COMMISSION STAFF WORKING DOCUMENT Details from individual Member States on their experience with Directive 2009/41 of the European Parliament and of the Council of May 2009 on the contained use of genetically modified micro-organisms (recast) for the period 2009-2014 Accompanying the document COMMISSION WORKING DOCUMENT Experience of Member States with Directive 2009/41 of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (recast) for the period 2009-2014
Date: 2016-12-20
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, application of EU law, environmental risk prevention, genetically modified organism, health control, interpretation of the law, microorganism, research body, research method, waste disposal

EN 

   EN 

   EUROPEAN COMMISSION  Brussels, 20.12.2016  SWD(2016) 445 final   COMMISSION STAFF WORKING DOCUMENT Details from individual Member States on their experience with Directive 2009/41 of the European Parliament and of the Council of May 2009 on the contained use of genetically modified micro-organisms (recast) for the period 2009-2014 Accompanying the document COMMISSION WORKING DOCUMENT Experience of Member States with Directive 2009/41 of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (recast) for the period 2009-2014 {COM(2016) 808 final}  
 
 
COMMISSION STAFF WORKING DOCUMENT 

Details from individual Member States on their experience with Directive 2009/41/EC of 
the European parliament and the Council of May 2009 on the contained use of 
genetically modified micro-organisms (recast) for the period 2009-2014  

Accompanying the document 

COMMISSION WORKING DOCUMENT 

Experience of Member States with Directive 2009/41/EC of the European Parliament 
and of the Council of 6 May 2009 on the contained use of genetically modified micro-
organisms (recast) for the period 2009 – 2014 

2 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.  DETAILS FOR INDIVIDUAL MEMBER STATE THREE YEAR REPORTS (raw 

data translated and compiled)   

1.  An overview of activities and installations 

2.  Notification and approval systems (and relevant changes)   

3. 

Inspection and enforcement issues 

4.  Problems with interpretation of the provisions 

5.  Accidents 

6.  Clinical Trials using the provisions of the Directive  

7.  Public consultation and information  

8.  Waste disposal 

9.  Other issues 

2.  TABLE OF COMPETENT AUTHORITIES   

3 

4 

39 

60 

87 

97 

102 

109 

119 

131 

135 

3 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
COMMISSION STAFF WORKING DOCUMENT 

Details from individual Member States on their experience with Directive 2009/41/EC of 
the European parliament and the Council of May 2009 on the contained use of 
genetically modified micro-organisms (recast) for the period 2009-2014  

1.  DETAILS  FRO  INDIVIDUAL  MEMBER  STATE  THREE  YEAR  REPORTS  (raw 

data translated and compiled) 

1 

Overview of activities and installations 

1.1      How  many  notifications  were  submitted  in  your  Member  State  under  Directive 
2009/41/EC on the contained use of GMMs during the reporting period 6 June 2009 and 5 
June 2014? 

Please provide as annex at your report, a table with all the information required by art 18(2) 
for each of the notifications received, under Directive 2009/41/EC. 

AUSTRIA 
GMMs 
Class 1 
Class 2 
Class 3 
Class 4 
Amendments to earlier notifications 
Total 

No. of notifications 
74 
137 
6 
0 
20 
237 

GMMs and GMOs combined 
GMM + GM plant 
GMM + GM animal 
Amendments to earlier notifications 
Total no. of notifications received  

No. of notifications  Class of GMM 
6 
14 
- 
20 

1 
1 
- 

BELGIUM 
GMMs 
Class 1 
Class 2 
Class 3 
Class 4 

No. of notifications 
253 
273 
69 
0 

4 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Amendments to earlier notifications1  
(Subsequent use notifications) 
Total 

GMMs and GMOs combined 
GMM + GM plant 

GMM + GM animal 

Amendments to earlier notifications 

Total no. of notifications received  

BULGARIA 
GMMs 
Class 1 
Class 2 
Class 3 
Class 4 
Amendments to earlier notifications 
Total 

418 

595 

No. of notifications  Class of GMM 
24 

risk class 1 GMM: 20 
risk class 2 GMM: 4 
risk class 3 GMM: 0 
risk class 1 GMM: 25 
risk class 2 GMM: 68 
risk class 3 GMM: 20 
GMM + GM plant: 19 
GMM + GM animal: 93 

113 

122 

136 notifications of 
GMMs/GMOs combined 

No. of notifications 
Two 
None 
None 
None 
None 
Two 

GMMs and GMOs combined 
GMM + GM plant 
GMM + GM animal 
Amendments to earlier notifications 
Total no. of notifications received  

No. of notifications  Class of GMM 
Two 
None 
None 
Two 

Both class 1 
Not applicable 
Not applicable 

CROATIA 
Nineteen (19) notifications were submitted in Croatia during mentioned period. 

GMMs 
Class 1 
Class 2 
Class 3 
Class 4 
Amendments to earlier notifications 
Total 

GMMs and GMOs combined 
GMM + GM plant 
GMM + GM animal 

No. of notifications 
17 
2 
0 
0 

19 

No. of notifications  Class of GMM 
2 
2 

1 
1 and 2 

1 Subsequent use notifications: since 2002, the Walloon decree of 04/07/2002 regarding the contained use of GMOs 
and/or  pathogens  doesn’t  distinguish  anymore  between  first  and  subsequent  contained  uses.  In  consequence,  all 
notifications for this region are treated as new activities (or first contained uses). 

5 

 
 
 
 
 
 
 
 
 
 
 
                                                 
Amendments to earlier notifications 
Total no. of notifications received  

19 

CYPRUS 
GMMs 
Class 1 
Class 2 
Class 3 
Class 4 
Amendments to earlier notifications 
Total 

No. of notifications 
1* 
1* 
0 
0 
0 
1* 

GMMs and GMOs combined 
GMM + GM plant 
GMM + GM animal 
Amendments to earlier notifications 
Total no. of notifications received  

No. of notifications  Class of GMM 
0 
0 
0 
0 

* Please note that both Class 1 and Class 2 Activities were included in one notification for the 
same installation. 

CZECH REPUBLIC 
GMMs 
Class 1 
Class 2 
Class 3 
Class 4 
Amendments to earlier notifications 
Total 

No. of notifications 

14 
  2 
  1 
  0 
35 
52 

No. of notifications  Class of GMM 

GMMs and GMOs combined 
GMM + GM plant 
GMM + GM animal 
Amendments to earlier notifications 
Total no. of notifications received  
Explanation note: According to the current Czech legislation, a new notification is required 
in every case a new GMO is to be used (not only new premises). This rule applies even to 
class 1 of contained use that means the national requirements are stricter than those set by the 
Directive. An amendment to the Czech Act of GMOs has been drafted with the aim  to ease 
this  administrative  burden  both  for  notifiers  and  for  the  Competent  Authorities.  The 
amendment is now in the legislative process. 

  0 
  0 
21 
   21 

  1 and 2 

6 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
DENMARK 
GMMs 
Class 1 
Class 2 
Class 3 
Class 4 
Amendments to earlier notifications 
Total 

No. of notifications 
244 
57 
0 
0 
440 
742 

GMMs and GMOs combined 
GMM + GM plant 
GMM + GM animal 
Amendments to earlier notifications 
Total no. of notifications received  

No. of notifications  Class of GMM 
31 
283 

1 and 2 
1 and 2 

314 

ESTONIA 
GMMs 
Class 1 
Class 2 
Class 3 
Class 4 
Amendments to earlier notifications 
Total 

No. of notifications 
3 
3 
2 
0 
0 
8 

GMMs and GMOs combined 
GMM + GM plant 
GMM + GM animal 
Amendments to earlier notifications 
Total no. of notifications received  

No. of notifications  Class of GMM 
0 
0 
0 
0 

NOTE: Labour inspectorate of Estonia  registers notifications only for GMO-s. There are no 
combined notifications in Estonia 

FINLAND 
GMMs 
Class 1 
Class 2 
Class 3 
Class 4 
Amendments to earlier notifications 
Total 

No. of notifications 
136 
104 
3 
0 
?? (what does the question specifically mean?) 
183  (an  individual  notification  may  contain 
activities from several classes) 

7 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
GMMs and GMOs combined 
GMM + GM plant 
GMM + GM animal 
Amendments to earlier notifications 
Total no. of notifications received  
*)  notified  together,  not  necessarily  used  in  combination;  please  also  note  that  this  answer 
does not cover situations where GMMs are used in combination with non-modified plants or 
animals or vice versa 

No. of notifications  Class of GMM 
12* 
12* 
?? 

1-2 
1-2 

FRANCE 
3500 notifications 

GMMs 
Class 1      
Class 2      
Class 3       
Class 4        
Amendments to earlier notifications 
Total 

No. of notifications 
1850 
1450 
 180 
   20 
 500 
3500 

GMMs and GMOs combined 
GMM + GM plant 
GMM + GM animal 
Amendments to earlier notifications 
Total no. of notifications received  

No. of notifications  Class of GMM 
 250 
2500 
 400 
3150 

1+2+3 
1+2+3+4 

GERMANY 
GMMs 
Class 1 
Class 2 
Class 3 
Class 4 
Amendments to earlier notifications 
Total 

No. of notifications 
1147 
2264 
106 
5 

3522 

GMMs and GMOs combined 
GMM + GM plant 
GMM + GM animal 
Amendments to earlier notifications 
Total no. of notifications received  

No. of notifications  Class of GMM 
12 
22 

2 
2 

34 

Please provide as annex at your report, a table with all the information required by art 18(2) 
for each of the notifications received, under Directive 2009/41/EC. 

8 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Class 3/4: see attached summary report of class 3 and class 4 contained uses. 

HUNGARY 
GMMs 
Class 1 
Class 2 
Class 3 
Class 4 
Amendments to earlier notifications 
Total 

No. of notifications 
5 
20 
none 
none 

25 

GMMs and GMOs combined 
GMM + GM plant 
GMM + GM animal 
GMM+GM animal + GM plant 
Amendments to earlier notifications 
Total no. of notifications received  

No. of notifications  Class of GMM 

2 
3 
2 

7 

2 
2 
2 

IRELAND 
GMMs 
Class 1 
Class 2 
Class 3 
Class 4 
Amendments to earlier notifications 
Total 

GMMs and GMOs combined 
GMM + GM plant 
GMM + GM animal 

No. of notifications 
70 
75 
5 
0 
0 
150 

No. of notifications  Class of GMM 
6 
10 

Class 1 
Class  1  and  Class  2 
GMMs 

Amendments to earlier notifications 
Total no. of notifications received  

0 
67 

ITALY 

Class 1 
Class 2 
Class 3 
Class 4 
Amendments to earlier notifications 
Total 

GMMs 

No. of notifications  

Installations  Activities 

33 
50 
5 
0 
18 
106 

N.A.* 
144 
8 
0 
13 
165 

Total 
33 
194 
13 
0 
31 
271 

(*) Notification is not due for class1 activity  

9 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: the following table only refers to activities with GMM inoculation. 

GMMs and GMOs combined 
GMM + GM plant 
GMM + GM animal 
GMM + GM animal 
Amendments to earlier notifications 
Total no. of notifications received  

No. of notifications  Class of GMM 

1 
39 
3 
4 
47 

2 
2 
3 
2 

LATVIA 
GMMs 
Class 1 
Class 2 
Class 3 
Class 4 
Amendments to earlier notifications 
Total 

GMMs and GMOs combined 
GMM + GM plant 
GMM + GM animal 
Amendments to earlier notifications 
Total no. of notifications received  

LITHUANIA 
GMMs 
Class 1 
Class 2 
Class 3 
Class 4 
Amendments to earlier notifications 
Total 

No. of notifications 
1 

1 

No. of notifications  Class of GMM 
1  

1 

1 

No. of notifications 
6 

6 

GMMs and GMOs combined 
GMM + GM plant 
GMM + GM animal 
Amendments to earlier notifications 
Total no. of notifications received  

No. of notifications  Class of GMM 
1 
2 
2 
5 

1 
1 
1 

MALTA 
GMMs 
Class 1 

No. of notifications 
6 

10 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Class 2 
Class 3 
Class 4 
Amendments to earlier notifications 
Total 

0 
0 
0 
0 
6 

GMMs and GMOs combined 
GMM + GM plant 
GMM + GM animal 
Amendments to earlier notifications 
Total no. of notifications received  

No. of notifications  Class of GMM 
0 
0 
0 
0 

NETHERLANDS 
GMMs 
Class 1 
Class 2 
Class 3 
Class 4 
New notifications 
Amendments to earlier notifications 
Total 

GMMs and GMOs combined 
GMM + GM plant 
GMM + GM animal 
Amendments to earlier notifications 
Total no. of notifications received  

No. of notifications 
--- 
--- 
--- 
--- 
519 
3281 

No. of notifications  Class of GMM 

3800 

In  the  Netherlands,  during  the  reporting  period  210  institutes  and  companies  were  actively 
involved  in  contained  use  activities  with  genetically  modified  organisms.  At  these  210 
institutes a total of 2315 licensed active contained use activities take place. This contained use 
involved not only activities with micro-organisms but also with genetically modified plants, 
animals,  viruses,  etc.  In  addition,  most  companies/institutes  carried  out  activities  with 
combinations of GMO's, i.e. not exclusively with GMM's. 15 new installations were notified 
compared to the last reporting period. In total 519 new notifications and 3281 amendments on 
earlier notifications were received during 2009-2014. In general more than one containment 
level was prescribed per notification.  
Overall in the Netherlands we encounter a rise of more than 60% in the amount of new and 
amended notifications in comparison to the figures of the last reporting period. 

POLAND 
GMMs 
Class 1 
Class 2 
Class 3 
Class 4 

No. of notifications 
250 
34 
2 
0 

11 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Amendments to earlier notifications 
Total 

286 

GMMs and GMOs combined 
GMM + GM plant 
GMM + GM animal 
Amendments to earlier notifications 
Total no. of notifications received  

PORTUGAL 
GMMs 
Class 1 
Class 2 
Class 3 
Class 4 
Amendments to earlier notifications 
Total 

GMMs and GMOs combined 
GMM + GM plant 
GMM + GM animal 
Amendments to earlier notifications 
Total no. of notifications received  

ROMANIA 
GMMs 
Class 1 
Class 2 
Class 3 
Class 4 
Amendments to earlier notifications 
Total 

No. of notifications  Class of GMM 
57 
98 

I 
I/II 

155 

No. of notifications 
2 
5 

- 
- 
- 

7 

No. of notifications  Class of GMM 

- 
- 
- 
- 

No. of notifications 
None 
None 
None 
None 
None 
None 

GMMs and GMOs combined 
GMM + GM plant 
GMM + GM animal 
Amendments to earlier notifications 
Total no. of notifications received  

No. of notifications  Class of GMM 
None 
None 
None 
None 

SLOVAKIA 
GMMs 
Class 1 
Class 2 
Class 3 
Class 4 

No. of notifications 
55  
8 
0 
0 

12 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Amendments to earlier notifications 
Total 

0 
63 

GMMs and GMOs combined 
GMM + GM plant 
GMM + GM animal 
Amendments to earlier notifications 
Total no. of notifications received  

No. of notifications 
12 
16 (class 1) + 10 (class 2)  1&2 

Class of GMM 
1 

38 

Since  1.1.2013  the  users  of  genetic  technologies  and  genetically  modified  organisms  aren´t 
obliged to notify the start of the new activity classified to the risk class 1 to the Ministry of 
the  Environment  of  the  Slovak  Republic  (hereinafter  referred  to  as  “the  ministry”).  Once 
every 6 months, the users of GMOs submit a summary notification on all the GMOs classified 
in the risk class 1, which they have carried out activities with, including their storage in the 
reporting period. 

SLOVENIA 
GMMs 
Class 1 
Class 2 
Class 3 
Class 4 
Amendments to earlier notifications 
Total 

GMMs and GMOs combined 
GMM + GM plant 
GMM + GM animal 
Amendments to earlier notifications 
Total no. of notifications received  

No. of notifications 
7 
36 
0 
0 
24 
74 

No. of notifications  Class of GMM 

3 

3 

2 in class 1; 1 in class2 

Information  required  by  art  18(2)  under  Directive  2009/41/EC  is  available  in  the  GMO 
Register at Slovene Biosafety Portal http://www.biotechnology-gmo.gov.si/. 

SPAIN 
GMMs + GMP + GMA= All GMOs (**) 
Class 1 
Class 2 
Class 3 
Class 4 
Amendments to earlier notifications 
Total 

GMMs and GMOs combined 
GMM + GM plant 

No. of notifications 
101 
103 
22 

226 

No. of notifications  Class of GMM 
35 

32 (Class 1) 
3 (Class 2) 

13 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
GMM + GM animal 

Amendments to earlier notifications 
Total no. of notifications received  

28 

63 

27 (Class 1) 
1 (Class 2) 

(**)  Under  the  scope  of  the  Spanish  Law  on  GMOs,  all  kind  of  genetically  modified 
organisms  are  included  in  the  requirements  for  contained  use  purposes.  So  we  have 
considered all the notifications received during the reporting period (GMMs + GM Plants + 
GM Animals) for the four classes of risk. 

SWEDEN 
Please note that one “notification” may include more than one GMM activity or new GMM 
use.  Numbers  in  table  are  approved  activities  and  the  “notifications”  are  stated  above  the 
table. 
Total number of notifications, applications and changes during the time period: 477 
Notification (class 1 and class 2, including new class 2 uses): 411 
Applications (class 3 and class 4): 18 
Changes to already approved GMM-activities: 143 

GMMs 

Class 1 

Class 2  

No.  of  notifications  (numbers  are  activities 
notified/approved during the time period) 
123  (7  were  later  closed  during  the  time 
period) 
102  (3  were  later  closed  during  the  time 
period) 
13 
2 

Class 3 
Class 4 
Amendments to earlier notifications * 
Total 
*Amendments  to  earlier  notifications  do  not  include  new  class  2  uses.  Such  uses  are  not 
included in this list but are a large part of the 411 “notifications” we have registered during 
the time period. 

240 

GMMs and GMOs combined 
GMM + GM plant 
GMM + GM animal 
Amendments to earlier notifications 
Total no. of notifications received  

No. of notifications  Class of GMM 

The list in the annex includes all active activities and uses within activities regardless of when 
it was notified. It is not possible to provide a list only covering 5 years. Please also note that 
one post in the list does not equal one activity or one GMM-use. 

UNITED KINGDOM 
GMMs 

No. of notifications 

14 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Installation or premises notification 

126 (125 from GB; 1 from NI) 

Class 2 

Class 3 

Class 4 

612 (602 from GB; 10 from NI) 

75 (all GB) 

2 (all GB) 

Amendments to earlier notifications 

197 (196 from GB; 1 from NI) 

Total 

1012 (1000 from GB; 12 from NI) 

a)  The figure for ‘amendments to earlier notifications’ includes changes to the contained 
use that may affect risk (55 significant changes), changes to required containment (6 
derogations) and transfer of contained use to a different installation (135 transfers).  

b)  Please note, the Directive is only concerned with genetically modified microorganisms 
(GMM)  and  does  not  require  collection  of  information  on  work  with  genetically 
modified organisms (GMOs i.e. animals and plants). Consequently, such information 
is not collected in a form that is amenable for reporting purposes. For completeness, 
figures  on  combined  work  with  GMMs  and  either  animals  or  plants  (which  may  or 
may  not  be  genetically  modified)  have  been  compiled  by  reviewing  individual 
notifications of GMMs.   

c)  The  figures  in  the  table  below  represent  a  subset  of  the  individual  contained  use 

notifications listed in the first table in section 1.1.  

GMMs and GMOs combined 

No. of notifications  Class of GMM 

GMM + plant 

GMM + animal 

18 

194 

class 1 (4); class 2 (9); 
& class 3 (5) 

class 1 (9); class 2 
(161); class 3 (24); 

Amendments to earlier notifications 

data not available 

data not available 

Total no. of notifications received  

212 

d)  Annex 1 provides details of contained  uses notified to  the UK competent authorities 

during the period of this report.  

15 

 
 
 
 
 
 
 
 
 
 
1.2 

Of the aforementioned notifications how many were notified for: 

AUSTRIA 

  Research purposes not applicable (see below). 
  Commercial purposes not applicable. 
  Other (please specify) not applicable. 

Note ad 1.2 and 1.4 
The former distinction of contained uses on the basis of the purpose (i.e. operations of type A 
and type B in Dir. 90/219/EEC) has been abolished by Dir. 2009/41/EC. In accordance with 
the current Directive notifiers are not obliged to specify the purpose of the contained use and 
therefore only the total number is available (total number of installations: 352). 

BELGIUM 

  Research purposes (Universities, research institutes): 313 
  Commercial purposes: 150 
  Other 

o  Hospitals: 88 
o  Education – Teaching: 12 
o  Public institutions (diagnostic, reference lab, quality control): 32 

BULGARIA 

 
 
 

Research purposes  
Commercial purposes  
Other (please specify)  

4 
0 
0 

CROATIA 
 
 
 

Research  
Commercial purposes  
Other (please specify)  

purposes 

FOURTEEN (14) 
FOUR (4) 
ONE (1) 

CYPRUS 
 
Research  
 
Commercial purposes   
 
Other (please specify)  

purposes 

1 
0 
0 

CZECH REPUBLIC 
 
Research   purposes 
 
Commercial purposes  

   57  (incl. amendments to earlier notifications) 
    7  (incl. amendments to earlier notifications) 

16 

 
 
 
 
 
 
 
 
 
 

Other  (please  specify)      9  detection  laboratories,  transport  companies  (incl. 
amendments to earlier notifications). 

DENMARK 
 
 
 

Research purposes 
Commercial purposes    
Other (please specify)    

ESTONIA 
 
Research  
 
Commercial purposes    
 
Other (please specify)    

purposes 

FINLAND 
 
Research  
 
Commercial purposes    
 
Other (please specify)    

purposes 

724 
60 
21  (large scale research) 

8 
0 
0 

146 (estimation) 
27 
10 (education, core laboratory services) 

FRANCE 
  Research  purposes 
  Commercial purposes  
  Other (please specify)  

3000 
 500 

GERMANY 
  Research purposes  _____ 
  Commercial purposes _____ 
  Other (please specify) _____ 
No information available (database cannot be evaluated concerning the above criteria) 

HUNGARY 
  Research  purposes 
  Commercial purposes  
  Other (please specify)  

IRELAND 
  Research  purposes 
  Commercial purposes  

25 
7 
none 

190 
  21 

} These figures are inclusive of  
} 67 GMO (GM plants and GM  

17 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  Other (please specify) i.e. State      6    
  TOTAL 

217 

 animals applications 

ITALY 
  Research purposes 
  Commercial purposes  
LATVIA 
  Research  purposes 
  Commercial purposes  
  Other (please specify)  

LITHUANIA 
  Research  purposes 
  Commercial purposes  
  Other (please specify)  

MALTA 
  Research  purposes 
  Commercial purposes  
  Other (please specify)  

149 
16 

1  
_____ 
_____ 

11 
_____ 
_____ 

6 
0___ 
0___ 

NETHERLANDS 
  Research  purposes 
  Commercial purposes  
  Other (please specify)  
Remark: due to reporting mechanisms it is not possible for the Netherlands to differentiate the 
issued licences between commercial or research purposes.  

--- 
--- 
--- 

POLAND 
  Research  purposes 
  Commercial purposes  
  Other (please specify)   25 clinical trials 

260 
1 

PORTUGAL 
  Research  purposes 
  Commercial purposes  
  Other (please specify)  

6 
1 
_____ 

18 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ROMANIA 
  Research  purposes 
  Commercial purposes  
  Other (please specify)  

SLOVAKIA 
  Research purposes 
  Commercial purposes  
  Other (please specify)  

SLOVENIA 
  Research  purposes 
  Commercial purposes  
  Other (please specify)  

SPAIN 
  Research  purposes 
  Commercial purposes  

None 
None 
None 

92 
16 
 0 

63 
11 
0 

200 
15  (products  close  to  commercial  development  phases, 

control quality procedures, manufacture of diagnostics, veterinary or human medicines). 

  Other (please specify)  

_____ 

SWEDEN 
 
 
 

Research purposes 
Commercial purposes   
Other (please specify)  
university level; 1 with destruction of GMM in waste, 1 with diagnostics. 

221 (both commercial and academics) 
6* 
12  with  education  at  both  high  school  level  and 

*Where  the  commercial  purpose  is  research  or  if  the  purpose  is  both  research  and 
commercialisation,  the  purpose  is  included  as  Research.  Several  small  business  companies 
have research as their main purpose for GMM use. Some also use GMM for production.  

UK 
  Research purposes 
  Commercial purposes  
  Other (please specify)  

719 in GB and 6 in NI 
229 in GB and 4 in NI 
52 in GB and 1 in NI  

Other in this case relates to Government Organisations. 

19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.3 

Please comment on the overall trend compared to the previous reporting period (e.g. 
has the overall number of notifications received increased or decreased, has there been 
an increase/decrease in respect of certain classes, commercial or research sectors etc.) 

AUSTRIA 
- 

BELGIUM 
From 6 June 2009 to 5 June 2014, 552 dossiers of installations covering 1150 notifications of 
contained uses of GMMs, GMOs and/or pathogens have been reviewed by the SBB acting as 
the advisory body for the competent authorities. 
-  It  is  not  appropriate  to  compare  two  different  reporting  time  period  (3  years  for  previous 
report  and  5  years  for  this  one)  but  in  general,  the  number  of  dossiers  and  notifications 
remained comparable if the average of notifications per year is considered. 
- Since 1993, Belgium has fully implemented Directive 90/219/EEC in three regional decrees 
thereby  extending  the  scope  to  GMOs  and  non-GM  pathogens.  This  means  that,  among  the 
1150  notifications,  426  of  them  exclusively  concerned  non-GM  pathogens  (37%)  and  482 
notifications  concerned  GMMs  and/or  GMOs  only  (42%).  The  remaining  242  notifications 
concerned contained uses of both GMMs/GMOs and non-GM pathogens (21%). 

Compared to the previous 3-year reporting period, the percentage of notifications for non-GM 
pathogens remains exactly the same. In contrast, there was a strong decrease of notifications 
concerning exclusively MGMs or GMOs in favour of combined operations with GM and non-
GM organisms. 
-  Subsequent  use  notifications:  In  Belgium,  from  2009  to  2014,  the  subsequent  use 
notifications have  steadily  increased. They account  for up to 82 % which  is a high increase 
compared  to  the  previous  reporting  period  when  they  represented  only  59  %  of  the  total 
number. 
-  With  respect  to  the  type  of  exploitations,  the  large  majority  of  GMMs  are  used  by  the 
university  research  laboratories  (60  %)  for  fundamental  research.  Sometimes  medical 
researches  with  GMMs  are  conducted  in  hospital  labs  (9%).  GMMs  are  handled  in 
pharmaceutical companies (23 %) for research purposes or production of enzymes, vaccines 
and therapeutic molecules. Rarely, GMMs are also used for teaching (2 %). 

BULGARIA 
All  four  notifications  received  concern  initial  approval  of  facilities  of  academic  institutions 
for  contained  use  of  GMM  class  1  (Article  6  of  the  Directive)  and  in  addition  two  of  them 
included  request  for  work  with  GM  plants  class  A  (see  answer  to  question  2.2).  All  four 
notifications were received after July 2012. We expect further notifications for initial approval 
of  facilities  from  between  two  and  five  academic  institutions.  All  will  include  work  with 
GMM class1 and it is possible that up to two of them will include work with GMM class 2. 
Additionally we expect that between 2 and 5 of the notifications will include work with GM 
plants class A and one or two work with GM animals class A. Notification for initial approval 
of facilities should be updated at least every two years. 

