Council Directive 98/81/EC of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms
Date: 1998-10-26
Institutions: Council of the European Union
Subjects: bio-industry, genetic engineering, genetically modified organism, occupational safety, preparation for market, public health

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COUNCIL  DIRECTIVE  98/81/EC

of  26  October  1998

amending  Directive  90/219/EEC  on 

the 

contained  use  of  genetically  modified

micro-organisms

THE  COUNCIL  OF  THE  EUROPEAN  UNION,

Having  regard  to  the  Treaty  establishing  the  European
Community,  and  in  particular  Article  103s(1)  thereof,

Having  regard  to  the  proposal  from  the  Commission (1),

Having regard to the opinion of the Economic and Social
Committee (2),

Acting  in  accordance  with  the  procedure  laid  down  in
Article  189c  of  the  Treaty (3),

(5)  Whereas  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  present  Directive;  other
the 
Community  legislation  such  as  Council  Directive
90/220/EEC  of  23  April  1990  on  the  deliberate
release 
the  environment  of  genetically
modified  organisms (4)  may  apply;

scope  of 

into 

(6)  Whereas  exemptions  pursuant  to  this  Directive  do
not  entail  exemptions  pursuant  to  any  other
Community  legislation  that  may  apply,  such  as
Directive  90/220/EEC;

(1)  Whereas,  within  the  meaning  of  the  Treaty,  action
by  the  Community  relating  to  the  environment
should  be  based  on  the  principle  that  preventive
action is to be taken and shall have as its objective
to  preserve,  protect  and  improve  the  environment
and  to  protect  human  health;

(7)  Whereas  for  all  activities  involving  GMMs  the
principles  of  good  microbiological  practice  and
good occupational safety and hygiene should apply
in 
relevant  Community
legislation;

accordance  with 

(2)  Whereas  contained  uses  of  genetically  modified
micro-organisms  (GMMs)  should  be  classified  in
relation to the risks they present for human health
and  the  environment;  whereas  such  classification
should  be  in  line  with  international  practice  and
based  on  an  assessment  of  the  risk;

(3)  Whereas 

level  of
in  order  to  ensure  a  high 
protection  the  containment  and  other  protective
measures  applied 
to  a  contained  use  must
correspond  to  the  classification  of  the  contained
use; whereas 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;

(4)  Whereas  appropriate  measures  should  be  adopted
and used for the control of the disposal of material
from  contained  uses  of  GMMs;

(1)  OJ  C  356,  22.11.1997,  p.  14  and
OJ  C  369,  6.12.1997,  p.  12.
(2)  OJ  C  295,  7.10.1996,  p.  52.
(3)  Opinion  of  the  European  Parliament  of  12  March  1997  (OJ
C  115,  14.4.1997,  p.  59),  Council  common  position  of  16
December  1997  (OJ  C  62,  26.2.1998,  p.  1)  and  Decision  of
the  European  Parliament  of  16  June  1998  (OJ  C  210,
6.7.1998).

(8)  Whereas  the  containment  and  other  protective
measures  applied  to  contained  uses  should  be
reviewed periodically;

(9)  Whereas people employed in contained uses should
be  consulted  in  accordance  with  the  requirements
of  relevant  Community  legislation,  in  particular
Council  Directive  90/679/EEC  of  26  November
1990  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) (5);

(10)  Whereas  weaknesses  have  been 

in
Directive 
the
administrative 
notification
requirements  should  be  linked  to  the  risk  of  the
contained  uses;

90/219/EEC (6); 
procedures 

identified 

whereas 

and 

(4)  OJ  L  117,  8.5.1990,  p.  15.  Directive  as  last  amended  by
Commission  Directive  97/35/EC  (OJ  L  169,  27.6.1997,
p.  72).

(5)  OJ  L  374,  31.12.1990,  p.1.  Directive  as  last  amended  by
Commission  Directive  97/59/EC  (OJ  L  282,  15.10.1997,
p.  33).

(6)  OJ  L  117,  8.5.1990,  p.  1.  Directive  as  amended  by
Commission  Directive  94/51/EC  (OJ  L  297,  18.11.1994,
p.  29).

