Proposal for a Directive of the European Parliament and of the Council on the contained use of genetically modified micro-organisms (Recast)
Date: 2007-11-29
Institutions: European Commission
Subjects: drafting of EU law, environmental impact, environmental risk prevention, exchange of information, genetically modified organism, microorganism, public health

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 29.11.2007 
COM(2007) 736 final 

2007/0259 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on the contained use of genetically modified micro-organisms 

(Recast) 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

On 1 April 1987 the Commission decided1 to instruct its staff that all legislative acts 
should  be  codified  after  no  more  than  ten  amendments,  stressing  that  this  is  a 
minimum  requirement  and  that  departments  should  endeavour  to  codify  at  even 
shorter  intervals  the  texts  for  which  they  are  responsible,  to  ensure  that  the 
Community rules are clear and readily understandable. 

The codification of Council Directive 90/219/EEC of 23 April 1990 on the contained 
use of genetically modified micro-organisms2 has been initiated by the Commission, 
and  a  relevant  proposal  has  been  submitted  to  the  legislative  authority3.  The  new 
Directive was to have superseded the various acts incorporated in it4. 

In  the  meantime  Council  Decision  1999/468/EC  of  28  June  1999  laying  down  the 
procedures  for the exercise of implementing powers conferred on the Commission5 
has  been  amended  by  Decision  2006/512/EC,  which  introduced  a  regulatory 
procedure  with  scrutiny  for  measures  of  general  scope  designed  to  amend 
non-essential  elements  of  a  basic  instrument  adopted  in  accordance  with  the 
procedure  referred  to  in  Article 251  of  the  Treaty,  including  by  deleting  some  of 
those  elements  or  by  supplementing  the  instrument  by  the  addition  of  new 
non-essential elements. 

In accordance with the joint statement of the European Parliament, the Council and 
the Commission6 on Decision 2006/512/EC, for this new procedure to be applicable 
to instruments adopted in accordance with the procedure laid down in Article 251 of 
the  Treaty  which  are  already  in  force,  those  instruments  must  be  adjusted  in 
accordance with the applicable procedures. 

It is therefore appropriate to transform the codification of Directive 90/219/EEC into 
a recast in order to incorporate the amendments necessary for the adjustment to the 
regulatory procedure with scrutiny. 

COM(87) 868 PV. 
Carried out pursuant to the Communication from the Commission to the European Parliament and the 
Council – Codification of the Acquis communautaire, COM(2001) 645 final. 
COM(2006) 286 final. 
See Annex VI, Part A of this proposal. 
OJ  L  184,  17.7.1999,  p.  23.  Decision  as  amended  by  Decision  2006/512/EC  (OJ  L  200,  22.7.2006, 
p. 11). 
OJ C 255, 21.10.2006, p. 1. 

1. 

2. 

3. 

4. 

5. 

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(cid:208) 90/219/EEC (adapted) 

2007/0259 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on the contained use of genetically modified micro-organisms 

(Text with EEA relevance)  

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Article ⌦ 175(1) ⌫ thereof, 

Having regard to the proposal from the Commission1, 

Having regard to the opinion of the European Economic and Social Committee2, 

Having regard to the opinion of the Committee of the Regions3, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty4,  

Whereas: 

(1) 

Council  Directive  90/219/EEC  of  23  April  1990  on  the  contained  use  of  genetically 
modified  micro-organisms5  has  been  substantially  amended  several  times6.  Since 
further amendments are to be made, it should be recast in the interests of clarity. 

(cid:216) new 

(2) 

Under the Treaty, action by the Community relating to the environment shall be based 
on  the  principle  that  preventive  action  shall  be  taken  and  shall  have  as  its  objective 

(cid:208) 90/219/EEC Recital 1 (adapted) 

1 
2 
3 
4 
5 

6 

OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ L 117, 8.5.1990, p. 1. Directive as last amended by Regulation (EC) No 1882/2003 of the European 
Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). 
See Annex VI, Part A. 

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⌦ , among other things, ⌫ to preserve, protect and improve the environment and to 
protect human health. 

(3)  Measures concerning the evaluation and best use of biotechnology with regard to the 
environment are a priority area on which Community action should concentrate. 

(cid:208) 90/219/EEC Recital 2 

(4) 

The development of biotechnology is such as to contribute to the economic expansion 
of  the  Member  States.  This  implies  that  genetically  modified  micro-organisms 
⌦ (GMMs) ⌫ will be used in operations of various types and scale. 

(cid:208) 90/219/EEC Recital 3 (adapted) 

(5) 

The  contained  use  of ⌦ GMMs ⌫  should  be  carried  out  in  such  a  way  as  to  limit 
their  possible  negative  consequences  for  human  health  and  the  environment,  due 
attention being given to the prevention of accidents and the control of waste. 

(cid:208) 90/219/EEC Recital 4 (adapted) 

(cid:208) 98/81/EC Recital 5 (adapted) 

(6) 

GMMs which are disposed of without appropriate provisions for specific containment 
measures to limit their contact with the general population and the environment do not 
fall  within  the  scope  of  the  present  Directive.  Other  Community  legislation  such  as 
⌦ 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 organisms7 may apply. 

(7)  Micro-organisms, if released into the environment in one Member State in the course 
of  their  contained  use,  may  reproduce  and  spread,  crossing  national  frontiers  and 
thereby affecting other Member States. 

(cid:208) 90/219/EEC Recital 5 

(8) 

In  order  to  bring  about  the  safe  development  of  biotechnology  throughout  the 
Community,  it  is  necessary  to  establish  common  measures  for  the  evaluation  and 

(cid:208) 90/219/EEC Recital 6 (adapted) 

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OJ  L  ⌦ 106,  17.4.2001,  p.  1 ⌫.  Directive  as  last  amended  by  ⌦ Regulation  (EC)  No  1830/2003 
(OJ L 268, 18.10.2003, p. 24) ⌫. 

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reduction  of  the  potential  risks  arising  in  the  course  of  all  operations  involving  the 
contained use of ⌦ GMMs ⌫ and to set appropriate conditions of use. 

(9) 

The  precise  nature  and  scale  of  risks  associated  with  ⌦ the  contained  use  of 
GMMs ⌫  are  not  yet  fully  known  and  the  risk  involved  must  be  assessed  case  by 
case. To evaluate the risk to human health and the environment, it is necessary to lay 
down requirements for risk assessment. 

(cid:208) 90/219/EEC Recital 7 (adapted) 

(10)  Contained uses of GMMs should be classified in relation to the risks they present to 
human  health  and  the  environment.  Such  classification  should  be  in  line  with 
international practice and based on an assessment of the risk. 

(cid:208) 98/81/EC Recital 2 

(cid:208) 98/81/EC Recital 3 

(11) 

In  order  to  ensure  a  high  level  of  protection,  the  containment  and  other  protective 
measures  applied  to  a  contained  use  must  correspond  to  the  classification  of  the 
contained use. In case of uncertainty, the appropriate containment and other protective 
measures for the higher classification should be applied until less stringent measures 
are justified by appropriate data. 

(12)  For all activities involving GMMs the principles of good microbiological practice and 
good  occupational  safety  and  hygiene  should  apply  in  accordance  with  relevant 
Community legislation. 

(cid:208) 98/81/EC Recital 7 

(13)  Appropriate  containment  measures  should  be  applied  at  the  various  stages  of  an 
operation to control emissions ⌦ and the disposal of material from contained uses of 
GMMs, ⌫ and to prevent accidents. 

