Brazil Regulatory News

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.

President Lula signed into law the Bill (PL) 1.459/2022 on Wednesday (Dec. 27), guiding in a new era for the approval and commercialization of pesticides in Brazil. Law 14.785 of 2023 is already in fo...

President Lula signed into law the Bill (PL) 1.459/2022 on Wednesday (Dec. 27), guiding in a new era for the approval and commercialization of pesticides in Brazil. Law 14.785 of 2023 is already in force, marking a paradigm shift in the regulatory landscape. 

Originating from the long-debated Bill (PL) 1.459/2022, initially proposed by former Senator Blairo Maggi in 1999 and extensively modified in the Chamber of Deputies, this legislative overhaul addresses outdated regulations. After two decades of scrutiny, the text returned to the Senate. 

One of the groundbreaking aspects of the new law is the revised timeline for the inclusion and modification of pesticide registrations. Ranging from 30 days to two years, the law addresses various aspects, including research, production, export, import, commercialization, or product use. Notably, Brazil's previous average of seven years for registering new products is set to see a significant reduction. 

For new products, a 24-month requirement is introduced, with an option for research and experimentation products to benefit from a special temporary registration, subject to a swift 30-day analysis by the Ministry of Agriculture. 

Crucially, the law designates the federal environmental agency for the registration of environmental control products and the Ministry of Agriculture for agricultural use. However, vetoes modified the original version, maintaining the tripartite system for registration and control of pesticides, involving the Ministries of Agriculture, Environment (via Ibama), and Health (represented by Anvisa). 

Another aspect of the vetoed provisions involved the creation of an evaluation and registration fee to contribute to the Federal Agricultural Fund (FFAP). Despite the veto, the law suggests various funding sources for FFAP, including funds from the Federal Government, the National Environment Fund (Law 7,797 of 1989), and donations. 

Other vetoes included provisions allowing the government to register products with pending re-analysis of ingredients, and exemptions for manufacturers from engraving warnings on packaging, both with concerns related to public health and environmental risks. 

In terms of risk analysis, the new law shifts focus from expressly prohibiting certain substances to labeling as "unacceptable risk" those presenting hazards to humans or the environment. Additionally, the law eliminates the possibility of registration challenges from organizations, such as trade associations and consumer and environmental groups. 

The legislation also increases fines for law violations, with amounts set proportionally to the severity of the offense. A novel provision allows agreements with state agencies for enforcement, with fines contributing to these agencies. 

While the legislation repeals certain offenses, it introduces penalties for producing, storing, transporting, importing, using, or marketing unregistered or unauthorized pesticides. These crimes may result in a prison sentence of three to nine years, with aggravating factors considered. 

ANVISA in Brazil has approved its regulatory agenda for the upcoming year, outlining plans to review and potentially revise multiple of existing standards. ANVISA intends to address over 170 items a...

ANVISA in Brazil has approved its regulatory agenda for the upcoming year, outlining plans to review and potentially revise multiple of existing standards. ANVISA intends to address over 170 items across different product categories, including cosmetics, pesticides, food, and sanitizers. Among its objectives are: 

• Reviewing criteria and procedures for imported products that do not require registration with ANVISA. 

• Identifying strategies to promote access to necessary information for the safe use of cosmetics and sanitizing products for consumers with visual impairments. 

• Defining technical requirements for the registration of paints with sanitizing properties. 

• Updating lists of permitted additives (e.g., preservatives or dyes) subject to use restrictions in personal hygiene products, cosmetics, and perfumes. 

Within this comprehensive agenda, particular focus will be placed on items related to Food Contact Materials (FCM), labeling, and cosmetics, with proposals to integrate Mercosur standards into the regulatory system. 

In a significant development for the food industry, the Brazilian regulatory landscape witnessed a noteworthy update with the publication of Normative Instruction - IN No. 267 on December 12, 2023. Th...