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(11)  Whereas  Directive  90/219/EEC  did  not  permit
sufficient adaptation to technical progress; whereas
the  technical  parts  of  that  Directive  need  to  be
adapted  to  technical  progress;

transported, destroyed, disposed of or used in any
other  way,  and  for  which  specific  containment
measures  are  used  to  limit  their  contact  with  the
general  population  and  the  environment;

(12)  Whereas 

the 

of  Directive
implementation 
90/219/EEC  could  benefit  from  the  addition  of  a
list  of  GMMs  that  are  safe  for  human  health  and
the  environment;  whereas  these  GMMs  should
meet  certain  criteria  in  order  to  establish  their
safety;

(13)  Whereas,  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  define
and  revise  these  criteria;

(14)  Whereas  there  is  now  considerable  experience  and
the

the  risks  associated  with 

knowledge  of 
contained  use  of  GMMs;

(15)  Whereas Directive 90/219/EEC should therefore be

amended accordingly,

HAS  ADOPTED  THIS  DIRECTIVE:

Article  1

Directive  90/219/EEC  is  hereby  amended  as  follows:

1.  Articles  2  to  16  shall  be  replaced  by  the  following:

‘Article  2

(d) “accident”  shall  mean  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;

(e)  “user”  shall  mean  any  natural  or  legal  person
responsible  for  the  contained  use  of  GMMs;

(f)  “notification”  shall  mean  the  presentation  of  the
requisite  information  to  the  competent  authorities
of  a  Member  State.

Article  3

Without  prejudice  to  Article  5(1)  this  Directive  shall
not  apply:

—  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  to  human  health  and
the  environment.  These  types  of  GMMs  shall  be
listed  in  Annex  II,  Part  C.

For  the  purposes  of  this  Directive:

Article  4

(a)  “micro-organism”  shall  mean  any  microbiological
entity,  cellular  or  non-cellular,  capable  of
replication  or  of  transferring  genetic  material,
including viruses, viroids, animal and plant cells in
culture;

(b) “genetically  modified  micro-organism”  (GMM)
shall  mean  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
genetic
to 

considered 

result 

in 

not 
modification;

(c)  “contained  use”  shall  mean  any  activity  in  which
micro-organisms  are  genetically  modified  or  in
stored,
which 

such  GMMs  are 

cultured, 

Article  5(3)  and  5(6)  and  Articles  6  to  12  shall  not
apply to the transport of GMMs by road, rail, inland
waterway,  sea  or  air.

This  Directive  shall  not  apply  to  the  storage,  culture,
transport,  destruction,  disposal  or  use  of  GMMs
which  have  been  placed  on  the  market  in  accordance
with  Council  Directive  90/220/EEC  of  23  April  1990
on  the  deliberate  release  into  the  environment  of
genetically  modified  organisms (*)  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.

(*) OJ  L  117,  8.5.1990,  p.  15.  Directive  as  last
amended  by  Commission  Directive  97/35/EC  (OJ
L  169,  27.6.1997,  p.  72).

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Article  5

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  incur,  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  6:

Class  1: 

Class  2: 

Class  3: 

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

as  well 

as 

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.

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

for  which 

as  well 

as 

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.

is  doubt  as  to  which  class 

4. Where  there 
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.

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  7,  9  and  10  or  on  request.

Article  6

1. The  user  shall  apply,  except  to  the  extent  that
paragraph 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 5(2) and the
containment  and  other  protective  measures  applied
shall  be  reviewed  periodically,  and  forthwith  if:

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

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

Article  7

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  8

Following  the  notification  referred  to  in  Article  7,
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  5(6),  which
shall be made available to the competent authority on
request.

Article  9

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.

1. For first and subsequent class 2 contained uses to
be carried out in premises notified in accordance with
Article  7,  a  notification  containing  the  information
listed  in  Annex  V,  Part  B  shall  be  submitted.

