answer Personnel engaged in cosmetic safety assessment shall meet the requirements of Guidelines for Identification and Assessment of Hazardous Substances in Cosmetics The requirements stipulated in the regulations.
Should be based on the source of raw materials Physical and chemical properties The preparation process affects the input of raw materials,Analysis of the situation where hazardous substances are generated or introduced during the production process of the product,Combining existing toxicology test data clinical research Population epidemiological investigation and other data,Identify potential risk substances in cosmetics,according to Guidelines for Identification and Assessment of Hazardous Substances in Cosmetics The evaluation principles, procedures, and other related requirements in the safety assessment of risk substances.
answer according to Technical specifications for cosmetic safety regulations Identify and evaluate potential risk substances in cosmetics using methods such as referencing risk assessment conclusions from authoritative domestic and foreign institutions,Including but not limited to the following situations
one When the following harmful substances may be present in the product,Special cosmetics should provide inspection reports issued by cosmetic registration and filing inspection agencies Ordinary cosmetics can provide inspection reports issued by cosmetic registration and filing inspection agencies,Or the registrant may follow Announcement on Optimizing the Management Measures for Filing and Inspection of Ordinary Cosmetics 2023year The13number Required inspection report.
1.mercury lead arsenic cadmium All registered or filed products must provide mercury lead arsenic Cadmium inspection report,The mercury limit in the product is1mg/kg The lead limit is10 mg/kg The arsenic limit is2 mg/kg The cadmium limit is5 mg/kg.
2.Dioxane Ingredients containing ethoxy structures in the formula, such as ethoxydiglycol polyethylene glycol PEG Class and its derivatives Fatty alcohol polyethers and their derivatives Polysorbate esters and their derivatives When using raw materials such as poloxamer, it is necessary to detect the presence of dioxane in the product,The limit value of dioxane in the product is30 mg/kg.
3.asbestos When the formula contains talc powder raw materials, asbestos in the product needs to be detected,Evaluate based on the test results,Under the existing detection methods,Asbestos must not be detected in the product.
4.free formaldehyde Ingredients containing formaldehyde slow-release agents such as imidazolidinylurea in the formula DMDMHydantoin double methylol Imidazolidinylurea sodium hydroxymethylglycinate 2-bromine-2-Nitropropane-1,3glycol 5-bromine-5-Nitro group-1,3-Dioxane Formaldehyde benzyl alcohol hemiacetal 7-Ethylbis (oxazolidine) When using raw materials such as dimethyl oxazolidine, it is necessary to detect free formaldehyde,Evaluate based on the test results.
5.methanol When ethanol is included in the formula Sum of isopropanol content≥10% w/w ,A test report for methanol in the product issued by a cosmetic registration and filing inspection agency should be provided,The methanol limit in the product is2000mg/kg.
two Technical specifications for cosmetic safety Raw materials with restricted requirements for hazardous substances present in the raw materials,Risk substances can be assessed through raw material quality specifications or raw material safety information documents It can also be evaluated by combining the inspection report of the risk substance content in the raw materials with corresponding quality management measures,To ensure that the relevant control indicators of the raw materials comply with Technical specifications for cosmetic safety requirement,Including but not limited to the following situations
1.Nitrosamine The formula contains hair dye such as2,6-Dihydroxyethylaminotoluene 2-amino-4-Hydroxyethylaminoanisole 2-methyl-5-Hydroxyethylaminophenol HCyellow2number N,N-double 2-Hydroxyethyl When dealing with raw materials such as phenylenediamine sulfate,Need to identify and evaluate the risk substance nitrosamines,This raw material is not used with nitrosylation system Maximum content of nitrosamines in raw materials 50g/kg Store in a container free of nitrite.
2.Secondary alkylamine Nitrosamine The formula contains trialkylamine Trialkanolamines and their salts such as triethanolamine,Or containing single chain alkylamine Single chain alkylamines and their salts such as tromethamine Aminomethylpropanol Pyrrolidone ethanolamine salt When using raw materials such as ethanolamine,Need to identify and evaluate the risk substance secondary alkylamine Nitrosamine,This raw material does not belong to the nitrosylation system (Nitrosating system) Use together Avoid the formation of nitrosamines The minimum purity is99% Maximum content of secondary alkylamine in raw materials 0.5% Maximum content of nitrosamines in the product 50g/kg Store in a container free of nitrite.
