Brazil Regulatory News

Brazil's regulatory landscape has embraced recent technological advancements in the registration of microbiological products. The SDA/Mapa - Ibama - Anvisa Joint Ordinance No. 1/2023, a recent pub...

Brazil's regulatory landscape has embraced recent technological advancements in the registration of microbiological products. The SDA/Mapa - Ibama - Anvisa Joint Ordinance No. 1/2023, a recent publication, has supplanted Joint Normative Instruction No. 3/2006, outlining the procedures governing the registration of microbiological products utilized in pest control, defoliation, desiccation, growth stimulation, and inhibition.

Microbiological inputs, derived from fungi, bacteria, and viruses, represent natural adversaries against various agricultural pests and diseases. Many of these products are born of biotechnology, a field in constant technological flux and expansion.

The new Joint Ordinance is designed to harmonize legislation with recent innovations. It introduces notable changes such as permitting the registration of inactivated microorganisms (previously limited to live ones) and regulating the registration of biostimulants, metabolites, and genetically modified organisms. This regulatory overhaul also seeks to streamline bureaucratic processes while elucidating various aspects of product registration.

These updated regulations align with developments in the biological agricultural inputs sector, offering greater transparency for both industries and regulatory bodies. Many of the emerging technologies were not covered by previous legislation.

It's crucial to emphasize that registrations will continue to undergo scrutiny from Anvisa (National Health Surveillance Agency), Ibama (Brazilian Environment Institute), and Mapa (Ministry of Agriculture and Livestock). However, the new regulations aim to expedite the process. Previously, registration of a biological product could take up to three years, but with these changes, the average duration is expected to be reduced to one year.

By reducing bureaucratic hurdles, the goal is to accelerate the registration of microbiological products, enabling them to enter the market more swiftly. It's important to note that product safety and efficacy will continue to undergo rigorous evaluation, ensuring the protection of public health and the environment. The ordinance provides legal certainty for companies and establishes clear quality control parameters, which were previously lacking, marking a significant milestone for the sector.

These regulations enhance the confidence of producers and consumers in the efficacy and safety of agricultural products used in Brazil, fostering greater sustainability and balance in the industry.

Brazil has been actively promoting the registration of microbiological products for pest control, evidenced by the increasing number of registrations in recent years. In 2023 alone, 33 low-impact products received registration.

Expectations are high that this new regulatory framework will further stimulate innovation and the development of novel agricultural microbiological inputs, contributing to a more responsible and regenerative agricultural landscape in Brazil.

Brazil's National Health Surveillance Agency (ANVISA) has recently made revisions to its roster of approved active ingredients found in pesticides, sanitizing disinfectants, and wood preservatives...

Brazil's National Health Surveillance Agency (ANVISA) has recently made revisions to its roster of approved active ingredients found in pesticides, sanitizing disinfectants, and wood preservatives.

These latest changes, officially unveiled on September 4th, build upon ANVISA's prior regulatory guidance outlined in Normative Instruction N° 103 of October 19, 2021, which laid out the authorized active components in these product categories.

ANVISA maintains a dynamic list, routinely subject to updates, with the most recent alterations encompassing the inclusion of the subsequent substances:

Flucarbazonesodium, Fluindapyr, Ipflufenoquin, Isocycloseram, Penflufen, Tetradecadiena, Tolpyralate.

These revisions came into immediate effect upon their publication.

Published on September 1st, Resolution RDC No 813/2023 supersedes the previous May 2022 resolution, RDC No 698/2022. While a significant portion of the 2022 requirements remains intact, this new regul...

Published on September 1st, Resolution RDC No 813/2023 supersedes the previous May 2022 resolution, RDC No 698/2022. While a significant portion of the 2022 requirements remains intact, this new regulation brings updates to the documentation necessary for manufacturers, importers, and distributors when registering bleach sanitizing products.

Moreover, the revised resolution segments labeling standards into two distinct sections, underscoring the mandatory safety language requirements.

These changes are set to take effect on September 13th, marking a crucial update in the regulation of bleach sanitizing products in Brazil.

Brazil is set to make significant strides in its chemical regulatory landscape with the reinstatement of the National Commission on Chemical Safety (CONASQ). This move, initiated by President Lula'...

Brazil is set to make significant strides in its chemical regulatory landscape with the reinstatement of the National Commission on Chemical Safety (CONASQ). This move, initiated by President Lula's administration, demonstrates a commitment to modernize chemical management in the country. The revival of CONASQ, which was disbanded in 2019, signifies a pivotal moment for Brazil, positioning it as a leader in Latin America's chemical regulatory efforts.  

CONASQ, prior to its dissolution in 2019, was a model of collaborative governance. Comprising representatives from government agencies, academia, non-governmental organizations (NGOs), and industry associations, the commission facilitated an interdisciplinary and multi-stakeholder approach to chemical safety. Under the leadership of the Ministry of Environment, CONASQ aimed to develop a robust framework for industrial chemical policy, with the goal of presenting a bill to Congress. 

