Proposal for a Council Decision authorising the placing on the market of feed produced from the genetically modified potato EH92-527-1 (BPS-25271-9) and the adventitious or technically unavoidable presence of the potato in food and other feed products under Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Only the German text is authentic)
Date: 2007-12-18
Institutions: European Commission
Subjects: animal nutrition, food safety, foodstuff, genetically modified organism, labelling, market approval, potato

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 18.12.2007 
COM(2007) 813 final 

Proposal for a 

COUNCIL DECISION 

authorising the placing on the market of feed produced from the genetically modified 
potato EH92-527-1 (BPS-25271-9) and the adventitious or technically unavoidable 
presence of the potato in food and other feed products under Regulation (EC) No 
1829/2003 of the European Parliament and of the Council 

(Only the German text is authentic) 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

The  attached  proposal  for  a  Council  Decision  concerns  feed  produced  from  the  genetically 
modified potato EH92-527-1 and the adventitious or technically unavoidable presence of the 
potato  in  food  and  other  feed  products,  for  which  a  request  for  placing  on  the  market  was 
submitted  by  BASF  Plant  Science  GmbH  to  the  competent  authorities  of  The  United 
Kingdom on 28 February 2005, under Regulation (EC) No 1829/2003 on genetically modified 
food and feed.  

On  10  November  2006,  the  European  Food  Safety  Authority  ('EFSA')  gave  a  favourable 
opinion  in  accordance  with  Articles  6  and  18  of  Regulation  (EC)  No  1829/2003  and 
concluded  that  it  is  unlikely  that  the  placing  on  the  market  of  the  products  containing, 
consisting of, or produced from potato EH92-527-1 as described in the application will have 
adverse effects on human or animal health or the environment1. 

On 13 April 2007, EFSA reconfirmed that the use of the nptII gene as a selectable marker in 
GM plants does not pose a risk to human or animal health or the environment.  

The authorisation for the cultivation and industrial use of potato EH92-527-1 is provided by 
Commission 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]  

Against  this  background,  a  draft  Commission  Decision  authorising  the  placing  on  the 
Community  market  of  feed  produced  from  the  genetically  modified potato EH92-527-1 and 
the  adventitious  or  technically  unavoidable  presence  of  the  potato  in  food  and  other  feed 
products was submitted to the Standing Committee on the Food Chain and Animal Health, on 
10  October  2007,  for  vote.  The  Committee  delivered  no  opinion:  ten  Member  States  (123 
votes)  voted  in  favour,  twelve  Member  States  (133  votes)  voted  against  and  five  Member 
States (89 votes) abstained. 

Consequently, pursuant to Article 35, paragraph 2 of Regulation (EC) No 1829/2003 and in 
accordance  with  Article  5  of  Council  Decision  1999/468/EC  modified  by  Council  Decision 
2006/512/EC, the Commission is required to submit to the Council a proposal relating to the 
measures to be taken, the Council having three months in which to act by a qualified majority, 
and inform the Parliament. 

1 

http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753816_1178620785504.htm 

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Proposal for a 

COUNCIL DECISION 

authorising the placing on the market of feed produced from the genetically modified 
potato EH92-527-1 (BPS-25271-9) and the adventitious or technically unavoidable 
presence of the potato in food and other feed products under Regulation (EC) No 
1829/2003 of the European Parliament and of the Council 

(Only the German 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  Regulation  (EC)  No  1829/2003  of  the  European  Parliament  and  of  the 
Council  of  22  September  2003  on  genetically  modified  food  and  feed2,  and  in  particular 
Articles 7(3) and 19(3) thereof, 

Whereas: 

(1) 

(2) 

(3) 

On  28  February  2005,  BASF  Plant  Science  GmbH,  submitted  to  the  competent 
authorities of the United Kingdom an application, in accordance with Articles 5 and 17 
of  Regulation  (EC)  No  1829/2003,  for  the  placing  on  the  market  of  genetically 
modified  potato  EH92-527-1  for  food  and  feed  uses,  food  and  feed  containing, 
consisting, or produced from potato EH92-527-1, with the exception of cultivation. 

It  follows  from  the  application  that  feed  produced  from  genetically  modified  potato 
EH92-527-1  is,  as  for  any  conventional  starch  potato,  a  by-product  of  the  starch 
processing and is the only intended use in the food and feed chains. 

On  10  November  2006,  the  European  Food  Safety  Authority  (‘EFSA’)  gave  a 
favourable  opinion  in  accordance  with  Articles  6  and  18  of  the  Regulation  (EC) 
No 1829/2003 and concluded that it is unlikely that the placing on the market of the 
products containing, consisting, or produced from potato EH92-527-13 as described in 
the application (the products) will have adverse effects on human or animal health or 
the  environment.  In  its  opinion,  EFSA  considered  all  the  specific  questions  and 
concerns raised by the Member States in the context of the consultation of the national 
competent authorities, as provided for by Articles 6(4) and 18(4) of that Regulation.  

