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AND POLICY CONSULTING 
German – Ukrainian Agricultural Policy 
Dialogue 
 
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          AgPP 16 
 
 
 
 
 
 
Policy Paper No.16 
 
 
Comment on the Law of Ukraine No 1103 “On the 
State Biosafety System for Developing, Testing, 
Transportation and Usage of Genetically Modified 
Organisms” 
 
 
 
 
 
 
 
 
 
Disclaimer: 
This paper was prepared by the author using publicly available information 
and data from various sources. All conclusions and recommendations included 
in this paper in no circumstances should be taken as the reflection of policy 
and views of the German Federal Ministry of Food, Agriculture and Consumer 
Protection. 
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Executive Summary 
 
Commercial use of genetic modification is a highly controversial issue all around the 
world. The hopes are that genetically modified organisms (GMOs) could have a role 
in ensuring food security. On the other hand, the scientific community is not yet in a 
position to give a definitive answer as to the dangers of GMOs for human health and 
the environment. Thus, law and policy makers find themselves in a difficult position 
of legislating in a very sensitive area, Ukraine being no exception.  
 
On Mai 31, 2007 the Verkhovna Rada adopted the Law of Ukraine “On the State 
Biosafety System for Developing, Testing, Transportation and Usage of Genetically 
Modified Organisms” (referred to further as the Law on GMOs). It is expected to 
bring a new quality into the relevant Ukrainian legislation as it is the first legal act in 
Ukraine that provides for a systematic approach in GMO handling. This comment 
starts with an overview of the GMO-related situation in Ukraine before the adoption 
of the Law on GMOs, continues with the presentation and assessment of the 
mechanisms introduced by the Law and ends with the recommendations on its 
improvement.  
 
Background 
 
According to the report of the USDA Foreign Agricultural Service1, Ukraine imported 
products valued at USD 39 million in 2005 that could contain GMOs, including 
soybean meal, soy sauce and soybeans. In 2006, these products accounted for 
almost USD 62 million. In this situation, it is of vital importance for Ukraine to 
develop a comprehensive set of legislative and organisational norms regarding GMOs 
to ensure their safe use. From human health perspective, it is necessary to have 
regulations in place that would allow on the market only these GMOs and products 
derived therefrom that successfully underwent safety testing and registration. For 
environmental safety it is necessary that measures to ensure coexistence are taken 
to avoid crossing of GMO plants with conventional ones. Finally, clear regulations on 
importation, sale and labelling of GMOs and products derived therefrom would create 
predictable sales conditions for interested importers and traders.  
 
Until now, Ukraine was lacking a legal act that would provide for a systematic 
approach in GMO handling. Provisions related to biotechnology were scattered in 
several different laws (e.g. the Law on Quality and Safety of Food Products2, the 
President’s Decree on the Interdepartmental Commission on Biological and Genetic 
Safety under the Council of National Safety and Defense3). Mandatory labelling of 
GMO food is required by article 15 of the Law on Consumer Rights Protection4. But 
this labelling provision is unclear on threshold and for this reason difficult to enforce. 
The Ukrainian biosafety system was launched in 1999 solely for genetically modified 
plants5. Even the ratification by Ukraine of the UN Cartagena Protocol on Biosafety in 
2002 did not result in the development of a biotechnology regulatory system.  
                                                 
1 Olena Pereyatenets “Ukraine Agricultural Biotechnology Report” 2007 
2 Law No 771/97 of 12 December 1997 
3 Decree No 672/2004 of 23 June 2004 
4 Law No 1023-12 of 12 Mai 1991 
5 Resolution of the Cabinet of Ministers “On Provisional Order for Importation, State Testing, Registration 
and Usage of Transgenetic Plants” No 1304 of 17 August 1998; under this resolution no biotech crop has 
ever been registered for cultivation in Ukraine (in total, five applications were received in 1997 – 1999). 
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In 2002, this legislative vacuum was addressed by the draft law “On the State 
Biosafety System for Developing, Testing and Usage of Genetically Modified 
Organisms”. It was passed in the first reading by the Verkhovna Rada already in 
November 2002. Since then, the draft was pending final approval by the Parliament. 
Quite unexpectedly, on May 30, 2007, it was replaced by the draft law “On the State 
Biosafety System for Developing, Testing, Transportation and Usage of Genetically 
Modified Organisms”6, passed by the Verkhovna Rada under a priority procedure on 
the following day. The draft law was submitted by the Cabinet of Ministers, together 
with nine other laws required for Ukraine’s WTO accession passed on that day. 
 
