Commission Implementing Decision (EU) 2017/2452 of 21 December 2017 renewing the authorisation for the placing on the market of products containing, consisting of, or produced from genetically modified maize 1507 (DAS-Ø15Ø7-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2017) 9044) (Text with EEA relevance. )
Date: 2017-12-21
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, food safety, foodstuff, labelling, maize, market approval, transgenic plant




L_2017346EN.01002501.xml










28.12.2017   


EN


Official Journal of the European Union


L 346/25








            COMMISSION IMPLEMENTING DECISION (EU) 2017/2452
of 21 December 2017
         
renewing the authorisation for the placing on the market of products containing, consisting of, or produced from genetically modified maize 1507 (DAS-Ø15Ø7-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council


(notified under document C(2017) 9044)


(Only the Dutch, English and French texts are authentic)
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (1), and in particular Articles 11(3) and 23(3) thereof,

Whereas:







(1)


On 27 February 2015, Pioneer Overseas Corporation and Dow AgroSciences Ltd jointly submitted to the Commission an application, in accordance with Article 11 and Article 23 of Regulation (EC) No 1829/2003, for renewal of the authorisation for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from genetically modified maize 1507 (hereinafter ‘maize 1507’). The scope of the renewal application also covers products other than food and feed containing or consisting of maize 1507. The scope of the application does not include cultivation.












(2)


The placing on the market of the products covered by the scope of the renewal application was previously authorised by two separate decisions: Commission Decision 2005/772/EC (2) and Commission Decision 2006/197/EC (3).












(3)


On 12 January 2017, the European Food Safety Authority (‘EFSA’) issued a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. Based on the data provided, it concluded (4) that no new hazards or modified exposure and no new scientific uncertainties were identified for the application for renewal that would change the conclusions of the original risk assessment (5) on maize 1507.












(4)


In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.












(5)


EFSA also concluded that the monitoring plan for environmental effects, consisting of a general surveillance plan, submitted by the applicant, is in line with the intended uses of the products.












(6)


Taking into account those considerations, the authorisation for the placing on the market of food and feed containing, consisting of, or produced from maize 1507 and of products consisting of it or containing it for other uses than food or feed, with the exception of cultivation, should be renewed.












(7)


A unique identifier has been assigned to genetically modified maize 1507, in accordance with Commission Regulation (EC) No 65/2004 (6), by Decision 2005/772/EC. That unique identifier should continue to be used.












(8)


On the basis of the abovementioned EFSA opinion, no specific labelling requirements, other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council (7), appear to be necessary for the products covered by this Decision. However, in order to ensure the use of those products remains within the limits of the authorisation granted by this Decision, the labelling of the products containing or consisting of maize 1507, with the exception of food products, should contain a clear indication that the products in question are not intended for cultivation. Since an application for the authorisation for the placing on the market of maize 1507 seeds for cultivation is pending, this labelling requirement should only apply until that authorisation is granted.












(9)


The authorisation holders should submit joint annual reports on the implementation and the results of the activities set out in the monitoring plan. These results should be presented in accordance with Commission Decision 2009/770/EC (8).












(10)


The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or the use and handling of the food and feed, including post-market monitoring requirements.












(11)


All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed referred to in Regulation (EC) No 1829/2003.












(12)


This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Articles 9(1) and 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (9).












(13)


The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. This implementing act was deemed to be necessary and the chair submitted it to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,





HAS ADOPTED THIS DECISION:



Article 1

Genetically modified organism and unique identifier

Genetically modified maize (Zea mays L.) line 1507, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier DAS-Ø15Ø7-1, in accordance with Regulation (EC) No 65/2004.


Article 2

Renewal of authorisation

The authorisation for the placing on the market of the following products is renewed in accordance with the conditions set out in this Decision:






(a)


foods and food ingredients containing, consisting of or produced from maize 1507;










(b)


feed containing, consisting of or produced from maize 1507;










(c)


maize 1507 in products containing it or consisting of it for any other use than those provided for in points (a) and (b), with the exception of cultivation.






Article 3

Labelling


1.   For the purposes of the labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘maize’.


2.   The words ‘not for cultivation’ shall appear either on a label or in a document accompanying the products containing or consisting of maize 1507, with the exception of food and food ingredients.
This requirement shall apply until the placing on the market of maize 1507 seeds for the purpose of cultivation is authorised.



Article 4

Method of detection

The method set out in point (d) of the Annex shall apply for the detection of maize 1507.


Article 5

Monitoring for environmental effects


1.   The authorisation holders shall ensure that the monitoring plan for environmental effects, as set out in point (h) of the Annex to this Decision is put in place and implemented.


2.   The authorisation holders shall submit to the Commission joint annual reports on the implementation and the results of the activities set out in the monitoring plan in accordance with Decision 2009/770/EC.



Article 6

Community register

The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed referred to in Article 28 of Regulation (EC) No 1829/2003.


Article 7

Authorisation holders


1.   The authorisation holders shall be:






(a)


Pioneer Overseas Corporation, Belgium, representing Pioneer Hi-Bred International, Inc., United States, and










(b)


Dow AgroSciences Ltd, United Kingdom, representing Dow AgroSciences LLC, United States.






