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  GMOs in a nutshellslide

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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?

    The safety of GMOs in respect to health and the environment depends on the characteristics of the recipient organism (or parent organism), the inserted genetic material, the final organism that is produced, the recipient environment and the interaction between the GMO and the environment. The objective of the environmental risk assessment is to identify and evaluate potential adverse effects of the GMO(s). These include direct or indirect, immediate or delayed effects, taking into account any cumulative and long term effects on human health and the environment which may result from the deliberate release or placing on the market of the GMO(s). The environmental risk assessment also requires evaluation in terms of how the GMO was developed and examines the potential risks associated with the new gene products produced by the GMO (for example toxic or allergenic proteins), and the possibility of gene-transfer (for example of antibiotic resistance genes).

    The risk assessment methodology, reproduced in Annex II to Directive 2001/18/EC, is as follows:

    • identification of any characteristics of the GMO(s) which may cause adverse effects;
    • evaluation of the potential consequences of each adverse effect;
    • evaluation of the likelihood of the occurrence of each identified potential adverse effect;
    • estimation of the risk posed by each identified characteristic of the GMO(s)
    • application of management strategies for risks resulting from the deliberate release or placing on the market of GMO(s);
    • determination of the overall risk of the GMO(s).

  6. Have GMOs already been authorised for release into the environment?

Ban on GMOs

  1. What are the national safeguard measures?
  2. Are there any national safeguard measures concerning GM foods?
  3. Are any national safeguard measures concerning GM seed varieties included in the common catalogue of varieties?
  4. 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


  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




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