New Anvisa Regulations for Sanitizing Products: RDC 989/2025 and IN 394/2025 – Comprehensive Guide for Regulatory Compliance 

Introduction 

Anvisa, Brazil’s regulatory authority for health-related products, has published revolutionary new regulations that will reshape the sanitizing products market in Brazil and Mercosul countries. On August 20, 2025, Resolution RDC 989/2025 and Normative Instruction IN 394/2025 were officially released, establishing updated requirements for sanitizing product regularization and replacing the outdated RDC 59/2010. 

These new RDCs represent a significant milestone in regulatory harmonization, aligning Brazilian legislation with Mercosul technical regulations while maintaining national specificities that ensure product safety and facilitate market access. 

Development Process and Background 

The regulatory revision process began in 2019 during the 50th Meeting of Mercosul’s Working Subgroup (SGT) No. 11 in Buenos Aires. The main objective was to align Brazilian legislation with the proposed technical regulation for registration and notification of sanitizing products throughout the Mercosul bloc. 

After extensive consultation through Public Consultation 776 published on February 7, 2020, the health-related products regulatory authority faced challenges in achieving complete harmonization due to climatic differences between Mercosul countries. This led to disagreements regarding analytical tolerances and shelf-life requirements (Chapters VI and VIII of the former RDC 59/2010). 

To address these challenges while maintaining regulatory progress, Anvisa adopted a strategic two-part approach: 

RDC 989/2025: Contains the harmonized Mercosul text 
IN 394/2025: Addresses non-harmonized requirements from the former RDC 59/2010, including analytical tolerances and shelf-life criteria 

Main Changes and Regulatory Requirements 

Risk Classification System 

The new regulations establish a clear risk classification system for sanitizing products: 

Risk Category 1 (Mandatory Notification): Products requiring notification procedures 
Risk Category 2 (Mandatory Registration): Products requiring formal registration 

LD50 evaluation criteria have been significantly refined: 

• Free-sale products: Evaluated in pure form 

• Professional-use products: Evaluated at final dilution concentration 

• Safety limits: Values exceeding 2,000 mg/kg for liquids and 500 mg/kg for solids 

This specification provides greater precision and standardization in risk assessment, considering different presentation forms and usage patterns of sanitizing products. 

Enhanced Safety Requirements 

The regulations introduce stringent safety requirements including: 

• Prohibition of carcinogenic, mutagenic, or teratogenic substances 

• Mandatory biodegradability requirements for anionic surfactants 

• Comprehensive toxicological evaluation protocols 

Labeling and Packaging Standards 

Harmonized labeling requirements ensure greater clarity and consumer safety: 

Mandatory Information Requirements: 

• Clear identification of active ingredients 

• Proper dilution instructions for professional products 

• Poison Control Centers contact information 

• Standardized warning statements 

Prohibited Practices: 

• Misleading or appealing information 

• Reuse of food packaging for sanitizing products 

• Unclear or confusing mandatory data 

The labeling system now offers more complete and consistent requirements applicable to all sanitizing product categories, ensuring comprehensive regulatory compliance. 

Volume Limits for Free-Sale Products 

Risk Category 1 products designated for free sale can now be commercialized in containers up to 10 kg or liters, providing greater flexibility for manufacturers while maintaining safety standards. 

National Specificities in IN 394/2025 

IN 394/2025 details critical national requirements: 

• Volume limits for various product categories 

• Analytical tolerances for quality control procedures 

• Shelf-life validation criteria including stability testing conditions 

• Specific technical requirements not covered in the harmonized Mercosul text 

Impact Analysis and Industry Implications 

Benefits for Citizens and Public Health 

The new regulatory framework offers significant advantages: 

• Enhanced product safety through more rigorous evaluation criteria 

• Transparent information via harmonized labeling requirements 

• Better market surveillance through improved classification systems 

Industry and Market Impact 

For the productive sector, these regulations provide: 

• International harmonization boosting free trade opportunities 

• Enhanced competitiveness in Mercosul markets 

• Streamlined regulatory processes for market access 

• Clear compliance pathways for national and international manufacturers 

Regulatory Compliance Strategies 

For Manufacturers Currently in Market 

Existing product holders should: 

1. Conduct comprehensive product reviews against new requirements 

2. Update labeling and packaging to meet harmonized standards 

3. Review risk classifications and adjust registration/notification status 

4. Implement quality control measures per new analytical tolerance requirements 

For New Market Entrants 

Companies seeking market entry should: 

1. Engage early with regulatory consultants familiar with Anvisa requirements 

2. Develop products considering Mercosul harmonization benefits 

3. Establish robust quality systems meeting GMP standards for sanitizing products 

4. Plan market strategy considering Brazilian and regional market access 

International Harmonization and Mercosul Integration 

The regulatory alignment represents a strategic milestone in Mercosul integration, facilitating: 

• Mutual recognition agreements between member countries 

• Reduced regulatory barriers for cross-border trade 

• Standardized safety assessment procedures 

• Enhanced regional competitiveness in global markets 

Future Perspectives and Regulatory Evolution 

Anvisa’s commitment to regulatory modernization suggests continued evolution in: 

• Digital submission processes for applications 

• Enhanced post-market surveillance systems 

• Greater harmonization with international standards 

• Integration with global regulatory trends 

Conclusion and Recommendations 

The publication of RDC 989/2025 and IN 394/2025 represents a transformative moment for Brazil’s sanitizing products sector. These regulations demonstrate Anvisa’s commitment to public health protection while facilitating market access and international competitiveness. 

Key recommendations for stakeholders: 

1. Immediate compliance assessment against new requirements 

2. Strategic planning for Mercosul market opportunities 

3. Investment in regulatory expertise and quality systems 

4. Engagement with regulatory consultants for implementation guidance 

The regulatory landscape continues evolving, and successful companies will be those that proactively adapt to these changes while leveraging new opportunities for growth and market expansion. 

For additional guidance and regulatory support, stakeholders should consider contacting Anvisa through official channels or engage specialized medical device consulting services familiar with Brazilian regulatory requirements. 

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