European Legislation and Responsible Person

Manufacturers exporting cosmetics to the EU before 2013 were in compliance with the EU Cosmetics Directive 76/768/EEC and the EU Cosmetics Regulation EC 1907/2006 after that.

The first practices of EC Cosmetic Regulation EC 1223/2009 started in January 2012. Together with revisions made during the transition from directive to regulation, there have been significant changes in the obligations of companies exporting cosmetic products to the EU.

New Cosmetic Regulation No. 1223/2009 in the European Union entered into force on 11 July 2013. Information included in the Cosmetic Regulation regarding the Safety Assessment when exporting products to the European market and the location of a professional European Responsible Person have become vital. New EU Cosmetics Legislation was accepted on 30 November 2009 and entered into force on 11 July 2013. It consists of 40 articles and 10 appendixes.

Why is the Responsible Person needed? What are the roles and responsibilities of the Responsible Person in Europe?

The Responsible Person is defined in more detail in Article 4.

The Responsible Person is responsible for ensuring that all obligations related to legislative conformity of the product are fulfilled before entering to the European Market and acting as a point of cosmetovigilance contact in Europe for the cosmetic product for which it is responsible.

In daily practice, the Responsible Person must comply with the following acts:

– Should ensure compliance with the requirements of the new regulation (Product Safety Assessment, GMP, Product Information File, notifications, content, labelling, claims and notification of serious undesirable effects),

– Should take immediate corrective measures and take steps such as collection/recall, when necessary in case of non-compliance with the legislation,

– Should ensure informing of the authorities and other operators in case of a risk related to the protection of human health,

– Should submit information and documents to the competent and national authorities to show compliance with the legislation, if necessary, – Should ensure that the competent authorities have access the Product Information File for a period of 10 years after the made available of the last batch on the market.

In Article 5 the duties and responsibilities of the Responsible Person are defined in detail.

– The Person Responsible should ensure that a cosmetic product introduced to the market is in compliance with the directive, if not he/she should take corrective actions such as recalling or withdrawing the product if necessary. If the product poses a threat to human health, he/she should inform the necessary authorities and perform the necessary corrective actions on the product.

– The Person Responsible should be in cooperation with the necessary authorities and competent authorities. He/she should ensure that the competent authorities have easy access to information about the product.

As Pim Group, we provide all of the services listed above through a single channel.