July 3-5, NMPA hosted an online training for the 2024 Cosmetic Registration and Filing Management to guide cosmetic safety assessment. Here is an excerpt of the highlights to share with you.
Guidelines for the Application of Cosmetic Ingredient Data
■ The seven main data types are not exhaustive, and if it is not possible to satisfy all seven, other data, such as toxicological data, can be used in accordance with the Guidelines.
■ Q: Is there a priority adoption order for the seven main ingredient data types?
A: Cosmetic registrants and recorders should follow the weight-of-evidence principle and select the most relevant and reliable ones to carry out assessment among the 7 types according to reasonableness, except for the restricted components, permitted preservatives, permitted sunscreens, permitted colorants and permitted hair dyes in the Technical Standards for Cosmetic Safety.
■ Restricted components, permitted preservatives, permitted sunscreens, permitted colorants and permitted hair dyes in the safety technical standards for cosmetics are referred to the updated documents. Such as the formaldehyde is updated from a restricted component to a prohibited component
■ International authoritative cosmetic safety assessment organizations published assessment conclusions, which enterprises have to analyze and judge the reliability and relevance of the data by themselves.
(1) It must comply with related regulations and use conditions of cosmetics in China.
(2) For ingredients with restricted use conditions, their assessment conclusions should be adopted when conditions are met.
(3) To adopt conclusions scientifically based on the data's reliability and relevance in case of different assessment results by different authoritative organizations.
■WHO, FAO and other organizations published safety limits or conclusions, which are based on food and occupational exposures, generally exempt from systemic toxicity, but require an assessment of partial toxicity, such as products used in the eye, which requires additional data on eye irritation and other data.
■ It is encouraged to use 3-year history of ingredient use.
(1) Same ingredient means the same serial number of the one in the IECIC.
(2)Historical use concentrations of ingredients can be cross-referenced, high exposure and long exposure times products, can be used in the assessment of products with low levels and short duration exposed. For example, cleanser refer to cream (same use area, different exposure time), cream refer to body lotion (high exposure, both resident categories), which cannot be reversed.
(3) Proofs.:
a. Instructions for the same ingredient
b. Registration number: If the use concentration is not shown, the production supply record is required.
c. Adverse Reaction Monitoring Information Statement.
d. Proof of listed sales data ( currently there is no regulation that the sales scale can not be in dozens, it can be foreign or domestic, different product categories, different companies, and if the data of other companies are used, the authorization letter should be submitted)
e. Other references.
■History of Safety in Diet:
(1) Systemic toxicity can be exempted and partial toxicity can be assessed by combining application points and modes used.
(2) The safety standards for food additives have clear quantity requirements, which should be scientifically converted into units when applied.
■Polymers with stable structure and properties (except those with high biological activity)
(1) Because of the large molecular, there is no consideration of transdermal absorption, no consideration of systemic toxicity, but do assess the partial toxicity.
(2) The supporting materials need to show the structural unit, average molecular mass, relative molecular weight, the oligomer content less than 1000 daltons, etc. As it is difficult for enterprises to prove that the ingredients are without biological activity, an explanation of the lack of biological activity can be issued.
If you have any questions related to cosmetic filing and registration, please contact us via info@enter-co.com.
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