Product Compliance
filing/registration/consulting/training
Q&A on the Filing of Ordinary Cosmetics by Beijing Food and Drug Administration Thirty seventh issue
Complete Safety Review Advanced Chapter
Information on the use of raw materials for products already on the market Equivalent to List of Used Cosmetics Ingredients Is that okay
The two cannot be equated.
Information on the use of raw materials for products already on the market hereinafter referred to as Raw material information It is used in special cosmetics within the validity period of the approval in our country,And not included in Technical specifications for cosmetic safety Objective inclusion of raw material usage without evaluation reports from internationally authoritative cosmetic safety assessment agencies,And perform dynamic updates. Raw material information The relevant data in can serve as evidence types for the complete safety assessment of cosmetics,Provide reference for cosmetic safety assessment,But no systematic evaluation was organized for the listed raw materials,Cosmetic registrant When the registrant uses relevant raw material information,Should comply with relevant national laws and regulations standard Requirements related to standardization,Conduct cosmetic safety assessment.Cosmetic registrant When the registrant is engaged in product production,If the raw materials exceed Raw material information Usage in,Should be in accordance with Technical Guidelines for Safety Assessment of Cosmetics 2021Year Edition Conduct safety assessment,Or according to Guidelines for the Use of Cosmetic Raw Material Data Use other raw material data types.
List of Used Cosmetics Ingredients It is produced within the territory of our country Objective inclusion of raw materials used in cosmetics sold,The highest historical usage of raw materials listed in this directory,Can be used as a cosmetic safety assessment report Simplified version Types of evidence,Provide reference for cosmetic safety assessment.Due to the lack of organized systematic evaluation of raw material safety,Cosmetic registrant When selecting the raw materials listed in this catalog, the registrant,Should comply with relevant national laws and regulations Mandatory national standards Requirements related to technical specifications,And bear the responsibility for product quality and safety.The raw materials included in this directory have been listed as prohibited components in cosmetics Management of restricted or permitted components,Cosmetic registrant The registrant shall comply with Technical specifications for cosmetic safety regulations,Choose to use products that comply with laws and regulations Mandatory national standards Raw materials required by technical specifications.
When filing ordinary cosmetics,Using new cosmetic ingredients that are still under safety monitoring,What are the precautions when conducting safety assessments on new raw materials according to Guidelines for Submitting Cosmetic Safety Assessment Data ,Cosmetics using new raw materials during the safety monitoring period belong to the first category of cosmetics,When filing, a cosmetic safety assessment report should be submitted.When evaluating new raw materials used in the product during the safety monitoring period,The purpose of using this raw material should be evaluated Scope of use or application Use concentration Do the usage restrictions and requirements comply with the technical requirements of the new raw materials. When filing ordinary cosmetics,Using nano materials,What are the precautions when conducting safety assessments on nanomaterials according to Regulations on the Management of Registration and Filing Materials for New Cosmetics Ingredients and Guidelines for Submitting Cosmetic Safety Assessment Data ,Nanomaterials refer to materials that have at least one dimension in a three-dimensional spatial structure1to100Nano sized or biologically insoluble artificial materials composed of them as basic units.The product formula contains nano materials,Should clearly include purity Crystal form Initial particle size distribution Raw material quality specifications for surface coating substances and other information,And based on the quality specifications of the raw material,Safety assessment of nano materials under formula usage,At the same time, it should be explained whether the toxicological testing methods used for evaluation are applicable to the detection of nanomaterials. Due to the small particle size of nanomaterials,There is a high risk of inhalation exposure,Therefore, the use of nanomaterials in products that may pose a risk of inhalation exposure is not encouraged. according to Regulations on Supervision and Management of Children's Cosmetics ,Children's cosmetics are not allowed to use raw materials prepared by new technologies such as nanotechnology,When there is no substitute material that must be used,The reasons should be explained in the product safety assessment materials,At least including the necessity analysis that the product formula must use this raw material and other raw materials cannot be replaced,Provide an explanation that the raw material is only based on nanotechnology,And fully evaluate the safety of children's use,When necessary,Provide safety evaluation test results as evidence support. When conducting safety assessments on plant extract raw materials,What are the main types of evidence and evaluation methods that can be used 1 Assessment conclusions published by international authoritative cosmetic safety assessment agencies. 2 world health organization WHO Food and Agriculture Organization of the United Nations FAO Waiting for the safety limits or conclusions announced by authoritative institutions. 3 Information on the use of raw materials for listed products released by regulatory authorities. 4 raw material3Annual usage history. 5 Safe consumption history. 6 Toxicological concern threshold TTC . But when evaluating, the following points should be noted(1)Should be based on the scientific and rational nature of data,Following Science fair Principles of Transparency and Case Analysis,Select the most relevant and reliable data types for evaluation.When necessary,It should be combined with the location and usage method of the product,Provide local toxicity data.(2)When conducting safety assessments on plant extract raw materials,If it is determined by oneself that it cannot be adopted Guidelines for the Use of Cosmetics Raw Materials Data Evaluate any data type in the,When conducting a complete assessment according to the risk assessment procedure,It is indeed impossible to retrieve relevant data on some toxicological endpoints of the raw materials,At the same time, the content of raw materials in the formula is relatively low,Does not have special effects such as spot removal, whitening, or hair loss prevention,And the number of raw materials in the above situation shall not exceed the total number of ingredients in the formula10%,At this point, final product safety testing can be conducted,Comprehensive evaluation and analysis of the safety of the final product.(3)Use toxicology attention threshold TTC When conducting an evaluation,Should be tested through laboratory testing or literature search,Collect the sources of plants Preparation process chemical composition Characteristic components Physical and chemical properties quality standard Impurities and other information,Identify as many single or large categories of components as possible,Especially the main chemical components and characteristic components, etc,The component content can be calculated based on the category of components.Except for necessary solvents or stabilizers added during the production process preservative Antioxidants and other external substances,The required ingredient content should not be less than50%. What are the common issues that arise when using historical data on the safe consumption of raw materials for evaluation 1 Adopting the World Health Organization WHO Food and Agriculture Organization of the United Nations FAO Waiting for the safety limits or conclusions announced by authoritative institutions,As allowed daily intake ADI Daily tolerated dose TDI Reference dose RfD Generally considered safe substances GRAS etc.,No analysis was conducted on the relevant materials,Adopting relevant conclusions without clarifying whether they comply with relevant regulations on cosmetics in China. 2 Directly adopt Chinese pharmacopoeia Oral safety data in China. 3 There is no corresponding relationship between the plant ingredients in the cosmetic formula and the safety consumption history data of the ingredient used in the application site. 4 The extraction process of plant ingredients in cosmetic formulas and the safety consumption history data of the ingredients used Like extracting solvents ,Inconsistent conditions such as impurity introduction.