COMMISSION STAFF WORKING DOCUMENT Accompanying the document Report from the Commission 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 for the period 2014 – 2018
Date: 2021-05-31
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, application of EU law, chemical accident, environmental impact, environmental risk prevention, genetically modified organism, health control, microorganism, waste disposal

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 31.5.2021  SWD(2021) 114 final  COMMISSION STAFF WORKING DOCUMENT Accompanying the document Report from the Commission 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 for the period 2014 – 2018 {COM(2021) 266 final}  
 
 
COMMISSION STAFF WORKING DOCUMENT 

PART I: GENERAL IMPLEMENTATION OF THE DIRECTIVE 

1.  

Notification and approval systems (and relevant changes)  

1.1  Which is  the Competent Authority  (CA) for Directive 2009/41/EC  on the contained 
use of GMMs in your Member State (Article 10(1) of the Directive)? (Provide details 
where  other  authorities,  ministries  or  scientific  institutions  are  involved  or  where 
authorities are established at national/regional level)  

2014 -2017 
AT  The  Federal  Ministry  of  Education,  Science  and  Research  is  CA  for  contained  uses  in 
Universities  and  scientific  institutions;  the  Federal  Ministry  of  Labour,  Social  Affairs, 
Health and Consumer Protection is CA for all other contained uses. 

BE  The EU regulatory framework concerning the contained use of GMMs is implemented and 
enforced in Belgium at the regional level. Three different regional decrees therefore exist. 
The scope of the Belgian regional legislation is broader than the scope of the EU Directive 
since it includes, in addition to genetically modified microorganisms (GMMs), genetically 
modified organisms (GMOs) and pathogenic organisms. 

A  Cooperation  agreement  concerning  biosafety  was  set  up  in  1997  to  ensure  that  the 
transposition and practical  implementation  of the “contained use” Directive are done in  a 
harmonised  way  between  the  three  Regions  at  the  administrative  and  scientific  level. 

The competent authorities in charge of the regional decree on contained use of GMMs (and 
pathogens) application are: 

-  For  Wallonia:  Service  Public  de  Wallonie,  Direction  Générale  Opérationnelle  3 
"Agriculture,  Ressources  naturelles  et  de  l'Environnement  (DGARNE),  Department  of 
Permits and Authorisations – External directions. 

-  For  the  Flemish  Region:  Departement  Omgeving,  Afdeling  Gebiedsontwikkeling, 
omgevingsplanning en –projecten (GOP), Environmental permit service. 

- For the Brussels-Capital Region: Institut Bruxellois pour la Gestion de  l’Environnement 
(IBGE) / Brussels Instituut voor Milieubeheer (BIM), Authorisation 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. 

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

CY  Ministry of Labour, Welfare and Social Insurance 
CZ  The  Ministry  of  the  Environment  is  the  CA  for  contained  use  of  GMMs  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 

1 

 
 
 
 
 
 
 
GMOs.  

An expert advisory body to the Ministry of the Environment, the Czech Commission for the 
Use  of  GMOs  and  Genetic  Products  (CzC  GMO),  deals  with  the  environmental  risk 
assessment.  Members  of  the  CzC  GMO  are  experts  from  administrative  authorities, 
scientists and representatives of environmental NGOs. 

DE  The  CAs  for  Directive  2009/41/EC  in  Germany  are  the  Federal  state  (Bundesländer) 
authorities  (n=16);  The  coordinating  Competent  Authority  is  the  Federal  Office  of 
Consumer Protection and Food Safety (BVL) 

DK  The working environment authority and the environmental protection agency 
EE  Labour Inspectorate 
EL  Directorate of Natural Environment Management and Biodiveristy 
ES 

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,Fisheries,  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) 

FI  Geenitekniikan  lautakunta  (Board  for  Gene  Technology)  is  the  licencing  authority.  The 
Board  has  members  of  several  ministries.  The  Board  uses  governmental  institutions  as 
expert institutions at need and it has nominated external experts as its presenting officials. 
The  supervisory  authority  for  contained  use  is  Sosiaali-  ja  terveysalan  lupa-  ja 
valvontavirasto Valvira (National Supervisory Authority for Welfare and Health). 

FR  Ministère de l'Enseignement Supérieur, de la Recherche et de l'Innovation pour l'utilisation 

confinée des OGM 
Autres:  Ministère  de  la  défense  pour  les  établissements  relevant  de  son  autorité;  Haut 
Conseil des biotechnologies (HCB) pour l'évaluation des projets 

HR  Ministry of Health and Ministry of Science and Education  
HU  Ministry of Agriculture and National Institute of Pharmacy and Nutrition 
IE  The Environmental Protection Agency is responsible for implementation of the legislation 
including  enforcement.  The  Department  of  Communications,  Climate  Action  and  the 
Environment is responsible for policy. 

IT  Ministry of Health (MoH) 

In  compliance  with  the  Italian  Legislative  Decree  206/2001,  CA  authorizes  GMMs 
installations  and  activities  in  accordance  with  the  opinions  of  the  Biotechnology  Health 
Technical Committee (BHTC) of the Ministry of Health (MoH). 

2 

 
 
 
 
The BHTC was established on 20th May 2015 and it has replaced, with the same functions, 
the previous “Inter-ministerial Commission for the GMM Evaluations” that had been laid 
down by Legislative Decree 206/2001. 

Regions, autonomous Provinces, Prefect and Mayor 

The  premises  holder  that  intends  to  carry  out  a  GMM  contained  use  (CU)  has  to  keep 
informed the concerned Region and autonomous Province where the installation is located. 

The  Region  and  the  autonomous  Province  are  informed  of  each  authorized  premise  by 
MoH. 

When a CU of class 3 or 4 is authorized, the MoH informs the Region and the autonomous 
Province. 

The MoH informs the Prefect, the Mayor and the Presidents of the Region and Province in 
which a CU is carried out; if the MoH considers, on the basis of the Biotechnology Health 
Technical  Committee  (BHTC)  assessment,  that  failure  of  the  containment  measures  can 
lead  to  serious  danger,  whether  immediate  or  delayed,  to  humans  outside  the  premise 
and/or  to  the  environment,  the  Prefect,  the  Mayor  and  the  Presidents  of  the  concerned 
Region  and  Province  draw  up  the  emergency  plans  promptly,  and  in  any  case,  within  60 
days, on the basis of information included in the notification submitted to the MoH. 

The Mayor is responsible to assure that the population at risk is informed about the relevant 
safety measures and about the correct behavior to be taken based on the emergency plans. 

The MoH with the support of the Civil Protection Department (Presidency of the Council of 
Ministers) ensures the appropriate consultations and the exchange of information with the 
Competent  Authorities  of  the  Member  States  concerned  and  makes  available  the  same 
information as that which is disseminated to Italian nationals. 

When  an  accident  occurs  the  user  must  inform  MoH  and  the  premises  holder  and,  if  the 
accident can lead to serious danger, whether immediate or delayed, to humans outside the 
premise  and/or  to  the  environment,  the  Ministry  for  the  Environment,  Land  and  Sea 
Protection and the Presidents  of the concerned  Region  and Province, the Prefects  and the 
Mayors  responsible  of  the  territory  that,  on  the  basis  of  their  competences,  activate  the 
emergency plan. 

The  Ministry  for  Environment,  Land  and  Sea  Protection,  Via  Cristoforo  Colombo,  44, 
00147, Rome - Directorate General for Environmental Assessments and Permits Unit IV - 
Assessment  and  reduction  of  risks  arising  from  chemicals  and  genetically  modified 
organisms is the Competent Authority for Directive 2001/18/EC. 

The Italian Medicines Agency (AIFA), Via del Tritone, 181, 00187, Rome, is the National 
Competent  Authority  (NCA)  for  medicinal  products  (human  use)  and  for  assessment  and 
authorization of clinical trials. Among the tasks of AIFA is to co-ordinate the inspections at 
manufacturing sites of finished medicinal products in order to ensure compliance with EU 
Good Manufacturing Practice and the related guidelines. All sites on the Italian territory are 
regularly  inspected,  in  order  to  guarantee  consistency  in  the  manufacturing  process  of 
medicinal  products  and  an  adequate  pharmaceutical  quality  of  the  finished  dosage  form. 

3 

 
 
 
 
 
 
 
The Ministry of Health, Directorate General for Animal Health and Veterinary Medicines – 
Offices 4 and 5 represents the NCA for veterinary medical products which is in charge for 
the marketing authorizations included the clinical trials on the animals. Among the tasks of 
NCA  there  are  the  inspections  at  manufacturing  sites  of  finished  medicinal  products  and 
active substances in order to ensure compliance with EU Good Manufacturing Practice and 
related  guidelines.  All  sites  on  the  Italian  territory  are  regularly  inspected,  both  for  the 
GMP  and  Pharmacovigilance  compliance  in  order  to  guarantee  consistency  in  the 
manufacturing process of medicinal products and an adequate pharmaceutical quality of the 
finished dosage form. 

The Ministry of Health, Directorate General for Animal Health and Veterinary Medicines – 
Office  6  is  the  NCA  for  controls  related  to  the  protection  of  animals  used  for  scientific 
purposes. 

The  Italian  National  Labor  Inspectorate  for  the  protection  of  the  workers  exerts  and 
coordinates  the  vigilance  on  the  national  territory  in  the  field  of  work,  contribution, 
compulsory insurance and social legislation, including vigilance on the protection of health 
and  safety  in  the  workplace,  within  the  limits  of  the  competences  attributed  to  the 
Inspection staff of the Ministry of Labor and Social Policies, as established by Legislative 
Decree 9 April 2008, n. 81. 

Institute of Food Safety, Animal Health and Environment “BIOR” 

LT  Ministry of Environment 
LU  Ministry of Health - Division of food security (SECUALIM) 
LV 
MT  The Environment and Resources Authority 
NL  Ministry  of  Infrastructure  and  Water  Management  (policy),  National  Institute  for  Public 
Health  and  the  Environment  (licensing),  COGEM  (advisory  board),  Human  Environment 
and Transport Inspectorate (Inspection) 

PL  Ministry of Environment 
PT  The Competent Authority for Directive 2009/41/EC is the Portuguese Environment Agency 
(APA).  We  belong  to  the  Ministry  of  the  Environment,  Spatial  Planning  and  Energy.  

The national legislation – Decree Law n.º 55/2015, establishes that the final approval of  a 
notification  for  contained  use  of  GMMs  and  GMOs  is  granted  by  the  Portuguese 
Environment Agency, after receiving a favourable opinion from the Directorate General of 
Health  (DGS)  and  National  Health  Institute  Doutor  Ricardo  Jorge  (INSA).  In  case  of 
contained use of GMOs (higher plants and animals) the Directorate General for Food and 
Veterinary (DGAV) is also consulted. 
-  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. 

RO 

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 national authority for scientific research, which assesses and analyses the notification 

4 

 
 
 
 
 
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 labor and social justice, 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.  

SE  Swedish Work Environment Authority; SWEA (Arbetsmiljöverket) 
SI 

The  CA  for  the  Directive  2009/41/EC  is  MINISTRY  OF  THE  ENVIRONMENT  AND 
SPATIAL  PLANNING  (MESP)  of  REPUBLIC  OF  SLOVENIA.  Registration  of  the 
installations  for  GM  animals  requires  a  consensus  of  the  Veterinary  authority  which 
operates under the Ministry of agriculture,  food and forestry. 

SK  The  Ministry  of  Environment  of    the  Slovak  Republic,  Department  of  environmental 

UK 

hazards and biosafety   
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 CA. The 
functions are delegated to HSE and DEFRA officials. 

In Scotland, the CA comprises Scottish Ministers and HSE and similarly these functions are 
delegated to HSE and Scottish Government officials. 

n  Northern  Ireland,  the  CA  is  the  Health  and  Safety  Executive  for  Northern  Ireland 
(HSENI) and Department of Agriculture, Environment and Rural Affairs (DAERA), acting 
jointly. HSENI officials  are provided with  technical  support from HSE, under an Agency 
Agreement. 

5 

 
 
 
 
2018 
AT 

BE 

BG 
CY 
CZ  
DE  

DK  

EE  
EL 

Federal  Ministry  of  Labour,  Social  Affairs,  Health  and  Consumer  Protection 

Federal Ministry of Education, Science and Research 
Service Biosafety and Biotechnology (SBB) of Sciensano 

Technical expert for the regional competent authorities 

Ministry of Environment and Water 
Department of Labour Inspection 
Ministry of the Environment 
The CAs for Directive 2009/41/EC in Germany are the Federal state (Bundesländer) 
authorities  Coordinating  Competent  Authority:  Federal  Office  of  Consumer 
Protection and Food Safety (BVL) 

The  Working  Environment  Authority  (WEA)  and  the  Environmental  Protection 
Agency (EPA) 
Labour Inspectorate 
Hellenic Ministry of Environment & Energy 
General Directorate of Environmental Policy 
Directorate of Natural Environment Management and Biodiversity 
Biodiversity Department 
Interministerial Council of GMO  
Board for Gene Technology 

Environmental Protection Agency 

ES  
FI  
FR    Ministère de l'enseignement supérieur, de la recherche et de l'innovation 
HR  
HU   Ministry of Agricuture, Department of Biodiversity and Gene Conservation 
IE  
IT 
LT  
LU  
LV 
MT 
NL  
PL 
PT 
RO 
SE  
SI  

Ministry of Environment 
Division of food safety (SECUALIM) 
Institute of Food Safety, Animal Health and Environment “Bior” 
The Environment and Resources Authority 
Ministry of Infrastructure and Water Management 

Portuguese Environment Agency 
NATIONAL ENVIRONMENTAL PROTECTION AGENCY 
Swedish Work Environment Authority 
REPUBLIC OF SLOVENIA 
MINISTRY OF THE ENVIRONMENT AND SPATIAL PLANNING (MESP) 
Ministry of Environment of the Slovak Republic 
United Kingdom 

SK 
UK 

1.1bis  Is  the  CA  for  Directive  2009/41/EC  in  your  Member  State  also  CA  for  Directive 

2001/18/EC on deliberate release into the environment of GMO? 

6 

 
 
 
 
  
 
 
 
1.2 

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

2014-2017 

also 
for 

1.1 bis Is the 
for 
CA 
Directive 
2009/41/EC 
your 
in 
Member 
State 
CA 
Directive 
2001/18/EC 
on 
deliberate 
release 
the 
environment 
of GMO? 

into 

Provide rationale: 

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

in 

AT  Yes 

BE  No 

Yes 

Yes 

BG  Yes 

Yes 

CY  No 

CZ  Yes 

DE  No 

DK  Yes 

No 

Yes 

Yes 

Yes 

The  Austrian  Gene  Technology  Act  covers  all  aspects  of 
genetically modified organisms 
The regional authorities corrected the limitation of the scope (to 
micro-organisms) by also guaranteeing a risk assessment of GM 
plants  and  GM  animals  used  in  laboratories,  greenhouses  or 
animal housing. This allows appropriate containment measures to 
be  adopted  if  necessary  to  protect  human  health  and  the 
environment during activities involving all types of GMOs. 

Bulgarian  GMO  Law  covers  all  GMO  as  it  will  be  complicated 
and confusing to have separate legislation for different groups of 
organisms. Activities with  GM plants and animals  are classified 
either as class A – no or negligible risk for the human or animal 
health and for the environment and class B – all other cases.  
There  was  no  need  because  there  were  no  activities  and/or 
installations involving GMOs 
Some  GM  plants  and  GM  animals  could  pose  risk  for  the 
environment if accidentally released. Therefore  contained use of 
all GMOs should be regulated. Besides, GMMs and other GMOs 
are often used in the same premises so the risk assessment of the 
contained use must consider GM plants and animals as well. 
The German GenTG has also implemented Directive 2001/18/EC 
and  extended  the  scope  of  2009/41/EC  to  the  contained  use  of 
GM plants and GM animals. 
In  1986  Denmark  implemented  the  first  Act  of  Parliament 
regarding regulation of GMO by which both genetically modified 
microorganism,  plants  and  animals  should  be 
regulated. 
Regarding the implementation of the directive in 1991, Denmark 

7 

 
 
 
 
 
 
  
EE  No 
EL  No 
ES  Yes 

FI  Yes 
FR  No 
HR  No 

HU  Yes 

IE  Yes 

IT  No 

No 
No 
Yes 

Yes 
Yes 
Yes 

Yes 

Yes 

No 

kept  the  legislation  on  genetically  modified  animals  and  plants 
together  with  the  microorganisms  mentioned  in  the  directive. 
This  regulation  has  been  and  still  is  based  upon  the  political 
attitude toward the subject.  
Ministry of Environment 
Strict interpretation 
Contained used activities with GMO are regulated under National 
Law 9/2004 
Coverage in legislation for all types of GM organisms. 
Pour raisons sociétales 
In  accordance  to  the  Ordinance  on  the  content,  scope  and 
methodology for the preparation of risk assessment in relation to 
contained  use  of  genetically  modified  organisms  ("Official 
Gazette" No. 84/2006) 
The  same  documentation  is  required  in  case  of  GM  plants  and 
GM animals as in case of GMMs. 
Transposing legislation has been extended to require notification, 
risk  assessment  and  enforcement  of  contained  use  activities  for 
GM plants and GM animals.  
According to  2001/18/EC  directive, the contained use of GMOs 
(e.g.  for  testing/research  purposes)  should  be  carried  out  by 
the  same 
implementing  containment  measures  based  on 
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 toat EC and national levels. 

Italian  CA  for  Directive  2009/41/EC  did  not  receive  any 
notification of contained use of GMOs. 

With the exclusion of combined uses of animals and plants with 
GMMs,  Italy  has  not  extended  the  Directive  2009/41/EC  to  the 
use of GM animals and GM plants therefore, if notifications will 
be submitted, the assessment will be focused on the risks for the 
operators and the environment that could occur during the GMM 
manipulation. 

The GMM CA is evaluating how such type of activities, from a 
legislative  point  of  view,  can  be  regulated  and  the  different 
measures  and  type  of  authorizations  that  should  be  applied. 

An  harmonized  approach  at  European  level  could  support  the 
decisions of Member States to adopt measures based on the same 
safety criteria for the humans and environment. 

LT  Yes 

LU  Yes 
LV  Yes 
MT  Yes 

Yes 

No 
No 
Yes 

Additional  specific  requirements  for  the  contained  use  of  GM 
plants and GM animals are planned to be prepared in the future. 
Directive 2009/41 is not yet transposed in national law. 
In Directive there is clear definition of GMM.  
Not applicable. 

8 

 
 
 
 
NL  Yes 

PL  Yes 

PT  Yes 

Yes 

Yes 

Yes 

RO  Yes 

No 

SE  No 

Yes 

SI  Yes 

Yes 

SK  Yes 

Yes 

UK  No 

Yes 

https://genteknik.nu/hitta-ratt-myndighet/ 

the  scope  of  the  Dutch  GMO  Decree  covers  directive  2009/41 
and directive 2001/18 and covers both GMM’s and GMO’s. 
The reason was the biosecurity of such products which in case of 
GM plants and animals risk might be higher 
The Decree Law n. º 55/2015 that transposes to national law the 
Directive 2009/41/EC stipulates in the scope that it applies to the 
contained uses of GMMs and GMOs (higher plants and animals). 
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.  
Responsibilities  concerning  GMOs  are  divided  between 
that  has  responsibilities  concerning  non-GMO: 
authorities 
Swedish Agency for Marine and Water Management (Havs- och 
vattenmyndigheten)  is  responsible  for  contained  use  of  water 
living GMO, SWEA is responsible for contained use of GMMs, 
Swedish Board of Agriculture is responsible for contained use of 
GMOs  not  regulated  elsewhere.  On  this  link  you  can  find  a 
the  responsibilities  and  authorities  (in 
representation  over 
Earlier 
Swedish): 
website about gene technology in Sweden is no longer up. 
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 
When  a  plant  and/or  animal  is  the  final  recipient  of  the  genetic 
modification/techniques  used,  it  may  become  a  GMO  (or  a 
paratransgenic  organism  which  keeps  the  GMM,  though  the 
genome  of  the  plant/animal  isn't  changed).  The  Directive 
2009/41/EC  already  set  measures  for  glasshouses  and  animal 
units in Annex I B and Annex I C. 
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. 

is 

that 

also 

requires 

domestic 

complementary 

legislation 
There 
(Environmental  Protection  Act  1990,  associated  regulations  and 
the  Genetically  Modified  Organisms  (Northern  Ireland)  Order 
risk  assessment  and  application  of 
1991) 
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 
and 
Governments  under 
Memorandums of Understanding. 

separate  Agency  Agreements 

9 

 
 
 
 
Provide rationale, in particular if the transposing legislation 
has  been  extended  to  the  contained  use  of  GM  plants  and 
GM animals: 

2018, 
In 
has 
the 
scope of the 
transposing 
legislation 
been 
changed  in 
your 
Member 
State? 

2018 

also 
for 

Is 
the  CA 
for Directive 
2009/41/EC 
in 
your 
Member 
State 
CA 
Directive 
2001/18/EC 
on 
deliberate 
release 
the 
environment 
of GMO? 

into 

AT  
BE  
BG  
CY  
CZ  
DE  
DK  
EE  
EL  
ES  
FI  
FR   No 

HR  
HU  
IE  
IT  
LT  
LU  
LV  
MT   Yes 
NL  
PL  
PT  
RO  
SE  
SI  
SK  

No 
No 
No 
No 
No 
No 
No 
No 
No 
No 
No 
No 

No 
No 

No 
No 
No 
No 
No 

No 
No 
No 
No 
No 

Le législateur français a considéré que le champ d'application de 
la réglementation sur les OGM doit être le même, qu'il s'agisse 
de micro-organismes, de plantes ou d'animaux. 

N/A 

10 

 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
UK  

No 

Is  there  any  change  in  the  notification  and  approval  system  with  respect  to  the  last 

1.3  
reporting period (2009-2014) in your Member State? If yes, elaborate. 

2014-2017 
AT  No 
BE  No 
BG  No 
CY  No 
CZ  Yes 

DE  No 
DK  No 
EE  No 
EL  No 
ES  No 
FI  No 

Czech Act No. 78/2004 Coll., on the Use of Genetically Modified Organisms and 
Genetic  Products,  as  amended, 
transposes  Directives  2001/18/EC  and 
2009/41/EC.  It  covers  contained  use  of  all  GMOs,  deliberate  release  into  the 
environment  (Part  B  of  Directive  2001/18/EC)  and  placing  on  the  market  of 
GMOs as such or in products, including their export and import. 

Formats of notifications, procedures of risk assessment etc. are laid down by the 
implementing  Decree  No.  209/2004,  on  Detailed  Conditions  for  the  Use  of 
Genetically  Modified  Organisms  and  Genetic  Products,  as  amended. 

The  Czech  legislation  is  stricter  than  Directive  2009/41/EC  as  regards  Class  1 
contained  use.  Until  the  end  of  2016,  a  new  notification  was  required  in  every 
case a new activity was to be carried out in previously notified Class 1 premises.  

According to the amendment to the Act No. 78/2004 Coll., which came into force 
on  1st  January  2017,  if  a  new  contained  use  is  to  be  carried  out  in  previously 
notified Class 1 premises, the user is required to submit a document on the risk 
assessment of the intended activity to the Ministry of the Environment. Although 
the Class 1 contained use may commence immediately after the submission of the 
assessment,  experts  from  the  Ministry´s  GMO  advisory  body  review  the 
assessment  at  the  same  time.  If  they  find  the  classification  of  the  activity 
incomplete  or  incorrect,  the  Ministry  is  empowered  to  require  additional 
information from the notifier and/or decide that the contained use be suspended.  

In conclusion, the requirements of the Czech Act on GMOs go beyond Article 7 
of the Directive even after the amendment. 

The implementing Decree 209/2004 was amended as well, especially as regards 
new notifications formats for various GMOs uses. Harmonised tables for the risk 
assessment of contained uses have been annexed to the Decree. These changes, in 
force  since  1  January  2017,  have  enhanced  clarity  of  notifications  both  for 
notifiers and for the competent authority.   

11 

 
 
  
  
 
 
  
  
  
  
 
 
 
 
 
  
  
  
  
  
  
FR  No 
HR  No 
HU  No 
IE  No 
IT  No 
LT  No 
LU  No 
LV  Yes 
MT  No 

NL  Yes 

PL  No 
PT  Yes 

RO  No 
SE  No 
SI  Yes 

SK  No 
UK  No 

2018 

The CA is changed. 
No  changes  were  applied  in  the  notification  and  approval  system  from  the  last 
reporting period 
on  1  March  2015  the  revised  GMO  Decree  and  GMO  Order  came  into  force. 
These new rules also resulted in different notification and reporting systems and 
thus also in the way data are presented in this report. Another consequence is that 
care  should  be  taken  when  analysing  and  comparing  these  data  with  those  in 
earlier reports. There were no changes in the scope of the Decree. 

In  2015  the  Decree  Law  n.º  2/2001  was  revoked  by  Decree  Law  n.º  55/2015.  

Regarding  to  the  approval  system  and  notification,  the  new  Law  does  not 
introduce significant changes, foreseeing, namely to: 

- clarify the legal framework for the contained use of GMOs (higher plants and 
animals); 

- for the purposes of the analysis of the notifications and giving opinion, this Law 
extend  the  consultation  in  the  context  of  the  evaluation  of  notifications  to  the 
Directorate  General  of  Health  (DGS)  and  the  Directorate  General  for  Food  and 
Veterinary  (DGAV),  in  addition  to  consulting  the  National  Health  Institute 
Doutor Ricardo Jorge (INSA); 

-  set  a  deadline  to  the  consulted  entities  for  issuing  opinions,  thus  allowing  the 
APA  to  decide  on  the  authorisations  of  notifications  within  the  time  limit; 

- introduce the obligation for notifiers to annually report on activities of contained 
use GMM/GMO.  

The  change  considers  the  administrative  procedures.  In  the  cases  the  notifier 
specifically requires the issue of a permit for work with GMOs, the notifier is due 
to cover the costs of a scientific opinion. 

In  2018,  did  you  have any  change  in  the  notification  and 
approval system in your Member State? 

Provide explanations 

12 

 
 
  
  
  
  
  
  
  
  
 
 
 
 
 
  
  
  
  
 
  
AT  
BE  
BG  
CY  
CZ  
DE  
DK  
EE  
EL  
ES  
FI  
FR 
HR  
HU  
IE  
IT  
LT  
LU  
LV  
MT  
NL  
PL  
PT  
RO  
SE  
SI  
SK  
UK  

1.4 

1.5 

No 
No 
No 
No 
No 
No 
No 
No 
No 
No 
No 
No 

No 
No 

No 
No 
No 
No 
No 

No 
No 
No 
No 
No 
No 

In  your  Member  State,  what  is  the  percentage  of  notifications1  which  were  not 
processed within the statutory timeframe in this reporting period? 

(to appear if reply to 1.4 > 0%) 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?  
Has this figure increased or decreased since the last reporting period? 

2014-2017 

1 For the definition of "notification" see the Annex. 

13 

 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
                                                 
1.4  In  your 
Member 
State,  what  is 
the 
percentage  of 
notifications 
which  were 
not  processed 
within 
the 
statutory 
timeframe  in 
this  reporting 
period?  

Percentage 
of 
notifications 
which  were 
not 
processed 
within 
statutory 
timeframe  in 
this 
reporting 
period?   

the 

AT  0% 
BE  > 0% 

1 

1.5  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? 

In Wallonia, any project for the contained use of GMO class 
2,  3  or  4  must  be  the  subject  of  an  application  for  an 
environmental permit. The Walloon legislation imposes strict 
deadlines  for  the  processing  of  permit  applications.  If  the 
decision  is  not  sent  within  the  legal  deadline,  the  permit  is 
supposed 
the  project  cannot  be 
implemented.) 

refused  and 

to  be 

In  the  Flemish  Region,  the  competent  authorities  can  only 
respect the time frame to deliver the authorization if the user 
has already obtained an environmental permit. Often the user 
chooses  to  start  the  procedure  to  obtain  the  environmental 
permit  when  he  starts 
to  obtain  an 
authorization, but the time frames are different: 45 days or 90 
days  for  an  authorization,  and  maximum  6  months  for  an 
permit. 
environmental 

the  procedure 

In the Brussels-Capital Region, notification procedures do not 
have any legal timeframe as users can implement their activity 
the  day  following  their  notification,  the  CA  doesn’t  have  to 
notify any decision. 

Approval / permit procedures have different legal timeframes 
regarding the biological class of risk of the operation. It leads 
to  the  delivery  of  a  permit  by  the  CA  based  on  its  external 
expert’s advice. This timeframe can be suspended if the CA or 
its external expert are waiting for complementary information 
from the users. Our procedure includes a visit  on site, which  
is an essential step to consider before declaring the dossier as 
complete.  This 
asking 
complementary  information  from  the  users,  suspending  and 
delaying the procedure.  

sometimes 

leads 

visit 

to 

BG  0% 

14 

 
 
  
  
  
 
 
 
  
  
CY  0% 
CZ  0% 
DE  > 0% 

DK  0% 
EE  0% 
EL  0% 
0% 
ES 
0% 
FI 
FR  > 0% 

HR  > 0% 

HU  > 0% 

IE 
IT 

0% 
> 0% 

14 

5 

9 

5 

13 

Non-compliance with the deadlines varies between 0 and 62% 
in  the  individual  federal  states.  This  is  particularly  due  to 
inadaquate  staffing  in  the  authorities,  to  the  necessary 
involvement  of  other  authorities  or  to  increasing  numbers  of 
requests at one timepoint. 

Nombre de déclarations  élevé par  rapport aux ressources qui 
ont été ajustées depuis 
There  was  a  short  time  gap  between  the  termination  of  one 
mandate  and  the  appointment  of  another  Committee  for 
contained use of GMO. 
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.  Also  the  communication  between  the  CA  and 
Gene Technology Advisory Committee has been improved.  

The  Legislative  Decree  n.  206/2006  lays  down  that  the  CA 
issues the authorizations of premises and activities according 
to  the  written  opinions  of  the  BHTC  members  that,  to  be 
the  members. 
considered  valid,  must  be  signed  by 

BHTC members evaluate the submitted notifications only the 
day of the meeting and the documents  are not  shared among 
the members before the  meeting because of electronic safety 
reasons of the mail system. 

Though  the  BHTC  meetings  are  planned  every  30-45  days, 
their  frequency  could  be  not  appropriate  and  it  is  hard  to 
increase  the  number  of  meetings  for  practical  reasons. 

Furthermore  a  web  platform,  with  suitable  electronic  safety 
measures  to  share  directly  with  the  BHTC  members  the 
notifications sent by the users, is not available. 

The  management  of  the  whole  Health  Technical  Committee 
(HTC)  of  MoH  is  entrusted  to  the  MoH  Directorate  General 
for  Collegial  Bodies  for  Health  Protection.  The  HTC 
regulation  does  not  allow  to  appoint  substitutes  of  HTC 
members  with  delegation  of  powers  to  issue  the  opinions  on 
the assessed GMM notifications. 

15 

 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
 
The  designation  and  replacement  of  BHTC  members 
inevitably  increases  the  difficulty  for  the  GMM  CA  to  plan 
and hold the BHTC meetings on time. 

The  submission  of  the  notifications  to  the  CA  occurs  by 
certified  mail  through  a  MoH  centralized  electronic  protocol 
system.  The  personnel  is  not  supported  by  appropriate 
software  to  make  available  the  documents  that  have  to  be 
assessed  and  time  to  prepare  efficiently  the  meetings  cannot 
saved. 
be 

To  date  the  GMM  CA  has  not  an  effective  and  functional 
electronic  archiving  system  or  program  to  retrieve  all 
information  provided  by  the  users  with  the  submitted 
notifications but only for part of them. The only mean through 
which  part  of  the  information  are  recorded  is  to  enter  them 
manually 
in  an  access  database.  To  retrieve  specific 
information  reported  in  the  notifications  it  is  consequently 
necessary  more  time  and,  in  several  cases,  to  carry  out 
manually the search of the paper documentation with a further 
unavoidable waste of time. 

to  downtimes 

Part  of  notifications  are  not  processed  within  the  statutory 
timeframe  due 
that  occur  when  further 
clarifications  or  integrations  are  requested  by  GMM  CA;  we 
observe that in several cases the period of time elapsed from 
sending the GMM CA requests to receiving the user responses 
can be very long. 

All the above mentioned reasons sometime imply an increase 
of  timeframe  with  which  the  notifications  are  processed, 
therefore for several of them the procedures are finalized with 
timing not aligned with statutory timeframe. 

Efforts are being made to lessen or prevent such delays in the 
future 

To  provide  a  web  platform  for  GMM  CA  and  BHCT 
members  to  share  electronically  the  documents  of  the 
notifications, to allow that the evaluations can be conducted in 
any moment and from any location, to obtain valid and signed 
opinions by each BHTC member. 

the 

information 

To open a web space on the mentioned platform in which the 
users  can  submit 
the 
notifications  or  to  update  the  contents  of  notifications 
previously submitted; to archive such type of information in a 
suitable  database  that  allows  to  retrieve  any  submitted 
information, to generate with the retrieved information ad hoc 
reports  and  keeping  track  along  the  time  of  the  changes 

required  with 

16 

 
 
 
 
 
 
 
 
 
LT  0% 
LU  0% 
LV  0% 
MT  0% 
NL  > 0% 

PL  0% 
PT  0% 
RO  0% 
SE  > 0% 

13 

1,4 

SI 

> 0% 

50 

SK  0% 
UK  > 0% 

1 

2018 

carried out by the users. 

in 

the  notification  process  were  due 

Not applicable 
Delays 
the 
implementation process of the new rules of the revised GMO 
Decree. The transition from the old to the new practice had a 
bigger impact than initially anticipated. Both the users and the 
authorities needed to adjust to the new practices. Furthermore, 
the  overall  complexity  of  the  notified  activities  are  steadily 
increasing resulting in increased processing times. 

to 

Only two notifications were delayed. The reason for delay in 
both  cases  is  a  combination  of  summer  vacation,  only  two 
officers  handling  notifications,  and  several  rounds  of 
requiring more information from the notifier. One notifier had 
several  notifications  sent  from  different  persons  in  the 
organisation and in some instances the same notification sent 
twice. SWEA now tries to give the notifier an e-mail with our 
notification  number  ("diarienummer"),  as  soon  as 
the 
notification  has  reached  the  officer  who  is  in  charge  for 
handling it. In that e-mail, SWEA states that we will read the 
notification  and  will  be  in  touch  after  that.  We  can  not 
compare to earlier time periods, as it is a very time-consuming 
process to calculate time "backwards" in time. But we have a 
feeling that our internal electronic system for GMM activities 
and  the  changed  regulations  2011  helped  to  speed  up  the 
notification process. 
the  Management  of 
According 
Genetically Modified Organisms (MGMO) Act  the Scientific 
Committee for the GMOs in the contained use has to evaluate 
and issue a scientific opinion on every notification. Therefore 
a big workload of the Scientific Committee for the GMOs in 
the contained use members is a main cause of the  delays. 

the  provisions  of 

to 

The  CA  requested  several  pieces  of  additional  information 
and  advice  was  sought  from  an  independent  scientific 
advisory committee resulting in a failure to meet the statutory 
deadline.    No  specific  measures  were  deemed  necessary  to 
remedy this issue as it was an unusual scenario that is unlikely 
to be repeated.  Please note the notifications that did not meet 
the statutory timeframe is less than 0.33% 

17 

 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
in  your  Member 
In  2018, 
State, what was the percentage 
of notifications which were not 
processed  within  the  statutory 
timeframe?  

of 
Percentage 
notifications  which 
were  not  processed 
within the statutory 
in 
timeframe 
2018?   

0% 

AT  
BE   > 0% 
BG   0% 
CY   0% 
0% 
CZ  
DE   > 0% 
DK   0% 
0% 
EE  
0% 
EL  
0% 
ES  
0% 
FI  
> 0% 
FR 
HR  
HU   0% 
IE  
IT  
LT  
LU  
LV  
MT   0 
NL   > 0% 
PL  
0% 
PT  
RO   0% 
SE  
SI  
SK  
UK   > 0% 

> 0% 
> 0% 
0% 

0% 
0% 
0% 

> 0% 

1 

15 

50 

5 

N/A 
11 

5 
11 

1 

the 

information 

From  your  experience  in  2018,  do 
you  have  new 
to 
report about difficulties in relation 
to 
process 
notification 
(including  causes  for  delays  in  the 
notification  process,  actions  taken 
to reduce those delays)? 
No 
No 
No 
No 
No 
Yes 
No 
No 
No 
No 
No 
No 

No 
No 

No 
No 
No 
No 
No 

No 
No 
No 
No 
Yes 
No 

1.6  What difficulties specific to the notification process, if any, did you encounter during 

the reporting period?2 

1.7   What in your opinion should be done or is done already to alleviate these difficulties? 

2014-2017 

2 Please note that clinical trials and gene drive modified organisms are addressed in dedicated sections of the 
questionnaire and that any difficulties related to those types of contained uses should be reported in the 
respective sections. 

18 

 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
                                                 
1.7 What in your opinion should be done or is 
done already to alleviate these difficulties? 

to 

the 
1.6  What  difficulties  specific 
notification  process, 
if  any,  did  you 
encounter  during  the  reporting  period? 
Please  note  that  clinical  trials  and  gene 
drive modified organisms are addressed in 
dedicated  sections  of  the  questionnaire 
and  that  any  difficulties  related  to  those 
types of contained uses should be reported 
in the respective sections. 

AT  none 
BE 

in 

the 

the 

In  the  Flemish  Region  :  Some  problems  are 
met 
terms 
interpretation  of 
‘notification’  and  ‘admission  request’.  The 
regional  legislation  for  the  Flemish  Region 
defines that a ‘notification’ or an ‘admission 
request’  can  be  submitted  for  subsequent 
activities of risk level 2. Besides a difference 
in  administration 
is  also  a 
fee 
difference in the way the competent authority 
shares  its  decision  (one  short  letter  versus  a 
complete  decision  including  the  external 
expert’s advice). This latter point is not clear 
to all users.   

there 

BG  Requirements  for  contained  use  of  GMO 
other  than  GMM  have  not  been  harmonized 
on  EU  level  and  differ  between  the  member 
states.  No  list  of  Generally  regarded  as  safe 
(GRAS) 
laboratory 
animals and cultivars has been adopted at EU 
level. 

laboratory 

strains, 

CY  There  was  no  difficulty  in  the  notification 

process. 

CZ  Before  the  amendment  of  the  notification 
formats  (set  by  the  implementing  Decree  as 
mentioned  in  1.3),  some  notifications  and 
risk  assessment  documents  were  not  well 
arranged,  therefore  they  were  difficult  to 
review.  
incomplete  application  documents,  difficult 
definition 
user 
further  class  1  uses), 
assessment  of 
concentration  effect,  questions  of 
fire 
protection,  handling  of  class  3**  organisms, 

(GMO 

status, 

issues 

DE 

not relevant 
To  solve  this  difficulty,  this  point  could  be 
cleared  out  by  explaining 
the 
difference  between  ‘notification’  and  ‘admission 
request’  as  a  kind  of  FAQ  on  the  Belgian 
Biosafety Server (www.biosafety.be)  

into  detail 

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, 
laboratory animals and cultivars is adopted at EU 
level,  because  they  account  for  most  of  the 
activities  done  at  universities  and  research 
institutions. 
No change is required. 

The  Ministry  with  its  experts  have  developed 
appropriate  formats  and  tables  for  notifications 
and  for  the  risk  assessment  to  be  used  by 
notifiers.  

reliable  consulting  for  users,  involvement  of  the 
ZKBS  (German  advisory  board)  in  difficult 
issues and cases of unclear risk assessment 

19 

 
 
  
 
procedures of inactivation in class 3 or 4 uses 

DK  See answer 3.2 

taking 

information 

EE  not difficulties 
EL  No notification in that period. 
ES  Generally  statutory  timeframe  is  fulfilled, 
although in the most of the cases the clock is 
is 
stopped  when  additional 
required.The  administrative  process  is  quite 
long 
the  previous 
into  account 
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).  On  the 
other  hand,    in  Spain,  clinical  trials  with 
GMOs  are  regulated  as  deliberate  reléase 
activities,  but  it  is  not  clear  if  facilities  in 
which  GMOs  are  handled  or  stored  must  be 
notified  as  contained  used  activities.  There 
are  also  problems    in  the  interpretation  if 
products obtained by new genetic techniques 
(NBT) and whether they are under the scope 
of Directive 2009/41/EC or not 

in 

FI  As  before,  the  outdated  definitions  of  the 
directive 2009/41/EC for GMM have been a 
major  problem 
the  present  research 
environment  with  its new molecular biology 
techniques.  This  leads  to  situations  where 
both 
the  operators  and  authorities  are 
uncertain  whether  a  notification  is  actually 
required or not.  

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 
apathogenic according to the directive, and if 
so, on what conditions?). 

is 

issue 

A  constant  administrative 
that 
research  groups  move  frequently  from  one 
institution  to  another,  or  their  old  premises 
are repaired, or the use of premises changes, 
leading 
the  same 
to  repeatedly  send  new 
operators  have 
notifications of their premises.  

to  a  situation  where 

Better  information  on  the  requirements  on  our 
webpage and the guide lines. 
better knowledge 
No notification in that period. 
The status of clinical trials and NBT needs to be 
harmonised at EU level 

a 

It  would  be  urgent  to  revisit  the  definitions  of  a 
GMO  in  directive  200/41/EC.  Perhaps  it  would 
be  even  useful  to  evaluate  the  pros  and  cons  of 
technology-based  regulation  versus  trait-based 
regulation  when  dealing  with 
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. 
Considering the constantly  changing premises of 
individual  research  groups  and  organizations  as 
the 
lessen 
well  as  SMEs,  possibilities 
administrative 
notification 
burden 
requirements of Article 6 should be examined.  

of 

to 

20 

 
 
 
 
FR  L'application 

(traitement 
"DUO" 
dématérialisé  des  dossiers)  utilisée  nécessite 
des 
répondre 
développements 
pleinement aux besoins 

pour 

HR  We  do  not  have  any  difficulties  in  the 

notification process. 

HU  None. 
IE  Classification of attenuated viral vectors 

See previous answer. 
- 

IT 
LT 
LU  Recently the GMO dossier was taken over by 
SECUALIM.  SECUALIM  does  not  have  a 
former  actions. 
complete  overview  of 
Luxembourg  does  not  apply  the  notification 
process,  we  still  have  an  authorisation 
procedure. 

Revoir  "DUO"  pour  améliorer  et  simplifier  le 
traitement des dossiers 

So  we  suggest  that  Union  make  list  with  of 
known  biological  agents  in  accordance  to  the 
hazards  and  in    accordance  to  certain  levels  of 
contained use of GMMs. 
None. 
In  February  2018 the CA liaised with  other CAs 
under  Directive  2009/41/EC  to  determine  how 
in 
attenuated  viral  vectors  were  classified 
respective Member States. The CA also discussed 
the matter with their Advisory Committee and the 
advice  was  that  they  should  continue  to  be 
classified as Class 2 GMMs.  

See previous answer. 
- 
Directive  2009/41  is  being  transposed  +  more 
resources have been recruited to perform on field 
inspections. 

LV  We do not have received any notification. 
MT  No  difficulties  were  encountered  during  the 

- 
Not applicable. 

Both  users  and  authorities  are  adjusting  to  the 
new practices. Authorities and users are involved 
in stream-lining these practices. 
better translation of required rules 
No particular difficulties were found. 
Not applicable. 
The notification procedure could be simplified in 
the  Directive  for  Class  1  and  Class  2  with  only 
notification  on  information  on  class,  type  of 
activity, 
contact 
information  for  responsible  persons  and  address 
to the workplace.  

organisation 

involved, 

notification process 

NL  See earlier answer; the overall complexity of 
the  notified  activities  are  steadily  increasing 
resulting in increased processing times. 

fit  well 

PL  none 
PT  No particular difficulties were found. 
RO  Not applicable. 
SE  The  risk  assessment  and  notification  system 
and  the  Directive  is  somewhat  ancient.  New 
methods  does  not  always 
in 
notification  of  "new  use  Class  2".  It  is 
difficult  to  explain  to  the  notifier  that  they 
need  to  do  a  case-by-case  notification  when 
it  is  a  high-throughput  system  with  very 
different  inserts  in  the  same  virus  vector  in 
the same "runs". The description of a "GMM 
use"  is  often  too  vauge  to  comply  with  the 
Directive,  giving  only  "gene  of  interest"  or 
"cDNAs" as identification of insert. Another 
complication is the limit between Class 1 and 
Class  2  for  GMM  uses  with  a  replication 
deficient  virus  vector  that  is  very  common 

21 

 
 
now:  on  one  hand,  the  vector  is  not  capable 
of replication in cells, on the other hand, the 
vector may contain genes that in worst case, 
if introduced to a worker, could give a single 
(cell  death, 
cell  unwanted  properties 
uncontrolled  growth,  carcinogenic  activity). 
Our current limit is between GMM uses with 
or  without  virion  particles:  when  there  is 
(risk  for)  particles,  it  should  be  handled  in 
Class  2,  and  when  there  are  no  particles 
present,  it  can  almost  always  be  handled  in 
Class  1.  (And  there  is  no  need  to  notify  a 
Class  1  activity  where  there  is  a  Class  2 
activity already.) 

SI  However, most of the delays were short and 
in  all  cases  the  notifiers  were  approached 
with  the  ample  explanation.  We  did  not 
receive  any  complaint  about  it.  Slightly 
longer  delays  are  caused  by  the  Veterinary 
authority  which  operates  under  the  Ministry 
of agriculture and forestry.  
----- 

SK 
UK  The  notification  requirements  under 

the 
GMO(CU)  Regulations 
regulations 
which  implement  Directive  2009/41/EC)  are 
is 
well-understood  by  users  and 
believed  to  be  a  high  level  of  compliance 
with these requirements in the UK. 

there 

(the 

MESP  put  a  lot  of  effort  to  explain  the  situation 
to  the  Veterinary  authority  in  order  to  acquire 
their consent sooner.  

------- 
The notification of contained use of GMM in the 
UK is working well. 

2018 

1.6  What  new  difficulties  specific 
the 
notification  process  did  you  encounter  in  2018, 
and in  your  opinion  what  should  be  done  or  is 
done already to alleviate these difficulties?  

to 

1.7  Were  there  new  reasons  in  2018 
for delays  in  the  notification  process 
and  what  efforts have  been  made to 
lessen  or  prevent  such  delays  in  the 
future? 

AT  
BE  
BG  
CY  
CZ  
DE   High complexity of application documents. 
DK  
EE  
EL  
ES  
FI  
FR  

Insufficient personnel 

no 

Réorganisation du processus administratif 

22 

 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
HR  
HU  
IE  
IT  
LT  
LU  
LV  
MT   No  difficulties  were  encountered  during 

notification process. 

the 

N/A 

NL  
PL  
PT  
RO  
SE  
SI  
SK   Amount of contained uses notified and submitted in 
one  notification  on  activities  under  risk  class  3. 

