The National Institutes for Food and Drug Control (NIFDC) of China recently published a set of frequently asked questions to clarify common issues encountered during cosmetic technical reviews. The topics addressed include product formulations, implementation standards, cosmetic labeling, and requirements for special cosmetics. Below are the details:
A: For plant-based ingredients obtained via steam distillation, the standard Chinese name should reflect the actual product of the distillation process, following the naming conventions outlined in the Inventory of Existing Cosmetic Ingredients in China 2021 (IECIC 2021).
Examples:
If an oil-like liquid is obtained from the steam distillation of Rosa rugosa flowers, it should be reported as "玫瑰（ROSA RUGOSA）花油" (Rosa rugosa Flower Oil).
If a water-based solution is obtained, it should be reported as "玫瑰（ROSA RUGOSA）花水" (Rosa rugosa Flower Water).
If the steam-distilled ingredient is not listed in the IECIC 2021 but the corresponding plant extract name is included, it can be reported under the plant extract name with clarification added in the formula remarks section.
Example:
If an oil-like liquid is derived from the steam distillation of Polianthes tuberosa flowers, it can be reported as "晚香玉（POLIANTHES TUBEROSA）提取物" (Polianthes tuberosa Extract), with a note in the formula table stating: "The used part is the flower, and the actual ingredient is Polianthes tuberosa Flower Oil."
A: According to the Provisions for Management of Cosmetic Registration and Filing Dossiers, when the formula contains ingredients directly sourced from plants, the specific plant part used must be indicated. For example, if the ingredient listed in the formula is "Peach (PRUNUS PERSICA) Juice," the specific part of the plant, such as "flesh," should be noted in the remarks section of the formula sheet, based on its source.
A:
1. Provide a brief description of the main steps in the actual production process, such as material feeding, mixing, and filling. If certain production steps like pre-mixing or filling are completed by different manufacturing facilities, this should be noted in the remarks.
2. Indicate the main production process parameters, such as temperature, ensuring they are consistent with the basic properties of the ingredients and the product form.
3. Include all ingredients in the formula, ensuring that the names or numbers of the raw materials are consistent with those in the formula table. If the same raw material is used in different stages, it should be clearly distinguished. Additionally, any auxiliaries, such as water or volatile solvents, that are used during production but removed in subsequent steps should be specified.
A: In the product standards, for ingredients that require a control range based on the declared formula amount, such as octocrylene with a 5% inclusion in the formula, if the upper control limit is set at 6% and the lower limit at 4%, the control range should be expressed as 4%-6%, (4-6)%, or (0.8-1.2) times the formula amount, avoiding unclear or ambiguous expressions like 5±20%, 5%±20%, etc.
A: The efficacy claims on the product label should fall within the scope of efficacy claims specified in the Cosmetic Registration and Filing Application Form under the classification code. They cannot exceed the efficacy range covered by the classification code. For example, if the classification code only includes the efficacy claim of "moisturizing," the product label can claim moisture-related benefits such as "moisturizing," "reducing moisture loss," or "relieving skin dryness." However, claims beyond the moisturizing scope, such as "firming" or "soothing," should not be included.
A: Under the Cosmetic Supervision and Administration Regulation, cosmetics are defined as daily chemical products applied to the surface of the skin, hair, nails, or lips by methods such as rubbing, spraying, or similar, with the purpose of cleaning, protecting, beautifying, or altering appearance.
Products claiming to be "microneedle" or "microsphere" are not considered cosmetics in China if their formulation, manufacturing process, application method, or product content form indicates they are not intended for application to the surface of the skin.
A: The Supervision and Administration Provisions on Children 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 a scientifically reasonable pH value range, quality control measures, and brief descriptions based on the product's formulation, manufacturing process, usage instructions, and related research data, in accordance with the Technical Guidelines for Children Cosmetics. Products that are exempt from pH testing, such as pure oily products (including wax-based), are exceptions as specified in the Working Rules for Cosmetic Registration and Filing Testing.
A: The Safety and Technical Standards for Cosmetics clearly state that oxidizing hair dye products must include safety warnings on the label, such as "Hair dye may cause serious allergic reactions." Therefore, for products that include skin allergy test methods or observation times on the label, the skin reaction observation time must be at least 48 hours to ensure all types of adverse skin reactions are observed.
A: In the sunscreen product SPF determination report, if the 95% confidence interval of the mean exceeds 17% of the mean, the test should be conducted with additional subjects based on the original test population, in accordance with the requirements of the Safety and Technical Standards for Cosmetics. The number of additional subjects should meet the standards outlined in the specifications, and statistical analysis should be conducted by combining the data from all subjects, including the original ones.
https://www.nifdc.org.cn/nifdc/bshff/hzhpjssp/hzhpspcjwtjd/index.html
