The National Health Surveillance Agency (ANVISA) has published on the 6th of February 2025, Resolution RDC No. 961/2025, amending Resolution RDC No. 56/2012 regarding the list of authorized monomers,...

The National Health Surveillance Agency (ANVISA) has published on the 6th of February 2025, Resolution RDC No. 961/2025, amending Resolution RDC No. 56/2012 regarding the list of authorized monomers, initiator substances, and polymers for use in plastic packaging and equipment intended for food contact. The list of monomers and other authorized substances contained in Part I and the list of authorized polymers contained in Part V of the Annex of the Resolution 56/2012 shall come into force with the addition of the substances contained in Annex I and Annex II of this Resolution. 

The new resolution, approved by ANVISA’s Collegiate Board of Directors, incorporates provisions from GMC/MERCOSUR Resolution No. 28/2024 into Brazil’s legal framework.

Key Changes in RDC No. 961/2025

Annex I: Expansion of Authorized Monomers and Initiator Substances:

The resolution adds Tetramethyl Bisphenol F Diglycidyl Ether (TMBPF-DGE) (CAS No. 113693-69-9) to the list of authorized monomers and initiator substances.

• Specific migration limits (LME) have been established for TMBPF-DGE and its derivatives
• Its use is restricted to macromolecular substance dispersions in water for beverage can coatings.

Annex II: Inclusion of a New Authorized Polymer:

• Polyamide-imide 2 (PAI-2) (poly-N-(4,4'-diphenylmethane trimellitamide imide)) has been added to the list of authorized polymers.
• This polymer, produced from 4,4'-diaminodiphenylmethane and benzoyl-3,4-dicarboxylic anhydride chloride, is permitted for use as a binder in coatings for high-temperature-resistant kitchen utensils.
• Restrictions include:
  • Maximum coating thickness of 60 µm.
  • Safe usage at temperatures up to 230°C, or up to 250°C for short durations (15 minutes max).

Regulatory Impact and Industry Implications

The amendments provide manufacturers with additional material options while maintaining stringent safety and compliance standards for food contact applications.

Effective Date

RDC No. 961/2025 comes into effect immediately upon publication in the Diário Oficial da União on February 6, 2025. For more details, you can consult the full resolution here (in Portughese). 

The Brazilian Health Regulatory Agency (Anvisa) has revised its pesticide evaluation guidance for mutagenicity, carcinogenesis, neurotoxicity, and reproductive toxicity.   Purpose of the Updat...

The Brazilian Health Regulatory Agency (Anvisa) has revised its pesticide evaluation guidance for mutagenicity, carcinogenesis, neurotoxicity, and reproductive toxicity.

Purpose of the Updated Guidelines

These guides are critical resources for assessing the toxicological concerns associated with pesticides. They provide recommended practices and methodologies for the analysis of different outcomes, ensuring a rigorous and thorough review process throughout product registration and future re-analysis.

Alignment with Scientific Advances and Legislation

Anvisa emphasises that these guidelines represent its understanding of current best practice and are in line with the latest scientific advances and regulatory requirements. The updates incorporate comments from public discussions and align with recent amendments to Brazilian pesticide regulation (Law 14,785 of December 27, 2023).

Objectives of the Revisions

The main objective of these revised guidance is to improve the transparency and clarity of the toxicological evaluation standards, especially throughout the re-analysis process.
The updated guidance is effective immediately.

Highlights of the Update

• Guidelines on pesticide mutagenicity, carcinogenesis, neurotoxicity, and reproductive toxicity have been updated.

• Improved transparency and clarity of the evaluation process.

• Included comments from public consultations and aligned with new legislative developments.

Anvisa’s Role in Pesticide Evaluation

Anvisa is responsible for the evaluation of pesticides, environmental control products, technical products, and related items in accordance with its objective of promoting and protecting the health of the Brazilian population.

Pesticide Registration and Re-Analysis

Unlike other products controlled by the Agency, the registration of pesticides is not legally subject to renewal or revalidation, and it is permanent. However, pesticides are subject to re-analysis to ensure product safety and limit possible damage. International or domestic organizations can request re-analysis.