The complexity of the assessment process threatened 
to  cause  delays  in  the  statutory  timeframe  for 
decision. 

The recipient was M. tuberculosis; one genome of a 
GMM  can  contain  about  5000  genes  and  18 
activities were notified using 11 groups of vectors. 

No 

new 

reasons.  

in  case  of 

To  prevent  delays 
the 
notification  desribed  above,  we  had  to 
find  some  „problem  points“  and  ask  the 
notifier  to  submit  a  new  notification 
related  to  these  points,  what  reduced  (a 
bit) 
the  number  of  contained  uses 
considered. 

The  period  of  time  during  which  the  ministry  is 
waiting  for  the  opinion  of  its  advisory  body  – 
recommendations 
the 
Biosafety  Committee  –  falls  (is  taken)  into  the 
statutory timeframe for decision. 

from  experts  and 

from 

If the same notifier submits a new notification under 
risk  class  3,  the  timeframe  of  45  days  for  decision 
will  apply  according  to  Article  9  par.  2,  letter  a)  of 
the Directive 2009/41/EC. 

We consider the period insufficient. 

We  think  that  the  period  of  time  during  which  the 
ministry  is  waiting  for  the  opinion  of  its  advisory 
body  should  not  be  taken  into  account,  or,  the 
Competent  Authority  should  have  the  possibility  to 
notification. 
influence 

extent 

the 

the 

of 

Isolation  of  the  laboratory  suite  was  doubted  by 
some  members  of  the  Biosafety  Committee  as  the 
enclosed  facility  of  containment  level  3  was  built 

23 

 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
 
 
 
 
inside of another laboratory. We would appreciate a 
guidance  on  „the  laboratory  is  separated  from  other 
areas  in  the  same  building“  (Annex  IV,  table  I  A, 
point 1 of the Directive).   

UK  

2.   Waste disposal  
2.1  What are the means by which waste containing GMMs is inactivated and disposed of, 
with  particular  reference  to  large  volumes  of  waste  material  (including  large  GM 
plants/animals or large quantities of plants/animals inoculated with GMMs)?  

2014 - 2017 
AT 

BE 

Waste  from  facilities  using  GMM/GMO  must  be  treated  appropriate  to  the  GMMs/GMOs 
risk  class  in  order  to  limit  its  contact  to  the  environment.  GMM/GMO  of  risk  classes  2-4 
must  be  inactivated  by  appropriate  measures.  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. 
In the Regional decrees implementing Directive 2009/41/EC, there is an explicit requirement 
to  inactivate  all  types  of  GMMs  and  GMOs  -  even  of  risk  class  1  -  by  appropriate  and 
validated means prior to disposal as waste. 

Inactivation can either be done on site, or 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  a  certified  or  accredited 
company.  

Steam  sterilisation  (autoclaving  of  solid  waste)  and  chemical  inactivation  (fluids)  are  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.  

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

BG  

The  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 followed. All approved facilities are 
part of academic institutions and only small to moderate amounts of waste are generated at 
any  given  time.  The  inactivation  takes  place  on  the  premises  and  is  usually  done  by 

24 

 
 
  
  
 
 
 
 
CY  

CZ  

autoclaving. Inactivated waste is disposed following the general requirements. 
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. 
GMMs are inactivated and disposed of in the same way and by the same means as infectious 
waste  containing  pathogenic  microorganisms  (by  autoclaving,  chemical  disinfectants  etc.) 

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

GM  plants  are  either  autoclaved  or  in  large  volumes  chopped,  seeds  are  ground  and  the 
resulting material composted in the area of the user´s facility. 

DE  

DK  

EE  
EL  
ES  

Usually,  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).  Some  facilities  are  individually  equipped  with  incinerators. 
Occasionally, chemical inactivation also plays a part in the treatment of waste. 
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. 
labor clothes, labor animals 
Not applicable 
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. 

FI  

FR  

HR  

Several methods can be used depending on the GMO, the facility and the methods available. 
For  example  heat  treatments  (autoclaving,  incineration,  burning,  steaming),  chemical 
treatments  (disinfectants,  acids,  alkali,  oxygenating  agents),  UV  treatments,  freezing 
(although  only  for  certain  plant  and  animal  materials),  mechanical  treatments  (shredding, 
pressure),  and  composting.  When  necessary,  two  or  more  methods  can  be  combined  or 
different methods may be used for different tissues of a GM-plant or animal.      
Les déchets  solides  et  liquides issus des activités de recherche mettant  en œuvre des  OGM 
sont inactivés par des procédures chimiques ou thermiques validées, sur le site de production 
et sont ensuite collectés comme DASRI pour incinération 
In  the Republic of Croatia, mostly GM waste was inactivated by chemical  liquid  (HOCl or 
other  disinfectant)  or  was  inactivated  by  autoclav  depends  by  class  of  risk  assessment  og 
GMO. If it is large amount GM waste then it is incinerated. 

25 

 
 
 
 
 
HU 

IE  

Usually  autoclave  or  burning.  Large  volume  of  waste  is  transported  and  disposed  by 
specialized companies according to the rules of hazardous waste management.  
Waste from biotechnological activities (both hazardous and non-hazardous) is treated under 
the national legislation concerning hazardous waste. 
All GMM waste irrespective of Class of the activity, must be inactivated by validated means 
prior to disposal. Class 1 and Class 2 GMM waste may be sent off site for treatment with the 
prior agreement of the CA. Class 3 GMM waste must be treated on site. GM animal remains 
whether inoculated with Class 1/2 GMMs or not must be treated by incineration /rendering. 
Waste from GM plants is usually autoclaved. 

By and large waste, emanating from GMO / GMM contained use activities  is treated by 

 - autoclaving of solid or liquid waste; 

- use of disinfectants to treat small volumes of liquid waste or routine spillages. 

IT  

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. Waste derived from animal treated with GMM are taken by authorized firms to 
be transported to the incinerator plant according to the Reg. (EC) No 1069/2009. 

The  waste  information  required  in  the  notification  refers  to  the  type  of  inactivation  that  is 
carried out inside the premises and whether a registered firm is used. 

For  laboratory  and  other  activities,  the  inactivation  of  GMMs  is  carried  out  respectively 
according to the article 5 of the Directive 2009/41/EC, the specifications provided in Table 
IA,  points  19-20,  and  Table  II,  points  22-23  of  the  Annex  IV  and  in  compliance  with  the 
current waste legislation. The applied measures have to be based on the risk assessment for 
the  human  health  and  the  environment  carried  out  by  the  user  and  to  be  reported  in  the 
notification. 

Waste  is  transferred  to  firms  authorized  in  compliance  with  the  Italian  Legislative  Decree 
n.152/2006 (ref. chapter IV). 

Waste  treatment  takes  place  on  the  basis  of  the  assessment  of  its  hazard  characteristics,  as 
laid  down  with  in  the  Annex  III  of  Directive  2008/98/EC,  and  on  the  assignment  of  a 
European  harmonized  code  in  accordance  with  Commission  Decision  2014/955/EU.  Based 
on the codes assigned to the waste, they are collected separately, e.g. solvents, carcinogenic 
substances, halogenated compounds, and afterwards taken by the mentioned authorized firms 
that provide for their disposal in chemical-physical treatment plants. 

The  responsibility  to  comply  with  the  legislation  in  force  on  inactivation  and  disposal  of 
waste  is  in  charge  to  the  waste  producer  up  to  final  destination  of  waste  and  it  cannot  be 
delegated to third parties. 

The  users  have  to  ensure  and  declare  in  the  submitted  notifications  the  compliance  to  the 
current  waste  legislation  based  on  the  agreements  they  stipulate  with  the  authorized  firms. 

The  authorized  firms  that  provide  such  type  of  service  are  not  directly  monitored  by  the 

26 

 
 
 
 
 
 
 
 
 
GMM CA consequently the means by which large volumes of waste materials are inactivated 
and/or disposed by these firms are not always reported in the submitted notifications. 

Comment related to the next question: 

Italian GMM CA has not authorised any waste treatment facility to inactivate waste arising 
from GM installations. 

The  authorized  firms  that  provide  such  type  of  service  are  not  directly  monitored  by  the 
CA. 
GMM 

As additional information it is to point out that the waste disposal plants must be authorized 
according  to  Legislative  Decree  No.  152  of  03/04/2006.  The  applications  must  to  be 
submitted to  the Region  or, in  some circumstances to  the Province/Metropolitan City when 
they  are delegated to  issue the authorizations. Copy of the  application has to  be sent  to  the 
Municipality and to the Italian National Institute for Environmental Protection and Research 
ISPRA  (Istituto  Superiore  per  la  Protezione  e  la  Ricerca  Ambientale).  The  issued 
authorizations  expire  after  10  years.  More  detailed  information  can  be  obtained  on  the 
http://www.catasto-rifiuti.isprambiente.it/index.php?pg=comaut. 
following  web 

site: 

The controls are applied by all the subjects that contribute to the issue of authorizations and 
territory. 
to 

that  carry  out  activities  on 

the  various  police  forces 

the  national 

The  Provinces,  the  Regional  Environmental  Protection  Agency,  the  Local  Health  Authority 
and other Bodies are responsible for monitoring the operations of the plant operators, which 
must  be  carried  out  in  compliance  with  the  regulations  in-force  and  the  specific  provisions 
contained  in  the  authorizations  (Legislative  Decree  No  152/2006,  articles  208  and  214). 

LT  
LU  
LV  
MT 

NL  

With  regard  the  waste  recycling  of  contained  use  activities,  several  authorized  firms  are 
involved in the waste disposal and to date this information is not required in the notification. 
There was no change since previous reporting. 
autoclave, incineration 
No experience. 
The only permitted Class 1 facility inactivates the small volume of waste it generates through 
autoclaving. 
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. 
GMO waste of all the classes  is inactivated at the premises itself. If this is not possible for 
waste of class 1 or 2, the waste has to  be transported in  well-defined and properly labelled 
containers to dedicated facilities. This transport has to comply with ADR. 

PL   Mostly are GM microorganism which don't have high mean. 
PT 

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

Although  there  are  no  waste  treatment  facilities  authorised  specifically  to  inactivate  waste 
arising  from  contained  use  premises,  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.   

27 

 
 
 
 
 
 
 
 
 
 
RO  

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 specific regulations on waste originating from medical 
care  and  dangerous  waste  in  general,  imposing  rules  for  storage,  for  incineration  and  for 
collection by an approved company. 

SE  

In Sweden, there is an absolute requirement of physical containment, why it is necessary to 
inactivate GMM. Inactivation of GMM is preferably done in-house. But waste from Class 1 
and Class 2 activities containing GMMs that are not inactivated can be transported under the 
Dangerous  Goods  regulations  to  a  “regular”  waste  treatment  facility  and  be  incinerated 
without  opening  the  transport  boxes.  Transportation  should  be  performed  under  the  same 
conditions as transportation of waste in Class 6.2. Waste containing GMMs from Class 1 or 
Class 2 can also be moved to a larger, central autoclave unit within the building or “campus” 
area  if  it  can  be  safely  transported  there.  If  GMMs  are  inactivated  in-house  by  a  validated 
physical  or  chemical  method,  they  are  considered  no  longer  active  and  the  waste  can  be 
waste.  
treated 

any 

as 

When  notifying  a  GMM  activity,  the  notifier  needs  to  provide  information  of  inactivation 
methods. If not inactivated, the name of receiver of the waste must be provided to SWEA. 
In all cases special attention is given to the waste treatment.  

SI  

In  the  risk  assessment  notifiers  must  elaborate  a  detailed  plan  for  waste  treatment, 
inactivation  procedures  and  final  disposal  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. 

SK  

As for the risk class 1, inactivation of GMMs/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 plowing 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.  

The user of genetic technologies and genetically modified organisms who gathers hazardous 
waste in annual volumes exceeding 1 tonne of hazardous waste is obliged to have the consent 
to  this  activity  from  Departments  of  Environmental  Protection  at  District  Offices  under 
Article  97  par.1  g)  of  the  Act  No  79/2015  on  waste  and  on  amendments  to  certain  acts.    

28 

 
 
 
 
 
 
 
Gathering  of  waste  means  the  preliminary  storage  of  waste  by  the  waste  holder  prior  to 
further management thereof that is not storage of waste. 

A waste producer is 

any 

original 

a) 
or 
b) anyone who carries out processing, mixing or other operations resulting in a change in the 
nature or composition of this waste. 

activities 

producer 

produce 

whose 

waste, 

Waste holder means the producer of the waste or person who is in possession of waste. 

UK  

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 
met:  
are 
a.  do  not  have  the  potential  to  cause  harm  to  human  health  or  the  environment;  
b.  must  be  biologically  contained  (e.g.  possess  multiple  disabling  mutations  or  restrictive 
nutrient 
laboratory);  
c.  do  not  have  the  capacity  to  establish  and  multiply  in  the  environment;  and  
d.  do  not  have  capacity  to  transfer  genetic  material  to  other  micro-organisms  (e.g.  non-
mobilisable plasmid). 

requirements 

be  met 

outside 

cannot 

that 

the 

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. rotaclave, 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 
the HSE inspection programme of notified premises. 

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 to deal with waste containing GMMs. These are 
primarily used for class 1 and class 2 waste, for example, in animal bedding or clinical waste 
from gene therapy trials. 

2018:  Do  you  have  changes  to  report  regarding  waste  disposal  for  2018,  compared  to  the 

information already reported for the period 2014 - 2017? 

2018 

Do you have changes to report regarding 
waste disposal for 2018, compared to the 
information  already  reported  for  the 
period 2014 - 2017? 

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

AT   No 
BE   No 
BG   No 

29 

 
 
 
 
 
 
 
 
  
  
  
Usually, 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).  Some  facilities  are  individually  equipped 
chemical 
with 
inactivation  also  plays  a  part  in  the  treatment  of 
waste.  

incinerators.  Occasionally, 

In 2018, the inactivation of soil containing GMO-
seeds by a validated steam method was authorized. 

Tous  les  OGM  sont  inactivés  sur  place  par 
traitement  chimique  et/ou  autoclavage  puis 
envoyés pour incinération 

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

CY   No 
CZ   No 
DE   Yes 

DK   No 
EE   No 
EL   No 
ES   No 
FI   No 
FR   No 

HR  
HU   No 
IE   No 
IT  
LT   No 
LU   No 
LV   No 
MT   No 

NL   No 
PL  
PT   No 
RO   No 
SE   No 
SI   No 
SK   No 
UK   No 

2.2 

Are  there  waste  treatment  facilities  in  your  Member  State  authorised  to  inactivate 
waste arising from contained use premises?  
If yes, specify how many per class of contained use. 

30 

 
 
  
  
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
AT 
BE  
BG  
CY  
CZ  
DE  
DK  
EE  
EL  
ES  
FI  
FR  
HR  
HU  
IE  
IT  
LT  
LU  
LV  
MT  
NL  
PL  
PT  
RO  
SE  
SI  
SK  
UK  

Yes 

Yes 

2014-2017  2018 
No 
Yes 
No 
No 
No 
Yes 
No 
Yes 
No 
Yes 
Yes 
Yes 
Yes 
Yes 
Yes 
No 
Yes 
Yes 
No 
No 
Yes 
No 
No 
Yes 
Yes 
No 
Yes 
Yes 

No 

comments if any 
Not known 
Not known 
Not known 
Not known 
Not known 

comments if any 

BELGIUM 2014 - 2017 

Waste treatment facilities 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

GERMANY 2014-2017 

Waste treatment facilities 
3 
1 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

GERMANY 2018 

31 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
 
 
  
  
 
 
 
 
 
 
 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

Waste treatment facilities 
3 
1 
0 
0 
4 

ESTONIA 2014 - 2017 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

Waste treatment facilities 
3 
3 
1 
1 
4 

SPAIN 2014 - 2017 

comments if any 
- 
- 
- 
- 
- 

comments if any 

the same as class 1 

the same as class 3 

Waste treatment facilities 

comments if any 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

FINLAND 2014 - 2017 

Class 1 

Waste treatment facilities 
8  municipal  incinerating  waste 
treatment  plants  +  dozens  of  on 
facilities  +  1 
laboratory 
site 
biowaste recycling plant 

Class 2 

1 hazardous waste plant + dozens 
of on site laboratory facilities 

Class 3 

Class 4 

7  on  site  laboratory  facilities  +  2 
for  class  2  GM  animals  (highest 
GM animal class) 
0 

Total 

>100 

FRANCE 2014 - 2017 

facilities 

comments if any 
This  question  is  partially  irrelevant, 
as  most  waste  is  treated  on  site  and 
anyway  inactivation  of  class  1  waste 
is optional. Also, we do not authorise 
municipal  waste 
for 
contained use, as they would not be in 
a  position  to  fulfil  the  obligations  of 
Articles 4 and 6 of the Directive. 
We do not authorise municipal waste 
facilities  for  contained  use,  as  they 
would not be in a position to fulfil the 
obligations of Articles 4 and 6 of the 
Directive. 
For  class  2,  inactivation  has  to  take 
place on site 

No BSL4 laboratories in Finland. The 
question  is  irrelevant  as  Class  4 
GMM waste must be managed in the 
lab. 

32 

 
 
 
 
 
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

Waste treatment facilities 
non 
oui 
oui 
oui 
Notre  système  d'information  ne 
nous  permet  pas  de  répondre  en 
l'état actuel des choses 

comments if any 
oui 
oui 
oui 
oui 

FRANCE 2018 

Waste treatment facilities 

Class 1 
Class 2 

Class 3 

Class 4 

Total 

CROATIA 2014 -2017 

comments if any 
Traiement chimique ou autoclavage 
Traitement 
chimique 
autoclavage et incinération 
Traitement  chimique  et  autoclavage 
et incinération 
Traitement  chimique  et  autoclavage 
et incinération 

et/ou 

Waste treatment facilities 
3 

comments if any 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

HUNGARY 2014 -2017 

Waste treatment facilities 

comments if any 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

IRELAND 2014 - 2017 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

Waste treatment facilities 
2 
1 
0 
0 
3 

LITHUANIA 2014 -2017 
Waste treatment facilities 
1 

Class 1 

comments if any 

comments if any 
JSC "Rietavo veterinarine sanitarija" 

33 

 
 
 
  
 
 
  
  
  
  
  
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
 
 
Class 2 
Class 3 
Class 4 
Total 

1 
1 
1 
1 

LUXEMBOURG 2014 - 2017 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

Waste treatment facilities 
1 
1 
1 
0 
1 

NETHERLANDS 2014 - 2017 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

Waste treatment facilities 
1 
1 
1 
1 
1 

ROMANIA 2014 -2017 

Waste treatment facilities 
autoclaving 
autoclaving 
autoclaving 
autoclaving and incineration 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

SWEDEN 2014 - 2017 

Class 1 

Waste treatment facilities 
6 

Class 2 
Class 3 
Class 4 
Total 

SLOVAKIA 2014 - 2017 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

Waste treatment facilities 
at least 1 
at least 1 
at least 1 
at least 1 
at least 1 

JSC "Rietavo veterinarine sanitarija" 
JSC "Rietavo veterinarine sanitarija" 
JSC "Rietavo veterinarine sanitarija" 
JSC "Rietavo veterinarine sanitarija" 

comments if any 

no level 4 facility in Luxembourg 
1 facility for all confinment levels 

comments if any 

there is only one facility 

comments if any 

comments if any 
4  regular  waste  treatment  plants;  2 
central  university  hospital  autoclave 
facilities  serving  both  hospital  and 
university. 

comments if any 

The  Ministry  of  Environment  of  the 

34 

 
 
 
 
  
  
  
 
 
  
  
  
  
 
 
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
neither 

facilities, 

Slovak  Republic  as  the  Competent 
Authority for the use of GMM/GMOs 
does  not  have  data  about  waste 
treatment 
the 
Competent  Authorities in  the field  of 
waste  could  provide  it  as  no  legal 
obligation  on  evidence 
regarding 
waste  arising  from  this  specific  kind 
of  activities  exists  and  the  existing 
registers  are  not  designed  to  retrieve 
the requested type of data. 

UNITED KINGDOM 2014 - 2017 
Waste treatment facilities 
5 
8 
0 
0 
13 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

comments if any 

If yes, how is the transfer of waste from the contained use premises to the authorised 
waste facility arranged/organised? 

2014 - 2017 
BE  

DE  

EE  
ES  

FI  

FR  
HR  
HU  

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 to incineration. Transport of waste material follows the UN recommendations of 
dangerous goods. 
The  internal  transport  of  the  GMO-containing  waste  is  carried  out  in  tightly  sealed, 
unbreakable and labeled  containers in  accordance with  the German Genetic Engineering Act 
(GenTG).  Transporting  on  public  roads  is  beyond  the  scope  of  the  GenTG  according  to  the 
regulations on dangerous goods transport. Transport and disposal are recorded. 
in special containers.  
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  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. 
In closed containers marked with GMO info. Class 2 waste which is not inactivated on site is 
transferred to the waste facilities by companies specialized in hazardous waste transport. 
Par prestataire de service autorisé 
In closed containers. 
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 

35 

 
 
 
 
  
  
  
  
  
 
 
 
 
IE  

LT  

LU  
NL  

RO  

SE 

SK  

UK 

commenced possessing an authorization, under controlled conditions and specifying the route 
of transfer. 
In accordance with the Article 3(2) of Directive 2009/41/EC on the contained use of GMMs, 
the transport of GMMs by road, rail, inland waterway, sea or air is excluded from the scope of 
the  Directive.  Transfer  of  waste  from  the  contained  use  premises  to  the  authorised  waste 
facility is regulated under the ADR Regulations  and the Waste Permit Regulations. 
There is one facility authorized under the EU and national legislation to handle veterinary and 
environmental  waste  including  GM  vertebrates.  Transportation  should  be  arranged  by  the 
waste treatment company according to EU and national rules. 

There were no cases of contained use of GMMs or GMOs of class 2-4. 
contained transport 
in the Netherlands there is one facility authorized for destruction of GMO-waste. This GMO-
waste may originate from all classes, where waste of class 3 and 4 has to be inactivated at the 
premises before transport and destruction. The waste is being transported by authorized waste 
carriers under ADR. 
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 
Four  waste  treatment  facilities  have  notified  GMM  activities  Class  1  dedicated  only  to 
destruction of GMMs, as well as two central autoclave facilities at university hospitals. Waste 
from  Class  1  and  Class  2  activities  containing  GMMs  that  are  not  inactivated  can  be 
transported  under  the  Dangerous  Goods  regulations.    Transport  within  a  university  hospital 
needs to be controlled and safe. 
In  Slovakia 

for  processing  of  organic  waste.  

specialized 

there  are 

facilities 

The  waste  arising  from  GM  installations  has  to  be  inactivated  before  the  transfer.  The 
inactivation  may  be  done  by  the  user  or  a  specialized  facility.  The  inactivated  waste  is  then 
transported for a final disposal (some materials may be recycled). Rules for dangerous waste 
apply  to  the  transfer  of  waste  from  the  GM  installation  to  the  authorised  waste  facility 
[Regulation  concerning  the  International  Carriage  of  Dangerous  Goods  by  Rail  (RID), 
(ADR)]. 
European  Treaty  on 

International  Road  Transport  of  Dangerous  Goods 

Landfill  of  waste  arising  from  health  care  and  veterinary  care  as  a  way  of  final  disposal  is 
forbidden. 

Landfill  of  waste  arising  from  health  care  and  veterinary  care  after  processing/treatment  is 
forbidden as well. 
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. 

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. 

36 

 
 
 
 
 
 
 
 
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. 

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. 

2018 
DE 

FR 
MT 

The  internal  transport  of  the  GMO-containing  waste  is  carried  out  in  tightly 
sealed,  unbreakable  and  labeled  containers  in  accordance  with  the  German 
Genetic  Engineering  Act  (GenTG).  Transporting  on  public  roads  is  beyond  the 
scope  of  the  GenTG  according  to  the  regulations  on  dangerous  goods  transport. 
Transport and disposal are recorded. 
Par transporteur agréé 
Waste generated by the Class 1 facility is first inactivated by same facility, and it 
is then transferred to a waste facility by a licensed waste carrier to be disposed of. 

2.3  

Is waste from contained use activities recycled after inactivation? 
If yes, specify for which purposes. 

AT  
AT 2018 
BE  

No 
No 
Yes  In  some  cases,  animal  by-products  (cage  bedding  and  excrements)  or  plant 

waste originating from contained use activities are composted. 

In one contained use activity of GMM, sludge from the sewage treatment plants 
are spread as fertilizer in field. 

BE 2018 

Yes  In  some  cases,  animal  by-products  (cage  bedding  and  excrements)  or  plant 

waste originating from contained use activities are composted. 

In one contained use activity of GMM, sludge from the sewage treatment plants 
are spread as fertilizer in field. 

No 
No 
No 
No 
Yes  The compost where material from GM plants has been deposited is used in the 

premises. 

in one instance: biogas plant 

No 
Yes 
Yes  one case: biogas plant 
Yes  Some but not all companies use their waste to produce biogas or fertilizer to be 
sold to the Danish farmers for the use of nutrition on the fields. This is not true 
for all produced GM waste, only in certain instances. More and more companies 
focus on the opportunity of producing biogas from production biomass. 

Yes  Some but not all companies use their waste to produce biogas or fertilizer to be 
sold to the Danish farmers for the use of nutrition on the fields. This is not true 

BG 
BG 2018 
CY  
CY 2018 
CZ  

CZ 2018 
DE  
DE 2018 
DK  

DK 2018 

37 

 
 
 
 
 
 
  
  
  
  
  
  
  
EE  
EE 2018 
EL  
EL 2018 
ES  
ES 2018 
FI  

for all produced GM waste, only in certain instances. 

More and more companies focus on the opportunity of producing biogas from 
production biomass. 

No 
No 
No 
No 
No 
No 
Yes  In special cases class 1 GMM waste has been accepted to be used as a part of 
biocomposting  process  or  for  biofuel  production.  Also,  composted  GM  plants 
can  under  certain  limits  be  used  as  part  of  growth  medium  (soil)  in  closed 
circulation.   

FI 2018 

Yes  For  compost  products  (only  two  operators  producing  large  volumes  of 

FR  
FR 2018 
HR 
HR 2018 
HU 
HU 2018 
IE  
IE 2018 
IT  
IT 2018 
LT 
LT 2018 
LU 
LU 2018 
LV 
LV 2018 
MT 
MT 2018 
NL 
NL 2018 
PL  
PL 2018 
PT  
PT 2018 
RO  
RO 2018 
SE  
SE 2018 
SI  

fermentation waste) 

No 
No 
No 

No 
Yes  After the applied alcaline treatment the waste was placed in a land disposal unit. 
No 
No 
No 

No 
Yes  It depends on recycled content 
No 
No 
No 
No 
No 
No  N/A 
No 
No 
No 

No 
No 
No 
No 
No 
No 
Yes 

 According  to  the  provisions  of  the  Decree  of  waste  management  (OJ  RS 
34/2008  and  103/2011)  all  wastes  should  be  separated  and  recycled.  After 
inactivation mostly plastic materials, glass, metals and paper are separated and 
recycled.  Chemicals  are  also  treated  as  required.  Several  waste  incineration 
facilities  are  often  used  by  the  notifiers  for  final  disposal  of  (inactivated  for 

38 

 
 
 
  
  
  
  
  
  
  
  
  
 
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
biosafety level 2 or higher) GMO waste.  

SI 2018 

SK 

Yes  According  to  the  provisions  of  the  Decree  of  waste  management  (OJ  RS 
34/2008  and  103/2011)  all  wastes  should  be  separated  and  recycled.  After 
inactivation mostly plastic materials, glass, metals and paper are separated and 
recycled.  Chemicals  are  also  treated  as  required.  Several  waste  incineration 
facilities  are  often  used  by  the  notifiers  for  final  disposal  of  (inactivated  for 
biosafety level 2 or higher) GMO waste. 

Yes  Some  materials  are  recycled  in  Slovakia.  Obligations  of  waste  holders  are 
specified under Article 14 of the Act No. 79/2015 on waste and on amendments 
to certain acts. 

2018: SAME INFO 

SK 2018 

Yes  Some  materials  are  recycled  in  Slovakia.  Obligations  of  waste  holders  are 
specified under Article 14 of the Act No. 79/2015 on waste and on amendments 
to certain acts. 

UK  
UK 2018 

No 
No 

3. 
3.1 

Inspection and enforcement issues  
Outline  the  procedure  undertaken  for  the  inspection  of  contained  use  premises 
(Article  16  of  the  Directive)  during  the  reporting  period,  under  your  contained  use 
legislation,  providing  details  of  the  number  and  the  overall  percentage  of 
premises/contained uses inspected. 

2014 - 2017 
AT 

BE 

BG 

Inspections were carried out randomly, based on the characteristics of the activity, e.g. risk 
class  of  the  GMMs/GMOs,  large  scale  equipment,  inoculation  of  animals,  etc.  In  the 
reporting  period  inspections  were  undertaken  in  installations  working  in  biosafety  level  1 
and 2, as well as in all installations working in biosafety level 3. 
In Wallonia, no specific control was required. There was only one issue that required the 
intervention of the inspection: it concerned an accident at a company. Controls were carried 
out  in  this  company  in  order  to  verify  the  implementation  of  corrective  measures. 

In the Flemish Region, 53 installations were inspected in the period from June 2014 till the 
end of 2017. 

In the Brussels-Capital Region, all the installations concerning a demand of biological class 
risk  2  (and  upper)  are  inspected  before  approval  /permit.  During  the  reporting  period,  7 
installations have been controlled in the frame of Inspection after approval /permit.  

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  should  be 

39 

 
 
 
 
 
  
  
 
 
 
 
inspected  at  least  once  every  two  years  but  in  practice  all  of  them  have  been  inspected 
annually.  Samples  can  be  taken  during  the  inspection  if  necessary  and  analysed  for 
presence of GMOs. 

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. 

The  number  of  inspections  during  reporting  period  is  as  follows:  2014  (whole  year)  -  16 
inspections;  2015  –  9  inspections;  2016  –  8  inspections;  2017(data  from  14  out  of  16 
regional inspectorates) –9 inspections. 
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. 100% 
of the premises that applied for GMMs use was inspected. 

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 
bodies  in  fulfilling  this  task.  CEI  undertakes  inspections  of  premises  authorised  for 
contained use of GMOs, in accordance with the yearly schedule based on: 

-  information  from  the  Ministry  of  Environment  on  notifications  and  authorisations,  
- results and findings of the previous inspections, 
- information from other sources. 

The inspections are targeted on compliance with the requirements for the appropriate risk 
class,  documentation,  waste  treatment,  labelling  and  transport  of  GMOs  within  the 
premises, training of the personnel etc. 

CY 

CZ 

Over 100 inspections of contained uses were carried out within the reported period; some of 
them  covered  several  premises  operated  by  one  user  (e.g.  various  laboratories  of  a 
university). All authorised premises were checked, some of them repeatedly.  
In Germany, the CAs of the Bundesländer are responsible for the inspection of contained 
use premises and uses and the resulting enforcement measures. 

DE 

Inspections are conducted on a case-by-case basis or as rule monitoring. 

Event-related inspections are carried out for instance in 

- new premises (mostly before commissioning), 
- significant changes in equipment, 
- inquiries or incidents. 

The  rule  inspections  are  carried  out  at  predetermined  intervals,  which  are  the  shorter,  the 
higher the security level and also the more intensive the use of the facility is. In addition, 
the 
inspections. 
Correspondingly, the following intervals result for rule monitoring: 

to  experience  gained  from  previous 

intervals  can  be  adapted 

40 

 
 
 
 
 
 
 
 
 
 
 
- BSL1 facilities: every 3 to 5 years, 
- BSL2 facilities: every 2 to 3 years, 
- BSL3 and BSL4 facilities: annually. 

DK 

EE 
EL 
ES 

During the reporting period almost all genetic engineering facilities were inspected at least 
once. 
When a class 2, 3 or 4 GMO location are notified the first time, it will always be visited to 
be  approved.  This  also  applies  when  changes  are  made  to  an  already  classified  location. 
There are 2 inspectors in Denmark who spend part of their working hours with inspection.  

The procedure for  class 1 GMO was changed in 2015 so that the work 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. 

5/75% 
No authorised premises in the reporting period. 
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. 

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 5 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.  

FI 

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  inspection  of  the  operators  which  commence  Class  2  or  3  use  of  GMOs  for  the  first 
time  or  start  using  higher  class  than  before  is  prioritized.  The  inspection  interval  is  risk 
based, so that active Class 3 use is inspected more often (at least every second year) than 
use. 
or 
Class 

1 

2 

During  the  reporting  period  23  notifications  or  applications  were    inspected    (5  %  of  all 
valid  notifications  and  applications).  Until  June  2016  two  full-time  inspectors  worked  in 
control  of  GMO  use,  after  that  only  one  full-time  inspector  has  been  in  charge  of 
supervision. 
2 visites sur site ont été effectuées ainsi que 800 contrôles distants  

FR 

41 

 
 
 
 
 
 
 
 
 
 
HR 
HU 

IE 

20 inspections without any measures. 
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).  
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 CA aims to inspect: 

- Class 2 GMM, Class 3 GMM, GM Animal / Plant activities once every 3 years;  

- Class 1 GMM contained use activities once every 6 years (given their history of safe use 
and negligible risk). 

During the reporting period 35 facilities were inspected comprising approximately 50%.  

IT 

According  to  the  Italian  Legislative  Decree  n.  206/2001,  the  inspection  functions  are 
exercised  by  officers  identified  by  the  BHTC  on  20  May  2015,  and  appointed  by  Health 
Minister  on  the  basis  of  designations  provided  by  other  institutional  Bodies.  If  needed, 
inspections to GMM installation/activity are requested by BHTC. 

No inspections have been requested by during the reporting period. 

In 2015 the National Centre for Disease Prevention and Control of MoH decided to start a 
project  for  a  training  course  for  inspectors  and  to  constitute  a  Directorate  permanent 
inspectorate  to  conduct  inspections  to  contained  use  premises.  The  project  ended  in  2017 
and a ministerial decree with the appointed inspectors has to be issued. 
There  was  no  change  of  requirements  for  inspection  of  contained  use  premises  since 
previous reporting. 13 premises were inspected. 
1 inspection carried out in 2017. The facility was 100% compliant. SECUALIM designed a 
new inspection cheklist and procedure in 2017 
No inspection provided due to lack of activities with GMM. 
Malta has no specialised inspectors on GMMs.  One should note that Malta only received 
one application to date (before this reporting period). 
During  the  period  from  6  June  2014-31  December  2017  the  inspectorate  carried  out  214 
inspections involving contained use, mainly audits-on-site with recent addition of audit-on-
desk for a small proportion of inspections. 

LT 

LU 

LV 
MT 

NL 

Year 2014 2015 2016 2017 
Number of inspections 40 78 69 27 
Percentage 16% 31% 28% 11% 

Up  to  1  January  2017  the  task  was  carried  out  by  five  inspectors  (about  4  FTE).  From  1 
January  2017  onwards  three  inspectors  are  responsible  for  conducting  these  inspections 

42 

 
 
 
 
 
 
PL 

PT 

RO 

SE 

to 

by 

the 

the 

out, 

after 

opinion 

relevant 

positions 

obtaining 

premises, 

(about  2.3  FTE).  The  inspectorate  has  the  aim  to  contact  each  user  at  least  every  five  to 
eight  years.  Based  on  risk,  compliance  and  complexity  of  work  this  frequency  may 
increase.  Inspections  generally  cover  containment,  annual  audits  of  the  biological  safety 
officer, waste treatment  and administrative obligations. With the new legislation effective 
march 2015, the correctness of class I and II risk assessments is an important topic as well. 
The Minister of the Environment responsible for environmental issues issues a permit for 
running  a  genetic  engineering  plant  in  which  the  closed  use  of  GMMs  or  GMOs  is  to  be 
location: 
carried 
1)  the  State  Sanitary  Inspection  the  state  voivodship  sanitary  inspector  -  in  terms  of 
occupational 
hygiene; 
2  )the  Chief  Labour  Inspection  -  in  the  area  of  meeting  occupational  safety  and  health 
processes. 
facilities, 
requirements 
100 % permises were inspected. 
Until the present date, the Inspectorate General for Agriculture, Fisheries, Environment and 
inspections  of  contained  use 
Spatial  Planning  (IGAMAOT)  hasn´t  carried  out 
instalations/activities. 
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. 
SWEA  can  perform  an  inspection  both  if  found  necessary  because  of  information  in  a 
notification, and as a control measure after notification has been processed. Our policy is to 
give priority to inspections of new installations for Class 3 and Class 4 activities. Class 1 
and  Class  2  installations  may  be  inspected  if  necessary.  We  also  can  plan  more  random 
inspections. We try to develop a mailing system for control of administrative compliance of 
Class 1 and sometimes Class 2 users, since there are large travel distances to several of our 
GMM users and the risks by definition are low or neglible. 

work 

and 

During the reporting time, 6 physical visits were made, all due to notifications. Three of the 
visits  were  only  information  and  discussions  because  of  misconceptions  or  unclear 
notifications  that  we  deemed  could  be  better  explained  when  discussed  person  to  person 
than by mail. The other visits also contained discussions but also physical inspection. One 
was a Class 3 activity that renewed their notification, one was not clear whether it should 
be a Class 2 or Class 3 activity and one was unclear how many activities they had in Class 
2.  
1 

Class 

and 

An inspection is pre-notified, since we often need to travel to the site. Several inspections 
are then usually performed within 2-3 days in the area, sometimes in the same organisation, 
sometimes  directed  to  different  organisations.  The  inspection  is  often  performed  together 
with  our  regional  work  environment  inspector,  who  can  inspect  work  environment  and 
installation.  
occupational 

aspects 

health 

the 

of 

Also,  22  Class  1  users  have  been  contacted  by  e-mail  and  regular  mail  concerning  their 
GMM activities notified more than five years earlier. We wanted to know the status of their 
GMM activities. If changed or no longer active, Swedish law obliges the user to notify that 
to SWEA. Two still remain to leave their answer. Of the 20 that answered our could not be 
reached, four had changed and made an update notification, four still had the same activity 

43 

 
 
 
 
 
SI 

SK 

UK 

and twelve did no longer have GMM activity or the company was proven no longer active. 
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.  In the reporting period 43 inspections were performed. 

The Slovak Environmental Inspectorate organised inspections to ensure that users comply 
with the Directive. There were 455 enclosed facilities checked during the reporting period, 
85% of the overall percentage of authorized contained uses.  
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. 

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

(under  domestic 

foot-and-mouth 

control 

the 

Higher  hazard  laboratories  receive  more  frequent  inspections.  CL4  laboratories  are 
inspected at least once per year, most being visited multiple times per year. 

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

Premises that only work 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.  

Inspections are generally topic-based and may cover a range of topics (e.g. containment and 
control,  training  and  competence,  audit  and  inspection  and  risk  assessment  etc.). 
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. 

44 

 
 
 
 
 
 
 
 
HSE undertakes a programme of 16 inspections of laboratories handling larger GMOs (e.g. 
animals,  plants  and  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 
measures.  
control 

HSE  has  a  specific  team  (Microbiology  and  Biotechnology  Unit  –  CEMHD8),  which 
implements  the inspection regime and  reviews the adequacy of notifications of biological 
agents (including GMMs). Currently the Microbiology and Biotechnology Unit comprises 
7  Specialist  Inspectors,  3  Principal  Specialist  Inspectors  and  1  Regulatory  Compliance 
Officer. 

In 2018, did you implement changes in the procedure undertaken for the inspection of 
contained  use  premises  (Article  16  of  the  Directive) under  your  contained  use 
legislation? 

In  2018,  did  you implement  changes 
in 
the procedure undertaken for the inspection of 
contained  use  premises  (Article  16  of  the 
Directive) under 
use 
your 
legislation? 

contained 

Provide details: 

AT   No 
BE   No 
BG   No 
CY   No 
CZ   No 
DE   No 
DK   No 
EE   No 
EL   No 
ES   No 
FI   No 
FR   No 
HR  
HU   No 
IE   No 
IT  
LT   No 
LU   No 
LV   No 
MT   No 

NL   No 
PL  

Malta  has  no  specialised  inspectors  on 
GMMs.  One  should  note  that  Malta  only 
received  one  application  to  date  (before  6 
June 2014). 

45 

 
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
PT   Yes 

RO   No 
SE   Yes 

SI   No 
SK   No 
UK   No 

the 

for 
Inspectorate-General 
In  2018, 
Agriculture, 
the  Sea,  Environment  and 
Territorial  Planning  established  a  guide  to 
support  the  inspection  of  operators  using 
genetically  modified  organisms  /  micro-
organisms. 

SWEA  can  perform  an  inspection  both  if 
found necessary because of information in a 
notification,  and  as  a  control  measure  after 
notification  has  been  processed.  Our  policy 
is  to  give  priority  to  inspections  of  new 
installations  for  Class  3  and  Class  4 
activities. 

In 2018, how many premises/contained uses have been inspected? 

In 2018, how many premises/contained uses have been inspected? 

AT   Inspections  were based on the  characteristics  of the activity, e.g. risk class,  large scale, 

inoculation of animals, etc. In the reporting period 31 inspections have been carried out. 
In the Flemish Region: 2 installations were inspected. 

BE  

In the Brussels-Capital Region and in Wallonia: 0  

BG   Inspections are performed by the regional inspectorates of Ministry of Environment and 

Water. 

In 2018 7 inspections of 7 premises have been carried out. 

CY   One premise (there is only one premise approved for contained use in Cyprus) has been 

inspected in 2018, 

CZ   22 premises: all that were notified in the time period and some premises in Class 2 and 3 
DE   1613 
DK   43 (just premises are inspected) 
EE   0 
EL   None - there were no premises working within the framework of Directive 2009/41/EC 

in 2018 

ES   80 
FI   Five premises / six notifications. 

FR   Visites  d'inspection  ou  de  conseil  :  11  établissements  en  recherche    +  7  en  production 

industrielle 

HR  
HU   None. 
IE   Four premises 

46 

 
 
  
  
  
  
 
 
  
 
 
  
IT  
LT   4 
LU   0 
LV   0 
MT   0 
NL   25 
PL  
PT  

In  2018,  10  premises  were  been  inspected,  that  held  permits  for,  globally,  15  confined 
uses. 

RO   Not applicable yet 
SE   1 
8 
SI  
SK   48 premises 
UK   22 inspections 

3.2  What were the issues most frequently encountered in the course of inspections carried 

out during the reporting period? 

2014 - 2017 
AT  The 

issues  most  frequently  encountered  did  not  affect  biosafety  but  concerned 

administrative issues only (e.g. documentation, lab journal) 
In 

Wallonia: 

BE 

/ 

In  the  Flemish  Region:  following  issues  (in  order  of  occurrence)  were  most  frequently 
encountered: 
- No permit or correct permit for the contained use of GMO’s and pathogens 
- No correct storage of biohazardous waste. 
- No correct labelling of biohazard materials. 
- No registration of training staff. 
- No register of used GMO’s/pathogens. 
- No restricted access to the laboratories in which contained use takes place. 
- No instructions for the correct use of disinfectants. 
- No microbial safety cabinet available 
- No validation of the disinfection method. 
- No biosafety manual. 
- No instructions in case of incident (fire). 

In the Brussels-Capital Region: 
-  The  biological 
-  Ancient  wood 
- No adequate validations of waste inactivation. 

class  notified 

risk 

furniture  which  was  not  suitable 

in 

the  dossier  was 

correct. 
for  effective  disinfection. 

not 

BG  No major issues have been encountered during the reporting period. 
CY  No problems have been encountered during the course of inspections. 
CZ  Most  frequent  deficiencies  found  by  the  Inspection  were  of  an  administrative  character: 
omission  to  update  some  part  of  the  documentation,  missing  signature  of  the  biosafety 
officer etc. These imperfections did not pose any risk to the environment. 
- missing or inadequate labelling of the work area, 

DE 

47 

 
 
  
  
 
 
 
 
 
- structural defects, deficiencies of basic Equipments, 
- inadequate protective clothing (lab coat etc.), 
-  lack  of  regular  testing  /  maintenance  of  equipment  such  as  safety  workbenches  and 
autoclaves, or poor documentation of these tests / maintenances, 
- missing suitable transport containers 
-  inadequate  or  delayed  instruction  of  employees  or  service  personnel  (cleaning  staff, 
craftsmen etc.), 
- cramped or untidy laboratories, 
- unsuitable or dirty surfaces (in the work area), 
- no clear distinction between writing and laboratory work areas, 
- insufficient hygiene or disinfection measures, 
- inaccurate operating instructions and hygiene plans, 
- inaccurate or incomplete recording of the genetic engineering operations, 
- inadequate or incorrect user risk assessment, 
- non-compliance with the notification requirements, 
-  no  notification  of  changing  of  safety-relevant  equipment  such  as  autoclaves  or  safety 
cabinets, 
- carrying out further BSL2 operations without prior notice, 
- missing or delayed notification of the change of responsible persons (project leader, BBS) 
or changes of security-relevant institutions, 
- incomplete recording of persons working in BSL2 (or higher). 

DK  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. Some times it also turns 
out that the company has forgotten to notify the research project and has just notified the 
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. 

some issues of choosing of labor gloves, washing of labour clothes 

EE 
EL  No authorised premises in the reporting period. 
ES  Problems most frequently encountered are: 

1)  Deficiencies  in  Good  Laboratory  Practices  (GLPs)  or  SOPs,  and  to  use  inadequate 
equipments,  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. 

FI 

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. 

48 

 
 
 
 
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. 
FR  Les 

: 
-  Traitement  des  déchets  d'activité  de  recherche  sur  les  OGM  de  classe  C1  et  C2 
- Non respect des confinements entre C2 et C3, agents biologiques et OGM des groupe 3* 

problèmes 

rencontrés 

sont 

HR  not applicable 
HU  Minor problems have been reported, as regards documentation. 
IE  Typical issues that arose during the course of site inspections included: 
- non notification of research projects involving GMOs / GMMs; 
- validation labels showing the date on which a piece of equipment was last validated and 
when next validation was due were not displayed; 
- incomplete records , lack of signage; 
Violations  are  not  significant  in  terms  of  posing  a  risk  to  human  health  and  the 
environment. 

IT  N.A.  
LT  There were no specific issues. 
LU  The  facility  was  still  under  construction  during  the  inspection.  Signe  regarding  the 
confinement  level  as  well  as  the  protective  gear  to  wear  were  forseen  but  not  yet  put  in 
place before entering the rooms.  
- 

LV 
MT  No matters to report. 
NL  The compliance is high, > 90%. The issues most frequently encountered were: 

• waste management was not according to regulation; 
• use of disinfectants that have not been admitted as biocides; 
• the biosafety officer did not perform all internal controls; 
•  there  were  no  clear  and  up  to  date  administrative  records  of  all  GMOs  held  by  the 
institution; 
• not all internal procedures and instructions for the safe handling of GMOs were drafted. 
• Details of the laboratory infrastructure was not according to regulations. 

PL  Usually  facilities  don't  follow  all  necessary  requirements  needed  for  safety  class.  But 
mostly  one  of  the  rooms  which  was  subjected  as  a  part  of  GM  facility  did  not  meet  all 
criteria for safety of class. 

