In the nearest months to come, the Verkhovna Rada is expected to pass a number of bills significantly changing the legal regulation of manufacture and circulation of pesticides and agrochemicals, such as,
- Draft Law on Amendments to Certain Laws of Ukraine on Improving the State Regulation of Pesticides and Agrochemicals Treatment (Reg. No. 4558);
- Draft Law on the Protection of Plants (reg. № 4600), and draft Laws related thereto, reg. No. 4601, reg. No. 4602, reg. No. 4603;
- Draft Law on Amendments to the Law of Ukraine on Pesticides and Agrochemicals for Improving the Requirements to the Labeling of Pesticides and Agrochemicals (Reg. No. 5237);
- Draft Law on Amendments to Article 4 of the Law of Ukraine on Pesticides and Agrochemicals related to the Importation of Pesticides into the Customs Territory of Ukraine (Reg. № 2289);
- Draft Law on the Chemical Safety and Chemical Substances Control; and
- Draft Law on the Development of Beekeeping and Protection of Bees (reg. No. 5274-1); and
- Draft Law on Biocidal Products
What is expected to be changed and how will it affect manufactures, importers, distributors, keepers and users of pesticides and agrochemicals?
Introducing “double registration” of pesticides and agrochemicals
The Draft Law on the Chemical Safety and Chemical Substances Control, which is required to be adopted under the decision of the National Security and Defense Council (NSDC) dated 19 March 2021, provides for “double registration” of pesticides:
the first one, in the manner set out in the Law of Ukraine on Pesticides and Agrochemicals – a usual thing to do for the domestic market;
the second one, in the manner set out in the Law of Ukraine on the Chemical Safety and Chemical Substances Control – a sort of novelty for Ukraine;
The procedure for state registration of pesticides and agrochemicals, which is set out in the Law of Ukraine on Pesticides and Agrochemicals, is destined to be somewhat changed as a result of adopting draft law 4558 – mostly by clarifying powers and authorities vested in government bodies in relation to the registration procedure.
It will be the Ministry of Health, not the State Food and Consumer Protection Service, who will list enterprises to pass state tests for toxicological and hygienic assessment. Once draft law No. 4558 is adopted, the Cabinet of Ministers will be required to approve updated procedures for state testing and state registration of pesticides and agrochemicals.
In return, Draft Law 5237 requires an environmental expert examination of materials submitted for state registration of pesticides and agrochemicals to deal with the assessment of their hazards for those who are not their targets, including bees. The methodology of such environmental expert examination will be approved by the Ministry of Environment, while the Cabinet of Ministers will approve a list of non-target objects. It is worth noting that the current Procedure for Environmental Expert Examination of Materials Submitted for Registration of Pesticides and Agrochemicals also requires assessing the hazards posed by pesticides and agrochemicals to non-target objects, including, in particular, bees. Provisions of the draft law are worded in such a way that it is unclear what the difference will be, but it is most likely that, under the current Procedure, not all of pesticides and agrochemicals will be required to pass pre-registration safety testing to verify whether they are safe for bees, while draft law No. 5237 would require such testing for all of them.
What will be treated as pesticides?
The definition of pesticide is important in the light of double registration introduced for pesticides only.
Draft Law No. 4600 defines pesticides as “plant protection products and biocidal products”.
Moreover, it suggests understanding the “plant protection products” as “plant protection products means products in the form in which they are supplied to the user, consisting of, or containing active substances, safeners or synergists, and intended for one of the following uses:
- protecting plants or plant products against all harmful organisms or preventing the action of such organisms, unless the main purpose of these products is considered to be for reasons of hygiene rather than for the protection of plants or plant products;
- influencing the life processes of plants, such as substances influencing their growth, other than as a nutrient;
- preserving plant products, in so far as such substances or products are not subject to special provisions of the Ukrainian laws on preservatives of the laws;
- destroying undesired plants or parts of plants, except algae unless the products are applied on soil or water to protect plants;
- checking or preventing undesired growth of plants, except algae unless the products are applied on soil or water to protect plants.
Draft law No. 4600 suggests defining the “biocidal product” as “any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action; any substance or mixture, generated from substances or mixtures which do not themselves fall under the first indent, to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action. A treated material that has a primary biocidal function shall be considered a biocidal product.”
However, in pursuance of NSDC decision of 19 March 2021, the Cabinet of Ministers must prepare and submit to the parliament a draft law on biocidal products by 19 June 2021, taking guidance from provisions of EU Regulation No. 528/2012.
Another draft law (No. 4558) proposes categorizing pesticides as plant growth regulators, which are currently regarded as agrochemicals. Moreover, under the draft law, chemicals not alone, but biological substances that affect the plant growth and development was well, will be treated as the plant growth regulators.
What are the new labeling and packaging requirements to pesticides and agrochemicals and what would be the consequences for improper labeling or packaging?
The substance and form of pesticides and agrochemicals labeling are also expected to be changed.
