Amended proposal for a Council Directive amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms
Date: 1997-06-12
Institutions: European Commission
Subjects: access to information, environmental risk prevention, genetically modified organism, microorganism, public health

COMMISSION OF THE EUROPEAN  COMMUNITIES 

Brussels,  12.06.1997 
COM(97) 240 final 

95/0340  (SYN) 

Amended proposal for a 

COUNCIL  DIRECTIVE 

amending Directive 90/219/EEC 
on the contained use of genetically modified  micro-organisms 

(presented by the Commission pursuant to Article  189 a (2) 
of the  EC-Treaty) 

EXPLANATORY  MEMORANDUM 

Pursuant to Article  189 (a) paragraph 2 of the EC treaty, the Commission submits an amended 
proposal  for  a  Council  Directive  amending  Directive  90/219/EEC  on  the  contained  use  of 
genetically  modified  micro-organisms.  The  amended  proposal  takes  account  of  a number  of 
amendments from the European Parliament adopted at its March 1997 Plenary Session. 

In general the Commission cannot accept amendments that seek to limit the information  given 
to the public or the Commission, introduce specific requirements for liability insurance, change 
the legal basis of the Directive or complicate its operation.  However the Commission can 
accept in full amendments 2, 3, 9, 10, 16, 17, 19, 31, 41, 42,49 and 56 which clarify  or further 
the principles of the Commission Proposal. 

In addition the Commission can partially accept amendments 4, 11, 27, 30 (merged with 29), 
37, 38, 39,43,47,48, 54 and 55.  Commentary on these amendments follows:-

Amendment 4 (Article 2 (a)) seeks to delete the words  "including viruses, viroids, animal and 
plant cells in culture, but excluding naked nucleic acid molecules.".  The Commission accepts 
the deletion of "but excluding naked nucleic acid molecules", but wishes to retain the other 
words to assist clarity and maintain the intended scope of the Directive. 

Amendment  11 makes a textual change in Article 6 (a) (1) deleting the word risk and adding 
the plural form of activity.  The Commission accepts this but has substituted contained  use(s) 
in place of activities to be consistent with other amendments. 

Amendment 27 requires in Article  14 (b) information  on safety measures to be included, 
regional administrative authorities to be informed  and a system of co-operation be established 
to guarantee public informed  in detail.  The Commission accepts, with rewording, the 
requirement for information  on safety measures which must be relevant to the emergency 
plans.  However the Commission cannot accept that the Directive would require the 
implementation of a regional system for co-operation within a Member State to guarantee the 
public are informed  in detail.  This is under the responsibility of the Member State. 

Amendment  30 the restriction of serious damage to public health or the environment in Article 
15.1  is  not  acceptable  to  the  Commission.  An  accident  is  defined  in  Article  2(f)  and  the 
proposed  wording  implies  that  damage  must  have  occurred,  whereas  the  current  definition 
covers  the  potential  hazard  from  the  accident.  The  proposed  addition  of  the  words  "and 
unintentionally  released"  added  at  end  of  the  second  indent  of  Article  15.1  has  not  been 
accepted  because  it  restricts  the  article  to  not  covering  accidents  by  self  inoculation 
(injection). 
The  deletion  of  the  word  emergency  in  the  fourth  indent  of  Article  Î5.1  is 
already  in the  Proposal.  The replacement  of the word  avoid  with  prevent  in Article  15.2 is 
accepted by the Commission. 

Amendment  37 (Article 20) seeks to limit the annexes that can be modified  by the committee 
procedure to Annex III par.l  -5 and annexes IV & V. The Commission accepts that annexes I 
& IIB (should be only amendable by the full  procedure.  The Commission is unable to accept 
restriction  on the procedure to amend annexes II and III.  The restriction  on amending  annex 

2 

ÏI  would  prevent  the  operation  of  the  list  of  types  of  GMMs  shown  to  be  safe  for  human 
health and the environment.  It would also prevent the rapid modification  of annex IIA which 
lists  techniques  of  genetic  modification  not  leading  to  a GMM  should  an,  as  yet  unknown, 
safety  issue indicate the need to further  restrict this annex.  The  exclusion  of  some parts of 
annex III would complicate amendments to the annex as a whole. 

Amendment 38 requires in Article 20 (a) (new) that within 6 months of implementation of the 
Directive,  following  a  Commission  proposal,  the  criteria  defining  GMMs  suitable  for 
inclusion  into Annex II B shall  be made  in accordance with Article  100a of the  EC  Treaty. 
The  Commission  has  accepted  this,  but  not  the  suggested  Treaty  base  of  100a  since  the 
Directive is made under Article  130S1. 

