On December 23, 2024, President Luiz Inácio Lula da Silva enacted without vetoes Law #15,070/2024 ("Bioinputs Law"), which regulates the production, use, and commercialization of bioinputs for agricultural, livestock, aquaculture, and forestry use in Brazil. The Bioinputs Law is established as a matter of national interest and must be followed by all federal entities according to its Article 1, Paragraph 1. Therefore, it becomes the primary source of regulation for a very useful tool in national agriculture – bioinputs – especially considering that Brazil has a vast biodiversity.

As provided in its Article 2, item II, bioinputs, commonly referred to as biological products, are products, processes, or technologies intended for use in the production, protection, storage, and processing of agricultural products or in aquaculture or planted forest production systems. Additionally, according to the legal definition, products will be considered bioinputs if they originate from plant, animal, microbial sources, or even if they result from biotechnological processes or are structurally similar/functionally identical to those of natural origin.

Bioinputs Law allows the production of those kind of products in two specific types of facilities, as derived from Article 2, items I and XVI: (i) biofactories, to produce bioinputs and bioinput inoculants for commercial purposes; and (ii) bioinput production units for personal use, where the production for commercial purposes is prohibited.

The regulation of bioinput production in units for personal use is relevant for addressing an issue that has long been discussed by the industry and lacked proper regulation, which is the so-called on-farm production of bioinputs. This type of production can be carried out by farmers individually or in the form of producer associations, cooperatives, integrated production, rural consortiums, agrarian condominiums, or similar structures (Article 10, Paragraph 3).

Thus, the Bioinputs Law expressly establishes in Article 10 that products resulting from the on-farm process can only be used for personal purposes – that is, bioinputs produced in production units for personal use cannot be commercialized (final part of Paragraph 3 of Article 10). However, the Law maintains a legal gap regarding the possibility of commercializing agricultural products obtained or processed from the use of bioinputs produced on-farm. This issue, which the Law does not address in depth, is sensitive for the industry and for society itself, given the risk of human consumption of products resulting from such process, without due regulation by the competent authorities.

The fact is that the lack of specific legislation addressing on-farm production had been causing several problems and risks, identified not only by the industry but also by authorities and researchers.¹  With the regulation in place, although not all the problems have been solved, this type of production is now subject to quality controls and government inspection, something that is essential for any type of activity that may result in a risk to human health and the environment, as is the case with the manufacture of products that will be used in food production. The Law, however, assigned the inspection of on-farm production to the agricultural agencies from the states and the Federal District, leaving the inspection of commercial production to the federal agricultural defense agency.

On the other hand, the Bioinputs Law also encourages commercial production by establishing the possibility of registering specific commercial products that can be used for on-farm production. These are bioinput inoculants, which are products composed of microorganisms, produced in a culture medium to initiate growth, for bioinput production purposes (Article 2, item VII). Article 5 of the Law states that the registration of bioinput inoculants also allows their commercialization as inputs for use in on-farm bioinput production units, i.e., to enable on-farm production using registered inputs. This also provides greater security to farmers and collectives involved in on-farm production, as registered products undergo more rigorous quality and technical control.

Furthermore, the approved Law strongly encourages innovation in the bioinput sector. It includes a significant amendment to Article 1 of Law #10,603/2002, expressly adding regulatory data submitted to authorities as a condition for the approval or maintenance of registration for bioinputs commercialization. It is worth noting that this amendment merely signed into law something that was previously inferred through interpretation of the provision, as prior to the Bioinputs Law, bioinputs could be classified under the concept of "pesticides, their components, and related products."

Some tax aspects, such as the establishment of a fee for the registration of facilities and products (TREPDA), reflecting the evident revenue-generating power of regulatory and inspection activities, are also addressed in the Bioinputs Law, among others.

Bioinputs Law came into effect on the date of its publication, which was on December 24, 2024. However, it is important to highlight that the Law, in its final and transitional provisions, introduced some important transitional rules, such as the exceptional authorization for the use of currently used bioinputs until specific regulations are enacted (Article 30), the validity of registrations and actions taken prior to its enactment (Article 31), the 12-month deadline for adjusting labels and packaging, which will be counted from the publication of a specific regulation by the Executive Branch (Article 32, caput), and the maintenance of the validity of authorizing acts for bioinput-producing facilities until their expiration date, exempting from costs the necessary updates to these authorization acts (Article 35).

The Law also states that, as a rule, remaining stocks of the products covered by this Law may be marketed until they are depleted, and a normative act from the federal agricultural defense agency may determine what will happen with processes filed but not yet approved as of the date this Law comes into force, without hindering or halting their processing (as per Paragraphs 1 and 2 of Article 32). Finally, it guarantees the continuity of bioinputs production for personal use, as well as the supply of inputs necessary for personal use production, until regulations and best practice guidelines are published (Article 36).

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