AgroPages-Ukraine Market Feature | Regulatory framework for plant protection products (PPP) in Ukraine-Agricultural news

At the heart of Eastern Europe, Ukraine plays a pivotal role in global food security with its vast farmlands and abundant agricultural resources. In recent years, Ukraine has faced not only geopolitical challenges but also the trials of war, which have undoubtedly had a profound impact on its agricultural economy and agrochemical market.

Against this backdrop, we have produced this special Ukraine Market Feature, published in our latest publication "Market Overview 2024", aiming to delve into the current situation, challenges, and future of Ukrainian agriculture and agrochemical regulation. At the same time, Ukrainian agricultural enterprises and experts are demonstrating extraordinary adaptability and determination, seeking new opportunities for development amidst turmoil.

In this Feature article, we've invited two regulatory experts from Polgar ACRO to dissect Ukraine's plant protection product regulations. They provide an in-depth analysis of the regulatory framework for plant protection products in Ukraine. The article will explore how Ukraine is undertaking legislative reforms, particularly after signing the Association Agreement, to amend legislation in the agrochemical sector to comply with EU laws and standards.

Author: Olena Guz, Head of Regulatory Affairs for CIS and Ukraine, Polgar ACRO (left);

Kateryna Babych, Senior Regulatory Affairs Manager, Polgar ACRO (right)

Currently plant protection products sector in Ukraine is regulated by the following legislative acts:

Law "On Plant Quarantine," No 3348-XII dated 30.06.1993;
Law "On Plant Protection"No 180-XIV dated 14.10.1998;
Law "On Pesticides and Agrochemicals"No 86/95-ВР dated 02.03.1995.

All those regulations were introduced and adopted in the mid-1990s and have neither been significantly amended nor undergone systematic review. Furthermore, the provisions of the aforementioned laws do not comply with European Union (EU) PPP legislation in the areas of quarantine and protection.

On March 21, 2014 Ukraine signed the Association Agreement with the EU expressing the commitment to join the European Union. Signing the Association Agreement has become a crucial step toward further legislative development aiming at complying with the EU laws and standards. The need to introduce legislative changes in regulatory fields for pesticides and agrochemicals, in order to harmonize with the EU, was evidentially undeniable.

In particular, according to Article 64 of the Association Agreement, Ukraine is required to align its legislation on sanitary and phytosanitary measures with that of the EU. Therefore, Ukraine has started developing several draft laws in order to launch the harmonization process. The primary goals of such draft legislation are to improve the procedures related to PPP and agrochemicals registration, in line with the following EU regulations:

Regulation (EU) No 1107/2009, which governs the placing of plant protection products on the market;
Regulation (EU) No 2019/1009, which establishes rules for placing fertilizers on the market.

The draft acts aim not only to adjust the Ukrainian legislation to European standards but also to fulfill obligations set forth in the Association Agreement between Ukraine and the EU, particularly in the area of sanitary and phytosanitary measures.

The draft Law on Plant Protection Products and Fertilizer Products outlines the following aspects¹:

Registration of Active Ingredients (AI(s))

The draft law introduces a new procedure of the registration of active ingredients making a parallel with the EU’s PPP safety and environmental standards. According to the draft law, companies shall obtain registrations of AIs prior to application for registration of PPPs, containing them, and submit more comprehensive data on toxicology, environmental impact, and residue levels for these AIs.

In Ukraine, unlike in the EU, where the approval of an active ingredient is a mandatory condition for the registration of formulation, it is currently possible to register only product formulations. Without a doubt, the approval of an active ingredient in the EU is a complicated and an expensive process. However, shall we bear in mind that, while the legislative changes are aiming at bringing Ukrainian legislation towards the EU, Ukraine is not yet a member of the EU, therefore, Ukraine is not bound by the EU laws. For example, Article 29 of Regulation 1107/2009 lists requirements for AI authorization, while recent Ukrainian draft law only partially covers such requirements. Article 8 of Regulation 1107/2009 outlines two types of dossiers – the summary and the complete ones, whereas, the Ukrainian draft law only refers to a dossier without such specification. There are many other discrepancies between the regulations. Thus, the registration of AIs in Ukraine, according to the draft law, has some similarities with the EU legislation and at the same time it differs. The approval of an active ingredient, according to the Regulation 1107/2009, will be binding for Ukraine when the latter will join the EU and consequently will have to implement this Regulation. If we look at an example of Latvia, an EU country which joined EU in 2004 and consequently implemented Regulation 1107/2009, we will find out that the PPPs, authorized prior to entering the EU were allowed to stay on the market until existing registration expired.

