Brazil: Regulatory affairs strategic for input companies, says AENDA board member

In the agricultural sector, one of Brazil's most essential and regulated industries, regulatory affairs work has become increasingly strategic, particularly in ensuring safety and efficiency in the use of new products and technologies. 

This analysis comes from Gabriela Uliana, master in agribusiness-focused toxicology and member of AENDA's Board of Directors (National Association of Phytosanitary Product Companies).

"The interface between company departments and public agencies, especially in the preparation and revision of package inserts and labels, is fundamental to ensure that agricultural input use recommendations reach the producer correctly. This includes not only safety in use but also compliance with required standards, both here and in international markets," stated Gabriela, who is also Brazil Regulatory Affairs Manager at Agroallianz, a DVA Group company.

Recently, new legislation came into effect, Law No. 14,785, published on December 27, 2023, bringing new criteria and procedures for product registration in Brazil. According to the specialist, this update presents itself as an "essential legal framework, modernizing aspects of the 1989 legislation that no longer covered technological innovations and advances in the area. The change aims to improve the product analysis and registration process, which contributes to introducing new technologies in the field, ensuring the country remains competitive against other producing countries."

Among the innovations brought by the new law, Gabriela Uliana highlights risk assessment, as well as its communication and management, as being in line with international analysis criteria, bringing increasingly safe use of pesticides. Additionally, the GHS (Globally Harmonized System of Classification and Labeling of Chemicals) is authorized for labels and package inserts.

"However, despite the importance and advancement provided by Law No. 14,785, the registration analysis and approval process still faces significant challenges. The slowness in evaluating and approving requests continues to be an obstacle to new technologies entering the market," the AENDA board member stated.

Although the new law is "an advance," the director emphasized, it still depends on complementary regulations through a new Decree, which will bring greater clarity to points not detailed in the legislation. She expected the Decree, combined with compliance with the deadlines established by the Law, to allow Brazilian farmers to access the newest technological solutions more quickly, keeping Brazil at the forefront of agricultural innovation.

Relevant to Agriculture

According to Gabriela, regulatory affairs in the agricultural sector go beyond simple compliance with standards: "They are directly linked to company strategy, which seeks to develop safer and more efficient products, aiming to quickly meet producer needs. Regulatory compliance, therefore, is not just about following rules, but creating solutions that are simultaneously innovative, effective, and sustainable."

"Currently, new technologies optimize natural resource use, promoting greater efficiency in agricultural operations, such as with drone use and product application with lower water volumes. These technologies, which are already part of many producers' daily routines, require precise and safe regulations to ensure their effectiveness and safety. In this context, regulatory affairs professionals play an essential role, not only in registering new solutions but also in raising awareness and guidance about the proper use of these technologies," added Agroallianz's regulatory affairs manager.

According to her, this connection between regulation and innovation "is fundamental for preserving and developing technologies that can be maintained in the market for longer. The interface between research and development areas and regulatory bodies is crucial for the process of introducing new products and technologies to be as quick and effective as possible, meeting the sector's technical, environmental, and safety requirements."

The specialist pointed out that in Brazil, the agricultural sector, despite representing a significant part of GDP and being one of the pillars of the national economy, is also one of the sectors most challenged by regulations, which often need to be adapted to keep pace with constant technological innovations. 

"In this scenario, companies like Agroallianz stand out by integrating research, development, and regulation, creating innovative solutions for the producer. In its seven years of operation, the company has proven to be a strategic partner, working with laboratories and research institutes to offer farmers solutions that meet their needs," she said.

Gabriela explained that a clear example of this innovation occurred in 2022, when three company formulations were prioritized by the Ministry of Agriculture, placing Agroallianz as the second company with the highest number of prioritized products: "This prioritization is a reflection of a transparent and objective process, which aims to expedite the approval of products that address the most urgent phytosanitary problems faced by Brazilian farmers."

"This collaboration between research, industry, and regulatory authorities demonstrates that, despite the challenges, the search for quick and efficient solutions for Brazilian agriculture is more alive than ever. And, with the regulation of the new Law No. 14,785 and advancement in technologies, Brazil is expected to continue consolidating its position of leadership in the global agricultural market," she said in conclusion.

(Editing by Leonardo Gottems, reporter for AgroPages)