Cosmetics Directive Covered by Obelis

On the 30th of November 2009, the new European Cosmetic Regulation, EC 1223/2009, was published in the official journal of the European Commission, hence putting it into force. The EC 1223/2009 is aimed at replacing the current Cosmetics Directive 76/768/EEC.

Read more: Cosmetics Regulation EC 1223/2009

To ascertain a better functioning of the European cosmetic market and a higher level of user protection, the New Regulation establishes a set of rules to be fulfilled by every cosmetic product to be placed on the market. This ensemble of guidelines stands for “compliance”, a confirmation that the cosmetic product to be commercialized meets the requirements of safety set out in the Regulation.

Read more: Compliance with EC 1223/2009

      -  “Only cosmetic products for which a legal or natural person is designated within the community as ‘responsible person’ shall be placed on the market” (Art.4, p.4).

As clearly indicated by the EC 1223/2009, designating a Responsible Person is a mandatory requirement.

Read more: Responsible Person EC 1223/2009

The new Cosmetics Regulation EC 1223/2009 clarifies requirements for safety of a cosmetic product and includes clearer requirements for manufacturers to compile an encompassing Product Information File prior to placing a cosmetics product on the European market. Improvements compared with the Cosmetic Directive 76/768/EEC:

Read more: Safety Tests EC 1223/2009

Prepared between 2002 and 2006 by ISO Technical Committee 217, Working Group 6, the ISO standard 22716:2007 was published in November 2007.
While being an international standard, ISO 22716:2007 was adopted by the European Committee for Standardization (CEN) to become also a European Harmonized Standard (as published in the Official Journal of the European Union on April 21st 2011 - 2011/C 123/04) in reference to the implementation of Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products.

Read more: CEN/ISO 22716:2007 – cGMP

The Cosmetics Directive 76/768/EEC was published on July 27, 1976. It allows cosmetic products in the European Economic Area to circulate freely and ensures their safety for use. A cosmetic product is any substance intended to make contact with external parts of the human body, or inside the mouth, with the intention of cleaning or perfuming them, changing their appearance, correcting odors, protecting them or maintaining their good condition. These products must not be harmful to health when used under normal conditions.

Read more: Cosmetics Directive 76/768/EEC

The Directive

The NEW Directive

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

Read more: Compliance with 76/768/EEC