2 

3 

OJ L 268, 18.10.2003, p 1. Regulation as amended by Commission Regulation EC) No 1981/2006 (OJ 
L 368, 23.12.2006, p. 99). 
http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753816_1178620785504.htm 

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(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

Accordingly,  EFSA  advised  that  no  specific  labelling  requirements  other  than  those 
provided  for  in  Articles  13(1)  and  25(2)  of  the  Regulation  (EC)  No  1829/2003  are 
necessary.  EFSA  also  considered  that  no  specific  conditions  or  restrictions  for  the 
placing  on  the  market  and/or  specific  conditions  or  restrictions  for  the  use  and 
handling,  including  post-market  monitoring  requirements,  and  no  specific  conditions 
for the protection of particular ecosystems/environment and/or geographical areas, as 
provided  for  in  point  (e)  of  Articles  6(5)  and  18(5)  of  the  Regulation,  had  to  be 
applied. 

In its opinion, EFSA concluded that the environmental monitoring plan submitted by 
the  applicant  is  in  line  with  the  intended  uses  of  the  products.  This  environmental 
monitoring will be carried out for the purpose of Commission 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. 4  

On 25 January 2007, following comments from the public and 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  Commission  consulted  the  European  Medicines  Agency  (EMEA) 
regarding  the  therapeutic  relevance  in  human  and  veterinary  medicine  of  antibiotics 
for  which  nptII  gene  allows  resistance.  Upon  reception  of  the  answer  of  EMEA,  the 
Commission requested EFSA to review its earlier safety assessments of nptII gene and 
GM plants comprising the nptII gene in the light of this response. On 13 April 2007, 
EFSA confirmed its earlier safety assessments of GM plants comprising the nptII gene 
concluding  that  the  presence  of  the  nptII  gene  in  GM  plants  for  food  and  feed  uses 
does not pose a risk to human or animal health or to the environment. 

In the light of the above considerations, authorisation should be granted. 

The  authorisation  for  the  cultivation  and  industrial  use  of  potato  EH92-527-1  is 
provided  by  Commission  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]  that  is 
providing for conditions for use and handling that aim to avoid any co-mingling with 
material derived from conventional potatoes intended for food or feed. 

Despite the application of these measures, it can not be excluded that the genetically 
modified potato and some products of the starch processing may be present in food or 
feed.  Such  a  presence  should  be  considered  adventitious  or  technically  unavoidable 
and can be accepted provided it is in a proportion no higher than 0.9 per cent. 

(10)  A unique identifier should be assigned to each GMO as provided for in Commission 
Regulation  (EC)  No  65/2004  establishing  a  system  for  the  development  and 
assignment of unique identifiers for genetically modified organisms5. 

4 
5 

OJ references to be completed. 
OJ L 10, 16.1.2004, p. 5. 

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(11)  All  information  contained  in  the  Annex  to  this  Decision  on  the  authorisation  of  the 
products  should  be  entered  in  the  Community  register  of  genetically  modified  food 
and feed as provided for in the Regulation. 

(12) 

In  accordance  with  Articles  4(2)  and  16(2)  of  the  Regulation,  the  conditions  for 
authorisation of the products bind all persons placing them on the market. 

(13)  This Decision should be notified through the Biosafety Clearing House to the Parties 
to  the  Cartagena  Protocol  on  Biosafety  to  the  Convention  on  Biological  Diversity, 
pursuant  to  Articles  9(1)  and  15(2),  c),  of  Regulation  (EC)  No  1946/2003  of  the 
European Parliament and of the Council of 15 July 2003 on transboundary movements 
of genetically modified organisms6. 

(14)  The Standing Committee on the Food Chain and Animal Health has not delivered an 
opinion within the time-limit laid down by its Chairman and the measures provided for 
in this Decision must therefore be adopted by the Council, 

HAS ADOPTED THIS DECISION: 

Article 1 
Genetically modified organism and unique identifier 

Genetically modified potato (Solanum tuberosum L.) EH92-527-1, as specified in point (b) of 
the Annex, is assigned the unique identifier BPS-25271-9, as provided for in Regulation (EC) 
No 65/2004. 

Article 2 
Authorisation 

The  following  products  are  authorised  for  the  purposes  of  Article  4(2)  and  Article  16(2)  of 
Regulation (EC) No 1829/2003, according to the conditions specified in this Decision: 

(a) feed produced from BPS-25271-9 potato; 

(b) foods containing, consisting of, or produced from BPS-25271-9 potato resulting from the 
adventitious or technically unavoidable presence of this GMO in a proportion no higher than 
0.9  per  cent  of  the  food  ingredients  considered  individually  or  food  consisting  of  a  single 
ingredient; 

(c)  feed  containing  or  consisting  of  BPS-25271-9  potato  resulting  from  the  adventitious  or 
technically unavoidable presence of this GMO in a proportion no higher than 0.9 per cent of 
the feed and of each feed of which it is composed. 

