LAW OF THE REPUBLIC OF MOLDOVA

of July 10, 2025 No. 199

About use of genetically modified microorganisms in the closed systems and about modification of some regulations

The parliament adopts this organic law.

This law shifts:

– The directive of the European parliament and Council 2009/41/EC of May 6, 2009 about use of genetically modified microorganisms in the closed systems (in the new edition), published in the Official magazine of the European Union by L 125 of May 21, 2009, CELEX: 32009L0041;

– The decision of the European commission 2000/608/EC of September 27, 2000 about the guidelines on risk assessment stated in annex III to the Directive 90/219/EES on use of genetically modified microorganisms in the closed systems (the notification under document number of C (2000) 2736), published in the Official magazine of the European Union by L 258 of October 12, 2000, CELEX: 32000D0608.

Chapter I. General provisions

Article 1. Purpose and subject of regulation

(1) the Purpose of this law is creation of the regulatory base necessary for implementation of the activities connected with use of genetically modified microorganisms in the closed systems according to the principle of precaution for the purpose of health protection of the person and the environment.

(2) For the purpose of ensuring biological safety in the field of use of genetically modified microorganisms in the closed systems the activities specified in part (1), is subject to specific mode of regulation and issue of permissions according to provisions of this law and international treaties which party is the Republic of Moldova.

(3) If the international treaties ratified by Parliament of the Republic of Moldova establish other regulations, than those which are provided by this law are applied regulations of international treaties.

Article 2. Scope of application

(1) This law is applied to activities for use of genetically modified microorganisms in the closed systems taking into account implementation of genetic modification at least by means of use of methods, stipulated in Item 1 appendix 1.

(Methods, stipulated in Item 2 appendices 1, do not lead 2) to genetic changes and do not fall under operation of this law.

(3) This law is not applied:

a) in cases when genetic modifications are received with use of the methods/technologies specified in Item 3 of appendix 1;

b) in case of use in the closed systems in which only the types of genetically modified microorganisms corresponding to 2 criteria listed in appendix are involved and which guarantees their safety for health of the person and the environment;

c) to activities for storage, cultivation, transportation, destruction, utilization, use of genetically modified microorganisms which were placed in the market, according to national regulations, before entry into force of this law.

(4) Provisions of Articles 12-21 are not applied to transportation of genetically modified microorganisms by road, railway, inland water, sea or air transport.

Article 3. Concepts

For the purposes of this law the following concepts are used:

1) accident – the incident attracting inadvertent and essential release to the environment of genetically modified microorganisms in the course of their use which can create immediate or delayed health hazard of the person or the environment;

2) biological safety – set of the measures taken for decrease or elimination of risks which can result from use of genetically modified microorganisms and make adverse effect on health of the person and the environment;

3) use risk assessment in the closed systems – scientific research according to direct or indirect, immediate or delayed risks for health of the person and the environment which use of genetically modified microorganisms in the closed systems can represent;

4) microorganism – the microbiological cellular or noncellular education capable to reproduction or transfer of genetic material, including viruses, viroida, cages of animals and plants in cultures;

5) genetically modified microorganism – microorganism which genetic material was changed using method, excellent from natural and which was not received as a result of natural crossing and/or recombination.

For the purpose of this determination:

a) genetic modification is made at least using the methods specified in Item 1 of appendix 1;

b) it is considered that the methods specified in Item 2 appendices 1, do not lead to genetic modifications;

6) the notification – submission to the Agency of the environment of information required according to this law;

7) the informer – the legal entity representing the notification containing information specified in appendix 6;

8) the action plan in emergency situations – package of measures and the actions applied in case of accident;

9) the magazine of laboratory accounting – the database managed by the user about the activities performed with genetically modified microorganisms in case of their use in the closed systems;

10) use in the closed systems – activities within which genetically modified microorganisms are cultivated, stored, transported are destroyed, utilized or used by any other method and for what special measures on isolation of their contact with the population and the environment and ensuring high level of protection of the population and the environment are taken;

11) the user – physical person or legal entity which bears responsibility for use of genetically modified microorganisms in the closed systems.

Chapter II. The administrative and regulating powers

Article 4. Powers of the Government

Government:

a) establishes the priority directions of state policy in the field of use of genetically modified microorganisms in the closed systems;

b) approves the subordinate regulatory base in the field of use of genetically modified microorganisms in the closed systems.

Article 5. Powers of the Ministry of the environment

(1) the Ministry of the environment is the central body of the public power responsible for development, promotion and coordination of realization of single state policy and the regulatory base in the field of use of genetically modified microorganisms in the closed systems.

(The Ministry of the environment provides 2):

a) development of the regulatory base in the field of use of genetically modified microorganisms in the closed systems;

b) coordination of accomplishment of international treaties on genetically modified microorganisms which party is the Republic of Moldova;

c) cooperation in the field of use of genetically modified microorganisms in the closed systems with other states and their similar structures according to the national legal system, rules of international law and agreements which party is the Republic of Moldova;

d) cooperation with the European commission in the field of the legislation on genetically modified microorganisms.

Article 6. Powers of the Agency of the environment

The agency of the environment is responsible for realization of policy and the regulatory base in the field of use of genetically modified microorganisms in the closed systems by administrative authority which performs the following powers:

a) provides accomplishment of provisions of the national legal system in the field of use of genetically modified microorganisms, performs monitoring and periodically reports to the Ministry of the environment on the course of their accomplishment, makes offers on introduction of amendments to the relevant legislation;

b) ensures functioning of the secretariat of the National commission on biological safety;

c) issues, prolongs, stops or withdraws permissions according to this law;

d) cooperates with the Ministry of the environment, the National commission on biological safety and monitoring bodies in the field of use of genetically modified microorganisms in the closed systems, including in emergency situations, for the purpose of risk minimization for health of the person and the environment;

e) advises and informs the public in decision making process according to the legislation on access for the public to information on the environment and confidentiality;

f) informs authorities and the public on issue, prolongation, suspension or withdrawal of permissions, and also on accidents;

g) constitutes and keeps the List of the legal entities having permissions to use of genetically modified microorganisms in the closed systems;

h) informs the Ministry of the environment in case of the accidents connected with genetically modified organisms including as a result of cross-border movements;

i) coordinates response measures and provides accomplishment of measures for recovery in case of accident or emergency situations within the activities connected with genetically modified organisms including in case of cross-border movements;

j) carries out monitoring of use of genetically modified microorganisms, including for the purpose of research and development according to the applicable regulatory base and without violation of confidentiality of the researches protected by the legislation on intellectual property;

k) constitutes at the end of every year the summary report on use in the closed systems of the 3rd and 4th classes which it was declared within year, including the description, the purpose and risks of use which is the national database necessary for preparation of national reports on use of genetically modified microorganisms in the closed systems and their representation of the environment by the Ministry to the international institutions.

Article 7. Powers of the Ministry of Health

The Ministry of Health is the central body of the public power having competence in use of genetically modified microorganisms of health sector, including the scientific research performed in the closed systems, and performing the following powers:

a) publishes regulations in the field of safety of the activities connected with genetically modified microorganisms;

b) establishes safety requirements when transporting of genetically modified pathogenic microorganisms.

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info