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Release into Environment of Genetically Modified Organisms Act

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Release into Environment of Genetically Modified Organisms Act - content
Issuer:Riigikogu
Type:act
In force from:01.01.2011
In force until:30.06.2014
Translation published:14.11.2013

Release into Environment of Genetically Modified Organisms Act1

Passed 14.04.2004
RT I 2004, 30, 209
Entry into force 01.05.2004

Amended by the following legal instruments (show)

PassedPublishedEntry into force
07.12.2006RT I 2006, 58, 43901.01.2007
11.01.2007RT I 2007, 6, 3201.02.2007
14.02.2007RT I 2007, 22, 11401.07.2007
18.12.2008RT I 2009, 3, 1501.02.2009
10.06.2009RT I 2009, 34, 22401.01.2010
22.04.2010RT I 2010, 22, 10801.01.2011, shall enter into force on the date specified in the decision of the Council of the European Union concerning abrogation of the derogation established with regard to the Republic of Estonia on the basis of Article 140(2) of the Treaty on the Functioning of the European Union, Decision No. 2010/146/EU of the Council of the European Union of 13 July 2010 (OJ L 196, 28.07.2010, pp. 24-26).
13.10.2010RT I, 08.11.2010, 118.11.2010, in part 01.01.2011
08.12.2010RT I, 17.12.2010, 1901.01.2011

Chapter 1 GENERAL PROVISIONS 

§ 1.  Scope of application of Act

 (1) The purpose of this Act is:
 1) to prevent possible adverse effects to human health and the environment upon release of genetically modified organisms into the environment or upon marketing genetically modified organisms and to ensure safe application of genetic engineering and the development thereof in an ethically responsible manner;
 2) to prevent the admixture of non-GM crops and GM crops and the unintended presence of genetically modified organisms in other products.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

 (2) This Act regulates:
 1) the r elease of genetically modified organisms into the environment;
 2) placing on the market of genetically modified organisms, and products containing or composed of such organisms;
 3) the handling of GM crops.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

 (3) This Act does not apply to:
 1) modification of genes of human beings by means of genetic engineering;
 2) organisms produced using such genetical modification proceedings or methods involving mutagenesis or by fusing the cells (including protoplasts) of such organisms, which may exchange genetic material also by using conventional breeding methods;
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]
 3) medicinal products for humans containing or composed of genetically modified organisms, that are addressed by other legislation;
 4) contained use of genetically modified organisms, including contained use of micro-organisms;
 5) transportation of genetically modified organisms by rail, road, inland water bodies, sea or air;
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]
 6) transportation of GM crops from one state to another via Estonia without unloading;
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]
 7) transportation of properly packaged seeds or plant propagating material of a GM crop authorised to the market of the European Union;
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

 (4) Clauses 5 (2) 3)-5) of this Act apply in the event specified in clause 4) of subsection (3) of this section.

 (5) [Repealed – RT I, 08.11.2010, 1 – entry into force 18.11.2010]

 (6) The provisions of the Administrative Procedure Act apply to the administrative proceedings provided in this Act, taking into consideration the specifications provided for in this Act.

§ 2.  Definitions

 (1) For the purposes of this Act ‘organism’ means any biological entity capable of replication or of transferring genetic material.

 (2) Genetically modified organism is an organism in which genetic material has been altered in a way that does not occur naturally.

 (3) [Repealed – RT I, 08.11.2010, 1 – entry into force 18.11.2010]

 (4) For the purpose of this Act, ‘product’ means a preparation containing or consisting of a genetically modified organism or a combination of genetically modified organisms.

 (5) For the purpose of this Act, ‘accident’ means the unintended release of large amounts of genetically modified organisms into the environment which is likely to have an adverse effect on human health or the environment.

 (6) For the purposes of this Act, ‘handling GM crops’ (hereinafter handling) means the cultivation, transportation or storage of a genetically modified crop on the basis of a marketing authorisation of the European Union.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

 (7) Handler of a GM crop (hereinafter handler) is a self-employed person or a legal person registered in the database of the locations and handlers of genetically modified crops who, for the purposes of this Act, cultivates, transports or stores genetically modified crops authorised for cultivation in the European Union on the basis of a marketing authorisation.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

§ 3.  Genetic modification

 (1) Genetic modification occurs through the use of at least one of the following techniques:
 1) recombinant nucleic acid techniques involving the formation of new combinations of genetic material outside an organism, and their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation;
 2) techniques involving the introduction into an organism of genetic material prepared outside the organism;
 3) techniques where live cells with new combinations of genetic material are formed through the fusion of two or more cells by means of methods that do not occur naturally.

 (2) The following techniques are not considered to result in genetic modification:
 1) in vitro fertilisation;
 2) natural processes such as: conjugation, transduction, transformation;
 3) polyploidy induction.

 (3) The provisions of subsection (2) apply on condition that the techniques do not involve the use of recombinant nucleic acid molecules or genetically modified organisms within the meaning of clause 1) of subsection (1) of this section.

§ 4.  Releasing genetically modified organisms into environment and placing genetically modified organisms and products on market

 (1) Release of genetically modified organisms into the environment means the removal of a genetically modified organism or a combination of genetically modified organisms from containment, or storage thereof outside such space for any purpose other than placing the genetically modified organisms on the market without taking any specific containment measures prescribed to limit their non-controlled spread.

 (2) The measure specified in subsection (1) of this section constitute a physical barrier or a physical barrier combined with a chemical or biological barrier which precludes any contact between a genetically modified organism and other organisms or which precludes the release of a genetically modified organism into the environment.

 (3) Placing a genetically modified organism or product on the market means making such organism or product available to a third party whether in return for payment or free of charge.

