Comprehensive Interpretation of Brazil REACH: Registration, Exemptions, Fees, and Risk Management

From the law's enactment in November 2024 to the release of the draft implementing regulation in May 2025, Brazil REACH has drawn extensively from EU experience in its institutional design, while demonstrating localized innovations in fee structures and enterprise size differentiation. Proactively establishing compliance systems is not only necessary for mitigating legal risks, but also a strategic choice for maintaining Brazil market access qualifications and enhancing supply chain competitiveness. Below, CIRS Group provides a comprehensive interpretation of Brazil REACH from the perspectives of registration, exemptions, fees, and risk management.

I. National Chemical Substance Inventory Registration

1.1 Registration Obligations and Thresholds

Obligated Parties:

• Manufacturers within Brazil
• Importers
• "Only Representatives" of foreign manufacturers in Brazil

Registration Threshold: Annual production or import volume ≥ 1 ton (calculated as the average over the past three years). This means that even if a single year does not reach 1 ton, registration is still required if the three-year average meets the threshold.

CIRS Reminder: New chemicals must be registered before market launch; registration must be completed before manufacturing or import activities begin.

1.2 Registration Information Requirements

1.3 Tonnage Band System (for fee payment and risk assessment)

1.4 Updates

If a chemical substance is planned for a new use, or if relevant data changes, updates must be completed by March 31 of the following year.

II. Risk Assessment Criteria

Brazil will screen priority assessment targets from registered substances based on seven criteria:

1. Environmental persistence, bioaccumulation, and toxicity (PBT)
2. Carcinogenicity
3. Mutagenicity
4. Reproductive toxicity
5. Endocrine disruption
6. Exposure level: including potential exposure levels, production or export quantities.
7. International convention relevance: whether included in international agreements or conventions to which Brazil is a party.

III. Fees

3.1 Annual Registration Fees

Note: R$ 50 is approx €8.60/$10.
R$ 2000  is approx €344/$400.

3.2 Risk Assessment Fees

Note: R$ 10,000 is approx €1,719/$2000.

3.3 Confidentiality Analysis Fees

3.4 Payment Deadlines

IV. Exemption Provisions

The law exempts the following 14 categories of substances from registration requirements:

1. Radioactive substances;
2. Chemical substances under development;
3. Chemical substances used exclusively for research;
4. Non-isolated reaction intermediates;
5. Substances for national defense purposes;
6. Waste;
7. Chemical substances, mixtures, and articles under customs supervision that have not undergone any treatment or modification;
8. Chemical reaction products unintentionally generated during the storage of other substances, mixtures, or articles, as well as those resulting from exposure of other substances or articles to environmental factors such as: a) Air; b) Sunlight; c) Humidity; d) Microorganisms;
9. The following products subject to specific legislation: a) Food; b) Processing technical aids; c) Food additives; d) Medicinal products, active pharmaceutical ingredients, medical gases and preparations, and substances classified as medical devices for prevention, diagnosis, or treatment of health conditions; e) Pesticides and their premixtures and finished products; f) Cosmetics, personal hygiene products, and perfumes; g) Disinfectants; h) Veterinary use; i) Animal feed; j) Fertilizers, inoculants, and correctives; k) Wood preservatives; and l) Environmental remediation agents;
10. The following substances, unless they have been chemically modified or contain or consist of chemicals hazardous to health or the environment according to GHS standards and requirements: a) Ores and concentrates, and other rocks and minerals, including coal and coke, crude oil, natural gas, liquefied petroleum gas, natural gas condensates, and gases and their components from mineral processing; b) Natural substances; c) Fats, essential oils, and fixed oils extracted by pressing, distillation, or extraction methods, even if purified, provided they maintain the same characteristics as the original product; and d) Glass, enamel, and ceramics;
11. Narcotics, psychotropic substances, and immunosuppressants;
12. Substances used exclusively as tobacco components and their derivatives;
13. Metal alloys used for structural purposes in the form of plates, strips, bars, profiles, ingots, beams, and similar forms;
14. Explosives and their accessories.

CIRS Insights

For related enterprises, particularly in industries such as chemicals, electronics, textiles, and automotive that involve chemical import and export, the following measures should be taken promptly:

1. Compile substance inventory: Conduct a comprehensive review of chemicals produced/imported in Brazil to confirm whether they meet the 1 ton/year threshold.
2. Prepare registration data: Collect core information such as CAS numbers, GHS classifications, SDS, and use descriptions in advance.
3. Determine representative mechanism: Foreign manufacturers should appoint an "Only Representative" in Brazil as early as possible.
4. Assess tonnage band: Calculate the average volume based on data from the past three years to determine the applicable tonnage band.

CIRS Group will continue to monitor subsequent developments in Brazil REACH, including the finalization of implementing regulations, the official launch date of the national registration system, and the release of specific risk assessment guidelines, to provide enterprises with timely compliance information and support.

About CIRS

Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services from regulatory compliance, laboratory testing, R&D to data services across multiple industries. This includes chemicals, cosmetics, food and food beverages, medical devices, agrochemical products, disinfectants, and consumer goods. It helps clients gain a competitive advantage by reducing business risks associated with regulatory affairs.

Our Services

• Brazil REACH pre-registration and full registration
• Brazil REACH Only Representative services
• Brazil chemical regulatory consulting and training

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.