COMMISSION WORKING DOCUMENT Report on the 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 2006 – 2009
Date: 2012-07-17
Institutions: European Commission
Subjects: EU Member State, application of EU law, chemical accident, environmental risk prevention, experiment on humans, genetically modified organism, health control, information processing, interpretation of the law, microorganism, research body, waste disposal

EUROPEAN COMMISSION 

Brussels, 17.7.2012  
COM(2012) 398 final 

COMMISSION WORKING DOCUMENT 

Report on the 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 2006 – 2009 

{SWD(2012) 216 final} 

EN 

   EN 

 
 
 
 
  
 
COMMISSION WORKING DOCUMENT 

Report on the 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 2006 – 2009 

TABLE OF CONTENTS 

Report  on  the  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 2006 – 2009 

Details are available in Annex I and II of this document, which are Commission staff working 
documents. 

EN 

2 

   EN 

 
COMMISSION WORKING DOCUMENT 

Report on the 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 2006 – 2009 

The  information  contained  in  this  report  has  been  compiled  by  the  Commission  from 
individual  reports  submitted  by  Member  States  in  accordance  with  Article  17  of  Directive 
2009/41/EC  on  the  contained  use  of  genetically  modified  micro-organisms.  Directive 
2009/41/EC is a recast of Directive 90/219/EEC amended by Directive 98/81/EC.1 

PREFACE 

Article  17(2)  of  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)  requires 
Member  States  to  send  a  summary  report  on  their  experience  with  the  Directive  to  the 
Commission  every  three  years.  According  to  Article  17(3),  the  Commission  shall  publish  a 
summary report based on the aforementioned reports. 

The two new Member States which acceded in January 2007 were required to submit reports 
on  their  experience  with  the  Directive  for  the  first  time  in  2009.  The  fifth  Commission 
summary  report  contained  information  on  their  transposition  into  national  law  of  Directive 
98/81/EC, the predecessor of Directive 2009/41/EC.  

Neither the European Commission nor any person acting on its behalf is responsible for any 
use made of the information contained in this report. 

INTRODUCTION 

This report is based on a sixth series of Member States' reports. The deadline for submission 
of the Member States' reports was 30 May 2010. Few Member States submitted their reports 
before the deadline, while a great number was delayed. The latest report was received on 6th 
March 2012. At the time of drafting this report, national reports had been received from all 
Member  States  with  the  exception  of  two  Member  States.  On  the  whole,  Member  States 
provided relevant information. 

Member States were requested to provide information on: 

– 

– 

– 

1 

Activities and installations  

Notification and approval systems  

Risk assessment and classification of contained uses 

Every  effort  has  been  made  to  ensure  the  accuracy  of  the  material  contained  in  this  report.  Member 
State national legislation transposing Directive 2009/41/EC into national law has been the subject of a 
conformity check carried out by the Commission. This report is without prejudice to the findings of the 
conformity check and any potential action on behalf of the Commission in accordance with Art 258 of 
the  Treaty  on  the  functioning  of  the  EU,  where  Member  States  have  been  found  to  have  incorrectly 
transposed Directive 2009/41/EC into national legislation. 

EN 

3 

   EN 

 
                                                 
– 

– 

– 

– 

– 

– 

– 

Accidents  

Inspection and enforcement issues 

Problems with interpretation of provisions  

Clinical trials using the provisions of the Directive  

Public consultation and information  

Protection of confidential information  

Waste disposal  

The following text summarises the information given by Member States under the headings 
provided  and  highlights  similarities  of  and  differences  between  the  experiences  of  the 
Member  States.  Further  details  from  the  individual  Member  States'  three-year  reports  are 
provided in two annexes of this report, which are Commission staff working documents. 

EN 

4 

   EN 

 
1. 

Overview of activities and installations 

Within the framework of Directive 2009/41/EC, contained  uses  must be notified to 
the  national  competent  authorities.  In  accordance  with  Article  2(c),  contained  use 
shall  mean  "any  activity  in  which  micro-organisms  are  genetically  modified  or  in 
which such GMMs are cultured, stored, transported, destroyed, disposed of or used 
in any other way, and for which specific containment measures are used to limit their 
contact with the general population and the environment".  