 (4) Placing on the market does not include:
 1) making genetically modified micro-organisms, including cell culture collections, available in operations regulated by Council Directive 90/219/EEC on the contained use of genetically modified micro-organisms (OJ L 117, 8.5.1990, pp. 1-14);
 2) making genetically modified micro-organisms not specified in clause 1) of this subsection available only for such operations where adequate strict containment measures are used for limiting contacts with the human population and the environment and ensuring a high level of protection;
 3) making genetically modified organisms available for the purpose of using them only upon such deliberate release into the environment, which complies with the requirements established in Part B of the 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 repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, pp. 1-39).
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

§ 5.  Gene Technology Commission

 (1) The Gene Technology Commission is an advisory body established within the area of government of the Ministry of the Environment.

 (2) The function of the Gene Technology Commission is to:
 1) advise governmental authorities in issues of gene technology and environmental risks arising from genetically modified organisms or products;
 2) advise notifiers applying for authorisation for release of genetically modified organisms into the environment, and notifiers applying for authorisation for placing genetically modified organisms or products on the market;
 3) review notifications for authorisation for release of genetically modified organisms into the environment, notifications for authorisation for placing genetically modified organisms or products on the market and notifications for contained use of genetically modified organisms;
 4) give an opinion on the deliberate release of genetically modified organisms into the environment, placing genetically modified organisms or products on the market and contained use of genetically modified organisms indicated in the notifications;
 5) provide consultations to the Labour Inspectorate on issues related to the contained use of genetically modified micro-organisms;
 6) provide consultations to the Ministry of Agriculture on issues related to the conduct of animal experiment involving genetically modified animals.

 (3) The membership of the Gene Technology Commission shall be established by an order of the Government of the Republic, taking into account that the Gene Technology Commission shall comprise of members who hold a relevant academic degree and represent various relevant research areas. The statutes of the Gene Technology Commission shall be approved by a regulation of the Government of the Republic. The statutes of the Gene Technology Commission shall establish the rights, obligations, rules of procedure, procedure for making decisions, operations procedure and procedure for remuneration of the Commission.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

 (4) The Gene Technology Commission shall include:
 1) two members to be appointed on the proposal of the Minister of the Environment;
 2) one member to be appointed on the proposal of the Minister of Economic Affairs and Communications;
 3) four members to be appointed on the proposal of the Minister of Agriculture. One of these four members must represent crop growers and one must represent crop processors;
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]
 4) one member to be appointed on the proposal of the Minister of Social Affairs;
 5) two members to be appointed on the proposal of the Rector of the University of Tartu;
 6) one member to be appointed on the proposal of the Rector of the Estonian University of Life Sciences;
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]
 7) one member to be appointed on the proposal of the Rector of Tallinn University of Technology;
 8) three members to be appointed on the proposal of the President of the Estonian Academy of Sciences;
 9) two members to be appointed on the proposal of environmental organisations.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

Chapter 2 RELEASE OF GENETICALLY MODIFIED ORGANISMS INTO ENVIRONMENT 

§ 6.  Release of genetically modified organisms into environment

 (1) genetically modified organisms shall be released into the environment only on the basis of a written authorisation of the Minister of the Environment (hereinafter authorisation). The specific list of data included in the authorisation and the format of the authorisation shall be established, based on the provisions of subsection 12 (5) of this Act, by a regulation of the Minister of the Environment.

 (2) A person wishing to release genetically modified organisms into the environment shall submit a notification for a corresponding authorisation to the Ministry of the Environment.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

 (3) [Repealed – RT I, 08.11.2010, 1 – entry into force 18.11.2010]

 (4) Authorisation is required if genetically modified organisms or products are to be released into the environment for a purpose other than that indicated in the marketing authorisation issued in a Member State of the European Union.

§ 7.  Notification for release of genetically modified organisms into environment

 (1) The notification shall contain:
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]
 1) the name, personal identification or registry code, address and contact details of the notifier;
 2) the names and qualifications of the persons to engage in the release into the environment of the genetically modified organisms;
 3) the name and characteristics of the genetically modified organisms to be released into the environment;
 4) the purpose of the release into the environment of the genetically modified organisms;
 5) the location, to the accuracy of the rural municipality or city, of the release into the environment of the genetically modified organisms;
 6) a description of the method of the release into the environment of the genetically modified organisms, and the characteristics of the receiving environment;
 7) a description of the presumed interactions between the genetically modified organisms and the receiving environment;
 8) the environmental monitoring plan;
 9) a description of waste treatment measures;
 10) an emergency response plan and a description of remediation methods and measures to be taken in the event of accident;
 11) a description of the potential impact on human health and the environment;
 12) the date of payment of the state fee.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

 (2) A summary of the dossier conforming to the requirements of Council Decision 2002/813/EC establishing, pursuant to Directive 2001/18/EC of the European Parliament and of the Council, the summary notification information format for notifications concerning the deliberate release of genetically modified organisms into the environment for purposes other than for placing on the market (OJ L 280, 18.10.2002, pp. 62–83) shall be appended to the notification.

 (3) An environmental risk assessment concerning the release of genetically modified organisms into the environment shall be appended to the notification containing an evaluation of the potential adverse effects of the release of genetically modified organisms into the environment. The risk assessment concerning the release of genetically modified organisms into the environment shall deal with the direct, indirect, immediate, delayed, cumulative and long-term impact on human health and the environment, and set out a risk management plan.

 (4) A detailed list of the data to be submitted in a notification, the format of notifications, the risk assessment procedure and a list of data to be submitted in the risk assessment shall be established by a regulation of the Minister of the Environment based on the requirements provided in subsections (1)-(3) of this section. In establishing the regulation, the Minister of the Environment shall take account of Commission Decision 2002/623/EC 2002 establishing guidance notes supplementing Annex II to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release of genetically modified organisms into the environment and repealing Council Directive 90/220/EEC (OJ L 200, 30.07.2002, pp. 22–33).

 (5) The Minister of the Environment may accept that
 1) releases of the same genetically modified organism or of a combination of genetically modified organisms on the same site, or
 2) on different sites for the same purpose and within a defined period may be notified in a single notification.

 (6) A notifier who has already released, based on an earlier authorisation, the genetically modified organisms specified in the notification into the environment shall include in the notification additional information concerning the results and environmental impact of such release.

