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 potato product (Solanum tuberosum L. line EH92-527-1) genetically modified for enhanced content of the amylopectin component of starch (Only the Swedish text is authentic)
Date: 2007-06-13
Institutions: European Commission
Subjects: marketing, marketing standard, plant variety right, potato, starch, transgenic plant

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 13.6.2007 
COM(2007) 336 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 potato product (Solanum tuberosum L. 
line EH92-527-1) genetically modified for enhanced content of the amylopectin 
component of starch 

(Only the Swedish text is authentic) 

(presented by the Commission) 

EN 

   EN 

 
 
 
  
1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

EXPLANATORY MEMORANDUM 

In  accordance  with  Article  13  of  Directive  2001/18/EC,  the  Swedish  authorities 
received  from  BASF  Plant  Science  a  notification  (Reference  C/SE/96/35-01) 
concerning the placing on the market of a potato (Solanum tuberosum L. line EH92-
527-1) genetically modified for enhanced content of the amylopectin component of 
starch. 

The notification originally covered cultivation and processing into industrial starch, 
as well as use in feed in the Community.  

In  accordance  with  Article  14  of  the  Directive,  the  Swedish  competent  authority 
forwarded  to  the  Commission  its  assessment  report  of  the  notification,  which 
concluded  that  genetically  modified  potato  should  be  placed  on  the  market  for  its 
intended uses. 

On  9  December  2005,  BASF  Plant  Science  informed  the  Swedish  competent 
authority of its intention to  exclude feed  uses  from  the  notification under  Directive 
2001/18/EC, limiting its scope to cultivation and production of starch for industrial 
uses. 

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 molecular characterisation, allergenicity, toxicity, an inadequate 
monitoring plan and the detection method of the product. 

In  light  of  these  objections,  and  in  accordance  with  Article  28(1)  of  Directive 
2001/18/EC and Article 22(5)(c) of Regulation(EC) No 178/20021, the Commission 
consulted  with  the  European  Food  Safety  Authority  (EFSA),  which  delivered  its 
opinion  on  24  February  2006  concluding  that,  from  all  evidence  provided,  the 
genetically modified potato (Solanum tuberosum L. line EH92-527-1) is unlikely to 
have an adverse effect on human and animal health or the environment in the context 
of its proposed uses. 

Whereby in accordance with Article 18(1) of Directive 2001/18/EC the Commission 
is required to take a decision in accordance with the procedure laid down in Article 
30(2)  of  Directive  2001/18/EC  to  which  Articles  5  and  7  of  Council  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  in  accordance  with 
Article 30 of Directive 2001/18/EC. 

The  Committee  which  was  consulted  on  4  December  2006  has  not  delivered  an 
opinion.  Therefore,  and  in  accordance  with  Article  5(4)  of  Decision  1999/468/EC, 
the Commission shall, without delay, submit to the Council a proposal relating to the 
measures to be taken and inform the European Parliament; the European Parliament 

1 

OJ L 31, 1.2.2002, p.1 

EN 

2 

   EN 

 
                                                 
10. 

11. 

was  informed  on  8  December  2006.  The  European  Parliament  may  consider 
appropriate to take a position in accordance with Article 8 of the above Decision. 

On  26  February  2007,  in  the  light  of  a  report  published  by  the  World  Health 
Organisation  listing  kanamycin  and  neomycin  as  'critically  important  antibacterial 
agents  for  human  medicine  and  for  risk  management  strategies  of  non-human  use', 
the  European  Medicines  Agency  issued  a  statement  highlighting  the  therapeutic 
relevance of both antibiotics in human and veterinary medicine. On 23 March 2007, 
taking  into  account  this  statement,  EFSA  confirmed  its  previous  assessment  of  the 
safe  use  of  the  antibiotic  resistance  marker  gene  nptII  in  genetically  modified 
organisms and their derived products for food and feed uses. 

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. 

EN 

3 

   EN 

 
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 potato product (Solanum tuberosum L. 
line EH92-527-1) genetically modified for enhanced content of the amylopectin 
component of starch 

(Only the Swedish text is authentic) 
(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) 

2 

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  (Reference  C/SE/96/3501)  concerning  the  placing  on  the  market  of  a 
genetically  modified  potato  product  (Solanum  tuberosum  L.  line  EH92-527-1)  was 
submitted  by  BASF  Plant  Science  (formerly  Amylogen  HB)  to  the  competent 
authority of Sweden. 