20 

 
 
 
 
 
 
 
CROATIA 
Not applicable. Croatia has been started with the procedure of notification of contained use of 
GMMs in the middle of 2012. 

CYPRUS 
There was an increase in the number of notifications received. The previous reporting period 
there was no GMMs notification received. 

CZECH REPUBLIC 
Most  institutions  submitted  their  notifications  during  the  first  years  after  the  Czech  Act  on 
GMOs  came  into  force  in  2004.  Since  2006,  the  number  of  new  subjects  starting  to  use 
GMMs has increased only moderately. Prevailing notifications concerned new activities with 
GMMs  in  previously  notified  premises  -  that  means  mostly  amendments  to  the  previous 
notifications have been submitted (see the explanation note to 1.1. above). The purpose of the 
notified activities has been almost entirely research and education (Universities). 

DENMARK 
There  has  been  an  increase  in  the  number  of  notifications  for  class  1  and  2.  Regarding  the 
classifications of locations there has also been an increase. 

ESTONIA 
This number has been increased, especially in class 3. In the previous reporting period there 
were no any class 3 notifications. 

FINLAND 
The overall number of notifications has increased. This is probably due to the current policy 
that each university research group notifies independently its GMO activities instead of joint 
notifications covering whole departments or units. 

FRANCE 
Generally, in all cases, the notifications are increasing. 

GERMANY 
The overall number of notifications has increased with respect to all classes. 

HUNGARY 
Compared to the previous reporting period, there has been an increase in the number of Class 
2  contained  use/installation  notifications  in  Hungary,  mainly  for  research  purposes.  In  our 

21 

 
 
 
 
 
 
 
 
 
 
view, the reason for that is that the Government sent detailed information to the universities, 
laboratories, and other contained use facilities on the obligatory to apply for consent for these 
activities. 
In  most  cases,  notifiers  propose  Class  2  for  contained  use  activities  or  installations  where 
Class 1 would be also appropriate. The notifiers’ reasoning behind is that by applying stricter 
contained use measures a higher level human health and environmental safety can be ensured. 
The  competent  authority  approves  the  proposed  Class  level  in  these  cases.    There  is  an 
increase in the number of GM animal notifications, too. 

IRELAND 
Compared to our submission for the 2006 – 2009 report, the number of applications received 
from  research  institutions    is  slightly  down  (87%  compared  to  90%  during  period  2006  - 
2009) but the trend is the same in that the majority of applications were submitted by users in 
research institutions. That said the current reporting period is 5 years as opposed to the 3 year 
duration of the 2006 – 2009 reporting period which could account for this slight difference  

Consistent  with  previous  years  the  majority  of  the  applications  submitted  during  the  period 
belonged to Class 1 (70). These were all applications in respect of first time use of premises. 
In contrast, 75 applications were received in respect of Class 2 GMM contained use activities, 
however  45 of these were in respect of first time use  of a premises and 30 corresponded to 
‘subsequent Class 2 contained use’, i.e. where the premises has been the subject of a previous 
notification to carry out Class 2 GMM contained use activities. 

The number of applications received from commercial users during the reporting period 2009 
– 2014 has increased by almost 50%. Again most likely the extended reporting period has had 
a bearing on this.  

ITALY 
The overall number of notifications remains stable (-2%, actually) with respect to the previous 
period (i.e. 6 June 2004 - 5 June 2009); some more “class 3” activities, fully balanced by the 
decrease  in  the  “class  1”  installations.  The  actual  period  is  characterised  by  a  significant 
number of amendments: 11% of the overall submissions have been due to revisions (minor, 
usually)  of  previous  notifications.  No  relevant  change  has  to  be  reported  in  terms  of  sector 
breakdown. 

LATVIA 
This is first notification regarding contained use in Latvia. 

LITHUANIA 
Compared to the previous reporting period 2006  - 2009, the overall number of notifications 
increased by 9 notifications for research purposes. 

MALTA 

22 

 
 
 
 
 
 
 
 
 
There  was  an  increase  from  the  last  reporting  period  since  we  received  one  application  to 
register Class 1 laboratory premises and notification of six Class 1 experiments. 

NETHERLANDS 
- 

POLAND 
The  majority  of  these  activities  have  taken  place  in  universities  or  research  institutions  for 
fundamental research. The number of installations and contained use activities increased, in 
comparison with the previous reporting period. 

PORTUGAL 
The number of notifications received during the present report period, increased to more than 
the  double  of  the  number  of  notifications  comparing  with  the  previous  report  period, 
regarding  the  same  classes  (classes  1  and  2)  and  in  the  great  majority  of  notifications  for 
research purposes (only one notification for commercial purposes). 

ROMANIA 
Not applicable. 

SLOVAKIA 
Compared  to the previous reporting period (2006-2009), the overall number of notifications 
on  the  contained  use  of  GMOs  has  slightly  increased.  The  similar  trend  is  seen  also  when 
compared number of notifications on the contained use of GMOs classified in the risk class 1 
and  2.  During  this  reporting  period,  we  haven´t  received  notifications  on  the  higher  risk 
classes  3  and  4.  The  number  of  notifications  for  the  research  and  commercial  purposes  in 
comparison to the previous reporting period has slightly increased, as well. 

SLOVENIA 
The  overall  number  of  the  notifications  has  slightly  increased.  However,  number  of 
installations  for  GMOs  in  the  biosafety  class  2  has  increased  significantly.  Some  of  the 
installations  were  newly  build  and  registered,  but  mainly  the  installations  that  were  already 
registered  in  the  biosafety  class  1 are  upgraded to  the  biosafety  class  2.  Consequently  there 
were  also  more  notifications  of  the  activities  in  the  biosafety  class  2.  Slight  increase  of  the 
activities with GMMs in the biosafety class 2 for commercial purposes was also recorded. 

At  the  moment  there  are  no  installations  and  activities  with  GMOs/GMMs  in  containment 
classified in biosafety class 3 or 4. 

SPAIN 

23 

 
 
 
 
 
 
 
 
 
 
Compared  to  the  previous  reporting  period  the  number  of  notifications  of  installations  has 
increased significantly (from 50 for the last reporting period to 139 for this reporting period), 
but taking into account that the current reporting period is broader (5 years). 
Especially, notifications of installations for class 2 activities are being increased. 

SWEDEN 
We  have  seen  a  small  decline  in  the  number  of  activities  for  contained  use  in  the  private 
sector. One reason is that a big company with many GM-activities has closed down most of 
its research in Sweden.  

Each  year  some  activities  are  closed  down  and  some  are  new,  while  some  moves  to  new 
locations. The number of new or moved activities decreased 2009 and there was a net increase 
between new and closed down GMM activities of only +1 GMM-activity. In 2010 there was a 
net  increase  of  +13.  For  2011  the  increase  was  +6  with  a  more  normal  inflow  of  new 
activities. For 2012 the numbers were more normal with a net increase of +35. The trend is 
kept for 2013 with a net increase of +32 and, so far, 2014 has a net increase of +18. 

UNITED KINGDOM 
a)  Comparison of the overall notifications between the reporting periods of 2006-2009 and 
2009-2014  indicates  that  the  average  number  of  notification  per  annum  is  not 
significantly different (i.e. 170 notifications per annum compared to 177 notification per 
annum).  Similarly,  there  is  no  significant  difference  across  the  notifications  at  the 
different risk classes. 

b)  Within  the  reporting  period,  there  was  a  dip  in  the  number  of  notifications  received  in 
2010/11  (140  notifications),  which  then  increased  each  year  to  a  peak  in  2013/14  (207 
notifications).  However,  when  taken  as  an  average  over  the  5  year  period,  the  average 
number of notifications is very similar to the previous reporting period. 

24 

 
 
 
 
 
 
 
 
1.4 

Number of installations approved to date: 

AUSTRIA 
Research Commercial Other (please specify) 
Commercial 
Research 
- 
- 
See Note ad 1.2 and 1.4. 

BELGIUM 
Research 
34 

Commercial 
261 

Other (please specify)  
- 

Other (please specify)  
Hospitals: 138 
Education-Teaching: 19 
Public institutions: 40 

BULGARIA 
Research 
4 

CROATIA 
Research 
12 

CYPRUS 
Research 
1 

Commercial 
None 

Other (please specify)  
None 

Commercial 
4 

Other (please specify)  
1 

Commercial 

Other (please specify)  

CZECH REPUBLIC 
Research 

Commercial 

82 

7 

Other:  detection  laboratories, 
transport companies 
8 

DENMARK 
Research 
1272 

ESTONIA 
Research 
4 

Commercial 
211 

Large scale  
29 

Commercial 

Other (please specify)  

25 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FINLAND 
Research 
information not available 
679 in total 

FRANCE 
Research 

Commercial 
information not available 

Other (please specify)  
information not available 

Commercial 

Other (please specify)  

Use is associates to the project in an installation but not for research structure 

GERMANY 
Research 

Commercial 

Other (please specify)  

No information available (database cannot be evaluated concerning the above criteria) 

BSL1 installations: 4 594 
BSL2 installations: 1 506 
BSL3 installations: 107 
BSL4 installations: 4 (2x in operation, 2x construction approval) 

HUNGARY 
Research 
14 

Commercial 
7 

Other (please specify)  

IRELAND 
Research 
17 

ITALY 

Commercial 
35 

Other (please specify)  
3 

Class  Commercial  Research  Other (Education) 
248 
198 
29 
475 

1 
2 
3 
Total 

16 
10 
1 
27 

16 
4 

20 

Total 
280 
212 
30 
522 

26 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
LATVIA 
Research 
1 

LITHUANIA 
Research 
- 

MALTA 
Research 
1 

Commercial 

Other (please specify)  

Commercial 
- 

Other (please specify)  
- 

Commercial 
0 

Other (please specify)  
0 

NETHERLANDS 
See remark under 1.2 

Research 

Commercial 

Other (please specify)  

POLAND 
Research 
63 

PORTUGAL 
Research 
2 

ROMANIA 
Research 
0 

SLOVAKIA 
Research 
74 

Commercial 
15 

Other (please specify)  
0 

Commercial 
1 

Other (please specify)  

- 

Commercial 
0 

Other (please specify)  
0 

Commercial 
6  

Other (please specify)  
0 

27 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLOVENIA 
Research 
56 

SPAIN 
139 

Research 
124 

Commercial 
8 

Other (please specify)  
1 education 

Commercial 
15 

Other (please specify)  

SWEDEN 
An  “installation”  is  always  included  in  an  “F-,  L-  or  R-activity”.  The  “installation”  may  be 
identical  for  more  than  one  “activity”.  An  “installation”  may  be  a  laboratory,  an  animal 
department, a large scale facility or any other similar physical place with equipment suitable 
for the GMM-activity. In a building or at a “site”, there may be one or several “installation”. 
Sometimes there may be more than one user (employer) in the same building or site. 

In Sweden, GMM-activities are notified from 113 users (employers) that are scattered at 32 
cities and 157 sites. Today a total number of 624 GMM-activities are active:  

23  users  (employers)  are  universities  or  other  research  institutes  with  a  total  of  472  GMM-
activities in class 1-4.  

There are three hospitals and 14 schools with GMM-activities with GMM-activities in class 1.  

73 users are commercial biotech companies, waste management companies or private schools 
with a total number of 115 GMM-activities in class 1 or class 2. But far from all activities are 
commercialisation; a large part is research. 

Research 
23  users  in  academia,  about 
500 GMM activities (class 1-
4) 
3  hospitals  (class  1,  notified 
by country councils) 

Commercial 
73  users  are  commercial, 
about  100  GMM  activities 
(class 1 and 2) 

Other (please specify)  
Schools  (high  school  level): 
14 GMM-activities (class 1) 

UNITED KINGDOM 
a)  881 installations (871 in GB and 10 in NI) have been approved to date in the UK. 

Research 

Commercial 

Other (please specify) 

509 (507 in GB; 2 in NI) 

327 (320 in GB; 7 in NI) 

45 (44 in GB; 1 in NI) 

28 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Other in this case relates to Government organisations. 

29 

 
 
 
 
1.5 

Number of activities approved to date: 

AUSTRIA 
Class 1 
1584 

Class 2 
422 

BELGIUM 
Class 1 
983 

Class 2 
972 

BULGARIA 
Class 1 
Four 

Class 2 
None 

CROATIA 
Class 1 
15 

Class 2 
2 

CYPRUS 
Class 1 
12 

Class 2 
12 

Class 3 
16 

Class 4 
0 

GMO 
- 

Class 3 
120 

Class 4 
0 

GMO 
794 

Class 3 
None 

Class 4 
None 

GMO 
Two 
plants, 
Class  A 
answer 
question 2.2) 

for  GM 
both 
(see 
to 

Class 3 
0 

Class 4 
0 

GMO 
0 

Class 3 

Class 4 

GMO 

2 Please note that only one installation was approved by the Department of Labour Inspection 
for Class 1 and Class 2 Activities. 

CZECH REPUBLIC 
Class 1 
65 

Class 2 
31 

Class 3 
1 

Class 4 
0 

GMO 
included 

DENMARK 
Class 1 
741 

Class 2 
161 

Class 3 
0 

Class 4 
0 

GMO 
71 

30 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
ESTONIA 
Class 1 
Research 

Class 2 
Research 

Class 3 
Research 

Class 4 

GMO 

FINLAND 
Class 1 
528 
*) Notifications on activities + installations 876 in total, of which 197 notifications merely for 
activities.  Please  note  that  the  total  number  includes  notifications  and  applications  also  on 
GM-plants and GM-animals and their combinations with GMMs. 

Class 2 
312 

Class 3 
7 

Class 4 
0 

GMO 
876*  

FRANCE 
Class 1 
Cf  1.1/1.4 

Class 2 
Cf  1.1/1.4 

Class 3 
Cf  1.1/1.4 

Class 4 
Cf  1.1/1.4 

GMO 
Cf 1.1/1.4 

GERMANY 
Class 1 
6959 

Class 2 
6986 

HUNGARY 
Class 1 
5 

Class 2 
27 

IRELAND 
Class 1 
255 

Class 2 
152 

ITALY 

Class 3 
358 

Class 4 
8 

GMO 

Class 3 

Class 4 

GMO 

Class 3 
5 

Class 4 
0 

GMO 
130 

Total number of authorisations 
(since Oct. 2001) 
Not-expired  authorisations  up  to 
date 
(*) Notification is not due for class1 activity  

Class 1  Class 2  Class 3  Class 4  GMO 
N.A. 
N.A.* 

454 

21 

0 

N.A.* 

143 

8 

0 

N.A. 

LATVIA 
Class 1 
1 

Class 2 

Class 3 

Class 4 

GMO 

31 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
LITHUANIA 
Class 1 
11 

Class 2 
- 

Class 3 
- 

Class 4 
- 

GMO 
- 

MALTA 
Class 1 
6 

Class 2 
0 

Class 3 
0 

Class 4 
0 

GMO 
0 

NETHERLANDS 
See remark under 1.1 

Class 1 

Class 2 

Class 3 

Class 4 

GMO 

POLAND 
Class 1 
250 

Class 2 
34 

PORTUGAL 
Class 1 
2 

Class 2 
5 

Class 3 
2 

Class 4 
0 

GMO 
325 

Class 3 
- 

Class 4 
- 

GMO 
(field 
1 
with maize)* 

trials 

* - Notification submitted accordance with Directive 2001/18/EC  

ROMANIA 
Class 1 
0 

Class 2 
0 

Class 3 
0 

Class 4 
0 

GMO 
0 

SLOVAKIA 
Class 1 
7052 

Class 2 
5626 

Class 3 
0 

Class 4 
0 

GMO 
Total number 197 
GMM, GM animals, GM plants  
(See Annex 1) 

Number of activities was quantified according to the organisms, genes and vectors that were 
used.  

Total number of submitted notifications to date: 

32 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Class 1 
90 

Class 2 
18 

Class 3 
0 

Class 4 
0 

GMO 
Overall 108 

SLOVENIA 
Class 1 
56 

Class 2 
27 

Class 3 
0 

Class 4 
0 

GMO 

SPAIN 
234  (The  number  of  activities  may  not  match  with  the  number  of  notification  pointed  out 
above) 

Class 1 
93 

Class 2 
122 

Class 3 
19 

Class 4 

GMO 

SWEDEN 
5 June 2014 (only still active; closed down are not included) 

Class 1 
396 

Class 2 
208 

Class 3 
18 

Class 4 
2 

GMO 

UNITED KINGDOM 

a)  In the UK, class 1 activities are not notified as a separate activity. Information on class 
1 activities is provided as part  of a  premises  (installations) notification but  this does 
not represent the overall number of class 1 activities being undertaken.  

Class 2 
1816 (1795 in 
GB; 21 in NI) 

Class 3 
211 (210 in GB; 
1 in NI) 

Class 4 
12 (all GB) 

GMO 
3 (all GB) 

33 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.6  Were  there  any  particular  difficulties  you  encountered  in  the  notification  process 
during the reporting period and what in your opinion could be done at EU or national level to 
alleviate these difficulties? 

AUSTRIA 
- 

BELGIUM 
Some problems are met in the interpretation of the terms “subsequent activity”: There is no 
definition of a subsequent “contained use” in the Directive. Although the regional legislation 
for  Brussels-Capital  Region  defines  a  subsequent  contained  use  as  "any  new  contained  use, 
modification or continuation of contained use in an installation which has been the subject of 
a  previous  notification  or  authorisation  for  a  contained  use  of  the  same  or  a  higher  class  of 
risk", the user does not always know when an activity is considered as a subsequent contained 
use, especially in case of a modification of the authorised activity. Moreover, it is impossible 
to distinguish the amendments to earlier notifications (see table point 1.1) with other types of 
subsequent contained uses (continuation of activity or new activity) as defined in the regional 
decrees. 

In Brussels-Capital Region some problems were encountered in the notification process due 
to the Brussels legislation which has set up numerous different procedures regarding the class 
of risk (8 in total). 

To solve this difficulty, the Brussels-Capital Region implements first use procedure when the 
subsequent notification is introduced after expiry of the first use authorisation. That way, the 
procedure is uniformly applied concerning the reception and the analysis of the notification, 
the visit on site, the expert advice reception and the authorisation delivery timeframe.  

This difficulty is not encountered in Walloon Region because there is no separate procedure 
for a first and a subsequent contained use. 

BULGARIA 
Directive 2009/41/EC provides only for the contained use of GM microorganisms but not for 
GM plants and animals. It will be helpful if the scope of the directive is extended to all GMO 
and unified requirements for contained use of GM plants and animals are established. 

In addition it will be useful if a list of Generally Regarded As Safe (GRAS) laboratory strains 
and  cultivars  is  adopted  at  EU  level,  because  they  account  for  most  of  the  work  done  at 
universities and research institutions. 

CROATIA 
- 

34 

 
 
 
 
 
 
 
 
 
 
 
 
CYPRUS 
There was no difficulty in the notification process. 

CZECH REPUBLIC 
The  current  Czech  legislation  on  contained  use  is  stricter  than  the  Directive  2009/41/EC:  a 
new  notification  is  required  in  every  case  a  new  GMO  is  to  be  used  -  even  in  Class  1  of 
contained use. 

The Ministry of the Environment as the Competent Authority has elaborated an amendment to 
the Czech Act of GMOs with the aim to ease this administrative burden both for notifiers and 
for the Authorities. The amended Act will comply with the Directive and will not go beyond 
the  EU  requirements.  The  amendment  is  now  in  the  legislative  process  and  is  expected  to 
come into force next year. 

DENMARK 
Class  1  notifications  make  up  most  of  the  notifications  and  there  is  a  lot  of  administrative 
work due to this. That is why we are currently working on a change in our procedures in order 
to make things easier for the companies as well as the authorities 

ESTONIA 
Was a question about approved installations. There is an enterprise with allowance in certain 
address. They want to move to another laboratory in the another building. Does they have to 
make new notification and get new allowance. 

FINLAND 
Problems are similar to the previous reporting period: 

  A major problem has been the definitions of the directive 2009/41/EC for GMMs, as they 
are  outdated  in  the  present  research  environment  with  its  new  molecular  biology 
techniques.    

  Classification  of  viruses  and  cell  cultures  has  also  been  problematic  in  some  cases.  A 
special problem has been the classification of pathogens that have been attenuated (= can 
an attenuated pathogen ever be considered non-pathogenic according to the directive, and 
if so, on what conditions?).  

  Clinical  trials  with  GM-viruses  are  a  borderline  case  between  contained  use  and 
deliberate  release  in  cases  where  it  cannot  be  completely  ruled  out  that  the  patients’  or 
animals’ excretions may contain live viruses.  

  Research groups move frequently from one institution to another which means they have 

to repeatedly send new notifications of their new premises 

FRANCE 
Implementation of the computing processing for projects. 

35 

 
 
 
 
 
 
 
 
 
GERMANY 
- 

HUNGARY 
In most cases notifier’s practice is lacking in the compilation of the notification dossiers, there 
are  lots  of  consultations  necessary  between  the  notifiers  and  the  Competent  Authority 
regarding the required documentation prior to submission or after the notification in the form 
of asking for further information 

IRELAND 
The deregulation of Class 1 GMMs.  

Class 1 GMM contained use activities are deemed to present negligible or no risk (article 4, 
Directive  2009/41/EC on the contained use  of GMMs). Class 1 GMMs are usually crippled 
strains  with  a  long  history  of  safe  use.  Annex  II  Parts  B  and  C  of  Directive  2009/41/EC 
provide  for  the  exclusion  of  GMMs  from  the  scope  of  the  Directive.  However,  the 
requirements under Part B are very onerous given the ‘not harmful’ status of Class 1 GMMs.  

Under  Directive  2000/54/EC  on  the  protection  of  workers  from  risks  related  to  exposure  to 
biological agents at work, it is not required that Hazard Group 1 Biological Agents (defined as 
unlikely  to  cause  human  disease)  be  notified to  the  Competent  Authority  rather  it  is  simply 
required that the principles of Good Occupational Safety and Hygiene be observed.  

Class 1 GMMs should be similarly dealt with.  

ITALY 
None. 

LATVIA 
Latvia  has  a  low  activity  in  this  field  and  therefore  we  do  not  have  any  difficulties  at  this 
moment. 

LITHUANIA 
There were no particular difficulties during the reporting period. 

MALTA 
No. 

36 

 
 
 
 
 
 
 
 
 
 
 
 
 
NETHERLANDS 
No. 

POLAND 
- 

PORTUGAL 
No particular difficulties were found. 

ROMANIA 
Not applicable. 

SLOVAKIA 
During this period we didn’t experience any difficulties in the notification process. 

SLOVENIA 
The notification process in Slovenia is well established; however slight delays are caused in 
the  notifications  in  which  the  external  experts  (Scientific  Committee)  or  another  CA 
(Veterinary authority) are involved. 

SPAIN 
Difficulties relating to: 

- Interpretation whether the GMO obtained by new genetic techniques is under the scope of 
the Directive 2009/41/EC or not. 

SWEDEN 
We have not encountered any specific problems with the notification process. The Provisions 
were  changed  2011  and  the  notification  process  was  enhanced  by  much  more  detailed 
instructions of what information the Competent Authority needs. The notification forms were 
also updated and tested by some users before launched to public access. See point 2.3. 

UNITED KINGDOM 
a)  The  notification  requirements  under  the  GMO(CU)  Regulations  (the  regulations  which 
implement Directive 2009/41/EC) are well-understood by users and there is believed to be 
a  high  level  of  compliance  with  these  requirements  in  the  UK.  The  only  area  that  has 
presented difficulties for users is in deciding when it is appropriate to notify the competent 
authorities when the contained use changes significantly.  

37 

 
 
 
 
 
 
 
 
 
 
 
b) This  has  been  addressed  by  working  with  users  (Institute  for  Safety  in  Technology  and 
Research)  to  provide  guidance  on  deciding  when  changes  to  the  contained  use  require 
notification. The guidance is available on-line: 

(http://www.istr.org.uk/docs/ISTR%20BSG%20Significant%20Change%20guidanc
e%20v1.pdf). 

c)  Subject to comments in sections 4.1 and 4.2, the notification of contained use of GMM in 

the UK is working well.   

38 

 
 
 
 
 
 
2 

Notification and approval systems (and relevant changes)  

2.1  Who is the Competent Authority (CA) for Directive 2009/41/EC on the contained use 
of GMMs in your Member State? (Please expand where other authorities or ministries 
are involved or where authorities are established at national/regional level) 

AUSTRIA 
The Ministry of Science, Research and Economy is CA for contained uses in Universities and 
scientific institutions in its purview; the Ministry of Health is CA for all other contained uses. 

BELGIUM 
The  regulatory  framework  concerning  the  contained  use  of  GMMs  is  implemented  and 
enforced in Belgium at the regional level. Three different regional decrees exist that have first 
fully implemented the Directive 90/219/EEC (extending the scope to GMOs and pathogens) 
and then transposed new provisions of Directive 98/81/EC. Directive 2009/41/EC is a recast 
of the European legislation on contained use and does not suppose the transposition of new 
provisions in the Belgian regional decrees. 

A  Cooperation  agreement  concerning  biosafety2  was  set  up  to  ensure  that  the  transposition 
and  practical  implementation  of  the  Directive  90/219/EEC  are  done  in  a  harmonised  way 
between the three Regions at the administrative and scientific level. This agreement is still in 
application for the recast Directive 2009/41/EC. 
The competent authorities in charge of the regional decree on contained use of GMMs (and 
pathogens) application are: 

  For 

the  Brussels-Capital  Region: 

la  Gestion  de 
l’Environnement (IBGE) / Brussels Instituut voor Milieubeheer (BIM), Authorisation 
Service 

Institut  Bruxellois  pour 

  For 

the  Walloon  Region:  Service  Public  de  Wallonie,  Direction  Générale 
l'Environnement 

Opérationnelle  3"Agriculture,  Ressources  naturelles  et  de 
(DGARNE), Department of Permits and Authorisations – External directions. 

  For the Flemish Region: Vlaamse Minister van Leefmilieu, Departement Leefmilieu, 

Natuur en Energie (LNE), Environmental permit service. 

At  the  federal  level,  the  competent  authority  in  charge  of  emergency  planning  for  the 
contained use of GMMs is the Federal Public Service Home Affairs. 

BULGARIA 
Ministry of Environment and Water is the Competent Authority for Directive 2009/41/EC on 
the  contained  use  of  GMMs  and  on  contained  use  of  other  GMOs.  Control  activities  are 
performed  by  the  regional  inspectorates  of  the  ministry  and  laboratory  analysis  by 
Environmental Executive Agency. 

CROATIA 

2 http://www.biosafety.be/COOPAG/COOPAGEN.html 

39 

 
 
 
 
 
 
 
 
                                                 
Competent Authorities for the purposes and official control in this Directive 2009/41/EC on 
the contained use of GMMs are: 
a) 

Ministry of science, education and sport. It is responsible for administrative procedure 
of contained uses. 
Ministry of Health as coordinative body in field of GMOs in Croatia, at same time, it 
is responsible for conducting official control on the contained use of GMM. Ministry 
of Health ensures that users of contained use of GMM comply with this Directive. 

b) 

Croatian Committee for contained use of GMO helps to competent authorities in procedure of 
assessing  class  of  risk  on  activity  in  which  microorganisms  are  genetically  modified  or,  in 
which such as GMMs cultured, stored. Croatian Committee for contained use is independent 
scientific  body  made  of  11  scientists’  different  knowledge  and  experience  of  GMO  and 
GMMs. Croatian committee is giving opinion on application on contained use of GMM and 
reviewing risk assessment. 

