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 123.2.38) genetically modified for flower colour (Only the Dutch text is authentic)
Date: 2006-12-04
Institutions: European Commission
Subjects: floriculture, market approval, marketing, transgenic plant

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 4.12.2006 
COM(2006) 758 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 123.2.38) genetically modified for flower colour 

(Only the Dutch text is authentic)  

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

In  accordance  with  Article  13  of  Directive  2001/18/EC,  the  Dutch  authorities 
received a notification (Reference C/NL/04/02) concerning the placing on the market 
of  a  carnation  (Dianthus  caryophyllus  L.,  line  123.2.38)  genetically  modified  for 
flower colour. 

The  notification  covers  import,  distribution  and  retailing  of  Dianthus  caryophyllus 
L., line 123.2.38 as for any other carnation in the Community. 

In  accordance  with  Article  14  of  the  Directive,  the  Dutch  competent  authority 
forwarded  to  the  Commission  its  assessment  report  of  the  notification,  which 
concluded  that  the  genetically  modified  carnation  (Dianthus  caryophyllus  L., 
line 123.2.38) 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), according 
to  Article  29(1)  and  in  accordance  with  Article  22(5)(c)  of  Regulation  (EC) 
No 178/20021, was consulted and delivered its opinion on 27 June 2006 concluding, 
from  all  evidence  provided,  that  cut  flowers  of  the  genetically  modified  carnation 
(Dianthus caryophyllus  L.,  line 123.2.38) 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  2001/18/EC  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  Commission, 

The  Committee,  consulted  on  18  September  2006,  has  not  delivered  an  opinion. 
Therefore, 
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 
was  informed  on  19  September  2006).  The  European  Parliament  may  consider 
appropriate to take a position in accordance with Article 8 of the above Decision. 

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OJ L 31, 1.2.2002, p.1. 

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9. 

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 
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 123.2.38) 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/EEC2,  and  in  particular  the  first 
subparagraph of Article 18(1) thereof, 

Having regard to the proposal from the Commission, 

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  a  Member  State,  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  123.2.38)  was  submitted  by  Florigene  Ltd, 
in 
Melbourne,  Australia, 
September 2004. 

the  competent  authority  of 

the  Netherlands 

to 

The notification covers import, distribution and retailing of Dianthus caryophyllus L., 
line 123.2.38 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  123.2.38)  for  ornamental  use  should  be 
withheld, if specific conditions are fulfilled. 

2 

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 certain Member States raised objections to the placing on 
the market of the product. 

The opinion adopted on 17 May 2006 (published 27 June 2006) by the European Food 
Safety Authority (EFSA), concluded, from all evidence provided, that cut flowers of 
the  genetically  modified  carnation  (Dianthus  caryophyllus  L.,  line  123.2.38)  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.  

An examination of each of the objections in the light of Directive 2001/18/EC, of the 
information  submitted  in  the  notification  and  of  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  123.2.38)  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 123.2.38) 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 
(EC)  No  65/2004  of 
Directive  2001/18/EC3  and  Commission  Regulation 
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 123.2.38 can not be used for human or animal consumption nor 
for cultivation. 

(11)  The  Committee  established  under  Article  30  of  Directive  2001/18/EC  has  not 
delivered  an  opinion  on  the  measures  laid  down  in  the  draft  Commission  Decision, 
following  its  consultation,  on  18  September  2006,  in  accordance  with  the  procedure 
laid down in Article 30(2) of that Directive. 

(12)  The  Commission,  under  Article  5(4)  of  Council  Decision  1999/468/EC,  should 
without delay, submit to the Council proposals relating to the measures to be taken and 
should  inform  the  European  Parliament;  the  European  Parliament  was  informed  on 
19 September 2006. 

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4 

OJ L 268, 18.10.2003, p. 24 
OJ L 10, 16.1.2004, p. 5-10 

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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/04/02). 

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  a  Dianthus  caryophyllus  L.  cell  culture, 
and  transformed  with  Agrobacterium  tumefaciens,  strain  AGL0,  using  the  vector 
pcGP1470, and resulting in line 123.2.38.  

The product contains the following DNA in three cassettes: 

(a) Cassette 1 

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

(b) Cassette 2  

The  constitutive  promoter  Mac,  the  petunia  dihydroflavonol  4  reductase  (DFR) 
cDNA, 
tumefaciens  gene  encoding 
the  Agrobacterium 
mannopine synthase (Mas). 

terminator  from 

the 

Simultaneous  expression  of  both  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. 

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 123.2.38). 

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Article 3 
Conditions for placing on the market 

The product may be put to ornamental use only, with the exception of cultivation, and may be 
placed on the market subject to the following conditions: 

1. 

2. 

3. 

4. 

5. 

1. 

2. 

3. 

4. 

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-4Ø644-4; 

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 verified by the Community Reference Laboratory, 
shall  be  made  available  to  the  competent  authorities  and  to  inspection  services  of 
Member States as well as to the Community control laboratories. 

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 to inspection services of Member States as well as to the 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  products,  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 the monitoring activities.  

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 

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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: 

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  these  existing  monitoring  networks  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 
Applicability 

This  Decision  shall  apply  from  the  date  on  which  the  detection  method  specific  to  the 
carnation (Dianthus caryophyllus L., line 123.2.38) referred to in Article 3(c) of this Decision, 
is verified by the Community Reference Laboratory.  

Article 6 
Addressee 

This Decision is addressed to the Kingdom of the Netherlands. 

Done at Brussels,  

For the Council 
The President 

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