On February 5, 2024, the China National Institutes for Food and Drug Control (NIFDC) released a set of five technical guidance principles, with three of them specifically addressing the topic of inhalation toxicity in cosmetics. These guidelines are as follows:
The "Guiding Principles" highlight that cosmetics, when applied to the skin, hair, nails, lips, or other body surfaces using methods like application or spraying, carry potential risks of inhalation exposure. These risks arise from factors such as the formulation, method of use, or inherent characteristics of the ingredients.
In compliance with the provisions set forth in the "Technical Guidelines for Cosmetic Safety Assessment" and the "Regulations for Registration and Filing Management of New Cosmetic Ingredients," the following requirements apply:
The "Technical Guidelines for the Study of Acute Inhalation Toxicity of Cosmetic Ingredients" align with safety evaluation requirements by incorporating relevant content like OECD 403 and GB/T 21605-2008. They guide the evaluation of acute inhalation toxicity, adhering to applicable regulations in China and providing a foundation for determining doses in subchronic toxicity tests.
The "Technical Guidelines for Acute Toxicity Classification of Cosmetic Ingredients in Inhalation Toxicity Testing" addresses safety evaluation specifics, considering content such as OECD Test Guidelines 412 and 413. They provide reference test designs and procedures for evaluating repeated dose inhalation toxicity of cosmetic ingredients posing inhalation exposure risks.
The "Technical Guidelines for the Study of 28-Day/90-Day Repeated Dose Inhalation Toxicity of Cosmetic Ingredients" classify acute inhalation toxicity of test substances. The derived data serve as a basis for designing 28-day/90-day repeated inhalation toxicity tests, selecting appropriate doses, and conducting relevant toxicological assessments.
The publication of these guidelines establishes technical standards and regulatory foundations for test substances, experimental animals, exposure methods, test methodologies, dosages, observation periods, endpoints, and test result analysis. They offer crucial guidance for ensuring the safety of cosmetic ingredients and promoting responsible practices within the industry.
When conducting inhalation toxicity assessments, it is important to follow the principle of "case-specific analysis." This involves selecting appropriate testing methods, such as acute inhalation toxicity testing, 28-day repeated dose inhalation toxicity testing, or 90-day repeated dose inhalation toxicity testing, based on the anticipated duration of use and exposure methods of the test substances. Comprehensive evaluation of test results, considering other relevant toxicological research, is vital.
The release of the "Technical Guidelines" provides scientific recommendations for studying acute and repeated inhalation toxicity of cosmetic ingredients. They guide the evaluation of inhalation toxicity, determination of inhalation LOAEL and/or NOAEL, and safety assessments of inhaled cosmetic ingredients.
Moreover, the registration and filing documentation for new ingredients require toxicological test data, which includes "inhalation toxicity testing" if the ingredient may be exposed through inhalation. Previously, the lack of official guidance specific to inhalation toxicity testing for cosmetic ingredients led many companies to avoid conducting this test by refraining from using the ingredient in aerosol formulations. The "Technical Guidelines" effectively address this gap, offering comprehensive guidance and enabling proper inhalation toxicity testing to ensure the safety of cosmetic ingredients.
