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Rules on GMOs in the EU - Harmonisation of controls

On 24 June 2011 the Commission adopted Regulation EC 619/2011, harmonising the implementation of the zero-tolerance policy on non-authorised genetically modified (GM) material in feed. This Regulation enters into force on 15 July 2011 and will address EU business operator's legal uncertainty when marketing feed imported from non-EU countries.

Prior to this Regulation, GM food and feed legislation did not provide rules for controlling the presence in feed of material which contains, consists of or is produced from GMOs undergoing EU authorisation or for GMOs with an expired authorisation. Consequently, EU countries' official controls applied different approaches for these GMOs.

Key points of the new Regulation

  • Sets a technical zero at a level of 0.1 % - the lowest level of GM material considered by the EU Reference Laboratory for the validation of quantitative methods;
  • Harmonises sampling and testing controls in all EU countries;
  • Limited to GM feed material;
  • GM material must comply with the following criteria:
    • be authorised for commercialisation in a non-EU country;
    • have a valid EFSA application under Article 17 of Regulation EC 1829/2003 or have an expired authorisation under Regulation EC 1829/2003;
    • authorisation pending for more than 3 months
      • have not been identified by EFSA as susceptible to have adverse effects on health or the environment when present under 0.1%;
      • quantitative method of analysis published by the EU reference laboratory;
      • certified reference material must be available to EU-countries and third parties;

Regulation EC 619/2011 - Sampling & analysis methods for official control of feed for GM material with a pending or expired

Midday Express 24 June 2011

Questions and Answers

Regulation EC 1829/2003


List of material which currently fulfils the requirements of Regulation (EC) No. 619/2011