Agile regulation of the biological input chain provides more sustainable agriculture

Brazil is one of the countries with high agility in the product approval process

03.06.2022 | 14:43 (UTC -3)
Cinthia Naomi Delfini, regulatory affairs specialist at Novozymes BioAg
Cinthia Naomi Delfini, regulatory affairs specialist at Novozymes BioAg

Raising awareness about the use of products that are less harmful to ecosystems has helped streamline regulatory processes for biological inputs in Brazil. The approval time for an inoculant by the regulatory bodies, for example, varies between 4 and 5 months and, for a biological defensive, between 7 months and 1 year, after carrying out all tests, including field tests. 15 years ago, the regulation of these same products took around 5 years, which indicates that we are on the way to an agriculture that is increasingly in tune with the environment.

This agility is explained by the safety that these products provide by using raw materials that are found in the ecosystem itself or that have low toxicological and environmental concern, which keeps the microbial fauna in constant harmony. The maintenance of the natural balance, added to the good results provided by the biological inputs, help to guarantee greater agility in the approval process. And the results with the use of biological inputs are expressive. In the case of inoculants, for example, the productivity index in a crop can increase by up to 6% with biological nitrogen fixation.

Currently, the regulation time for a biological input in Brazil is similar to that practiced in the United States and Canada, countries that have sought in conservation agriculture a great ally in relation to climate change. With this agility, the tendency is for the use of inoculants and biodefensives to grow more and more in all producing regions of Brazil. It is worth remembering that each product category has a regulatory process.

According to data from the Ministry of Agriculture, from 1991 to 2021, 433 biological products were registered in the country. In 2020 alone, there were 96. Of this total, 61% are directly linked to microorganisms. 

Registration of a biodefensive product requires approval from the National Health Surveillance Agency (Anvisa), the Ministry of Agriculture, Livestock and Food Supply (Mapa) and the Brazilian Institute for the Environment and Natural Resources (Ibama). However, the MAPA is the body responsible for granting the registration.

Biological inoculants, especially those that already use approved raw material in other products, such as bacteria of the genus Azospirillum, used for nitrogen fixation in soy and corn plants, only need to be evaluated by the MAPA.

In order to follow the sanitary methodologies of consumer markets around the world, the companies that develop this type of product follow international methodologies. All data packages are applied, taking into account, of course, differences in ecosystems with specific studies, in addition to good manufacturing practices. 

There are many opportunities for the development of new biological products in a country as rich in biodiversity as Brazil. But, above all, it is necessary to focus on safety, which is why it is important for the farmer to understand that acquiring a product registered and approved by the competent bodies is of fundamental importance not only for biodiversity, but also for public health.

With the advancement of research on biological products, it is possible to strengthen food safety. Biological manufacturing companies in the world are growing due to the increase in demand. In past decades, there was no agility in regulation. Today, the market is consolidated and Brazilian agriculture is gaining awareness of the importance and need for management that uses biodiversity to its advantage.

With a rich ecosystem due to the fact that it is a tropical country, Novozymes is already working on the development of new products for Brazil and hopes to start the regulatory process soon. And for the growth and strengthening of the production of biological inputs in the country, the support of partnerships with research and development companies, such as Embrapa and universities, is essential for the development of biological inputs.

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