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Country's Decision or any other Communication
Record information and status
Record ID
115796
Status
Published
Date of creation
2020-11-27 15:40 UTC (chantal.bruetschy@ec.europa.eu)
Date of publication
2020-11-27 15:40 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 29 20485
Email:anastasia.pagida@ec.europa.eu
Url:European Commission - Health and Food Safety Directorate General SANTE
Title / Reference number of the decision or communication
Desicion authorising the placing on the market of a carnation (Dianthus caryophyllus L., line FLO-40685-2) genetically modified for flower colour
Date of the decision
2019-09-05
Is the decision taken prior to entry into force of the Protocol?
No
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
Yoshihiro Irino
Manager
Suntory
Suntory France S.A.S.
44-52 Boulevard du Parc 92200 Neuilly-sur- Seine, France
Neuilly-sur- Seine
France, 92200
Phone:+33 1 4968 2700
Email:Yoshihiro.Irino@suntory.eu
Result of the decision
  • Approval of the import and/or use of the LMO(s) with conditions
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.
Reasons
EU regulatory requirements
LMO identification
FLO-4Ø685-2 - Moonvista™ carnation
Stephen Chandler Changes in quality and/or metabolite content - Pigmentation / Coloration Resistance to herbicides - Chlorsulfuron, Sulfonylurea
Show detection method(s)
Risk assessment
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
Stephen Chandler

Changes in quality and/or metabolite content - Pigmentation / Coloration
Resistance to herbicides - Chlorsulfuron, Sulfonylurea
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
Stephen Chandler

Changes in quality and/or metabolite content - Pigmentation / Coloration
Resistance to herbicides - Chlorsulfuron, Sulfonylurea
Additional Information
Additional Information
EU detection method validated by the EU reference laboratory for GM Food and Feed (EURL GMFF)