Proposal for a Council Decision concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a carnation (Dianthus caryophyllus L., line 123.8.12) genetically modified for flower colour
Date: 2008-11-18
Institutions: European Commission
Subjects: Netherlands, floriculture, genetically modified organism, market approval

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 18.11.2008 
COM(2008) 754 final 

Proposal for a 

COUNCIL DECISION 

concerning the placing on the market, in accordance with Directive 2001/18/EC of the 
European Parliament and of the Council, of a carnation (Dianthus caryophyllus L., line 
123.8.12) genetically modified for flower colour 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

In  accordance  with  Article  13  of  Directive  2001/18/EC,  the  Dutch  authorities 
received  in  October  2006  by  Florigene  Ltd,  Melbourne,  Australia,  a  notification 
concerning the placing on the market of a genetically modified carnation (Dianthus 
caryophyllus L., line 123.8.12).  

The  notification  covers  import,  distribution  and  retailing  of  Dianthus  caryophyllus 
L., line 123.8.12 as for any other carnation. 

In accordance with the procedure provided for in Article 14 of Directive 2001/18/EC, 
the Dutch competent authority prepared an assessment report, which concluded that 
the genetically modified carnation (Dianthus caryophyllus L., line 123.8.12) should 
be  placed  on  the  market  for  import,  distribution  and  retailing  as  for  any  other 
carnation.  

The Commission forwarded the assessment report to all other Member States, some 
of  which  raised  and  maintained  objections  to  the  placing  on  the  market  of  the 
products in terms of monitoring plan, allergenicity and toxicity, and detection of the 
product. 

In  light  of  these  objections,  the  European  Food  Safety  Authority  (EFSA)  was 
consulted  and  delivered  its  opinion  in  March  2008  concluding,  from  all  evidence 
provided,  that  cut  flowers  of  the  genetically  modified  carnation  (Dianthus 
caryophyllus L., line 123.8.12) are unlikely to have an adverse effect on human and 
animal  health  or  the  environment  in  the  context  of  its  proposed  ornamental  use. 
EFSA  also  found  that  the  scope  of  the  monitoring  plan  provided  by  the  consent 
holder is in line with the intended use of the carnation. 

Whereby the Commission in accordance with Article 18 of Directive 2001/18/EC is 
required  to  take  a  decision  in  accordance  with  the  procedure  laid  down  in  Article 
30(2)  of  the  Directive  to  which  Articles  5  and  7  of  Decision  1999/468/EC  shall 
apply, having regard to the provisions of Article 8 thereof. 

A draft of the measures to be taken was submitted, in accordance with Article 5(2) of 
Decision  1999/468/EC,  for  opinion,  to  the  Committee  set  up  under  Article  30  of 
Directive 2001/18/EC. 

The  Committee,  consulted  on  15  September  2008,  has  not  delivered  an  opinion, 
which  requires  that  the  Commission,  in  accordance  with  Article  5(4)  of  Decision 
1999/468/EC,  shall,  without  delay,  submit  to  the  Council  a  proposal  relating  to  the 
measures to be taken and inform the European Parliament. The European Parliament 
may consider appropriate to take a position in accordance with Article 8 of the above 
Decision. 

Article  5(6)  of  Decision  1999/468/EC  provides  that  the  Council  may,  where 
appropriate  in  view  of  any  such  position,  act  by  qualified  majority  on  the  proposal 
within  a  period  set  at  three  months  in  accordance  with  Article  30(2)  of  Directive 
2001/18/EC. If within that three-month period, the Council has indicated by qualified 
majority that it opposes the proposal, the Commission shall re-examine it; whereas if, 
on expiry of that period, the Council has neither adopted the proposed implementing 

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act nor indicated its opposition, then the proposed implementing act shall be adopted 
by the Commission. 

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Proposal for a 

COUNCIL DECISION 

concerning the placing on the market, in accordance with Directive 2001/18/EC of the 
European Parliament and of the Council, of a carnation (Dianthus caryophyllus L., line 
123.8.12) genetically modified for flower colour 

(Text with EEA relevance) 

THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, 

Having regard to Directive 2001/18/EC of the European Parliament and of the Council of 12 
March 2001 on the deliberate release into the environment of genetically modified organisms 
and  repealing  Council  Directive  90/220/EEC1,  and  in  particular  the  first  subparagraph  of 
Article 18(1) thereof, 

After consulting the European Food Safety Authority, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

Pursuant to Directive 2001/18/EC, the placing on the market of a product containing 
or  consisting  of  a  genetically  modified  organism  or  a  combination  of  genetically 
modified  organisms  is  subject  to  written  consent  being  granted  by  the  competent 
authority  of  the  Member  State  that  received  the  notification  for  the  placing  on  the 
market of that product, in accordance with the procedure laid down in that Directive. 