PT  Not applicable. 
RO  Not applicable. 
SE  Common  errors  are  the  text  needed  to  accompany  the  biohazard  sign  (most  occupational 
health),  how  and  where  to  inactivate  GMM  and  the  limits  between  different  GMM 
activities  or  GMM  uses  (both  concerning  responsibilities,  as  well  as  descriptions).  Other 
issues were the class of the notification: Class 3 or Class 2?  
In  the  3-year  reporting  period  only  minor  infringements  were  disclosed  such  as  minor 
equipment  and  furnishing  inadequacies  or    insufficient  documentation  management  (e.g. 
emergency  action  plans  were  not  sent  to  the  local  authorities  as  required,  yearly  reports 

SI 

49 

 
 
 
 
 
were not sent to the ministry, notifier failed to report the closure of the installation, etc.) At 
the present,  containment measures and  good laboratory practice are well observed, so the 
inspection process only encounter minor administrative infringements. 

SK  Only minor deficiencies in fulfilling the requirements for enclosed facilities documentation 

were found. 
UK  The  most 

frequently 

encountered 

issues 

(formally 

raised 

following 

inspections/investigations indicating GM activities) were: 
the  activities  being  undertaken; 
•  Risk  assessments  not  sufficient 
•  Adequacy  of  standard  control  measures  (e.g.  sealability;  HEPA  filtrations  restricted 
access) with respect to on-going planned preventative maintenance; 
• Training provision and training  records  – insufficient to  demonstrate  competence of the 
user 

to  cover  all 

2018 
AT 

The  issues  most  frequently  encountered  did  not  affect  biosafety  but  concerned 
administrative issues only (e.g. documentation, lab journal) 

BE   No change relative to period 2014-2018 
BG   No major issues have been encountered during the reporting period. 
CY   No issues. 
CZ   Like before, only minor administrative issues. 
DE  

- missing or inadequate labelling of the working area, 
- structural defects, deficiencies of basic equipment, 
- inadequate protective clothing (lab coat etc.), 
- lack of regular testing / maintenance of equipment such as safety workbenches and 
autoclaves, or poor documentation of these tests / maintenances, 
- inadequate transport containers, 
-  inadequate  or  delayed  instruction  of  employees  or  service  personnel  (cleaning  staff, 
craftsmen etc.), 
- cramped or untidy laboratories, 
- unsuitable or dirty surfaces (in the work area), 
- no clear distinction between writing and laboratory work areas, 
- insufficient hygiene or disinfection measures, 
- inaccurate operating instructions and hygiene plans, 
- inaccurate or incomplete recording, 
- inadequate or incorrect risk assessment by the user, 
- insufficient labelling of gmo-specimen  
- violate the notification requirements 

DK   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.  Some  times  it  also 
turns out that the company has forgotten to notify the research project and has just notified 
the 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. 
0 

EE 
EL  None 

50 

 
 
 
 
 
ES 

Restricted access for type 2, practicable windows for type 2, do not use the corresponding 
PPE (protective equipment) when working in type 1 and 2 

FI  Most  frequently  encountered  issues  were  missing  notices  concerning  new  containment 
level 1 premises and inadequate or insufficient bookkeeping and/or risk assessment. Some 
operators  had  shortcomings  in  the  action  plans  and  in  recording  staff  education. 
Sometimes  changes  of  responsible  persons  had  not  been    reported  to  the  authorities.  In 
situations where GM-micro-organisms were used in animal facilities, attention needed to 
be paid for ensuring proper information flow between the experimental animal facility and 
the GMM user. 

FR  Validation des procédures d'inactivation des déchets liquides 
HR 
HU  No issues were encountered. 
IE 

Typical issues that arose during the course of site inspections included: 
- non notification of GMMs that were held in storage; 
-  validation  certification  for  autoclave  was  not  available  during  the  course  of  the 
inspection.  

- 

- 

IT 
LT 
LU  N.A. 
LV 
MT  N/A 
NL 
PL 
PT 
RO  Not applicable 
SE 
SI 

no other than reported last year 

Processes under analysis. 

Common errors are the text needed to accompany the biohazard sign 
In the reporting period only minor infringements were disclosed such as minor equipment 
and  furnishing  inadequacies  or  insufficient  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.). At the present, 
containment  measures  and  good  laboratory  practice  are  well  observed,  so  the  inspection 
process only encounter minor administrative infringements. 
SK  Contained use without notification (activities classified risk class 1).  
UK  The  most  frequently  encountered  issues  formally  raised  following  inspections  were: 

-  Risk  assessments  not  sufficient  to  cover  all  the  activities  being  undertaken; 
-  Adequacy  of  standard  control  measures  (eg  sealability;  HEPA  filtration,  restricted 
access) with respect to on-going planned preventative maintenance; 
- Training provision and training records – insufficient to demonstrate competence of the 
user. 

3.3  What were the corresponding enforcement actions taken?  

2014 - 2017 
AT 
BE 

improvement measures 
In 
In the Flemish Region: 

Wallonia: 

/ 

51 

 
 
  
 
 
 
 
 
 
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 
didn't 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 
written. 
infringement 

was 

In the Brussels-Capital Region: 

The  permit  imposes  to  provide  to  the  CA  pictures  or  documents  as  a  proof  that  the 
corrective measures have been taken. 

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

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. 

No injunctions have been issued during the reporting period and no contained use activities 
have been stopped. 

DE 

CY  No enforcement action was taken during the reporting period. 
CZ  The  deficiencies  in  the  documentation  were  corrected  either  right  at  the  time  of  the 
inspection or immediately afterwards. The CEI requirements were met within the set time 
limits and without problems. 
-verbal information and requests for removal of defects during the inspection (in the case of 
immediately implementable, smaller measures), 
-  revision  letter  or  minutes  requesting  the  rectification  of  deficiencies  and  deadlines, 
-  inclusion  of  conditions  in  approval  decisions  (in  the  case  of  new  annexes  or  significant 
changes), 
-  give  notice  of  orders  for  rectification  of  defects  or  of  subsequent  conditions, 
- initiation of administrative offense proceedings, 
- in individual cases, the (temporary) prohibition of genetic engineering works. 

DK  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. 
recommendations 

EE 
EL  No authorised premises in the reporting period. 
ES  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 

52 

 
 
 
 
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). 

FI  No  changes  since  the  previous  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.  

FR  Des instructions ont été données pour corriger les problèmes 
HR  not applicable 
HU  Providing detailed information on what kind of documentation is required. 
IE  By  and  large  violations  are  quickly  rectified.  Other  than  to  request  resolution  within  a 
certain timeframe, more stringent enforcement actions (such as serve notices, prosecutions 
as specified under the national legislation) have not proved necessary. 

IT  N.A.  
LT  During  carry  out  of  inspections  there  were  fulfilled  questionnaires  according  to  the 

2009/41/EC directive IV Annex. 

- 

LU  Report requiring corrective actions to be taken 
LV 
MT  No actions taken. 
NL  Most of the violations are not significant. In those cases the inspectorate sends a letter and 
requests for remedial actions within a given time frame. For more serious cases a report of 
the offence is made or a penalty is imposed on a daily basis in case of non-compliance. 

PL  We try to informed applicants about frequently mistakes done by other. 
PT  Not applicable. 
RO  Not applicable. 
SE  All errors were corrected within the notification procedure.  
SI 

Two decisions and 16 written warnings with a time limit were issued and in some cases the 
enforcing measure was only verbal communication with written minutes. 

In  one  case  the  insitution  of  the  notifier  was  reorganised  into  two  separate  legal  entities, 
none of them intended to carry on work with GMOs and they failed to notify the closure of 
installation. In this case the GMO inspector issued the decision for a formal deletion of the 
aforementined installation from the GMO Registry. 
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. 

SK  There were issued 9 decisions on fines. 
UK 

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 

53 

 
 
 
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. 

HSE’s  Enforcement  Policy  Statement  sets  out  the  factors  that  inspectors  consider  when 
deciding 
action 
(www.hse.gov.uk/enforce/enforcepolicy.htm) 

enforcement 

appropriate 

upon 

most 

the 

2018 
AT 
BE  

Premises had to take improvement measures 
In 

Wallonia: 

In the Flemish Region: 

/ 

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  didn't  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 the Brussels-Capital Region: 

The  permit  imposes  to  provide  to  the  CA  pictures  or  documents  as  a  proof  that  the 
corrective measures have been taken. 

BG  

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. 

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. 

No  injunctions  have  been  issued  during  the  reporting  period  and  no  contained  use 
activities have been stopped. 
No enforcement actions. 
Like before, no penalty was imposed. In few cases, the user just got a notice from the 

CY  
CZ  

54 

 
 
 
 
 
 
 
 
 
DE  

DK  

EE 
EL 
ES 

FI 

FR 
HR 
HU 
IE 

IT 
LT 
LU 
LV 
MT 
NL 
PL 
PT 
RO 
SE 
SI 

SK 
UK 

Inspection. 
- verbal instructions 
-  revision 
- inclusion of conditions in decision of approval 

letters  requesting 

the  rectification  of  deficiencies  with  deadlines, 

of 

offense 

initiation 

proceedings, 

administrative 

- 
- in individual cases, the (temporary) prohibition of genetic engineering works 
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. 
Nothing 
None 
No enforcement  action  were necessary  during this  period.  Inspection visits are  always 
carried  out  and  information  is  required  from  the  applicants  to  verify  that  these 
deficiencies have been rectified before authorizing the facilities. 
No  changes  since  the  previous  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 the issue was presented to the Board of Gene Technology, which 
can decide whether additional measures are needed besides a written complaint and an 
order to the operator to fulfil the requirements of the Gene Technology Act.  

Enforcement measures taken: obligation to provide procedures 

No actions were taken. 
By  and large violations are quickly  rectified. Other than to  request  resolution  within a 
certain  timeframe,  more  stringent  enforcement  actions  (such  as  serve  notices, 
prosecutions as specified under the national legislation) did not prove necessary. 

- 
None taken 
- 
N/A 
one more warning letter was sent during 2018 

Processes under analysis. 
Not applicable 
errors were corrected within he notificiation procedure 
Four written warnings with a time limit were issued. All of the notifiers complied and 
remediated  the  shortcomings  within  the  given  time  limit.  Therefore  we  believe  they 
understand the purpose of the biosafety system and want to contribute to the adequate 
biosafety themselves. 
A fine to the user. 
Inspectors used the following enforcement tools to ensure that users of GMMs comply 

55 

 
 
 
  
 
 
with the legislation: 

-  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). 

3.4 What actions were taken by the user (and/or advised by the CA) in order to minimise the 

occurrence of these issues in the future? 

2014-2017 
Information and regular training of the staff 
In Wallonia: / 

AT 
BE  

2018 
Information and regular training of the staff 
In 

Wallonia: 

/ 

In  the  Flemish  Region:    Shortcomings  had  to  be 
corrected  case  by  case  and  were  inspected  during  a 
inspection.  
follow-up 

In  the  Flemish  Region:    Shortcomings  had  to  be 
corrected case by case and were inspected during a 
inspection.  
follow-up 

In  the  Brussels-Capital  Region:  Issues  had  to  be 
corrected by the user.  

In  the  Brussels-Capital  Region:  Issues  had  to  be 
corrected by the user.  

BG   No  specific  actions  have  been  undertaken  as  no 
major  issues  have  been  encountered  during  the 
inspections. 

CY   Not applicable. 
CZ   Users  consult  the  requirements  in  advance  with  the 

CA. 

DE   The  identified  deficiencies  were  remedied  by  the 
users  usually  promptly  or  within  the  specified 
deadline.  If  required,  the  frequency  of  official 
inspections  was  increased.  The  authorities  usually 
offer  early  consultations.  The  users  took  different 
measures 
the 
problems,  i.e.  nomination  of  a  dedicated  person  for 
dealing  with  legal  and  safety  requirements  and 
keeping in touch with competent authorities, training 
of biosafety officers and of project leaders etc. 

the  occurrence  of 

to  minimise 

DK  

If any serious problems we will revisit the company. 

EE 

better  choosing  of  gloves,  better  labor  clothes 
washing arrangement 

EL  No authorised premises in the reporting period. 
ES 

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

from 

No  specific  actions  have  been  undertaken  as  no 
major  issues  have  been  encountered  during  the 
inspections. 
N.R. 
The  users  may  apply  various  checklist,  guidelines 
and  methodology  documents  published  and 
disseminated by the Ministry. 
The  identified  deficiencies  were  remedied  by  the 
users  usually  promptly  or  within  the  specified 
deadline.  If  required,  the  frequency  of  official 
inspections  was  increased.  The  authorities  usually 
offer  early  consultations.  The  users  took  different 
measures 
the 
problems, i.e. nomination of a dedicated person for 
dealing  with  legal  and  safety  requirements  and 
touch  with  competent  authorities, 
keeping 
training of biosafety officers and of project leaders 
etc. 
If  any  serious  problems  we  will  revisit 
company. 
No actions needed 

the  occurrence  of 

to  minimize 

the 

in 

No actions 
Many  consultations  from  the  users  (notifiers)  are 
received during the authorization procedure to solve 
doubts  about    the  facilities  or  equipments.  CA 
informs about specific actions required in each case.  

56 

 
 
 
 
 
 
 
 
 
 
the  other  hand, 

On 
the  CNB  makes  several 
recommendations  to  users  in  order  to  improve  their 
installations  although  the  measure  to  implement 
wouldn’t be compulsory. 
The operators followed the instructions given during 
inspections, according to their statement to Valvira. 

FI 

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 
legislation  when 
technology 
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 
emphasized to operators. 

in-house  control  systems  was 

inspector  also  ensures 

The  operators  followed  the  instructions  given 
during inspections, confirmed by their statement to 
the 
Valvira.  The 
requested documents will arrive to the CA. Whether 
the  operator  has  actually  taken  further  actions  can 
be  ensured  at  latest  during  the  next  inspection,  but 
they  can  be  observed  when 
in  many  cases 
inspecting  other  operators  working  in  the  same 
institute  and  using  common  premises  and 
infrastructure, such as waste management. 

that 

Apart  from  giving  specific  instructions  to  correct 
deficiencies:  
the 

observed 

-  Future  plans  of  GMO  activities  were  discussed 
with  operators.  Inspectors  gave  instructions  about 
the  liabilities  of  gene  technology  legislation  when 
activities.  
types 
starting 

new 

of 

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

organizational 

-Importance  of 
emphasized to operators. 

in-house  control  systems  was 

FR  Des  actions  de  communication  sont  menées  à 

écriture et validation des procédures 

destination des publics concernés 
not applicable 

HR 
HU  Notifiers took account of the documentation required 

No actions were taken. 

IE 

by the authorities. 
The  user  is  requested  to  respond  to  the  enforcement 
action  in  writing  within  a  specified  timeframe 
thereby 
the 
the  CA 
completed. 
enforcement 

if  and  how 

informing 

action 

was 

The user is requested to respond to the enforcement 
action  in  writing  within  a  specified  timeframe 
thereby 
the 
the  CA 
completed. 
enforcement 

if  and  how 

informing 

action 

was 

In addition, multi-user sites (institutions) are required 
to  have  Biological  Safety  Committees  (BSC)  and 
Biological Safety Officers (BSO) in place who liaise 
between the user and the CA and who impress upon 
the user then need to comply with the legislation.  

In  addition,  multi-user  sites  (institutions)  are 
required  to  have  Biological  Safety  Committees 
(BSC)  and  Biological  Safety  Officers  (BSO)  in 
place  who  liaise  between  the  user  and  the  CA  and 
who impress upon the user the need to comply with 
the legislation. 

IT 

N.A.  

57 

 
 
 
 
 
 
 
 
 
  
 
 
 
There were no specific issues. 
/ 
- 

LT 
LU 
LV 
MT  Not applicable. 
NL 

Four warning letters were send. All the violations had 
ceased within the given time frame. 

PL  We  try  to  informed  applicants  about  frequently 

mistakes done by other. 

PT  Not applicable. 
RO  Not applicable. 
SE 

SI 

As  all  errors  were  corrected,  we  expect  new 
notifications  from  the  same  notifier  to  be  more 
accurate.  
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.  

SK  Designation of responsible person who will take part 
the  Ministry  of 
in 
Environment  for  the  users  of  genetic  technologies 
and GMMs/GMOs about the legal requirements.  

training  organised  by 

the 

UK  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 
further 
inspection.  There  were  5  specific  instances,  where 
issues were raised by inspectors via written direction, 
specifically  referring  to  failure  to  comply  with  the 
GMO(CU) Regulations. 

the  prioritisation 

inform 

for 

to 

- 
N.A. 
- 
N/A 
no other than reported last year 

Processes under analysis. 
Not applicable 
- 

During  the  15  years  of  notification  process  we 
realised  some  notifiers  need  more  help  and  advice 
than  the  others.  So  in  the  collaboration  with  The 
Scientific  Committee  CA  regularly  helps  with  the 
pre-notification/renovation  visits  of  the  premises 
and  onsite  discussion  of  the  possible  containment 
measures. 
Training of all employees.  

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. 

3.5  What type of corrective and/or preventive actions taken, if any, did you apply in order 

to minimise the occurrence of these issues in the future? 

AUSTRIA 2014-2017 
Issue 

1 

AUSTRIA 2018 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

Issue 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

1 

58 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
BELGIUM 2014-2017 

Issue 

Enforcement action(s) 

1 

2 

3 

4 

In  the  Flemish  Region: 
See above 
In  the  Brussels-Capital 
Region:  The  biological 
risk  class  notified  in  the 
dossier was not correct. 

In  the  Brussels-Capital 
Region:  Ancient  wood 
furniture were present in 
facilities, not suitable for 
effective disinfection. 
In  the  Brussels-Capital 
Region:  No  adequate 
of  waste 
validations 
inactivation 
were 
undertaken. 

Shortcomings  had  to  be 
corrected 
The  biological  risk  class 
was  adapted,  so  as  the 
information  on  the  door 
of the laboratory, and the 
work practices. 
Ancient  wood  furniture 
were 
and 
removed 
by  modern 
replaced 
equipment,  suitable  for 
disinfection. 
Adequate 
validation 
procedures  were  set  up 
for waste inactivation. 

BELGIUM 2018 

1 

2 

Issue 

See above 

The  biological  risk  class 
notified  in  the  dossier 
was not correct. 

Enforcement action(s) 

Shortcomings  had  to  be 
corrected 
The  biological  risk  class 
was  adapted,  so  as  the 
information  on  the  door 
of the laboratory, and the 
work 

practices.    

Corrective/preventive 
measure(s) 
Follow-up inspection. 

The  inspectors  and  direct 
contacts  of  users  made 
them  aware  of  biosafety 
topics 
before 
approval/permit. 
The  inspectors  and  direct 
contacts  of  users  made 
them  aware  of  biosafety 
topics 
before 
approval/permit. 
The  inspectors  and  direct 
contacts  of  users  made 
them  aware  of  biosafety 
topics 
before 
approval/permit. 

Corrective/preventive 
measure(s) 
Follow-up inspection. 

The  inspectors  and  direct 
contacts  of  users  made 
them  aware  of  biosafety 
before 
topics 
approval/permit. 

3  Ancient  wood  furniture 
were present in facilities, 
not  suitable for effective 
disinfection. 

4  No  adequate  validations 
inactivation 

of  waste 
were undertaken. 

Ancient  wood  furniture 
were 
and 
removed 
replaced 
by  modern 
equipment,  suitable  for 
disinfection. 
Adequate 
validation 
procedures  were  set  up 
for waste inactivation. 

The  inspectors  and  direct 
contacts  of  users  made 
them  aware  of  biosafety 
before 
topics 
approval/permit. 
The  inspectors  and  direct 
contacts  of  users  made 
them  aware  of  biosafety 
topics 
before 
approval/permit. 

BULGARIA 2014-2017 

Issue 

Enforcement action(s) 

Corrective/preventive 

59 

 
 
 
 
 
 
 
 
 
 
measure(s) 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

1 

BULGARIA 2018 
Issue 

1 

CYPRUS 2014-2017 
Issue 

1 

CYPRUS 2018 

Issue 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

1 

CZECH REPUBLIC 2014-2017 

Issue 

Enforcement action(s) 

1  Administrative 
deficiencies 

CZECH REPUBLIC 2018 

Issue 

Enforcement action(s) 

1 

GERMANY 2014-2017 

Issue 

Enforcement action(s) 

1 

of 

Corrective/preventive 
measure(s) 
actions: 
Preventive 
Notifiers  can  consult  the 
CA  in  advance  of  the 
the 
submission 
notification  and  during 
the 
use. 
contained 
Various 
guidelines, 
formats and checklists are 
available  for  the  notifiers 
/ users on the CA´s GMO 
website. 

Corrective/preventive 
measure(s) 

Corrective/preventive 
measure(s) 

60 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
GERMANY 2018 
Issue 

1 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

DENMARK 2014-2017 

Issue 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

1 

DENMARK 2018 
Issue 

1 

ESTONIA 2014-2017 
Issue 

1 

2 

golves  will  break  very 
easily 
is  not  washing 
there 
lab, 
the 
mashine 
employees  wash 
their 
labclothes at home 

in 

ESTONIA 2018 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

Enforcement action(s) 

to 

recommentation 
change supplier 
recommenation 
to 
arrange better system for 
cleaning clothes 

Corrective/preventive 
measure(s) 
better choosing of gloves 

buying  washing  mashine 
for the laboratory 

Issue 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

1 

GREECE 2014-2017 
Issue 

1 

GREECE 2018 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

Issue 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

1 

SPAIN 2014-2017 
Issue 

Enforcement action(s) 

Corrective/preventive 

61 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 

SPAIN 2018 

Issue 

1 

measure(s) 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

FINLAND 2014-2017 

Issue 

Enforcement action(s) 

1  Neglect 

of 

risk 
assessment  of  new  type 
of  GMO-activities  and 
submitting  notifications 
to CA when needed. 

2 

3 

4 

5 

The 
of 
problems 
information  flow  within 
the  organization 
and 
organizational 
across 
borders. 

of 

information 
Lack 
among 
the  operators 
about  the  liabilities  of 
gene 
technology 
legislation 
Lack  of  knowledge  of 
legislative 
the 
boundaries 
the 
of 
authorities 

Commencing  the  use  of 
virus 
GM-influenza 
risk 
without  making 
and 
assessment 

informed 

the 
Valvira 
Gene 
Board 
Technology 
a 
possible  violation  of  the 

about 

for 

in 

about 
of 

Corrective/preventive 
measure(s) 
Future  plans  of  GMO 
activities  were  discussed 
and 
with 
operators 
gave 
inspectors 
the 
instructions 
gene 
liabilities 
technology 
legislation 
when  starting  new  types 
of activities. 
Contact  with  the  persons 
of  waste 
in 
charge 
management 
and 
infrastructure 
maintenance 
the 
organization.  Education 
of  operators  about  their 
to  ensure 
responsibility 
gaining  the  information 
about 
in 
conditions affecting to the 
safety of GMO use. 
Presentations 
biotechnology 
Visits, 
associations. 
lectures and presentations 
in educational institutes. 
Contacts  to  occupational 
authorities. 
health 
the 
Information 
gene 
legislation 
for 
technology 
occupational  safety  and 
health authorities. 
The 
was 
operator 
requested  to  interrupt  the 
use 
of  GM-influenza 
virus  until  the  CA  had 

the  changes 

on 

on 

in 

62 

 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
notification 
submitting 
or  application  to  the  CA 
(Board 
Gene 
for 
Technology). 

gene 
legislation. 

technology 

FINLAND 2018 

Issue 

Enforcement action(s) 

1 

2 

Taking  new  premises 
into  class  1  contained  
giving 
use  without 
in 
notice  or  neglect 
bookkeeping, 
risk 
assessment  and  making 
the action plan. 

The  operator  had  used 
class 1 GMMs for years/ 
extended  period  without 
the  notification 
giving 
concerning  the  premises 
for contained use.  

3 

class  3 
Commencing 
activity 
premises 
in 
which  were  notified  as 
containment 
level  2+ 
premises 

for 

informed 

the 
Valvira 
Gene 
Board 
about 
a 
Technology 
the  gene 
violation  of 
technology 
legislation 
and  issue was presented 
for  the  Board  of  Gene 
Technology.  A  written 
note  of  complaint  was 
written  to  the  operator 
and  it  was  ordered  to 
obey  the  duty  to  give 
notification to  the Board 
for Gene Technology.  
Valvira 
the 
Board 
Gene 
Technology 
about 
a 
violation  of 
the  gene 
legislation 
technology 
and  issue was presented 
for  the  Board  of  Gene 
Technology.  A  written 
note  of  complaint  was 
written  to  the  operator. 
As  the  class  3  use  had 
the 
already  ended 
operator  was  adviced  to 
submit  an  application  of 

informed 

for 

, 

the 

risk 
evaluated 
assessment  and  handled 
the 
notification 
concerning  its  use  by  the 
operator.  The  operator 
sent a new notification on 
Class  2  use,  which  was 
handled by the CA. 

that 

Corrective/preventive 
measure(s) 
operators  were 
The 
the 
about 
educated 
of 
gene 
requirements 
technology 
legislation, 
and  the  operator  had  to 
in  a  written 
confirm 
statement 
the 
inspector’s  orders  have 
been followed.  
Valvira  (  the  supervisory 
authority) asked for more 
information  to  find  out 
whether  the  use  of  class 
GMMs 
caused 
had 
adverse  effects  or  risk  of 
adverse 
effects 
considering  the  nature  of 
use. 
the 

authority 
Supervisory 
asked 
the  operator  for 
more  information  to  find 
out  whether  the  use  of 
class  3  GMMs  had 
caused  adverse  effects  or 
risk  of  adverse  effects 
(considering the nature of 
the  use).  It  appeared  that 
there 
been 
adverse  effects  and  the 
risk  for  adverse  effects 
was  estimated  very  small 
considering  the  nature  of 

had 

not 

63 

 
 
 
 
 
  
 
 
planned  commencing  of 
class 3  use to Board for 
Gene  Technology,  when 
needed.   

the  GMM  activities  and 
the  use  of  containment 
level  3  measures  during 
the work.  

Enforcement action(s) 

Corrective/preventive 
measure(s) 

FRANCE 2014-2017 
Issue 

1 

FRANCE 2018 

Issue 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

1 

CROATIA 2014-2017 

Issue 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

1 

CROATIA 2018 

Issue 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

1 

HUNGARY 2014-2017 

Issue 

Enforcement action(s) 

1 

HUNGARY 2018 
Issue 

Enforcement action(s) 

1 
2 
3 
4 
5 

0 
0 
0 
0 
0 

- 
- 
- 
- 
- 

IRELAND 2014-2017 

Issue 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

Corrective/preventive 
measure(s) 
- 
- 
- 
- 
- 

Corrective/preventive 
measure(s) 

64 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Liaise  with  BSO/BSC. 
CA  provides  seminars  on 
the 
legislative 
requirements. 

Liaise with BSO/BSC 

Liaise with BSO/BSC 

Corrective/preventive 
measure(s) 
Liaise with BSO/BSC. 

Liaise with BSO/BSC 

1  Non-notification 

of 
projects 
/ 

research 
involving  GMOs 
GMMs 

2  Validation 

labels 
the  date  on 
showing 
which 
of 
piece 
a 
last 
equipment  was 
validated and the date of 
next  validation  are  not 
displayed. 

3 

Incomplete 
lack of signage 

records 

/ 

of 

Provide  the  user  with 
details  of  notification 
requirements, 
forms, 
timelines and require the 
an 
submission 
application  within 
a 
certain  period.  Provide 
links to legislation. 
Clarify  if  validation  is 
completed  or  not.  If  not, 
require that validation be 
a 
completed  within 
certain  timeframe.  If  it 
has 
completed 
require  that  a  validation 
label be displayed within 
a certain timeframe. 
Require  that  records  be 
completed  /  erection  of 
signs  with  confirmation 
in  writing  within 
a 
certain time period. 

been 

IRELAND 2018 

Issue 

Enforcement action(s) 

1 

2 

 non 
of 
notification 
GMMs that were held in 
storage; 
validation 
certification 
for  autoclave  was  not 
available  

If 

the  user 

Request 
to 
submit  risk  assessments 
to the CA 
Clarify  if  validation  was 
completed. 
not, 
require that validation be 
completed  within 
a 
certain  timeframe.  If  it 
has 
been  
completed  require  that  a 
validation  certificate  be 
the  CA 
to 
submitted 
within 
certain 
a 
timeframe. 

ITALY 2014-2017 
Issue 

Enforcement action(s) 

1  N.A. 
2  N.A. 
3  N.A. 
4  N.A. 

N.A. 
N.A. 
N.A. 
N.A. 

Corrective/preventive 
measure(s) 
N.A. 
N.A. 
N.A. 
N.A. 

65 

 
 
 
 
 
 
5  N.A. 

N.A. 

N.A. 

ITALY 2018 

Issue 

1 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

LITHUANIA 2014-2017 

Issue 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

1 

LITHUANIA 2018 
Issue 

1 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

LUXEMBOURG 2014-2017 

Issue 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

1 

LUXEMBOURG 2018 

Issue 

1  N.A. 

Enforcement action(s) 

N.A. 

Corrective/preventive 
measure(s) 
N.A. 

LATVIA 2014-2017 
Issue 

Enforcement action(s) 

1 

- 

- 

Corrective/preventive 
measure(s) 
- 

LATVIA 2018 

Issue 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

1 

MALTA 2014-2017 
Issue 

1 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

66 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
MALTA 2018 

Issue 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

1 

NETHERLANDS 2014-2017 

Issue 

Enforcement action(s) 

1 

NETHERLANDS 2018 

Issue 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

Corrective/preventive 
measure(s) 

1 

POLAND 2014-2017 
Issue 

1 

POLAND 2018 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

Issue 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

1 

PORTUGAL 2014-2017 

Issue 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

1 

PORTUGAL 2018 
Issue 

1 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

ROMANIA 2014-2017 

Issue 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

1 

67 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ROMANIA 2018 
Issue 

1 

SWEDEN 2014-2017 
Issue 

1 

SWEDEN 2018 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

Issue 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

1 

SLOVENIA 2014-2017 

Issue 

Enforcement action(s) 

1 

Failure 
closure of installation 

to  notify 

the 

Decision  for  a  formal 
deletion 

Corrective/preventive 
measure(s) 
registration  CA 
Upon 
specifically  explains  the 
conditions  for  a  deletion 
of  the  installation  from 
the register 

2  Minor  equipment  and 

Written warnings 

3 

furnishing inadequacies 
Insufficient 
documentation 
management 

Written warnings 

SLOVENIA 2018 
Issue 

Enforcement action(s) 

Corrective/preventive 
measure(s) 

1  Minor  equipment  and 

Written warnings 

2 

furnishing inadequacies 
Insufficient 
documentation 
management 

Written warnings 

SLOVAKIA 2014-2017 

Issue 

Enforcement action(s) 

1  Missing documents 

Fine 

Corrective/preventive 
measure(s) 
Completing 
documentation 
Designation 

of 

of 

68 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
  
  
 
 
SLOVAKIA 2018 
Issue 

Enforcement action(s) 

1 

contained  use  without 
notification 

fine  

UNITED KINGDOM 2014-2017 

Issue 

Enforcement action(s) 

Letter 

Letter 

Letter 

Letter 

Letter 

1 

‘sealable 

(GMO(CU))  Reg  18(1) 
Sch 8 - CL3 laboratories 
to 
must  be 
permit  disinfection’  or 
‘sealable for fumigation’ 
2  GMO(CU)  Regulation 
8(1) risk assessments are 
reviewed regularly 

3  GMO(CU) 

Reg18(1) 
Schedule  8  requires  that 
of 
written 
records 
training  are  kept 
for 
those  staff  working  at 
CL3 

4  GMO(CU)  Reg  8  and 
Reg  26  GMSC  not  in 
provide 
to 
place 
advice  on 
competent 
RA, 
classification  of 
work 

5  GMO(CU)  Reg  18(1) 
Schedule  8  requires  that 
of 
written 
records 
for 
training  are  kept 
those  staff  working  at 
CL3 

UNITED KINGDOM 2018 

Issue 

Enforcement action(s) 

1 

(GMO(CU))  Reg  18(1)  
Sch  8  CL3  laboratories 
to 
must  be 

‘sealable 

Letter 

responsible person 

of 

Corrective/preventive 
measure(s) 
publication 
the 
decision  on  the  fine  on 
the  Inspectorate's  website 
and  on  the  Enviroportal 
website 

Corrective/preventive 
measure(s) 
Formal  response  required 
setting  out  timeframe  for 
corrective measures 

Formal  response  required 
setting  out  timeframe  for 
corrective measures 
Formal  response  required 
setting  out  timeframe  for 
corrective measures 

Formal  response  required 
setting  out  timeframe  for 
measures. 
corrective 
Projects 
stopped  until 
reviewed by GMSC 

Formal  response  required 
setting  out  timeframe  for 
corrective measures 

Corrective/preventive 
measure(s) 
Formal  response  required 
setting  out  timeframe  for 
corrective measures 

69 

 
 
 
 
 
 
 
 
permit  disinfection’  or 
‘sealable for fumigation’ 
2  GMO(CU)  Regulation 
8(1) risk assessments are 
reviewed regularly 
3  GMO(CU)  Reg  18(1) 
Schedule  8  requires  that 
of 
records 
written 
training  are  kept 
for 
those  staff  working  at 
CL3 

Letter 

Letter 

Formal  response  required 
setting  out  timeframe  for 
corrective measures 
Formal  response  required 
setting  out  timeframe  for 
corrective measures 

4.  
4.1  

4.2 

Accidents  
Provide information reported by the users on accidents (as required in Article 14(1) of 
the Directive) to the CA during the reporting period.  

Provide information on the measures taken by you, as a CA, on the basis of Articles 
14(2) and 15(1) of the Directive. 

4.3   Comment on a possible improvement regarding the occurrence of similar accidents, as 

a result of the measures taken by the user(s) and/or by the CA. 

4.1  

4.2 

Provide 
information 
reported  by  the  users 
on 
(as 
accidents 
required 
in  Article 
14(1)  of  the  Directive) 
to  the  CA  during  the 
reporting period.  

Provide 
information 
on the measures taken 
by  you,  as  a  CA,  on 
the  basis  of  Articles 
14(2)  and  15(1)  of  the 
Directive. 

4.3   Comment  on  a  possible 
regarding 
improvement 
the  occurrence  of  similar 
accidents,  as  a  result  of 
the measures taken by the 
user(s) and/or by the CA. 

No accidents were reported 

not applicable 

No accidents were reported 

not applicable 

not applicable 

In  Wallonia  one 
accident 
occurred  due  to  a  technical 
failure. 
competent 
authority  has  been  informed 
and  corrective  measures  have 
been taken.  

The 

The  external  technical  expert 
has  been  informed  and  has 
analysed 
documents 
some 
(with  actions  undertaken  and 
future  actions  pointed  out)  as 
well  as  the  intern  contingency 
plan.  The  external  technical 
expert  gave  advise  on 
the 
measures that should be taken.  

AT 
2014-
2017 
AT 
2018 
BE 
2014-
2017 

BE 
2018 

accident 
In  Wallonia  one 
occurre  due  to  a  human  error. 
The  competent  authority  has 

The  external  technical  expert 
has  been  informed  (by  phone 
and by online assessment form) 

/ 

70 

 
 
 
 
 
 
 
 
 
 
 
 
  
  
BG 
2014-
2017 

BG 
2018 

CY 
2014-
2017 
CY 
2018 

CZ 
2014-
2017 
CZ 
2018 
DE 
2014-
2017 

been  informed  and  corrective 
measures have been taken. 

analysed 
(with 

some 
has 
and 
documents 
actions 
undertaken  and  future  actions 
pointed  out)  as  well  as  the 
intern  contingency  plan.  The 
external  technical  expert  gave 
advise  on  the  measures  that 
should be taken. 

have 

accidents 
to 

been 
No 
notified 
the  Ministry  of 
Environment and Water during 
the reporting period. 
been 
accidents 
No 
notified 
the  Ministry  of 
to 
Environment and Water during 
the reporting period. 
No  accidents  were  reported 
during that period. 

have 

have 

accidents 
to 

been 
No 
notified 
the  Ministry  of 
Environment and Water during 
the reporting period. 
been 
accidents 
No 
notified 
the  Ministry  of 
to 
Environment and Water during 
the reporting period. 
Not Applicable 

have 

Not  applicable  as  no  accidents 
have been notified.  

Not  applicable  as  no  accidents 
have been notified. 

Not Applicable  

No accident reported. 

No  accident  happened  in  the 
Czech  Republic  during 
the 
reporting period. 
No accident occured during the 
reporting period. 
1.  Water  damage  in  a  class  3 
tuberculosis) 
premise 

(M. 

Due  to  a  sensor  failure  the 
automatic lock of a full storage 
tank  of  an  autoclave  did  not 
work.  As  a  consequence,  the 
storage tank, that was used for 
the 
collecting  water 
shower  and  hand  basin  of  the 
air  lock  chamber  flowed  over 
and dispended from the airlock 
chamber into the internal BSL3 
corridor of an BSL3 laboratory 
and  also  to  further  premises 
floor  below.  
including 

from 

the 

2.  Malfunction  of  a  fermenter  

No  measures 
taken  under 
Articles 14(2) and 15(1) of the 
Directive. 
Not applicable 

N.R. 

not applicable 

1.  After  discovery,  the  rooms 
were  immediatly  blocked.  The 
CA  was  immediatly  informed 
by the user. During the incident 
(around  midnight)  no  work 
took  place.  The  water  was 
qualified 
by 
absorbed 
inactivated, 
personnel 
and 
desinfected. 
surfaces  were 
Permission 
to  resume  work 
was  not  given  by  the  CA  until 
some actions were taken by the 
user  (negative  testing  for  M. 
tuberculosis,  restoration  of  full 
function  of  the  autoclave  as 
well as the doors of the airlock 
chamber, 
staff 
members,  regular  maintenance 
barriers). 
of 

training  of 

spill 

to 

false  signalling  a 
Due 
fermenter was opened that was 
still  in  progress  to  cultivate  a 

2.  The  discharged  culture  and 
material 
contaminated 

71 

 
 
  
  
 
 
 
 
  
stock of recombinant E. coli W 
followed  by  a  discharge  of  a 
large 
amount  of  bacteria 
culture.  

3.  Release  of  virus-active 
(recombinant  FLUAV-vaccine 
the 
strains)  wastewater 
sewage  system  with  possible 
entry  into  surrounding  waters 

into 

- 

in 

to 

floor  drains 

two 
The 
cleaning  rooms  of  the  premise 
were 
the 
contrary 
blueprints - not connected with 
sewage 
the 
in-house 
inactivation  system  but 
led 
directly  to  the  public  sewage 
system.  Thus,  residues  of  the 
seed  solution  from  the  vaccine 
residues  of 
containers  and 
allantoic 
infected 
the 
chicken 
harvesting  containers  arrived 
without  sufficient  inactivation 
in  the  public  sewage  system 
and  were  released 
the 
environment.  

liquid  of 
eggs 

from 

into 

4.  Infection  with  recombinant 
MRSA 

tried  to  repair 

The infection of one laboratory 
staff  member  was  presumably 
due to a leaky hose connection 
in  biofilm  experiments  with  S. 
aureus.  The  laboratory  staff 
member 
the 
connection  when  his  glove 
presumably  came 
in  direct 
face. 
contact  with 
Approximately  one  year  later 
he and also his wife developed 
disease  symptoms  and  surgical 
removal  of  the  furuncles  was 
neccessary.  The  microbial 
analysis 
the 
recombinant strain.  

identified 

the 

protective 
(personal 
equipment)  were  inactivated, 
contaminated 
surfaces  were 
desinfected.  The  staff  member 
was  examinated  by  the  doctor. 
The  bacteria  are  apathogenic 
and  are  classified  as  class  1 
organisms.  The  CA  was 
immediatly  informed  by  the 
user. The staff member as well 
as  the  environment  were  not 
endangered.  

of 

his 

own 

Committee 

3.  The 
regional  CA  was 
immediatly  informed  by  the 
user.  The  regional  CA  has 
forwarded  the  information  to 
different  regional  and  national 
authorities  and  involved  them 
in  the  next  steps.  The  user 
provided 
risk 
assessment.  The  public  was 
informed by declarations of the 
company 
the 
and 
authorities.The 
coordinating 
CA  (BVL)  was  asked  for 
the  ZKBS 
involvement  of 
(Central 
on 
Biological  Safety).  With  the 
participation  of  further  experts 
the  ZKBS  concluded  that  after 
release  of 
recombinant 
the 
FLUAV,  a  significant  dilution 
of  the  virus  particles  occurred 
in  the sewage system  and later 
in 
the  surrounding  waters. 
FLUAV  show  a  low  tenacity 
and 
to 
resistance 
environmental  influences.  Due 
to 
short-term 
least 
exposure  to  high  temperatures 
in 
process 
cleaning 
performed by the company and 
(ii)  the  presence  of  detergents 
and  high  concentrations  of 
microorganisms and suspended 
the  wastewater, 
matter 
inactivation, 
to 
which 
degradation  or  adsorption  of 
viral  particles,  the  inactivation 

in 
lead 

(i)  at 

a 

72 

 
 
 
 
 
 
 
the  majority  of  virus 
of 
particles  can  be  expected.  In 
view  of  the  low  concentration 
of  infectious  viral  particles  in 
surrounding  water,  an 
the 
exceeding  of 
infectious 
the 
dose in humans or wildbirds by 
aerosols  or 
respiration  of 
droplets  seems  very  unlikely. 

The 

The 
faulty  connection  was 
corrected  immediately  by  the 
company. 
correct 
connection  of  all  lines  in  the 
and 
factory  was 
confirmed.  There  were  several 
consultations  and  inspections 
CA.  
by 

regional 

checked 

the 

of 

4.  Different  authorities  and 
Ministries  including  the  CA 
after 
were 
involved 
the 
determination 
recombinant 
strain. 
Examination  of  surrounding 
laboratory  staff 
contacts  of 
members, family members and 
further persons, were instigated 
and 
the 
carried  out  by 
competent  health  authority. 
the 
Decontamination 
complete 
(H2O2 
fumigation)  was 
instigated. 
The CA inspected the premise. 
There were consultings and the 
instigation 
the 
to 
operating instructions.  
none 

premise 

adjust 

of 

N/A 

N/A 

N/A 

No measures needed 

N/A 

N/A 

N/A 

none 

N/A 

N/A 

0 

0 

No accidents reported. 

No accidents reported. 

73 

DE 
2018 
DK 
2014-
2017 
DK 
2018 
EE 
2014-
2017 
EE 
2018 
EL 

 
 
 
 
  
  
  
2014-
2017 
EL 
2018 
ES 
2014-
2017 
ES 
2018 
FI 
2014-
2017 

FI 
2018 
FR 
2014-
2017 
FR 
2018 
HR 
2014-
2017 
HR 
2018 
HU 
2014-
2017 
HU 
2018 
IE 
2014-
2017 
IE 
2018 
IT 
2014-
2017 

No 
accidents 
reporting period 
Accidents were not reported 

reported 

in 

No  measures  were  required  in 
reporting period 
Accidents were not reported 

Accidents  have  not  been 
reported by the users.  
A  few  needle  stick  accidents 
concerning 
employee 
the 
working with a GMM. Also, an 
in 
effluent 
the 
overflow 
premises  of  a 
large  scale 
operator  had  possibly  led  to 
release  of  live  class  1  GM 
organisms  from  the  contained 
use. 

No accidents reported in 2018. 

report 

Accidents  have  not  been 
reported by the users.  
In 
the 
the  accident 
operators  must  describe  which 
corrective  measures  they  have 
already taken and what kind or 
measures they are going to take 
to  prevent  similar 
in  order 
accidents 
the  future.  A 
in 
presenting official of the Board 
and 
each 
examines 
these 
whether 
decides 
sufficient. 
measures 
are 
the 
Valvira  supervises 
that 
corrective 
are 
actually taken.   
- 

measures 

case 

None 

None 

None 

None 

executed 

inspector  follows 

Valvira's 
that  
the  corrective  and  preventive 
by 
measures  were 
requesting  information  about  the 
actions  taken  from  the  operators. 
In  the  effluent  overflow  case  the 
pumping  capacity  was  increased, 
automatic monitoring of the liquid 
level was added to stop pumping at 
the  threshold  level,    and  the  staff 
was educated to foresee,  recognize 
and  prevent similar situations. 

- 

None 

None 

not applicable 

not applicable 

not applicable 

No accidents were reported. 

No accidents were reported. 

None. 

None. 

- 

No  accidents  were  reported 
during the reporting period. 

No  accidents  were  reported 
during the reporting period. 

Not applicable 

No  accidents  were  reported 
during the reporting period 
No accident has been reported, 
despite the legislative decree n. 
the 
lays 
206/2001 
measures referred to Article 14 

down 

No  accidents  were  reported 
during the reporting period 
N.A. 

n/a 

N.A. 

74 

 
 
  
  
  
 
 
 
  
IT 
2018 
LT 
2014-
2017 
LT 
2018 
LU 
2014-
2017 
LU 
2018 
LV 
2014-
2017 
LV 
2018 
MT 
2014-
2017 
MT 
2018 
NL 
2014-
2017 

(2)  and  15  (1)  of  the  Directive 
and  requires  that,  in  the  event 
of an accident, the user  should 
keep  informed  the  holder  of 
premise and the CA. 

No accidents were reported. 

No accidents were reported. 

No accidents were reported. 

0 

0 

no accidents reported 

no accidents reported 

no accidents reported 

No accident reported 

No accident reported 

No accident reported 

- 

No accidents registrated. 

- 

No, accidents 

No, measures taken  

No accidents occurred. 

Not applicable. 

Not applicable. 

No accidents occurred. 

N/A 

N/A 

number 

of 

accidents: 

0 

Number of incidents: 9, details 
incidents: 
of 

-  A  needle  stick  injury  with  a 
GM  tumor  cell  line  in  mouse 
work.  

-  A  fire,  causing  heavy  smoke 
damage  in  several  GMO  labs. 
The  containment  was  not 
fire.  
breached 

the 

by 

-  During  renovation  activities 
in  a  lab,  GMO  waste  is  not 
properly  being  disposed  of. 
Instead the waste ends up in an 
open 
with 
container 
construction  waste  outside  of 
building. 
the 

-  A  small  amount  of  GMO 

all 

cases  of 

reported 
In 
incidents 
the  BSO  was 
contacted  and  entered  into  an 
agreement  with  the  CA.  In 
some  cases 
those  directly 
involved  in  the  incident  were 
interviewed.  One  case  has  led 
to  a  follow-up  extensive  audit. 
No  accidents  occurred,  hence 
no reporting to  MS or EC was 
necessary. 

temporary  and 

In  the  case  of  the  needle  stick 
injury,  a  safer  kind  of  needle 
should  prevent  future  incidents.  In 
case  of  the  clarification  system, 
both 
technical 
measures  should  prevent  future 
incidents.  The  incident  with  GMO 
waste  asked  for  better  procedures. 
Maintenance  work  will 
be 
followed  by  internal  inspection  of 
BSO before units are brought back 
on line. 

