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Country's Decision or any other Communication
Record information and status
Record ID
103153
Status
Published
Date of creation
2012-02-29 16:38 UTC (Guy.VAN-DEN-EEDE@ec.europa.eu)
Date of last update
2020-11-27 15:39 UTC (chantal.bruetschy@ec.europa.eu)
Date of publication
2020-11-27 15:39 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 2963814
Email:hans.moons@ec.europa.eu
Url:European Commission - Health and Food Safety Directorate General SANTE
Title / Reference number of the decision or communication
Decision authorising the placing on the market of a carnation (Dianthus caryophyllus L., line 123.8.12 Moonaqua, FLO-40689-6) genetically modified for flower colour
Date of the decision
2009-07-20
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
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/use of the LMO(s) with conditions
Conditions
The product may be put to ornamental use only and cultivation is not allowed. The product 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-4Ø689-6;
(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 Community Reference Laboratory is publicly available at http://gmo-crl.jrc.ec.europa.eu
(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 inspection services of Member States as well as to 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.
Reasons
EU regulatory requirements
LMO identification
FLO-4Ø689-6 - Moonaqua™ carnation
Dr Yoshikazu Tanaka Changes in quality and/or metabolite content - Pigmentation / Coloration Resistance to herbicides - Chlorsulfuron, Sulfonylurea
Risk assessment
European Food Safety Authority (EFSA) opinion on the placing on the market for import of genetically modified carnation Moonaqua 123.8.12
FLO-4Ø689-6 - Moonaqua™ carnation
Dr Yoshikazu Tanaka

Changes in quality and/or metabolite content - Pigmentation / Coloration
Resistance to herbicides - Chlorsulfuron, Sulfonylurea
C/NL/06/01 Application to import carnation variety FLORIGENE Moonaqua™ (123.8.12)
FLO-4Ø689-6 - Moonaqua™ carnation
Dr Yoshikazu Tanaka

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 Feed (EU-RL GMFF)

Records referencing this document (1)
IDDescription
1record(s) found
Country's Decision or any other Communication1 record