Cosmetics safety assessment refers to the scientific assessment of known or potential adverse effects in cosmetics that are harmful to human health by using existing scientific data. The cosmetics registrant and filer shall carry out its own or entrust a professional institute to carry out a cosmetic product safety assessment to ensure that the product will not cause harm to human health under normal, reasonable, and foreseeable conditions of application.
Identify the source of safety risk
Cosmetics can generally be considered as a combination of various cosmetic product ingredients. The safety risks of cosmetics mainly come from formulas and ingredients, packaging materials, flammable, and explosive substances.
Cosmetic formulas and ingredients are the main factors affecting the safety of cosmetics. The safety assessment of cosmetics formulas and raw materials mainly considers the safety of various ingredients in the formula, as well as whether there will be chemical reactions between ingredients that will produce toxic and harmful substances. In addition, attention should also be paid to whether the ingredients carry safety risk substances. The concept that the assessment of substance toxicity is closely related to the dose should be integrated throughout the cosmetics safety management process.
Cosmetic packaging materials, especially those in contact with the contents, are important elements of cosmetic product safety assessment. Cosmetic packaging materials are diverse, mainly plastic and glass. Therefore, it is necessary to consider whether the cosmetic packaging materials will release and introduce toxic and harmful substances, and whether there will be a chemical reaction with the contents. The appearance of some cosmetic packaging materials may scratch consumers or cause other injuries, and some may cause infants and children to swallow and eat by mistake, which is also the focus of cosmetic product safety assessment.
In addition, the safety assessment of finished cosmetic products should also pay attention to whether the products contain flammable and explosive substances. It is necessary to assess the safety risks to consumers when storing and using products.
When carrying out the cosmetic product safety assessment, we should clearly understand the main sources of cosmetic product safety risks, and comprehensively and thoroughly identify and analyze them according to the actual situation to ensure product quality and safety.
Two ways to carry out cosmetic product safety assessment
The Technical Specification for the Safety of Cosmetics (Edition 2015) (hereinafter referred to as the "Technical Specification") stipulates the safety technical requirements for cosmetics. The Technical Guidance for the Safety Evaluation of Cosmetics (Edition 2021) (hereinafter referred to as the "Technical Guidance") specifies the procedures and form requirements for the safety assessment of cosmetics. The Work Specifications for Cosmetics Registration and Record-filing Inspection specifies the inspection items for cosmetic registration and filing, as well as the format of the inspection report. These three documents are the core documents of cosmetic product safety assessment.
According to the Technical Guidance, there are two main ways to assess the risk of cosmetics. One is to use the existing relevant safety data or information to carry out a "comparison" assessment, that is, to compare the concentration of raw materials in the formula with the safety limit specified in domestic and foreign regulations or the concentration in the listed products with the same method. If the concentration is lower than the safety limit or the historical use concentration, it can be assessed as safe; The other is to use the relevant test and statistical data to carry out a "calculation" assessment, that is, to assess the safety of cosmetic product ingredients according to the procedure specified in the Technical Guidance. Generally, the second method is more rigorous and scientific, but relatively time-consuming and laborious. The two methods can be used in combination. From the perspective of convenience, the first method can be preferred, and the second method can be used as a supplement when individual cosmetic product ingredients lack data or information.
Specifically, there are four main sources of data for "comparison" assessment. The first is the cosmetic product ingredients in the list of restricted components, permitted preservatives, permitted sunscreen, permitted colorants, and permitted hair dyes in the Technical Specification. The use of these cosmetic product ingredients must meet the requirements of the Technical Specification. The second is the safety limit or conclusion published by domestic and foreign authoritative organizations, including the World Health Organization, the Food and Agriculture Organization of the United Nations, the European Union Scientific Committee on Consumer Safety, etc., such as the conclusion on the safe use of cosmetics, the daily allowable intake, the daily tolerated dose, the reference dose, the generally recognized as safe substance (GRAS), and the fragrance standard issued by the International Fragrance Association (IFRA). Third, the concentration of raw materials in products with the same usage method that has been listed in our enterprise for at least 3 years (i.e. the historical usage concentration of our enterprise) is used as evidence for evaluation. The historical usage concentration of raw materials can be mutually referenced, and products with high exposure and long exposure time can be used for evaluation of products with low exposure and short exposure time, and vice versa is not possible. Fourth, the highest historical use of ingredients published by the cosmetic regulatory department.
The "calculation" assessment mainly includes four steps: hazard identification, dose-response relationship, exposure assessment, and risk characterization. Among them, hazard identification refers to identifying the possible toxic effects of substances; the Dose-response relationship refers to the toxic effect caused by substances reaching a certain concentration or content, and the initial dose of different toxic effects is generally different; The exposure assessment focuses on the contact between human body and substances, including the daily contact amount, contact site and contact route; Risk characterization is to obtain relevant parameters based on the above three steps, and then calculate the safety margin of substances.
After assessing the cosmetic ingredient safety, it is also necessary to identify the risk substances in raw materials, that is, to confirm whether raw materials contain risk substances, the amount of risk substances, and whether there are safety risks. The identification methods include but are not limited to raw material inspection, finished product inspection, request for raw material quality specifications, etc. All products shall identify lead, mercury, arsenic, and cadmium through finished product inspection. After completing all the assessment steps, a safety assessment conclusion can be made.
Analysis and utilization of assessment results
In addition to conducting the pre-marketing cosmetic product safety assessment as required, the cosmetic registrant and filer shall also analyze and utilize the assessment results and carry out reassessment and other work to further prevent and control safety risks.
The use method on the cosmetic product labels should be consistent with the relevant content in the safety assessment report. When conducting the safety assessment, the use method marked on the cosmetic product labels should be assessed, because the use method is directly related to the exposure dosage and exposure site of the product, which will significantly affect the cosmetic safety assessment results.
The reassessment system is a new system proposed by the Cosmetics Supervision and Administration Regulations (CSAR). Based on the scientific and technological means and cognitive level at the time of cosmetic registration and notification, the product or ingredients are considered to be safe, but according to the development of scientific research, there is a change in the understanding of the safety of cosmetics and cosmetic product ingredients, or evidence that cosmetics, cosmetic product ingredients may have defects, the drug regulatory department at or above the provincial level can order the registrant and filer of cosmetics and new cosmetic ingredients to carry out safety reassessment or directly organize to carry out safety reassessment. If the reassessment results show that cosmetics, or cosmetic product ingredients cannot guarantee safety, the original registration department shall cancel the registration the filing department shall cancel the filing, and the drug regulatory department under the State Council shall include the cosmetic product ingredients in the list of ingredients prohibited for cosmetics production and make it public.
What’s more, the Rules for Registration and Notification Dossiers of Cosmetics clearly state that the registrant, filer, or domestic responsible person shall fill in the information of the manufacturer of ingredients used in the product and upload the ingredient safety information document issued by the cosmetic product ingredients manufacturer. If the cosmetic product ingredients manufacturer has submitted the relevant information through the Cosmetic Ingredient Safety Information Registration Platform, the cosmetics registrant and filer can fill in the ingredient submission code and associate the cosmetic product ingredient safety information document, instead of filling in the ingredient information item by item. This is a new measure taken by the regulatory authorities to reduce the burden of the application work of the cosmetics registrant and the filer, but it is recommended that the registrant and the filer request relevant information from the raw material manufacturer, because the cosmetic product ingredients safety information is the basis for conducting the cosmetic product safety assessment, especially the impurity information of the cosmetic product ingredients will significantly affect the cosmetic product safety assessment.
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