Brazil Regulatory News

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.

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.

The Brazilian federal government launched the "Selo Verde Brasil" (Green Seal Brazil) Program to promote sustainable development and reduce greenhouse gas emissions. The decree establishing the progra...

The Brazilian federal government launched the "Selo Verde Brasil" (Green Seal Brazil) Program to promote sustainable development and reduce greenhouse gas emissions. The decree establishing the program was officially published on 18 June 2024, signalling Brazil's renewed commitment to responsible environmental practices.

Program Objectives

The Green Seal Brazil Program aims to certify products and services that meet pre-defined sustainability requirements. This certification will provide consumers and businesses with accurate and verifiable information, thus encouraging informed choices and promoting sustainable consumption. Another important objective is to strengthen sustainable public procurement processes in the country.

Implementation and Standards

According to the decree, the program will follow both national and international environmental certification standards, ensuring reciprocity and mutual recognition with similar global initiatives. This strategy aims to facilitate the acceptance of Green Seal Brazil in international markets, thereby enhancing the global competitiveness of Brazilian products.

Integration with Existing Initiatives

Green Seal Brazil will be integrated with existing certification programs and sustainability initiatives. It will be aligned with public policies that promote sustainable products and services and support the Ministry of Finance's Ecological Transformation Plan. This comprehensive integration is designed to strengthen the country's green economy and promote transparency, social inclusion and income generation.

Role of the Conformity Assessment Bodies

The certification process will be carried out by conformity assessment bodies accredited by the National Institute of Metrology, Quality and Technology (Inmetro). These bodies will verify that products and services comply with the sustainability requirements set out in specific Brazilian technical standards.

Future Impact and Commitment

In order to ensure the effective implementation of the program, the Ministry of Development, Industry, Commerce and Services may enter into contracts, technical cooperation agreements or adjustments with public and private entities. The visual identity of the Green Seal Brazil will be established by an act of the Minister of State for Development, Industry, Commerce and Services.

Conclusion

The launch of the Green Seal Brazil represents a significant step forward in the promotion of a green economy in Brazil. It reaffirms the country's commitment to sustainability and environmental protection, aiming at a greener and more prosperous future. This decree will take effect on the date of its publication, marking a new era of sustainable and conscious practices in Brazil.

On 24 May 2024, the Brazilian National Health Surveillance Agency (ANVISA) updated the INCI Translation Panel with the translation of 1,016 International Nomenclature Cosmetic Ingredients (INCI) into ...

On 24 May 2024, the Brazilian National Health Surveillance Agency (ANVISA) updated the INCI Translation Panel with the translation of 1,016 International Nomenclature Cosmetic Ingredients (INCI) into Portuguese. Including another update published on 10 May, a total of 1,148 entries were added in May.

Mandatory INCI Name Translations

According to ANVISA Regulation RDC No. 773, which came into force on 1 November 2023, all personal care products, cosmetics, and perfumes sold in Brazil must have their chemical composition in Portuguese on the label. This regulation amends the previous regulation (RDC No. 646) to ensure transparency and accessibility for Brazilian consumers. The translation can be provided directly on the label or in a digital format accessible through a code on the packaging.

Ingredients Excluded from the Update

As a result of the update, all requests for inclusion received before 23 May were thoroughly reviewed. However, some ingredients were excluded from the panel for the following reasons:

1) The INCI provided by the user was not found in the European Cosmetic Ingredients (CosIng) database

2) The ingredient is prohibited for cosmetic products under the regulatory framework for personal hygiene products, cosmetics, and fragrances (RDC No. 529/2021).

Future Updates and Availability

Products manufactured until 31 October 2023 may be sold until their respective expiry dates, according to Art. 4^th of RDC No. 646 of 2022, as amended by RDC No. 773 of 2023.

Starting in 2025, translation will be added every two months (in odd months), while translation changes/corrections will be made every six months (in July and December).

The chemical composition in Portuguese can be displayed in print or digital format, preferably on a mobile device, and is preceded by the phrases "Composition (Portuguese):" or "Ingredients (Portuguese)".

ANVISA has made the entire database of the panel public via a spreadsheet, allowing users to download changes on the specified date. The update is scheduled for July 2024 and will include new additions and adjustments to translated ingredients to ensure traceability and prevent ANVISA from being held liable for obsolete translations.