Amendment 39 concerns Article 21.  The Commission has accepted a 2a comitology procedure 
which gives flexibility  to the Council to adopt different  measures to those proposed by the 
Commission instead of the 3b procedure contained in the Commission Proposal for the 
modification of Directive 90/2 î 9/EEC.  Concerning the report of experience with the Directive 
the Commission considers that this requirement is present in Article 18.3 and the report will be 
made available to Parliament.  However the proposal in the amendment that the decisions and 
minutes of the committee are made available to the  public is not acceptable to the Commission, 
since it conflicts with the agreement between the Commission and the European Parliament 
(applicable from 1.12.1996)  on transparency and publicity of committee meetings. 

Amendment 43 proposes in Annex III new wording for par.2 a and a specific reference to 
Directive 90/679/EEC on the protection of workers from biological agents in par. 3.  These 
changes are acceptable to the Commission.  The addition of a specific  risk assessment 
procedure for human health is not acceptable to the Commission since the Directive covers 
human health and the environment.  The Commission feels specific guidance of this nature 
would best be produced in guidance to the Annex.  The Commission has accepted text from par. 
5a and par. 5b which assist the clarity of the Commission Proposal. 

Amendments 47 and 48 (Annex IV Table la) amend the requirements for surfaces in 
laboratories.  The Commission accepts that the surfaces should be resistant to water, 
decontamination agents and easy to clean.  The Commission has not accepted the change in 
specification for floors walls and ceilings which are in excess of the requirements of Directive 
90/679/EEC on the protection of workers from biological agents, which also covers GMMs, 
since this measure is primarily related to worker protection. 

Amendments 54 and 55 (Annex IV Table II) amend the requirements for surfaces in facilities 
for other activities.  The Commission accepts that benches, if fitted, should be included at all 
levels and that the surfaces should be resistant to water and decontamination agents.  The 
Commission has not accepted the change in specification  for floors walls and ceilings.  The 
requirement that floors must be resistant at level 2 should remain to be applied on a case by case 
basis depending on the risk assessment which considers the size of the operation.  The 
alterations at levels 3 and 4 are not required due to the absence of very large scale production of 
those agents, 

The Commission can accept in principle amendments  7, 8, 14,15, 21, 22, 23, 24,25, 35 and 
68. Commentary on these amendments follows:-

2> 

Amendment 7 concerning Article 2 (c) is acceptable with a minor rewording to refer to annex II 
C. 

Amendment 8 links the risk assessment to the containment and control measures in Article 6a, 
the Commission accepts the principle but has altered the wording to assist clarity. 

Amendments  14 and 15 seek to introduce the principle of good microbiological practice and the 
requirement to review its application in the workplace in Article 6a (2).  The Commission 
accepts the inclusion of the principle in the Directive, but feels that such technical measures are 
best located in the preface to Annex IV which details the containment and control measures to 
be applied. 

Amendments 21, 22, 23, 24, 25, and 35 introduce the separation of classes 3 and 4 for  different 
notification  requirements in Articles 10, 11, 12 and  18, requiring an explicit consent for 
subsequent activities for class 4 and implicit consent for class 3.  The Commission accepts the 
principle of these amendments to strengthen the administrative controls for high risk work but 
intends to retain the equal treatment of classes 3 & 4, accordingly making both subject to 
explicit consent for all uses in Article 10a (3). 

Amendment 68 seeks to amend the definition of contained use in Article 2 (c) to avoid possible 
confusion  over the use of the word limit.  The Commission accepts the principle of this 
amendment but proposes to replace "avoid their contact with" by expressing the principle aim 
of the Directive using the words "provide a high level of safety  for". 

The Commission has not accepted amendments  1, 6, 12, 13, 18, 20, 26, 28, 32, 33, 34, 36, 40, 
44, 45, 46, 50, 51, 52, 53, 57 and 58. Commentary on these amendments follows:-

Amendment  1  proposing to change the legal basis of the Proposal  from  130S.1 to  100A is not 
acceptable  to the Commission.  Legally,  since the  scope of Directive  90/219/EEC  is not  being 
significantly  altered,  and  it  does  not  impact  directly  on  the  functioning  of  the  harmonised 
market,  there  is  no  legal  argument  to  change  the  legal  basis  of  the  Directive  from  130S1  to 
100A.  In  addition  the  change  of  legal  base  would  prevent  Member  States from providing  in 
their national legislation containment and control measures which are more stringent than those 
provided for in the Directive. 

Amendments  18  &  20  seek  to  separate  class  3  and  4  activities  for  different  notification 
requirements are not acceptable because the Commission believes that such a separation would 
complicate the operation of the Directive and could lead to confusion. 

