Brazil Consults on New Rules for Cosmetic Fractionation

On January 13, 2026, Brazil unveiled two public consultations on a proposed resolution and a draft normative instruction regarding the fractionation of personal hygiene products, cosmetics, and perfumes (collectively "cosmetic products"). The consultations, running from January 20 to March 20, 2026, aim to collect stakeholders' views on the proposed technical requirements, best practices for fractionation, and the categories of cosmetic products permitted for direct-to-consumer fractionation. If adopted, the draft resolution would replace Resolution RDC No. 108/2005.^1-2

Scope of Application

Fractionation activities under the proposed resolution are limited to cosmetic products that have completed regularization (i.e., registration or notification) with the Brazilian Health Regulatory Agency (Anvisa), are in their final formulation, and require only fractionation and labeling before consumer delivery. The shelf life of the fractionated product shall not exceed that of the original product. In addition, reuse of primary packaging is permitted, provided it complies with regulatory requirements.

The proposed resolution applies to all companies engaged in the regularization, production, import, or fractionation of cosmetic products sold directly to consumers. Both the product regularization holder and the fractionation entity share responsibility for ensuring the quality and safety of fractionated products, regardless of whether new or reused packaging is used.

Cosmetic Products Eligible for Fractionation

To ensure clarity on which products may be included under the fractionation framework, the draft normative instruction specifies products that are eligible or prohibited for fractionation based on risk, as outlined below:

Eligibility	Product Type	Details
Allowed	Low-risk cosmetic products	1) Grade 1 products, excluding those intended for eyes or mucosal contact; 2) Grade 2 products, excluding those that require registration, have sunscreen or antibacterial/antiseptic functions, or are intended for eyes or mucosal contact.
Prohibited	High-risk cosmetic products	Category 2 products that require registration, have sunscreen or antibacterial/antiseptic functions, or are intended for eyes or mucosal contact.
Prohibited	Disposable personal hygiene products	Products defined as disposable under Resolution RDC No. 640/2022.

In addition to the product-based eligibility criteria, the draft normative instruction further addresses packaging considerations associated with fractionation activities. Specifically, it identifies 16 types of packaging that are unsuitable for reuse due to challenges in cleaning and disinfection, such as aerosol containers, ampoules, dropper bottles, tubes, and non-woven materials.