Hainan's trial self-check guidance covers formulas, ingredients and safety assessments

The documents apply to internal reviews of general cosmetics filing dossiers in Hainan

On June 18, 2026, the Hainan Provincial Medical Products Administration issued trial technical guidance and a supporting checklist for self-checking general cosmetics filing dossiers. The attachments state that the documents apply to domestic and imported general cosmetics filers and domestic responsible persons in Hainan. The guidance is a recommended technical reference rather than a legally binding instrument; matters not addressed remain governed by current national regulations and technical standards.

Filers and quality and safety officers should maintain a closed internal review process

The guidance calls for filing materials to be lawful, truthful, accurate, complete, consistent and traceable. Filers retain ultimate responsibility for dossier compliance, while quality and safety officers review truthfulness, compliance and completeness and lead pre-filing checks, post-filing reviews, corrective action and record retention. The supporting checklist converts the topics into review items that companies can document.

Formulas and ingredients are major review areas in the attachments

Companies should verify ingredient sequence numbers, names, percentages and purposes in the manufacturing formula, confirm that all ingredient percentages total 100%, and list ingredients in descending order of content. Ingredient names should use the standard Chinese, INCI or English names in the Inventory of Existing Cosmetic Ingredients in China. The documents also flag prohibited ingredients, restricted ingredients used above their limits and unfiled new ingredients. When using a new cosmetic ingredient under safety monitoring, the filer should provide its registration or filing information, meet its technical requirements and obtain authorization from the ingredient registrant, filer or domestic responsible person.

Labels, testing and safety assessment materials should align with product information

Information in the filing platform, retained dossier and actual product should be consistent, including formula, label, manufacturing, testing and efficacy information. Product safety assessments should follow the applicable guidance and supporting documents, with complete evidence uploaded. Product names, formulas and ingredient concentrations should match the filing information, and ingredients presenting potential safety risks should be supported by evidence of safe use.

Companies should use both attachments as a pre-submission control

Regulix® recommends that Hainan filers and domestic responsible persons make the checklist a fixed pre-submission step, assign responsibility for preparation, review, correction and approval, and retain completed records. Overseas brands and their domestic responsible persons should pay particular attention to certificates of free sale, authorization documents, materials for formulas designed specifically for China, Chinese translations and safety assessment evidence.