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    Home > Active Ingredient News > Drugs Articles > The key points of the cosmetic safety risk assessment report under the new regulations

    The key points of the cosmetic safety risk assessment report under the new regulations

    • Last Update: 2021-07-17
    • Source: Internet
    • Author: User
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           On April 9, 2021, the State Drug Administration expanded its recruitment, and the official website also released the " Cosmetics Safety Evaluation Technical Guidelines (2021 Edition)", "Cosmetics Classification Rules and Classification Catalog", "Cosmetics Efficacy Claim Evaluation Standards") three The notification document will be implemented on May 1, 2021, which has attracted great attention from the industry
    .
    Regardless of safety or efficacy, the release of these three documents has given cosmetics more clear and scientific guidelines and directions, and the supervision of cosmetics has become stricter.
    Many industry practitioners have said that in this way Under the strict supervision of China, many small cosmetics companies and illegal enterprises will be eliminated

    .

           1.
    Applicable objects of cosmetic safety assessment

           The "Technical Guidelines for Cosmetic Safety Assessment (2021 Edition)" is applicable to the safety assessment of cosmetic raw materials and products
    .

           1) Safety assessment of raw materials

           2) Safety assessment of cosmetic products:

           2.
    Regulatory requirements for cosmetic safety assessment

           Before 2010, there was no guidance document for the safety risk assessment of cosmetics in my country.
    In order to guide the development of the safety assessment of cosmetics, relevant cosmetic safety assessment regulations have been formulated successively since 2010.
    The following table is summarized:

           3.
    When is the safety assessment of cosmetics needed?

           4.
    Example of a typical cosmetic safety assessment report (simplified version)

           The cosmetics safety assessment report can be divided into "Raw Material Safety Assessment Report" and "Product Safety Assessment Report", including the following examples:

           1 Safety assessment report of cosmetic raw materials

           The safety assessment report of cosmetic raw materials usually includes the abstract, the nature of the original product, the assessment process, the analysis of the assessment results, risk control measures or recommendations, the safety assessment conclusion, the signature and resume of the safety assessor, references and appendices
    .

           2 Safety assessment report of cosmetic products

           The safety assessment report of cosmetic products usually includes abstract, product introduction, product formula, formula design principles (only for children's cosmetics), safety assessment of each ingredient in the formula, assessment of possible risk substances, risk control measures or recommendations, and safety assessment conclusions , signature and content security assessors resume, references and appendices
    .

           The "Technical Guidelines for Cosmetics Safety Assessment (2021 Edition)" notice requires that before May 1, 2024, cosmetics registrants and recorders can submit simplified product safety assessment reports and cosmetic product safety assessments in accordance with the relevant requirements of the "Technical Guidelines" An example of the report (simplified version) is as follows:

    Sample of cosmetic safety assessment report (simplified version)                                 

           1.
    Summary

           xxx facial cream is a resident cosmetic, suitable for the face.
    According to the relevant provisions of the "Technical Guidelines for Cosmetic Safety Assessment", the formula used water, glycerin, cetyl alcohol, peanut alcohol, phenoxyethanol, flavor and dipalmitoyl hydroxypreserved Seven kinds of raw materials such as acid are evaluated, harmful substances and microorganisms of the products are tested, and two risk substances such as diethylene glycol and phenol that may exist are evaluated

    .
    The results show that the product will not cause harm to human health under normal, reasonable and foreseeable use

    .

           2.
    Product introduction

           1.
    Product name: xxx cream

           2.
    How to use the product: This product can be applied to the face

    .

           3.
    Average daily usage (g/day): 1.
    54*

           4.
    Product resident factor: 1.
    00

           5.
    Exposure dose (SED) = average daily usage × residence factor × percentage of ingredients in formula × transdermal absorption rate ÷ body weight#

           Note: *Refer to "THE SCCS NOTES OF GUIDANCE FOR THE TESTING OF COSMETIC INGREDIENTS AND THEIR SAFETY EVALUATION (10TH REVISION)" for average daily usage
    .

           # Weight is generally the default adult weight (60 kg); the transdermal absorption rate is calculated as 100%
    .

           Three, product formula

           The ingredients used in this formula have been listed in the "Used Cosmetic Raw Materials Catalog" or "Cosmetics Safety Technical Specifications" (2015 edition), and the product formula table is shown in Table 1
    .

