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Compliance with the Cosmetics Directive 76/768/EEC

In order to ensure that a cosmetic product complies with the Cosmetics Directive, the following steps must be taken:

  • Classification of the product - this includes making sure that the product is viewed as a cosmetic product by EU regulation, ensuring its safety for use and identifying the relevant laws applicable to the cosmetic product
  • Appoint a European Authorized Representative – the Cosmetics Directive requires an EU representative for non-European manufacturers of cosmetic products who wish to sell within the European Economic Area. An E.A.R. is responsible for placing the product on the market and keeping the product information available to the relevant competent authority. It is also the primary contact for EU authorities.
  • Create technical file – this must include the qualitative and quantitative composition of the product, physic-chemical and micro-biological specifications of the raw materials and the finished product and the methods of manufacture.
  • Prepare a safety assessment – this must show that the product is safe for human use under normal conditions, and must include the name and address of the qualified persons responsible for this assessment.
  • Labelling and language requirements – the name and address of the manufacturer, the nominal content, date of minimum durability, precautions for use, a batch number, the product’s name and function and ingredients.
  • Notify the product to Competent Authorities and Toxic Centres – this may be implemented differently by different EU Member State laws.

For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community.

Non-Compliance

The directive portrays European Law enforced within the European Economic Area (EEA); non-compliance with the directive’s requirements will result in the removal of the product from the EEA.

 

 

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