1. Cosmetic Raw Materials Data Usage Guide contains seven main types of raw material data. Is there a weight order relationship between the various evidence types?
Raw materials that are restricted components, permitted preservatives, permitted sunscreens, permitted colorants, and permitted hair dyes in the Cosmetic Safety Technical Specifications shall meet the relevant requirements of the Cosmetic Safety Technical Specifications, that is, evidence type (I) among the seven types of evidence. Other raw materials can use any of the remaining six types of evidence in combination with the characteristics of the raw materials and actual conditions, and there is no weight order relationship between the above six types of evidence.
2. If a product formula contains a plant extract, and the plant is in the "Chinese Food Composition Table", is it only necessary to provide evidence to prove that the plant is in the "Chinese Food Composition Table" to exempt the systemic toxicity of the plant extract?
If only the evidence of the plant in the "Chinese Food Composition Table" is provided, and it cannot be proved whether the plant extract is mixed with other risky substances in the production process, such as risky extraction solvents, the systemic toxicity of the plant extract cannot be exempted. In accordance with the relevant requirements of the Cosmetic Raw Material Data Usage Guide, raw materials with a history of safe consumption should also be fully studied on their consumption history, production processes, etc., to ensure that the raw materials or raw materials used to prepare the raw materials have safe edible characteristics.
3. What is the difference between the 3-year use history of raw materials in the full version of the safety assessment and the evidence type 3 in the simplified version of the safety assessment?
The biggest difference between the two is that the assessment basis for the 3-year use history of raw materials in the full version can be raw materials that have a use history of more than 3 years (including 3 years) that is not owned by the company. It should be noted that a letter of authorization issued by the raw material manufacturer or the cosmetics manufacturer using the same raw material should also be provided. In addition, the 3-year use history of raw materials in the full version further clarifies the criteria for determining the same raw material, that is, the serial number is the same in the catalog of used cosmetic raw materials (2021 edition), and proof materials that the raw material is the same need to be submitted. At the same time, it is clearly required to provide proof of market sales data. The cosmetics registrant should analyze the sales situation, and the results can reflect the safety of the raw material in the population.
4. When a cosmetics filing person conducts a compatibility assessment between cosmetics and packaging materials, is it necessary to conduct research in accordance with the Technical Guidelines for Compatibility Testing and Assessment of Cosmetics and Packaging Materials?
The compatibility assessment methods for cosmetics and packaging materials by cosmetics registrants include but are not limited to extract study reports on packaging materials using appropriate simulant liquids, historical safety data or reports of cosmetic products, compatibility study reports on cosmetic packaging materials based on food, drug or self-developed methods, and comprehensive evaluation of cosmetic safety reports based on data or statements or quality control reports provided by suppliers, as well as cosmetic stability test results. Cosmetics registrants can use one or more of these methods to assess the compatibility of cosmetics and packaging materials. If the cosmetics registrant is unable to provide the above safety assessment information or finds that the cosmetics interact with its packaging materials and affect the quality and safety of the cosmetics, relevant research should be conducted in accordance with the Technical Guidelines for the Compatibility of Cosmetics and Packaging Materials.
5. What are the drug and food-related standards that cosmetics filers can refer to when conducting compatibility assessments between cosmetics and packaging materials?
Drug-related standards mainly include:
Guidelines for Compatibility Tests between Pharmaceutical Packaging Materials and Drugs YBB00142002-2015
Technical Guidelines for Compatibility Studies between Chemical Injections and Plastic Packaging Materials (Trial)
Technical Guidelines for Compatibility Studies between Chemical Injections and Elastomer Seals (Trial) and Technical Guidelines for Compatibility Studies between Chemical Injections and Medicinal Glass Packaging Containers (Trial), etc.
Food-related standards mainly include:
GB31604.1-2023 National Food Safety Standard General Rules for Migration Tests of Food Contact Materials and Products
GB4806.1-2016 National Food Safety Standard General Safety Requirements for Food Contact Materials and Products and GB5009.156-2016 National Food Safety Standard General Rules for Pretreatment Methods for Migration Tests of Food Contact Materials and Products, etc.
In addition, the GB31604 series of standards also include the determination of harmful substances such as heavy metals and phthalates for reference.
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