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Belgian Biosafety Advisory Council
Concluded procedures

Index

Statute

Internal Rules

Composition

Meetings of the members

Running Procedures

Concluded Procedures

Advices of the Council

Expert Groups

Documents and Publications

Useful documentation

Press

Links

Contact

Concluded procedures

Belgian notifications for transgenic plants to be placed on the EU market under Directive 2001/18/EC - Part C
Belgian notifications for deliberate release of GMO's other than higher plants for any other purpose than for placing on the market
Belgian notifications for deliberate release of genetically modified higher plants for any other purpose than for placing on the market
Notifications submitted under Regulation (EC) 726/2004 on medicinal products
Notifications submitted under Regulation 1829/2003 on genetically modified food and feed
Notifications submitted under the Novel Food Regulation 258/97



Belgian notifications for transgenic plants to be placed on the EU market under Directive 2001/18/EC - Part C

Ref.
Company
GMO
Advice of the Council
End of Council's procedure
More info about the dossier
C/BE/96/01
Bayer CropScience
oilseed rape (MS8 x RF3)
26 Jan. 2004
Text of the advice
(English - PDF)
27 Jan. 2004
Letter to the authority
(French - PDF)
Link
C/BE/98/01
Bayer CropScience
soybean (A2704-12, A5547-127)
n.a.
30 July 2004
Notification withdrawed from the regulatory process by the Company
C/BE/99/01
Monsanto, Syngenta Seeds
sugar beet (T9100152)
n.a.
16 Apr. 2004
Notification withdrawed from the regulatory process by the Companies

Belgian notifications for deliberate release of GMO's other than higher plants for any other purpose than for placing on the market

Ref.
Company
GMO
Advice of the Council
End of Council's procedure
More info about the dossier
B/BE/03/B3
Transgene
Human adenovirus
serotype 5
deleted in E1 and E3
26 Mar. 2004
Text of the advice
(English - PDF)
2 Apr.
Letter to the authority
(French - PDF)
Link
5 July 2004
Text of the advice
(English - PDF)
6 July 2004
Letter to the authority
(French - PDF)
B/BE/04/BV1
Pfizer Animal
Health Group
Recombinant
Feline herpes virus
15 July 2005
Text of the advice
(English - PDF)
15 July 2005
Letter to the authority
(French - PDF)
Link
B/BE/07/BVW1
Actogenix
Recombinant Lactococcus lactis expressing hIL-10
18 January 2008
Text of the advice
(English - PDF)
22 January 2008
Letter to the authority
(French - PDF)
Link
B/BE/07/BVW3
GENimmune
Recombinant
Vaccinia virus with gene of Hepatitis B virus
7 March 2008
Text of the advice
(English - PDF)
7 March 2008
Letter to the authority
(French - PDF)
Link
B/BE/08/BVW1
MedImmune
Recombinant
bovine Parainfluenza virus with genes of human Parainfluenza virus and Respiratory syncitial virus

12 February 2009
Text of the advice
(English - PDF)
18 June 2009
Addendum
(English - PDF)

12 February 2009
Letter to the authority
(French - PDF)
link
B/BE/09/BVW1
Roche
Recombinant Vaccinia virus expressing hIL-2 and proteins of HPV virus
9 September 2009
Text of the advice
(English - PDF)

9 September 2009
Letter to the authority
(French - PDF)
Link
B/BE/11/BVW1
Transgene
Recombinant Vaccinia virus expressing MUC1 antigen and hIL-2
30 September 2011
Text of the advice
(English - PDF)
30 September 2011
Letter to the authority
(French - PDF)
Link
B/BE/11/V3
Laboratorios Hipra
Recombinant Actinobacillus pleuropneumoniae with modified virulence factors
16 April 2012
Text of the advice
(English - PDF)
16 April 2012
Letter to the authority
(French - PDF)
Link
B/BE/11/BVW2
Bn Immuno Therapeutics
Recombinant Vaccinia virus and Fowlpox virus expressing PSA and immunological costimulatory molecules
7 August 2012
Text of the advice
(English - PDF)
7 August 2012
Letter to the authority
(French - PDF)
Link
B/BE/12/BVW1
Theravectys
Two recombinant non-pathogenic, non-replicative Lentiviruses for therapeuthic vaccination of HIV infected patients
11 September 2012
Text of the advice
(English - PDF)
11 September 2012
Letter to the authority
(French - PDF)
Link
B/BE/12/BVW2
Celladon
Recombinant Adeno-associated virus (rAAV) expressing SERCA2a enzym
23 January 2013
Text of the advice
(English - PDF)
23 January 2013
Letter to the authority
(French - PDF)
link