CYPRUS 
The Competent Authority for Directive 2009/41/EC on the contained use of GMMs in Cyprus 
is  the  Minister  of  Labour,  Welfare  and  Social  Insurance  through  the  Department  of  Labour 
Inspection. 

CZECH REPUBLIC 
The  Ministry  of  the  Environment  is  the  CA  for  contained  use  of  all  GMOs  in  the  Czech 
Republic.  The  Ministry  of  the  Environment  cooperates  closely  with  the  Ministry  of  Health 
and Ministry of Agriculture regarding the health and agricultural aspects of the use of GMOs. 

DENMARK 
The WEA is CA for the contained use of GMM’s. For notifications with plants and animals 
the EPA is involved too. This also applies for productions. 

ESTONIA 
Competent  authority  is  The  Labour  Inspectorate  of  Estonia.  Labour  Inspectorate  has  to  ask 
opinion  from  Committee  of  Gene  Technology  of  Estonia.  This  Committee  makes  their 
sessions  4  times  in  the  year.  This  Committee  works  under  Ministry  of  the  Environment  of 
Estonia. 

FINLAND 
For  notifications  and  approval  the  CA  is  the  Board  for  Gene  Technology.  The  supervisory 
authority  responsible  for  the  inspections  is  the  National  Supervisory  Authority  for  Welfare 
and Health, Finland (Valvira). 

FRANCE 

40 

 
 
 
 
 
 
 
 
 
Ministère  de  l’Education  Nationale,  de  l’Enseignement  Supérieur  et  de  la  Recherche. 
Direction Générale de la Recherche et de l’Innovation. 

GERMANY 
The  CAs  for  Directive  2009/41/EG  in  Germany  are  the  Federal  state  (Bundesländer) 
authorities. 

HUNGARY 
In Hungary, there are two Competent Authorities established at national level, depending on 
the  main  goal  of  the  application:  one  is  the  Ministry  of  Agriculture  in  case  of 
agricultural/commercial  notifications,  the  second  is  the  National  Institute  for  Quality  and 
Organizational Development in HealthCare and Medicine in case of clinical trial notifications. 
As part of the authorisation procedure, the Genetic Engineering Advisory Board is consulted. 
The  Board  is  a  scientific  advisory  body  composed  of  19  representatives  delegated  by  the 
Hungarian  Academy  of  Sciences,  the  relevant  government  ministries  and  civil  society 
organisations  in  the  field  of  environmental  protection,  health,  biotechnology  and  consumer 
protection. 

IRELAND 
The  Environmental  Protection  Agency  has  responsibility  for  the  implementation  of  the 
legislation.  The  Department  of  the  Environment,  Community  and  Local  Government 
(DECLG) has responsibility for policy. 

ITALY 
According  to  the  Italian  Legislative  Decree  206/2001,  CA  is  the  Ministry  of  Health,  which 
authorises GMM installations and activities “in accordance with the conclusions of the Inter-
ministerial Commission for the GMM Evaluations (further on CIV)”. 

LATVIA 
During the reporting period 6 June 2009 and 5 June 2014 the Competent Authority (CA) for 
Directive 2009/41/EC on the contained use of GMMs in Latvia was the Food and Veterinary 
Service of Republic of Latvia. In order to achieve the scientific integrity and  independence, 
the Scientific Expert Committee was established. The role of the Scientific Expert Committee 
is to provide the CA with the scientific advice. 

Further CA for Directive 2009/41/EC on the contained use of GMMs in Latvia will be State 
Scientific Institute “Institute of Food Safety, Animal Health and Environment “BIOR”. 

The State Labour Inspectorate, in conformity with the regulatory enactments regarding labour 
protection when coming into contact with biological substances, shall ensure the supervision 
and control of such safety and labour protection measures which are related to the contained 
use of genetically modified micro-organisms. 

41 

 
 
 
 
 
 
 
 
 
LITHUANIA 
There  were  no  relevant  changes  since  the  last  report  in  2009.    According  to  the  Law  on 
Genetically Modified Organisms  the Ministry  of Environment is  a  Competent Authority  for 
Directive  2009/41/EC  on  the  contained  use  of  GMMs.  The  GMO  Experts  Committee  was 
established by the Order on Genetically Modified Organisms Experts Committee and consists 
of 9 scientists with different scientific background. They analyze the report of risk assessment 
prepared  by  the  notifier  and  makes  scientific  proposals  and  conclusions  to  the  Competent 
Authority.  The  GMO  Steering  Committee  was  established  by  the  Order  on  Genetically 
Modified Organisms Steering Committee and is a political advisory body for the development 
and  enforcement  of  national  regulatory  system  with  respect  to  biosafety  issues  including 
contained  use  of  GMMs  and  GMOs.  This  Committee  consists  of  21  members  appointed  by 
relevant  state  authorities  (e.g.  The  Ministry  of  Health,  The  Ministry  of  Agriculture,  State 
Food and Veterinary Service), the subordinated organizations, national biotech industry, non-
governmental  organizations  and  scientific  institutions.  The  State  Environment  Protection 
Service is responsible for inspection of contained use of GMMs and GMOs. 

Notification  and  approval  systems  are  determined  in  the  Order  on  Regulation  on  Contained 
Use  of  Genetically  Modified  Micro-organisms  and  the  Order  on  Criteria  for  Genetically 
Modified Micro-organisms Classification in conformity to Directive 2009/41/EC.  

MALTA 
The Malta Environment and Planning Authority 

NETHERLANDS 
- 

POLAND 
The  regulatory  framework  concerning  the  contained  use  of  GMMs  is  implemented  and 
enforced  in  Poland  at  the  national  level.  The  Ministry  of  the  Environment  is  the  competent 
authority  in  Poland.  After  receipt  and  verification  of  the  notification,  the  Ministry  forwards 
the  notification  to  the  National  Commission  on  GMOs  (advisory  body)  for  assessment  by 
reviewers.  The  consent  for  contained  use  of  GMOs  shall  be  issued  within  three  months  of 
receipt of the notification. 

PORTUGAL 
The Competent Authority for Directive 2009/41/EC is the Portuguese Environment Agency, 
just  as  it  was  for  Directive  98/81/EC.  We  belong  to  the  Ministry  of  Environment,  Spatial 
Planning and Energy.  

In the present national legislation - Decree Law n.2/2001, the final approval of a notification 
is  granted  by  the  Portuguese  Environment  Agency,  after  receiving  a  favourable  opinion 
approval from the Directorate General of Health. 

42 

 
 
 
 
 
 
 
 
 
ROMANIA 
The Romanian legislation provides  for a procedure at the national level for notification  and 
authorization  in  accordance  with  the  provisions  of  this  Directive,  established  through  the 
Emergency Government Ordinance No 44/2007 on the contained use of genetically modified 
microorganisms (GMMs) as amended by Law No 3/2008. 

Under  these  legal  acts,  the  institutional  framework  for  the  implementation  of  the  GMMs 
contained  use  legislation  is  ensured  by  the  National  Environmental  Protection  Agency,  as 
competent authority, and the following authorities with responsibilities in the field of GMMs: 
-  The  central  public  authority  for  education  and  research,  which  assesses  and  analyses  the 
notification dossier of contained use activities in research and development domain and issues 
a notice; 
-  The  central  public  health  authority,  which  assess  and  analyses  the  notification  dossier  of 
GMMs  that  may  have  adverse  effects  on  human  health,  issues  a  notice,  develops  and 
implements plans for inspection and control; 
- The central public authority for labour, family, social protection and elderly, which assess 
and analyses all the notification dossiers with GMMs activities, issues a notice, develops and 
implements plans for inspection and control; 
-  The  central  public  authority  for  agriculture,  which  evaluates  and  analyses  notification 
dossiers of contained use activities in the agriculture, forestry, live-stock domain and issues a 
notice; 
- The Biosafety Commission  - interdisciplinary scientific body, with an advisory role in the 
decisions making process by NEPA, independent in carrying out its scientific activity, which 
issues a scientific notice;  
- The National Sanitary Veterinary and Food Safety Authority, which ensures the inspection 
and control of the facilities where contained use activities with GMMs are developed; 
-  National  Environmental  Guard,  as  the  control  body,  subordinated  to  the  central  public 
authority  for  the  environmental  protection,  ensures  the  inspection  and  the  control  of  the 
contained use GMMs activities   
National Environmental Protection Agency, as the competent authority, after the acceptance 
of  the  notification  and  subsequent  to  the  achievement  of  the  public  information  and  public 
consultation procedure, based on the notices issued by the responsible authorities and by the 
Biosafety Commission, issues the authorization on the GMMs contained use activities. 

SLOVAKIA 
For  the  contained  use  of  GMOs  in  our  Member  State,  there  are  involved  only  two  national 
authorities.  The  Ministry  of  the  Environment  of  the  Slovak  Republic  as  the  competent 
authority (policy making, policy implementation, national and international coordination) and 
the Slovak Environmental Inspection as the inspection organ (enforcement and control). 

SLOVENIA 
Ministry  of  the  Environment  and  Spatial  Planning  of  Slovenia  (MESP),  Dunajska  47,  1000 
Ljubljana  Slovenia,  is  a competent  authority  to  decide  upon  registration  of  the  premises  for 
contained  use  of  GMOs  and  upon  approvals  for  the  work  with  GMOs  in  containment. 

43 

 
 
 
 
 
 
Registration  of  the  installations  for  GM  animals  requires  a  consensus  of  the  Veterinary 
authority which operates under the Ministry of agriculture and forestry. 

SPAIN 
In  Spain,  Directive  2009/41/EC  has  been  transposed  in  the domestic  legislation  through  the 
Law  9/2003  and  Royal  Degree  178/2004  and  the  subsequent  modifications.  For  the 
implementation in our country of this legislation there are two different CAs:  

1)  At  national  level,  the  Inter-ministerial  Council  for  GMOs  (CIOMG)  and  the  National 
Commission  on  Biosafety  (CNB)  at  the  Ministry  of  Agriculture,  Food  and  Environment 
(Madrid, Spain). They are CAs for the activities of contained use carried out by Government 
Public Research Institutes or for activities with GMOs focused on medical purposes (clinical 
trials,  human  and  animal  medicines/vaccines,  etc.).  The  first  one  (CIOMG)  is  the  CA  for 
grating  permits  at  national  level  and  the  CNB  is  the  scientific  body  dealing  with  the  risk 
assessment of activities and installations, which report to the CIOMG and also to the CAs of  
the Spanish regions. 

2)  At  regional  level,  the  Autonomous  Communities  (Spanish  regions)  are  the  CAs  for 
granting  permits  for  most  of  the  activities  carried  out  with  GMOs  (except  in  the  cases 
mentioned above). 

SWEDEN 
Swedish Work Environment Authority is the CA for contained use of GMM. Other authorities 
are responsible for contained use of plants and animals which are not regulated by the 
Directive 2009/41/EC. Se point 2.2. 

UNITED KINGDOM 
a) 

In England and Wales, the Health and Safety Executive (HSE) and the Secretary of State 
for  the  Department  for  Environment,  Food  and  Rural  Affairs  (DEFRA)  form  the 
Competent Authority. The functions are delegated to HSE and DEFRA officials.  

b)  In  Scotland,  the  Competent  Authority  comprises  Scottish  Ministers  and  HSE  and 

similarly these functions are delegated to HSE and Scottish Government officials.  

c) 

In  Northern  Ireland,  the  Competent  Authority  is  the  Health  and  Safety  Executive  for 
Northern  Ireland  (HSENI)  and  the  Department  of  the  Environment3,  acting  jointly. 
HSENI  officials  are  provided  with  technical  support  from  HSE,  under  an  Agency 
Agreement. 

3 The Department of Environment has been replaced by the Department of Agriculture, Environment and Rural 
Affairs which was established on 9 May 2016 

44 

 
 
 
 
 
 
 
 
 
 
 
                                                 
2.2 

Has the scope of the transposing legislation been extended to the contained use of GM 
plants and GM animals in your Member State? 

AUSTRIA 
Yes 

GMOs 
GM animals 
GM plants 
Amendments to earlier notifications 
Total 
Note ad 2.2 
Austrian legislation requires notification of all (i.e. first and subsequent class 1) uses 
of GM vertebrate animals. Since Jan. 1, 2013 (transposition date of Directive 
2010/63/EC) all uses including breeding of GM animal species protected under that 
Directive require specific authorizations. 

No. of notifications 
797 
15 
- 
812 

BELGIUM 
Yes 

GMOs 
GM animals 
GM plants 
Amendments to earlier notifications4  
Total 

No. of notifications 
170 
51 
183 
221 

BULGARIA 
Yes,  Bulgarian  legislation  classifies  GM  plants  and  animals  either  as  class  A  –  no  or 
negligible risk for the human or animal health and for the environment and class B – all other 
cases. 

GMOs 
GM animals 
GM plants 
Amendments to earlier notifications 
Total 

No. of notifications 
0 
2, both Class A  
2 
2 

CROATIA 
Yes 

GMOs 
GM animals 
GM plants 

No. of notifications 
2   
2  

4 Subsequent use notifications: since 2002, the Walloon decree of 04/07/2002 regarding the contained use of GMOs 
and/or  pathogens  doesn’t  distinguish  anymore  between  first  and  subsequent  contained  uses.  In  consequence,  all 
notifications for this region are treated as new activities (or first contained uses). 

45 

 
 
 
 
 
 
 
 
 
                                                 
Amendments to earlier notifications 

Total 

4 

CYPRUS 
No 

There was no need because there were no activities and/or installations involving GMOs. 

GMOs 
GM animals 
GM plants 
Amendments to earlier notifications 

No. of notifications 
0 
0 
0 

Total 

0 

CZECH REPUBLIC 
Yes  

GMOs 
GM animals 
GM plants 
Amendments to earlier notifications 

No. of notifications 
  4 
  3 
38 (mostly lab. mice) 

Total 

45 

DENMARK 
Yes  

GMOs 
GM animals 
GM plants 
Amendments to earlier notifications 

No. of notifications 
26 
4 

Total 

30 

ESTONIA 

Yes:  For GM animals  

No: 

For GM plant 

46 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
GMOs 
GM animals 
GM plants 
Amendments to earlier notifications 

No. of notifications 

Total 

FINLAND 
Yes 

Labour  Inspectorate  doesn’t  gather 
these data. 

GMOs 
GM animals 
GM plants 
Amendments to earlier notifications 

No. of notifications 
17 
14 
what  does  this  question  specifically 
mean? 

Total 

31 

No. of notifications 

FRANCE 
Yes 

GMOs 
GM animals 
GM plants 
Amendments to earlier notifications 

Total 

GERMANY 
Yes 

GMOs 
GM animals 
GM plants 
Amendments to earlier notifications 

No. of notifications 
54 
30 

Total 

84 

HUNGARY 
Yes 

47 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
GMOs 
GM animals 
GM plants 
Amendments to earlier notifications 

No. of notifications 
2 
none 

Total 

2 

IRELAND 
Yes 

GMOs 
GM animals 
GM plants 
Amendments to earlier notifications 

No. of notifications 
61 
6 

Total 

67 

ITALY 
Yes  
According  to  2001/18/EC  directive,  the  contained  use  of  GMOs  (e.g.  for  testing/research 
purposes)  should  be  carried  out  by  implementing  containment  measures  based  on  the  same 
principles as laid down in 90/219/EEC: it is not expected any notification to CAs. Contained 
uses of GMOs are non-regulated activities, both to at EC and national levels. 

No. of notifications 
GMOs 
N.A. 
GM animals 
GM plants 
N.A. 
Amendments to earlier notifications  N.A. 
N.A. 
Total 

LATVIA 
Yes  

GMOs 
GM animals 
GM plants 
Amendments to earlier notifications 

Total 

No. of notifications 

48 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
No. of notifications 

LITHUANIA 
Yes  

GMOs 
GM animals 
GM plants 
Amendments to earlier notifications 

Total 

MALTA 
Yes  

GMOs 
GM animals 
GM plants 
Amendments to earlier notifications 

No. of notifications 
0 
0 
0 

Total 

0 

NETHERLANDS 
Yes 

See remark under 1.1 
GMOs 
GM animals 
GM plants 
Amendments to earlier notifications 

Total 

POLAND 
- 

GMOs 
GM animals 
GM plants 
Amendments to earlier notifications 

Total 

No. of notifications 

No. of notifications 

49 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PORTUGAL 
Yes 

GMOs 
GM animals 
GM plants 
Amendments to earlier notifications 

Total 

No. of notifications 

- 
- 
- 

- 

ROMANIA 
No 
Not for the time being. Romania limited the scope of the transposition legal act to the scope of 
the Directive on the contained use of GMMs.  

GMOs 
GM animals 
GM plants 
Amendments to earlier notifications 

No. of notifications 
0 
0 
0 

Total 

0 

SLOVAKIA 
Yes 

GMOs 
GM animals 
GM plants 
Amendments to earlier notifications 

No. of notifications 
3 
4 
0 

Total 

7 

SLOVENIA 
Yes.  
The  biosafety  framework  in  Slovenia  is  covered  by  horizontal  legislation  based  on 
Management  of  Genetically  Modified  Organisms  (MGMO)  Act  (OJ  RS  23/2005  and 
amended  OJ  RS  21/2010).  The  Act  implements  the  provisions  of  the  Directive  2009/41/EC 
and beside GMMs regulates also GM plants and animals. 

GMOs 

No. of notifications 

50 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
             
GM animals 
GM plants 
Amendments to earlier notifications 

Total 

SPAIN 
Yes.  

3 

3 

GMOs 
GM animals 
GM plants 
Amendments to earlier notifications 

No. of notifications 
35 
28 

Total 

63 

SWEDEN 
Yes.  

GMOs 
GM animals 
Swedish Board  of Agriculture:  all other GM 
animals except water living organisms 

Swedish  Agency  for  Marine  and  Water 
Management: GM water living organisms 

GM plants 

Swedish Board of Agriculture 

Amendments to earlier notifications 

No. of notifications 
Swedish Board of Agriculture: 59 
permits (for premises) during the 
period June 2009-June 2014 of 
which 43 were valid in June 2014.  
Swedish Agency for Marine and 
Water Management: 5 permits (for 
premises) and 3 notifications (for 
GMO) during the period June 2009-
June 2014 
Swedish Board of Agriculture: 
About 30 premises have a permit for 
contained use of GM plants. The 
permits are valid for five years and 
the number of premises has been 
steady for the last ten years. New 
activities and plant species are to be 
notified to the CA. An estimate of 
notified operations with plants since 
2009 is about 10 per year. 

Total  

78 permits and 3 notifications 

51 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
UNITED KINGDOM 

a)  Yes.  The  legislation  has  been  extended  to  require  notification,  risk  assessment  and 
application of control measures for contained use of GM plants or GM animals (referred to 
as larger GMOs in the UK legislation) that present a risk to human health greater than the 
unmodified  parental  organism.  Such  work  is  rare,  and  there  has  only  been  one  such 
contained use notified in the reporting period. 

GMOs 

GM animals 

GM plants 

Amendments to earlier notifications 

Total 

No. of notifications 

0 

1 

0 

1 

b)  There  is  also  complementary  domestic  legislation  (Environmental  Protection  Act  1990, 
associated  regulations  and  the  Genetically  Modified  Organisms  (Northern  Ireland)  Order 
1991) that requires risk assessment and application of containment for the contained use of 
larger  GMOs  to  ensure  protection  of  the  environment.  HSE  inspects  premises  working 
with larger GMOs on behalf of DEFRA, Scottish and Welsh Governments under separate 
Agency Agreements. 

52 

 
 
 
 
 
 
2.3  What % of notifications was not processed within the statutory timeframe?  

AUSTRIA 
0 

BELGIUM 
In Belgium, the procedure for the notification of contained use of GMOs and/or pathogens is 
a part of the general procedure for application of an environmental permit. Furthermore, the 
Brussels-Capital Region and the Flemish Region define two timeframes, one for the technical 
expert  (the  SBB)  to  write  an  advice,  and  one  for  the  competent  authority  to  deliver  the 
authorisation. 

The timeframe for the Brussels and Flemish competent authorities to deliver the authorisation 
is linked to the timeframe  for delivering the environmental permit, which is longer than the 
contained  use  authorisation  timeframe.  The  competent  authorities  can  only  respect  the 
timeframe  to  deliver  the  authorisation  if  the  user  has  already  obtained  an  environmental 
permit. 

An authorisation can only be delivered when the environmental permit has been obtained. For 
a  small  percentage  of  the  dossiers,  the  delivery  of  the  advice  by  the  SBB  to  the  competent 
authority  was  postponed,  often  due  to  a  ‘stop  the  clock’  (awaiting  further  information  from 
the user, visit of the facility…). 

In the Walloon region, the user submits a biosafety dossier to the technical expert (the SBB) 
before any application for an environmental permit. Hence the timeframe starts only when the 
user submits his application for an environmental permit to the competent authority, to which 
the  advice  of  the  technical  expert  is  joined.  During  this  5-year  reporting  period,  all 
applications for contained use of GMOs and/or pathogens were processed within the statutory 
timeframe of the environmental permit. 

BULGARIA 
All notifications were processed within the statutory timeframe. 

CROATIA 
None. 

CYPRUS 
0 

CZECH REPUBLIC 
None. For notifications of Classes 1 and 2 contained use there are no authorisation procedures 
with set time limits for the CA. 

53 

 
 
 
 
 
 
 
 
 
 
 
DENMARK 
0 % 

ESTONIA 
0 % 

FINLAND 
0 

FRANCE 
About 10% 

GERMANY 
No information available. 

HUNGARY 
In case of 3 notifications, approximately in 10% of all cases. 

IRELAND 
0 % 

ITALY 
It’s  hard  to  estimate  such  a  percentage  for  the  whole  reporting  period.  In  fact,  a  time-
monitoring system has been implemented only in April 2013; since then, we have calculated 
an average percentage of about 15%. However, in the first half of 2014, the figure has been 
significantly lower (less than 5%). 

LATVIA 
0 

LITHUANIA 
- 

MALTA 

54 

 
 
 
 
 
 
 
 
 
 
 
 
 
N/A 

NETHERLANDS 
38% 

POLAND 
For  10%  of  the  notification  was  postponed,  often  due  to  a  “stop  the  clock”  procedure 
(awaiting further information from the notifier, etc.). 

PORTUGAL 
0 

ROMANIA 
- 
SLOVAKIA 
- 

SLOVENIA 
30%  of  the  notifications  were  not  processed  in  the  given  timeframe.  However,  most  of  the 
delays were short and in all cases notifiers were approached with the ample explanation. We 
did not receive any complaint about it. 

SPAIN 
Generally  statutory  timeframe  is  fulfilled,  although  in  the  most  of  the  cases  the  clock  is 
stopped when additional information is required. 

SWEDEN 
We have not recorded this but it is not a significantly large percentage. 

UNITED KINGDOM 
3.7%. 

55 

 
 
 
 
 
 
 
 
 
 
 
 
2.4  What  gave  rise  to  such  delays  in  the  notification  process  and  what  efforts  are  being 

made to lessen or prevent such delays in the future? 

AUSTRIA 
- 

BELGIUM 
The  reason  for  delay  in  delivering  the  advice,  if  any,  was  often  the  lack  of  pertinent 
information  needed  to  perform  a  correct  analysis  of  the  contained  use  activity,  requiring 
further information from the user. Hence the timeframe is generally longer that the legal one 
because of a “stop the clock” while the competent authority is waiting for some information. 
To extend the timeframe, the Brussels competent authority implements most of the time a first 
use  procedure  when  the  subsequent  notification  is  introduced  after  expiry  of  the  first  use 
authorisation. 

BULGARIA 
Not applicable, see answer to question 2.3. 

CROATIA 
Not applicable. 

CYPRUS 
Not applicable. 

CZECH REPUBLIC 
see 2.3 
However,  the  CA  often  asks  the  notifiers  for  clarification  of  some  data  in  the  submitted 
notifications  and/or  for  additional  information.  To  prevent  these  delays,  the  Czech  CA 
provides guidelines and there is a possibility of consultations with the notifiers in advance. 

DENMARK 
Not applicable. 

ESTONIA 
No answer. 

FINLAND 
Not applicable. 

56 

 
 
 
 
 
 
 
 
 
 
 
FRANCE 
No modification in the future. 

GERMANY 
- 

HUNGARY 
The  following  efforts  have  been  made  to  prevent  the  delays:  consultation  between  notifiers 
and the Competent Authority prior to  submission or asking for further information  after the 
submission. 
Furthermore,  there  have  been  some  changes  in  the  internal  structure  of  the  Ministry  of 
Agriculture. This was the reason that in one case, the notification has been released after the 
authority’s deadline. Since this case, there has not been any delay in the authority’s work. 

IRELAND 
Not applicable. 

ITALY 
Dead time between CIV’s meetings. Meeting frequency has been increased (now every three 
weeks);  however,  in  urgent  cases,  CIV  may  be  convened  at  any  time.  Moreover,  we  are 
studying an ICT solution which should allow to speed up the authorization process. 

LATVIA 
Latvia has a low activity in this field. 

LITHUANIA 
- 

MALTA 
N/A 

NETHERLANDS 
In the Netherlands all activities with GMO's and GMM's need a license, resulting in lots of 
work for the competent authority. In combination with related work, like development of new 
licensing software, discussions about new legislation and a shortage of personnel it was not 
possible to process al the licenses within the applicable timeframe of 45 days. The mentioned 
new  legislation  will,  among  others, change  the license  for  class  I  and  mostly  class  II  into  a 

57 

 
 
 
 
 
 
 
 
 
 
 
notification scheme, thus lessening the effort needed. It is planned to put this new legislation 
into force before the end of 2014. 

POLAND 
The  duration  of  the  procedure  depends  on  the  Commission  on  GMOs  and  the  reviewers, 
whose opinion is necessary to grant consents for contained use of GMOs in Poland. 

PORTUGAL 
- 

ROMANIA 
- 

SLOVAKIA 
- 

SLOVENIA 
Most of the delays are short and are mainly caused due to a very short period (30 days only) 
for  The  Scientific  Committee  to  evaluate  and  give  an  opinion  on  the  risk  assessment  of  the 
notifications.  Slightly  longer  delays  are  caused  by  the  Veterinary  authority  which  operates 
under the Ministry of agriculture and forestry. MESP put a lot of effort to explain the situation 
to the Veterinary authority in order to acquire their consent sooner. 

SPAIN 
There are delays in the statutory timeframe by several reasons: 
1)  The administrative process is quite long taking into account the previous assessment by 
the National Commission on Biosafety, visits and control at the facilities and the different 
procedures, opinions or permits granted by the CIOMG and the different CAs (CIOMG 
or regions). 

2)  Request for additional information to the notifiers. 
3)  Timeframes between meetings of the National Commission on Biosafety (usually it held 

one a month) 

4)  Previous inspections to the facilities before granting permits. 

SWEDEN 
In  the  beginning  of  the  time  period  the  notification  procedure  was  somewhat  more  time 
consuming. We got more incomplete notifications than now. With our new provisions which 
came  into  force  from  New  Year  2012,  the  notification  procedure  has  been  simplified.  We 
have developed new forms for notification of class 1 and class 2 which can be downloaded 

58 

 
 
 
 
 
 
 
 
 
and sent electronically to us. The notifications have become significantly better with the new 
forms, which simplifies our work. 

