1 . Do all cosmetic ingredients need to be evaluated for phototoxicity and photosensitivity?
Registrants/filers can use the 7 types of evidence in the "Guidelines for the Use of Cosmetic Raw Materials Data" to conduct safety assessments of most raw materials in the "Catalogue of Used Cosmetic Raw Materials". For a few raw materials that cannot use the above types of evidence, it is necessary to confirm the possible health hazards of the raw materials, including phototoxicity and photosensitivity, according to the requirements of the "Technical Guidelines for Cosmetic Safety Assessment" based on the product's usage methods, exposure routes, etc. According to the structural characteristics of the raw materials, if the raw materials are fully analyzed or tested to prove that they do not have ultraviolet absorption properties, or there is no possibility of exposure to strong outdoor ultraviolet radiation (such as ordinary cosmetics used for rinse-off and night use), the evaluation of skin phototoxicity and photosensitivity can be exempted.
2 . When conducting migration experiments on packaging materials that come into direct contact with cosmetics, what are the migrating substances that can be of concern?
According to the Technical Guidelines for Compatibility Testing and Evaluation of Cosmetics and Packaging Materials: Migration testing is a study conducted based on predicted target extractables, including extractables and their degradation products in packaging materials, products produced by reactions between packaging materials and cosmetics, etc. The analytical methods used in migration testing should be methodologically validated to confirm that the methods can sensitively, accurately and stably detect extractables in cosmetics. If necessary, adsorption testing can be carried out to examine the effect of packaging material adsorption on cosmetic ingredients.
When conducting migration tests, experimental plans should be designed specifically according to the materials of different packaging materials and the types of cosmetics, and the following items should be paid attention to.
1. Plastics: Migration of residual monomers, additives and their degradation products, etc.
2. Glass: Effect of alkaline ion release on pH of cosmetics; Migration of harmful elements; Migration of additives in light-proof glass containing colorants. For glass containers with internal coatings, coatings, etc., the integrity of the film, i.e., the migration of additives in the film, etc.
3. Metals: Migration of metal ions; corrosion of metal by contents; integrity of metal coatings before and after the test, migration of additives in the coating, etc.
4. Rubber: Migration of residual monomers, additives and their degradation products, etc. For rubber accessories with coatings, coatings, etc., the integrity of the film and the migration of additives in the film, etc.
5. Ceramics: Migration of harmful elements in ceramic glazes; for ceramic containers with internal coatings, coatings, etc., the integrity of the film and the migration of additives in the film, etc.
6. Membrane cloth: Migration of additives such as fluorescent brighteners.
7. Capsule shell: Migration of additives such as colorants.
8. Others: Refer to the above packaging material concerns, design a migration test plan, and examine the compatibility of packaging materials and cosmetics
3 . When conducting a complete safety assessment of cosmetic products, in which cases can the preservative efficacy evaluation not be conducted?
According to 7.3.3 of the Cosmetic Safety Assessment Technical Guidelines: For products with the same preservative system and similar formula, the product safety assessment can refer to the existing information and experimental data. According to the product characteristics, products that are not easily contaminated by microorganisms, that is, non-aqueous products, products mainly containing organic solvents, products containing water such as water activity <0.7, ethanol content >20% (volume), high/low pH value (≥10 or ≤3), products with filling temperature higher than 65°C, products that are disposable or cannot be opened, etc., do not need to be evaluated for preservative efficacy, but the cosmetic safety assessor should explain the relevant situation.
If you have any questions related to cosmetic safety assessment, please contact us via info@enter-co.com.
Also, you can follow us on LinkedIn for the latest cosmetic and toothpaste compliance information.
Comments