The notification originally covered the placing on the market of Solanum tuberosum L. 
line EH92-527-1 for cultivation and processing into industrial starch, as well as use in 
feed in the Community. 

In accordance with the procedure established by Article 14 of Directive 2001/18/EC, 
the competent authority of Sweden prepared an assessment report , which concluded 
that  there  is  no  scientific  evidence  to  indicate  that  the  placing  on  the  market  of  the 

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). 

EN 

4 

   EN 

 
                                                 
(5) 

(6) 

(7) 

(8) 

(9) 

Solanum tuberosum L. line EH92-527-1 poses any risk to human and animal health or 
the environment for the requested uses. 

The assessment report was submitted to the Commission and the competent authorities 
of the other Member States, which raised and maintained objections to the placing on 
the market of the product. 

On 9 December 2005, BASF Plant Science informed the Swedish competent authority 
of its intention to exclude feed uses from the notification under Directive 2001/18/EC, 
limiting  its  scope  to  cultivation  of  the  Solanum  tuberosum  L.  line  EH92-527-1  and 
production of starch for industrial uses.  

An application for the placing on the market of feed and food containing, consisting 
of,  or  produced  from  Solanum  tuberosum  L.  line  EH92-527-1  was  submitted,  on  25 
April 2005, by BASF Plant Science under Regulation (EC) No 1829/20033. 

The  opinions  of  the  European  Food  Safety  Authority  concerning  the  placing  on  the 
market of Solanum tuberosum L. line EH92-527-1 for cultivation and industrial starch 
production under Directive 2001/18/EC and feed and food under Regulation (EC) No 
1829/2003, published on 24 February 2006, concluded that the product is unlikely to 
have an adverse effect on human and animal health or the environment in the context 
of its proposed uses.  

An examination of each of the objections maintained by the Member States in the light 
of  Directive  2001/18/EC,  of  the  information  submitted  in  the  notification  and  of  the 
opinion of the European Food Safety Authority, discloses no evidence to believe that 
the placing on the market of Solanum tuberosum L. line EH92-527-1 is likely to cause 
adverse  effects  on  human  and  animal  health or  the  environment  in  the  context  of  its 
proposed uses. 

(10)  On  26  February  2007,  in  the  light  of  a  report  published  by  the  World  Health 
Organisation  listing  kanamycin  and  neomycin  as  'critically  important  antibacterial 
agents for human medicine and for risk management strategies of non-human use', the 
European Medicines Agency issued a statement highlighting the therapeutic relevance 
of both antibiotics in human and veterinary medicine. On 23 March 2007, taking into 
account this statement, EFSA confirmed its previous assessment of the safe use of the 
antibiotic  resistance  marker  gene  nptII  in  genetically  modified  organisms  and  their 
derived products for food and feed uses. 

(11)  A unique identifier should be assigned to the Solanum tuberosum L. line EH92-527-1 
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/EC4 
and  Commission  Regulation  (EC)  No  65/2004  of  14  January  2004  establishing  a 

3 
4 

OJ L 268, 18.10.2003, p. 1 
OJ L 268, 18.10.2003, p. 24 

EN 

5 

   EN 

 
                                                 
system  for  the  development  and  assignment  of  unique  identifiers  for  genetically 
modified organisms5. 

(12)  The  proposed  labelling,  on  a  label  or  in  an  accompanying  document,  of  products 
containing  or  consisting  of  Solanum  tuberosum  L.  line  EH92-527-1  should  include 
wording  to  inform  operators  and  final  users  that  such  material  cannot  be  used  for 
human or animal consumption. 

(13)  Until  a  Community  Decision  under  Regulation  (EC)  No  1829/2003  authorising  the 
placing on the market of the Solanum tuberosum L. line EH92-527-1 for uses as or in 
feed  and  food  enters  into  force,  potato  tubers  should  be  cultivated,  handled, 
transported and processed to prevent the genetically modified potato product or the by-
products resulting from the industrial starch production process from entering the food 
and  feed  chains;  whereby  such  material  should  be  exclusively  used  for  industrial 
purposes or destroyed. 

(14)  Member  States  should  utilise  the  registers  established,  in  accordance  with  Article 
31(3)(b)  of  Directive  2001/18/EC,  for  recording  the  location  of  GMOs  grown  under 
Part C of the Directive, inter alia to facilitate monitoring and general surveillance and 
for the purpose of inspection and control. 