75 

 
 
 
 
 
  
  
 
 
 
 
 
local 

sewers 

material  was  discharged  onto 
the 
system, 
because of a release of air from 
a  clarification  system  that  led 
to  an  unintentional  flow  of 
GMO  material  to  the  drain. 

-  possible  discharge  of  small 
amount  of  GMO  from  small 
bioreactor  into  sewers  due  to 
on 
miscommunication 
of 
disinfection 
bioreactor. 

status 

-  A  needle  stick  injury  during 
work  with  mice  to  screen  for 
loss  of  GMO  in  their  blood, 
following 
treatment  with 
GMO.  Mice  turned  out  to  be 
clean. 

-  Change  from  under-pressure 
to over-pressure in DM-III unit 
that  was  not  yet  in  use  for 
during 
experiment.  Cause: 
valves  were 
maintenance 
operated,  but  not  reconfigured 
to 
at 
proper 
completion  of  the  work.  The 
system  malfunctioned  a  few 
months  after  the  maintenance 
performed. 
work 

state 

was 

the 

-  A  needle  stick  injury  during 
work  with  a  GMO.  Employee 
was 
curative 
medication,  as  a  precautionary 
measure.  

put 

on 

NL 
2018 

incidents 

-  A  needle  stick  injury  during 
work  with  a  GMO.  Employee 
was  put  on  antibiotics,  as  a 
precautionary measure.  
in  2018: 
7  CU 
-  DM-II  GMO  waste  was  not 
disposed  of  in  the  prescribed 
manner 
-  ML-I  GMO  was  handled  in 
conventional lab (no discharge) 
-  Company  using  GMO's 

all 

cases  of 

reported 
In 
incidents 
the  BSO  was 
contacted  and  entered  into  an 
agreement  with  the  CA.  In 
those  directly 
some  cases 
involved  in  the  incident  were 
interviewed.  One  case  has  led 

No other comments than given last 
time. 

76 

 
 
 
 
 
 
 
Use 

into 

appointed 

of 
in  ML-II 

BSO 
without 
-  During  construction  works 
the duct of a vetilation outlet of 
an  ML-I 
lab  got  breached 
-  ML-I  GMO  was  accidentally 
sewers 
discharged 
ineffective 
- 
lab, 
desinfactant 
resulting  in  a  possible  small 
discharge 
GMO 
-  Use  of  combination  of 
host/vectors  at  containment 
level ML-II, instead of ML-III. 
The  work  was  discontinued 
and GMO's destroyed. 
No accidents so far. 

of 

to  a  follow-up  extensive  audit. 
No  accidents  occurred,  hence 
no reporting to  MS or EC was 
necessary. 

Standard procedure 

No  accidents  were  reported  in 
this period. 

Not applicable. 

No  accidents  were  reported  in 
this period. 
Not applicable  

No  accidents  were  reported  in 
this period. 
Not applicable  

Not applicable  

Not applicable 

Not applicable 

Not applicable 

No accidents were reported. 

No accidents were reported. 

- 

- 

- 

PL 
2014-
2017 
PL 
2018 
PT 
2014-
2017 
PT 
2018 
RO 
2014-
2017 
RO 
2018 
SE 
2014-
2017 
SE 
2018 
SI 
2014-
2017 

In  the  reporting  period  CA  in 
Slovenija  did  not  received  any 
report of an accident involving 
GMMs,  GM  animals  or  GM 
plants.  

SI 
2018 

No  accidents  were  reported  in 
the reporting period. 

emergency 

requirements 
cases 

No  measures  were  taken  since 
there  were  no  reports.  All 
for 
neccessary 
the 
are 
implemented  in  the  legislative 
framework. 
The  biosafety  framework  in 
Slovenia 
by 
horizontal  legislation  based  on 
of 
Management 

covered 

is 

Genetically 
Modified 
Organisms  (MGMO)  Act  (OJ 
RS  23/2005  and  amended  OJ 
The  Act 
RS 

21/2010). 

77 

 
 
  
 
 
 
  
  
  
  
 
  
implements  the  provisions  of 
the  Directive  2009/41/EC  and 
therefore also the provisions of  
Articles  14(2) 
and  15(1). 
Together  with  the  notification 
documentation  the  notifier  is 
obliged  to  propose  a  plan  of 
the  case  of  an 
actions 
accident.  The  plan  is  assessed 
by  the  CA  and  the  Scientific 
Committee 
to 
No 
contained 
activities 
use 
occured  during  the  reporting 
period 

accidents 

related 

in 

in 

Slovakia.   

The notified contained uses did 
not  foresee  any  transboundary 
impacts in case of an accident.  
No 
to 
contained 
activities 
use 
occured  during  the  reporting 
Slovakia. 
period 

accidents 

related 

in 

The notified contained uses did 
not  foresee  any  transboundary 
impacts in case of an accident. 
Not applicable 

Not applicable 

The  CA  carried  out  a  full 
investigation  of  the  cause  of 
accident.  
the 

causes  of 

Immediate 
the 
accident  and  consequences  of 
resulting 
the 
member  of  staff  concerned 
as:  
identified 
were 

infection  of 

IP was given sharps training when 
handling  GM  viruses  and  other 
GM  biological  agents  and 
the 
mandatory training courses on GM 
biosafety  for  all  staff  involved  in 
GM  work.  The  IP  and  other 
relevant 
staff  were 
informed  of  old  accident  and 
emergency 

laboratory 

procedures.   

-  Failure  to  follow  acceptable 
procedures  when  using  sharps 
viruses.  
with 

GM 

-  Failure 
to  carrying  out 
procedures  in  the  designated 
laboratory.  

-  Failure  to  notifying  relevant 

assessments 

Risk  assessment  –  management  of 
risk 
for  GMOs 
(vaccinia  virus  and  others)  have 
been  reviewed.  Risk  assessments 
have  been  given  a  defined  review 
period  of  one  year  for  medium  to 
high  residual  risk  and  up  to  three 
years  for  low  residual  risk.  High 
risk  procedures  and  biosafety 

78 

No  accidents  were  reported 
during the reporting period. 

SK 
2014-
2017 

SK 
2018 

No  accidents  were  reported  in 
2018.  

UK 
2014-
2017 

UK 
2018 

to 

Level 

There  have  been  no  accidents 
notified 
the  UKCA  as 
required  under  Article  14(1) 
during the reporting period. 
Injured  person  (IP)  working  in 
2 
Containment 
laboratory  preparing  GM  non-
replicative  oncogenic  Lister 
vaccinia 
before 
virus 
transferring the virus in loaded 
syringes 
the  Biological 
Services  Unit  in  the  animal 
unit  for  inoculation  into  mice. 
Whilst preparing the syringes a 
miscalculation  of  the  amount 
of virus in the cryotubes led to 
the IP trying to put some of the 
viral  stock  back 
the 
cryotube using the syringe and 
inadvertently 
the 
needle into their left forefinger.  

stabbing 

to 

in 

to 

 
 
 
  
 
  
 
 
 
 
 
people  about  the  accident  in  a 
fashion.  
timely 

Underlying 
identified 

causes 

were 
as:  

-  Inadequate  risk  assessment 
for  procedures  using  sharps 
with  GM  biological  agents.  

training 

Inadequate 

- 
and 
competence  assessment  for  the 
sharps  with  GM 
use  of 
agents.  
biological 

- 
Inadequate  accident  and 
emergency procedures and OH 
provision 

Report  sent  to  the  European 
Commission 

issues  such  as  the  use  of  sharps 
with  virus  has  been  prioritised  in 
relevant 
risk  assessments.  All 
reviewed  risk  assessments  are  re-
issued  to  researchers  and  related 
recorded.  
staff 

and 

in 

Emergency  procedures  –  formal 
established 
procedures 
and 
implemented 
for  accident  and 
emergencies  when  working  with 
GM  vaccinia  virus  and  other  GM 
biological  agents.  Clear  lines  of 
communication  defined 
the 
event of an accident or emergency 
and 
of 
training. 
procedures 
through 
Definitive  guidance 
staff 
working  with  GM  vaccinia  virus 
and  other  GM  biological  agents 
when 
or 
immunocompromised  has  been 
established  and  training  provided 
recorded.  
and 

staff  made 

pregnant 

aware 

for 

Occupational  health  -  the  role  of 
OH  in  accident  and  emergencies 
formalised.  Agreed 
protocols 
produced  for  post-incident  actions 
with  occupational  health’s  role 
clearly  defined  and  systems  in 
place  to  ensure  they  are  provided 
information.  
with  all 

relevant 

Training – lessons learnt document 
prepared  and  issued  across  the 
University  for  compliance  via  the 
Groups. 
H&S  Management 
Appropriate  sharps 
training  for 
handling  GM  viruses  and  other 
and 
GM 
mandatory training courses on GM 
biosafety established, implemented 
and  recorded  for  all  staff  involved 
in GM work.  

biological 

agents 

5.  

Public consultation  

79 

 
 
 
 
 
 
 
 
 
 
 
 
5.1 

Do  you  carry  out  any  public  consultation  under  your  contained  use  legislation,  in 
accordance with Article 12 of the Directive? 

If  yes,  provide  details  of  those  public  consultations  and  of  the  information  made 
publicly available as part of the consultations.  

2014 - 2017 
AT  No 
BE  Yes  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. 

The consultation also gives the public the possibility to express comments, observations 
or objections regarding the contained uses. The CA take the 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. 

A similar procedure of public consultation is established in Wallonia during the course 
of the environmental permit demand to the competent authority. 

In  Wallonia,  requests  for  environmental  permits  for  this  type  of  activity  are  rarely 
subjected  to  opposition  or  comments  from  residents.  In  case  a  remark  is  made  by  the 
public, it is taken into account in the summary report which is sent to the CA and, where 
appropriate,  special  operating  conditions  which  should  be  added  to  the  permit  are 
proposed to the competent authority. 

In  the  Flemish  and  Brussels-Capital  Regions,  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.  

BG  Yes  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. 

established 

A public registers of the premises for contained use of GMOs and permissions for work 
electronic 
were 
at 
http://www.moew.government.bg/bg/priroda/gmo/registri-gmo/ 
(in  Bulgarian  only). 
Information contained in notifications can be received from the Ministry of Environment 
and water upon request with the exception of confidential and personal data. 

are  maintained 

form 

and 

an 

in 

CY  No 
CZ  No 

80 

 
 
 
 
  
 
 
 
 
 
 
 
  
  
DE  Yes  Public consultation is carried out in case of approval procedures (class 3 or 4 activities). 
Authorizations are usually published in the Federal State Gazette and on the homepages 
of the CAs of the Federal  States.  The following  information  is  published: file number, 
security level, operator, location of the installation, title of the work, period and location 
of the public display of the approval documents. The public has the possibility to have 
the documents sent to them, to see them and to file a complaint against the permit. 

DK  Yes  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 the application 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. 

EE  No 
EL  Yes  Public  consultation 

in  cooperation  with 
law  and 
local/decentralised  authorities.  However  no  public  consultation  took  place  during  the 
reporting period because no notifications were received. 

is  required  by 

takes  place 

ES  Yes  Only notifications of class 3 and 4 activities are made available to the public through the 
Ministry Webpage. Information provided by the notifier is published in compliance with 
the laws regarding the protection of personal details.  

FI  No 
FR  Yes  "Dossier d'information au public" transmis au Maire de la commune d'implantation de la 

structure 

HR  Yes  On website Ministry of Health and Ministry of Science and Education  
HU  Yes  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. 
IE  Yes  Notifiers submitting applications in  respect  of Class  3/4  GMM contained use activities 
are required to publish a notice in a newspaper informing the public of submission of the 
application to  the CA, the nature of the proposed activity  and inviting  members of the 
public to make representations to the CA within a period of 4 weeks.  

IT  Yes  No  public  consultations  have  been  carried  out  during  the  reporting  period.  The  list  of 
GMM authorized installations is publicly available on the Ministry of Health website, at 
the following address:  
http://www.salute.gov.it/imgs/C_17_pagineAree_4243_listaFile_itemName_0_file.pdf 

Additional information regarding the public consultation: 

Public consultation is mandatory when a notification for a class 4 premise is submitted to 
the Ministry of Health. In this case the notifier, at the same time of the submission and at 
his own expense: 

a)  submits  a  copy  of  the  notification  to  the  municipality  where  the  class  4  premise  is 
planned; 

b) the same day the notifier shall issue a notice of the filing of the documentation on the 

81 

 
 
  
  
 
 
 
 
two  most  widely  disseminated  newspapers  in  the  territory  concerned,  indicating  the 
place where it is possible to view it. 

Anyone  who  intends  to  provide  informative  and  evaluation  elements  that  he  or  she 
considers to be negative for the authorization of the class 4 premise, may submit written 
comments  to  the  Ministry  of  Health  and  the  local  Authorities  within  30  days  of  the 
publication of the notice referred to the previous paragraph. 

Public is also informed before a contained use commences when the MoH considers, on 
the basis of the  Biotechnology Health Technical Committee assessment,  that failure of 
the containment measures can lead to serious danger, whether immediate or delayed, to 
humans outside the premise and/or to the environment. In this case the MoH informs as 
soon as possible the Prefect, the Mayor and the Presidents of the concerned Region and 
Province that draw up the emergency plans promptly and, in any case, within 60 days. 

The emergency plan is drawn up on the basis of information included in the notification 
submitted to the MoH. 

The  Mayor  is  responsible  to  assure  that  the  population  at  risk  is  informed  about  the 
relevant  safety  measures  and  about  the  correct  behavior  to  be  taken  based  on  the 
emergency plans. 

The  information  included  in  the  emergency  plan  has  to  be  updated  at  appropriate 
intervals. 

Information  on  such  emergency  plans,  including  the  relevant  safety  measures  to  be 
applied, has to be made publicly available 

The  MoH  with  the  support  of  the  Civil  Protection  Department  (Presidency  of  the 
Council  of  Ministers)  ensures  the  appropriate  consultations  and  the  exchange  of 
information with the Competent Authorities of the Member States concerned and makes 
available the same information as that which is disseminated to Italian nationals. 

LT  Yes  The Ministry of Environment has published information about contained use of GMMs 
the  public  via  Ministry's  website  http://gmo.am.lt  preserving 
and  GMOs 
confidentiality  rights  and  intellectual  property  according  to  the  Order  on  Public 
Information  and  participation  and  the  Order  on  Genetically  Modified  Organisms 
Information System. 

to 

LU  Yes  A notice indicating the purpose of the application for authorization is posted for fifteen 
days  in  the  municipality  where  the  operation  is  planned  by  the  care  of  the  college  of 
mayors and aldermen. The posting must take place no later than ten days after the receipt 
of the file. 

The  display  must  take  place  simultaneously  at  the  town  hall  and,  quite  clearly,  at  the 
location  where  the  operation  is  planned.  From  the  day  of  posting,  a  copy  of  the 
application  with  its  annexes,  with  the  exception  of  information  recognized  as 
confidential. 

LV  No 
MT  No  Not applicable. 
NL  Yes  In the Netherlands licensing of the GMO contained use facilities and the authorization of 

contained use activities are two distinct legal processes. 

82 

 
 
 
 
 
 
 
 
 
 
  
The contained use facilities for GMO’s are part of a general environmental permit for the 
premises.  The  public  is  consulted  during  this  licensing  procedure.  During  the 
consultation process details concerning the number and containment level of the various 
rooms destined for contained use of GMO’s, are made publicly available. Once such a 
general environmental permit for the facility is obtained users may start their authorized 
GMO-activities.  The  GMO-notifications  are  not  subject  to  public  consultation,  but  the 
general public may access a public web-based database to obtain general information on 
the notifications (such as user, title, municipality of the facility and authorization date). 

PL  Yes  We have online register lists with all contained use of GMO/GMM 
PT  No 
RO  Yes  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 
the  public. 
within  30  days 

receives  comments 

the  display, 

from 

from 

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. 

    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. 

In no case the following information shall be kept confidential: 

-  The  general  characteristics  of  the  genetically  modified  micro-organisms,  name  and 
activity;  
and 
address 
containment; 
use 
- 
The 
environment; 
human 
-  Any 
- The emergency plans. 

of 
and  measures 
and 

notifier, 
contained 
on 

of 
class 
harmful 

location 

the 
of 

of 
the 

effects 

health 

the 

SE  No 
SI  Yes 

 Management  of  Genetically  Modified  Organisms  (MGMO)  Act    provides  that    the  
public  is  to  be  consulted  on  aspects  of  the  proposed  contained  use in the cases of 
contained  use  installations  for  BSL  3  and  4.  Since  no  notification  for  BSL  3  or  4 
facilities  has  been  received  in  SLOVENIA  no  public  consulatation  was  carried  out  so 
far. 

SK  Yes  The Ministry is obliged to inform the public on the substantial part of the application for 
(http://www.minzp.sk/postupy-ziadosti/geneticky-

approval 

through 

Internet 

the 

83 

 
 
 
  
 
 
 
 
 
 
 
  
modifikovane-organizmy/pripomienky-k-ziadostiam-ohlaseniam/  ),  and  by  any  other 
appropriate means as well if it is necessary to effectively inform the public, with a call 
for 

and  with 

comments 

submission.   

deadline 

public 

their 

the 

for 

Publicly  available  are  made  the  substantial  part  of  the  application,  summary  of  risk 
assessment and the  emergency plan. 

The Ministry evaluates the comments after the deadline for submission of comments to 
the application published and will let the party* and the advisory body  of the ministry 
them. 
“The 

Committee 

Biological 

comment 

Safety” 

for 

on 

to 

The  Ministry  will  not  give  the  party  and  the  advisory  body  such  comments  which 
express general questions on the use of GMOs and personal attitude/opinion and are not 
specifically  related  to  the  genetically  modified  organism  or  other  issue  which  the 
view. 
application 

technical 

contains, 

point 

from 

of 

a 

*Party  to  the  proceeding  is  the  applicant  and  also  a  civic  association  under  certain 
conditions 

Generally, the Ministry is obliged to inform the public through the Internet as well as by 
any other appropriate means, 

a) on the substantial part of content of the applications for approval , as well as on issued 
permits  (contained  use,  intentional  introduction  of  GMO  into  the  environment,  placing 
on the market), 

b)  summary  report  on  issued  approvals  for  contained  use  classified  into  risk  classes  3 
and  4,  comprising  description,  purpose  and  risks,  as  well  as  reporting  in  form  of 
summary announcement information format, 

c) evaluation report when products are placed on the market, 

d) a report on monitoring results, 

e)  information  about  detected  unauthorized  introduction  into  the  environment  or 
measures, 
placement 

adopted 

market 

safety 

and 

the 

on 

on 

f) decisions on adopted safety measures. 

UK  Yes  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. 

The  CA  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 

84 

 
 
 
  
 
 
 
 
 
 
the  Register 

is  held  at  HSENI  headquarters  83  Ladas  Drive,  Belfast. 

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

this 

The  CA  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. 

2018 
AT   No 
BE   No 
BG   No 
CY   No 
CZ   No 
DE   Yes  Public consultation is carried out in case of approval procedures (class 3 or 4 activities).  

Authorizations are usually published in the Federal State Gazette and on the homepages of 
the CAs of the Federal States. The following information is published: file number, security 
level,  operator,  location  of  the  installation,  title  of  the  work,  period  and  location  of  the 
public  display  of  the  approval  documents.  The  public  has  the  possibility  to  have  the 
documents sent to them, to see them and to file a complaint against the permit. 
DK   Yes  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 
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. 

EPA  makes 

application 

decision 

about 

the 

the 

a 

EE   No 
EL   No 
ES   No 
FI   No 
FR   No  Néant 
HR     
HU   No 
IE   Yes  During 2018, one notification for the contained use of a Class 3 GMM was submitted to the 
CA,  in  respect  of  which,  the  notifier  published  a  notice  in  a  newspaper  circulating  in  the 
district  of  the  proposed  contained  use  activity.  The  notice  informed  the  public  of  the 
submission  of  the  notification  to  the  CA,  the  nature  of  the  proposed  activity  and  invited 
members of the public to make representations to the CA within a period of 4 weeks. 

IT 
LT   No 
LU   No 
LV   No 
MT   No  N/A 
NL   Yes  In the Netherlands licensing of the  GMO contained use  facilities and the authorization of 

85 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
contained use activities are two distinct legal processes. 

The contained use facilities for GMO’s are part of a general environmental permit for the 
premises.  
The  public  is  consulted  during  this  licensing  procedure.  During  the  consultation  process 
details  concerning  the  number  and  containment  level  of  the  various  rooms  destined  for 
contained use of GMO’s, are made publicly available. Once such a general environmental 
permit  for  the  facility  is  obtained  users  may  start  their  authorized  GMO-activities.  The 
GMO-notifications are not subject to public consultation, but the general public may access 
a  public  web-based  database  to  obtain  general  information  on  the  notifications  (such  as 
user, title, municipality of the facility and authorization date). 

PL 
PT   No 
RO   Yes  All  the  notifications  are  published  on  the  website  of  NEPA.  Public  information  at  the 
national  level  is  performed  in  cooperation  with  the  county  environmental  agencies, 
functioning under the National Environmental Protection Agency. All the risk assessments 
submitted  by  the  notifiers  and  the  summary  of  all  the  decisions  taken  by  the  competent 
authority  are  published  on  the  website  of  NEPA:  http://www.anpm.ro/biosecuritate  , 
http://www.anpm.ro/notificari. 

SE   No 
SI   No 
SK   No 
UK   No 

5.2 

(if yes to question 5.1) Provide details of any public reaction, if received, in response 
to the consultations. 

2014 - 2017 
BE 

In Wallonia, there was only one dossier for a permit application concerning the contained 
use of genetically modified organisms of risk class 2, for which there was an  observation 
during the public inquiry concerning the proximity of the laboratory to the residences and a 
school. 

In  the  Flemish  and  Brussels  Capital  Regions,  there  was  no  public  reaction  received  in 
response  to  consultations  and/or  information  made  publicly  available  under  Directive 
2009/41/EC.  

BG  No public reactions have been received so far about contained use of GMO. 
DE  none 
DK  None 
EL 
ES  No comments were received. 
FR  Pas de réactions portées à notre connaissance 
HR  not applicable 
HU  No public reactions received to date. 
IE  No  public  reaction  has  been  received  in  response  to  consultations    and/  or  information 

made publicly available to date. 

IT  N.A. 

86 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
LT  There were no public reaction received. 
LU  None received 
NL  The public consultation concerns the facility in its entirety and not only or specifically the 
GMO facilities within such a premises. In general, received public comments focus on the 
overall premises, and very rarely on the aspect of the GMO facilities in particular. 

Since no consulatations were carried out, no reactions were received. 

PL 
RO  Not applicable. 
SI 
SK  No reactions from public were received in the reporting period. 
UK  A  summary  of  responses  to  the  consultation  on  the  proposed  consolidation  of  the 
Genetically Modified Organisms (Contained Use) Regulations, which were predominantly 
supportive of the proposals, has been published at: 
https://webcommunities.hse.gov.uk/connect.ti/HSEmeetings/view?objectId=618981 

2018 
DE   no response 
DK   None 
IE   No public reaction was received. 
NL   The public consultation concerns the facility in its entirety and not only or specifically the 
GMO facilities within such a premises. In general, received public comments focus on the 
overall premises, and very rarely on the aspect of the GMO facilities in particular. 

RO   Not applicable 

6. 

Interpretation and implementation of Directive 2009/41/EC  
Please  note  that  clinical  trials  and  gene  drive  modified  organisms  are  addressed  in 
dedicated sections of the questionnaire, so answers related to those types of contained 
uses should be reported in the respective sections. 

6.1  What  aspects  concerning  the  interpretation  of  the  Directive,  if  any,  give  you 

difficulties as CA? 

2014-2017 
AT  none 
BE  There are some elements to be considered for the interpretation of the GMO definition in 

the context of Gene Editing techniques. 

The CA of the Flemish Region got a request concerning genetic modifications induced in 
plants  and  animals  by  the  transient  presence  of  the  CRISPR/Cas9  system  delivered  as 
purified ribonucleoprotein with  or without a homologous repair DNA template. Does this 
fall under the scope of the legislation of contained use? Based on an advice from the SBB 
on this request,  the CA concluded that the intended uses under containment of animals and 
plants genetically modified as described before should be considered for exclusion from the 
scope of the Decree of the Flemish Government of 6 February 2004, according to Annex 15 
B of this Decree (Annex II Part A of Directive 2009/41/EC).  

BG  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. 

87 

 
 
  
 
 
 
 
 
 
 
It is not entirely clear how the provisions of the Directive should be applied in some special 
cases,  e.g.  when  GMM  is  administered  in  hospital  during  clinical  trial  or  in  the  case  of 
microorganism collections where the organisms are stored under cryogenic conditions. It is 
not clear whether in those cases notifications of the premises should be submitted. 

CY  None. 
CZ  Sub-cellular  elements:  whether  a  specific  element  falls  under  the  definition  of  “micro-
organism” or not. Consequently, whether certain  activities and premises (e.g. trade in life 
sciences  products  that  includes  their  storage  and  distribution)  have  to  be  notified. 

New gene techniques: whether a specific technique and the resulting organism fall within 
the scope of the Directive. 

DE  A  clear  position  of  Commission  is  still  missing  whether  new  techniques  of  genetic 
modification (ODM, using nuclease derived techniques (e. g. CRISPR-Cas)) fall within the 
scope of Directive 2009/41/EC. 

Some  CAs  of  the  federal  states  further  encountered  problems  with  the  interpretation  of 
Annex IV of the Directive 2009/41/EC and suggested a more precise wording of standards. 
DK  Scientist in some cases are confused to which class is appropriate for their laboratory work. 

This is especially true concerning Adeno associated virus vectors. 
there is not this field activity in Estonia 

EE 
EL  No difficulties in interpretation. 
ES 

In Spain, clinical trials with GMOs are regulated as deliberate reléase activities, but it is not 
clear if facilities in which GMOs are handled or stored must be notified as contained used 
activities. There are also problems  in the interpretation if products obtained by new genetic 
techniques, and whether they are under the scope of Directive 2009/41/EC or not. 

FI 

1) The definition of a GMO is getting increasingly vague because new molecular biology 
techniques have evolved. It is no longer clear which organisms are actually covered by the 
directive.  

 2) The concept of premises is obscure in certain cases, e.g. where rodents are transported 
in  Scantainers  or  plants  in  closed  growth  chambers  to  another  room  or  building  for 
temporary  procedures  (such  as  photographing  or  scanning).  In  research,  unanticipated 
needs  for  moving  the  GMOs  temporarily  to  new  premises  for  non-repeating  procedures 
may arise quickly, which can cause an administrative problem.  

FR  Pas de difficulté 
HR 
HU  New techniques not  considered to  result in  genetic modification can trigger interpretation 

/ 

problems. 

to  apply:  Directive  2009/41/EC  or  2001/18/EC) 

Another problem is how to distinct between contained use and deliberate release (i.e. which 
directive 
in  case  of  clinical 
biotechnological  applications.  We  propose  to  continue  the  discussions  at  EU  level 
regarding this important issue. 
1. New techniques, 

IE 

2. Procedure for the notification of Class 1 GMM activities.  

IT  GM plants and GM animals 

88 

 
 
 
 
 
 
 
It should be clarified whether the contained use of GM plants and GM animals have to be 
covered by Directive 2009/41/EC or Directive 2001/18/EC. The definition of contained use 
given in Directive 2009/41/EC include GMM and not GMO. 

LT  No specific aspects with the interpretation of the provisions were reported. 
/ 
LU 
- 
LV 
MT  None. 
NL  Although  the  directive  is  relatively  recent,  technological  developments  in  the  GMO  field 
are  huge  and  lead  to  problems  related  to  (A)  definition  of  GMO’s  in  relation  to,  among 
others, synthetic biology and gene editing techniques,  and (B) differences in interpretation 
of the annexes between the Member States. These problems are similar with the problems 
encountered with directive 2001/18. 

PL  None 
PT  No difficulties have arisen regarding interpretation of the Directive 2009/41/EC. 
RO  Not applicable 
SE  There are no definitions of "recombinant nucleic acid" and "mutatgenesis", that sometimes 
give rise to academic discussion whether a method is included or not within the scope of 
the Directive. SWEA interprets "mutagenesis" as the well known techniques with chemical 
or physical mutation methods, common at the time of the first Directive 1990 (90/219/EEC) 
and not the later methods involving nucleic acids and site specificity. We try to explain this 
on our website. It is difficult to understand why some "new" methods should be included 
and why some should not. 

Of the “new techniques”, it is unfortunate that the Crispr-Cas-techniques are interpreted as 
only one type. We have several GMM uses involving Crispr-Cas and gene editing, where 
both  the  Cas-gene  and  gRNA  are  provided  by  vectors  in  cells  (or  cells  in  laboratory 
animals). The purpose for those experiments are often to explore gene function and the cell 
cultures or laboratory animals are never going to be anything else than experiments. Hence, 
there is no commercial aspect for not calling the experiments “contained use of GMM” 

SI  None. 
SK 
UK  The UK has no significant issues with the interpretation of the Directive. 

----- 

6.2  What  aspects  concerning  the  implementation  of  the  Directive,  if  any,  give  you 

difficulties as CA? 

2014-2017 
AT  none 
BE 
BG  No major difficulties have been experienced in implementing Directive 2009/41/EC during 

/  

the reporting period. 

CY  None. 
CZ  The same problems as mentioned in the previous point. 
DE  There is only one waste disposal facility in Germany for the incineration of class 2 waste. 
This challenges the inactivation of larger elements such as HEPA filters contaminated with 
cytostatica.  

89 

 
 
 
 
 
 
 
DK  The class 1 notifications. 
EE  N/A 
EL  No difficulties in implementation. 
ES  The  difficulties  on  the  implementation  of  the  Directive  are  related  to  the  difficulties 

FI 

described in the preceding paragraph.  
1) As mentioned in the previous point,  the outdated definitions of the directive 2009/41/EC 
for GMMs have been a major problem in the implementation. 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  in  the  scope  of  the 
directive.  

2)  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 apathogenic according to the directive, and if so, on 
what conditions?). 

3)  Research  groups  move  frequently  from  one  institution  to  another,  which  means  they 
have  to  repeatedly  send  new  notifications  of  their  new  premises.  During  the  reporting 
period,  many  of  the  old  premises  have  also  been  renovated,  meaning  that  the  notifiers 
sometimes have moved temporarily into other premises and then  back to the old building 
where  the  facilities  have  changed.  As  the  research  units  are  typically  large  and  complex, 
this has caused a great administrative burden. 

4) Waste management of Class 1 organisms has been problematic in some cases. Biological 
waste  can  no  more  be  dumped  and  incineration  of  wet  or  moist  biowaste  is  not 
recommendable  for  environmental  reasons,  some  operators  would  like  to  recycle  their 
contained use waste. Rather than a technical issue, this is an administrative problem, as the 
interplay  of  GMO,  waste,  transport  and  fertilizer  legislations  is  a  real  challenge. 

5)  The  development  of  chemicals  legislation  has  led  to  a  situation  where  users  of  
pathogenic GMMs have few effective disinfectants available. The users in the laboratories 
are also poorly informed about the suitable products presently available for their particular 
GMMs.   

FR  Pas de difficulté 
/ 
HR 
HU  None. 
IE 

1. How new techniques (those techniques discussed by the new techniques working group 
(2007  -  2012)  and  more  recently  such  techniques  as  CRISPR-Cas  and  TALEN)  will  be 
2009/41/EC.  
regulated 

Directive 

under 

2.  The  notification  of  Class  1  GMM  activities  which  present  no  or  negligible  risk  to  the 
environment.  They are usually crippled strains  that would not  survive in  the environment  
and  often  they  have  a  long  history  of  safe  use.  The  notification  procedure  is  time 
consuming. 

IT  Waste  disposal:The  monitoring  of  waste  disposal  is  carried  out  at  regional  and  national 
level by several CAs. To date the information required about waste management, including 
the  type  and  form  of  wastes  generated,  their  treatment,  final  form  and  destination  are 
assessed  on  documental  basis  with  the  notification.  To  implement  the  verification 
procedures could be difficult to realize. 

90 

 
 
 
 
 
Accidents:  As  no  accident  were  reported  to  GMM  CA  at  least  since  June  2009,  it  is 
presumable  an  undereporting  of  the  accidents  by  the  users.  The  GMM  CA  considers  this 
aspect difficult to improve. 
Gene drive modified organisms 
No  explicit  reference,  definition  and  measures  are  given  in  the  Directive  2009/41/EC  for 
gene drive modified organisms. 

LT  No specific aspects with the implementation of the Directive were reported. 
LU  Directive not yet transposed 
- 
LV 
MT  None. 
NL 

(1)  New  apparatus  (e.g.  large  pipetting  robot)  in  relation  to  the  needed  containment 
measures, (2) the use of desinfectants that have not, or not yet been admitted as a biocide 
for use under laboratory conditions, (3) the Netherlands encounter differences in the (strict) 
GMO-regulations and the less strict regulation of wild type pathogens. This could partly be 
explained  by  the  implementation  of  the  legislation  in  the  Netherlands,  but  seems  also 
caused by a lack of harmonization at EU level. 

SI 

PL  None 
PT  No difficulties have arisen regarding implementing of the Directive 2009/41/EC. 
RO  Not applicable 
SE  The notification procedure for Class 1 and Class 2 is of limited value. We think that it could 
be simplified in the Directive for Class 1 and Class 2, only including information on class, 
type  of  activity,  organisation  involved,  contact  information  for  responsible  persons  and 
address to the workplace.  
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. 
----- 

SK 
UK  The UK applies a hazard and risk-based approach to its regulation and inspection activities. 
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. 

The greatest burden on the CA 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 the majority of the CA 
time spent on reviewing notifications is biased towards the lower risk work. 

One further aspect of the Directive that places a burden on the CA 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 

91 

 
 
 
 
with  which  techniques  are  developed  and  adapted,  this  can  present  challenges  for 
interpretation and potential for disproportionate application of the legislation. 

6.3 

From the difficulties you have identified in the previous reporting periods, which ones 
have you solved at national level and how? 

6.4   What should be done or is done already to address the difficulties identified?  

2014-2017 

6.3  From 
the  difficulties  you  have 
the  previous  reporting 
identified 
periods,  which  ones  have  you  solved  at 
national level and how? 

in 

6.4  What  should  be  done  or  is  done 
the  difficulties 
already 
identified? 

address 

to 

AT  not applicable 
BE  See above for the Gene Editing techniques.  With  regards  to  the  regulatory  status  of 
organisms  genetically  modified  through  the 
use  of  Gene  Editing 
a 
harmonized legal interpretation at EU level is 
urgently needed. 

not applicable 

techniques, 

BG  One  difficulty  observed  during  the  previous 
reporting  period  was  that  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 
thaliana,  etc.).  The 
E.coli,  Arabidopsis 
and 
the 
of 
awareness 
is  used  under 
obligations  when  GMO 
improved  significantly. 
containment  has 

requirements 

In application for clinical trials, the applicant 
is required to provide information as a filled 
form  on  the  containment  measures  for  each 
hospital (which should be registered as such 
under  the  Bulgarian  legislation)  where  the 
medicinal product will be administered. That 
information 
formal 
notification.  In  all  applications  examined  so 
far activities were considered Class 1.  

considered 

is  not 

informs 

regularly 

In  addition,  Ministry  of  Environment  and 
Water 
the  Customs 
Agency  and  the  government  agencies  that 
fund scientific research about the institutions 
that  have  premises  with  valid  notifications 
for 
contained  uses  of  GMOs.  That 
information  should  be  taken  into  account 
when decisions are made for import of GMO 
for  contained  use  and  for  funding  scientific 
research. 

CY  Not Applicable. 
CZ  Sub-cellular  elements:  we  do  not  consider 
GMOs. 

plasmids 

as 

DNA  vaccines:  according  to  our  experts,  a 
DNA  vaccine  does  not  fall  under  the  scope 

like  what 

Not Applicable. 
General 
sub-cellular 
issues, 
elements  are  covered  by  the  definition  of 
GMM and the legislative status of organisms 
developed  by  new  gene  techniques,  should 
be resolved at EU level. 

92 

 
 
 
 
 
  
 
 
 
 
the  vaccine, 

of  the  Directive.  However,  during  the  phase 
of  development  of 
the 
vaccinated  animals  should  be  treated  as 
GMOs  until  appropriate  studies  prove  that 
the  plasmid  DNA  has  not  been  integrated 
into the host genome.  

DE  With  regard 

to 

the  distinction  between 
genetic engineering activities in containment 
and  approvement  of  clinical  trials  with 
GMOs,  an  administrative  agreement  was 
reached in March 2015 between the relevant 
federal and competent authorities. 

DK  No  problems  have  been  solved  at  a  national 

level. 

EE  Not difficulties 
EL  No difficulties. 
ES  We  have  asked  European  Commission  to 
the  difficulties 
advise  our  CA  about 
concerning 
and 
implementation of the Directive described in 
preceding  paragraphs.  CNB  periodically 
regarding 
updated 
contained  uses  activities.  An  electronic 
procedure has been launched to improve our 
system for processing of notifications.  

interpretation 

guidances 

national 

the 

FI  Only  one  where  a  case  was  solved 
concerning recycling of Class 1 GMM waste. 
This  required  extensive 
the 
notifier  and  their  collaborators  on  different 
procedures and showing that the composting 
process  chosen  really  inactivates  the  GMMs 
(ie.  that  there  are  no  live  GMMs  in  the 
composted material which is to be recycled).  

testings  by 

FR  Néant 
/ 
HR 
HU  No relevance. 
the 
IE  During 

last 

reporting  period 

the 
regulation  of  Class  1  GMM  contained  use 
activities  was 
being  
problematic.  These  activities  continue  to  be 

identified 

as 

statements 

concerning 

There are many discussions how to interpret 
the  GMO  definition.  The  ZKBS  adopted 
position 
the 
assignment  of  new  breeding  techniques  and 
organisms  resulting  from  the  use  of  modern 
nuclease technologies. 
The  only  suggestion 
that  class  1 
notifications  are  taken  out  of  the  Danish 
legislation. 
N/A 
No difficulties. 
It  would  be  desirable  to  have  harmonised 
the 
Guidelines 
regarding: 
Commission) 

at  EU 

(from 

level 

is 

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 
the  scope  of 
whether 
not. 
Directive 

they  are  under 
2009/41/EC 

or 

We  have  tried  to  communicate  the  EU-level 
the 
to 
difficulties 
relevant national authorities.  

the  Commission  and 

Néant 
/ 
No relevance. 
1.  Some  direction  from  the  Commission  on 
the evaluation of new techniques in terms of 
whether  they  fall  within  the  scope  of  the 
GMO  legislation  and  that  this  be  done  in  a 

93 

 
 
 
 
 
 
 
 
regulated since it is a legislative requirement 
however the submission of annual reports by 
the  user  is  no  longer  required  and  Class  1 
GMM  contained  use  activities  are  inspected 
once every 6 years.  

IT  N.A. 

LT  There were no specific difficulties identified 
in the previous reporting periods. 2016-05-04 
The  Ministry  of  Environment  and  Vilnius 
the  Workshop 
University 
"GMM/GMO 
USE: 
NOTIFICATIONS,  RISK  ASSESSMENT 
AND  CONTROL".  LT,  IR  and  NL  experts 
shared 
their  experience  and  knowledge 
gained. 

CONTAINED 

organized 

LU  The national law is under revision 
LV 
MT  Not applicable. 

- 

NL 

In  the  last  report  we  signalled  issues  related 
to  single  use  bioreactors  and  cell  sorters 
(FACS). For the latter general measures were 
developed  and  included  as  provisions  in  the 
Ministerial Order. For single use bioreactors 
requirements  were 
general 
developed  and  implemented  in  the  daily 
practice. 

information 

PL  None 

PT  No  difficulties  have  been  identified  in  the 

previous reporting period. 

RO  Not applicable 
SE 

n.a. 

SI 

In collaboration with Slovenian Biochemical 
Society  we  prepared  and  published  a 
of 
brochure  which 

examples 

gives 

harmonised 

way.  

2.  The  notification  requirements  for  Class  1 
GMM  contained  use  activities  could  be 
aligned  with  Directive  2000/54/EC  on  the 
protection  of  workers  from  risks    related  to 
exposure to  biological  agents  at  work  which 
does not require the notification of activities 
involving risk group 1 biological agents.  
A  better  cooperation  with 
the  different 
National  Competent  Authorities  and  an 
throughout  Europe 
harmonized  approach 
could result useful for the CAs and the users 
- 

The national law is under revision 
- 
Not  applicable.  However,  further  training 
and  capacity  building  would  be  relevant  to 
pre-empt any future difficulties. 
For  (1)  discussions  at  EU  level  might  be 
helpful.  For  (2)  EU-action  seems  logical. 
Numbers correspond with  answer on second 
question.  

Dissemination  of  actual  law  and  rules  for 
applicants. 
No difficulties have been identified. 

Not applicable. 
The  notification  procedure  for  Class  1  and 
Class  2  is  of  limited  value.  We  think  that  it 
could be simplified in the Directive for Class 
1 and Class 2, only including information on 
class, type of activity, organisation involved, 
contact  information  for  responsible  persons 
and address to the workplace.  
Inclusion  of  safe  organisms  in  Part  C  of  the 
Annex  II  of  Directive  2009/41/EC  could 
contribute  to  reduction  of  the  size  of  the 

94 

 
 
 
and 

forms 

adequate 
notification 
documentation needed for the notification od 
BSL 1 an BSL 2 installations and organisms. 
We  have  a  positive  feed  back  from  the 
notifiers. 
------ 

SK 
UK  The UK CA has streamlined the notification 
system  to  spend  less  time  assessing  class  2 
activities  as  the  risks  are  likely  to  be  well 
limited 
understood 
consequences 
loss  of 
containment  or  accidental  exposure.  This 
involves targeted assessment identifying key 
biological  hazards  and  foreseeable  risks 
(routes  of  exposure/loss  of  containment) 
which  could  realise  the  hazard  based  on  the 
nature of the activity. 

users  with 
the  event  of 

by 
in 

notifications. 

------ 
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 
to  be  notified.  
Subsequent  class  2  contained  uses  could  be 
carried out, following approval by an internal 
safety committee, without the need to notify 
CA. 
national 
the 

required 

is 

 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 
in  assessing 
time 
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 
classification. 
over 
degree 

spent  by 

the  CA 

of 

This approach would allow the CA to divert 
more  resource  to  the  assessment  of  high 
reviewing 
hazard 
inspections. 
notifications 

including 
and 

work, 

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. 

95 

 
 
 
 
 
Questionnaire 2018 
6.  Interpretation  and 
implementation  of  Directive  2009/41/EC.  Please  provide 
information regarding  notifications  of  contained  uses  of  GMMs  (and  GMOs  when 
appropriate) produced with new mutagenesis techniques: 

AT 

1  notification:  Use  of  the  commercial  do-it-yourself  "Bacterial  Gene  Engineering 
DIY-CRISPR-Cas9-Kit"  (The  Odin)  with  E.coli  K12  as  recipient  organism  for 
educational purposes (school project) 

BE   New  mutagenesis  techniques,  particularly  the  CRISPR/Cas  systems  are  used  and  notified 
since  around  2015  in  research  and  development  by  several  investigational  groups 
(universities, companies). The system is used to modify genetically animal and human cells 
(cell  lines  and  primary  cells),  plant  cells  and  other  micro-organisms.  Transgenic  animals 
(mice, xenopus) and plants obtained by the CRISPR/Cas systems have also been notified in 
Belgium. 

BG   No  notifications  of  contained  uses  of  GMMs  and  GMOs    produced  with  new  mutagenesis 

techniques have been received so far in Bulgaria. 
CY   There have not been used new mutagenesis techniques. 
CZ   Organisms  (microorganisms  -  mostly  cell  cultures,  some  plants  and  laboratory  mice) 
produced by new mutagenesis techniques had been considered as GMOs within the scope of 
the Czech Act on GMOs (Act No. 78/2004 Coll.) even before ECJ ruling of July 2018. These 
GMOs were used only in contained space. 

DE   Most  of  these  procedures  are  only  recorded  by  the  researcher  and  not  notified  to  the 
authorities.  The  details  are  not  known  to  the  authorities.  Nevertheless,  new  mutagenesis 
techniques (especially CRISPR-Cas9) are widely used to generate knock out-, knock in-, and 
point mutations mostly into the genome of human or mammalian cells in culture. There are 
also  approaches  to  modify  the  expression  of  viral  proteins  (HPV,  HIV-1).  The  CRISPR-
Cas9-system is going to be transferred directly as ribonucleoprotein complex, by plasmids, or 
by viral vector systems.  

DK   N/A 
EE   N/A 
EL   No notifications produced in reporting period 
ES   This information has already been sent to the CA in the European Commission.3  

3  Spain  provided  a  document  “LEGISLATION  ON  GMOs  AND  THE  IMPACT  OF  THE  JUDGMENT  OF 
THE  EU  COURT  OF  JUSTICE  ON  DIRECTED  MUTAGENISIS”,  which  had  two  sections  related  to  the 
contained use of organisms obtained by new mutagenesis techniques: 
“The  implication  of  the  Court  ruling  on  deliberate  release  and  confined  use  activities  is  also  analyzed. 
Seventeen  notifications  of  contained  use  activities  were  presented  to  national  competent  authorities  between 
2015 and 2018. All notifications were evaluated according to the case by case principle and the safety of the 
final  products  was  considered  using  the  same  methodology  described  in  current  legislation  for  GMO.  The 
questions arise on whether this methodology will be applicable for new technological developments.   
In terms of research, development and innovation, the wide range of applications derived from the new genetic 
editing  techniques  is  highlighted.  The  growing  interest  in  genome  editing  results  in  an  increase  of  scientific 
publication  in  recent  years. More  than  20  species  have  been  used  in  agricultural  research  studies,  analyzing 
several  characteristics  such  as  the  impovement  of  productive  yields  or  the  biotic  and  abiotic  stress.  The 
National  Research  Agency  has  financed  more  than  800  projects  including  genome  editing  actitivities.  This 
number it is expected to increase in the future. The authorization procedure of these activities (mainly contained 
use activities) will delay their implementation by EU researchers in comparision to those from other countries. 
This will reduce their competitiveness in terms of novelty in publications, technological transfer or patents.” 
“Between 2015 and 2018, 17 notifications were received of activities involving the contained use of genetically 
modified organisms with new techniques. The modified organisms were principally cells, but also animals and 
viruses. These notifications are addressed according to the precautionary principle and on a case-by-case basis. 

96 

 
 
 
 
                                                 
FI   Requirement  for  the  notification  of  this  type  of  information  (specific  details  on  the 
techniques used) is not stipulated in the national GMO regulations, and therefore it cannot be 
collected  comprehensively  from  individual  notifications.  Hence,  we  have  currently  no 
statistics  on  the  use  of  new  mutagenesis  techniques  in  contained  use.  Information  on  new 
mutagenesis techniques is sometimes obtained on a voluntary basis e.g. when the operators 
describe such activities in a notification, report them during inspections, or when the operator 
asks the CA for clarification of the scope of the Gene Technology Act. 

