CFDA to Adjust Administrative Licensing Requirements for Plant-Based Cosmetic New Ingredients

CFDA is planning to adjust the application requirements of administrative licensing of plant-based cosmetic new ingredients.

Changes to administrative licensing for plant-based cosmetic new ingredients include:

1. Redefinition of plant-based cosmetic new ingredients:
plant-based cosmetic new ingredients refer to ingredients sourced from plants (including algae) which are used in cosmetic produced for the first time within mainland China. Highly purified ingredients extracted from plants are excluded from this definition. Plant-based cosmetic new ingredient should be from a single plant source. If necessary, additives such as solvent, stabilizer or preservative etc. can be added to facilitate the storage and use.

2. General requirements of application for plant-based cosmetic new ingredients:
The standard Chinese name of the ingredient should be used when registering plant-based cosmetic new ingredients. If the name is not included in INCI, it could be named according to the standard Chinese naming rules. In addition, the Latin names and used parts of the sourced plants should be noted. Medical terms are not allowed to use for promoting medical effect of plant-based cosmetic ingredients.

Administrative licensing of plant-based cosmetic new ingredients refers to the Requirements for Application and Acceptance of Administrative Licensing for Cosmetics and Guidance on Application and Review of New Cosmetic Ingredients. Generally, the required items for toxicological test including:  

①  acute oral toxicity or acute dermal toxicity test
②  dermal irritation test, dermal corrosion test, acute eye irritation test and acute eye corrosion test
③  dermal hypersensitivity test
④  dermal phototoxicity and photosensitive test (necessary for ingredients with ability to absorb ultraviolet)
⑤  mutagenicity test (at least including one genetic mutation test and one chromosome aberration test)
⑥  subchronic oral toxicity test or subchronic dermal toxicity test
⑦  teratogenicity test
⑧  chronic toxicity test and carcinogenesis test

a)  Varying toxicological testing and testing exemptions for plant-based cosmetic new ingredients

Toxicological test items can be reduced according to the specific characteristics of the plant-based cosmetic new ingredients. If the plant-based cosmetic ingredients is to be used in preservatives and cosmetics categorized as sun screens, colorants, hair colors, whitening agents and other special functions with high risks for the first time globally, the applicant should provide toxicological risk assessment reports (including animal testing).

• If the plant-based cosmetic ingredient is not categorized as a special function cosmetic ingredient and is to be used for the first time globally, the applicant does not have to provide reports ⑦ and ⑧.
• If the plant-based cosmetic ingredients which is not categorized as a special function cosmetic ingredient, has a safety profile backed by evidence proving it has used safely for more than 5 years, generally the applicants do not have to provide reports ①⑤⑥⑦⑧.   The procedure is different for ingredients which are also edible, the applicants still have to provide reports ①⑤⑥.
• Special function cosmetics with enough evidence to prove they have been safely used by international consumers for more than 5 years, generally the applicants do not have to provide reports①⑥⑦⑧.
• If non-special function new plant-based cosmetic ingredients have enough evidence to prove they have been safely used by international consumers for more than 5 years, generally the applicants do not have to provide reports ①⑤⑥⑦⑧.
• If non special function new plant-based cosmetic ingredients have been assessed as safe ingredients by international authorities, generally no toxicological test reports are necessary. The applicants should provide the risk assessment result and report of these plant-based cosmetic new ingredients. Moreover, the risk assessment items and methods of toxicological tests should be in accordance with the requirements of Chinese cosmetic regulations and standards.

3. History of Safe Consumption Criteria

Plant-based ingredients which are also considered as food which have already been issued with a safe food certificate from Chinese administrations or other equivalent qualifications, (and plant-based ingredients considered both food and drugs) can be regarded as plant-based ingredients with safe consumption history.

CFDA is now asking for public comments on this adjustment, and the stakeholders can contact CFDA to convey their ideas before December 10^th 2015.

* Reference Link: 食品药品监管总局药化注册司公开征求调整植物类化妆品新原料行政许可申报资料要求有关事宜意见