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On June 4, 2025, the Brazilian Health Regulatory Agency (Anvisa) released the Manual for the Verification of Skin and Eye Safety of Hair Ointments (the Manual), aiming to guide stakeholders in preparing the necessary documentation for registering these products.1
Regulatory Background on Hair Ointments
In Brazil, cosmetic products require market authorization from Anvisa prior to commercialization, through either the registration or notification pathway. Hair ointments were previously regulated under the notification pathway. However, in response to reported cases of serious eye injuries, Anvisa issued Resolution RDC No. 814/2023 in September 2023, reclassifying hair ointments as products subject to registration.
In addition to establishing the registration requirement for hair ointments, the resolution defines additional dossier requirements for these products, beyond those applicable to other cosmetic categories, as outlined in Article 4. This article specifies five key components, including the requirement to demonstrate skin and eye safety. To assist stakeholders in fulfilling this obligation and to promote market compliance, Anvisa developed this dedicated manual.
Key Points from the Manual
Drawing on current regulatory standards and supporting scientific evidence, the Manual instructs companies on compiling dossiers to substantiate skin and eye safety. The required tests and documents, as well as their key considerations, are presented in the table below.
No. | Test and Dossier Requirement | Key Points |
1 | In vitro studies on eye irritation/corrosion potential | a. One or more studies can be conducted, using validated and internationally accepted methods within an integrated strategy consistent with the Guidance Document on Integrated Approaches to Testing and Assessment (IATA) for Serious Eye Damage and Eye Irritation. b. The test or series of tests shall confirm that the finished product is classified as "No Category" under the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) regarding eye irritation and serious eye damage. |
2 | Clinical studies on skin compatibility | Studies conducted on the finished product should include assessments of primary irritation, cumulative irritation, skin sensitization, photoallergy, and phototoxicity. |
3 | Ingredient dossiers | The documentation shall demonstrate the quality and safety of ingredients used in the formulation, with a focus on impurities that pose toxicological risks, particularly 1,4-dioxane (CAS No. 123-91-1) and ethylene oxide (CAS No. 75-21-8). |
4 | Safety assessment report | a. The report shall include all data supporting the product's safety, accompanied by an analysis of the weight of the related evidence. b. The report shall be signed by both the technical manager and the legal representative of the company. |
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