           Table 1 Product formula table

           Note: This formula is only an example, not the actual formula
    .
    The product formula should provide all the raw materials and arrange them in descending order of content

    .

           Fourth, the safety assessment of each ingredient in the formula

           Table 2 Safety assessment of each ingredient

           V.
    Safety assessment of possible risk substances

           In accordance with the requirements of the "Technical Guidelines for Cosmetic Safety Assessment" and based on the current level of scientific knowledge, this product evaluates the risk substances that may be brought in by cosmetic raw materials, produced or brought in during the production process, and the results show that:

           The production of this product complies with relevant national laws and regulations, and strict management and control of the production process and product packaging materials are carried out
    .

           The safety risk substances that may exist in the product are technically unavoidable impurities that are brought into by raw materials
    .
    The remaining trace impurities will not cause harm to human health under normal and reasonable use conditions

    .
    See Table 3 for the hazard identification table of product safety risk substances

    .

           Table 3 Hazard identification table of safety risk substances in cosmetics

           In addition, the inspection report of the product showed that its lead, mercury, arsenic, cadmium, and dioxane inspection results met the limit requirements of Table 2 "Limits of Hazardous Substances in Cosmetics" of the "Safety Technical Specifications for Cosmetics" (2015 Edition)
    .

           6.
    Risk control measures or suggestions

           This product is a facial cream, applied to the face, and can be used daily
    .

           This product does not need to be marked with warning words
    .

           7.
    Safety assessment conclusion

           This product is a facial cream (residential cosmetics) that can be used daily and applied to the face
    .
    The main exposure method is transdermal absorption.
    According to the characteristics of the product, only the transdermal route is considered in the exposure assessment of this product

    .

           Through the comprehensive evaluation of the following aspects of the product:

           1.
    The safety assessment results of each ingredient show that all ingredients will not cause harm to human health at the concentration of this product;

           2.
    The detection and evaluation results of possible safety risk substances show that they will not cause harm to human health;

           3.
    The microbiological test results show that the microorganism of the product meets the relevant requirements of the "Cosmetics Safety Technical Specification" (2015 edition);

           4.
    The hazardous substance test results show that the hazardous substance content of the product meets the relevant requirements of the "Cosmetics Safety Technical Specification" (2015 edition);

           5.
    Unforeseen harmful interactions between the ingredients in the formula

    .

           In summary, it is believed that the product will not cause harm to human health under normal, reasonable and foreseeable use conditions
    .

           8.
    The signature of the security assessor

           Evaluator: xxx

           Date: xx, xx, 20xx

           Address: xxxxxxxxxxxxxxxx

           Evaluator: xxx

           Date: xx, xx, 20xx

           Address: xxxxxxxxxxxxxxxx

           Nine, safety evaluator resume

           .
    .
    .

           10.
    References

           Format example:

           1.
    The State Food and Drug Administration, Announcement on Issuing the Safety Technical Specifications for Cosmetics (2015 Edition), No.
    268 of 2015

           2.
    Ralph Gingell, Jeannie B.
    Kirkpatrick, and David R.
    Subchronic Toxicity Study of 1,3-Propanediol Administered Orally to Rats.
    International Journal of Toxicology, 2000,19: 27-32

           3.
    Safety Assessment of Brown Algae-Derived Ingredients as Used in Cosmetics.
    Final report 2019 available from CIR

           11.
    Appendix

           1.
    Toxicological report of 1,3-propanediol and peanut alcohol provided by raw material suppliers

           2.
    Use cetyl alcohol's cream data with the record number xxx

           3.
    Test report of diethylene glycol and phenol in the product

           4.
    IFRA certificate of flavor

           Note: The information provided in the appendix is ​​only for the sample report, and the certification documents provided by the raw material supplier can be provided according to the actual situation of the product, and the concentration of risk substances calculated based on the material provided by the raw material supplier, provided by the raw material supplier Other flavor certification documents or other certification documents such as the statement of compliance with GB/T 22731-2017 daily flavor standards
    .

           references

           [1]        About the author: Drip Sinan, male, senior engineer in biomedicine, based on the quality management of the biomedical industry, focusing on the biomedical industry
    .
           

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