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

associated 

and 

any 

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

formal  authorisation 

from 

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 
in
the  notification 
paragraph  1,  or  earlier  with  the  agreement  of  the
competent  authority.

referred 

to 

Article  10

1. For  first  and  subsequent  class  3  or  class  4
contained  uses  to  be  carried  out  in  premises  notified
in accordance with Article 7, 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  11

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  7,  9  and  10.

information  given, 

2. The  competent  authorities  shall  examine  the
conformity  of  the  notifications  with  the  requirements
of  this  Directive,  the  accuracy  and  completeness  of
the 
the
assessment  referred  to  in  Article  5(2)  and  the  class  of
contained uses and, where appropriate, the suitability
of the containment and other protective measures, the
waste  management, 
response
and 
measures.

the  correctness  of 

emergency 

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  9  and  10,  any  period  of  time  during
which  the  competent  authority:

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

—  is  carrying  out  a  public  inquiry  or  consultation  in

accordance  with  Article  13

shall  not  be  taken  into  account.

Article  12

the  user  becomes  aware  of 

If 
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  7,  9  and  10  shall  be  modified.

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.

Article  13

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  19.

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Article  14

Article  16

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

1. Member  States  shall  be  required  to:

(a)  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;

(b) information  on  such  emergency  plans,  including
the  relevant  safety  measures  to  be  applied,  is
supplied  in  an  appropriate  manner,  and  without
their  having 
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.

to  request 

it, 

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  15

1. Member  States  shall  take  the  necessary  measures
to  ensure  that,  in  the  event  of  an  accident,  the  user
immediately 
shall  be 
the
required 
in  Article  11  and
competent  authority  specified 
provide  the  following  information:

inform 

to 

—  the  circumstances  of  the  accident,

—  the 

identity  and  quantities  of 

the  GMMs

concerned,

—  any  information  necessary  to  assess  the  effects  of
the  general

the  health  of 

the  accident  on 
population  and  the  environment,

—  the  measures  taken.

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

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

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

(b) 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 
their
effectiveness  and  an  analysis  of  the  accident,
including recommendations to limit its effects and
avoid  similar  accidents  in  the  future.

response  measures 

taken 

and 

in  consultation  with 

2. The  Commission, 
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.’

2.  Articles  18,  19  and  20  shall  be  replaced  by  the

following:

‘Article  18

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  10  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
in
to 
summary  based  on 
paragraph  2,  the  first  time  being  on  5  June  2004.

the  reports  referred 

—  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.

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.

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Article  19

3.  The  following  Article  shall  be  inserted:

1. Where  its  disclosure  affects  one  or  more  of  the  items
in  Article  3(2)  of  Council  Directive
mentioned 
90/313/EEC  of  7  June  1990  on  the  freedom  of  access
to  information  on  the  environment (*),  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.

competent 

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

shall  decide, 

3.
In  no  case  may  the  following  information,  when
submitted  according  to  Articles  7,  9  or  10,  be  kept
confidential:

—  the  general  characteristics  of  the  GMMs,  name  and

address  of  the  notifier,  and  location  of  use,

—  class  of  contained  use  and  measures  of  containment,

—  the evaluation of foreseeable effects, in particular any
the

effects  on  human  health 

and 

harmful 
environment.

4. The  Commission  and  the  competent  authorities  shall
not divulge to third parties any information decided to be
confidential  according  to  paragraph  2  and  notified  or
otherwise  provided  pursuant  to  this  Directive,  and  shall
protect  intellectual  property  rights  relating  to  the  data
received.

5.
If,  for  whatever  reasons,  the  notifier  withdraws  the
notification,  the  competent  authority  must  respect  the
confidentiality  of  the  information  supplied.

‘Article  20a

Before  5  December  2000  Annex  II,  Part  B,  listing  the
criteria  for  inclusion  of  types  of  GMMs  into  Annex
II,  Part  C,  shall  be  adopted  by  the  Council  acting  by
qualified  majority  on  a  proposal 
the
Commission.  Amendments  to  Annex  II,  Part  B,  shall
be  adopted  by  the  Council  acting  by  qualified
majority  on  a  proposal  from  the  Commission.’

from 

4.  The  Annexes  are  replaced  by  the  Annexes  shown  in

the  Annex  hereto.

Article  2

1. Member  States  shall  bring  into  force  the  laws,
regulations  and  administrative  provisions  necessary  to
comply with this Directive not later than 18 months after
the  date  of  its  entry  into  force.  They  shall  forthwith
inform  the  Commission  thereof.

When  Member  States  adopt  these  provisions,  they  shall
contain  a  reference  to  this  Directive  or  shall  be
accompanied  by  such  reference  on  the  occasion  of  their
official  publication.  The  methods  of  making  such
reference  shall  be  laid  down  by  Member  States.

