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
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  COM(2016) 808 final   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 {SWD(2016) 445 final}  
 
 
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 

TABLE OF CONTENTS 

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. 

Details are available in the accompanying Commission staff working document. 

2 

 
 
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 

The  information  contained  in  this  document  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. 

INTRODUCTION 

Directive  2009/41/EC  on  the  contained  use  of  genetically  modified  micro-organisms1 
(GMMs) requires the Commission to publish every three year a summary report on Member 
States experience with that Directive2, based on individual reports to be sent by the Member 
States to the Commission3.  The present report covers the period from June 2009 to June 2014 
following the previous report for the period 2006-20094.  

This  report  is  based  on  26  Member  States'  reports5,  given  that  two  Member  States  did  not 
submit individual reports. Croatia, which became a Member State of the Union in July 2013, 
was requested to submit the report on its experience with the Directive for the first time as of 
2013.  

Member States were requested to provide information on: 

  Activities and installations 

  Notification and approval systems 

  Accidents 

 

Inspection and enforcement issues 

  Problems with interpretation of provisions 

  Clinical trials using the provisions of the Directive 

1 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), OJ L 125, 21.5.2009,  p. 75 
2 Article 17(3) of Directive 2009/41/EC 
3 Article 17(2) of Directive 2009/41/EC. 
4 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, COM(2012) 398 final, 17.7.2012. 
5 The information for each Member State, as submitted, is available on …(internet site) 

3 

 
 
 
 
 
                                                            
  Public consultation and information 

  Waste disposal 

The  information  contained  in  this  report  is  based  on  Member  States  individual  reports  and, 
therefore, does not represent the position of the European Commission6. 

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

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 the accompanying Commission staff working document.  

6  In  particular,  this  report  is  without  prejudice  to  any  potential  action  in  accordance  with  Article  258  of  the 
Treaty on the Functioning of the European Union.    

4 

 
 
 
 
 
 
 
 
                                                            
1.  Overview of activities and installations (reporting period 06.06.2009 – 05.06.2014) 

In  accordance  with  Article  2(c)  of  Directive  2009/41/EC,  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  containment  classes:  Class  1  represents 
activities of no or negligible risk; Classes 2, 3 or 4 represent activities of low, moderate and 
high risk, respectively.7  

Within the framework of Directive 2009/41/EC, the premises for contained use activities must 
be notified to the national competent authorities when they are to be used for the first time. 
Following  this  notification  subsequent  class  1  contained  use  may  proceed  without  further 
notification, whereas higher containment class levels require additional specific notification. 
The Czech Republic is currently amending its legislation which requires a new notification in 
each case of contained use even for Class 1 activities.  

According  to  the  information  provided,  most  contained  use  activities  in  the  Member  States 
fell into class 1 or class 2. Fewer class 3 and 4 activities were being carried out. According to 
its  national  report,  there  were  no  GMMs  contained  use  activities  in  Romania  during  the 
reporting period.   

Most activities were related to research. Several activities served commercial purposes such 
as the manufacture of diagnostics, of veterinary/medicinal products or involving clinical trials. 
Activities were also carried out in hospitals, public institutions, education (universities) or in 
detection laboratories. 

2.  Notification and approval system (and relevant changes) 

National systems differed slightly in terms of authorities involved.  

In many Member States (Bulgaria, the Czech Republic, Denmark8, Ireland, Lithuania, Malta, 
the  Netherlands,  Poland,  Portugal,  Romania,  Slovakia,  and  Slovenia),  the  Competent 
Authorities for the notification and approval were the Ministry of Environment or Agencies 
focusing on environmental issues. In other Member States (Austria, Croatia, Cyprus, Estonia, 
France, Hungary, Italy, Latvia, the United Kingdom), the tasks of the Competent Authorities 
were carried out by other Ministries alone or in collaboration with others like the Ministry of 
Health (Austria9, Croatia10, Italy, United Kingdom), the Ministry of Labour (Cyprus, Estonia), 
the  Ministry  of  Agriculture  and  Rural  Development  (Hungary,  Latvia),  the  Ministry  of 
National/Higher  Education,  Science  and  Research  (France),  specific  authorities  for 
Biotechnology/Biosafety  (Belgium,  Finland,  Spain),  Work  Environment  (Sweden)  or  Food 
and Consumer Protection (Germany).  