UNITED KINGDOM 

a)  Requirement for further information from the user in order to assess the adequacy of 
the risk assessment (this involved 3 rounds of exchange of information); 2) Timescales 
for assessment of notifications were not met; and 3) Delay in issuing of the clearance 
letters  to  be  sent  to  the  notifiers.  The  performance  of  the  notification  process  is 
monitored and improvements in procedures identified and remedied. The performance 
(which was of a high standard) has improved with all deadlines being met. 

59 

 
 
 
 
 
3. 

Inspection and enforcement issues  

3.1 

the  procedure  undertaken 

Outline 
inspection  of  contained  use 
for 
installations/activities during the reporting period providing details of the number and 
the overall percentage of installations/activities inspected. Please mention the number 
of specialised inspectors available for inspections under Directive 2009/41/EC. 

the 

AUSTRIA 
Inspections  were  based  on  the  characteristics  of  the  activity,  e.g.  risk  class,  large  scale 
equipment,  inoculation  of  animals,  etc..  In  the  reporting  period  147  inspections  were 
undertaken in 61 installations, i.e. about 18 % of installations. The total number of inspectors 
available is 10. 

BELGIUM 
Procedure 
Inspections were  organised in the three regions by different  inspectorates on a regular  basis 
and  concerned  contained  uses  with  GMOs  as  well  as  pathogens.  In  the  Flemish  Region 
inspections were done by 2 inspection bodies, the Flemish Agency for Care and Health of the 
Flemish Community and the Environmental Inspection Department of the Flemish Competent 
Authority, respectively concerning Public Health and Environment. 

Failures or non-respect by the user of the applicable conditions delivered in the environmental 
permit may give rise to a criminal penalty or an administrative fine. In case that the offense is 
likely  to  cause  a  substantial  and  immediate  harm  to  public  health  and  the  environment,  the 
license may be suspended or revoked by the competent authority. 

Number and the overall percentage of inspected installations 
During  the  period  from  6  June  2009  until  5  June  2014,  the  Flemish  Environmental 
Inspectorate  Division  carried  out  161  inspections  controlling  contained  use  at  131  different 
installations. 

From these 131 installations, 67 were required to have an authorisation and 64 were not. This 
means  that  less  than  30%  of  the  installations  having  an  authorisation  were  controlled.  Over 
the  last  5  years  an  average  of  0,42  full  time  equivalents  a  year  was  spent  on  Directive 
2009/41/EC inspections including preparation of the inspection, the inspection itself and the 
administrative  consequences  of  the  inspection  (writing  exhortations  and  official  reports  of 
infringement). 

In  the  Brussels-Capital  Region,  25%  of  the  installations  were  controlled.    For  the  Walloon 
Region,  we  do  not  have  detailed  information  but  it  is  estimated  that  3%  of  the  installations 
were controlled. 

In summary, 177 inspections were carried out by the Environmental Inspection Departments 
in  the three regions  (161  inspections  in  the  Flemish  Region,  14  inspections  in  the Brussels-
Capital Region and 2 inspections in the Walloon Region). 

Number of inspectors 

60 

 
 
 
 
 
 
 
 
 
 
 
In the Flemish Region, the Environmental Inspectorate has 6 specialised inspectors involved 
in controlling contained use activities. In the Brussels-Capital Region, 5 inspectors received 
training  in  biosafety  and  are  performing  controls  on  the  contained  use  activities.  In  the 
Walloon  region,  no  specialized  inspectors  are  appointed  for  biosafety.  These  inspectors  are 
not  spending  their  full  time  on  controlling  contained  use  of  GMO’s  and  pathogens.  As 
inspectors fulfil several tasks covering multiple matters concerning the environment or public 
health, only a certain percentage of their time can be dedicated to inspection of contained use 
activities. 

BULGARIA 
Inspections  are  performed  by  the  regional  inspectorates  of  Ministry  of  Environment  and 
Water. Representatives of Environmental Executive Agency and the Ministry are also present. 
Facilities to be inspected and the schedule of inspections are approved yearly by the Minister 
of  the  Environment  and  Water  based  on  the  list  of  actual  or  potential  operators  that  might 
work with GMOs. Additionally, unscheduled inspections may take place when unauthorised 
use  of  GMO  is  suspected.  After  receiving  notification  for  initial  approval  of  facilities  for 
contained use of GMO, inspections are performed to verify conformity with the requirements 
for safe work at given containment class. Approved facilities are inspected at least once every 
two years. Samples can be taken during the inspection if necessary and analysed for presence 
of GMOs. 

The number of inspections during five year period is as follows: 2011 - 23 inspections; 2012 – 
14 inspections; 2013 – 18 inspections; 2014 –14 scheduled inspections, ongoing. 

Currently in each of the sixteen regional inspectorates there is at least one person appointed to 
undertake  inspections  for  contained  use  and  release  into  the  environment  of  GMOs.  In 
addition,  there  is  an  analytical  laboratory  (two  people)  in  the  Environmental  Executive 
Agency  that  performs  the  necessary  analytical  work  and  whose  staff  participates  in 
inspections and collection of samples. 

CROATIA 
Periodically  sites  visiting.  In  Croatia  there  are  two  specialised  inspectors  of  Ministry  of 
Health available for inspection under Directive 2009/41/EC.  

CYPRUS 
The Department of Labour Inspection during the reporting period has carried out inspections 
in the premises of the installation approved for the use of GMMs and in various premises in 
order to verify whether GMMs are used. About 20 Labour Inspectors were partially involved 
under the instructions of a specialised Labour Inspection Officer. 

CZECH REPUBLIC 
The  Authority  responsible  for  the  state  supervision  of  the  use  of  GMOs  is  the  Czech 
Environmental  Inspectorate  (hereinafter  “CEI”).  It  co-operates  with  other  state  supervision 

61 

 
 
 
 
 
 
 
 
information from the Ministry of Environment on notifications and authorisations;  

bodies in fulfilling this task. CEI undertakes inspections of subjects authorised for contained 
use of GMOs, in accordance with the yearly schedule based on:  
- 
-  results and findings of the previous inspections;  
- 
The  inspections  are  targeted  on  compliance  with  requirements  for  the  contained  space, 
documentation,  waste  treatment,  transport  of  GMOs,  equipment  of  the  premises,  training  of 
the personnel etc.  

information from other sources and ad hoc initiatives;  

Totally 141 inspections were carried out in contained use premises within the reported period. 
All authorised facilities were checked, some of them repeatedly.  

CEI  consists  of  the  Headquarters  and  10  Regional  Inspectorates.  At  each  of  them,  one 
inspector  has  been  trained  for  GMOs  supervision,  although  it  represents  only  part  of  their 
agenda,  depending  on  the  number  of  GMO  facilities  in  the  region  (there  are  no  GMO 
premises  in  3  regions,  nevertheless  the  inspectors  have  been  trained  there  as  well).  That 
means 10 regional inspectors and 1 person at the Headquarters deal part-time with inspections 
under  the  Directive.  An  inspection  is  always  carried  out  by  2  inspectors  (either  2  regional 
inspectors or 1 regional plus 1 from the Headquarters). 

DENMARK 
When a location is notified the first time it is always visited to be approved. This also applies 
when changes are made to an already classified location. There are 5 inspectors in Denmark 
who spend part of their working hours with inspection.  

This procedure is about to change. In the future we are planning to allow class 1 GMO work 
to start based on the notification. There does not have to be a visit to the locations before they 
can start. Instead there will be inspections afterwards at selected locations. 

ESTONIA 
There is one inspector for such inspections, but during reporting period there is no inspections 
made.  

FINLAND 
An  inspector  from  the  National  Supervisory  Authority  for  Welfare  and  Health,  Finland 
(Valvira)  contacts  the  operator  before  the  inspection  and  prepares  an  inspection  report  after 
the  visit.  From  2007  it  has  also  been  possible  to  use  a  written  inspection  procedure  for  the 
inspection of earlier inspected activities and premises, if certain conditions are met.  

The operators which commence the class 2 or 3 use of GMOs for the first time or start use of 
higher  class  are  inspected  within  a  year  after  the  CA  has  handled  the  notification  or  the 
application. The inspection interval is risk based, so that class 3 use is inspected more often 
(at least every second year) than class 1 or 2 use. During the reporting period 135 inspections 
were  performed  (33  %  of  all  valid  notifications).  With  the  exception  of  a  ten  month  period 
when only one inspector was available, two full-time inspectors worked in control of GMO 
use. 

62 

 
 
 
 
 
 
 
 
 
FRANCE 
25 visits/controls, 0, 7 %. 
2 inspectors. 

GERMANY 
In  Germany,  the  Federal  state  authorities  are  responsible  for  monitoring  installations  and 
work  involving  genetic  engineering  and  for  implementing  the  resultant  enforcement 
measures. 

Inspections  are  conducted  when  there  is  a  need  for  them  and  also  on  a  routine  basis  when 
there is no specific need for them. 

Inspections  conducted  when  there  is  a  need  for  them  to  take  place,  for  example,  in  the 
following cases: 
- 
- 
- 

New installations (mainly before they are put into service), 
Significant alterations to installations, 
Requests or incidents. 

The routine inspections are conducted at fixed intervals which are shorter the higher the safety 
level  involved  and  also,  in  some  cases,  the  more  intensively  the  installation  is  used.  The 
intervals  may  also  be  adjusted  to  take  into  account  unusual  circumstances  and  the  lessons 
learned  from  previous  inspections.  Routine  inspections  are  conducted  at  approximately  the 
following intervals: 

- 
- 
- 

S1 installations: every three to six years, 
S2 installations: every two to three years, 
S3 and S4 installations: annually. 

During the reporting period almost all installations used for genetic engineering underwent at 
least one on-site inspection.  

The  number  of  inspectors  varies  depending  on the  size  of  the  Federal  state,  their  respective 
responsibilities and the number of installations located in the Federal states which are used for 
genetic engineering. 

See also the extended scope of German legislation on genetic engineering: it covers not only 
installations where work involving GM micro-organisms is carried out but also installations in 
which work is carried out involving (exclusively) GM plants or GM animals. 

HUNGARY 
Laboratories  complying  with Class  1  and  Class  2 containment  level  specifications  also 
conform to  the requirements of the quality assurance systems of Good Laboratory Practices 
(GLP).   The  GLP  requirements  themselves  are  stricter  than what  is  needed  to  execute for 
Class 1 and Class 2 containment measures for GMOs.  The audits are conducted once a year 
and  the  compliance  with  GLP  is  checked  every  two  years.  Every  contained  use  has  been 
verified in these schemes. Each contained use has been verified by 4 inspectors (on average). 

63 

 
 
 
 
 
 
 
 
 
 
 
IRELAND 
As per our suggestion in our submission on report 2006 – 2009, we continue to believe that 
the wording in the Directive could be more explicit requiring the establishment of biological 
safety committees as well as the appointment of a biological safety officer particularly where 
large multi user centres are involved.  

Each  year  a  draft  site  inspection  plan  for  GMO/GMM  contained  use  activities  is  drawn  up. 
During the site inspection we consult with a competent person on site (usually the biological 
safety  officer).  We  use  a  checklist  originally  adopted  by  the  European  Enforcement  Project 
(EEP).  We  do  not  charge  for  site  inspections.  The  level  of  compliance  within  GMO/GMM 
contained use facilities is high.  

Class 2 GMM, Class 3 GMM, GM Animal / Plant activities are inspected once every 3 years. 
Class 1 GMM contained use activities are inspected once every 6 years (given their history of 
safe  use  and  negligible  risk).  The  inspection  of  Class  1  GMM  contained  use  activities  on  a 
less regular basis was deemed necessary give the small team of 2 persons with responsibility 
for both licensing and enforcement  and both contained use and deliberate release. 

Enforcement activities carried out during reporting period: 

From  6th  
June 
2009 
9 

17 

Year 

Number  of 
installations 
inspected 
% 
of 
installations 
inspected 

2010 

2011 

2012 

2013 

17 

33 

16 

31 

8 

16 

14.5 

29 

73. 

Until  5th   
June 
2014 
4 

ITALY 
According to the Italian Legislative Decree  206/2001, the inspection functions are exercised 
by officers identified by CIV (art. 17); moreover, if needed, CIV can request the inspection of 
a GMM installation/activity (art. 18). No inspections have been requested by CIV during the 
reporting period. 

LATVIA 
As there is only class 1 the State Labour Inspectorate is not involved. 

LITHUANIA 
There were no relevant changes with regard to control procedure requirements since the last 
report in 2009.  

64 

 
 
 
 
 
 
 
 
 
 
In the period 2009 – 2014 about 15 inspections were conducted by one specialised inspector. 

MALTA 
One inspection of the class one facility was conducted by the permitting officer prior to the 
permit  being  issued  to  check  for  compliance  with  the  legislation  for  class  1  installations. 
There  are  no  specialised  inspectors  on  GMMs;  one  should  note  that  Malta  only  had  one 
application to date. 

NETHERLANDS 
Annually 50-60 contained use facilities have been inspected by ILT, which is about 20-25% 
per year. The task is carried out by 4 different inspectors,  total about 2 FTE. ILT has the aim 
to contact each user at least every four year. Based on risk and compliance and complexity of 
work  this  frequency  may  increase.  Prime  concern  is  that  the  mandatory  Biological  Safety 
Officer  (BSO)  performs  the  annual  audits.  So  the  inspection  for  a  great  part  focuses  on  the 
administrative  obligations.  The  inspection  always  includes  a  random  reality  check  of 
compliance  including  among  others.  The  GMOs  handled,  the  way  of  working  and 
containment integrity. This latter aspect is also inspected by the inspectors of local authorities. 

POLAND 
Three  authorities  carry  out  inspections  of  contained  use  installations:  The  State  Labour 
Inspection  is  in  charge  of  the  safety  and  hygiene  of  work;  they  inspect  the  labelling  of 
facilities, the safety measures and the equipment used. The State Sanitary Inspection controls 
biological factors, whereas the Environmental Protection Inspection is in charge of the control 
of wastes from contained use activities. These three authorities can carry out inspections on 
their  own  initiative  or  upon  request  by  the  Ministry  of  Environment.  The  State  Labour 
Inspection has conducted 13 inspections. 

PORTUGAL 
Until  the  present  date,  the  Inspectorate-General  for  Agriculture,  Fisheries,  Environment  and 
inspections  of  contained  use 
Spatial  Planning 
installations/activities. 

(IGAMAOT)  hasn’t  carried  out 

ROMANIA 
National Environmental Guard (NEG) is the control and inspection body under the Ministry 
of  Environment  and  Climate  Change.  Within  the  Biodiversity,  Biosecurity  and  Protected 
Areas of NEG Control Directorate, there are inspectors with responsibility regarding control 
and  inspection  activities  for  the  entire  domain  of  activities  in  the  directorate,  not  strictly 
specialized  in  accordance  with  Directive  2009/41/EC.  They  also  have  other  inspection  and 
control duties in accordance with Directive 2001/18/EC, as well as on biodiversity and natural 
protected areas. 

65 

 
 
 
 
 
 
 
 
 
SLOVAKIA 
The  authority  responsible  for  the  state  supervision  of  the  use  of  GMOs  is  the  Slovak  
Inspectorate of Environment ( SIE).  In total 9 inspectors have been trained on the supervision 
of  GMOs,  although  inspections  under  Directive  2009/41/EC  represent  only  a  part  of  their 
agenda, depending on the number of GMO facilities in the region. SIE cooperates with other 
state  supervision  bodies  in  fulfilling  this  task.  SIE  regularly  carries  out  inspections  in 
accordance  with  a  yearly  schedule,  based  on  the  information  provided  by  the  own  findings 
mainly previous inspection reports and scientific publications, information of the Ministry of 
the Environment and other authorities. Inspections are based by that date known information 
on the inspected facility involving maps of the facility, information about the used donor and 
recipient  organisms,  genes  used  for  the  genetic  manipulation,  plasmids  as  well  as  used 
techniques and risk assessment.  

Inspections  are  targeted  on  compliance  with  the  requirements  for  the  premises,  waste 
treatment,  transport  of  GMOs,  record  keeping,  training  of  personnel,  etc.  The  requirements 
for safe work with GMOs are also inspected although laboratory safety is not the main task of 
the inspections.  

The last day of the inspection there is a final meeting with the responsible persons, where the 
outcome and findings of the inspection is discussed in detail. It is common SIE practise that 
the  responsible  persons  are  informed  about  the  outcome  immediately  and  according  to  the 
Slovak  law,  a  detailed  protocol  or  report  is  written  and  sent  to  the  head  of  the  inspected 
facility.  Detailed  procedure  of  the  inspection,  based  on  the  Slovak  law,  was  issued  by  the 
publishing house of the Slovak Academy of Sciences in 2008, ISBN 978-80-224-1048-9. 

During the reporting period through 141 inspections all the 467 registered installations were 
inspected,  i.e.  all  the  permitted  activities  were  inspected  (100%).  In  general,  each  permit 
holder is visited at least once  every 3 years;  but larger institutes are visited once or twice a 
year. Inspection visits were carried out also in the institutions for which permits for contained 
use of GMO were not issued 

SLOVENIA 
Installations and activities are inspected according to annual plan of inspections ensuring that 
each  installation  is  inspected  at  least  every  four  years,  or  more  often  depending  on  the 
outcome  of  the  previous  inspection.  Newly  registered  installations  are  inspected  as  soon  as 
possible. The inspections are undertaken according to the adopted procedure using checklists 
what  ensures  uniform  proceeding  at  all  installations.  In  the  reporting  period  47  inspections 
were performed. 

Slovenia  has  two  specialised  environmental  inspectors  for  GMOs.  Each  inspector  has  been 
available for 5% of full working time for inspections of GMMs, GM plants and GM animals 
under Slovenian MGMO Act what ensures regular and thorough supervision. 

SPAIN 
There is not an Official Body for inspection under Directive 2009/41/EC in Spain. Generally, 
the Spanish regions are the competent for the inspection actions. 

66 

 
 
 
 
 
 
 
 
Nevertheless,  after  the  application  of  the  notification  by  the  users  and  before  giving  the 
consent,  specialised  member(s)  of 
the  National  Commission  on  Biosafety  (CNB) 
accompanied  by  a  representative  of  the  competent  region  where  the  installation  is  placed, 
regularly  carry  out  visits  and  controls  on  the  premises.  They  check  the  records  of  activities 
and  the  major  objective  of  control  is  to  confirm  the  effectiveness  of  the  respective 
containment level and to evaluate compliance with relevant approval conditions. 

100% of installations are visited and controlled. 

There are 4 members from the Biotechnology Unit  at the Ministry  of the Agriculture, Food 
and Environment, as part of the National Commission on Biosafety (CNB), who participate at 
the visits and controls. 

SWEDEN 
In most cases we inspected activities as part of the process of accepting notifications for class 
2 or give permits for class 3 work. The focus was on activities with the potential greatest risk. 

17 installations/activities was inspected. The number of specialised inspectors is two who also 
have  many  other  duties  according  to  contained  use  of  GMM  as  well  as  other,  non-GMM 
related duties. 

UNITED KINGDOM 

a)  In  the  UK,  inspections  are  undertaken  by  HSE  and  HSENI.  HSE  carries  out  such 
inspections  across  Great  Britain  and  applies  the  same  inspection  regime  to  all 
contained use work with high-hazard biological agents (including GMMs). Inspection 
is  undertaken  by  HSE  specialist  microbiology  inspectors.  In  Northern  Ireland 
HSENI’s inspections (mostly class 1 and 2 GMM contained uses) are carried out by a 
non-specialist inspector, who calls on HSE for specialist support, when required.  

b)  The  inspection  programme  in  Great  Britain  covers  contained  uses  involving  GMMs, 
larger GMOs, non-genetically-modified human pathogens (under domestic legislation 
implementing Directive 2000/54/EC on the protection of workers from risks related to 
exposure to biological agents at work) and non-genetically-modified specified animal 
pathogens (derived from domestic legislation and implementing Directive 2003/85/EC 
on Community measures for the control of foot-and-mouth disease).  

c)  The  inspection  programme  is  prioritised  according  to  a  hazard  and  risk  system  that 
focuses  on activities  in  CL3  and  CL4  laboratories.  Contained  uses  involving  GMMs 
are not targeted per se but captured as part of this programme. 

d)  Higher  hazard  laboratories  receive  more  frequent  inspections.  CL4  laboratories  are 

inspected at least once per year, most being visited multiple times per year.  

e)  CL3  laboratories  are  inspected  based  on  a  prioritisation  scheme  that  considers  the 
inherent hazard of the work, the safety performance of the user and time elapsed since 

67 

 
 
 
 
 
 
 
 
 
 
 
 
last  inspection.  Those  laboratories  undertaking  class  3  contained  uses  are  generally 
inspected every 2-5 years. 

f)  Premises  only  working  with  class  1  and  2  GMMs  are  not  inspected  as  part  of  a 
proactive  inspection  programme.  However,  many  of  the  premises  will  be  visited  as 
part  of  other  inspection  or  engagement  visits.  For  example,  HSE’s    Regulatory 
Compliance  Officer  (RCO)  may  provide  advice  on  compliance  with  the  legislation 
either  through  site  visits  or  presentations  at  industry  led  events.  Similarly,  the  lower 
containment  laboratories  may  be  scrutinised  as  part  of  a  CL3  inspection  or  a  larger 
GMO  inspection  at  that  specific  premises.  Furthermore,  an  inspection  may  be 
instigated  should  issues  be  identified  from  a  contained  use  or  premises  notification, 
where in the view of the inspector further enquiries are merited.  

g)  Inspections are generally topic-based and cover containment and control, training and 
competence,  audit  and  inspection  and  risk  assessment.  Preparation  for  an  inspection 
will include a review of the notified GM contained uses at the site. The topic of risk 
assessment evaluates the correctness of final  classification and considers compliance 
with the GMO (CU) Regulations. 

h)  As  mentioned  in  para  2.2(b),  HSE  undertakes  a  programme  of  ~15  inspections  of 
laboratories handling larger GMOs (e.g. animals, plants, insects) each year on behalf 
of  DEFRA  and  the  Devolved  Administrations.  This  includes  a  review  of  the  risk 
assessments and inspection of the premises used for the contained use work, to check 
the adequacy of the containment and control measures.  

i)  HSE has a specific team (Biological Agents Unit – CEMHD8), which implements the 
inspection  regime  and  reviews  the  adequacy  of  notifications  of  biological  agents 
(including  GMMs).  Currently  the  Biological  Agents  Unit  comprises  of  7  Specialist 
Inspectors, 4 Principal Specialist Inspectors and 1 Regulatory Compliance Officer. In 
Northern Ireland there is one part time inspector. A joint inspection with a Specialist 
Inspector  from  HSE  of  all  the  notified  centres  is  carried  out.    Inspections  are  also 
carried out by the local inspector to deal with specific topics during this period.  

j)  Over the period of the report, there have  been  645 inspections undertaken by HSE’s 
Biological Agents Unit, of which 342 were at sites where work with GMMs and larger 
GMOs (e.g. animals, plants, and insects) is undertaken. This represents in  the region 
of  ~40%  of  all  the  GM  premises  notified  and  includes  100%  of  the  CL3  and  CL4 
notified premises. 

68 

 
 
 
 
 
 
 
 
 
3.2  What were the problems most frequently encountered during the course of inspections 

carried out during the reporting period? 

AUSTRIA 
- 

BELGIUM 
The most frequent or severe problems encountered were related to: 
- Waste management : the inactivation method is non-adequately validated; 
- Authorisation : absence or non-compliance for the use of non GM-pathogens; 
- Risk signalisation: absence of biohazard signs; 
- Storage of contaminated laboratory equipment: lack of measures; 
- Accident prevention and emergency response plans; 
- Biosafety cabinets: certification of the HEPA filtered closed system; 
- Restricted access to the controlled area. 
The inspectors of the Brussels-Capital region pay particular attention on the waste 
management. The principal control matters are: sufficient evacuation frequency, on-site 
inactivation, availability of disinfectants, and waste disposal by a certified waste collector. 

BULGARIA 
Most academic institutions were not aware that facilities for contained use of GMO should be 
approved and registered even when they work only with model organisms routinely used in 
scientific research (e.g. laboratory strains of E.coli, Arabidopsis thaliana, etc.). 

CROATIA 
One technical issue (floor surface). 

CYPRUS 
No problems have been encountered during the course of inspections. 

CZECH REPUBLIC 
Apart  from  one  case  of  unauthorised  GMM,  most  frequent  deficiencies  found  by  the 
Inspection were of an administrative character: missing updates or parts of the documentation 
etc. These imperfections did not mean any risk to the environment. 

DENMARK 
When  examining  the  notifications  for  research  projects  the  risk  assessment  is  often  not 
sufficient.  During  inspections  some  times  the  written  material  on  working  procedures  does 
not always correspond to the way things are carried out in practise. Sometimes it also turns 
out  that  the  company  has  forgotten  to  notify  the  research  project  and  has  just  notified  the 

69 

 
 
 
 
 
 
 
 
 
location where the project is going to take place. Companies don’t always remember to give 
the information that a location is no longer being used for work with GMM’s. 
Examples of things that are not in order when inspecting could be a missing sign on the door 
or on a freezer, disorder in the laboratory, alterations in the room, that have not been notified, 
lack of maintenance making the laboratory less cleaning friendly. 

ESTONIA 
No. 

FINLAND 
In general, documents were available but could be outdated or inaccurate. Inadequate book-
keeping or risk assessment and taking new premises into use without giving notice were the 
most frequent problems. Also, persons responsible for the notification had sometimes left for 
another job without informing the authorities.  

In some cases, training of the staff was not recorded.  

In several cases, the premises were not properly marked or there were minor problems with 
waste  management.  In  some  cases,  protective  measures  in  use  needed  adjustment  or  rarely 
used personal protective equipment was missing. 

Sometimes it was unclear for operators that it is their responsibility to evaluate whether the 
waste  management  practice  or  equipment  maintenance  is  appropriate  considering  the  GMO 
use 

FRANCE 
Treatment of solid and liquid waste 

GERMANY 
During inspections inspectors look at the structural and technical characteristics of the 
installation, at organisational aspects and at the documentation relating to the work involving 
genetic engineering. The following problems have frequently been identified: 

- 
- 
- 

- 
- 

- 
- 
- 

Lack of or insufficient indication of access points, 
Protective clothing (overalls, etc.) not worn or insufficient, 
Lack of regular inspection/servicing of equipment, such as safety workbenches 
and autoclaves, or shortcomings in record-keeping concerning such 
inspections/servicing,  
Lack of appropriate transport containers, 
Failure to provide timely instructions, or inadequate instructions for staff or 
service personnel (cleaners, tradesmen, etc.), 
Cramped or untidy laboratories, 
Inappropriate or dirty surfaces (in the work area), 
No clear separation of areas used for writing, on the one hand, and laboratory 
work, on the other, 

70 

 
 
 
 
  
 
 
 
 
- 
- 
- 
- 
- 
- 

- 

Insufficient hygiene or disinfection measures. 
Imprecise operating instructions and hygiene plans, 
Imprecise or incomplete records on work involving genetic engineering, 
Insufficient or deficient internal risk assessment, 
Performance of further S2 work without prior notification, 
Lack of or late reporting of changes to responsible staff (project leaders, 
biosecurity officers) or of alterations to installations of relevance to safety, 
Incomplete records regarding persons involved in work at safety level 2 (or 
higher). 

