1. What are the main local toxicity and systemic toxicity tests for cosmetic safety assessment?
Local toxicity:
(1) Skin and/or eye irritation/corrosiveness;
(2) Skin sensitization (skin allergy reactions);
(3) Skin phototoxicity;
(4) Skin photoallergic reactions.
Systemic toxicity:
(1) Acute toxicity (Acute oral and/or dermal);
(2) Genetic toxicity;
(3) Repeated dose toxicity;
(4) Reproductive developmental toxicity;
(5) Chronic toxicity/carcinogenicity;
(6) Toxicokinetics, etc.
2. What types of evidence can be used to evaluate the safety of ingredients and/or risk substances in the simplified version of the cosmetic safety assessment report?
According to the Technical Guidance for the Safety Evaluation of Cosmetics (2021 Edition), at least one type of evidence should be selected for evaluation in the following order to determine its safety:
(1) The use of restricted components, permitted preservatives, permitted sunscreen, permitted colorants, and raw materials in the list of permitted hair dye and risk substances with limited requirements in the Technical Specification for the Safety of Cosmetics. The use of these cosmetic raw materials shall meet the requirements of the Technical Specification.
(2) The published safety limits or conclusions of domestic and foreign authorities, such as the WHO, FAO, SCCS, CIR, etc., including 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). If there are restrictions (such as irritant requirements), based on the historical use concentration of the raw materials, toxicological testing of the product or raw materials, or clinical testing results in humans, their limits or conclusions can be used if they meet their restrictions; If there is only a conclusion of systemic toxicity assessment, combined with the historical use concentration of raw materials, toxicological test results of products or raw materials, or human clinical test results, after evaluating the local toxicity such as product irritation, the limit or conclusion can be used.
(3) 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 company) is used as evidence for evaluation. In principle, the concentration of raw materials used in product formulas with the same usage site and method shall not be higher than the historical usage concentration of the raw materials in our company. If it is higher than the historical usage concentration, a safety assessment shall be conducted in accordance with the Technical Guidance to prove its safety; 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. However, it is necessary to fully analyze and explain its rationality from the target population, usage site, and usage method.
The supporting documents for the enterprise's historical usage concentration shall be provided, including: 1) Domestic special products and imported products: registration or filing formula (shall be consistent with the formula submitted at the time of application), product registration certificate or filing evidence, product listing documents; 2) Domestic general products: production records, process sheets, ingredient lists (all three of the above shall include raw material content or calculable raw material content), filing evidence, product listing documents; 3) Description of adverse reaction monitoring; 4) Other supporting documents.
(4) When none of the above three types of evidence can be evaluated, the highest historical usage of raw materials announced by the cosmetics regulatory departments can provide a reference for evaluation. The concentration of raw materials used in the product shall not be higher than the highest historical usage of raw materials published by the cosmetics regulatory department.
For raw materials and/or hazardous substances that cannot use any of the above types of evidence, their safety shall be evaluated and demonstrated in accordance with the evaluation procedures required by the Technical Guidance.
3. How to evaluate the safety of raw materials or risk substances in cosmetics that cannot use any type of evidence of a simplified version report?
For the raw materials that cannot be used for all four types of evidence in question 2 above, a complete evaluation is required. The complete evaluation of raw materials shall be carried out in accordance with the 4. Risk Assessment Procedure and 6.1. Safety Assessment Principles are specified in the Technical Guidance, and an explanation shall be given whether the application risk of the raw material in the product is within an acceptable range.
4. Under what circumstances are raw materials exempt from conducting systemic toxicity assessments?
The safety limits and conclusions (including daily allowable intake (ADI), tolerable daily dose (TDI), reference dose (RfD), generally recognized safe substances (GRAS), raw materials with a long history of consumption, etc.) published by authoritative institutions such as the WHO, FAO, as well as raw materials derived from extracts of edible parts whose extraction process do not involve biochemical or chemical reactions, and original composition structure has not changed. After analyzing the relevant information, the relevant conclusions can be adopted under the condition that the relevant national regulations are met.
5. What are the databases commonly used for cosmetic safety assessment?
(1) Cosmetic Ingredient Safety Evaluation Database established by the U.S. Cosmetic Ingredient Evaluation Committee
(2) Cosmetic Ingredients Database of the European Commission
(3) European Chemicals Agency database
(4) WHO food additive-related databases
(5) Health and environmental toxicology database of food-related substances evaluated by EFSA
(6) FDA generally recognized as a safe substances database
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