New Legislation on Brazilian Agricultural Bioinputs

The new Bioinputs Law regulates the production, commercialization, and use of bioinputs in the agricultural, aquaculture, and forestry sectors. It updates existing laws on pesticides and fertilizers and introduces regulatory guidelines to ensure a smooth transition and implementation of the bioinputs framework.

Scope of the law: provides for production, import, export, registration, commercialization, use, inspection, supervision, research, experimentation, packaging, labeling, advertising, transportation, storage , fees, provision of services, disposal of waste and packaging and incentives for the production of bio-inputs for agricultural, livestock, aquaculture and forestry use, including production for the purpose of own use.

Definition of Bioinputs: product, process or technology of plant, animal or microbial origin, including that originating from a biotechnological process, or structurally similar and functionally identical to that of natural origin, intended for use in the production, protection, storage and processing of agricultural products or in aquatic production systems or planted forests, which interferes with the growth, development and response mechanism of animals, plants, microorganisms, soil and derived substances and that interacts with physical-chemical and biological products and processes.

IMMEDIATE CHANGES WITH THE PUBLICATION OF THE LAW

1. Law No. 10,603, of December 17, 2002 (Data Protection Law) will be amended with the inclusion of bio-inputs in its scope.  
2. Law No. 14,785, of December 27, 2023 (Pesticide Law) and Law No. 6,894, of December 16, 1980 (Fertilizer Law) will be updated with the exclusion of bioinputs that will be treated by the new Bioinput Law . In short, pesticides of biological origin, biofertilizers and inoculants.
3. On-farm producers acquire the right to produce their own bio-inputs and are prohibited from multiplying commercial products.
4. Semiochemical products with exclusively mechanical action, such as plates and traps, and food attractants for use in monitoring insects in which the active ingredients come exclusively from biological fermentation or food and their residues are now exempt from registration.

There will be no immediate changes, with the exception of the semiochemicals mentioned in the item above.

ASPECTS THAT WILL NEED REGULATION

1. Definitions: categories of bioinputs, new product, low toxicity and low ecotoxicity product, among others.
2. Legislation for transitional provisions.
3. Registration of products with multiple functions.
4. Registration requirements for each category of bioinput – no major changes are expected in the requirements for product registration, considering the current scenario.
5. RRR: Reprocessing, rework and revalidation

There are other aspects, mainly related to On farm, tax incentives, fees, clones, among others, which will be discussed in due course.

PRODUCT REGISTRATION

1. Registration of bioinputs or bioinput inoculums produced or imported for commercial purposes is mandatory.
2. MAPA will continue being the registering agency
3. ANVISA and IBAMA will only be involved in the registration processes of new products intended for phytosanitary control. Products that are not for pest and/or disease control, such as inoculants and biofertilizers, will continue to be evaluated only by MAPA.

There’s no definition of a new product yet.  It is expected to be included in the regulatory decree.

4. Possibility of registering a product with multiple functions, which must meet the requirements of the most restrictive category

TRANSITIONAL PROVISIONS

1. Deadline for regulating the Law: up to 360 days
2. Until this law is regulated, the process for new registrations will follow that set out in specific legislation
3. Registered products remain fully valid and will not be cancelled. It will only be necessary, at the appropriate time, to carry out a migration to adapt to the new guidelines.  
4. The rule of MAPA will provide for the forwarding and treatment of processes filed and not yet approved by the date of entry into force of this Law, without prejudice or interruption in its processing. In other words, the idea is that it will not have any impact on products already registered, as well as processes in the queue awaiting analysis.
5. After specific regulation, the sector will have 12 months to adapt to the new regulations.

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