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The general principles of the Guidelines include:
Personnel engaged in cosmetic safety assessments shall meet the requirements specified in the Guidelines.
The identification of risk substances in cosmetics shall involve:
i. The analyze of risk substances introduced by ingredients and those generated from the production process based on the consideration of their source, physicochemical properties, and preparation techniques.
ii. The employment of available toxicological test data, clinical studies, population epidemiological investigations, and other relevant documents.
Safety assessments of risk substances shall be conducted following the principles and procedures outlined in the Guidelines.
Identification and assessment of substances with potential risk in cosmetics shall be based on the Safety and Technical Standards for Cosmetics (STSC) and risk assessment conclusions from Chinese and international authoritative institutions, etc., including but not limited to the following situations:
I. Risk substances
In the possible presence of the following hazardous substances, special cosmetics shall have testing reports issued by cosmetic registration and notification testing institutions. General cosmetics may have above-mentioned testing reports or testing reports issued by notifiers per the requirements of the Announcement on Optimizing the Measures for Notification and Filing Testing Management of General Cosmetics (No. 13 of 2023).
No. | Risk Substances Contained | Products | Restriction Requirements |
1 | Mercury | All products | ≤ 1 mg/kg in the product |
2 | Lead | All products | ≤ 10 mg/kg in the product |
3 | Arsenic | All products | ≤ 2 mg/kg in the product |
4 | Cadmium | All products | ≤ 5 mg/kg in the product |
5 | Dioxane | Products whose formula contains ingredients with an ethoxy structure, such as ethoxydiglycol, PEG and its derivatives, aliphatic alcohol polyethers, and their derivatives, polysorbates and their derivatives, poloxamer | ≤ 30 mg/kg in the product |
6 | Asbestos | Products whose formula contains alc | Shall not be detected |
7 | Free formaldehyde | Products whose formula contains formaldehyde slow-release agents, such as imidazolidinyl urea, DMDM hydantoin, diazolidinyl urea, sodium hydroxymethylglycinate, 2-bromo-2-nitropropane-1,3-diol, 5-bromo-5-nitro-1,3-dioxane, benzylhemiformal, 7-ethylbicyclooxazolidine, dimethyl oxazolidine | Free formaldehyde in the product shall be tested and assessed based on the testing results |
8 | Methanol | Product whose sum of alcohol and isopropyl alcohol concentrations is ≥10% (w/w) | ≤2000 mg/kg in the product |
II. Assessment of risk substances in cosmetic ingredients
For ingredients themselves regulated by the STSC with restrictions on risk substances, the risk substances can be assessed through:
The ingredient quality specifications or ingredient safety information documents;
The testing report of the risk substance concentrations in the ingredients, in conjunction with corresponding quality management measures.
These two documents are used to ensure the relevant control indicators of the ingredients meet the STSC requirements, including but not limited to the following situations:
No. | Risk Substances Contained | Products | Restriction Requirements |
1 | Nitrosamine | Product whose formula contains 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. | 1. Nitrosamine shall not be used with the nitrosating system 2. The maximum concentration of nitrosamine in the ingredient shall be 50 g/kg 3. The product shall be stored in a container free of nitrite |
2 | Sec-alkylamines and nitrosamines | Product whose formula contains trialkylamines, trialkanolamines and their salts (e.g.triethanolamine) or monoalkylamines, monoalkanolamines and their salts (e.g. tromethamine, aminomethyl propanol, piroctone olamine, ethanolamine) | 1. Sec-alkylamines and nitrosamines shall not be used with the nitrosating system 2. Nitrosamine formation shall be avoided 3. Minimum purity: 99% 4. Maximum concentration of sec-alkylamines in ingredient: 0.5% 5. Maximum concentration of nitrosamines in product: 50 g/kg 6. The product shall be stored in nitrite-free container |
3 | Sec-alkylamines and nitrosamines | Products whose formula contains fatty acid dialkylamides and dialkanolamides such as cocamide DEA, palm kernelamide DEA, cetyl-PG hydroxyethyl palmitamide. | 1. Sec-alkylamines and nitrosamines shall not be used with the nitrosating system 2. Nitrosamine formation shall be avoided 3. Maximum concentration of sec-alkylamines in product: 0.5% 4. Maximum concentration of nitrosamines in product: 50 g/kg 5. Maximum concentration of sec-alkylamines in the ingredient: 5% 6. The product shall be stored in nitrite-free container |
III. Assessment of risk substances in cosmetic products
For ingredients in products regulated by the STSC with restrictions on risk substances, the risk substances can be assessed through:
The ingredient quality specifications or ingredient safety information documents;
The testing report of the risk substance concentrations in the ingredients or products, in conjunction with corresponding quality management measures.