A  notification  concerning  the  placing  on  the  market  of  a  genetically  modified 
carnation  (Dianthus  caryophyllus L.,  line  123.8.12)  was  submitted  by  Florigene  Ltd, 
Melbourne, Australia, to the competent authority of the Netherlands in March 2007. 

The notification covers import, distribution and retailing of Dianthus caryophyllus L., 
line 123.8.12 as for any other carnation. 

In accordance with the procedure provided for in Article 14 of Directive 2001/18/EC, 
the competent authority of the Netherlands prepared an assessment report, which was 
submitted  to  the  Commission  and  the  competent  authorities  of  the  other  Member 
States. That assessment report concludes that no reasons have emerged on the basis of 
which consent for the placing on the market of cut flowers of the genetically modified 
carnation  (Dianthus  caryophyllus  L.,  line  123.8.12)  for  ornamental  use  should  be 
withheld, if specific conditions are fulfilled. 

1 

OJ  L  106,  17.4.2001,  p.  1.  Directive  as  last  amended  by  Regulation  (EC)  No  1830/2003  (OJ  L  268, 
18.10.2003, p.24).  

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(5) 

(6) 

(7) 

(8) 

The competent authorities of other Member States raised objections to the placing on 
the market of the product. 

The opinion adopted on 12 March 2008 (published 26 March 2008) by the European 
Food Safety Authority (hereafter EFSA)2, concluded, from all evidence provided, that 
cut  flowers  of  the  genetically  modified  carnation  (Dianthus  caryophyllus  L.,  line 
123.8.12)  are  unlikely  to  have  an  adverse  effect  on  human  and  animal  health  or  the 
environment in the context of its proposed ornamental use. EFSA also found that the 
scope of the monitoring plan provided by the notifier is in line with the intended use of 
the carnation.  

An  examination  of  the  full  notification,  additional  information  provided  by  the 
notifier,  specific  objections  raised  by  the  Member  States  and  the  opinion  of  EFSA, 
discloses  no  reason  to  believe  that  the  placing  on  the  market  of  cut  flowers  of  the 
genetically  modified  carnation  (Dianthus  caryophyllus  L.,  line  123.8.12)  will 
adversely  affect  human  or  animal  health  or  the  environment  in  the  context  of  its 
proposed ornamental use. 

A unique identifier has been assigned to the genetically modified carnation (Dianthus 
caryophyllus L., line 123.8.12) for the purposes of Regulation (EC) No 1830/2003 of 
the  European  Parliament  and  of  the  Council  of  22  September  2003  concerning  the 
traceability  and  labelling  of  genetically  modified  organisms  and  the  traceability  of 
food and feed products produced from genetically modified organisms and amending 
Directive  2001/18/EC3  and  Commission  Regulation  (EC)  No  65/2004  of  14  January 
2004 establishing a system for the development and assignment of unique identifiers 
for genetically modified organisms4. 

(9) 

In light of the opinion of the European Food Safety  Authority, it is not necessary to 
establish  specific  conditions  for  the  intended  use  with  regard  to  the  handling  or 
packaging of the product and the protection of particular ecosystems, environments or 
geographical areas. 

(10)  Proposed  labelling,  on  a  label  or  in  an  accompanying  document,  should  include 
wording  to  inform  operators  and  final  users  that  the  cut  flowers  of  Dianthus 
caryophyllus L., line 123.8.12 can not be used for human or animal consumption nor 
for cultivation.  

(11)  A  detection  method  as  required  by  Annex  III  B.D.12  of  Directive  2001/18/EC,  was 
verified, tested and single-laboratory validated for the Dianthus caryophyllus L., line 
123.8.12  in  January  2008  by  the  Community  Reference  Laboratory  established  by 
Regulation (EC) No 1829/20035 . 

2 

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5 

The  EFSA  Journal(2008)  662,  1-21,  "Opinion  of  the  Scientific  Panel  on  Genetically  Modified 
Organisms on a request from the Commission related to the notification (Reference C/NL/06/01) for the 
placing  on  the  market  of  the  genetically  modified  carnation  Moonacqua  123.8.12  with  a  modified 
colour,  for  import  of  cut  flowers  for  ornamental  use,  under  Part  C  of  Directive  2001/18/EC  from 
Florigene" 
OJ L 268, 18.10.2003, p. 24 
OJ L 10, 16.01.2004, p. 5-10 
OJ L268, 18.10.2003, p.1. Regulation as amended by Commission Regulation (EC) No 1981/2006 (OJ 
L 368, 23.12.2006, p. 99) 

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(12)  The measures provided for in this Decision are in accordance with the opinion of the 

Committee set up under Article 30(1) of Directive 2001/18/EC. 

