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On October 6, 2025, Brazil launched two public consultations concerning artisanal personal hygiene products, cosmetics, and perfumes (collectively referred to as "cosmetic products"). Open from October 13 to November 26, 2025, the consultations seek public input on draft regulations, which cover both a resolution establishing simplified procedures and technical requirements, and a normative instruction defining the product categories eligible for artisanal production. The final regulations are expected to take effect 60 days after their official publication.1-2
Scope and Applicability
The proposed framework applies to small-scale production of cosmetic products that are low-risk and simple in formulation. It is designed for products and producers that do not require industrial infrastructure, complex testing, or the oversight of a technically responsible professional.
The key eligibility criteria for products and producers are summarized below:
Aspect | Eligibility Criteria |
Products | 1) Pose low health risk, and are not intended for sensitive areas or vulnerable populations; 2) Maintain low microbiological risk, e.g., through non-aqueous formulations or high alcohol content acting as automatic preservatives; 3) Exhibit simple composition and production, complying with prohibited and restricted substances lists; 4) Involve actual transformation of raw materials rather than simple assembly or dilution of industrial products; 5) Carry only basic sensory or functional claims inherent to the product's composition and traditional use, and exclude therapeutic or efficacy claims; 6) Avoid relying on a technical responsible professional to perform or assess safety, efficacy, or quality control tests. |
Producers | 1) Perform all critical production steps manually, without industrial machinery; 2) Maintain full control over formulation, raw materials, production steps, basic quality control, filling, and labeling; 3) Operate on a small scale, consistent with artisanal production, and avoid industrial batch features such as automation, large-scale labor division, and staff employed for mass production; 4) Assume full responsibility for product safety, quality, and compliance with artisanal requirements. |
Eligible Product Categories
Under the draft normative instruction, seven product groups can be produced artisanally. For each group, the draft outlines the information that artisanal producers shall follow for correct product selection and labeling, covering group descriptions, examples of permitted products, allowed and prohibited claims, and essential safety warnings. As an illustration, the table below outlines two product groups from the draft.
Product Category | Description | Product Examples | Allowed Claims | Prohibited Claims | Mandatory Warnings |
Air fresheners | Products for indoor use, without direct contact with the body, designed to impart a pleasant fragrance. | Scented candles, fragrance sachets, reed diffusers, and sprays. | Fragrance the environment, impart pleasant aroma, and mask odors. | Deliver therapeutic effects, purify the air, eliminate bacteria, and repel insects. | - External use only. - Keep out of reach of children and pets. - In case of contact with the eyes, rinse thoroughly with water. - Flammable (for sprays). |
Solid body soaps | Products in solid form, produced by saponification, intended exclusively for cleansing and hygiene of the skin | Saponified bar soaps | Clean, sanitize, and fragrance. | Kill bacteria, act as antiseptic, whiten the skin, treat acne, provide therapeutic effects, and exfoliate chemically. | - External use only. - Keep out of reach of children. - If irritation occurs, discontinue use and seek medical advice. - Avoid contact with the eyes. |
Technical and Labeling Requirements
Under the draft artisanal cosmetics framework, products are not required to be registered or notified with the Brazilian Health Regulatory Agency (Anvisa), and artisanal producers are not required to obtain a Company Operating Authorization (AFE). However, to ensure product safety and traceability, the draft resolution establishes minimum technical and hygienic standards specifically adapted to artisanal production.
Artisanal producers are expected to implement basic good manufacturing practices (GMP), including maintaining clean and hygienic facilities, equipment, and utensils, practicing personal hygiene, and ensuring proper handling and storage of raw materials and final products. To complement these measures, the shelf life of artisanal cosmetic products is limited to six months from the date of manufacture.
Concerning labeling, artisanal cosmetic products shall contain key information for safe use. Labels should display at minimum the product name, brand (if any), producer contact information, ingredients list, manufacturing date and shelf life, and an indication that the product is "ARTISANAL". In addition, claims that require testing or that are inconsistent with the products' low-risk nature are prohibited.
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