The formula contains fatty acid double chain alkyl amides and fatty acid double chain alkyl alcohol amides such as cocoamide DEA Palm kernel oil amideDEA Whale wax base-PG-When using raw materials such as hydroxyethyl palmitamide,Need to identify and evaluate the risk substance secondary alkylamine Nitrosamine,This raw material does not belong to the nitrosylation system (Nitrosating system) Use together Avoid the formation of nitrosamines Maximum content of secondary alkylamine in the product0.5%,Maximum content of nitrosamines50g/kg Maximum content of secondary alkylamine in raw materials5% Store in a container free of nitrite.
three Technical specifications for cosmetic safety Raw materials with restricted requirements for hazardous substances present in the product,Risk substances can be assessed through raw material quality specifications or raw material safety information documents It can also be evaluated through inspection reports on the content of risk substances in raw materials or products, in conjunction with corresponding quality management measures,To ensure that the product complies with Technical specifications for cosmetic safety requirement,Including but not limited to the following situations
Acrylamide The formula contains polymers synthesized from acrylamide as the starting material, such as acrylamide/Sodium acrylate copolymer polyacrylamide Polyacrylic acid ester-13 Polyquaternary ammonium salt-7When waiting for raw materials,Need to identify and evaluate the risk substance acrylamide,Maximum residual amount of acrylamide monomer in resident type products0.1mg/kg,Maximum residual amount of acrylamide monomer in other products0.5mg/kg.
four Hazard identification,When there may be the following risk substances in the product, an inspection report on the content of risk substances in the raw materials or products can be provided,Or include raw material quality specifications or raw material safety information documents that include control requirements for the risk substance,And based on this, conduct a risk assessment on it,To ensure its safe use.
1.Diethylene glycol The formula contains the following ingredients such as glycerol Propylene glycol glycol,Ethoxydiglycol polyethylene glycol PEG Class and its derivatives Polysorbate esters and their derivatives Fatty alcohol polyether and its derivatives, etc,Need to identify and evaluate diethylene glycol,The limit value can refer to the evaluation conclusion of authoritative institutions.
2.phenol Regarding the raw materials that may introduce phenol,When phenoxyethanol is prepared by the addition reaction of phenol and ethylene oxide,Need to identify and evaluate the risk substance phenol,The limit value can refer to the evaluation conclusion of authoritative institutions.
3.methanol The formula contains ethanol Denatured ethanol When using raw materials such as isopropanol ethanol Sum of isopropanol content<10% w/w ,Need to identify and evaluate the risk substance methanol.
4.pesticide residue Understanding the preparation process of plant-based raw materials is essential,Plant raw materials such as vegetable oil that are directly used after mechanical processing only Plant leaf juice, etc,Need to identify and evaluate pesticide residues,The limit value can refer to relevant requirements in China and internationally.
5.hydroquinone For raw materials that may introduce hydroquinone, such asα-Arbutin β-Arbutin, etc,Need to identify and evaluate the risk substance hydroquinone,The limit value can refer to the evaluation conclusion of authoritative institutions.
6.benzene For raw materials that may introduce benzene, such as carbomer, etc,Need to identify and evaluate the risk substance benzene,The residual amount in the product should be≤2 mg/kg.
five Proof or safety information from the raw material manufacturer is required,Confirm that it does not belong to Technical specifications for cosmetic safety Prohibit raw materials from the raw material catalog,Including but not limited to the following situations
1.When the formula contains mineral grease,It is necessary to confirm the entire refining process and be able to prove that the obtained substance is not a carcinogen.
2.Containing propellant propane butane Isobutane,Need to confirm the butadiene content≤0.1%(w/w).
3.Originating from petroleum Mixed alkanes of coal tar, such asC15-19Alkane C18-21Alkane,Need to provide itCASnumber,And according to Technical specifications for cosmetic safety Provide relevant quality specifications or proof materials in accordance with relevant requirements.asCASbe entitled as64741-76-0of,Need to confirm the content of dimethyl sulfoxide extract≤3% CASbe entitled as64742-46-7of,It is necessary to confirm the entire refining process and be able to prove that the obtained substance is not a carcinogen.
six Assessment of Risk Substances to Consider in Children's Cosmetics
Based on the physiological characteristics of children,Children's cosmetics should complete the above tasks one to four In addition to the identification and assessment of prescribed risk substances,Further identification and assessment of the following risk substances are required
1.When the formula contains ingredients such as Curacao aloe vera,Need to identify and evaluate the risk substance anthraquinone,Its evaluation can refer to the evaluation conclusions of authoritative institutions.
2.When the formula contains cocoamidopropyl betaine,It is necessary to identify and evaluate the presence of cocoamidopropyl dimethylamine 3,3-Dimethylaminopropylamine and monochloroacetic acid,The limit value can refer to the evaluation conclusions of authoritative institutions or relevant standards in China.
3.The formula contains essence When it comes to plant essential oils or spice ingredients,It is necessary to identify and evaluate the allergenic components involved,If it contains alternating leaves and white millets MELALEUCA ALTERNIFOLIA Leaf oil time,Need to identify and evaluate the risk substance methyl eugenol,The limit value can refer to the evaluation conclusion of authoritative institutions.
4. When glycerol is included in the formula,Its purity should be≥ 95.0%,Identification and evaluation of diethylene glycol content should≤0.1%.
