歐盟批準(zhǔn)轉(zhuǎn)基因玉米Bt11 × 59122 × MIR604 × 1507 × GA21的上市

(1)

On 1 July 2011, Syngenta submitted an application for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from Bt11 × 59122 × MIR604 × 1507 × GA21 maize (‘the application’) to the national competent authority of Germany in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003. The application also covered the placing on the market of genetically modified maize Bt11 × 59122 × MIR604 × 1507 × GA21 in products consisting of it or containing it for other uses than food and feed as any other maize, with the exception of cultivation.

(2)

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

(3)

On 21 February 2014, Syngenta extended the scope of the application to all sub-combinations of the single genetic modification events constituting Bt11 × 59122 × MIR604 × 1507 × GA21 maize, except the sub-combination 1507 × 59122, which was already authorised by Commission Decision 2010/432/EU (3).

(4)

On 31 March 2016, Syngenta updated the scope of the application by excluding the following four sub-combinations, which were in the scope of another application: Bt11 × GA21 maize, MIR604 × GA21 maize, Bt11 × MIR604 maize, and Bt11 × MIR604 × GA21. These sub-combinations were authorised by Commission Implementing Decision (EU) 2016/1685 (4).

(5)

On 26 August 2016, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 (5). EFSA concluded that genetically modified maize Bt11 × 59122 × MIR604 × 1507 × GA21, as described in the application, is as safe and as nutritious as its conventional counterpart and non-genetically modified commercial varieties as regards the potential effects on human health and the environment, and no safety concerns were identified for any of the 20 sub-combinations covered by the scope of the application.

(6)

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 Article 18(4) of Regulation (EC) No 1829/2003.

(7)

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.

(8)

In its opinion, EFSA recommended the collection of relevant information on expression levels of the newly expressed proteins, if any of the 20 sub-combinations were to be created via targeted breeding approaches and commercialised. In line with this recommendation, specific conditions should be laid down to that effect.

(9)

Taking into account those considerations, authorisation should be granted to the products containing, consisting of, or produced from genetically modified maize Bt11 × 59122 × MIR604 × 1507 × GA21, and the following twenty sub-combinations thereof, consisting of: five sub-combinations of four events (Bt11 × MIR604 × 1507 × GA21, Bt11 × 59122 × 1507 × GA21, Bt11 × 59122 × MIR604 × GA21, Bt11 × 59122 × MIR604 × 1507, 59122 × MIR604 × 1507 × GA21); nine sub-combinations of three events (Bt11 × 59122 × MIR604, Bt11 × 59122 × 1507, Bt11 × 59122 × GA21, Bt11 × MIR604 × 1507, Bt11 × 1507 × GA21, 59122 × MIR604 × 1507, 59122 × MIR604 × GA21, 59122 × 1507 × GA21, MIR604 × 1507 × GA21); and six sub-combinations of two events (Bt11 × 59122, Bt11 × 1507, 59122 × MIR604, 59122 × GA21, MIR604 × 1507 and 1507 × GA21).

(10)

A unique identifier should be assigned to each genetically modified organism (hereinafter ‘GMO’) in accordance with Commission Regulation (EC) No 65/2004 (6).

(11)

On the basis of the EFSA opinion, no specific labelling requirements, other than those 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 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 within the limits of the authorisation granted by this Decision, the labelling of the products containing or consisting of maize Bt11 × 59122 × MIR604 × 1507 × GA21 and the sub-combinations, with the exception of food products, should be complemented by a clear indication that the products in question are not intended for cultivation.

(12)

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 the standard reporting format requirements laid down in Commission Decision 2009/770/EC (8).

(13)

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 results of the activities set out in the specific conditions of this authorisation.

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

(17)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time-limit laid down by its chair. 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,

(a)

the unique identifier SYN-BTØ11-1 × DAS-59122-7 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) Bt11 × 59122 × MIR604 × 1507 × GA21;

(b)

the unique identifier SYN-BTØ11-1 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) Bt11 × MIR604 × 1507 × GA21;

(c)

the unique identifier SYN-BTØ11-1 × DAS-59122-7 × DAS-Ø15Ø7-1 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) Bt11 × 59122 × 1507 × GA21;

(d)

the unique identifier SYN-BTØ11-1 × DAS-59122-7 × SYN-IR6Ø4-5 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) Bt11 × 59122 × MIR604 × GA21;

(e)

the unique identifier SYN-BTØ11-1 × DAS-59122-7 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 for genetically modified maize (Zea mays L.) Bt11 × 59122 × MIR604 × 1507;

(f)

the unique identifier DAS-59122-7 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) 59122 × MIR604 × 1507 × GA21;

(g)

the unique identifier SYN-BTØ11-1 × DAS-59122-7 × SYN-IR6Ø4-5 for genetically modified maize (Zea mays L.) Bt11 × 59122 × MIR604;

(h)

the unique identifier SYN-BTØ11-1 × DAS-59122-7 × DAS-Ø15Ø7-1 for genetically modified maize (Zea mays L.) Bt11 × 59122 × 1507;

(i)

the unique identifier SYN-BTØ11-1 × DAS-59122-7 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) Bt11 × 59122 × GA21;

(j)

the unique identifier SYN-BTØ11-1 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 for genetically modified maize (Zea mays L.) Bt11 × MIR604 × 1507;