(cid:208) 90/219/EEC Recital 9 and 
98/81/EC Recital 4 (adapted) 

(14)  Any person, before undertaking for the first time the contained use of a ⌦ GMM ⌫ 
in a particular installation, should forward to the competent authority a notification so 
that the authority may satisfy itself that the proposed installation is appropriate to carry 

(cid:208) 90/219/EEC Recital 10 
(adapted) 

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out  the  activity  in  a  manner  that  does  not  present  a  hazard  to  human  health  and  the 
environment. 

(15) 

It  is  also  necessary  to  establish  appropriate  procedures  for  the  case-by-case 
notification  of  specific  operations  involving  the  contained  use  of  ⌦ GMMs ⌫, 
taking account of the degree of risk involved. 

(cid:208) 90/219/EEC Recital 11 
(adapted) 

(16) 

In  the  case  of  operations  involving  high  risk,  the  consent  of  the  competent  authority 
should be given. 

(cid:208) 90/219/EEC Recital 12 

(17)  The  containment  and  other  protective  measures  applied  to  contained  uses  should  be 

reviewed periodically. 

(cid:208) 98/81/EC Recital 8 

(18) 

It  may  be  considered  appropriate  to  consult  the  public  on  the  contained  use  of 
⌦ GMMs ⌫. 

(cid:208) 90/219/EEC Recital 13 
(adapted) 

(cid:208) 98/81/EC Recital 9 (adapted) 

of 

(19)  People  employed  in  contained  uses  should  be  consulted  in  accordance  with  the 
requirements 
particular 
Community 
⌦ Directive 2000/54/EC  of  the  European  Parliament  and  of  the  Council  of 
18 September 2000 ⌫ on the protection of workers from risks related to exposure to 
biological  agents  at  work  (seventh  individual  Directive  within  the  meaning  of 
Article 16(1) of Directive 89/391/EEC)8. 

legislation, 

relevant 

in 

(20)  Appropriate measures should be taken to inform any person liable to be affected by an 

accident on all matters relating to safety. 

(cid:208) 90/219/EEC Recital 14 

8 

OJ L ⌦ 262, 17.10.2000, p. 21 ⌫. 

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(21)  Emergency plans should be established to deal effectively with accidents. 

(cid:208) 90/219/EEC Recital 15 

(22) 

If an accident occurs, the user should immediately inform the competent authority and 
communicate the information necessary for assessing the impact of that accident and 
for taking the appropriate action. 

(cid:208) 90/219/EEC Recital 16 

(23) 

It  is  appropriate  for  the  Commission,  in  consultation  with  the  Member  States,  to 
establish  a  procedure  for  the  exchange  of  information  on  accidents  and  for  the 
Commission to set up a register of such accidents. 

(cid:208) 90/219/EEC Recital 17 

(24)  The contained use of ⌦ GMMs ⌫ throughout the Community should be monitored, 

and to this end Member States should supply certain information to the Commission. 

(cid:208) 90/219/EEC Recital 18 
(adapted) 

(cid:208) 98/81/EC Recitals 12 and 13 
(adapted) and 2001/204/EC 
Recital 2 (adapted) 

(25)  ⌦ In  order  to  be  considered  safe  for  human  health  and  the  environment,  GMMs 
should meet the list of criteria as defined in Annex II, Part B. To take account of the 
pace  at  which  biotechnology  is  advancing,  the nature  of  the  criteria  to  be  developed 
and  the  limited  scope  of  this  list,  it  is  appropriate  for  the  Council  to  revise  those 
criteria,  which  should,  where  necessary,  be  supplemented  by  guidance  notes  to 
facilitate their application. ⌫ 

(cid:216) new 

(26)  The measures necessary for the implementation of this Directive should be adopted in 
accordance  with  Council  Decision  1999/468/EC  of  28  June  1999  laying  down  the 
procedures for the exercise of implementing powers conferred on the Commission9. 

(27)  Power should be conferred on the Commission in particular to adopt the amendments 
necessary to adapt Annex II, Part A, and Annexes III, IV and V to technical progress 

9 

OJ  L  184,  17.7.1999,  p.  23.  Decision  as  amended  by  Decision  2006/512/EC  (OJ  L  200,  22.7.2006, 
p. 11). 

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and  to  adapt  Annex  II,  Part  C.  Since  those  measures  are  of  general  scope  and  are 
designed to amend non-essential elements of this Directive, they should be adopted in 
accordance with the regulatory procedure with scrutiny provided for in Article 5a of 
Decision 1999/468/EC. 

(28)  The  new  elements  introduced  into  this  Directive  only  concern  the  committee 
procedures. They therefore do not need to be transposed by the Member States. 

(29)  This  Directive  should  be  without  prejudice  to  the  obligations  of  the  Member  States 
relating to the time-limits for transposition into national law of the Directives set out in 
Annex VI, Part B, 

⌦ HAVE ⌫ ADOPTED THIS DIRECTIVE: 

(cid:208) 90/219/EEC (adapted) 

(cid:208) 90/219/EEC 

Article 1 

This  Directive  lays  down  common  measures  for  the  contained  use  of  genetically  modified 
micro-organisms with a view to protecting human health and the environment. 

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(cid:208) 98/81/EC Art. 1 pt. 1 (adapted) 
(cid:206)1 Corrigendum, 98/81/EC 
(OJ L 93, 8.4.1999, p. 27) 
(adapted) 

For the purposes of this Directive ⌦ the following definitions shall apply ⌫: 

Article 2 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

“micro-organism” ⌦ means ⌫ any microbiological entity, cellular or non-cellular, 
capable of replication or of transferring genetic material, including viruses, viroids, 
animal and plant cells in culture; 

“genetically  modified  micro-organism”  (GMM) ⌦ means ⌫  a  micro-organism  in 
which the genetic material has been altered in a way that does not occur naturally by 
mating and/or natural recombination; within the terms of this definition: 

(i) 

genetic modification occurs at least through the use of the techniques listed in 
Annex I, Part A; 

(ii) 

the techniques listed in Annex I, Part B, are not considered to result in genetic 
modification; 

“contained use” ⌦ means ⌫ any activity in which micro-organisms are genetically 
modified  or  in  which  such  GMMs  are  cultured,  stored,  transported,  destroyed, 
disposed of or used in any other way, and for which specific containment measures 
are used (cid:206)1 to limit their contact with, and to provide a high level of safety for, the 
general population and the environment;   

“accident” ⌦ means ⌫ any incident involving a significant and unintended release 
of GMMs in the course of their contained use which could present an immediate or 
delayed hazard to human health or the environment; 

“user” ⌦ means ⌫ any natural or legal person responsible for the contained use of 
GMMs; 

“notification”  ⌦ means ⌫  the  presentation  of  the  requisite  information  to  the 
competent authorities of a Member State. 

1. Without prejudice to Article 4(1) this Directive shall not apply: 

Article 3 

(a) 

(b) 

where  genetic  modification  is  obtained  through  the  use  of  the  techniques/methods 
listed in Annex II, Part A; or 

for  contained  uses  involving  only  types  of  GMMs  meeting  the  criteria  listed  in 
Annex II, Part B which establish their safety for human health and the environment. 
These types of GMMs shall be listed in Annex II, Part C. 

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2. Article 4(3) and (6) and Articles 5 to 11 shall not apply to the transport of GMMs by road, 
rail, inland waterway, sea or air. 

(cid:208) 98/81/EC, Art. 1 pt. 1 (adapted) 

3. This Directive shall not apply to the storage, culture, transport, destruction, disposal or use 
of  GMMs  which  have  been  placed  on 
accordance  with 
Directive ⌦ 2001/18/EC ⌫ or pursuant to other Community legislation, which provides for 
a  specific  environmental  risk  assessment  similar  to  that  laid  down  in  the  said  Directive, 
provided that the contained use is in accordance with the conditions, if any, of the consent for 
placing on the market. 

the  market 

in 

(cid:208) 98/81/EC, Art. 1 pt. 1 

Article 4 

1. Member States shall ensure that all appropriate measures are taken to avoid adverse effects 
on human health and the environment which might arise from the contained use of GMMs. 

