European Union | BCH-DEC-EU-103151 | Country's Decision or any other Communication | Biosafety Clearing-House

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Country's Decision or any other Communication (DEC)
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BCH-DEC-EU-103151-2   |   PDF   |   Print   |  
published: 29 Feb 2012 last updated: 27 Nov 2020
Amendment
No
BCH-DEC-EU-115826-1 Country's Decision or any other Communication Decision on the renewal of authorising the placing on the market of carnation FLO-40644-6 (line Moonlite) genetically modified for flower colour
FLO-4Ø644-6 - Moonlite™ carnation | Carnation, DIACA
General Information
Decision authorising the placing on the market of a carnation (Dianthus caryophyllus L., line 123.2.38 Moonlite, FLO-40644-4) genetically modified for flower colour
EN
11 Jul 2007
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 put to ornamental use only, with the exception of cultivation, and may be placed on the market subject to the following conditions:
(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 FLO-4Ø644-4;
(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 verified by the Community Reference Laboratory, shall be made available to the competent authorities and to inspection services of Member States as well as to the Community control laboratories.
(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 the Community 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-14834-6 Living Modified Organism FLO-4Ø644-6 - Moonlite™ carnation
    SUntory Holdings Ltd. | Changes in quality and/or metabolite content (Pigmentation / Coloration), Resistance to herbicides (Sulfonylurea)
  • BCH-RA-EU-103150-5 Risk Assessment generated by a regulatory process European Food Safety Authority (EFSA) opinion on the placing on the market for import of genetically modified carnation Moonlite 123.2.38
    FLO-4Ø644-6 - Moonlite™ carnation | Carnation, DIACA, Resistance to herbicides, Changes in quality and/or metabolite content
  • BCH-RA-NL-108636-3 Risk Assessment generated by a regulatory process C/NL/04/02 Application to import carnation variety FLORIGENE Moonlite (FLO-40644-6) with modified flower colour
    FLO-4Ø644-6 - Moonlite™ carnation | Carnation, DIACA, Resistance to herbicides, Changes in quality and/or metabolite content
Additional Information
EU detection method validated by the EU Reference Laboratory for GM Food Feed (EU-RL GMFF)
EN
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Country's Decision or any other Communication Country's Decision or any other Communication 1