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Beijing Drug Administration: A Question and Answer 35th issue
How to use the conclusions of international authoritative cosmetic safety assessment agencies for the safety assessment of cosmetic raw materials
According to the report released by the National People's Procuratorate Guidelines for the Use of Cosmetic Raw Material Data ,Choose the European Consumer Council SCCS American Cosmetic Ingredient Evaluation Committee CIR And other internationally authoritative cosmetic safety assessment agencies have published safety assessment conclusions for raw materials,Analysis of relevant evaluation data is required,Under the relevant regulations and usage conditions of cosmetics in China,Relevant evaluation conclusions can be adopted,For raw materials with restricted usage conditions,The evaluation conclusion should be adopted under the condition that the limiting conditions are met.When the evaluation results of different authoritative institutions are inconsistent,Based on the reliability and correlation of the data,Scientifically and reasonably adopt relevant evaluation conclusions.
According to the report released by the National People's Procuratorate Guidelines for the Use of Cosmetic Raw Material Data ,Raw materials with a history of safe consumption,Dealing with its consumption history Conduct comprehensive and thorough research on production processes, etc,Ensure that the raw materials or the raw materials used to prepare the raw materials have safe edible properties.This type of raw material can be exempted from system toxicity during safety assessment,Combining product usage location and usage method, etc,Assess local toxicity.
According to the report released by the National People's Procuratorate Cross referencing Read-across Method Application Technical Guidelines ,Cross referencing Read-across Refers to the similarity based on chemical structure or biological activity,By utilizing one or more similar chemical substances Similar objects Predicting the toxicological endpoint data of another or a class of structurally similar specific chemical substances Target chemical substance Methods for obtaining the same toxicological endpoint information.
Cross referencing is suitable for structures that are clearly defined,Non functional ingredients or risk substances lacking systematic toxicology data.Not applicable to those with anti-corrosion properties Sunscreen to color Raw materials for hair dyeing and whitening functions.
Beijing Drug Administration: A Question and Answer Thirty sixth issue
Guidelines The main text consists of ten parts,Including scope of application Basic principles and requirements Requirements for Security Assessors Risk assessment procedure Toxicological testing Safety assessment of raw materials Safety assessment of cosmetic products Security Assessment Report Explanation and Definition,Main principles for safety assessment Personnel and other personnel have been clearly identified,Established evaluation procedures Requirements for safety assessment of raw materials and products, as well as the content of the assessment report Simplified version of security assessment report requirements, etc.
Guidelines There are four appendices in total,appendix1And Appendix2It specifies the contents that should be included in the safety assessment reports for raw materials and cosmetic products separately,appendix3And Appendix4Examples of complete and simplified product safety assessment reports were provided separately.
according to Technical Guidelines for Safety Assessment of Cosmetics ,The complete cosmetic safety assessment should include abstract Product Introduction Product formula Formula design principles Only applicable to children's cosmetics Safety assessment of each component in the formula Assessment of potential risk substances Risk control measures or recommendations Conclusion of Safety Assessment Signature of security assessors Resume of Safety Assessor reference appendix.Compared with the simplified version of security assessment content,The complete version of the safety assessment should also reflect the results of the preservative challenge Stability testing results and compatibility evaluation results between the product and packaging materials,And corresponding testing reports.
The four steps of risk assessment for cosmetic raw materials and risk substances Hazard identification Dose-response relationship Exposure assessment Risk Characteristics Description.
Frequently Asked Questions about Zhejiang Yaowen Children's Cosmetics Filing Information
The formula design of children's cosmetics should follow safety priority Essential efficacy The principle of minimalist formula,Combining the physiological characteristics of children,From the safety of raw materials stable function Evaluate the scientificity and necessity of the raw materials used in compatibility and other aspects,Especially essence and spice Coloring agent Raw materials such as preservatives and surfactants.Suggest following Technical Guidelines for Children's Cosmetics 2.7.2.2Analyze the specific requirements of essence one by one Containing allergens Coloring agent preservative The situation of surfactants.It is not recommended to use raw materials with specific safety risks Like formaldehyde emitter And raw materials listed as banned substances in other countries or regions,If necessary to use,The reasons should be explained in the product safety assessment materials,And conduct a thorough evaluation of the safety of children's use.
Common raw materials for formaldehyde slow-release agents include Imidazolidinylurea 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) Dimethyloxazolidine.
Common quaternary ammonium cationic surfactants include Hexadecyltrimethylammonium chloride Product Name 1631 Octadecyltrimethylammonium chloride Product Name 1831 .
Essence of children's productsIFRAThe certificate should include allergen information.The content of allergenic spice components in the product should be calculated separately,If it is in the category of resident products>0.001%,In rinsing products>0.01%When,Annotate on product labels.
give an example The formula of the children's moisturizer product has been added0.05%Essence,Data on potentially allergenic spice components shows linalool33.1602%,That product contains linalool 33.1602*0.05%=0.01658% >0.001%,Should be labeled on the label This product contains linalool Similar expressions.
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.
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.
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.
When glycerol is included in the formula,Its purity should be≥95.0%,Identification and evaluation of diethylene glycol content should≤0.1%.