The commission worked diligently over several years, drawing inspiration from regulatory models in the European Union. By 2018, they had prepared a comprehensive draft that, if enacted, would have established Brazil as the first major economy in Latin America to adopt such progressive chemical regulation. 

However, the dissolution of CONASQ put these efforts on hold. In response, a Congressman introduced a less comprehensive bill in the Chamber of Deputies in 2019. This bill, known as PL 6120/2019, provided a foundation for those advocating for a new chemical management system. Interestingly, this version would later be entirely replaced by another bill heavily influenced by the original CONASQ draft from 2018.  

The Significance of PL 6120/2019 

PL 6120/2019 represents Brazil's version of a national chemical regulation. It outlines key components such as the establishment of a hazardous chemical registry, rules for chemical prioritization, risk assessment, and risk management. This legislation is pivotal for enhancing chemical safety, protecting public health, and promoting environmental sustainability in Brazil. 

The Implications of CONASQ's Revival 

The reinstatement of CONASQ signals a positive shift in Brazil's approach to chemical management. It sets the stage for a modernized regulatory infrastructure that aligns with international standards and best practices. This move is also likely to be well-received by officials from the Organization for Economic Cooperation and Development (OECD), who have been actively considering Brazil for accession. 

CONASQ's thought leadership and expertise will not only benefit Brazil but also play a crucial role in regional efforts for regulatory collaboration. Neighboring countries will have access to a valuable resource as they work towards enhancing chemical safety and harmonizing regulations across Latin America. 

The revival of the National Commission on Chemical Safety (CONASQ) in Brazil is a significant step towards establishing a modern chemical management system in the country. With the reintroduction of this respected council, Brazil is poised to lead the way in Latin America's chemical regulatory landscape. PL 6120/2019, inspired by CONASQ's work, promises to bring about essential reforms in chemical safety and management. 

As Brazil looks ahead to a future with strengthened chemical regulations, it positions itself as a responsible and forward-thinking player in global chemical management efforts. This development is not only a win for Brazil but also a promising sign for regional collaboration and harmonization of chemical regulations across Latin America. 

Brazil's health regulatory agency, ANVISA recently announced a proposal to amend Resolution RDC 778/2023, which governs food additives and adjuvants in food technology. This proposed resolution s...

Brazil's health regulatory agency, ANVISA recently announced a proposal to amend Resolution RDC 778/2023, which governs food additives and adjuvants in food technology. This proposed resolution seeks to establish a maximum tolerable residual limit for ethylene oxide in food additives, aiming to enhance consumer protection.

Ethylene Oxide Regulation

The proposed amendment to RDC 778/2023 introduces a crucial regulation concerning ethylene oxide levels in food additives. Specifically, it sets a maximum tolerable residual limit of 0.01 mg/kg for ethylene oxide in food additives. Ethylene oxide is a chemical used in various industrial processes, and its presence in food additives must be carefully controlled to ensure consumer safety.

Exceptions for Certain Food Additives

While the proposed regulation imposes strict limits on ethylene oxide, it includes exceptions for specific food additives. These exceptions apply to food additives that comply with the identity, purity, and composition specifications established by JECFA (Joint FAO/WHO Expert Committee on Food Additives) or FCC (Food Chemicals Codex). The listed food additives exempt from the maximum tolerable residual limit are as follows:

1. Polyoxyethylene (20) sorbitan monolaurate, polysorbate 20, INS 432
2. Polyoxyethylene (20) sorbitan monooleate, polysorbate 80, INS 433
3. Polyoxyethylene (20) sorbitan monopalmitate, polysorbate 40, INS 434
4. Polyoxyethylene (20) sorbitan monostearate, polysorbate 60, INS 435
5. Polyoxyethylene triestearate (20) sorbitan, polysorbate 65, INS 436
6. Grafted copolymer of polyvinyl alcohol (PVA) and polyethylene glycol (PEG), INS 1209
7. Polyethylene glycol, INS 1209

These additives, when meeting the specified criteria, will not be subject to the ethylene oxide limit, ensuring that they continue to be safe for consumption.

Public Consultation

ANVISA has initiated a public consultation period to gather feedback and comments from stakeholders and the general public. Interested parties are encouraged to submit their comments and suggestions regarding this proposed regulation within 45 days of the issuance of the public notice, which was posted on August 23, 2023. 

Ensuring Food Safety

The proposed regulation of ethylene oxide in food additives underscores ANVISA's dedication to ensuring the safety and quality of food products in Brazil. By setting a clear limit and providing exceptions for additives meeting stringent criteria, ANVISA aims to protect consumers from potential health risks associated with ethylene oxide exposure.

This important regulatory change reflects ANVISA's ongoing efforts to adapt and enhance food safety standards, aligning with international best practices while considering the unique needs of the Brazilian population. To submit your comments and engage in the public consultation process, visit ANVISA's official website.

