Document from CIS Legislation database © 2003-2022 SojuzPravoInform LLC

LAW OF THE REPUBLIC OF MOLDOVA

of June 9, 2022 No. 152

On regulation and control of genetically modified organisms

The Parliament adopts this organic law.

This law shifts the Directive 2001/18/EC of the European Parliament and Council of March 12, 2001 about deliberate release to the environment of genetically modified organisms and recognition of the invalid Directive of Council 90/220/EEC published in the Official Magazine of the European communities L 106 of April 17, 2001 with the last changes made by Regulations (EU) of 2019/1381 European Parliament and Council of June 20, 2019.

Chapter I General provisions

Article 1. Sphere of regulation and purpose of the law

(1) This law establishes the regulatory and institutional base necessary for implementation of activities for obtaining, testing, use, realization of genetically modified organisms and transactions on their import / export, with respect for the principle of precaution, for the purpose of ensuring protection of health of the person and the environment, taking into account social and economic interests of the population and the country.

(2) For ensuring biological safety in the field of genetically modified organisms the specified types of activity fall under the special mode of regulation and permission according to provisions of this law and international treaties which party is the Republic of Moldova.

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

Article 2. Scopes of the law

(1) This law regulates the following types of activity:

a) deliberate release to the environment of genetically modified organisms for other purposes, than placement in the market;

b) placement in the market of genetically modified organisms in the form of independent products or components of products;

c) cross-border movement of genetically modified organisms in the form of independent products or components of products in connection with the types of activity provided by Items and) and b).

(2) This law is not applied:

a) to the organisms received using methods of genetic modification, specified in Item 3 of appendix 1;

b) to the genetically modified organisms transported by railway, road transport, inland waterway or air way.

Article 3. The basic principles of state policy in sphere of activity on release to the environment and to placement in the market of genetically modified organisms

State policy in sphere of activity on release to the environment and to placement in the market of genetically modified organisms is based on the following principles:

a) the principle of precaution according to which deliberate release to the environment of genetically modified organisms and placement in the market of the products containing genetically modified organisms or consisting of them is allowed only in the absence of the direct or indirect, immediate or long-term adverse impact capable to cause cumulative long-term adverse effect on the health of the person and the environment established as a result of the risk assessment which is carried out in a transparent way on the basis of safe scientific methods and available scientific and specifications;

b) the principle of safety of transactions on creation, content, burial, testing, commercial use, cross-border movement of the genetically modified organisms and products consisting of genetically modified organisms in the form of independent products or components of products;

c) the principle of priority of health protection of the person and the environment over receipt of economic benefit from use of genetically modified organisms;

d) the principle of transparency in relation to consumers according to which general availability of information on the potential risks arising when using genetically modified organisms and about the actual situation concerning distribution of genetically modified organisms in the Republic of Moldova is provided.

Article 4. Basic concepts

For the purposes of this law the following basic concepts are used in value:

the protective clause - the security tool providing in case of serious danger possibility of departure from this law if important and legitimate interests on ensuring health protection of the person and the environment are protected;

unique identification code - the combination of figures and letters allowing to identify genetically modified organism on the basis of event of genetic transformation and providing access to specific information on him;

deliberate release - intended introduction to the environment of genetically modified organism or combination of genetically modified organisms concerning which measures for isolation and restriction of their contact with the population and the environment, including for ensuring high level of their safety were not taken;

the place - space where there is introduction of genetically modified organisms;

risk management - application of adequate measures of biological safety for minimization of the revealed risks and decrease in their effects for the purpose of achievement of foreseen effects;

genetic modification / genetic transformation - modification of heritable genetic structure of organism with use of the methods specified in Item 1 of appendix 1;

the notification - submission to the Agency of the environment of information required according to this law;

genetically modified organism - any organism, except for human which genetic material was changed by the method other than crossing or natural recombination. For the purposes of this determination:

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

b) the methods specified in Item 2 appendices 1, are not considered as leading to genetic modification;

test for laboratory research - sample of genetically modified organism or part of genetically modified product which is exposed to the analysis for verification of certain characteristics of all material;

product - any product placed in the market containing genetically modified organism or consisting of genetically modified organism or combination of genetically modified organisms;

traceability - possibility of identification and tracking of genetically modified organism in the form of independent product or component of product at all stages of management (production, processing and distribution) for the purpose of ensuring high level of protection of health of consumers;

zone of genetic safety - the territory within which the any kinds of activities connected with use of genetically modified organisms are prohibited.