7 Article 4(3) of Directive 2009/41/EC 
8 Together with the Danish Working Authority 
9 Together with the Ministry of Science, Research and Economy 
10 Together with the Ministry of Science, Education and Sports  

5 

 
 
 
 
 
 
 
 
 
 
 
                                                            
risk 
Some  Member  States 
assessment/authorisation  process.  In  Belgium  and  Germany,  the  Competent  Authorities  are 
established at regional level, and in Spain and the United Kingdom certain competences are 
delegated to the regional authorities. 

scientific  bodies 

advisory 

employ 

also 

the 

in 

Denmark  has  started  to  review  its  national  procedures  in  order  to  facilitate  the  process  for 
both companies and authorities.  

With  the  exception  of  Cyprus  and  Romania,  Member  States  have  extended  the  transposed 
provisions  of  Directive  2009/41/EC  on  GMM  to  the  contained  uses  of  GM  plants  and  GM 
animals. Poland provided no information on this aspect. 

In general, with a small number of exceptions, Member States declare processing notifications 
within the statutory timeframe.  When delays occurred, they were mostly due to requests for 
additional information, lack of clarity on the notification submission requirements on the part 
of  applicants,  the  involvement  of  more  than  one  national body  in  the approval  process,  and 
delays  in  the  delivery  of  the  opinion  by  the  scientific  advisory  body  responsible  for  the 
assessment of the notifications.    

3.  Accidents 

Few  Member  States  (Finland,  the  Netherlands,  Slovakia,  Sweden  and  United  Kingdom) 
reported  accidents  according  to  the  definition  laid  down  in  Article  2(d)  of  Directive 
2009/41/EC and the procedures laid down in Articles 14 and 15 of that Directive.  

Finland received few notices of mild accidents (i.e. needle pricks) in class 2 activities with no 
consequences.  The  Netherlands  reported  13  incidents,  without  consequences  on  health  or 
environment, namely a small fire in a biosafety cabinet in a laboratory, a small collision in a 
corridor  while  transporting  wastes  (class  2  micro-organism  was  present  in  the  waste),  a 
centrifuge failure (GM Neisseria), an ice-machine failure, a needle accident with a low titre of 
GM Influenza, 2 incidents with an isolator housing animals with GM Influenza, damages to a 
glass  wall  of  a  laboratory,  a  technical  defect,  a  mistake  in  the  technical  construction  of  a 
ventilation  system,  and  a  cell  line  infected  with  GM  SARS-virus  was  fixed  with  an  old 
fixative which although expired, proved to be effective.    

Slovakia  reported  3  accidents  caused  by  fire  in  different  facilities  including  the  Institute  of 
Virology (class 1 and 2 GMOs), the Institute of Neuroimmunology (class 1 and 2 GMOs), and 
the  Slovak  University  of  Technology  (class  1  GMOs).  Sweden  reported  one  accident 
involving a needle accident (student accidentally stuck herself with a syringe containing a GM 
virus vaccine).  

The United Kingdom reported 8 accidents involving contained use  of GMMs  or  GMOs. Of 
the  eight  accidents  reported,  six  involved  class 2  GMMs,  and  two  involved  class  3  GMMs. 
The  reported  accidents  included  two  needle  stick  injuries  (Toxoplasma  gondii  and 
Mycobacterium  marinum),  a,  instrument  measurement  failure,  an  accidental  splashing,  (a 
droplet of culture of Pseudomonas aeruginosa splashed into the eye), a drop of a box of plates 
containing 36 plates of Yersinia pestis, a centrifuge failure which could potentially led to an 
aerosol  of  GM  Legionella  pneumophila  exposure,  a  drainage  system  failure  (Fusarium 
graminearum),  and  two  filtration  failures  with  GM  viruses  (Lentivirus  vector  with  inserted 
sequence encoding for shRNA against KIAA0020 and Hepatitis C virus). 

6 

 
 
 
 
 
 
 
 
 
 
Belgium reported one accident (fire) in a biological waste storage room without the competent 
authority having been informed.  

According  to  the  information  provided  by  the  Member  States,  when  accidents  occurred, 
corrective measures were taken for both the procedural and structural safety aspects, and for 
the  safety  of  humans  and  the  environment.  The  institutions  involved  made  the  necessary 
adjustments to avoid similar events in the future, such as adapting or changing the standard 
operating  procedures,  amending  the  risk  management  procedures,  improving  containment 
practices,  and  providing  training  for  staff.    Affected  personnel  were  given  prophylactic 
treatment  and/or  vaccination,  and  were  monitored  to  ensure  full  recovery  (in  the  cases  of 
accidental sticking with needles).  