 (7) The notifier may use the data concerning the release of genetically modified organisms into the environment or results thereof from notifications previously submitted by other notifiers, provided that these notifiers have given their agreement in writing.

§ 8.  Additional information

 (1) For each following release into the environment of a genetically modified organism or combination of organisms, previously notified in the context of the same research project, a new notification shall be submitted which may include references to the data presented in the previous notification and to the outcome of the release into the environment provided therein.

 (2) The notifier or authorisation holder is required to immediately inform the Ministry of the Environment in writing if:
 1) the notifier or authorisation holder plans to release the genetically modified organism or combination of organisms into the environment in a manner other than the one indicated in the notification;
 2) during processing the notification, new information has become available regarding the possible negative consequences of releasing the genetically modified organism or combination of organisms into the environment;
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]
 3) following the grant of authorisation, new information has become available, regarding the possible negative consequences of releasing the genetically modified organism or combination of organisms into the environment.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

 (3) Upon granting the authorisation, the Minister of the Environment shall take into account the information specified in clauses 1) and 2) of subsection (2) of this section.

 (4) The Ministry of the Environment shall publish the information specified in clause 3) of subsection (2) of this section in at least one national daily newspaper. The requirements for the contents of the information to be submitted to and published by the Ministry of the Environment shall be established by a regulation of the Minister of the Environment.

 (5) Upon becoming evident of the facts specified in subsection (2) of this section, the notifier or authorisation holder shall:
 1) review the measures specified in the notification and adjust them as necessary;
 2) take measures necessary to protect human health or the environment.

§ 9.  Review of notification for release of genetically modified organisms into environment

 (1) The Ministry of the Environment shall forward a proper notification to the Gene Technology Commission and inform the notifier thereof in writing. The Ministry of the Environment shall forward a summary of the notification to the European Commission in accordance with the requirements of Council Decision 2002/813/EC.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

 (2) [Repealed – RT I, 08.11.2010, 1 – entry into force 18.11.2010]

 (3) Upon reviewing a notification, the Gene Technology Commission shall:
 1) verify, whether the notification meets the requirements provided for in this Act and legislation established on the basis thereof;
 2) assess the risks involved in the release of genetically modified organisms into the environment and, in particular, the harmful effects to human health and the environment, which may be the direct or indirect result of the transfer of genes from genetically modified organisms to other organisms;
 3) require information from governmental authorities, state agencies and research institutions, if necessary;
 4) perform or order tests or analyses, if necessary, for verification of the information submitted in the notification;
 5) inform the local authority and the Environmental Board of the planned location of release of the genetically modified organisms into the environment;
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]
 6) make a reasoned request, if necessary, that the notifier submit additional information.

 (4) The notifier shall cover any justified costs of tests or surveys to be performed for verification of information before performance of the tests or surveys. The costs of tests or surveys shall also be covered by the notifier if authorisation is not granted on the grounds specified in subsection 12 (4) of this Act.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

 (5) [Repealed – RT I, 08.11.2010, 1 – entry into force 18.11.2010]

§ 10.  Publication of notification and authorisation

 (1) The Ministry of the Environment shall publish, at the expense of the notifier, a notice concerning the commencement of processing of a notification and of the grant of authorisation in the official publication Ametlikud Teadaanded and in at least one national daily newspaper within seven days after the date of receipt of the notification or grant of authorisation.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

 (2) The notice shall contain, as a minimum, the following information:
 1) the name of the notifier and, if the notifier is a legal person, the registry code, and the address and other contact details of the notifier;
 2) a summary of the notification or authorisation;
 3) the name of the genetically modified organisms and the location, to the accuracy of the rural municipality or city, of the release into the environment of the genetically modified organisms;
 4) a notation as to where the notification can be examined;
 5) the term within which an opinion can be presented or proposals can be made concerning the release into the environment of the genetically modified organisms.

 (3) The term specified in clause 5) of subsection (2) of this section shall not be shorter than thirty days and not longer than sixty days.

 (4) The Minister of the Environment shall provide a written response to the proposal specified in clause 5) of subsection (2) of this section within two weeks after receipt of the proposal, informing the person whether the proposal has been accepted or rejected and providing the reasons underlying acceptance or rejection.

§ 11.  Conclusion and proposal of Gene Technology Commission

 (1) Within 60 days after receiving a notification for release of genetically modified organisms into the environment, the Gene Technology Commission shall make one of the following written conclusions:
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]
 1) the planned release of genetically modified organisms into the environment complies with this Act and legislation established on the basis thereof, is safe to human health and the environment and does not have an adverse impact on the ecosystem functioning;
 2) the safety of the planned release of genetically modified organisms into the environment to human health and the environment has not been sufficiently proven and it may have an adverse impact on the functioning of the ecosystem;
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]
 3) the planned release of genetically modified organisms into the environment complies with this Act and legislation established on the basis thereof and is safe to human health and the environment, provided that the additional requirements set forth in the conclusion are complied with.

 (2) Within the term specified in subsection (1) of this section, the Gene Technology Commission shall make a proposal to the Minister of the Environment to:
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]
 1) grant authorisation, if the release of genetically modified organisms into the environment complies with this Act and legislation established on the basis thereof, and is safe to human health and the environment;
 2) refuse to grant authorisation, if the release of genetically modified organisms into the environment does not comply with this Act or legislation established on the basis thereof or the safety of the release into the environment to human health or the environment has not been sufficiently proven;
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]
 3) grant an authorisation and thereby establish additional requirements which prevent possible threats, if the notification complies with the requirements established by legislation.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

 (3) The Gene Technology Commission shall submit a proposal to the Minister of the Environment for establishment of additional requirements along with the reasons therefor.

§ 12.  Grant, amendment, suspension and revocation of authorisation

 (1) The provisions of the Administrative Procedure Act concerning open proceedings apply to the grant of authorisation, taking into account the specifications arising from this Act. The provisions concerning open proceedings do not apply to the amendment, suspension or revocation of authorisation.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

 (2) After receiving a proposal from the Gene Technology Commission, but not later than within 90 days following the receipt of a proper notification, the Minister of the Environment shall grant authorisation or inform the notifier in writing of the refusal to grant authorisation and provide the reasons therefore in writing. Authorisation shall not be granted for longer than ten years.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

 (3) The Minister of the Environment shall grant authorisation if a notification for release of genetically modified organisms into the environment complies with this Act and legislation established on the basis thereof.