These two documents are used to ensure that the products meet the STSC requirements, including but not limited to the following situations:
No. | Risk Substance Contained | Products | Restriction Requirements |
1 | Acrylamide | Products whose formula contains polymers synthesized from acrylamide as the starting ingredient, such as acrylamide/sodium acrylate copolymer, polyacrylamide, polyacrylate-13, polyquaternium-7 | 1. Maximum residue level of acrylamide monomers: 0.1 mg/kg for leave-on products. 2. Maximum residue level of acrylamide monomers: 0.5 mg/kg for other products |
IV. Risk substances requiring testing reports or safety documents
After hazard identification, if the following risk substances are found in the products, a testing report on the concentration of risk substances in the ingredients or products, or ingredient quality specifications or ingredient safety information documents containing corresponding control requirements for the risk substances can be provided.
No. | Risk Substances Contained | Products | Assessment Reference |
1 | Diethylene glycol | Products whose formula contains glycerin, propylene glycol, glycol, ethoxydiglycol, PEGs and their derivatives, polysorbates and their derivatives, aliphatic alcohol polyethers and their derivatives, etc. | The limit values in the assessment conclusions of authoritative institutions |
2 | Phenol | Products containing ingredients may introduce phenol, (e.g., phenoxyethanol) | The limit values in the assessment conclusions of authoritative institutions |
3 | Methanol | Products whose formula contains alcohol, denatured alcohol, and isopropyl alcohol (when total ethanol and isopropanol content<10% w/w) | / |
4 | Pesticide residues | Products containing plant-derived ingredients directly used after mechanical processing, such (e.g. plant oils and plant leaf juices) | China’s and international requirements for limit values |
5 | Hydroquinone | Products containing ingredients that may introduce hydroquinone (e.g., α-arbutin, β-arbutin) | The limit values in the assessment conclusions of authoritative institutions |
6 | Benzene | Products containing ingredients that may introduce benzene (e.g., carbomer) | Residual level of benzene shall be ≤2 mg/kg |
V. Ingredients requiring supporting documents from ingredient manufacturer
When the formula contains the following ingredients, supporting documents or ingredient safety information from the ingredient manufacturer shall be provided to confirm that the ingredient is not included in the prohibited list in the STSC, including but not limited to the following situations:
No. | Ingredients Contained | Required Documents or Safety Information |
1 | Petrolatum | Documents or safety information is needed to confirm the entire refining process and prove that the obtained substance is not a carcinogen |
2 | Propellants, such as propane, butane, isobutane | Documents or safety information is needed to confirm that butadiene concentration is ≤0.1% (w/w) |
3 | Mixed alkanes derived from petroleum and coal tar, such as C15-19 alkanes, C18-21 alkanes | CAS numbers and relevant quality specifications or supporting documents per STSC requirements. e.g. when the CAS number is 64741-76-0, documents or safety information is needed to confirm dimethyl sulfoxide extract concentration is ≤3%; when the CAS number is 64742-46-7, documents or safety information is needed to confirm the entire refining process and prove that the obtained substance is not a carcinogen. |
VI. Assessment of risk substances in children’s cosmetics
Considering the physiological characteristics of children, in addition to identifying and assessing the risk substances specified in items I to IV above, the following risk substances are also required to be identified and assessed in children’s cosmetics:
No. | Risk Substances Contained | Products | Assessment Reference |
1 | Anthraquinone | Product whose formula contains Aloe Barbadensis | The limit values in the assessment conclusions of authoritative institutions |
2 | Cocamidopropyl dimethylamine, 3,3-dimethylaminopropylamine, and monochloroacetic acid | Products whose formula contains cocamidopropyl betaine | Assessment conclusions of authoritative institutions or relevant Chinese standards for limit values |
3 | Sensitizing ingredients (e.g., methyleugenol) | Product whose formula contains flavors, plant essential oil, or fragrances (e.g., melaleuca alternifolia leaf oil) | Assessment conclusions of authoritative institutions for limit values |
4 | Diethylene glycol | Product whose formula contains glycerin | 1. Glycerin purity: ≥95.0% 2. Diethylene glycol content: ≤0.1% |
The Guidelines only provide assessment requirements for common cosmetic risk substances at current technology and cognition levels. Enterprises are encouraged to conduct comprehensive risk substances identification based on the ingredient source, composition, production technique, packaging materials, and other aspects. Risk substances not included in the Guidelines shall be assessed per requirements in the Technical Guidelines for Cosmetic Safety Assessment. Only ingredients believed to be safe after assessments can be used in cosmetics.
The Guidelines was developed referring to existing cosmetic laws and regulations as well as current scientific knowledge. It will be updated and adjusted timely to align with related regulations, industry development, and technology advancements.
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