4.  Inspection and enforcement issues  

The  national  reports  showed  both  similarities  and  differences  in  the  implementation  and 
enforcement processes required by articles 10 and 16 of Directive 2009/41/EC in the Member 
States. 

In  some  Member  States  inspections  were  conducted  by  specialised  inspectors  from  the 
Competent  Authority,  while  in  others  inspections  were  carried  out  at  the  request  of  the 
Competent  Authorities  by  specialised  inspectors  from  other  ministries  or  services.  The 
number of inspectors involved in GMM control also varied among Member States.  

The  control  procedures  included  regular  annual  inspections  according  to  set  criteria 
(periodicity, class of risk, etc.), ad hoc unannounced inspections, audits of facilities approved 
for the first time, sampling of materials, and audits of documentation and processes.     

In Austria, inspections were organised and conducted on the basis of the characteristics of the 
activity  (e.g.  risk  class,  large  scale  equipment,  inoculation  of  animals).    In  Belgium,  the 
inspections were organised in the three regions by different inspectorates on a regular basis, 
and concerned contained uses of GMMs including pathogens.  

In the Czech Republic and in Bulgaria, the inspections were carried out on the basis of annual 
schedule.  

In Denmark, all activities were inspected upon notification of new premises or of changes in 
existing ones. The Danish authorities informed the Commission that this procedure is about to 
change to allow Class 1 GMM work to start based on the notification alone with inspections 
following after the start of operations. 

In  Finland,  Ireland,  Lithuania,  and  the  United  Kingdom,  the  inspection  intensity  was  based 
mainly on the Class of the contained use activity.  

In Germany, although the way inspections were conducted varied among the federal states in 
terms of periodicity, common approaches based on risk classification and the use patterns of 
the facility were followed.   

7 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Three  Member  States  (Estonia,  Lithuania,  and  Malta)  considered  that  specific  training 
programmes for inspectors and joint inspections with other Member States would improve the 
inspection process. 

During inspections, some issues were identified with regard to: waste management; inaccurate 
or  outdated  documentation;  lack  of  knowledge  regarding  the  newest  GM  technologies; 
insufficient  recording  of  the  training  of  the  staff;  contained  use  of  GMOs/GMMs  without 
having  obtained the proper authorisation;  poor  or  missing  identification and signalisation  of 
genetic engineering facilities or  laboratories; adequacy of standard control  measures;  and in 
some  instances,  insufficient  biosafety  measures  (decontamination,  protective  clothing, 
restricted access, etc.).  

In  terms  of  enforcement,  in  all  Member  States  which  provided  individual  reports,  when 
inspections identified situations requiring corrective actions, the competent authorities declare 
to have used a number of instruments (warnings, infraction notices, etc.) to ensure remedial 
action  and  compliance  on  the  part  of  operators  within  a  set  timeframe.  In  all  reported 
instances, operators promptly complied and implemented the corrective actions requested by 
the authorities.       

5.  Problems with interpretation of the provisions  

In Austria, Croatia, Cyprus, Germany, Italy, Latvia, Lithuania, Malta, Portugal, Romania and 
Slovakia, no specific problems with the interpretation of the provisions were reported. 

Belgium had difficulties  interpreting the provisions  of the Directive 2009/41/EC concerning 
commercial  activities  involving  bacterial  transformation.  In  one  instance,  a  GMM  falling 
within the scope  of 2009/41/EC was produced using techniques  (self-cloning)  which do not 
fall under the scope of Directive 2009/41/EC. In another instance, a commercially available 
(via the internet) bacterial transformation kit was used to produce a Class 1 GMM.  While the 
transformation  kit  is  not  sold  in  Belgium,  its  availability  via  the  internet  could  potentially 
make  the  enforcement  of  the  provisions  of  2009/41/EC  difficult.  Belgium  and  Poland, 
questioned  whether  activities  involving  GM  plant  and  animal  cells  should  be  considered  as 
GMM  activities.    However,  the  definition  of  microorganism  under  2009/41/EC  is  clear  in 
including animal and plant cell in culture within its scope11 

Belgium,  the  Czech  Republic,  Finland,  Hungary,  the  Netherlands,  Spain  and  the  United 
Kingdom  encountered  problems  in  assessing  whether  the  application  of  certain  new 
techniques  resulting  in  a  GMM  fell  within  the  scope  of  Directive  2009/41/EC.    They 
considered that the Union regulatory framework for the new techniques should be reviewed to 
clarify  whether  organisms  obtained  with  these  new  techniques  fall  under  the  scope  of  the 
Directive.  