Amendments  44,  45  and  46  which  seek  to  reintroduce  the  distinction  of  purpose  into  the 
revision  of  the  Directive,  are  not  acceptable  to  the  Commission.  The  Commission  seeks  to 
regulate  the  activity,  for  example  laboratory  work,  irrespective  of the final purpose  for  which 
the work is being undertaken. 

Amendments 26, 36, 57 and 58 have not been accepted by the Commission. These amendments 
seek to limit the information  available to the public or aspects of activities that can be subject to 
public  consultation  to  solely  health  and  environmental  protection  and  emergency  plans.  The 

VJ 

Commission feels that these restrictions will not improve public confidence  in the regulation of 
this technology. 

Amendments  32  and  33  seek  to  restrict  information  required  to  be  given  to  Competent 
Authorities  and  the  Commission  in  the  event  of  an  accident,  to  that  which  presents  possible 
serious  damage.  Under  these  amendments  the  choice  of  what  is  covered  by  health  and 
environmental protection and emergency plans is left with the notifier.  These amendments are 
not acceptable to the Commission. 

Amendments  13 and 28 deal with the issue of liability insurance and the provision of  financial 
security  and  are  not  acceptable  to  the  Commission.  The  subject  of  liability  is  under 
consideration  by  the  Commission,  which  intends  to produce  a white  paper  on  environmental 
liability.  The  Commission  wishes  to  deal  with  this  matter  in  a  horizontal  manner  to  avoid 
different  liability requirements in different  Directives. 

Amendments  6,  12 and  34 have not been accepted  by the Commission  because they  duplicate 
provisions present in Article 2(h), 12.2 and duties present in Articles 8, 9 and 10 respectively. 

Amendment  40 has not been accepted  by the Commission  because  it produces a duplication  of 
existing text within the same annex, which does not assist the clarity of the text. 

Amendments  50  and  51  have  not  been  accepted  by  the  Commission.  These  amendments 
increase the burden of control  measures, by making them requirements,  without the option to 
decide if they are necessary  in all cases.  These measures will not always be required  and thus 
not always increase safety levels. 

Amendment  52 has not been accepted by the Commission.  This precautionary measure should 
not  be  specifically  required  for  class  2  activities.  The  amendment  is  in  excess  of  the 
requirements  of  Directive  90/679/EEC  on  the  protection  of  workers  from  biological  agents, 
which covers GMMs, and this measure is primarily related to worker protection. 

Amendment  53  is technically  invalid  since  the  genetically  modified  micro-organisms  are not 
required to be in a closed system and as such has not been accepted by the Commission. 

S 

Amended Proposal for a 

COUNCIL DIRECTIVE 
amending Directive 90/219/EEC 
on the contained use of genetically modified  micro-organisms 
(presented by the Commission pursuant to Article  189a paragraph 2 of the EC Treaty) 

COMMISSION PROPOSAL 

AMENDED PROPOSAL 

Recital 3a (new) 

of 

the. 

principle 

good 
Whereas 
microbiological practice and the principles 
of safety  and health  at work  laid  down in 
the relevant Community laws should apply 
in  which  genetically 
to  all  activities 
modified  micro-organisms are used; 

Recital 4a (new) 

Whereas  specific  measures  should  be 
adopted  and  used  for  the  control  of  the 
disposal  of material from the  activities  of 
the  contained  use  of  genetically  modified 
micro-organisms: 

Article 2(a) 

(a)  The following  words are added at the  (a)  The following  words are added at the 
end  of  paragraph  (a):  "including  viruses,  end  of  paragraph  (a):  "including  viruses, 
viroids  and  animal  and  plant  cells  in  viroids  and  animal  and  plant  cells  in 
culture  but  excluding  naked  nucleic  acid  culture (words deleted).": 
molecules-"; 

Article 2(c) 

(c) 

"contained  use"  shall  mean:  any  (c) 

transported  or  cultured,  stored,  used, 

"contained  use"  shall  mean:  any 
operation  in  which  micro-organisms  are  operation  in  which  micro-organisms  are 
genetically  modified  or  in  which  such  genetically  modified  or  in  which  such 
genetically  modified  micro-organisms  are  genetically  modified  micro-organisms  are 
cultured,  stored,  used, 
transported  or 
destroyed  [deleted  words], and  for  which  destroyed  [deleted  words], and  for  which 
physical  barriers,  or  a  combination  of  physical  barriers,  or  a  combination  of 
physical  barriers  together  with  chemical  physical  barriers  together  with  chemical 
and/or biological barriers, are used to limit  and/or  biological  barriers,  are  used  to 
their  contact  with  the  general  population  provide  a  high  level  of  safety  for  the 
and  the  environment;  or  any  activity  in  general  population  and  the  environment; 
which 
in  which  genetically 
organisms  are  disposed  o[\  for  which  modified  micro-organisms are disposed  of, 
physical or chemical or biological  barriers,  for  which  physical  or  chemical  or 
or  any  combination  of  these  types,  are  biological  barriers, or  any  combination  of 
these  types,  are  used  to  provide  a  high 
used to limit their contact  with the general 
level  of  safety  for  the  general  population 
population and the environment;" 
and the environment;" 

