Official translation

Official translation Official translation REPUBLIC OF LITHUANIA LAW ON GENETICALLY MODIFIED ORGANISMS 12 June 2001 No. IX-375 Vilnius CHAPTER ONE GENERAL PROVISIONS Article

1. Purpose and Scope of the Law
2. This Law establishes the spheres of activities involving genetically modified organisms and genetically modified products, their state management and regulation, also the rights, duties and responsibility of the users of the said organisms and products.
3. The Law shall apply to all natural and legal persons who are connected with deliberate release into the environment, use, placing on the market, carrying out of tests and research, and other activities involving genetically modified organisms and genetically modified products, provided for by this Law, in the territory of the Republic of Lithuania.
4. This Law shall not establish compulsory safety requirements for the carriage of genetically modified organisms and genetically modified products across the territory of the Republic of Lithuania in transit, also by rail, road, inland waterway, sea or air. The above requirements shall be established by other legal acts of the Republic of Lithuania. Article
5. Definitions
6. "Organism" is any biological entity capable of replication and/or of transferring genetic material.
7. "Genetically modified organism" means an organism (except for humans) in which the genetic material has been altered in a way which does not occur naturally and which has acquired properties which may not be acquired naturally by mating and/or natural recombination.
8. "Genetically modified product" means a preparation consisting of, or containing, genetically modified organisms or their parts, which is placed on the market.
9. "Deliberate release" means production and use of genetically modified organisms and genetically modified products meeting all safety and risk assessment requirements, without taking any additional measures to limit the effects on human health and the environment.
10. "Accident" means any incident involving unintended release of genetically modified organisms and genetically modified products which have or may have adverse effects on human health and the environment.
11. "Use" means any activity in which genetically modified organisms are propagated, cultured or used otherwise in a contained manner and/or genetically modified products are manufactured and placed on the market, genetically modified organisms and genetically modified products are deliberately released into the environment, imported, exported, also tests and research work.
12. "Users" means natural and legal persons who have been given authorisation for a certain activity according to the procedure established by law and who are using for the activity genetically modified organisms and genetically modified products.
13. "Contained use" means any operation in which organisms are genetically modified or in which such genetically modified organisms are cultured, stored, destroyed or disposed of, transported for production purposes; also research and tests during which the effects of the organisms on humans and the environment are under strict control.
14. "Notification" means the submission to the Ministry of the Environment of information on the intended release into the environment, placing on the market and/or contained use of genetically modified organisms and genetically modified products, also on other activities provided for in this Law, involving the use of genetically modified organisms and genetically modified products.
15. "Risk assessment" means evaluation of the risk posed to human health and the environment by the use of genetically modified organisms and/or genetically modified products.
16. "Placing on the market" means putting into circulation, marketing, importing, exporting, leasing, selling or otherwise supplying or making genetically modified organisms and/or genetically modified products available to a natural or legal person who is or may be engaged in the activities involving genetically modified organisms and/or genetically modified products.
17. "Safety examination of a genetically modified product" means evaluation of the properties of a genetically modified product, which may affect human health and the environment and presentation of conclusion about the safety of the genetically modified product.
