Commercial Information Circulars

24-hour hotline : 23 922 922

Ref : EIC 230/4

11 May 2001

Dear Sirs,

Commercial Information Circular No. 84/01

European Union (EU)*: Directive on Genetically Modified Organisms (GMOs)

The European Commission (EC) has published a revised Directive governing the deliberate release into the environment of genetically modified organisms (GMOs), including the placing on the market of GMOs as or in products within the European Community. A copy of the revised Directive (Directive 2001/18/EC of 12 March 2001) is appended (pdf format ) to this Circular for reference.

2. The Directive sets out the controlling procedures for releasing GMOs into the environment to protect human health and the environment. It defines GMO to mean an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination. Major points of the controlling procedures are as follows:

   1. Any person, who wish to release into the environment of a GMO or of a combination of GMOs, must submit a notification to the competent authority of the Member State within whose territory the release is to take place;

   2. Before submitting the notification regarding the releasing into the environment of GMOs, the notifier has to carry out an environment risk assessment;
       
   3. The notification should contain a technical dossier containing information that is necessary for carrying out the environment risk assessment;

   4. In the case of notification regarding the placing on the market of GMOs as or in products, the notification should also include a plan for monitoring the effects of the GMOs after their placing on the market, a proposal for labelling the GMO products and a proposal for packaging the GMO products;

   5. The relevant competent authorities of Member States shall examine the notifications received and inform the notifier of the result of its assessment within 90 days indicating whether the notifier may proceed with the release of the GMO products. The consent for release of GMO products to the environment is limited to a maximum of ten years, both for first time consent and subsequent renewal consent;

   6. As a safeguard measure, where a Member State, as a result of new or additional information made available since the date of the consent, considers that a GMO as or in a product constitutes a risk to human health or the environment, the Member State may provisionally restrict or prohibit the use and/or sale of that GMO as or in a product on its territory; and

   7. At all stages of the placing on the market of GMO as or in a product, Member States shall take measures to ensure traceability of the product.

3. The revised Directive shall be implemented as from 17 October 2002 by which Member States are required to have transposed the revised Directive into their national laws. Since then, the revised Directive will replace the existing directive governing the release into the environment of GMOs (Directive 90/220/EEC)..

4. To further specify the requirements on traceability and labelling of GMOs and GMO derived products, the EC has announced intention to bring forward appropriate legislative proposals. We shall keep traders informed of further developments.

ENQUIRIES

5. For enquiries about the contents of this Circular, please contact the undersigned at telephone number 2398 5684.

Yours faithfully,

 

(Miss Helen YUNG)

for Director-General of Trade and Industry

* : The EU Member States are Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden and the United Kingdom.

Note : While every effort is made to ensure the accuracy of the above information, the Department cannot guarantee this to be so and will not be held liable for any reliance placed on the same.