The Law “On the State Biosafety System for Developing, Testing, Transportation and 
Usage of Genetically Modified Organisms” entered into force on the day of its 
publication on June 21, 2007. Its adoption fills the dangerous legislative vacuum, 
and is an important step towards the development and implementation of a 
comprehensive regulatory framework on commercial use of genetic modification in 
Ukraine. 
 
It is important to note that there was no public debate over this draft law. Despite 
the fact that the issue of GMOs in seeds, crops and food is a very controversial one, 
the environmental NGOs, consumers’ associations and other potentially interested 
stakeholders had no opportunity to provide comments and suggestions on the draft 
law to the responsible parliamentary committees.  
 
What this note is about 
 
The aim of this note is to give a comment on the above Law on GMOs. Its positive 
aspects – as regards food and environmental safety – will be discussed and the 
aspects that require further improvement pointed out. The analysis is made in a 
wider context of the gradual approximation of Ukrainian legislation to European 
Union law. 
 
It should be noted that the European Union has the strictest code of laws governing 
GMOs in the world, reflecting the serious reservations that many countries still have, 
from both health and environmental perspectives. The EU allows the use of genetic 
engineering in agriculture and food production but, at the same time, sets tight 
safety standards to protect consumer health and environment. 
 
Content of the Law on GMOs in brief 
 
According to article 5 of the Law on GMOs, following activities fall within its scope: 
  
? genetic engineering activities in the closed environment;  
? genetic engineering activities in the open environment;  
? state registration of GMOs and products produced using GMOs (further – GMO 
products); 
? putting into circulation of GMOs and GMO products; 
? export, import and transit of GMOs.  
 
                                                                                                                                                 
According to this resolution, import of biotech crops requires a mandatory permission of the Ministry of 
Agricultural Policy. 
6 Draft law No 3595 of 30 May 2007 
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The Law introduces following instruments: 
 
? mandatory state registration of GMOs and GMO products, including plant 
protection agents produced using GMOs and GMO-based crop varieties and 
animal breeds; a time limit of 120 days for granting or refusing registration; 
first registration to be limited to a maximum of 5 years and may be renewed 
(article 14);  
 
? release of GMOs into the environment as well as production, putting into 
circulation and import of GMOs and GMO products is prohibited until they are 
state registered under the Law on GMOs. There are two exemptions in place: 
1) import of non-registered GMOs and GMO products for the purposes of 
study, research and testing and 2) releasing of GMOs into the environment 
for the purpose of testing (article 16 and 13 respectively); 
 
? mandatory permission for 1) import of non-registered GMOs for the purposes 
of study, research and testing, 2) import of GMO products for the purposes of 
study and research, 3) transit through Ukraine of non-registered GMOs as 
well as for 4) release of GMOs into the open environment; a time limit of 45 
days for granting or refusing permission (article 19); 
 
? mandatory licensing of genetic engineering activities carried out in the closed 
environment (article 12) and in the open environment (article 7); 
 
? environmental risk inspections of GMOs to be carried out by the Central 
Executive Authority of Environment and Natural Resources (article 9); 
 
? sanitary and epidemiological inspections of GMOs and GMO products to be 
carried out by the Central Executive Authority of Health Care (article 10); 
 
? monitoring of GMO food products as well as feed products to ensure that only 
registered GMO sources are used - to be carried out by the Central Executive 
Authority of Health Care and Central Executive Authority of Agricultural Policy 
respectively (article 10 and 11); 
 
? the possibility of establishing GMO free zones as well as mandatory space 
between fields with conventional and GMO plants in case of cultivation (article 
14); 
 
? mandatory information on GMO usage to the public (article 20); 
 
? the possibility of the competent authority to reject the registration of GMOs or 
GMO products if sound scientific information proves that their designated use 
brings hazard to human health or the environment (article 14).  
 
