Authorisation of genetically modified maize 59122

Procedure completed

2018/2568(RSP) Authorisation of genetically modified maize 59122
Lead ENVI PIETIKÄINEN Sirpa (EPP), BALAS Guillaume (S&D), MAZURONIS Valentinas (ALDE), BOYLAN Lynn (GUE/NGL), STAES Bart (Verts/ALE), EVI Eleonora (EFD)
Lead committee dossier: ENVI/8/12162
Legal Basis RoP 106-p2


  • 2018/03/01 Decision by Parliament, 1st reading/single reading
    • T8-0051/2018 summary


  • Decision by Parliament, 1st reading/single reading: T8-0051/2018


(these mark the time of scraping, not the official date of the change)

activities/0/docs/0/text added
  • The European Parliament adopted by 405 votes to 205, with 25 abstentions, a resolution objecting to the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of, or produced from genetically modified maize 59122 (DAS-59122-7) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed.

    On 19 July 2016, Pioneer Overseas Corporation and Dow AgroSciences Ltd. jointly submitted an application for the renewal of the authorisation for the placing on the market of foods and feed containing, consisting of, or produced from genetically modified (GM) maize 59122.

    GM maize 59122 expresses proteins conferring resistance to coleopteran insect pests belonging to the genus Diabrotica such as larvae of western corn rootworm and the PAT protein which confers tolerance to glufosinate containing herbicides.

    Although the European Food Safety Authority (EFSA) adopted a favourable opinion to renew the authorisation, many critical comments were submitted by Member States in relation to the first EFSA opinion during the three-month consultation period relating to:

    • that ‘the monitoring conducted for GM maize 59122 is unable to provide meaningful results for the current assessment and to resolve uncertainties associated with the risk assessment conducted prior to authorisation, e.g. as regards exposure of the environment’;
    • that ‘the monitoring approach implemented for GM maize 59122 is not in line with requirements of Annex VII of Directive 2001/18/EC’.

    Other areas of concern are: (i) the fact that several studies demonstrate that the immunogenicity of Cry proteins in mice have not been submitted by the applicant; (ii) the residues from spraying with glufosinate were not assessed; (iii) the fact that residues from the spraying of complementary herbicides could be expected to be present in the crops.

    Members considered that it would be unacceptable from a food safety perspective, as well as highly inconsistent, to authorise the import of a glufosinate tolerant GM maize given that the authorisation for the use of glufosinate in the Union expires on 31 July 2018 due to its reproductive toxicity.

    On the basis of these considerations, Parliament considered that the Commission’s implementing decision is not compatible with Union law which requires the provision of the basis for ensuring a high level of protection of human life and health, animal health and welfare, the environment and consumer interests, while ensuring the effective functioning of the internal market.

    As a result, Parliament asked the Commission to withdraw its draft implementing decision.

    On a procedural level, Members recalled that since the entry into force of authorisation procedure for GMOs, authorisation decisions have been adopted by the Commission without the support of the Standing Committee on the Food Chain and Animal Health.

    The return of the dossier to the Commission for final decision, which is very much the exception for the procedure as a whole, has become the norm for decision-making on genetically modified food and feed authorisations. This practice has also been deplored by Commission President Juncker as not being democratic.

    Parliament called on the Commission to suspend any implementing decision regarding applications for authorisation of genetically modified organisms until the authorisation procedure has been revised in such a way so as to address the shortcomings of the current procedure.

    It also called on it to advance work on the Commission proposal amending Regulation (EU) No 182/2011 as a matter of urgency and to ensure that, inter alia, if no opinion is delivered by the Food Chain and Animal Health Standing Committee with respect to GMOs approvals, either for cultivation or for food and feed, the Commission will withdraw the proposal.

    Lastly, the Commission is called on not to authorise the import of any genetically modified plant for food or feed uses which has been made tolerant to a complementary herbicide which is banned, or which will be banned in the near future, in the Union.


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© European Union, 2011 – Source: European Parliament