October 19, 2010, SFDA (State Food and Drug Administration) held the "Training on Data Requirements for Notification of Cosmetic Safety Risk Assessment". Over 200 representatives from cosmetics industry participated in this training.
Firstly, the Division Head Liu Baojun clarified the definition of risk substances in the Guide for Risk Assessment of Possible Substances with Safety Risks in Cosmetics and highlighted that dangerous substances should be brought in from raw materials, produced or introduced during the production process. Then he introduced the current status of submission since the effective date of the new regulations on April 1st and explained SFDA's opinions of examination and approval point by point.
In April there is no submission; in May 9 new products submitted with 8 risk assessment rejected; in June 56 new products submitted with 4 disapproved and 52 required for additional information; in July 50 new products submitted with 8 disapproved and 42 required for additional information; in August 39 new products submitted with 3 disapproved and 36 required for additional information; in September 64 new products submitted with all required for additional information. At the beginning risk assessment was understood just as a simple promise by companies. Due to a lack of comprehensive analysis for their products, the submissions were almost rejected. From July the situation has been improved and the dossiers submitted become more compliant with the new regulation. Based on additional information, evaluation experts will give more detailed comments and the requirements for additional information will also be increasingly specific.
The Division Head Chen Shaozhou interpreted the terms of Guide for Risk Assessment of Possible Substances with Safety Risks in Cosmetics. Overall, officials hope the implementationion of new Measures facilitates the submissions of companies and is not confined to form. However, for Chinese local companies, the risk assessment is actually a process of information collection and literature review by companies and assessment based on these, due to weak research capacity and few cases of developing and using new raw ingredients.
Information submitted focus on the source of the dangerous substance, an overview of the substance (chemical, biological properties), the concentration of the dangerous substance, test reports and so on.
Companies need to note that although the assessment proceeds from certain or some raw ingredients, the risk assessment of substances in cosmetics aims at the whole product. SFDA took up the management of cosmetic ingredients from September 2008 and has issued related regulations. New cosmetic ingredients shall meet the examination and approval requirements for raw ingredients, which is more difficult than the risk assessment of final cosmetic products.
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