(15) 

(16) 

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

In  order  to  complement  existing  field  studies  carried  out  in  northern  Europe,  which 
indicated that the cultivation of Solanum tuberosum L. line EH92-527-1 is unlikely to 
have  adverse  effects  on  the  environment,  additional  measures  to  monitor  potato-
feeding  organisms  in  the  fields  and  their  vicinity  where  Solanum  tuberosum  L.  line 
EH92-527-1  is  commercially  cultivated  should  be  put  in  place  as  part  of  the 
monitoring programme. 

(17)  Prior to the placing on the market of the Solanum tuberosum L. line EH92-527-1, the 
necessary measures to ensure its labelling and traceability at all stages of its placing on 
the  market,  including  verification  by  appropriate  validated  detection  methodology, 
should be applicable.  

(18)  A detection method for the Solanum tuberosum L. line EH92-527-1 has been validated 
by  the  Community  Reference  Laboratory  as  referred  to  in  Article  32  of  Regulation 
(EC)  No  1829/2003,  in  accordance  with  Commission  Regulation  (EC)  No  641/2004 
on detailed rules for the implementation of Regulation (EC) No 1829/20036. 

(19)  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; 

5 
6 

OJ L 10, 16.01.2004, p. 5-10 
OJ L 102, 07.04.2004, p.14. 

EN 

6 

   EN 

 
                                                 
HAS ADOPTED THIS DECISION: 

Article 1 
Consent 

Without  prejudice  to  other  Community  legislation,  in  particular  Regulation  (EC)  No 
1829/2003,  written  consent  shall  be  granted  by  the  competent  authority  of  Sweden  to  the 
placing on the market, in accordance with this Decision, of the product identified in Article 2, 
as notified (Reference C/SE/96/3501) by BASF Plant Science. 

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  organism  to  be  placed  on  the  market  as  or  in  products, 
hereinafter  ‘the  product’  is  potato  (Solanum  tuberosum  L.)  modified  for  enhanced 
content  of  the  amylopectin  component  of  starch,  which  has  been  transformed  with 
Agrobacterium tumefaciens, using the vector pHoxwG, resulting in line EH92-527-1. 
The product contains the following DNA in two cassettes: 

(a)  Cassette 1: 

An  nptII-type  kanamycin  resistance  gene  originating  from  Tn5,  under  the 
regulation  of  a  nopaline-synthase  promoter  for  expression  in  plant  tissue  and 
terminated by a polyadenylation sequence from the Agrobacterium tumefaciens 
nopaline-synthase gene. 

(b)  Cassette 2: 

A segment of the potato gbss gene encoding for granule bound starch synthase 
protein inserted in reversed orientation under the control of the gbss-promoter 
isolated  from  potato,  and  terminated  by  a  polyadenylation  sequence  from  the 
Agrobacterium tumefaciens nopaline-synthase gene. 

2. 

The consent shall cover genetically modified Solanum tuberosum L. line EH92-527-
1 as or in products. 

Article 3 
Conditions for placing on the market 

The  product  may  be  placed  on  the  market  for  cultivation  and  industrial  use  subject  to  the 
following conditions: 

(a) 

In accordance with Article 15(4) of Directive 2001/18/EC, the period of validity of 
the consent shall be 10 years starting from the date at which the consent for Solanum 
tuberosum L. line EH92-527-1 is issued; 

EN 

7 

   EN 

 
 
 
 
 
(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

The unique identifier of the products shall be BPS-25271-9; 

Without  prejudice  to  Article  25  of  Directive  2001/18/EC,  the  consent  holder  shall 
make available positive and negative control samples of the product and its genetic 
materials  and  reference  materials  to  the  competent  authorities  and  to  inspection 
services  of  Member  States  as  well  as  to  the  Community  control  laboratories  on 
request; 

A detection method specific to Solanum tuberosum L. line EH92-527-1, validated by 
the Community Reference Laboratory as referred to in the Annex of Regulation (EC) 
No 1829/2003 is available for the purpose of inspection and control; 

Without prejudice to specific labelling requirements provided by Regulation (EC) No 
1829/2003,  the  words  ‘This  product  contains  genetically  modified  organisms’  or 
‘This product contains genetically modified EH92-527-1 potato’ and the words ‘not 
for  human  consumption'  shall  appear  either  on  a  label  or  in  a  document 
accompanying the product. Pending Community approval of the product for use as or 
in feed, the words 'not for animal consumption' shall also appear on this label or in 
the document accompanying the product.  

