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Brussels, 14th March 2011

GMO controls: Commission issues requests Bulgaria to implement micro-organism rules

The European Commission decided today to request Bulgaria to implement correctly Directive 2009/41/EC that concerns activities around genetically modified micro-organisms. The Commission considers that Bulgaria has failed to meet the Directive's requirements to take all adequate measures to limit possible risk to human health and the environment, which might arise from such activities. The request takes the form of a reasoned opinion under EU infringement procedures. Bulgaria now has two months to inform the Commission of measures taken to implement the Directive correctly, failing which the Commission may decide to refer Bulgaria to the EU Court of Justice.

The issue

When micro-organisms are genetically modified, cultured, stored, transported, destroyed or used in any other way, humans and the environment may be exposed to risk. Directive 2009/41/EC requires Member States to ensure that all measures necessary are taken in order to avoid activities related to genetically modified micro-organisms having negative consequences on human health and/or the environment..

The Commission considers that the manner in which Bulgaria has implemented the Directive fails to control all possible risk to human health and the environment. For example, the Directive requires any new information on - or modification to - activity with significant possible risk to be notified to the competent authorities, whereas Bulgaria's national legislation requires such notification only where new scientific and "other information” exists. Bulgaria has also failed to legally provide for its obligation to send the Commission annual reports on certain activities.

In response to the Commission opening infringement procedures on 15 April 2010, Bulgaria amended its Genetically Modified Organisms Act. However, the new provisions do not address all deficiencies in the national legislation identified by the Commission. As a result, the Commission has decided to send Bulgaria a reasoned opinion formally requesting Bulgaria to comply with all aspects of the Directive.


Directive 2009/41/EC classifies risk of exposure to negative consequences in the following manner: no or negligible risk, low risk, moderate risk and high risk. Detailed criteria for assessing risk, as well as protective measures for each of the four levels of risk are laid down.

National competent authorities examine notified activities and protective measures.

If they so wish, national competent authorities may consult groups or the public on any aspect of the notified activities.

If an accident occurs, competent authorities and Member States which also may be affected are to be immediately informed.

More information on the infringement procedure: MEMO/11/162

More information on genetically modified food and feed:

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