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National Node of the BCH
Country's Decision or any other Communication
Record information and status
Record ID
110116
Status
Published
Date of creation
2016-04-20 09:33 UTC (Joachim.Kreysa@ec.europa.eu)
Date of last update
2016-04-20 09:39 UTC (Joachim.Kreysa@ec.europa.eu)
Date of publication
2016-04-20 09:39 UTC (Joachim.Kreysa@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
Commission Implementing Decision (EU) 2015/692 of 24 April 2015 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a carnation (Dianthus caryophyllus L., line 25958) genetically modified for flower colour (notified under document C(2015) 2765)
Date of the decision
2015-04-24
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 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
Florigene
Florigene Ltd
16 Gipps Street, Collingwood,
Melbourne, Victoria
Australia, VIC 3066
Phone:+442078399370
Email:s.mitchell@suntory-uk.co.uk
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Conditions
The product may be placed on the market subject to the following conditions: (a) In accordance with Article 19(3)(b) of Directive 2001/18/EC, 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 IFD-25958-3; (c) Without prejudice to Article 25 of Directive 2001/18/EC, the methodology for detecting and identifying the product, including experimental data demonstrating the specificity of the methodology as single-laboratory validated by the EU Reference Laboratory is publicly available at http://gmo-crl.jrc.ec.europa.eu/valid-2001-18.htm; (d) 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 to inspection services of Member States as well as to EU control laboratories; (e) The words 'This product is a genetically modified organism' or 'This product is a genetically modified carnation', and the words 'not for human or animal consumption nor for cultivation' shall appear either on a label or in a document accompanying the product
Reasons
EU regulatory requirements
LMO identification
IFD-25958-3 - Moonberry carnation
Dr Yukihisa Katsumoto Changes in quality and/or metabolite content - Pigmentation / Coloration Resistance to herbicides - Chlorsulfuron, Sulfonylurea
Risk assessment
Scientific Opinion on a notification (reference C/NL/09/01) for the placing on the market of the genetically modified carnation IFD-25958-3 with a modified colour, for import of cut flowers for ornamental use, under Part C of Directive 2001/18/EC from Florigene
IFD-25958-3 - Moonberry carnation
Dr Yukihisa Katsumoto

Changes in quality and/or metabolite content - Pigmentation / Coloration
Resistance to herbicides - Chlorsulfuron, Sulfonylurea
Decision document
Additional Information
Additional Information
Detection method for the event carnation IFD-25958-3 verified by the European Union Reference Laboratory for GM Food and Feed (EURL GMFF)