Turning Regulatory Obstacles Into Opportunities for Crop Protection Companies in Eastern Europe
22 March 2022 Editor’s Note: Several months ago, AgriBusiness Global planned a special report on Eastern Europe — long before the current situation between Ukraine and Russia became a global crisis. The conflict in Eastern Europe has escalated and the outcome and the long-term results are unknown. With this uncertainty, we have chosen to focus this report on other key countries in Eastern Europe. AgriBusiness Global is following the Ukraine situation closely and will offer analysis of the impact on agriculture as it becomes viable.
The regulatory environment around the world continues to remain in flux. Those who export their products must comply with the destination country’s rules about residue levels and other regulatory requirements. Nowhere is that more relevant than in European countries. Many Eastern European growers send their crops to their western European counterparts.
To get a better understanding of the challenges and opportunities involved in entering the market, AgriBusiness Global™ interviewed Dr. Julia Dempe, Head of Crop Protection Emerging Markets & Products Division, and Dr. Piyatida (Tung) Pukclai, Asia-Pacific Business Development & Regulatory Policy Lead, for knoell, which offers crop input manufacturers registration and regulatory compliance worldwide.
How would you characterize the regulatory environment for traditional chemicals in Eastern Europe right now?
Eastern Europe varies from country to country. Countries such as Hungary, Poland, Romania, and the Baltic states are already part of the EU and follow strict EU regulations governing pesticides registration and usage. Pesticide registration regulations in Poland are in line with EU. Therefore, several popular products withdrawn from the market due to more stringent limits and there will be many more to be withdrawn. Ukraine, Belarus, and Moldova have their own national registration policies that allow for more flexibility.
Belarus regulators are developing their own systems and strengthening the cooperation and recognition between member countries of the Eurasian Custom Union (EACU). EACU member countries have their own registration requirements and standards, which are not always in line with the EU’s regulatory system. This also concerns the decisions to restrict the use of or ban certain products. Ukraine and Moldova focus on harmonization with the EU. Ukraine plans to fully harmonize with 1107/2009 in the next few years, as well as implement Directive 128/2009/ЕС, harmonizing with biocides and MRLs regulations. A significant step forward is the introduction of a GLP certified toxicological laboratory in Ukraine, which will conduct research studies under renewed OECD guidelines.
Moldova´s pesticide registration system is similar to the one of the Ukraine but the authorities are monitoring and following the EU’s decisions to remove obsolete and dangerous products.
One important point is: Pesticide residual levels in exported products from Eastern Europe must comply with EU standards. Thus, we expect a harmonization of rules throughout the region.
How would you characterize the regulatory environment for biologicals in Eastern Europe right now?
As all the European countries they are interested in the biological pesticides but rely a lot on the European frameworks that are not yet defined in all cases. The growth potential is immense as they have huge agricultural areas. Companies from Eastern Europe try to bring their products on the strict and difficult European market, which is a big challenge for them.
Are there any major differences between how Eastern European countries view these products?
Taking glyphosate as example, it is not a major concern in Eastern Europe. In Poland, there is not much more discussion on glyphosate compared to Western EU. Belarus is in no hurry to ban it, considering the absence of any suitable substitutes. Glyphosate has not been banned in Moldova and there is no plan to ban it. However, with the introduction of a new generation of herbicides, local authorities will likely follow existing EU trends.
What regulatory changes have occurred in the past year or two that caused manufacturers and distributors to change how they develop, manufacture, and/or distribute products?
Main changes are:
- EU regulations and harmonization of local rules with European standards and banning of pesticides and active substances that prohibited in EU
- Longer timeframe for registering pesticide products
- Biologicals: Not for every product the guidance is completely clear
What factors are driving any regulatory changes?
Pesticide residual levels, environmental protection (ecotox), soil health, etc. Looking at the transparency regulation under the General Food Law also more politically related aspects.
How have growers responded to these changes?
Regarding the residue issue, growers are considering minimizing environmental damage and optimizing consumption. Combining chemical pesticides with biological, physical, and other non-chemical methods should lead to a slight decline in the use of traditional pesticides in the near future.
How do you see the regulatory environment changing over the next few years?
Harmonization of national registration regulations with European regulations/standards and increasing number of banned pesticides (GreenDeal, Farm to Fork Strategy for the EU).
What can manufacturers due to take advantage (or manage) any regulatory changes/trends?
It is a good opportunity for manufacturers who have a regulatory know-how and dossier for registration. Trying to be as best as possible prepared for any regulatory obstacles.
What else do we need to know?
In order to enter Eastern European markets, it would be good to find a reliable partner that knows how to get a registration done in those countries as each country has its own specific characteristic that should be considered at the first place. Still a lot of these countries require submission and discussion with authorities in local language which can be a challenge.
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