On October 5, 2026, Brazil's National Health Surveillance Agency (Anvisa) published Collegiate Board Resolution No. 1.045/2026 (RDC 1.045/2026) and Normative Instruction No. 474/2026 (IN 474/2026) in the Official Gazette (DOU), establishing dedicated regulatory rules for the production and sale of artisanal cosmetics for the first time, with exemptions from or simplifications of requirements such as product registration/notification, company operating authorization, and technical responsibility. The two provisions will enter into force simultaneously 60 days after publication.
Eligibility Conditions and Simplified Requirements for Artisanal Producers
The new rules apply to producers whose production is predominantly manual and small-scale, who keep all stages under their complete control, from ingredient selection to packaging, and who do not outsource any of these processes. Products must use simple formulations with ingredients of recognized safe use and must not contain high levels of water, so as to ensure a lower risk of microbiological contamination.
IN 474/2026 specifies the product categories eligible for this regime, including:
- alcohol-based perfumery products
- ambient odorizers (home fragrances)
- solid bath products
- solid soaps
- solid shampoos and conditioners
- body oils and body butters
- bar underarm deodorants.
Main simplifications
Producers manufacturing the above products by hand are no longer subject to the same regulatory requirements as large industrial companies.
Specifically, they are exempted from product registration or notification with Anvisa; exempted from the company operating authorization (AFE), a document otherwise required for conventional factories; granted automatic sanitary licensing by local health surveillance authorities without prior review, visit, or inspection, subject only to post-hoc verification; exempted from the obligation to hire a technical responsible person, with product safety falling directly under the artisanal producer's own responsibility; and subject to a maximum shelf life of 12 months, in line with the characteristics of artisanal formulations.
Sales channels
The new rules allow artisanal producers to sell products through their own stores, craft fairs, social media, their own websites, and e-commerce platforms (marketplaces), and allow family members or assistants to sell on the producer's behalf.
Safety and Labeling Requirements
Good manufacturing practices
Simplification does not mean relaxed control. Artisanal producers remain responsible for the safety and quality of their products and must follow good manufacturing practices adapted to the artisanal scale, including:
- maintaining strict hygiene of the production environment and utensils; not using wooden or porous utensils that are difficult to clean;
- observing the shelf life of raw materials; evaluating the quality of finished products before they are placed on the market; setting up a channel for consumer inquiries and complaints;
- and keeping records of complaints received and the measures taken.
Labeling requirements
Product labels must mandatorily indicate the product name, the list of ingredients, the date of manufacture, the shelf life, the production address, the weight or volume, warning statements, and the indication "PRODUTO ARTESANAL" (artisanal product).
Post-market surveillance
Market surveillance remains the responsibility of state and municipal health surveillance authorities, which may verify producers' compliance after they have started their operations.
Key Impacts on Cosmetics Companies
(1) Understanding the scope of application: The artisanal cosmetics regime applies only to the seven categories of products that meet the eligibility conditions and to small-scale producers operating manually without outsourcing; cosmetics produced by conventional industrial manufacturing remain subject to registration or notification under Brazil's current system, and products exported to Brazil cannot invoke the exemptions under the artisanal regime.
(2) Watching market and channel opportunities: By opening digital sales channels such as social media and e-commerce platforms and allowing family members and assistants to take part in sales, the new rules are expected to expand Brazil's artisanal and niche cosmetics market, with categories such as solid shampoos, body oils, and home fragrances likely to see growth.
(3) Noting compliance baselines and post-market surveillance: Even under the simplified regime, products must still meet good manufacturing practices, the 12-month maximum shelf life, and mandatory labeling requirements (including the "PRODUTO ARTESANAL" indication), and state and municipal health surveillance authorities will conduct post-market checks after operations begin.
CIRS Reminder
Cosmetics in Brazil are uniformly regulated by Anvisa. The new rules only open a simplified pathway for eligible artisanal cosmetics; the registration and notification requirements for conventional cosmetics remain unchanged. Companies planning to export to Brazil or engage in related business should follow the implementation of RDC 1.045/2026 and IN 474/2026 after they enter into force in 60 days, as well as the enforcement approaches of state and municipal health surveillance authorities.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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