Contained use activities  are  classified  into four classes: class 1 represents activities 
of no or negligible risk; classes 2, 3 or 4 represent activities of low, moderate or high 
risk, respectively.  

Premises for contained use activities as well as installations must be notified as well. 
Some Member States notify the installations on the reason that activities are difficult 
to count. Some Member States require notifications for activities with GM plants or 
GM animals under contained use.  

According to the Member States' reports, no contained use activity involving GMMs 
was  carried  out  in  Bulgaria,  Cyprus,  Estonia,  Latvia,  Malta,  and  Romania  in  the 
reporting period. 

According  to  the  information  provided,  most  activities  fell  into  class  1  or  class  2. 
Fewer class 3 and 4 activities were being carried out, but the number was increasing. 
Most  activities  were  related  to  research.  Several  activities  served  commercial 
purposes such as the manufacture of diagnostics, veterinary/medicinal products. 

2. 

Notification and approval system (and relevant changes) 

The  national  systems  differed  slightly  in  terms  of  authorities  involved.  In  many 
Member States, the Ministry of Environment or agencies focusing on environmental 
issues  were  the  Competent  Authority.  In  other  Member  States,  Competent 
Authorities  included  the  Ministry  of  Health,  the  Ministry  of  Labour  and  Social 
Insurance,  the  Ministry  of  Agriculture  and  Rural  Development,  or  the  Ministry  of 
Science  and  Research.  In  Belgium  and  Germany  the  Competent  Authorities  were 
established at regional level. In several Member States additional authorities and in 
particular advisory bodies were involved in the authorisation process.  

Under the provisions of the Directive, the first-time use of an installation for class 1 
activities  must  be  notified,  the  subsequent  use  of  a  class  1  activity  may  proceed 
without further notification (article 6 and 7). However, Czech legislation required a 
new notification in case that a new GMO was  to be used (not only new  premises). 
Class  2  activities  follow  a  similar  procedure  as  class  1,  while  class  3  and  class  4 
activities may not proceed without prior consent of the Competent Authority. 

In  Sweden,  the  Competent  Authority  has  commenced  to  review  the  regulations  on 
the  contained  use  of  genetically  modified  organisms  for  simplifying  the  procedure 
for  notification  of  GMM  activities.  Portugal  has  started  to  review  its  national 
contained use legislation to strengthen the role of experts in the whole process, and 
for determining fees for the processing of notifications. 

EN 

5 

   EN 

 
3. 

Risk assessment and classification of contained uses 

Most  Member  States  integrated  into  their  own  national  legislation  the  Commission 
risk assessment guidelines, while others referred directly to these guidelines. 

In  the  majority  of  Member  States,  activities  were  classified  into  four  classes  as 
provided for by the Directive. Finland noticed that the classification of viruses, cell 
cultures and of pathogens that had been attenuated was problematic in some cases. 

In general, the users are required to compile their own risk assessment, as provided 
for  under  Article  4(2)  of  the  Directive.  However,  in  some  Member  States  the  risk 
assessment must be carried out or at least verified by a professional consultant and is 
reviewed by an expert advisory body. 

4. 

Accidents 

Few  Member  States  (Finland,  Ireland,  the  Netherlands  and  United  Kingdom) 
reported  accidents  according  to  the  definition  laid  down  in  Article  2(d)  of  the 
Directive. Finland reported one accident involving an experiment with an enterotoxin 
gene  from S. aureus without safety  measures which generated health consequences 
for the user. Ireland reported an accident generated by the breaking of the glass end 
Pasteur  pipette  during  the  aspiration  of  supernatant  from  a  trypsinised  genetically 
modified lentivirus-infected HeLa cell culture. The content penetrated the skin of the 
user.  The  Netherlands  reported  9  incidents,  without  consequences  on  health  or 
environment. The United Kingdom reported 7 accidents involving GMM belonging 
to class 2, namely two peristaltic pump failures (E. coli HMS174 (DE3) genetically 
modified  to  express  Neisseria  meningitidis  surface  proteins  as  well  as  H5N1 
Influenza  virus),  an  incubator  failure  (M.  tuberculosis),  a  blockage  of  a  steel  pipe 
(vaccine influenza virus), a failure of the injection procedure (pigs injected with GM 
Actinobacillus pleuropneumoniae), and two needle stick injuries (vaccinia virus and 
Leishmania mexicana). 