 
Assessment of the Law  
 
As can be seen above, the Law on GMOs introduces several important mechanisms 
as regards GMO handling in Ukraine. Some of them, like monitoring of GMO 
products, have been introduced in Ukraine for the first time, the others, like 
registration, were available until now only for biotech plants. Monitoring of GMO 
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products is of special importance as it allows to control the GMO products after their 
putting into circulation.  
 
Also important, the Law provides a framework for further measures. It foresees, 
amongst others, the approval of the safety criteria for GMO handling, the procedure 
for licensing genetic engineering activities in closed and open environments and the 
procedure for granting permission for the transit of GMO through Ukraine.  
 
The Law on GMOs is not a large document, particularly when bearing in mind that EU 
legislation in this area is made up of several different regulations and directives7. At 
the same time, it covers a wide range of GMO related issues from the registration of 
GMO-based crop varieties to activities related to GMO products. As a consequence, it 
is in some aspects rather general and would need secondary legislation. The most 
striking example is storage of GMOs, which is addressed by one general sentence 
only (see article 17). Likewise underregulated is the issue of transportation and 
recycling of GMOs. Additionally, some mechanisms introduced by this Law to ensure 
biosafety need specification, above all the procedure for state registration, which is 
at the heart of the system. These issues will have to be covered by secondary 
legislation.  
 
The analysis of the objectives of the Law on GMOs gives information on the intended 
Ukrainian policy regarding commercial use of GMOs in the nearest future. Article 3 of 
the Law provides that its objective is to ensure conditions for a safe usage of GMOs. 
According to this article, protection of human health and the environment has 
priority over possible economic advantages of GMOs. On the other hand, the Law 
foresees state support both to genetic engineering and to research in the area of 
biological and genetic safety in the developing, study and practical usage of GMOs. It 
means that Ukraine intends firmly to benefit from GMO technology. As a result, we 
can expect increased scientific research in this field. 
 
A very positive feature of the Law on GMOs is that it introduces mandatory 
information on GMO usage to the public. Its article 20 ensures availability of this 
information to the public, which is in line with EU laws. Additionally, according to 
article 14 of the Law, the registers of GMOs and GMO products shall be published on 
the Internet website of the responsible central authority and in media. Only 
confidential data under Ukrainian legislation can be kept secret, but the Law states 
clearly that information on effects of the GMO on human health and on the 
environment can in no case be considered confidential.  
 
However, EU legislation goes a step further - the public in the EU should be 
consulted during the process of granting authorization for the proposed GMO release 
into environment. At present, due to the lack of the relevant secondary legislation, it 
is impossible to say whether Ukraine will follow the EU in this regard. 
 
The major weakness of the Ukrainian Law on GMOs is that it does not introduce a 
single control agency that would take on responsibility for ensuring the safe 
developing, testing, transportation and usage of GMOs. Instead of that, regulatory 
                                                 
7 Directive 2001/18/EC on the deliberate release into the environment of GMOs; Regulation (EC) No 
1829/2993 on genetically modified food and feed; Directive 90/219/EEC as amended by Directive 
98/81/EC on the contained use of genetically modified microorganisms; Regulation (EC) No 1946/2003 on 
transboundary movements of GMOs; Regulation (EC) No 1830/2003 concerning the traceability and 
labelling of GMOs and the traceability of food and feed products produced from GMOs, and some other 
instruments that have been adopted in connection with this legislation.  
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and control responsibilities are divided amongst five central bodies: the Cabinet of 
Ministers and the Central Executive Authorities of Education and Science, 
Environment and Natural Resources, Health Care, and Agricultural Policy. The 
authority of each body is specified in articles 7 – 11, and it is the Cabinet that 
coordinates the actions.  
 
