Record details

General information

Country submitting the decision or communication

European Union

Competent National Authority(ies) responsible for the decision or communication

Record #49387

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 on the renewal of authorising the placing on the market of carnation FLO-40644-6 (line Moonlite) genetically modified for flower colour

Date of the decision

2017-02-28

Is the decision taken prior to entry into force of the Protocol?

Jurisdiction

European Union

Is this an amendment to a previous decision / communication?

Yes

BCH decision amended

Record #103151

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

FLO-4Ø644-6 - Moonlite™ carnation
Stephen Chandler

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-40644-6.

Decision or communication details

Subject(s) of the decision

Decision on LMOs for direct use as food or feed, or for processing (Article 11, LMOs-FFPs)
- Decision on domestic use of an LMO, including its placing on the market

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?

Importer’s or Applicant’s contact details

Record #115481

Suntory Flowers

Suntory Flowers Limited

4-17-5, shiba, Minato-ku

Tokyo

Japan, 108-0014

Phone:	+61 3 409 387 386
Email:	info@florigene.com
Url:	Florigene.com

Result of the decision

Approval of the import/use of the LMO(s) with conditions

Conditions

See article 3 of the decision

Reasons

EU regulatory requirements on detection method

LMO identification

Record #14834

FLO-4Ø644-6 - Moonlite™ carnation

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

Risk assessment

Record #108636

C/NL/04/02 Application to import carnation variety FLORIGENE Moonlite (FLO-40644-6) with modified flower colour

FLO-4Ø644-6 - Moonlite™ carnation
Stephen Chandler

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

Record #103150

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
Stephen Chandler

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

Decision document

Consent RENEWAL FLO-40644-6 (C/NL/04/02-001)(in Dutch)

Dutch assessment report on the RENEWAL of FLO-40644-6 (C/NL/04/02-001)

EU GMO Register

Additional Information

EU detection method validated by the EU Reference Laboratory for GM Food Feed (EU-RL GMFF). In 2017 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.

Other relevant website address or attached documents

EU Reference Laboratory for GM Food Feed (EU-RL GMFF)

EU detection method carnation FLO-40644-6