EU Cosmetic Law

Institute Dr. Schrader

EU Cosmetic Law

Why safety assessment and safety report are required?

Since the July 11th, 2013 the EU Cosmetic Regulation (EC) No 1223/2009 of the European Parliament and of the Council of November 30th, 2009 on cosmetic products is in full force in the member states of the EU and replaces the previous national legislation, where safety assessments were already required by law.

Contrary to pharmaceutical drugs cosmetic products are not subject to registration and must not pass an interminable official licensing process. The health and safety of cosmetic products shall be confirmed by a safety assessor prior to bringing them on the market. The safety assessor performs an evaluation of the ingredients contained, considering their toxicological profile and the conditions of use of the product. Special user groups, such as children are of specific consideration. Article 10 of the regulation (EC) No 1223/2009 calls:

“In order to demonstrate that a cosmetic product complies with Article 3, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I.”

The preparation of safety assessments for cosmetic products is required by law since 1993 (6th Amendment to the Cosmetics Directive 76/768/EEC).

With the regulation (EC) No 1223/2009 of the European Parliament and of the Council of November 30th, 2009 on cosmetic products the requirements of the documents are specified in more detail.

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