【EXCLUSIVE】Brazilian parliament amends agrochemical registration rules, see what changes been made

Date:02-14-2022

The Brazilian Chamber of Deputies, last Wednesday (February 9), approved the PL 6299/02 bill that modernizes and optimizes the rules for registering agrochemicals in the country. 

Improving timeline

Among the main changes is establishing a maximum period of two years for the release of new molecules, ending the average delay of seven years currently observed.

MAPA acts as coordinator

Another important change is the centralization in the Ministry of Agriculture, Livestock, and Supply (MAPA) of the inspection and analysis of agrochemicals in Brazil. MAPA will be responsible, for example, for granting a “temporary registration” if the product authorization period is not met. Therefore, the release of research and tests must be granted within 30 days.

The National Health Surveillance Agency (Anvisa), the Brazilian Institute for the Environment and Renewable Natural Resources (Ibama) of the Ministry of the Environment will continue to take on its previous responsibility for analyzing the products from the toxicological and environmental point of view, but under the coordination of MAPA. The appointment of a coordinator for the process means that the priorities of rural producers can be met, as well as the analysis must be carried out by Anvisa or Ibama when removing a product from the market, and MAPA must also assess the economic impacts of the removal of a product for Brazilian agriculture, an important sector for the Brazilian economy.   MAPA as coordinator will collect the fee for the registration of the products and this fee will be destined for improvements in the areas of registration of the 3 ministries. Currently the fees are charged by the 3 ministries without this reverting to improvement in the sectors involved.  The bill will bring more transparency, all of which will be computerized, enabling the traceability of the analysis. 

PL 6299/02 changes the designation of the agrochemicals to “pesticides”. When used in forests and water environments, agrochemicals are now called “environmental control products” by the project. Their registration will be the responsibility of the Brazilian Institute for the Environment and Renewable Natural Resources (Ibama), of the Ministry of the Environment.

The two ministries (Agriculture and Environment) and the Ministry of Health, through the National Health Surveillance Agency (Anvisa), continue to issue opinions on the procedures for registration or change of pesticides. Still, only the registering body MAPA can apply penalties and audit companies and research institutes.

Temporary authorization and registration

The text of the new law also establishes that, if the application does not have a conclusive opinion issued within two years, a “temporary authorization” (TA) will be given for the application of an existing product in another crop for which it was not initially indicated. In addition, the Brazilian government is obliged to issue the temporary registration (TR) for a new pesticide if the government has not yet analyzed the registration application process after 2 years of application, as long as the product was registered in at least three Organization for Economic Cooperation and Development (OECD) member countries. With this, the availability of these products to rural producers is predictable. OECD is an entity that brings together 38 nations with different levels of requirements on the subject.

The project approved by the Brazilian parliament adopts the concept of “unacceptable risk”, classified as the one that is present in the product even with the implementation of risk management measures. Therefore, it will be up to the registrant body to assess the acceptable level of risk of the product that is intended to be registered in the country, without specific limitations such as the current ones.

About fines

On the other hand, the text increases the number of fines for disregarding the law. For example, from the maximum of BRL20,000, fines go up from BRL2,000 to BRL2 million. The fines may be cumulative and doubled in the event of recidivism. In the case of continued infraction, the fine will be daily until the cause of the infraction ceases, without prejudice to the immediate stoppage of the activity or interdiction.

Changes to biopesticide registration

Biological pesticides produced for their use only on private crops in organic or conventional production systems will be exempted from registration. 

Biological products must be registered, the law authorizes the production of biological products for their own use called “on-farm” - the farmer can produce these products on his own farm. For this, he must have technical assistance and the same inform the inspection agent of the state what and how it is producing. The “on-farm” production unit must be registered with MAPA, indicating the technical person in charge, and the product cannot be marketed. The commercial product used for multiplication must be registered, and biological control agents that are exotic or do not occur in the country are prohibited. However, the so-called “family farmers” will not need to comply with these rules.

Next step

The Brazilian Senate must analyze the changes made to the original 2002 bill and put it to a vote. The agricultural parliamentary front - FPA estimates that it will take approximately 60 days, and if approved by the SENATE, the process will be sanctioned by the president of the republic.

(Editing by Leonardo Gottems, reporter for AgroPages)