All the institutions where the accidents took place, made the necessary adjustments 
for  improving  the  procedural  aspects  to  avoid  similar  events  in  future,  such  as 
adapting  or  changing  the  company’s  standard  operating  procedure;  in  one  case  the 
risk  assessment  was  amended;  in  another  case  the  staff  was  trained  for  the  new 
technical method which raised problems. 

5. 

Inspection and enforcement issues  

The national reports show a varying level of control in different Member States. In 
some  Member  States  the  inspections  were  conducted  by  the  Competent  Authority, 
while  in  others  the  inspections  were  managed  independently  from  the  Competent 
Authority.  The  number  of  inspectors  involved  in  GMM  control  varied  strongly  per 
Member States. The control procedures were also quite different in EU 27. 

In  Denmark  all  activities  were  inspected  upon  notification  of  new  premises  or 
changes of already classified locations, while Austria only carried out spot checks. In 
Finland,  Germany,  Lithuania  and  the  United  Kingdom  the  inspection  intensity  was 
based  mainly  on  class  of  contained  use.  In  Finland  the  class  3  use  was  inspected 
more often (at least every second year) than class 1 or 2 use (at least every 5 years /4 

EN 

6 

   EN 

 
years  respectively);  in  the  United  Kingdom,  sites  working  at  class  2  were  visited 
approximately  every  5  years,  sites  working  at  class  3  approximately  every  3  years 
and  sites  working  at  class  4  approximately  every  year.  Lithuania  inspected  the 
premises at least every 3 years for class 1 uses, every 2 years for class 2, and every 
year for class 3 and 4 uses. In Finland for some specific cases, a written inspection 
procedure was in place. 

Some  Member  States  such  as  Cyprus,  Denmark,  Romania,  Portugal,  the  Slovak 
Republic,  Slovenia  and  the  United  Kingdom  appointed  specialist  inspectors  for  the 
contained use of GMMs. 

During inspections, the following improvements were found to be necessary: Users 
already actively engaged in the contained use of GMOs/GMMs without having first 
obtained  the  authorisation  to  do  so;  lack  of  knowledge  regarding  the  consent 
conditions issued in respect of the contained use activity; lack of a dedicated person 
for dealing with legal and safety requirements; lack of training of biosafety officers 
or  the  project  leaders;  the  notifying  the  location  without  notifying  the  activities; 
others. 

6. 

Problems with interpretation of the provisions  

Some Member States named topics which need further clarification, in relation with 
a  necessary  update  of  technical  and  scientific  advancement  and/or  further 
harmonization on the European level. 

In  Austria,  Bulgaria,  Cyprus,  Estonia,  Latvia,  Lithuania,  Malta,  Portugal,  Romania 
and  Slovakia  no  specific  problems  with  the  interpretation  of  the  provisions  were 
reported. For the New Member States, in the majority of the cases the reason is the 
lack of activities due to the lack of notifications. 

Belgium,  Czech  Republic,  Hungary  and  the  Netherlands  encountered  problems  in 
assessing whether the application of certain new techniques resulted in a genetically 
modified organism and fell within the scope of Directive 2009/41/EC. At the request 
of the Competent Authorities of Directive 2001/18/EC the Commission set up a New 
Techniques  Working  Group  in  October  2007  to  assess  a  non-exhaustive  list  of 
techniques  as  to  whether  they  result  in  the  production  of  a  genetically  modified 
organism  or  microorganism  as  defined  under  Directives  2001/18/EC  and 
2009/41/EC.  The  outcome  is  expected  to  help  to  clarify  whether  certain  new 
techniques  result  in  genetically  modified  organisms  and  fall  within  the  scope  of 
Directive 2009/49/EC. 

