Brazil Regulatory News

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.

On October 9, 2024, the Senate Social Affairs Committee (CAS) approved the creation of the National Inventory of Chemical Substances in Brazil. This proposal, part of Bill PL 6120/2019, marks the thir...

On October 9, 2024, the Senate Social Affairs Committee (CAS) approved the creation of the National Inventory of Chemical Substances in Brazil. This proposal, part of Bill PL 6120/2019, marks the third and final approval needed from Senate committees, having already passed through the Committee on Environment (CMA) and the Committee on Science, Technology, Innovation, Communication, and Information Technology (CCT). Now, the bill moves to the Senate Plenary for a final vote.

The proposal, identified as Bill PL 6120/2019, obliges manufacturers and importers to register detailed information about their chemical substances, including their production quantities, potential risks, and classification according to Brazilian standards. The data will be used by regulatory bodies to evaluate environmental and health risks. This initiative also incorporates measures to promote alternative testing methods that avoid animal testing, unless no other reliable options exist.

Additionally, the CAS approved a request for urgency, which means the bill will soon head to the Senate Plenary for final voting. If approved, this will mark a significant step toward stronger chemical safety regulations in Brazil, aiming to reduce the environmental impact and mitigate risks to human health.

The bill outlines strict penalties for non-compliance, ranging from fines to suspension of production. The inventory’s implementation is seen as an essential move for industries working with chemicals, ensuring that Brazil aligns its standards with global environmental and health practices​

Brazil’s National Health Surveillance Agency (ANVISA) has issued a key regulatory update that impacts the cosmetics industry. On September 23, 2024, ANVISA introduced RDC 907/2024, a comprehensive r...

Brazil’s National Health Surveillance Agency (ANVISA) has issued a key regulatory update that impacts the cosmetics industry. On September 23, 2024, ANVISA introduced RDC 907/2024, a comprehensive rule that replaces and consolidates earlier regulations governing the production and sale of cosmetics, personal hygiene products, and perfumes in Brazil.

This newly issued regulation supersedes several previous standards, including RDC 752/2022, RDC 841/2023, and Article 13 of RDC 814/2023. It aims to streamline processes and provide clearer guidance for manufacturers and sellers within the sector.

Key Aspects of RDC 907/2024

The regulation covers several areas to ensure the safety, quality, and proper labeling of cosmetic products available to Brazilian consumers. Among the most notable updates are:

1. Product Notification and Registration
   The Regulation outlines specific steps that businesses must follow to notify or register products with ANVISA before launching them on the market. 

2. Product Definitions and Classification
   Clear definitions have been established for what constitutes a cosmetic, personal hygiene product, or perfume, including their respective classifications.

3. Labeling Requirements
   The new Regulation reinforces strict labeling requirements, to ensure that consumers are provided with clear and accurate information about the products they purchase. Labels must include important details such as ingredients, expiration dates, and usage instructions.

4. Microbiological Control
   RDC 907/2024 introduces stringent microbiological control requirements to safeguard consumer health. Cosmetic products must meet specific safety standards to ensure they are free from harmful microorganisms before reaching the market.

The updated regulation aims to align Brazil’s cosmetics standards with international best practices, providing a more robust framework for product safety and consumer protection. For companies in the cosmetics and personal care industry, RDC 907/2024 provides clearer guidance and simplifies compliance requirements. 

Manufacturers, importers, and distributors will need to adapt to the new rules, ensuring that their products meet the updated standards to avoid delays or penalties when launching new . 

For more detailed information on the new regulations: the full text of RDC 907/2024

On 23 September 2024, the Brazilian regulatory agency ANVISA (the National Health Surveillance Agency) published two draft standards for public comment regarding the use of regenerated cellulose films...

On 23 September 2024, the Brazilian regulatory agency ANVISA (the National Health Surveillance Agency) published two draft standards for public comment regarding the use of regenerated cellulose films in food contact applications. These standards propose specific lists of substances authorized for the manufacture of such films and outline the conditions for their use.

Details of Draft Standards on Regenerated Cellulose Film

The first draft standard focuses on regenerated cellulose film, which is divided into two categories:

1. Annex I: Contains the authorized list of substances for uncoated regenerated cellulose films.

2. Annex II: Lists the permitted substances for regenerated cellulose films coated with cellulose derivatives.

The draft outlines the substances allowed for these types of films and sets clear conditions of use. Interested stakeholders are invited to review the details and submit their comments.

Adoption of Mercosur Standard for Cellulose Materials

In a second draft standard on cellulose materials intended for food contact, ANVISA is seeking to adopt a Mercosur standard. This proposed regulation would apply to regenerated cellulose films based on their intended use, specifically in cases where the films:

1. Are themselves a finished product, or

2. Are part of a finished product containing other materials.

It is important to note that this draft would not apply to synthetic regenerated cellulose casings, as they are governed by a separate standard.

Public Consultation Period

ANVISA encourages interested parties to review the proposed drafts and provide feedback during the public consultation period, which runs from 30 September to 14 November 2024. This is an opportunity to contribute to the development of clear regulations that ensure the safety and compliance of food contact materials in Brazil.