SFDA consults on Guidance to Application and Review of Children Cosmetics: requirements on formula, safe use, and application and review criteria are standardized in the draft proposal.
A Guidance to the application and review of children (including infants) cosmetics in China has been released for public commentary, according to a notice published by the State Food and Drug Administration (SFDA) yesterday. The draft guidance puts forward a number of new requirements on formula, safe use, and application and review criteria of cosmetic products used for children under 12.
Formula
The proposal makes clear that components with special functions such as whitening and freckle removing, etc. are unsuitable to be adopted for children cosmetics. SFDA does not encourage the use of new chemicals or technology like Genentech or nano materials, either.
Safety Assessment
The draft rule demands formula producers strengthen the safety risk assessment of organic solvents (such as essence or ethanol), cationic surfactants, penetration enhancers and other ingredients used in children formula. The safety risk assessment should be conducted combined with the use method.
Application
Application materials for children cosmetics must contain documents about safety-based formula design report (including an integrated analysis report of formula), conditions and requirements of the choice of ingredients, production process and quality control, etc. The draft standard is attached with a sample of formula design report and the integrated analysis report of formula for industry reference.
Technical and Form Reviews
The proposal specifies that “The microbial colonies in children cosmetics must not exceed 500 CFU/mL or 500 CFU/g”; children product shall have no skin/eye irritation, no phototoxicity, nor allergic effects.
The product name, label and instruction manual should be marked with descriptions like “for children”; the outer package should also have precautionary statements like “Apply to children and must be used under the supervision of an adult”.
The agency also makes public in the draft its decision to re-evaluate the safety assessment of children cosmetics that have already been approved, depending on the toxicological research progress in this field.
Public comments on this guidance are expected to return by 29 February 2012, one month before its effectiveness on 1 April 2012.
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