How to assess amendment procedures and testing requirements when China's cosmetics safety specifications change
Different changes call for different compliance procedures
The National Medical Products Administration (NMPA) has issued Announcement No. 99 of 2026, explaining how cosmetics registration and filing information should be amended or updated when the Safety and Technical Standards for Cosmetics are revised. Covering cosmetics, including toothpaste, the announcement addresses ingredient lists, limits, and testing methods. It applies to products already registered or filed, as well as products under technical review or being prepared for submission.
For companies, the appropriate procedure depends on whether a revision affects the formulation, safety evidence, efficacy evidence, or the interpretation of test results. The announcement does not itself list newly prohibited or restricted ingredients or establish one effective date for all revisions. Product adjustment plans must therefore be linked to the relevant revision and its implementation date. The announcement alone does not establish whether a particular ingredient has become prohibited or restricted.
Assess testing exemptions separately from safety and efficacy obligations
For products already registered or filed that need changes because prohibited, restricted, or permitted ingredient lists have been revised, replacing the affected ingredient with a base ingredient such as a solvent or filler, or reducing its amount, can qualify for an exemption from registration or filing testing, provided the change is explained and a safety assessment is conducted. If the adjustment may affect efficacy, efficacy must still be reevaluated, with the product name, labeling, and other relevant information amended in line with the results.
A fragrance change requires a safety assessment and evidence of compliance with relevant Chinese national standards or International Fragrance Association (IFRA) standards. Formulation changes outside the situations described above require new registration or filing testing and a safety assessment before an amendment application is submitted. Applications meeting the applicable conditions may be submitted before the relevant revision takes effect.
This distinction affects both dossier preparation and project scheduling: an exemption from registration or filing testing does not remove safety assessment or efficacy evaluation obligations. Companies should separately assess the safety of the revised formulation, whether existing efficacy evidence continues to support the claims, and whether the name and labeling need corresponding changes. A reduction in ingredient concentration alone does not justify assuming that no documentation needs updating.
For limits and methods, first determine whether existing evidence remains adequate
When microbiological or harmful-substance limits change, registrants and filing entities must assess their products. If existing test reports and assessment results already meet the revised requirements, they may update the product's applicable standard themselves before implementation and retain the registration or filing documentation for inspection. If the evidence does not meet the revised requirements, companies may adjust manufacturing processes or quality controls and repeat the relevant testing. Once compliance is demonstrated, they may submit an amendment application before implementation.
When quality and safety testing methods are supplemented or updated, the key question is whether the difference between the existing and revised methods affects test results or their interpretation. If it does not, companies may update the applicable product standard and retain the supporting documentation as provided in the announcement. If it does, they should address the relevant process or quality-control changes and repeat the applicable testing before seeking an amendment once the revised requirements are met.
The basis for updating a standard therefore needs to be supported by specific reports, assessments, or method-comparison conclusions. Changing a method name in the dossier without assessing its effect on the interpretation of results would leave the procedural choice insufficiently supported. Companies should consider mapping each revision to the relevant item in the product standard, the available evidence, and the resulting action, creating a record that can be reviewed.
Products in development or under review require a check of testing milestones and supplementary evidence
For products whose registration or filing testing began before the relevant revision takes effect, the resulting reports may be used for registration or filing. Separate transitional provisions cover changes to efficacy test methods for sunscreen, freckle-removing and whitening, and anti-hair-loss products: products already enrolled for registration testing before implementation do not need to repeat efficacy testing using the revised method. The condition concerns enrollment for registration testing; it should not be replaced with a test of whether the product itself has already been registered.
Special cosmetics under technical review may adjust affected prohibited, restricted, or permitted ingredients at the supplementary submission stage. Replacing an ingredient with a base ingredient or reducing its amount requires an explanation and safety assessment and may qualify for the registration-testing exemption under the announcement. If efficacy may be affected, the supplementary submission must include the corresponding efficacy evaluation data for the revised formulation. Replacement with a non-base ingredient requires new registration testing and a safety assessment; fragrance changes require a safety assessment and evidence of compliance with the relevant standards.
These arrangements allow companies to organize amendment evidence according to the product's regulatory stage. Products being prepared for submission and those already under review still need to be assessed against their respective conditions. Possessing an existing test report does not establish that it can be retained for every formulation change.
Turn the impact assessment into a practical dossier plan
Companies should consider maintaining a product-level revision impact list identifying the applicable change and effective date, affected formulation or test items, evidence that can be retained, additional studies and documentation needed, and the proposed standard-update or amendment route. This is a compliance management recommendation, not a new standardized submission form required by the announcement.
Scheduling can prioritize products needing repeat testing, efficacy evaluation, or manufacturing-process changes, followed by coordinated evidence review across R&D, quality, and regulatory teams. Where companies may update standards themselves, they should retain the evidence supporting that choice rather than interpreting self-maintenance as an exemption from assessment.
Regulix® can help companies assess ingredient compliance and registration or filing amendment routes, review the relevant submission materials, and translate changes to the specifications into product-specific dossier preparation plans.
