From January 1, 2021, the "Regulations on the Supervision and Administration of Cosmetics" (hereinafter referred to as the "Regulations") will be officially implemented. The "Regulations" solidified the reform achievements in the field of cosmetics in recent years into regulations, and comprehensively opened a new chapter in the supervision of cosmetics. There are 80 articles in the "Regulations", of which 22 explicitly mention "cosmetic quality and safety", and 11 explicitly mention "efficacy claims".
In order to standardize and guide the evaluation of cosmetic safety and efficacy claims in my country and cooperate with the smooth implementation of the "Regulations", the State Drug Administration issued the "Technical Guidelines for Cosmetics Safety Evaluation (2021 Edition)" (hereinafter referred to as "Technical Guidelines") and the "Evaluation Specifications for Cosmetics Efficacy Claims" (hereinafter referred to as "Evaluation Specifications"), which will be implemented from May 1, 2021. The promulgation and implementation of the "Technical Guidelines" and "Evaluation Specifications" further stipulate the evaluation methods and basic principles that can be selected for the evaluation of cosmetic safety and efficacy claims at this stage, and have become important standards for cosmetic safety risk assessment and efficacy claim evaluation. It is of great significance for the healthy development of the entire industry and the effective protection of the legitimate rights and interests of consumers to provide scientific and standardized guidance for the development of safety and efficacy evaluation in the cosmetics industry. This article sorts out the evaluation of safety and efficacy claims under the Regulations and regulations.
"Technical Guidelines" and Cosmetics Safety Evaluation
The promulgation and implementation of the "Technical Guidelines" further strengthened the responsibilities of safety assessors, optimized the assessment methods, simplified the assessment content of a series of formulas, and increased the safety assessment of children's cosmetics.
Enhance the responsibility and professionalism of security assessors
The "Guidelines for Cosmetics Safety Risk Assessment" requires safety assessors to have a college degree or above or other formal qualifications. More than 5 years of relevant professional experience. For the safety evaluation report, the safety evaluator shall be responsible for its scientificity, accuracy, authenticity and reliability, and the evaluator's resume and signature are required to be attached to the evaluation report to implement responsibilities. At the same time, the "Technical Guidelines" require cosmetic registrants and filers to conduct safety assessments by themselves or entrust professional institutions to form safety assessment reports, and be responsible for their authenticity and scientificity.
Supplemental sensitization risk assessment
The Technical Guidelines further improve and supplement the cosmetic risk assessment procedures. The risk assessment procedure for cosmetic raw materials and risk substances is divided into 4 steps. For the first step - hazard identification, health hazard effects such as photoallergy, corrosiveness, repeated dose toxicity and inhalation exposure are supplemented, which is consistent with the "Cosmetic Safety". Technical Specifications (2015 Edition) to match the indicators of hazard identification used in toxicological safety assessment and risk assessment; for the second step - dose-response relationship assessment, the expected non-induced sensitization dose of sensitizing raw materials ( NESIL) assessment method; for the fourth step - exposure assessment, the transdermal absorption test method in the latest edition of the "Guidelines for the Safety Assessment of Cosmetic Raw Materials" of the European Union's Scientific Committee on Consumer Safety (SCCS) was used to clarify the raw materials and/or Or the acquisition of the experimental data of the percutaneous absorption of risk substances, and the calculation principle of the absorption rate of raw materials with different molecular weights when there is no percutaneous absorption data is added.
Emphasis on the use of new methods and historical evidence
In recent years, natural animal and plant extracts and bio-fermentation raw materials have become a new trend in research and development in the cosmetic market. However, their components are complex, and the safety risk assessment of such cosmetic raw materials is challenging. In order to ensure the safety of complex biological raw materials to the greatest extent, the "Technical Guidelines" improves the three aspects of raw material specification requirements, safety assessment methods and sources of evidence for safety assessment reports, so as to reduce the potential safety hazards of such complex raw materials in product application. In the raw material specification requirements, the report on the physical and chemical properties of raw materials derived from animals requires the content of characteristic components, and the type/method of biotechnology is required for raw materials derived from biotechnology. In the safety assessment method, new methods such as Threshold of Toxicological Concern (TTC) and grouping/cross-reference commonly used in the world are added: for raw materials or risk substances with a clear chemical structure and no serious mutagenic warning structure, the content is low and In the absence of systematic toxicology research data, the threshold of toxicological concern (TTC) method can be used for evaluation; for non-efficacy components or risk substances lacking systematic toxicological research data, grouping/cross-reference can be used for evaluation. Among the evidences that can be used in the cosmetic product safety assessment report, it is allowed to use the raw material concentration (ie: the historical use concentration of the company) in the products that have been marketed (at least 3 years) with the same method of use as the evidence for assessment, but it needs to be evaluated from the target. The population, the parts of use and the ways of use are fully analyzed to explain its rationality.
