Brazil Regulatory News

The Brazilian Health Regulatory Agency (ANVISA) has issued a technical note detailing the classification process for formulated products derived from equivalent technical products. This guidance ensur...

The Brazilian Health Regulatory Agency (ANVISA) has issued a technical note detailing the classification process for formulated products derived from equivalent technical products. This guidance ensures 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 using 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 Without 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 ensure 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.

Why These Updates Matter

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), identifying substances permitted for use under specific conditions and limitations. This includes preservatives, colorants, filters, and straighteners.

• Public Consultation No. 1,305: Addresses the negative list (Lista Negativa), banning substances deemed 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 for Brazilian cosmetics. By aligning with international regulatory benchmarks, ANVISA is ensuring Brazilian products meet global standards for safety and quality.

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.

Key Regulatory Highlights

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

   • Updates substances that are permitted with restrictions based on safe usage 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 enhance consumer protection.
   • Includes substances flagged for their health risks by the latest toxicological studies.

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.

Next Steps

After the consultation period ends, ANVISA will analyze contributions and finalize the regulatory updates. These changes will ensure Brazilian 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 Portughese) 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, importation, exportation, registration, commercializat...

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

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

To promote sustainable practices, the law introduces financial incentives for the research, development, and use of bioinputs, particularly supporting microenterprises, cooperatives, and family farmers. Simplified registration processes are available for certain low-risk products, and traditional practices by indigenous communities and small-scale producers are supported through exemptions for self-use bioinput production.

The introduction of TREPDA, a tax on bioinput registration, 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.

It also amends and revokes specific provisions of existing laws to align with modern practices, including updates to the legal framework for fertilizers, environmental control products, and bioinput registration requirements.

With this law, Brazil takes a significant step toward promoting sustainable agricultural development, enhancing food security, and protecting its rich biodiversity. By fostering the production and use of bioinputs, the country strengthens 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). 

The Brazilian Senate will review Projeto de Lei Nº 3.428/2023, which seeks to reduce the maximum allowable lead content in paints and similar surface coatings from 600 parts per million (ppm) to 9...

The Brazilian Senate will review Projeto de Lei Nº 3.428/2023, which seeks to reduce the maximum allowable lead content in paints and similar surface coatings from 600 parts per million (ppm) to 90 ppm. The proposal was approved by the House of Representatives on October 16, 2024, and now moves to the Senate for consideration.

Key Provisions of PL 3428/2023

The bill applies to paints and related materials used for surface protection, decoration, and preparation. Exceptions include industrial and maritime paints, which may contain up to 600 ppm due to technical requirements. Paints that exceed 90 ppm but fall within the 600 ppm exception must display a warning label (in Portuguese):

“Perigo: contém chumbo. Não aplicar em superfícies acessíveis a crianças e/ou mulheres grávidas." ("Warning: Contains Lead. Not for use on surfaces accessible to children or pregnant women.")

Compliance and Penalties

Manufacturers and importers will have 365 days to meet the new requirements. Non-compliance will lead to penalties, including product seizure and fines. Regulatory authorities will oversee enforcement, ensuring adherence to the regulation and protect public safety and the environment.

Advancing Paint Technology

This initiative reflects advances in paint technology that allow for safer, lead-free alternatives without compromising performance. If enacted, the proposal would repeal Law 11.762/2008, which currently regulates limits in paints in Brazil. The law is part of Brazil’s commitment to reduce toxic substances, protect health and promote sustainable development. For more details, see the proposal (in Portuguese) here.

Brazil has achieved a milestone in sustainable development and public safety. On 13 November 2024, President Lula officially sanctioned Law 15.022/24, previously known as PL6120/19, creating the Nati...

Brazil has achieved a milestone in sustainable development and public safety. On 13 November 2024, President Lula officially sanctioned Law 15.022/24, previously known as PL6120/19, creating the National Inventory of Chemical Substances. This groundbreaking legislation establishes a robust framework for the evaluation, control, and management of chemical substances produced, imported, or used in Brazil.

Development: Filling a Critical Gap in Chemical Safety

Until now, Brazil lacked a systematic mechanism to monitor chemicals entering its market. This gap created challenges in assessing risks to human health and the environment. With the implementation of Law 15.022/24, Brazil now joins a select group of countries with advanced regulatory systems, aligning itself with global best practices.

The centerpiece of the law is the National Inventory of Chemical Substances, a comprehensive tool for effective risk assessment and management. This positions Brazil as a leader in Latin America in the responsible management of chemicals and strengthens its commitment to sustainable development.

A Collaborative Effort: Key Stakeholders in the New Law

The success of this initiative is the result of years of collaboration among various stakeholders, including:

• Ministério do Meio Ambiente e Mudança do Clima (Ministry of the Environment and Climate Change)

• Abiquim (Brazilian Chemical Industry Association)

• Conasq (National Chemical Safety Commission)

These organizations, along with countless other contributors, have worked tirelessly to ensure that the law meets the needs of industry while protecting public and environmental health.

Looking Ahead: Ensuring Compliance and Sustainable Practises

At GPC, we are closely monitoring the implementation of Law 15.022/24 and will provide updates as it develops. Companies operating in Brazil must prepare to adapt to the requirements of the new legislation. We are committed to supporting companies effectively navigate these changes and ensure compliance with the National Inventory of Chemical Substances.

The sanctioning of Law 15.022/24 is a milestone for Brazil, reflecting its dedication to sustainable development and environmental responsibility. By adopting this legislation, the country sets a strong example for others in the region and reaffirms its alignment with international standards.

As expected, the Federal Senate has approved Bill 6120/2019, which aims to establish the National Inventory of Chemical Substances. The bill seeks to regulate the use, commercialization, and control o...

As expected, the Federal Senate has approved Bill 6120/2019, which aims to establish the National Inventory of Chemical Substances. The bill seeks to regulate the use, commercialization, and control of these substances in Brazil, with the aim of reducing harmful impacts on public health and the environment. The bill now awaits presidential approval.

Purpose of the National Inventory

The National Inventory will serve as a strategic tool to identify and monitor chemical substances produced or imported in the country. It will enable more effective risk management of these substances, promote chemical safety, and help align Brazil with international best practices for regulating chemical products.

Legislative Process and Amendments

The bill has passed through several stages in Congress, including consideration of amendments and adjustments to the text. The final version approved by the Senate includes two drafting amendments aimed at improving the clarity of the document without changing its main content.

Expected Timeline for Presidential Approval

The President has 15 business days from the day the bill is officially received by the Executive Branch to make his decision. During this period, the President may either fully sanction the bill, partially or entirely veto it, or allow it to become law by tacit approval if no action is taken within the deadline. It is expected that the approval process will be completed by the end of October 2024, depending on the exact date the bill reaches the President's office.

If sanctioned, PL 6120/2019 will represent a major step forward in Brazil's policy for controlling chemical substances, providing greater protection to the population and the environment from the risks of exposure to hazardous products.