Guidance

The scope of this KPI includes company-level activities for manufacturers that sell beauty and personal care products in the United States. Company-level activities for products sold in other regions are not to be considered.


Final formulations, not packaging materials are in scope for this KPI.

  • For B, ingredient risk assessments must consider the aggregate exposure to individual ingredients from all products that are sold by a manufacturer and arrive at an acceptable margin of safety.  These risk assessments should take into action exposure to vulnerable populations such as children under the age of three, the elderly, pregnant and breast-feeding women, and people with compromised immune systems (as described in the EU Cosmetic Products Regulation (EC) No. 1223/2009).  


Product-level risk assessments must be performed for all products that are sold by a manufacturer and must account for interactions between individual ingredients in final formulations to justify safe use by consumers.


Resources for performing risk assessment, formulating products for adequate microbiological protection, and post-market safety surveillance include, but are not limited to, those listed in the Resources section.


Resources

The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation - 9th Revision: The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation is a document compiled by the members of the Scientific Committee on Consumer Safety (SCCS). The document contains information on the different aspects of testing and safety evaluation of cosmetic substances in Europe, with an emphasis on cosmetic ingredients and finished products. It is designed to provide guidance to public authorities and to the cosmetic industry in order to improve harmonized compliance with the current cosmetic EU legislation.


European Chemicals Agency Guidance on Information Requirements and Chemical Safety Assessment (ECHA): This guidance document describes the information requirements under REACH with regard to substance properties, exposure, use and risk management measures, in the context of the chemical safety assessment.


Microbiological Safety and Cosmetics: The FDA provides guidance and resources on Microbiological Safety for Cosmetics such as Good Manufacturing Practice for Cosmetics, Microbiological Methods for Cosmetics, and Product Testing.


Cosmetics Europe The Personal Care Association: Cosmetics Europe is the European trade association for the cosmetics and personal care industry and provides information on ingredient safety assessment, manufacturing according to good manufacturing practices, marketing, labeling, and market surveillance. 


Definitions

Risk assessment: A systematic process to evaluate the potential risks associated with consumer exposure to individual ingredient hazards or final formulations when used in products under conditions of instructed use or foreseeable isuse.


Postmarket surveillance: The practice of monitoring the safety of beauty and personal care products after they have been released on the market.