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National Node of the BCH
Country's Decision or any other Communication
Record information and status
Record ID
102063
Status
Published
Date of creation
2011-07-25 09:57 UTC (Guy.VAN-DEN-EEDE@ec.europa.eu)
Date of last update
2020-01-08 16:13 UTC (chantal.bruetschy@ec.europa.eu)
Date of publication
2020-01-08 16:13 UTC (chantal.bruetschy@ec.europa.eu)

General information
Country submitting the decision or communication
  • European Union
Competent National Authority(ies) responsible for the decision or communication
European Commission - Health and Food Safety Directorate General SANTE
Rue Belliard, B232
Brussels
Belgium, 1040
Phone:+32 2 2962362
Fax:+32 2 2964736
Email:chantal.bruetschy@ec.europa.eu
Url:European Commission - Health and Food Safety Directorate General SANTE
Title / Reference number of the decision or communication
Authorisation of the placing on the market of maize MON863 genetically modified for resistance to corn rootworm
Date of the decision
2005-08-08
Is the decision taken prior to entry into force of the Protocol?
No
Jurisdiction
  • European Union
Is this an amendment to a previous decision / communication?
No
Decision or communication details
Subject(s) of the decision
Uses of the LMO(s)
  • LMOs for direct use as food
  • LMOs for direct use as feed
  • LMOs for processing
Has the decision been taken in the absence of a domestic regulatory framework and in accordance with Article 11.6?
No
Importer’s or Applicant’s contact details
Monsanto Europe S.A.
Avenue de Tervuren 270-272
Brussels
Belgium, B-1150
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Conditions
ACCORDING TO COMMISSION DECISION 2005/608/EC ON MON863 FOR FEED USES

(a) the period of validity of the consent shall be 10 years starting from the date on which the consent is issued;
(b) the unique identifier of the product shall be MON-ØØ863-5;
(c) without prejudice to Article 25 of Directive 2001/18/EC, the consent holder shall, whenever requested to do so, make positive and negative control samples of the product, or its genetic material, or reference materials available to the competent authorities and inspection services of Member States as well as to the Community control laboratories;
(d) without prejudice to specific labelling requirements provided by Regulation (EC) No 1829/2003 the words 'This product contains genetically modified organisms' or 'This product contains genetically modified MON 863 maize' shall appear either on a label or in a document accompanying the product, except where other Community legislation sets a threshold below which such information is not required;
(e) as long as the product has not been authorised for the placing on the market for the purpose of cultivation, the words 'not for cultivation' shall appear either on a label or in a document accompanying the product.
Reasons
Conditions contribute to comply with legal requirements of EU genetic engineering legal framework.
LMO identification
MON-ØØ863-5 - YieldGard™ Rootworm™ maize
Resistance to antibiotics - Kanamycin Resistance to diseases and pests - Insects - Coleoptera (beetles)
Show detection method(s)
Risk assessment
Opinion of the Scientific Panel on GMOs on the placing on the market for import and processing of insect-protected genetically modified maize MON863 and MON863 x MON810
MON-ØØ863-5 - YieldGard™ Rootworm™ maize
Resistance to antibiotics - Kanamycin
Resistance to diseases and pests - Insects - Coleoptera (beetles)
MON-ØØ863-5 x MON-ØØ81Ø-6 - YieldGard™ Rootworm™ maize
Resistance to antibiotics - Kanamycin
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths)
Additional Information
Additional Information
Authorisation Decisions 2005/608/EC and 2006/68/EC expired on 12 January 2016.