HAS ADOPTED THIS DECISION: 

Article 1 
Consent 

Written consent shall be granted by the competent authority of the Netherlands to the placing 
on  the  market,  in  accordance  with  this  Decision,  of  the  product  identified  in  Article  2,  as 
notified by Florigene Ltd, Melbourne, Australia (Reference C/NL/06/01). 

The  consent  shall,  in  accordance  with  Article  19(3)  of  Directive  2001/18/EC,  explicitly 
specify the conditions to which the consent is subject, which are set out in Articles 3 and 4. 

Article 2 
Product 

1. 

The  genetically  modified  organisms  to  be  placed  on  the  market  as  product, 
hereinafter  ‘the  product’,  are  cut  flowers  of  carnation  (Dianthus  caryophyllus  L.), 
with modified flower colour, derived from the Dianthus caryophyllus L. cell culture, 
and  transformed  with  Agrobacterium  tumefaciens,  strain  AGL0,  using  the  vector 
pCGP1991 and resulting in line 123.8.12. 

The product contains the following DNA in three cassettes: 

(a) Cassette 1 

The petunia dfr gene from Petunia X Hybrida encoding dihydroflavonol 4-reductase 
(DFR), a key enzyme in the anthocyanin biosynthetic pathway. The dfr gene is 
under control of its own promoter and terminator.  

(b) Cassette 2  

The  promoter  from  a  snapdragon  gene  encoding  chalcone  synthase,  petunia 
flavonoid  3'5'  hydroxylase  (F3'5'H)  cDNA,  a  key  enzyme  in  the  anthocyanin 
biosynthetic  pathway,  the  terminator  from  the  petunia  gene  encoding  a 
phospholipid transfer protein homologue. 

Simultaneous  expression  of  both  dfr  and  f3’5’h  genes  in  carnation  results  in  a 
modified flavonoid synthesis in flowers, and subsequent formation of the blue 
pigment delphinidin. 

(c) Cassette 3 

The cauliflower mosaic virus 35S promoter, a non-translated region from the cDNA 
corresponding to the petunia gene encoding chlorophyll a/b binding protein 5, 
the SuRB (als) gene coding for a mutant acetolactate synthase protein (ALS), 
which  confers  tolerance  to  sulfonylurea,  derived  from  Nicotiana  tabacum, 
including its terminator. 

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This gene was used for in vitro selection. 

2. 

The  consent  shall  cover  progeny  derived  through  vegetative  reproduction  of  the 
genetically modified carnation (Dianthus caryophyllus L., line 123.8.12). 

Article 3 
Conditions for placing on the market 

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) 

(b) 

(c) 

(d) 

(e) 

1. 

2. 

3. 

the period of validity of the consent shall be 10 years starting from the date on which 
the consent is issued; 

the unique identifier of the product shall be FLO- 4Ø689-6; 

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  

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; 

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. 

Article 4 
Monitoring 

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 and animal health or the 
environment arising from handling or use of the product referred to in Article 2(1),, 
is put in place and implemented. 

The  consent  holder  shall  directly  inform  the  operators  and  users  concerning  the 
safety  and  general  characteristics  of  the  product  and  of  the  conditions  as  to 
monitoring,  including  the  appropriate  management  measures  to  be  taken  in  case  of 
accidental cultivation. 

The consent holder shall submit to the Commission and to the competent authorities 
of the Member States annual reports on the results of all monitoring activities. The 
first annual report shall be submitted one year after final consent is granted. 

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4. 

Without  prejudice  to  Article  20  of  Directive  2001/18/EC,  the  monitoring  plan  as 
notified shall be revised by the consent holder, where appropriate and subject to the 
agreement  of  the  Commission  and  the  competent  authority  of  the  Member  State 
which  received  the  original  notification,  and/or  by  the  competent  authority  of  the 
Member  State  which  received  the  original  notification,  subject  to  the  agreement  of 
the Commission, in the light of the results of the monitoring activities. Proposals for 
a  revised  monitoring  plan  shall  be  submitted  to  the  competent  authorities  of  the 
Member States. 

5. 

The consent holder shall be in the position to give evidence to the Commission and 
the competent authorities of the Member States of the following : 

a) 

b) 

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 products; and 

that  the  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. 

Article 5 
Addressee 

This Decision is addressed to the Kingdom of the Netherlands. 

Done at Brussels,  

For the Council 
The President 

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