Introducing a List of Banned Co-Formulants

A new provision of a draft law creates a list of co-formulants that are banned from being used in PPPs, reflecting their potential risks to human health and the environment. Manufacturers, in order to comply with the safety regulations, will be required to re-register existing and register new products, eliminating any co-formulants included in this list.

Dated on September 16, 2024 the list of co-formulants in Annex III of Regulation 1107/2009 includes 145 substances, which are not accepted for inclusion in PPPs in the EU. And currently there is no list of prohibited co-formulants in Ukraine.

Introducing a List of Banned Active Ingredients

To enhance protection against harmful substances, the draft legislation introduces a new, detailed list of banned active ingredients, harmonized with those not approved in the EU. The active ingredients, which are identified as posing unacceptable risks, shall no longer be authorized for use or registration in Ukraine.

Same as with co-formulants, there currently is no an officially approved list of banned active substances in Ukraine. The AIs prohibited in Ukraine are included into the Annexes A and B of the Stockholm Convention on Persistent Organic Pollutants. If we compare this aspect with other countries, the conclusion shall be that the members of the Associated Trio (Georgia, Moldova and Ukraine) undergoing the process of harmonization implemented the following. For instance, in case of Georgia since the latter started harmonizing its legislation it was not possible to apply for the new registration of PPPs containing active ingredients not approved in the EU. Moreover, in Moldova existing registrations which contained AIs not approved in the EU were immediately canceled. None of these actions took place In Ukraine yet and the agrochemical companies, in spite of the war, still authorize their products.

Aligning Ukraine's Chemical Safety Laws with EU Standards: The Introduction of the Ukrainian REACH

In addition, the Law of Ukraine "On Chemical Safety and Chemical Product Management," adopted in December 2022 and set to come into force on June 29, 2024, is often referred to as ‘the Ukrainian equivalent of the EU's REACH regulation’. Its primary goal is to align Ukraine's chemical safety regulations with EU standards, protecting human health and the environment from the harmful effects of chemicals. The law introduces a mandatory registration and monitoring system for chemical substances and abolishes ineffective licensing for particularly hazardous chemicals. This legislative framework lays the foundation for the national system to manage chemicals based on the EU regulations, including REACH and CLP.² Additionally, this law is part of broader efforts to harmonize Ukraine’s legal framework with the EU legislation, particularly in the fields of environmental and chemical safety.³

Conclusional remarks

To sum up, the legislative actions have taken place and still ongoing in Ukraine harmonizing its legislation with the EU laws, however, the draft law on PPPs is still under consideration and has not been adopted yet. We can track the main tendencies of harmonization; however, we can also state that the draft law does not fully implement Regulation 1107/2009, but it does bring Ukrainian legislation closer to compliance with the EU.

In addition, one shall not forget about a transition period, when the new legislation framework will be adopted, especially when it comes to switching to the new systems the elaboration and adoption of laws is a time-consuming process, and the implementation is even longer as it requires the preparation of specialists and necessary equipment, and other measures and resources. Therefore, while the current system still in place and considering the future possible adoption of new laws and transition period there is still a time to register the products according to the present-day regulations.