It  shall  also  be  indicated  on  the  label,  or  in  an  accompanying  document,  that  the 
product contains an altered starch composition; 

Throughout  the  validity  of  the  consent,  the  consent  holder  when  placing  Solanum 
tuberosum L. line EH92-527-1 on the market in a Member State shall directly inform 
operators  and  users  on  the  safety  and  general  characteristics  of  the  product,  of  the 
legal  requirements  for  the  placing  on  the  market  of  material  harvested  from  crops 
containing this line; 

(h) 

In  view  that  this  decision  covers  only  cultivation  and  industrial  use,  the  consent 
holder shall ensure that potato tubers of Solanum tuberosum L. line EH92-527-1 are; 

(i) 

physically  separated  from  potatoes  for  food  and  feed  uses  during  planting, 
cultivation, harvest, transport, storage and handling in the environment; 

(ii)  delivered  exclusively  to  designated  starch  processing  plants,  notified  to  the 
relevant  national  competent  authority,  for  processing  into  industrial  starch 
within  a  closed  system,  either  by  time  or  space  separation,  to  avoid  any  co-
mingling with material derived from potatoes intended for food or feed;  

(iii)  only  processed  into  industrial  starch  on  the  basis  that,  pending  Community 
approval of the product for use as or in feed, the by-product material from this 
process is used exclusively for industrial purposes or destroyed. 

Article 4 
Monitoring 

1. 

Throughout the period of validity of the consent;  

(a)  The  consent  holder  shall  ensure  that  the  monitoring  plan,  to  monitor  for  any 
adverse  effects  on  human  and  animal  health  or  the  environment  arising  from 

EN 

8 

   EN 

 
handling  or  use  of  the  product,  is  put  in  place  and  implemented.  This 
monitoring plan includes case-specific monitoring, general surveillance and an 
Identity Preservation System (IPS), as contained in the notification and may be 
subject to further modifications as laid down in this Article. 

(b)  The consent holder shall ensure that monitoring includes data as to the area of 
land cultivated with Solanum tuberosum L. line EH92-527-1 and the quantity 
of harvested material.  

(c)  Pending Community approval of the product for use as or in feed, the consent 
holder  shall  ensure  that  information  as  to  the  disposal  of  the  by-products  is 
made available. 

(d)  The consent holder shall be in the position to give evidence to the Commission 

and the competent authorities of the Member States: 

(i) 

(ii) 

that the existing monitoring networks, as specified in the monitoring plan 
contained  in  the  notification,  gathers  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. 

(e)  The  consent  holder  shall  extend  the  existing  monitoring  networks,  to  include 
all  growers  of  Solanum  tuberosum  L.  line  EH92-527-1,  on  the  basis  of  the 
questionnaire and reporting system detailed in the notification. 

(f)  The  consent  holder  shall  carry  out  specific  field  studies  to  monitor  potential 
adverse  effects  on  potato-feeding  organisms  in  the  fields  and  their  vicinity 
where Solanum tuberosum L. line EH92-527-1 is cultivated in accordance with 
the requirements laid down in Annex I. 

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 time being one year after final consent is granted. 

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. 

2. 

3. 

EN 

9 

   EN 

 
Article 5 
Addressee 

This Decision is addressed to the Kingdom of Sweden. 

Done at Brussels, 

For the Council 
The President 

EN 

10 

   EN 

 
 
 
ANNEX I 

Monitoring of potato-feeding organisms in the fields where Solanum tuberosum L. line EH92-
527-1 is cultivated and in their vicinity. 

1. 

2. 

3. 

4. 

5. 

The  consent  holder  shall  undertake  field  studies  to  monitor  the  potential  adverse 
effects  on  potato-feeding  organisms  in  the  fields  where  Solanum  tuberosum  L.  line 
EH92-527-1 is cultivated and in their vicinity. 

The  monitoring  study  shall  focus  on  model  potato-feeding  organisms  in  the  potato 
fields  and  in  their  vicinity,  representative  of  key  ecological  functions  in  the 
agricultural environment. 

The  monitoring  study  shall  take  into  account  the  latest  scientific  findings  and  use 
state-of-the-art protocols including statistical analysis of the data in accordance with 
standard methods. 

The  results  of  these  studies  shall  be  evaluated  in  view  of  the  risk  assessment 
contained in the notification and reported as provided for in Article 4(2). 

Where appropriate, the results of these studies shall be used to review and modify the 
monitoring plan proposed in the notification as provided for in Article 4(3). 

EN 

11 

   EN