Market Overview

Agrochemical Regulations in Latin-American Countries

General Overview, Challenges and Changes

These national regulations make the

Author: Ana Santillsns
difference between countries like Brazil,
Mrs. Santillana has more than 15 years of experience in the agrochemical
Chile and Costa Rica with high regulatory
and chemical sectors at a multinational level. She has held Management
positions in companies such as BASF and IQV. Since 2012, she is Associate barriers and countries with low barriers
Director at Dextra International, a leading consultancy and representation like Paraguay, Uruguay and Honduras.
firm in the agrochemical business. In most of the countries the equivalence
process has been implemented (Brazil,
The economy in most Latin American market in Latin America, that in fact is Guatemala, Argentina). The basic of the
countries recorded a very significant the biggest market worldwide, is Brazil. process is the same as in the European
growth in the last decade. The difficulties Apart from Brazil there are some other Union with a 2-stage process: chemical
that the continent faced in the 90's have big markets like Argentina, Mexico, and toxicological equivalence. Chile
been largely overcome. Paraguay, Colombia, Ecuador and is currently evaluating dossiers under
Nowadays the agrochemical sector Chile. The agrochemical market value chemical identity, but has published
is facing a good moment, as we see for these markets is between 300 million already a new regulation that considers
international companies investing in new USD (Ecuador) and 2,500 million USD the chemical equivalence process that
registrations and looking for alliances (Argentina). might enter into force in 2016.
with strong local distribution companies There are some medium sized markets One of the important difficulties that
every day. There are many business like Peru, Costa Rica, Guatemala and overseas companies faced with technical
opportunities and the ratio regulatory Bolivia which are in some cases growing grade registrations come up when a full
investment/potential market is, on a faster than other mature markets. dossier has to be submitted. Many Latin
general basis, good enough for generic Latin America is cultivating and American countries are requesting chronic
products. producing a wide range of crops, including toxicological studies that in some other
Some Latin American countries have ones produced in other areas of the world areas of the world are not allowed by
been affected by the slowdown of the like cereals, citrus or vegetables, and also law to be conducted by each individual
global crisis, but still have good prospects specific crops that Latin America countries registrant.
of growth in the coming years. World Bank export to the rest of the world. Sugarcane The registration process for new active
forecasts for 2015 a GDP-increase of 5% is cultivated in the humid tropics, being substances in these markets is different
in Bolivia, 3% in Peru and 2.9% in Chile. Brazil the first producer in the world. The to the one followed by active ingredients
There are some exceptions like Venezuela production and export of bananas for that already have a background in the
due to the political situation, where a some Latin American countries represent respective Ministries.
decrease of a 5% is expected during this an important income. Mexico is the first With regard to formulated products,
year. exporter in the world of mango and there is a wider range of regulations.
The agriculture in Latin America avocado. Colombia and Brazil are in Each country has established different
represents approximately between 4% the top 3 exporters of coffee. Argentina requirements. Toxicological concern is
and 13% of the GDP in each respective and Brazil are the bigger producers of a common point as well as residues.
country. In countries like Argentina, soybean, only after the United States. Latin American countries export their
Guatemala and Bolivia agriculture All Latin American countries have set agricultural products mainly to the United
represents over 10%. their own regulations to control the use States and the European Union, so the
In terms of agrochemical consumption, and sale of agrochemical products. Each Maximum Residue Limit established for
we have to consider different factors government has established the process each crop are of high relevance.
like arable surface, productivity and and requirements that the industry has to Most of the countries require local
technology. The biggest agrochemical fulfill. efficacy trials to assure that the use of the

4 Latin America Focus July 2015 www.agropages.com


agrochemical product is safe under the
particular climate conditions of the country.
In fact, some countries of the Andean Pact
demand the trial in two different areas
because the soil and climate varies from
the coast to the forest.
One of the biggest difficulties that
face international companies with the
registration of formulated products is
the decision on crops investment. One
botrycide used in grapes in France or
Spain, could have an excellent control in
Ecuadorian roses. The local knowledge
of crops and uses is a key point for a
good investment and a good consequent
marketing position.
There is an increasing concern in the
area for the effect on honeybees. Some
Ministries of Agriculture are now starting
to require an acute toxicological study.
The Andean Community has a common
regulatory process (Decision 436). Bolivia
has been the last one in implementing it.
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However there are some movements that
could lead again to national regulations in
the near future.
The timings to get the registrations in
Latin America, after complete information
has been submitted to the authorities,
varies from approximately 6 months to 5
years. In some cases several ministries
are involved and in other cases, the
Ministry of Agriculture has a leading role.
In Colombia, 3 Ministries take part in
the registration process: the Ministry of
Health (INS), the Ministry of Environment
(ANLA) and the Ministry of Agriculture
(ICA). In Chile, by contrast, the Ministry
of Agriculture is responsible for all the
process (SAG).
Costa Rica, today, is facing a real
difficult situation in order to authorize new
registrations. The industry has been in
discussions with the authorities for several
years in order to modify the agrochemical
regulation to speed up the process.
Market Overview
Latin American countries represent
a good opportunity for agrochemical
companies that can bring new solutions
and new sources of agrochemicals. The
expertise and knowledge of local people
is of high importance to invest properly on
registrations. From our dilated experience
in those markets, a preliminary analysis of
crops and diseases is a key for success.
Investment in registrations is limited for all
companies, whether the regulatory budget
is high or low, so companies are required
to make the most of their investments.
In order to assure this purpose, a
supranational knowledge of all Latin
American markets leads to a cost saving
and timing reduction.
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July 2015 Latin America Focus 5