Anvisa Creates Simplified Regulatory Framework for Artisanal Cosmetics
On October 5, 2026, Anvisa published RDC No. 1,045/2026, regulating Article 27, §2 of Law No. 6,360/1976, as amended by Law No. 15,154/2025, and establishing a simplified sanitary framework for artisanal personal care products, cosmetics, and perfumes. The regulation will enter into force 60 days after its publication, providing the sector with a transition period to adapt to the new regulatory requirements.
The new regulation implements the legal mandate introduced in 2025 requiring the creation of differentiated requirements for the artisanal production of these products. According to Anvisa, the objective is to balance regulatory simplification for small-scale producers with the preservation of minimum health and safety standards.
Under the RDC, products that qualify as artisanal are exempt from prior registration or notification with Anvisa, as well as from the requirement to obtain an Operating Authorization (Autorização de Funcionamento de Empresa – AFE). In addition, any applicable local sanitary license must be granted automatically, without prior inspection, although producers remain subject to subsequent oversight and enforcement by the competent health authorities.
To benefit from this simplified framework, products must cumulatively meet specific criteria relating to low health risk, low microbiological contamination risk, simple formulations and manufacturing processes, and predominantly manual, small-scale production. The regulation also requires producers to retain full control over all manufacturing stages, prohibiting outsourcing of production activities and excluding operations that exhibit characteristics typically associated with industrial manufacturing.
The regulation further limits the claims that manufacturers may make, allowing only simple claims consistent with the cosmetic, hygiene, or fragrance purpose of the product. Therapeutic claims, as well as any claims that would require safety or efficacy testing to substantiate, remain prohibited.
Although the RDC waives prior market authorization requirements, it places full responsibility for the safety, quality, and regulatory compliance of products on the artisanal producer. The regulation also establishes minimum good manufacturing practice requirements, labeling obligations, complaint-handling mechanisms, basic traceability measures, and a maximum shelf life of 12 months.
Complementing the RDC, IN No. 474/2026 establishes the categories of products eligible for artisanal classification, including, among others, alcohol-based fragrances, air fresheners, solid soaps, solid shampoos and conditioners, body oils and butters, and stick deodorants.
In practice, the new framework creates an intermediate regulatory category for low-risk artisanal products that is clearly distinct from the regime applicable to industrial cosmetic manufacturing. At the same time that it lowers regulatory barriers for small producers, the regulation preserves manufacturers’ responsibility for product safety and maintains the applicability of sanitary inspections and administrative penalties in the event of non-compliance.
While the RDC represents a significant regulatory simplification initiative, its practical implementation will require close attention from market participants, particularly regarding product classification criteria, the boundaries of the concept of “artisanal production,” and the approach that state and local health authorities may adopt when enforcing the new framework.
The Life Sciences & Healthcare team at Souto Correa Advogados is available to discuss any questions regarding these developments at lifesciences@soutocorrea.com.br.correa.com.br.