FR   Le  nombre  de  dossiers  est  stable  sur  les  quatre  dernières  années  (un  peu  plus  de  1000 

dossiers de demande d'autorisation par an). 

HR4     
HU   Up  to  date  there  are  no  new  notifications  concerning  activities  on  new  mutagenesis 

IE  

techniques.  
Five  notifications  for  contained  use  activities  involving  organisms  produced  using  new 
directed mutagenesis techniques’ were received during 2018. 
• 4 notifications with cells; and, 
• 1 notification with a yeast. 

IT 
LT   The  Competent  Authority  of  Directive  2009/41  has  not  received  any  application  linked  to 

new mutagenesis techniques yet.  

LU   No notifications were received using new mutagenesis techniques. 
LV   No notifications 
MT   N/A 
NL   Please  see  also  the  earlier  sent  document  "NL  response  to  questions  court  ruling 

13dec.DOCX"5.  
Regarding  contained  use:  NL  has  consistently  considered  applications  of  NBTs  in  the 
Netherlands  as  GMOs,  except  for  the  use  of  “traditional”  mutagenesis  techniques  (induced 
by  exposure  to  chemical  substances  or  irradiation).  Dutch  national  authorities  have  applied 
the EU GMO legislation to these organisms and their products in accordance with Directive 
2009/41 and in conformity with relevant elements of the Court Ruling in this regard.  

PL 
PT   None notification was submitted with GMMs produced with new mutagenesis techniques. 
RO   NEPA  registered  a  notification  under  the  Directive  2009/41/EC  on  the  contained  use  of 
Listeria  monocytogenes,  in  order  to  obtain  a  genetically  modified  strain  of    Listeria 
monocytogenes  in  containment  conditions  to  establish  the  high  pressure  stress  response 

They were therefore submitted and assessed according the procedure laid down in the national legislation for 
activities involving the contained use of GMOs.” 

4 Croatia has not submitted a report for the year 2018 but provided a statement on the “Directive 2009/41/EC 
and new mutagenesis techniques”: 
“In accordance with your request, we hereby would like to inform you that Croatian competent authorities for contained 
use  of  GMOs  have  considered  applications  of  NBTs  in  the  Republic  of  Croatia  as  GMOs,  except  for  the  use  of 
“traditional” mutagenesis techniques (induced by exposure to chemical substances or irradiation). 
In the Republic Croatia there were notified 52 closed systems of contained use of GMOs by the end of 2018. According, at 
last information that only in 14 closed systems of contained use of GMOs were used new mutagenesis techniques such as 
ODM, CRISPER/ Cas9, cisgenesis, intragenesis and agro infiltration. 
Croatian national authorities have applied the EU GMO legislation to these organisms and their products in accordance 
with Directive 2009/41 and in conformity with relevant elements of the Court Ruling in this regard.” 
5 Section of that document related to the contained use of organisms obtained by new mutagenesis techniques: 
“NL  has  consistently  considered  applications  of  NBTs  in  the  Netherlands  as  GMOs,  except  for  the  use  of  “traditional” 
mutagenesis  techniques  (induced  by  exposure  to  chemical  substances  or  irradiation).  Dutch  national  authorities  have 
applied  the  EU  GMO  legislation  to  these  organisms  and  their  products  in  accordance  with  Directive  2009/41  and  in 
conformity with relevant elements of the Court Ruling in this regard.” 

97 

 
 
 
 
                                                                                                                                                        
 
mechanism.  This  activity  with  genetically  modified  microorganisms  that  was  authorized  in 
2018, uses classical mutagenesis and CRISPR - Cas 9 (NT) technique. 

SE   There  are  no  definitions  of  "recombinant  nucleic  acid"  and  "mutatgenesis",  that  sometimes 
give rise to academic discussion whether a method is included or not within the scope of the 
Directive.  SWEA  interprets  "mutagenesis"  as  the  well  known  techniques  with  chemical  or 
physical mutation methods, common at the time of the first Directive 1990 (90/219/EEC) and 
not the later methods involving nucleic acids and site specificity. We try to explain this on 
our  website.  It  is  difficult  to  understand  why  some  "new"  methods  should  be  included  and 
why some should not. 

SI  

SK  

Several  laboratories  use  new  mutagenesis  techniques  to  prepare  GMMs  for  a  research 
purpose in Slovenia, all of the projects were notified to the CA. No gene drive projects were 
proposed for the time being. 
In  Slovakia,  4  users  are  actively  working  with  new  mutagenesis  techniques  and 
thereof. 
GMMs/GMOs 

produced 

Activities are classified under risk class 1 and class 2. user A 
GMO  organisms:  non-pathogenic  bacterial  Escherichia  coli  and  yeast  Saccharomyces 
laboratory  work  only. 
cerevisiae  and  Pichia  pastoris  strains  used 

research 

for 

Aminoacid  exchanges  of  several  selected  amino  acid  residues  in  yeast  and  human  Ire1 
proteins  and  plant  nasturtium  Tropaeolum  majus  xyloglukan  endotransglycosylase  protein 
TmXET6.3  were  performed  by  mutagenesis  of  respective  genes  in  cloning  plasmids  using 
QuikChange II Site-Directed Mutagenesis Kit (Agilent Technologies). Mutated variants has 
been cloned into expressing yeast vectors and tested for changed phenotype in yeast or by in 
assays.  
vitro 

Aim of these works: The amino acid exchanges were made for structure/function analysis of 
the proteins (enzymes) mentioned above. 

user B 

The recipient: XL-1 Blue supercompetent cells 
musculus  
The 
Targeted 
shock 
Aim  of  these  works:  Plasmid  storage  and  isolation  /  Scientific  purposes,  antibody  testing 

Homo 
transformation 

donor: 
mutagenesis, 

sapiens; 

thermal 

caused 

Mus 

by 

user C 

1.) bacteria, yeast 

Targeted mutagenesis techniques have been performed to exchange codon bases, deletion of 
interest,  or  fusions  with  various  DNA  fragments.  
genes, 

labeling  of  genes  of 

Purpose: basic research 

2.) Mycobacteria 

Standardly  used  e.g.  allele  exchange  methods  that  result  in  interruption  or  deletion  of  the 
genes under study that can be considered as targeted mutagenesis. 

98 

 
 
 
 
 
 
 
 
 
 
 
 
 
user D 

silkworms - Bombyx mori  
(several dozens over several  generations) 

Purpose: suppression of gene expression for neuropeptides and their receptors by CrisprCas9 
system  (deletion  /  mutation  of  genes)  -  functional  analysis  of  neuropeptides  and  their 
receptors  

UK  This  would  be  too  difficult  to  answer  due  to  lack  of  available  resource  to  revisit  and 
interrogate  every  single  notification  received  as  we  have  received  in  2018.  This  is 
approximately  220  notifications  and  we  would  envisage  that  around  half  of  these  involve 
some from of new mutagenesis techniques. 

Questionnaire 2018 
Please provide information and views on the impact of the outcome of the ruling of the Court 
of Justice of the European Union on new mutagenesis techniques for you as CA for Directive 
2009/41/EC.  Provide  also  information  on  how  such  impact  is  or  will  be  addressed  in  your 
country: 

BE  

AT   No  impact,  as  according  to  the  Austrian  Gene  Technology  Act  only  non-directed 
mutagenesis  is  exempted.  Therefore  all  new  mutagenesis  techniques  are  fully  covered  by 
the Austrian legislation. 
There is no impact of the outcome of the ruling of the CJE on new mutagenesis techniques 
for us in contained uses of GMOs. Risk assessment and management of contained uses of 
GMMs  and  GMOs  obtained  by  these  new  techniques  are  performed  in  the  same  way  as 
other GMOs obtained by techniques already aimed by Directive 2009/41/EC (annex 1, part 
A). 
BG   The 

considerations  might  be 

the  questions  posed: 

following 

relevant 

to 

1.  The  Court  ruling  is  in  the  context  of  Directive  2001/18/EC,  and  not  Directive 
2009/41/EC. Directive 2009/41/EC does not refer directly to Directive 2001/18/EC, but at 
the present stage, we work with the assumption that the Court ruling will be relevant to the 
contained  use  of  genetically  modified  microorganisms  (GMMs).  The  exact  consequences 
though remain to be formally established (see our comments below). 

2. The definition of GMMs is given in Article 3 in conjuncture with Annex I of Directive 
2009/41/EC,  while  the  definition  of  genetically  modified  organisms  (GMOs)  is  given  in 
Article  2  in  conjuncture  with  Annex  I  of  Directive  2001/18/EC.  The  definitions  are 
practically identical, so we consider that any conclusions related to the definition of GMO 
the  definition  of  GMM.  
the  necessary  changes 
are 

likely  be  relevant  with 

to 

The conditions for exclusion of organisms from the scopes of the Directive 2009/41/EC and 
Directive 2001/18/EC are given in Annex IIA and Annex IB respectively. They are similar 
to  some  extent  but  there  are  significant  differences.  The  exclusion  criteria  in  Directive 
2009/41/EC  are  broader  and  include  cell  fusion  of  all  types  of  cells  and  even  more 
importantly  self-cloning.  Under  some  circumstances,  application  some  of  the  new 
techniques  for  genome  modification,  might  be  considered  to  result  in  self-cloning. 

Notably Directive 2009/41/EC does not contain recital equivalent to recital 17 of Directive 

99 

 
 
 
 
 
 
 
 
 
 
2001/18/EC. In the light of the Court ruling it will seem that in order to the exclude a GMM 
from the scope of the Directive 2009/41/EC is enough to fulfill the criteria in Annex IIA, 
without  necessity  to  demonstrate  that  the  organisms  are  obtained  by  means  of 
techniques/methods which have conventionally been used in a number of applications and 
have  a  long  safety  record.  Under  this  interpretation  some  of  GMMs  obtained  by  gene 
editing, might be considered result of self-cloning and thus outside the scope of Directive 
2009/41/EC. 

3.  Directive  2009/41/EC  does  not  cover  GMOs  other  than  GMMs.  It  remains  unclear 
whether  and  to  what  extent  the  national  legislation  regulating  the  contained  use  of  GMO 
different  from  GMM  should  follow  Directive  2001/18/EC  or  Directive  2009/41/EC,  in 
particular  with  the  respect  to  the  definition  of  GMO  and  the  exclusion  criteria.  Thus  the 
relevance of the Court ruling in those cases remains unclear to us.  

4. Bulgaria considers the organisms, incl. microorganisms, obtained through the use of gene 
editing  and  other  similar  techniques  to  be  GMO  and  thus  applies  the  relevant  national 
legislation  for  contained  use.  Bulgarian  national  legislation  on  contained  use  of  GMO 
covers not only GMMs but also all other GMOs. 

5. We expect that the main difficulty in applying and enforcing the relevant legislation for 
the contained use of GMOs obtained through gene editing or some other techniques will be 
their  detection  and  identification.  As  stated  in  a  number  of  replies  from  the  MS  in  the 
context  of  Directive  2001/18/EC,  detection  and  identification  of  such  GMOs  can  be  a 
significant  technical  and  financial  challenge  when  the  introduced  changes  are  very  small 
and/or not known in advance and in some cases it might be outright impossible. In the case 
of microorganisms additional difficulties will arise from the high natural variability of their 
genomes  and  the  fast  rates  of  evolution.  It  can  be  impossible  to  decide  on  the  basis  of 
sequencing  data  alone  if  a  certain  DNA  pattern  is  result  of  natural  process,  chemical  or 
traditional  genetic  engineering  or  use  of  gene  editing. 
physical  mutagenesis, 

6.  The  considerations  above  show  that  there  might  be  some  legal  uncertainties  about  the 
application of Directive 2009/41/EC in the light the Court ruling on Case Case C-528/16. It 
will  helpful  if  the  European  Commission  requests  an  opinion  from  its  Legal  Services  on 
that  issue  and  provides  it  to  the  member  states  as  a  background  for  further  discussions. 

7.  It  should  be  noted  that  the  European  GMO  legislation  has  been  developed  with 
agricultural  (plants  in  particular)  applications  and  the  traditional  genetic  engineering 
techniques in  mind. The field  of biotechnology is strongly technology driven and modern 
applied  molecular  biology  has  undergone  huge  progress  in  the  last  15  years.  In  order  to 
ensure high level of protection of human health and environment, while allowing the citizen 
to  benefit  fully  from  the  new  technologies  European  regulatory  framework  should 
adequately reflect  the recent  technical  developments.  The issues surrounding  gene editing 
and  some  other  topics  seem  to  show  that  it  is  increasingly  difficult  to  accommodate  the 
developments of modern biotechnology by non-legislative means. So in future discussions, 
serious  consideration  should  be  given  to  the  possibility  to  amend  or  fully  update  the 
European GMO legislation. 

CY   No views. 
CZ   As  regards  primary  research,  the  ECJ  ruling  means  only  administrative  burden  for 
scientists.  What  is  more  detrimental,  is  the    impact  on  innovations.  Projects  aiming  at 

100 

 
 
 
 
 
DE  

developing gene edited crops are not realized because it would be practically impossible to 
place a new GMO on the market in EU.  
In the past,  several  Federal  States have  regulated genome-edited organisms as  genetically 
modified organisms on a precautionary basis, since the European legislation has left room 
for interpretation on this topic. These Federal States do not see major practical problems if 
the decision of the European Court of Justice (ECJ) is applied also to the field of contained 
use.  

Nevertheless, the application of the decision of the ECJ on the area of directive 2009/41/EC 
(similar  to  placing  on  the  market  as  regulated  in  2001/18/EC)  does  not  clarify  the 
topics: 
legislation,  but 

raise  additional  questions.  This 

following 

regards 

the 

- self-cloning using new molecular techniques (SDN3) – will it continue to be exempt from 
regulation under directive 2009/41/EC? 

-  who  decides  on  the  time  point  when  mutagenesis  techniques  can  be  regarded  as  safe? 
What are the criteria for this decision? 

-  using  CRISPR-Cas9  variants  (new  molecular  techniques,  NMT)  like  dCas9  with  non-
functional nuclease, gene function can be transiently altered. Will the application of these 
techniques  lead  to  the  creation  of  GMOs,  even  if  the  genomes  of  the  organisms  are  not 
altered? 

-  will  the  use  of  the  dCas13  variant  (also  a  NMT)  only  modifying  RNA  also  lead  to  the 
creation of a GMO? 

Genetic  engineering  operations  need  to  be  monitored  by  the  responsible  competent 
authorities. The surveillance of organisms which can not be distinguished from organisms 
arisen from classical mutagenesis rises problems regarding detection methods of GMOs not 
use. 
also 
only 

deliberate 

contained 

release 

field 

but 

the 

for 

of 

in 

Directive  2009/41/EC  does  not  seem  to  be  well  equipped  for  risk  assessment  of  genome-
edited organisms resulting from SDN3 techniques. 

DK   N/A 
EE   N/A 
EL  

No noticeable impact currently under the framework of 2009/41/EC due to lack of reported 
cases of contained use in Greece 
This information has already been sent to the CA in the European Commission.  
Currently  the  legal  situation  is  ambiguous  as  to  whether  the  ECJ  Decision  applies  to 
contained  use  or  to  certain  traditional  mutagenesis  techniques  other  than  chemical  or 
radiation  mutagenesis.  In  this  legally  uncertain  situation,  the  Board  for  Gene  Technology 
has  made  a  non-consensus  interim  decision  that  contained  use  is  out  of  scope  of  ECJ 
Decision. However, the Board has also asked for Commission Legal Service's clarification 
on the situation, especially in the context of deletion mutagenesis where no foreign DNA is 
inserted  in  the  genome.  Currently  the  legal  status  of  new  mutagenesis  techniques  in 
contained use is evaluated by the Board on a case-by-case basis, as some variations of these 
techniques (e.g. gene drives) may result in GMOs. 
Le  nombre  de  dossiers  à  traiter  pourrait  être  multiplié  par  10  voire  20.  L'AC  n'a  pas  les 
moyens  administratifs  de  traiter  un  tel  flux  selon  les  règles  actuellement  applicables  aux 

ES  
FI  

FR  

101 

 
 
 
 
 
 
 
OGM 

HR  
HU   After  the  ruling  of  the  Court  of  Justice  of  the  European  Union  on  new  mutagenesis 
techniques  the  gene  technology  authority  requested  the  users  to  report  about  all  the  gene 
technology  activities  including  the  activities  on  new  mutagenesis  techniques  that  are 
currently carried out in class 1. Furthermore the gene technology authority informed all the 
stakeholders about the outcome of the ruling and called upon them to submit notifications 
for authorisations with regard to class 2, 3 and 4, if applicable. 
To date the Irish CA has considered organisms produced using  ‘new directed mutagenesis 
techniques’  to  be  GMOs,  and  has  applied  the  GMO  legislation  accordingly.  However  as 
raised by other MS in more recent times, the basis for applying the ECJ ruling to Directive 
2009/41/EC needs to be clarified since the ECJ based its decision on Directive 2001/18/EC.  

IE  

In  addition  Directive  2009/41/EC  relates  to  the  contained  use  of  Genetically  Modified 
Micro-organisms (GMMs). The scope of national transposing legislation was expanded to 
include GMOs other than GMMs (GM plants and GM animals). This makes the connection 
tenuous. 
its  application 
between 

the  ECJ  decision  and 

to  GMOs  even  more 

Other difficulties arising from the ECJ ruling include detection and identification of GMMs 
/ GMOs generated using new directed mutagenesis techniques. 

IT 
LT  

There is no experience how to handle such type of Applications and what criteria to use for 
risk assessment and how to assess the risk itself. It would be helpful better explanation of 
the list of New mutagenesis techniques and what risk assessment methodology and safety 
measures to use for each New mutagenesis technique.  Harmonized EU legislation of New 
mutagenesis techniques would be welcome. 

LU   Clarification  is  needed  as  Annex  II  of  directive  2009/41  excludes  mutagenesis  from  the 
techniques generating GMM. No information is available if targeted or random mutagenesis 
meant? 
is 

Do notifications have to be addressed to CA by users when NMT are applied since they are 
not  considered  to  produce  GMM  according  to  Annex  II  of  directive  2009/41?  

Directive  2009/41  does  not  have  an  equivalent  to  recital  17  of  directive  2001/18  which 
excludes organisms obtained through certain techniques of genetic modification which have 
conventionally  been  used  in  a  number  of  applications  and  have  a  long  safety  record. 
Clarification is needed how organisms generated through NMT are to be considered GMM 
or non GMM? 

Since the ruling of the European Court of Justice now states that all mutagenesis techniques 
invented after 2001 produce GMOs, does this restriction also apply to Directive 2009/41? 
However, the ruling was in reference to Directive 2001/18, which does not directly refer to 
Directive 2009/41. 

Moreover, the application of several of the new mutagenesis techniques generate organisms 
that  resemble  those  produced  by  self-cloning.  So,  if  these  GMM  are  outside  the  scope  of 
2009/41  as  long  as  they  stay  in  confined  use  conditions,  do  they  become  GMOs  when 
outside? Do notifications have to be addressed to the CA when techniques are used that do 

102 

 
 
  
 
 
 
 
 
not create GMM? 

LV   Application  of  classic  mutagenesis  methods  and  release  of  mutagenic  organisms  in  the 
environment  is  not  concern  in  Latvia.  It  is  possible  that  there  are  in  environment  some 
varieties having traits obtained from chemical mutagenesis used historically (method is not 
used 

anymore).   

CRISPR/Cas method is not widely used at the moment, but it may become more applied in 
future to obtain new varieties. It is used in limited amount in laboratory experiments.  

MT   N/A 
NL  

In  the  Netherlands,  the  EU  Court  ruling  itself  has  no  consequences  for  national 
implementation  or  inspections.  The  Dutch  authorities  have  always  considered  organisms 
produced by any new breeding technique as GMOs, excluding only products resulting from 
the  use  of  “traditional”  mutagenesis  techniques  (induced  by  exposure  to  chemical 
substances  or  irradiation)  from  the  application  of  the  GMO  legislation.  Dutch  national 
authorities  have  applied  the  EU  GMO  legislation  to  these  organisms  and  their  products.  

The Court has added significant elements to the legal interpretation of the existing GMO-
legislation regarding new techniques, directed mutagenesis techniques in particular and the 
exemption mechanism of directive 2001/18/EC.  These elements need to  be addressed and 
alia: 
inter 
are 

- The scope of what is to be understood by mutagenesis, is undefined and must be clarified 
by  authorities  or  the  EU-legislator  in  order  to  provide  clarity  and  legal  certainty; 

-  The  scope  of  the  existing  exemption  for  mutagenesis  is  limited  to  products  obtained  by 
mutagenesis  techniques  “that  have  conventionally  been  used  in  a  number  of  applications 
and have a long safety record” 

The  Court  has  not  explained  what  constitutes  mutagenesis,  nor  how  to  determine  when 
mutagenesis techniques or methods have traditionally been used and have proven to be safe. 
By consequence, the Court’s ruling urges the legislator and authorities to keep the directive 
up-to-date in respect of technical and scientific progress. It is therefore urgent and essential 
that EU-authorities and the EU-legislator address these issues without undue delay in order 
to provide clarity and legal certainty. 

The Netherlands has noted with disappointment the Commission’s position that it will not 
tackle  a  revision  of  the  GMO  legislation  any  more  as  its  mandate  will  soon  expire.  The 
Netherlands is firmly convinced of the urgent need of a revision of the GMO legislation as 
appropriate,  taking  into  consideration  the  consequences  of  the  CJEU  ruling  for  the 
implementation thereof.  

To that end, the Netherlands aims to promote that a revision of the EU GMO legislation and 
addressing  the  consequences  of  the  CJEU  ruling  are  adequately  included  in  the  mandate 
and Programme of Work of the incoming Commission.  

This matter is still under evaluation. 

PL 
PT  
RO   No impact 
- 
SE  
 New mutagenesis techniques to prepare GMMs for a research purpose in Slovenia are used 
SI 

103 

 
 
 
 
 
 
 
 
 
 
in many laboratories that routinely notify the projects to CAs. For the time being we have 
encountered no difficulties with the above mentioned ruling. 

SK   Not known, yet. We rarely get opinions of the scientists, although we have requested them.  

The users notify all activities. 

UK   As far as Directive 2009/41/EC is concerned, little has changed for the UK.  Conventional 
mutagenesis  continues  to  be  exempted.      Since  the  CJEU  case  was  announced,  there  was 
never a position or statement to say that the use of ‘modern’ techniques of mutagenesis (e.g. 
CRISPR/Cas9) constituted ‘mutagenesis’ in the meaning of the Directive and Regulations 
and therefore exempt from the requirements.  The UK GM (contained use) guidance, which 
was  last  updated  in  2014,  will  be  updated  to  remove  ambiguity  relating  to  what  may  be 
ruling.  
considered 

as  mutagenesis 

line  with 

bring 

into 

the 

to 

it 

This  impacts  significantly  on  Deliberate  Release  and  the  appropriate  UK  Government 
agencies are working to ensure clarity across the GM regimes.  If any changes need to be 
communicated, this will be done at the earliest opportunity to users. 

PART II: OVERVIEW OF CONTAINED USES AND PREMISES 

In  this  part  of  the  questionnaire  you  are  invited  to  submit  information  on  the  number  of 
notifications and amendments submitted for contained uses of GMMs and on the number of 
premises for contained use of GMMs, according to the classification of contained use. If also 
covered under your contained use legislation, similar questions for GMOs (GM animals and 
GM plants) will be asked. 

- GMMs 

7.1  How many notifications of contained uses of GMMs were submitted in your Member 

State under the Directive during the reporting period?  

Report  all  types  of  notifications  and  amendments  to  existing  notifications  by  class; 
this includes GMMs, combined uses of GMMs and GMOs (to be reported according 
to  the  GMM  class),  clinical  trials  (where  applicable)  and  gene  drive  modified 
organisms (where applicable). 

AUSTRIA 2014-2017 

Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
45 
138 
5 
-- 
188 

No.  of  amendments 
(according to Art. 11) 
-- 
-- 
-- 
-- 
-- 

AUSTRIA 2018 

Classification  of  contained  use  No. of notifications submitted              

No.  of  amendments 

104 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

(according to Art. 6, 8 and 9) 
26 
31 
1 
-- 
58 

(according to Art. 11) 
1 
5 
-- 
-- 
6 

BELGIUM 2014-2017 
Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

BELGIUM 2018 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
57 
141 
9 
0 
207 

No.  of  amendments 
(according to Art. 11) 
80 
203 
19 
0 
302 

Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
27 
23 
3 
0 
53 

No.  of  amendments 
(according to Art. 11) 
43 
49 
5 
0 
97 

BULGARIA 2014-2017 
Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

BULGARIA 2018 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
1 
0 
0 
0 
1 

No.  of  amendments 
(according to Art. 11) 
9 
0 
0 
0 
9 

Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
0 
0 
0 
0 
0 

No.  of  amendments 
(according to Art. 11) 
3 
0 
0 
0 
3 

CYPRUS 2014-2017 

Classification  of  contained  use  No. of notifications submitted              

No.  of  amendments 

105 

 
 
 
 
 
 
 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

CYPRUS 2018 

(according to Art. 6, 8 and 9) 
1 
1 
0 
0 
1 

(according to Art. 11) 
0 
0 
0 
0 
0 

Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
0 
0 
0 
0 
0 

No.  of  amendments 
(according to Art. 11) 
0 
0 
0 
0 
0 

CZECH REPUBLIC 2014-2017 

Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
201 **  
47 
2 
0 
250 

No.  of  amendments 
(according to Art. 11) 
5 ***  
0 
0 
0 
5 

**  According  to  the  Czech  Act  on  GMOs,  a  new  notification  or  (since  1/1/2017)  a 
submission of the written risk assessment was required in every case a new activity was to be 
carried out in previously notified Class 1 premises (see Q 1.3). The number summarizes these 
notifications and submissions of risk assessments during the reporting period. 
***  In these  cases the notifiers had assessed their activities as Class 1 but  the CA´s  expert 
advisory  body,  after  the  review  of  the  risk  assessment,  required  the  contained  uses  to  be 
classified as Class 2, mostly due to the presence of viral particles. 

CZECH REPUBLIC 2018 

Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 

Class 2 
Class 3 
Class 4 
Total 

No.  of  amendments 
(according to Art. 11) 
2 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
25  (see  the  notes  to  the  report 
2014-2017) 
20 
1 
0 
46 

0 
0 
0 
2 

GERMANY 2014-2017 
Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
884 

No.  of  amendments 
(according to Art. 11) 
1243 

106 

 
 
 
 
 
 
Class 2 
Class 3 
Class 4 
Total 

2490 
61 
3 
3438 

392 
52 
0 
1687 

GERMANY 2018 

Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
232 
713 
22 
30 
997 

No.  of  amendments 
(according to Art. 11) 
150 
66 
2 
0 
218 

DENMARK 2014-2017 
Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
356 
43 
0 
0 
399  420  (including  animals 
and plants) 

No.  of  amendments 
(according to Art. 11) 
45 
8 
0 
0 
53 

DENMARK 2018 

Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
158 
24 
0 
0 
182 

No.  of  amendments 
(according to Art. 11) 
8 
1 
0 
0 
9 

ESTONIA 2014-2017 
Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

ESTONIA 2018 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
4 
4 
1 
0 
5 

No.  of  amendments 
(according to Art. 11) 
4 
4 
1 
0 
5 

Classification  of  contained  use 
(according to Art. 4(3)) 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 

No.  of  amendments 
(according to Art. 11) 

107 

 
 
 
 
 
 
 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

0 
0 
0 
0 
0 

0 
0 
0 
0 
0 

GREECE 2014-2017 
Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

GREECE 2018 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
0 
0 
0 
0 
0 

No.  of  amendments 
(according to Art. 11) 
0 
0 
0 
0 
0 

Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
0 
0 
0 
0 
0 

No.  of  amendments 
(according to Art. 11) 
0 
0 
0 
0 
0 

SPAIN 2014-2017 

Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
74 
196 
56 
0 
325 

No.  of  amendments 
(according to Art. 11) 
0 
0 
0 
0 
0 

SPAIN 2018 

Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
8 
54 
6 
0 
68 

No.  of  amendments 
(according to Art. 11) 
0 
0 
0 
0 
0 

FINLAND 2014-2017 
Classification  of  contained  use 
(according to Art. 4(3)) 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 

No.  of  amendments 
(according to Art. 11) 

108 

 
 
 
 
 
 
 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

120 
64 
0 
0 
184 

23 
15 
0 
0 
38 

FINLAND 2018 

Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 

Class 2 

Class 3 
Class 4 
Total 

No.  of  amendments 
(according to Art. 11) 
0 

2 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
40  (11  of  which  joint  Class  1 
GMM 
Class 
and 
notifications) 
21  (  5  of  which  pure  Class  2 
not 
GMM 
including  other  GMOs  or 
Classes) 
0 
0 
45 
4  mixed 
notifications  with  both  GM-
animals and Class 1 GMMs) 

notifications, 

(including 

0 
0 
0 

0 

FRANCE 2014-2017 
Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

FRANCE 2018 

Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 

Class 2 

Class 3 

Class 4 
Total 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
1900 
1900 
180 
20 
4000 

No.  of  amendments 
(according to Art. 11) 
1900 
1900 
180 
20 
4000 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 

No.  of  amendments 
(according to Art. 11) 
720=  717  (research)  +  3 
(industrial production) 
679 = 676 (research) + 3 
(industrial production) 
46  =  45  (research)  +  1 
(industrial production) 
2 (research) 
1447 

CROATIA 2014-2017 
Classification  of  contained  use 
(according to Art. 4(3)) 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 

No.  of  amendments 
(according to Art. 11) 

109 

 
 
 
 
 
  
  
  
  
  
 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

24 
7 
0 
0 
31 

/ 
/ 
/ 
/ 
/ 

CROATIA 2018 

Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

HUNGARY 2014-2017 
Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

HUNGARY 2018 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 

No.  of  amendments 
(according to Art. 11) 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
24 
36 
0 
0 
60 

No.  of  amendments 
(according to Art. 11) 
0 
0 
0 
0 
0 

Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
1 
4 
0 
0 
5 

No.  of  amendments 
(according to Art. 11) 
0 
2 
0 
0 
2 

IRELAND 2014-2017 
Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

IRELAND 2018 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
50 
26 
0 
0 
76 

No.  of  amendments 
(according to Art. 11) 
6 
2 
0 
0 
8 

Classification  of  contained  use 
(according to Art. 4(3)) 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 

No.  of  amendments 
(according to Art. 11) 

110 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

8 
6 
1 
0 
15 

2 
3 
0 
0 
5 

ITALY 2014-2017 

Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
38 
370 
14 
0 
422 

No.  of  amendments 
(according to Art. 11) 
55 
115 
9 
0 
179 

ITALY 2018 

Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 

No.  of  amendments 
(according to Art. 11) 

LITHUANIA 2014-2017 

Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
9 
2 
0 
0 
11 

No.  of  amendments 
(according to Art. 11) 
2 
0 
0 
0 
2 

LITHUANIA 2018 

Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
1 
0 
0 
0 
1 

No.  of  amendments 
(according to Art. 11) 
0 
0 
0 
0 
0 

LUXEMBOURG 2014-2017 

Classification  of  contained  use 
(according to Art. 4(3)) 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 

No.  of  amendments 
(according to Art. 11) 

111 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

0 
13 
0 
0 
13 

0 
/ 
0 
0 
1 

LUXEMBOURG 2018 
Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 

Total 

LATVIA 2014-2017 
Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

LATVIA 2018 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
0 
0 
0 
no 
Luxembourg 
0 

No.  of  amendments 
(according to Art. 11) 
0 
0 
0 
no  level  4  facility  in 
Luxembourg 
0 

facility 

level 

in 

4 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
- 
- 
- 
- 
- 

No.  of  amendments 
(according to Art. 11) 
- 
- 
- 
- 
- 

Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
1 
0 
0 
0 
1 

No.  of  amendments 
(according to Art. 11) 
0 
0 
0 
0 
0 

MALTA 2014-2017 
Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

MALTA 2018 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
0 
0 
0 
0 
0 

No.  of  amendments 
(according to Art. 11) 
0 
0 
0 
0 
0 

Classification  of  contained  use  No. of notifications submitted              

No.  of  amendments 

112 

 
 
 
 
 
 
 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

(according to Art. 6, 8 and 9) 
0 
0 
0 
0 
0 

(according to Art. 11) 
0 
0 
0 
0 
0 

NETHERLANDS 2014-2017 

No. of notifications submitted              
(according to Art. 6, 8 and 9)* 
306  

Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 

Class 2 

Class 3 

Class 4 

Total 

* counting from 1-3-2015 

NETHERLANDS 2018 
Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 

680  

81  

0 

1067 

Class 2 

Class 3 

Class 4 

Total 

368 

32 

0 

468 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
68 

in  previous 

No.  of  amendments 
(according to Art. 11) 
included 
number 
included 
number 
included 
number 
included 
number 

in  previous 

in  previous 

in  previous 

in  previous 

in  previous 

No.  of  amendments 
(according to Art. 11) 
Included 
number 
Included 
number 
Included 
number 
Included 
number 
Included 
number 

in  previous 

in  previous 

in  previous 

POLAND 2014-2017 
Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

POLAND 2018 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
189 
54 
1 
0 
244 

No.  of  amendments 
(according to Art. 11) 
0 
4 
0 
0 
4 

Classification  of  contained  use  No. of notifications submitted              

No.  of  amendments 

113 

 
 
 
  
 
 
 
(according to Art. 6, 8 and 9) 

(according to Art. 11) 

(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

PORTUGAL 2014-2017 

Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
10 
7 
0 
0 
17 

No.  of  amendments 
(according to Art. 11) 
0 
0 
0 
0 
0 

PORTUGAL 2018 

Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
2 
5 
1 
0 
8 

No.  of  amendments 
(according to Art. 11) 
0 
0 
0 
0 
0 

ROMANIA 2014-2017 
Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

ROMANIA 2018 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
0 
1 
0 
0 
1 

No.  of  amendments 
(according to Art. 11) 
none 
none 
none 
none 
none 

Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
0 
1 
0 
0 
1 

No.  of  amendments 
(according to Art. 11) 
- 
- 
- 
- 
- 

SWEDEN 2014-2017 

Classification  of  contained  use  No. of notifications submitted              

No.  of  amendments 

114 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(according to Art. 4(3)) 
Class 1 

Class 2 

Class 3 
Class 4 
Total 

included 

(according to Art. 6, 8 and 9) 
49  (only  Art.  6)  (concernning 
at least 68 activities, more than 
1  can  be 
in  one 
notification;  3  closed  during 
period) 
201 (51 (Art. 6) + 155 (Art. 8): 
48  new  activities,  2  closed 
during period. Includes at least 
201  new  GMM  uses:  more 
than  1  use  can  be  notified  in 
one notification.) 
8 (Art. 6) + 18 (Art. 9) 
1 + 1 (Art. 6, Art. 9) 
244 

(according to Art. 11) 
- 

- 

- 
- 
notifications 
135 
amending 
earlier 
notifications  that  did  not 
affect  risks  (NOT  art. 
11) 

SWEDEN 2018 

Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
Art 6: 55 
Art 

No.  of  amendments 
(according to Art. 11) 
- 
- 

55 

6: 

Class 3 

Class 4 

Total 

Art 8: 170 
Art 

Art 9: 20 
Art 

6: 

6: 

9 

- 

1 

- 

Art 9: 1 
55+55+170+9+20+1+1=311 

- 

SLOVENIA 2014-2017 
Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
16 

Class 2 
Class 3 
Class 4 
Total 

20 
- 
- 
36 

No.  of  amendments 
(according to Art. 11) 
7  amendments  and  7 
deletions of installations 
1 amendment 
- 
- 
15 

SLOVENIA 2018 

Classification  of  contained  use  No. of notifications submitted              

No.  of  amendments 

115 

 
 
 
 
 
 
 
 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

(according to Art. 6, 8 and 9) 
3 
6 
0 
0 
9 

(according to Art. 11) 
0 
0 
- 
- 
- 

SLOVAKIA 2014-2017 
Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

SLOVAKIA 2018 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
170 
15 
--- 
---- 
185 

No.  of  amendments 
(according to Art. 11) 
--- 
--- 
--- 
--- 
--- 

Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
  37 
  4 
  1 
  --- 
  42 

No.  of  amendments 
(according to Art. 11) 
-- 
-- 
-- 
-- 
-- 

UNITED KINGDOM 2014-2017 

Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
123 
430 
34 
2 
589 

No.  of  amendments 
(according to Art. 11) 
0 
30 
4 
0 
34 

UNITED KINGDOM 2018 

Classification  of  contained  use 
(according to Art. 4(3)) 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of notifications submitted              
(according to Art. 6, 8 and 9) 
46 
130 
8 
1 
185 

No.  of  amendments 
(according to Art. 11) 
N/A 
10 
6 
1 
17 

Number of premises for contained uses of GMMs (as referred to in Article 6) with a 

7.2 
valid notification as per December 2017 / December 2018:  

116 

 
 
 
 
 
 
 
AUSTRIA 2014-2017 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of premises  
95 
95 
5 
-- 
195 

AUSTRIA 2018 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of premises  
105 
94 
5 
-- 
204 

BELGIUM 2014-2017 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of premises  
132 
123 
24 
0 
279 

BELGIUM 2018 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of premises  
122 
121 
28 
0 
271 

Comments 
-- 
-- 
-- 
-- 
-- 

Comments 
-- 
-- 
-- 
-- 
-- 

Comments 

It  is  impossible  to  list  all  premises  for  all 
installations;  Only  the  number  of  installations  are 
taken  into  account  in  this  table.  Because  it  is  not 
possible to distinguish the installations that have a 
valid  notification  from  the  others,  we  report  the 
number  of  approved  contained  use  activities  from 
2007 to 2017. The period of 10 years correspond to 
the  maximum  validity  that  could  be  given  for  a 
contained use authorisation. 

Comments 

It  is  impossible  to  list  all  premises  for  all 
installations;  Only  the  number  of  installations  are 
table. 
taken 

account 

into 

this 

in 

Because  it  is  not  possible  to  distinguish  the 
installations that have a valid notification from the 
others, we report the number of approved contained 
use activities from 2008 to 2018. The period of 10 

117 

 
 
 
 
 
 
 
 
  
  
  
  
 
 
  
  
  
  
 
years  correspond  to  the  maximum  validity  that 
could be given for a contained use authorisation. 

BULGARIA 2014-2017 

Class 1 

Class 2 
Class 3 
Class 4 
Total 

No. of premises  
5 

0 
0 
0 
5 

Comments 
3  of  those  premises 
also 
valid 
have 
notification  for  Class 
A  activities  with  GM 
plants. 
N/A 
N/A 
N/A 
N/A 

BULGARIA 2018 

Class 1 

Class 2 
Class 3 
Class 4 
Total 

No. of premises  
5 

Comments 
3 

of 

those 

premises 

also 

have 

valid 

notification 

for 

Class 

A 

0 
0 
0 
5 

activities with GM plants. 
N/A 
N/A 
N/A 
N/A 

CYPRUS 2014-2017 

Class 1 

Class 2 

Class 3 
Class 4 
Total 

No. of premises  
1 

1 

0 
0 
1 

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

CYPRUS 2018 

Class 1 

No. of premises  
1 

Comments 
Please  note  that  only  one  installation  was 
the  Department  of  Labour  
approved  by 

118 

 
 
 
 
 
 
 
 
 
 
 
 
Class 2 
Class 3 
Class 4 
Total 

1 
0 
0 
1 

Inspection for Class 1 and Class 2 Activities. 
0 
0 
0 
Please  note  that  only  one  installation  was 
approved  by 
the  Department  of  Labour  
Inspection for Class 1 and Class 2 Activities. 

CZECH REPUBLIC 2014-2017 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of premises  
68 
91 
2 
0 
161 

Comments 
no comments 
no comments 
no comments 
no comments 
no comments 

CZECH REPUBLIC 2018 
No. of premises  
71 
92 

Class 1 
Class 2 

Class 3 
Class 4 
Total 

3 
0 
166 

GERMANY 2014-2017 

Comments 
Class 1 only 
some  premises  are 
Class 2 and Class 1 
no comments 
no comments 
no comments 

Class 1 
Class 2 
Class 3 
Class 4 

Total 

No. of premises  
4696 
1708 
101 
4 

6509 

Comments 
no 
no 
no 
3x  in  operation,  1x 
construction approval 
no 

GERMANY 2018 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of premises  
4681 
1734 
104 
5 
6524 

Comments 
- 
- 
- 
- 
- 

DENMARK 2014-2017 

Class 1 

No. of premises  
835 

Comments 
477 Premises with  an 

119 

 
 
 
 
 
 
 
 
 
 
 
 
Class 2 

Class 3 
Class 4 
Total 

125 

0 
0 
960 

DENMARK 2018 

active project 
75  Premises  with  an 
active project 
0 
0 
549 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of premises  
35 
6 
0 
0 
41 

Comments 
x 
x 
x 
x 
x 

ESTONIA 2014-2017 

Class 1 
Class 2 
Class 3 

Class 4 
Total 

No. of premises  
6 
6 
1 

0 
6 

Comments 
No comments 
same as class 1 
one 
classes 1-3 
No comments 
No comments 

laboratory  has 

ESTONIA 2018 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of premises  
0 
0 
0 
0 
0 

GREECE 2014-2017 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of premises  
0 
0 
0 
0 
0 

Comments 
0 
0 
0 
0 
0 

Comments 
0 
0 
0 
0 
0 

GREECE 2018 

Class 1 
Class 2 

No. of premises  
0 
0 

Comments 
0 
0 

120 

 
 
 
 
 
 
 
 
 
 
 
 
Class 3 
Class 4 
Total 

0 
0 
0 

SPAIN 2014-2017 

0 
0 
0 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of premises  
69 
57 
12 
0 
138 

Comments 
no 
no 
no 
no 
no 

SPAIN 2018 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of premises  
8 
9 
1 
0 
19 

Comments 
No comments 
No comments 
No comments 
No comments 
No comments 

FINLAND 2014-2017 

Class 1 

Class 2 
Class 3 
Class 4 
Total 

No. of premises  
386 

162 
4 
0 
552 

Comments 
=  notifications  for  premises;  may  contain 
rooms in different addresses and buildings 
idem 
- 
- 
Premises are located in 168 different addresses 

FINLAND 2018 

Class 1 

Class 2 

Class 3 

Class 4 
Total 

No. of premises  
? 

? 

3 

0 
166 

Comments 
It  is  currently  not  possible  to  combine  the 
information  on  premises  and  classification  in 
the gene technology register as the database is 
not relational. 
It  is  currently  not  possible  to  combine  the 
information  on  premises  and  classification  in 
the gene technology register as the database is 
not relational 
Cumulative  number  of  different  addresses  in 
valid  notifications  until  the  end  of  December 
2018.This  number  could  be  picked  by  hand 
from the individual Class 3 applications. 
- 
Cumulative  number  of  different  addresses  in 
the  end  of 
the  valid  notifications  until 

121 

 
 
 
 
 
 
 
 
 
 
December 2018. 

FRANCE 2014-2017 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

Comments 
néant 
néant 
néant 
néant 
Notre système d'information ne nous permet pas 
en l'état de répondre à cette question 

No. of premises  
néant 
néant 
néant 
néant 
Notre 
système 
d'information ne nous 
permet  pas  en  l'état 
de  répondre  à  cette 
question 

FRANCE 2018 

No. of premises  

Class 1 
Class 2 
Class 3 
Class 4 
Total 

- 
- 
- 
- 

CROATIA 2014-2017 

Comments 
Our IT resources do not allow us to answer this 
Our IT resources do not allow us to answer this 
Our IT resources do not allow us to answer this 
Our IT resources do not allow us to answer this 
Our IT resources do not allow us to answer this 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of premises  
23 
7 
0 
0 
30 

Comments 
/ 
/ 
/ 
/ 
/ 

CROATIA 2018 

No. of premises  

Comments 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

HUNGARY 2014-2017 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of premises  
2 
90 
0 
0 
92 

Comments 
no 
no 
no 
no 
Each seperate institute belonging to one university 

122 

 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
is  considered  as  one  seperate  premises  for 
contained use. All together 22 notifications contain 
92 premises. 

HUNGARY 2018 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of premises  
1 
2 
0 
0 
3 

Comments 
0 
0 
0 
0 
0 

IRELAND 2014-2017 

Class 1 

Class 2 
Class 3 
Class 4 
Total 

No. of premises  
14 

10 
0 
0 
24 

Comments 
Many  of  these  premises  (institutions  in  particular) 
are multi-user sites. 
As above 
- 
- 
- 

IRELAND 2018 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of premises  
5 
6 
1 
0 
12 

Comments 
- 
- 
- 
- 
- 

ITALY 2014-2017 

No. of premises  
88 

141 

9 
0 
238 

Comments 
Only  4  out  of  88  are  authorized  for  gene  therapy 
clinical  trials  (see  No.  reported  in  Part  III  section 
10). 
Only  16  out  of  141  are  authorized  in  gene  therapy 
clinical  trials  (see  No.  reported  in  Part  III  section 
10). 
N.A. 
N.A. 
N.A. 

No. of premises  

Comments 

Class 1 

Class 2 

Class 3 
Class 4 
Total 

ITALY 2018 

Class 1 
Class 2 

123 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Class 3 
Class 4 
Total 

LITHUANIA 2014-2017 

Class 1 
Class 2 

Class 3 
Class 4 
Total 

No. of premises  
15 
2 

0 
0 
16 

Comments 
- 
The premises according to one of 2 notifications for 
the 2cnd class are the same as for the 1st class 
- 
- 
- 

LITHUANIA 2018 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of premises  
14 
1 
0 
0 
15 

Comments 
0 
0 
0 
0 
To  date  number  of 
notification 

labs  according 

to  Valid 

LUXEMBOURG 2014-2017 
No. of premises  
0 
1 
0 
0 
1 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

Comments 
0 
0 
0 
0 
0 

LUXEMBOURG 2018 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of premises  
0 
2 
2 
0 
2 

Comments 
/ 
/ 
/ 
/ 
Transposition  of  Directive  2009/41  is  ongoing. 
SECUALIM projects to gather information once the 
directives has ben transposed in national law. 

LATVIA 2014-2017 

Class 1 
Class 2 
Class 3 

No. of premises  
- 
- 
- 

Comments 
- 
- 
- 

124 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Class 4 
Total 

- 
- 

LATVIA 2018 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of premises  
1 
0 
0 
0 
1 

MALTA 2014-2017 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

MALTA 2018 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of premises  
1 
0 
0 
0 
1 

No. of premises  
1 
0 
0 
0 
1 

- 
- 

Comments 
- 
- 
- 
- 
- 

Comments 

Comments 

NETHERLANDS 2014-2017 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of premises  
380 
274 
101 
0 
415 

Comments 
non 
non 
non 
non 
In  the  Netherlands  premises  for  contained  use  may 
consist of more than one containment level (e.g. 1, 2 
and 3). 