2. To this end the user shall carry out an assessment of the contained uses as regards the risks 
to  human  health  and  the  environment  that  these  contained  uses  may  pose  ,  using  as  a 
minimum  the  elements  of  assessment  and  the  procedure  set  out  in  Annex  III,  sections  A 
and B. 

3.  The  assessment  referred  to  in  paragraph  2  shall  result  in  the  final  classification  of  the 
contained uses in four classes applying the procedure set out in Annex III, which will result in 
the assignment of containment levels in accordance with Article 5: 

Class 1: 

activities  of  no  or  negligible  risk,  that  is  to  say  activities  for  which  level  1 
containment is appropriate to protect human health as well as the environment. 

Class 2: 

activities  of  low  risk,  that  is  to  say  activities  for  which  level  2  containment  is 
appropriate to protect human health as well as the environment. 

Class 3: 

activities of moderate risk, that is to say activities for which level 3 containment 
is appropriate to protect human health as well as the environment. 

Class 4: 

activities of high risk, that is to say activities for which level 4 containment is 
appropriate to protect human health as well as the environment. 

4. Where there is doubt as to which class is appropriate for the proposed contained use, the 
more stringent protective measures shall be applied unless sufficient evidence, in agreement 
with the competent authority, justifies the application of less stringent measures. 

5. The assessment referred to in paragraph 2 shall especially take into account the question of 
disposal  of  waste  and  effluents.  Where  appropriate,  the  necessary  safety  measures  shall  be 
implemented in order to protect human health and the environment. 

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6. A record of the assessment referred to in paragraph 2 shall be kept by the user and made 
available in an appropriate form to the competent authority as part of the notification pursuant 
to Articles 6, 8 and 9 or on request. 

Article 5 

1. The user shall apply, except to the extent that point 2 of Annex IV allows other measures to 
be  applied,  the  general  principles  and  the  appropriate  containment  and  other  protective 
measures set out in Annex IV corresponding to the class of the contained use, so as to keep 
workplace  and  environmental  exposure  to  any  GMMs  to  the  lowest  reasonably  practicable 
level, and so that a high level of safety is ensured. 

2.  The  assessment  referred  to  in  Article  4(2)  and  the  containment  and  other  protective 
measures applied shall be reviewed periodically, and forthwith if: 

(a) 

(b) 

the containment measures applied are no longer adequate or the class assigned to the 
contained uses is no longer correct, or 

there is reason to suspect that the assessment is no longer appropriate judged in the 
light of new scientific or technical knowledge. 

Article 6 

When premises are to be used for the first time for contained uses, the user shall be required 
to submit to the competent authorities, before commencing such use, a notification containing 
at least the information listed in Annex V, Part A. 

Article 7 

Following  the  notification  referred  to  in  Article  6,  subsequent  class  1  contained  use  may 
proceed  without  further  notification.  Users  of  GMMs  in  class  1  contained  uses  shall  be 
required to keep the record of each assessment referred to in Article 4(6), which shall be made 
available to the competent authority on request. 

Article 8 

1.  For  first  and  subsequent  class  2  contained  uses  to  be  carried  out  in  premises  notified  in 
accordance with Article 6, a notification containing the information listed in Annex V, Part B 
shall be submitted. 

2.  If  the  premises  have  been  the  subject  of  a  previous  notification  to  carry  out  class  2  or  a 
higher  class of contained uses and  any associated consent  requirements have been  satisfied, 
the class 2 contained use may proceed immediately following the new notification. 

The  applicant  can,  however,  himself  request  a  decision  on  a  formal  authorisation  from  the 
competent  authority.  The  decision  must  be  made  within  a  maximum  of  45  days  from  the 
notification. 

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3. If the premises have not been the subject of a previous notification to carry out class 2 or a 
higher class of contained uses, the class 2 contained use may, in the absence of any indication 
to  the  contrary  from  the  competent  authority,  proceed  45  days  after  submission  of  the 
notification  referred  to  in  paragraph  1,  or  earlier  with  the  agreement  of  the  competent 
authority. 

Article 9 

1.  For  first  and  subsequent  class  3  or  class  4  contained  uses  to  be  carried  out  in  premises 
notified  in  accordance  with  Article  6,  a  notification  containing  the  information  listed  in 
Annex V, Part C shall be submitted. 

2. A class 3 or higher class of contained use may not proceed without the prior consent of the 
competent authority which shall communicate its decision in writing: 

(a) 

at the latest 45 days after submission of the new notification, in the case of premises 
which have been the subject of a previous notification to carry out class 3 or a higher 
class  of  contained  uses  and  where  any  associated  consent  requirements  have  been 
satisfied  for  the  same  or  a  higher  class  than  the  contained  use  with  which  it  is 
intended to proceed; 

(b) 

at the latest 90 days after submission of the notification, in other cases. 

Article 10 

1.  Member  States  shall  designate  the  authority  or  authorities  competent  to  implement  the 
measures  which  they  adopt  in  application  of  this  Directive  and  to  receive  and  acknowledge 
the notifications referred to in Articles 6, 8 and 9. 

2.  The  competent  authorities  shall  examine  the  conformity  of  the  notifications  with  the 
requirements  of  this  Directive,  the  accuracy  and  completeness  of  the  information  given,  the 
correctness of the assessment referred to in Article 4(2) and the class of contained uses and, 
where appropriate, the suitability of the containment and other protective measures, the waste 
management, and emergency response measures. 

3. If necessary, the competent authority may: 

(a) 

ask  the  user  to  provide  further  information  or  to  modify  the  conditions  of  the 
proposed contained use or to amend the class assigned to the contained use(s). In this 
case  the  competent  authority  may  require  that  the  contained  use,  if  proposed,  does 
not begin, or, if in progress, is suspended or terminated, until the competent authority 
has  given  its  approval  on  the  basis  of  the  further  information  obtained  or  of  the 
modified conditions of the contained use; 

(b) 

limit the time for which the contained use should be permitted or subject it to certain 
specific conditions. 

4. For the purpose of calculating the periods referred to in Articles 8 and 9, any period of time 
during which the competent authority: 

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(a) 

is awaiting any further information which it may have requested from the notifier in 
accordance with paragraph 3(a), or 

(b) 

is carrying out a public inquiry or consultation in accordance with Article 12 

shall not be taken into account. 

Article 11 

1. If the user becomes aware of relevant new information or modifies the contained use in a 
way  which  could  have  significant  consequences  for  the  risks  posed  by  it,  the  competent 
authority shall be informed as soon as possible and the notification pursuant to Articles 6, 8 
and 9 shall be modified. 

2.  If  information  subsequently  becomes  available  to  the  competent  authority  which  could 
have  significant  consequences  for  the  risks  posed  by  the  contained  use,  the  competent 
authority  may  require  the  user  to  modify  the  conditions  of,  or  suspend  or  terminate,  the 
contained use. 

Where  a  Member  State  considers  it  appropriate,  it  may  provide  that  the  public  shall  be 
consulted on aspects of the proposed contained use, without prejudice to Article 18. 

