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Official filing Q&A | Cosmetic safety assessment Introduction to Complete Safety Evaluation and Special Topic on Filing of Children's Cosmetics

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.

Raw materials with a history of safe consumption,Which toxicities can be exempted

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.

Toxicological concern threshold TTC What are the basic conditions for the application of methods
According to the report released by the National People's Procuratorate Toxicological concern threshold TTC Method Application Technical Guidelines ,TTCThe method is applicable to clear chemical structures,Cosmetics raw materials or risk substances with low content and lack of systematic toxicology research data.
The following raw materials or hazardous substances are not applicable to this guideline,include Metal or metal compound highly oncogenic Like aflatoxin Nitroso compounds and benzidine, etc protein steroid Substances with high molecular weight There are strong bioaccumulation substances and radioactive chemicals, etc Nano materials Inorganic substances When evaluating the safety risks of inhalation exposure routes for raw materials with inhalation risks Has anti-corrosion properties Sunscreen to color Raw materials for hair dyeing and whitening functions.
Can plant extracts be usedTTCEvaluate the law
According to the training interpretation of the Central Inspection Institute,Plant extracts have complex components and variations between batches,There are difficulties in identification and analysis techniques,Therefore, under certain conditions,Some unknown components in the raw materials can be usedTTCMethod for evaluation.
According to the report released by the National People's Procuratorate Toxicological concern threshold TTC Method Application Technical Guidelines ,For mixtures such as plant extracts,It is necessary to determine whether the substance to be evaluated isDNAReactive mutagens/Carcinogen,Identify as many single or large categories of components as possible,Except for necessary solvents or stabilizers added during the production process preservative Antioxidants and other external substances,It is necessary to ensure that the ingredient content is not less than50 %.For known components,Conduct safety assessments using appropriate evaluation methods separately,To ensure safe use,If it contains structurally similar components,Dose superposition evaluation should be conducted.For those who belong to nonDNAReactive mutagens/Unknown components of carcinogens,If unable to determineCramercategory,Its overallCramerCategory byCramer IIIEvaluate the class.Yes, it cannot be ruled outDNAReactive mutagens/Unknown components of carcinogens,useDNAReactive mutagens/CarcinogensTTCThreshold evaluation.
What is cross referencing What is the scope of application of cross referencing

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

What are the main regulations and technical documents related to cosmetic safety assessment
Main regulations
Regulations on the Supervision and Administration of Cosmetics
Management Measures for Registration and Filing of Cosmetics
Regulations on the Management of Registration and Filing Materials for Cosmetics
Technical Guidelines for Safety Assessment of Cosmetics
Technical specifications for cosmetic safety
Classification rules and catalog for cosmetics
Regulations on the Management of Cosmetics Labels
Technical documents
Guidelines for the Use of Cosmetic Raw Material Data Clarified the seven main types of raw material data in safety assessment Usage requirements and required supporting documents
International authoritative index of cosmetic safety assessment data Used in cosmetics in our country Not included in Technical specifications for cosmetic safety in,SCCSandCIRObjective collection of raw materials for published cosmetic safety assessment reports
Information on the use of raw materials for products already on the market Used in special cosmetics within the validity period of the approval document Not included in Technical specifications for cosmetic safety in Objective inclusion of raw material usage without authoritative evaluation reports
Toxicological concern threshold TTC Method Application Technical Guidelines This method is suitable for chemical structure clarification And it does not contain raw materials or risk substances with serious mutagenic warning structures,When the content is low and there is a lack of systematic toxicology research data,Can be used as a reference
Cross referencing Read-across Method Application Technical Guidelines This method is applicable to non functional ingredients or risk substances that lack systematic toxicology research data,Can be used as a reference
Guidelines for the application of integrated testing and evaluation strategies for skin sensitization Suitable for evaluating the skin sensitization of cosmetic raw materials
Technical Guidelines for Stability Testing and Evaluation of Cosmetics Guidelines for Testing and Evaluation Techniques of Cosmetics Anti corrosion Challenge Technical Guidelines for Compatibility Testing and Evaluation of Cosmetics and Packaging Materials Suitable for stability evaluation of cosmetics Evaluation of the efficacy of cosmetic anti-corrosion system Compatibility evaluation of containers or carriers in direct contact with cosmetic contents with products
Guidelines for Identification and Assessment of Hazardous Substances in Cosmetics according to Technical specifications for cosmetic safety The regulations stipulate,Identify and evaluate potential risk substances in cosmetics using methods such as referencing risk assessment conclusions from authoritative domestic and foreign institutions
Guidelines for Submitting Cosmetic Safety Assessment Data Refined the classification and submission requirements for cosmetic safety assessment data,Guide the registrant to accurately and standardly submit safety assessment materials.
How to comprehensively understand the safety assessment of cosmetics Technical Guidelines for Safety Assessment of Cosmetics abbreviation Guidelines

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.

What is included in the complete safety evaluation report

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.

What is the four step risk assessment method

The four steps of risk assessment for cosmetic raw materials and risk substances Hazard identification Dose-response relationship Exposure assessment Risk Characteristics Description.

Commonly used toxicology databases and login websites
1 U.S.ACIRCosmetic ingredient database
http://www.cir-safety.org/
2 european unionCosIngdatabase
https://ec.europa.eu/growth/tools-databases/cosing/
OECDdatabase
http://www.echemportal.org/echemportal/
european unionECHAdatabase 
http://echa.europa.eu/home

Frequently Asked Questions about Zhejiang Yaowen Children's Cosmetics Filing Information

What should be included in the principles of children's formula design

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 .

Children's cosmetics contain essence,How to provide security assessment materials How to calculate allergen content

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.

What are the special requirements for identifying and evaluating hazardous substances in children's cosmetics

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%.