Notifications submitted under the Royal Decree of 21 February 2005 on Deliberate release of genetically modified higher plants for any other purpose than for placing on the market
Ref. Company GMO
Advice of the Council
End of Council's procedure
More info about the dossier
B/BE/07/V2
Vlaams Interuniversitair Instituut voor Biotechnologie (VIB)
Poplar
(Populus tremula x Populus alba) with altered lignin composition for the production of bio-ethanol
25 April 2008
Text of the advice
(English - PDF)

29 April 2008
Letter to the authority

(French - PDF)

11 July 2008
Letter to the ministers

(English-PDF)

B/BE/10/V1
Universiteit Gent
Potato
(Solanum tuberosum ssp. tuberosum L.)
with improved resistance to Phytophtora infestans
10 February 2011
Text of the advice
(English - PDF)
10 February 2011
Letter to the authority

(French - PDF)
B/BE/10/V2
BASF Plant Science
Potato
(Solanum tuberosum ssp. tuberosum L.)
with improved resistance to Phytophtora infestans
10 February 2011
Text of the advice
(English - PDF)
10 February 2011
Letter to the authority

(French - PDF)
B/BE/11/V4
VIB
Maize
(Zea mays)
with modified growth characteristics
16 March 2012
Text of the advice
(English - PDF)
16 March 2012
Letter to the authority
(French - PDF)
B/BE/13/V1
VIB
Poplar
(Populus tremula x Populus alba) with a modified wood composition
02 Oct. 2013
Text of the advice
(English - PDF)
2 Oct. 2013
Letter to the authority


Notifications submitted under Regulation (EC) 726/2004 on medicinal products

Ref.
Company
GMO
Advice of the Council
Consultation on the Environmental Risk Assessment
organised by EMA
More info about the dossier
Cerepro
Ark Therapeutics Ltd
Human adenovirus
serotype 5
deleted in E1 and E3 and
containing the Herpes simplex virus-thymidine kinase gene
02 Feb. 2007
Opinion on the dossier and the day 70 assessment report drafted by the Spanish competent authority
27 Oct. 2007
Opinion on the responses of the applicant on the Day 120 list of questions

26 Apr. 2007
Negative opinion of EMEA

Link to Website of EMEA

Hiprabovis IBR
marker live

Laboratorios HIPRA S.A. Bovine Herpes virus strain CEDDEL with deletion of the genes that code for glycoprotein E and the enzyme thymidine kinase 15 June 2009
Opinion on the dossier and the day 70 assessment report drafted by the competent authority of UK

12 Nov. 2010
Positive opinion of EMA

27 Jan. 2011
Authorisation valid throughout the EU

Link to website of EMA

Fluenz MedImmune LLC Influenza virus reassortants

8 April 2009
Opinion on the dossier and the day 80 assessment report drafted by the competent authorities of France and Belgium

17 June 2010
Opinion on the responses of the applicant on the Day 120 list of questions

13 September 2010
Opinion on the responses of the applicant on the Day 150 list of questions

21 October 2010
Positive opinion of EMA

27 Jan. 2011
Authorisation valid throughout the EU

Link to website of EMA

Purevax rabies Merial Canarypox virus expressing the surface glycoprotein G gene from Rabies virus

15 March 2010
Opinion on the dossier and the day 70 assessment report drafted by the competent authority of Belgium

28 October 2010
Opinion on the responses of the applicant on the Day 150 list of questions

8 December 2010
Positive opinion of EMA

18 Feb. 2011
Authorisation valid throughout the EU

Link to website of EMA

Proteq West Nile Merial Canarypox virus expressing the preM and E genes of West Nile virus

26 August 2010
Opinion on the dossier and the day 70 assessment report drafted by the competent authorities of France

8 April 2011
Opinion on the responses of the applicant on the Day 120 list of questions

9 June 2011
Positive opinion of EMA

5 Aug. 2011
Authorisation valid throughout the EU

Link to website of EMA

Glybera Amsterdam Molecular Therapeutics Adeno-associated virus expressing a human lipoprotein lipase gene variant

30 April 2011
Opinion on the dossier and the day 80 assessment report drafted by the EMA rapporteur

10 January 2011
Opinion on the responses of the applicant on the Day 120 list of questions

9 May 2011
Opinion on the responses of the applicant on the Day 150 list of questions

24 June 2011
Negative opinion of EMA

19 July 2011
Revised opinion of EMA

25 Oct. 2012
Authorisation valid throughout the EU

Link to website of EMA

Nobivac Myxo-RHD Intervet International Myxoma virus expressing the capsid protein gene of rabbit haemorrhagic disease virus 17 May 2010
Opinion on the dossier and the day 70 assessment report drafted by the EMA rapporteur

