The scientific Committee of the European Commission on consumer safety (SCCS) has published updated guidance for the safety assessment of nanomaterials in cosmetics. This document updates the Guidance SCCS 2012 (SCCS / 1484/12). Recall that before the EU changed the rules for salicylic acid and climbazole.
The new regulation covers the principal elements of the safety assessment – General provisions (section 2), characteristics of the material (section 3) impact assessment (section 4), hazard identification and characterization the dose-response (section 5) and risk assessment (section 6). The guide includes key considerations for the safety assessment of nanomaterials intended for use in cosmetics.
The regulatory definition of nanomaterial is given in the Cosmetics regulation (EC) No. 1223/200. SCCS suggests that when assessing the safety of a material consisting of small particles, applicants should also consider the recommendation of the EU (2011/696/EU). “If new or already approved cosmetic ingredient complies with the criteria for determining it as a nanomaterial, it will be evaluated based security data related to nanoscale properties”, – say the representatives of the SCC.
As a minimum, applicants must provide specifications on all these parameters, which are related to the nanomaterial. According to the Manual, the characteristics of the nanomaterial need to be defined at the stage of raw materials in the cosmetic composition, and during exposure for Toxicological evaluations. The Guidance States that SCCS may request a detailed description of the production processes, any surface modifications, and the preparatory steps carried out for integrating the nanomaterials in the final cosmetic products, as input to the security evaluation process.
The safety assessment of nanomaterials produced according to the same procedure as for non-nanoscale ingredients, but with special reference to the aspects of nanorazmernoi. In accordance with the guidance of the SCCS considers that the method of calculation of the impact of nanomaterials on the skin and oral will not materially differ from the calculation of the impact of traditional cosmetic ingredients. In the new regulation it is noted that the calculation of the effect of aerosols containing nanomaterials may be more difficult.
SCCS will require data Toxicological studies. According to the Manual, testing nanomaterials to determine the risk or characteristics of the dose-response should be performed taking into account aspects related to nanotechnology. The Guide noted that, historically, the calculation of the safety of a cosmetic ingredient based on the measured Toxicological point of departure, as well as on the evaluation of internal exposure, in terms of dose and systemic exposure.
The Guide recognizes that in connection with the European Union ban on testing cosmetic ingredients and products on animals, the conclusion on the systemic side effects of a new cosmetic ingredient may not be possible or possible only in exceptional cases.
However, the data obtained for compliance with other cosmeticscop standards should be used and provided to the extent possible. In other cases, the applicant will be required to collect relevant information and data from various alternative (non-animal) methods, and to combine these data to create an overall weight of evidence in support of the safety of cosmetic ingredients.
SCCS notes that in connection with the evolving nature of studies on the safety of nanomaterials, it may revise the Guidance in future to reflect any new scientific knowledge.