The new EU Cosmetics Regulation No. 1223/2009 will go into full effect on July 11th 2013, and will replace the Cosmetics Directive (76/768/EEC) which ensured free circulation of cosmetic products throughout the EU, as well as a high protection of consumers. The new EU Cosmetics Regulation sets out more detailed requirements regarding the Cosmetic products and aims to harmonize national regulations among the 27 European member states.
What are the consequences for Cosmetics companies?
Some of the major changes are the implementation of well-defined minimum requirements for cosmetic product safety reports (according to Annex I of the EU Cosmetics Regulation No. 1223/2009). Additionally, there must be a “product information file” prepared for each cosmetic product. This file has to be stored for 10 years after the product has been withdrawn from the market. And some further new details are described in the following explanation.
A “responsible person”, based in Europe, must be appointed for each marketed cosmetic product. This means e.g., if a cosmetic product is manufactured in the EU, the manufacturer is (automatically) the “responsible person”. This person is responsible for ensuring certain safety requirements, which involves for each product keeping an up-to-date “Product Information File” readily accessible to authorities which should contain e.g.:
Then, there is a need for a system which must enable the identification, the analysis and the reporting of all serious undesirable effects of a cosmetic product to the authority. These cosmetics safety systems are usually called “cosmetovigilance systems”.
And after collection and qualification of all mandatory data to safely describe the cosmetic product according to the EU Cosmetics Regulation No. 1223/2009, these data have to be notified to the EU via the “Cosmetic Products Notification Portal” (CPNP). This applies to products that were placed on the market under the previous Cosmetic Directive and to any new cosmetic products introduced in the EU.
How can ProductLife support Cosmetics companies?
ProductLife has the expert knowledge and an expert team, who supports different Cosmetics companies also on implementing this new EU Cosmetics regulation. ProductLife can provide the following support:
For manufacturers and suppliers who are producing cosmetic dossiers documentation currently "in-house" and who are relying on the services of a safety assessor, the financial impact will potentially be significant in preparation for July 2013/post 2013, depending on the level of "in-house" expertise available.
ProductLife can provide services and resources at the client´s site or fully outsourced from its own sites or propose a combination of both solutions, depending on the project itself.
What are the risks for Cosmetics companies not to be compliant with the Cosmetics Regulation?
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2–3 December 2014, Drug Information Association 15th Conference on European Electronic Document Management (eDM), Berlin
14–16 October 2014, Cosmetic Compliance Summit, London
13–15 October 2014, TOPRA 2014 Annual Symposium, Brussels