Standardized evaluation requirements for children's cosmetics
The "Technical Guidelines" stipulate that the safety risk assessment of products and raw materials used in children's cosmetics should be carried out according to the physiological and use characteristics of children: in the exposure assessment, the particularity of children's exposure should be considered; in the product microbiological assessment, children should be Special attention is paid to microbial contamination of cosmetics. The "Technical Guidelines" clarifies my country's technical requirements for the safety assessment of children's cosmetics for children's physiology and use characteristics, including: in hazard identification and exposure calculation, it should be considered that children have skin barrier and physical developmental insufficiency and other physiological functions In terms of formula design principles, it is necessary to clarify the principles of formula design and explain the necessity of using raw materials in the formula; in terms of raw material use, in principle, it is not allowed to use freckle whitening, acne removal, hair removal , Deodorant, anti-dandruff, anti-hair loss, hair dyeing, perming raw materials, if the raw materials that may have the above-mentioned effects are used for other purposes, the necessity of use and the safety of children's cosmetics should be evaluated; Cosmetic raw materials with a long history of safe use are not encouraged to use raw materials prepared by new technologies such as genetic technology and nanotechnology. If no alternative raw materials must be used, the reasons should be explained and the safety of children's cosmetics should be evaluated.
Simplified evaluation requirements for series products
For the multi-color, multi-flavor and other series of cosmetic products on the market, the "Technical Guidelines" stipulates that if the product formula is different in the type or content of the colorant or fragrance, the content and type of the basic formula and the same series name are the same. Products, you can refer to the existing information and data, only to evaluate the adjustment components, and to ensure product safety. However, if different raw materials in the product formulation have the same mechanism of action to produce systemic toxicity, the cumulative exposure of the raw materials should be considered and a case-by-case analysis should be carried out. This measure, which only evaluates the adjustment components for a series of products, reduces the workload of evaluation and improves the efficiency of safety evaluation while strictly supervising the quality and safety of products, thereby reducing the burden on enterprises and providing enterprises with R&D series of beauty products. innovative vitality.
Evaluation Specification and Efficacy Claim Evaluation
Before the promulgation of the "Regulations", my country required that the waterproof efficacy of sunscreen and sunscreen products should be evaluated in accordance with the requirements of the "Cosmetic Safety Technical Specifications". Compared with the "Cosmetics Safety Technical Specifications", the "Evaluation Specifications" expounds and stipulates the definition, evaluation categories, basic principles, responsibility requirements, responsibilities and requirements of evaluation agencies in the evaluation of efficacy claims.
Clarified the definition and evaluation principles of efficacy claim evaluation
Cosmetic claims are descriptive descriptions of products in various forms, involving product functions, ingredients, characteristics, etc. my country's regulations on the management of cosmetic claims are constantly improving. The “Regulations on the Management of Cosmetics Labeling” require that cosmetic labels should be true, accurate, scientific and legal. The “Regulations” strengthen the management of cosmetic claims, emphasizing that cosmetic efficacy claims should have sufficient scientific basis. "Evaluation Standard" divides scientific basis into three categories: literature, research data and cosmetic efficacy claims evaluation test results. Among them, the cosmetic efficacy evaluation claims test includes three categories: human efficacy evaluation test, consumer use test and laboratory test, requiring its experimental design to conform to statistical principles and the experimental data to meet statistical requirements. Based on this, the "Evaluation Specification" defines the evaluation of cosmetic efficacy claims as scientific testing and reasonable evaluation of the efficacy claims of cosmetics under normal conditions of use through literature research, research data analysis, or cosmetic efficacy evaluation tests. The process of making corresponding evaluation conclusions.
