Brazil Regulatory News

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Senator Blairo Maggi in 1999 and extensively modified in the Chamber of Deputies, this legislative overhaul addresses outdated regulations.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.  

The trade bloc of South America (Mercosur) has released a preliminary regulatory proposal aimed at modernizing the roster of permissible additives for food contact materials. Should the proposal g...

The trade bloc of South America (Mercosur) has released a preliminary regulatory proposal aimed at modernizing the roster of permissible additives for food contact materials.

Should the proposal gain approval, it would result in an update to technical regulation No 02/12. The key addition would be the inclusion of tetramethyl bisphenol F diglycyl ether in the 'positive list' for food contact materials, which specifies authorized plastics and polymeric coatings.

Additionally, the proposal would impose restrictions on the use of polyamide-imide 2, confining it to being a binding agent exclusively for high-temperature resistant cookware.

For these changes to become legally binding in each of the Mercosur countries, namely Argentina, Brazil, Paraguay, and Uruguay, they would need to integrate this standard into their national legislations.

Interested parties are invited to submit their comments on the proposal by the 30th of October.

ANVISA; Brazil's National Health Surveillance Agency routinely revises its router of approved active ingredients in pesticides, sanitizing disinfectants, and wood preservatives. The updated guideline...

ANVISA; Brazil's National Health Surveillance Agency routinely revises its router of approved active ingredients in pesticides, sanitizing disinfectants, and wood preservatives. The updated guidelines, which were made public on the 26th and 27th of September, represent an amendment to ANVISA's earlier directive (No. 103, dated 19th October 2021) that outlined the sanctioned active components for these products. Modifications to the specifications encompass a range of adjustments, such as alterations in concentration thresholds and the inclusion of specific product applications.

The September update notably modified the specifications of almost thirty substances, including Ammonium glufosinate, benzovindiflupyr, buprofezin, ciproconazole, difenoconazole, emamectin benzoate, indoxacarb, isocycloseram, paenibacillus, pyraclostrobin, spiropidion, and zeta-cypermethrin.

The revised regulations came into immediate effect.