Ukraine: approbation of GMOs in the environment

Starting from 1 June 2009, it will be necessary to obtain a permit for approbation of GMOs in the environment.

Permits are issued by the Ministry of Natural Resources of Ukraine (the “Ministry”) to legal entities and individuals (the “Subjects” and each individually – a “Subject”) for the period of the GMO’s state approbation, which in any case cannot exceed five years. Within the term of validity of the permit each GMO may be approbated only once. The main condition for obtaining permit is an investigation of the safety of GMOs for human health and the environment.

The Ministry issues permits within 45 calendar days of obtaining of the necessary documents as required by the Order No. 308. The Ministry may refuse to issue the permit if:

• it gains new scientifically based information about the danger of GMO’s to human health and the environment;
• it detects false information in the documents submitted;
• a Subject fails to provide the required documents, including minutes of public hearings as to the conduction of the GMO’s state approbation, and the methods and techniques of the identification of the GMO’s;
• a Subject violates the requirements to execute and/or regarding the content of the required documents.

A permit may be annulled in the event that the Ministry obtains credible scientific information which may result in the re-assessment of the impact of GMOs on human health and/or the environment, or if a Subject commits a violation of the permit conditions.

The refusal to issue a permit or its annulment may be appealed by the Subject within 30 business days.

Law: Resolution No. 308 of the Cabinet of Ministers of Ukraine On Approval of the Order of Issuance of Permit for Conducting the State Approbation (Trial) of Genetically Modified Organisms in the Environment, dated 2 April 2009