Act no.XXVII of 1998 on gene technology activities.

This Act, recognising the possibilities and risks related to genetical activities affecting the human environment and to genetically modified organisms, and in order to preserve the balance in nature, to protect human health, to ensure scientific and economic development, regulates the (a) genetic modification of natural organisms, b) the establishment of a genetic modification facility, (c) genetically modified organisms and products thereof (1. for use in a closed system, 2. for non-marketing purposes, 3. for placing on the market, 4. disposal, 5. from a country outside the European Economic Area (or third country), 6. for export to a third country, 7. for carriage between Member States of the European Economic Area), (d) genetically modified crops and conventional and organic for the coexistence of farmed crops in a given area (side-by-side cultivation). Topics covered by this Act, in relation to genetic engineering activities, are regarding food systems and cultivation, animal feed, livestock and animal production, plant production, protection of environment and health. Article 2 provides for all definitions of used terms. The performance of genetic engineering activities shall be carried out by the Reviewer of Genetic Engineering Procedures Committee (article 4).
The Act is divided into five main Chapters as follows: I. General provisions; II. Licensing and registration; III. Rules for the authorization of coexistence; IV. Official controls and measures (also education, training, information); V. Miscellaneous and final provisions. Several European Union legislation compliance issues are indicated in article 38.
As regards wild animals or protected natural organisms, the provisions of this Act shall apply save as otherwise provided for in the Nature Conservation Act. (4) Protected natural organisms should not be genetically modified. The protection status of species cannot be altered due to gene technology reasons. With the exceptions laid down in Articles 13(1) and 15(1), gene technology activities are subject to related authorizations. The Gene Technology Authority shall decide on the applications for authorisations taking into account the opinion of the Gene Technology Committee. The Gene Technology Authority may reject the application for authorisation or issue approval against the opinion of the Gene Technology Committee.