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Q1: When notifying general cosmetics, on what condition can it be exempted from submitting the toxicological test report of the product? What are the exceptions?
A1: According to (2) of Article 33 of the Rules for Registration and Notification Dossiers of Cosmetics, the toxicological test report of general cosmetics can be exempted from submission where the manufacturer of general cosmetics has obtained the production quality management system related qualifications issued by government authorities in the country/region where it is located, and the safety risk evaluation result of the product can fully confirm the safety of the product. The exceptions are as follows:
1.The product claims it is for infant/child use
2.The product uses new cosmetic ingredient that is in safety monitoring
3.According to the results of the quantitative grading score, the notifier, the Chinese responsible person, the manufacturer are listed as a key regulatory objects.
It can be exempted from submission of toxicological test report where the general cosmetics are produced by several manufacturers and all the manufacturers have obtained the production quality management system related qualifications issued by government authorities in the country/region where it is located.
Q2: For sunscreen spray products the formula of which contains propellant, how to fill in the control range of physical and chemical indicators of sunscreens in the product implementation standards correctly?
A2: There are two fill-in methods: method including propellant or method excluding propellant, however behind the control range of sunscreen indicators it must be noted whether the propellant is contained.
For example,sunscreen spray products propellant filling volume is “Total mass of propellant : Total mass of ingredient for formulation = 60 : 40”, the formulation declaration volume of the sunscreen “ethylhexyl salicylate” is 4.5%(excluding propellant), and its control range can be set at 3.6%-5.0%(excluding propellant), or at 1.44%-2.0%(including propellant).
Q3: For hair dye products, how to fill in the control range of physical and chemical indicators of hair dyes in the product implementation standards correctly?
A3: shall be filled in according to the formulation declaration volume of hair dyes. For two or more doses of mixed hair dye products there are two ways to fill in: Firstly, fill in the control range of hair dye indicators according to the concentration of doseⅠor each hair dye in the dye. Secondly, fill in that in accordance with the concentration of each hair dye when they are mixed in use and specifying the mixing ratio.
Q4: Where the inspection method is adopted as quality control measure in “microorganism and physicochemical indicators and quality control measure” in product implementation standards, how to fill in it correctly?
A4: According to 3 of (5) of Article 30 of the Rules for Registration and Notification Dossiers of Cosmetics, where inspection method is adopted as quality control measure, the specific name of the inspection method shall be filled in correctly and reasonable inspection frequency shall be noted. Where inspection method outside Safety and Technical Standards for Cosmetics(STSC) is adopted as quality control measure, this method and specific inspection methods contained in STSC shall be validated. The validation result shall comply with requirements and complete inspection method and method validation materials shall be kept the file for reference.
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