Possible changes in the regulation of GMOs and GM-products
On 16 November 2022, the Draft Law № 5839 of 05 July 2021 (“The Draft Law”) was adopted as a basis with a shortened preparation period for the second reading. The Draft Law aims at the systemic review of current regulation of handling of GMOs and GM products as well as at the implementation of acts of the European Union into the legislation of Ukraine. Furthermore, creating single legislation with the EU in the relevant field is necessary to fulfil the international obligations of Ukraine under Article 54 of the Association Agreement between Ukraine and the EU.
In general, the adaptation of Ukrainian legislation to the EU standards is carried out in several areas since the Draft Law is quite comprehensive. Indeed, The Draft Law is intended not only to replace the current Law of Ukraine “On state biosafety system for creating, testing, transportation and use of genetically modified organisms” (“The Current Law”) but also to expand the scope of regulation by taking into account the EU legislation on the use of genetically modified food and feed, transboundary movements of GMOs, deliberate release of GMOs into the environment etc.
Main changes proposed
First, the Draft Law proposes to regulate, in much greater detail, the exercise of genetic engineering activity in the closed system. Indeed, it is suggested to implement four levels of risk in the practice of genetic engineering activity in the secure system, which vary from the absence of danger, or the presence of a minimal one, to the presence of increased risk. At the same time, genetic engineering activity that corresponds to level I, the lowest, must be carried out on a declarative basis, while the action that corresponds to higher levels of danger – is on a permission basis.
Second, the Draft Law also regulates in greater detail the handling of GMOs in the open system. In particular, the procedure of obtaining a permit for conducting studies and testing of GMOs in the open system will now be regulated by a separate article, which specifies in detail the information that must be present in the application for a permit as well as lists the grounds for a refusal to issue a permit.
Third, the regulation of state registration in handling GMOs is improved. As stated in the explanatory note of the Draft Law, its main provisions provide for the implementation of European mechanisms of GMOs’ state registration. Indeed, the Draft Law envisages the introduction of three state registers in electronic form: the State Register of subjects genetic engineering activity; the State Register of permits to conduct studies and testing of GMOs in an open system; the State Register of GM sources.
Fourth, unlike the Current Law, the Draft Law separately addresses the issue of marking GMOs as GM products which are food products. Proposed provisions in more detail regulate the labelling of GMOs compared to the Law of Ukraine “On information for consumers on food products”. In particular, a ban is imposed on the labelling of “non-GMO” products, which, by their origin, composition, and used raw materials (ingredients), cannot contain GMOs.
Fifth, the whole section in the Draft Law is devoted to the transboundary movements of GMOs. Indeed, the import and export of GMOs are allowed, provided the GM source is registered. As in the Current Law, the exception is made for exports for scientific research purposes. However, in this case, the requirement is established to receive a permit to import GMOs, which are assigned to conduct a genetic engineering activity of level I risk in the closed system. Furthermore, the issue of transit in the Draft Law is regulated in greater detail than the Current Law, providing a list of information that has to be indicated in the Application for a permit to move GMOs or GM products in transit through the customs territory of Ukraine. Besides, the rules of conduct were provided in case of unintentional release of GMOs into the surrounding natural environment during transit.
Sixth, the Draft Law aims to enhance state supervision over compliance with legislation on the handling of GMOs and response measures. The Draft Law considers as an infringement a violation of rules of handling GMOs during the exercise of genetic engineering activity in the closed system; a violation of the order, regulations and requirements for taking GMOs during studies and testing in the open system; placing on the market of genetically modified products in violation of the requirements of the legislation. A separate article is devoted to proceedings in cases of violation of the legislation in the handling of GMOs.
In case of adoption, the Draft Law will enter into force the next day after its publication. However, its enactment will occur only three years after entering into force. As of 13 January 2023, the comparative table was prepared for the second reading, and the Draft Law expects the second reading.