Article 12 

Article 13 

1. The competent authorities shall ensure that before a contained use commences: 

(a) 

(b) 

an emergency plan is drawn up for contained uses where failure of the containment 
measures  could  lead  to  serious  danger,  whether  immediate  or  delayed,  to  humans 
outside  the  premises  and/or  to  the  environment,  except  where  such  an  emergency 
plan has been drawn up under other Community legislation; 

information  on  such  emergency  plans,  including  the  relevant  safety  measures  to  be 
applied, is supplied in an appropriate manner, and without their having to request it, 
to bodies and authorities liable to be affected by the accident. The information shall 
be updated at appropriate intervals. It shall also be made publicly available. 

2.  The  Member  States  concerned  shall  at  the  same  time  make  available  to  other  Member 
States  concerned,  as  a  basis  for  all  necessary  consultation  within  the  framework  of  their 
bilateral relations, the same information as that which is disseminated to their nationals. 

Article 14 

1. Member States shall take the necessary measures to ensure that, in the event of an accident, 
the  user  shall  be  required  to  inform  immediately  the  competent  authority  specified  in 
Article 10 and provide the following information: 

(a) 

the circumstances of the accident; 

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(b) 

(c) 

the identity and quantities of the GMMs concerned; 

any  information  necessary  to  assess  the  effects  of  the  accident  on  the  health  of  the 
general population and the environment; 

(d) 

the measures taken. 

2. Where information is given pursuant to paragraph 1, the Member States shall be required 
to: 

(a) 

(b) 

ensure  that  any  measures  necessary  are  taken,  and  immediately  alert  any  Member 
States which could be affected by the accident; 

collect, where possible, the information necessary for a full analysis of the accident 
and,  where  appropriate,  make  recommendations  to  avoid  similar  accidents  in  the 
future and to limit the effects thereof. 

1. Member States shall be required to: 

Article 15 

(a) 

(b) 

consult with other Member States likely to be affected in the event of an accident on 
the proposed implementation of emergency plans; 

inform the Commission as soon as possible of any accident within the scope of this 
Directive,  giving  details  of  the  circumstances  of  the  accident,  the  identity  and 
quantities  of  the  GMMs  concerned,  the  response  measures  taken  and  their 
effectiveness and an analysis of the accident, including recommendations to limit its 
effects and avoid similar accidents in the future. 

2. The Commission, in consultation with the Member States, shall establish a procedure for 
the  exchange  of  information  pursuant  to  paragraph  1.  It  shall  also  set  up  and  keep  at  the 
disposal  of  the  Member  States  a  register  of  accidents  within  the  scope  of  this  Directive, 
including an analysis of the causes of the accidents, experience gained and measures taken to 
avoid similar accidents in the future. 

(cid:208) 90/219/EEC 

Article 16 

Member  States  shall  ensure  that  the  competent  authority  organises  inspections  and  other 
control measures to ensure user compliance with this Directive. 

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(cid:208) 98/81/EC, Art. 1 pt. 2 

Article 17 

1. Member States shall send to the Commission, at the end of each year, a summary report on 
class 3 and class 4 contained uses notified during that year pursuant to Article 9 including the 
description, purpose and risks of the contained use(s). 

2.  Every  three  years,  Member  States  shall  send  the  Commission  a  summary  report  on  their 
experience with this Directive, the first time being on 5 June 2003. 

3. Every three years, the Commission shall publish a summary based on the reports referred to 
in paragraph 2, the first time being on 5 June 2004. 

4. The Commission may publish general statistical information on the implementation of this 
Directive and related matters, as long as it contains no information likely to cause harm to the 
competitive position of a user. 

Article 18 

1.  Where  its  disclosure  affects  one  or  more  of  the  items  mentioned  in  Article  4(2)  of 
Directive ⌦ 2003/4/EC of the European Parliament and of the Council ⌫10, the notifier may 
indicate the information in the notifications  submitted pursuant  to this Directive that should 
be treated as confidential. Verifiable justification must be given in such cases. 

(cid:208) 98/81/EC, Art. 1 pt. 2 (adapted) 

(cid:208) 98/81/EC, Art. 1 pt. 2 

The competent authority shall decide, after consultation with the notifier, which information 
will be kept confidential and shall inform the notifier of its decision. 

2. In no case may the following information, when submitted according to Articles 6, 8 or 9, 
be kept confidential: 

(a) 

(b) 

(c) 

the  general  characteristics  of  the  GMMs,  name  and  address  of  the  notifier,  and 
location of use; 

the class of contained use and the containment measures ; 

the  evaluation  of  foreseeable  effects,  in  particular  any  harmful  effects  on  human 
health and the environment. 

10 

OJ L ⌦ 41, 14.2.2003, p. 26 ⌫. 

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(cid:208) 98/81/EC Art. 1 pt. 2 (adapted) 
(cid:214) new 

3.  The  Commission  and  the  competent  authorities  shall  not  divulge  to  third  parties  any 
information ⌦ deemed ⌫ to be confidential according to ⌦ the second subparagraph of ⌫ 
paragraph  1  and  notified  or  otherwise  provided  pursuant  to  this  Directive,  and  shall  protect 
intellectual property rights relating to the data received. 

4.  If,  for  whatever  reasons,  the  notifier  withdraws  the  notification,  the  competent  authority 
must respect the confidentiality of the information supplied. 

Article 19 

(cid:214) The Commission shall adopt the  amendments necessary to adapt Annex II, Part A, and 
Annexes III, IV and V to technical progress and to adapt Annex II, Part C. 

(cid:214) Those  measures,  designed  to  amend  non-essential  elements  of  this  Directive,  shall  be 
adopted  in accordance with the (cid:214) regulatory  procedure (cid:214) with scrutiny  ⌦ referred 
to ⌫ in Article 21 ⌦ (2) ⌫. 

(cid:208) 98/81/EC Art. 1 pt. 3 

Article 20 

Amendments to Annex II, Part B, shall be adopted by the Council acting by qualified majority 
on a proposal from the Commission. 

(cid:208) 1882/2003, Art. 3, Annex III, 
pt. 19 (adapted) 
(cid:214) new 

1. The Commission shall be assisted by a committee. 

Article 21 

2. Where reference is made to this paragraph, Articles 5(cid:214) 5a(1) to (4)  and ⌦ Article ⌫ 7 
of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 

3. The Committee shall adopt its rules of procedure. 

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(cid:208)  

Article 22 

Directive 90/219/EEC, as amended by the acts listed in Annex VI, Part A, is repealed, without 
prejudice to the obligations of the Member States relating to the time-limits for transposition 
into national law of the Directives set out in Annex VI, Part B. 

References  to  the  repealed  Directive  shall  be  construed  as  references  to  this  Directive  and 
shall be read in accordance with the correlation table in Annex VII. 

This Directive shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Article 23 

(cid:208) 90/219/EEC 

Article 24 

This Directive is addressed to the Member States. 

Done at Brussels, […] 

For the European Parliament 
The President 
[…] 

For the Council 
The President 
[…] 

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(cid:208) 98/81/EC Art. 1 pt. 4 

ANNEX I 

PART A 

Techniques of genetic modification referred to in Article 2(b)(i) are, inter alia: 

1. 

2. 

3. 

Recombinant  nucleic  acid  techniques  involving  the  formation  of  new  combinations 
of genetic material by the insertion of nucleic acid molecules produced by whatever 
means outside an organism, into any virus, bacterial plasmid or other vector system 
and their incorporation into a host organism in which they do not naturally occur but 
in which they are capable of continued propagation. 

Techniques  involving  the  direct  introduction  into  a  micro-organism  of  heritable 
material  prepared  outside 
including  micro-injection, 
the  micro-organism, 
macro-injection and micro-encapsulation. 

Cell  fusion  or  hybridisation  techniques  where  live  cells  with  new  combinations  of 
heritable  genetic  material  are  formed  through  the  fusion  of  two  or  more  cells  by 
means of methods that do not occur naturally. 

