Commission Implementing Decision (EU) 2015/698 of 24 April 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean 305423 (DP-3Ø5423-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2015) 2773) (Text with EEA relevance)
Date: 2015-04-24
Institutions: European Commission
Subjects: animal feedingstuffs, food safety, foodstuff, labelling, market approval, soya bean, transgenic plant




L_2015112EN.01007101.xml










30.4.2015   


EN


Official Journal of the European Union


L 112/71








            COMMISSION IMPLEMENTING DECISION (EU) 2015/698
of 24 April 2015
         
authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean 305423 (DP-3Ø5423-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council


(notified under document C(2015) 2773)


(Only the Dutch 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 7(3) and 19(3) thereof,

Whereas:







(1)


On 14 June 2007, Pioneer Overseas Corporation submitted to the competent authority of the Netherlands an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from 305423 soybean (‘the application’).












(2)


The application also covers the placing on the market of 305423 soybean in products consisting of it or containing it for any other uses than food and feed as any other soybean, with the exception of cultivation.












(3)


In accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council (2) and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.












(4)


On 18 December 2013, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 (3). It concluded that 305423 soybean, as described in the application, is as safe as its non-genetically modified counterpart with respect to potential effects on human and animal health or the environment in the context of its intended uses.












(5)


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.












(6)


In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products. In addition, EFSA recommended a post-market monitoring plan to be implemented, focusing on the collection of consumption data for the European population.












(7)


Taking into account those considerations, authorisation should be granted to the products.












(8)


A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004 (4).












(9)


Food, food ingredients and feed containing, consisting of, or produced from soybean 305423 should be labelled in accordance with the requirements provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003.












(10)


On the basis of the EFSA opinion, confirming that fatty acid composition of the seeds of soybean 305423 and derived oil has been changed in relation to the conventional counterpart, a specific labelling appears to be necessary in accordance with Articles 13(2)(a) and 25(2)(c) of Regulation (EC) No 1829/2003.












(11)


In order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of products containing or consisting of the GMO for which authorisation is requested, with the exception of food products, should be complemented by a clear indication that the products in question must not be used for cultivation.












(12)


Regulation (EC) No 1830/2003 of the European Parliament and of the Council (5) lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.












(13)


The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC (6). The EFSA opinion does not justify the imposition of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Article 6(5) and Article 18(5) of Regulation (EC) No 1829/2003.












(14)


The authorisation holder should also submit annual reports on the implementation and the results of the activities set out in the post-market monitoring plan.












(15)


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












(16)


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 Article 9(1) and point (c) of Article 15(2) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (7).












(17)


The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act 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 305423 soybean (Glycine max (L.) Merr.), as specified in point (b) of the Annex to this Decision, is assigned the unique identifier DP-3Ø5423-1, as provided for in Regulation (EC) No 65/2004.


Article 2

Authorisation

The following products are authorised for the purposes of Articles 4(2) and 16(2) of Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision:






(a)


foods and food ingredients containing, consisting of, or produced from DP-3Ø5423-1 soybean;










(b)


feed containing, consisting of, or produced from DP-3Ø5423-1 soybean;










(c)


DP-3Ø5423-1 soybean in products containing it or consisting of it for any other use than (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 ‘soybean’.


2.   For the purposes of the labelling requirements laid down in Articles 13(2)(a) and 25(2)(c) of Regulation (EC) No 1829/2003, the words ‘with increased monounsaturated fat and reduced polyunsaturated fat’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products.


3.   The words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of DP-3Ø5423-1 soybean with the exception of products referred to in point (a) of Article 2.



Article 4

Monitoring for environmental effects


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


2.   The authorisation holder shall submit to the Commission 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 5

Post-market monitoring in accordance with Article 6(5)(e) of Regulation (EC) No 1829/2003


1.   The authorisation holder shall ensure that the post-market monitoring plan of the DP-3Ø5423-1 soybean oil, as set out in point (g) of the Annex, is put in place and implemented.


2.   The authorisation holder shall submit to the Commission annual reports on the implementation and the results of the activities set out in the post-market monitoring plan for the duration of the authorisation.



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, as provided for in Article 28 of Regulation (EC) No 1829/2003.


Article 7

Authorisation holder

The authorisation holder shall be Pioneer Overseas Corporation.


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 Pioneer Overseas Corporation, Avenue des Arts 44, 1040 Brussels, Belgium.




Done at Brussels, 24 April 2015.


For the Commission

Vytenis ANDRIUKAITIS
            

Member of the Commission






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

(2)  Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).

(3)  EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), 2013. Scientific Opinion on application EFSA-GMO-NL-2007-45 for the placing on the market of herbicide-tolerant, high-oleic acid, genetically modified soybean 305423 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Pioneer. EFSA Journal 2013;11(12):3499, 35 pp. doi:10.2903/j.efsa.2013.3499.

(4)  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).

(5)  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).

(6)  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).

(7)  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)   Applicant and authorisation holder








Name


:


Pioneer Overseas Corporation




Address


:


Avenue des Arts 44, 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 of America.
(b)   Designation and specification of the products







1.


Foods and food ingredients containing, consisting of, or produced from DP-3Ø5423-1 soybean.










2.


Feed containing, consisting of, or produced from DP-3Ø5423-1 soybean.










3.


DP-3Ø5423-1 soybean in products containing it or consisting of it for any other use than 1 and 2, with the exception of cultivation.




The genetically modified DP-3Ø5423-1 soybean, as described in the application, has a reduced expression of the soybean enzyme omega-6 desaturase, which results in a high oleic acid and reduced linoleic acid profile, and expresses an optimised Glycine max-hra gene, which confers tolerance to acetolactate synthase-inhibiting herbicides.
(c)   Labelling







1.


For the purposes of the specific 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 ‘soybean’.










2.


For the purposes of the labelling requirements laid down in Articles 13(2)(a) and 25(2)(c) of Regulation (EC) No 1829/2003, the words ‘with increased monounsaturated fat and reduced polyunsaturated fat’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products.










3.


The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying products containing or consisting of DP-3Ø5423-1 soybean with the exception of products referred to in point (a) of Article 2.




(d)   Method for detection







—


Event specific real-time PCR based method for the quantification of DP-3Ø5423-1 soybean.










—


Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003 on genomic DNA extracted from soybean seeds, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx










—


Reference Material: ERM-BF426 accessible via the Joint Research Centre (JRC) of the European Commission, the Institute for Reference Materials and Measurements (IRMM) at http://www.irmm.jrc.be/html/reference_materials_catalogue/index.htm




(e)   Unique identifier

DP-3Ø5423-1
(f)   Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity

Biosafety Clearing-House, Record ID: see [to be completed when notified].
(g)   Conditions or restrictions on the placing on the market, use or handling of the products


Post-market monitoring in accordance with Article 6(5)(e) of Regulation (EC) No 1829/2003







1.


The authorisation holder shall collect the following information:






(i)


quantities of DP-3Ø5423-1 soybean oil and 305423 soybeans for oil extraction, imported into the European Union for the placing on the market as or in products for food;










(ii)


in case of import of products mentioned under (i), results of database searches in FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed.














2.


The authorisation holder shall, based on the information collected and reported, review the nutritional assessment conducted as part of the risk assessment.




(h)   Monitoring plan for environmental effects

Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
[Link: plan published on the internet]

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.