6 

OJ L 287, 5.11.2003, p. 1. 

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Article 3 
Labelling 

For the purposes of the labelling requirements laid down in Article 25(2) of Regulation (EC) 
No 1829/2003, the ’name of the organism’ shall be ’amylopectin starch potato’. 

Article 4 
Monitoring for environmental effects 

1. 

The  monitoring  plan  for  environmental  effects  provided  for  in  Article  4  of 
Commission  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]  shall  be  considered  as 
also applicable for the purpose of this Decision. 

2. 

The  authorisation  holder  shall  submit  to  the  Commission  annual  reports  on  the 
implementation and the results of the monitoring activities.  

Those reports shall clearly state which parts of the reports are considered to be confidential, 
together  with  a  verifiable  justification  for  confidentiality  in  accordance  with  Article  30  of 
Regulation (EC) No 1829/2003.  

Confidential parts of such reports shall be submitted in separate documents. 

Article 5 
Community Register 

The information in the Annex to this Decision shall be entered in the Community register of 
genetically  modified  food  and  feed,  as  provided  for  in  Article  28  of  Regulation  (EC)  No 
1829/2003. 

Article 6 
Authorisation holder 

The authorisation holder shall be BASF Plant Science GmbH, Germany. 

This Decision shall apply for a period of 10 years from the date of its notification. 

Article 7 
Validity 

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Article 8 
Addressee 

This  Decision  is  addressed  to  BASF  Plant  Science  GmbH,  Carl-Bosch-Str.38,  D-67056 
Ludwigshafen, Germany. 

Done at Brussels, 

For the Council 
The President 

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ANNEX 

(a) 

Applicant and Authorisation holder: 

Name: 

BASF Plant Science GmbH 

Address: 

Carl-Bosch-Str.38, D-67056 Ludwigshafen, Germany 

(b) 

Designation and specification of the products:  

1) 

2) 

3) 

Feed produced from BPS-25271-9 potato; 

Foods  containing,  consisting  of,  or  produced  from  BPS-25271-9  potato 
resulting  from  the  adventitious  or  technically  unavoidable  presence  of  this 
GMO  in  a  proportion  no  higher  than  0.9  per  cent  of  the  food  ingredients 
considered individually or food consisting of a single ingredient; 

Feed  containing  or  consisting  of  BPS-25271-9  potato  resulting  from  the 
adventitious or technically unavoidable presence of this GMO in a proportion 
no  higher  than  0.9  per  cent  of  the  feed  and  of  each  feed  of  which  it  is 
composed. 

The genetically modified potato BPS-25271-9, as described in the application, has an 
altered  starch  composition  (higher  amylopectin/amylose  ratio).  The  modification 
implies inhibition of the expression of granule bound starch synthase protein (GBSS) 
responsible for amylose biosynthesis. As a result, the starch produced has little or no 
amylose  and  consists  of  amylopectin  which  modifies  the  physical  properties  of  the 
starch.  An  nptII  gene,  conferring  kanamycin  resistance,  was  used  as  a  selectable 
marker in the genetic modification process. 

(c) 

Labelling: 

For  the  purposes  of  the  labelling  requirements  laid  down  in  Article  25(2)  of 
Regulation  (EC)  No  1829/2003,  the  ’name  of  the  organism’  shall  be  ’amylopectin 
starch potato’. 

(d) 

Method for detection: 

– 

– 

– 

Event  specific  real-time  quantitative  PCR  based  method  for  genetically 
modified potato BPS-25271-9. 

Validated by the Community reference laboratory established under Regulation 
(EC) No 1829/2003, published at http://gmo-crl.jrc.it/statusofdoss.htm 

Reference  Material:  ERM®-BF421  accessible  via  the  Joint  Research  Centre 
(JRC)  of  the  European  Commission,  the  Institute  of  Reference  Materials  and 
Measurements (IRMM) at 
http://www.irmm.jrc.be/html/reference_materials_catalogue/index.htm 

(e) 

Unique identifier: 

BPS-25271-9 

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(f) 

Information required under Annex II to the Cartagena Protocol on Biosafety to 
the Convention on Biological Diversity: 

Biosafety Clearing House, Record ID: see [to be completed when notified].  

(g) 

Conditions or restrictions on the placing on the market, use or handling of the 
products: 

Not required. 

(h) 

Monitoring plan: 

Monitoring plan for environmental effects provided for in Article 4 of Commission 
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. 

(i) 

Post  market  monitoring  requirements  for  the  use  of  the  food  for  human 
consumption: 

Not required. 

Note:  links to relevant documents may need to be modified over the time. Those 
modifications will be made available to the public via the updating of the Community register 
of genetically modified food and feed. 

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