PART B 

Techniques  referred  to  in  Article  2(b)(ii)  which  are  not  considered  to  result  in  genetic 
modification,  on  condition  that  they  do  not  involve  the  use  of  recombinant-nucleic  acid 
molecules  or  GMMs  made  by  techniques/methods  other  than  the  techniques/methods 
excluded by Annex II, PART A: 

(1) 

(2) 

(3) 

in vitro fertilisation; 

natural processes such as: conjugation, transduction, transformation; 

polyploidy induction. 

_______________ 

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ANNEX II 

PART A 

Techniques or methods of genetic modification yielding micro-organisms to be excluded from 
the  Directive  on  condition  that  they  do  not  involve  the  use  of  recombinant-nucleic  acid 
molecules  or  GMMs  other  than  those  produced  by  one  or  more  of  the  techniques/methods 
listed below: 

1. 

2. 

3. 

4. 

Mutagenesis. 

Cell fusion (including protoplast fusion) of prokaryotic species that exchange genetic 
material by known physiological processes. 

Cell fusion (including protoplast fusion) of cells of any eukaryotic species, including 
production of hybridomas and plant cell fusions. 

Self-cloning  consisting  in  the  removal  of  nucleic  acid  sequences  from  a  cell  of  an 
organism  which  may  or  may  not  be  followed  by  reinsertion  of  all  or  part  of  that 
nucleic acid (or a synthetic equivalent) with or without prior enzymic or mechanical 
steps, into cells of the same species or into cells of phylogenetically closely related 
species  which  can  exchange  genetic  material  by  natural  physiological  processes 
where the resulting micro-organism is unlikely to cause disease to humans, animals 
or plants. 

Self-cloning may include the use of recombinant vectors with an extended history of 
safe use in the particular micro-organisms. 

(cid:208) 2001/204/EC Art. 1 (adapted) 

PART B 

Criteria establishing the safety of GMMs for human health and the environment 

This Annex describes in general terms the criteria to be met when establishing the safety of 
types  of  GMMs  for  human  health  and  the  environment  and  their  suitability  for  inclusion  in 
Part C. It ⌦ shall ⌫ be supplemented by guidance notes ⌦ 1 ⌫ for the easy application of 
such criteria, such notes being developed and, if necessary, amended by the Commission in 
accordance with the procedure referred to in Article 21 ⌦ (2) ⌫. 

1. 

INTRODUCTION 

Types  of  GMMs  listed  in  Part  C  in  accordance  with  the  procedure  referred  to  in 
Article 21 ⌦ (2) ⌫ are excluded from the scope of this Directive. GMMs will be 
added to the list on a case-by-case basis and exclusion will relate only to each clearly 

1 

See  Commission  Decision  2005/174/EC  of  28  February  2005  establishing  guidance  notes 
supplementing Part B of Annex II to Council Directive 90/219/EEC on the contained use of genetically 
modified micro-organisms (OJ L 59, 5.3.2005, p. 20). 

EN 

19 

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identified  GMM.  This  exclusion  applies  only  when  the  GMM  is  used  under 
conditions  of  contained  use  as  defined  in  Article 2(c).  It  does  not  apply  to  the 
deliberate release of GMMs. For a GMM to be listed in Part C, it must be proved that 
it meets the criteria given below. 

(cid:208) 2001/204/EC Art. 1 

2. 

GENERAL CRITERIA 

2.1. 

Strain verification/authentication 

Identity of the strain must be precisely established. Modification must be known and 
verified. 

2.2. 

Documented and established evidence of safety 

Documented evidence of the safety of the organism must be provided. 

2.3. 

Genetic stability 

Where any instability could adversely affect safety, evidence of stability is required. 

3. 

SPECIFIC CRITERIA 

3.1. 

Non-pathogenic 

The  GMM  should  not  be  capable  of  causing  disease  or  harm  to  a  healthy  human, 
plant or animal. Since pathogenicity includes both toxigenicity and allergenicity, the 
GMM should therefore be: 

3.1.1.  Non-toxigenic 

The  GMM  should  not  produce  increased  toxigenicity  as  a  result  of  the  genetic 
modification nor be noted for its toxigenic properties. 

3.1.2.  Non-allergenic 

(cid:208) 2001/204/EC Art. 1 (adapted) 

The  GMM  should  not  produce  increased  allergenicity  as  a  result  of  the  genetic 
modification nor be a noted allergen, having, for example, allergenicity comparable 
in 
in 
particular  with 
Directive ⌦ 2000/54/EC ⌫. 

the  micro-organisms 

identified 

that 

of 

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3.2. 

No harmful adventitious agents 

(cid:208) 2001/204/EC Art. 1 

The  GMM  should  not  harbour  known  harmful  adventitious  agents  such  as  other 
micro-organisms,  active  or latent, existing alongside or inside  the GMM that could 
cause harm to human health and the environment. 

3.3. 

Transfer of genetic material 

The modified genetic material must not give rise to harm if transferred nor should it 
be  self  transmissible  or  transferable  at  a  frequency  greater  than  other  genes  of  the 
recipient or parental micro-organism. 

3.4. 

Safety for the environment in the event of a significant and unintended release 

GMMs must not produce adverse effects on the environment, immediate or delayed, 
should any incident involving a significant and unintended release occur. 

GMMs that do not meet the above criteria may not be included in Part C. 

(cid:208) 98/81/EC, Art. 1 pt. 4 (adapted) 

PART C 

Types of GMMs which meet the criteria listed in Part B: 

(to  be  completed 

… 
Article 21 ⌦ (2) ⌫) 

in  accordance  with 

the  procedure  ⌦ referred 

to ⌫ 

in 

_______________ 

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ANNEX III 

PRINCIPLES TO BE FOLLOWED FOR THE ASSESSMENT REFERRED TO IN 
ARTICLE 4(2) 

This Annex describes in general terms the elements to be considered and the procedure to be 
followed  to  perform  the  assessment  referred  to  in  Article 4(2).  It  ⌦ shall ⌫  be 
supplemented, as regards in particular section B, by guidance notes ⌦ 1 ⌫ to be developed 
in 
by 
Article 21 ⌦ (2) ⌫. 

the  procedure  ⌦ referred 

in  accordance  with 

the  Commission 

to ⌫ 

(cid:208) 98/81/EC, Art. 1 pt. 4 

A. 

1. 

ELEMENTS OF ASSESSMENT 

The following should be considered as potentially harmful effects: 

– 

– 

– 

– 

– 

disease to humans including allergenic or toxic effects, 

disease to animals or plants, 

deleterious effects due to the impossibility of treating a disease or providing an 
effective prophylaxis, 

deleterious effects due to establishment or dissemination in the environment, 

deleterious  effects  due  to  the  natural  transfer  of  inserted  genetic  material  to 
other organisms. 

2. 

The assessment referred to in Article 4(2) should be based on the following: 

(a) 

the  identification  of  any  potentially  harmful  effects,  in  particular  those 
associated with: 

(i) 

the recipient micro-organism; 

(ii) 

the genetic material inserted (originating from the donor organism); 

(iii) 

the vector; 

(iv) 

the donor micro-organism (as long as the donor micro-organism is used 
during the operation); 

(v) 

the resulting GMM; 

(b) 

the characteristics of the activity; 

1 

See Commission Decision 2000/608/EC of 27 September 2000 concerning the guidance notes for risk 
assessment outlined in Annex III of Directive 90/219/EEC on the contained use of genetically modified 
micro-organisms (OJ L 258, 12.10.2000, p. 43). 

EN 

22 

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B. 

3. 

4. 

5. 

(c) 

the severity of the potentially harmful effects; 

(d) 

the likelihood of the potentially harmful effects being realised. 

