CE Testing and Marking

CE Mark

The CE mark was introduced in 1995. ‘CE’ stands for Communauté Européenne (European Community). CE marking was created to encourage the free circulation of goods within the European community.

TRaC can assist your company in acquiring the CE Mark with CE Mark testing and certification. Through our testing and certification procedures we can prove a product's compliance with all applicable CE marking directives.

The idea of the CE marking is to provide a clear indication that a given product meets the requirements of relevant CE marking directives and therefore should not be stopped at Member State borders, and should enjoy free movement between Member States.

The CE Marking system was originally intended for customs officers at entry points to the EU and between Member States to indicate compliance with the appropriate requirements. Over time however the CE marking has been adopted to mean more (even if not strictly true) – the product is safe and complies with legislation.

Get a feel for our recent seminar by viewing our CE marking directives update video.

New Approach directives are based on the following principles:

• Harmonisation is limited to essential requirements.
• Only products fulfilling the essential requirements may be placed on the market and put into service.
• Harmonised standards, the reference numbers of which have been published in the Official Journal and which have been transposed into national standards, are presumed to conform to the corresponding essential requirements.
• Application of harmonised standards or other technical specifications remains voluntary, and manufacturers are free to choose any technical solution that provides compliance with the essential requirements.
• Manufacturers may choose between different conformity assessment procedures provided for in the applicable directive.

CE Marking and the Law

New Approach directives apply to products that are intended to be placed (or put into service) on the Community market for the first time. Consequently, the directives apply to new products manufactured in the Member States, and to new, as well as used and second-hand, products imported from third countries.

CE marking is a process that follows the ‘new approach’ directive. The new approach provides a framework that helps the legislative body to write a CE marking directive such that it looks and feels like any other. For example, the directive might say (in summary), test to a harmonized standard and by doing so, the manufacturer has provided a presumption to the technical aspects of the directive. It must then compile technical documentation (which again is the same across all CE marking directives) and how to CE mark.

Member States do not (on the whole) adopt European legislation and have to transpose it into their own National law for it to have an affect. In the UK for example CE marking directives are enacted as secondary legislation and given a Statutory Instrument number (SI). This process allows Member States to customize the European Directive into their own law, for example by indicating enforcement authorities, and penalties in the case of non-compliance etc.

• The concept of product varies between New Approach directives, and it is the responsibility of the manufacturer to verify whether or not the product is within the scope of one or more directives.
• Products that have been subject to important changes may be considered as new products that have to comply with the provisions of the applicable directives when placed on the Community market and put into service. This has to be assessed on a case-by-case basis, unless otherwise provided for.
• Products, which have been repaired without changing the original performance, purpose or type, are not subject to conformity assessment according to the New Approach directives.
• Products specially or exclusively intended for military or police purposes are explicitly excluded from the scope of certain New Approach directives. For the other directives, Member States may, under certain conditions, exclude from their field of application according to Article 296 of the EC Treaty, products intended specifically for military purposes.

When can the CE Mark be affixed onto a Product?

CE Marking Essential requirements set up by New Approach directives may overlap or complement each other, depending on the hazards covered by these requirements that are related to the product in question.
The placing on the market and putting into service can only take place when the product complies with the provisions of all applicable directives, and when the conformity assessment has been carried out in accordance with all applicable directives.

Where the same product or hazard is covered by two or more directives, the application of other directives can sometimes be excluded following an approach that includes a risk analysis of the product with a view to intended use as defined by the manufacturer.

At what point am I placing the product on the market?

Placing on the market is the initial action of making a product available for the first time on the Community market, with a view to distribution or use in the Community. Making available can be either for payment or free of charge.

Putting into service takes place at the moment of first use within the Community by the end user. However, the need to ensure, in the framework of market surveillance, that products are in compliance with the provisions of the directives when being put into service is limited. A product must comply with the applicable New Approach directives when it is placed on the Community market for the first time and put into service.

Member States are obliged:

• not to prohibit, restrict or impede the placing on the market and putting into service of products that comply with the applicable New Approach directives; and
• to take any measures necessary to ensure that products are placed on the market and put into service only if they do not endanger the safety and health of persons, or other interests covered by the applicable directives, when correctly constructed, installed, maintained, and used in accordance with their purpose.

Who is responsible for the CE marking?

The CE marking of a product is the responsibility of the person who places it on the community’s market. This will be the manufacturer where they reside within the EU however would be the importer or authorized representative is located outside the EU. It is important to understand that there are legal implications with CE marking since by offering something for sale, that person takes on the CE marking responsibility and hence is stating that, amongst other things, the product is safe.

Manufacturer

A manufacturer, in the meaning of New Approach, is the person who is responsible for designing and manufacturing a product with a view to placing it on the Community market on his own behalf.
The manufacturer has an obligation to ensure that a product intended to be placed on the Community market is designed and manufactured, and its conformity assessed, to the essential requirements in accordance with the provisions of the applicable New Approach directives.

The manufacturer may use finished products, ready-made parts or components, or may subcontract these tasks. However, he must always retain the overall control and have the
necessary competence to take on responsibility for the product.

Authorised Representative

The manufacturer may appoint any natural or legal person to act on his behalf as an authorised representative. For the purposes of New Approach directives the authorized representative must be established inside the Community.

The authorised representative is explicitly designated by the manufacturer, and he may be addressed by the authorities of the Member States instead of the manufacturer with regard to the latter’s obligations under the New Approach directive in question. The manufacturer remains generally responsible for actions carried out by an authorised representative on his behalf.

Importer

An importer (a person responsible for placing on the market) – in the meaning of New Approach directives – is any natural or legal person established in the Community who places a product from a third country on the Community market.

The importer must ensure that he is able to provide the market surveillance authority with the necessary information regarding the product, where the manufacturer is not established in the Community, and has no authorised representative in the Community.

The natural or legal person who imports a product into the Community may, in some situations, be considered as the person who must assume the responsibilities placed on the manufacturer according to the applicable New Approach directives.

Compliance with Directives

Essential requirements

• Essential requirements lay down the necessary elements for protecting the public interest. Essential requirements are mandatory. Only products complying with essential requirements may be placed on the market and put into service.
• Essential requirements must be applied as a function of the hazards inherent to a given product.

Presumption of Conformity

• Conformity with a national standard that transposes a harmonised standard, whose reference has been published, confers a presumption of conformity with the essential requirements of the applicable New Approach directive that is covered by such a standard.
• References (such as titles, identification numbers) of harmonized standards are published in the Official Journal for the directive in question.
• Member States must publish the reference of the national standard that transposes a harmonised standard. It is useful to indicate in the publication the link with the legislation in question.
• The application of harmonised standards, which give a presumption of conformity, remains voluntary in the field of New Approach directives. Thus, the product may be manufactured directly on the basis of the essential requirements.