China Seeks Public Input on Technical Guidelines for Identification and Assessment of Cosmetic Risk Substances

On March 29, 2024, China National Institutes for Food and Drug Control (NIFDC) released two draft guidance documents intended to improve cosmetics safety assessment procedures. These documents, namely the Guidelines for Submission of Cosmetics Safety Assessment Dossiers (Draft for Comments) (the Submission Guidelines) and the Technical Guidelines for Identification and Assessment of Cosmetic Risk Substances (Draft for Comments) (the Technical Guidelines for Risk Substances), are currently open for public feedback until April 8, 2024. Interested parties are encouraged to submit their comments to [email protected] before the deadline.

This article primarily focuses on the Technical Guidelines for Risk Substances, while a separate analysis of the Submission Guidelines is also available.

Technical Guidelines for Risk Substances

Comprehensive hazard identification and assessment of potential safety risks associated with cosmetic ingredients are critical components of safety assessment reports. The Technical Guidelines for Risk Substances aims to standardize this process and offers practical guidance to industry practitioners. Key highlights of this draft include:

1. Identification of Common Risk Substances and Their Usage Restrictions in Cosmetics

No.	Risk Substances	Products Requiring Assessment	Limits in Cosmetics
1	Mercury	All cosmetics to be registered or notified	≤1 mg/kg
2	Lead		≤10 mg/kg
3	Arsenic		≤2 mg/kg
4	Cadmium		≤5 mg/kg
5	Dioxane	Product formula containing ingredients with ethoxy structure such as ethoxydiglycol, PEGs and their derivatives, polysorbates and their derivatives, Poloxamer, etc.	≤30 mg/kg
6	Asbestos	Product formula containing talc ingredients	Not be tested out
7	Methanol	When the sum of ethanol and isopropyl alcohol content ≥ 10% (w/w)	≤2,000mg/kg
8	Nitrosamines	Product formula containing hair dyes such as 2,6-dihydroxyethylaminotoluene, 2-amino-4-hydroxyethylaminoanisole, 2-methyl-5-hydroxyethylaminophenol, HC Yellow No. 2, N,N-bis(2-hydroxyethyl)-p-phenylenediamine sulfate, etc.	Do not use with nitrosating system. The maximum content of nitrosamines in the product is 50μg/kg. Store in containers without nitrites.
9	Secondary alkylamine, nitrosamines	Product formula containing ingredients such as trialkylamines, trialkanolamines and their salts such as triethanolamine, etc., or contains 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%. Maximum content of secondary alkylamines in the raw materials is 0.5%. The maximum content of nitrosamines in the product is 50μg/kg. Store in containers without nitrites.
9	Secondary alkylamine, nitrosamines	Product formula containing fatty acid dialkylamides and dialkanolamides such as cocamide DEA, palm kernelamide DEA, etc.	Do not use with nitrosating system. Avoid forming nitrosamine. 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.
10	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.
11	Benzene	Product formula containing ingredients that may bring benzene, such as carbomer, etc.	≤2 mg/kg
12	Buta-1,3-diene	Product formula containing propellants propane, butane, or isobutane	≤ 0.1%(w/w)
13	Free formaldehyde	Product formula containing formaldehyde releasing ingredients, such as imidazolidinyl urea, DMDM hydantoin, diazolidinyl urea, sodium hydroxymethylglycinate, dimethyl oxazolidine, etc.	Assess based on test results
14	Diethylene Glycol	Product formula containing ingredients such as glycerin, propylene glycol, ethylene glycol, ethoxydiglycol, PEGs and its derivatives, polysorbates and their derivatives, fatty alcohol polyethers and their derivatives, etc.	The assessment conclusions of authoritative organizations should be used as the reference for the substance’s limits.
14	Diethylene Glycol	Children cosmetics’ formula contains glycerin, and its purity ≥ 95.0%	≤0.1%
15	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.
16	Pesticide residue	Product formula containing plant ingredients that are used directly after mechanical processing, such as plant oil, plant leaf juice, etc.	Relevant laws and regulations in China should be used as the reference for the substance’s limits.
17	Hydroquinone	Product formula containing ingredients that may bring hydroquinone, such as α-arbutin, β-arbutin, etc.	The assessment conclusions of authoritative organizations should be used as the reference for the substance’s limits.

2. Specification of Dossier Requirements for Assessing Cosmetic Risk Substances

In line with the Working Rules for Cosmetic Registration and Notification Testing, if risk substances are listed as mandatory testing items (e.g., mercury, lead, arsenic, cadmium, etc.), a testing report from a recognized testing institution shall be submitted.

For ingredients subject to usage restrictions outlined in the Safety and Technical Standards for Cosmetics (STSC) that may contain risk substances (e.g., nitrosamines, acrylamide, etc.), quality specifications or ingredient safety documents may suffice.

For risk substances brought into some ingredients, such as diethylene glycol, phenol, etc., a testing report on their content in the final product or in the ingredients, or ingredient safety information documents, shall be provided.

3. Special Emphasis on Assessing Risk Substances Relevant to Children's Cosmetics

In addition to completing the identification and assessment of the above risk substances, children's cosmetics also need to identify and assess the following risk substances.

No.	Risk Substances	Products Requiring Assessment	Limits in Cosmetics
1	Anthraquinone	Product formula containing ingredients such as aloe barbadensis	The assessment conclusions of 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 of authoritative organizations or relevant Chinese standards should be used as the reference for the substance’s limits.
3	Allergenic ingredients, for example, methyl eugenol	Product formula containing essence, plant essential oils (aromatics) or fragrance ingredients, for example, melaleuca alternifolia leaf oil	The assessment conclusions of authoritative organizations should be used as the reference for the substance’s limits.
4	Diethylene Glycol	Children cosmetic product formula contains glycerin, and its purity ≥ 95.0%	≤0.1%