Since 2006, Anvisa has carried out 19 re-evaluations of pesticides and is currently carrying out four re-analyses. The provision of updated instructions will increase transparency in the evaluation of these products.

*Source

On November 13, 2024, Brazilian President Lula sanctioned Law 15.022/24, previously known as PL 6120/24, establishing the National Inventory of Chemical Substances. This law establishes a comprehensiv...

On November 13, 2024, Brazilian President Lula sanctioned Law 15.022/24, previously known as PL 6120/24, establishing the National Inventory of Chemical Substances. This law establishes a comprehensive framework for effective risk assessment and management of chemical substances in Brazil. Previously, Brazil regulated chemicals through sector-specific laws covering areas such as pharmaceuticals, cosmetics, pesticides, sanitizing products, and explosives. With this new law, Brazil joins a select group of countries with advanced systems for monitoring chemicals entering its market and assessing risks to human health and the environment.  

At the core of the law is the National Inventory of Chemical Substances, a tool designed to assess and control the risks associated with chemical substances used, produced or imported into the national territory. Its main objective is to minimize adverse effects on health and the environment.  

This milestone is the result of collaboration between several Brazilian stakeholders, including the Ministry of the Environment and Climate Change (Ministério do Meio Ambiente e Mudança do Clima), the Brazilian Chemical Industry Association (Abiquim) and the National Chemicals Safety Commission (Conasq).  

Regulations are expected to be published in early 2025 that will further elaborate on key elements of the law. One such regulation is expected to define the operational framework of the Committees responsible for overseeing the evaluation of chemical substances.  

Key News 2024

• Brazil Proposes Stricter Lead Limits in Paints 
  The Brazilian Senate is reviewing Projeto de Lei Nº 3.428/2023, which aims to reduce the lead content in paints from 600 ppm to 90 ppm. Industrial and maritime paints will still be allowed to contain up to 600 ppm, but will have to carry warning labels in Portuguese. If enacted, manufacturers and importers will have one year to comply, and the existing Law 11.762/2008 will be repealed. Read more here. 

• Brazil Updates Cosmetics Regulations with RDC 907/2024 
  On September 23, 2024, ANVISA introduced RDC 907/2024, replacing several previous regulations to streamline compliance for cosmetics, personal hygiene, and perfume products. The update includes stricter labeling, mandatory registration, and enhanced microbiological controls. Companies must comply with these new requirements to avoid penalties. Read more here. 

• Brazil Implements Groundbreaking Chemical Management Law
  On November 13, 2024, Brazil took a major step forward in chemical safety with the sanctioning of Law 15.022/24, formerly known as PL6120/19, by President Lula. The law establishes the National Inventory of Chemical Substances, which provides a comprehensive framework for the evaluation, control and management of chemicals produced, imported, or used in Brazil. Companies operating in Brazil should prepare to comply with the new requirements as implementation progresses. Read more here.

On 26 December 2024, the Brazilian Health Regulatory Agency (ANVISA) issued a technical note detailing the toxicological classification process for formulated products derived from equivalent technica...

On 26 December 2024, the Brazilian Health Regulatory Agency (ANVISA) issued a technical note detailing the toxicological classification process for formulated products derived from equivalent technical products. The guidelines aim to ensure consistency in toxicological classification, particularly when complete product studies are unavailable, aligning with the standards of RDC No. 294, issued on July 29, 2019.

Overview of Toxicological Classification

ANVISA's classification framework evaluates formulated products based on available toxicological studies or, when unavailable, by analyzing the toxicological properties of individual components. This approach ensures comprehensive health and safety assessments, adhering to Good Laboratory Practices (GLP) and the standards set by the Brazilian Ministry of Agriculture.

Key Health Endpoints Assessed

The classification process relies on toxicological studies that address the following health endpoints:

• Acute oral toxicity (LD50)

• Acute dermal toxicity (LD50)

• Acute inhalation toxicity (LC50)

• Corrosion and irritation

• Sensitization

• Mutagenicity

When multiple toxicological endpoints are considered, the most restrictive classification is applied to ensure safety.