(k)

the unique identifier SYN-BTØ11-1 × DAS-Ø15Ø7-1 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) Bt11 × 1507 × GA21;

(l)

the unique identifier DAS-59122-7 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 for genetically modified maize (Zea mays L.) 59122 × MIR604 × 1507;

(m)

the unique identifier DAS-59122-7 × SYN-IR6Ø4-5 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) 59122 × MIR604 × GA21;

(n)

the unique identifier DAS-59122-7 × DAS-Ø15Ø7-1 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) 59122 × 1507 × GA21;

(o)

the unique identifier SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) MIR604 × 1507 × GA21;

(p)

the unique identifier SYN-BTØ11-1 × DAS-59122-7 for genetically modified maize (Zea mays L.) Bt11 × 59122;

(q)

the unique identifier SYN-BTØ11-1 × DAS-Ø15Ø7-1 for genetically modified maize (Zea mays L.) Bt11 × 1507;

(r)

the unique identifier DAS-59122-7 × SYN-IR6Ø4-5 for genetically modified maize (Zea mays L.) 59122 × MIR604;

(s)

the unique identifier DAS-59122-7 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) 59122 × GA21;

(t)

the unique identifier SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 for genetically modified maize (Zea mays L.) MIR604 ×1507;

(u)

the unique identifier DAS-Ø15Ø7-1 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) 1507 × GA21.

(a)

foods and food ingredients containing, consisting of, or produced from the GMOs referred to in Article 1(1);

(b)

feed containing, consisting of, or produced from the GMOs referred to in Article 1(1);

(c)

GMOs referred to in Article 1(1) in products containing them or consisting of them for any other use than those provided in points (a) and (b), with the exception of cultivation.

Name

:

Syngenta Crop Protection NV/SA

Address

:

489, Avenue Louise, 1050 Brussels, Belgium

(1)

foods and food ingredients containing, consisting of, or produced from genetically modified maizes (Zea mays L.) as specified in (e);

(2)

feed containing, consisting of, or produced from genetically modified maizes (Zea mays L.) as specified in (e);

(3)

genetically modified maizes (Zea mays L.) as specified in (e) in products containing them or consisting of them for any other use than those provided in points (1) and (2), with the exception of cultivation.

(1)

For the purposes of the labelling requirements laid down in Article 13(1) and Article 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 on the label of and in the accompanying documents of the products containing or consisting the maizes specified in (e) with the exception of products referred to in point (a) of Article 2.

(1)

Event specific real-time quantitative PCR based methods for SYN-BTØ11-1, DAS-59122-7, SYN-IR6Ø4-5, DAS-Ø15Ø7-1 and MON-ØØØ21-9 maizes; the detection methods are validated on the single-trait events and verified on genomic DNA extracted from seeds of SYN-BTØ11-1 × DAS-59122-7 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9 maize;

(2)

Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx;

(3)

Reference Material: ERM®-BF412 (for SYN-BTØ11-1), ERM®-BF424 (for DAS-59122-7), ERM®-BF423 (for SYN-IR6Ø4-5) and ERM®-BF418 (for DAS-Ø15Ø7) accessible via the Joint Research Centre (JRC) of the European Commission, Institute for Reference Materials and Measurements (IRMM) at https://crm.jrc.ec.europa.eu and AOCS 0407-A and AOCS 0407-B (for MON-ØØØ21-9) accessible via the American Oil Chemists Society at http://www.aocs.org/LabServices/content.cfm?ItemNumber=19248.

SYN-BTØ11-1 × DAS-59122-7 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9;

SYN-BTØ11-1 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9;

SYN-BTØ11-1 × DAS-59122-7 × DAS-Ø15Ø7-1 × MON-ØØØ21-9;

SYN-BTØ11-1 × DAS-59122-7 × SYN-IR6Ø4-5 × MON-ØØØ21-9;

SYN-BTØ11-1 × DAS-59122-7 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1;

DAS-59122-7 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9;

SYN-BTØ11-1 × DAS-59122-7 × SYN-IR6Ø4-5;

SYN-BTØ11-1 × DAS-59122-7 × DAS-Ø15Ø7-1;

SYN-BTØ11-1 × DAS-59122-7 × MON-ØØØ21-9;

SYN-BTØ11-1 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1;

SYN-BTØ11-1 × DAS-Ø15Ø7-1 × MON-ØØØ21-9;

DAS-59122-7 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1;

DAS-59122-7 × SYN-IR6Ø4-5 × MON-ØØØ21-9;

DAS-59122-7 × DAS-Ø15Ø7-1 × MON-ØØØ21-9;

SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9;

SYN-BTØ11-1 × DAS-59122-7;

SYN-BTØ11-1 × DAS-Ø15Ø7-1;

DAS-59122-7 × SYN-IR6Ø4-5;

DAS-59122-7 × MON-ØØØ21-9;

SYN-IR6Ø4-5 × DAS-Ø15Ø7-1;

DAS-Ø15Ø7-1 × MON-ØØØ21-9.

(1)

The authorisation holder shall inform the Commission if any of the sub-combinations were to be created via targeted breeding approaches and commercialised.

(2)

If it is the case, the authorisation holder shall collate information on the expression levels of the newly expressed proteins.