Belgium,  Finland,  Slovenia,  the  United  Kingdom  and  Sweden  pointed  out  that  the  large 
number of notifications, the high information requirements for each notification, the detailed 
reporting  system,  and  the  complexity  of  the  different  procedures  can  result  in  a  heavy 
administrative burden for both authorities and notifiers. Spain and France also pointed to the 
burden  of  the  large  number  of  inspections  required  in  order  to  enforce  the  provisions  of 

11 Article 2(a) of Directive 2009/41/EC 

8 

 
 
 
 
 
 
 
 
 
 
                                                            
Directive 2009/41/EC.  Belgium considered that the procedures regarding the notification of 
contained uses of GMMs and pathogens should be made more uniform. In Hungary, a lot of 
consultations  are  necessary  between  the  notifiers  and  the  Competent  Authority  on  the 
documentation  and  information  requirements  before  the  submission  and/or  after  the 
submission  of  the  notification.  In  Slovenia,  delays  occurred  when  the  external  experts 
(Scientific  Committee)  or  another  national  body  was  involved  in  the  processing  of  a 
notification.   

The  Netherlands  reported  a  number  of  specific  technical  issues  including  differences  in  the 
(strict) GMO-regulations and the less strict regulation of wild type pathogens (Netherlands). 
The  Netherlands  also  believed  there  is  a  need  for  simplification  and  harmonisation  of 
disinfectants used as biocides in laboratories. 

In Belgium, some problems were encountered with the interpretation of the terms "subsequent 
contained  use  activity"  following  the  first  time  notification  of  premises  for  a  particular 
containment class activity. The notifier does not always know when an activity is considered 
to be a subsequent contained use of the same containment class, especially in cases when the 
authorised  activity  is  modified.  Moreover,  it  is  not  always  possible  to  distinguish  the 
amendments  to  earlier  notifications  from  other  types  of  subsequent  contained  use  activities 
(continuation of activity or new activity). In the 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).  

In Finland, the classification of viruses, cell cultures, and especially of pathogens, which have 
been  attenuated,  has  also  been  problematic.  On  the  same  subject,  Finland,  the  Netherlands, 
and the United Kingdom would like to see that the definitions in the Directive be reviewed to 
take into account new techniques or technological advances.   

Finland  also  added  that,  as  research  groups  may  move  from  one  institution  to  another,  the 
need  for  new  notifications  of  the  new  premises  each  time  creates  additional  administrative 
work.  

Ireland and Denmark considered that there is a need for deregulation of Class 1 GMMs as the 
requirements under Annex II, Part B of the Directive is considered to be rather heavy given 
the  'non  harmful'  status  of  Class  1  GMMs.  Similarly,  Spain,  Sweden,  and  the  United 
Kingdom, would like to simplify the procedures for Class 1 and 2 activities. For Slovenia, the 
inclusion  of  safe  organisms  in  Part  C  of  the  Annex  II  of  Directive  2009/41/EC  could 
contribute to the reduction of the number and size of notifications.  

Belgium, Hungary, Lithuania, the Netherlands and the Czech Republic would welcome better 
explanation,  early  guidance  and  harmonised  views  across  the  EU  on  gene  therapy,  on 
synthetic biology, and on other new techniques or technological advances.   

Lithuania,  Estonia,  and  Malta  would  welcome  more  exchanges  on  experiences  and  training 
among Member States.  

6.  Clinical trials using the provisions of the Directive  

The  national  reports  showed  that  Member  States  addressed  clinical  trials  in  considerably 
different  ways.  Some  Member  States  regarded  clinical  trials  as  falling  exclusively  under 

9 

 
 
 
 
 
 
 
 
 
 
Directive 2001/18/EC (Sweden or Netherlands), while other Member States, ( Denmark and 
Finland) regarded them as falling exclusively within the scope of Directive 2009/41/EC.  

Another  reported  issue  was  the  potential  borderline  situation  between  contained  use  and 
deliberate  release  in  clinical  trials  with  GM-viruses  in  which  it  cannot  be  excluded  that 
patients' or experimental animals' excretions may contain the tested viruses. 

