Q&As on Ordinary Cosmetics Filing in Guangzhou (Vol. 56)

We have collected the latest FAQs on ordinary cosmetics filing from the Guangzhou Administration for Market Regulation and translated them into English for your reference.

1. How should safety assessments be conducted for products that are used in combination with two or more doses?

Products that are mixed and used in two or more doses should be assessed for the safety of each component after mixing, according to the usage methods described in the instructions. When there are different usage methods related to safety, such as different concentrations and proportions, each case should be assessed separately. When the parts in the usage method can also be used independently, they should be assessed separately.

2. What information should be provided when assessing the use of nanomaterials in a formulation?

The dermal absorption, safety risks, and other biological behaviors of nanomaterials are closely related to the specific characterization of the ingredients. When conducting a safety assessment for products containing nanomaterials in the formulation, the quality specifications issued by the ingredients manufacturer should be provided, along with safety assessment data based on these quality specifications and the supported amount used in the formulation.

3. Which ingredients are exempt from systemic toxicity assessment?

(1) Safe levels or conclusions published by authoritative organizations such as the World Health Organization (WHO) and the Food and Agriculture Organization (FAO), such as Acceptable Daily Intake (ADI), Tolerable Daily Intake (TDI), Reference Dose (RfD), Generally Recognized As Safe (GRAS), ingredients with a long history of consumption, etc., require analysis of relevant information. If compliant with the regulations for cosmetics in China, these conclusions may be adopted.

(2) Compounds not considered for dermal absorption. Chemically synthesized polymers made up of one or more structural units linked by covalent bonds, with an average relative molecular mass greater than 1000 Daltons and oligomers with a relative molecular mass less than 1000 Daltons constituting less than 10% of the polymer, which are stable in structure and properties (excluding ingredients with high biological activity).

4. What are the differences between the safety assessment of children's cosmetics and that of ordinary cosmetics?

The safety assessment of children's cosmetics should comply with the principles and requirements of the "Technical Guidelines for Cosmetic Safety Assessment," oriented by exposure and taking into account the physiological characteristics of children, as well as the method of use, site of action, amount used, and residue levels of the product. Exposure data should consider the characteristics of children's body surface area to weight ratio, the behavioral developmental characteristics of infants (such as sucking, scratching, etc.), and the metabolic capacity of infants, which may lead to higher exposure levels compared to adults. The formulation design of children's cosmetics should reasonably use preservatives, colorants, surfactants, sunscreens, and fragrances, etc., on the premise of safety first and efficacy as necessary.

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