HUNGARY 
Minor problems have been reported, as regards documentation 

IRELAND 
Violations are few and are not significant in terms of posing a risk to human health and the 
environment 

ITALY 
N.A. 

LATVIA 
Not relevant. 

LITHUANIA 
There were no specific problems carried out during reporting period. 

MALTA 
None. 

NETHERLANDS 
Compared to other areas compliance is relatively high (> 80-90%). In about 10 % of the cases 
the  BSO  failed  to  perform  a  (complete)  annual  audit.  Most  problems  encountered  are  new 
(technological) developments like single use bioreactors, the use of antibacterial coatings and 
the  use  of  simple  modification  kits  in  secondary  school  biology  teaching.  Also  the  use  of 
disinfectants that have not, or not yet been admitted as a biocide, is a point of concern. For the 
inspectors it's sometimes a challenge to meet the knowledge of the scientist working with the 
newest technology. See also the remarks under 4.1. 

POLAND 

71 

 
 
 
 
 
 
 
 
 
 
Frequent  offences  detected  were  the  lack  of  an  emergency  plan  and  the  lack  of  signage  on 
entrances  to  laboratories  where  GMO  activities  are  carried  out.  In  some  installations,  the 
formal requirements had been violated, e.g. waste produced was not properly recorded. 

PORTUGAL 
- 

ROMANIA 
Not applicable. 

SLOVAKIA 
Shortcomings  in  fulfilment  of  the  permit  responsibilities  mainly  shortcomings  in  waste 
treatment,  storage  GMOs  and  record  keeping.  Also  the  use  of  GMO  without  permit  due  to 
ignorance of the law. 

SLOVENIA 
At  the  beginning,  just  after  the  MGMO  Act  had  entered  into  force,  the  main  goal  of  the 
inspections was to ensure that all installations for work with GMOs submitted a notification.  

Later  in  the  3-year  reporting  period  only  minor  infringements  were  disclosed  with  the 
documentation management (e.g. emergency action plans were not sent to the local authorities 
as required, yearly reports were not sent to the ministry, notifier failed to report the closure of 
the  installation,  etc.)  The  situation  is  similar  up  to  the  present,  containment  measures  and 
good  laboratory  practice  are  well  observed,  so  the  inspection  process  only  encounter  minor 
administrative infringements. 

SPAIN 
Problems most frequently encountered are: 

1)  Deficiencies  in  Good  Laboratory  Practices  (GLPs)  or  SOPs,  and  to  use  inadequate 
equipment,  inappropriate  contained  measures  and/or  waste  disposal  procedures  for  the 
confined level notified. 

2)  Lack of Internal  Biosafety Committees at the installations. The CNB always  recommend 
establishing this kind of internal committees in order to implement properly the confined and 
control measures according with the class of risk and to have a Biosafety Officer in charge of 
these issues. 

SWEDEN 
There was not any specific problem that we encountered. If any it was mostly about who was 
responsible for different issues. 

72 

 
 
 
 
 
 
 
 
 
 
 
UNITED KINGDOM 

a)  The most frequently encountered issues (formally raised following 

inspections/investigations indicating GM activities) are: 

•  Validation of inactivation method for GMMs or contaminated waste; 
•  Risk assessments not sufficient to cover all the activities being undertaken; 
•  Adequacy of standard control measures (e.g. saleability; HEPA filtrations 

restricted access) with respect to on-going planned preventative maintenance; 
•  Training provision and training records – insufficient to demonstrate competence 

of the user; and 

•  Significant change notification or reclassification required – where the contained 

use has changed such that the risks are different or greater. 

73 

 
 
 
 
 
3.3  What were the corresponding enforcement actions taken?  

AUSTRIA 
The Ministry of Science, Research and Economy reports 8 improvement notices and 2 
prosecutions. 
The Ministry of Health: - 

BELGIUM 
If shortcomings were revealed in the application of containment measures an exhortation was 
drawn  up  and  the  user  had  to  comply  with  these  exhortations  within  a  limited  timeframe. 
Afterwards follow-up inspections have been carried out and if the user still did not comply an 
official report of infringement was written. Also if the shortcomings were that severe that a 
risk existed that the contained use could be breached a report of infringement was written. In 
general, shortcomings were quickly rectified so that no coercive measures, such as a cessation 
order or withdrawal of authorisation, have been taken. 

BULGARIA 
When it is found that GMOs are used or are about to be used in the near future in facilities 
that have not been approved and registered for such contained use regional inspectorate issues 
injunction  ordering  notification  for  initial  approval  to  be  submitted  to  the  Ministry  of 
Environment and Water within 40 days and prescribing that no work with GMOs should be 
carried  out  before  the  approval  procedure  is  completed.  So  far,  such  injunctions  have  been 
issued on four occasions (see answers to Part 1 and questions 3.4 and 3.5). 

Similar  measures  will  be  taken  if  work  with  Class  2-4  GMM  or  Class  B  GM  plants  and 
animals that has not been notified takes place. 

When it is found out that facility for contained use of GMO or the activities taking place in 
them  do  not  comply  fully  with  relevant  requirements,  injunction  will  be  issued  prescribing 
measures  than  need  to  be  taken  and  the  timeframe.  If  observed  issues  of  non-compliance 
could result in increased risk for human or animal health or for the environment all activities 
involving GMOs will be stopped. 

CROATIA 
Competent Authority has been given grace period of 1 year to improve conditions. 

CYPRUS 
No enforcement action was taken. 

CZECH REPUBLIC 

74 

 
 
 
 
 
 
 
 
 
 
The  deficiencies  in  the  documentation  were  corrected  either  right  at  the  time  of  the 
inspections or immediately afterwards. The CEI requirements were met within set time limits 
and without problems. 

DENMARK 
When a company has not  notified e.g. a research project they are given an order with  short 
notice to get the matter settled. Regarding the other problems experienced it depends on the 
situation. Sometimes companies are given advice on how to make things right. If the problem 
is more serious companies may be given an order with notice to get the matter settled. 

ESTONIA 
None taken. 

FINLAND 
No  changes  since  the  2009  report.  Most  often  the  inspectors  ordered  correcting  measures 
already  during  the  inspection  visit  and  discussed  them  together  with  the  operator.  The 
measures to be taken are always written down in the inspection report, and if necessary, the 
operator has to confirm in a written statement that the inspector’s orders have been followed.  

In more severe cases a written note of complaint is written to the operator and their superiors, 
and in very severe cases the issue is presented for the Board of Gene Technology, which has 
more authority in enforcement actions. Usually, however, the operators are very co-operative, 
and inspectors’ orders and recommendations are followed without problems. 

FRANCE 

GERMANY 
The Federal state authorities deploy a range of measures to deal with the complaints or 
shortcomings: 
- 

Verbal indications and requests for remedial action during the inspection (in 
the case of minor measures which can be implemented immediately), 
Improvement notices or documented records with a request for remedial 
action, with a deadline being set, 
Inclusion of requirements in authorisation and approval decisions (in the case 
of new installations or substantial changes), 
decisions with instructions on remedial action or additional requirements, 
Initiation of proceedings for regulatory offences, 
In individual cases, a (temporary) ban on work involving genetic engineering, 
as well. 

- 

- 

- 
- 
- 

75 

 
 
 
 
 
 
 
 
 
 
The operator or project leader has to report the implementation of the measures required to the 
authority. In individual cases the authority carries out an immediate, on-site inspection of the 
implementation of the measures. In most cases this takes place as part of the next routine 
inspection.  

HUNGARY 
Providing detailed information on what kind of documentation is required. 

IRELAND 
The  compliance  record  for  contained  use  of  GMOs  is  high.    The  CA  does  not  receive 
complaints  and  to  date  has  been  notified  of  few  incidents.    Violations  are  few  and  are  not 
significant,  and  other  than  to  request  in  writing  resolution  within  a  certain  timeframe,  more 
stringent  enforcement  actions  (such  as  serve  notices,  prosecutions  as  specified  under  the 
national legislation) has not proved necessary. 

ITALY 
N.A. 

LATVIA 
Not relevant. 

LITHUANIA 
- 

MALTA 
No breach detected. 

NETHERLANDS 
In most cases a warning is given and the user is asked for an improvement plan. For serious 
cases a provisional order for penalty payment is issued. 

POLAND 
If  there  were  any  encountered  problems  during  the  course  of  inspection  the  CA  would  ask 
users for supplementing notifications and improving conditions in installations. 

PORTUGAL 
- 

76 

 
 
 
 
 
 
 
 
 
 
 
ROMANIA 
Not applicable. 

SLOVAKIA 
Corrective measures and penalties. 

SLOVENIA 
Written warnings with a time limit were issued and in some cases the enforcing measure was 
only verbal communication with written minutes. All of the notifiers were keen to make good 
a  deficiency,  therefore  we  believe  they  understand  the  purpose  of  the  biosafety  system  and 
want to contribute to adequate biosafety themselves. 

SPAIN 
Users  have  to  correct  the  deficiencies  before  beginning  the  activities.  If  they  not  fulfil  the 
requirements  requested  by  the  CNB,  the  favourable  opinion  is  not  released  by  the  National 
Commission on Biosafety (CNB) and the permit is no granted by Competent Authority (the 
Inter-ministerial  Council  for  GMOs  (CIOMG)  at  national  level  or  the  CA  of  the  affected 
Spanish region). 

SWEDEN 
In  most  cases  we  asked  the  inspected  organisations  to  complete  their  notifications  or 
applications for permits.  In a few cases we sent an inspection notice where we presented the 
problem and asked them to correct the problem within a given time frame. 

UNITED KINGDOM 

a)  Inspectors use a range of enforcement tools to ensure that users of GMMs comply 

with the legislation. These include: 

•  Verbal instructions to achieve required improvements (used where users are 

broadly compliant – minor issues); 

•  Providing written direction to achieve compliance e.g. letter (used where there is a 

material breach of the legislation); 

•  Serving statutory enforcement notices, requiring improvements to achieve the 

required level of compliance (Improvement Notices) within a specific timeframe 
or the immediate cessation of work where it poses an immediate risk to human 
health or the environment (Prohibition Notices); 

•  Withdrawal or variation of consent or addition of conditions to carry out the 

notified GM contained use; and 

•  Prosecution – where it is in the public interest to hold the user accountable for a 

failure to meet their legal obligations. 

77 

 
 
 
 
 
 
 
 
 
 
b)  HSE’s Enforcement Policy Statement sets out the factors that inspectors consider 

when deciding upon the most appropriate enforcement action 
(www.hse.gov.uk/enforce/enforcepolicy.htm). 

78 

 
 
 
 
3.4 

How many enforcement actions were taken during the reporting period? 

AUSTRIA 
- 

BELGIUM 
During  this  reporting  period,  on  a  total  number  of  177  inspections,  147  exhortations  were 
written  and  7  official  reports  of  infringement  were  sent  to  users  (3  because  of  a  non-
compliance  determined  by  follow-up  inspections  and  4  because  of  the  absence  of 
environmental permit or an authorisation. 

BULGARIA 
4 (see answer to question 3.3). 

CROATIA 
One (1). 

CYPRUS 
0. 

CZECH REPUBLIC 
One fine was imposed for contained use of a GMM (Class 2) that had not been notified. 

DENMARK 
Approx. 10. 

ESTONIA 
0. 

FINLAND 
In  inspection  minutes  approximately  700  orders  of  correcting  measures  were  given  (on   
average  5  corrective  measures  /  inspection,  no  further  statistics  available).  Valvira  did  not 
give notes of complaint during this reporting period as the operators followed the instructions 
given during inspections, according to their statement to Valvira.  

In two cases Valvira informed the Board for Gene Technology about a possible violation of 
the gene technology legislation, and the Board gave the operator more accurate conditions for 
the GMO use for the future. 

79 

 
 
 
 
 
 
 
 
 
 
 
 
There were no issues taken to court. 

FRANCE 
0 

GERMANY 
An improvement notice or documented record is usually drawn up for each on-site inspection. 
The number of formal instructions and proceedings for regulatory offences is markedly lower, 
and varies according to need.  

HUNGARY 
None. 

IRELAND 
All site inspections are followed up with a letter to the user making recommendations in an 
effort to strengthen and harmonise containment measures 

ITALY 
N.A. 

LATVIA 
0 

LITHUANIA 
- 

MALTA 
0 

NETHERLANDS 
A provisional order for penalty payment has been used on average of once per year. None of 
these  orders  lead  to  the  payment  of  the  fine,  as  the  offence  was  terminated  after  this  first 
action. In total six such orders have been issued in the report period. Only once in this period 
a report was drafted for criminal law sanctions 

POLAND 

80 

 
 
 
 
 
 
 
 
 
 
 
 
3 

PORTUGAL 
- 

ROMANIA 
Not applicable. 

SLOVAKIA 
26 

SLOVENIA 
Four written warnings with a time limit were issued in the reporting period. 

SPAIN 
Many  enforcement  actions  were  taken  but  the  final  checks  have  not  given  grounds  for 
administrative action. 

SWEDEN 
Several inspections were performed as part of the notification/permission process, why the 
notifier/user was asked to deliver corrected information or documents that were missing.  

UNITED KINGDOM 
a)  There were 0 statutory enforcement notices served and 0 prosecutions taken in relation to 

breaches of the GMO(CU) Regulations in the period of the report. 

b)  There  were  0  withdrawals  or  variations  of  consent  for  contained  use  of  GMMs  in  the 

period of the report. 

c)  There  were  12  specific  instances,  where  issues  were  raised  by  inspectors  via  verbal 
instruction/written  direction,  specifically  referring  to  a  failure  to  comply  with  the 
GMO(CU) Regulations. 

d)  Note that other enforcement action (including verbal, written, notices and prosecutions) 
have  been  taken  at  the  same  premises,  however  this  action  resulted  from  a  failure  to 
comply  with  other  health  and  safety  (e.g.  requirements  of  Directive  200/54/EC  on  the 
protection  of  workers  from  risks  related  to  exposure  to  biological  agents  at  work, 
implemented by the Control of Substances Hazardous to Health Regulations 2002 and the 

81 

 
 
 
 
 
 
 
 
 
 
 
 
 
Control  of  Substances  Hazardous  to  Health  Regulations  (Northern  Ireland)  2003  in  the 
UK)  or  environmental  legislation  (Specified  Animal  Pathogens  Orders  2008  and  2009 
which  is  domestic  legislation)  and  may  have  applied  to  the  laboratories  where  users 
undertake GM contained uses. 

82 

 
 
 
 
 
3.5  What actions were taken by the user (and/or advised by the CA) in order to minimise 
the occurrence of these problems in the future? 

AUSTRIA 
- 

BELGIUM 
In general, the user adjusts the operating procedures on his own or at the inspector’s request. 
A toolbox meeting could be organised if needed. 

For recurrent problems, the competent authority asks the user to be compliant to the 
environmental permit and authorisation within a limited timeframe. 

BULGARIA 
On  all  four  occasions  when  injunction  was  issued,  institutions  submitted  notifications  for 
initial approval of facilities for contained use of GMO within the prescribed timeframe  (see 
answers to Part 1 questions). Two more institutions have  notified the Ministry that they are 
planning to register facilities in the near future in order to start contained use of GMO. 

Ministry  of  Environment  and  Water  submitted  information  letters  to  all  actual  or  potential 
operators which might work with GMOs about legislation on contained use of GMO and their 
obligations under that legislation. 

CROATIA 
The  laboratory  was  improved  as  Competent  Authority  suggested.    The  laboratory  has  been 
improved technical conditions in accordance to ordinance of Good laboratory practice. 

CYPRUS 
Not applicable. 

CZECH REPUBLIC 
Users  often  consulted  potential  problems  with  the  Authorities  (CEI  and  the  Ministry  of  the 
Environment)  in  advance  of  the  activity.  Based  on  the  experience  gained,  the  Authorities 
provided  guidance  and  formats  for  various  aspects  of  contained  use  notifications  and 
reporting  (e.g.  advice  on  equipment  of  the  premises  according  to  the  containment  level, 
formats for yearly reports and other documentation, guidance for notification of clinical trials 
with  GM  medicinal  products,  recommendations  for  transport  of  GM  laboratory  animals). 
Thanks to this approach, the number of deficiencies was low. 

DENMARK 

83 

 
 
 
 
 
 
 
 
 
 
 
There  have  not  been  any  big  problems  with  this  so  no  actions  have  been  taking  other  than 
giving information to the companies that the CA has been in contact with. 

ESTONIA 
There was no need for actions. 

FINLAND 
The operators followed the instructions given during inspections, according to their statement 
to Valvira. 

Apart from giving specific instructions to correct the observed deficiencies: 

  Future  plans of  GMO  activities were discussed with  operators and inspectors 
gave  instructions  about  the  liabilities  of  gene  technology  legislation  when 
starting new types of activities.  

  Operators  were  advised to  ensure  that  new  or  changed  information  related  to 
GMO  use  is  shared  efficiently  within  the  organization  and  (when  needed) 
across organizational borders. 

Importance of in-house control systems was emphasized to operators. 

FRANCE 
Corrective  actions  are  organized  by  the  users  in  the  month  even  at  the  latest  3  months 
following the identified problem. 

GERMANY 
The shortcomings ascertained were usually rectified by the operators or users promptly or 
within the deadline set. Where necessary the frequency of official inspections was/is 
increased.  

Internal procedures were improved by the following, inter alia: 

- 

- 
- 

Discussion of problems and special safety measures as part of the annual 
instructions to staff, 
Circulars, updated operating instructions and SOPs,  
Improved consultation between operators, project leaders, biosecurity officers, 
occupational safety experts, works doctors, etc. 

With regard to new/planned genetic engineering installations, or prior to substantial changes 
there was/is frequently  

HUNGARY 
Notifiers took account of the documentation required by the authorities. 

84 

 
 
 
 
 
 
 
 
 
 
 
 
IRELAND 
To  date  the  CA  has  dealt  with  such  incidents  by  first  and  foremost  giving  seminars  on  the 
legislation in academic institutions thereby making both users and potential users aware of the 
legislation and the need to comply with it (and emphasising that it is the responsibility of the 
user to comply with it).  

In addition, the CA has instructed institutions (in particular) on the need to have a Biological 
Safety Committee and a Biological Safety Officer who are aware of the research being carried 
out and who in turn can inform potential users of the need to comply with the legislation and 
to put appropriate containment measures in place for all GMM contained use activities. This 
has largely been achieved through correspondence with Heads of Department. 

ITALY 
N.A. 

LATVIA 
Not relevant. 

LITHUANIA 
- 

MALTA 
N/A 

NETHERLANDS 
Most users comply after a warning. If not, imposing sanctions always convinces them to do 
so. 

POLAND 
- 

PORTUGAL 
- 

ROMANIA 
Not applicable. 

85 

 
 
 
 
 
 
 
 
 
 
 
 
SLOVAKIA 
Inspections were to ensure  
- increase the level of the scientific details of the proposal,  
- Valuable regular contacts between the applicants and inspectors via telephone and e-mail, 
- The renewal of certain equipment. 

SLOVENIA 
CA was always open to advise the notifiers during the preparation of the notifications and at 
the beginning we realised that a preparation of a vast documentation required for registration, 
including detailed risk assessment, posed a serious challenge even for bigger research groups. 

The CA organised two Workshops for the notifiers. The main topics of the workshops were 
risk  assessment  and  the  preparation  of  the  documentation.  During  the  process  we  realised 
some  notifiers  needed  more  help  and  advice,  so  in  the  collaboration  with  the  Scientific 
Committee  CA regularly helps with the pre-notification/renovation visits of the premises and 
on-site discussion of the possible containment measures. 

SPAIN 
First  of  all,  the  main  positive  action  in  order  to  prevent  problems  is  to  clarify  questions 
through previous consultations between the users and officials from the Biotechnology Unit 
before applying the final notifications to the Competent Authority. 

On  the  other  hand,  the  CNB  makes  several  recommendations  to  users  in  order  to  improve 
their installations although the measure to implement wouldn’t be compulsory. 

SWEDEN 
Correction  of  lacking  or  wrong  information,  providing  documents  that  were  missing.  Every 
inspection  is  an  opportunity  to  increase  the  knowledge  of  our  rules  and  compliance  of  the 
rules to the persons we meet. Knowing that we are coming, is enhancing the notification rate 
as well as the update rate for older notifications. 

UNITED KINGDOM 
a)  The user formally responds to the enforcement action in writing within a given timeframe 
setting  out  how  the  matters  have  been  rectified.  The  information  is  used  to  inform  the 
prioritisation for further inspection. 

86 

 
 
 
  
 
 
 
 
 
 
4. 

Problems with interpretation of the provisions 

4.1  What  aspects  of  implementation  of  Directive  2009/41/EC  on  the  contained  use  of 

GMMs place the greatest burden on you as a Competent Authority? 

AUSTRIA 
- 

BELGIUM 
1) The main problems which are met with the interpretation of the provisions of the Directive 
2009/41/EC are related to the scope of the legislation: 
-  A  question  from  the  European  Commission  was  addressed  to  the  competent  authority 
concerning the point of view for the status of a genetic modification of a  Lactococcus lactis 
strain  which  produce  Nisin  V  (consisting  of  polypeptides  with  an  antibiotic  action)  such  as 
defined  by  Directive  2009/41/EC.  Advices  from  the  Member  States  and  the  working  group 
“New  Techniques”  were  unanimous  about  the  fact  that  it  is  concerning  a  genetic  modified 
bacteria, but that the technique used for this activity (self-cloning) made it not falling under 
the scope of contained use of GMOs (Directive 2009/41/EC). 
- A question from the European Commission was addressed to the competent authorities for 
Directive  2009/41/EC  concerning  the  commercialisation  of  a  commercial  kit  for  the 
transformation  of  Bacillus  subtilis  (DIYbio  kit).  They  were  wondering  if  the  use  of  this  kit 
falls  under  the  scope  of  contained  use  of  GMOs  (Directive  2009/41/EC)  or  not.  Belgium 
considered the micro-organism transformed by means of this type of cloning kits as a GMM, 
due to the presence of the GFP gene. The contained use is of risk class 1 and according to the 
Belgian regional legislation it has to be notified to the competent authorities. In Belgium, the 
DIYbio  kit  is  not  commercialised  but  can  be  easily  purchased  via  the  internet  and 
consequently be used by biohackers. However, it seems very difficult to control the use of this 
kind of activities. From a biosafety point of view, there is a need to improve the awareness of 
people  potentially  using  those  kits.  On  one  hand  through  education  in  biosafety  and  on 
another hand by stimulating the distribution company to indicate the users they have to apply 
biosafety measures by adding a note in the user manual. 
-  A  significant  number  of  innovating  therapies  are  actually  being  developed  and  applied. 
There is a need to evaluate these newly developed therapies in order to see whether they fall 
under  the  scope  of  contained  use  of  GMOs  as  defined  under  Directives  2009/41/EC  and 
2001/18/EC. More specifically, a question from the European Enforcement Project (EEP) was 
addressed to the competent authorities concerning therapies based on synthetic naked DNA. 
We  are  of  the  opinion  that  plasmid  DNA  is  a  genetic  material  but  that  it  should  not  be 
considered as a (micro)biological entity that is capable of replication or of transferring genetic 
material  by  itself.  The  injection  of  naked  DNA  in  patients  is  therefore  not  submitted  to  the 
legislation of contained use or deliberate release of GMOs. 

2) The too detailed reporting system and the complexity of the different procedures are also 
pointed out by the Brussels competent authority. 

BULGARIA 

87 

 
 
  
 
 
 
 
There  is  no  clear  procedure  to  distinguish  whether  a  clinical  trial  of  products  containing 
genetically modified organisms (both for human and for veterinary use) should be considered 
contained use and when release into the environment. 

CROATIA 
- 

CYPRUS 
None. 

CZECH REPUBLIC 
New gene techniques:  The question whether a specific technique and the resulting GMM fall 
within the scope of the Directive has to be resolved. 

Clinical  trials  with  medicinal  products  containing  GMO:  The  decision  whether  a  clinical 
study falls under the contained use or deliberate release legislative is difficult in cases when a 
minimal  possibility  of  release  of  viable  GMMs  into  the  environment  exists  (e.g.  shedding 
from the patient). 

DENMARK 
The class 1 notifications. 

ESTONIA 
Luck of knowledge for this inspector, not specific education. 

FINLAND 
1)  The  definition  of  a  GMO  is  getting  increasingly  vague  because  new  molecular  biology 
techniques  have  evolved.  The  legal  uncertainty  caused  by  this  is  getting  increasingly 
difficult for both the operators, CAs and the supervisory authorities, as it is no longer clear 
which organisms are actually covered by the directive.  

2)  As  noted  already  earlier,  research  groups  relocate  quite  frequently  which  increases  the 
number of new notifications and subsequently the regulatory burden for both the operators 
and authorities. 

FRANCE 
Implementation of the controls. 

GERMANY 

88 

 
 
 
 
 
 
 
 
 
 
 
 
This point is currently under discussion between the Federal and Land authorities; the 
results of these discussions are likely to be included in the next report. 

HUNGARY 
New  techniques  not  considered  to  result  in  genetic  modification  can  trigger  interpretation 
problems. 

Another problem is how to distinct between contained use and deliberate release (i.e. which 
directive to apply: Directive 2009/41/EC or 2001/18/EC) in case of clinical biotechnological 
applications.  We  propose  to  continue  the  discussions  at  EU  level  regarding  this  important 
issue. 

IRELAND 
The regulations of Class 1 GMM contained use activities (history of safe use and low risk) see 
section 1.6. 

ITALY 
We don't see any critical aspects. 

LATVIA 
The  Competent  Authority  did  not  have  problems  with  implementation  of  Directive 
2009/41/EC on the contained use of GMMs. 

LITHUANIA 
No specific problems with the interpretation of the provisions were reported. 

MALTA 
The Authority did not experience any specific burden, although it has a lack of resources and 
training on the subject. However it should be also noted that the Authority only received one 
application. 

NETHERLANDS 
Although the directive is relatively recent, technological developments in this field are huge 
and lead to problems related to (1) definition of GMOs in relation to among others, synthetic 
biology, (2) new apparatus like single use bioreactor and cell sorters (FACS) in relation to the 
needed  containment  measures,  (3)  differences  in  interpretation  of  the  annexes  between  the 
Member States. Next to that on a regular basis discussions about (4) whether or not a coating 
is  sufficient  antibacterial  and  (5)  the  use  of  disinfectants  that  have  not,  or  not  yet  been 
admitted as a biocide, are signalled. Besides that, the Netherlands encounter differences in the 
(strict)  GMO-regulations  and  the  less  strict  regulation  of  wild  type  pathogens.  This  could 

89 

 
 
 
 
 
 
 
 
 
 
partially be explained by the implementation legislation of the Netherlands, but seems also be 
caused by a lack of harmonization at EU level. 

POLAND 
- 

It is unclear how activities involving plant and animal cells should be classified – as 
GMM activities or activities involving GM plants or animals.  

-  Several notifications involving the contained use of Saccharomyces have been submitted 
in Poland. So far, these activities have been classified as contained use. Poland also 
requests clarification as to the appropriate risk class for activities with GM higher plants 
and GMs.  

PORTUGAL 
No problems have arisen regarding interpretation of the provisions of Directive 2009/41/EC. 

ROMANIA 
Not applicable. 