2. Member States shall communicate to the Commission
the  text  of  the  main  provisions  of  national  law  which
they  adopt  in  the  field  covered  by  this  Directive.

Article  3

This  Directive  enters  into  force  on  the  day  of  its
publication  in  the  Official  Journal  of  the  European
Communities.

Article  4

(*)  OJ  L  158,  23.6.1990,  p.  56.

This  Directive  is  addressed  to  the  Member  States.

Article  20

Done  at  Luxembourg,  26  October  1998.

Amendments  necessary  to  adapt  Annex  II,  Part  A,  and
Annexes  III  to  V  to  technical  progress  and  to  adapt
Annex II, Part C, shall be decided in accordance with the
procedure  laid  down  in  Article  21.’

For  the  Council

The  President

W.  SCHÜSSEL

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ANNEX

‘ANNEX  I

PART  A

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

1.  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.

2.  Techniques  involving  the  direct  introduction  into  a  micro-organism  of  heritable  material  prepared

outside  the  micro-organism  including  micro-injection,  macro-injection  and  micro-encapsulation.

3.  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  techniques/methods  excluded  by  Annex  II,  PART  A:

(1) in  vitro  fertilisation;

(2) natural  processes  such  as:  conjugation,  transduction,  transformation;

(3) 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  the  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.  Mutagenesis.

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

physiological processes.

3.  Cell  fusion  (including  protoplast  fusion)  of  cells  of  any  eukaryotic  species,  including  production  of

hybridomas  and  plant  cell  fusions.

4.  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.

PART  B

Criteria  establishing  the  safety  of  GMMs  to  human  health  and  the  environment:

. . .  (to  be  completed  in  accordance  with  the  procedures  in  Article  20a)

PART  C

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

. . .  (to  be  completed  in  accordance  with  the  procedure  in  Article  21)

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ANNEX  III

PRINCIPLES  TO  BE  FOLLOWED  FOR  THE  ASSESSMENT  REFERRED  TO  IN  ARTICLE  5(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  5(2).  It  will  be  supplemented,  as  regards  in  particular
section B, by guidance notes to be developed by the Commission in accordance with the procedure set out
in  Article  21.

These  guidance  notes  shall  be  completed  no  later  than  5  June  2000.

A. ELEMENTS OF ASSESSMENT

1.  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  5(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;

(c)  the  severity  of  the  potentially  harmful  effects;

(d) the  likelihood  of  the  potentially  harmful  effects  being  realised.

B. PROCEDURE

3.  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.

4.  In  general,  only  GMMs  which  show  the  following  characteristics  would  be  considered  appropriate  for

inclusion  in  class  1  as  defined  in  Article  5:

(i)  the  recipient  or  parental  micro-organism  is  unlikely  to  cause  disease  to  humans,  animals  or

plants (1);

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

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(ii) 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  plants (1),  or  likely  to  cause  deleterious  effects  in  the
environment;

(iii) the  GMM  is  unlikely  to  cause  disease  to  humans,  animals  or  plants (1)  and  is  unlikely  to  have

deleterious  effects  on  the  environment.

5.  In  order  to  obtain  the  necessary  information  to  implement  this  process  the  user  may  firstly  take  into
account  relevant  Community  legislation  (in  particular  Council  Directive  90/679/EEC (2)).  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.

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  and  transmissibility
of the disease likely to be caused. Directive 90/679/EEC 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  5(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.

6.  The  hazard  identification  process  carried  out  in  accordance  with  paragraphs  3  to  5,  should  lead  to  the

identification  of  the  level  of  risk  associated  with  the  GMM.

7.  Selection of the containment and other protective measures should then be made on the basis of the level

or  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  paragraph  6.

8.  The  analysis  carried  out  as  described  above  will  finally  lead  to  the  assignment  of  the  activity  to  one  of

the  classes  described  in  Article  5(3).

9.  The final classification of the contained use should be confirmed by reviewing the completed assessment

referred  to  in  Article  5(2).

(1)  This  would  only  apply  to  animals  and  plants  in  the  environment  likely  to  be  exposed.
(2)  OJ L 374, 31.12.1990, p. 1. Directive as last amended by Commission Directive 97/59/EC (OJ L 282, 15.10.1997, p.

