Select Committee on European Communities Second Report - Written Evidence

Memorandum by the Embassy of the Republic of Hungary


  1. After more than one year of preparation a framework-law had been worked out in 1996-97 in Hungary. The law was passed by the Hungarian Parliament in March 1998. It is going to set in force in January 1999.

  2. Although the provisions of the law are originally based on two European Community directives (90/219/EEC Council Directive on the contained use of genetically modified microorganisms and 90/220/EEC Council Directive on the deliberate release of genetically modified organisms into the environment), the subject of the Hungarian regulation is much broader than the EC's one. The scope of the Hungarian regulation covers all kind of genetically modified organisms with the exception of humans. The protected and wild (game) organisms are prohibited to be modified.

  3. The act is a framework-law which is going to be backed by several decrees of the competent ministries. The ministerial decrees will adapt in deep details the above mentioned two directives' rules (for example the annexes—forms to fill in by the applicants—of the directives).


  4. Following elements of the law can be considered fully or partly harmonised with the provisions of the above mentioned two directives.

(a) Authorising system

  Permit is obligatory:

    —  to establish genetechnological laboratory;

    —  to modify natural living organism;

    —  to use gmo in contained system;

    —  to release gmo into the environment;

    —  to commercialise gmo on the market;

    —  to export and to import gmo.

(b) Institutions which are responsible for permitting gmo-activities:

    —  independent committee of genetechnology (prepares the decisions and gives opinion; consisting of 17 representatives of the competent ministries, of the Hungarian Academy of Sciences, of the National Committee on Technological Development and of the non-governmental organisations).

    —  authorities of genetechnology under the control of the competent ministries (there will be several authorities according to the industries where application of GMO is intended; authorities give the permits, control the application, in certain, defined cases* restrict or ban the gmo-activity, take back the permit, fine).

  5. [Authorising responsibility is shared by three ministries—Ministry of Agriculture, Ministry of Welfare, Ministry of Industry, Commerce and Tourism—in accordance with the most common applications of biotechnology. (Biotechnological activities are divided into three categories by the law. These are the following:

    (a)  plant-and animal-breeding, food-and feed-production;

    (b)  human health-care, medicine-production;

    (c)  industrial use not included in the preceding two categories.)

  6. The Ministry of Environmental Protection also has an important role as a consultant (veto-authority) in giving an expert opinion on the activities to be permitted.]

    1.  GMO-activity can be restricted or banned if there is new information relating to the risk of the activity (especially in case of danger to the health or to the environment). If it is banned gmo should be destroyed.

    2.  GMO-activity-permit can be taken back and the permittee can be fined in case of violation of law or of provisions written in the permit.

  7. Deadlines in decision-making on the applications for permit.

  In case of activity relating to:

    —  genetic modification or contained use of gmo: 90 days

    —  deliberate release of gmo into the environment or commercialisation of gmo on the market: 180 days

    —  export or import of gmo: 60 days

    —  establishment of gmo-labs: 45 days

  8. Publication of the draft-permit[32] and the permit.[33]

  Deadlines for public comments on the draft-permits (from the date when it was published)

  In case of:

    —  genetic modification or contained use of gmo: 30 days

    —  deliberate release of gmo into the environment or commercialisation of gmo on the market: 40 days

  9. Publication of the finalised version of the permit.

    —  genetic modification or contained use of gmo;

    —  deliberate release of gmo into the environment or commercialisation of gmo on the market;

  10. Adaptation of the provisions of the Regulation 258/97/EC of the European Parliament and the Council on novel food and novel food ingredients.

  11. The law on genetechnological activity amends the Act No. 1995 XC on foodstuffs by adapting the definitions relating to novel food and to labelling of novel food of the above mentioned European regulation.


  12. A database will be set up for the registration of the relevant information relating to permitted:

    —  genetic modifications;

    —  contained use;

    —  deliberate release into the environment;

    —  commercialisation;

    —  establishment of labs.

  The data will be provided for by the competent authorities.

  13. Products consisting of or containing GMO as well as products derived from GMO will be labelled.

  14. In waste-management three categories are differentiated: hazardous waste of biotechnological activity; waste of GMO used in food-production is harmless; waste is to be analysed by the authorities which determine the way of handling and neutralising it.

  15. Biosafety officer should be employed by the companies and institutes which deal with biotechnology. Biosafety officer is responsible for fulfilments of the laws and of the provisions written in the permit by the company or institute.

  16. Responsibility for the damages caused by GMO-activities is defined in accordance with the Hungarian Civil Code's provisions regarding to liability for hazardous operation (objective responsibility with the exception of vis major).

  17. Measures defined in the Criminal Code of the Hungarian Republic are used if the permitted GMO-activity realises a crime.

  18. Permits for transporting of GMO will be given in the GMO-activity-permits.

  19. In the vicinity of natural protected areas genetic protection zones will be set up where the release of GMO is not allowed.

  20. Partial retroactive force: In 60 days after the act on genetechnological activity sets in force, those contained use, deliberate release, commercialisation and import of GMO which were executed before the new regulation would have set in force, should be notified to the competent authorities. The competent authorities will control the notified activities whether these fulfil or not the legal requirements. If the requirements are not met the activity should be banned and restoring of the original environmental situation will be ordered.

  21. Ministerial decrees following the act will regulate in details:

    —  labelling;

    —  genetic protection zone;

    —  conditions (technical, technological, environmental, natural protection, health) of GMO-activities;

    —  procedure and structure of the committee of genetechnology;

    —  rules of export and import of GMO;

    —  conditions of employment and education of the biosafety officer;

    —  provisions for data-registration;

    —  fees for permits;

    —  genetechnological fine.

2 June 1998

32   Altered maize kills friend as well as foe, New Scientist, 2 May 1998. Back

33   It should be noted that it is unlikely that this crop will be grown in the UK due to climatic requirements, however it demonstrates that the regulatory system can fail to pick up impacts on biodiversity. Back

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