 (4) The Minister of the Environment shall not grant authorisation if:
 1) the safety of the genetically modified organism to human health or the environment has not been sufficiently proven;
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]
 2) the notification contains false information;
 3) the release of the genetically modified organisms into the environment does not comply with legislation.

 (5) The following shall be specified in an authorisation:
 1) the name and main characteristics of the genetically modified organisms to be released into the environment;
 2) the name, registry code or personal identification code, address and contact details of the person to release the genetically modified organisms into the environment;
 3) minimum requirements for the safe release into the environment of the genetically modified organisms, including handling and storage requirements;
 4) the location of the release into the environment of the genetically modified organisms;
 5) the extent of environmental monitoring and terms for submission of reports concerning the results of environmental monitoring;
 6) the term of validity of the authorisation.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

 (6) genetically modified organisms shall be released into the environment only on the terms and conditions established in the authorisation. Genetically modified organisms shall not be placed on the market on the basis of the authorisation.

 (7) The Minister of the Environment shall temporarily suspend an authorisation if after the grant of the authorisation, possible negative consequences relating to the release of the genetically modified organisms into the environment become evident.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

 (8) During the temporary suspension of an authorisation, the Minister of the Environment may amend the terms and conditions of the authorisation or revoke the authorisation on the basis of a risk assessment carried out on a proposal of the Gene Technology Commission and at the expense of the authorisation holder.

 (9) The Minister of the Environment shall revoke an authorisation if:
 1) the notification contains false information;
 2) the authorisation holder fails to comply with the provisions provided for in the authorisation;
 3) the safety of the release of the genetically modified organisms into the environment to human health or the environment has not been sufficiently proven;
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]
 4) the release of the genetically modified organisms into the environment does not comply with legislation.

 (10) The Minister of the Environment shall amend an authorisation in the event specified in clause 8 (5) 1) of this Act.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

§ 13.  Simplified procedure for release of genetically modified organisms into environment

  The release of genetically modified organisms into the environment pursuant to a simplified procedure shall be carried out in accordance with Commission Decision 1994/739/EC establishing simplified procedures concerning the deliberate release into the environment of genetically modified plants (OJ L 292, 12.11.1994, pp. 31–34).

§ 14.  Provision of information on results on deliberate release of genetically modified organisms into environment

 (1) After the deliberate release of genetically modified organisms into the environment, the authorisation holder shall submit to the Ministry of the Environment an environmental monitoring report in compliance with Commission Decision 2003/701/EC establishing a format for presenting the results of the deliberate release into the environment of genetically modified higher plants for purposes other than placing on the market (OJ L 254, 08.10.2003, pp. 21–28).

 (2) If necessary, the Minister of the Environment shall establish, by a regulation, the requirements for the contents of environmental monitoring reports concerning the release into the environment of genetically modified organisms other than genetically modified higher plants and the requirements for presenting the results of environmental monitoring.

§ 15.  Extension of term validity of authorisation

 (1) An authorisation holder shall submit a notification for extension of the term of validity of the authorisation to the Ministry of the Environment at least nine months prior to the expiry thereof.

 (2) For extension of an authorisation, a written notification shall be submitted together with the following documents and information:
 1) a copy of a valid authorisation;
 2) an environmental monitoring report;
 3) new information, if any, concerning the potential threat to human health or the environment which could result from the release of genetically modified organisms into the environment;
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]
 4) if necessary, a proposal to amend the terms or conditions of the authorisation.

 (3) The provisions of §§ 9-12 of this Act and the requirements of the legislation established on the basis of subsection 6 (1) of this Act apply to the review of notifications for extension of authorisations, to making the notifications public and to the extension of authorisations.

 (4) During reviewing the extension of an authorisation, the authorisation holder may continue to release genetically modified organisms into the environment until the final decision is made concerning extension of the authorisation.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

Chapter 3 PLACING GENETICALLY MODIFIED ORGANISMS OR PRODUCTS ON MARKET 

§ 16.  Placing genetically modified organisms or products on market

 (1) Genetically modified organisms or products may be placed on the market only based on the written authorisation of the Minister of the Environment (hereinafter marketing authorisation). The specific list of data to be included in the marketing authorisation and the format of marketing authorisations shall be established, based on the provisions of subsection 22 (5) of this Act, by a regulation of the Minister of the Environment.

 (2) In order to obtain marketing authorisation, a person wishing to place a genetically modified organism or product on the market shall submit a notification to the Ministry of the Environment.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

 (3) No marketing authorisation is required for the placing on the market, within the Republic of Estonia, of genetically modified organisms or products which have been placed on the market or released into the environment based on a marketing authorisation issued in a Member State of the European Union.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

 (4) Marketing authorisation is required if the genetically modified organisms or products are to be placed on the market for a purpose other than the purpose indicated in the marketing authorisation issued in a Member State of the European Union.

