China: Cosmetics Safety and Specification Standard 2022 (STSC 2022)

On March 31, 2022, the China National Institute for Food and Drug Administration (NIFDC) published a draft Safety standard and technical standard for cosmetics 2022 (hereinafter referred to as the “STSC 2022 Project”) for comments. The consultation ends at April 30, 2022. Interested parties who have suggestions can complete the feedback form and email it to [email protected] before this date.

Along with the STSC 2022 project has also been published (for comments) Explanation of revision and comparison table of revisions of safety standards and technical standards for cosmetics 2022}} (draft for comments).

SNTC presentation

Safety and technical standards for cosmetics 2015 (hereinafter referred to as “STSC 2015”), based on the Cosmetic Hygiene Supervision Regulation issued in 1989, is a comprehensive technical standard for the supervision and safety testing of cosmetics in China. It specifies general safety standards: prohibited/restricted/permitted ingredients, as well as methods for testing cosmetics.

The Chinese NIFDC plans to introduce a more systematic and complete version to replace the existing 2015 version.

Comparison of STSC 2015 and STSC 2022 project

Compared to the 2015 version, the general structure of the 2022 version has not fundamentally changed. The STSC 2022 project revises content that is not suitable for current surveillance practices, retains content that is still applicable, includes previously approved editions (published as notices) and also standardizes or improves certain terms and expressions.

The main changes in each chapter are as follows:

Chapter 1 – Presentation

- Revises and improves definitions of prohibited ingredients, sunscreens, hair dyes, wash-off cosmetics, eye cosmetics, and safety hazards.

- Adds general requirements for the pH of cosmetics to be greater than 2.0 and less than 11.5.

- Remove provisions on mercury. Following the entry into force of STSC 2022, the mercury limit for eye contour cosmetics containing organic mercury preservatives will be less than 1 mg/kg, as is the case for other cosmetic products.

(Comparison of limit values ​​for mercury)

Chapter 2 Prohibited/Restricted Ingredients in Cosmetics

Chapter 3. Permitted Ingredients in Cosmetics

- Regulates the list of ingredients allowed in cosmetics.

- Adds new authorized preservative Ethyl Lauroyl Arginate HCL.

- Removes mercury-containing preservatives such as phenylmercury salts (including borate) and thimerosal.

- Removes 3-benzylidene camphor sunscreen.

- Remove 2-Chloro-p-phenylenediamine and 2-Chloro-p-phenylenediamine sulfate hair dye, and add approved Galla-Royce Gallnut Extract or Gallic Acid hair dye.

- Standardizes certain terms and corrects certain expressions.

Chapter 4 – Physical and chemical test methods

- Expands the field of physical and chemical testing of preservatives, sunscreens, dyes, hair dyes and other ingredients.

- Adds new test methods based on previous versions.

- Revises 15 testing methods based on previous versions.

- Add the Chinese name, CAS number, molecular formula, and molecular weight information specified in the standards to the app.

- Unifies the format and style of text. For example, the Chinese and English names of the tested ingredients are standardized.

- The detection limit expression has been unified, some test methods have been corrected, and reagent preparation methods have been added.

Chapter 5 – Methods of microbiological analysis

- Standardizes and revises relevant terms, symbols, and method symbols with reference to relevant national standards such as the Chinese Pharmacopoeia (2020 edition).

- Some of the requirements for the thermotolerant E. coli test, the Staphylococcus aureus test, the Pseudomonas aeruginosa test, and the mold and yeast test have been amended.

Chapter 6. Methods of toxicological tests

- Changes two test methods based on previous versions and adds eight new test methods (transcutaneous electrical resistance (TER) test); in vitro short-term exposure (STE) test method; local lymph node analysis: DA (LLNA: DA); local lymph node test: BrdU-ELISA (LLNA: BrdU-ELISA) Direct peptide reactivity test (DPRA) 3T3 NRU in vitro phototoxicity test Skin photoallergy test In vitro micronuclei in mammalian cells

- Standardizes text format, style, and sequence of toxicological test methods.

- Standardizes product categories and formulations, such as changing the category “hair growth” to “prevention of hair loss”.

- Clarifies some of the test requirements, defining prerequisites, clarifying dosage design, data processing, and criteria for evaluating results.

Chapter 7 – Human Safety Test Method

- Indicates that a product safety assessment must be supplemented by a written confirmation issued prior to human clinical trials.

- Removes the description of applicable product categories in methods.

- Based on advances in medical research and professional experience in trial registration and reporting, STSC 2022 adjusts and improves subject screening and exclusion requirements, as well as sampling methods for various product dosage forms.

Chapter 8 – Human Efficacy Method

- Includes two test methods based on previous editions, namely: Test Method for Measuring the Effectiveness of Skin Whitening Cosmetics and Test Method for Measuring the Effectiveness of Anti-hair Loss Cosmetics.

- Referring to the relevant ISO standards in conjunction with registration and notification requirements, STSC 2022 clarifies the requirements for evaluating the results of waterproofing sun protection products.

Chemlinked overview

STSC 2022 puts more emphasis on ingredient safety and improves testing methods for greater technical and scientific accuracy. The introduction of STSC 2022 will not only affect the control of cosmetics under the new regulations, but will also directly affect the research, development and production of cosmetics. Therefore, ChemLinked invites interested parties to pay attention to the new standards and actively submit their comments before the deadline.

Link to original document:

China NIFDC Notice of Request for Public Comments on the Revision of the Technical Safety Standard for Cosmetics

Leave a Comment

Your email address will not be published.