Registering biopesticides in Brazil: Staphyt's advice

Staphyt Brazil works supporting its clients to find the best and most efficient route through the regulatory landscape to achieve your objectives for registrations of pesticides, biopesticides, inoculants and fertilizers in Brazil.

Thanks to the combination of expertise, Staphyt supports its clients through each stage of their products life by providing them with innovative solutions to secure their developments.

Brazilian legislation has been developing the regulation of biopesticides in large steps to specify requirements, reduce the period for approval of registration (less than 1 year), which promotes a regulatory framework favorable to the development of an ecologically correct market, as well as the predictions which indicate that the market will continue to grow strongly in Brazil.

In order to be better prepared for this growing demand, Staphyt recently announced the arrival of its new Head of Regulatory Affairs for Brazil, Daniela Maia. Daniela holds a Bachelor in Biology and has acquired 14 years of experience in Regulatory Affairs, first working for consultancy companies and more recently with a major biological company in Brazil, developing her expertise in both biological and chemical products, but mainly focused on biopesticides.

In the current legislation in Brazil, biopesticides are under pesticides law, following specific legislations for each product category:

• MICROBIOLOGICALS (joint ordinance ″01/2023″): Fungi, bacteria, virus (living and inactivated organisms), including GMO. This ordinance is the first Brazilian legislation that brought the ″biostimulants″ terminology, but includes only products based on microorganisms and related to biotic factors. 

  For other products considered as biostimulants in other countries, such as those based on aminoacids, plant extracts, seaweed extracts, humic and fulvic acids and other substances, they can be classified as a biofertilizers or biochemicals depending on the product claim, due that it should be evaluated case-by-case.

• MACROBIOLOGICALS (joint normative instruction ″INC 02/2006″): Natural enemy, predator; 

• BIOCHEMICALS (joint normative instruction ″INC 32/2006″): Substances from natural sources with a non-toxic mode of action to the targets, including Plant Growth Regulator (PGR) – natural or synthetic, Proteins, Aminoacids, Enzymes; 

• SEMIOCHEMICALS (joint normative instruction ″INC 02/2006″): Pheromones, sexual attractive; 

• PHYTOCHEMICALS: plant extracts. Specific legislation is under discussion.

The registration process in Brazil involves three authorities: Ministry of Agriculture (MAPA), Ministry of Health (ANVISA) and Ministry of Environment (IBAMA), with MAPA being responsible for issuing the Register Certificate.

About biopesticides categories, with the exception of biochemicals, the need to register the technical product must be examined on a case-by-case basis; registration of the technical product is not required, but certain information on the active ingredient is required.

To register a biopesticides, it is necessary to present the laboratory studies package (physico-chemical, ecotoxicology and toxicology). The studies conducted in other countries are accepted for registration purposes, as long as they are carried out under Good Laboratory Practices (GLP).

Efficacy trials must necessarily be performed in Brazil. It is necessary to present 3 field trials per target and/or crop (depending on the product category) in 3 different regions (only one season is enough). For microbiological, macrobiological and semiochemicals categories, the registration is per target, so the product may be indicated for all crops with the occurrence of the biological target to be registered. If there is a product already registered in Brazil by any company, based on the same active ingredient, for the same intended target or use, then only 1 efficacy trial is required. Staphyt also has a strong and reliable network of field trial stations (officially recognized by the Ministry of Agriculture), located in the main agricultural regions of Brazil.

In general, residue studies are not required for biopesticides products. However, products in the biochemical category must be assessed on a case-by-case basis. 

For the process of importing samples and performing trials in Brazil, it is necessary to obtain a previous approval from the local authorities, called EUP (Experimental use permit). If the active ingredient is already registered in Brazil, obtaining the EUP takes around 1 month and, if the active ingredient has not yet been registered, around 4 months. If the manufacturing/formulation of the product is national and the active ingredient is already registered, then the EUP is not necessary.

After conducting the studies, preparing and submitting the dossier to the competent authorities, the estimated period for obtaining registration is currently 12 months. For the submission, which must be done by a local company, a fee of around $4,000 is required by the Brazilian governments for product registration in Brazil - ANVISA (toxicological evaluation) and IBAMA (checklist and evaluation).

Once the federal registration is obtained, before starting to market the product, it will be necessary to register in all Brazilian states where the product will be sold. Each state has its own legislation, procedures and fees, however, it will not be necessary to generate additional data at this stage, using the same federal register documentation.

The Staphyt Brazil team is fully able to help your company carry out your projects and bring your products to the Brazilian market, supporting you from A to Z.

contato@staphyt.com

Staphyt Brazil - Regulatory Affairs Team

Sant’Ana, D. Carolina

Maia, Daniela

This article was originally published in AgroPages magazine 2024 Biologicals Special.