genetically  modified  micro-  or  any  activity 

G 

Article 3 

This  Directive  shall  not  apply  where 
genetic  modification  is  obtained  through 
the use of the techniques or methods listed 
in Annex II, or for contained-use activities 
involving  other 
types  of  genetically 
modified  micro-organisms  known  to  be 
safe 
the 
environment.  Such  types  of  genetically 
their 
modified  micro-organisms 
characteristics  are  listed  in  Annex  II, Part 
B 

human 

health 

and 

and 

for 

This  Directive  shall  not  apply  where 
genetic  modification  is  obtained  through 
the use of the techniques or methods listed 
in Annex II, or for contained-use activities 
involving  other 
types  of  genetically 
modified  micro-organisms  known  to  be 
safe 
the 
environment.  Such  types  of  genetically 
their 
modified  micro-organisms 
characteristics  are  listed  in  Annex  II, Part 
Band Part C: 

human 

health 

and 

and 

for 

Article 6 (3) 

3.  The  assessment  should  result  in  the 
categorization 
contained-use 
activities  in  the  following  four  classes  of 
risk: 

the 

of 

of 

the 

3.  The assessment shall result in the final 
categorization 
contained-use 
activities  in  the  following  four  classes  of 
risk  and  serve  to  determine  the  level  of 
containment  and  control  measures 
in 
accordance with Article 6a: 

Article 6 (3 a) (new) 

3 a  Where  there  is  doubt  as  to  which  of 
two  classes  of  risk  is  appropriate  for  the 
proposed  contained-use  activityfiesl  the 
higher  classification  should  be  assigned 
until sufficient  evidence justifies the use of 
the lower classification. 

Article 6 (4a) (new) 

4a.  When assessing the risk entailed in an 
activity  involving  genetically  modified 
micro-organisms, the  question  of  disposal 
shall  be  taken  especially  into  account. 
Where  appropriate,  the  necessary  safety 
measures shall be implemented  in order to 
protect human health and the environment. 

Article 6a (1) 

1.  The  user  shall  apply  the  containment 
and control measures from  the appropriate 
Table(s) in Annex IV corresponding to the 
risk  class  of  the  activity,  so  as  to 
keep workplace 
environmental 
and 
exposure 
to  any  genetically  modified 
micro-organisms  to  the  lowest  reasonably 
practicable  level,  and  so  that  a  high  level 
of safety is ensured." 

1.  The  user  shall  apply  the  containment 
and control  measures from  the appropriate 
Table(s) in Annex IV corresponding to the 
class  of  the  contained  use(s).  so  as  to 
keep workplace 
environmental 
and 
exposure 
to  any  genetically  modified 
micro-organisms  to  the  lowest  reasonably 
practicable  level,  and  so  that  a  high  level 
of safety  is ensured." 

"3 

Article 10(1) 

1.  For  the  first  and  subsequent  Class  2 
activities  to  be  carried  out  in  premises 
notified  in  accordance  with  Article  8,  a 
notification  containing 
information 
listed  in  Annex  V,  Part  B  shall  be 
submitted. 

the 

1.  For  the  first  and  subsequent  Class  2 
contained  usefs^  to  be  carried  out  in 
premises  notified 
in  accordance  with 
Article  8,  a  notification  containing  the 
information  listed in Annex V, Part B shall 
be submitted. 