14 July 2011
Positive opinion of EMA

7 Sept. 2011
Authorisation valid throughout the EU

Link to website of EMA

Poulvac E. Coli Pfizer Ltd Live aroA gene deleted Escherichia coli, type 078 9 May 2011
Opinion on the dossier and the day 70 assessment report drafted by the EMA rapporteur
13 July 2012
Positive opinion of EMA

15 June 2012
Authorisation valid throughout the EU

Link to website of EMA

Notifications submitted under Regulation 1829/2003 on genetically modified food and feed

Ref.
Organism and transformation event
Company
Activity
Advice of the Council
More info about the dossier
EFSA/GMO/UK/2004/04

LLRICE62

 

Bayer CropScience Food/Feed
Import and processing
11 April 2008
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/UK/2004/05 maize
(
1507 x NK603)
Pioneer Hi-Bred /Mycogen Seeds
Food/Feed
Import and processing
19 June 2006
Text of the advice
(English - PDF)

Link to EFSA
Website
EFSA/GMO/UK/2004/06
Maize
(MON863 x NK603)
Monsanto
Food/Feed
Import and processing
1 Feb. 2006
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/BE/2004/07
Maize
(MON863 x
MON810 x NK603)
Monsanto
Food/Feed
Import and processing
1 Feb. 2006
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/UK/2004/08 H7-1 Roundup Ready Sugar Beet KWS SAAT AG / Monsanto
Food, feed produced from GM Plants
(derived products)

12 Mar. 2007
Text of the advice
(English - PDF)

21 June 2007
Revised advice

(English - PDF)

Link to EFSA Website
EFSA/GMO/UK/2005/09 Cotton
(MON531 x MON1445)
Monsanto
Food, feed produced from GM Plants
(derived products)
14 Sept. 2012
Text of the advice
(English - PDF)
Link to EFSA website
EFSA/GMO/UK/2005/11 Maize
(MIR604)

Syngenta seeds

Food/Feed
Import and processing
2 Oct. 2009
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/NL/2005/12 Maize
(59122)
Pioneer Hi-Bred /Mycogen Seeds
Food/Feed
Import and processing
14 June 2007
Text of the advice

(English - PDF)
Link to EFSA Website
EFSA/GMO/NL/2005/13 LLCotton25 Bayer CropScience Food/Feed
Import and processing
12 Mar. 2007
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/NL/2005/15 Maize
(1507 x 59122)

Dow AgroSciences/
Pioneer Hi-Bred

 

Food/Feed
Import and processing
2 Oct. 2009
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/NL/2005/18

Soybeen
A2704-12

 

Bayer CropScience
Food/Feed
Import and processing
23 Jan. 2008
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/UK/2005/19 Syngenta

Maize
GA21

Food/Feed
Import and processing
07 Dec. 2007
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/UK/2005/20 Maize
( 59122 x NK603)

Pioneer Hi-Bred

Food/Feed
Import and processing
29 Jan. 2009
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/UK/2005/21 Maize
( 59122 x 1507 x NK603)
Pioneer Hi-Bred Food/Feed
Import and processing

15 June 2009
Text of the advice
(English - PDF)

Link to EFSA Website

EFSA/GMO/NL/2005/22

Maize
(NK603)
Monsanto Food/Feed
Import and processing
CULTIVATION
2 Oct. 2009
Text of the advice
(English - PDF)
Link to EFSA Website

EFSA/GMO/NL/2005/24

Soybeen
40-3-2
Monsanto CULTIVATION 3 Oct. 2012
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/UK/2005/25

T45 oilseed rape

 

Bayer CropScience Food/Feed
Import and processing
05 May 2008
Text of the advice
(English - PDF)

Link to EFSA Website  
EFSA/GMO/CZ/2005/27

Maize
MON 88017

Monsanto Food/Feed
Import and processing
13 July 2009
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/CZ/2006/33 Maize
(MON 88017 x MON 810)
Monsanto Food/Feed
Import and processing
06 November 2009
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/NL/2006/36

Soybean
MON89788

Monsanto Food/Feed
Import and processing
26 Sep. 2008
Text of the advice
(English - PDF)
Link to EFSA Website 
EFSA/GMO/NL/2007/37

Maize
MON89034

Monsanto
Food/Feed
Import and processing
03 Feb. 2009
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/NL/2007/38 Maize
(MON89034 x NK603)
Monsanto Food/Feed
Import and processing
06 November 2009
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/NL/2007/39 Maize
(MON89034 x 88017)
Monsanto Food/Feed
Import and processing
07 May 2010
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/UK/2007/43 Soybean
356043
Pioneer Food/Feed
Import and processing
23 Sept. 2011
Text of the advice
(English - PDF)