Article 5. General prohibitions

(1) According to the principle of precaution, in order to avoid adverse effect on health of the person and on the environment deliberate release to the environment of genetically modified organism, including for research purposes and development or for any other purposes, except placement in the market, without the permission issued by the Agency of the environment according to Chapter III provisions is forbidden.

(2) Any genetically modified organism in the form of independent product or component of product intended for deliberate release shall not be considered suitable for placement in the market without preliminary satisfactory testing for stages of research and development in ecosystems in which use of such genetically modified organisms can be reflected.

(3) Cultivation of genetically modified higher plants is forbidden in the natural territories protected by the state, and also in their vicinities at distance smaller, than distance from the next sources of pollen able to cause undesirable alien pollination.

(4) Cultivation for commercial purposes of genetically modified plant varieties is forbidden within 20 years from the date of adoption of this law.

(5) According to the procedure of exception cultivation of genetically modified higher plants for the purposes of the scientific research conducted in the conditions excluding possibility of pollination with sibling species is not forbidden.

(6) placement in the market of genetically modified organism in the form of independent product or component of product without availability of the permission issued by the Agency of the environment according to Chapter IV provisions Is forbidden.

(7) placement in the market of genetically modified organism in the form of independent product or component of product Is forbidden if marking and packaging do not correspond to conditions, stipulated by the legislation in the respective area.

(8) it is not considered placement in the market:

a) provision of genetically modified microorganisms, including collections of cultures, for their use in the conditions of isolation;

b) provision of genetically modified organisms, except the microorganisms specified in Item a), for the purpose of their use only for types of activity where adequate measures of strict isolation on restriction of their contact with the population and the environment and on ensuring high level of safety are taken;

c) provision of genetically modified organism for use is exclusive for the purpose of deliberate releases to the environment according to the requirements provided by Chapter III.

(9) the Genetically modified organisms containing the genes of resistance to antibiotics used in case of treatment of diseases of the person or diseases of animals cannot be placed in the market according to Chapter IV provisions.

(10) Any person representing the notification according to provisions of Chapters III or IV shall prepost assessment of environmental risk (further - OER) for health of the person and the environment developed according to the requirements stated in annex 2.

(11) use of genetically modified organism or combination of such organisms in other purposes, except those which are already specified in the notification requires submission of the separate notification.

Chapter II the Administrative and regulating competences

Article 6. Powers of the Government

Government:

a) establishes the priority directions of state policy in the field of genetically modified organisms;

b) approves the regulatory base in the field of genetically modified organisms for ensuring execution of this law;

c) takes measures for restriction or prohibition of cultivation of genetically modified cultures in all territory of the country or in its separate parts.

Article 7. Powers of the Ministry of the environment

(1) the Ministry of the environment is the body given authority on development, promotion and coordination of realization of single state policy and the regulatory base in the field of genetically modified organisms.

(The Ministry of the environment provides 2):

a) development of state policy and the regulatory base in the field of genetically modified organisms;

b) development and representation to the Government on approval of requirements for restriction or prohibition of use in all territory of the country or in its separate parts of genetically modified organism or group of genetically modified organisms provided that such measures are proportional and non-discriminatory and are proved by the imperative reasons connected with tasks of policy of environmental protection, land use, social and economic influence, avoiding of presence of genetically modified organisms at other products and tasks of agricultural policy;

c) participation of the public in decision making concerning genetically modified organisms;

Warning!!!

This is not a full text of document! Document shown in Demo mode!

If you have active License, please Login, or get License for Full Access.

With Full access you can get: full text of document, original text of document in Russian, attachments (if exist) and see History and Statistics of your work.

Get License for Full Access Now

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

Effectively work with search system

Database include more 50000 documents. You can find needed documents using search system. For effective work you can mix any on documents parameters: country, documents type, date range, teams or tags.
More about search system

Get help

If you cannot find the required document, or you do not know where to begin, go to Help section.

In this section, we’ve tried to describe in detail the features and capabilities of the system, as well as the most effective techniques for working with the database.

You also may open the section Frequently asked questions. This section provides answers to questions set by users.

Search engine created by SojuzPravoInform LLC. UI/UX design by Intelliants.