On July 11, 2013, the previously applicable legal regulations were superseded by Regulation (EC) No. 1223/2009 (EU Cosmetics Regulation). The EU Cosmetics Regulation primarily affects manufacturers, importers, and distributors of cosmetic products.
The EU Cosmetics Regulation has established uniform rules that every cosmetic product made available on the market must comply with.
The Regulation aims to ensure the proper functioning of the internal market and a high level of human health protection.
Cosmetic products within the meaning of the EU Cosmetics Regulation are substances or mixtures intended to be placed in contact externally with the parts of the human body (skin, hair system, nails, lips, and external intimate organs) or with the teeth and the mucous membranes of the oral cavity, with a view exclusively or principally to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition, or correcting body odours.
In the context of distribution and sale, all distributors, importers, and manufacturers must comply with the provisions of the EU Cosmetics Regulation. It must also be noted that there are no transitional provisions until the full applicability of the EU Cosmetics Regulation. Therefore, cosmetic products placed on the market since July 11, 2013, must, without exception, comply with the requirements of the EU Cosmetics Regulation.
Particular innovations in connection with the EU Cosmetics Regulation include stringent requirements for the labelling of ingredients. Distributors now have due diligence obligations to fulfil. For instance, they must verify whether the minimum durability date of the products has expired and whether the products are adequately labelled in accordance with the Regulation. Furthermore, distributors are subject to numerous other obligations, all of which must be observed. There is also now a regulated framework for advertising claims.
There is also an obligation to have a safety assessment carried out for each individual product. A product information file must also be maintained for each cosmetic product placed on the market. Furthermore, sampling and analysis of cosmetic products must be carried out reliably and reproducibly. There are also provisions regarding the traceability of products in the market. A reporting obligation for undesirable effects in cosmetic products also exists.
A Europe-wide product-related notification procedure, known as notification, has also been introduced. According to the EC Cosmetics Regulation, only cosmetic products that have been previously notified may be distributed since July 11, 2013. Without notification, cosmetic products are not marketable and may not be distributed. Until July 10, 2013, cosmetic products distributed in Germany could optionally be reported to the Federal Office of Consumer Protection and Food Safety or to the EU Notification Portal for Cosmetic Products (CPMP). Since July 11, 2013, notification must be made exclusively via the EU Notification Portal.
We also clarify that cosmetic products that were placed on the market before July 11, 2013, and continue to be distributed after July 11, 2013, are also subject to the notification obligation.
In summary, it can therefore be stated that the enactment of the EU Cosmetics Regulation has brought about significant changes in the distribution of cosmetics. As the provisions of the EU Cosmetics Regulation are likely to constitute market conduct rules within the meaning of the Act Against Unfair Competition (UWG), violations of the Regulation are subject to warning letters, inter alia, from competitors and relevant associations.
Therefore, as a manufacturer, importer, or distributor of cosmetic products, you should ensure that you comply with the provisions of Regulation (EC) No 1223/2009 (EU Cosmetics Regulation) in the context of distributing cosmetic products.
Please do not hesitate to contact us should you have any further questions on this matter.
Goldberg Attorneys 2013
Attorney Michael Ullrich, LL.M. (Information Law)
Specialist Lawyer for Information Technology Law (IT Law)
Email: info@goldberg.de
