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General issues

  1. What are GMOs?
  2. Facts and figures about GMOs
  3. Who assesses the safety of GMOs?

GM Food and Feed

  1. Is the placing on the EU market of GM food and feed governed by any legislation?
  2. What are the principles of the Regulation on GM food and feed?
  3. What is the authorisation procedure under the Regulation on GM food and feed?
  4. Have GMOs already been approved for use in food or feed products?
  5. What are the current rules on genetically modified varieties and seeds?
  6. What is the timeline for GM food and feed approval?

GMOs in the environment

  1. What are GMOs released into the environment?
  2. What does Directive 2001/18/EC introduce?
  3. What is the procedure for authorisation of the experimental release of GMOs into the environment?
  4. What is the procedure for authorising the placing on the market of GMOs as such or as a component in products?
  5. How is the environmental risk of GMOs assessed?
  6. Have GMOs already been authorised for release into the environment?

Ban on GMOs

  1. What are the national safeguard measures?
  2. A number of Member States have invoked the so-called 'safeguard clause' of the previous Directive 90/220/EEC. This clause is also included in Directive 2001/18/EC (Article 23), which replaces Directive 90/220/EEC. This safeguard clause provides that where a Member State has justifiable reasons to consider that a GMO, which has received written consent for placing on the market, constitutes a risk to human health or the environment, it may provisionally restrict or prohibit the use and/or sale of that product on its territory.

    The safeguard clause was invoked on nine separate occasions under Directive 90/220/EEC during the late 1990s and in 2000, three times by Austria, twice by France, and once each by Germany, Luxembourg, Greece and the United Kingdom. The scientific evidence provided by these Member States as justification for their measures was submitted to the Scientific Committee(s) of the European Union for opinion.

    In all of these cases, the Committee(s) deemed that there was no new evidence which would justify overturning the original authorisation decision.

    In spite of the repeal of Directive 90/220/EEC, eight of the nine bans remained in place (UK has withdrawn its ban) and were re-notified under the safeguard provision of Directive 2001/18/EC. In view of the new regulatory framework, the Commission has examined the additional information provided by certain Member States which have invoked the safeguard clause and has submitted it to EFSA for evaluation.

    In its opinion of July 2004, EFSA concluded, as for all previous arguments and information, that the additional information did not invalidate the original risk assessments for the products in question. Consequently, the Commission was required to submit draft decisions, initially to the Regulatory Committee, requesting the Member States concerned to lift their national safeguard measures. The Regulatory Committee, on 29 November 2004, failed to reach a qualified majority either in favour or against any of these proposals. Under these circumstances, and in accordance with EU comitology procedures, the proposals were transmitted to the Council. On 24 June 2005 the Council rejected the proposals of the Commission to lift the national safeguard clauses.

    The European Commission has requested EFSA to upgrade its opinion of July 2004 taking into consideration any scientific information indicating that the GMOs in question pose a potential risk to human health or the environment under the conditions of their consents. EFSA, in its opinion, issued on 29 March 2006, concluded, as for all previous arguments and information, the scientific evidence currently available did not invalidate the original risk assessments for the products in question. In the light of the EFSA opinion, the Commission proposed two draft Council decisions requesting Austria to repeal its measures concerning MON810 and T25 maize. On 18 December 2006, the Council rejected the proposals of the Commission to lift the national safeguard clauses. The Commission has now three options according to EU comitology rules: to submit amended proposals to the Council; re-submit the same proposals or present legislative proposals through co-decision procedure.

    The companies which developed the remaining 3 products subject to safeguard clauses (Bt176, Ms1Rf1 and Topas 19/2.) indicated that seeds of these varieties are no longer offered for sale. Therefore, the Commission intends to adopt in April 2007 the necessary measures to formalise the definitive withdrawal of the products from the market.

    In January 2005, Hungary invoked the safeguard clause in order to prohibit the cultivation of MON 810 maize on its territory. The Commission submitted the information provided by Hungary to EFSA for its evaluation. In June 2005, EFSA concluded that this information did not invalidate the initial risk assessment of MON 810. The Regulatory Committee, on 18 September 2006, failed to reach a qualified majority either in favour or against any of these proposals. Under these circumstances, and in accordance with EU comitology procedures, the proposals were transmitted to the Council. On 20 February 2007 the Council rejected the proposal of the Commission to lift the national safeguard clauses. The Commission now has three options according to EU comitology rules: to submit amended proposals to the Council; re-submit the same proposals or present legislative proposals through co-decision procedure.

    A link to the list of pending safeguard clauses is available in Annex 3.

    TOP


  3. Are there any national safeguard measures concerning GM foods?
  4. Are any national safeguard measures concerning GM seed varieties included in the common catalogue of varieties?
  5. Which EU countries ban the cultivation of GMOs?

Rules on GMOs already on the market

  1. Why it is important to trace GMOs in the EU market?
  2. How does traceability work in practice?
  3. What are the rules on traceability of GMOs?
  4. What are the rules on labelling of GMO products?
  5. Exemption from the traceability and labelling requirements.
  6. Will the meat or milk of an animal fed with GM feed also be labelled as genetically modified?

Asynchronous authorisations

  1. What is asynchronous authorisation?
  2. What is the impact of GMO asynchronous authorisations on the EU market?

Contamination with unauthorised GMOs

  1. Emergency Measures

Co-existence

  1. What are the rules on co-existence between transgenic crops and traditional or organic crops?

The international environment

  1. Is the regulatory framework in line with international trade rules?
  2. Codex Alimentarius
  3. What are the rules governing the movement and international trade of GMOs?
  4. WTO case on GMO
  5. OECD

ANNEX

 
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