18. "Genetically modified product safety control " means control of safety of genetically modified products exercised by state institutions and agencies, seeking to establish whether the genetically modified product which is being placed on the market complies with the mandatory safety requirements. CHAPTER TWO COMPETENCE AND FUNCTIONS OF STATE INSTITUTIONS Article
19. System of State Management of the Use of Genetically Modified Organisms and Genetically Modified Products In the Republic of Lithuania, State management of activities involving the use of genetically modified organisms and genetically modified products shall be carried out by the Ministry of the Environment. Article
20. Competence of the Ministry of the Environment The Ministry of the Environment shall: 1) lay down the procedure for submitting the notifications about genetically modified organisms and genetically modified products; 2) in conjunction with the Ministry of Health and the Ministry of Agriculture, the State Food and Veterinary Service establish the procedure for assessing the risks presented to the environment and human and animal health by genetically modified organisms and genetically modified products, and the information required for risk assessment; 3) receive the notifications from natural and legal persons about genetically modified organisms and genetically modified products; 4) give authorisation for activities involving the use of genetically modified organisms and genetically modified products, revoke and cancel the authorisation according to the procedure laid down by this Ministry; 5) in the manner prescribed by the Government announce to the public and the institutions authorised by the State, which are responsible for market surveillance and state safety examination, about the giving, suspension and revocation of authorisation and about the cases of accidents, publishing a notice to the effect in the publication "Valstybės žinios" (supplement "Informaciniai pranešimai"); 6) lay down mandatory requirements for labelling of genetically modified organisms and genetically modified products, except foodstuffs containing genetically modified organisms or consisting thereof, or manufactured therefrom; 7) together with the Ministry of Health, the State Food and Veterinary Service establish criteria for the classification of genetically modified organisms; 8) build and manage the database of genetically modified organisms and genetically modified products; 9) perform the functions assigned to it by this Law and other legal acts of the Republic of Lithuania. Article
21. Competence of the Ministry of Health The Ministry of Health shall: 1) together with the State Food and Veterinary Service establish mandatory safety requirements for food which contains genetically modified organisms or consists thereof or is manufactured therefrom; 2) together with the Ministry of Economy, the Ministry of Agriculture and the State Food and Veterinary Service establish the mandatory labelling requirements for foodstuffs containing genetically modified organisms or consisting thereof or manufactured therefrom; 3) establish the procedure of safety examination of food which contains genetically modified organisms or consists thereof or is manufactured therefrom; 4) together with the Ministry of Agriculture set the requirements for the manufacturing or placing on the market of food which contains genetically modified organisms or consists thereof or is manufactured therefrom; 5) together with the State Food and Veterinary Service establish the procedure for conducting safety examination of products; 6) establish the procedure of acceptance for use, registration and use of medicinal products, medicines containing or manufactured from genetically modified organisms, except for veterinary products and veterinary medicines; 7) perform the functions assigned to it by this Law and other legal acts of the Republic of Lithuania. Article
22. Competence of the Ministry of Agriculture The Ministry of Agriculture shall: 1) participate, in the manner laid down by the Government or the institution authorised by it, in carrying out the assessment of risk posed to agriculture by genetically modified organisms and genetically modified products; 2) perform the functions assigned to it by this Law and other legal acts of the Republic of Lithuania. Article
23. Competence of the State Food and Veterinary Service The State Food and Veterinary Service shall: 1) together with the Ministry of Health establish the requirements for manufacturing and placing on the market foodstuffs and their constituent parts which contain genetically modified organisms or consist thereof or are manufactured therefrom; 2) carry out safety examination of genetically modified products according to the established procedure; 3) establish the procedure of approval, registration and use of veterinary products, veterinary equipment, veterinary medicines which contain genetically modified organisms or which are manufactured therefrom; 4) perform the functions assigned to it by this Law and other legal acts of the Republic of Lithuania. Article
24. State Safety Control of Genetically Modified Organisms and Genetically Modified Products State safety control of genetically modified organisms and genetically modified products shall be exercised by: 1) the Ministry of Environment or an institution authorised by it – the control of the release into the environment of genetically modified organisms; 2) according to their competence, the State Food and Veterinary Service, the Ministry of Agriculture and the Ministry of Health or the institutions authorised by them – the safety control of placing on the market of genetically modified organisms and genetically modified products, and market surveillance; 3) according to their competence, the Ministry of Environment, the State Food and Veterinary Service, the Ministry of Agriculture and the Ministry of Health or the institutions authorised by them – the control of the contained use of genetically modified organisms; 4) the Ministry of Health or an institution authorised by it – the safety control of medical and pharmaceutical products consisting of, or manufactured from, genetically modified organisms; 5) the State Food and Veterinary Service – the safety control of veterinary products and preparations, marketable feedingstuffs consisting of, or manufactured from, genetically modified organisms. CHAPTER THREE REGULATION OF ACTIVITIES INVOLVING THE USE OF GENETICALLY MODIFIED ORGANISMS AND GENETICALLY MODIFIED PRODUCTS Article
25. Authorisation for the Activities Involving the Use Genetically Modified Organisms and Genetically Modified Products
26. In the Republic of Lithuania, natural and legal persons who wish to engage in the activities involving the use of genetically modified organisms and genetically modified products must be given an authorisation by the Ministry of the Environment. In order to obtain the authorisation, they shall submit to the Ministry of the Environment a notification as regards their intention to engage in the activities involving the use of genetically modified organisms and genetically modified products.
