Brazil Regulatory News

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.

In its continuous efforts to ensure the safety of food contact materials and promote sustainability in the industry, the Brazilian Health Regulatory Agency (Anvisa) recently published the 6th edition ...

In its continuous efforts to ensure the safety of food contact materials and promote sustainability in the industry, the Brazilian Health Regulatory Agency (Anvisa) recently published the 6th edition of its "Questions and Answers" document. This update addresses changes resulting from regulatory updates and aims to provide clearer guidance on materials in contact with food.

New Inclusions and Sustainability Focus

The updated document includes new questions covering a range of topics such as chemical recycling of plastic materials, biodegradable or compostable packaging, references for updating positive lists, and more. One particularly relevant aspect highlighted in Question 22 centers around sustainability, aligning with the broader goals of the National Solid Waste Policy (Law 12.305/2010) and the National Solid Waste Plan (Planares).

Circular Economy and Recycling Initiatives

The Planares emphasizes actions related to the circular economy, which prioritizes reduction, reuse, and reintroduction of materials, reducing pressure on natural resources, greenhouse gas emissions, and waste generation. Despite a 22.10% recycling rate of plastic waste from packaging in 2018, challenges persist, especially in the flexible materials category.

The Brazilian Chemical Industry Association (Abiquim) notes the success of mechanical recycling in Brazil but highlights obstacles, particularly in the food and beverage market, which represents almost 30% of the global polyolefin market. To address these challenges, the document advocates for the essential role of chemical recycling in recycling all types of plastic waste, aligning with global initiatives in the United States and the European Union.

Chemical Recycling Processes and Regulatory Clarifications

Anvisa received inquiries about the utilization of chemical recycling processes in the production of plastic packaging for food. The updated document clarifies that processes of complete depolymerization, resulting in monomers indistinguishable from original monomers and meeting purity standards, can be used without specific petitioning or authorization. However, processes obtaining mixtures, oligomers, or intermediates require specific evaluation and petitioning.

Contributing to Sustainable Goals

The adoption of chemical recycling processes in the production of food packaging aligns with Planares' objectives, particularly Goals 4 and 6. Goal 4 aims to reduce waste and rejections sent for environmentally appropriate final disposal, with an indicator to recover 48.1% of the total mass of Urban Solid Waste nationwide by 2040. Goal 6 focuses on increasing the recovery of the dry fraction of waste, with indicators targeting the recovery of 20% of dry recyclables by 2040 and the recovery of 50% of general packaging through reverse logistics systems by 2040.

Conclusion

Anvisa's commitment to regulatory quality and sustainability is evident in this latest guidance. The agency acknowledges the importance of addressing challenges in the recycling landscape and emphasizes the role of chemical recycling in achieving sustainable practices.

For further inquiries or to stay updated on Anvisa's guidance, you can contact the agency's Central Assistance or refer to the latest version of the "Questions and Answers" document.

The Brazilian Association of Technical Standards (ABNT) has taken an important step forward in enhancing safety measures concerning chemical substances with the introduction of the new standard "NBR ...

The Brazilian Association of Technical Standards (ABNT) has taken an important step forward in enhancing safety measures concerning chemical substances with the introduction of the new standard "NBR 17160 - Safe Storage and Incompatibility of Chemical Products." This standard, which entered National Consultation on 02/19/2024 and is accessible until 03/19/2024, signifies a crucial development in the field of chemical storage and compatibility.

Background: This standard is built upon the foundation of the German international standard "TRGS 510 - Storage of hazardous substances in non-stationary containers." The primary focus of NBR 17160 is to establish criteria for determining storage classes of chemical products. This is achieved by utilizing hazard classifications according to NBR 14725 and transport classifications according to Resolution 5998/ANTT, which was the prevailing standard during the document's formulation.

Objective: The core objective of NBR 17160 is to provide a comprehensive framework for segregating chemical products based on their respective chemical incompatibilities. This approach is crucial in minimizing the risk of hazardous reactions between substances, ensuring the safety of storage facilities and personnel.

Key Features:

1. Creation of Storage Classes: The standard introduces a system of classes to facilitate the segregation of chemical products. This categorization is designed to align with the classifications of hazards according to NBR 14725, creating a standardized approach to storage.

2. Rules for Safe Storage: NBR 17160 establishes explicit rules for the safe storage of chemical products within each class. This includes specific guidelines for handling various groups of substances, such as explosives, flammable liquids, and oxidizing agents. These rules contribute to maintaining a secure environment and preventing accidents.

3. Alignment with International Standards: Drawing inspiration from international standards like TRGS 510 ensures that Brazil remains in sync with global best practices. This alignment enhances the country's ability to participate in international trade while upholding high safety standards.

Accessing the Standard: To gain insights into the intricacies of the NBR 17160 standard, interested individuals can access the full text on the ABNT website through this link. The document is located under the ABNT/CB-010 Chemistry committee, titled "PROJETO ABNT NBR 17160 Armazenamento seguro e incompatibilidade de produtos químicos." However, it's essential to note that the window for accessing and providing improvement comments closes on 03/19/2024.

The introduction of NBR 17160 marks a stride in ensuring the safe storage and compatibility of chemical substances in Brazil. This standard not only establishes clear guidelines for storage but also reflects a commitment to international standards, emphasizing the importance of safety in handling and storing chemical products. As stakeholders engage in the National Consultation, their input and feedback will contribute to refining and implementing a standard that sets a benchmark for safety in the chemical industry.