On September 30, 2026, the Brazilian Health Regulatory Agency (Anvisa) Diretoria Colegiada approved, at its 18th ordinary public meeting of 2026, a Resolution of the Collegiate Board (RDC) and a Normative Instruction (IN) that set simplified technical and sanitary requirements for artisanal personal hygiene products, cosmetics and perfumes in Brazil, following the sanction of Lei 15.154 in July 2025. The Anvisa notice of September 30, 2026 states that products in this category do not need prior regularization at Anvisa, and that they must still follow defined rules and limits. The same meeting opened a separate 60-day consultation on a regulatory-sandbox draft. That draft is not the artisanal cosmetics rule.
Brazilian artisanal cosmetics and perfume producers (solid soaps, solid shampoos and conditioners, bar deodorants, body oils and butters, alcohol-based perfumes, room odorizers and solid bath products on the IN eligibility list), small-scale personal care brands and online marketplaces selling those products in Brazil, and pharmacists and the Responsavel Tecnico supporting artisanal workshops must adapt production to simplified good manufacturing practices, mandatory labeling, a maximum shelf life of 12 months from manufacture, sensory or basic-functional claims only, and the IN product list, while remaining exempt from prior Anvisa registration under Lei 15.154, on publication in the Diario Oficial da Uniao, a date the September 30, 2026 Anvisa notice does not state, or non-compliant artisanal products face ANVISA sanitary surveillance enforcement, market withdrawal and penalties under Lei 9.782/1999.
What did the September 30, 2026 approval change?
The IN is the official list of product groups that may be made and sold as artisanal items: alcohol-based perfumery, room odorizers, solid bath or immersion products, solid body soaps, solid shampoos and conditioners, body oils and butters, and bar underarm deodorants. The RDC sets the simplified technical and sanitary requirements and the simplified procedures for producing and selling those products.
Director Marcelo Moreira, rapporteur, tied the rules to Lei 15.154, sanctioned in July 2025, after a process Anvisa opened in August 2025 and two public consultations. The notice does not publish an RDC number or the Diario Oficial text.
| Point | What the approval sets |
|---|---|
| Eligible products (IN) | Alcohol-based perfumery, room odorizers, solid bath or immersion products, solid body soaps, solid shampoos and conditioners, body oils and butters, bar underarm deodorants |
| Prior Anvisa registration | Not required for products classified as artisanal hygiene, cosmetics and perfumes |
| Manufacturing | Simplified good manufacturing practices: basic hygiene and control rules for safety |
| Label | Mandatory labeling |
| Shelf life | Maximum of 12 months from manufacture |
| Claims | Simple sensory claims, or basic functional claims limited to cleaning, hydration and perfuming. No therapeutic claims. No complex efficacy tests |
Who must follow the artisanal list?
The rules hit producers of the IN groups in Brazil, and brands and online marketplaces that sell those artisanal hygiene and perfume products into the Brazilian market. A pharmacist or Responsavel Tecnico who supports an artisanal workshop is in the same chain: the product still has to match the list, the label, the shelf life and the claim limits even though prior Anvisa registration is waived.
Products outside the IN groups stay on the ordinary Anvisa path. The notice does not extend the waiver to sunscreens, children's products or other higher-risk categories treated by registration or notification.
What must be in place before the RDC enters into force?
No entry-into-force day is stated. The obligations bind when the RDC and IN are published and enter into force in the Diario Oficial da Uniao. Until that publication, the September 30, 2026 approval is the Collegiate decision, not a dated compliance clock.
- Map every artisanal SKU against the IN groups. A formula outside the list does not take the registration waiver.
- Write simplified good manufacturing practices as basic hygiene and in-process control, and apply them on the workshop floor.
- Set the labelled shelf life at no more than 12 months from the manufacture date.
- Rewrite claims so they stay sensory, or functional only for cleaning, hydration or perfuming, with no therapeutic appeal and no complex efficacy dossier.
- Keep the Lei 15.154 exemption file: the product is on the IN list, and prior Anvisa regularization is not filed for that SKU.
- Brief the Responsavel Tecnico and any marketplace seller on the same limits, so a listing does not add a claim the RDC forbids.
What happens if a product misses the limits?
The Anvisa notice does not quote a fine amount for this RDC. Non-compliant artisanal products remain inside Anvisa sanitary surveillance. Withdrawal from the market and penalties under Lei 9.782/1999 are the enforcement path the agency's statute already gives the authority when a product is sold outside the conditions set for it. A product that is not on the IN list, or that carries a therapeutic claim, is not covered by the waiver and falls back to ordinary regularization.
Continuous per-jurisdiction monitoring of Anvisa board decisions surfaces an approval of this kind the moment the agency publishes the notice.
Next, confirm each SKU is on the IN list, lock the 12-month shelf life and the claim wording, and watch the Diario Oficial for the RDC and IN texts and their entry into force. Brief production, the Responsavel Tecnico and marketplace operators on the same checklist before that publication.
