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LAW OF UKRAINE

of August 23, 2023 No. 3339-IX

About state regulation of genetic and engineering activities and the state control of placement in the market of genetically modified organisms and products

This Law determines legal and organizational basis of state regulation of genetic and engineering activities, ensuring ecological, genetic, food and biological safety of the state and the state control of placement in the market of genetically modified organisms and products.

Section I. General provisions

Article 1. Terms and their determination

1. In this Law terms are used in the following value:

1) biological safety (biosafety) - system of the actions directed to prevention and/or elimination of irreversible negative impact of genetically modified organisms on human health, other live organisms and the surrounding environment;

2) the open system system assuming contact of genetically modified organisms with people, other live organisms and the surrounding environment during creation, testing and/or practical use, in particular cultivation, including cultivation, processing, storage, transportation, destruction or burial;

3) genetic engineering - set of methods, methods and technologies of receipt of recombinant nucleinic acids, allocation of genes from organism (cages), implementation of manipulations with genes and their introductions in organisms of other type;

4) genetic safety - system of the measures directed to prevention or reduction of possible negative impact of genetically modified organism by human genome or genome of any other live organism;

5) genetically engineered activities - the scientific and technical activities connected with creation, research and testing of genetically modified organisms in the closed system and/or with research and testing of genetically modified organisms in open system;

6) genetically modified products (further - GM-products) - the products containing, consisting or made from one or several genetically modified organisms and intended for placement in the market;

7) GM-products as forage - the forage containing, consisting or made from one or several genetically modified organisms;

8) GM-products as foodstuff - the foodstuff containing, consisting or made from one or several genetically modified organisms;

9) genetically modified source (further - GM-source) - the line of genetically modified plants, animals, mushrooms or microorganisms containing:

a) the certain genetic modification with specific localization in the genome performed by methods of genetic engineering; or

b) more than one genetic modification performed by methods of genetic engineering and received in the way:

crossing of simple GM-sources, each of which contains already existing modifications; or

repeated genetic modification of the existing GM-source; or simultaneous introduction of several genes or signs;

10) genetically modified organism (dalee-GMO) - any organism, except the person in whom genetic material is purposefully changed owing to transfer in genome of organism recipient of exogenous nucleinic acid by method which does not occur in the natural way, owing to crossing and/or natural recombination;

11) GMO, used for production of forages, - GMO, intended for feeding of animals, or used as raw materials or ingredient for production of forages;

12) GMO used for production of foodstuff is the GMO intended for consumption by the person as foodstuff or used as raw materials or ingredient for production or preparation of foodstuff;

13) state registration of GMO - entering into the State register of GMO of data on GMO, including about GM-source, with indication of the purposes of its use;

14) the State register of GMO - the single state information system containing data on GMO which underwent state registration;

15) the State register of permissions to carrying out researches and testing of GMO in the state information system containing data on the issued permissions to carrying out researches and testing of GMO in the open system opened sisteme-Edinaya;

16) the State register of subjects of genetic and engineering activities - the single state information system containing the information about subjects of genetic and engineering activities;

17) research and testing of GMO in open system - activities which lead to release of GMO in the open system performed before its state registration for any purposes except placement in the market;

18) the closed system system of implementation of genetic and engineering activities as a result of which genetic modifications are brought in microorganism or such GMO is cultivated, processed, stored, used, transported, is liable to destruction or burial using protective measures;

19) the protective measures measures accepted by the subject of genetic and engineering activities for prevention and prevention of emergence of risks of negative impact of GMO on health of the person and/or the surrounding environment including in case of inadvertent release of GMO;

20) network of post-registration monitoring of GMO - the system of account which is kept by the owner of state registration of the corresponding GMO which contains information on persons to whom such owner directly gave such GMO or GM-products which is made consists or contains the corresponding GMO;

21) microorganism - any microbiological formation of cellular or noncellular structure capable to self-reproduction or transfer of genetic material, including viruses, viroida, and also cages of animal or phytogenesis cultivated by in vitro;

22) intentional release of GMO - any conscious and permitted release of GMO to the environment which is not assuming application of protective measures;

23) inadvertent release of GMO - any event during which there is accidental release of GMO which can exert obvious or delayed negative impact on health of the person and/or the environment;

24) organism - any biological education, including microorganism capable to self-reproduction or transfer of genetic material;

25) risk assessment the GMO-evidence-based analysis of GMOs properties and/or GM-products performed for the purpose of establishment of the possible direct or mediated, obvious or delayed risk of GMO and its possible negative impact on health of the person and/or the surrounding environment;

26) post-registration monitoring of GMO - monitoring of possible negative impacts on health of the person and/or the environment which can arise owing to use of GMO;

27) processing GMO-any activities connected with GMO including genetically engineered activities in the closed system, researches and testing of GMO in open system, placement in the market of GMO and GM-products, any actions connected with transition of right of possession or property right to GMO;

28) products made from GMO - the products made (received) fully or partially from GMO, but which are not containing and not consisting of GMO;

