European Union | BCH-DEC-EU-110116 | Country's Decision or any other Communication | Biosafety Clearing-House

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Country's Decision or any other Communication (DEC)

published: 20 Apr 2016 last updated: 30 Nov 2020
Amendment
No
General Information
Authorisation of the placing on the market, of a carnation (Dianthus caryophyllus L., line 25958) genetically modified for flower colour
EN
09 Jul 2015
No
Subject of the decision, notification, communication or declaration
  • Decision on LMOs for direct use as food or feed, or for processing (Article 11, LMOs-FFP)
LMOs for direct use as food or feed, or for processing (LMOs-FFP)
  • LMOs for processing
No
Result of the decision
Approval of the import and/or use of the LMO(s) with 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
EN
EU regulatory requirements
EN
LMO identification & risk assessment
  • BCH-LMO-SCBD-104611-2 Living Modified Organism IFD-25958-3 - Moonberry carnation
    Suntory Holdings Limited(SHD) | Changes in quality and/or metabolite content (Flavonoids (e.g. anthocyanin), Pigmentation / Coloration), Resistance to herbicides (Chlorsulfuron, Sulfonylurea)
  • BCH-RA-EUR-110115-3 Risk Assessment generated by a regulatory process 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 | Carnation, DIACA, Resistance to herbicides, Changes in quality and/or metabolite content
  • BCH-RA-NL-108255-2 Risk Assessment generated by a regulatory process C/NL/09/01 Application to import carnation variety FLORIGENE Moonberry (IFD-25958-3) with modified flower colour
    IFD-25958-3 - Moonberry carnation | Carnation, DIACA, Resistance to herbicides, Changes in quality and/or metabolite content
Document on the decision, communication, notification or declaration
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)
EN
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