Q&A About Guidelines for Safe Consumption History of New Cosmetic Ingredients

1.What is the background for formulating the Guidelines for Research and Determination of Safe Edible History of New Cosmetic Ingredients (Trial)?

According to the Regulations on the Supervision and Administration of Cosmetics, applicants for the registration or filling of new cosmetic ingredients must submit safety assessment reports. For new ingredients with a well-established history of safe edible use, certain toxicological tests may be exempted.

With the aim of implementing the Provisions on Supporting Innovation in Cosmetic Ingredients issued by the NMPA and making full use of existing data, the NIFDC organized the drafting of the Guidelines for Research and Determination of Safe Edible History of New Cosmetic Ingredients (Trial) (hereinafter referred as the Guidelines). The Guidelines will provide technical guidance for collecting and evaluating data related to safe edible use, as well as its application in safety assessments.

2.What are the requirements for the source materials proving safe consumption history?

Materials supporting safe consumption use must originate from food, agriculture, health, or other relevant regulatory authorities, or from technical institutions with functional or technical capabilities in food safety assessment. Such supporting evidence should be authoritative and generally publicly available (e.g., official announcements, notices, technical standards). What’s more, domestic regulatory authorities must be at the provincial/municipal level or higher; foreign regulatory authorities must be at the national level; technical institutions must be internationally recognized authoritative bodies.

Additionally, when citing such evidence, a comprehensive analysis must be provided, including its background, specific content, and relevant food safety regulatory requirements, to fully demonstrate the safety of edible use.

3.What consistency or correlation should exist between the new ingredient intended for registration/filing and the food ingredient documented in the safe edible history?

The new ingredient for registration/filling must be consistent with or relevant to the food ingredient described in the safe edible history evidence. Registrants/Notifiers (hereinafter “Applicants”) should analyze both the safe edible history evidence and the properties of the new ingredient.

It is worth noting that if processing methods differ from those used for food (e.g., extraction with other solvents), the components, enrichment levels, residual solvents, etc., must be analyzed based on the specific process. If the new ingredient is bio-fermented, materials must prove the safety of the final fermented product for edible use.

4.What are the common types of proof materials for safe edible history?

Common types of proof materials include ordinary food ingredients, regional specialty food ingredients, novel food ingredients, dual-use food and medicine ingredients, health food ingredients and so on. The Guidelines also list examples and basic requirements to assist Applicants in collecting and utilizing such information. Since some ordinary food ingredients lacking official data, Applicants may provide evidence of such ingredients’ commercial sale as food in China, analyze their safe consumption history, and demonstrate traceability and relevance to the new cosmetic ingredient.

5: Can proof materials released by foreign regulatory authorities or technical institutions be used?

Proof materials from foreign regulatory authorities or authoritative technical institutions can be used when such evidence meets the principles and requirements outlined in the Guidelines. Besides, Applicants must also provide: its background information, including country(or region), regulatory/technical body details, release date and full content, specific food safety regulatory applications, background data from safety assessments and so on.

6. How to carry out safety risk assessment for new cosmetic ingredients with a safe edible history?

Where food specifies intake limits or restrictions: assess its safety based on the new ingredient’s intended scope of use, safe dosage, etc. Where no explicit intake limit exists: conduct reasonable assessments using data on dietary habits and typical consumption levels. If raw materials are further processed (e.g., plant extracts),  it is necessary to consider conversion factors.

If edible intake limits or typical consumption levels cannot support the intended cosmetic use, repeat-dose toxicity tests and other necessary data can be sued to supplement the assessment of its application scope and safety dosage. Meanwhile, full and standardized toxicological test reports must be submitted.

Furthermore, safe edible history primarily exempts systemic toxicity tests. However, if the new ingredients has the whitening efficacy, long-term dermal safety risks cannot be ruled out. Therefore, additional data or studies are required.

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