It is worth noting that although the "Regulations" divide cosmetics into ordinary cosmetics and special cosmetics according to the degree of risk, the "Evaluation Standards" for cosmetics produced and operated within the territory of the People's Republic of China (including domestic and imported cosmetics sold publicly in Whether it is an ordinary efficacy cosmetic or a special efficacy cosmetic, an efficacy claim evaluation is required, and its efficacy evaluation obligation cannot be exempted based on the degree of risk of the cosmetic. Nevertheless, cosmetics with different efficacy claims should be evaluated according to different evaluation criteria, and the evaluation principles for efficacy claims are summarized in Table 1. According to the requirements of the new regulations, cosmetic efficacy claims must be based on scientific evidence, and cosmetics such as freckle whitening, sun protection, anti-hair loss, acne removal, repair, and nourishment must be evaluated for human efficacy.
In addition to the above-mentioned efficacy claims for cosmetic products, those who make product efficacy claims by claiming the efficacy of raw materials should also carry out literature research, research data analysis or efficacy claim evaluation tests to confirm that the raw materials have the claimed efficacy, and at the same time, the efficacy claims of the raw materials and products are required. should be sufficiently relevant.
Provides evaluation agency selection and requirements
For evaluators and institutions, cosmetic registrants and filers can make efficacy claim evaluations by themselves, or they can entrust third-party evaluation agencies. Although the current laws and regulations do not specify the specific qualifications of third-party evaluation agencies, they are required to have corresponding capabilities. The State Food and Drug Administration has announced the list of 14 cosmetic registration and filing inspection and testing institutions capable of "human safety inspection and efficacy evaluation", and has made a complete list of the inspection items that each institution has acquired. In addition, the "Evaluation Specification" requires that institutions undertaking the evaluation of cosmetic efficacy claims should establish good laboratory specifications, complete the evaluation of efficacy claims and issue reports, and sort out relevant data such as the evaluation data of product efficacy claims or test reports issued by them. , archive and save for future reference, and be responsible for the authenticity and reliability of the report issued.
Guidance for compiling abstracts based on cosmetic efficacy claims
The main display method of cosmetic claim evaluation is a summary document, which at least includes basic product information, efficacy claim evaluation items and evaluation institutions, evaluation methods and results, evaluation conclusions and other relevant information. After the cosmetic registrant, filer or evaluation agency conducts the evaluation of cosmetic efficacy claims, a summary of the basis for the efficacy claim shall be compiled according to the evaluation conclusion. However, the following two categories of products are exempt from publishing their evaluation summaries: one is those that can be directly identified by the senses, such as cleaning, makeup removal, beauty modification, etc.; the other is those that produce effects through simple physical covering, adhesion, friction, etc. Identifies products that have only physical effect claims. Cosmetics that claim new efficacy can also be exempted if they belong to these two categories of products.
Identify the responsible subject for the evaluation of cosmetic efficacy claims
The "Evaluation Specification" clearly stipulates that cosmetic registrants and filers are responsible for the evaluation of cosmetic efficacy claims, and are responsible for the scientificity, authenticity, reliability and traceability of the abstracts on which the efficacy claims are based. Article stipulates the relevant penalties for failure to publish the summary of the basis for the claims of cosmetic efficacy in accordance with the regulations.
The "Technical Guidelines" and "Evaluation Specifications" are important support for the "Cosmetics Supervision and Administration Regulations" in terms of cosmetic safety and efficacy, and they are also the only safety risk assessment and efficacy claim evaluation regulations promulgated and implemented in our country so far. The implementation and implementation of the "Technical Guidelines" and "Evaluation Specifications" put forward solutions and institutional requirements for the evaluation of quality, safety and efficacy claims in my country's current cosmetics market from a practical level, and traced back to the source to ensure the safety of cosmetics. It is of great significance to unify market standards, standardize claims of efficacy, and establish a scientific and effective cosmetic evaluation system.
In terms of risk assessment, cosmetics companies and practitioners need to pay attention to the information released by the government and the interpretation of relevant policies in a timely manner, train professional risk assessment personnel, establish and improve the risk assessment and risk management system of products, and draw lessons from the European Union on the safety of new cosmetic raw materials and new technologies. Advanced experience in performance evaluation; in terms of efficacy and safety evaluation, cosmetic companies should follow the "Regulations" and "Evaluation Specifications" to provide a summary of the basis for cosmetic efficacy claims, and accept social supervision. At the same time, it is recommended to increase investment in cosmetic efficacy evaluation. Intensify efforts in control, train cosmetic efficacy evaluation personnel with relevant qualifications, and establish and enhance national cosmetic brands. (Excerpted from "Daily Cosmetics Science" Issue 7, 2021)
Source: China Food and Drug Network