§ 17.  Notification for marketing authorisation

 (1) The notification shall contain:
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]
 1) the name, personal identification code or registry code, address and contact details of the producer or importer and distributor;
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]
 2) the purpose of placing the product on the market;
 3) if necessary, the geographical area of placing the product on the market;
 4) the name of the product and the name and characteristics of the genetically modified organism contained in the product;
 5) a description and conditions of use of the product;
 6) a description of an appropriate environment for the product;
 7) a description of the presumed interaction between the genetically modified organisms contained in the product and the environment receiving such organisms;
 8) the name of the field of use of the product and a description of the planned manner of use thereof;
 9) the conditions for preservation and storage of the product;
 10) a list of measures to be taken in the event of misuse of the product;
 11) a description of the outcome of research carried out with the product and of the test releases into the environment of the product, including a description of the effect of the product on human health and the environment;
 12) the proposed design of the packaging and labelling of the product including, where necessary, an overview of types of packaging to prevent the release into the environment of the genetically modified organisms or products;
 13) an estimate of the volume of production or import of the product;
 14) a description of the means and conditions of transport of the products;
 15) an environmental monitoring plan prepared taking into account Council Decision 2002/811/EC establishing guidance notes supplementing Annex VII to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release of genetically modified organisms into the environment and repealing Council Directive 90/220/EEC (OJ L 280, 18.10.2002, pp. 27–36);
 16) a description of waste treatment measures as necessary;
 17) an emergency response plan and a description of remediation methods and measures to be taken in the event of accident;
 18) [Repealed – RT I, 08.11.2010, 1 – entry into force 18.11.2010]
 19) a summary of the notification in compliance with the requirements of Council Decision 2002/812/EC establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council the summary information format relating to the placing on the market of genetically modified organisms or products (OJ L 280, 18.10.2002, pp. 37–61);
 20) the date of payment of the state fee.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

 (2) A risk assessment related to the genetically modified organisms or products, prepared in conformity with the provisions of subsection 7 (3) of this Act, shall be appended to the notification.

 (3) A detailed list of the data to be submitted in a notification, the format for notifications, the risk assessment procedure and a list of the data to be presented in the risk assessment shall be established by a regulation of the Minister of the Environment based on the requirements provided in subsections (1)-(3) of this section. In establishing the regulation, the Minister of the Environment shall take Commission Decision 2002/623/EC into account.

 (4) If it has been proven, based on scientific research or results of the release into the environment of the genetically modified organisms, that placing genetically modified organisms or products on the market is safe to human health and the environment, then with the consent of the Gene Technology Commission the information specified in subsection (2) of this section need not be submitted.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

 (5) If the notifier has placed on the market, based on an earlier marketing authorisation, or released into the environment the genetically modified organisms or products specified in the notification, the notifier shall append the results of the placing on the market of the genetically modified organisms or products and the environmental impact thereof, regardless of where they were placed on the market.

 (6) The notifier may refer to data concerning the placing on the market modified organisms or results thereof from notifications previously submitted by other notifiers, provided that these notifiers have given their agreement in writing.

 (7) A separate notification shall be submitted for each new product which contains the same genetically modified organisms but is prescribed to be used in a different manner.

§ 18.  Review of notifications for placing genetically modified organisms or products on market

 (1) The Ministry of the Environment shall forward the notification to the Gene Technology Commission and inform the notifier thereof in writing. The Ministry of the Environment shall forward a summary of the notification to the European Commission.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

 (2) [Repealed – RT I, 08.11.2010, 1 – entry into force 18.11.2010]

 (3) Upon reviewing a notification, the Gene Technology Commission shall:
 1) verify, whether the notification meets the requirements of this Act and legislation established on the basis thereof;
 2) assess the measures planned for ensuring the safety of the product;
 3) assess the potential adverse effect on human health and the environment which may be the direct or indirect result of transfer of genes from genetically modified organisms to other organisms;
 4) require information from governmental authorities, state agencies and research institutions as necessary;
 5) perform or order tests or analyses, as necessary, for verification of the information submitted in the notification.

 (4) Before submitting a notification, a state fee at the rate specified in the State Fees Act shall be paid for reviewing the notification. The notifier shall cover any justified costs of tests or surveys to be performed for verification of information before performance of the tests or surveys. The costs of tests or surveys shall also be covered by the notifier if the marketing authorisation is not granted on the grounds specified in subsection 22 (4) of this Act.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

 (5) [Repealed – RT I, 08.11.2010, 1 – entry into force 18.11.2010]

§ 19.  Publication of notifications and authorisations for placing genetically modified organisms or products on market

  The provisions of § 10 of this Act apply to the publication of the notifications and authorisations for placing genetically modified organisms or products on the market.

§ 20.  Conclusion and proposal of Gene Technology Commission

 (1) After receiving a notification for placing on the market of genetically modified organisms or products, the Gene Technology Commission shall prepare a written conclusion pursuant to the provisions of subsection 11 (1) of this Act.

 (2) The Gene Technology Commission shall make a proposal to the Minister of the Environment pursuant to the provisions of subsection 11 (2) of this Act.

 (3) The Gene Technology Commission has the right to request more specific information concerning the placing on the market of genetically modified organisms or products from the notifier. The reasons for such request shall be provided.

 (4) The Gene Technology Commission shall submit to the Minister of the Environment a proposal for setting additional conditions together with the reasons therefor.

 (5) If necessary, the Gene Technology Commission has the right to provide an opinion concerning a notification for marketing authorisation submitted in another Member State or reasonably request additional information concerning such notification.

§ 21.  Assessment report

 (1) After receiving a proposal from the Gene Technology Commission, but not later than within 90 days following the receipt of a proper notification, the Minister of the Environment shall draw up a written assessment report whereby the Minister makes the initial decision to grant or refuse the marketing authorisation. The notifier shall not have any legitimate expectation to obtain the authorisation on the basis of the initial decision made in the assessment report.

 (2) If the initial decision to grant the marketing authorisation to the notifier has been made in an assessment report, the Ministry of the Environment shall send the assessment report to the notifier and the European Commission without delay. The requirements for assessment reports shall be established by a regulation of the Minister of the Environment.

 (3) If the initial decision to refuse to grant the marketing authorisation to the notifier has been made in an assessment report, the Ministry of the Environment shall send the assessment report to the European Commission no sooner than 15 days after sending the assessment report to the notifier and no later than 105 days following the receipt of the valid notification.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

§ 22.  Grant of marketing authorisation

 (1) The provisions of the Administrative Procedure Act concerning open proceedings apply to the grant of marketing authorisation, taking into account the specifications arising from this Act. The provisions concerning open proceedings do not apply to the amendment and revocation of marketing authorisation.

