Challenges of Pesticide Markets and Regulatory Requirements in Colombia and the Andean Community

lng. Yonny Javier Zárate Amaya

CEO Global and Director of Regulatory Affairs

Gestar Service S.A.S.

Engineer Yonny Zarate, founder and director of regulatory affairs of Gestar Service S.A.S., has worked in the agricultural and environmental sector for over 20 years, both as a server of the Colombian Agricultural Institute ICA; National Competent Authority for pesticide registrations, fertilizers and manures, adjuvants, biological inputs, biopesticides, and others. He has also worked as a consultant to the Ministry of Environment and Sustainable Development of Colombia, the Food and Agriculture Organization of the United Nations, FAO, now working for the agrochemical industry in the world. In this interview, he gave us a summary of the agrochemical market outlook in Colombia and explained the keys to the regulatory process for registering agrochemicals in Colombia and the Andean community. It is worth noting that Mr. Zarate was part of the high-level group of negotiations of the Andean Decision 804 of 2015, on registration and control of pesticides of chemical synthesis, which makes us understand his extensive knowledge in the application of the regulation.

In your opinion, what are the most important challenges in the agrochemicals market segment? 

The Colombian agricultural industry faces great challenges, mainly due to the high dependence on imported raw materials. Colombia buys from countries such as China, the United States, Canada, and Russia about 98% of the raw materials are used to produce agricultural products consumed in national production. 

Other challenges following the COVID 19 sanitary crisis include the conflict between Russia and Ukraine, which has increased the prices of raw materials and foodstuffs and has boosted general price inflation in the national economy, trade conflicts between China and the United States resulting in a shortage of containers at international ports, the rise in the exchange rate, the increase in energy prices and higher freight costs for maritime transport.

What aspects do you consider positive for the agrochemicals market? 

Undoubtedly, every problem brings opportunities. It is worth noting that the reactivation of trade relations between Colombia and Venezuela has boosted Colombian exports of fertilizers and pesticides. 

The agrochemical industry is dynamic and is constantly seeking to increase competitiveness and new business scenarios with countries such as Morocco, Germany, and others.

What are the figures for the agrochemical market in Colombia? 

Experts from the Virtual Business Center reported that during January and June 2022, 900 thousand tons of agrochemicals were imported between fertilizers, fungicides, herbicides, insecticides, and other categories. The price of the merchandise reached USD$ 1,075 million CIF, the highest figure since 2017, with a variation of 35.2% compared to the same period of 2021. Fertilizers are the most imported line with 835.7 thousand tons, equivalent to a share of 92.8% of the total, an amount that cost USD$ 692.7 million. 

The 5 companies that imported the largest quantities are Yara Colombia (246,691 tons, 27.4% share), Nitrofert (133,500 tons, 14.8%), Precisagro (90,234 tons, 10.0%), Disan Colombia (63,514 tons, 7.01%) and C.I. Acepalma (60,467 tons, 6.7%).

The main origins of the merchandise are the United States, China, Canada, Germany, and Russia. 

The above figures do not include biological products for agricultural use. These are beginning to become a trend among farmers' tastes and preferences because of their significant contribution to sustainable agriculture. In this line of business there is a great future in Colombia, so I invite the industry to grow with this agribusiness alternative. 

The crops that consume the most phytosanitary products are rice, potatoes, flowers, bananas, among others. 

In recent years, the country achieved 52 admissibilities to export agricultural products including Hass avocado to China, Japan and Korea, Tahiti acid lime and cannabis seed to Peru, yellow Pitahaya (dragon fruit) to Argentina, pineapple to Uruguay, coffee beans to Ecuador, paprika to the United States and Uchuva to the European Union, etc. 

In 2023, according to the Rural Agricultural Planning Unit (Upra), in March fertilizer prices fell the most in the last two years, with an average of 3.28%, maintaining the downward trend since July 2022. 

Regarding the accumulated variation, the record indicates that between January and March 2023 the indicator fell 4.87%, while, for the same period of 2022, there was an increase of 12.98%. 

Between January and March 2023, simple fertilizers showed a drop of 5.58% compared to the 11.89% growth recorded in 2022, which means "oxygen to farmers' pockets". 

What is the outlook for local distributors? 

