FAQs from Beijing Cosmetics Review and Inspection Center on Ordinary Cosmetics Filing (Vol. 38)

We have collected the latest FAQs on ordinary cosmetics filing from the Beijing Cosmetics Review and Inspection Center and translated them into English for your reference.

1. Does the "Guidelines for the Use of Cosmetic Ingredients Data" specify a hierarchy of weight among the seven main types of ingredient data?

For ingredients classified as restricted components, permitted preservatives, permitted UV filters, permitted colorants, and permitted hair dyes in the "Safety and Technical Standards for Cosmetics", compliance with the relevant requirements is necessary, precisely evidence Type 1 among the seven types. For other ingredients, any of the remaining six evidence types can be used based on the ingredient's characteristics and actual conditions, with no hierarchical weight among these six types.

2. If a product formulation contains a plant extract and the plant is listed in the "China Food Composition", is it sufficient to provide evidence of this listing to exempt the plant extract from systemic toxicity evaluation?

Providing evidence that a plant is listed in the "China Food Composition" is insufficient to exempt its extract from systemic toxicity evaluation. This does not demonstrate whether the extraction process introduces other hazardous substances, such as risky solvents. According to the "Safety and Technical Standards for Cosmetics", ingredients with a history of safe consumption should undergo comprehensive research on their consumption history and production processes to ensure the safety of the ingredients used.

3. When using a complete safety assessment with a 3-year usage history of an ingredient as evidence, how does it differ from Evidence Type 3 in a simplified safety assessment?

The critical difference is that the complete safety assessment allows the use of a 3-year (or more) usage history from other companies as evidence. It requires an authorization letter from the ingredient manufacturer or a cosmetics company using the same ingredient. Additionally, the complete assessment specifies criteria for determining the same ingredient: it must have the same entry number in the "Inventory of Existing Cosmetic Ingredients in China (IECIC 2021)" and proof that it is the same ingredient. It also requires market sales data to be provided, with the cosmetics registrant analyzing sales to demonstrate the ingredient's safety in the population.

4. When conducting compatibility assessments between cosmetics and packaging materials, should cosmetics registrants adhere to the "Technical Guidelines for Compatibility Testing and Evaluation of Cosmetics and Packaging Materials"?

Cosmetic registrants can assess the compatibility between cosmetics and packaging materials through various methods, including but not limited to – conducting extract studies using appropriate simulants, utilizing historical safety data or reports of cosmetic products, compatibility studies based on food, drug, or proprietary methods, data or declarations from suppliers, quality control reports, and comprehensive safety assessments from cosmetic stability tests. Registrants may use one or multiple approaches to evaluate compatibility. If they cannot provide the necessary safety assessment data or if interactions affecting the quality and safety of the cosmetics are detected, they should refer to the "Technical Guidelines for Compatibility Testing and Evaluation of Cosmetics and Packaging Materials" for further studies.

5. What relevant pharmaceutical and food standards can cosmetic registrants refer to when conducting compatibility assessments between cosmetics and packaging materials?

Relevant pharmaceutical standards include: "Guidelines of Evaluating Compatibility between Pharmaceutical Packaging and Pharmaceuticals" YBB00142002-2015", "Technical Guidelines for Compatibility Studies of Chemical Drug Injections and Plastic Packaging Materials (Trial)", "Technical Guidelines for Compatibility Studies of Chemical Drugs and Elastomeric Seals (Trial)", and "Technical Guidelines for Compatibility Studies of Chemical Drug Injections and Pharmaceutical Glass Packaging Containers (Trial)". Food-related standards include: GB31604.1-2023 "National Food Safety Standard - General Rules for Migration Testing of Food Contact Materials and Articles", GB4806.1-2016 "National Food Safety Standard - General Safety Requirements for Food Contact Materials and Articles", and GB5009.156-2016 "National Food Safety Standard - General Rules for Pre-treatment Methods for Migration Testing of Food Contact Materials and Articles". Additionally, the GB31604 series provides references for the determination of harmful substances such as heavy metals and phthalates.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.