The Overview
The focus of this issue is regulation and the developments in the registration landscape, inspired in part by the workshops held at New AG International’s Annual event in Berlin in April of this year.
There is a review of Brazil’s regulatory system in this issue. One of the key debates to come is on-farm production. There are also moves to simplify the registration process, which is one of the objectives of the bio-inputs program from 2020.
Speaking in Berlin, Giel Tettelaar, Chairman at EFCI Register, a notified body, gave an overview of where we were with the Fertilising products regulation (FPR) 2019/1009. You can listen here why Tettelaar feels that the FPR is at an interesting point.
The workshop included insights from another notified body CerTrust, with representatives Ildiko Varga and Marton Toth. Adrian Parra Garcia from Field Fisher gave industry feedback on navigating current legislation to biostimulants in Europe.
But what about other parts of the world? New AG International spoke to Guillermo Aponte who gave some perspective on the registration process for crop protection products in Bolivia including biopesticides.
Aponte is a regulatory specialist with SML Limited, responsible for Andean countries & Paraguay, with the collaboration of AgroAdvice Peru.
Next year could provide a crunch moment since Bolivia does not appear to be on-track to re-evaluate and re-register the agrochemicals in accordance with the harmonizing regulation for the Andean community – CAN (Bolivia, Colombia, Ecuador and Peru).See question 2.
1. To begin with, can you give a summary of the changes to the legislation for agrochemicals for members of the Andean Community (Comunidad Andina, CAN) introduced in 2017? The Legislation with the objective of harmonizing the registration and control standards for chemical pesticides for agricultural use in the Andean community – CAN (Bolivia, Colombia, Ecuador and Peru) – was approved in 1998, and came into effect in 2002, establishing an initial period of 5 years (till 2007) for the authorities to carry out the re-evaluation of chemical pesticides for agricultural use, registered before its entry into force. After successive extensions, June 25th, 2019 was established as the deadline for adaptation to the Standard. It also incorporated in its Complementary Provisions an article, where an exceptional period was granted for Bolivia until June 25th, 2025.
Basically, the big change was to incorporate the Ministries of Health and Environment in the evaluation of the products, not only the Ministry of Agriculture.
2. What were the implications for the member countries? Can you give some numbers on the reduction in registered products for Bolivia? When the new regulation entered, there were more than 3,500 registrations approved and about 3,000 registrations that were active at that moment in time (December 2nd, 2017). Also during the last 5 years of the previous regulation 480 new registrations were approved per year.
During this new period (over 6 years), Bolivia only approved 130 registrations (20 per year) [of agrochemicals].
3. Is it possible that there could be another extension beyond June 2025 for Bolivia? Both the private and the public sector understand that it won’t be possible to conclude the revaluation of the old registers till June, 2025 ( 1,374 dossiers were submitted, but only 152 were approved till June 14th, 2024. And that's only half of the dossiers that should be submitted). That's why both of them (local chambers and Senasag Bolivia) are working internally on a proposal to extend the period for another 10 years. A couple of years ago, the authorities already asked the Andean community-CAN to extend the period, but they said it was too early. Now, the deadline is very close and they need to makea decision.
4. How many of the current crop protection products registered in Boliva are biopesticides? What product types do they tend to be and for which crops in Bolivia? [eg trichaderma, beauvaria b etc] April, 2024 (official data): -Fungicides: 15 -Insecticides: 17 -Others: 10
Most of them are Beauveria sp. Trichoderma sp. and Bacillus sp.
The most important crop in Bolivia is soybean, that means that most of the registrations are for this crop.
5. Would it be fair to say that usage is higher than the number of registrations suggest? I can´t certify it, but it is very probable it is happening.
6. In terms of the registration process, I understand Bolivia only requires one authority (chapter) to register a biopesticide - Senasag - whereas other countries within CAN involve three authorities - the ministries of agriculture, health, and environment. Please can you expand on these differences? In Bolivia, Ecuador and Peru, only one authority (Agriculture) is involved; this simplifies the process and reduces the cost. In Colombia, the 3 ministries must approve a biopesticide.
7. For the registration dossier, can you give an indication the length of time for the four member countries of Peru, Ecuador, Colombia and Bolivia? Field trials (2 in different location per crop) take 6 to 12 months to get samples and the final approval
It takes 15 to 24 months to get the approval of the dossier (except Bolivia that takes 36 to 60 months, or more)
8. Paraguay provides an interesting example. It is not a CAN member, but you mentioned that they had a quick registration process for biopesticides - as short as 6 months. Please can you explain why Paraguay stands out in this regard? Paraguay doesn’t belong to the Andean community. The registration process only involves the Agriculture authorities (like Argentina, Chile and other South American countries), and takes 6 to 12 months. The government promotes the needs of farmers to incorporate the new products / technologies. ●
Luke Hutson, New AG InternationalChief Analyst
A center-pivot irrigation system watering a wheat field in Eastern Idaho, USA at sunset