 (2) The Minister of the Environment shall grant marketing authorisation of genetically modified organisms or products or refuse to grant marketing authorisation and shall inform the notifier thereof after completion of the European Union standard procedure regarding the assessment report. In the course of the standard procedure the European Commission, within 60 days after the submission of the assessment report, gathers the comments and reasoned objections of the Member States and the public and on the basis thereof the Minister of the Environment shall, within 105 days after the submission of the assessment report of the European Commission, make a decision to grant or refuse the marketing authorisation. The calculation of the term of processing the marketing authorisation shall be suspended for the time limit which the Minister of the Environment has additionally granted to the notifier for submission of additional information.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

 (3) The maximum term of validity of marketing authorisation is ten years. Within 30 days, the Minister of the Environment shall inform the Member States and the European Commission of granting marketing authorisation.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

 (4) The Minister of the Environment shall not grant marketing authorisation if:
 1) placing the genetically modified organisms or products on the market poses a risk to human health or the environment;
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]
 2) the notification contains false information;
 3) placing genetically modified organisms or products on the market does not comply with legislation.

 (5) The following information shall be indicated in a marketing authorisation:
 1) the name, main characteristics, identity and unique identifier of the product and the genetically modified organism contained therein;
 2) conditions which ensure the safe use, including safe handling and storage, of the product;
 3) the name, personal identification code or registry code, address and contact details of the authorisation holder;
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]
 4) special conditions related to environmental protection;
 5) date of expiry of the marketing authorisation;
 6) an obligation to provide control samples at the request of the Commission of Gene Technology;
 7) an environmental monitoring plan, taking account of the provisions of Council Decision 2002/811/EC;
 8) product labelling requirements.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

 (6) A marketing authorisation grants a person the right to release into the environment the genetically modified organisms or products specified in the authorisation.

§ 23.  Communication of placing genetically modified organisms or products on market

 (1) After placing genetically modified organisms or products on the market, the authorisation holder shall submit to the Ministry of the Environment an environmental monitoring report concerning the genetically modified organisms or products, the requirements for the contents and procedure for submission of which shall be established by a regulation of the Minister of the Environment.

 (2) If before or after being granted marketing authorisation, the notifier receives new information on the threats which the genetically modified organisms or products are likely to pose to human health or the environment, the notifier must immediately inform the Ministry of the Environment of such threats and apply appropriate health and environmental protection measures. The Ministry of the Environment shall publish such information in at least one national newspaper. The requirements for information to be submitted to and published by the Ministry of the Environment shall be established by a regulation of the Minister of the Environment.

§ 24.  Packaging and labelling of products

 (1) Marketed products must be packaged and labelled. The labelling must be clearly visible and understandable. A product shall be placed on the market together with accompanying documents that bear the unique identifier of the genetically modified organism.

 (2) The labelling on the package of a product shall bear at least the following information:
 1) the name of the product;
 2) the text " Toode sisaldab geneetiliselt muundatud organisme " [this product contains genetically modified organisms];
 3) the name of the genetically modified organism contained in the product;
 4) the name and address of the person in charge of marketing;
 5) a reference to possibilities of obtaining additional information.

 (3) [Repealed – RT I, 08.11.2010, 1 – entry into force 18.11.2010]

 (4) For products where adventitious or technically unavoidable traces of genetically modified organisms authorized in the European Union cannot be excluded, a minimum threshold may be established below which these products shall not have to be labelled. The threshold levels shall be established by the European Commission in accordance with the provisions of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (OJ L 184, 17.7.1999, pp. 23-26).
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

§ 25.  Amendment and revocation of marketing authorisation

 (1) If, based on new scientific information, there is reason to believe that a genetically modified organism or product poses a risk to human health or the environment then, on the proposal of the Commission of Gene Technology and based on the results of risk assessment carried out at the expense of the authorisation holder, the Minister of the Environment shall amend the conditions of the marketing authorisation or revoke the authorisation.

 (11) The Minister of the Environment shall inform the Member States and the European Commission of the activities specified in subsection (1) of this section, including of learning of the information, which may result in the amendment or revocation of a marketing authorisation.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

 (2) The Minister of the Environment shall revoke a marketing authorisation if:
 1) false information has been given in the notification for marketing authorisation;
 2) the marketing authorisation holder fails to comply with the conditions provided for in the authorisation;
 3) the genetically modified organisms or products pose a risk to human health or the environment;
 4) placing the genetically modified organisms or products on the market does not meet the requirements of legislation.

§ 26.  Extension of marketing authorisation

  The provisions of subsections 15 (1), (2) and (4) and §§ 18–22 of this Act and the requirements of the legislation established on the basis of subsection 16 (1) of this Act apply to reviewing notifications for extension of marketing authorisation and to making such fact public.

§ 27.  Simplified procedure for placing on market of genetically modified organisms or products

  If the Gene Technology Commission finds that the placing on the market of genetically modified organisms or products has been safe to human health and the environment for a period of at least five years, the Gene Technology Commission may make a proposal to the Minister of the Environment to request application of the simplified procedure for placing on market of the genetically modified organisms or products from the European Commission.

§ 28.  Genetically modified food and feed

  Regulation 1829/2003/EC of the European Parliament and of the Council on genetically modified food and feed (OJ L 268, 18.10.2003, pp. 1–23) applies to genetically modified organisms used for food or feed, and to placing food and feed containing or composed of genetically modified organisms on the market.

Chapter 31 HANDLING GM CROPS 
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

§ 281.  Handling GM crops

 (1) A handler shall handle GM crops with the due care in order to prevent its genetic admixture with non-GM crops and possible damage arising therefrom.

 (2) A person who has been entered in the database of the locations and handlers of GM crops is allowed to handle GM crops.

 (3) Before commencement of handling, the handler shall appoint a person in charge of proper handling and the person’s name shall be entered in the database of the locations and handlers of GM crops.

 (4) The following shall be observed upon handling a GM crop:
 1) the growing distance requirement;
 2) the growing period requirement;
 3) transportation requirements;
 4) storage requirements;
 5) the requirement to remove, within the prescribed growing period, plants emerging from a GM crop grown as a preculture from the field of successive crop before the given volunteer plants which are about to emerge have started to create pollen, viable seeds or other propagating material;
 6) the requirement to clean the equipment and machinery used in production.