SLOVAKIA 
- 

SLOVENIA 
The greatest burden for the CA  are notifications which contain a lot of information, that need 
to  be  processed  in  the  notification  procedure.  Assessing  risks  of  the  notified  organisms  is  a 
very  responsible  task.  On  the  other  hand  the  notifiers  complain  that  the  preparation  of  the 
notifications  and  risk  assessments  are  laborious  and  time  consuming.  There  is  a  fine  line 
between necessary and redundant information. 

SPAIN 
The main issues would be: 

-  A lot of visits to the installations, 
- 

Problems in the interpretation if GMOs obtained by new genetic techniques, and whether 
they are under the scope of Directive 2009/41/EC or not. 

SWEDEN 
The notification procedure. 

UNITED KINGDOM 

90 

 
 
 
 
 
 
 
 
 
 
 
 
a)  The UK applies a hazard and risk-based approach to its regulation and inspection activities 
(see answer to question 3.1). The UK has recently consolidated the Genetically Modified 
Organisms  (Contained  Use)  Regulations  2000  and  its  amending  regulations,  which 
transpose the Directive, to make them more risk based and proportionate and more closely 
reflect  the  requirements  of  the  Directive.  The  UK  is  able  to  implement  a  regulatory 
framework  that  permits  the  risks  from  contained  use  of  genetically  modified  micro-
organisms to be controlled in a risk based and proportionate manner.  

b) The  greatest  burden  on  the  competent  authorities  in  the  UK,  from  the  implementation  of 
the Directive, is in the technical assessment of class 2 notifications. Whilst the UK ensures 
that all notifications are reviewed, and endeavours to ensure statutory timescales are met, 
the time spent reviewing lower-risk class 2 activities is disproportionate due to the amount 
of  information  required  and  the  volume  of  notifications  received  (~90%  of  activity 
notifications  are  class  2).  Furthermore,  a  large  proportion  of  these  notifications  (~50%) 
involve  work  with  multiply  disabled  viral  vectors,  the  risks  from  which  are  well  defined 
and  the  control  measures  established.  The  consequence  of  this  is  that  majority  of  the 
competent  authorities  time  spent  on  reviewing  notifications  is  biased  towards  the  lower 
risk work.  

c)  One further aspect of the Directive that places a burden on the competent authorities is the 
emphasis, within the definitions of genetic modification in the Directive, on the techniques 
used  in  the  contained  use  to  determine  whether  or  not  the  Directive  applies.  Given  the 
rapid nature with which techniques are developed and adapted, this can present challenges 
for interpretation and potential for disproportionate application of the legislation. 

91 

 
 
 
 
 
 
4.2  What could be done to improve the process at EU and/or national level? 

AUSTRIA 
- 

BELGIUM 
1) A working group on New Techniques (NTWG) at the European level has been set up and 
started its work in 2008. Member States have each appointed scientific experts to participate 
in the NTWG, which is examining a range of new techniques to assess whether they should 
be considered to lead to GMOs or GMMs as defined under Directive 2001/18/EC or Directive 
90/219/EEC,  respectively.  A  final  report  has  been  published  in  December  2011,  giving 
recommendations on editorial changes and further consideration on separate opinions per new 
technique. 

We  are  of  the  opinion  that  the  current  risk  assessment  principles  and  methodology,  and  the 
GMO regulatory framework, seem robust enough to deal with the new techniques listed in the 
report. But because the science and technology developments in the field of synthetic biology 
evolve rapidly, those should be reviewed regularly. Action should be taken if voluntary codes 
or  current  regulatory  procedures  appear  insufficient.  In  this  regards,  exchange  between  the 
research  community,  risk  assessors  and  policy  makers  will  be  key  to  expand  scientific  and 
technical  knowledge  and  to  fill  the  potential  gaps  in  risk  assessment  and  regulation  of 
evolving  developments.  Further  approaches  to  reconsider  effective  risk  governance  should 
also be taken in  a global  perspective, allowing international coordination and  dialogue. It is 
therefore important for the European Union to advance further in defining a harmonized view 
about safety and regulatory oversight of Synthetic Biology (Pauwels K, Willemarck N, Breyer 
D,  Herman  P  (2012).  Synthetic  Biology.  Latest  developments,  biosafety  considerations  and 
regulatory challenges. Ref: D/2012/2505/46.  
http:// http://www.biosafety.be/PDF/120911_Doc_Synbio_SBB_FINAL.pdf).  

2)  As  abovementioned  and  under  point  1.3,  the  Brussels  regional  decree  defines  too  many 
different  procedures  regarding  the  notification  of  contained  uses  of  GMOs  and  pathogens. 
The Brussels Capital Region considers the possibility to make procedures more uniform. 

BULGARIA 
As applications for clinical trials of products containing genetically modified organisms (both 
for human and for veterinary use) are expected to increase it might be beneficial if guidance 
documents or legislation at EU level are adopted that harmonise the procedures for evaluation 
of the risks for the environment in these cases. 

CROATIA 
At EU level important process is to organize a meeting of contained use of GMOs emphases 
of conducting official control of contained use of GMO. 

CYPRUS 

92 

 
 
 
 
 
 
 
 
 
No changes. 

CZECH REPUBLIC 
The  evaluation  of  new  gene  techniques  should  be  completed  at  EU  level.  It  should  be  laid 
down  whether  a  certain  new  technique  of  genetic  modification  and  the  resulting  GMM  fall 
within the scope of the existing legislative framework. 

Legislative framework for clinical trials with GMM should be discussed at EU level. Current 
deliberate  release  notification  formats  are  designed  for  field  trials  with  GM  plants,  not  for 
clinical trials with  GMMs. Similarly, contained use  formats are suitable for  microbiological 
laboratories, not for hospitals. 

Implementing  rules  for  notifications  of  gene  therapy  clinical  trials  should  be  improved  at 
national level. 

DENMARK 
The only suggestion is that the class 1 notifications are taken out of the Danish legislation. 

ESTONIA 
Specific training programme for this inspector with joint inspections with other member state 
authorities. 

FINLAND 
At the EU-level it would be important to update the definition of a GMO. Perhaps it would be 
even  useful  to  evaluate  the  pros  and  cons  of  technology  based  regulation  versus  trait-based 
regulation when dealing with a rapidly developing technology. Also, the Commission could 
give more specific guidance on the classification of pathogenic organisms in cases where their 
pathogenicity  has  been  attenuated.  Moreover,  guidance  on  the  notification  procedures 
concerning clinical treatments of patients with GMMs would be most welcome.  

As  to  the  regulatory  burden  caused  by  the  frequent  relocation  of  groups,  institution  level 
notifications could be a solution in principle. However, this has been already tried in Finland. 
Unfortunately  institution  level  notifications  led  to  a  situation  where  neither  the  institution, 
CA,  nor  the  supervisory  authority  were  always  fully  aware  which  research  groups  were 
currently working in an institution, which premises they used and what GMOs were used. As 
a result, most notifications are nowadays made at the research group level. 

At the national level there is a clear need for more education. Having Biosafety Officers in the 
major research institutes would be an option, but the concept of a BSO is unknown in Finland 
and not likely to be accepted in the present economic situation. 

93 

 
 
 
 
 
 
 
 
 
    
 
 
FRANCE 
Financial means and number of inspectors. 

GERMANY 
This point is currently under discussion between the Federal and Land authorities; the 
results of these discussions are likely to be included in the next report. 

HUNGARY 
We  propose  to  continue  the  discussions  at  EU  level  regarding  these  two  important  issues 
mentioned under 4.1. 

IRELAND 
See section 1.6. 

ITALY 
N.A. 

LATVIA 
At the moment and based on the experience we do not have any significant suggestions that 
could be done for the further improvements at EU and /or national level. 

LITHUANIA 
Organization  of  meetings  for  competent  authorities  and  inspectors  to  share  the  experience 
gained  under  the  Directive  2009/41/EC  on  contained  use  of  GMMs  and  GMOs.  Better 
explanation  of  gene  therapy,  Synthetic  biology and  other  new  techniques,  their  terminology 
would be valuable. 

MALTA 
Exchange of experiences/training would be deemed relevant. 

NETHERLANDS 
Simplify and harmonize the allowance of disinfectants as biocides in laboratories. Screen for 
new  developments  and  give  harmonized  guidance  in  an  early  stage.  Possibly  look  into  the 
differences between EU legislation of GMO's and wild type pathogens in order to harmonize 
some of the provisions. It is suggested to call a meeting of the CA to discuss these items. 

POLAND 

94 

 
 
 
 
 
 
 
 
 
 
 
- 

PORTUGAL 
- 

ROMANIA 
- 

SLOVAKIA 
- 

SLOVENIA 
Inclusion  of  safe  organisms  in  Part  C  of  the  Annex  II  of  Directive  2009/41/EC  could 
contribute to reduction of the number and size of the notifications. 

SPAIN 
It  would  be  desirable  to  have  harmonised  Guidelines  at  EU  level  (from  the  Commission) 
regarding: 

1)  Clinical Trials in order to clarify whether they have to be carried out under the scope of 

Directive 2009/41/EC or/and the Directive 2001/18 /EC (or both, “case by case”). 

2) Problems in the interpretation if GMOs obtained by new genetic techniques, and whether 

they are under the scope of Directive 2009/41/EC or not. 

3) It would be desirable to tackle new simplified procedures for Class 2 activities, which have 

increased a lot for the last years. 

At national level, and in order to improve understanding of provisions and requirements for 
user,  the  National  Commission  on  Biosafety  (CNB)  has  developed  a  Guide  for  notifiers, 
which has been applied since the last year (2013). 

SWEDEN 
The notification procedure is of limited value for class 1 and 2. If there must be notifications, 
we think it is enough to give information on class and type of activity, organisation involved, 
contact  information  for  the  responsible  persons  and  address  to  the  workplace.  In  our  view 
notification of class 1 and class 2 can be abolished altogether without problems. The risks in 
this  field  can  be  taken  care  of  by  the  work  environment  legislation  and  the  general 
environment legislation. 

95 

 
 
 
 
 
 
 
 
 
 
 
 
 
UNITED KINGDOM 
a)  The  notification  requirements  for  class  2  contained  uses  could  be  aligned  with  Directive 
2000/54/EC  on  the  protection  of  workers  from  risks  related  to  exposure  to  biological 
agents  at  work  which  requires  only  the  first  class  2  contained  use  at  a  given  premises  is 
required to be notified.  Subsequent class 2 contained uses could be carried out, following 
approval  by  an  internal  safety  committee,  without  the  need  to  notify  the  national 
Competent Authority.  

b) Alternatively,  the  information  requirements  for  class  2  notifications  could  be  minimised 
(e.g. a description of recipient organism, donor material, evaluation of foreseeable effects 
and an indication of class). This would limit the requirement from users in providing the 
relevant  information  and  the  time  spent  by  the  Competent  Authority  in  assessing 
compliance with the legislation. Similarly the EC could populate the Annex II Part C of the 
Directive  with  a  list  of  multiply  disabled  vectors  for  class  1  contained  uses  -  this  would 
provide greater delineation of class 1 and 2 contained uses and minimise the degree of over 
classification. 

c)  This  approach  would  allow  the  Competent  Authority  to  divert  more  resource  to  the 

assessment of high hazard work, including reviewing notifications and inspections. 

d) The definitions of genetic modification within the Directive should be reviewed to ensure 
they  take  account  of  technological  advances,  new  fields  or  disciplines  (e.g.  synthetic 
biology)  and  there  should  be  an  effective  means  of  implementing  any  revisions. 
Alternatively, consideration should be given to shifting the emphasis from the technique to 
the final product in determining whether the GMM is encompassed by the legislation. 

96 

 
 
 
 
 
 
 
5. 

Accidents 

Provide details of accidents (including the identity of the GMM, the class of activity involved 
and  quantities  of  GMMs  concerned  where  the  accident  has  involved  a  spillage)  as  defined 
under Article 2(d) of Directive 2009/41/EC, reported to the CA during the reporting period. In 
addition  provide  details  of  the  measures  taken  by  the  user  (and/or  advised  by  the  CA)  to 
prevent the occurrence of similar accidents. 

AUSTRIA 
No accidents were reported. 

BELGIUM 
The three Belgian regional regulations mention that the user must declare immediately to the 
competent authority an accident that occurs in a contained use installation. 

For  the  current  reporting  period,  no  accident  has  been  declared  in  Belgium.  However,  in 
Brussels-Capital  region  one  accident  (fire)  occurred  in  a  biological  waste  storage  room 
without the competent authority has been informed. Corrective measures have been taken. 

BULGARIA 
There  were  no  accidents  notified  to  the  Ministry  of  Environment  and  Water  during  the 
reporting period. 

CROATIA 
None.  

CYPRUS 
No accidents were reported during that period. 

CZECH REPUBLIC 
No accident happened in the Czech Republic during the reporting period. 

DENMARK 
There have been no accidents. 

ESTONIA 
No accidents. 

97 

 
 
 
 
 
 
 
 
 
 
 
 
 
FINLAND 
During the reporting period the Board received a few notices of mild accidents (needle pricks 
etc.)  in  class  2  with  no  consequences.  The  operators  were  advised  of  proper  working 
practices. 

FRANCE 
0 

GERMANY 
No accidents as defined under Article 2(d) of Directive 2009/41/EC. 

HUNGARY 
No accidents occurred to date. 

IRELAND 
No accidents reported. 

ITALY 
No accidents have been reported. 

LATVIA 
0. 

LITHUANIA 
No accidents were reported. 

MALTA 
No accidents occurred. 

NETHERLANDS 
Thirteen incidents were reported. The Dutch authorities concluded in each of these cases that 
the incidents did not result in harm to people or the environment.  

The first incident was caused by a small fire in a biosafety cabinet in a ML-I laboratory. No 
GMOs were present in the cabinet and the lab containment stayed undamaged. In a second 
incident GM cell lines had been mixed with wild type cell lines and subsequently handled as 
non-GMO samples. The inactivation procedure turned out to be similar to the procedure used 

98 

 
 
 
 
 
 
 
 
 
 
 
 
for GM cell lines. In a third ML-I incident a small amount (mL) effluent of GM cell lines had 
been accidently disposed in a sink. Survival of the cell lines in the sewer was unlikely 
(biological restriction). 

A fourth incident concerns the transport of ML-I and ML-II waste. Due to a small collision in 
a corridor, the secondary containment was broken. A check on presence of GMOs showed 
that a class 2 micro-organism was present in the waste. The primary containment (Petri dishes 
and tubes) was still closed but cleaning had been carefully performed to prevent any further 
spread.  

In the fifth incident a tube containing GM Neisseria had been broken in a centrifuge, which 
was  located  in  a  ML-I  lab.  The  rotor  was  kept  closed  and  moved  to  the  ML-II  lab  for 
subsequent  cleaning.    People  that  might  have  been  exposed  were  followed  clinically.  No 
health problems were detected. In the sixth incident a ML-II lab was flooded with a few cm 
water leaked from a broken ice machine. At the time of the flooding, no activities with GMO's 
were  taking  place  and  all  the  GMO  material  was  present  in  incubators.  The  lab  journal 
showed that no incidents concerning spoiling GMOs on the lab floor had been reported. It was 
concluded  that  no  GMOs  had  been  present  in  the  water.  In  the  seventh  incident  a  needle 
accident  with  a  low  titre  of  GM  Influenza  occurred.  The  researcher  was  vaccinated  on 
forehand,  got  a  tamiflu  prescription  and  was  followed  clinically.  No  health  problems  were 
detected.  

Two incidents occurred with an isolator housing animals with GM Inluenza. In one incident 
the door of the lock was not tightly closed, under pressure was lost and the alarm went off. In 
the  second  incident  a  rip  in  a  glove  was  detected.  In  both  cases  people  were  vaccinated  on 
forehand, got a Tamiflu prescription and were followed clinically. No health problems were 
detected. In a tenth incident a glass wall of a ML-III laboratory was damaged. At the time of 
the incident activities with wild type HIV in a biosafety cabinet were ongoing. Loss of under 
pressure  was  minimal.  It  was  concluded  that  release  of  a  GMO  or  wild  type  had  been  very 
unlikely.  

In  the  eleventh  incident  the  under  pressure  in  a  DM-III  facility  was  lost  due  to  a  technical 
defect. At that moment all animals were housed in isocages (HEPA filtered, under pressure) 
and no activities took place. It was concluded that a release of GMOs would have been highly 
unlikely. In the twelfth incident a mistake in a technical construction of a ventilation system 
was reported. Air from a ML-III could have been released, without Hepa filtering, into a ML-
II  laboratory  when  a  power  outage  would  happen.  It  had  been  concluded  that  no  release  of 
GMO’s  from  the  ML-III    to  the  ML-II  laboratory  could  have  been  occurred,  since  all 
activities in the ML-III laboratory were performed in a biosafety cabinet and no incidents of 
spill had been reported. In the thirteenth incident it was reported that a cell line infected with 
GM  SARS-virus  was  fixed  with  a  presumably  old  fixative  and  the  culture  handled  as  fixed 
material.  The  researcher  was  clinically  followed  and  the  fixative  was  tested  afterwards.  It 
happened that the fixative was still fully active 

POLAND 
No accidents have been reported during the reporting period. 

99 

 
 
 
  
 
 
 
 
PORTUGAL 
No accidents were reported in this period. 

ROMANIA 
Not applicable. 

SLOVAKIA 
2010 – The Institute of virology, Slovak Academy of Sciences, Bratislava – fire 
The fire broke out during the building reconstruction of the northern facade of The Institute of 
virology building. The fire was localized in laboratories and offices on the third floor. Direct 
fire damaged installations approved for the contained use of genetically modified organisms 
on this floor. Other installations approved for the contained use of GMOs on the second and 
on the fourth floor were damaged by smoke and water during the extinguishing a fire. There 
was  no  leak  of  stored  GMOs,  because  GMOs  were  stored  in  the  deep  freezer  boxes  in  the 
corridors  by  the  staircase  at  that  time  and  they  weren´t  exposed  to  the  fire.  There  were  no 
activities  carried  out  regarding  GMOs  in  the  approved  installations  at  that  time  (holidays, 
moving  of  laboratories).  The  Institute  of  Virology  works  with  GMOs  classified  in  the  risk 
class 1 and 2.  

the  Institute  of  Virology  spread 

2010 – The Institute of Neuroimmunology, Slovak Academy of Sciences, Bratislava – fire 
The  fire  from 
the  Institute  of 
Neuroimmunology, which is housed in the same building. The fire didn´t affect installations 
approved  for  the  contained  use  of  GMOs,  although  they  were  damaged  by  its  effect 
(temperature,  smoke,  water  that  got  there  after  extinguishing  a  fire  on  the  fourth  floor). 
Subsequently, these spaces were reconstructed. There was no leak of GMOs, because at that 
time,  there  were  no  GMOs  in  these  installations.  The  Institute  of  Neuroimmunology  works 
with GMOs classified in the risk class 1 and 2.  

the  area  of 

to 

2013 – Slovak University of Technology, Bratislava – fire 
In the laboratory approved for the contained use of GMOs was fire caused by the burning of 
the electrical socket. There were no GMOs in the laboratory at that time. Slovak University of 
Technology works with GMOs classified in the risk class 1. 

SLOVENIA 
No accidents involving GMMs/GMOs were reported in Slovenia. 

SPAIN 
No accidents were reported during this reporting period. 

SWEDEN 
A  Ph.D. student was going to inject a mouse intravenously in its tail but instead she prickled 
herself in a finger. The syringe contained genetically modified vaccinia virus. After nine days 

100 

 
 
 
 
 
 
 
 
 
a blister appeared on her finger. Eleven days after the incident the finger was swollen and she 
had a fever. No treatment was needed and she recovered from her illness. The class of activity 
was 2. 

UNITED KINGDOM 
a)  Annex 2 provides details of all the accidents involving contained use of GMMs or larger 
GMOs notified to the UK competent authorities in the reporting period. Whilst there were 
12  accidents  (12  in  GB;  0  in  NI)  notified  during  this  period  4  of  these  did  not  meet  the 
accident criteria as set out in the Directive but are included for information. 

101 

 
 
 
 
 
6. 

Clinical Trials using the provisions of the Directive  

6.1 

How  many  gene  therapy  clinical  trial  applications  were  carried  out  under  Directive 
2009/41/EC on the contained use of GMMs during the reporting period? 

AUSTRIA 
Not  applicable.  In  its  “Gene  Technology  Act”  Austria  has  a  special  legal  regulation  for 
applications concerning gene therapy in context with clinical trials. Therefore the regulations 
on contained use do not apply for these approvals. 

BLEGIUM 
From 6 June 2009 to 5 June 2014, 8 clinical trials were carried out. 

BULGARIA 
One  application  for  clinical  trial  involving  immunostimulatory  product  based  on  Vaccinia 
virus (not gene  therapy as  such) was filed. Positive opinion on the risk for the environment 
was  issued  in  April  2014,  but  clinical  trials  were  not  conducted  due  to  reasons  unrelated  to 
GMO. 

CROATIA 
None. 

CYPRUS 
None. 

CZECH REPUBLIC 
None. 

DENMARK 
There have been 7. 

ESTONIA 
0 applications 

FINLAND 
There were two on-going clinical trials. 

102 

 
 
 
 
 
 
 
 
 
 
 
 
 
FRANCE 
12/year. 

GERMANY 
12. 

HUNGARY 
None. 

IRELAND 
None. 

ITALY 
4 class2 activities (class1 activities are not included / notifications are not due). 

LATVIA 
0. 

LITHUANIA 
No clinical trials were notified. 

MALTA 
No clinical trials took place. 

NETHERLANDS 
In  the  Netherlands  gene  therapy  is  regulated  under  directive  2001/18.  A  common 
interpretation of directives 2001/18 and 2009/41 in this respect is needed. 

POLAND 
25  clinical  trials  with  GMMs  were  carried  out  in  Poland.  Clinical  trials  with  GMMs  also 
require  decisions  of  the  Minister  of  Health,  the  Ethical  Committees  and  the  Minister  of 
Environment. 

PORTUGAL 
Regarding Directive 2009/41/EC, and for the period between 6 June 2009 and 5 June 2014, 
we confirm that there were no gene therapy clinical trials applications carried out. 

103 

 
 
 
 
 
 
 
 
 
 
 
 
ROMANIA 
Only one clinical  trial with  TG4040 (MVA-HCV) in  combination with pegylated interferon 
alfa-2a  and  ribavirin  versus  pegylated  interferon  alfa-2a  and  ribavirin  in  treatment-naïve 
patients  with  chronic  genotype  1  hepatitis  C.-2010,  was  carried  (notified  in  2010).  Clinical 
trials were authorised under Directive 2001/18/EC. 

SLOVAKIA 
The  Slovak  scientists  using  genetic  technologies  and  genetically  modified  organisms  have 
tried  to  develop  new  medicines  for  the  treatment  of  diseases,  like  for  instance  cancer, 
Alzheimer  disease  and  others  for  several  years.  They  have  used  a  transduction  altered 
genetically  modified  mammalian  cells,  which  they  applicate  into  the  bodies  of  mice  and 
watching  their  possible  therapeutic  effect  on  tumour  cells  that  were  transplanted  to  them 
before. By this way, genome of mice isn´t modified. For the period of years 2009 – 2014, the 
ministry  has  received  42  notifications  on  activities  the  results  of  which  contribute  to 
understand  the  cause  and  development  of  various  serious  diseases  and  their  treatment.  In 
2013, there was submitted an application on consent for the first and every other introduction 
of combination of genetically modified organisms into the environment (PROSTAVAC-V/F 
+/- GM-CSF) to the ministry, which was submitted by the corporation PPD Slovak Republic 
s. r. o., SK in representation of BN ImmunoTherapeutics Inc., USA. Applicant didn´t submit 
necessary information to the application, and that´s why the ministry asked him to complete 
requested  data.  Whereas  the  applicant  didn´t  eliminate  deficiencies  of  his  application,  the 
ministry stopped the process in this case 

SLOVENIA 
One gene therapy clinical trial on animals was notified in Slovenia. 

SPAIN 
Clinical trials with GMMs are assessed in Spain case by case, but in any case, most of them 
are dealt as Part B notifications (Directive 2001/18/CE), as usually patients don’t stay at the 
hospital for a long period and we consider that biosafety measures have to be taken in order to 
avoid accidental release of the GMM into the environment. 

SWEDEN 
In Sweden clinical trials with GMMs is performed under Directive 2001/18/EG. Three such 
trials have been applied for in Sweden during the period June 2009 - June 2014. 

UNITED KINGDOM 
a)  In the UK, the GMO(CU) Regulations, allow clinical trials to be undertaken as contained 
use  activities  on  a  case  by  case  basis.  The  competent  authorities  for  contained  use  and 
deliberate  release  work  collaboratively  where  there  is  uncertainty  over  which  legislation 
should apply to the clinical trial. 

104 

 
 
 
 
 
 
 
 
b) The majority of clinical trials with GMMs in humans are class 1 activities hence would not 
individually require notification to the Competent Authority (other than the first use of the 
premises for work with GMMs). The total number of class 2 clinical trials notified during 
the reporting period is 9 (all in GB; none in NI).   

105 

 
 
 
 
 
6.2 
Please comment on the overall trend compared to the last reporting period (e.g. has the 
overall  number  of  gene  therapy  clinical  trial  applications  carried  out  under  Directive 
2009/41/EC increased or decreased etc.)  

AUSTRIA 
Not applicable – see 6.1. 

BELGIUM 
Compared  with  the  previous  reporting  period,  there  is  a  significant  increase  in  the 
notifications for gene therapy clinical trials (4 times). 

BULGARIA 
The application for clinical trial mentioned above is the first that involves medicinal product 
containing or consisting of GMM. We expect the number of such applications to increase. 

CROATIA 
Not applicable. 

CYPRUS 
Not applicable. 

CZECH REPUBLIC 
The  hindrance  for  clinical  trials  in  the  Czech  Republic  is  lack  of  facilities  that  would  meet 
very strict requirements for final preparation of gene therapy medicinal products. 

DENMARK 
There has been an increase since there was only 1 clinical trial in the last period. 

ESTONIA 
The same – no gene therapy clinical trial applications. 

FINLAND 
The number has increased. In addition to  notifications, the Finnish CA has  received several 
requests  on  whether  clinical  trials  are  considered  in  Finland  as  contained  use  or  field  trials 
under Directive 2001/18/EC. 

106 

 
 
 
 
 
 
 
 
 
 
 
 
FRANCE 
Increased. 

GERMANY 
The  number  of  clinical  trials  has  decreased;  in  the  last  (three-year  report)  there  were  14 
clinical trials. 

HUNGARY 
Not applicable. 

IRELAND 
It  has  remained  the  same  –  No  clinical  trials  are  performed  under  the  contained  legislation 
rather they are performed under Part B of the deliberate release legislation. 

ITALY 
7  class2  activities  during  the  last  reporting  period,  i.e.  6  June  2004  -  5  June  2009.  Class2 
activities have been halved, probably because of the increase in the class1 activities; in fact, 
comparing the actual and the previous reporting period, new class1[class2] installations with 
inpatient  rooms,  -  which  are  suitable  for  gene  therapy  clinical  trial  applications  – 
increased[decreased] of 4[3]. 

LATVIA 
This is first notification regarding contained use in Latvia. 

LITHUANIA 
- 

MALTA 
Remained constant – no applications. 

NETHERLANDS 
N.A. 

POLAND 
The number of applications on clinical trials has increased compared with previous period. 