PROCEDURE 

The first stage in the assessment process should be to identify the harmful properties 
of  the  recipient  and,  where  appropriate,  the  donor  micro-organism,  any  harmful 
properties associated with the vector or inserted material, including any alteration in 
the recipient's existing properties. 

In  general,  only  GMMs  which  show  the  following  characteristics  would  be 
considered appropriate for inclusion in class 1 as defined in Article 4(3): 

(i) 

(ii) 

the recipient or parental micro-organism is unlikely to cause disease to humans, 
animals or plants2; 

the nature of the vector and the insert is such that they do not endow the GMM 
with  a  phenotype  likely  to  cause  disease  to  humans,  animals  or  plants3,  or 
likely to cause deleterious effects in the environment; 

(iii) 

the  GMM  is  unlikely  to  cause  disease  to  humans,  animals  or  plants4  and  is 
unlikely to have deleterious effects on the environment. 

(cid:208) 98/81/EC, Art. 1 pt. 4 (adapted) 

take 

into  account 

In order to obtain the necessary information to implement this process the user may 
firstly 
(in  particular 
relevant  Community 
Directive ⌦ 2000/54/EC ⌫).  International  or  national  classification  schemes 
(e.g. WHO,  NIH,  etc.)  and  their  revisions  due  to  new  scientific  knowledge  and 
technical progress may also be considered. 

legislation 

of 

and 

disease 

transmissibility 

These schemes concern natural micro-organisms and as such are usually based on the 
ability of micro-organisms to cause disease to humans, animals or plants and on the 
severity 
caused. 
the 
Directive ⌦ 2000/54/EC ⌫  classifies  micro-organisms,  as  biological  agents,  into 
four classes of risk on the basis of potential effects on a healthy human adult. These 
classes  of  risk  can  be  used  as  guidance  to  the  categorisation  of  the  contained  use 
activities in the four classes of risk referred to in Article 4(3). The user may also take 
into  consideration  classification  schemes  referring  to  plant  and  animal  pathogens 
(which  are  usually  established  on  a  national  basis).  The  abovementioned 
classification  schemes  give  only  a  provisional  indication  of  the  risk  class  of  the 
activity and the corresponding set of containment and control measures. 

likely 

be 

to 

2 
3 
4 

This would only apply to animals and plants in the environment likely to be exposed. 
This would only apply to animals and plants in the environment likely to be exposed. 
This would only apply to animals and plants in the environment likely to be exposed. 

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6. 

7. 

8. 

9. 

(cid:208) 98/81/EC, Art. 1 pt. 4 

The hazard identification process carried out in accordance with points 3 to 5, should 
lead to the identification of the level of risk associated with the GMM. 

Selection of the containment and other protective measures should then be made on 
the basis of the level of risk associated with the GMMs together with consideration 
of: 

(i) 

the characteristics of the environment likely to be exposed (e.g. whether in the 
environment  likely  to  be  exposed  to  the  GMMs  there  are  known  biota  which 
can  be  adversely  affected  by  the  micro-organisms  used  in  the  contained  use 
activity); 

(ii) 

the characteristics of the activity (e.g. its scale; nature); 

(iii)  any  non-standard  operations  (e.g.  the  inoculation  of  animals  with  GMMs; 

equipment likely to generate aerosols). 

Consideration of items (i) to (iii) for the particular activity may increase, reduce or 
leave unaltered the level of risk associated with the GMM as identified under point 6. 

The analysis carried out as described above will finally lead to the assignment of the 
activity to one of the classes described in Article 4(3). 

The  final  classification  of  the  contained  use  should  be  confirmed  by  reviewing  the 
completed assessment referred to in Article 4(2). 

_______________ 

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ANNEX IV 

CONTAINMENT AND OTHER PROTECTIVE MEASURES 

General principles 

1. 

These tables present the normal minimum requirements and measures necessary for 
each level of containment. 

Containment  is  also  achieved  through  the  use  of  good  work  practices,  training, 
containment  equipment  and  special  installation  design.  For  all  activities  involving 
GMMs the principles of good microbiological practice and the following principles 
of good occupational safety and hygiene, shall apply: 

(i) 

to  keep  workplace  and  environmental  exposure  to  any  GMM  to  the  lowest 
practicable level; 

(ii) 

to  exercise  engineering  control  measures  at  source  and  to  supplement  these 
with appropriate personal protective clothing and equipment when necessary; 

(iii) 

to test adequately and maintain control measures and equipment; 

(iv) 

to  test,  when  necessary,  for  the  presence  of  viable  process  organisms  outside 
the primary physical containment; 

(v) 

to provide appropriate training of personnel; 

(vi) 

to establish biological safety committees or subcommittees, if required; 

(vii)  to formulate and implement local codes of practice for the safety of personnel, 

as required; 

(viii)  where appropriate to display biohazard signs; 

(ix) 

to provide washing and decontamination facilities for personnel; 

(x) 

to keep adequate records; 

(xi) 

to prohibit eating, drinking, smoking, applying cosmetics or the storing of food 
for human consumption in the work area; 

(xii)  to prohibit mouth pipetting; 

(xiii)  to  provide  written  standard  operating  procedures  where  appropriate  to  ensure 

safety; 

(xiv)  to  have  effective  disinfectants  and  specified  disinfection  procedures  available 

in case of spillage of GMMs; 

(xv)  to  provide  safe  storage  for  contaminated  laboratory  equipment  and  materials, 

when appropriate. 

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2. 

The titles of the tables are indicative: 

Table I A presents minimum requirements for laboratory activities. 

Table  I  B  presents  additions 
glasshouse/growth-room activities involving GMMs. 

to  and  modifications  of  Table  I  A  for 

Table  I  C  presents  additions  to  and  modifications  of  Table  I  A  for  activities  with 
animals involving GMMs. 

Table  II  presents  minimum  requirements  for  activities  other  than  laboratory 
activities. 

In some particular cases, it might be necessary to apply a combination of measures, 
from Table I A and Table II, of the same level. 

In some cases users may, with the agreement of the competent authority, not apply a 
specification  under  a  particular  containment  level  or  combine  specifications  from 
two different levels. 

In  these  tables  “optional”  means  that  the  user  may  apply  these  measures  on  a 
case-by-case basis, subject to the assessment referred to in Article 4(2). 

3. 

Member States may, in implementing this Annex, incorporate in addition the general 
principles  in  points  1  and  2  in  the  following  tables  for  the  sake  of  clarity  of  the 
requirements. 

Table I A 

Containment and other protective measures for laboratory activities 

Specifications 

Containment levels 

1 

2 

3 

4 

1  Laboratory suite: 

isolation1 

Not 
required 

2  Laboratory: sealable 
for fumigation 

Not 
required 

Not 
required 

Not 
required 

Required 

Required 

Required 

Required 

Equipment 

3  Surfaces resistant to 
water, acids, alkalis, 
solvents, disinfectants, 
decontamination 
agents and easy to 
clean 

Required 
(bench) 

Required 
(bench) 

Required 
(bench, floor) 

Required 
(bench, floor, 
ceiling, walls) 

