Cosmetic Color Regulation in Europe

Color is an extremely important component within the cosmetic industry, but manufacturers sometimes find it difficult to fully understand the regulations that surround color and colorants.  Cosmetic Design-Europe recently interviewed the Dr. Chris Flower of the Cosmetics Toiletry and Perfumer Association (CTPA) to take a better look into the legislation in Europe in regards to these ingredients.

In Europe, cosmetics colorants are regulated under the European Cosmetic Products Regulation (EC) No 1223/2009 which states that only the colors listed in this legislation Annex IV are permitted for use in cosmetics.  As defined in the Regulation, cosmetic colorants are “substances which are exclusively or mainly intended to color the cosmetic product… in addition, precursors of oxidative hair colorants shall be deemed colorant”.  The team at the CTPA has stated that manufacturers are allowed to generate color by another means, meaning that it would not be subject to the need to be on Annex IV however they must still be safe.  In some cases, there are specific purity criteria which apply to certain colorants in Annex IV and in some cases some colors may not be used for certain product types.  Therefore, the bottom line is that any colorant that is not listed in Annex IV to the Regulation may not be used in cosmetics and placed on the European market.

CTPA Director-General Dr. Chris Flower told Cosmetic Design- Europe that a number of errors crept into the colors annex when the Cosmetic Products Directive changed to the current Regulation which has led to some real problems with manufacturers.  In order to add new colors and be approved, a file of safety information has to be submitted and assessed by the European Commission’s Expert Scientific Committee making this sometimes problematic.  Currently, Regulation No 1223/2009 has prohibition on animal testing and manufacturers are not allowed to sell cosmetics that contain ingredients that have been tested on animals.  However, in order to prove that the ingredients are compliant with the Cosmetic Products Regulations, animal testing is almost necessary to provide adequate data.

In conclusion, the main problem here is that it is very difficult to get new colors approved due to the fact that with having no data means the EC will not grant approval.  Yet with the current regulation, in order to generate adequate data the cosmetic will most likely be banned from use due to the level of testing required.  This leaves Europe in a tough situation and future regulations must be adapted for this industry.

As a company that has been working as Cosmetic Regulatory Consultants for over 20 years, we offer an immense knowledge regarding these regulations.  Our Focal Point Research team have been successful in this industry because we combine both scientific and regulatory knowledge into our practice. We are the Regulatory Consultants that you should trust to be knowledgeable and honest about your product.