Brazil Regulatory News

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.

In the field of food safety, regulations play a key role in protecting public health and ensuring the integrity of consumables. Recently, Brazil introduced a new regulation, RDC No. 854/2024, which fo...

In the field of food safety, regulations play a key role in protecting public health and ensuring the integrity of consumables. Recently, Brazil introduced a new regulation, RDC No. 854/2024, which focuses on metallic materials in contact with food.

Scope and Applicability: The new regulation casts a wide net, covering various metallic materials used in the production, transportation and storage of food and raw materials. From packaging to utensils, coatings to equipment, if it's made of metal and interacts with food, it falls under the scope of this regulation.

Key Provisions: At its core, the Regulation emphasizes the importance of ensuring that metallic materials do not pose a risk to human health or compromise the quality of food. Some noteworthy provisions include:

1. Prevention of Contamination: Metallic materials must not leach harmful substances that could contaminate food.

2. Preservation of Quality: The materials should not change the composition or sensory characteristics of food in an unacceptable way.

3. Specific Conditions: Certain exceptions, such as partially varnished or tin-exposed packaging are allowed, under specific conditions.

4. Integrity Assurance: Various techniques are permitted for the construction of metallic packaging seams to maintain their integrity.

5. Hermetic Sealing: Metal lids must be hermetically sealed to preserve the freshness of the food.

6. Recycling: While encouraged, recycling of metallic materials must comply with strict specifications outlined in the regulation.

Permitted Materials: The Regulation provides an extensive list of approved raw materials for the manufacture of metal packaging and equipment. From stainless steel alloys to copper and aluminium, these materials must meet rigorous safety standards.

Limits and Migration Tests: To ensure compliance, strict limits are set for the migration of substances from metallic materials to food. Testing protocols include total migration, specific migration and composition limit tests, all designed to maintain food safety standards.

Importance of Compliance: Compliance with these regulations is not only a legal obligation, but a fundamental responsibility shared by manufacturers, distributors and all stakeholders in the food industry. Meeting these standards is essential to maintaining consumer confidence and protecting public health.

Final Provisions: The new regulation comes into effect on May 2, 2024, with a 180-day grace period for industry players to adapt. It is imperative that companies proactively adapt to these requirements to ensure the safety and quality of their products.

In conclusion, the introduction of RDC No. 854/2024 marks a significant step forward in strengthening food safety standards. By complying with these regulations, stakeholders can maintain the integrity of the food supply chain and protect the well-being of consumers. Compliance is not only a legal necessity but a moral imperative in the pursuit of a safer, healthier food ecosystem.

Moving towards environmental preservation, Brazil has recently issued a draft rule for public comment outlining the requirements and procedures aimed at controlling the import, export, recycling, re...

Moving towards environmental preservation, Brazil has recently issued a draft rule for public comment outlining the requirements and procedures aimed at controlling the import, export, recycling, recovery, trade, use, and transportation of metallic mercury within its borders. This decision, based on Decree nº 97.634, issued on 10 April 1989 and in alignment with the Minamata Convention on Mercury, represents an important moment in Brazil's commitment to sustainability and environmental responsibility.

Strengthening Environmental Regulations

The implementation of these regulations underscores Brazil's commitment to protecting its natural resources and ecosystems. By establishing stringent requirements and procedures for mercury waste disposal, Brazil aims to mitigate the harmful effects of mercury pollution on both human health and the environment.

Brazil's Role in Global Environmental Governance

This initiative not only positions Brazil as a leader in environmental governance but also demonstrates its proactive approach to addressing global environmental challenges. Through adherence to international standards and active participation in the Minamata Convention, Brazil is making a valuable contribution to the global effort to reduce mercury pollution and promote a healthier planet.

Starting April 1st, 2024, paints and varnishes intended for real estate use must be registered with Anvisa if they have sanitizing properties. This requirement applies to products formulated with sub...

Starting April 1st, 2024, paints and varnishes intended for real estate use must be registered with Anvisa if they have sanitizing properties. This requirement applies to products formulated with substances having antimicrobial or disinfectant capabilities, including insecticide or repellent components.

The recent regulatory update, outlined in Collegiate Board Resolution - RDC 847, issued on March 6, 2024, establishes guidelines for proving product effectiveness and outlines the registration process. Additionally, the resolution specifies rules governing labeling, packaging, and sale of these items.

It's important to note that paints designed solely for enhancing or safeguarding walls, without sanitizing properties, remain exempt from health surveillance measures.

Guidance for Manufacturers and Importers

Alongside the new regulations, Anvisa has released Technical Note 18/2024/SEI/Cosan/GHCOS/DIRE3/Anvisa. This note provides valuable insights for companies involved in the production or importation of these products.

Key points covered in the technical note include:

• The necessity of obtaining a Business Operating Authorization (AFE) for manufacturing sanitizing products.
• Instructions regarding the subject code for registration petitions and their respective categories.
• Guidelines for making changes to products post-registration.
• Details regarding the validity period of registration.

These measures aim to ensure the safety and efficacy of sanitizing paints and varnishes used in real estate applications, enhancing consumer confidence and regulatory compliance within the industry.