Domestic agrochemical distributors face problems due to direct competition from large international companies such as Sino Agri Leading, Rainbow, Eastchem, Sino Chemical, NGC, E-Tong, Zhongshan Chemical, Agro-Unitek and others that have entered the domestic agrochemical market directly with their own B2C businesses, which will surely cause great benefits to end consumers and a strong price dispersion. They also face the commoditization of products due to the lack of innovation of domestic products, the increase in the sector's portfolios that causes losses of up to 5% and low rentability.

Now let's talk about the company. Why and what is Gestar Service S.A.S. for? 

Gestar Service, an agricultural and environmental company, was born from my heart, it is a lifelong ambition, a personal and professional dream, as well as a desire to explore my capabilities and vocation of service to others.

Gestar Service S.A.S., was founded on February 26, 2010, with the vision of providing regulatory services solutions and to be a company recognized as the leading agricultural and environmental technical department in Colombia and the entire Andean Community of Nations in terms of registration, control, monitoring and technical assistance of products for agricultural use. 

This is a journey that I undertook to bring the company's services to the world! From the beginning we have positively impacted the agrochemical industry in search of food safety and sustainability of the planet, inspired by 4 pillars that I was taught from home: i) reliability, ii) quality in doing, iii) transparency and iv) success for all, always focused on the agility of the processes to meet the needs of customers and stakeholders. 

Why does the agrochemical industry prefer Gestar Service's regulatory services? 

We are a company built on solid principles and we promote services with superior levels of quality, reliability, and competitive prices for the agrochemical industry worldwide. 

Today we find ourselves in a favorable scenario of quality services, transparency, competitive and sustainable prices, which makes us worthy of a good reputation as a leading provider of regulatory services for the registration of manufacturers, importers, exporters, pesticides, fertilizers, adjuvants, growth regulators, biopesticides, plant extracts, biological inoculants, antimicrobials, agricultural soil conditioners, etc. 

We have a multidisciplinary professional team in agronomic, environmental, sanitary, chemical, biological, and other related professions. Our team is strengthened with 12 direct and indirect collaborators located throughout the country, working for clients not only in Colombia, but also for clients in other countries. 

What are Gestar Service's complementary services? 

The regulatory services we provide to the agrochemical industry, we complement them with integral solutions oriented to:

• Elaboration of protocols and agronomic efficacy tests. 

• Disaster risk management plans. 

• Toxicological and agronomic dossiers. 

• Environment risk assessment ERA. 

• Environmental management plans-PMA. 

• Environment impact studies EIA. 

• Environment compliance reports ICA’s. 

• Environment audits. 

• R&D activities, commercial product development. 

• Pesticide residues trials, MRL calculations and PHI pre-harvest Interval. 

• Application of GHS on classification and labeling of pesticides. 

• Training processes in good agricultural practices and safe handling of pesticides, involving sales force, suppliers, transporters, storers and end users. 

• Technical assistance in regulatory strategic planning, brand registrations and patent protection evaluation. 

• Contractual support and negotiation with third parties with a focus on registration and administration of registrations. 

• Holding services or product registration holding in "turn-key projects". Representation of domestic and foreign companies in the agrochemical industry. 

We currently have the best cooperation with customers and business partners in China, United States of America, Spain, Argentina, Ecuador, Uruguay, Colombia and other countries in the Andean Region and Central America. 

These complementary services are proudly provided by our strategic allies through cooperation agreements with the National University of Colombia, the best public university in the country. With the University we hire young professionals recently graduated from different academic programs and the Colombian Agricultural Research Corporation-AGROSAVIA, which is a science, technology and innovation entity that contributes to technical change to improve the productivity and competitiveness of national agriculture. 

What is the regulatory framework for the registration of pesticides? Could you give us some general information about the registration process? 

Our country is part of the Andean Community of Nations and in the region all actors interested in positioning their trademarks, taking out their registrations and fulfilling responsibilities before, during and after registration, must comply with CAN Resolution 804 of 2015 and the Andean technical manual implemented with CAN Resolution 2075 of 2019. These regulations establish all harmonized procedures for the registration and control of pesticides for use in agriculture.

The application of these regulations is done in 10 sections where the risks to public health, the environment and agriculture are evaluated by the authorities considering as the object of evaluation the technical grade active ingredient, the formulated and additives. 

