Summary of Prohibited and Restricted Raw Materials for Cosmetics and Their Adjustments

◾In 2021, the "Catalogue of Prohibited Raw Materials for Cosmetics" and "Catalogue of Prohibited Plant (Animal) Raw Materials for Cosmetics" were released, laying the foundation for the current management of prohibited raw materials. Compared with the previous ones, the main contents and characteristics of the adjustment and revision include the following three aspects:

◾In 2023 (Notice No. 41), the banned raw material Benweimod (catalog number 1285) was added, and the impurity management limit standard for "benzene" was simultaneously added. The notice will be implemented immediately from the date of publication.

◾In 2024 (Notice No. 12), five new banned raw materials were added, namely bimatoprost (1286), latanoprost (1287), tafluoroprost (1288), tafluoroacetamide (1289), and trovoprost (1290), which will be officially implemented from the date of publication.

◾In 2026 (Announcement No. 6), 7 new categories of prohibited substances in cosmetics will be added, and key limit values for microorganisms and dioxane will be adjusted simultaneously. This is the most extensive regulatory update in recent years.

◾2026 (Announcement No. 48): Optimize the management rules for the prohibition of mercury and its compounds, cancel the original exemption clauses, comprehensively tighten the control of mercury substances, and officially implement on July 1, 2026.

◾Implementation on July 1, 2026: New regulations for the complete ban of mercury and its compounds.

◾Implemented on January 1, 2027: Control standards for total bacterial count limit, dioxane limit, 4-methylbenzylidene camphor, 6-aminocresol, perfluorooctane sulfonic acid and its salts, perfluorooctanoic acid and its salts in eye/lip/children's cosmetics.

◾Implemented on January 1, 2028: Control standards for the prohibition of butylphenylmethylpropanal, cyclotetradimethylsiloxane, and zinc pyrithione.

◾Transitional compliance: Cosmetics produced or imported before the implementation of the new regulations can be sold until the end of their shelf life; Encourage enterprises to implement new standards in advance.

The revised list of prohibited raw materials includes 1297 prohibited raw materials and 109 prohibited plant (animal) raw materials, totaling 1406. The core compliance points are:

◾The scope of prohibited raw materials is not limited to the substances listed in the catalog. Substances identified as having unacceptable risks after evaluation are also prohibited from use. Enterprises need to conduct a comprehensive risk assessment;

◾Natural and artificial radioactive substances shall not increase during the production process and must comply with health protection limits;

◾Impurity exemption: benzene impurity limit ≤ 2mg/kg, D4 impurity limit ＜ 0.1% (w/w);

◾Plant (animal) raw materials, including their extracts and products, are prohibited. If there is no clear indication of prohibited parts, the entire plant is prohibited;

◾Core principles: Prohibited raw materials ≠ absolutely not detectable, impurities that cannot be avoided by technology, compliance standards for finite values, and safety risk assessments for infinite values to ensure no health hazards.

◾The determination of the banned plant animal catalog requires a dual verification mechanism, which checks both the Chinese and Latin names. As long as the Latin scientific name appears in the banned catalog, regardless of whether its Chinese name is consistent, the raw material is banned.

◾Pay attention to distinguishing between "hazardous substances" and "illegal additions": the former is not actively added, but refers to impurities or by-products (such as dioxane, benzene) that are passively generated, introduced, or migrated during raw materials, packaging materials, production, storage, and transportation processes; The latter intentionally and proactively adds ingredients that are explicitly prohibited by the state, such as hormones and antibiotics.

◾Risk substance control: Identify risk substances based on their sources and production processes, refine classification, standardize assessment, and improve technical guidance to prevent and control risks.

◾Implementation time: officially implemented from January 1, 2028, with a transition period of 2 years.

◾Transition period rules: Products produced or imported before the implementation of the new regulations can be sold until the end of their shelf life, and companies are encouraged to upgrade their compliance in advance.

◾Core control requirements: Strictly distinguish product usage scenarios, accurately control concentration limits, and implement the prohibition requirements for children's products and inhalation risk products.

◾When restricted substances are not used as preservatives, the product label must also indicate the name of the raw material and its specific function.

◾Only when products containing salicylic acid may be used by children under three years old and have long-term contact with the skin, should a corresponding warning label be added on the label - 'Do not use for children under three years old'.

◾When the concentration of formaldehyde exceeds 0.05%, it should be marked as' containing formaldehyde '.

◾There should be a correct understanding and application of "limiting conditions", such as silver nitrate being only allowed to be used for products that dye eyelashes and eyebrows. Not to be used for hair dye products such as "one wash black" or "white to black" shampoos.

Approved preservatives:

Approved sunscreen:

Approved coloring agents:

◾Approved colorants in the list, salts and lakes generated by reacting with non prohibited substances, are also allowed to be used in cosmetics.

◾Insoluble barium, strontium, zirconium lakes, and salts must undergo insolubility testing before they can be used;

◾Colorants that have both sun protection and sunscreen functions must also comply with sunscreen control standards.

Approved hair dye:

◾All hair dye products must be mandatory to label with unified warning signs, strictly control the user population, applicable parts, and mixing ratios. Hair dye may cause serious allergic reactions and should not be used to dye eyebrows and eyelashes. If it accidentally gets into the eyes, it should be rinsed immediately.

◾When used in conjunction with oxidized milk, the mixing ratio should be clearly indicated.