33).

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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.

2.  The  titles  of  the  tables  are  indicative:

Table  I  A  presents  minimum  requirements  for  laboratory  activities.

Table  I  B  presents  additions  to  and  modifications  of  Table  I  A  for  glasshouse/growth-room  activities
involving GMMs.

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  5(2).

3.  Member  states  may,  in  implementing  this  Annex,  incorporate  in  addition  the  general  principles  in

paragraphs  1  and  2  in  the  following  tables  for  the  sake  of  clarity  of  the  requirements.

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Table  I  A

Containment  and  other  protective  measures  for  laboratory  activities

Specifications

Containment levels

1

2

3

4

Laboratory  suite:  isolation (1)

Not  required

Not  required

Required

Required

Laboratory:  sealable  for  fumigation

Not  required

Not  required

Required

Required

1

2

Equipment

3

4

5

6

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)

Entry  to  lab  via  airlock (2)

Not  required

Not  required

Optional

Required

Negative  pressure  relative  to  the  pressure  of  the
immediate environment

Not  required

Not  required

Required  except
for (3)

Required

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

Not  required

Not  required

Required
(HEPA) (4)  —
extract  air
except  for (3)

Required
(HEPA) (5)  —
input  and
extract  air

7 Microbiological  safety  post

Not  required

Optional

Required

Required

8

Autoclave

On  site

In  the  building

En  suite (6)

In  lab  =
double-ended

System  of  work

9

Restricted  access

Not  required

Required

Required

Required

10

Biohazard  sign  on  the  door

Not  required

Required

Required

Required

11

Specific  measures  to  control  aerosol  dissemination Not  required

Required
minimise

Required  prevent Required  prevent

13

Shower

Not  required

Not  required

Optional

Required

14

Protective  clothing

Suitable
protective
clothing

Suitable
protective
clothing  and
(optional)
footwear

Suitable
protective
clothing

Complete  change
of  clothing  and
footwear  before
entry  and  exit

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Specifications

Containment levels

1

2

3

4

15 Gloves

Not  required

Optional

Required

Required

18

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

Optional

Required

Required

Required

Waste

19

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

effluent 

in 

Not  required

Not  required

Optional

Required

20

Inactivation of GMMs in contamined material and
waste

Optional

Required

Required

Required

Other  measures

21

Laboratory  to  contain  its  own  equipment

Not  required

Not  required

Optional

Required

23 An  observation  window  or  alternative  is  to  be

Optional

Optional

Optional

Required

present  so  that  occupants  can  be  seen

(1)  Isolation  =  the  laboratory  is  separated  from  other  areas  in  the  same  building  or  is  in  a  separated  building.
(2)  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.

(3)  Activities  where  transmission  does  not  occur  via  airborne  route.
(4)  HEPA  =  High  efficiency  particulate  air.
(5)  Where  viruses  which  are  not  retained  by  HEPA  filters  are  used,  extra  requirements  will  be  necessary  for  extract  air.
(6)  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

1

2

3

4

Building

1

Greenhouse:  permanent  structure (1)

Not  required

Required

Required

Required

Equipment

3

Entry  via  a  separated  room  with  two  interlocking
doors

Not  required

Optional

Optional

Required

4

Control  of  contaminated  run-off  water

Optional

Minimise (2)
run-off

Prevent  run-off

Prevent  run-off

System  of  work

6 Measures  to  control  undesired  species  such  as

Required

Required

Required

Required

insects,  rodents,  arthropods

7

Procedures  for  transfer  of  living  material  between
the  glasshouse/growth-room,  protective  structure
and 
laboratory  shall  control  dissemination  of
genetically  modified  micro-organisms

Minimise
dissemination

Minimise
dissemination

Prevent
dissemination

Prevent
dissemination

(1)  The  glasshouse  shall  consist  of  a  permanent  structure  with  a  continuous  waterproofed  covering,  located  on  a  site  graded  to  prevent  entry  of

surface-water  run-off  having  self-closing  lockable  doors.

(2)  Where  transmission  can  occur  through  the  ground.

