Frequently Asked Questions on Cosmetic Technical Review by the National Institutes for Food and Drug Control (NIFDC) in China

We have collected questions issued by China's National Institutes for Food and Drug Control (NIFDC) concerning cosmetic technical reviews and translated them into English for your reference.

1. How long should the skin allergy test for oxidative hair dye products be observed?

The Safety and Technical Standards for Cosmetics clearly states that oxidative hair dye products should include safety warnings on the product label, such as "Hair dyes may cause severe allergic reactions". Therefore, if the product label specifies a skin allergy test method or observation time, the skin reaction should be observed for at least 48 hours to ensure all types of adverse skin reactions are detected.

2. How do you understand the relationship between product label claims and classification code efficacy claims?

The efficacy claims on the product label should fall within the scope of the classification code efficacy claims reported in the "Cosmetic Registration and Filing Application Form." The claims mentioned above cannot exceed the efficacy range covered by the classification code. For example, if the classification code only includes the claim "moisturizing", the product label can claim related benefits such as "moisturizing," "reducing moisture loss," or "relieving skin dryness". However, it cannot claim benefits outside the moisturizing scope, such as "firming" or "soothing".

3. How should it be handled if the 95% confidence interval of the mean in the sunscreen product Sun Protection Factor (SPF) determination report exceeds 17% of the mean?

Then additional subjects should be included in the test according to the requirements of the "Safety and Technical Standards for Cosmetics". The number of additional subjects should comply with the specification's requirements, and a statistical analysis should be conducted on the combined data from all subjects, including the original ones.

4. Do products claiming to be "microcrystal" or "microneedle" fall within the definition of cosmetics?

If products claiming to be "microcrystal" or "microneedle" are determined, based on their formulation, production process, usage method, and product form, to not be applied to the surface of the skin, then according to the Cosmetics Supervision and Administration Regulations (CSAR), they fall outside the definition of cosmetics.

5. How should the pH value be set for children's cosmetics?

The "Provisions on the Supervision and Administration of Children’s Cosmetics" encourage the development of product standards for children's cosmetics that are stricter than mandatory national standards and technical specifications. Children's cosmetics should set scientifically reasonable pH value parameters, index ranges, and quality management measures based on the "Technical Guidelines for Children's Cosmetics", considering product formulation, production process, usage method, and related research data. Products that do not require pH testing, such as purely oily (including wax-based) products, are exceptions according to the "Inspection Work Standards for the Registration and Filing of Cosmetics".

6. How should the standard Chinese name be reported for plant ingredients obtained through steam distillation in a formula?

When plant materials obtained through steam distillation are used in a formula, the standard Chinese name should be reported according to the actual product derived from the preparation process, following the naming conventions in the "Inventory of Existing Cosmetic Ingredients in China (IECIC 2021)". For example, the oily liquid obtained from steam distillation of ROSA RUGOSA flowers should be reported as "ROSA RUGOSA flower oil," and the aqueous solution should be reported as "ROSA RUGOSA flower water."

If the "Inventory of Existing Cosmetic Ingredients in China (IECIC 2021)" does not include a corresponding name for an ingredient obtained through steam distillation, but the name of the corresponding plant extract is listed, it can be reported under the plant extract name and explained in the formula's remark column. For example, the oily liquid obtained from steam distillation of POLIANTHES TUBEROSA flowers can be reported as "POLIANTHES TUBEROSA extract," with a note in the remark column stating "the part used is the flower, actually POLIANTHES TUBEROSA flower oil".

7. How should the specific part used be indicated for ingredients directly derived from plants in a formula?

According to the "Provisions on the Management of Cosmetic Registration and Filing Data", when using ingredients directly derived from plants in a formula, the part of the plant used should be specified. For example, if the ingredient is reported as "PRUNUS PERSICA juice", the part used, such as "fruit pulp", should be noted in the remark column of the formula.

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