Brazil has taken substantial strides towards regulating per- and polyfluoroalkyl substances (PFAS). The introduction of Brazil's National PFAS Control Policy Bill No. 2726/2023 in the Chamber of D...

Brazil has taken substantial strides towards regulating per- and polyfluoroalkyl substances (PFAS). The introduction of Brazil's National PFAS Control Policy Bill No. 2726/2023 in the Chamber of Deputies marks a significant leap forward in establishing a comprehensive national framework for PFAS control.

The proposed policy casts a broad net, with a primary focus on environmental preservation and sustainable practices. It places a solemn responsibility on federal, state, and municipal public authorities to rigorously enforce and execute the policy. Moreover, it imposes a mandate on companies and industries that employ PFAS, compelling them to furnish annual reports on PFAS consumption and disposal.

This legislative endeavor outlines a series of measures designed to gradually diminish the prevalence of PFAS in products and manufacturing processes. Additionally, it wields its influence to launch public awareness campaigns, aimed at educating citizens about the inherent health and environmental hazards posed by PFAS. The bill also underscores the significance of research into technologies for remediating PFAS contamination.

In terms of procedural advancement, the bill has made its way through the initial of four approval Commissions as of July 4th, 2023. Should it secure approval from all four Commissions, it will proceed directly to the Senate for voting. In cases where it gains approval from some commissions while facing rejection from others, it will be brought before the Plenary of the Chamber of Deputies for further scrutiny before making its way to the Senate.

The acting President Geraldo Alckmin has signed a decree on the 24th of this month, reestablishing a beneficial tax regime. This development marks a pivotal step towards revitalizing a sector that ser...

The acting President Geraldo Alckmin has signed a decree on the 24th of this month, reestablishing a beneficial tax regime. This development marks a pivotal step towards revitalizing a sector that serves as a central point for the nation's industrial production.

The decree pertains to the revival of the Special Regime for the Chemical Industry (Reiq), which extends tax exemptions to the sector. By bringing back this specialized regime, the Brazilian government aims to enhance the competitive landscape for chemical businesses, which play a pivotal role in generating both direct and indirect employment opportunities. Notably, the chemical industry accounts for a substantial 11% of the country's industrial GDP, a figure underscored by data from the Brazilian Chemical Industry Association (Abiquim).

Scheduled for publication in the Federal Official Gazette on the 25th, this decree is set to redefine the trajectory of the chemical industry. "This sector plays a strategic role in the neo-industrialization initiative and the overall fortification of the industry. Reiq stands as a crucial driver for market competitiveness, job creation, and income generation," remarked President Alckmin.

However, the impact of this decree transcends mere tax exemptions. In addition to restoring previous tax conditions, the new legislation introduces supplementary credits for companies willing to invest in expanding their production capacities or embarking on the establishment of new plants, particularly those harnessing natural gas for fertilizer production.

Established in 2013, Reiq holds the key to enhancing the chemical industry's resilience. It entails the exemption of PIS/Cofins taxes on core products pivotal to the first- and second-generation petrochemical domain. The resulting downstream products encompass an array of essential goods, including fertilizers, active medicinal ingredients, plastics, fibers, rubbers, paints, and inputs for the food and beverage sector. By mitigating cost disparities between local chemical enterprises and their global counterparts, this scheme bolsters the industry's competitive prowess on a global scale.

A comprehensive study conducted by the esteemed Getúlio Vargas Foundation (FGV) in 2021 underscores the profound impact of Reiq. The benefits of this regime cascade beyond the confines of the chemical industry, permeating the entire Brazilian economy. The study revealed an upswing in revenue, heightened productivity, and the preservation of employment opportunities. Intriguingly, projections from the study hinted at the possibility of an annual productivity plunge ranging from R$2.7 billion to R$5.7 billion within the sector if the benefits were to be rescinded.

Furthermore, the study sheds light on Reiq's potential to inject up to R$5.5 billion into the GDP, coupled with a yearly influx of no less than R$2 billion in tax revenue. These numbers underscore the substantial economic gains this specialized tax regime can usher in.

The newly signed decree, however, comes with certain commitments. Chemical plants and industries are expected to forge formal agreements with the Special Secretariat of the Federal Revenue of Brazil, encompassing various stipulations. These commitments encompass compliance with occupational health and safety regulations, adherence to environmentally restorative actions, maintenance of fiscal regularity, procurement of verified emissions reductions certificates, and sustaining workforce levels equivalent to, or exceeding, those present on January 1, 2022.

As this rejuvenated tax regime takes center stage, a vigilant eye will be cast on its implementation. The meticulous oversight of the scheme will be undertaken by various entities, including the Secretariat for Industrial Development, Innovation, Trade, and Services (SDIC), operating in synergy with the Federal Revenue Service, the Ministry of Labor and Employment, and the Ministry of the Environment and Climate Change.