Considerations on COM(2013)758 - Placing on the market for cultivation of a maize product (Zea mays L., line 1507) genetically modified for resistance to certain lepidopteran pests - Main contents
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| dossier | COM(2013)758 - Placing on the market for cultivation of a maize product (Zea mays L., line 1507) genetically modified for resistance to ... |
|---|---|
| document | COM(2013)758  |
| date | November 6, 2013 |
(2) A notification (Reference C/ES/01/01) concerning the placing on the market of a genetically modified maize product (Zea mays L., line 1507, hereinafter also '1507 maize') was submitted in 2001 by Pioneer Hi-Bred International, Inc. and Mycogen Seeds to the competent authority of Spain.
(3) The notification covers the placing on the market of seeds of varieties derived from the Zea mays L., line 1507 for cultivation in the Union. The scope of the notification, as confirmed by the consent-holder on 23 February 2007, does not cover the commercial use of the product as a plant tolerant to glufosinate in the Union, since the pat gene for glufosinate tolerance was only to be used as a marker gene. In addition, the conditions of approval of the active substance glufosinate have been restricted to uses as herbicide for band or spot application by Commission Implementing Regulation (EU) No 365/2013[2] amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance glufosinate. Therefore broadcast applications on maize fields cannot be authorised.
(4) In accordance with the procedure under Article 14 of Directive 2001/18/EC, the competent authority of Spain prepared an assessment report, which concluded that there is no scientific evidence to indicate that the placing on the market of the Zea mays L. line 1507 poses any risk to human and animal health or the environment for the requested uses.
(5) The assessment report was submitted in August 2003 to the Commission and the competent authorities of the other Member States, some of which raised and maintained objections to the placing on the market of the product.
(6) The opinion of EFSA, adopted on 19 January 2005[3], concluded that Zea mays L. line 1507 is unlikely to have an adverse effect on human and animal health or the environment in the context of its proposed use.
(7) The Commission convened a technical meeting with national competent authorities on 19 June 2006, to address the remaining objections of Member States in view of the EFSA opinion; certain Member States raised their concerns relating to the risk assessment of the product and requested a better explanation of the potential effects of the Bt toxin on non-target organisms and their monitoring.
(8) The Commission subsequently requested EFSA to complement its opinion on Zea mays L. line 1507 by providing more specific information concerning the lepidopteran species referred to in the EFSA opinion of 19 January 2005; EFSA was also asked to recommend whether more precise risk management measures, notably monitoring plans, including specific scientific research studies on non-target organisms and taking account of geographical regions, should be implemented. EFSA adopted the annex complementing its opinion on non-target organisms on 7 November 2006 (published 21 November 2006). After the publication of the above annex, eleven scientific studies, published after the adoption of the EFSA opinion of 19 January 2005, came to the attention of the Commission. Therefore the Commission requested EFSA on 24 July 2008 to review these studies, as well as any other relevant study, and confirm its risk assessment of 1507 maize or comment on whether these studies would lead EFSA to alter its conclusions or refine them.
(9) On 29 October 2008 EFSA adopted its opinion which concluded that these publications do not provide new information that would change previous risk assessments conducted on maize 1507. Having also considered other recent scientific publications, EFSA reaffirmed its previous conclusions on the environmental safety of maize 1507.
(10) Following a request of the Commission to consider whether new scientific elements might require a revision of its scientific opinion of 19 January 2005, EFSA adopted on 19 October 2011[4] a Scientific Opinion updating the evaluation of the environmental risk assessment and risk management recommendations on insect resistant genetically modified maize 1507 for cultivation. The EFSA GMO Panel concludes that, subject to appropriate management measures, maize 1507 cultivation is unlikely to raise safety concerns for the environment. In addition, on 18 October 2012, EFSA adopted a Scientific Opinion[5] supplementing the 2011 opinion and providing with additional evidence and further clarifications.
(11) Following a further request of the Commission for a consolidated opinion, EFSA adopted on 18 October 2012[6] a Scientific Opinion updating the risk assessment conclusions and risk management recommendations on the genetically modified insect resistant maize 1507. The GMO EFSA Panel did not identify new scientific publications reporting new information that would invalidate its previous conclusions on the safety of maize 1507.
