Q&As on Ordinary Cosmetics Filing in Guangzhou (Vol. 72)

We have collected the latest FAQs on ordinary cosmetics filing from the Guangzhou Administration for Market Regulation and translated them into English for your reference.

1. In the recent update of the general cosmetics (toothpaste) filing management system, a new option for "Safety Assessment Attachment Type" has been added under the "Product Safety Assessment Data" module. How should this be selected?

This option was newly introduced to facilitate the retrieval and statistical analysis of the full-version safety assessment. If the filer submits the full-version safety assessment report as an attachment, the option "Full-Version Safety Assessment Report" should be selected. If, in accordance with the Guidelines for the Use of Cosmetic Ingredient Data, the product falls under Category II cosmetics, and the filer submits only the basic conclusion of the full-version safety assessment as an attachment, the option "Basic Conclusion of Safety Assessment (Report to be Archived by the Enterprise)" should be selected. If a simplified safety assessment report is submitted, no selection is required.

2. How do you determine the toxicological endpoints that need to be assessed for ingredients?

The registrant/filer should follow the requirements of the Technical Guidelines for Cosmetics Safety Assessment to determine potential health hazard effects of ingredients based on factors such as product usage, exposure routes, and actual exposure levels.

Additionally, depending on the physicochemical properties of the ingredient, quantitative structure-activity relationships, toxicological data, usage history, clinical studies, epidemiological investigations, and toxicity data of similar compounds, certain toxicological endpoints may be added or exempted from assessment. For example, if sufficient evidence confirms that a certain ingredient has a history of safe consumption, the assessment of systemic toxicity as a toxicological endpoint may be exempted.

3. How do you assess the phototoxicity and photoallergenicity of cosmetic ingredients?

The registrant/filer may apply the seven types of evidence outlined in the Guidelines for the Use of Cosmetic Ingredient Data to conduct safety assessments for most ingredients listed in the Inventory of Existing Cosmetic Ingredients in China (IECIC).

For a small number of ingredients where the above evidence types cannot be applied, the registrant/filer should follow the requirements of the Technical Guidelines for Cosmetic Safety Assessment to determine potential health hazard effects, including phototoxicity and photoallergenicity, based on factors such as product usage and exposure routes.

If a comprehensive analysis or testing of the ingredient’s structural characteristics demonstrates that it does not have UV absorption properties or that it has no potential for outdoor strong UV exposure (e.g., ingredients used in rinse-off products or cosmetics intended for nighttime use), the assessment of skin phototoxicity and photo allergenicity may be exempted.

4. Do "Microcrystal" or "Microneedle" products fall within the definition of cosmetics?

If a product claimed to be a "microcrystal" or "microneedle" product is comprehensively determined – based on its formulation, manufacturing process, method of use, and the physical form of its contents – to be not applied to the surface of the skin, then such a product falls outside the scope of the definition of cosmetics as stipulated in the Cosmetics Supervision and Administration Regulations.

5. How do you understand the relationship between product label claims and the efficacy claims in classification codes?

The efficacy claims stated on the product label must fall within the scope of efficacy claims specified in the classification code reported in the Cosmetic Registration and Notification Dossier. The claims on the label cannot exceed the efficacy scope covered by the classification code. For example, if the reported efficacy claim under the classification code is solely "moisturizing," the product label draft may include claims related to moisturizing functions, such as "moisturizing," "reducing moisture loss," or "relieving skin dryness." However, claims beyond the scope of moisturizing, such as "firming" or "soothing," are not permitted.

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 service@cirs-group.com.

Further Information

https://scjgj.gz.gov.cn/zmhd/cjwt/pthzpba/content/post_10027732.html