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New Regulation on Cosmetic Products


From today, 12 July 2013, cosmetic products in the EU are ruled by Regulation (EC) No 1223/2009, replacing the old “Cosmetics Directive” 76/768/EEC.  

The switch to a regulation was necessary, due to the many amendments made to the Directive.


The new Regulation introduces some new rules to improve consumer information and safety of cosmetic products (see below). However, concerning animal welfare, Regulation 1223/2009 will not lead to many changes. Just like the Directive, it provides the prohibition of animal testing in the European Union for finished products, ingredients or combinations of ingredients as well as the placing of such products and ingredients on the EU market. The safety testing of products and new ingredients must be replaced by alternative non-animal based methods.


Nevertheless, legally the new regulation differs a lot from the old Directive. While a regulation enters into force immediately, a directive has to be transposed into national law by the Member States which often causes delays and different interpretation of the text, as shown in the case of Directive 2010/63/EU on the protection of animals used for scientific purposes. When the Directive entered into force on 1 January 2013, the majority of Member States had not fully transposed the legislation into national law. Even today, seven months later, there are 12 Member States which have not ended the process of transposition.


So from today, the rules stated in Regulation (EC) No 1223/2009 are directly applicable in all Member States.


The changes introduced by the new Regulation concern the improvement of consumer protection in general, not animal welfare in particular. The new rules shall combat misleading information and ensure product safety:


-          Stronger safety requirements for cosmetic products

Until now, manufacturers had to provide an information file for each product including the safety assessment. From now on, they also need to state their reasoning behind the conclusions they draw from the safety assessment.


-          responsible person for each product

A cosmetic product can only be placed on the EU market if a legal or natural person, the so called ‘responsible person’ is clearly designated to it. By this, responsibilities and obligations like keeping the product information file, which includes the safety assessment, can clearly be traced to one person.


-          More Consumer friendly labeling

All nanomaterials must be indicated on the list of ingredients of a product.

Manufacturers wanting to put a claim on their product like ‘48hrs efficiency’ will have to fulfill certain criteria beforehand to avoid misleading information. 


-          Centralized information portal for all cosmetic products in the EU

One centralized notification portal for all cosmetic products placed on the EU market. Before, they were on a national level. Now, information is stored centrally and can be retrieved within seconds in all EU Member States. 


-          Reporting serious undesirable effects

The responsible person is obliged to report serious undesirable effects to national authorities; the authorities have to collect and share this information among all Member States.