The Netherlands, Spain, Hungary, Czech Republic, Belgium, Finland saw a need for 
clarification  of  the  scopes  of  Directive  2009/41/EC  and  Directive  2001/18/EC  with 
respect to clinical trials.  

Other problems encountered in case of implementation of the Directive 2009/41/EC 
were  the  following:  difficulties  with  the  detection  and  identification  of  GMOs 
(Germany),  lack  of  clarity  of  terminology  (Germany,  Finland);  huge  number  of 
notifications  of  class  1  to  be  reviewed  (Denmark),  or  huge  number  of  inspections 
(Ireland);  high  number  of  notifications  for  viral  vectors  with  low  risk  (United 
Kingdom) which created a significant administrative burden; difficulties in obtaining 

EN 

7 

   EN 

 
feedback from the users working with GMO/GMM (Spain). Member States proposed 
different measures such as to include safe organisms in Part C of the Annex II of the 
Directive 2009/41/EC (Slovenia), to set up a EU GMM Working Group focusing on 
research activities from the perspective of Directive 2009/41/EC, and to change the 
requirements for notifying class 2 activities (United Kingdom). 

7. 

Clinical trials using the provisions of the Directive  

The  national  reports  showed  that  the  Member  States  addressed  clinical  trials  in 
considerably different ways. Some Member States regarded clinical trials as falling 
exclusively under Directive 2001/18/EC (for example Sweden), while other Member 
States such as Denmark and Finland regarded them as falling exclusively within the 
scope of Directive 2009/41/EC. Other Member States (Spain, UK) decide on a case 
by case basis whether a clinical trial is regarded as contained use or as a deliberate 
release. 

In  terms  of  numbers,  France  has  reported  228  clinical  trials,  a  large  increase  in 
numbers  compared 
trials  using 
GMO/GMM  were  conducted  in  Bulgaria,  Cyprus,  Estonia,  Finland,  Hungary, 
Ireland, Latvia, Lithuania, Malta, Portugal, Romania, Slovakia and Slovenia. 

to  previous  reporting  periods.  No  clinical 

8. 

Public consultation and information 

Member  States  generally  prescribed  public  consultation  as  part  of  the  authorisation 
procedure.  The  approach  of  the  Member  States  was  diverse.  Some  Member  States 
focussed the public consultation only on class 3 and 4 (Austria), other Member States 
allowed the Competent Authorities to decide for the rest of the classes whether the 
public consultation was needed (Ireland, Portugal, Poland, Romania).  

The  majority  of  Member  States  established  a  web  based  system  for  regular  public 
consultation.  Some  Member  States  had  electronic  registers  (databases)  for 
applications  submitted  under  Directive  2009/41/EC.  In  Belgium,  Bulgaria,  Czech 
Republic, Denmark, Ireland, Lithuania, the Netherlands, Poland, Romania, Slovakia 
and  the  United  Kingdom,  the  general  public  had  access  to  the  summary  of  the 
applications available in these databases.  

Hungary  requested  from  the  notifier  a  summary  of  the  risk  assessment  for  public 
information  purposes  which  was  available  for  consultation  at  the  Secretariat  of  the 
Gene  Technology  Advisory  Board.  In  the  Netherlands  only  the  notifier's  name,  the 
title of the project and the issuing date of the licence were published but members of 
the public could request access to an issued licence. 

Other approaches to communicate to the public information relevant in the context of 
Directive  2009/41/EC  included  public  meetings  of  advisory  bodies  (the  United 
Kingdom, Czech Republic), seminars (Czech Republic, Malta), publications such as 
annual reports (Belgium, Germany, Czech Republic), or leaflets (Malta). In Denmark 
the approved notifications were published in national and local newspapers.  