Despite the war, the yield level of agricultural production in Ukraine remains significant

According to the State Statistics Service of Ukraine, the yield of sugar beet (one of the main crops in Ukraine) amounted to 541 centner per hectare (c/ha) in 2022, while in 2021 it was 479 c/ha. In 2022 the yield of grain and legume crops was 45.8 c/ha, whereas, in 2021 it was 53.9 c/ha. The yield of sunflower amounted to 21.6 c/ha in 2022, and to 24.6 c/ha in 2021, the yield of fruit and berry crops remained almost at the same level: in 2021 – 117.3 c/ha and in 2022 – 116.1 c/ha, while yield of grape increased from 76.1 c/ha in 2021 to 89 c/ha in 2022. The yield of potato also increased from 166 c/ha in 2021 to 174 c/ha in 2022.⁴

In 2022, the areas treated with pesticides amounted to 12.9 million ha, while in 2021 – 16.6 million ha, which can be a consequence of war as some areas have been occupied by the Russian troops. Even in a condition of the full-scale invasion by Russia, Ukraine remains one of the leading exporters of agricultural products. Thus, for instance, according to the Ministry of Agrarian Policy and Food of Ukraine between 2022 and 2024, the area under oilseed crops in Ukraine increased. Specifically, soybean production in Ukraine has grown 2.2 times since the 2020/2021 marketing year. Overall, in 2023 and 2024 Ukraine exported 67.4 million tons of grain, oil crops and their processing products. In recent years, Ukraine ranks first in the world in exporting sunflower seeds, second - sunflower oil, third - rapeseed, fourth - corn, sixth - wheat and barley, eighth - soybeans.⁵

Therefore, Ukraine stands as an attractive country for PPP manufacturers and distributers. We would recommend you to enter the Ukrainian market in the next couple of seasons, while the harmonization with the EU legislation is still ongoing, as the regulatory requirements have not been changed yet and the registration budgets are considerably affordable if compared with the registrations in the EU. We believe, in the future the consensus would be found when it comes to the development of regulatory legislation aiming at complying with the EU laws, as the pesticide market is very important for agrochemical players – Ukrainian national manufacturers as well as foreign manufacturers.

Verkhovna Rada of Ukraine. (n.d.). Draft law on plant protection products and fertilizers. Verkhovna Rada of Ukraine. Retrieved from https://itd.rada.gov.ua/billInfo/Bills/Card/43799
Ukrinform. (2022, December 1). Parliament passes law on chemical safety and management of chemical products. Ukrinform. Retrieved from https://www.ukrinform.ua/rubric-society/3625898-rada-uhvalila-zakon-pro-himicnu-bezpeku-ta-upravlinna-himprodukcieu.html
Ministry of Environmental Protection and Natural Resources of Ukraine. (n.d.). Strengthening environmental and chemical safety. Ministry of Environmental Protection and Natural Resources of Ukraine. Retrieved from https://mepr.gov.ua/diyalnist/reformy/posylennya-ekologichnoyi-himichnoyi-bezpeky/
State Statistics Service of Ukraine. (2024). Statistical Yearbook of Ukraine 2022.
Ministry of Agrarian Policy and Food of Ukraine. (n.d.). Ukrainian agricultural sector demonstrates resilience and remains one of the leaders in export of agricultural products. Ministry of Agrarian Policy and Food of Ukraine. Retrieved from https://minagro.gov.ua/news/ukrainskyi-ahrosektor-demonstruie-stiikist-ta-zalyshaietsia-odnym-z-lideriv-eksportu-sh-produktsii

About Polgar Acro

Polgar ACRO is an agrochemical consultancy with 14 years of experience in the registration of pesticides, biocides, fertilizers, growth regulators, biostimulants, biopesticides, surfactants and other chemical products. Polgar ACRO, with headquarters in Budapest, Hungary, and regional offices in Ukraine, Uzbekistan, Kazakhstan and Russia, is also covering CEE part of the EU alongside with Belarus, Moldova and Georgia.

The company provides a comprehensive regulatory support, including strategic planning of registration road map, budget and capitalization, oversight of A.I. and PPP dossier generation, regulatory support for producers at every stage of product lifecycle, DGA, study monitoring, submissions and follow up, regulatory support of M&A deals, task forces supervision, providing seminars and trainings, setting up and overseeing regulatory partnerships. Polgar ACRO supports registration decisions and provides advocacy for clients - gets a product authorized at a lowest cost in the fastest way.

Polgar is proud of its successful 500+ registrations for more than 70+ international client’s portfolio. Polgar ACRO’s team consists of 25 professionals and is able to provide support in 10+ languages.

This article was originally published in AgroPages magazine 2024 Market Insight. Download to read more.

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