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Commission Implementing Decision (EU) 2019/1303 of 26 July 2019 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize 5307 (SYN-Ø53Ø7-1), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (notified under document C(2019) 5493) (Text with EEA relevance.)

Commission Implementing Decision (EU) 2019/1303 of 26 July 2019 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize 5307 (SYN-Ø53Ø7-1), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (notified under document C(2019) 5493) (Text with EEA relevance.)

Implementing Decision (EU) 2019/1303 · Decision · 10 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Genetically modified organism and unique identifier

Article 1

Genetically modified maize ( Zea mays L.) 5307, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier SYN-Ø53Ø7-1, in accordance with Regulation (EC) No 65/2004.

Authorisation

Article 2

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 SYN-Ø53Ø7-1 maize; (b) feed containing, consisting of or produced from SYN-Ø53Ø7-1 maize; (c) products containing or consisting of SYN-Ø53Ø7-1 maize for uses other than those provided for in points (a) and (b) of this Article, with the exception of cultivation.

Labelling

Article 3

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 on the label of and in the documents accompanying products containing or consisting of SYN-Ø53Ø7-1 maize, with the exception of products referred to in point (a) of Article 2.

Method for detection

Article 4

The method set out in point (d) of the Annex shall apply for the detection of SYN-Ø53Ø7-1 maize.

Monitoring for environmental effects

Article 5

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.

Community register

Article 6

The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as referred to in Article 28(1) of Regulation (EC) No 1829/2003.

Authorisation holder

Article 7

The authorisation holder shall be Syngenta Crop Protection AG, Switzerland, represented by Syngenta Crop Protection NV/SA, Belgium.

Validity

Article 8

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

Addressee

Article 9

This Decision is addressed to Syngenta Crop Protection NV/SA, Avenue Louise 489, 1050 Brussels, Belgium.

Supplementary provisions

ANNEXSupplementary provisions

ANNEX (a)    Applicant and Authorisation holder: Name : Syngenta Crop Protection AG Address : Schwarzwaldallee 215, CH-4058 Basel, Switzerland Represented by Syngenta Crop Protection NV/SA, Avenue Louise 489, 1050 Brussels, Belgium. (b)    Designation and specification of the products: (1) food containing, consisting of or produced from SYN-Ø53Ø7-1 maize; (2) feed containing, consisting of or produced from SYN-Ø53Ø7-1 maize; (3) products containing or consisting of SYN-Ø53Ø7-1 maize for uses other than those provided for in points (1) and (2), with the exception of cultivation. The genetically modified SYN-Ø53Ø7-1 maize, as described in the application, expresses the protein eCry3.1Ab, which confers resistance to certain coleopteran pests, and the protein PMI, which was used as a selection marker. (c)    Labelling: (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 documents accompanying the products containing or consisting of SYN-Ø53Ø7-1 maize, with the exception of products referred to in point (a) of Article 2. (d)    Method for detection: (1) Event specific real-time quantitative PCR based method for detection of the genetically modified maize SYN-Ø53Ø7-1. (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: AOCS 0411-C and AOCS 0411-D are accessible via the American Oil Chemists Society (AOCS) at https://www.aocs.org/crm (e)    Unique identifier: SYN-Ø53Ø7-1 (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 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 register of genetically modified food and feed.

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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