Other  Member  States  (Spain,  United  Kingdom)  decide  on  a  case  by  case  basis  whether  a 
clinical  trial  is  regarded  as  contained  use  or  as  a  deliberate  release.  In  Austria,  there  are 
special legal national provisions for applications concerning gene therapy in clinical trials.  

Bulgaria, the Czech Republic and Hungary considered that there is a need to discuss whether 
clinical  trials  fall  under  the  scope  of  Directive  2009/41/EC  or  under  the  scope  of  Directive 
2001/18/EC. Bulgaria, Finland, Hungary, Spain and the Czech Republic showed support for 
harmonisation  of  the  guidance  and  the  procedures  for  the  evaluation  and  notification  of 
clinical trials with GMMs at Union level.  

Some Member States (Belgium, Denmark, France, Finland, Italy, Poland, Slovenia and Spain) 
reported  increase  in  the  notifications  for  gene  therapy  clinical  trials,  while  in  Germany  the 
number has decreased.  

There  were  no  clinical  trials  using  GMMs  in  Austria,  Croatia,  Cyprus,  the  Czech  Republic, 
Estonia, Hungary, Ireland, Latvia, Lithuania, Malta, and Portugal. 

Bulgaria,  Spain  and  the  Czech  Republic,  would  like  to  see  clarity  on  the  legislative 
framework concerning clinical trials with GMMs.    

7.  Public consultation and information  

Member States generally conducted public consultations as part of the authorisation process, 
as foreseen under Article 12 of Directive 2009/41/EC. The approaches of public consultations 
varied  among  the  Member  States.  Some  Member  States  (Austria,  Czech  Republic,  France, 
Ireland, Romania and  Spain) focussed the public consultation only on class 3 and 4. Others 
(Poland),  allowed  the  Competent  Authorities  to  decide  whether  a  public  consultation  was 
needed on the basis of the Class of the activities.  

The  majority  of  Member  States  established  a  web  based  system  for  regular  public 
consultations.  Some  Member  States  had  electronic  registers  (databases)  for  applications 
submitted under Directive 2009/41/EC.  

In Belgium, the Czech Republic, Latvia, Poland, Romania, Slovakia, Slovenia, Spain and the 
United  Kingdom,  the  public  had  access  to  the  information  or  summary  of  the  applications 
available in the data bases. 

In  Hungary,  the  notifications  published  on  the  internet  contain  a  summary  of  the  risk 
assessment available at the Secretariat of 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.  

10 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Other  approaches  to  communicate  to  the  public  relevant  information  in  the  context  of 
Directive 2009/41/EC, included public meetings of advisory bodies and seminars (the Czech 
Republic), publications of annual reports (Croatia, the Czech Republic, Germany, Spain and 
the  United  Kingdom),  local  or  national  newspapers  (Denmark,  Netherlands),  brochures 
(Estonia),  competent  Ministry  publications  (Slovakia),  and  publications  of  the  minutes  of 
meetings (the United Kingdom). In Malta there were two radio interviews.   

In some Member States (Austria, Bulgaria, Cyprus, Finland, Portugal and Sweden), no public 
consultations  were  carried  out,  because  no  application  was  received  during  the  reporting 
period  for  the  classes  under  Directive  2009/41/EC  which  the  national  provisions  call  for  a 
public consultation.  

With  the  exception  of  Slovenia  and  the  United  Kingdom,  Member  States  received  no 
responses  to  public  consultations  and  information  made  publicly  available  under  Directive 
2009/41/EC during the reporting period. In the two Member States which received responses, 
the summaries of the comments were made available on the Competent Authorities' website. 
In  Ireland,  the  Competent  Authority  received a letter  from  a  member  of  the  public;  seeking 
additional  information  on  the  implications/risk  associated  with  class  3  GMM  contained  use 
activity (GM strains of Hepatitis).  

8.  Waste disposal  

In  general,  Member  States  declare  addressing  waste  management  by  class  or  category  of 
waste  in  accordance  with  the  requirements  of  Article  5  and  of  Annex  IV  of  Directive 
2009/41/EC.  The  Member  States  which  did  not  provide  any  information  on  these  aspects 
explained that there was no activity in this area.  

Few  Member  States  (Belgium,  Lithuania,  Poland  and  Portugal),  prescribed  that  all  types  of 
residues had to be inactivated prior to disposal. In Spain, the waste inactivation is optional for 
class 1 and obligatory for class 2, 3 and 4 but the Competent Authority recommends operators 
to inactivate the GMOs in all cases.  

