Commission Implementing Decision (EU) 2018/1109 of 3 August 2018 renewing the authorisation for the placing on the market of products containing, consisting of, or produced from genetically modified maize 59122 (DAS-59122-7) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2018) 4978) (Only the Dutch, English and French texts are authentic) (Text with EEA relevance) (revoked)
EU Decision 2018/1109 · Adopted 1 August 2018 · Extends to United Kingdom
Commission Implementing Decision (EU) 2018/1109
of 3 August 2018
renewing the authorisation for the placing on the market of products containing, consisting of, or produced from genetically modified maize 59122 (DAS-59122-7) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council
(notified under document C(2018) 4978)
(Only the Dutch, English and French texts are authentic)
(Text with EEA relevance) (revoked)
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Annotations to the whole text
Textual amendments
- F1
Decision revoked (E.W.S.) (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 6 para. 55 (with reg. 23)
Contents
- 1Genetically modified organism and unique identifier Repealed
- 2Renewal of authorisation Repealed
- 3Labelling Repealed
- 4Method for detection Repealed
- 5Monitoring plan for environmental effects Repealed
- 6Register Repealed
- 7Authorisation holder Repealed
- 8Validity Repealed
- 9Addressee Repealed
- Annex Annex Repealed
- Repealed
1Genetically modified organism and unique identifierF1
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2Renewal of authorisationF1
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3LabellingF1
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4Method for detectionF1
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5Monitoring plan for environmental effectsF1
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6RegisterF1
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7Authorisation holderF1
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8ValidityF1
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9AddresseeF1
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F1
- (a)
Authorisation holder:
- (1)
The authorisation holder is Corteva Agriscience LLC, 9330 Zionsville Road, Indianapolis, Indiana, 46268-1054, United States of America.
- (2)
The authorisation holder is represented in Great Britain by Corteva Agriscience UK Limited, Cpc2 Capital Park, Fulbourn, Cambridge, England, CB21 5XE.
- (1)
- (b)
Designation and specification of the products:
- (1)
food containing, consisting of, or produced from maize 59122;
- (2)
feed containing, consisting of, or produced from maize 59122;
- (3)
maize 59122 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 59122, as described in the application, expresses the Cry34Ab1 and Cry35Ab1 proteins, derived from Bacillus thuringiensis, which confer resistance to certain coleopteran pests, including Western corn rootworm, and the PAT protein, derived from Streptomyces viridochromogenes, which confers tolerance to glufosinate-ammonium based herbicides and was used as a selection marker.
- (1)
- (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 maize 59122, with the exception of food and food ingredients.
- (1)
- (d)
Method for detection:
- (1)
Event specific real-time quantitative PCR based method for detection of the genetically modified maize DAS-59122-7.
- (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®-BF424 (for DAS-59122-7) is accessible via the Joint Research Centre (JRC) of the European Commission, at https://ec.europa.eu/jrc/en/reference-materials/catalogue/
- (1)
- (e)
Unique identifier:
DAS-59122-7
- (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 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 of the European Parliament and of the Council.
[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.