and market surveillance.
- Decision 768/2008: Provides a common framework for placing products on the market and contains reference provisions for future legislative changes.
- Regulation (EU) No 2019/1020: Focuses on market surveillance and compliance with product safety requirements.
The new legal framework creates clear and uniform rules for product legislation in the EU. It provides a reliable accreditation system, a credible CE marking and a strengthened conformity assessment system, which ultimately contributes to the safety and quality of products on the EU market.
Importance of the CE marking
The CE marking is an important quality mark for products sold in the European Economic Area (EEA). It signifies that a product meets the applicable EU requirements regarding health, safety and environmental protection. For manufacturers, CE marking represents an important obligation that must be carefully observed.
CE marking serves as a declaration by the manufacturer that the product complies with EU requirements and has undergone all relevant conformity assessment procedures. This marking is not only a sign of safety for consumers but also enables the free movement of goods within the EEA. It is required for numerous product categories, especially those that can have significant impacts on health and safety.
Products bearing the CE marking enjoy the trust of consumers and authorities within the EEA and demonstrate that they have been tested for safety. This marking not only promotes trade within the EEA but also strengthens consumer confidence in the quality and safety of products.
CE marking is more than just a label; it is a fundamental component of product safety in Europe. For manufacturers, CE marking means ensuring compliance with stringent EU standards, which ultimately helps ensure that only safe and tested products enter the market.
Procedure for CE marking
The six most important steps of the CE marking procedure are described below:
- Determine the applicable directive(s) and harmonised standards
The first step for manufacturers is to determine which EU directives and harmonised standards apply to their product. These may include safety, health, environmental protection and other requirements. Each directive can contain a set of specific requirements that the product must meet to be compliant. - Check the product-specific requirements
The manufacturer must ensure that the product meets the specific requirements of the relevant directive. This can include meeting performance criteria, complying with design specifications and other conformity aspects listed in the directives. - Determine whether an independent conformity assessment is required
For certain products, especially those with higher safety risks (e.g. gas boilers, medical devices, etc.), an independent conformity assessment is required. This assessment must be carried out by a notified body - an organisation designated by EU countries to assess product conformity. - Test the product and determine its conformity
In this step, various tests are carried out to confirm that the product meets all required provisions of the applicable directives. These tests can relate to safety, health and functionality, among other aspects. - Prepare and maintain the technical documentation
Manufacturers are obliged to prepare and keep up-to-date comprehensive technical documentation. This includes detailed information on the design, manufacture and operation of the product, by which conformity with applicable EU standards and requirements can be demonstrated. - Affix the CE marking and issue the EU declaration of conformity
Once it is ensured that the product meets all relevant EU requirements, the manufacturer may affix the CE marking to the product. In addition, they must issue an EU declaration of conformity. This is a formal declaration by the manufacturer stating that the product complies with all applicable EU directives.
Elements of CE marking
Several components play an important role in CE marking to ensure products meet EU requirements and safety standards.
Conformity assessment procedures
These are the procedures by which it is assessed whether a product meets the requirements of the applicable directives. The complexity of these procedures can vary depending on the potential risk associated with the product.
The role of notified bodies
For certain products, especially those with higher risks, the involvement of a notified body is required. A notified body is an organisation designated by an EU country that assesses the conformity of certain products before they are placed on the market. These bodies are independent and authorised to carry out tests and issue certificates confirming compliance with EU standards.
Technical documentation
The manufacturer must assemble technical files that demonstrate the product meets all EU requirements. These files generally include design and manufacturing details, risk assessments, technical drawings, instructions and test results. The technical documentation must be retained for a period (usually 10 years) after the last product was placed on the market and must be made available to national authorities upon request.
EU declaration of conformity
This is a formal declaration by the manufacturer that the product complies with all applicable EU requirements. The declaration includes information about the product, the directives to which it conforms, the standards used and the identity of the manufacturer. It must be signed by a person who works for the manufacturer or their authorised representative in the EU.
Appearance of the CE marking
When all of the above steps have been completed and it has been confirmed that the product meets the relevant requirements, the CE marking can be affixed to the product. The CE marking is a visible declaration that the product complies with applicable EU directives and regulations. It must be affixed to the product or its data plate in a visible, legible and indelible form.
Market surveillance
Once a CE-marked product is on the market, it is subject to market surveillance by national authorities. This is intended to ensure that it continues to comply with EU standards. If a product is found to be non-compliant, measures may be taken up to and including withdrawal of the product from the market.
Understanding these key components is essential for manufacturers and distributors to ensure their products comply with EU regulations and standards and thus secure their access to the European market.
Further information the EU Blue Guide
The EU Blue Guide is a comprehensive guide intended to facilitate the application and understanding of EU product rules. The guide is particularly useful for manufacturers, importers and distributors who wish to place products on the European market.
The Blue Guide explains important terms and requirements contained in EU directives and regulations for harmonising product rules. It provides precise information on topics such as CE marking, conformity assessment procedures, accreditation and market surveillance. The guide helps economic operators to understand and correctly apply often complex EU rules.
The Blue Guide can be accessed here: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52016XC0726%2802%29