In an Opinion issued to manufacturers on July 24, 2017, the French National Agency for Medicines and Health Products Safety (ANSM) reminds manufacturers and Responsible Persons that cosmetic products may be added to other cosmetic products, if, and only if a safety assessment was carried out in accordance with the provisions of Cosmetic Regulation 1223/2009, for every single mixture recommended.
Text of the ANSM Opinion issued to manufacturers
Throughout their campaign of inspections focused on tailor-made cosmetic products, ANSM highlighted the fact that some companies market cosmetic products like ‘boosters’, about which labels and sales literature read they may be mixed by consumers with any other cosmetic product of a given category, for example, any skincare milk or cream, to get a personalized cosmetic product.
Under Article 3 of the Cosmetic Regulation, a cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use, taking into account, in particular, the product labelling and instructions for use.
As regards this point, in accordance with Articles 10 and 11 of the Cosmetic Regulations, the Responsible Person shall, prior to placing a cosmetic product on the market, ensure it has undergone a safety assessment and a cosmetic product safety report is set up.
As a result, such products may be made available on the market only if the safety assessment carried out beforehand guarantees every single mixture recommended is safe for human health (Recital 4, Articles 3, 10, and 11, paragraph 2.b of the Cosmetic Regulation).
In conclusion, ANSM reminds manufacturers …
