Industry information

Overview of foreign cosmetics safety evaluation management measures

2020-08-20 10:11:36 Joes

The EU has a relatively complete cosmetics safety evaluation management system. The cosmetic safety evaluation guidelines issued by the European Commission for Consumer Safety (SCCS) have been used for reference by regulatory authorities in many countries and regions. According to EU "Cosmetic Regulation 1223/2009", listed cosmetics must be safe for consumers under normal, reasonable and foreseeable conditions. At the same time, the regulations clarify that ensuring the safety of cosmetics is the duty of the person responsible for cosmetics. The person responsible for cosmetics should entrust professional safety assessors to conduct safety risk assessments on the products and their raw materials. The responsible person should be responsible for the safety of the products and their raw materials and keep relevant Security risk assessment materials.


The EU’s "Cosmetic Regulation 1223/2009" requires that before cosmetics are put on the market, the person responsible for cosmetics should ensure that the cosmetics have completed the safety risk assessment according to relevant requirements, and the cosmetics safety risk assessment report should comply with the relevant requirements of Appendix I of the EU "Cosmetic Regulation 1223/2009" Claim. In addition, the EU "Cosmetics Regulation 1223/2009" also specifically emphasizes that the safety of products must be professionally evaluated by safety assessors with relevant qualifications to ensure product safety. As part of the Product Information File (PIF), the cosmetic safety risk assessment report should be updated in real time and available for review by the regulatory authorities at any time.


   In order to help cosmetics companies better understand the relevant requirements of Appendix I of the EU "Cosmetics Regulation 1223/2009", the European Commission has specially formulated the "Commission Implementation Decision-Guidelines on Appendix I". It is worth noting that the EU "Cosmetics Regulation 1223/2009" does not directly describe the requirements of product microbiological indicators, heavy metals and other risk substance management limits, but it requires cosmetic safety risk assessment to consider the impact of these factors on product safety and risk assessment.


   United States In the United States cosmetics regulatory system, there are no specific requirements for safety evaluation, but in the actual supervision and related regulations, the requirements for the safety evaluation of cosmetics are reflected.


  In the United States, cosmetics manufacturers or distributors are responsible for the safety of cosmetics. The US Food and Drug Administration (FDA) website makes it clear that cosmetics manufacturers or individuals are legally responsible for product safety.


   In terms of the safety of final cosmetic products, the United States requires that cosmetic products and their ingredients be safe under the intended use. The US Food, Drug and Cosmetic Act stipulates that it is prohibited to trade adulterated, shoddy and mislabeled cosmetics; cosmetic containers or products must not contain substances that may cause harm during use (except coal tar hair dyes), and must not contain polluting or rotten substances , Do not use colorants in violation of regulations, and do not produce, pack or store under unsanitary conditions.


  Related departments in the United States have issued a list of banned or restricted raw materials. For new raw materials, except for colorants, the United States has not established a licensing management system. According to the relevant US regulatory system, the FDA has no mandatory requirements on the test methods used by companies to ensure the safety of cosmetic raw materials, nor is it mandatory for companies to submit corresponding materials, but cosmetics companies need to hold detailed materials on the safety of raw materials.


   The United States does not have specific requirements for the limit of microbes in cosmetics, but the FDA has issued microbiological detection and analysis methods. Regarding the limits of risky substances such as heavy metals in cosmetics, the United States has stricter requirements for mercury content. In addition, because asbestos is a type of carcinogen, the FDA stipulates that asbestos should not be contained in talc for cosmetics.


   Japan Japanese cosmetics regulations require that cosmetics companies are responsible for product safety, and companies must evaluate and record the safety of products before they are put on the market. In terms of product safety risk assessment, Japan follows the principle of self-management by enterprises. Except for compliance with the relevant laws and regulations on the quality, efficacy and safety of pharmaceuticals, medical devices, etc., regulatory authorities do not make other requirements. The "Cosmetics Safety Evaluation Guidelines" (2008) issued by the Japan Cosmetic Industry Federation recommends that the safety of cosmetics should be evaluated on a product basis.


  In Japan, final cosmetic products must meet the requirements of Japan's "Cosmetic Standards", and products that have deteriorated, mixed with foreign matter, or are contaminated by microorganisms must not be sold. Cadmium compounds, mercury and its compounds, strontium compounds, selenium compounds, and methanol are listed as prohibited components in Japan's "Cosmetic Standards". In addition, according to the "Quality Management of Talc Powder" in Japan, when talc is used as a raw material in cosmetics or quasi-drugs, it must be used after confirming that it does not contain asbestos according to X-ray analysis; if the raw material has not been tested, it must be used. Test the finished product. For other risky substances, although the relevant Japanese laws and regulations have no limit provisions for the time being, they require companies to bear the responsibility for quality and safety.


   Some products in Japanese quasi-drugs are cosmetics in my country. According to Japan's "Licensing Application for Quasi-Drugs, etc.", companies need to determine whether the quasi-drugs contains new functional ingredients or new additives (non-functional ingredients), whether they are new dosage forms, new contents, new compatibility, and new usage. Etc., submit different degrees of physical and chemical analysis, stability and toxicology test reports.