Brazil has incorporated tribasic copper sulfate into pesticide and household cleaning product regulations under Monograph C55, enhancing health and environmental protection standards for copper-based compounds.
Brazil Updates Copper-Based Compounds Safety Guidelines
Tribasic copper sulfate now regulated under Monograph C55.
What changed
Tribasic copper sulfate included in Monograph C55 for active ingredient regulation.
Pesticides affected with new safety and quality control requirements.
Household cleaning products must comply with updated copper compound standards.
Environmental protection emphasized under ICS code 13 for health and safety.
Who it affects
Pesticide manufacturers must ensure tribasic copper sulfate compliance with Monograph C55.
Cleaning product producers need to meet new copper-based compound safety standards.
Wood preservative manufacturers must follow updated regulatory framework.
Importers and exporters must ensure products meet Brazil’s SPS system requirements.
Key dates
Regulation Analysis: Incorporation of Tribasic Copper Sulfate under Monograph C55 in Brazil
Brazil has formally incorporated tribasic copper sulfate into its regulatory framework for pesticides, household cleaning products, and wood preservatives by adding subitem C55.7 to Monograph C55 – Copper-Based Compounds. This inclusion was established through Normative Instruction 461 of 22 July 2026, which adopted the previously notified Draft Resolution 1390 (23 March 2026)1. The regulation enhances health and environmental protection standards for copper-based compounds by subjecting tribasic copper sulfate to the same compliance requirements as other active ingredients listed in Monograph C55, originally published under Normative Instruction 103 of 19 October 20211.
Key Regulatory Provisions
1. Inclusion of Tribasic Copper Sulfate in Monograph C55
- Tribasic copper sulfate (C55.7) is now classified under Monograph C55 – Copper-Based Compounds, which governs active ingredients used in:
- Pesticides,
- Household cleaning products, and
- Wood preservatives1.
- The regulation does not introduce new standalone requirements for tribasic copper sulfate but subjects it to the existing Monograph C55 framework, which likely includes:
- Registration and authorization procedures,
- Maximum residue limits (MRLs),
- Labeling and safety data sheet (SDS) requirements, and
- Environmental and toxicological risk assessments1 (implied by the monograph’s scope).
2. Legal Basis and Adoption Process
- Draft Resolution 1390 (23 March 2026) was the precursor to Normative Instruction 461 (22 July 2026), which formally adopted the regulation1.
- The final text of Normative Instruction 461 was published in the Brazilian Official Gazette (DOU – Diário Oficial da União) and is available only in Portuguese1.
- The 60-day comment period for international stakeholders ended on 26 September 2026, as notified by Brazil’s National Enquiry Point under the WTO SPS Agreement1.
3. Applicable Authority and Enforcement
- The Brazilian Health Regulatory Agency (Anvisa) is the competent authority responsible for:
- Implementing and enforcing Monograph C55,
- Handling comments and inquiries related to the regulation (via its International Affairs Office – AINTE), and
- Overseeing compliance for products containing tribasic copper sulfate1.
- Contact details for regulatory inquiries:
- Email: rel@anvisa.gov.br
- Phone: +(55 61) 3462 5402/5404/54061.
Compliance Requirements for Tribasic Copper Sulfate
| Regulation | Key Requirement | Deadline/Threshold | Authority |
|---|---|---|---|
| Normative Instruction 461 (22 July 2026) | Inclusion of C55.7 (tribasic copper sulfate) in Monograph C55 for pesticides, household cleaning products, and wood preservatives1. | Effective upon publication in the DOU (22 July 2026)1. | Anvisa |
| Monograph C55 (via Normative Instruction 103, 19 Oct 2021) | Compliance with registration, labeling, MRLs, and risk assessment requirements for copper-based compounds1. | Ongoing (no specific deadline; applies to new and existing products). | Anvisa |
| WTO SPS Notification | 60-day comment period for international stakeholders, ending 26 September 20261. | Comment period closed; regulation now in force. | Anvisa (via WTO) |
Summary Answer
Brazil has incorporated tribasic copper sulfate (C55.7) into its regulatory framework for copper-based compounds through Normative Instruction 461 (22 July 2026), which amends Monograph C55 under Normative Instruction 103 (2021)1. The regulation subjects tribasic copper sulfate to existing compliance standards for pesticides, household cleaning products, and wood preservatives, including registration, labeling, and risk assessment requirements1. The 60-day comment period for international stakeholders ended on 26 September 2026, and the regulation is now in force1. Anvisa is the responsible authority for enforcement and inquiries1. For further details, the final text of Normative Instruction 461 is available in Portuguese via the provided links1.
Sources
- ↩ Draft Resolution 1390, 23 March 2026 https://docs.wto.org/imrd/directdoc.asp?DDFDocuments/T/G/SPS/NBRA2483A1.docx