 (5) More detailed requirements for handling GM crops shall be established by a regulation of the Minister of Agriculture.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

§ 282.  Training to handle GM crops

 (1) Persons in charge of handling GM crops and employees of enterprises engaged in handling GM crops shall have undergone training in handling GM crops and they shall hold a certificate proving the completion of the training.

 (2) The certificate proving the completion of the training shall be valid for five years. If the persons in charge of handling and the employees of the enterprises engaged in handling GM crops participate in in-service training organised by the Agricultural Board during the term of validity of the certificate, the term of validity of the certificate proving the completion of the training shall be extended by another five years after the expiry of the term of validity.

 (3) The programme of the training in handling GM crops, the requirements established for obtaining a certificate, the procedure for issue of a certificate and the frequency of in-service training shall be established by a regulation of the Minister of Agriculture.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

§ 283.  Database of locations and handlers of GM crops

 (1) The database of the locations and handlers of GM crops (hereinafter database) is a national database established by the Government of the Republic where data of the locations, handlers and the fields of activity of the handlers of GM crops are processed with the aim of keeping account of them and ensuring effective supervision.

 (2) The statutes of maintenance of the database shall be established by a regulation of the Government of the Republic.

 (3) The chief processor of the database is the Ministry of Agriculture and the authorised processor is the Agricultural Board.

 (4) The handler is responsible for the correctness of the data included in the database, except for the incorrect data entered in the database by mistake. Within ten working days after the date of the change of the data, the handler shall inform the authorised processor in writing about the change of the data which served as the basis for making an entry into the database.

 (5) The Agricultural Board shall make a decision to enter data into the database and enter the data of the handler of the GM crops into the database after the submission of the relevant application and the certificate proving the completion of the training in handling GM crops.

 (6) The handler shall, annually, not later than one month before the commencement of growing the GM crop, submit to the authorised processor of the database the data of the GM crop and the time and field of cultivation.

 (7) The Agricultural Board may exclude a handler from the database if the handler has caused the spread or the risk of the spread of a GM crop due to repeated violation of the provisions of this Act.

 (8) The substantive and formal requirements for the entry of the locations and handlers of GM crops, the procedure for processing applications and the list of documents to be annexed to applications shall be established by a regulation of the Minister of Agriculture.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

§ 284.  Notification

 (1) At least three months before the commencement of growing a GM crop, a person who would like to grow the GM crop shall inform in writing the possessors of the fields that remain within the notification distance about the intention to grow the GM crop. The notification distance is the twofold growing distance and the handler shall inform the possessors of the fields falling within the distance about the intention to grow the GM crop.

 (2) A person who would like to grow a GM crop and the growing distance of whose field includes other fields whose possessors intend to grow non-GM crops of the same species or a crop of another plant species which is able to crossbreed with the former in a field that falls within the growing distance, may commence growing the GM crop only if the person has reached a written agreement with the possessors of the said fields. In accordance with clause 281 (4) 1) of this Act, the growing distance is the minimum permitted distance from the edge of a field of a GM crop to a field of the same plant species that is grown using the conventional or organic method or that of another plant species which is able to crossbreed with the GM crop.

 (3) The substantive and formal requirements for notifications informing of growing a GM crop, the length of the notification distance and the list of the documents to be annexed to the notification shall be established by a regulation of the Minister of Agriculture.

 (4) In the event of the sale, lease or other transfer of the land, the person on whose land GM crops have been grown shall, during the term of validity of the requirement set out in clause 281 (4) 2) of this Act and before the transfer of ownership or possession, inform the person who acquires the land or gains possession of the land about growing the GM crop. During the term of validity of the aforementioned requirement the acquirer and the possessor shall follow the requirement established in clause 281 (4) 5) of this Act.

 (5) A person who would like to grow a GM crop shall inform the apiary owner who has expressed the wish to be informed of any situation where the apiary is located up to three kilometres from a field where GM crops are to be grown in writing of the intention to cultivate the GM crop.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

Chapter 4 DATA OF GENETICALLY MODIFIED ORGANISMS 

§ 29.  Storage of data and classification of data as confidential business information

 (1) The data submitted in notifications for release of genetically modified organisms into the environment or for placing on the market of genetically modified organisms shall be stored in the environmental register.

 (2) The notifier may make a reasoned request in a notification for classification of a part of the data as confidential business information.

 (3) The Minister of the Environment shall decide which data is to be maintained as confidential business information and shall inform the notifier of the decision. The data classified as business secret by the Minister of the Environment are not deemed to be public information even if the notifier withdraws the notification.

 (4) The following data shall not be classified as confidential business information by the Minister of the Environment:
 1) the general description of genetically modified organisms, the name and address of the notifier, the purpose, place and time of releasing the organisms into the environment, and the planned manner of use thereof;
 2) the method for monitoring genetically modified organisms and the monitoring plan, and remedial action to be taken in the event of accident;
 3) the environmental risk assessment information.
[RT I, 08.11.2010 – entry into force 18.11.2010]

 (5) The Agricultural Board shall preserve the data of certificates proving the completion of training and the details of the documents serving as the basis for issuing the certificates in the database for ten years after the date of submission of an application for handling a GM crop.
[RT I, 08.11.2010 – entry into force 18.11.2010]

 (6) A handler shall keep accurate accounts of the fulfilment of the requirements. Documents relating to the handling and notification thereof shall be preserved for at least ten years.
[RT I, 08.11.2010 – entry into force 18.11.2010]

§ 30.  Exchange of information and consultations with European Commission

  The Minister of the Environment shall establish, by a regulation, the procedure for regulating the exchange of information and consultations with the European Commission in issues related to the release of genetically modified organisms into the environment and placing genetically modified organisms or products on the market.