Most Member States use autoclave or chemical treatment to dispose of GMM waste, and/or 
incinerate  GM  plants  and  animals.  In  Germany,  there  are  two  genetic  engineering  facilities 
where large animals can be disposed of with the help of a digester (alkaline hydrolysis).  

Some  Member  States  (Germany,  France,  Ireland,  Lithuania  and  the  United  Kingdom),  had 
waste treatment facilities dedicated to GM waste inactivation. In Austria, the Netherlands, and 
Finland, there is one waste treatment facility dedicated to GM waste inactivation, otherwise 
the operators inactivate it themselves. In countries where there are no authorised GM waste 
treatment facilities, the users inactivate their GMO waste themselves (Denmark, Estonia) or 
use  the  general  waste  treatment  facilities  available  (Belgium,  Bulgaria,  Hungary,  the  Czech 
Republic, Spain and Sweden).  

9.  Summary and Conclusions 

During  the  period  2009-2014  most  contained  use  activities  declared  by  Member  States  fell 
within class 1 or class 2. Although there are significantly fewer class 3 and 4 activities being 

11 

 
 
 
 
 
 
 
 
carried  out,  their  number  is  increasing.  Most  activities  were  related  to  research  but  several 
served commercial purposes such as the manufacture of diagnostics, veterinary and medicinal 
products.  

Member States applied the Directive in a similar fashion in terms of administration, handling 
of  the  notifications,  inspections,  waste  disposal  and  public  consultation  and  information. 
Differences arose in those areas covered by the Directive on which Member States have either 
enacted  additional  legislation  as  for  example,  in  extending  the  provisions  of  Directive 
2009/41/EC to cover GM plants and animals, maintaining the requirements for notification for 
each Class 1 activity, or when they apply the provisions of 2009/41/EC as in requiring for all 
Classes,  inactivation  of  waste  before  disposal  or  employing  independent  advisory  scientific 
bodies for the assessment of notifications. 

The  national  reports  showed  that,  in  the  Member  States,  several  and  at  times  different 
authorities,  ministries  and/or  agencies  are  involved  in  the  notification  and  approval  process 
and  in  inspection  and  enforcement.  The  process  of  notification  and  approval  is  similar  and 
timelines well respected.  Inspections are conducted systematically and on an ad hoc basis in 
all premises or in specific class (classes 3 and 4) activities using specialised staff.   

When  inspections  identified  areas  for  improvement,  national  reports  indicated  that  the 
competent authorities ensured that notifiers acted to rectify the situation within set deadlines.   

Accidents  in  the  reporting  Member  States  were  few  and  minor  in  significance  in  terms  of 
human  health  and  the  environment.  In  all  reported  cases,  Member  States  reported  that  the 
appropriate corrective measures were undertaken in all accidents involving humans/personnel, 
on  the  processes  and  operating  procedures,  and  the  contained  used  premises  and/or 
installations.   

The  national  reports  show  that  problems  of  interpretation  of  the  provisions  of  the  Directive 
arise  in  some  reporting Member  States,  particularly in  the  cases  of  the definition  of  genetic 
modification in the Directive, in the case of notifications involving modifications using novel 
techniques,  in  the assessment of the various  classes  of GMMs,  in  the subsequent  'contained 
use' activity, and as regards to clinical trials in the context of the Directive. In their reports, 
several  Member  States,  stressed  that  the  problems  mentioned  above  and  the  actual 
administration  of  the  process  (number  of  notifications,  processing  of  notifications  and 
approval,  inspections,  etc.)  result  in  a  significant  administrative  burden  which  merits 
examination with the view to harmonise and simplify to the extent possible.  

In  terms  of  public  consultation  and  information,  almost  all  reporting  Member  States  have 
implemented provisions for conducting public consultations, and for informing the public on 
the outcome of their activities under the Directive. Although the internet was primarily used, 
other  means  of  communication  (seminars,  meetings,  brochures,  etc.)  were  employed.  In 
general, there were no responses to public consultations. 

Finally, in terms of waste disposal, all reporting Member States have declared having enacted 
waste management provisions according to the GM class. In some instances, Member States 
required  the  most  stringent  waste  management  treatment  for  all  classes  of  GMMs.    Both 
specialised and no specialised waste treatment facilities were used.  

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