CE Marking Directive 93/68/EEC

Table of Contents

  • Scope
  • The Directive
  • Path to EU Market Entry
  • EU Labeling
  • Post-Market Surveillance
  • Risks of Non-Compliance

Scope

The CE Marking of products is intended to support the free movement of goods within the European Economic Area. All products that bear CE marking must comply with all requirements of the applicable directives. Where a product carries appropriate CE marking, the member countries of the European Economic Area must allow the product to be placed on the market.

CE Marking directives cover many product areas. The current CE Marking directives are:


The Directive

The CE Marking Directive 93/68/EEC was adopted on July 22, 1993 in order to introduce a harmonized set of rules concerning the affixing and use of CE marking.

The abbreviation ‘CE’ comes from the French phrase ‘Conformité Européene’ which literally translates as ‘European Conformity.’

The CE marking on a product is a declaration from the manufacturer that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislations laid out in the various product directives.

European Directives lay out non-negotiable safety and environmental criteria that products must meet in order to be introduced to the EU market. The CE marking is a sign that these requirements have been met.

The CE Marking Directive gives a comprehensive and detailed description of the CE initials, as well as any other marks specific to certain directives, and how conformity with these marks can be achieved.

Once the requirements have been met, the product must carry the CE marking. The marking must be no smaller than 5mm high. The grid is for information only and is not considered part of the marking. Also, the C and E are not formed by perfect semicircles.

The manufacturer must:

  • Be European
  • Have an official department located within the European Community
  • Have an official agent or representative willing to share the liability for the CE marking and hold the Declaration of Conformity.

Path to EU Market Entry: EU Compliance

The manufacturer or supplier should use one of the product conformity assessment modules available within the directive to demonstrate that the product complies with the essential requirements. One of the most common options for product assessment is to apply the relevant standards to the product and/or prepare relevant documentation such as the Technical File. The CE Marking should be affixed legibly and indelibly to the product. The manufacturer should also prepare and sign a ‘Declaration of Conformity.’

Many of the CE Marking Directives include provision for the appointment of Notified Bodies. These are organizations appointed by the Member States in which they are based. Their details are ‘notified’ to the European Commission, who then publish these details in the Official Journal of the European Communities.

The specific functions of Notified Bodies regarding compliance assessment for specific products are defined by the directives. For most, the involvement of a Notified Body is only required for high-risk and safety-critical products.


EU Labeling

The label (inner & outer packaging) and manual of any device aimed to be made available within the EU Market should follow the language requirements which are exerted by the National Laws of each EU member states. The outcome of a correct compliance strategy would require the description of the device and its operating instructions along with precautions and warnings to be translated to the official language(s) of the EU state it is to be sold in.

The final artwork of a device labeling & instructions for use, must follow certain language requirements – click here to review the EU language requirements.


Post-Market Surveillance

It is the responsibility of each manufacturer which is making product available on the EU Market under their own name to continue to collect information related to use of their products after they have been made available to consumers as well as to ensure that they continue to comply as the legislation applicable to their products evolves.

Manufacturers should keep their Authorized Representative apprised of any changes products design, manufacturer, labeling, etc that could potentially impact the compliance of their product.

As consumers use the products, any incidents reported by end-users should also be recorded within the respective technical documentation and, depending on the circumstances, reported to the Competent Authorities.

When a manufacturer becomes aware of non-compliant product entering the market, non-compliant batches, etc. they should take action immediately to resolve the situation.


Risks of Non-Compliance

Manufacturers illegally apply the CE Marking to their products everyday - either out of ignorance of the requirements placed upon them, assuming their producer's CE Mark extends to them by default (which is incorrect) or through blatant disregard for the applicable legislation(s). While the intent of the CE mark is to ensure free circulation, simply applying it without taking the appropriate measures to comply does not provide unbridled access to the EU Market.

Should you choose to take the risk to ship product to Europe which has not followed the required path to compliance as detailed above, you should also be prepared for the consequences.

The main consequences include, but are not limited to:

  • Being publicly reported to the RAPEX
  • Warehousing Fees
  • Requested Withdrawal
  • Mandated Withdrawal
  • Product Recall (from end-users and/or the market)
  • Complete ban on marketing of the product
  • Destruction of the product
  • Fines
  • Revocation of the CE Marking

Ultimately, the prescribed actions that are to be taken in the case that a product is found to be non-compliant will vary depending on the EU Competent Authority which identified the breach, the EU Member State, cooperation from the brand owner and the actions taken by the appointed Authorized Representative. Above all else, the professionalism and expertise of the appointed Authorized Representative in dealing with various Competent Authorities and handling such situations play a vital role in the successful recovery of your brand in the EU Market.


Interested in learning more about cosmetic compliance in the EU Market? Contact us now!

Get in touch