Chapter 5 SUPERVISION AND COMPENSATION FOR DAMAGE 
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

§ 31.  Supervision

 (1) Supervision over compliance with the requirements of this Act and legislation established on the basis thereof shall be exercised by the Environmental Inspectorate pursuant to the procedure provided by the Environmental Supervision Act, except in the events provided for in subsections (2)-(6) of this section.
[RT I, 08.11.2010 – entry into force 18.11.2010]

 (2) The Agricultural Board and the Environmental Board shall exercise supervision over the use of genetically modified plant varieties, the production and packaging of the seed and propagating material of species of agricultural and horticultural plants containing or composed of genetically modified organisms and the cultivating material of forestry plants containing or composed of genetically modified organisms for marketing purposes, and over the marketing, import and export of such material pursuant to the procedure provided by the Plant Propagation and Plant Variety Rights Act, taking into account the requirements of this Act.
[RT I, 08.11.2010 – entry into force 18.11.2010]

 (3) The Agricultural Board shall exercise supervision over the plant protection products containing or composed of genetically modified organisms pursuant to the procedure provided in the Plant Protection Act, taking into account the requirements of this Act.
[RT I, 08.11.2010 – entry into force 18.11.2010]

 (4) The Agricultural Board, the Tax and Customs Board and the Consumer Protection Board shall exercise supervision over the fertilizers containing or composed of genetically modified organisms pursuant to the procedure provided in the Fertilizers Act, taking into account the requirements of this Act.
[RT I, 08.11.2010 – entry into force 18.11.2010]

 (5) The Veterinary and Food Board and the Consumer Protection Board shall exercise supervision over the food containing or composed of genetically modified organisms pursuant to the procedure provided in the Food Act, taking into account the requirements of this Act.
[RT I, 08.11.2010 – entry into force 18.11.2010]

 (6) The Veterinary and Food Board shall exercise supervision over the feed containing or composed of genetically modified organisms pursuant to the procedure provided in the Feedingstuffs Act, taking into account the requirements of this Act.
[RT I, 08.11.2010 – entry into force 18.11.2010]

 (7) The Agricultural Board shall exercise supervision over compliance with the handling requirements.
[RT I, 08.11.2010 – entry into force 18.11.2010]

 (8) The person exercising supervision has the right to issue precepts for the purpose of ensuring the implementation of this Act. In the event of failure to comply with a precept, sanctions may be imposed pursuant to the procedure provided for in the Substitutive Enforcement and Penalty Payment Act. The maximum penalty payment shall be 13 000 euros.
[RT I, 08.11.2010 – entry into force 18.11.2010]

§ 32.  Compensation for damage and remedying damage

 (1) Damage caused by handling GM crops shall be compensated by the handler in the event of exceeding the threshold established by Regulation (EC) No 1829/2003 of the European Parliament and of the Council.

 (2) [Repealed – RT I, 08.11.2010 – entry into force 18.11.2010]

 (3) The Minister of the Environment shall evaluate, at the expense of the polluter, whether or not environmental damage has been successfully eliminated.
[RT I, 08.11.2010 – entry into force 18.11.2010]

Chapter 51 LIABILITY 
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

§ 33.  Violation of requirements for release into environment of genetically modified organisms or placing on market of genetically modified organisms or products

 (1) Violation of the requirements for release of genetically modified organisms into the environment or the requirements for placing genetically modified organisms or products on the market is punishable by a fine of up to 300 fine units.

 (2) The same act, if committed by a legal person, is punishable by a fine of up to 32 000 euros.

§ 331.  Violation of requirements for handling GM crops

 (1) Violation of the requirements for handling GM crops – is punishable by a fine of up to 200 fine units.

 (2) The same act if committed by a legal person is punishable by a fine of up to 3200 euros.
[RT I, 08.11.2010, 1 - entry into force 01.01.2011]

§ 34.  Violation of requirements for packaging and labelling genetically modified organisms or products

 (1) Violation of the requirements for packaging and labelling genetically modified organisms or products is punishable by a fine of up to 100 fine units.

 (2) The same act, if committed by a legal person, is punishable by a fine of up to 6400 euros.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

§ 341.  Violation of obligation to notify of growing GM crop

 (1) Failure to notify the possessor of a field, the acquirer of land, the recipient of possession of land or the owner of an apiary about the intention to grow or about growing GM crops is punishable by a fine of up to 200 fine units.

 (2) The same act, if committed by a legal person, is punishable by a fine of up to 13 000 euros.
[RT I, 08.11.2010, 1 - entry into force 01.01.2011]

§ 342.  Violation of notification obligation of notifier or holder of authorisation

 (1) Violation of the notification obligation of a notifier or a holder of authorisation is punishable by a fine of up to 200 fine units.

 (2) The same act, if committed by a legal person, is punishable by a fine of up to 13 000 euros.
[RT I, 08.11.2010, 1 - entry into force 01.01.2011]

§ 35.  Proceedings

 (1) The provisions of the General Part of the Penal Code apply to proceedings regarding the misdemeanours provided for in §§ 33-342 of this Act.

 (2) The Environmental Inspectorate, Agricultural Board, Veterinary and Food Board, Consumer Protection Board and Tax and Customs Board are the extrajudicial bodies who conduct, within the limits of their competence, proceedings in misdemeanour cases provided for in §§ 33-342 of this Act.
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

Chapter 6 IMPLEMENTING PROVISIONS 

§ 36.  Implementation of Act

  Until the time all databases related to environmental protection are consolidated in the environmental register, the data submitted in notifications for release of genetically modified organisms into the environment or for placing on the market of genetically modified organisms shall be stored by the Ministry of the Environment in the form of a state agency database.

§ 37. – § 40. [Omitted from this text.]

§ 41.  Entry into force of Act

  This Act shall enter into force on 1 May 2004.


1 Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release of genetically modified organisms into the environment and repealing Council Directive 90/220/EEC (OJ L 106, 17.04.2001, pp. 1–38) and Commission Recommendation of 13 July 2010 on guidelines for the development of national co-existence measures to avoid the unintended presence of genetically modified organisms in conventional and organic crops (OJ C 200, 22.7.2010, pp. 1 5).
[RT I, 08.11.2010, 1 - entry into force 18.11.2010]

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