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China's National Medical Products Administration (NMPA) has proposed revisions to the implementation guidelines for the Safety and Technical Standards for Cosmetics (STSC), clarifying when registrants and filing entities must update product registrations and notifications to comply with revised safety requirements.
The updated Cosmetic Safety and Technical Guidelines set out how cosmetic safety assessment reports should be prepared, documented and submitted, and specify the evidence and procedures required when manufacturers make formulation changes to existing products.
The consultation comes as NMPA prepares to implement 18 recently adopted revisions to the STSC, with phased compliance dates of 1 January 2027 and 1 January 2028. Those revisions include stricter microbiological requirements, new limits for certain substances and additional prohibited ingredients (see box).
The proposed implementation measures form part of China's broader effort to strengthen cosmetic safety oversight and provide greater regulatory clarity on how companies should manage compliance when product formulations change.
The changes are expected to trigger reformulation and compliance programmes across China's cosmetics sector, particularly for manufacturers of eye, lip and children's products and those using affected preservatives, UV filters, fragrance ingredients or fluorinated substances. Companies may need to update formulations, safety assessments, registration dossiers and product labels, while ingredient suppliers and testing laboratories are likely to face increased demand for compliance support ahead of the 2027 and 2028 implementation deadlines.
The consultation notice does not indicate whether any additional transition periods will be granted.
Implementation
For cosmetics registered or filed before the proposed revised standards take effect, registrants will need to submit a variation application if changes are required to meet the new requirements.
Where affected ingredients are replaced with base materials such as solvents or fillers, or where the concentration of a regulated substance is reduced, registrants may submit an explanation of the formulation changes and conduct a safety assessment without carrying out new registration or filing tests.
However, where the changes affect product efficacy, a new efficacy evaluation must be conducted and any associated information – including the product name and labelling – updated accordingly.
Where a fragrance or flavouring is replaced, registrants and filing entities must conduct a safety assessment of the replacement substance and provide evidence demonstrating compliance with relevant national standards or International Fragrance Association (IFRA) requirements.
For formulation changes that fall outside these circumstances, registrants will be required to conduct new registration or filing tests, complete a safety assessment and then submit a variation application.
The consultation is open for comment until 21 July.
Key cosmetics standards updates
Safety limits tightened on:
- eye, lip and children's cosmetics – limit of 100CFU/g or ml (total plate count);
- dioxane – limit reduced to 10mg/kg; and
- mercury and its compounds – limit of 1mg/kg.
Newly prohibited ingredients include:
- butylphenyl methylpropional (Lilial);
- cyclotetrasiloxane (D4);
- perfluorooctane sulfonic acid (PFOS) and its salts; and
- perfluorooctanoic acid (PFOA) and its salts.
Substances moving to the prohibited list include:
- zinc pyrithione;
- 4-Methylbenzylidene camphor; and
- 6-Amino-m-cresol.
Use restrictions revised for:
- salicylic acid;
- climbazole;
- methylisothiazolinone;
- benzophenone-3;
- homosalate;
- octocrylene;
- Acid Violet 43;
- o-phenylphenol and its salts;
- polyaminopropyl biguanide;
- toluene-2,5-diamine; and
- toluene-2,5-diamine sulfate.