Classification in the Absence of Complete Studies

For products lacking toxicological studies, the classification relies on the properties of individual components. This process involves:

1. Researching Component Classifications: Using databases like the European Chemicals Agency (ECHA).

2. Verifying Cut-off Values: Ensuring compliance with Brazilian regulatory thresholds.

3. Calculating Component Concentrations: Determining the exact concentration of components in the product to guide classification.

The classification extends to critical hazards, such as:

• Respiratory sensitization

• Carcinogenicity

• Reproductive toxicity

• Specific target organ toxicity (single and repeated exposure)

• Aspiration hazards

Packaging and Labeling Requirements

To  promote transparency and compliance, the document specifies requirements for labeling and package inserts:

• Chemical names of hazardous components.

• Relevant toxicological information for user safety.

• Warning phrases compliant with ABNT NBR 14725, the Brazilian standard for labeling and hazard communication.

Additionally, hazard classification details must be included in the Optimized Reading Leaflet (FLORA), part of the Register of Agrochemicals.

Significance of the Updates Guidelines

This technical note underscores ANVISA's commitment to public health, environmental safety, and regulatory alignment. By establishing clear criteria for classifying toxicological risks, the Agency ensures:

• Enhanced Safety: Protecting workers, users, and the environment from hazardous exposures.

• Regulatory Clarity: Providing industries with structured methodologies for compliance.

• Global Alignment: Strengthening Brazil’s adherence to international safety standards.

ANVISA's updated guidelines for toxicological classification offer a robust framework for ensuring the safe use, labeling, and management of formulated products. For further details, refer to the complete guidelines available (in Portuguese)  here.

On December 27, 2024, ANVISA announced two critical public consultations—No. 1,304 and No. 1,305—aimed at revising regulations for substances used in personal hygiene products, cosmetics, and perf...

On December 27, 2024, ANVISA announced two critical public consultations—No. 1,304 and No. 1,305—aimed at revising regulations for substances used in personal hygiene products, cosmetics, and perfumes. These updates are set to improve consumer safety, align with international standards, and strengthen Brazil’s position in the global cosmetics market.

Key Updates in Public Consultations No. 1,304 and 1,305

• Public Consultation No. 1,304: Focuses on the Restrictive List (Lista Restritiva), which identifies substances permitted for use under specific conditions and limitations. These include preservatives, colorants, filters, and straighteners.

• Public Consultation No. 1,305: Addresses the Negative List (Lista Negativa), which bans substances that are considered unsafe for use due to their toxicity. Examples include Lilial, Lyral, and selenium disulfide.

Why Are These Updates Important?

These revisions aim to incorporate the latest scientific research on ingredient safety, reducing health risks while promoting global competitiveness of Brazilian cosmetics. By aligning with international regulatory benchmarks, ANVISA ensures that Brazilian products meet global standards for safety and quality.

Key Regulatory Highlights

1. Restrictive List (Consultation No. 1,304):

   • Updates substances that are permitted with restrictions based on safe use levels.

   • Focuses on refining conditions for preservatives, filters, and other cosmetic components.

2. Negative List (Consultation No. 1,305):

   • Expands the list of banned substances to improve consumer protection.

   • Includes substances that have been identified by the latest toxicological studies as posing a risk to human health.

Supporting Documentation

ANVISA has provided detailed resources, including:

• Scientific assessments of key substances.

• Meeting agendas outlining  regulatory discussions.

• International benchmarks to support the proposed updates.

Why These Changes Matter

Updating the restrictive and negative lists:

• Protects consumer health by addressing the risks of toxic substances.

• Strengthens Brazil’s competitiveness in the global cosmetics market by aligning with international safety standards.

• Promotes innovation and transparency in regulatory practices.

How to Participate

• Contribution Period: January 7, 2025, to March 7, 2025

• Stakeholders can submit their input through ANVISA’s official forms, with detailed guidance available on the consultation page. This process invites contributions from industry experts, public health advocates, and other stakeholders.

Next Steps

After the consultation period ends, ANVISA will analyze the contributions and finalize the regulatory updates. These changes will ensure Brazilian that personal care and cosmetic products meet evolving safety standards while maintaining global market relevance.

For more information and to participate, you can access Consultation No. 1,304 here (in Portuguese) and Consultation No. 1,305 here (in Portuguese). 