29) products which are not containing GMO, - the products (which are not processed, partially processed or processed), made (created) without application of methods of genetic engineering which does not exert negative impact on health of the person and/or the surrounding environment;

30) referensny samples GMO-reference material GMO which properties are uniform and suitable for assessment of method (technique) of determination of GMO or establishments of certain properties of the researched material. Referensny samples include positive sample (GM-source or its genetic material) and negative sample (The parent organism or its genetic material used for the purposes of genetic modification);

31) risk of GMO - possibility of any negative consequences and possible scales of impact on health of the person and/or the environment owing to the address with GMO;

32) risk levels when implementing genetic and engineering activities in the closed system degree of potential danger of GMO for health of the person and/or the surrounding environment that can arise when implementing genetic and engineering activities in the closed system;

33) placement of GMO and GM-products in the market - any ownership of GMO and GM-products for the purpose of realization, including the offer to realization or to any other form of transfer of property on GMO and GM-products on paid basis and/or on other beginnings, including realization, distribution and/or other forms of transfer of property on GMO and GM-products, except return to the previous owner. For the purposes of this Law production (cultivation) of genetically modified plants, animals, mushrooms, microorganisms is considered placement in the market of GMO and GM-products;

34) the subject of genetically engineering activities - person performing genetically engineering activities according to this Law;

35) cross-border movement of GMO - any import to customs area of Ukraine, export from customs area of Ukraine or transit through customs area of Ukraine of GMO and/or GM-products.

2. Other terms are used in this Law in the values given in the laws of Ukraine "About the basic principles and requirements to safety and quality of foodstuff", "About safety and hygiene of forages", "About the state control of compliance with law about foodstuff, sterns, by-products of animal origin, veterinary medicine and wellbeing of animals", "About seeds and landing material", "About protection of the rights to plant varieties", "About the state support of agricultural industry of Ukraine".

Article 2. The legislation of Ukraine in the sphere of the address with GMO

1. The legislation of Ukraine in the sphere of the address with GMO consists of the Constitution of Ukraine, this Law, the laws of Ukraine "About the basic principles and requirements to safety and quality of foodstuff", "About information for consumers concerning foodstuff", "About system of public health", "About seeds and landing material", "About protection of the rights to plant varieties", "About safety and hygiene of forages", "About protection of the surrounding environment", "About the basic principles of the state supervision (control) in the sphere of economic activity", "About the state control of compliance with law about foodstuff, sterns, by-products of animal origin, veterinary medicine and wellbeing of animals", "About protection of the rights to inventions and useful models", other regulatory legal acts adopted according to them, and also the corresponding international treaties, which consent to be bound is provided by the Verkhovna Rada of Ukraine.

2. If the international treaty of Ukraine which consent to be bound is provided by the Verkhovna Rada of Ukraine establishes other rules, than those that are provided by this Law, rules of the international treaty are applied.

Article 3. Law coverage

1. Operation of this Law extends to the relations in the sphere of the address with GMO:

1) genetically engineering activities in the closed system;

2) research and testing of GMO in open system;

3) state registration of GMO;

4) placement in the market of GMO and hypermarket of products;

5) marking of GM-products;

6) measures of the state control over the address with GMO.

2. Operation of this Law does not extend to the relations arising in connection with:

1) registration and the address of any products intended for the medical purposes, including medicines;

2) registration and address of veterinary medicines;

3) application of methods (acceptances) of change of genetic material of live organisms without use of recombinant molecules of nucleinic acids, including on self-cloning, methods of mutagenesis, merge of plant cells (protoplasts), and also on:

extracorporal fertilization;

the conjugation, transduktion, transformation happening under natural conditions;

inductive poliploidiya

3. Operation of this Law does not extend to genetically engineering activities concerning human body, bodies, fabrics and separate cages as a part of human body.

Article 4. The principles of state policy in the sphere of the address with GMO

1. State policy in the sphere of the address with GMO is based on the principles:

1) legality - compliance of the Constitution of Ukraine and to the laws of Ukraine, the international obligations of Ukraine;

2) opennesses - providing open entry to information on genetically engineering activities in Ukraine, GM-products and the address with GMO;

3) priority of preserving human health and protection of the surrounding environment in comparison with receipt of economic benefits;

4) prevention of possible negative impacts on human health and surrounding environment;

5) observance of rules of the treatment of the animals excluding cruelty;

6) providing ecological safety, genetic safety, food security and biosafety during creation, research, testing and use of GMO;

7) control of GMO and GM-products at all stages of the treatment of them;

8) coordination and coordination of long-term strategy, plans and development programs of genetically engineering activities in Ukraine with other nation-wide plans and programs.

Section II. Powers of executive bodies and other state bodies and organizations in the sphere of the address With GMO

Article 5. Executive bodies in the field of the address with GMO

1. In the sphere of the address with GMO treat system of executive bodies:

1) Cabinet of Ministers of Ukraine;

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