107 

 
 
 
 
 
 
 
 
 
 
 
 
PORTUGAL 
- 

ROMANIA 
See answer 6.1. 

SLOVAKIA 
For  the  period  of  years  2009  –  2014,  the  ministry  hasn´t  received  any  application  (gene 
therapy clinical trial). 

SLOVENIA 
Since  no  clinical  trial  was  notified  in  the  previous  reporting  period,  one  notification  may 
indicate a slight growth. 

SPAIN 
Clinical trials applications are increased since the last report but all of them are considered as 
deliberate releases. 

SWEDEN 
- 

UNITED KINGDOM 
a)  It  is  not  possible  to  provide  a  comment  on  the  overall  trend  as  the  numbers  of  class  2 
notified  clinical  trials  is  small  and  there  is  no  comparator  from  the  previous  EC  report 
(2006-2009). However, the notified trials have been evenly spread over the period of the 
report. 

108 

 
 
 
 
 
 
 
 
 
 
 
7.  

Public consultation and information 

7.1 

Provide  details  of  public  consultations  and/or  information  made  publicly  available 
under Directive 2009/41/EC during the reporting period.  

AUSTRIA 
Public consultation is foreseen only in cases of work with GMO in Safety Level 3 
(large scale) and Safety Level 4. As we did not receive any such applications so far, 
public consultation was not carried out. 

BELGIUM 
Public consultation is  performed,  when relevant, through the general procedures  established 
under  the  regional  environmental  laws.  The  procedures  for  public  consultation  aim  at 
providing  general  information  to  the  neighbourhood  regarding  the  contained  use  of  GMOs 
and/or pathogens. 

In the Flemish and Brussels Capital Regions, this information is given via a "public dossier", 
which  is  a  short  summary  of  the  full  notification  drafted  by  the  user  and  containing 
information  written  in  everyday  language  and  without  any  reference  to  confidential 
information. A similar procedure of public consultation is established in the Walloon Region 
during the course of the environmental permit demand to the competent authority. 

The  consultation  also  gives  the  public  the  possibility  to  express  comments,  observations  or 
objections  regarding  the  contained  uses.  The  competent  authorities  take  these  comments, 
observations  or  objections  into  account  when  drafting  their  final  decision.  All  decisions  are 
made  available  to  the  public  for  a  time-limited  period.  Appeals  against  decisions  may  be 
submitted to the competent authority within that period. 

In the Flemish and the Brussels Capital Region, public consultation occurs only in the frame 
of the environmental permit demand. To that purpose, a copy of the public dossier is joined to 
this demand. Public information is provided primarily in two ways. First, general information 
(in French and/or in Dutch) focusing on legal and administrative aspects can be found on the 
websites of the three regional competent authorities: 

  Brussels Capital Region: http://www.ibgebim.be 
  Flemish Region: http://www.lne.be 
  Walloon Region: http://environnement.wallonie.be/ 

Second,  scientific  and  technical  information  (in  English,  Dutch  and  French)  is  provided 
through the "Belgian Biosafety Server" (http://www.biosafety.be), a website managed by the 
SBB. 

BULGARIA 
During  the  reporting  period  no  public  consultations  were  conducted,  as  there  is  no  such 
requirement  when  initial  approval  of  facilities  for  contained  use  of  GMO.  Such  public 
consultations should take place before permission is granted for work that involves contained 
use of GMM Class 2, 3 or 4 and GMO Class B. 

109 

 
 
  
 
 
 
 
 
 
 
A public registers of the premises for contained use of GMOs and permissions for work were 
established 
form 
(http://www.moew.government.bg/?show=top&cid=229&lang=bg).  Information  contained  in 
notifications can be received from the Ministry of Environment and water upon request with 
the exception of confidential and personal data. 

maintained 

electronic 

and 

are 

an 

in 

CROATIA 
In first quarter of the year Ministry of Health has been published Annual report of the Council 
of  GMOs  from  previous  year.  There  is  Annual  report  about  submitted  notifications  of 
contained use. Annual report is performed on Ministry´s website. 

CYPRUS 
No  public  consultations  and/or  information  were  made  publicly  available  under  Directive 
2009/41/EC during the reporting period because there was no need for that. 

CZECH REPUBLIC 
According to the Czech Act on GMOs, no public consultations are required for Class 1 and 2 
contained uses. Notifications of Class 3 and 4 contained uses are made available to the public 
on the internet and announced via the relevant municipality. Public hearing is organised in the 
course  of  an  authorisation  process  in  case  the  Ministry  of  the  Environment  has  received 
negative  opinion  and/or  specific  comments  from  the  public,  in  which  environmental  risk 
assessment results are doubted or an objection to insufficient protection of the health and the 
environment is made.  

During the reporting period, only one notification of Class 3 was submitted. The notification 
was published as required; no comments from the public were received.  Therefore no public 
hearing was carried out. 

In  general,  the  public  is  informed  on  GMOs  by  different  means:  websites  of  the  relevant 
Authorities,  yearly  public  meetings  of  the  Czech  Commission  for  the  use  of  GMOs  (an 
advisory body of the Ministry of the Environment), seminars, publications etc.  

The  Ministry  of  the  Environment  has  established  and  updated  the  register  of  subjects 
authorised for contained use of GMOs (“Register of Users”) on its website www.mzp.cz. The 
Register contains the name and address of a user, specification of GMO, purpose and class of 
the use. Summaries of emergency plans are published as well. Regarding Class 3 and 4, the 
full authorisation decision should be published. 

Information in English is available at the Czech national Biosafety Clearing House webpage 
www.mzp.cz/biosafety 
formats  and  guidance 
documents. 

legislation,  notification 

including 

the 

DENMARK 

110 

 
 
 
 
 
 
 
 
 
 
All notifications are registered in a common database between the WEA and the EPA. Other 
authorities  can  get  access  to  this  database  when  needed.  The  public  can  apply  for  access 
following  the  rules  laid  down  in  the  Law  concerning  Access  to  Public  Records.  Before  the 
EPA makes a decision about an application for production the application is presented to the 
local authorities and if necessary other parties of interest. All of the approved notifications for 
production are published in a national and a local newspaper. When the approval is published 
you have 4 weeks to file a complaint against the decision to the Environmental Appeal Board. 

ESTONIA 
Specific information pages: http://www.envir.ee/et/gmo 
http://www.agri.ee/et/eesmargid-tegevused/toiduohutus/toidugrupid/geneetiliselt-muundatud-

toit 

http://vm.ee/et/node/9868 

Different brochures about GMO’s are available in the printing form and in the pdf-form: 
http://www.envir.ee/sites/default/files/gmoeesti.pdf 

Introductions about different programmes: 
http://www.voru.envir.ee/orb.aw/class=file/action=preview/id=1993/Bioloogilise+mitmekesis

use+kaitse+strateegia+ja+tegevuskava.pdf 

FINLAND 
None arranged for contained use. 

FRANCE 
200 for contained use level 3 and level 4. 

GERMANY 
Publication of the annual ZKBS activity report. 
Publication of all general ZKBS position statements. 
Publication of the list of classified microorganisms. 

HUNGARY 
The  Biotechnology  Advisory  Board  ensures  that  civil  society  organizations  are  involved  in 
the  authorisation  procedure.  The  Registry  Office  appointed  by  the  Competent  Authority 
makes  information  concerning  contained  use  available.  Notifications  are  published  on  the 
internet. The notification of an activity has to include a short, easily understandable summary 
of  the  risk  assessment  for  public  information  purposes,  which  can  be  consulted  at  the 
Secretariat of the Gene Technology Advisory Board. 

IRELAND 

111 

 
 
 
 
 
 
 
 
 
 
 
 
Under  the  implementing  legislation  -  (GMO  (Contained  Use)  Regulations  2001  to  2010)  - 
public consultation is required to be carried out for Class 3/4 contained use activities and it 
may be carried out at the discretion of the CA for Class 2 contained use activities. During the 
reporting period: 

  notices were published in newspapers in respect of 4 x Class 3 GMM contained use 

activities.  

  no  public  consultations  were  carried  out  in  respect  of  Class  4  GMM  contained  use 

activities since no Class 4 GMM applications were received.  

  With  regard  to  applications  for  Class  2  GMM  activities,  the  CA  did  not  deem  it 

necessary to consult the public on any of the applications received. 

The  GMO  Register  listing  GMO  users  is  made  available  for  public  viewing  at  the 
headquarters  of  the  CA.  Considerable  technical  guidance  relating  to  the  contained  use  of 
GMMs/GMOs is published on the CA’s website (www.epa.ie). 

ITALY 
No public consultations have been carried out during the reporting period. The list of GMM 
authorised  installations  is  publicly  available  on  the  Ministry  of  Health  website,  at  the 
following address: 
http://www.salute.gov.it/imgs/C_17_pagineAree_3377_listaFile_itemName_0_file.pdf 

LATVIA 
The  relevant  information  (the  summary  of  the  information  provided  by  the  notifier,  the 
documents that illustrate the procedures of decision taking) had been made publicly available. 
is  published  on  web  page  of  Food  and  Veterinary  Service 
The 
(http://www.pvd.gov.lv/lat/lab_izvlne/registri/darbbas_ar_mo). 

information 

LITHUANIA 
During  the  reporting  period  The  Ministry  of  Environment  has  published  information  about 
contained  use  of  GMMs  and  GMOs  to  the  public  through  the  Competent  Authority’s  Web 
Site http://gmo.am.lt, preserving confidentiality rights and intellectual property according the 
Order  on  Public  Information  and  Participation  and  the  Order  on  Genetically  Modified 
Organisms Information System. The main tasks of the national GMO information system are 
to store, process and guarantee access to any available data about GMM and GMO, excluding 
confidential information 

MALTA 
Two Radio interviews on GMOs in general. 

NETHERLANDS 
In  the  Netherlands  in  the  case  of  a  large  scale  production  the  dossier  was  made  public  by 
means of an advertisement in a national newspaper in order to give the public the opportunity 
to  make  objections before the license was issued. All  other dossiers were made  public after 

112 

 
 
 
 
 
 
 
 
 
the  license  was  issued.  This  was  done  by  publishing  the  name  of  the  notifier,  title  of  the 
project and the issuing date of the licence on the Internet. In addition anybody could request 
to look into a specific dossier at the GMO office and the public concerned can object to an 
issued  licence.  Within  the  reporting  period  a  public  consultations  was  performed  for  5 
licenses  for  installations  for  large  scale  use  of  GMO's.  In  2  cases  comments  were  received, 
not leading to modifications of the license. 

POLAND 
Public consultation forms part of the approval procedure for all class notifications under the 
polish law on public information. All applications are available to the public. The consultation 
gives  the  public  the  possibility  to  express  their  comments  or  objections  regarding  the 
contained uses. The competent authority takes into account the comments before a decision.  

The  provisions  for  public  participation  in  the  authorization  process  require  public  access  to 
the  notification  while  restricting  public  access  to  confidential  information.  General 
the  website 
information  on  contained  use  activities 
http://gmo.mos.gov.pl. 

is  provided  on 

in  Poland 

PORTUGAL 
In  the  past  the  Competent  Authority  carried  out  public  consultation,  which  had  no  public 
reaction.  Therefore  and  although  the  legislation  foresees  that  the  competent  authority  could 
promote  public  consultation  procedures  when  considered  appropriate,  no  consultation 
procedures were carried out for the notifications presented in the current period. 

ROMANIA 
The  national  legislation  transposing  Directive  2009/41/EC  includes  provisions  regarding 
public  consultation  and  public  information  in  the  decision  making  process  regarding  the 
contained use of GMMs. 

The approval procedure is public, National Environmental Protection Agency, publishes it on 
the website www.anpm.ro, within 10 days from acceptance of the notification and within 30 
days from the display, receives comments from the public. 

For  the  contained  use  classes  3  and  4,  National  Environmental  Protection  Agency  holds 
public debates and elaborates a report that is send to the authorities that are involved in the 
notification procedure. 

The  public  information  at  the  national  level  is  made  in  collaboration  with  county 
environmental  agencies  that  are  subordinated  to  the  National  Environmental  Protection 
Agency. 

All risk assessments submitted by the notifiers and the summary of all decisions taken by the 
competent  authority  are  published  on  the  NEPA  website:  www.anpm.ro  and  if  necessary, 
public  debates  are  held  during  the  authorization  procedure  for  contained  use  of  genetically 
modified microorganisms. 

113 

 
 
 
 
 
 
 
 
 
 
Confidential  information  is  treated  in  conformity  with  Directive  2009/41/EC.  The  CA 
ensuring the confidentiality of the information and of the intellectual property rights. 

The  general  characteristics  of  the  genetically  modified  micro-organisms,  name  and 

In no case the following information shall be kept confidential: 
-  
address of the notifier, and location of the activity;  
- 
- 
- 

The class of contained use and measures of containment; 
Any harmful effects on human health and the environment; 
The emergency plans; 

SLOVAKIA 
All  the  information  is  publicly  available  at  our  websites:  www.enviro.gov.sk  and 
www.gmo.sk.  In  2009,  the  ministry  published  the  publication  “The  national  framework  for 
using  of  the  genetically  modified  organisms  and  products  consisting  of  them  in  Slovakia”. 
This  publication  is  addressed  to  the  professional  public  but  also  to  the  general  public.  It 
provides  enough  information  on  the  processes,  which  are  being  applied  in  creating,  testing 
and approving GMOs and products consisting of them. 

SLOVENIA 
GMO  registry  containing  basic  information  on  GMOs  and  installations  is  available  at  the 
ministry  and  also  worldwide  at  the  Slovene  Biosafty  Portal  http://www.biotechnology-
gmo.gov.si/. 

SPAIN 
Only  notifications  of  class  3  and  4  activities  are  made  available  to  the  public  through  the 
Ministry Webpage.  

Twelve activities of class 3 have been made public during this period through the publication 
of an information format of the activity on the Web of the Ministry of Agriculture, Food and 
Environment  and  the  Web  of  the  regional  CAs  or  through  others  ways.  No  CBI  is  made 
public.  

Other way to give information to the public is with a General Annual Report of the Ministry 
which includes data regarding activities under Directive 2009/41/EC.  

SWEDEN 
No public consultations have been done during the reporting period. 

UNITED KINGDOM 
a)  The Regulations  which transpose Directive 2009/41/EC in  GB have  been  reviewed and 
consolidated  and  came  into  force  on  1  October  2014.  As  part  of  this  process,  a  public 
consultation  was  undertaken  from  28  October  –  20  December  2013.  The  consultation 
document,  the  public  response  to  the  consultation  and  the  HSE  response  to  the  issues 

114 

 
 
 
 
 
 
 
 
 
 
raised are captured in documents (http://www.hse.gov.uk/consult/condocs/cd263.htm) on 
the HSE website. The equivalent Northern Ireland regulations are also being consolidated 
and it is anticipated that they will come into operation in 2015.  A public consultation ran 
from 9 June to 15 September 2014 and the consultation document can be accessed on the 
HSENI  site  http://www.hseni.gov.uk/cd_gmo.pdf.    A  summary  of  the  consultation 
responses and HSENI’s response will be published in due course. 

b)  The Competent Authority maintains a public register of information on all notifications 
concerning  contained  use  (with  the  exception  of  those  withheld  for  reasons  of  national 
security). This contains information on premises and individual contained uses including 
the  nature  of  the  work  to  be  carried  out  at  the  premises,  the  purpose  of  individual 
contained uses and the characteristics of the GMOs involved. The register can be found 
on 
the  HSE  website  [http://www.hse.gov.uk/biosafety/gmo/publicregister.htm].  In 
Northern Ireland the Register is held at HSENI headquarters 83 Ladas Drive, Belfast. 

c)  The  Scientific  Advisory  Committee  on  Genetic  Modification  (Contained  Use) 
(SACGM(CU)),  which  provides  technical  and  scientific  advice  to  the  UK  competent 
authorities on all  aspects of the human and environmental risks of the contained  use of 
GMOs  publishes  minutes  of  its  meeting,  annual  reports  and  has  in  the  past  held  open 
public meetings although no public meetings were held during this reporting period. 

d)  The  Competent  Authority  in  GB  has  received  a  number  of  requests  for  information 
relating  to  GMMs  under  the  Freedom  of  Information  Act/Environmental  Information 
Act,  all  of  which  have  been  answered  to  deadline.  No  requests  have  been  received  in 
Northern Ireland. 

115 

 
 
 
 
 
 
 
7.2 
Provide details of public reaction (if any) received in response to consultations and/or 
information made publicly available under Directive 2009/41/EC during the reporting period. 

AUSTRIA 
Not applicable. 

BELGIUM 
During  the  reporting  period,  no  public  reaction  have  been  received  in  response  to 
consultations and/or information made publicly available under Directive 2009/41/EC. 

BULGARIA 
No public reactions have been received so far about contained use of GMO. 

CROATIA 
No reaction to contained use reports. 

CYPRUS 
Not applicable. 

CZECH REPUBLIC 
No public reaction was received. 

DENMARK 
There have not been any public reactions. 

ESTONIA 
http://www.agri.ee/sites/default/files/public/juurkataloog/UURINGUD/eki_tarbijauuringud/O

STUEELISTUSED_2005___MAHETOIT.pdf 

(There is no reported results about public reactions during reporting time). 

FINLAND 
Not applicable. 

FRANCE 
No response following the public consultation. 

116 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
GERMANY 
- 

HUNGARY 
No public reactions received to date. 

IRELAND 
No  public  reaction  has  been  received  in  response  to  consultations  and/or  information  made 
publicly available under Directive 2009/41/EC during the reporting period. However on one 
occasion  the  Agency  received  a  letter  from  a  member  of  the  public,  (June  2012),  seeking 
additional information on the implications / risks associated with a Class 3 GMM contained 
use activity (GM strains of Hepatitis).  

The Agency replied providing details of the nature and purpose of the Class 3 GMM activity, 
the  containment  measures  to  be  employed,  treatment  of  spillages  and  waste  and  protective 
clothing to be worn by those carrying out the activity. 

ITALY 
N.A. 

LATVIA 
There  was  no  public  reaction  received  in  response  to  information  made  publicly  available 
under Directive 2009/41/EC during the reporting period. 

LITHUANIA 
No specific reactions were received. 

MALTA 
None. 

NETHERLANDS 
Both cases mentioned above, the response asked for a total ban on GMO's. 

POLAND 
During the reporting period, there was no public reaction in response to consultations. 

117 

 
 
 
 
 
 
 
 
 
 
 
 
 
PORTUGAL 
- 

ROMANIA 
Not applicable. 

SLOVAKIA 
- 

SLOVENIA 
Only  one  public  hearing/consultation  was  organised  in  the  processing  of  the  gene  therapy 
notification. Discussion proved to be on a very high expert level and no objections were filed. 

SPAIN 
No comments were received. 

SWEDEN 
To our knowledge there have been no public reactions during the reporting period. 

UNITED KINGDOM 
a)  Overall users were content with the proposed changes to the GMO (CU) Regulations in the 
consultations mentioned in 7.1(a). The summary of responses to the GB consultation and 
the 
website 
captured 
(http://www.hse.gov.uk/consult/condocs/cd263.htm).  on the HSE website. A summary of 
the NI consultation responses and HSENI’s response will be published in due course. 

response 

HSE 

HSE 

the 

are 

on 

118 

 
 
 
 
 
 
 
 
 
 
8. 

Waste disposal 

8.1  What are the means by which GM waste is inactivated and disposed of with particular 
reference to large volumes  of waste material  - (including large  or  large quantities  of 
GM plants and/or GM animals, in particular where those plants and animals have been 
inoculated with GMMs)?  

AUSTRIA 
Waste from facilities using GMM must be treated as appropriate to the risk class in order to 
limit  their  contact  with  the  general  population  and  the  environment  and  to  prevent  their 
replication  in  the  environment.  GMM  of  class  2-4  which  are  capable  of  replication  under 
environmental  conditions  must  be  inactivated.  Animals  which  have  been  inoculated  with 
GMM in a non-survival project must be killed by an approved humane method and disposed 
of by incineration. 

BELGIUM 
In the Belgian Regional decrees implementing Directive 2009/41/EC, there is an explicit legal 
requirement  to  inactivate  all  types  of  GMOs  -  even  of  risk  class  1  -  by  appropriate  and 
validated means prior to disposal as waste. Inactivation can either be done on site, either after 
transport in biohazard containers to a waste processing company. 

In each region, these requirements are completed by specific regulations on waste originating 
from medical care and dangerous waste in general, including waste from animal experiments, 
imposing  rules  for  storage,  for  incineration  and  for  collection  by  an  certified  or  accredited 
company. 

Steam  sterilisation  (autoclaving  of  solid  waste)  or  chemical  inactivation  (fluids)  is  the 
predominant means of inactivation of large volumes of GM waste material in situ. Taking into 
account  the  broadened  scope  of  the  contained  use  legislation  toward  the  intentional  use  of 
pathogenic organisms,  waste streams are not  limited  to  GM waste. This  explains why other 
means,  like  high  temperature  and  high  pressure  alkaline  hydrolysis  of  animal  carcasses,  are 
evaluated on a case-by-case basis and are subject to validation. 

Smaller amounts of waste material originating from contained use facilities are often treated 
by  steam  sterilisation,  chemical  inactivation  or  are  collected  by  specialised  companies  for 
incineration of hazardous waste in authorised waste-processing firms. 

A  new  type  of  autoclave  has  been  presented  by  to  the  SBB.  It  is  a  combined  system  for 
treatment  of  infectious  waste  in  which  the  waste  is  crunched,  as  well  as  autoclaved.  The 
crushing  reduces  the  waste  to  pieces  of  8mm  and  diminishes  the  waste  volume  of  80%. 
Afterwards, the crunched waste is autoclaved during 20min at 135°C. 

Regarding  waste  management,  the  Brussels-Capital  region  notes  that  it  is  very  complex  to 
apply simultaneously the different existing legislations on animal waste, health care waste and 
dangerous waste. 

119 

 
 
  
 
 
 
 
 
 
 
 
BULGARIA 
All  kind  of  waste  must  be  inactivated  and  disposed  in  appropriate  manner.  The  manner  of 
inactivation and disposal is described in notification for approval of the facility as information 
for waste management and processing.  

During the approval process is ensured that the relevant European and national requirements 
are strictly followed. All approved facilities are part of academic institutions and only small to 
moderate amounts of waste are produced at any given time. The inactivation takes place on 
the premises and is done by autoclaving of the waste. Inactivated waste is disposed following 
the general requirements for such material. 

CROATIA 
GMM materials waste treated: autoclaves/chemical inactivation, incinerators. Big question is 
a quantity of volume of waste (it is different from plant, GMM or and animal). 

CYPRUS 
There  were  no  large  volumes  of  waste  material.  For  the  inactivation  of  the  GM  waste, 
chemical disinfection and autoclave were used. For the final disposal inactivated GM waste 
was transferred to a facility authorised for treatment of clinical waste. 

CZECH REPUBLIC 
GMMs are inactivated and disposed of in the same way and by the same means as infectious 
waste containing pathogenic microorganisms (by chemical disinfectants, autoclaving etc.). 

Likewise,  GM  laboratory  animals  and  animals  inoculated  with  GMMs  are  disposed  of  as 
other infectious animals.  

GM  plants  are  either  autoclaved  or  in  large  volumes  chopped,  the  seeds  ground  and  the 
resulting material composted. 

DENMARK 
For class 1 the treatment of the  waste is based on the risk assessment in each specific case. 
For class 2 the waste has to be inactivated with validated methods before final discharge. For 
class  3  the  waste  has  to  be  inactivated  before  final  discharge  with  validated  chemical  or 
physical methods. For class 4 only a validated physical inactivation is sufficient. 

ESTONIA 
There  aren’t  large  quantities  GM  plants  or  GM  animals  activities  in  Estonia.  All  activities 
with  GM  animals  are  in  the  laboratories  and  they  are  in  contained  use.  All  waste  will 
inactivate  according  good  laboratory  practise  and  safety  rules.  Waste  will  inactivated  as 
dangerous waste. 

120 

 
 
 
 
 
 
 
 
 
 
 
FINLAND 
For  GM  micro-organisms  autoclaving  or  chemical  inactivation  (disinfectants  chosen 
according to the organism). GM-vertebrates are first terminated with the appropriate method 
(depending on the species) and then frozen and incinerated or buried (burial not accepted if 
the animals were inoculated with pathogenic GMMs). Cenorhabditis elegans and Drosophila 
are usually autoclaved.  

Most  GM-plants  are  autoclaved,  but  there  is  a  list  of  recommended  methods  for  different 
species  and  their  tissues,  depending  on  whether  the  specific  plant  tissue  is  capable  of 
reproduction. GM-plants inoculated with pathogenic GMMs must be autoclaved. 

FRANCE 
Process for inactivation: Chemical, thermal. 

GERMANY 
Waste  disposal  is  carried  out  according  to  §  13  GenTSV  (Genetic  Engineering  Safety 
Regulations); usually the waste is autoclaved for 20 min at 121 °C or 134 °C. There are two 
genetic  engineering  facilities  in  Germany  where  large  animals  can  be  disposed  of  with  the 
help of a digestor (alkaline lysis). 

HUNGARY 
Waste  from  biotechnological  activities  (both  hazardous  and  non-hazardous)  is  treated  under 
the national legislation concerning hazardous waste. 

IRELAND 
The  CA  stipulates  in  consent  conditions  issued  to  the  GMO  user  that  all  waste  must  be 
inactivated by validated means. In the event that the user does not have an autoclave on site5, 
the  CA  may  agree  to  the  user  sending  the  waste  off  site  for  inactivation  and  disposal  – 
however, this only applies to waste arising from Class 1 GMM activities. 

Waste arising from Class 2/3 or 4 GMM activities must be inactivated on site using validated 
procedures  (autoclaving  or  chemical  inactivation  in  the  case  of  liquid  waste).  The  only 
exception  to  this  would  be  where  GM  and/or  non-GM  animals  have  been  inoculated  with 
Class 1 or Class 2 GMMs. In this instance the animal remains are transported off site to waste 
treatment  facilities  authorised  for  the  inactivation  of  Class  1/2  GMMs,  under  the  national 
legislation implementing Directive 2009/41/EC. The inactivation of large animals (where heat 
penetration in  a laboratory  sized autoclave would  not be feasible) inoculated with Class 1/2 
GMMs, or any sized animal inoculated with Class 3/4 GMMs, has not arisen to date and such 
a decision would be made on a case-by-case basis.  
GM Plant waste is inactivated by autoclaving or off-site incineration. 

5 On the site of the GMO/GMM installation 

121 

 
 
 
 
 
 
 
 
 
                                                 
ITALY 
Basically,  two  methods  are  in  use:  thermal  inactivation,  by  using  dedicated  equipment  for 
biological  waste  sterilization  (e.g.  overkill  thermal  cycle  with  temperature  >  121  °  C); 
chemical inactivation, by using sodium hypochlorite and/or soda. 

After  the  inactivation,  for  their  disposal,  wastes  are  transferred  to  firms  authorized  in 
compliance with the Italian Legislative Decree n.152/2006 (ref. chapter  IV). 

LATVIA 
All bacterial and plant material including petri dishes, liquid growth media, disposable plastic 
ware, plant material and soil are sterilized by autoclaving. Thereafter the waste is disposed as 
regular municipal waste. 