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4  Entry to lab via 

airlock2 

5  Negative pressure 

relative to the pressure 
of the immediate 
environment 

6  Extract and input air 
from the laboratory 
should be 
HEPA-filtered 

7  Microbiological safety 

post 

8  Autoclave 

System of work 

9  Restricted access 

10  Biohazard sign on the 

door 

11  Specific measures to 
control aerosol 
dissemination 

13  Shower 

Not 
required 

Not 
required 

Not 
required 

Not 
required 

Optional 

Required 

Required 
except for3 

Required 

Not 
required 

Not 
required 

Required 
(HEPA)4 — 
extract air 
except for3 

Required 
(HEPA)5 — 
input and 
extract air 

Not 
required 

On site 

Not 
required 

Not 
required 

Not 
required 

Optional 

Required 

Required 

In the 
building 

En suite6 

In lab = 
double-ended 

Required 

Required 

Required 

Required 

Required 

Required 

Required 
minimise 

Required 
prevent 

Required 
prevent 

Not 
required 

Not 
required 

Optional 

Required 

14  Protective clothing 

Suitable 
protective 
clothing 

Suitable 
protective 
clothing 

(cid:208) Corrigendum, 98/81/EC 
(OJ L 93, 8.4.1999, p. 27) 

Suitable 
protective 
clothing and 
(optional) 
footwear 

Complete 
change of 
clothing and 
footwear 
before entry 
and exit 

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15  Gloves 

Not 
required 

(cid:208) 98/81/EC Art. 1 pt. 4 

Optional 

Required 

Required 

18  Efficient vector 
control (e.g. for 
rodents and insects) 

Waste 

19  Inactivation of GMMs 
in effluent from hand-
washing sinks or 
drains and showers 
and similar effluents 

20  Inactivation of GMMs 
in contaminated 
material and waste 

Other measures 

Optional 

Required 

Required 

Required 

Not 
required 

Not 
required 

Optional 

Required 

Optional 

Required 

Required 

Required 

21  Laboratory to contain 
its own equipment 

Not 
required 

Not 
required 

Optional 

Required 

23  An observation 

Optional 

Optional 

Optional 

Required 

window or alternative 
is to be present so that 
occupants can be seen 

1 

2 

3 
4 
5 

6 

Isolation  =  the  laboratory  is  separated  from  other  areas  in  the  same  building  or  is  in  a  separate 
building. 
Airlock  =  entry  must  be  through  an  airlock  which  is  a  chamber  isolated  from  the  laboratory.  The 
clean  side  of  the  airlock  must  be  separated  from  the  restricted  side  by  changing  or  showering 
facilities and preferably by interlocking doors. 
Activities where transmission does not occur via airborne route. 
HEPA = High efficiency particulate air. 
Where viruses which are not retained by HEPA filters are used, extra requirements will be necessary 
for extract air. 
With validated procedures, allowing the safe transfer of material into an autoclave outside the lab, 
and providing an equivalent level of protection. 

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Table I B 

Containment and other protective measures for glasshouses and growth-rooms 

The terms “glasshouse” and “growth-room” refer to a structure with walls, a roof and a floor 
designed and used principally for growing plants in a controlled and protected environment. 

All provisions of Table I A shall apply with the following additions/modifications: 

Specifications 

Containment levels 

(cid:208) 98/81/EC (adapted) 

1 

2 

3 

4 

Building 

1  ⌦ Glasshouse ⌫: 
permanent structure1 

Not 
required 

Required 

Required 

Required 

Equipment 

3  Entry via a separate 
room with two 
interlocking doors 

Not 
required 

4  Control of 

Optional 

contaminated run-off 
water 

Optional 

Optional 

Required 

Minimise2 run-off  Prevent 
run-off 

Prevent 
run-off 

System of work 

6  Measures to control 
undesired species 
such as insects, 
rodents, arthropods 

Required 

Required 

Required 

Required 

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29 

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Minimise 
dissemination 

Minimise 
dissemination 

Prevent 
dissemination 

Prevent 
dissemination 

7  Procedures for 

transfer of living 
material between the 
glasshouse/growth-
room, protective 
structure and 
laboratory shall 
control dissemination 
of ⌦ GMMs ⌫ 

1 

2 

The glasshouse shall consist of a permanent structure with a continuous waterproof covering, located 
on  a  site  graded  to  prevent  entry  of  surface-water  run-off  ⌦ ,  and  with ⌫  self-closing  lockable 
doors. 
Where transmission can occur through the ground. 

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(cid:208) 98/81/EC Art. 1 pt. 4 

Table I C 

Containment and other protective measures for activities in animal units 

All provisions of Table I A shall apply with the following additions/modifications: 

Specifications 

Containment levels 

1 

2 

3 

4 

Facilities 

1  Isolation of animal unit1  Optional 

Required 

Required 

Required 

2  Animal facilities2 

separated by lockable 
doors 

Optional 

Required 

Required 

Required 

3  Animal facilities 

Optional 

Optional 

Required 

Required 

designed to facilitate 
decontamination 
(waterproof and easily 
washable material 
(cages, etc.)) 

4  Floor and/or walls easily 

Optional 

washable 

Required 
(floor) 

Required 
(floor and 
walls) 

Required 
(floor and 
walls) 

5  Animals kept in 

Optional 

Optional 

Optional 

Optional 

appropriate containment 
facilities such as cages, 
pens or tanks 

6  Filters on isolators or 

isolated room3 

Not 
required 

Optional 

Required 

Required 

1 

2 

3 

Animal unit: a building, or separate area within a building containing facilities and other areas such 
as changing rooms, showers, autoclaves, food storage areas, etc. 
Animal  facility:  a  facility  normally  used  to  house  stock,  breeding  or  experimental  animals  or  one 
which is used for the performance of minor surgical procedures. 
Isolators:  transparent  boxes  where  small  animals  are  contained  within  or  outside  a  cage;  for  large 
animals, isolated rooms may be more appropriate. 

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Table II 

Containment and other protective measures for other activities 

Specifications 

Containment levels 

1 

2 

3 

4 

General 

1  Viable micro-

Optional 

Required 

Required 

Required 

organisms should be 
contained in a system 
which separates the 
process from the 
environment (closed 
system) 

2  Control of exhaust 

gases from the closed 
system 

Not 
required 

Required, 
minimise 
dissemination 

Required, 
prevent 
dissemination 

Required, 
prevent 
dissemination 

3  Control of aerosols 
during sample 
collection, addition of 
material to a closed 
system or transfer of 
material to another 
closed system 

4  Inactivation of bulk 
culture fluids before 
removal from the 
closed system 

5  Seals should be 

designed so as to 
minimise or prevent 
release 

Optional 

Required, 
minimise 
dissemination 

Required, 
prevent 
dissemination 

Required, 
prevent 
dissemination 

Optional 

Required, by 
validated 
means 

Required, by 
validated 
means 

Required, by 
validated 
means 

No specific 
requirement 

Minimise 
dissemination 

Prevent 
dissemination 

Prevent 
dissemination 

6  The controlled area 

Optional 

Optional 

Required 

Required 

should be designed to 
contain spillage of the 
entire contents of the 
closed system 

7  The controlled area 

should be sealable to 
permit fumigation 

Not 
required 

Optional 

Optional 

Required 

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Equipment 

8  Entry via airlock 

Not 
required 

Not required  Optional 

Required 

9  Surfaces resistant to 
water, acids, alkalis, 
solvents, disinfectants, 
decontamination agents 
and easy to clean 

Required 
(bench if 
any) 

Required 
(bench if 
any) 

Required 
(bench if any, 
floor) 

Required 
(bench, floor, 
ceiling, walls)

10  Specific measures to 

Optional 

Optional 

Optional 

Required 

adequately ventilate the 
controlled area in order 
to minimise air 
contamination 

11  The controlled area 

should be maintained at 
an air pressure negative 
to the immediate 
surroundings 

Not 
required 

12  Extract and input air 
from the controlled 
area should be HEPA 
filtered 

Not 
required 

System of work 

13  Closed systems should 
be located within a 
controlled area 

Not 
required 

14  Access should be 

restricted to nominated 
personnel only 

Not 
required 

Not required  Optional 

Required 

Not required  Required 

(extract air, 
optional for 
input air) 