I must emphasize that the national pesticide registry is the only instrument for the industry to be able to import, produce and commercialize phytosanitary products in the national territory. 

The Andean regulation empowers each country to autonomously regulate internally the technical, legal, and other pertinent measures, in order to develop the necessary instruments to comply with the objectives of the Community Decision. 

In that order, Colombia has established its own regulation in accordance with the criteria of graduality and specificity for the registration of pesticides, as well as the necessary mechanisms of interaction between agricultural, health and environmental authorities to make pesticide registrations more agile and comply with the principles of the Community regulation. 

Environmental regulation:

• Decree 1076 of 2015, regulates the environmental licensing process and the environmental management department for companies.

• Resolution 1442 of 2008, regulates the procedure for the issuance, content, modification, validity, and follow-up of the environmental authorization in the Environmental Technical Opinion.

• Resolution 1675 of 2013, regulates the management plan for the return of pesticide containers after use and consumption and annual collection goals or percentages.

Health regulations: 

• Decree 1843 of 1991, establishes the documentary and technical requirements for the control and epidemiological surveillance in the use and handling of pesticides, as well as for the authorization of the toxicological technical opinion. 

Agricultural regulation:

• Resolution 1580 of 2022, establishes the requirements and procedures for registration of manufacturing, formulating, importing, distributing, exporting companies and phytosanitary products. 

• Resolution 90833 of 2021, establishes the provisions for the registration of manufacturers, formulators, packers, and importers of adjuvants for agricultural use, as well as the requirements for the registration of adjuvant products for agricultural use. 

• Resolution 68370 of 2020, establishes the requirements for the registration of producers, contract producers, packers, importers, and technical departments of agronomic efficacy tests; as well as the requirements for the registration of biofertilizers, biological inoculants, microbial agents, plant extracts, biochemicals, and the entire range of biological inputs for agricultural use. 

• Resolution 150 of 2003, adopts the technical regulation of fertilizers and soil conditioners for Colombia. 

The most recent advance in terms of registrations is the launch by the Colombian Agricultural Institute-ICA of the 'SimplifICA' platform, which is a tool for agricultural producers and agribusiness to register as manufacturers, importers or exporters, reducing time in the procedures and approval of product registrations. 

With SimplifICA, the regulatory authority seeks to digitize through a real-time data analysis system to strengthen decision-making capacity with systematized, measurable, and traceable information that allows better management of sanitary risks. 

Which Colombian authorities participate in the registration process of phytosanitary products? And what requirements are necessary? 

In Colombia, the administrative process to obtain the registration of pesticides is led by the Colombian Agricultural Institute ICA, which operates as the National Competent Authority to grant the national registration of pesticides. It evaluates possible phytotoxic effects, agronomic efficacy trials, MRL pesticide residue limits, re-entry period and pre-harvest Interval-PHI. 

However, ICA does not act alone. There are two other authorities with administrative and financial autonomy to evaluate the public health and environmental components. 

The National Environmental Licensing Authority (ANLA), which evaluates different levels of environmental risk from exposure to the phytosanitary product in birds, aquatic organisms, bees and earthworms, in the soil, surface and ground water, as well as in the air. Likewise, environmental monitoring is carried out after product registration using the environmental management plan as a control and management instrument. Companies must submit an environmental compliance report every year.

The National Institute of Health (INS), in turn, evaluates the risks and hazards of acute toxicity that may be caused by phytosanitary products on the health of workers who use the products; transporters, storers, applicators, farmers, among others in the framework of the life cycle.

What controls are in place in Colombia after registration and what are the responsibilities of the registrants? 

Registration holders must keep their registrations updated according to regulatory changes. Modifications are made when it is necessary to change the holder or registration holder, when a new country of origin is added, a manufacturer, a formulator, when new uses of the formulated product are added, changes in dosage or toxicological classification ratios. 

There are also official controls after a successful registration or release so that the product can be marketed in the Colombian territory, the most significant of which is the one made by the Environmental Authority-ANLA to the environmental management plan, The most significant of these is the environmental management plan, through which manufacturers, importers and the entire commercial chain share responsibilities in the management of containers or hazardous waste after the use of phytosanitary products, and those carried out by the Colombian Agricultural Institute at ports, airports, land border crossings, warehouses, production plants, laboratories and commercial warehouses throughout the country. No less important are the controls and follow-ups carried out by the health authority-INS on cases and outbreaks of intoxication of agricultural workers due to exposure to pesticides.