NETHERLANDS 2018 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of premises  
393 
283 
103 
0 
432 

Comments 
non 
non 
non 
non 
In  the  Netherlands  premises  for  contained  use  may 
consist of more than one containment level (e.g. 1, 2 

125 

 
 
 
 
 
 
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
and 3). The total number of premises is 432. 

POLAND 2014-2017 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of premises  
189 
54 
1 
0 
244 

Comments 
- 
- 
- 
- 
- 

POLAND 2018 

No. of premises  

Comments 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

PORTUGAL 2014-2017 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of premises  
12 
7 
0 
0 
19 

Comments 
No comments. 
No comments. 
No comments. 
No comments. 
No comments. 

PORTUGAL 2018 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of premises  
14 
8 
1 
0 
23 

ROMANIA 2014-2017 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of premises  
0 
2 
0 
0 
2 

Comments 
None. 
None. 
None. 
None. 
None. 

Comments 
none 
none 
none 
none 
none 

ROMANIA 2018 

No. of premises  

Comments 

126 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

0 
1 
0 
0 
1 

SWEDEN 2014-2017 

- 
- 
- 
- 
- 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of premises  
414 
242 
14 
1 
691 

Comments 
Premises may overlap. 
Premises may overlap. 
Premises may overlap. 
- 
- 

SWEDEN 2018 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of premises  
470 
297 
23 
2 
792 

Comments 
- 
- 
- 
- 
- 

SLOVENIA 2014-2017 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of premises  
54 
16 
- 
- 
70 

Comments 
including 9 animal facilities and 2 greenhouses 
- 
- 
- 
11 

SLOVENIA 2018 

Class 1 

Class 2 

Class 3 
Class 4 
Total 

No. of premises  
58 

17 

0 
0 
75 

Comments 
including  10  animal  facilities  and  2  greenhouses4 
premises  were  renovated  or  changed  and  the  CA 
was notified 
3  premises were renovated or changed and the CA 
was notified 
0 
0 
7 

SLOVAKIA 2014-2017 

Class 1 
Class 2 

No. of premises  
80 
23 

Comments 
--- 
--- 

127 

 
 
 
 
 
 
 
 
 
 
 
 
Class 3 
Class 4 
Total 

1 
--- 
104 

SLOVAKIA 2018 

--- 
--- 
--- 

Class 1 
Class 2 
Class 3 

Class 4 
Total 

No. of premises  
  3 
 15 
 --- 

 --- 
 18 

Comments 
-- 
 --- 
 The  notification  on  risk  class  3  was  submitted  in 
2017. 
 --- 
 -- 

UNITED KINGDOM 2014-2017 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of premises  
417 
235 
72 
7 
731 

UNITED KINGDOM 2018 
No. of premises  
446 
279 
73 
7 
805 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

Comments 
N/A 
N/A 
N/A 
N/A 
N/A 

Comments 
N/A 
N/A 
N/A 
N/A 
N/A 

Number  of  contained  uses  of  GMMs  (including  combined  uses  of  GMMs  and 

7.3 
GMOs) with a valid notification4 or approval as per December 2017 / December 2018. 

AUSTRIA 2014-2017 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
222 
11 
-- 
233 

Comments 

-- 
-- 
-- 
-- 

AUSTRIA 2018 

Class 2 
Class 3 
Class 4 

No.  of  contained 
uses 
190 
12 
-- 

Comments 

-- 
-- 
-- 

128 

 
 
 
 
 
 
 
 
 
 
 
 
 
Total 

202 

-- 

BELGIUM 2014-2017 

Class 2 

Class 3 
Class 4 
Total 

No.  of  contained 
uses 
class 1 : 594 class 2 : 
883 
96 
0 
1573 

BELGIUM 2018 

Class 2 

Class 3 
Class 4 
Total 

No.  of  contained 
uses 
class 

451 

1: 

class 2: 863 
82 
0 
1396 

Comments 

Class 1 row is missing in this table. 

Because  it  is  not  possible  to  distinguish  the 
installations  that  have  a  valid  notification  from 
the  others,  we  report  the  number  of  approved 
contained use activities from 2007 to 2017. The 
period  of  10  years  correspond  to  the  maximum 
validity  that  could  be  given  for  a  contained  use 
authorisation. 

Comments 

line corresponding to Class 1 is missing 

/ 
/ 
Because  it  is  not  possible  to  distinguish  the 
installations that have a valid notification from 
the  others,  we  report  the  number  of  approved 
contained use activities from 2008 to 2018. The 
period of 10 years correspond to the maximum 
validity that could be given for a contained use 
authorisation. 

BULGARIA 2014-2017 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
0 
0 
0 
0 

Comments 

N/A 
N/A 
N/A 
N/A 

BULGARIA 2018 

Class 2 
Class 3 

No.  of  contained 
uses 
0 
0 

Comments 

N/A 
N/A 

129 

 
 
 
 
  
  
 
 
 
 
 
 
 
Class 4 
Total 

0 
0 

N/A 
N/A 

CYPRUS 2014-2017 

Class 2 

Class 3 
Class 4 
Total 

No.  of  contained 
uses 
1 

0 
0 
1 

CYPRUS 2018 

Class 2 

Class 3 
Class 4 
Total 

No.  of  contained 
uses 
1 

0 
0 
1 

Comments 

in 

the  Cyprus 

the  following 
Notification  of  GMM  used 
labs/departments  of 
Institute  of 
Neurology  and  Genetics:  Molecular  Virology, 
Electron  Microscope 
/  Molecular  Pathology, 
Molecular  Genetics  and  Thalassemia,  Molecular 
Genetics and Treatment Operation, Neurology E 
NA 
NA 
the  following 
Notification  of  GMM  used 
labs/departments  of 
Institute  of 
Neurology  and  Genetics:  Molecular  Virology, 
/  Molecular  Pathology, 
Electron  Microscope 
Molecular  Genetics  and  Thalassemia,  Molecular 
Genetics and Treatment Operation, Neurology E 

the  Cyprus 

in 

Comments 

in 

the  Cyprus 

Notification  of  GMM  used 
the  following 
labs/departments  of 
Institute  of 
Neurology 
and  Genetics:Molecular  Virology, 
/  Molecular  Pathology, 
Electron  Microscope 
Molecular  Genetics  and  Thalassemia,  Molecular 
Genetics and Treatment Operation, Neurology E 
- 
- 
- 

CZECH REPUBLIC 2014-2017 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
205 
2 
0 
207 

Comments 

no comments 
no comments 
no comments 
no comments 

CZECH REPUBLIC 2018 

Class 2 

No.  of  contained 
uses 
235 

Comments 

according  to  notified 

130 

 
 
 
 
 
 
 
 
 
 
Class 3 
Class 4 
Total 

3 
0 
238 

GERMANY 2014-2017 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
7027 
320 
14 
7361 

GMMs  
no comments 
no comments 
no comments 

Comments 

no 
no 
no 
no 

GERMANY 2018 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
8026 
364 
13 
8403 

Comments 

- 
- 
- 
- 

DENMARK 2014-2017 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
114 
0 
0 
114 

Comments 

- 
- 
- 
- 

DENMARK 2018 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
149 
0 
0 
149 

Comments 

x 
x 
x 
x 

ESTONIA 2014-2017 

Class 2 
Class 3 

Class 4 
Total 

No.  of  contained 
uses 
6 
1 

0 
6 

Comments 

No comments 
On 
classes 1-3 
N/A 
one 

laboratory  has 

laboratory  has 

131 

 
 
 
 
 
 
 
 
 
 
 
 
classes 1-3 

Comments 

0 
0 
0 
0 

ESTONIA 2018 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
0 
0 
0 
0 

GREECE 2014-2017 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
0 
0 
0 
0 

Comments 

0 
0 
0 
0 

GREECE 2018 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
0 
0 
0 
0 

Comments 

0 
0 
0 
0 

SPAIN 2014-2017 

Class 2 

Class 3 
Class 4 
Total 

No.  of  contained 
uses 
137 

55 
0 
192 

Comments 

49 notifications regarding GMMs, class 1, 
were also notified. 
NO 
NO 
NO 

SPAIN 2018 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
54 
6 
0 
60 

Comments 

Valid notification 
Valid notification 
Not apply 
Not apply 

FINLAND 2014-2017 

132 

 
 
 
 
 
 
 
 
 
 
 
 
 
Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
210 
5 
0 
215 

Comments 

- 
- 
- 
- 

FINLAND 2018 

Class 2 

Class 3 

Class 4 
Total 

No.  of  contained 
uses 
202 

6 

0 
208 

Comments 

This is a cumulative number of all valid notifications 
until  the  end  of  December  2018.  This  number  may 
contain  several  different  notifications  b  ythe  same 
operator if it has later taken new Class 2 GMM:s into 
use. 
Cumulative  number  of  valid  notifications  until  the 
end of December 2018. 
- 
- 

FRANCE 2014-2017 

Class 2 
Class 3 
Class 4 
Total 

Comments 

néant 
néant 
néant 
Notre système d'information ne nous permet pas 
en l'état de répondre à cette question 

No.  of  contained 
uses 
néant 
néant 
néant 
Notre 
système 
ne 
d'information 
nous  permet  pas  en 
l'état  de  répondre  à 
cette question 

FRANCE 2018 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
- 
- 
- 
5000 

Comments 

- 
- 
- 
Around 5000 files from all mixed classes 

CROATIA 2014-2017 

Class 2 
Class 3 
Class 4 

No.  of  contained 
uses 
7 
0 
0 

Comments 

/ 
/ 
/ 

133 

 
 
 
 
 
 
 
 
 
 
 
Total 

7 

/ 

CROATIA 2018 

No.  of  contained 
uses 

Comments 

Class 2 
Class 3 
Class 4 
Total 

HUNGARY 2014-2017 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
36 
0 
0 
36 

Comments 

no 
no 
no 
no 

HUNGARY 2018 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
4 
0 
0 
4 

Comments 

0 
0 
0 
0 

IRELAND 2014-2017 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
26 
0 
0 
26 

Comments 

- 
- 
- 
- 

IRELAND 2018 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
9 
0 
0 
9 

Comments 

- 
- 
- 
- 

ITALY 2014-2017 

No.  of  contained  Comments 

134 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
uses 
329 

11 
0 
340 

Only  160  out  of  329  concern 
research  and 
development  purposes,  68  research  and  studies  in 
which animals are used and 62 production and control 
of biological substances or medicines 
Research and development 
N.A. 
N.A. 

No.  of  contained 
uses 

Comments 

Class 2 

Class 3 
Class 4 
Total 

ITALY 2018 

Class 2 
Class 3 
Class 4 
Total 

LITHUANIA 2014-2017 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
2 
0 
0 
2 

Comments 

- 
- 
- 
- 

LITHUANIA 2018 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
2 
0 
0 
2 

Comments 

0 
0 
0 
To  date  number  of  activities  according  to  valid 
notifications 

LUXEMBOURG 2014-2017 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
13 
0 
0 
13 

Comments 

0 
0 
0 
0 

LUXEMBOURG 2018 

No.  of  contained 
uses 

Comments 

135 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Class 2 
Class 3 
Class 4 
Total 

0 
0 
0 
0 

LATVIA 2014-2017 

/ 
/ 
/ 
/ 

Class 2 
Class 3 
Class 4 
Total 

LATVIA 2018 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
- 
- 
- 
- 

Comments 

- 
- 
- 
- 

No.  of  contained 
uses 
0 
0 
0 
0 

Comments 

- 
- 
- 
- 

Comments 

Comments 

MALTA 2014-2017 

Class 2 
Class 3 
Class 4 
Total 

MALTA 2018 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
0 
0 
0 
0 

No.  of  contained 
uses 
0 
0 
0 
0 

NETHERLANDS 2014-2017 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
1053 
251 
0 
2908 

Comments 

non 
non 
non 
this figure totals the notifications for class 1, 2 and 3. 

136 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
NETHERLANDS 2018 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
1053 
251 
0 
2908 

Comments 

non 
non 
non 
this figure totals the notifications for class 1, 2 and 3. 

POLAND 2014-2017 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
54 
1 
0 
55 

Comments 

- 
- 
- 
- 

POLAND 2018 

No.  of  contained 
uses 

Comments 

Class 2 
Class 3 
Class 4 
Total 

PORTUGAL 2014-2017 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
14 
0 
0 
14 

Comments 

No comments. 
No comments. 
No comments. 
No comments. 

PORTUGAL 2018 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
18 
1 
0 
19 

Comments 

None. 
None. 
None. 
None. 

ROMANIA 2014-2017 

No.  of  contained 
uses 

Comments 

137 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Class 2 
Class 3 
Class 4 
Total 

1 
0 
0 
1 

ROMANIA 2018 

none 
none 
none 
none 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
1 
- 
- 
1 

Comments 

- 
- 
- 
- 

SWEDEN 2014-2017 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
1469 
28 
1 
1498 

Comments 

- 
- 
- 
- 

SWEDEN 2018 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
1600 
30 
2 
1632 

Comments 

- 
- 
- 
- 

SLOVENIA 2014-2017 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
26 
- 
- 
80 

Comments 

- 
- 
- 
- 

SLOVENIA 2018 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
32 
0 
0 
32 

Comments 

0 
0 
0 
0 

138 

 
 
 
 
 
 
 
 
 
 
 
 
SLOVAKIA 2014-2017 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
112 
--- 
--- 
112 

Comments 

--- 
--- 
--- 
--- 

SLOVAKIA 2018 

Class 2 
Class 3 

Class 4 
Total 

No.  of  contained 
uses 
  23 
 18 

 --- 
 41 

Comments 

 -- 
 All  18  activities  were 
notification. 
 -- 
 -- 

the  scope  of  one 

UNITED KINGDOM 2014-2017 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
2246 
235 
14 
2495 

Comments 

N/A 
N/A 
N/A 
N/A 

UNITED KINGDOM 2018 

Class 2 
Class 3 
Class 4 
Total 

No.  of  contained 
uses 
2376 
243 
15 
2634 

Comments 

N/A 
N/A 
N/A 
N/A 

- GM animals and GM plants 

8.1   How  many  notifications  for  contained  uses  of  GMOs6,  i.e.  GM  animals  and  GM 
plants, (excluding combined uses with GMMs) were submitted in your Member State 
during the reporting period? 

* If you use a different classification system (than classes 1, 2, 3, 4), explain the link between 
the classification and the category of the risk. 

6 This question did not appear in the questionnaire of those Member States which declared that they have not 
extended the scope of the Directive to GM animals and GM plants in their national legislation. 

139 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
AUSTRIA 2014-2017 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

GM plants 

No. 
of 
notifications 
submitted 

No. 
amendments 

of 

Class 1 
Total 
* If you use a different classification system (than classes 1, 2, 3, 4), explain the link between 
the classification and the category of the risk. 

734 
734 

AUSTRIA 2018 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

GM plants 

No. 
of 
notifications 
submitted 

No. 
amendments 

of 

Class 1 
Class 2 
-- 
-- 
Total 

78 
4 
-- 
-- 
82 

103 
-- 
-- 
-- 
103 

1 
-- 
-- 
-- 
1 

-- 
-- 
-- 
-- 
-- 

BELGIUM 2014-2017 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

GM plants 

No. 
of 
notifications 
submitted 

No. 
amendments 

of 

Class 1 
Class 2 
Class 3 
Class 4 
Total 

10 
2 
0 
0 
12 

7 
2 
0 
0 
9 

4 
0 
0 
0 
4 

9 
3 
0 
0 
12 

BELGIUM 2018 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

GM plants 

No. 
of 
notifications 
submitted 

No. 
amendments 

of 

Class 1 

2 

3 

0 

0 

140 

 
 
 
 
 
 
 
 
 
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
Class 2 
Class 3 
Class 4 
Total 

1 
0 
0 
3 

2 
0 
0 
5 

0 
0 
0 
0 

2 
0 
0 
2 

BULGARIA 2014-2017 
GM animals 
Classification  of 
contained use* 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

GM plants 

No. 
of 
notifications 
submitted 

No. 
amendments 

of 

Class  A,  no  or 
negligible  risk for 
the 
or 
human 
animal  health  and 
for 
the 
environment  -  3 
premises 
Class  B,  all  other 
cases - 0 premises 
N/A 
N/A 
Total7 

0 

0 

1 

5 

0 

N/A 
N/A 
0 

0 

N/A 
N/A 
0 

0 

N/A 
N/A 
1 

0 

N/A 
N/A 
5 

BULGARIA 2018 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

Class  A,  no  or 
negligible  risk for 
or 
human 
the 
animal  health  and 
for 
the 
environment  -  3 
premises 
Class  B,  all  other 
cases 
0 
premises 
N/A 
N/A 
Total8 

– 

0 

0 

N/A 
N/A 
0 

0 

0 

N/A 
N/A 
0 

7 3 premises, all for Class A activities with GM plants 
8 3 premises, all for Class A activities with GM plants. 

GM plants 

No. 
of 
notifications 
submitted 

0 

0 

N/A 
N/A 
0 

No. 
amendments 

of 

3 (check) 

0 

N/A 
N/A 
3 (check) 

141 

 
 
 
 
 
 
 
 
 
 
                                                 
CZECH REPUBLIC 2014-2017 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

GM plants 

No. 
of 
notifications 
submitted 

No. 
amendments 

of 

Class 1 

Class 2 
Class 3 
Class 4 
Total 

115**  see 
note at point 7 

the 

2 
0 
0 
117 

0 

0 
0 
0 
0 

CZECH REPUBLIC 2018 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

Class 1 

Class 2 
Class 3 
Class 4 
Total 

18  (see  the  note 
1 
on 
Class 
notifications 
in 
item 7) 
0 
0 
0 
18 

0 

0 
0 
0 
0 

GERMANY 2014-2017 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

9**  see  the 
note  at  point 
7 
2 
0 
0 
11 

0 

0 
0 
0 
0 

GM plants 

No. 
of 
notifications 
submitted 

No. 
amendments 

of 

3 

0 
0 
0 
3 

0 

0 
0 
0 
0 

GM plants 

No. 
of 
notifications 
submitted 

No. 
amendments 

of 

Total 

GERMANY 2018 
Classification  of  GM animals 

GM plants 

142 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
contained use* 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

No. 
of 
notifications 
submitted 

No. 
amendments 

of 

- 
- 
- 
- 
Total 

- 
- 
- 
- 
- 

- 
- 
- 
- 
- 

- 
- 
- 
- 
- 

- 
- 
- 
- 
- 

DENMARK 2014-2017 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

GM plants 

No. 
of 
notifications 
submitted 

No. 
amendments 

of 

x 
x 
x 
x 
Total 

x 
x 
x 
x 
21 

x 
x 
x 
x 
0 

x 
x 
x 
x 
68 

x 
x 
x 
x 
x 

DENMARK 2018 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

GM plants 

of 
No. 
notifications 
submitted 

No. 
amendments 

of 

x 
x 
x 
x 
Total 

x 
x 
x 
x 
26 

x 
x 
x 
x 
0 

x 
x 
x 
x 
5 

x 
x 
x 
x 
0 

SPAIN 2014-2017 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

GM plants 

of 
No. 
notifications 
submitted 

No. 
amendments 

of 

1 
2 
3 

19 
8 
1 

0 
0 
0 

5 
0 
0 

0 
0 
0 

143 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4 
Total 

0 
28 

0 
0 

0 
5 

0 
0 

SPAIN 2018 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

1 

2 
3 
4 
Total 

10  Notifications 
contained 
for 
uses 
of  GM 
animals and their 
correspondent 
premises.  

0 
0 
0 
10 

0 

0 
0 
0 
0 

FINLAND 2014-2017 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

1 
2 

3 
Total 

17 
1  (Class  2  of 
animals 
GM 
corrssponds 
to 
Classes  3-4  of 
GMMs  and  GM 
plants) 
- 
18 

6 
- 

- 
6 

FINLAND 2018 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

GM plants 

of 
No. 
notifications 
submitted 

2 
Notifications 
for  contained 
uses  of  GM 
plants 
and 
their 
correspondent 
premises.  
0 
0 
0 
0 

GM plants 

No. 
of 
notifications 
submitted 

No. 
amendments 

of 

0 

0 
0 
0 
0 

No. 
amendments 

of 

11 
8 

0 
19 

2 
6 

- 
8 

GM plants 

No. 
of 
notifications 
submitted 

No. 
amendments 

of 

144 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
animals, 

animals, 

1 
plants 
2 
plants 
3 plants 
4 plants 
Total 

1 

8 

2 

0 

- 
- 
8 

0 

0 

- 
- 
0 

0 

0 

0 
0 
0 

0 

0 

0 
0 
0 

FRANCE 2014-2017 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

GM plants 

No. 
of 
notifications 
submitted 

No. 
amendments 

of 

Total 

2500 
2500 

2500 
2500 

250 
250 

250 
250 

FRANCE 2018 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

to 

animals 
GMO 
and  plants 
are 
covered  by  our 
legislation. 
Unable 
differentiate 
records  regarding 
microorganisms, 
animals 
plants 
- 
- 
- 
Total 

and 

- 

- 
- 
- 
- 

- 

- 
- 
- 
- 

CROATIA 2014-2017 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

GM plants 

No. 
of 
notifications 
submitted 

No. 
amendments 

of 

- 

- 

- 
- 
- 
- 

- 
- 
- 
- 

GM plants 

No. 
of 
notifications 
submitted 

No. 
amendments 

of 

145 

 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
Total 

3 
3 

1 
1 

3 
3 

CROATIA 2018 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

GM plants 

of 
No. 
notifications 
submitted 

No. 
amendments 

of 

Total  

HUNGARY 2014-2017 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

GM plants 

No. 
of 
notifications 
submitted 

No. 
amendments 

of 

1 
2 
Total 

16 
22 
38 

0 
0 
0 

3 
5 
8 

0 
0 
0 

HUNGARY 2018 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

GM plants 

of 
No. 
notifications 
submitted 

No. 
amendments 

of 

class 1 
class 1 
class 2 
0 
Total 

0 
1 
5 
0 
6 

0 
0 
0 
0 
0 

1 
0 
0 
0 
1 

0 
0 
0 
0 
0 

IRELAND 2014-2017 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

GM plants 

of 
No. 
notifications 
submitted 

No. 
amendments 

of 

Class 1 
Total 

16 

- 

8 

- 

146 

 
 
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IRELAND 2018 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

GM plants 

No. 
of 
notifications 
submitted 

No. 
amendments 

of 

- 
- 
- 
- 
Total 

5 
- 
- 
- 
5 

1 
- 
- 
- 
1 

2 
- 
- 
- 
2 

- 
- 
- 
- 
- 

ITALY 2018 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

GM plants 

No. 
of 
notifications 
submitted 

No. 
amendments 

of 

Total 

LITHUANIA 2014-2017 
GM animals 
Classification  of 
contained use* 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

GM plants 

of 
No. 
notifications 
submitted 

No. 
amendments 

of 

Total 

LITHUANIA 2018 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

GM plants 

No. 
of 
notifications 
submitted 

No. 
amendments 

of 

0 
0 
0 
0 

1  
0 
0 
0 

0 
0 
0 
0 

0 
0 
0 
0 

0 
0 
0 
0 

147 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Total 

1 

0 

0 

0 

MALTA 2014-2017 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

GM plants 

No. 
of 
notifications 
submitted 

No. 
amendments 

of 

0 
Total 

0 

0 

0 

0 

MALTA 2018 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

GM plants 

No. 
of 
notifications 
submitted 

No. 
amendments 

of 

0 
Total 

0 

0 

0 

0 

NETHERLANDS 2014-2017 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

GM plants 

No. 
of 
notifications 
submitted 

No. 
amendments 

of 

-- 
Total 

-- 

-- 

-- 

-- 

NETHERLANDS 2018 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

GM plants 

No. 
of 
notifications 
submitted 

No. 
amendments 

of 

-- 
-- 
-- 
-- 
Total 

-- 
-- 
-- 
-- 
-- 

-- 
-- 
-- 
-- 
-- 

-- 
-- 
-- 
-- 
-- 

-- 
-- 
-- 
-- 
-- 

148 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
POLAND 2014-2017 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

GM plants 

of 
No. 
notifications 
submitted 

No. 
amendments 

of 

2 
Total 

10 
30 
40 

10 
30 
40 

2 
2 
2 

2 
2 
2 

POLAND 2018 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

GM plants 

No. 
of 
notifications 
submitted 

No. 
amendments 

of 

Total 

PORTUGAL 2014-2017 
GM animals 
Classification  of 
contained use* 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

GM plants 

No. 
of 
notifications 
submitted 

No. 
amendments 

of 

class 1 
class 2 
class 3 
class 4 
Total 

4 

4 

PORTUGAL 2018 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

3 

3 

GM plants 

No. 
of 
notifications 
submitted 

No. 
amendments 

of 

- 
- 
- 
- 
Total 

- 
- 
- 
- 
- 

- 
- 
- 
- 
- 

- 
- 
- 
- 
- 

- 
- 
- 
- 
- 

149 

 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
SWEDEN 2014-2017 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 

of 

No. 
amendments  

of 

0 

0 

Not  water  living 
(Board 
of 
Agriculture 
reporting) 
living 
Water 
(Agency 
for 
Marine and Water 
Management 
reporting) 
Total 

67 

9 

76 

SWEDEN 2018 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 
x 
x 
x 
x 
x 

of 

No. 
amendments  

of 

x 
x 
x 
x 
x 

x 
x 
x 
x 
Total 

SLOVENIA 2014-2017 
Classification  of 
contained use* 

GM animals 

No. 
amendments  

of 

of 

No. 
notifications 
submitted 
1  installation  1 
activity 
- 
- 
- 
2 

Class 1 

- 
- 
- 
Total 

GM plants 

No. 
of 
notifications 
submitted 

No. 
amendments 

of 

33 

0 

33 

GM plants 

No. 
of 
notifications 
submitted 
x 
x 
x 
x 
x 

GM plants 

of 
No. 
notifications 
submitted 

No. 
amendments 

of 

x 
x 
x 
x 
x 

No. 
amendments 

of 

SLOVENIA 2018 
Classification  of  GM animals 

GM plants 

150 

 
 
 
 
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
contained use* 

class 1 

- 
- 
- 
- 
Total 

of 

No. 
notifications 
submitted 
1  installation  1 
activity 
- 
- 
- 
- 
- 

No. 
amendments  

of 

- 

- 
- 
- 
- 
- 

SLOVAKIA 2014-2017 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 
15 
3 
---- 
---- 
18 

risk class 1 
risk class 2 
risk class 3 
risk class 4 
Total 

SLOVAKIA 2018 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 
6 
--- 
--- 
--- 
6 

1 
2 
3 
4 
Total 

of 

No. 
amendments  

of 

--- 
---- 
---- 
---- 
---- 

of 

No. 
amendments  

of 

--- 
--- 
--- 
--- 
--- 

UNITED KINGDOM 2014-2017 
Classification  of 
contained use* 

GM animals 

of 

No. 
notifications 
submitted 
table, 
see 
comments below 

No. 
amendments  

of 

see 

table, 
comments 
below 

Unable 
complete 
table, 
comments below 

to 
this 
see 

No. 
of 
notifications 
submitted 
- 

- 
- 
- 
- 
- 

GM plants 

No. 
of 
notifications 
submitted 
33 
----- 
----- 
----- 
33 

GM plants 

of 
No. 
notifications 
submitted 
10 
--- 
--- 
--- 
10 

GM plants 

No. 
of 
notifications 
submitted 
table, 
comments 
below 

see 

No. 
amendments 

of 

- 

- 
- 
- 
- 
- 

No. 
amendments 

of 

---- 
---- 
---- 
----- 
----- 

No. 
amendments 

of 

--- 
--- 
--- 
--- 
--- 

No. 
amendments 

of 

table, 
see 
comments below 

151 

 
 
 
 
 
 
 
 
 
Total 

UNITED KINGDOM 2018 
Classification  of 
contained use* 

GM animals 

No. 
notifications 
submitted 
Unable 
complete 
table see  

of 

No. 
amendments  

of 

to 
this 

Unable 
complete 
table see  

to 
this 

GM plants 

No. 
of 
notifications 
submitted 
Unable 
to 
complete  this 
table see  

No. 
amendments 

of 

Unable 
complete 
table see  

to 
this 

N/A 
N/A 
N/A 
N/A 

N/A 
N/A 
N/A 
N/A 

N/A 
N/A 
N/A 
N/A 

N/A 
N/A 
N/A 
N/A 

to 
this 
see 

Unable 
complete 
table 
comments below 
N/A 
N/A 
N/A 
Total 

8.2   Did  you encounter  specific challenges related to  notifications  for GM plants  or GM 

animals? 

2014 - 2017 
AT  no 
BE  No  specific  challenges  were  encountered  with  notifications  of  GM  plants  or  GM 

animals. 

BG 

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,  as  the 
requirements differ significantly between the member states at present. 

CZ  No 
DE  The  German  GenTG  has  also  implemented  Directive  2001/18/EC  and  extended  the 
scope  of  2009/41/EC  to  the  contained  use  of  GM  plants  and  GM  animals.There  is  no 
distinction between GMM, GM plants and GM animals in notification procedures. There 
is  no  consideration  in  collection  of  data,  the  numbers  are  included  under  7.  So  our 
database can not be evaluated concerning those criteria. 
- 

DK 
ES  Challenges regarding notification were described in previous questions.  
FI  Yes, about the legal status of the progeny of CRISPR-Cas9 modified plants. Also about 
the  legal  status  and  classification  of  certain  CRISPR-Cas9  insects  (no  gene  drive 
situation).  In  general  issues  about  the  legal  status  arise  where  the  genome    of  an 
organism has been modified with site specific mutagenesis, especially when an existing 
mutant organism is reverted to wild type with novel mutagenesis techniques. 

FR  Non 
HR  No 
HU  No 
IE  No 
LT  There were no notifications for contained uses of GMOs submitted. 
MT  Not applicable. 
NL  No, except the fact that due to our reporting system it is not possible for the Netherlands 

152 

 
 
 
 
 
 
 
 
 
 
to differentiate on this and to fill out the above table. The data given in questions 7.1 to 
7.3 encompass also activities with GM plants and GM animals.   

PL  Environmental Risk Assessment 
PT  No particular difficulties were found regarding specif challenges related to notifications 

about GM plants or GM animals. 

SE  There  are  no  classifications  sytems.  No  GMOs  should  escape  regardless  of  species. 

Case-by-case. 
No challenges today, but in future if different classes or differentiate between contained 
use and deliberate release - how to assess the risks?  

SI  No specific challenges were encountered related to notifications of GM animals or GM 
plants  respectively.  Members  of  the  Scientific  Committee  are  nominated  according  to 
the  provisions  of  the  Slovene  GMO  act.  The  provisions  ensure  that  the  members  are 
nominated  in  order  to  cover  adequate  fields  of  expertise  for  GMMs,  GM  animals  and 
GM plants.  
---- 

SK 
UK  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 
has, historically, not been collected in a form that is amenable for reporting purposes. 

2018 
AT   no 
BE   No  specific  challenges  were  encountered  with  notifications  of  GM  plants  or  GM 

animals. 

BG   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,  as  the 
requirements differ significantly between the member states at present. 

CY   GMOs are not covered under the contained use legislation in Cyprus. The Department of 
Labour  Inspection  is  not  the  competent  authority  for  GMOs  it  is  the  Department  of 
Environment however no notification was submitted to the Department of Environment 
in 2018. 

CZ   No. 
DE   No  challenge  but  comment:  The  German  GenTG  has  also  implemented  Directive 
2001/18/EC  and extended the scope of 2009/41/EC  to  the contained use of GM plants 
and GM animals. There is no distinction between GMM, GM plants and GM animals in 
notification procedures. There is no consideration in collection of data, the numbers are 
included under 7. So our database cannot be evaluated concerning those criteria. 

DK   No 
EE   N/A 
EL   No notifications received 
ES  No 
FI  

(1)  The  legal  status  of  the  progeny  of  GMO:s  that  do  not  inherit  the  modification.  (2) 
Classification in certain cases, especially when GMMs are used in combination with GM 
animals or GM plants. (3) Whether the ECJ decision is to be applied also to contained 
use;  (4)  Legal  status  when  an  existing  mutant  organism  is  reverted  to  wild  type  using 
novel mutagenesis techniques. 

FR 
HR 
HU   No 

153 

 
 
 
 
 
IE   No 
IT 
LT   The activity is with already genetically modified mice, 1st risk class 
LU   No 
LV   We did have notifications about GM plants and/or GM animals 
MT   N/A 
NL   No, except the fact that due to our reporting system it is not possible for the Netherlands 
to differentiate on this and to fill out the above table. The data given in questions 7.1 to 
7.3 encompass also activities with GM plants and GM 

PL 
PT   Not applicable. 
RO   Not yet 
SE   xxxx 
SI 

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.  Therefore  the 
legislative and administrative aspect of GM plants and GM animals is well covered. 
SK   We  did  not  encounter  any  specific  challenges  related  to  notifications  on  GM  plants  or 

GM animals. 

UK   Please note the Directive is only concerned with GMMs and does not require collection 
of  information  on  work  with  GMOs  (animals  and  plants)  Consequently,  such 
information has, historically, not been collected in a form that is amenable for reporting 
purposes. 

PART  III:  INVESTIGATIONAL  MEDICINAL  PRODUCTS  THAT 
CONTAIN OR CONSIST OF GMOs 
In  this  part  of  the  questionnaire  you  are  invited  to  submit  information  about  the  different 
activities  related  to  the  manufacturing  and  administration  of  investigational  medicinal 
products for human and veterinary use that contain or consist of GMOs.9 
If  manufacturing  of  investigational  medicinal  products  is  common  for  both  human  and 
veterinary use, please report this activity under the "Human use" part. 

III.1 Human use 
a. Manufacturing 
9.1 

Is  the  manufacturing  of  investigational  medicinal  products  for  human  use  that 
contain or consist of GMOs notified and/or authorised under Directive 2009/41/EC in 
your Member State? 
If  yes,  were  there  any  notifications  and/or  authorisations  for  manufacturing 
investigational  medicinal  products  for  human  use  that  contain  or  consist  of  GMOs 
submitted in your Member State during the reporting period? 

9.2 

Is 

the  manufacturing 

of 
9.1 
investigational  medicinal  products  for 
human  use  that  contain  or  consist  of 
GMOs  notified  and/or  authorised 
in  your 
under Directive  2009/41/EC 

9.2  Were  there  any  notifications  and/or 
authorisations 
manufacturing 
for 
investigational medicinal products for human 
use 
that  contain  or  consist  of  GMOs 
submitted  in  your  Member  State  during  the 

9 This includes but is not limited to Advanced Therapy Medicinal Products ("ATMPs"). 

154 

 
 
 
 
 
 
 
 
                                                 
Member State? 
Yes 
AT 
AT 2018  Yes 
Yes 
BE 
BE 2018  Yes 
Yes 
BG 
BG 2018  Yes 
No 
CY 
CY 2018  No 
Yes 
CZ 
CZ 2018  Yes 
Yes 
DE 
DE 2018  Yes 
No 
DK 
DK 2018  No 
No 
EE 
EE 2018  No 
No 
EL 
EL 2018  Yes 
Yes 
ES 
ES 2018  No 
Yes 
FI 
FI 2018  Yes 
Yes 
FR 
FR 2018  Yes 
No 
HR 
HR 2018 
Yes 
HU 
HU 2018  No 
No 
IE 
IE 2018  Yes 
Yes 
IT 
IT 2018 
No 
LT 
LT 2018  No 
Yes 
LU 
LU 2018  No 
No 
LV 
LV 2018  No 
No 
MT 
MT 2018  Yes 
No 
NL 
NL 2018  No 
Yes 
PL 
PL 2018 
Yes 
PT 
PT 2018  Yes 

reporting period? 
No 
No 
Yes 
Yes 
No 
No 

No 
No 
Yes 
Yes 

No 
Yes 

Yes 
No 
Yes 
Yes 

No 

No 
Yes 

No 

No 
No 

No 

Yes 
Yes 

155 

 
 
  
  
  
  
  
  
  
  
  
 
 
  
  
 
 
  
  
  
  
  
  
  
 
 
No 
RO 
RO 2018  Yes 
No 
SE 
SE 2018  No 
No 
SI 
SI 2018  No 
No 
SK 
SK 2018  No 
Yes 
UK 
UK 2018  Yes 

If yes, provide details: 

BELGIUM 2014-2017 
Total  no.  of 
Classification 
notifications* 
contained use 

No 

Yes 
Yes 

Class 1 
Class 2  

Class 3 
Class 4 
Total 

5 
7 
for 
(one 
veterinary use) 

5 
3 
(one 
veterinary use) 

for 

1 
0 
13 

1 
0 
9 

No 
of 
of                                     
authorisations* 

No. 
of 
notifications 
concerning 
ATMPs 
4 
6 
(one 
veterinary 
use) 
0 
0 
10 

for 

No. 
of 
authorisations 
concerning 
ATMPs 
4 
3 
for 
(one 
veterinary use) 

0 
0 
7 

* Report all notifications/authorisations, including those related to ATMPs (and if relevant, specify how 
many notifications/authorisations were for human and veterinary use, e.g: 4, out of which 1 for human and 
veterinary uses; or 4 for human and veterinary uses) 

BELGIUM 2018 
Classification 
contained use 

Total  no.  of 
notifications*  

No 
of 
of                                     
authorisations* 

Class 1 
Class 2  

Class 3 
Class 4 
Total 

5 
5 

0 
0 
10 

5 
for 
(one 
11 
veterinary use) 
1 
0 
17 
This 
concerns 
period 
2014-
December 

table 
the 
June 

No. 
of 
notifications 
concerning 
ATMPs 
5 
10 

No. 
of 
authorisations 
concerning 
ATMPs 
5 
5 

1 
0 
16 

0 
0 
10 

156 

 
 
  
  
  
  
  
  
  
 
 
 
 
 
 
2018 

GERMANY 2014-2017 
Total  no.  of 
Classification 
notifications*  
contained use 

Class 1 
Class 2  
Class 3 
Class 4 
Total 

of 
of                                     
No 
authorisations* 

of 
No. 
notifications 
concerning 
ATMPs 

of 
No. 
authorisations 
concerning 
ATMPs 

GERMANY 2018 
Classification 
contained use 

Total  no.  of 
notifications*  

No 
of 
of                                     
authorisations* 

No. 
of 
notifications 
concerning 
ATMPs 

No. 
of 
authorisations 
concerning 
ATMPs 

Class 1 
Class 2  
Class 3 
Class 4 
Total 

SPAIN 2014-2017 
Classification 
contained use 

Total  no.  of 
notifications*  

No 
of 
of                                     
authorisations* 

No. 
of 
notifications 
concerning 
ATMPs 

No. 
of 
authorisations 
concerning 
ATMPs 

Class 1 
Class 2  
Class 3 
Class 4 
Total 

FINLAND 2014-2017 
Classification 
contained use 

Total  no.  of 
notifications*  

Class 1 

Class 2  
Class 3 
Class 4 
Total 

(all 
7 
human use) 
0 
0 
0 
7 

for 

7 

0 
0 
0 
7 

No 
of 
of                                     
authorisations* 

No. 
of 
notifications 
concerning 
ATMPs 
7 

No. 
of 
authorisations 
concerning 
ATMPs 
7 

0 
0 
0 
7 

0 
0 
0 
7 

157 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FRANCE 2014-2017 
Classification 
contained use 

Total  no.  of 
notifications*  

No 
of 
of                                     
authorisations* 

Class 1 
Class 2  
Class 3 
Class 4 
Total 

néant 
néant 
néant 
néant 
néant 

néant 
néant 
néant 
néant 
néant 

FRANCE 2018 
Classification 
contained use 

Total  no.  of 
notifications*  

of 
No 
of                                     
authorisations* 

2 
3 

2 
3 

Class 1 
Class 2  
Class 3 
Class 4 
Total 

ITALY 2014-2017 
Classification 
contained use 

Total  no.  of 
notifications*  

No 
of 
of                                     
authorisations* 

No. 
of 
notifications 
concerning 
ATMPs 
néant 
néant 
néant 
néant 
néant 

of 
No. 
notifications 
concerning 
ATMPs 
2 
2 

No. 
of 
notifications 
concerning 
ATMPs 
1 
13 
2 
0 
16 

No. 
of 
authorisations 
concerning 
ATMPs 
néant 
néant 
néant 
néant 
néant 

of 
No. 
authorisations 
concerning 
ATMPs 
2 
2 

No. 
of 
authorisations 
concerning 
ATMPs 
0 
10 
1 
0 
11 

Class 1 
Class 2  
Class 3 
Class 4 
Total 

1 
13 
2 
0 
16 

0 
10 
1 
0 
11 

PORTUGAL 2014-2017 
Total  no.  of 
Classification 
notifications*  
contained use 

Class 1 
Class 2  
Class 3 
Class 4 
Total 

PORTUGAL 2018 

No 
of 
of                                     
authorisations* 

No. 
of 
notifications 
concerning 
ATMPs 

No. 
of 
authorisations 
concerning 
ATMPs 

1 

1 

1 

1 

158 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
  
  
 
Classification 
contained use 

Total  no.  of 
notifications*  

of 
No 
of                                     
authorisations* 

of 
No. 
notifications 
concerning 
ATMPs 

of 
No. 
authorisations 
concerning 
ATMPs 

Class 1 
Class 2  
Class 3 
Class 4 
Total 

2 

2 

2 

2 

UNITED KINGDOM 2014-2017 
Total  no.  of 
Classification 
notifications*  
contained use 

No 
of 
of                                     
authorisations* 

to 
this 

Unable 
provide 
information 
(see below) 

to 
Unable 
provide 
this 
information  (see 
below) 

Class 1 

Class 2  
Class 3 
Class 4 
Total 

No. 
of 
notifications 
concerning 
ATMPs 
Unable 
provide 
information 
(see below) 

to 
this 

No. 
of 
authorisations 
concerning 
ATMPs 
Unable 
provide 
information 
(see below) 

to 
this 

No. 
of 
authorisations 
concerning 
ATMPs 

UNITED KINGDOM 2018 
No 
of 
of                                     
Classification 
authorisations* 
contained use 

Total  no.  of 
notifications*  

No. 
of 
notifications 
concerning 
ATMPs 

Class 1 
Class 2  
Class 3 
Class 4 
Total 

9.3  What challenges, if any, did you as a CA encounter in implementing the Directive in 
relation to the manufacturing of investigational medicinal products for human use that 
contain or consist of GMOs (e.g. notification, risk assessment, authorisation, control, 
etc.)? 

9.4  What in your opinion should be done or is done already to address these challenges? 

in 

implementing 

9.3  What  challenges,  if  any,  did  you  as  a 
CA  encounter 
the 
Directive in relation to the manufacturing 
of  investigational  medicinal  products  for 
human  use  that  contain  or  consist  of 
GMOs  (e.g.  notification,  risk  assessment, 
authorisation, control, etc.)? 

9.4  What  in  your  opinion  should  be  done 
or 
is  done  already  to  address  these 
challenges? 

159 

 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
AT 
AT 
2018 
BE 

BE  
2018 

none 
none 

not applicable 
not applicable 

the 

manufacturing 

of 
Sometimes, 
investigational medicinal products (IMP) has 
been made in another country. The applicant 
describes the manufacturing of IMP but does 
not  provide  sufficient  details  (for  example: 
lentiviral  vectors, 
cells 
transduced  with 
information  concerning 
the  absence  of 
residual  free  functional  LV  in  the  final 
product  is  often  not  sufficiently  detailed).  If 
the manufacturing of IMP is made in another 
country,  to  what  extent  do  we  verify  all  the 
data?  

In  Wallonia,  some  dossiers  have  been 
notified  under  contained  use  but  not 
the  competent  authority 
authorized  by 
because  the  applicant  does  not  introduce  his 
application for an environmental permit. 

the 

manufacturing 

of 
Sometimes, 
investigational medicinal products (IMP) has 
been made in another country. The applicant 
describes the manufacturing of IMP but does 
not  provide  sufficient  details  (for  example: 
lentiviral  vectors, 
cells 
transduced  with 
information  concerning 
the  absence  of 
residual  free  functional  LV  in  the  final 
product  is  often  not  sufficiently  detailed).  If 
the manufacturing of IMP is made in another 
country,  to  what  extent  do  we  verify  all  the 
data?  

In  Wallonia,  some  dossiers  have  been 
notified  under  contained  use  but  not 
authorized  by 
the  competent  authority 
because  the  applicant  does  not  introduce  his 
application for an environmental permit. 

no 

has 

experience  with 
manufacturing  of  investigational  medicinal 
products  for  human  use  that  contain  or 
consist  of  GMOs.  Only  applications  for 
clinical 
products 
manufactured elsewhere have been received.  
experience  with 
Bulgaria 
manufacturing  of  investigational  medicinal 
products  for  human  use  that  contain  or 

trials  with 

such 

has 

no 

to  be  aware 
authorities 

that 
The  applicants  need 
different 
should 
competent 
evaluate  the  same  data  and  they  should 
provide  all  the  information  concerning  the 
manufacturing  of  IMP  in  their  application 
dossier.    It  could  be  interesting  to  create  a 
network  of  experts  evaluating  the  different 
aspects  of  the  medicinal  products  (safety, 
share 
biosafety,  quality) 
information. 

in  order 

to 

In Wallonia, in our advices, we remind to the 
applicant 
is  not  an 
authorization and that he should introduce an 
application for an environmental permit. 

that  our  advice 

to  be  aware 
authorities 

that 
The  applicants  need 
different 
should 
competent 
evaluate  the  same  data  and  they  should 
provide  all  the  information  concerning  the 
manufacturing  of  IMP  in  their  application 
dossier.    It  could  be  interesting  to  create  a 
network  of  experts  evaluating  the  different 
aspects  of  the  medicinal  products  (safety, 
biosafety,  quality) 
share 
information. 

in  order 

to 

In Wallonia, in our advices, we remind to the 
applicant 
is  not  an 
authorization and that he should introduce an 
application for an environmental permit. 

that  our  advice 

No  specific  opinion,  see  reply  to  Question 
10. 

No  specific  opinion,  see  reply  to  Question 
10. 

160 

BG  Bulgaria 

BG  
2018 

 
 
 
 
 
 
consist  of  GMOs.  Only  applications  for 
clinical 
products 
manufactured elsewhere have been received. 

trials  with 

such 

CY  Not Applicable. 
None  no  investigation  of  GMOs  for  human 
CY  
use in Cyprus. 
2018 
CZ  Not applicable 
not applicable 
CZ 
2018 
DE 

In Germany, the manufacturing of an ATMP 
requires  further  authorization  by  the  CA 
responsible  for  good  clinical  practices.  In 
relation to the implementation of 2009/41/EC 
(GenTG)  there  is  no  destinction  between 
GMO status and ATMP status. Evaluation of 
numbers  of  manufactured  ATMPs  is  not 
database. 
possible 

with 

our 

DE 
2018 

to 

the  distinction  between 
With  regard 
genetic engineering activities in containment 
and  approvement  of  clinical 
trials  with 
GMOs,  an  administrative  agreement  was 
reached in March 2015 between the relevant 
federal and competent authorities. 

comment  (no  challenge):  In  Germany,  the 
manufacturing  of  an  ATMP  requires  further 
authorization by the CA responsible for good 
clinical  practices. 
the 
In 
implementation  of  2009/41/EC  (GenTG) 
there  is  no  destinction  between  GMO  status 
and ATMP  status.  Evaluation of numbers of 
manufactured  ATMPs  is  not  possible  with 
our database. 

relation 

to 

Not Applicable. 
N.R. 