(12) An examination of each of the Member State objections in the light of (i) Directive 2001/18/EC, (ii) the information submitted in the notification and (iii) the opinions of EFSA, discloses no evidence to indicate that the placing on the market of Zea mays L. line 1507 is likely to cause adverse effects on human and animal health or the environment in the context of its proposed use.
(13) Zea mays L., line 1507 has been approved for feed use under Directive 2001/18/EC in accordance with Commission Decision 2005/772/EC[7] and for food use under Regulation (EC) No 1829/2003 in accordance with Commission Decision 2006/197/EC[8].
(14) A unique identifier has been assigned to the Zea mays L., line 1507 for the purposes of Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC[9] and Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms[10].
(15) Prior to the placing on the market of the Zea mays L., line 1507, the necessary measures to ensure its labelling and traceability at all stages of its placing on the market, including verification by appropriate validated detection methodology, should be applied. A detection method for the Zea mays L., line 1507 has been validated by the European Union Reference Laboratory as referred to in the Annex of Regulation (EC) No 1829/2003, in accordance with Commission Regulation (EC) No 641/2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003[11].
(16) For the purpose of appropriate information for operators and consumers, and to facilitate better management practices, the label, or an accompanying document, should also indicate that the product protects itself against the European corn borer (Ostrinia nubilalis), pink borers (Sesamia spp.), fall armyworms (Spodoptera frugiperda), black cutworms (Agrotis ipsilon) and south-western corn borers (Diatraea grandiosella).
(17) As EFSA indicated in its opinion of 19 January 2005, 'the only adverse effect identified was the possibility that resistance to Bt toxin might evolve in corn borers exposed to 1507 maize following cultivation for some years. The Panel accepts the monitoring plan developed by the applicant to monitor specifically for resistance in corn borers and recommends that cultivation should be accompanied by appropriate risk management strategies to minimise exposure of both target and non-target insects to Bt toxins'. Therefore the consent holder should carry out monitoring and provide instruction to farmers in order to ensure the implementation by them of required measures, such as the planting of refuge maize and monitoring, to minimise development of resistance in target pests and to assist farmers in cultivating Zea mays L., line 1507.
(18) In accordance with the EFSA Opinion of 19 January 2005, '(..) management recommendations for the cultivation of 1507-maize, as given by the applicant to users of 1507 maize, considers measures to reduce exposure of non-target lepidoptera (as well as the target pest), such as the use of non-transgenic border rows as refugia for the target that would also reduce exposure of field margin weeds (and hence non-target lepidoptera) to pollen from Bt maize'.
(19) The refugia strategy should take into account further recommendations of EFSA in its opinions of 19 October 2011 and 18 October 2012. In particular, EFSA advises in its opinion of 2011 that 'In the case of a cluster of fields with an aggregate area greater than 5 ha of Bt-maize, there shall be refugia equivalent to 20% of this aggregate area, irrespective of individual field and farm size'. In its updating opinion of 2012, EFSA recommends that 'in regions where maize 1507 and Cry1Ab-expressing maize events would be cultivated together, refuge areas equivalent to 20% of the total Lepidoptera-active Bt-maize area are established due to the potential for cross-resistance between Cry1Ab and Cry1F'. EFSA further recommends in its Supplementing opinion of 2012 that 'If a maize 1507 field has margins, then sown strips of non-Bt-maize, placed between the edges of the Bt-maize crop and each margin, are considerably more effective as a mitigation measure at reducing expected mortality than a single block of non-Bt-maize of comparable area, wherever the latter is planted'.
(20) For the purpose of best possible handling and use of the product, the consent holder should distribute with each bag of seeds to the operators a leaflet detailing information about the product and practices for its use.
(21) Monitoring should be conducted in accordance with Article 20(1) of Directive 2001/18/EC, the monitoring plan and revisions submitted by the notifier including commitments made in response to requests from competent authorities, and the opinions of EFSA.
(22) It is appropriate to provide for post-marketing surveillance measures to address unanticipated effects of maize lines expressing Bt proteins on non-target organisms in particular.
(23) As indicated in the notification, the consent holder should undertake a monitoring study of unanticipated potential adverse effects on non-target organisms from cultivation of 1507 maize and report the outcome of this study to the rapporteur competent authority and the European Commission; the consent holder should also report to the competent authorities of the other Member States.
(24) The Committee established under Article 30(1) of Directive 2001/18/EC has not delivered an opinion within the time-limit laid down by its Chairman.