Bioinputs Law: A new regulatory framework for sustainable agriculture in Brazil

On December 24, 2024, Law No. 15,070 of December 23, 2024 (“Bioinputs Law”), which regulates the production, use, and commercialization of bioinputs in the agricultural sector, was published in the Official Gazette of the Union (DOU). The new law encourages the production of biological inputs or bioinputs for agricultural, livestock, aquaculture, and forestry use, representing a milestone for sustainability in Brazilian agriculture.

The establishment of specific regulations for bioinputs provides legal certainty and reinforces Brazil’s role in promoting the adoption of science and innovation applied to biological-based product.

Bioinputs are defined by the new Law as products, processes or technologies of plant, animal or microbial origin, including those from biotechnological processes, or structurally similar and functionally identical to those 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 interfere with the growth, development and response mechanism of animals, plants, microorganisms, soil and derived substances and which interact with products and physical, chemical and biological processes.

These organisms can be employed as biofertilizers, promoting the development of robust root systems to enhance water and nutrient acquisition. Furthermore, they can stimulate plant resistance to pests, drought, and various environmental stressors, among other beneficial applications.

The registration of biofactories, importers, exporters, and traders of bioinputs inoculants, as well as of bioinputs inoculants produced or imported for commercial purposes, is mandatory in Brazil and must comply with Law 15,070/2024, being under the responsibility of the federal agency for agricultural defense, MAPA.

Before the specific regulation, biological products used in pest and disease control were regulated by Law 14.785/2023 (Pesticide Law). As for plant nutrition bioinputs, they were governed by Law 6.894/1980 (Fertilizer Law). In parallel, MAPA had been establishing differentiated protocols for the registration of biological products through Joint Normative Instructions (INC).

The innovations brought by Law 15.070/2024 include:

(i) Exemption from Registration and Agronomic Prescription for Own Use: Article 11 exempts from the registration requirement biological inputs produced for own consumption on rural properties. The use of biological inputs for own use is exempt from agronomic prescription, according to Article 29, paragraph 2.

(ii) Incentives for the Use of Bioinputs: Articles 19 to 23 establish official mechanisms to encourage the use of bioinputs agriculture, such as the development of public policies aimed at products, processes and technologies related to the promotion of bioeconomy and sociobiodiversity.

(iii) Inspection and Control Fee: The new Law creates the Agricultural Defense Establishment and Product Registration Fee (Trepda), intended to finance the inspection and control activities of bioinputs. The fee ranges from R$ 350 to R$ 3,500.00, depending on the type of registration and the size of the establishment. Cases of simplified or automatic registrations are exempt from the Trepda payment.

(iv) Definition of Technical Terms: the law presents definitions of different relevant technical terms such as, for example, the definition of a biofactory as being the establishment for the production of bioinputs for commercial purposes and that has facilities and equipment that allow for quality control and environmental and sanitary safety.(v) Procedures for Registration and Production: The law establishes procedures for the registration of establishments and products, as well as regulating production for both personal use and commercial production.

It is emphasized that the acts performed and the registrations granted before the publication of Law 15.070/2024, based on the specific legislations of the agricultural and livestock input areas, will remain validated until their respective expiration dates. Similarly, the process of new registrations will continue to follow the previous specific regulations until the regulation of the Bioinputs Law, which is expected to be created by the Executive Branch within a period of up to 360 (three hundred and sixty) days from the date of publication of the new Law, December 24, 2024.

If you would like to learn more about the new Bioinputs Law, please do not hesitate to contact our team: regulatorio@kasznarleonardos.com.