Not applicable 
not applicable 

- 

- 

N/A 
N/A 

DK  N/A 
N/A 
DK 
2018 
EE 
EE 
2018 
EL  Not applicable 
None 
EL 
2018 
ES 

This question has been addressed in previous 
section 
in  procedures  between  MS 
Differences 
(Some  MS  have  considered  these  activities 
as  contained  use  and  other  MS  as  deliberate 

ES 
2018 

Labour Inspectorate don't deal with this area  Labour Inspectorate don't deal with this area 
N/A 

There is not such kind of premises 

Not applicable 
N/A 

This question has been addressed in previous 
section 
Harmonise procedures between MS.  

161 

 
 
 
release).  
1)  Notifying  multisite 

FI 

trials; 

and  

2) the concept of "notifier" (whether it is the 
company  developing  the  product,  the  CRO, 
or  the  hospital/vaccination  clinic  where  the 
and 
ATMP 

administrated); 

is 

3) who should be the individual appointed as 
the responsible person? (We have tried to be 
flexible  on  points  1,  2  and  3.);  and 

of 

Interplay 
use,  GMP, 
contained 
occupational  safety,  and  ABS  regulations 
to  avoid 
should  be  clarified 
unnecessary 
the 
regulatory  burden 
operators and authorities involved. 

so  as 

for 

4)  supervision  of  ATMP  manufacturing 
according  to  GMO  legislation  is  somewhat  
overlapping  with  GMP  supervision  and  (in 
certain  cases)  also  with  occupational  safety 
supervision  (protection  of  workers  from 
exposure to biological agents).  
No special challenges, when it is question of 
traditional gene modification techniques. 
néant 
- 

not applicable 

FI 
2018 
FR 
FR 
2018 
HR 
HR 
2018 
HU  None. 
HU 
2018  
IE 

No challenges were encountered. 

The CA has not received any applications of 
this  type.  Investigational  medicinal  product 
is  defined  as  "A  pharmaceutical  form  of  an 
active  substance  or  placebo  being  tested  or 
used  as  a  reference  in  a  clinical  trial, 
including  a  product  with  a  marketing 
authorisation  when  used  or  assembled 
(formulated  or  packaged)  in  a  way  different 
from  the  authorised  form,  or  when  used  for 
an  unauthorised  indication,  or  when  used  to 
gain further information about the authorised 
form". 
n/a 

for 

The  holder  of  a  premise  and  the  user 
the  manufacturing  of 
responsible 
investigational  medicinal  products 
that 
contain  or  consist  of  GMOs  are  required  to 
provide 
of 
considerable 
information  to  GMM  CA;  part  of  these 

number 

a 

IE 
2018 
IT 

- 

néant 
- 

/ 

Not relevant. 
- 

Not applicable 

n/a 

requested 

Information 
a 
notification may be improved and simplified. 
It  is  desirable that the requested information 
by  every  European  CA  can  be  harmonized. 

submit 

to 

A better cooperation with the other National 

162 

 
 
 
 
 
 
 
 
information could be not held and they have 
to  be  provided  by  the  clinical  trial  sponsor. 
Sponsor,  holder  and  user  could  encounter 
difficulties  to  cooperate  in  order  to  prepare 
the  CA, 
the  notification 
especially  in  case  of  multicenter  clinical 
trials. 

to  submit 

to 

The  management  of  the  controls  to  GMM 
premises  and  activities  should  take  also  into 
consideration  that  the  same  premises  and 
activities  are  inspected  for  several  crosswise 
CAs. 
aspects 

different 

by 

for 

i) 
for 
ii)  for 

Examples  of  involved  CAs  in  proceedings 
Italian  National  Labor 
controls  are: 
the  protection  of 
Inspectorate 
the 
workers; 
the  Italian 
the  GMP: 
Medicines  Agency  and  Directorate  General 
for Animal Health and Veterinary Medicines 
on 
of  MoH 
medicines/IMP/ATMPs 
for 
human  and  veterinary  use;  iii)  for  controls 
related  to  the  protection  of  animals  used  for 
scientific  purposes:  Local  Health  Authority 
(at  regional  level)  and  Directorate  General 
for Animal Health and Veterinary Medicines 
of MoH; iv) CAs involved in  the  control on 
waste management. 

controls 
respectively 

the 

- 
- 

IT 
2018 
LT 
LT 
2018 
LU  Directive not yet transposed 
Directive not yet transposed 
LU 
2018 
LV  No experience. 
LV 
2018 
MT  Not applicable. 
MT 
2018 
NL 
NL 
2018  
PL 

risk assessment 

-- 
-- 

N/A 

- 

Competent  Authorities  would  allow  to  get 
more  data  and  to  improve  the  monitoring 
system, most of all it would be important  to 
reach an harmonization among the European 
CAs. 

- 
- 

Transposition of the directive is ongoing 
Transposition of the directive is ongoing 

No experience. 
- 

Not applicable. 
N/A 

-- 
-- 

sharing  procedures  across  Member  States 
(for example ERA, notification, etc.) 

163 

 
 
 
 
  
  
PL 
2018 
PT 

PT 
2018 

The  CA  didn’t  encounter  any  challenges  in 
implementing the Directive in relation to this 
subject.            
The  CA  didn’t  encounter  any  challenges  in 
implementing the Directive in relation to this 
subject.             
RO  Not applicable.  
Not applicable 
RO 
2018 
SE  All  GMO  that  are  medicinal  products  are 
handled 
release.  Only 
preparations  and  sample  analysis  may  be 
notified  as  any  other  contained  use  of 
GMMs. A challenge is that applicants can be 
confused what part is contained use and what 
part is not. But MPA and SWEA cooperates 
in  order  to  make  the  process  for  applicants 
smooth. 
- 

deliberate 

as 

No challenges were encountered 
No experience 

SE 
2018 
SI 
SI 
2018 
SK 
SK 
2018  
UK  Unfortunately  we  cannot  provide 

---- 
 --- 

been 

have 

this 
information as it is not specifically recorded.  
There 
broad 
definitely 
notifications  covering  the  manufacturing  of 
vectors  for  use  as  IMPs  (e.g.  lentiviral 
vectors)  but  sometimes  these  notifications 
could cover a range of cargo genes and is not 
necessarily  exhaustive.  We  would  estimate 
the  number  of  notifications  in  the  reporting 
period to  be between 5-10 class 2.  There is 
no  notification  requirement  for  class  1 
activities. 
We are not aware of any. Only if the activity 
of  manufacturing  the  IMP  was  a  class  2  (or 
higher)  activity  would  notification  be 
received.    Often  this  would  be  a  class  1 
activity  so  no  activity  notification  would  be 
required.  Unfortunately  we  cannot  provide 
this  information  as  it  is  not  specifically 
recorded. 

UK 
2018 

The  CA  didn’t  encounter  any  challenges  in 
implementing the Directive in relation to this 
subject. 
Not applicable. 

Not applicable.  
Not applicable 

future 

actions 

be 
Possible 
implementation of ERA for inspectors of the 
GMP 
practice) 
qualification.  

(good  manufacturing 

can 

- 

- 
- 

----- 
 --- 

Not applicable 

N/A 

164 

 
 
  
  
 
b. Administration (clinical trials) 

10.1 

Is  the  administration  of  investigational  medicinal  products  for  human  use  that 
contain or consist of GMOs notified and/or authorised under Directive 2009/41/EC in 
your Member State? 

10.2  Were  there  activities  described  in  10.1  notified  and/or  authorised  in  your  Member 

State during the reporting period?  

10.1  Human  use  -  Administration 
(clinical  trials)  Is  the administration 
of  investigational  medicinal  products 
for human use that contain or consist 
of  GMOs  notified  and/or  authorised 
under Directive  2009/41/EC  in  your 
Member State? 
Yes 
AT 
AT 2018  Yes 
Yes 
BE 
BE 2018 
Yes 
No 
BG 
BG 2018  No 
No 
CY 
CY 2018  No 
No 
CZ 
CZ 2018  No 
No 
DE 
DE 2018  No 
Yes 
DK 
DK 2018  Yes 
No 
EE 
EE 2018 
EL 
EL 2018 
ES 
ES 2018 
FI 
FI 2018 
FR 
FR 2018 
HR 
HR 2018 
No 
HU 
HU 2018  No 

No 
Yes 

No 
Yes 

Yes 
No 

Yes 
Yes 

No 
No 

10.2 Were there such activities notified 
and/or  authorised in  your  Member 
State during the reporting period? 

Yes 

Yes 
Yes 

Yes 

Yes 

Yes 

No 

Yes 

Yes 
Yes 

Yes 

165 

 
 
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
No 

No 

No 
Yes 

IE 
IE 2018 
IT 
IT 2018 
LT 
LT 2018 
No 
Yes 
LU 
LU 2018  Yes 
No 
LV 
LV 2018  No 
No 
MT 
MT 2018  Yes 
No 
NL 
NL 2018  No 
Yes 
PL 
PL 2018 
PT 
PT 2018 
Yes 
No 
RO 
RO 2018  No 
No 
SE 
SE 2018 
SI 
SI 2018 
No 
No 
SK 
No 
SK 2018 
Yes 
UK 
UK 2018  Yes 

No 
No 

Yes 

If yes, provide details: 

AUSTRIA 2014-2017 
Classification 
contained use 

Total  No.  of 
notifications*  

Yes 

No 

No 

No 

No 

No 

No 

No 

Yes 

Yes 

Class 1 
Class 2  
Class 3 
Class 4 
Total 
* Report all notifications/authorisations, including those related to ATMPs 

1 
3 
-- 
-- 
4 

of                                     

Total  No.  of 
authorisations*  

of 

No 
notifications 
concerning 
ATMPs 
1 
3 
-- 
-- 
4 

of 
No 
authorisations 
concerning 
ATMPs 

166 

 
 
  
  
 
 
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
 
 
 
 
 
  
  
  
  
  
  
  
  
  
  
AUSTRIA 2018 
Classification 
contained use 

Total  No.  of 
notifications* 

of                                     

Total  No.  of 
authorisations*  

of 

Class 1 
Class 2  
Class 3 
Class 4 
Total 

3 
1 
-- 
-- 
4 

-- 
-- 
-- 
-- 
-- 

BELGIUM 2014-2017 
Classification 
contained use 

Total  No.  of 
notifications*  

of                                     

Total  No.  of 
authorisations*  

of 

Class 1 
Class 2  
Class 3 
Class 4 
Total 

22 
1 
0 
0 
23 

22 
1 
0 
0 
23 

BELGIUM 2018 
Classification 
contained use 

Total  No.  of 
notifications*  

of                                     

Total  No.  of 
authorisations*  

of 

Class 1 
Class 2  
Class 3 
Class 4 
Total 

43 
0 
0 
0 
43 

43 
0 
0 
0 
43 

DENMARK 2014-2017 
Classification 
contained use 

Total  No.  of 
notifications*  

of                                     

Total  No.  of 
authorisations*  

of 

No 
notifications 
concerning 
ATMPs 
3 
1 
-- 
-- 
4 

No 
notifications 
concerning 
ATMPs 
20 
1 
0 
0 
21 

No 
notifications 
concerning 
ATMPs 
43 
0 
0 
0 
43 

No 
notifications 
concerning 
ATMPs 
4 
0 
0 
0 
4 

No 
of 
authorisations 
concerning 
ATMPs 
-- 
-- 
-- 
-- 
-- 

of 
No 
authorisations 
concerning 
ATMPs 
20 
1 
0 
0 
21 

No 
of 
authorisations 
concerning 
ATMPs 
43 
0 
0 
0 
43 

No 
of 
authorisations 
concerning 
ATMPs 
4 
0 
0 
0 
4 

167 

Class 1 
Class 2  
Class 3 
Class 4 
Total 

4 
0 
0 
0 
4 

DENMARK 2018 

4 
0 
0 
0 
4 

 
 
 
 
 
 
 
Classification 
contained use 

Total  No.  of 
notifications*  

of                                     

Total  No.  of 
authorisations*  

of 

FINLAND 2014-2017 
Classification 
contained use 

Total  No.  of 
notifications*  

of                                     

Total  No.  of 
authorisations*  

of 

FINLAND 2018 
Classification 
contained use 

Total  No.  of 
notifications*  

of                                     

Total  No.  of 
authorisations*  

of 

Class 1 
Class 2  
Class 3 
Class 4 
Total 

8 
0 
0 
0 
8 

8 
0 
0 
0 
8 

Class 1 
Class 2  
Class 3 
Class 4 
Total 

7 
0 
0 
0 
7 

7 
0 
0 
0 
7 

Class 1 
Class 2  
Class 3 
Class 4 
Total 

6 
0 
0 
0 
6 

6 
0 
0 
0 
6 

FRANCE 2014-2017 
Classification 
contained use 

Total  No.  of 
notifications*  

of                                     

Total  No.  of 
authorisations* 

of 

Class 1 
Class 2  
Class 3 
Class 4 
Total 

néant 
néant 
néant 
néant 
néant 

néant 
néant 
néant 
néant 
néant 

FRANCE 2018 
Classification 
contained use 

Total  No.  of 
notifications*  

of                                     

Total  No.  of 
authorisations*  

No 
notifications 

of 

No 
notifications 
concerning 
ATMPs 
0 
0 
0 
0 
0 

No 
notifications 
concerning 
ATMPs 
7 
0 
0 
0 
7 

No 
notifications 
concerning 
ATMPs 
6 
0 
0 
0 
6 

No 
notifications 
concerning 
ATMPs 
néant 
néant 
néant 
néant 
néant 

of 
No 
authorisations 
concerning 
ATMPs 
0 
0 
0 
0 
0 

No 
of 
authorisations 
concerning 
ATMPs 
7 
0 
0 
0 
7 

No 
of 
authorisations 
concerning 
ATMPs 
6 
0 
0 
0 
6 

of 
No 
authorisations 
concerning 
ATMPs 
néant 
néant 
néant 
néant 
néant 

No 
of 
authorisations 

168 

 
 
 
 
 
 
concerning 
ATMPs 

concerning 
ATMPs 

No 
notifications 
concerning 
ATMPs 
7 
53 
0 
0 
60 

No 
notifications 
concerning 
ATMPs 
Unable 
provide 
information 
(see below) 

to 
this 

No 
of 
authorisations 
concerning 
ATMPs 
4 
47 
0 
0 
51 

of 
No 
authorisations 
concerning 
ATMPs 
Unable 
provide 
information 
(see below) 

to 
this 

No 
of 
authorisations 
concerning 
ATMPs 

Class 1 
Class 2  
Class 3 
Class 4 
Total 

ITALY 2014-2017 
Classification 
contained use 

Total  No.  of 
notifications*  

Class 1 
Class 2  
Class 3 
Class 4 
Total 

7 
53 
0 
0 
60 

4 
47 
0 
0 
51 

of                                     

Total  No.  of 
authorisations*  

of 

UNITED KINGDOM 2014-2017 
Classification 
contained use 

Total  No.  of 
notifications*  

Total  No.  of 
authorisations7* 

of                                     

of 

to 
this 

Unable 
provide 
information 
(see below) 

to 
Unable 
provide 
this 
information  (see 
below) 

Class 1 

Class 2  
Class 3 
Class 4 
Total 

UNITED KINGDOM 2018 
Classification 
contained use 

Total  No.  of 
notifications*  

of                                     

Total  No.  of 
authorisations*  

of 

No 
notifications 
concerning 
ATMPs 

Class 1 
Class 2  
Class 3 
Class 4 
Total 

10.3  What challenges, if any, did you as a CA encounter in implementing the Directive in 
relation to the administration of investigational medicinal products for human use that 

169 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
contain or consist of GMOs (e.g. notification, risk assessment, authorisation, control, 
etc.)? 

10.4  What in your opinion should be done or is done already to address these challenges? 

AT 

AT 
2018 
BE 

in 

relation 

10.3 What challenges, if any, did you as 
a  CA  encounter  in  implementing  the 
to 
Directive 
the administration  of 
investigational 
medicinal  products  for  human  use  that 
contain  or  consist  of  GMOs 
(e.g. 
assessment, 
notification, 
authorisation, control, etc.)? 
not  applicable,  due  to  specific  regulations 
in Austria 
none 

risk 

on 

Belgium, 

depending 

In 
the 
characteristics  and mode of administration 
of the medicinal product, it is possible that 
the  GMO  aspects  of  clinical  trials  with 
medicinal  products 
for  human  use 
containing  or  consisting  of  GMOs  do  not 
require 
the 
deliberate  release  frameworks  (Directive 
2001/18/EC 

authorisation  under 

Part 

an 

– 

B).   

10.4 What in your opinion should be 
done  or  is  done  already  to  address 
these challenges? 

not applicable 

not applicable 

If the framework to be followed is not 
clear  to  the  applicant,  it  is  strongly 
advised to request a national scientific-
technical  advice 
the 
Federal  Agency  for  Medicines  and 
Health Products (FAMHP) prior to the 
submission  of 
trial 
the 
application.   

clinical 

(STA) 

from 

When  there  is  no  possible  release  of  the 
GMO in the environment that may confer a 
risk  to  human  health  or  the  environment 
(e.g.  in  case  of  GM  medication  taken  at 
home,  no  risk  of  shedding,  spreading,…), 
or if proper management procedures and/or 
working practices are taken to prevent any 
possible  release  conferring  a  risk,  then  a 
‘contained use’ procedure will generally be 
sufficient. 

However,  if  there  is  a  probability  of 
possible  release  that  may  confer  a  risk  to 
human  health  or  the  environment  which 
cannot  be  avoided  by  proper  management 
procedures  or  working  practices, 
a 
notification  under  ‘deliberate  release’  is 
also  required.  The  applicant  does  not 
always  know  what  procedure  should  be 
applied (“contained use only” or deliberate 
release and contained use). 

170 

 
 
 
 
  
 
 
BE  
2018 

BG 

on 

Belgium, 

depending 

the 
In 
characteristics  and mode of administration 
of the medicinal product, it is possible that 
the  GMO  aspects  of  clinical  trials  with 
for  human  use 
medicinal  products 
containing  or  consisting  of  GMOs  do  not 
require 
the 
deliberate  release  frameworks  (Directive 
2001/18/EC 

authorisation  under 

Part 

an 

– 

B).   

When  there  is  no  possible  release  of  the 
GMO in the environment that may confer a 
risk  to  human  health  or  the  environment 
(e.g.  in  case  of  GM  medication  taken  at 
home,  no  risk  of  shedding,  spreading,…), 
or if proper management procedures and/or 
working practices are taken to prevent any 
possible  release  conferring  a  risk,  then  a 
‘contained use’ procedure will generally be 
sufficient. 

However,  if  there  is  a  probability  of 
possible  release  that  may  confer  a  risk  to 
human  health  or  the  environment  which 
cannot  be  avoided  by  proper  management 
a 
procedures  or  working  practices, 
notification  under  ‘deliberate  release’  is 
also  required.  The  applicant  does  not 
always  know  what  procedure  should  be 
applied (“contained use only” or deliberate 
release and contained use). 

Administration 
investigational 
of 
medicinal  products  for  human  use  that 
contain  or  consist  of  GMOs  is  notified 
under  Directive  2001/18/EC  as 
is 
considered  to  involve  release  into  the 
environment.  

it 

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

release 

into 

If the framework to be followed is not 
clear  to  the  applicant,  it  is  strongly 
advised to request a national scientific-
technical  advice 
the 
Federal  Agency  for  Medicines  and 
Health Products (FAMHP) prior to the 
submission  of 
trial 
the 
application.   

clinical 

(STA) 

from 

The  SBB  in  collaboration  with  the 
Belgian  federal  agency  for  medicines 
are  preparing  a  document  “guideline” 
aiming 
in 
determining  the  regulatory  procedures 
they must follow 

applicants 

help 

to 

We  expect  that  the  current  process  on 
the interplay between EU medicine and 
GMO  legislation  will  clarify  most  of 
the 
identified  and  common 
approaches  will  be  adopted  by  the  EU 
member  states  regarding  clinical  trials 
of GMO medicinal products. 

issues 

It  is  not  entirely  clear  to  us  how  the 
provisions  of  the  Directive  2009/41/EC 
should  be  applied  when  GMM 
is 
administered  in  hospital  during  clinical 

171 

 
 
 
 
 
 
 
trial  but  the  patients  are  not  kept  under 
contained conditions for the duration of the 
trial. 

is 

required 

In application for clinical trials in Bulgaria, 
the  applicant 
to  provide 
information  on  the  containment  measures 
(which  should  be 
for  each  hospital 
registered  as  such  under  the  Bulgarian 
legislation)  where  the  medicinal  product 
will  be  administered.  That  information  is 
not  considered  formal  notification.  All 
applications examined so far involved only 
Class 1 activities. 
investigational 
of 
Administration 
medicinal  products  for  human  use  that 
contain  or  consist  of  GMOs  is  notified 
under  Directive  2001/18/EC  as 
is 
considered  to  involve  release  into  the 
environment. 

it 

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

release 

into 

It  is  not  entirely  clear  to  us  how  the 
provisions  of  the  Directive  2009/41/EC 
should  be  applied  when  GMM 
is 
administered  in  hospital  during  clinical 
trial  but  the  patients  are  not  kept  under 
contained conditions for the duration of the 
trial. 

is 

required 

In application for clinical trials in Bulgaria, 
the  applicant 
to  provide 
information  on  the  containment  measures 
for  each  hospital 
(which  should  be 
registered  as  such  under  the  Bulgarian 
legislation)  where  the  medicinal  product 
will  be  administered.  That  information  is 
not  considered  formal  notification.  All 
applications examined so far involved only 
Class 1 activities. 
Not Applicable. 
No  investigation  of  GMOs  for  human  use 
in Cyprus. 
Not applicable 

BG 
2018 

CY 
CY 
2018 
CZ 

We hope that the current process on the 
interplay  between  EU  medicine  and 
GMO legislation will continue and will 
further  clarify  most  of 
issues 
identified and common approaches will 
be  adopted  by  the  EU  member  states 
regarding  clinical 
trials  of  GMO 
medicinal products. 

the 

Not Applicable. 
N.R. 

Not applicable 

172 

 
 
 
 
 
 
CZ 
2018 
DE 

DE 
2018 
DK 
DK 
2018 
EE 

EE 
2018 
EL 

EL 
2018 
ES 

ES 
2018  

FI 

FI 
2018 

not applicable 

not applicable 

- 

- 

None 
None 

engineering 
and 

With  regard  to  the  distinction  between 
genetic 
in 
activities 
approvement  of 
containment 
clinical 
an 
administrative  agreement  was  reached 
in  March  2015  between  the  relevant 
federal and competent authorities. 
- 

trials  with  GMOs, 

N/A 
N/A 

Labour  Inspectorate  don't  deal  with  this 
area 
There is not such kind of premises 

Labour Inspectorate don't deal with this 
area 
N/A 

No activities reported. 

N/A 

CLINICAL  TRIALS  WITH  GMOs  ARE 
AUTHORISED  UNDER  DIRECTIVE 
2001/18/EC  
Differences  in  procedures  between  MS 
(Some MS have considered these activities 
as  contained  use  and  other  MS  as 
deliberate release). 
1)  Decision  whether  the  clinical  trial  is 
contained  use  or  deliberate  release;  and 

2)  classification  of 

the  GMM;  and  

interplay  of  various 

regulations 
3) 
concerning  GMOs, 
pharmaceuticals, 
occupational  safety,  waste  treatment,  and 
patient rights. 

1)  Decision  whether  the  clinical  trial  is 
contained  use  or  deliberate  release;  this  is 
easier  when  the  medicinal  product  has 
the 
already  a  marketing  approval  as 
issues  have  been  examided 
shedding 
the 
during 

approval 

proecess.   

No  activities  reported,  therefore  no 
associated challenges. 
N/A 

CLINICAL  TRIALS  WITH  GMOs 
ARE 
UNDER 
AUTHORISED 
DIRECTIVE 2001/18/EC  
Harmonise procedures between MS.  

the 

clarifies 

interplay 

this  hopefully 

Commission  working  group  is  already 
considering 
of 
pharmaceutical  and  GMO  legislation, 
the 
and 
situation.However,  it  is  likely  not  to 
solve  all  the  issues.  It  would  be  worth 
examining  whether  GMO  medicinal 
product  production  and  clinical  trials 
should be legally separated from GMO 
directives.  Also,  the  linkages  between 
occupational  safety,  patient  rights  and 
waste treatment  issues  outside hospital 
environment  (e.g. in  homecare) should 
be considered. 
Commission  working  group  is  already 
considering 
of 
pharmaceutical  and  GMO  legislation, 
the 
and 
situation.  However,  it  is  likely  not  to 
solve  all  the  issues.  It  would  be  worth 

this  hopefully 

interplay 

clarifies 

the 

173 

 
 
 
 
FR 
FR 
2018 

HR 
HR 
2018 
HU 

HU 
2018 
IE 
IE 
2018 
IT 

examining  whether  GMO  medicinal 
product  production  and  clinical  trials 
should be legally separated from GMO 
directives.  Also,  the  linkages  between 
occupational  safety,  patient  rights  and 
waste treatment  issues  outside hospital 
environment  (e.g. in  homecare) should 
be considered. 
néant 
Le  périmètre  d'application  de 
la 
Directive  pour  les  essais  cliniques  sur 
des  personnes  humaines    pourrait  être 
clarifié 
/ 

No relevance. 

2)  classification  of 

the  GMM;  and 

interplay  of  various 

3) 
concerning  GMOs, 
occupational 

safety,  waste 

regulations 
pharmaceuticals, 
treatment, 

and patient rights. 
néant 
Difficulté  à  apprécier  l'utilisation  confinée 
et disséminée dans le cas d'essais cliniques 
sur des personnes humaines 

not applicable 

the  deliberate 

In  Hungary  the  requirements  for  GMO 
submission  in  clinical  trials  could  be 
release 
accepted  under 
directive  2001/18/EC  of  the  European 
Parliament and of the Council of 12 March 
2001  on  the  deliberate  release  into  the 
environment  of  genetically  modified 
organisms and repealing Council Directive 
90/220/EC. 

No.  of  authorisation  of  investigational 
medicinal  products  for  human  use  that 
contain  or  consist  of  GMOs  under 
deliberate  release  directive  2001/18/EC 
last 3 years: 3 clinical trials. 
No challenges were encountered. 

- 

Not applicable 
n/a 

Not applicable 
n/a 

1: 

for 

difficulties 

Challenge 
the 
stakeholders.  They  are  due  to  different 
interpretations  of  the  definitions  given  in 
Directive  2009/41/EC  and  in  Directive 
2001/18/EC (e.g. GMM vs. GMO in which 
the last includes also the first or to interpret 
the  means  of  “deliberate  release”  in  a 
context of “contained use”) and to different 
approaches  used  throughout  Europe  to 
assess 
the  humans  and 
environment. 

the  risk  for 

Harmonization of the different point of 
views  of  the  different  Countries  at 
European  level  should  be  the  primary 
aim.  The  work  and  the  documents, 
produced  by  Commission  Services, 
focused 
interplay 
between  the  GMO,  GMM  and  the 
medicinal  products  legislation,  are  to 
consider  as  very  useful  approaches  for 
the Italian GMM CA and the involved 
stakeholders. 

to  optimize 

the 

The  different 

interpretations 

lead  EU 

Challenge 1: could be faced and settled 

174 

 
 
 
 
 
  
  
 
 
 
amending  the  Directive  2009/41/EC 
and Directive 2001/18/EC  with  ad hoc 
provisions  focused  on  clinical  trials  in 
administered. 
are 
which 

IMPs 

Challenge  2  and  3:  provide  the  user  a 
clear  information,  previously  shared 
with  the  involved  National  CAs,  to  be 
published on the CAs institutional web 
sites. 

simplify 

With  regard  to  the  challenge  3,  an 
additional  analysis  shared  at  European 
level  could 
the 
further 
approaches followed by involved CAs, 
users and sponsors. The scope is also to 
keep  the  European  Commission  and 
Member States informed about the type 
of  Clinical  Trials  authorized  under  the 
Directive  2009/41/EC  and  to  publish 
the 
the 
relevant 
site. 
Commission 

information  on 
web 

level 

Challenge  4  and  5:  could  be  dealt 
importing 
the 
at  national 
approach  reported  in  the  mentioned 
documents  produced  by  Commission 
service  or  producing  harmonized 
documents 
the  European 
Member States. 

among 

follow  different 
to 
Member  States 
procedures  and  users/sponsors  to  comply 
to  different  rules  in  order  to  get  the  same 
type  of 
in  different 
Countries. 

authorizations 

Challenge  2:  difficulties  for  the  user  and 
the sponsor related to different approaches 
Countries. 
among 

EU 

the 

trial 

is  carried  out,  and 

Though  the  Directive  2009/41/EC  lays 
down common measures for the contained 
use of GMMs, the installations, in which a 
clinical 
the 
contained  activities,  by  which  the  IMPs 
containing  or  consisting  of  GMMs,  are 
administered,  can  be  subject,  in  several 
European  Countries, 
to  authorizations 
issued according to  Directive 2001/18/EC. 

authorization 

The  above  mentioned  not  harmonized 
approach  could  entail  that  a  deliberate 
issued 
release 
notwithstanding  the  user  risk  assessment 
reports and proves a priori that there is no 
deliberate  release  in  the  environment  of 
GMMs. 

is 

the 

Challenge  3:  to  avoid  misunderstandings 
involved  stakeholders  and 
among 
GMM  CA  whether  an  application,  for  a 
clinical trial in which an IMP consisting of 
GMM is used, has to be or not submitted to 
get  an  authorization  to  deliberate  release 
according  to  the  Part  B  of  the  Directive 
2001/18/EC). 

that  were 

Part of these cases can be found among the 
clinical studies listed on the website of the 
Joint 
Center 
Research 
(http://gmoinfo.jrc.ec.europa.eu/gmo_brow
se.aspx) 
in 
compliance  with  the  article  6  of  the 
Directive  2001/18/EC,  assuming  and 
giving 
intentional 
deliberate 
release  of  GMM  occurs 
although this in conclusion is not or would 
not be confirmed. 

submitted, 

that  an 

sure 

for 

Challenge  4:  find  a  simplified  approach, 

175 

 
 
 
 
 
 
 
 
 
 
 
where possible, according to the Directives 
provisions. 

to  apply  on 

Without  prejudice  to  the  right  of  each 
their 
European  Country 
territory  the  legislation  that  is  considered 
more  appropriate,  it  is  presumable  that  an 
harmonized  approach  could  result  more 
adequate in  terms  of human resources and 
time  spent  by  the  CAs  to  assess  the 
notification  and  by  the  premises  holder, 
the 
user 
notification. 

to  prepare 

sponsor 

and 

Challenge 5: to establish the relevant cases 
for  which  a 
risk  assessment  by  a 
notification has to be submitted or not if a 
medicine  used  in  the  clinical  trial  has 
obtained  the  marketing  authorization  by 
procedure. 
EMA 

centralized 

In  these  cases,  the  risks  to  consider  could 
be  different  for  a  new  clinical  trial  if 
compared  to  those  assessed  in  order  to 
obtain  the  marketing  authorization.  This 
last aspect need to be assessed on a case by 
case basis by the Italian GMM CA and it is 
also for this reason that in Italy, to conduct 
a  clinical  trial  for  which  a  deliberate 
release  can  be  excluded,  the  GMM  CA 
issues  the  authorizations  for  the  premise 
and 
activity 
performed in it. 

the  GMM 

contained 

IT 
2018 
LT 
LT 
2018 
LU 

LU 
2018 
LV 
LV 
2018 
MT 
MT 
2018 
NL 

- 
- 

Directive not yet transposed 

Directive not yet transposed 

- 
- 

Not applicable. 
N/A 

-- 

- 
- 

Transposition  of 
ongoing 
Transposition  of 
ongoing 
- 
- 

Not applicable. 
N/A 

-- 

the  directive 

is 

the  directive 

is 

176 

 
 
 
 
 
  
  
NL 
2018 
PL 

PL 
2018 
PT 

PT 
2018 

-- 

risk assessment 

into 

release 

The legal framework of the GMOs clinical 
trial  –  deliberate 
the 
environment of GMOs or contained use of 
GMOs - is defined on a case-by-case basis 
taking  into  account  the  specificity  of  the 
GMO  clinical  trial.  Therefore  the  clinical 
trials  don´t  fall  exclusively  whitin  the 
scope  of  Directive  2009/41/EC  or 
2001/18/EC. 
Directive 

There  were  no  activities  notified  and/or 
authorised  regarding  clinical  trials  using 
medicinal  products  for  human  use  that 
contain  or  consisit  of  GMOs  under  
Directive  2009/41/EC  -  contained  use  of 
GMOs. 

However  under  Directive  2001/18/EC 
there  were  submitted  and  authorised  three 
notifications in  2016 for deliberate release 
into  the  environment  with  GMOs  for 
clinical  trials  on  medicinal  products  for 
use.  
human 

the 

administration 

The  CA  had  difficulty  determinated 
of 
whether 
investigational  medicinal  products 
for 
human  use  that  contains  or  consist  of 
GMOs - clinical trials, fall under the scope 
of  Directive  2009/41/EC  or  under  the 
2001/18/EC. 
Directive 
scope 

of 

for 

evaluation 

considered 

should  be 

We 
a 
that 
harmonisation  of  the  guidance  and  the 
procedures 
and 
the 
notification of clinical trials with GMMs at 
Union level. 
The legal framework of the GMOs clinical 
trial  –  deliberate 
the 
environment of GMOs or contained use of 
GMOs - is defined on a case-by-case basis 
taking  into  account  the  specificity  of  the 
GMO  clinical  trial.  Therefore  the  clinical 

release 

into 

-- 

sharing  procedures  across  Member 
States  (for  example  ERA,  notification, 
etc.) 

The CA would like to see clarity on the 
legislative 
concerning 
framework 
clinical trials with GMMs. 

The CA would like to see clarity on the 
legislative 
concerning 
framework 
clinical trials with GMMs. 

177 

 
 
  
  
 
 
 
 
trials  don´t  fall  exclusively  within  the 
scope  of  Directive  2009/41/EC  or 
Directive 2001/18/EC. 
Not applicable.  
Not applicable 

Not applicable.  
Not applicable 

RO 
RO 
2018 
SE 
SE 
2018 
SI 
SI 
2018 

SK 
SK 
2018 
UK 

UK 
2018 

No challenges experienced yet. 
- 

of 

for  humans 

- 
investigational 
Administration 
medecinal  products 
that 
contain  or  consist  of  GMOs  is  notified 
and/or authorised under  Directive 2001/18 
in Slovenia. 
---- 
 --- 

this 
Unfortunately  we  cannot  provide 
information  as 
is  not  specifically 
it 
recorded.    Some  class  2  activities  have 
definitely  been  notified  and  we  would 
estimate that this would be between 10-15 
for  the  reporting  period.  There  is  no 
notification  required  for  class  1  activities 
which likely accounts for the bulk of work 
administration 
involving 

of 

IMPs.   

to 

the 

industry  relating 

Nothing in addition to the issues raised by 
lack  of 
the 
consistency  across  member  states 
in 
relation  to  the  requirements  to  notify  and 
which regulatory route (CU v DR) 
Nothing in addition to the issues raised by 
lack  of 
the 
in 
consistency  across  member  states 
relation  to  the  requirements  to  notify  and 
which regulatory route (CU v DR) 

industry  relating 

the 

to 

III.2 Veterinary use 
a. Manufacturing 

n.a. 
- 

- 
- 

---- 
 --- 

It  is  our  understanding  that  the  EC 
working  groups  on  GMO-Pharma 
interplay are trying to address some of 
these issues through provision of better 
information  and  guidance  on  risk 
assessment for certain  types of vectors 
etc.    At  a  national  level  the  CA  is 
discussing with the medicines regulator 
to  see  if  there  are  ways  to  streamline 
clinical  trials  whilst  complying  with 
the  different 
under 
requirements 
regimes. 

It  is  our  understanding  that  the  EC 
working  groups  on  GMO-Pharma 
interplay are trying to address some of 
these issues through provision of better 
information  and  guidance  on  risk 
assessment for certain  types of vectors 
etc.    At  a  national  level  the  CA  is 
discussing with the medicines regulator 
to  see  if  there  are  ways  to  streamline 
clinical  trials  whilst  complying  with 
the  different 
under 
requirements 
regimes 

178 

 
 
 
 
11.1 

11.2 

Is  the  manufacturing  of  investigational  medicinal  products  for  veterinary  use  that 
contain or consist of GMOs notified and/or authorised under Directive 2009/41/EC in 
your Member State?  

If  yes,  were  there  any  notifications  and/or  authorisations  for  manufacturing 
investigational medicinal products for veterinary use that contain or consist of GMOs 
submitted in your Member State during the reporting period? 

the 

manufacturing 

11.1  Veterinary  use  -  Manufacturing 
Is 
of 
investigational  medicinal  products 
for veterinary  use  that  contain  or 
consist  of  GMOs  notified  and/or 
under Directive 
authorised 
2009/41/EC in your Member State? 
Yes 
AT 
AT 2018  Yes 
Yes 
BE 
BE 2018  Yes 
No 
BG 
BG 2018  Yes 
No 
CY 
CY 2018  No 
Yes 
CZ 
CZ 2018  Yes 
Yes 
DE 
DE 2018  Yes 
No 
DK 
DK 2018  No 
No 
EE 
EE 2018  No 
Yes 
EL 
EL 2018  Yes 
Yes 
ES 
ES 2018  No 
Yes 
FI 
FI 2018  Yes 
Yes 
FR 
FR 2018  Yes 
No 
HR 
HR 2018 
Yes 
HU 
HU 2018  No 

11.2  Were  there  any  notifications  and/or 
for 
authorisations 
manufacturing 
products 
medicinal 
investigational 
for veterinary use that contain or consist of 
GMOs  submitted  in  your  Member  State 
during the reporting period? 

Yes 

No 
Yes 

No 

No 

No 

No 
Yes 

Yes 

No 

No 
Yes 

No 

No 
Yes 

No 

Yes 

179 

 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
  
 
 
  
No 
IE 
IE 2018  Yes 
Yes 
IT 
IT 2018 
No 
LT 
LT 2018  No 
Yes 
LU 
LU 2018  Yes 
No 
LV 
LV 2018  No 
No 
MT 
MT 
No 
2018 
No 
NL 
NL 2018  No 
No 
PL 
PL 2018 
Yes 
PT 
PT 2018  Yes 
No 
RO 
RO 2018  Yes 
No 
SE 
SE 2018  No 
No 
SI 
SI 2018  Yes 
No 
SK 
SK 2018  No 
Yes 
UK 
UK 2018  Yes 

If yes, provide details: 

No 
No 

No 

No 

No 

No 

No 

No 

No 

No 

Yes 

Yes 

No. of notifications  

of                                     

No of authorisations 

AUSTRIA 2014-2017 
Classification 
contained use 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

no data available 
no data available 
-- 
-- 

BELGIUM 2014-2017 

180 

 
 
  
 
 
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
 
 
 
  
  
  
  
 
 
 
Classification 
contained use 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of notifications  

of                                     

No of authorisations 

0 
1 
0 
0 
1 

0 
0 
0 
0 
0 

No. of notifications  

of                                     

No of authorisations 

GERMANY 2014-2017 
Classification 
contained use 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of notifications  

of                                     

No of authorisations 

GERMANY 2018 
Classification 
contained use 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of notifications  

of                                     

No of authorisations 

SPAIN 2014-2017 
Classification 
contained use 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of notifications  

of                                     

No of authorisations 

FRANCE 2014-2017 
Classification 
contained use 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

néant 
néant 
néant 
néant 
néant 

néant 
néant 
néant 
néant 
néant 

HUNGARY 2014-2017 

181 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Classification 
contained use 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

No. of notifications  

of                                     

No of authorisations 

0 
10 
0 
0 
10 

0 
10 
0 
0 
10 

UNITED KINGDOM 2014-2017 
Classification 
contained use 
Class 1 

No. of notifications  

of                                     

No of authorisations 

Unfortunately  we  do  not  have 
this  information  but  we  cannot 
recall any being submitted. 

Unfortunately  we  do  not  have  this 
information but we cannot recall any 
being submitted. 

Class 2 
Class 3 
Class 4 
Total 

No. of notifications  

of                                     

No of authorisations 

UNITED KINGDOM 2018 
Classification 
contained use 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

11.3  What challenges, if any, did you as a CA encounter in implementing the Directive in 
relation to the manufacturing of investigational medicinal products for veterinary use 
that  contain  or  consist  of  GMOs  (e.g.  notification,  risk  assessment,  authorisation, 
control, etc.)? 

11.4  What in your opinion should be done or is done already to address these challenges? 

in 

implementing 

11.3 What challenges, if any, did you as a 
the 
CA  encounter 
Directive in relation to the manufacturing 
of  investigational  medicinal  products  for 
veterinary  use  that  contain  or  consist  of 
GMOs  (e.g.  notification,  risk  assessment, 
authorisation, control, etc.)? 
none 
none 
/ 
/ 

AT 
AT 2018  
BE 
BE 2018 

11.4  What  in  your  opinion  should  be 
done or is done already to address these 
challenges? 

not applicable 
not applicable 
/ 
/ 

182 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
BG 

BG 2018 

no 

has 

experience  with 
Bulgaria 
manufacturing  of  investigational  medicinal 
products  for  veterinary  use  that  contain  or 
consist of GMOs.  
experience  with 
Bulgaria 
manufacturing  of  investigational  medicinal 
products  for  veterinary  use  that  contain  or 
consist of GMOs. 
Not Applicable. 

has 

no 

CY 
CY 2018  No investigation of GMOs for veterinary use 

to 

the 

implementation 

CZ 
CZ 2018 
DE 

in Cyprus. 
Not applicable 
not applicable 
In Germany, the manufacturing of an ATMP 
requires  further  authorization  by  the  CA 
responsible  for  good  clinical  practices.  In 
relation 
of 
2009/41/EC (GenTG) there is no destinction 
between  GMO  status  and  ATMP  status. 
Evaluation  of  numbers  of  manufactured 
ATMPs is not possible with our database. 
comment  (no  challenge):  In  Germany,  the 
manufacturing  of  an  ATMP  requires  further 
authorization by the CA responsible for good 
clinical  practices. 
the 
In 
implementation  of  2009/41/EC  (GenTG) 
there  is  no  destinction  between  GMO  status 
and ATMP status. Evaluation of numbers of 
manufactured  ATMPs  is  not  possible  with 
our database. 
None 
DK 
DK 2018  N/A 
EE 

DE 2018 

relation 

to 

No specific opinion, see reply to Question 
10. 

No specific opinion, see reply to Question 
10. 

Not Applicable. 
N.R. 

Not applicable 
not applicable 
- 

- 

N/A 
N/A 

Labour Inspectorate don't deal with this area  Labour  Inspectorate  don't  deal  with  this 

EE 2018 
EL 

There is not such kind of premises 
No activities reported. 

EL 2018 
ES 

ES 2018 

FI 

FI 2018 

None 
This question has been addressed in previous 
section 
Differences 
in  procedures  between  MS 
(Some  MS  have  considered  these  activities 
as contained use and other MS as deliberate 
release). 
Basically  the  same  as  for  human  ATMPs, 
except  that  it  is  harder  to  find  any  national 
experts on the risk assessment. 
Not encountered during the reporting period. 

reported, 

area 
N/A 
No  activities 
associated challenges. 
N/A 
This  question  has  been  addressed 
previous section 
Harmonise procedures between MS.  

therefore  no 

in 

A  network  of  experts  that  the  CAs  could 
approach  when  necessary  would  be  most 
welcome. 
- 

183 

 
 
néant 

not applicable 

FR 
FR 2018 
HR 
HR 2018 
HU 
HU 2018  No challenges were encountered. 
IE 

No. 

The CA has not received any applications of 
this  type.  Investigational  medicinal  product 
is  defined  as  "A  pharmaceutical  form  of  an 
active  substance  or  placebo  being  tested  or 
used  as  a  reference  in  a  clinical  trial, 
including  a  product  with  a  marketing 
authorisation  when  used  or  assembled 
(formulated  or  packaged)  in  a  way  different 
from  the  authorised  form,  or  when  used  for 
an  unauthorised  indication,  or  when  used  to 
gain further information about the authorised 
form". 
n/a 
Manufacturing 
investigational 
medicinal  products  or  marketed  medicinal 
products  for  veterinary  use  that  contain  or 
consist  of  GMMs 
regulated  under 
Directive  2009/41/EC  and  the  GMM  CA 
expects  that  notifications  of  the  involved 
premises  and  the  contained  activities  are 
authorized. 
and 
submitted 

an 

of 

is 

IE 2018 
IT 

néant 

/ 

Not relevant. 
- 
Not applicable 

the 

improve 

exchange  of 

n/a 
To 
the 
information  required  by  EU  Commission 
cooperating  with  the  Directorate-General 
for  Animal  Health 
and  Veterinary 
Medicines  of  the  MoH  that  is  the  CA  for 
the  monitoring  of  manufacturing  of 
veterinary medicinal products. 

To date the information required through the 
notifications  do  not  include  explicitly  if  the 
investigational  medicinal  product 
is  for 
veterinary  use  or  if  it  is  marketed  and  such 
type  of  information  can  be  acquired  only  in 
part  by  the  context  of  the  information 
provided  by 
the  user.  To  date  no 
notifications  have  been  submitted  to  GMM 
CA. 

IT 2018 
- 
LT 
- 
LT 2018 
Directive not yet transposed 
LU 
LU 2018  Directive not yet transposed 
LV 
LV 2018 
MT 
MT 2018  N/A 
NL 

- 
- 
Not applicable. 

-- 

- 
- 
Transposition of the directive is ongoing 
Transposition of the directive is ongoing 
- 
- 
Not applicable. 
N/A 
-- 

184 

 
 
  
  
  
  
 
  
  
NL 2018 
PL 

-- 
not applicable 

-- 
sharing  procedures/experiences 
Member  States 
notification, etc.) 

across 
(for  example  ERA, 

PL 2018 
PT 

PT 2018 

The  CA  didn’t  encounter  any  challenges  in 
implementing the Directive in relation to this 
subject. 
The  CA  didn’t  encounter  any  challenges  in 
implementing the Directive in relation to this 
subject. 
Not applicable.  
RO 
RO 2018  Not applicable 
SE 

as 

deliberate 

All  GMO  that  are  medicinal  products  are 
release.  Only 
handled 
preparations  and  sample  analysis  may  be 
notified  as  any  other  contained  use  of 
GMMs. A challenge is that applicants can be 
confused what part is contained use and what 
part is not. But MPA and SWEA cooperates 
in  order  to  make  the  process  for  applicants 
smooth. 
- 
- 

SE 2018 
SI 
SI 2018  We have not encountered any challenges for 

The CA didn’t encounter any challenges in 
implementing  the  Directive  in  relation  to 
this subject. 
The CA didn’t encounter any challenges in 
implementing  the  Directive  in  relation  to 
this subject. 
Not applicable.  
Not applicable 
Possible 
be 
implementation  of  ERA  for  inspectors  of 
the  GMP  (good  manufacturing  practice) 
qualification.  

actions 

future 

can 

- 
- 
- 

the time being. 
----- 
 --- 
None 

SK 
SK 2018 
UK 
UK 2018  None.  Unfortunately  we  do  not  have  this 

----- 
 --- 
Not applicable. 
N/A 

information 

b. Administration (clinical trials) 

12.1 

Is  the  administration  of  investigational  medicinal  products  for  veterinary  use  that 
contain or consist of GMOs notified and/or authorised under Directive 2009/41/EC in 
your Member State? 

