Obelis European Authorized Representative Center (O.E.A.R.C.)

Consolidated Cosmetic Directive 76/768/EEC Results in New Requirements

Consolidated Cosmetic Directive 76/768/EEC—-New Requirements

The recent publication of the Consolidated Cosmetic Directive 76/768/EEC on 18 February 2005 has brought new requirements to cosmetics manufacturers. Some of the main additions to this Directive include Annexes II and III, which contain an even more comprehensive list of prohibited products. Also, this directive contains new obligations concerning the labeling of the product’s validity date. Specifically in Article 6.1c of CCD 76/768/EEC it states that

“the date of minimum durability shall be indicated by the words “best used before the end of” followed by either:
- the date itself, or
- details of where it appears on the packaging.
The date shall be clearly expressed and shall consist of either the month and year or the day, month, and year in that order. If necessary, this information shall be supplemented by an indication of the conditions which must be satisfied to guarantee the stated durability.

Indication of the date of durability shall not be mandatory for cosmetic products with a minimum durability of more than 30 months. For such products, there shall be an indication of the period of time after opening for which the product can be used without harm to the consumer. This information shall be indicated by the symbol given in Annex VIIIa followed by the periods of (in months and/or years).”

In addition, two amendments were published on 20 June 2005 and the other on 9 September 2005 respectively. These publications amend the 76/768/EEC Directive concerning cosmetic products for the purpose of amending Annexes II, III, IV, and VI regarding technical progress.

For more information on how the Consolidated Cosmetic Directive will affect your products, please contact Obelis European Authorized Representative Center (O.E.A.R.C.) today.

Obelis O.E.A.R.C. has over 17 years of experience offering superior regulatory compliance consulting to manufacturers of medical devices, in-vitro medical devices, and cosmetics worldwide. Contact us for more information.

Please visit Obelis, s.a. at Medica 2005 in Hall #13, Booth #A14.

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