9. 

Protection of confidential information  

Article  18  of  Directive  2009/41/EC  provides  for  the  protection  of  confidential 
information. The competent authority shall determine whether information submitted 

EN 

8 

   EN 

 
by  the  notifier  may  be  considered  confidential in accordance with the requirements 
of article 18(1) of the Directive.  

Generally  speaking,  the  operator  may  indicate  in  his/her  application  to  the 
Competent  Authority  those  data  he/she  wishes  to  be  treated  as  confidential.  Most 
Member  States  decided,  based  on  the  operator's  request,  that  some  specific  data  be 
kept  confidential  (Ireland,  Austria,  Belgium).  In  the  Netherlands  a  general 
description of the confidential parts had to be submitted in order to give the public 
insight into the risk assessment. 

Member States took appropriate measures to protect confidential information. In the 
Netherlands  only  authorised  staff  had  access  to  the  rooms  where  confidential 
information was handled. The tendency of Member States was to ask for a technical 
dossier with non-sensitive information and, if applicable, an annex with confidential 
data (Belgium, the Netherlands). 

10. 

Waste disposal  

Member States addressed waste management by class or by category of waste. The 
Member States who did not provide any information on these aspects mentioned that 
either there were no change since the previous report, or explained that there was no 
activity in this area. 

According  to  Directive  2009/41/EC,  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. Few Member States (Belgium, Lithuania, Portugal and Spain) 
prescribed that all types of residues had to be inactivated prior to disposal, thus going 
beyond what the Directive requires. 

Starting  with  level  2,  Member  States  request  a  description  of  the  containment  and 
other  protective  measures  to  be  applied,  including  information  about  waste 
management,  including  the  wastes  to  be  generated,  their  treatment,  final  form  and 
destination,  in  accordance  with  directive  2009/41/EC.  For  level  1,  the  Directive 
requests information on waste management as a summary. 

Some  Member  States  had  waste  treatment  facilities  dedicated  to  GM  waste 
inactivation  (Germany,  Finland,  Ireland,  and  the  United  Kingdom).  In  countries 
where  there  were  no  authorised  GM  waste  treatment  facilities  the  users  inactivated 
their GMO waste themselves (Denmark) or use the general waste treatment facilities 
available (Hungary, Czech Republic). 

11. 

Conclusions  

Most contained use activities fell within class 1 or class 2. Significantly fewer class 3 
and 4 activities were being carried out, but the number is increasing. Most activities 
were  related  to  research  but  several  serve  commercial  purposes  such  as  the 
manufacture  of  diagnostics,  or  veterinary  or  medicinal  products.  On  the  whole,  the 
Member  States  applied  the  Directive  in  a  similar  fashion.  Differences  arose  as 

EN 

9 

   EN 

 
Member  States  enacted  additional  legislation  in  almost  all  areas  covered  by  the 
Directive. 

The  national  reports  showed  that  the  Member  States  addressed  clinical  trials  in 
different ways. Some Member States applied Directive 2009/41/EC on the contained 
use of GMMs, others Directive 2001/18/EC on the deliberate release of GMOs into 
the environment, and yet others applied other national legislation. These differences 
stem from differences in the interpretation of annexes of Directive 2001/18/EC and 
Directive 2009/41/EC, in particular, as the latter Directive had not been specifically 
designed  for  clinical  trials.  However,  both  Directives  attribute  the  competence  to 
regulate clinical trials with GM microorganisms essentially with the Member States, 
Directive  2009/41/EC  by  setting  minimum  standards  leaving  it  up  to  the  Member 
States  to  go  beyond  those  minimum  standards,  and  Directive  2001/18/EC  by 
attributing the competence for authorising part B notifications to the Member States. 
Some  Member  States  raise  the  point  that  further  harmonization  would  be  useful. 
However, most importantly, both Directives share as common objective a high level 
of protection so that from a safety point of view further harmonisation at Union level 
is at present not a priority for the Commission. 

EN 

10 

   EN