China Releases Technical Guidelines for Identification and Assessment of Cosmetic Risk Substances

On March 29, 2024, China National Institutes for Food and Drug Control (NIFDC) introduced the draft version of the Technical Guidelines for Identification and Assessment of Cosmetic Risk Substances (the “Technical Guidelines”) for public review. Following this, on April 30, 2024, the finalized edition of the Technical Guidelines was published by the NIFDC, accompanied by several FAQs designed to address pertinent queries.

Drawn from both domestic and international regulatory frameworks and relevant assessment conclusions, the Technical Guidelines summarizes common types of risk substances in cosmetics along with their limit requirements. Moreover, guided by principles of risk management, the Technical Guidelines refines and categorizes the submission requirements for assessment dossiers concerning these risk substances into several situations. Here are the key highlights:

1. Submission of Testing Reports from Recognized Testing Institutions

In cases where the following hazard substances are present in cosmetics, the testing reports issued by cosmetic registration and notification testing institutions shall be provided for both special and general cosmetics. Notably, notifiers of general cosmetics can also use self-testing report, provided they adhere to the criteria stipulated in the Announcement on Optimizing the Measures for Notification Testing Management of General Cosmetics (No. 13 of 2023).

No.	Risk Substances	Products/Ingredients Requiring Assessment	Limits in Cosmetics
1	Mercury	All cosmetics to be registered or notified	≤1 mg/kg
	Lead		≤10 mg/kg
	Arsenic		≤2 mg/kg
	Cadmium		≤5 mg/kg
2	Dioxane	Product formula containing ingredients with ethoxy structure such as ethoxydiglycol, PEGs and their derivatives, etc.	≤30 mg/kg
3	Asbestos	Product formula containing talc	Not be detected
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2. Assessment of Risk Substances in Ingredients Subject to Use Restrictions Stipulated by STSC (Targeting Ingredients)

Ingredients subject to use restrictions on risk substances in the ingredients themselves, as specified in the Safety and Technical Standards for Cosmetics (STSC), necessitate risk substances assessment via ingredient quality specifications or safety information documents, or via testing reports of the risk substance's concentrations in the ingredients, in conjunction with corresponding quality management measures.

No.	Risk Substances	Products/Ingredients Requiring Assessment	Limits in Cosmetics
1	Sec-alkylamines and nitrosamines	Product formula containing ingredients such as trialkylamines, trialkanolamines and their salts such as triethanolamine, etc., or containing monoalkylamines, monoalkanolamines and their salts such as tromethamine, aminomethyl propanol, etc.	Do not use with nitrosating system. Avoid the formation of nitrosamines. Purity should not be lower than 99%. The maximum content of sec-alkylamines in the ingredient is 0.5%. The maximum content of nitrosamines in the product is 50μg/kg. Store in containers without nitrites.
1	Sec-alkylamines and nitrosamines	Product formula containing fatty acid dialkylamides and dialkanolamides such as cocamide DEA, palm kernelamide DEA, etc.	Do not use with nitrosating system. Avoid the formation of nitrosamines. The maximum content of secondary alkylamides in the final product is 0.5%, and nitrosamine is 50μg/kg. The maximum content of secondary alkylamides in the raw materials is 5%. Store in containers without nitrites.
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3. Assessment of Risk Substances in Ingredients Use Restrictions Stipulated by STSC (Targeting Products Added with the Ingredients)

For ingredients subject to limits on the risk substances in products added with such ingredients as specified in the STSC, the risk substances shall be assessed through the ingredient quality specifications or ingredient safety information documents, or through the testing report of the risk substance’s concentrations in the ingredients or products, in conjunction with corresponding quality management measures.

No.	Risk Substances	Products/Ingredients Requiring Assessment	Limits in Cosmetics
1	Acrylamide	Product formula containing polymers synthesized with acrylamide as the starting material, such as acrylamide/sodium acrylate copolymer, polyacrylamide, polyquaternium-7, etc.	Acrylamide monomers in leave-on product shall not be more than 0.1 mg/kg. Acrylamide monomers in other products shall not be more than 0.5 mg/kg.

4. Submission of Testing Reports on Risk Substances’ Contents

In cases where the following potential risk substances are found in the products after hazard identification, testing reports on the risk substances’ contents in ingredients or products shall be provided. Alternatively, ingredient quality specifications or ingredient safety information documents containing the control requirements for the risk substances can be provided.

No.	Risk Substances	Products/Ingredients Requiring Assessment	Limits in Cosmetics
1	Diethylene Glycol	Product formula containing ingredients such as glycerin, propylene glycol, ethylene glycol, PEGs and its derivatives, polysorbates and their derivatives, etc.	The assessment conclusions of authoritative organizations should be used as the reference for the substance’s limits.
2	Phenol	Product formula containing ingredients that may bring phenol, such as Phenoxyethanol	The assessment conclusions of authoritative organizations should be used as the reference for the substance’s limits.
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5. Assessment of Ingredients Not in the Prohibited Ingredients List in the STSC

For ingredients not in the Prohibited Ingredients List in the STSC, supporting documents or ingredient safety information issued by the ingredient manufacturer shall be provided to confirm the ingredient’s absence in the STSC.

No.	Ingredient not included in the list of prohibited ingredients in the STSC	Limits in Cosmetics
1	Product formula containing petrolatum	The entire refining process shall be confirmed and the obtained substance shall be proved not a carcinogen.
2	Product formula containing propellants such as propane, butane, and isobutane	The butadiene concentration shall be ≤0.1% (w/w).
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6. Special Considerations for Children's Cosmetics

Special emphasis is placed on additional assessment requirements for children's cosmetics. In addition to pass the identification and assessment of all the above risk substances, children's cosmetics must undergo scrutiny for additional specific risk substances.

No.	Risk Substances	Products/Ingredients Requiring Assessment	Limits in Cosmetics
1	Anthraquinone	Product formula containing ingredients such as aloe barbadensis	The assessment conclusions from authoritative organizations should be used as the reference for the substance’s limits.
2	Cocamidopropyl dimethylamine, 3,3-dimethylaminopropylamine, monochloroacetic acid	Product formula containing cocamidopropyl betaine	The assessment conclusions from authoritative organizations or relevant Chinese standards should be used as the reference for the substance’s limits.
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ChemLinked Comments

Compared to prior methodologies for identifying and assessing risk substances, the Technical Guidelines represents a significant advancement. It offers clarity on submission requirements for risk substance assessment dossiers across diverse scenarios and recognizes the validity of ingredient safety information documents as assessment tools. This holistic approach is poised to empower the industry in evaluating and mitigating potential cosmetic risks, thereby improving risk identification, analysis, and prevention practices.