On 11 July 2013, Regulation (EC) No. 1223/2009 (EU Cosmetics Regulation) replaced the previously applicable legal regulations. 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 meet.
The Regulation aims to ensure the functioning of the internal market and a high level of health protection.
Cosmetic products within the meaning of the EU Cosmetics Regulation are substances or mixtures intended to come into contact externally with the parts of the human body (skin, hair system, nails, lips and external intimate regions) or with the teeth and mucous membranes of the oral cavity for the sole or predominant purpose of cleansing them, perfuming them, changing their appearance, protecting them, keeping them in good condition or influencing body odour.
In the context of distribution and sales, all distributors, importers and manufacturers have to comply with the regulations of the EU Cosmetics Regulation. It must also be taken into account that there are no transitional arrangements until the EU Cosmetics Regulation is fully applicable. Cosmetic products placed on the market since 11 July 2013 must therefore comply with the requirements of the EU Cosmetics Regulation without exception.
Particular innovations in connection with the EU Cosmetics Regulation are that there are now strict requirements for the labelling of ingredients. Traders now have to fulfil inspection obligations. Among other things, they have to check whether the best-before date of the products has expired and whether the products are sufficiently labelled in the sense of the regulation. In addition, there are numerous other obligations for traders, all of which must be complied with. There is also now a regulated right to make advertising claims.
There is also an obligation to have a safety assessment carried out on each individual product. A product information file must also be kept on the cosmetic product placed on the market. Furthermore, sampling and analysis of the cosmetic products must be reliable and reproducible. There are also provisions regarding the traceability of products in the market. There is also an obligation to report undesirable effects in cosmetic products.
A Europe-wide product-related notification procedure has also been introduced, the so-called notification. According to the EC Cosmetics Regulation, since 11.07.2013 only cosmetic products that have been notified beforehand may be distributed. Without notification, cosmetic products are not marketable and may not be distributed. Until 10.07.2013, cosmetic products distributed in Germany could be notified either to the Federal Office of Consumer Protection and Food Safety or to the EU notification portal for cosmetic products, CPMP. Since 11.07.2013, a notification must be made exclusively via the EU notification portal.
We would also like to clarify that cosmetic products which have already been placed on the market before 11.07.2013 and which are further distributed after 11.07.2013 are also subject to the notification obligation.
In summary, it can thus be stated that the enactment of the EU Cosmetics Regulation has brought about considerable changes in the context of the distribution of cosmetics. Since the provisions of the EU Cosmetics Regulation are likely to constitute rules of market conduct within the meaning of the Unfair Competition Act (UWG), infringements of the Regulation by competitors and the corresponding associations, among others, are subject to a warning.
Therefore, as a manufacturer, importer or distributor of cosmetic products, you should ensure that you comply with the regulations of Regulation (EC) No 1223/2009 (EU Cosmetics Regulation) in the context of the distribution of cosmetic products.
Please do not hesitate to contact us if you have any questions on this topic.
Goldberg Lawyers 2013
Attorney at Law Michael Ullrich, LL.M. (Information Law)
Specialist lawyer for information technology law (IT law)
E-mail: info@goldberg.de
