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Country's Decision or any other Communication (DEC)
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BCH-DEC-EU-115796-1   |   PDF   |   Print   |  
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last updated: 27 Nov 2020
Amendment
No
General Information
Desicion authorising the placing on the market of a carnation (Dianthus caryophyllus L., line FLO-40685-2) genetically modified for flower colour
EN
05 Sep 2019
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 genetically modified carnation Dianthus caryophyllus L., line FLO-40685-2, may be placed on the market subject to the following conditions:
(a)  the genetically modified carnation may only be used for ornamental purposes;
(b)  the cultivation of the genetically modified carnation is not allowed;
(c)  without prejudice to confidentiality requirements set out in Article 25 of Directive 2001/18/EC, the methodology for detecting and identifying the genetically modified carnation, including experimental data demonstrating the specificity of the methodology, as validated by the European Union Reference Laboratory is publicly available at http://gmo-crl.jrc.ec.europa.eu/valid-2001-18.htm;
(d)  without prejudice to confidentiality requirements set out in Article 25 of Directive 2001/18/EC, the consent holder, whenever requested to do so, makes 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 Union 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’ appear either on a label or, for non-pre- packaged products, in a document accompanying the genetically modified carnations.
EN
EU regulatory requirements
EN
LMO identification & risk assessment
  • BCH-LMO-SCBD-14835-11 Living Modified Organism FLO-4Ø685-2 - Moonvista™ carnation
    SUntory Holdings Ltd. | Changes in quality and/or metabolite content (Pigmentation / Coloration), Resistance to herbicides (Sulfonylurea)
  • BCH-RA-EU-115794-1 Risk Assessment generated by a regulatory process Part C notification (reference C/NL/13/02) from Suntory Holdings Limited for the import, distribution and retailing of carnation FLO-40685-2 cut flowers with modified petal colour for ornamental use
    FLO-4Ø685-2 - Moonvista™ carnation | Carnation, DIACA, Resistance to herbicides, Changes in quality and/or metabolite content
  • BCH-RA-NL-115460-1 Risk Assessment generated by a regulatory process Application to import cut-flowers of carnation (Dianthus caryophyllus) line FLO-40685-2 for distribution and retail (C/NL/13/02)
    FLO-4Ø685-2 - Moonvista™ carnation | Carnation, DIACA, Resistance to herbicides, Changes in quality and/or metabolite content
Document on the decision, communication, notification or declaration
Additional Information
EU detection method validated by the EU reference laboratory for GM Food and Feed (EURL GMFF)
EN