Cosmetic Products Regulation

Cosmetics Regulation (EC) No. 1223/2009 explicitly addresses nanomaterials in cosmetic products. If a cosmetic product contains nanomaterial, which is clearly defined in the regulation, the responsible person ((i.e. manufacturers, importers or third persons appointed by them) of the product should submit both general and nano-specific information to the European Commission (EC), via the Cosmetic Products Notification Portal (CPNP), six months before the product being launched on the market. If EC raises concerns about the safety of the nanomaterial in the product, EC shall request the Scientific Committee on Consumer Safety (SCCS) to perform a thorough risk assessment of such nanomaterial for use in the product, within six month. For nanomaterials that are not yet included in Annexes III, IV V, or VI of the Cosmetics Regulation (i.e., have not yet undergone a full risk assessment by the SCCS), the responsible person should provide the EC with at least the following information: i) the identification of the NM;  ii) the physicochemical characteristics of the NM;  iii) an estimation of the annual quantity of NM, intended to be placed on the market through the cosmetic product; iv) the toxicological profile of the NM; v) the reasonably foreseeable exposure conditions; and vi) the safety data of the NM and its respective risk assessment. Taking into account the risk assessment conclusion from the SCCS, the EC may amend Annexes II (List of substances prohibited in cosmetic products) and III (List of substances which cosmetic products must not contain except subject to the restrictions laid down). Exceptions are cosmetic products that contain nanomaterials that are approved as colorants, UV filters or preservatives, they must be authorised by the European Commission prior to their use in cosmetic products. All nanomaterials in the cosmetic product should be clearly indicated in the list of ingredients. The names of such components shall be followed by the word ‘nano’ in brackets.

Apart from the risk assessment which forms the basis for regulatory decisions, SCCS is also responsible for providing and updating the guidance for the safe use of nanomaterials in cosmetic products. For example, SCCS published Checklists for Applicants Submitting Dossiers on Cosmetic Ingredients, including a schematic outline for the safety assessment of nanomaterials and minimum information requirements of nanomaterials used in cosmetics, as well as the Guidance on the Safety Assessment of Nanomaterials in Cosmetics, and the latest version of the SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation.

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