On May 13, 2025, Brazil’s Ministry of the Environment and Climate Change (MMA) published a draft implementing regulation for the Chemical Management Law (Brazil REACH), aimed at operationalizing Law No. 15,022 of November 13, 2024. The draft establishes a National Inventory of Chemical Substances to regulate the registration, hazard identification, assessment, and management of chemicals, with the goal of reducing health and environmental risks.
Key Provisions
1. Registration System
1.1 Registration Obligations
Under Brazil REACH, chemicals (including substances in mixtures) produced or imported at ≥1 tonne/year (based on a three-year average) must be registered in the National Chemical Substance Registration System. Obligated entities include manufacturers, importers, or foreign manufacturers’ "Only Representatives".
1.2 Registration Content
|
Category |
Details |
|
Company Information |
Legal name, CNPJ/CPF, contact person, legal representative, country/city of origin, import city, production site |
|
Substance Information |
IUPAC name, common name, CAS number, NCM code, GHS hazard classification |
|
Production & Use |
Annual average volume (reported in 4 tonnage bands), use categories, industries, downstream products |
1.3 Tonnage Range (Production or Import) (for fees and risk assessment)
- Range I: 1–10 tonnes/year
- Range II: 10–100 tonnes/year
- Range III: 100–1,000 tonnes/year
- Range IV: >1,000 tonnes/year
1.4 Updates and Maintenance
- Registration information must be updated by March 31 each year.
- New chemicals must be registered before they can be marketed.
- The registration system will ultimately form and continuously update the National Chemical Inventory.
2. Prioritization and Risk Assessment
- Prioritization Criteria: Based on a substance's hazards (e.g., carcinogenicity, mutagenicity, reproductive toxicity, persistence, bioaccumulation) and exposure potential (production volume, uses).
- Risk Assessment: Conducted by a technical committee using internationally accepted methods, considering health, environmental, social, economic, and technical factors.
- Public Participation: Draft risk assessments and risk management measures will be open for public consultation.
3. Risk Management Measures
- Measure content: includes risk mitigation measures, implementation timeline, responsible parties, and transitional arrangements.
- Implementation responsibility: manufacturers, importers, and downstream users must implement the risk management measures determined by the review committee.
4. Limitations on animal testing
- Principle: Animal testing should only be used as a last resort, with priority given to alternative methods (replace, reduce, refine).
- Data usage: Existing animal testing data can be used, but new animal testing cannot be required for prioritization.
5. International cooperation and confidentiality system
- International cooperation: Encourages sharing data, methods, and experiences with other countries to promote regulatory alignment.
- Confidentiality: Companies may apply to protect trade secrets but must justify the reasons and duration; governments may lift confidentiality if necessary.
6. Fee system
- Registration fee (charged by production/import volume Ranges)
- Risk assessment fee (determined by company size, production volume, joint submissions, etc.)
- Confidentiality review fee
I. Annual registration fee
|
Size/Production Range for Registration Fee |
Range I: 1–10 tons |
Range II: 10–100 tons |
Range III: 100–1,000 tons |
Range IV: >1,000 tons |
|
Individuals, micro and small enterprises |
R$ 50.00 |
R$ 50.00 |
R$ 50.00 |
R$ 500.00 |
|
Other legal entities |
R$ 2,000.00 |
R$ 3,000.00 |
R$ 5,000.00 |
R$ 5,000.00 |
II. Risk assessment fee
|
Size/Production Range for Registration Fee |
Range I: 1–10 tons |
Range II: 10–100 tons |
Range III: 100–1,000 tons |
Range IV: >1,000 tons |
|
Individuals, micro and small enterprises |
R$ 50.00 |
R$ 50.00 |
R$ 50.00 |
R$ 50.00 |
|
Other legal entities (individual submission) |
R$ 2,000.00 |
R$ 3,000.00 |
R$ 5,000.00 |
R$ 7,500.00 |
|
Other legal entities (joint submission) |
R$ 1,500.00 |
R$ 2,250.00 |
R$ 3,750.00 |
R$ 10,000.00 |
III. Confidentiality analysis fee
|
Company size |
Fee by CAS number |
|
Individuals, micro and small companies |
R$ 312.00 |
|
Other companies |
R$ 780.00 |
IV. Payment deadline
|
Fee category |
Explanation of payment due date |
|
Registration fee |
By the last business day of March each year |
|
Risk assessment fee |
Individual submission: Pay within 30 days after the technical committee's decision on 'whether the provided data is sufficient' is announced Joint submission: Pay within 60 days after the decision is announced |
|
Confidentiality application fee |
Pay within 30 days after submitting the application |
Note: The currency unit is Brazilian Real (R$). Registration fees will be collected starting 3 years after the national registration system is launched.
Currently, the public consultation period for this draft has ended, and the English version of the draft has also been published. If you wish to provide comments or improvement suggestions on the draft regulatory decree of Law No. 15.022/24, please email conasq@mma.gov.br to obtain specific instructions on how to submit suggestions.