Required 
(input and 
extract air) 

Optional 

Required 

Required 

Required 

Required 

Required 

15  Biohazard signs should 

be posted 

17  Personnel should 

shower before leaving 
the controlled area 

18  Personnel should wear 
protective clothing 

Not 
required 

Not 
required 

Required 

Required 

Required 

Not required  Optional 

Required 

Required 
(work 
clothing) 

Required 
(work 
clothing) 

Required 

Complete 
change before 
exit and entry 

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Waste 

22  Inactivation of GMMs 
in effluent from 
handwashing sinks and 
showers or similar 
effluents 

23  Inactivation of GMMs 
in contaminated 
material and waste 
including those in 
process effluent before 
final discharge 

Not 
required 

Not required  Optional 

Required 

Optional 

Required, by 
validated 
means 

Required, by 
validated 
means 

Required, by 
validated 
means 

_______________ 

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ANNEX V 

⌦ INFORMATION REQUIRED FOR THE NOTIFICATION REFERRED TO IN 
ARTICLES 6, 8 AND 9 ⌫ 

(cid:208) 98/81/EC, Art. 1 pt. 4 (adapted) 

(cid:208) 98/81/EC Art. 1 pt. 4 

PART A 

Information required for the notification referred to in Article 6: 

– 

– 

– 

– 

– 

– 

– 

name of user(s) including those responsible for supervision and safety, 

information  on  the  training  and  qualifications  of  the  persons  responsible  for 
supervision and safety, 

details of any biological committees or subcommittees, 

address and general description of the premises, 

a description of the nature of the work which will be undertaken, 

the class of the contained uses, 

only  for  class  1  contained  uses,  a  summary  of  the  assessment  referred  to  in 
Article 4(2) and information on waste management. 

Information required for the notification referred to in Article 8: 

PART B 

– 

– 

– 

– 

– 

– 

– 

the date of submission of the notification referred to in Article 6, 

the names of the persons responsible for supervision and safety and information on 
their training and qualification, 

the  recipient,  donor  and/or  parental  micro-organism(s)  used  and,  where  applicable, 
the host-vector system(s) used, 

the source(s) and the intended function(s) of the genetic material(s) involved in the 
modification(s), 

the identity and characteristics of the GMM, 

the purpose of the contained use, including the expected results, 

the approximate culture volumes to be used, 

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– 

– 

– 

a  description  of  the  containment  and  other  protective  measures  to  be  applied, 
including  information  about  waste  management,  including  the  wastes  to  be 
generated, their treatment, final form and destination, 

a summary of the assessment referred to in Article 4(2), 

the  information  necessary  for  the  competent  authority  to  evaluate  any  emergency 
response plans, if required under Article 13(1). 

Information required for the notification referred to in Article 9: 

PART C 

(a) 

(b) 

(c) 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

the date of submission of the notification referred to in Article 6, 

the  names  of  the  persons  responsible  for  supervision  and  safety  and 
information on their training and qualification; 

the recipient or parental micro-organism(s) to be used, 

the host-vector system(s) to be used (where applicable), 

the source(s) and intended function(s) of the genetic material(s) involved in the 
modification(s), 

the identity and characteristics of the GMM, 

the culture volumes to be used; 

a description  of  the  containment and other protective  measures to be  applied, 
including information about waste management, including the type and form of 
wastes to be generated, their treatment, final form and destination, 

the purpose of the contained use, including the expected results, 

a description of the parts of the installation; 

(d) 

information about accident prevention and emergency response plans, if any: 

– 

– 

– 

any specific hazards arising from the location of the installation, 

the preventive measures applied, such as safety equipment, alarm systems and 
containment methods, 

the  procedures  and  plans  for  verifying  the  continuing  effectiveness  of  the 
containment measures, 

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– 

– 

a description of information provided to workers, 

the  information  necessary  for  the  competent  authority  to  evaluate  any 
emergency response plans, if required under Article 13(1); 

(e) 

a copy of the assessment referred to in Article 4(2). 

_______________ 

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(cid:207) 

ANNEX VI 

Part A 

Repealed Directive with list of its successive amendments 
(referred to in Article 22) 

Council Directive 90/219/EEC 
(OJ L 117, 8.5.1990, p. 1) 

Commission Directive 94/51/EC 
(OJ L 297, 18.11.1994, p. 29) 

Council Directive 98/81/EC 
(OJ L 330, 5.12.1998, p. 13) 

Council Decision 2001/204/EC 
(OJ L 73, 15.3.2001, p. 32) 

Regulation (EC) No 1882/2003 of the European 
Parliament and of the Council 
(OJ L 284, 31.10.2003, p. 1) 

Annex III, point 19, only 

Part B 

List of time-limits for transposition into national law 
(referred to in Article 22) 

Directive 

Time-limit for transposition 

90/219/EEC 

94/51/EC 

98/81/EC 

23 October 1991 

30 April 1995 

5 June 2000 

_____________ 

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ANNEX VII 

CORRELATION TABLE 

Directive 90/219/EEC 

This Directive 

Article 1 

Article 2 

Article 1 

Article 2 

Article 3, introductory phrase 

Article 3(1), introductory phrase 

Article 3, first indent 

Article 3, second indent 

Article 4, first paragraph 

Article 4, second paragraph 

Article 5 

Article 6 

Article 7 

Article 8 

Article 9 

Article 10 

Article 3(1)(a) 

Article 3(1)(b) 

Article 3(2) 

Article 3(3) 

Article 4 

Article 5 

Article 6 

Article 7 

Article 8 

Article 9 

Article 11(1), (2) and (3) 

Article 10(1), (2) and (3) 

Article 11(4), introductory phrase 

Article 10(4), introductory phrase 

Article 11(4), first indent 

Article 11(4), second indent 

Article 12, first paragraph 

Article 12, second paragraph 

Article 13 

Article 14, first paragraph 

Article 14, second paragraph 

Article 10(4)(a) 

Article 10(4)(b) 

Article 11(1) 

Article 11(2) 

Article 12 

Article 13(1) 

Article 13(2) 

Article 15(1), introductory phrase 

Article 14(1), introductory phrase 

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Article 15(1), first indent 

Article 15(1), second indent 

Article 15(1), third indent 

Article 15(1), fourth indent 

Article 14(1)(a) 

Article 14(1)(b) 

Article 14(1)(c) 

Article 14(1)(d) 

Article 15(2), introductory phrase 

Article 14(2), introductory phrase 

Article 15(2), first indent 

Article 15(2), second indent 

Article 16 

Article 17 

Article 18 

Article 19(1) 

Article 19(2) 

Article 14(2)(a) 

Article 14(2)(b) 

Article 15 

Article 16 

Article 17 

Article 18(1), first subparagraph 

Article 18(1), second subparagraph 

Article 19(3), introductory phrase 

Article 18(2), introductory phrase 

Article 19(3), first indent 

Article 19(3), second indent 

Article 19(3), third indent 

Article 19(4) 

Article 19(5) 

Article 20 

Article 20a 

Article 21(1) 

Article 21(2), first subparagraph 

Article 18(2)(a) 

Article 18(2)(b) 

Article 18(2)(c) 

Article 18(3)  

Article 18(4)  

Article 19 

Article 20 

Article 21(1) 

Article 21(2) 

Article 21(2), second subparagraph 

_________ 

Article 21(3) 

Article 22 

_________ 

_________ 

EN 

_________ 

_________ 

Article 22 

Article 23 

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Article 23 

Annexes I-V 

_________ 

_________ 

Article 24 

Annexes I-V 

Annex VI 

Annex VII 

_____________ 

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