Spotlight on the Crop Protection Regulatory Landscape in Brazil

 

When considering pesticides regulation in Brazil, three government entities are involved for establishing registration standards.

 

• The Brazilian Institute for the Environment and Renewable Natural Resources (IBAMA) evaluates physical-chemical, environmental fate, toxicological and ecotoxicological data.

 

• The National Health Surveillance Agency (ANVISA) is the responsible for toxicological and genotox evaluation and also defines the maximum residue limits to be fixed in foods based on data submitted by the registrants.

 

• The Ministry of Agriculture, Livestock and Supply (MAPA) evaluates products agronomical efficacy granting the Registration Certificate after receiving Health and Environment manifestations. 

 

Due to increasing crop production each year, the Brazilian pesticide market cannot produce enough to satisfy its own demands. Some interesting forecasts have shown that for soybeans (which accounts for 47% of pesticides consumed), the production to 2017/18 will result in 117,4 million tons, consolidating this sector in Brazil, together with the biggest in the world. (Globo Rural Magazine April.2018). Brazil’s grain production is expected to total 229,7 million tonnes, according to the National Food Supply Company – CONAB.  These numbers represent the development of productivity and the progress of the harvest in 2017/18 for soybean, corn (the second-largest crop produced in Brazil), followed by cotton and beans. Still according to Globo Rural Magazine, products used in coffee, sugar cane, soybeans, maize and cotton are the main drivers for the sector´s growth representing 82% of the agrochemical sales, with rises also highlighted in the wheat, potato, fruit and vegetable sectors.  US and China are the main pesticides providers to the Brazilian market where herbicides and insecticides represent the greatest part of the sales. 

 

 

Among the reasons for the growing interest for Biocontrol Products in crops are the exhaustion in search for novel chemical molecules, enhanced by their high costs of financing, in addition to pest and disease increasing resistance to the effects caused by the use of such molecules.

 

Biocontrol Products global Market was estimated at US$3,09 billion in 2017 and should reach US$6,01 billion in 2022, growing interannually about 14.21%. The benefits regarding agriculture and environment associated with the use of such products are the 

factors that contribute to the growth of this global market. (Agrolink -Leonardo Gottems  May 2018)

 

Latin America, is a perfect, growing and active region that offers new opportunities to expand the market of Biocontrol Products as a good option to control pests and diseases. Regarding Brazil, an interesting forecast is the annual growth at about 15 per cent, since according to the Ministry of Agriculture, Livestock and Supply - MAPA, the proportion of approvals for biocontrol products improved from 7% to 60% from 2010 to 2016 in relation to chemical conventional pesticides.   

 

 

Despite Brazilian production numbers and growth of the national agricultural economy, the bureaucracy of registration processes, became more complex and laborious, making access to the pesticides market restricted and costly. A scenario that might worsen the situation with the lack of knowledge about the local regulatory landscape and local procedures to be followed.  

 

CESIS is a Consulting Company based in Brasilia/Brazil that has been working offering regulatory support for 13 years, helping clients to understand how to present each companies knowledge in a registration dossier in the ever-changing regulatory landscape. Our regulatory team come from diverse backgrounds with most of our consultants holding senior positions in government and industry before joining CESIS.

 

Together with a Network of Latin American partners, CESIS offers regulatory support for chemical and biological pesticides, as well as fertilizers, biostimulants and plant amendments.  CESIS also works with biocides and veterinary products.  These services expand each one of the companies´ability to provide scientific and regulatory expertise, harmonized registration strategies and technical guidance in different countries.

 

With the world´s largest and growing agricultural market, Latin America offers new opportunities for maket expansion.  CESIS, a Brazil-based corporation, together with Latin American partners, constitute a multidisciplinary team of experts providing support to clients with high-quality services that offer the best outcome in each project meeting deadlines while also being responsable and nimble assisting compainies in monitoring complex regulatory programs and obteining registrations to commercialize their technologies.  Our success is based on our experts having a clear understanding and knowledge of local procedures, culture, and excellent bilingual skills in the juristictions that present challenges to our clients.  The company entirely maintains the commitment to professionalism and respect for the confidentiality established since its inception 13 years ago.   

 

 

Strategic regulatory guidance: 

 

• Assessory in Pre-registration meetings

• Data gap analysis according to current  requirements following country local specifications

• Data compensation

• Assemblage and submission of dossiers

• Study design and monitoring

• Efficacy assessment

• Chemistry evaluation

• Toxicology evaluation

• Ecotoxicology evaluation

 

• Technical active ingredients

• Manufacturing-use products

• End-use produts

 

Risk assessment