Brazil Regulatory News

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​

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.

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 September 6, 2024, ANVISA (Brazil’s National Health Surveillance Agency) issued Resolution RDC 902/2024 which introduces updated regulatory requirements aimed at enhancing the control of substanc...

On September 6, 2024, ANVISA (Brazil’s National Health Surveillance Agency) issued Resolution RDC 902/2024 which introduces updated regulatory requirements aimed at enhancing the control of substances and products under sanitary surveillance in Brazil.

Key Changes for Controlled Substances and Medical Products

The Resolution outlines important changes that affect:

• The registration and renewal procedures for controlled substances.

• The criteria for labeling, storage, and distribution of medical products.

• New measures to ensure the safe marketing and distribution of these substances in Brazilian markets.

Increased Monitoring and Reporting Requirements

One of the key aspects of the new resolution is its focus on strengthening the monitoring mechanisms for substances considered to have a high potential for abuse or risk to ensure that they are only used in a regulated and controlled manner. This includes new guidelines for handling, dispensing, and reporting activities related to controlled substances.

Additionally, RDC 902/2024 outlines specific requirements for facilities involved in the manufacture, distribution, and sale of these products, including the need for enhanced tracking systems and detailed reporting to ensure full transparency throughout the supply chain.

Implementation Timeline and Compliance Advice

The resolution is part of ANVISA’s broader strategy to enhance public health and safety by reducing risks associated with the improper use of controlled substances while streamlining regulatory procedures for compliant businesses.

The new guidelines will take effect in the coming months, and companies operating in this sector are encouraged to familiarize themselves with the new requirements to ensure compliance and avoid disruption to their operations.

The Environment Commission (CMA) took another step towards enhancing chemical safety in Brazil by approving Bill PL 6.120/2019 on 11 September 2024. The Bill establishes the National Inventory of Che...

The Environment Commission (CMA) took another step towards enhancing chemical safety in Brazil by approving Bill PL 6.120/2019 on 11 September 2024. The Bill establishes the National Inventory of Chemical Substances, which will evaluate and control the risks associated with chemical substances used across the country. Originating from the Chamber of Deputies, the proposal received a positive endorsement from Rapporteur Beto Faro (PT-PA), who had also supported the measure in the Commission on Science, Technology, Innovation, and Information (CCT). In the CMA, Senator Fabiano Contarato (PT-ES) served as an ad hoc rapporteur, presenting Faro’s report. The bill now moves to the Social Affairs Commission (CAS) for final analysis, before being sent to the president for sanction.

Creation of Registry to Protect Health and the Environment

The primary goal of the Bill is to reduce the harmful impacts of chemical substances on both human health and the environment. To achieve this, the Bill establishes a Technical Committee for the Evaluation of Chemical Substances and a Deliberative Committee of Chemical Substances, both composed of experts in environmental science, health, chemistry, trade, and metrology. Additionally, the creation of a Chemical Substances Registry will serve as the foundation for the inventory, creating a publicly accessible database of substances that are imported or produced in Brazil.

Key Provisions and Responsibilities

The Bill outlines the criteria and deadlines for including substances in the registry and assigns responsibilities to manufacturers, importers, and professional users of these chemicals. It also introduces penalties for non-compliance, including warnings, fines, and in severe cases, suspension of the substance’s production along with potential seizure. Fines can vary significantly, ranging from 5% of the minimum wage to up to 40,000 times the minimum wage.

The registry will include information about the producer or importer, the quantity produced, the hazard classification based on Brazilian regulations, and usage recommendations. Manufacturers and importers will have up to three years to submit the necessary information after the registry is made public. For newly produced substances, the deadline will be March 31st of the following year.

Substances produced or imported in volumes of one tonne or more per year will need to be registered. However, certain exceptions apply, including radioactive substances, substances in development, those intended for national defense, and products regulated by specific laws, such as food, medicines, pesticides, cosmetics, fertilizers, and veterinary products.

Intellectual Property Protection and Risk Evaluation

For new substances that require unique studies conducted in Brazil to generate necessary information, the bill grants intellectual property rights for up to 10 years over these studies. Third parties may register a substance only if authorized by the study's owner to access the data.

Substances included in the registry will undergo a risk evaluation process led by the Technical and Deliberative Committees. This evaluation will be based on criteria such as environmental toxicity, carcinogenic potential, and effects on human reproduction. The bill also places restrictions on animal testing, only allowing it when all scientifically reliable alternative methods have been exhausted.

Introduction of New Fees

To finance the regulatory process, the Bill introduces a Registration, Evaluation, and Supervision Fee for Chemical Substances. The specific amounts will be determined by the future regulation. The fee will be charged for the registration of substances, those subjected to risk assessments, and in cases where protection of a substance’s identity is requested due to trade or industry secrecy concerns.