12.2  Were  there  activities  described  in  12.1  notified  and/or  authorised  in  your  Member 

State during the reporting period?  

Is 

medicinal 

the administration 

12.1 
of 
products 
investigational 
for veterinary  use  that  contain  or  consist 
of  GMOs  notified  and/or  authorised 
in  your 
under Directive  2009/41/EC 
Member State? 
Yes 

AT 

12.2  Were  there  any  such  activities 
in  your 
notified  and/or  authorised 
Member  State  during  the  reporting 
period? 

Yes 

185 

 
 
 
 
 
 
 
 
 
No 
No 

No 
Yes 

No 
Yes 

AT 2018  Yes 
Yes 
BE 
BE 2018 
Yes 
No 
BG 
BG 2018  No 
No 
CY 
CY 2018  No 
No 
CZ 
CZ 2018  No 
No 
DE 
DE 2018  No 
No 
DK 
DK 2018  Yes 
No 
EE 
EE 2018 
EL 
EL 2018 
ES 
ES 2018 
FI 
FI 2018 
FR 
FR 2018 
HR 
HR 2018 
No 
HU 
HU 2018  No 
No 
IE 
IE 2018 
IT 
IT 2018 
LT 
LT 2018 
No 
Yes 
LU 
LU 2018  Yes 
No 
LV 
LV 2018  No 
No 
MT 
MT 2018  No 
No 
NL 
NL 2018  No 

Yes 
Yes 

No 
Yes 

No 
No 

No 

No 
Yes 

No 

No 

No 

No 

No 
Yes 

No 

No 

No 

No 

No 

No 

186 

 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
 
 
  
  
  
  
  
  
No 

Yes 

PL 
PL 2018 
PT 
PT 2018 
Yes 
No 
RO 
RO 2018  No 
No 
SE 
SE 2018 
SI 
SI 2018 
SK 
SK 2018 
No 
Yes 
UK 
UK 2018  Yes 

Yes 
No 

No 
No 

If yes, provide details: 

No 

No 

No 

Yes 

Yes 

No. of notifications  

of                                     

No. of authorisations  

AUSTRIA 2014-2017 
Classification 
contained use 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

no data available 
no data available 
-- 
-- 

No. of notifications  

of                                     

No. of authorisations  

BELGIUM 2014-2017 
Classification 
contained use 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

0 
1 
1 
0 
2 

FRANCE 2014-2017 
Classification 
contained use 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

néant 
néant 
néant 
néant 
néant 

No. of notifications  

of                                     

No. of authorisations  

0 
1 
1 
0 
2 

néant 
néant 
néant 
néant 
néant 

187 

 
 
  
 
 
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
 
 
No. of notifications  

UNITED KINGDOM 2014-2017 
Classification 
contained use 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

1 

of                                     

No. of authorisations  

1 

No. of notifications  

of                                     

No. of authorisations  

UNITED KINGDOM 2018 
Classification 
contained use 
Class 1 
Class 2 
Class 3 
Class 4 
Total 

12.3  What challenges, if any, did you as a CA encounter in implementing the Directive in 
relation to the administration of investigational medicinal products for veterinary use 
that  contain  or  consist  of  GMOs  (e.g.  notification,  risk  assessment,  authorisation, 
control, etc.)? 

12.4  What in your opinion should be done or is done already to address these challenges? 

in 

encounter 

implementing 

12.3  What  challenges,  if  any,  did  you  as  a 
CA 
the 
Directive  in  relation  to  the administration 
of 
investigational  medicinal  products 
for veterinary use that contain or consist of 
GMOs  (e.g.  notification,  risk  assessment, 
authorisation, control, etc.)? 
none 
none 
For veterinary use, it is not easy to know if the 
notifications are clinical trials or research and 
development. 

12.4  What  in  your  opinion  should 
be  done  or  is  done  already  to 
address these challenges? 

not applicable 
not applicable 
/ 

For veterinary use, it is not easy to know if the 
notifications are clinical trials or research and 
development. 

/ 

no 

has 

Bulgaria 
with 
administration  of  investigational  medicinal 
products for human use that contain or consist 
of  GMOs.  Whether  a  clinical  trial  will  be 

experience 

No  specific  opinion,  see  reply  to 
Question 10. 

188 

AT 
AT 2018 
BE 

BE 2018 

BG 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
BG 2018 

no 

has 

experience 

considered  to  involve  contained  use  of  GMO 
or  release 
the  environment  will  be 
into 
decided on a case-by-case basis. 
Bulgaria 
with 
administration  of  investigational  medicinal 
products for human use that contain or consist 
of  GMOs.  Whether  a  clinical  trial  will  be 
considered  to  involve  contained  use  of  GMO 
or  release 
the  environment  will  be 
into 
decided on a case-by-case basis. 
Not Applicable. 

CY 
CY 2018   No  investigation  of  GMOs  for  veterinary  use 

CZ 
CZ 2018 
DE 

in Cyprus. 
Not applicable 
not applicable 
The administration of VIMP containig GMOs 
is  under  the  scope  of  2001/18/EC.  The 
authorization  of  field  trials  with  GMOs  is 
challenging 
public 
consultations. 
- 
DE 2018 
None 
DK 
DK 2018  N/A 
EE 

Labour Inspectorate don't deal with this area 

especially 

due 

to 

EE 2018 
EL 

There is not such kind of premises 
No activities reported. 

EL 2018 
ES 

ES 2018 

FI 

FI 2018 

FR 
FR 2018 

UNDER 

N/A 
CLINICAL  TRIALS  WITH  GMOs  ARE 
AUTHORISED 
DIRECTIVE 
2001/18/EC  
Differences in procedures between MS (Some 
MS  have  considered 
these  activities  as 
contained  use  and  other  MS  as  deliberate 
release). 
Not  encountered  during  the  reporting  period, 
but in an earlier case we encountered the same 
trials. 
challenges  as 
However, the issues related to GMM shedding 
were  different  when  the  test  subjects  were 
dogs. 
Not  encountered  during  the  reporting  period, 
but risk management methods are a  challenge, 
if  the  test  subjects  are  pets  or  companion 
animals. 
néant 

for  human  clinical 

No  specific  opinion,  see  reply  to 
Question 10. 

Not Applicable. 
N.R. 

Not applicable 
not applicable 
- 

- 
N/A 
N/A 
Labour  Inspectorate  don't  deal  with 
this area 
N/A 
No  activities  reported,  therefore  no 
associated challenges. 
N/A 
CLINICAL  TRIALS  WITH  GMOs 
ARE 
UNDER 
DIRECTIVE 2001/18/EC  
Harmonise procedures between MS.  

AUTHORISED 

The  commission  working  group  is 
already tackling the challenges. 

- 

néant 

189 

 
 
  
  
not applicable 

No relevance. 

HR 
HR 2018 
HU 
HU 2018  No challenges were encountered. 
IE 
IE 2018 
IT 

None 
n/a 
Administration of an investigational medicinal 
products  or  marketed  medicinal  products  for 
veterinary  use  that  contain  or  consist  of 
GMMs  is  considered,  if  a  deliberate  release 
has  been  excluded,  a  contained  activity  and 
consequently 
the 
2009/41/EC.  
Directive 

regulated  under 

is 

it 

GMM  CA  expects  that  notifications  of  the 
involved premises and the contained activities 
authorized. 
to 
are 

submitted 

be 

To  date  the  information  required  through  the 
notifications  do  not  include  explicitly  if  the 
investigational  medicinal  product 
for 
veterinary  use  or  if  it  is  marketed  and  such 
type of information can be acquired at least in 
information 
part  by 
user.  
provided 

the  context  of 
by 

the 
the 

is 

To  date  no  notifications  have  been  submitted 
to GMM CA. 

IT 2018 
LT 
LT 2018 
LU 

- 
- 
Directive not yet transposed 

LU 2018  Directive not yet transposed 

LV 
LV 2018 
MT 
MT 2018  N/A 
NL 
NL 2018 
PL 

- 
- 
Not applicable. 

-- 
-- 
risk assessment 

/ 

No.relevance. 
- 
None 
n/a 
To  improve  the  exchange  of  the 
EU 
information 
required 
Commission  cooperating  with 
the 
Directorate  General 
for  Animal 
Health  and  Veterinary  Medicines  of 
MoH that is the CA for the protection 
of 
scientific 
purposes. 

animals  used 

for 

by 

is 

is 

the  directive 

the  directive 

- 
- 
Transposition  of 
ongoing 
Transposition  of 
ongoing 
- 
- 
Not applicable. 
N/A 
-- 
-- 
sharing 
knowledge/experiences/solutions 
with other Member States 

PL 2018 
PT 

The  legal  framework  of  the  GMOs  clinical  We  considered  that  should  be  a 

190 

 
 
  
 
 
 
 
 
 
  
  
trial –  deliberate  release into the environment 
of  GMOs  or  contained  use  of  GMOs  -  is 
defined  on  a  case-by-case  basis  taking  into 
account  the  specificity  of  the  GMO  clinical 
trial.  Therefore  the  clinical  trials  don´t  fall 
exclusively  whitin  the  scope  of  Directive 
2001/18/EC. 
or  Directive 
2009/41/EC 

There  were  no  activities  notified  and/or 
authorised 
trials  using 
regarding  clinical 
medicinal  products  for  veterinary  use  that 
contain  or  consist  of  GMOs  under    Directive 
2009/41/EC - contained use of GMOs.The CA 
had  difficulty  determinated  whether 
the 
administration  of  investigational  medicinal 
products  for  veterinary  use  that  contains  or 
consist of GMOs - clinical trials, fall under the 
scope  of  Directive  2009/41/EC  or  under  the 
scope of Directive 2001/18/EC. 
The  legal  framework  of  the  GMOs  clinical 
trial –  deliberate  release into the environment 
of  GMOs  or  contained  use  of  GMOs  -  is 
defined  on  a  case-by-case  basis  taking  into 
account  the  specificity  of  the  GMO  clinical 
trial.  Therefore  the  clinical  trials  don´t  fall 
exclusively  whitin  the  scope  of  Directive 
2001/18/EC. 
or  Directive 
2009/41/EC 

There  were  no  activities  notified  and/or 
trials  using 
regarding  clinical 
authorised 
medicinal  products  for  veterinary  use  that 
contain  or  consist  of  GMOs  under  Directive 
-  contained  use  of  GMOs. 
2009/41/EC 

PT 2018 

The  CA  had  difficulty  determinated  whether 
the administration of investigational medicinal 
products  for  veterinary  use  that  contains  or 
consist of GMOs - clinical trials, fall under the 
scope  of  Directive  2009/41/EC  or  under  the 
scope of Directive 2001/18/EC. 
Not applicable.  
RO 
RO 2018  Not applicable 
SE 

A future challenge may be a Clinical trial with 
caged animals.  

SE 2018 
SI 
SI 2018 

- 
- 
- 

harmonisation  of  the  guidance  and 
the procedures for the evaluation and 
notification  of  clinical  trials  with 
GMMs at Union level. 

We  considered  that  should  be  a 
harmonisation  of  the  guidance  and 
the procedures for the evaluation and 
notification  of  clinical  trials  with 
GMMs at Union level. 

Not applicable.  
Not applicable 
Swedish  authorities  will  discuss  and 
agree if and when a Clinical trial with 
caged animal will be applied for. 
- 
- 
Administration  of 
investigational 
medecinal products for veterinary use 

191 

 
 
 
 
 
------ 
--- 
None. 

SK 
SK 2018 
UK 
UK 2018  None.  Unfortunately  we  do  not  record  this 
information  but  we  can  recall  one  as  an 
example  of  a  first  use  on  a  premises 
notification 

that  contain  or  consist  of  GMOs  is 
notified  and/or  authorised  under 
Directive 2001/18 in Slovenia. 
------- 
--- 
None. 
N/A 

PART IV: GENE DRIVE MODIFIED ORGANISMS 

The  purpose  of  this  section  is  to  gather  information  on  whether  notifications  for  contained 
uses of gene drive modified organisms have been submitted in the Member States and how 
the Directive is implemented in this respect. 

13.1  Has  your  Member  State  taken  any  measure  regarding  gene  drive  modified  organisms 

under the Directive? 
If yes, provide details: 

No 
AT 
AT 2018  No 
No 
BE 
BE 2018  No 
No 
BG 
BG 2018  No 
No 
CY 
CY 2018  No 
No 
CZ 
CZ 2018  No 
Yes 
DE 

DE 2018  No 
No 
DK 
DK 2018  No 
No 
EE 
EE 2018  No 
No 
EL 
EL 2018  No 

Involvement of the advisory board ZKBS (position statement 
in  Febr.  2016):  Genetic  engeneering  procedures  to  generate 
gene  drive  organisms  are  allocated 
to  class  2.  The 
recommendation of specific safety measures will be done by 
the ZKBS in a case by case assessment .  

192 

 
 
 
 
 
 
 
 
 
 
  
 
  
 
  
 
  
 
  
 
 
  
 
  
 
  
 
No 
ES 
ES 2018  No 
No 
FI 
No 
FI 2018 
Yes 
FR 
FR 2018  No 
No 
HR 
HR 2018 
No 
HU 
HU 2018  No 
No 
IE 
No 
IE 2018 
No 
IT 
IT 2018 
No 
LT 
LT 2018  No 
No 
LU 
LU 2018  No 
No 
LV 
LV 2018  No 
No 
MT 
MT 2018  No 
Yes 
NL 

NL 2018  No 
No 
PL 
PL 2018 
No 
PT 
PT 2018  No 
No 
RO 
RO 2018  No 
Yes 
SE 

The  Netherlands  amended  its  rules  on  contained  use  of 
GMO’s to accommodate applications for gene drive modified 
organisms, in such a way that in all cases a permit instead of 
a notification is required. This amendment of the Ministerial 
Order came into force on 1 July 2016. 

For  contained  use  of  GM  plants,  any  consent  holder  should 
inform  the  Swedish  Board  of  Agriculture  if  a  modification 
driver.  
can 

function 

gene 

as 

a 

For  contained  use  of  GM  animals,  the  form  for  notification 
will  be  amended  if  there  will  be  future  notifications 
animals.  
concerning 

drive 

gene 

For  contained  use  of  GMMs,  gene  drive  may  be  of  interest 
only  if  a  GMM  is  based  on  an  eukarytic  organism  and  the 
organism  can  give  rise  to  new  organisms.  A  cell  culture  is 

193 

 
 
  
 
  
 
  
 
  
 
 
  
 
  
 
  
 
 
  
 
  
 
  
 
  
 
 
  
 
 
  
 
  
 
 
 
SE 2018  Yes 
No 
SI 
SI 2018 
SK 
SK 2018 
UK 

Yes 

No 

UK 2018  Yes 

probably  not  enough  fit  to  give  rise  to  new  organisms.  If  a 
GMM  would  be  modified  with  a  gene  drive  mechanism,  it 
should  be  contained  use  of  at  least  Class  2.  The  risk 
assessment should catch the risks in this case, given that the 
consequences if the GMM escapes from the containment will 
be more than neglible. 
Swedish Board of Agriculture-  GM plants/animals 

NB 

the 

directive 

only 

covers 

GMMs. 

The  only  notifications  which  would  be  required  under  the 
directive  would  be  modification  of  a  microorganism  (e.g. 
yeast).  However, the CA has issued guidance on gene editing 
and  drive  (prepared  by  SACGM)  to  advise  users  of 
configurations of CRISPR Cas9 that would raise concerns.  
The  only  notifications  which  would  be  required  under  the 
directive  would  be  modification  of  a  microorganism  (e.g. 
yeast).  However, the CA has issued guidance on gene editing 
and  drive  (prepared  by  SACGM)  to  advise  users  of 
configurations of CRISPR Cas9 that would raise concerns.  

13.2  Are  there  any  notifications  on  gene  drive  modified  organisms  submitted  under  your 

contained use legislation? 
Questionnaire  2018:  Have  you  received  notifications  on  gene  drive  modified 
organisms submitted under your contained use legislation? 

2014-2017 
No 
No 
No 
No 
No 
Yes 
No 
No 
No 
No 
No 
Yes 
No 
No 
No 

2018 
No 
No 
No 
No 
No 
No 
No 
No 
No 
No 
No 
No 

No 
No 

AT 
BE 
BG 
CY 
CZ 
DE 
DK 
EE 
EL 
ES 
FI 
FR 
HR 
HU 
IE 

194 

 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
IT 
LT 
LU 
LV 
MT 
NL 
PL 
PT 
RO 
SE 
SI 
SK10 
UK 

Yes 
No 
No 
No 
No 
No 
No 
No 
No 
No 
No 
Yes 
No 

No 
No 
No 
No 
No 

No 
No 
No 
No 
Yes 
No 

If yes, list all notifications (one notification per line): 

GERMANY 2014-2017 

For each notification  Type of organism  Scope 

a 

Drosophila 
melanogaster 

2009/41/EC 
basic 
research 

FRANCE 2014-2017 

For each notification  Type of organism  Scope 

a 
b 
c 
d 
e 

néant 
néant 
néant 
néant 
néant 

néant 
néant 
néant 
néant 
néant 

ITALY 2014-2017 

For each notification  Type of organism  Scope 

a 

Culicidae: 
GM 
Anopheles  gambia 
and 
Anopheles 
arabiensis 

Development 
of  genetically 
modified 
mosquitoes 
for 
malaria 

the 

of                                            

of                                            

Classification 
contained use* 
1 

Classification 
contained use* 
néant 
néant 
néant 
néant 
néant 

of                                            

Classification 
contained use* 
Class  2.  The  premise  is 
in  accordance 
certified 
with 
Arthropod 
Containment  Level  2 
(ACL2)  by  a  private 
third-party firm 

10 Slovakia provided a clarification, after the submission of its individual reports, that organisms reported in this 
part of its report were organisms obtained via new genomic techniques such as CRISPR-Cas (and not gene drive 
modified organisms). 

195 

 
 
 
 
 
 
 
 
                                                 
 
Classification 
contained use* 
1 

of                                            

1 

1 

control 

SLOVAKIA 2014-201711

For each notification  Type of organism  Scope 

a 

b 

c 

coli, 

CHO 
expressing 

Escherichia 
Saccharomyces 
cerevisiae, 
cells 
CaV 2.2 channel 
Escherichia 
Saccharomyces 
cerevisiae 

coli, 

cells 
CHO 
expressing CaV 2.2 
channel 

and 
gene 

basic 
research 
(using 
CRISPR-
Cas9 ) 
ABF2 
LEU2 
basic 
research 
(using 
CRISPR-
Cas9 ) 
basic 
research  gene 
for  Grina 
- 
Glutamate 
receptor, 
ionotropic, 
N-methyl  D-
aspartate-
associated 
protein 
(using 
CRISPR-
Cas9 ) 

1 

Classification 
contained use* 
 risk class 1 

of                                            

SLOVAKIA 2018 

For each notification  Type of organism  Scope 

a 

bacteria, yeast 

on 

Basic 
research 
introducing 
point 
mutations  or 
deletions  into 
the 
genes 
studied.  –  no 
to 
success 
date 

11 Slovakia provided a clarification, after the submission of its individual reports, that organisms reported in this 
part of its report were organisms obtained via new genomic techniques such as CRISPR-Cas (and not gene drive 
modified organisms). 

196 

 
 
 
 
 
 
                                                 
* If you use a different classification system (than classes 1, 2, 3, 4), explain the link between 
the classification and the category of the risk. 

13.3   Are  you  implementing  specific  containment  measures  for  gene  drive  modified 

organisms? 
If yes, provide details: 

No 
AT 
AT 2018  No 
No 
BE 
No 
BE 2018 
BG 2018  No 
No 
CY 
CY 2018  No 
No 
CZ 
CZ 2018  No 
Yes 
DE 

DE 2018  Yes 
No 
DK 
DK 2018  No 
No 
EE 
No 
EE 2018 
No 
EL 
No 
EL 2018 
No 
ES 
No 
ES 2018 
No 
FI 
No 
FI 2018 
Yes 
FR 
No 
FR 2018 
No 
HR 
HR 2018 
No 
HU 
HU 2018  No 

-  access  doors  are  kept  closed  at  all  times  and  are  provided  with  brushes  or 
rubber 
lips 
-  all  doors  have 
lock  cylinders  preventing  an  escape  of  fruit  flies 
-  it  was  also  recommended  to  secure  the  access  doors  with  a  gauze  curtain  in 
rooms  
husbandry 
animal 
- works with flies are only carried out in internal rooms without windows and 
lines 
with 
- 
up 
rooms 
-  no  nutrient  media  are  stored 
-  the  flies  are  killed  by  freezing  for  12  hours  at  -20  °C  before  disposal  
-  before  opening  the  culture  containers  and  during  the  works,  the  flies  are 
constantly anesthetized with CO2 
case by case assessment 

air 
are 
the  animal  husbandry 

gauze 
suitable 

supply 
set 

Drosophila 

secured 

exhaust 

traps 

and 

in 

néant 

197 

 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
No 
No 
No 

IE 
IE 2018 
IT 
IT 2018 
No 
LT 
No 
LT 2018 
No 
LU 
LU 2018  No 
No 
LV 
LV 2018  No 
No 
MT 
MT 2018  No 
NL 

Yes  We are still considering what containment measures are necessary and need to 
be implemented. Here we provide more general observations on this topic. The 
classification system of Dir. 2009/41 and corresponding containment measures 
is focused on pathogenicity of (micro-)organisms. There are no specific general 
containment  measures  implemented  for  gene  drive  modified  organisms. 
However, the biology of gene drive modified organisms may require different 
containment  measures.  The  risk  assessment,  as  well  as  the  containment 
measures most suited for a specific gene drive modified organism, is therefore 
always  carried  out  on  a  case-by-case  basis.  The  GMO  Decree  gives  room  for 
imposing specific containment measures on top of, or as an alternative for, the 
general containment measures. 

NL 2018  Yes  Next to the fact that our National Health Institute wrote a report on risk analysis 
on gene drive organisms and suggested containment measures, please find some 
topic.  
general 

observations 

this 

on 

The  classification  system  of  Dir.  2009/41  and  corresponding  containment 
measures  is  focused  on  pathogenicity  of  (micro-)organisms.  There  are  no 
specific  general  containment  measures  implemented  for  gene  drive  modified 
organisms. However, the biology of gene drive modified organisms may require 
different  containment  measures.  Therefore  we  bring  again  the  report  of  our 
National  Health  INstitute  to  your  attention  and  urge  you  to  organise  on  short 
notice  a  meeting  where  this  report,  the  suggested  measures  and  the  (legal) 
framework to implement these can be discussed with Commission and Member 
States. 

No 

PL 
PL 2018 
No 
PT 
No 
PT 2018 
No 
RO 
RO 2018  No 
No 
SE 
No 
SE 2018 
No 
SI 
No 
SI 2018 

198 

 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
  
 
 
  
  
  
  
  
  
  
  
No 
SK 
No 
SK 2018 
No 
UK 
UK 2018  No 

13.4   Are there any particular  challenges, for  you as  a  CA,  in  implementing the Directive 
with regard to the contained use of gene drive modified organisms (e.g. notification, 
risk assessment, authorisation, control, etc.)? 
If yes, provide details: 

No 
AT 
AT 2018  No 
BE 

Yes  A 

be 

will 

GDO 

considered 

GMO. 
Belgium  has  integrated  contained  uses  of  GMOs  (plants  and  animals)  in  its 
regional  legislation  implementing  Directive  2009/41/EC.  As  such,  principles 
for  risk  assessment  and  management  of  contained  use  of  GDOs  will  be  those 
followed for GMOs. Similarly, same administrative procedures will be applied 
(notification, authorisation, control). 

as 

a 

In the processes of risk assessment and management, the SBB is of the opinion 
that  specific  characteristics  of  the  GDO  should  be  considered.  The  most 
being: 
relevant 

- The rapid spread of the GDO-carried modification through several generations 
of 
organisms; 
- 
technology; 
- Generally, GDOs will be not pathogen and the environment will be the only at 
risk. 

developmental 

target 
early 

non-target 

stage 

The 

the 

of 

or 

These features highlight uncertainties about environmental risk assessment and 
have to be taken into consideration for the containment of activities with GDOs, 
regarding: 
for 

example 

-  The  adaptation  of  the  containment  to  a  technology  still  in  development 
containment); 
(“balanced” 
- The adaptation of the containment to organisms such as arthropods. 

BE 2018 

Yes  A GDO will be considered as a GMO. 

Belgium  has  integrated  contained  uses  of  GMOs  (plants  and  animals)  in  its 
regional  legislations  implementing  Directive  2009/41/EC.  As  such,  principles 
for  risk  assessment  and  management  of  contained  use  of  GDOs  will  be  those 
followed for GMOs. Similarly, same administrative procedures will be applied 
control) 
(notification, 

authorisation, 

In the processes of risk assessment and management, the SBB is of the opinion 
that  specific  characteristics  of  the  GDO  should  be  considered.  The  most 
being: 
relevant 

199 

 
 
  
  
  
  
 
 
 
  
  
 
 
 
 
- The rapid spread of the GDO-carried modification through several generations 
of 
organisms; 
- 
technology; 
- Generally, GDOs will be not pathogen and the environment will be the only at 
risk; 

non-target 
of 

developmental 

target 
early 

stage 

The 

the 

or 

These features highlight uncertainties about environmental risk assessment and 
have to be taken into consideration for the containment of activities with GDOs, 
regarding: 
for 

example 

-  The  adaptation  of  the  containment  to  a  technology  still  in  development 
(“balanced” 
containment); 
- The adaptation of the containment to organisms such as arthropods; 

BG 

Yes  So far the experience  with  contained use of  gene drive modified organisms  is 
limited  which  makes  risk  assessments  more  difficult.  In  addition  different 
groups  of  modified  organisms  have  different  reproductive  and  ecological 
characteristics which will make it even more important to use the case-by-case 
approach. 

We expect that most gene drive modified organisms will be animals and plants 
and will be outside of the scope of Directive 2009/41/EC. 

BG 2018  Yes  So far the experience with  contained use of  gene drive modified  organisms  is 
relatively  limited  which  makes  risk  assessments  more  difficult.  In  addition 
different  groups  of  modified  organisms  have  different  reproductive  and 
ecological  characteristics  which  will  make  it  even  more  important  to  use  the 
approach. 
case-by-case 

We expect that most gene drive modified organisms will be animals and plants 
and will be outside of the scope of Directive 2009/41/EC. 

No 
CY 
CY 2018  No 
No 
CZ 
CZ 2018  No 
No 
DE 
DE 2018  No 
No 
DK 
DK 2018  No 
No 
EE 
No 
EE 2018 
No 
EL 
No 
EL 2018 
No 
ES 
Yes  Spanish  CA  have  not  received  notification  on  gene  drive  modified  organism 
ES 2018 
under contained use legislation. However, CA will attend expert meeting hosted 
by  EFSA  to  gain  operational  experience  and  improve  knowledge  on  these 
organisms.  

200 

 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
FI 

FI 2018 

Yes  If  the  notifier  has  an  existing  notification  of  Class  1  use,  they  can  take  new 
Class 1 organisms into use without a new  notification. This means that if the 
user has  classified the gene drive organism in the risk assessment into Class 1, 
the  licencing  CA  does  not  necessarily  get  to  know  about  the  gene  drive 
organism  before  the  point  where  the  supervisory  authority  performs  an 
inspection. 

Yes  We  have  not  had  experience  of  gene  drive  cases,  so  it  is  not  clear  what  the 
problems  would  be  un-der  existing  legislation,  but  risk  assessment,  correct 
classification and risk management measures are likely issues meriting further 
discussion. 

FR 
FR 2018 

Yes  néant 
Yes  La question de la spécificité des mesures de confinement à prévoir pour le Gene 

Drive mériterait d'être évaluée au niveau communautaire 

No 

HR 
HR 2018 
No 
HU 
HU 2018  No 
IE 

Yes  Risk assessment  and what additional data (if any) should be included / looked 

for in a risk assessment. 

IE 2018 

Yes  Risk assessment and what additional data (if any) should be included / looked 

for in a risk assessment. Risk management. 

IT 

Yes  It  is  difficult  to  interpret  the  Directive  2009/41/EC  regarding  the  contained 
activities  of  gene  drive  modified  organisms  as  no  specific  provisions  are  laid 
it. 
down 

in 

Additional  measures,  in  addition  to  those  provided  by  the  user,  may  be 
requested  by  the  BHTC  on  the  basis  of  the  evaluation  of  the  notification 
submitted. 

Italy  has  not  issued  any  decree  including  provisions  regarding  gene  drive 
modified  organisms  under  the  Directive  2009/41/EC.  To  date  the  different 
aspects  regarding  such  type  of  notifications  are  assessed  case  by  case. 

The  containment  measures  to  apply  to  the  contained  uses  of  gene  drive 
modified  organisms  are  not  regulated  at  European  level  and  provisions  of 
Directive  2009/41/EU  are  not  directly  applicable  e.g.  to  Genetically  Modified 
Arthropods (GMAs), therefore additional requirements are necessary to ensure 
that performed activities with gene drive modified organisms can be considered 
safe for the humans, animals and environment. 

Examples in this regard are: the availability of appropriate primary barriers, the 
GMAs  can  be  identified  individually,  they  actively  hide,  they  can  react 
differently  to  the  light  or  humidity,  they  can  adhere  on  different  surfaces  and 
follow the air flows. 

IT 2018 
LT 
LT 2018 

No 
Yes  There  is  no  experience  how  to  handle  such  type  of  Applications  and  what 

201 

 
 
  
  
 
  
  
 
 
 
 
  
  
  
criteria to use for risk assessment and how to assess the risk itself.  

No 
LU 
LU 2018  No 
No 
LV 
LV 2018  No 
No 
MT 
MT 2018  No 
NL 

Yes  As indicated in 13.3 there is a discrepancy between the containment measures 
needed for pathogenic micro-organisms (as these are stipulated in the Directive) 
and  those  needed  to  contain  gene  drive  modified  organisms  appropriately. 
Consequently different control measures may be required also. 
NL 2018  Yes  As indicated in above there is a discrepancy between the containment measures 
needed for pathogenic microorganisms (as these are stipulated in the Directive) 
and  those  needed  to  contain  gene  drive  modified  organisms  appropriately. 
Consequently different control measures may be required also. 

No 

PL 
PL 2018 
No 
PT 
No 
PT 2018 
No 
RO 
RO 2018  No 
SE 

Yes  Formally,  GM  plants  are  not  included  under  Directive  2009/41/EC.  But  there 
will probably be need for a higher containment level for GM plants with gene 
drive  modifications.  For  GM  animals,  the  risk  assessment  and  notification 
procedure will probably be more challenging.  

SE 2018 
SI 
SI 2018 
SK 
SK 2018 
UK 

No 
No 
No 
No 
No 
Yes  The directive only covers GMMs and the vast majority of potential gene drive 
organisms  are  likely  to  be  insects  and  rodents  so  no  notification  would  be 
required.   Only  yeast  would  be considered a GMM  and therefore captured by 
the directive.  At the moment there is limited work being done in this area and 
the regulator is fully aware of it but if it increases it may be difficult to regulate. 
Risk assessment is difficult as GDOs pose unique challenges although it should 
be  noted  that  an  individual  in  the  UK  CA  is  about  to  publish  a  paper  jointly 
with colleagues from NL, DE and BE on using the framework in 2009/41/EC to 
risk  asses  GDOs  for  contained  use.    This  paper has  been  accepted  in  Applied 
Biosafety and will be published imminently. 

UK 2018  No 

13.5  What  in  your  opinion  should  be  done  or  is  done  already  to  address  the  challenges 

identified, with the aim to facilitate the implementation of the Directive?  

AT 

Basic questions have to be clarified first 

202 

 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
AT 2018  Not applicable. Until now no gene drive applications have been received by the CA. 
BE 

Some  adaptations  should  be  considered  for  the  particular  case  of  GDOs.  However 
considering  that  risk  assessment  is  a  case-by-case  procedure,  Directive  remains 
appropriate for protection of (the human health and) the environment during contained 
GDOs. 
use 

of 

The  Biosafety  and  Biotechnology  Unit  (SBB)  has  participated  in  the  elaboration  of 
guidelines  that  could  help  users  and  competent  authorities  in  the  classification  and 
management of such activities with GDOs (in press, Biosafety Journal, 2018). 

BE 2018  Some  adaptations  should  be  considered  for  the  particular  case  of  GDOs.  However 
considering  that  risk  assessment  is  a  case-by-case  procedure,  Directive  remains 
appropriate for protection of (the human health and) the environment during contained 
GDOs. 
use 

of 

The Service Biosafety and Biotechnology (SBB) has participated in the elaboration of 
guidelines  that  could  help  users  and  competent  authorities  in  the  classification  and 
management  of  such  activities  with  GDOs  (Applied  Biosafety  Journal,  Vol.  23(1), 
2018). 

BG 

BG 2018 

It may be appropriate to consider initially that any gene drive modified organisms will 
pose high risk for the environment and to apply stringent containment measures. Such 
measures  should  use  at  least  two  different  containment  strategies  suitable  for  the 
specific modified organism. Less stringent containment can be used on a case-by-case 
lower. 
basis 

demonstrated 

risks 

that 

the 

are 

is 

if 

it 

In principle, gene drive modified organisms can move across borders so it is important 
to establish mechanisms for fast and effective cooperation between EU member states 
when such organisms are released into the environment, deliberately or accidentally. 
It may be appropriate to consider initially that any gene drive modified organisms will 
pose high risk for the environment and to apply stringent containment measures. Such 
measures  should  use  at  least  two  different  containment  strategies  suitable  for  the 
specific modified organism. Less stringent containment can be used on a case-by-case 
lower. 
basis 

demonstrated 

risks 

that 

the 

are 

is 

if 

it 

In principle, gene drive modified organisms can move across borders so it is important 
to establish mechanisms for fast and effective cooperation between EU member states 
when such organisms are released into the environment, deliberately or accidentally. 
Not Applicable. 

CY 
CY 2018  N.R. 
Not applicable 
CZ 
CZ 2018  not applicable 
- 
DE 
- 
DE 2018 
N/A 
DK 
DK 2018  N/A 
EE 
EE 2018  N/A 

Labour Inspectorate don't deal with this area 

203 

 
 
 
 
 
 
EL 
EL 2018  Not Applicable due to no implementation of measures regarding gene drive under the 

No notifications or measures applicable to date. 

ES 

framework of Directive 2009/41/EC 
It  would  be  desirable  to  have  harmonised  Guidelines  at  EU  level  (from  the 
Commission)  regarding  notifications  for  contained  uses  of  gene  drive  modified 
organism. 

ES 2018  Expert meetings hosted by EFSA or the European Comission.  
FI 

Gene  drive  is  not  an  issue  for  those  Member  States  regulating  GM  plants  and  GM 
animals,  as long  as  necessary containment  measures are maintained.  However, in  the 
Member  States  which  only  regulate  GMMs,  additional  legal  measures  may  be 
necessary. 

FI 2018  Directive  2009/41/EC  does  not  cover  GM  plants  and  animals,  so  there  is  no 

harmonised legislation on them. 
néant 

FR 
FR 2018  Clarifier  au  niveau  UE  les  mesures  de  confinement  à  prévoir  dans  le  cas  du  Gene 

Drive. 
/ 

HR 
HR 2018 
HU 
HU 2018  No relevance. 
IE 
IE 2018 
IT 

We propose detailed discussions at EU level regarding this important issue. 

As above 
as above 
The Directive 2009/41/EU could  be  amended  and a detailed  and harmonized  guiding 
document,  that  would  clearly  report  the  required  specifications  with  the  needed 
explanations, could be adopted by European Member States and issued by Commission 
services. Such type of requirements may be adopted and applied, on voluntary basis, by 
MSs also before that the Directive is amended. 

IT 2018 
LT 

LT 2018 

LU 
LU 2018 
LV 
LV 2018 
MT 
MT 
2018 
NL 

As  we  do  not  have  any  experience,  however  it  would  be  valuable  to  establish 
harmonized  EU  procedure  for  gene  drive  modified  organisms  including  notification, 
risk assessment, authorization and control requirements. 
It  would  be  helpful  clearer  explanation  of  GM  gene  drive  and  what  risk  assessment 
methodology and safety measures to use.  Harmonized EU legislation for Gene drive 
would be welcome. 
transposition of directive is ongoing 
transposition of directive is ongoing 
- 
- 
No past experience to comment on this 
No past experience to comment on this. 

An  active  and  frequent  exchange  of  information  and  experiences  regarding  the 
contained use of gene drive modified organisms should be arranged at EU-level. This 
should result in a guidance document or eventually a change of the directive. Also EU-
guidance on how to  inform  member states in  case a high risk incident  with  GMM or 
GMO  should  be  explicitly  extended  to  gene  drive  modified  organisms,  as  these 
organisms may pass borders. 

204 

 
 
  
  
PL 
PL 2018 
PT 

NL 2018  An  active  and  frequent  exchange  of  information  and  experiences  regarding  the 
contained use of gene drive modified organisms should be arranged at EU-level. This 
should result in a guidance document or eventually a change of the directive. Also EU-
guidance on how to  inform  member states in  case a high risk incident  with  GMM or 
GMO  should  be  explicitly  extended  to  gene  drive  modified  organisms,  as  these 
organisms 
borders. 
The  fact  that  in  Italy  a  contained  use  experiment  with  living  gene  drive  modified 
mosquitos is now taking place, adds to the necessity of a swift action from your side! 
knowledge/experience flow between Member States 

may 

pass 

The CA didn’t encounter any  challenges in  implementing  the Directive in relation  to 
this subject.             

PT 2018  The CA didn’t encounter any  challenges in  implementing  the Directive in relation  to 

this subject. 
Not applicable.  
RO 
RO 2018  Not applicable 
SE 

Since  gene  drive  concerns  eukarytic  organisms,  the  issue  may  be  more  relevant  for 
Directive  2001/18/EC.  SWEA  believes  that  a  proper  risk  assessment  of  a  GMM  use 
will catch any risk with such organisms that are GMMs. The containment levels 2-4 in 
the  Directive  2009/41EC  is  enough  to  protect  the  environment  and  workers  also  for 
contained use of GMMs with gene drive modifications.   
- 
- 

SE 2018 
SI 
SI 2018  Management  of  Genetically  Modified  Organisms  (MGMO)  Act  (OJ  RS  23/2005  and 
amended  OJ  RS  21/2010)  specifies  the  requirements  for  the  content  of  the 
notifications.  Notifiers  have  to  provide  information  on  the  intended  use  of  Class  1 
organisms together with the notification of the premises. Furthermore the notifiers are 
obliged to submit a  yearly report  on all activities with GMOs, including new Class 1 
organisms that were not notified yet. The notification and the yerly reports are assessed 
by  the  Scientific  Committee.  We  observed  no  intent  to  use  gene  drive  modified 
organisms.  Therefore  no  special  measures  for  gene  drive  organisms  were  taken  in 
Slovenia. 
---- 
 ---- 
It is difficult to regulate GDOs (under the directive) as it is only applicable to GMMs.  
A number of member states include GM plants and animals in their national legislation 
(as does the UK) but in the UK there are no activity notification requirements (or class 
of work) for GM plants/ animals.  There is a lack of consistency in the approach across 
member states with regard to this type of work.    
It is difficult to regulate GDOs (under the directive) as it is only applicable to GMMs.  
A number of member states include GM plants and animals in their national legislation 
(as does the UK) but in the UK there are no activity notification requirements (or class 
of work) for GM plants/ animals.  There is a lack of consistency in the approach across 
member states with regard to this type of work.    

SK 
SK 2018 
UK 

UK 2018 

205 

 
 
  
 
 
 
 
PART V: ADDITIONAL COMMENTS 

Thanks  for  providing  comments  on  any  other  aspects  of  the  Directive  or  on  other 
related legislation. 

2014-2017 
AT  no comments 
BE 
BG  Regarding the EU legislation on the contained use of GMO we think important open issues 
are: 

present 

at 

1. Harmonization of requirements for contained use of GMO other than GMM between the 
to  gene  drive  modified  organisms; 
regard 
member  states, 

in  particular  with 

2. Clarifying the requirements and procedures applicable to medicinal products that contain 
or consist of GMOs, in particular with regard to clinical trials. 

- 

CY  No comments. 
CZ 
DE 
DK 
EE  N/A. I hope that Estonian Medicine Agency will answer parts III and IV 
EL 
ES 
FI 
FR  néant 
HR 
HU  No. 
IE 
IT  Waste 

disposal 

As additional information it is to point out that the waste disposal plants must be authorized 
according  to  Legislative  Decree  No.  152  of  03/04/2006.  The  applications  must  to  be 
submitted to the Region or, in some circumstances to the Province/Metropolitan City when 
they are delegated to issue the authorizations. Copy of the application has to be sent to the 
Municipality  and  to  the  Italian  National  Institute  for  Environmental  Protection  and 
Research ISPRA (Istituto Superiore per la Protezione e la Ricerca Ambientale). The issued 
authorizations  expire  after  10  years.  More  detailed  information  can  be  obtained  on  the 
http://www.catasto-rifiuti.isprambiente.it/index.php?pg=comaut. 
following  web 

site: 

The controls are applied by all the subjects that contribute to the issue of authorizations and 
to  the  various  police  forces  that  carry  out  activities  on  the  national  territory. 

The Provinces, the Regional Environmental Protection Agency, the Local Health Authority 
and other Bodies are responsible for monitoring the operations of the plant operators, which 
must be carried out in compliance with the regulations in-force and the specific provisions 
contained  in  the  authorizations  (Legislative  Decree  No  152/2006,  articles  208  and  214). 

206 

 
 
 
 
 
  
 
 
  
  
  
  
  
  
  
 
 
 
 
Transfer of waste 

The  transfer  of  waste  material  is  organized  by  firms  registered  in  the  National 
Environmental Operators Register, that is laid down with the art. 212 of Legislative Decree 
No.  152/2006,  and  that  is  currently  regulated  by  the  Decree  of  the  Ministry  for  the 
Environment  and  Protection  of  the  Territory  and  the  Sea  No.  120/2014.  The  professional 
register  consists  of  a  national  committee  at  Ministry  for  Environment,  Land  and  Sea 
Protection  and  in  regional  or  provincial  committees  established  at  the  Chambers  of 
Commerce of the regional capitals and of the autonomous provinces of Trento and Bolzano. 

The reference legislation and the consultation of the registered operators are reported in the 
ministerial web site: www.albonazionalegestoriambientali.it. 

Furthermore  the  transfer  of  waste  has  to  comply  with  the  Legislative  Decree  n.  35  of 
27/01/2010  (transposition  act  of  the  Directive  2008/68/EC  on  the  inland  transport  of 
dangerous  goods  -  as  amended).  The  CA  is  the  Italian  Ministry  of  Infrastructures  and 
Transport. 

LT 
LU 
LV  Latvia had very limited experience with contained use of GMM many  years ago. For this 

moment there is no activities in this filed. 

MT 
NL  non 
PL 
PT 
RO  The  most  relevant  and  not  yet  resolved  problem  of  interpretation  regards  the  question 
whether  clinical  trials  with  GMOs  fall  within  the  scope  of  to  the  contained  use  or  the 
environmental release directives. In fact some Member States treated trials with GMMs in 
clinical  settings  as  deliberate  release  of  GMOs,  while  some  others  considered  the  GMM 
use. 
as 
clinical 

contained 

trials 

Needs and priorities for further guidance on risk assessment of: 

- LM fish 

- LMOs produced through synthetic biology 

LM 

- 
- 
- potential implications for Risk Assessment of Gene Drive Experiments 

dwelling 

LM 

soil 

organisms 
birds 

SE  Directive  2000/54/EG  on  the  protection  of  workers  from  risks  related  to  exposure  to 
biological  agents  at  work  is  currently  under  revision  concerning  technical  changes  of  the 
Annexes. There might be a change of some safety measures in Annexes V and VI of that 
Directive.  Maybe  this  can  impact  on  the  containment  measures  in  Annex  IV  of  Directive 
2009/41/EC? 

SI 

207 

 
 
 
 
 
  
  
  
  
  
 
  
SK 

In Annex - Glossary of terms (for the purposes of the questionnaire for the years 2017 to 
2020) please provide an example what it means „contained combined uses of GMMs and 
GMOs“: 

1. step: stable transfection of genetic materials into the MDA-MB-231 NucLight Red cells,  

+  2.  step:  application  of  the  genetically  modified  MDA-MB-231  NucLight  Red  cells  to 
mice. 
Note to answer on number of notifications of CONTAINED USES submitted for risk class 
1:  Since  1  January  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 
Ministry  of  the  Environment  of  the  Slovak  Republic.  Once  every  6  months,  the  users  of 
GMOs and GMMs submit a summary notification on all the GMOs and GMMs classified 
in the risk class 1, which they have carried out activities with, including their storage in the 
reporting period. 

UK 

/ 

2018 
AT  
BE  
BG   Regarding the EU legislation on the contained use of GMO we think important open issues 
at 
are: 
present 
1. Harmonization of requirements for contained use of GMO other than GMM between the 
member  states, 
to  gene  drive  modified  organisms; 
regard 
2. Further clarifying the requirements and procedures applicable to medicinal products that 
contain or consist of GMOs, in particular with regard to clinical trials. 

in  particular  with 

CY  
CZ  
DE   - 
DK  
EE  
EL  
ES   Contained used activities and their correspondent premises with GM cells have been also 
notified to Spanish CA under Directive 2009/41/EC. GM cells are not included in Part II of 
this survey.   

FI   As the concept of circular economy is gaining ground in the EU, the legislative issues on 
recycling  large  quantities  of  GMM  waste  or  byproducts  should  be  addressed.  Also,  the 
relationship  between  GMO  legislation  and  the  regulations  on  the  transportation  of 
dangerous goods should be clarified. 
les 
génomique 

: 
nouvelles 
La  France  n'est  pas  actuellement  en  mesure  de  traiter  l'ensemble  des  utilisations 
correspondant au champs de la directive dans le cadre de la réglementation en vigueur et 
élargi par l'arrêt de la CJUE du 25 juillet 2018. 

de  mutagenèse 

FR   L'édition 

techniques 

et 

HR  
HU  
IE  
IT  

208 

 
 
 
 
  
 
  
  
  
  
  
  
  
  
  
  
LT  
LU  
LV  
MT     
NL   non 
PL  
PT  
RO  
SE  
SI  
SK  
UK  

209