LITHUANIA 
According  to  the  Order  on  Regulation  on  Contained  Use  of  Genetically  Modified 
Microorganisms,  the  notifier  has  to  provide  information  concerning  the  waste  management, 
including the amount and type of waste, the methods of inactivation and the final form of the 
waste and destination. In all cases, all types of GMMs had to be inactivated prior to disposal.  

Waste was mainly inactivated through thermal (autoclaving) or chemical means (e.g. sodium 
hypochlorite).  In  case  of  GM-vertebrates, their  remains  were  transported  to  waste  treatment 
facility for inactivation under the EU and national legislation. 

MALTA 
The only permitted Class 1 facility inactivates the small volume of waste it generates through 
autoclaving. 

NETHERLANDS 
A  Ministerial  Decision  provides  that  all  waste  has  to  be  inactivated  by  validated  means. 
Waste storage must comply with the rules as laid down in an annex to the Ministerial Order. 
In general waste disposal and inactivation was performed in-house. If this was not possible, 
the waste had to be transported to dedicated waste facilities. 

POLAND 
The  notifier  must  provide  information  about  the  foreseen  quantity  of  aerosols  and 
contaminated  sewages  resulting  from  the  contained  use  activity.  Information  about  storage 
and inactivation methods must be provided. All waste must be inactivated prior to disposal if 
it  is  not  guaranteed  that  no  harmful  effects  will  occur  otherwise.  In  case  of  class  3  and  4 
activities, the water from sinks, showers, glass houses and animal houses must be inactivated 
as well. 

122 

 
 
 
 
 
 
 
 
 
 
PORTUGAL 
In all cases, including activities at risk class 1 and 2, effluents, residues and wastes must be 
inactivated prior to disposal-autoclave. 

ROMANIA 
In national legislation, Emergency Government Ordinance 44/2007 as amended by Law NO 
3/ 2008, regulates the necessary measures on waste management: 

Inactivation  of  genetically  modified  micro-organisms  from  materials  and 
hazardous  waste  is  optional  for  the  contained  use  class  1  and  binding  for  the 
contained use of classes 2, 3 and 4. 
Inactivation  of  genetically  modified  micro-organisms  in  effluent  from  hand 
washing  sinks  or  drains,  showers  and  similar  effluents  is  not  necessary  for  the 
contained use classes 1 and 2, is optional for contained use Class 3 and binding for 
the contained use of class 4. 

- 

- 

- 

These requirements are completed by regulations on waste from medical activities that require 
specific rules. 

SLOVAKIA 
As  for  the  risk  class  1,  inactivation  of  GMOs  is  optional.  There  is  required  a  minimal 
inactivation by a disinfectant solution of an adequate concentration and duration of action. In 
the risk class 2 - 4, there is required a sterilization at temperature 120 °C during 30 minutes. 
GM plants are being liquidated by crushing and ploughing on the land or by sterilization and 
GM animals by the killing in the installations for the contained use, moving into PVC covers, 
depositing in the fridge for cadavers and then they are transported to the incinerator.  

Transport  of  GMOs  is  realized  according  to  the  European  Treaty  on  International  Road 
Transport  of  Dangerous  Goods  (ADR)  and  the  Regulation  concerning  the  International 
Carriage  of  Dangerous  Goods  by  Rail  (RID).  In  case,  the  applicant  of  genetic  technologies 
and genetically modified organisms is producing more than 10 tons of hazardous waste a year 
or 100 tons of other waste, he is obliged to work out a plan on the origin of waste according to 
the Act No. 223/2001 Coll. on the waste, as amended. If the applicant disposes more than 100 
kg  of  the  hazardous  waste  a  year,  or  if  the  carrier  transports  annually  more  than  100  kg  of 
hazardous waste, the consent for the management of hazardous waste including its transport is 
needed.  

Waste  management  plan  involves  the  collection,  transport,  assessment  and  liquidating  of 
waste  including  supervising  these  activities  and  following  care  about  the  places,  where  the 
liquidation was carried out. The liquidation of waste is carried out in the special installation 

SLOVENIA 
In all cases special attention is given to the waste treatment.  In the risk assessment, notifiers 
must elaborate a detailed plan for waste treatment, inactivation procedures and final disposal 

123 

 
 
 
 
 
 
 
 
 
of  the  wastes  and  waste  waters  in  concord  with  Regulation  of  risk  assessment  of  work  with 
genetically  modified  organisms  in  contained  use  (OJ    RS  45/2004)  and  Decree  of  waste 
management (OJ RS 34/2008 and 103/2011).  

The  waste  disposal  mode  must  be  included  in  the  risk  assessment  and  is  taken  into 
consideration by the Scientific Committee before the premises for contained use of GMOs are 
registered  or  approval  for  work  with  GMOs  in  the  contained  system  is  issued.  For the  time 
being the biggest volume of biosafety class 1 GMMs is limited to semi-industrial reactors of 
1000 l. 

SPAIN 
The waste material is treated and eliminated following the legal requirements for each type of 
waste. Usually autoclaves  and chemical treatments are used  for GMMs  and incineration for 
GM plants and animals. 

In  Spain  we  follow  the  provisions  according  to  Directive  2009/41/EC,  so  it  means  that,  for 
laboratory activities the inactivation of GMMs in effluent from hand-washing sinks or drains 
and  showers  and  similar  effluents  was  not  required  for  containment  levels  1  and  2,  it  was 
optional  for  level  3  and  obligatory  for  level  4;  however,  for  laboratory  activities  the 
inactivation  of  GMMs  in  contaminated  material  and  waste  was  optional  for  level  1  and 
obligatory for levels 2, 3 and 4. Nevertheless, the CNB always recommends the inactivation 
of all GMOs in the cases of ‘not required or optional’.  

Generally,  there  are  waste  treatment  certified  companies  which  collect  the  waste  after  the 
treatment is carrying out. 

SWEDEN 
In many cases the waste is autoclaved within the premises for contained use of GMM. Waste 
from  contained  use  at  BSL  1  and  BSL  2  are  sometimes  sent  to  incineration  plants.  Dead 
monkeys  with  GMM  from  contained  use  BSL  3  are  autoclaved  to  become  sterilized  on  the 
surface.  They  are  then  sent  to  incineration  plants  in  locked  containers.  Dead  mice  and  rats 
with GMM from BSL 1 and 2 activities are frozen and transported to incineration plants. 

Waste from GM plants, including soil, pots etc. are usually autoclaved. Premises with large 
volumes  of  waste  gather  this  in  a  container,  special  for  this  purpose,  that  is  send  for 
incineration. The same container is brought back to the premises where it is kept in a locked 
area. 

UNITED KINGDOM 
a)  The  Regulations  transpose  the  requirements  of  the  directive  in  respect  of  GM  waste. 
Contained  uses  will  generate  contaminated  waste,  which  must  be  inactivated  by  a 
validated means at class 2, 3 and 4. Inactivation at class 1 is only not required where the 
following criteria are met:  

(i) do not have the potential to cause harm to human health or the environment;  

124 

 
 
 
 
 
 
 
 
 
(ii) Must be biologically contained (e.g. possess multiple disabling mutations or 
restrictive nutrient requirements that cannot be met outside the laboratory);  

(iii) do not have the capacity to establish and multiply in the environment; and  

(iv) Do not have capacity to transfer genetic material to other micro-organisms (e.g. non-

mobilisable plasmid).  

b)  The risk assessment should conclude whether inactivation of waste at class 1 is required 
and  the  methods  for  achieving  this.  For  the  purposes  of  the  Regulations,  any  of  the 
following  methods,  i.e.  disinfection,  off-site  treatment  (e.g.  autoclave,  incinerator)  or 
autoclave  may  be  considered  to  be  validated  means  and  comply  with  the  Regulations. 
This  is  provided  appropriate  steps  are  taken  to  confirm  the  efficacy  of  the  method,  the 
appropriate  control  measures  are  put  in  place  for  the  safe  transport  and  storage  of  the 
waste  material and  the process  is  completed in  a  safe  manner.  The level  of  compliance 
forms an important part of  HSE’s inspection programme of notified premises. 

c)  Autoclaving remains the most popular choice of method of inactivation. However, there 
has been an increase in the number of commercial waste disposal companies inactivating 
GM  waste  e.g.  incinerators  at  GM  registered  sites  deal  with  waste  containing  GMMs. 
These  are  primarily  used  for  class  1  waste,  for  example,  in  animal  bedding  or  clinical 
waste from gene therapy trials. 

125 

 
 
 
 
 
8.2 
Are  there  waste  treatment  facilities  in  your  Member  State  which  are  authorised  to 
inactivate  waste  arising  from  GM  installations  and  for  what  classes  of  activity?  How  is  the 
transfer of waste from the GM installation to the authorised waste facility arranged/organised? 

AUSTRIA 
In Vienna there is one waste treatment facility that has submitted a notification for Class 1-
GMOs in order to carry out the inactivation of GMO waste delivered by installations. 

It  is  mandatory  to  inactivate  solid  and  liquid  waste  from  class  2  contained  uses  inside  the 
installation. 

BELGIUM 
Biologically  contaminated  waste  originating  from  contained  use  activities,  which  is  not 
inactivated in situ, is collected for incineration in installations that are authorised for treatment 
of  hazardous  waste  (authorised  in  an  environmental  permit).  Both  the  specialised  transport 
companies (certified for collection of hazardous waste) and the waste-processing firms have 
to comply with regional regulations regarding waste treatment, imposing rules for collection 
and  storage  prior 
the  UN 
recommendations of dangerous goods. 

incineration.  Transport  of  waste  material  follows 

to 

to 

In  the  Flemish  region,  an  initiative  aiming  at  authorising  (in  the  environmental  permit) 
installations  for  steam  sterilisation  operating  at  large  scale  may  provide  an  alternative 
treatment  method  for  infectious  waste  including  GM  waste  originating  from  research 
(Vlaams  Reglement  voor 
the  provisions  of  VLAREA 
facilities.  According 
Afvalvoorkoming en –beheer), infectious waste mainly consists of medical waste presenting a 
risk of infection. This initiative, which aims at reducing transport logistics costs of infectious 
waste  intended  for  incineration,  necessitates  a  revision  of  the  Flemish  waste  regulations  in 
order  to  create  a  regulatory  framework  for  inactivation  of  infectious  waste  by  wet  heat 
sterilisation.  Cost,  benefit  and  environmental  considerations  will  determine  whether  this 
alternative  treatment  method  of  infectious  material  will  be  preferred  above  incineration  as 
hazardous waste. 

BULGARIA 
There  are  no  waste  treatment  facilities  in  Bulgaria  which  are  specifically  authorised  to 
inactivate waste arising from GM installations. There are installations authorised for treatment 
of hospital and other bio hazardous waste that can be used for treatment and disposal of GM 
material should a necessity arise. Inactivation of all GM waste is done by autoclaving on the 
premises of the approved facilities. 

CROATIA 
In  Croatia  GM  waste  is  inactivated  in  autoclave  or  with  chemicals  (chemical  inactivation). 
Inactivated  waste  GM  materials  are  transported  by  authorising  company  for  that  kind  of 
waste. 

126 

 
 
 
 
 
 
 
 
 
CYPRUS 
There are no waste treatment facilities in Cyprus authorised to inactivate waste arising from 
GM installations. 

CZECH REPUBLIC 
There  are  no  special  waste  facilities  for  material  from  GM  installations.  GMMs  are 
inactivated  at  the  premises  where  they  have  been  used  and  the  resulting  waste  is  treated 
together with other hazardous waste from the premises (laboratories, hospitals etc.). 

DENMARK 
No, there are no authorised waste treatment facilities in Denmark. The companies take care of 
their GM waste themselves. 

ESTONIA 
There aren’t specific inactivating GMO waste installations in Estonia. Every laboratory has its 
own equipment and rules for this. If the waste will send outside from laboratory, the waste is 
inactivated already. 

FINLAND 
Most  of  the  GMO  operators  inactivate their  GMO-waste  themselves.  However,  there is  one 
waste treatment facility, Ekokem, which has a long experience of GM-waste inactivation and 
treats  class  1-2  GMO  waste.  For  transferring  the  GMO  waste  to  the  Ekokem  facility,  the 
operators use the services of waste transport companies. Well-sealed and marked containers 
are required for transportation.  

The  Board  for  Gene  Technology  does  not  give  separate  authorisation  to  the  problem  waste 
facilities. 

FRANCE 
Yes  for  the  containment  levels  1,  2  and  3.  The  transfer  of  waste  from  the  initial  GM 
installation to the authorised waste facilities if the contained level is not broken.  For the level 
4 the waste was inactivated on site. 

GERMANY 
Two  waste  treatment  facilities  authorised  to  deal  with  waste  arising  from  level  1genetic 
engineering facilities. 

Two  genetic  engineering  facilities  carrying  out  biosafety  level  2  genetic  engineering  work, 
which  carry  out  only  waste  inactivation  (the  facilities  are  operated  by  universities  and  are 
used  primarily  for  the  autoclaving  of  safety  post  filters.  The  facilities  consist  of  one  or  two 
high-volume pass-through autoclaves and the antechambers required as a 'black area'). 

127 

 
 
 
 
 
 
 
 
 
 
Waste  containing  GMOs  is  transported  in-house  in  closed  and  labelled  containers  protected 
from breakage in accordance with German genetic engineering law or,  when transported on 
public  roads  outside  the  scope  of  the  Genetic  Engineering  Act,  in  accordance  with  the 
provisions governing the transport of dangerous goods (GGVSEB). 

HUNGARY 
Some waste treatment facilities in Hungary are authorized to pursue such activities; however, 
they  are  not  specialized  solely  to  the  treatment of  waste  arising  from  GM  installations.  The 
activity of inactivating waste arising from GM installations falls under a separate registration 
procedure.  The  transfer  from  the  installation  to  the  waste  treatment  facility  can  only  be 
commenced possessing an authorization, under controlled conditions and specifying the route 
of transfer 

IRELAND 
Presently, there are two facilities in Ireland authorised to inactivate waste containing GMMs. 
One facility is authorised to accept waste containing Class 1 GMMs only, while the second 
facility is authorised to accept waste containing Class 1 and/or Class 2 GMMs. While the CA 
advises  that  the  inactivation  of  Class  2  GMMs  should  take  place  on  site,  it  is  not  always 
feasible  to  decontaminate  GM  or  non-GM  animal  remains  inoculated  with  GMMs  in 
laboratory sized autoclaves (owing perhaps to large animal size).  

In  these  instances,  the  animal  remains  are  transported  to  the  decontamination  facility  in 
accordance with the waste treatment facility’s own procedures. Usually this entails that once 
killed,  the  animal  remains  are  bagged,  stored  frozen  while  awaiting  collection,  transported 
frozen  in  refrigerated  vans  and  cremated  from  frozen.  GMM  waste  other  than  GMM 
inoculated  animal  remains  is  transported  off  site  in  sealed  containers.  Transportation  is 
arranged by the waste treatment company. 

ITALY 
Inactivation  is  always  done  within  GM  installations  and  Italian  CA  has  not  authorised  any 
waste treatment facility to inactivate waste arising from GM installations. 

LATVIA 
No. 

LITHUANIA 
There  is  facility  authorized  under  the  EU  and  national  legislation  to  handle  veterinary  and 
environmental  waste  including  GM-vertebrates.  Transportation  was  arranged  by  the  waste 
treatment company. There were no cases of contained use of GMMs or GMOs of class 2-4. 

MALTA 

128 

 
 
 
 
 
 
 
 
 
Class  1  waste  is  disposed  of  in  a  landfill  and  is  carried  to  the  facility  by  licensed  waste 
carriers. 

NETHERLANDS 
In the Netherlands there is one facility authorised for destruction of GMO-waste. 

POLAND 
In Poland there are not special waste treatment facilities authorised to inactivate waste arising 
from  GM  installations.  The  proceedings  of  hazardous  waste  are  regulated  by  the  Act  on 
Waste from 2012. 

PORTUGAL 
There  are  several  companies  dedicated  to  inactivate  biological  waste,  who  operate  mainly 
with hospital contaminated residues, and also with GM biological waste. Usually, the waste 
treatment  company  supplies  proper  collectors  to  the  GM  installation  and,  depending  on  the 
quantities of waste produced collects the waste and inactivates it in their facilities. 

ROMANIA 
Emergency  Government  Ordinance  No  44/2007  as  amended  by  Law  No  3/  2008,  requires 
users  of  contained  use  of  genetically  modified  micro-organisms,  the  endowment  with 
equipment of autoclaving for the waste inactivation from such activities. 

SLOVAKIA 
In our Member state we have specialized facilities for processing organic waste. In the first 
place,  before  the  transfer,  the  carrier  is  obligate  to  inactivate  the  waste  arising  from  GM 
installations at the place and after it is possible to transport waste to a specialized facility. The 
transfer  of  waste  from  the  GM  installation  to  the  authorised  waste  facility  is  organised 
according  to  the  Regulation  concerning  the  International  Carriage  of  Dangerous  Goods  by 
Rail  (RID)  and  the  European  Treaty  on  International  Road  Transport  of  Dangerous  Goods 
(ADR). 

SLOVENIA 
Several waste incineration facilities are registered in Slovenia and often used by the notifiers 
for GMO  final  waste disposal.  The notifiers make contracts for transport and destruction of 
GMO waste with the entitled companies. 

SPAIN 
Yes,  the  transfer  of  waste  from  the  GM  installation  to  the  authorised  waste  facilities  is 
arranged  by  the  users.  These  treatment  facilities  are  authorised  by  the  Spanish  Regional 

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Competent Authorities for the waste inactivation. They collect the waste which is conducted 
to their own facility where is inactivated by thermal, chemical or incineration methods. 

SWEDEN 
Incineration  plants  that  incinerates  waste  with  active  GMM  must  notify  their  activity  to  us. 
Waste  containing  GMM  from  class  1  and  class  2  activities  can  be  sent  to  incineration  in 
containers marked as waste class 9 or 6.2 according to the international transport regulations 
(ADR).  The  company  that  transports  the  waste  and  the incineration  plant  must  be  informed 
about the content of GMM. 

Incineration  facilities  that  accept  waste  from  GM  plants  do  not  need  any  specific 
authorization. 

UNITED KINGDOM 
a) 

In  Northern  Ireland,  all  waste  is  treated  at  the  site  of  origin,  either  by  chemical  means 
and/or  autoclave.  Inactivated  waste  then  goes  to    land  fill.    There  is  no  large  scale 
production of GM waste in Northern Ireland. 

b)  There are currently 12 registered sites authorised to inactivate waste containing GMMs. 
Of  these  four  are  permitted  to  inactivate  class  1  waste  and  eight  are  permitted  to 
inactivate class 2 waste. 

c) 

It  is  the  waste  producer’s  responsibility,  in  all  cases,  to  ensure  that  the  waste  is 
inactivated or correctly packaged in approved containers and labelled appropriately. The 
waste producer completes a consignment note confirming the waste type and any specific 
precautions that need to be taken, sending a copy with the waste and retaining a copy for 
their records. This should all be verified before the driver removes the waste from site. 

d)  All  drivers  are  required  to  have  the  appropriate  level  of  training,  which  includes  the 
transport  of  dangerous  goods,  the  correct  use  of  personal  protective  equipment  and  an 
appreciation  of  standard  operating  procedures,  local  rules  and  risk  assessments. 
Additionally, drivers are trained in the use of waste spillage kits, which contain a surface 
disinfectant and are located in vehicles. 

e)  On  arrival  at  the  plant,  the  driver  informs  the  plant  manager  that  GM  waste  has  been 
delivered, hands over the consignment note for verification and it is then passed back to 
the waste producer to confirm that the waste has been processed. 

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9. 

Other issues 

Please provide comments on any other aspects of the Directive or on other related legislation. 

AUSTRIA 
- 
BELGIUM 
No other issues. 

BULGARIA 
It  is  not  entirely  clear  how  the  provisions  of  Directive  2009/41/EC  will  be  applied  together 
with  the  provisions  of  the  proposed  Regulation  on  clinical  trials  on  medicinal  products  for 
human use.  

If the contained use of GMO remains within the scope of the proposed Regulation on official 
controls,  this  may  require  changes  in  implementation  of  Directive  2009/41/EC  on  national 
level, with respect to competent control authorities in particular. 

CROATIA 
Croatia suggests: 

a)  In  article  18  of  the  preamble  to  Directive  2009/41/EC  word  “CONSULT”  to 

change in word “REPORT” 

b)  According to the article 23 of the preamble to Directive 2009/41/EC suggest EU 
Commission  to  establish  a  Register  of  accidents  causing  by  GMMs.  This 
information will be more applicable 

During  official  control  we  noticed  is  necessary  to  uniform  ordinance  of  the  Annex  of 
Directive 2009/41/EC with ordinance of Directive 2000/54/EC on the protection of workers 
related to exposure to biological agents. 

CYPRUS 
No other comment. 

CZECH REPUBLIC 
With  the  development  of  molecular  biology  and  synthetic  biology,  questions  are  likely  to 
emerge  whether  specific  sub-cellular  elements  (modified  or  synthesized)  fall  under  the 
definition of “micro-organism” or not. 

DENMARK 
- 

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ESTONIA 
None. 

FINLAND 
- 

FRANCE 
Without comments. 

GERMANY 
This point is currently under discussion between the Federal and Land authorities; the results 
of these discussions are likely to be included in the next report. 

HUNGARY 
It would be a great help for us if an EU-level register would be established. This should not 
necessarily  be  a  public  register  but  an  information  source  for  Competent  Authorities  who 
could  register  the  basic  information  (including  the  name  of  applicant,  the  general 
characteristics of the GMMs, protective measures to be taken, Article 18 (2) (c) issues, etc.) 
regarding the notification they have received. In this way, Member States could consult and 
cooperate more closely if there are similar facilities/activities or emerging questions. It would 
also speed up the preparation of the 3-year national reports. 

IRELAND 
None. 

ITALY 
Nothing to report. 

LATVIA 
- 

LITHUANIA 
The information is provided in the item 4.2. 

MALTA 

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No comment. 

NETHERLANDS 
No other comment. 

POLAND 
No comment. 

PORTUGAL 
- 

ROMANIA 
Romania  considers  that  it  is  necessary  to  clarify  the  scopes  of  Directive  2009/41/EC  and 
Directive 2001/18/EC concerning clinical trials. 

SLOVAKIA 
- 

SLOVENIA 
- 

SPAIN 
- 

SWEDEN 
Today we have a lot of experience of contained use of GMMs in science and technology. In 
most cases, there are no problems with GMMs for the environment or the human health. Gene 
technology is not by itself harmful. It can be used for illegal purposes, but this is not the scope 
of the legislation for contained use of GMM. Our view is that there is no reason to treat risks 
posed by GMMs differently than for microorganisms that have not been genetically modified. 

The directives 2009/41/EC and 2000/54/EC on the protection of workers from risks related to 
exposure to biological agents at work gives parallel legislations for contained use of GMM in 
the  EU  member  countries.  We  think  that  the  two  directives  can  be  merged  to  an  efficient 
legislation that takes into account risks to the environment as well as the work environment. 
In  our  view,  there  is  no  need  for  special  legislation  for  GMMs,  except  the  demand  to  keep 
them contained if they have not been approved for deliberate release. 

133 

 
 
 
 
 
 
 
 
 
 
 
UNITED KINGDOM 
a)  Whilst  recognizing  that  the  opinion  of  the  expert  committees  (SCHER,  SCENIHR  and 
SCCS) on a working definition of synthetic biology, has only recently been published, the 
EC  should  develop  its  position  on  the  emerging  topic  of  synthetic  biology  in  relation  to 
Directive  2009/41/EC,  in  a  timely  manner,  to  avoid  individual  Member  States  having  to 
introduce separate and disparate legislation on this topic. 

b) The  EC  should  consider  the  need  for  a  meeting  of  the  Competent  Authority  of  Member 
States  for  contained  use.  The  Competent  Authority  has  not  met  during  the  period  of  this 
report. 

c)  The EC should consider how best to use and share the information provided as part of the 
statutory reporting under the Directive (e.g. annual reports of class 3 and 4 contained uses) 
to inform development of policy and guidance. 

d)  The EC should consider whether the purpose of Annex II, Part C of the Directive is 

delivering its intended purpose, given that this annex has yet to be populated. The US 
National Institute for Health ‘Guidelines for Research Involving Recombinant or Synthetic 
Nucleic Acid Molecules’6, specifically Section III-F-8 Appendix C, provides an example 
that may be useful in considering this matter. 

6 Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules 
http://osp.od.nih.gov/sites/default/files/NIH_Guidelines_0.pdf 

134 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
2. COMPETENT AUTHORITIES 

AUSTRIA 
Competent Authority Federal Ministry of Health 

BELGIUM 
Competent  Authority7  Biosafety  and  Biotechnology  Unit  (SBB),    Technical  expert  for  the 
regional authorities 

BULGARIA 
Competent Authority  Ministry of Environment and Water 

CROATIA 
Competent Authority  Ministry of Science, Education and Sports and Ministry of Health  

CYPRUS 
Competent Authority  Department of Labour Inspection 

CZECH REPUBLIC 
Competent Authority  Ministry of the Environment of the Czech Republic 

DENMARK 
Competent Authority  Danish  Working  Environment  Authority  (WEA)  and  The  Danish 
Environmental Protection Agency (EPA) 

ESTONIA 
Competent Authority  LABOUR INSPECTORATE OF ESTONIA 

FINLAND 
Competent Authority  The Board for Gene Technology 

7 art. 12, §2, 4° of the Cooperation Agreement between the Federal state and the Regions on 
the  administrative  and  scientific  co-ordination  concerning  Biosafety  of  25  April  1997:  “the 
SBB ensures the obligations relating to the exchange and the transmission of information and 
the reports imposed by the European regulations relating to the contained use of genetically 
modified micro-organisms…” 

135 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
 
FRANCE 
Competent Authority  Ministère de l’Education Nationale, de l’Enseignement Supérieur et de 
la Recherche. Direction Générale de la Recherche et de l’Innovation 

GERMANY 
Competent  Authority  Coordinating  Competent  Authority:  Federal  Office  of  Consumer 
Protection and Food Safety (BVL) 

HUNGARY 
Competent Authority  Ministry of Agriculture, Hungary 

IRELAND 
Competent Authority  Environmental Protection Agency Ireland 

ITALY 
Competent Authority Ministry of Health 

LATVIA 
Competent Authority  Ministry of Agriculture  

LITHUANIA 
Competent Authority  The Ministry of Environment of Lithuania 

MALTA 
Competent Authority  Malta Environment and Resources Authority 

NETHERLANDS 
Competent Authority  Ministry of Infrastructure and the Environment 

POLAND 
Competent Authority  Ministry of the Environment,  

PORTUGAL 
Competent Authority  Portuguese Environment Agency 

ROMANIA 
Competent Authority  NATIONAL ENVIRONMENTAL PROTECTION  AGENCY (NEPA) 

136 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLOVAKIA 
Competent Authority  The Ministry of the Environment of The Slovak Republic 

SLOVENIA 
Competent Authority  REPUBLIC OF SLOVENIA  MINISTRY OF THE ENVIRONMENT 
AND SPATIAL PLANNING (MESP) 

SPAIN 
Competent Authority  National Commission on Biosafety (CNB) and Interministerial 
Commission on GMOs (CIOMG), Ministry of Agriculture, Food and Environment 

SWEDEN 
Competent Authority  Swedish Work Environment Authority 

UNITED KINGDOM 
Competent Authority  Health and Safety Executive Great Britain (GB) and Northern Ireland 
(NI) 

137