Enacted on December 23, 2024, Law No. 15,070 establishes a comprehensive regulatory framework for bioinputs in Brazil, covering their production, import, export, registration, commercialization, and u...

Enacted on December 23, 2024, Law No. 15,070 establishes a comprehensive regulatory framework for bioinputs in Brazil, covering their production, import, export, registration, commercialization, and use. This landmark legislation integrates sustainability into agricultural, livestock, aquaculture, and forestry practices, aligning Brazil’s agricultural policy with global environmental goals.

Scope and Coverage

The law applies to different farming systems, including conventional, organic, and agroecological methods. It covers bioinputs such as biostimulants, biological control agents, biofertilizers, and inoculants. And it regulates all aspects of bioinput production. By requiring strict registration of biofactories, importers, exporters, and commercial entities, the legislation ensures high standards of quality and safety while encouraging innovation in bioinput technologies.

Incentives and Simplified Procedures

To promote sustainable practices, the law introduces financial incentives for the research, development, and use of bioinputs, in particular to support microenterprises, cooperatives, and family farmers. Simplified registration procedures are available for certain low-risk products, and traditional practices of indigenous communities and small-scale producers are supported through exemptions for the production of bioinputs for personal use.

Regulatory and Financial Mechanisms

The introduction of TREPDA, a bioinput registration tax, provides a financial mechanism for regulatory oversight while ensuring affordability through capped rates and exemptions for simplified procedures. Additionally, transitional measures ensure that existing bioinputs can continue to be used while the industry adjusts to the new standards.

Legal Revisions and Future Outlook

The law amends and revokes specific provisions of existing laws to bring them into line with modern practices, including updates to the regulatory framework for fertilizers, environmental control products, and bioinput registration requirements.

With this law, Brazil is taking an important step towards promoting sustainable agricultural development, improving food security, and protecting its rich biodiversity. By promoting the production and use of bioinputs, the country is strengthening its position as a global leader in sustainable agriculture. For more details, you can access the law (available in Portuguese) here.

The Brazilian Health Regulatory Agency (Anvisa) has announced the launch of three public consultations (CPs) to revise the regulatory framework for herbal medicines. This initiative, announced on Nove...

The Brazilian Health Regulatory Agency (Anvisa) has announced the launch of three public consultations (CPs) to revise the regulatory framework for herbal medicines. This initiative, announced on November 27, 2024, also includes the approval of the Regulatory Impact Analysis Report (AIR) for this revision process. This initiative aims to ensure safe and rational access to medicinal plants and herbal medicines for the Brazilian population while promoting the sustainable use of biodiversity and strengthening the local pharmaceutical industry.

Overview of Proposed Changes

The public consultations address updates to Resolution RDC 26/2014 and its complementary normative instructions (INs). The focus areas are:

1. Simplified Registration Process: The first consultation deals with the registration of herbal medicines.

2. Restrictions and Prohibitions: The second consultation deals with rules on restrictions and prohibitions related to the registration and notification of herbal medicines.

3. Pesticide Residue Lists: The third consultation deals with a review of the list of pesticide residues evaluated in cultivated plant species used in herbal medicine production.

The consultations also include a proposal for a new guideline for the registration and notification of herbal medicines, which will replace the existing IN 04/2014.

Importance of Herbal Medicines in Brazil

Herbal medicines, derived from medicinal plants, are recognized by the World Health Organization (WHO) as an important therapeutic option. In Brazil, they are widely used and are an integral part of the National Policy on Medicinal Plants and Herbal Medicines (PNPMF). This policy seeks to:

• Ensure safe access to herbal medicines.

• Promote the sustainable use of biodiversity.

• Develop the national production chain and pharmaceutical industry.

The revisions aim to align Brazil’s herbal medicine regulations with international standards, improve domestic access to quality products and enhance their global competitiveness.

Public Participation and Contributions

To ensure transparency and inclusiveness, Anvisa is inviting contributions from the public, academia and industry stakeholders, the deadline is the 5th of March 2025. The results are expected to bring Brazil’s regulatory framework closer to international benchmarks and promote a safer, more efficient and competitive herbal medicine market. For more details, refer to the consultation here (in Portuguese).