Commission Implementing Decision (EU) 2016/2050 of 22 November 2016 as regards the placing on the market of a genetically modified carnation (Dianthus caryophyllus L., line SHD-27531-4) (notified under document C(2016) 7443) (Text with EEA relevance )
Commission Implementing Decision (EU) 2016/2050 of 22 November 2016 as regards the placing on the market of a genetically modified carnation (Dianthus caryophyllus L., line SHD-27531-4) (notified under document C(2016) 7443) (Text with EEA relevance )
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
1. Written consent shall be granted by the competent authority of the Netherlands to the placing on the market of genetically modified carnation ( Dianthus caryophyllus L., line SHD-27531-4) notified by Suntory Holdings Limited, Osaka, Japan (Reference C/NL/13/01) and defined in Article 2.
2. The consent shall be given in writing and shall explicitly specify the requirements set out in Articles 3 and 4 and the unique identifier set out in Article 2(2).
3. The consent shall be limited to the placing on the market of cut flowers of the genetically modified carnation as a product.
4. The consent shall cover progeny derived through vegetative reproduction of the genetically modified carnation.
5. The period of validity of the consent shall be 10 years starting from the date on which the consent is issued.
1. The genetically modified organism to be placed on the market, is a carnation ( Dianthus caryophyllus L.) with modified flower colour, derived from a Dianthus caryophyllus L. cell culture, and transformed with Agrobacterium tumefaciens , strain AGL0, using the vector pCGP1991, and resulting in line SHD-27531-4.
The genetically modified carnation contains the following DNA in three cassettes:
(a)
Cassette 1
The petunia dfr gene encoding dihydroflavonol 4-reductase (DFR), a key enzyme in the anthocyanin biosynthetic pathway, including its own promoter and terminator.
(b)
Cassette 2
The promoter sequence from snapdragon chalcone synthase gene, flavonoid 3′5′-hydroxylase ( f3′5′h ) from Viola hortensis cDNA encoding F3′5′H, a key enzyme in the anthocyanin biosynthetic pathway, and the terminator from the D8 petunia gene encoding a putative phospholipid transfer protein.
These two cassettes were inserted into the plant genome to obtain the desired flower colour.
(c)
Cassette 3
The Cauliflower mosaic virus 35S promoter, the 5′-untranslated region from the petunia gene encoding chlorophyll a/b binding protein, the SuRB ( als ) gene coding for a mutant acetolactate synthase protein (ALS) derived from Nicotiana tabacum, which confers tolerance to sulfonylurea, including its own terminator. This trait was used as a marker in the selection of transformants.
2. The unique identifier of the genetically modified carnation shall be SHD-27531-4.
The genetically modified carnation 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 shall not be 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 the confidentiality requirements set out in 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 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’ shall appear either on a label or in a document accompanying the genetically modified carnations.
1. Throughout the period of validity of the consent, the consent holder shall ensure that the monitoring plan, contained in the notification and consisting of a general surveillance plan to check for any adverse effects on human health or the environment arising from handling or use of the genetically modified carnation, is put in place and implemented.
The monitoring plan is available at [Link: plan published on the internet].
2. The consent holder shall directly inform the operators and users concerning the safety and general characteristics of the genetically modified carnation and of the conditions as to monitoring, including the appropriate management measures to be taken in case of accidental cultivation.
3. The consent holder shall submit to the Commission and to the competent authorities of the Member States annual reports on the results of the monitoring activities.
4. The consent holder shall be in the position to give evidence to the Commission and the competent authorities of the Member States:
(a)
that the existing monitoring networks, including national botanic survey networks and plant protection services, as specified in the monitoring plan contained in the notification, gather the information relevant for the monitoring of the genetically modified carnation; and
(b)
that these existing monitoring networks referred to in point (a) have agreed to make available that information to the consent holder before the date of submission of the monitoring reports to the Commission and competent authorities of the Member States in accordance with paragraph 3.