2.   Both authorisation holders shall be responsible for fulfilling the duties imposed on authorisation holders by this Decision and Regulation (EC) No 1829/2003.



Article 8

Validity

This Decision shall apply for a period of 10 years from the date of its notification.


Article 9

Addressee

This Decision is addressed to:






(a)


Pioneer Overseas Corporation, Avenue des Arts 44, B-1040 Brussels — Belgium, and










(b)


Dow AgroSciences Europe Ltd., European Development Center, 3B Park Square, Milton Park, Abingdon, Oxon OX14 4RN — United Kingdom.








Done at Brussels, 21 December 2017.


For the Commission

Vytenis ANDRIUKAITIS
            

Member of the Commission






(1)  
            OJ L 268, 18.10.2003, p. 1.

(2)  Commission Decision 2005/772/EC of 3 November 2005 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L., line 1507) genetically modified for resistance to certain lepidopteran pests and for tolerance to the herbicide glufosinate-ammonium (OJ L 291, 5.11.2005, p. 42).

(3)  Commission Decision 2006/197/EC of 3 March 2006 authorising the placing on the market of food containing, consisting of, or produced from genetically modified maize line 1507 (DAS-Ø15Ø7-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 70, 9.3.2006, p. 82).

(4)  Scientific opinion on an application for renewal of authorisation for continued marketing of maize 1507 and derived food and feed submitted under Articles 11 and 23 of Regulation (EC) No 1829/2003 by Pioneer Overseas Corporation and Dow AgroSciences LLC. The EFSA Journal (2017); 15(1):4659.

(5)  Opinion of the Scientific Panel on Genetically Modified Organisms on an application for the placing on the market of insect-tolerant genetically modified maize 1507, for food use, under Regulation (EC) No 1829/2003 from Pioneer Hi-Bred International/Mycogen Seeds. EFSA Journal (2005) 182, 1-22; and Scientific Opinion of the Panel on Genetically Modified Organisms on Application (EFSA-GMO-RX-1507) for renewal of authorisation for the continued marketing of existing products produced from maize 1507 for feed use, under Regulation (EC) No 1829/2003 from Pioneer Hi-Bred International, Inc./Mycogen Seeds. EFSA Journal (2009) 1138, 1-11.

(6)  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 (OJ L 10, 16.1.2004, p. 5).

(7)  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 (OJ L 268, 18.10.2003, p. 24).

(8)  Commission Decision 2009/770/EC of 13 October 2009 establishing standard reporting formats for presenting the monitoring results of the deliberate release into the environment of genetically modified organisms, as or in products, for the purpose of placing on the market, pursuant to Directive 2001/18/EC of the European Parliament and of the Council (OJ L 275, 21.10.2009, p. 9).

(9)  Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms (OJ L 287, 5.11.2003, p. 1).




ANNEX

(a)   

Applicants and Authorisation holders:








Name


:


Pioneer Overseas Corporation




Address


:


Avenue des Arts 44, B-1040 Brussels, Belgium




On behalf of Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, P.O. Box 1014, Johnston, IA 50131-1014, United States
         
and







Name


:


Dow AgroSciences Europe Ltd.




Address


:


European Development Center, 3B Park Square, Milton Park, Abingdon, Oxon OX14 4RN, United Kingdom




On behalf of Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268-1054, United States
         


(b)   

Designation and specification of the products:







(1)


foods and food ingredients containing, consisting of, or produced from maize 1507;










(2)


feed containing, consisting of, or produced from maize 1507;










(3)


maize 1507 in products containing it or consisting of it for any other use than those provided for in points (1) and (2), with the exception of cultivation.




Maize 1507, as described in the application, expresses the Cry1F protein, derived from Bacillus thuringiensis subsp. aizawai, which confers resistance to the European corn borer (Ostrinia nubilalis) and certain other lepidopteran pests, and the PAT protein, derived from Streptomyces viridochromogenes strain Tü494, which confers tolerance to the herbicide glufosinate-ammonium.


(c)   

Labelling:







(1)


For the purposes of the labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘maize’.










(2)


The words ‘not for cultivation’ shall appear either on a label or in a document accompanying the products containing or consisting of maize 1507, with the exception of food and food ingredients.




This requirement shall apply until the placing on the market of maize 1507 seeds for the purpose of cultivation is authorised.


(d)   

Method for detection:







(1)


Event specific real-time quantitative PCR based method for detection of the genetically modified maize DAS-Ø15Ø7-1.










(2)


Validated by the Community reference laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx










(3)


Reference Material: ERM®-BF418 (for DAS-Ø15Ø7-1) is accessible via the Joint Research Centre (JRC) of the European Commission at https://ec.europa.eu/jrc/en/reference-materials/catalogue/






(e)   

Unique identifier:

DAS-Ø15Ø7-1


(f)   

Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity:

[Biosafety Clearing-House, Record ID number: published in the Community register of genetically modified food and feed when notified].


(g)   

Conditions or restrictions on the placing on the market, use or handling of the products:

Not required.


(h)   

Monitoring plan for environmental effects:

Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
[Link: plan published in the Community register of genetically modified food and feed]


(i)   

Post-market monitoring requirements for the use of the food for human consumption:

Not required.


Note: links to relevant documents may need to be modified over the time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.