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The new EU Cosmetics Regulation

Legal Text and New Changes

There is a new EU legislation – Regulation 1223/2009 – governing the laws on cosmetics throughout the European Union. This will fully replace previous EU legislation on this subject, namely Directive 76/768/EC, from 11 July 2013. Some provisions already apply. The main changes introduced by the new EU cosmetic regulation include:

o Preparing an Information File (PIF): The Cosmetics Regulation clarifies the format and content of the product safety assessment. Beginning in July 2013 all dossiers will have to be in line with Annex I of the new Regulation.

o Product Labeling: The presence of nanomaterials must be indicated with the term “nano” (in brackets) after the ingredient. For example: Titanium Dioxide [nano]

o Product Notification: Beginning in January 2012, a new, simplified and centralized system will replace the current national competent authority notification process. This new system will be at the EU level, requiring a company to notify the European Commission electronically. This notification system will be mandatory by July 2013.

o Designation of a “Responsible Person”: Beginning in July 2013, cosmetics companies will be required to have a designated legal or natural person within the EU – known as a “responsible person” – if they wish to have products placed on the European market. This person is charged with handling the dossiers of cosmetics companies as well as ensuring compliance of a product with all the requirements of the new Cosmetics Regulation.

Market Research Report on the EU Cosmetics Regulation

Our market research on the subject of cosmetics now covers the updates due to come into effect through Regulation 1223/2009.

Business Service Providers

Below is a list of consultants for those seeking assistance in ensuring compliance with the Cosmetics Regulation. Those marked with an asterisk also provide “Responsible Person” services.

EcoMundo *

CE.way Regulatory Consultants Ltd *

Compliance Services International (CSI) *

Contact Information:

If you have additional questions not covered on this website, please send an email to the following address: Office.BrusselsEC@trade.gov and reference "Cosmetics Inquiry" in the subject line. One of our specialists will respond to your inquiry as soon as possible.