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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

2

3

Isolation  of  animal  unit (1)

Optional

Required

Required

Required

Animal facilities (2)  separated  by  lockable  doors

Optional

Required

Required

Required

facilities 

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

designed 

to 

Optional

Optional

Required

Required

4

Floor  and/or  walls  easily  washable

Optional

Required  (floor)

Required  (floor
and  walls)

Required  (floor
and  walls)

5

6

Animals  kept  in  appropriate  containment  facilities
such  as  cages,  pens  or  tanks

Optional

Optional

Optional

Optional

Filters  on  isolators  or  isolated  room (3)

Not  required

Optional

Required

Required

(1)  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.

(2)  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.

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

Optional

Required

Required

Required

2

Control  of  exhaust  gases  from  the  closed  system

Not  required

Required,
minimise
dissemination

Required,
prevent
dissemination

Required,
prevent
dissemination

3

4

5

6

7

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

Optional

Required,
minimise
dissemination

Required,
prevent
dissemination

Required,
prevent
dissemination

Inactivation  of  bulk  culture  fluids  before  removal
from  the  closed  system

Optional

Required,  by
validated means

Required,  by
validated means

Required,  by
validated means

Seals  should  be  designed  so  as  to  minimise  or
prevent release

No  sepecific
requirement

Minimise
dissemination

Prevent
dissemination

Prevent
dissemination

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

Optional

Optional

Required

Required

The  controlled  area  should  be  sealable  to  permit
fumigation

Not  required

Optional

Optional

Required

Equipment

8

9

Entry  via  airlock

Not  required

Not  required

Optional

Required

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  adequately  ventilate  the
controlled  area 
to  minimise  air
in  order 
contamination

Optional

Optional

Optional

Required

11 The controlled area should be maintained at an air

Not  required

Not  required

Optional

Required

pressure  negative  to  the  immediate  surroundings

12

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

Not  required

Not  required

Required
(extract  air,
optional  for
input  air)

Required  (input
and  extract  air)

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Specifications

Containment levels

1

2

3

4

System  of  work

13 Closed  systems  should  be 

located  within  a

Not  required

Optional

Required

Required

controlled  area

14 Access should be restricted to nominated personnel

Not  required

Required

Required

Required

only

15

Biohazard  signs  should  be  posted

Not  required

Required

Required

Required

17

Personnel  should  shower  before 
controlled  area

leaving 

the

Not  required

Not  required

Optional

Required

18

Personnel  should  wear  protective  clothing

Required  (work
clothing)

Required  (work
clothing)

Required

Complete  change
before  exit  and
entry

Waste

22

23

Inactivation  of  GMMs 
handwashing 
sinks  and 
effluents

in 

effluent 

showers  or 

from
similar

Not  required

Not  required

Optional

Required

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

Optional

Required,  by
validated means

Required,  by
validated means

Required,  by
validated means

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ANNEX  V

PART  A

Information  required  for  the  notification  referred  to  in  Article  7:

—  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 5(2) and information

on  waste  management.

PART  B

Information  required  for  the  notification  referred  to  in  Article  9:

—  the  date  of  submission  of  the  notification  referred  to  in  Article  7,

—  the  name  of  the  persons  responsible  for  supervision  and  safety  and  information  on  the  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),

—  identity  and  characteristics  of  the  GMM,

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

—  approximate  culture  volumes  to  be  used,

—  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  5(2),

—  the  information  necessary  for  the  competent  authority  to  evaluate  any  emergency  response  plans  if

required  under  Article  14.

PART  C

Information  required  for  the  notification  referred  to  in  Article  10:

(a)  —  the  date  of  submission  of  the  notification  referred  to  in  Article  7,

—  the  name  of  the  persons  responsible  for  supervision  and  safety  and  information  on  the  training  and

qualification;

(b) —  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  functions(s)  of  the  genetic  material(s)  involved  in  the  modification(s),

—  identity  and  characteristics  of  the  GMM,

—  the  culture  volumes  to  be  used;

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(c)  —  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,

—  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,

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

—  a  description  of  information  provided  to  workers,

—  the  information  necessary  for  the  competent  authority  to  evaluate  any  emergency  response  plans  if

required  under  Article  14;

(e)  a  copy  of  the  assessment  referred  to  in  Article  5(2).’