27. Before making a decision on the giving of an authorisation to engage in the activities involving the use of genetically modified organisms and/or genetically modified products, the Government or the institution authorised by it shall summarise, in the established manner, risk assessment and safety examination of the genetically modified organisms and/or genetically modified products. Article
28. Rights and Duties of the User
29. Having received the conclusion of the Ministry of the Environment on the risk posed to the environment and human health by the genetically modified organisms and products, the user shall have the right to use the genetically modified organisms and genetically modified products for which the authorisation has been given in any other country and the validity whereof in the territory of the Republic of Lithuania has been given a legal basis according to the procedure laid down by the Ministry of Foreign Affairs.
30. The user shall have the right to receive from the Ministry of the Environment, the Ministry of Health and the Ministry of Agriculture information about genetically modified organisms and/or genetically modified products and the use thereof.
31. The user must comply with all requirements specified in the authorisation.
32. The user must take any measures necessary to protect the environment and human health from potential negative impact of the genetically modified organisms and products.
33. In the event of an accident the user shall be required immediately to inform the Ministry of the Environment and to take all measures to limit the negative effects.
34. The user shall provide information and data relating to the genetically modified organisms and genetically modified products used by him to the Ministry of the Environment according to the procedure laid down by the Government or the institution authorised by it.
35. The user shall conduct the assessment of risks posed to the environment and human health by the genetically modified organisms and carry out safety examination of genetically modified products according to the procedure laid down by the Ministry of the Environment and the Ministry of Health according to their competence. CHAPTER FOUR DATA ON GENETICALLY MODIFIED ORGANISMS AND GENETICALLY MODIFIED PRODUCTS Article
36. Data Base of Genetically Modified Organisms and Genetically Modified Products
37. The Ministry of the Environment shall build and manage the data base of genetically modified organisms and genetically modified products for the purpose of ensuring control of the use of genetically modified organisms and genetically modified products. CHAPTER FIVE PROVISION OF INFORMATION TO THE PUBLIC AND PARTICIPATION IN DECISION MAKING Article
38. Provision of Information to the Public and Participation in Decision Making The public shall have the right to participate, according to the procedure established by legal acts, in the making of decisions relating to the use of genetically modified organisms and genetically modified products and to receive information thereon. CHAPTER SIX FINAL PROVISIONS Article
39. Liability for the Violations of this Law Natural and legal persons who violate the requirements of this Law shall be held liable according to the procedure established by the laws of the Republic of Lithuania. Article
40. Compensation for Damage Natural and legal persons who inflict damage on the environment, human health, property and interests of other legal an natural persons by their activities involving the use of genetically modified organisms and genetically modified products must compensate for the damage inflicted and, where possible, restore the object of the environment to its previous condition according to the procedure laid down by laws and other legal acts. If damage has been caused to the environment or human health, the interests of the State shall be represented by the Ministry of the Environment and the Ministry of Health according to their competence. Article
41. Entry into Force of the Law This Law shall enter into force as of 31 December
42. Article
43. Recommendation to the Government Prior to the entry into force of this Law, the Government or the institution authorised by it shall draft and approve legal acts necessary for the implementation thereof. I promulgate this Law passed by the Seimas of the Republic of Lithuania. PRESIDENT OF THE REPUBLIC VALDAS ADAMKUS Annex to Republic of Lithuania Law No IX-375 On Genetically Modified Organisms The Law of the Republic of Lithuania on Genetically Modified Organisms has been harmonised with Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and Council Directive 98/81/EC of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms.