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Country's Decision or any other Communication
Record information and status
Record ID
115825
Status
Published
Date of creation
2020-12-03 08:25 UTC (chantal.bruetschy@ec.europa.eu)
Date of publication
2020-12-03 08:25 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
Decision on the renewal of authorising the placing on the market of carnation FLO-40689-6 genetically modified for flower colour
Date of the decision
2018-11-09
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?
Yes
BCH decision amended
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
FLO-4Ø689-6 - Moonaqua™ carnation
Dr Yoshikazu Tanaka

Changes in quality and/or metabolite content - Pigmentation / Coloration
Resistance to herbicides - Chlorsulfuron, Sulfonylurea
Reasons for the amendment
This authorization concerns a renewal of the existing authorization for the importation of cut flowers of genetically modified carnation FLO-40689-6.
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
Florigene
Florigene Ltd
16 Gipps Street, Collingwood,
Melbourne, Victoria
Australia, VIC 3066
Phone:+442078399370
Email:s.mitchell@suntory-uk.co.uk
Result of the decision
  • Approval of the import and/or use of the LMO(s) with conditions
Conditions
See article 3 of the renewal decision (in Dutch) and article 3 of EU Commission Decision 2009/244/EC
Reasons
EU regulatory requirements on detection method
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
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
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
Additional Information
Additional Information
EU detection method validated by the EU Reference Laboratory for GM Food Feed (EU-RL GMFF). In 2018 the authorization has been renewed by the Netherlands. This authorization is valid for the whole European Union. The corresponding risk assessment document and the consent document are added to this record.