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: Do all cosmetic ingredients need to be evaluated for phototoxicity and photoallergenicity?

A: Registrants/filers can apply the seven types of evidence outlined in the Guidelines for Use of Cosmetic Ingredient Data to conduct safety assessments for most ingredients listed in the Inventory of Existing Cosmetic Ingredients in China (IECIC 2021). For a small number of ingredients where the above evidence types cannot be applied, safety assessments should be conducted in accordance with the Technical Guidelines for Cosmetic Safety Assessment, taking into account factors such as product usage and exposure routes to determine potential health hazards, including phototoxicity and photoallergenicity. If a comprehensive analysis or testing based on the ingredient’s structural characteristics demonstrates that it does not have UV absorption properties, or if the ingredient is used in products with no potential for outdoor strong UV exposure (e.g., rinse-off products or cosmetics intended for nighttime use), the evaluation of skin phototoxicity and photoallergenicity may be exempted.

2: What migratory substances should be considered when conducting migration tests on packaging materials that come into direct contact with cosmetics?

A: According to the Technical Guidelines for Compatibility Testing and Evaluation of Cosmetics and Packaging Materials, migration testing is conducted based on predicted target leachables, including extractables and their degradation products from the packaging materials, as well as reaction products generated between the packaging materials and cosmetics. The analytical methods used for migration testing should be validated to ensure they can detect leachables in cosmetics with sensitivity, accuracy, and stability. If necessary, adsorption tests may also be conducted to assess the impact of packaging material adsorption on cosmetic ingredients.

When conducting migration tests, experimental protocols should be designed based on the material composition of the packaging and the type of cosmetic product. The following aspects should be considered:

1. Plastics: Migration of residual monomers, additives, and their degradation products.
2. Glass: Release of alkaline ions and its impact on cosmetic pH; migration of hazardous elements; migration of additives in tinted glass containing colorants. For glass containers with internal coatings or films, the integrity of the coating/film and the migration of additives within the film should be assessed.
3. Metals: Migration of metal ions; corrosion of metal by the cosmetic contents; integrity of metal coatings before and after testing, as well as migration of additives within the coating.
4. Rubber: Migration of residual monomers, additives, and their degradation products. For rubber components with coatings or films, the integrity of the coating/film and the migration of additives within the film should be evaluated.
5. Ceramics: Migration of hazardous elements from ceramic glazes. For ceramic containers with internal coatings or films, the integrity of the coating/film and the migration of additives within the film should be examined.
6. Nonwoven fabrics (mask sheets, wipes, etc.): Migration of optical brighteners and other additives.
7. Capsule shells: Migration of colorants and other additives.
8. Others: Migration test protocols should be designed based on the considerations outlined above to assess the compatibility between packaging materials and cosmetics.

3: Under what circumstances can preservative efficacy testing be omitted in a comprehensive safety assessment of cosmetic products?

A: According to section 7.3.3 of the Technical Guidelines for Cosmetic Safety Assessment, for products with the same preservative system and similar formulations, existing data and experimental results can be referenced for safety evaluation. Preservative efficacy testing may be omitted for products that are not prone to microbial contamination based on their characteristics, including: Anhydrous products (non-water-containing products), products primarily composed of organic solvents, water-containing products with a water activity < 0.7, products with ethanol content > 20% (by volume), products with extreme pH values (≥10 or ≤3), products filled at temperatures above 65°C, single-use products or products with non-reopenable packaging. However, cosmetic safety assessors should provide justification for omitting preservative efficacy testing based on these conditions.

4: On November 15, 2024, the National Institutes for Food and Drug Control (NIFDC) released the Information on Ingredients Used in Marketed Products (Revised Draft for Comments). How does it differ from the current Information on Ingredients Used in Marketed Products (April 30 version)?

A: First: The scope of ingredient information has been expanded. Compared to the current Information on Ingredients Used in Marketed Products (April 30 version), the Revised Draft for Comments (November 15 version) has extended its coverage from only special cosmetics to include general cosmetics as well. The number of recorded ingredients has increased by 1,344, reaching a total of 3,578, and the recorded usage data has expanded to 5,240 entries, making the collected information more comprehensive.

Second: The principles for data usage have been refined. In the Information on Ingredients Used in Marketed Products (Revised Draft for Comments) (November 15 version), the principles for using the same ingredient with the same application method are described in more detail. The usage amount of an ingredient can be referenced in the following order of application areas: whole body, torso, face (including neck), hands and feet, head, hair, lips, eyes, and nails (fingernails/toenails). When referencing ingredient usage from other areas for eye-area products, an additional eye irritation assessment is required. The ingredient usage amounts for lips and eyes cannot be referenced from hands, feet, head, or hair. For body hair, only the usage amounts from the whole body or torso can be referenced. If the application areas include both the head and hair, the ingredient usage amount for the head can be referenced. If application areas include the face (including neck), eyes, and/or lips, the ingredient usage amount for the face (including neck) can be referenced. However, if the application area includes the eyes, an additional eye irritation assessment is required. For other products applied to multiple areas, the usage amount should be referenced from the higher-level application area with the same usage method. Compared to the current Information on Ingredients Used in Marketed Products (April 30 version), the revised principles are more detailed, improving the efficiency and accuracy of data utilization.

Third: Increased usage limits for some ingredients. In the Information on Ingredients Used in Marketed Products (Revised Draft for Comments) (November 15 version), the usage limits for certain ingredients have been adjusted. For example, in the Information on Ingredients Used in Marketed Products (April 30 version), the usage amount of Pinus Strobus Bark Extract for leave-on applications on the whole body was 0.000025%. However, in the Information on Ingredients Used in Marketed Products (Revised Draft for Comments) (November 15 version), the usage amount for Pinus Strobus Bark Extract in the same application method and area has been increased to 0.6%.

About CIRS

The CIRS cosmetic team is dedicated to ensuring that cosmetic products meet stringent global regulatory standards. It can provide one-stop services covering the whole life-cycle of a personal care product, which includes cosmetic ingredient development, physical/chemical tests, toxicological tests (in vivo & in vitro), efficacy studies (in vivo & in vitro), ingredient registration, and product registration.

Cosmetic services in China:

• China Cosmetic Registration and Filing;
• China New Cosmetic Ingredient Registration and Filing;
• China Cosmetic Ingredient Quality and Safety Information Code Application (NMPA Code);
• China Cosmetics Safety and Efficacy Test;
• China Cosmetic Safety Assessment Report;
• China Toothpaste Filing;
• China Disinfectant Notification; and
• China Cosmetic Formula/Label/Claim Review

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

Further Information

https://yjj.beijing.gov.cn/yjj/xxcx/kpxc/hzp36/543488610/index.html