(2)Common questions during cosmetic review in China

Q1: If the registration address of cosmetic manufacturer(registrant, notifier who manufacture cosmetics on their own and their entrusted manufacturers) is not consistent with its actual manufacturing address, how to mark the manufacturer address?

A1: According to the provisions of CSAR and Measures for Administration of Cosmetic Label, the names and addresses of the registrant, notifier and their entrusted manufacturers should be marked on cosmetic label. If the registration address is not consistent with the actual manufacturing address, the actual manufacturing address stated on the production license shall be marked.

Q2: When applying for the registration of special cosmetics, how to fill in and submit the SPF value, SPF value after bathing and PA level in the registering application form of sunscreen cosmetics in cosmetic submission and review system?

A2:When submitting, the SPF value, SPF value after bathing and PA level in the registering application form should be consistent with the information such as SPF value marked in product Chinese name and label sample.

Q3: What should registrant or Chinese RP pay attention to when submitting the classification code in registering application form of special cosmetics?

A3: According to the requirements of relevant regulations such as the Classification Rules and Classification Catalogue of Cosmetics, classification code in registering application form should be filled in and submitted correctly and normatively so as to avoid omission or mistakes of filling. The relevant content in the submission materials should comply with the classification code. For example, content such as efficacy claims, directions for use, site of action, applicable people should be consistent with the classification code. If the product contains propellant, the product dosage shall contain “aerosol”. If “Infants””children” are included in the users, it shall conform to the relevant provisions of children’s cosmetics.

Q4: How to conduct safety evaluation on flavour?

A4: Flavour, the category ingredient, can’t use the highest historical use concentration of “flavour” in IECIC 2021 as the evaluation evidence and it shall be evaluated in accordance with the principles and requirements in the Technical Guidance for the Safety Evaluation of Cosmetics. Or providing the documents certifying the flavour used by the product comply with the requirements of practical regulations of IFRA or Chinese(flavour)related  national standards.

Q5: When the nano ingredient in the formula is evaluated, which relevant materials should be provided?

A5: When the nano ingredient in the formula is evaluated, the ingredient quality specification issued by ingredient manufacturer should be provided , and also the safety evaluation materials based on the quality specification and supporting the formula use concentration.

Q6: How to mark in the formula list if nano ingredient is included in the formula?

A6: According to the Rules for Registration and Notification Dossiers of Cosmetics,  “(nano-scale)” should be marked behind the name of nano ingredient.


ZMUni Chinese Cosmetic Regulation Compliance Centre 中贸合规中心

Contact us: info@zmuni.com

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