In all cases, the registration holder always has shared responsibilities with the distribution and trade chain from the "cradle to the grave". 

From your experience in regulatory affairs, what do you recommend to foreign companies to start a commercial agrochemical business in Colombia? 

All new and established companies in the agrochemical market have the fundamental challenge of complying with agricultural, health and environmental regulations. 

Secondly, they must define a sustainable business model, which can be B2B or B2C, for this I recommend selecting a good regulatory agent to help them in commercial strategies, market research, regulatory affairs, portfolio analysis, advice on importer selection, registration processes and post-registration services. 

The third recommendation is to establish your own company in Colombia with full or partial control to help you do the registrations and model good direct business with local distributors and hire a national team that works with a business plan focused on technical, commercial, and marketing areas. Today the business trends are digital marketing, eComerce, dropshipping, online store, network marketing and other digital tools that are growing rapidly in Colombia and Latin American countries. 

How long does it usually take to register pesticides and other inputs for agricultural use in Colombia? What is the period of validity of the registration certificate? How much does it cost to register 1 product? 

These are many questions at once, but I will answer them as follows: 

All registrations of product for agricultural use; pesticides, regulators, adjuvants, biologicals and fertilizers, in Colombia are valid indefinitely. 

The estimated term for the deliberation of a registration process of a phytosanitary product; herbicide, fungicide, acaricide, insecticide, among others of chemical nature and regulators for agricultural use is approximately between 12 and 18 months, which implies the procedure before the health, environmental and agricultural authorities and the completion of all technical studies to submit the dossier to the ICA. This period is due to the considerable number of processes that are in the evaluation queue waiting to be analyzed. Therefore, one of the most important points that companies holding or applying for registration must comply with is the quality of the dossier to be submitted, with the objective of reducing the possibility of receiving additional information requirements from the authorities, which will demand more time for the company to comply with them and also for the government to analyze it or even, with the possibility of the process being rejected due to lack of documents, studies and information. 

To release a biological product, pheromones, biofertilizers, biochemicals, natural PGRs and plant extracts, there is a faster process, based on their low toxicity profile, and the approval of the registration process can take between 10 and 12 months. Except for biopesticides, which must go through an environmental license process in the experimental or research phase and an environmental license for their commercial release, which increases the release time to 2 or 3 years.

The placing on the Colombian market of an adjuvant only implies the action of the health and agricultural authorities, reducing the time required for the release of the product to between 4 and 8 months. 

In the case of fertilizers and soil conditioners, the registration release processes are faster based on their low toxicity profile, and the approval of the registration process can take between 10 and 12 months. 

Finally, the registration costs of each product are variable because they depend on the intrinsic characteristics, composition, and number of molecules of each product, as well as the scope of the business that the client requires. I would recommend that interested companies consult with us so that we can provide them with the advice they need to satisfy all their regulatory service needs. 

Finally, let's talk about Gestar Service's growth and expansion plans for the next years. 

Colombian agribusiness is growing more and more and that motivates us to continue strengthening our team in regulatory services in Colombia to keep us in the first places. 

Our technical department of regulatory affairs is always looking for new challenges and continuous improvement of the services we offer to the industry, so we are looking for new strategic allies to expand our offices to the Andean markets, Mexico, and Central America. 

We are in discussions with several fellow regulatory affairs firms to form a national and international network of services and strengthen our capabilities as external business consultants worldwide. 

To learn more about us and our services, please do not hesitate to contact us.

Eng. YONNY JAVIER ZÁRATE AMAYA  Global CEO and Manager of Regulatory Affairs  Agroindustrial Park of the West  Autopista Medellin Highway KM 1.5 Via Siberia, Bodega 2-Local 73  Mobile/Wechat: +57 3007379706  info@gestarservice.com www.gestarservice.com  Cota, Cundinamarca, Colombia

This article was initially published in AgroPages' '2023 Latin America Focus' magazine.

If you would like to share your company's story. Please contact Christina Xie at christina@agropages.com