Link to EFSA Website
EFSA/GMO/FR/2007/45 Soybean
305423
Pioneer
Food/Feed
Import and processing
14 March 2014
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/UK/2007/48 Maize (MIR604xGA21) Syngenta Crop Protection Food/Feed
Import and processing
05 Oct 2010
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/UK/2007/49 Maize (Bt11xGA21) Syngenta Food/Feed
Import and processing
06 November 2009
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/UK/2007/50 Maize (Bt11xMir604) Syngenta Food/Feed
Import and processing
05 Oct 2010
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/NL/2008/51 Cotton GHB614 Bayer CropScience Food/Feed
Import and processing
21 April 2009
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/NL/2008/52 Soybean A5547-127 Bayer Crop Science Food/Feed
Import and processing
16 June 2011
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/CZ/2008/54 Maize MON88017 Monsanto CULTIVATION 16 March 2012
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/UK/2008/56 Maize Bt11 x MIR604 x GA21 Syngenta Food/Feed
Import and processing
05 Oct 2010
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/UK/2008/60 Maize GA21 Syngenta Food/Feed
Import and processing
CULTIVATION
10 Feb. 2012
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/CZ/2008/62 Maize MON89034 x 1507 x MON88017 x 59122 Monsanto
Dow AgroSciences
Food/Feed
Import and processing
17 Dec 2010
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/NL/2009/65 Maize MON89034 x 1507 x NK603
Monsanto
Dow AgroSciences
Food/Feed
Import and processing
17 Dec 2010
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/NL/2009/70 Maize
MON87460
Monsanto
Food/Feed
Import and processing
25 March 2013
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/NL/2009/73 Soybean
MON87701 x MON89788
Monsanto Food/Feed
Import and processing
27 Apr. 2012
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/NL/2010/78 Soybean
MON87705
Monsanto Food/Feed
Import and processing
07 Dec. 2012
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/BE/2010/79 Soybean
MON87701
Monsanto Food/Feed
Import and processing
23 Sept. 2011
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/DE/2010/82 Maize
MIR162
Syngenta
Food/Feed
Import and processing
29 Aug. 2012
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/NL/2010/87 Oilseed rape
GT73
Monsanto
Food/Feed
Import and processing
16 Apr. 2013
Text of the advice
(English - PDF)
Link to EFSA Website
EFSA/GMO/NL/2011/97 Cotton
T304-40
Bayer CropScience
Food/Feed
Import and processing
14 March 2014
Text of the advice

(English - PDF)
Link to EFSA Website
EFSA/GMO/NL/2012/107 pollen of maize MON810 Monsanto Pollen as or in food 25 Jan. 2013
Text of the advice
(English - PDF)
Link to EFSA Website
RX-MON810 Maize
MON810
Monsanto Food/Feed
Import and processing
CULTIVATION
17 November 2009
Text of the advice
(English - PDF)
Link to EFSA Website
RX-Bt11 Maize
Bt11

Syngenta

 

Food/Feed
Import and processing
 17 March 2009
Text of the advice
(English - PDF)
Link to EFSA Website
RX-1507 Maize 1507

Pioneer

 

Feed 2 Oct. 2009
Text of the advice
(English - PDF)
Link to EFSA Website
RX-MS8/RF3 Oilseed rape MS8/RF3 Bayer Bio-Science Food/Feed materials 11 Dec. 2009
Text of the advice
(English - PDF)

Link to EFSA Website
RX-GT73 Oilseed rape GT73 Monsanto Food/Feed additives
Feed materials
12 Feb. 2010
Text of the advice
(English - PDF)
Link to EFSA Website
RX-MON863 Maize MON863 Monsanto Food/Feed additives
Feed materials
 
18 June 2010
Text of the advice
(English - PDF)
Link to EFSA Website
RX-40-3-2 Soybean 40-3-2 Monsanto Food/Feed 18 August 2011
Text of the advice
(English - PDF)
Link to EFSA Website
RX-MON531 Cotton MON531 Monsanto Food/Feed additives
Feed materials
 
16 Dec. 2011
Text of the advice
(English - PDF)
Link to EFSA Website
RX-MON1445 Cotton MON1445 Monsanto Food/Feed additives
Feed materials  
10 Feb. 2012
Text of the advice
(English - PDF)
Link to EFSA Website

Notifications submitted under the Novel Food Regulation 258/97

Organism and transformation event
Company
Food/Feed
Advice of the Council
End of Council's procedure
More info about the dossier
Maize
Bt11
(pZO1502)
Syngenta
(Novartis Seeds AG)
Bt11 Sweet maize
1 Apr. 2004
Text of the advice
(English - PDF)
2 Apr. 2004
Letter to the authority
(French - PDF)
Link
23 Sep. 2004
Text of the advice
(English - PDF)
11 Oct. 2004
Letter to the authority
(French - PDF)




© Biosafety and Biotechnology Unit - 2005