The Law does not introduce a requirement for labelling either. The relevant 
provisions are contained in the resolution8 (postanova) of the Cabinet of Ministers of 
1 August 2007, issued for the execution of the Laws on Consumer Rights Protection 
and on Children Foodstuff. It foresees mandatory labelling of foodstuff containing 
GMOs. According to the resolution, GMO content that is over the prescribed threshold 
– set at 0.9% - is subject to mandatory labelling. This particular provision aligns with 
EU norms, which also set the threshold at 0.9%. As a result, import into Ukraine and 
sale of food products containing more than 0.9% of GMO material will be only 
possible under the condition that they are properly labelled9. Additionally, the 
resolution introduces a ban on imports, production and sales of children foodstuff 
with GMOs.   
 
Apart from the above, it is article 12 of the Law on GMOs that merits attention: 
according to it, each company seeking a license for carrying out genetic engineering 
activities in the closed environment should set up a commission, comprising of its 
employees, whose task would be to carry out the initial risk assessment. If Ukraine 
decides to follow EU legislation, this risk assessment will then be examined by a 
competent authority, and on this basis the decision of granting or refusing a license 
will be taken. In this case, law makers should clarify the methodology to be followed 
and elements to be considered to perform the risk assessments that would allow for 
their uniform carrying out by the companies. The Law on GMOs does not provide for 
such rules. In no case the risk assessment conducted by the interested company 
should be the sole basis for the final decision.  
 
Conclusion 
 
The adoption of the Law on GMOs was a first and absolutely necessary step in 
dealing with an important issue of food and environmental safety in both practical 
and legal terms. Still, the Law needs further improvement and development, and it is 
the relevant secondary legislation adopted on its basis that will determine the 
effectiveness of the system.  
 
Based on the above analysis, we recommend to: 
 
? adopt as soon as possible implementing regulations on the basis of the Law 
and for its execution to make the system workable. First, the registration 
procedure for GMOs and GMO products should be specified - as this procedure 
is a main instrument for ensuring biosafety in GMO handling – and system of 
control over the observance of safety rules in genetic engineering activities 
developed; 
 
? establish a single control agency that would take on responsibility for 
ensuring the safe developing, testing, transportation and usage of GMOs to 
                                                 
8 Resolution No 985 of 1 August 2007 
9 Resolution will come into force on November 1, 2007 
 7 
ensure transparency and avoid loopholes in the biosafety system that could 
result from splitted responsibilities;  
 
? include provisions on labelling of GMO food products in the Law on GMOs as 
the laws have higher legal force than resolutions. It should be noted that the 
labelling of GMO products is a unique instrument for ensuring consumers the 
freedom of choice – choice between conventional and GMO products; 
 
? establish a common methodology to conduct the risk assessment; it should 
take account of potential cumulative long-term effects associated with the 
interaction with other GMOs and the environment;  
 
? involve the public in the decision making process regarding the intended GMO 
release; arrangements for such consultation, including a reasonable time 
period, should be laid down in order to give the public and interested 
groups/organisations the opportunity to voice their opinion. 
 
And last but not least, special attention should be paid to ensuring the enforcement 
of the Law. At present, there are three laboratories in Ukraine where GMOs can be 
identified in food and other products that contain or may contain GMOs.  It is crucial 
for Ukraine to set up more independent test centers engaged in estimation of GMO 
concentration. Without operational laboratories and keeping up with the newest 
technologies, it would be impossible to detect GMOs and thus to make the provisions 
of the Law enforceable.  
 
Author: Justyna Jaroszewska 
Lector: Heinz Strubenhoff  
 
Kyiv, September 2007 


Comment on the law of Ukraine No 1103 \u201cOn the state biosafety system for developing, testing, transportation and usage of genetically modified organisms\u201d

Comment on the law of Ukraine No 1103 \u201cOn the state biosafety system for developing, testing, transportation and usage of genetically modified organisms\u201d

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