In a significant development for the food industry, the Brazilian regulatory landscape witnessed a noteworthy update with the publication of Normative Instruction - IN No. 267 on December 12, 2023. This latest instruction, which amends its predecessor, IN No. 211 from March 1, 2023, introduces crucial modifications to the regulations governing food additives and technology coadjutants.

Understanding the Changes

The amendments outlined in IN No. 267 encompass a spectrum of aspects, ranging from technological functions to maximum limits and conditions for the use of food additives and coadjutants. As the industry grapples with evolving consumer preferences, health considerations, and technological advancements, staying abreast of these regulatory changes is imperative for businesses to thrive.

Implications for Businesses

For companies operating in the food sector, compliance with these regulatory adjustments is not only a legal requirement but also a strategic imperative. Non-compliance could lead to serious consequences, including legal repercussions and damage to a brand's reputation.

The MMA (Ministry of Environment of Brazil) is calling for non-governmental entities to join their National Commission for Chemical Safety (Conasq). Published on Monday (Nov 13th), this notice invite...

The MMA (Ministry of Environment of Brazil) is calling for non-governmental entities to join their National Commission for Chemical Safety (Conasq).
Published on Monday (Nov 13th), this notice invites organizations from civil society, the private sector, academia, and professional entities to be a part of this crucial commission. The deadline for registration is November 24th!
The Conasq is dedicated to fostering integrated actions for the environmentally responsible management of chemical products. Its mission is to proactively address health and environmental risks associated with these substances. By promoting the safe use of chemicals, the commission aims to minimize their presence in consumer products while advocating for safer alternatives.
Brazil is making strides towards a safer and healthier future!

The President of Ibama (Brazilian Institute of environment) has issued a groundbreaking resolution regarding the control of Hydrofluorocarbons (HFCs) imports.  The resolution outlines stringent me...

The President of Ibama (Brazilian Institute of environment) has issued a groundbreaking resolution regarding the control of Hydrofluorocarbons (HFCs) imports. 

The resolution outlines stringent measures to regulate the importation of HFCs and HFC-containing mixtures. This action is taken in compliance with the Kigali Amendment of the Montreal Protocol on Substances that Deplete the Ozone Layer. 

The key provisions of the resolution include: 

• Definition of Terms: The resolution provides comprehensive definitions, including those for substances that deplete the ozone layer (SDO), the Montreal Protocol, Global Warming Potential (GWP), ton of CO2 equivalent, and various categories related to HFCs. 

• Import Quotas: The resolution establishes a quota system for the import of HFCs, delineating annual maximum limits in CO2 equivalent tons. These quotas are assigned based on various criteria, including the importer's historical activities and the type of HFCs involved. 

• Control Mechanisms: Companies involved in importing HFCs are required to submit electronic forms detailing their activities by April 30 of the subsequent year. Failure to provide accurate information will result in penalties. 

• Reduction Targets: The resolution outlines a phased reduction in the national quota for HFC imports, with a freeze for the year 2024 and subsequent annual reductions from 2029 onwards. 

• Performance and Technical Reserves: The national quota will be divided into performance and technical reserves, ensuring responsible import practices. The technical reserve is set aside for new market entrants and those who have exhausted their specific quota. 

• Utilization of Quotas: Importers must adhere to strict procedures for utilizing their quotas, including registration with Ibama and the Unique Foreign Trade Portal. The resolution emphasizes the importance of accurate information and compliance with the stipulated regulations. 

• Transfer of Quotas: The resolution permits the transfer of quotas between companies under specific conditions, subject to Ibama approval. This measure aims to foster collaboration and responsibility within the industry. 

• Cessation of Import: Companies choosing not to utilize their import quotas for two consecutive years will have their quotas permanently transferred to the technical reserve. 

This landmark resolution reflects Brazil's commitment to international environmental agreements and signals a proactive approach to mitigating the impact of HFCs on the ozone layer and global warming.