As far as it goes to the substance of labeling, there is one fundamental change, i.e., it must contain prohibitions and restrictions in terms of hazards to non-target objects, such as, in particular, bees (draft law No. 5237).
However, the Ministry of Environment still has to approve packaging and labeling requirements to pesticides and agrochemicals to prevent them from being mistaken for food, beverage, medicinal product and fodder (draft law No. 4558) and may approve additional labeling requirements (draft law No. 5237).
As regards the form, there is a significant change here as well – all information about the pesticide or agrochemical must be available on the label (draft law No. 4558). However, the same rule in another draft law (No. 4600) states that each unit of goods [pesticides or agrochemicals] must be accompanied with directions attached to the product unit and/or placed on its label.
Improperly labeled or packaged products will be classified as “counterfeit pesticides and agrochemicals” and must be withdrawn and disposed of.
New requirements to the circulation
Pesticides must be accompanied with a chemical safety passport (draft Law on the Chemical Safety and Chemical Substances Control). The distributors who are recorded in the state register of plant protection professional users, distributors and consultants and who employ at least one consultant holding a valid certificate of training (draft law No. 4600) are the only who will be able to sell pesticides.
Significant restrictions on the use of pesticides are expected in order to protect bees. Thus, they will be allowed for use before sunrise and after sunset only (draft law № 5274-1), provided that beekeepers, the population, local government body should be timely notified.
Release from insurance
So far the civil liability insurance of business entities against damages which may be caused to the environment and public health during the storage and application of pesticides and agrochemicals is still a compulsory one. Draft laws No. 4558 and No. 4600 make the insurance during the storage and use of pesticides and agrochemicals no longer compulsory.
Though the manufacture of particularly hazardous chemicals, such as, pesticides, requires licensing for the time being, draft law No. 4558 is intended to clarify that the “production, including packaging” would require licensing. Thus, a license will also be needed to package pesticides.
What are the requirements to the advertising of pesticides?
So far the laws contain no requirements or restrictions on the advertising of pesticides. However, draft law No. 4600 introduces such requirements to the pesticide advertising. The advertising should, among other things, contain a name of the product, number and date of state registration and go together with the words “Use pesticides safely. Always read label and product information before use,” which text should take at least 15 percent of the entire advertising area (duration).
The advertising of pesticides that fall under the hazard class one or two would be generally prohibited.
Specifics related to the importation into Ukraine
Draft law No. 2289 suggests canceling the state registration of the country of origin as a prerequisite to import pesticides not registered in Ukraine for the purposes of their registration. This draft law is expected to be soon adopted in the second reading. This will enable initiating a procedure for state registration of a foreign pesticide in Ukraine, even before this pesticide is registered in the country of origin.
However, natural persons will be prohibited from importing (shipping) into Ukraine any pesticides and agrochemicals (draft laws No. 4558 and № 4600).
State control (inspections) and liability
According to draft law 4600, state inspectors will be granted rather vaguely defined rights to have “unhampered access without warning to places of state control and places where other official measures are taken.”
Withdrawing and disposing of counterfeit products
In addition, state inspectors will be authorized to withdraw and dispose of counterfeit pesticides and agrochemicals (draft law No. 4558). The “counterfeit pesticides and agrochemicals” are defined in draft law No. 4600, which definition includes, in particular, improperly labeled products. In addition, according to this definition, products that do not meet the other requirements applicable to pesticides and agrochemicals and/or products which packaging contains registered trademark for goods and services used in violation of the owner's rights will also be treated as “counterfeit pesticides and agrochemicals.”
Draft law No. 4601 states that manufacturing, buying, keeping and transporting plant protection products for their sales and selling counterfeit plant protection products will entail criminal liability. The liability for manufacturing and/or selling plant protection products without their state registration will be imprisonment from 8 to 10 years.
The liability for administrative offenses related to plant protection products is increased as well (draft law No. 4602). To be more specific, placing in the market, packaging, transporting, storing, using, applying, mixing and/or disposing of plant protection products and/or their active substances in violation of the requirements of the laws of Ukraine on the protection of plants will be punished by a fine of UAH 3,400 to UAH 6,800.
Draft law No. № 4600 introduces finest that are significantly higher. So, among other things, a fine for violation of the requirements to plant protection products being placed in the market is up to 18 minimum wages (UAH 108,000, as of May 2021), for failure to notify of the use of plant protection products, up to 15 minimum wages (UAH 90,000, as of May 2021).
Thus, significant changes are awaiting manufacturers, importers, distributors, keepers and users of pesticides and agrochemicals in terms of the legal regulation of manufacture and circulation of pesticides and agrochemicals. However, the proposed changes should not be treated as a rule set in stone – as a matter of practice, many legislative initiatives are changed and modified while the draft law goes from registration and adoption in the Verkhovna Rada and signing by the President. It is often the case in view of the initiative of active business and its legal advisers. Therefore, we urge market players not to be indifferent to the future “rules of the game.”