The European Parliament adopted by 442 votes to 160 with 20 abstentions, a resolution objecting to the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize 4114 (DP-ØØ4114-3), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council.

The application for placing on the market was submitted on 27 November 2014 by Pioneer Overseas Corporation, on behalf of Pioneer Hi-Bred International Inc., established in the United States of America, to the national competent authority of the Netherlands. On 19 April 2018, EFSA adopted a favourable opinion in relation to the application.

GM maize 4114 was developed to express three insecticidal proteins (Cry1F, Cry34Ab1and Cry35Ab1) for protection against specific lepidopteran and coleopteran pests, and the PAT protein conferring tolerance to the herbicidal active ingredient glufosinate-ammonium.

Main observations

Lack of assessment and controls of complementary herbicides and their residues

Members considered that the application of complementary herbicides, in this case glufosinate, is part of regular agricultural practice in the cultivation of herbicide-resistant plants. It can therefore be expected that they will be exposed to both higher and repeated doses, which will not only lead to a higher burden of residues in the harvest, and therefore in the imported product, but may also influence the composition of the genetically modified plant and its agronomic characteristics.

The use of glufosinate has not been permitted in the Union since 1 August 2018, as it has been classified as toxic to reproduction and thus falls under the cut-off criteria set out in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market.

Members also stressed the following points:

-information on residue levels of herbicides and their metabolites is essential for a thorough risk assessment of herbicide-tolerant GM plants. However, the impact of spraying GM maize with herbicides has not been assessed;

-as part of the coordinated multiannual control programme of the Union for 2019, 2020 and 2021, Member States are not obliged to measure glufosinate residues on any maize imports in order to ensure compliance with maximum residue levels (MRLs) . Therefore, it cannot be guaranteed that glufosinate residues on GM maize 4114 will comply with Union MRLs.

Bt toxins

Members indicated that a 2017 scientific study on the possible health impacts of Bt toxins and residues from spraying with complementary herbicides concludes that specific attention should be paid to the herbicide residues and their interaction with Bt toxins . However, this was not investigated by EFSA.

Lack of democratic legitimacy

The vote on 14 January 2019 of the Standing Committee on the Food Chain and Animal Health delivered no opinion, meaning that the authorisation was not supported by a qualified majority of Member States.

The Commission deplored the fact that, since the entry into force of the GMO authorization procedure, the Commission has adopted authorisation decisions without the support of the opinion of the Member States’ committee. 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.

In the light of these considerations, Parliament considered that the draft Commission implementing decision is not consistent with Union law, which aims to provide the basis for ensuring a high level of protection of human life and health, animal health and welfare, and environmental and consumer interests in relation to genetically modified food and feed, while ensuring the effective functioning of the internal market.

Accordingly, Parliament called on the Commission to:

- withdraw its draft implementing decision;

- not to authorise the import, for food or feed uses, of any GM plants which have been made tolerant to a herbicide that is not authorised for use in the Union, in this case glufosinate;

- not to authorise any herbicide-tolerant GM plants without a full assessment of the residues from spraying with complementary herbicides, metabolites and commercial formulations as applied in the countries of cultivation;

- fully integrate the risk assessment of the application of complementary herbicides and their residues into the risk assessment of herbicide-tolerant GM plants, regardless of whether the GM plant concerned is to be cultivated in the Union or is for import into the Union for food and feed uses;

- suspend any implementing decision regarding applications for authorisation of genetically modified organisms (GMOs) until the authorisation procedure has been revised in such a way as to address the shortcomings of the current procedure, which has proven inadequate;

- withdraw proposals for GMO authorisations if no opinion is delivered by the Standing Committee on the Food Chain and Animal Health, whether for cultivation or for food and feed uses.

Parliament reiterated its commitment to advancing work on the Commission proposal amending Regulation (EU) No 182/2011 (the Comitology Regulation). It called on the Council to move forward with its work in relation to that Commission proposal as a matter of urgency.