Article  10 (2a) (new) 

a  decision 
from 

2a.  The  applicant  can,  however,  himself 
formal 
request 
a 
authorization 
competent 
authority.  This  decision  must  be  made 
within  a  maximum  of  45  days  from  the 
notification. 

on 
the 

Article  10a (2) 

2. 
If  no  previous  notification  has  been 
submitted  for  Class  3 or a higher  class  of 
activities,  the  contained  use  may  not 
proceed  without 
the 
competent 
competent 
authority.  The 
authority shall communicate its decision in 
latest  90  days  after 
the 
writing  at 
submission of the notification. 

the  consent  of 

2. 
If no previous notification has been 
submitted  for  Class  3 or a higher  class of 
contained  use,  the  contained  use  may  not 
proceed  without 
the 
competent 
competent 
authority.  The 
authority shall communicate its decision in 
latest  90  days  after 
the 
writing  at 
submission of the notification. 

the  consent  of 

Article  10a (3) 

If a previous  notification  has been 
3. 
submitted  for  Class  3 or a higher  class of 
the  associated  consent 
activities  and 
requirements  have  been  satisfied, 
the 
contained  use  may  in  absence  of  any 
indication 
the 
competent  authority  proceed  45 days  after 
submission  of  the  new  notification,  or 
the 
earlier  with 
competent authority." 

the  agreement  of 

the  contrary 

from 

to 

If a previous  notification  has  been 
3. 
submitted  for  Class  3 or a higher  class  of 
activities  and 
the  associated  consent 
requirements  have  been  satisfied  for  the 
same  or  higher  class,  the  contained  use 
may  not  proceed  without  the  consent  of 
the  competent  authority.  The  competent 
authority shall communicate its decision in 
writing  at 
latest  45  days  after 
the 
submission of the notification. 

Article  14(b) 

on 

Information 

emergency 
(b) 
plans 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. 

Information  on  emergency  plans 
(b) 
and relevant safety measures 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, 

Article  15(2) 
(a) 
in  the  second  indent,  the  word 
"avoid" is replaced by the word "prevent" 

£ 

Article  16(1) (a) (new) 

In  point  (a)  of  paragraph  1 of  Article  16. 
the  word  "liable"  is  replaced  bv  the  word 
liKciy  . 

! 

Article 20 

In Article 20,  the words "Annexes II to V" 
In Article  20, the words "Annexes  II to  V" 
are  replaced  1 iy  the  words  "Annexes  I  to  are replaced by the word,s "Annexes II part 
V". 

A. II part C and annexes  III to V". 

Article 20a (new) 

Within  six  months  of  the  implementation 
date of this Directive specified  in Article  2. 
the  criteria  for  the  inclusion  of  certain 
types  of  genetically  modified  micro 
organisms  in  Annex  II.  Part  B.  shall  be 
in  accordance  with  Article 
laid  down 
130Slofthe  EC Treaty. 

Article 21 

shall 

the  opinion  of 

The  Commission 

3. 
adopt 
measures  which  shall  apply  immediately. 
Howeverr  if  these  measures  are  not  in 
the 
accordance  with 
committee, they shall be communicated  by 
the Commission  to the  Council  forthwith. 
In  that  event  the  Commission  mav  defer 
application  of  the  measures  which  it  has 
decided  for  a period  of  not  more  than  one 
month 
such 
from 
communication-

date 

the 

of 

The  Council,  acting  by  a  qualified 
majority,  may  take  a  different  decision 
within  the  time-limit  referred  to  in  the 
previous  subparagraph. 

Annex II part  B 

Types of genetically modified 

B. 
micro-organisms wliich have j)een shown 
to be safe for  luman health and the 
environment ; nd  which are, therefore, 
excluded front the Directive:" 

B.  Criteria  establishing  the safety  of 
genetically  modified  micro-organisms  to 
human health and the environment, 

Annex II part C (new) 

CL  Types  of genetically  modified  micro 
organisms which meet tie  criteria  listed 
in part  B 

Annex III par. 2 

3 

a. 

2. 
Article  6 
following: 

The  assessment  referred  to  in 
the 

should  be  based  on 

The assessment  referred  to  in  Article 

2. 
6 should be based on the  following: 

(i) 

the recipient  micro-organism; 

the 
(ii) 
material; 

inserted 

(donated) 

genetic 

(iii) 

the  vector; 

the  donor  micro-organism 

(iv) 
(if  the 
donor  micro-organism  is  used  during  the 
operation); 

a.  The  identification  of  any  potentially 
harmful 
in 
particular  any  potentially  harmful  effects 
caused by: 

the  operation 

effects  of 

(i) 

the recipient  micro-organism; 

the 
(ii) 
material; 

inserted 

(donated) 

genetic 

(iii) 

the vector; 

the resulting genetically  modified 

(v) 
micro-organisms. 

(iv) 
the 
the  donor  micro-organism  (if 
donor  micro-organism  is  used  during  the 
operation); 

The 
b. 
harmful  effects. 

severity  of 

the  potentially 

the resulting genetically  modified 

(v) 
micro-organisms. 

The likelihood of the potentially 

c. 
harmful  effects  being  realized. 

The 
b. 
harmful  effects. 

severity  of 

the  potentially 

The likelihood of the potentially 

c. 
harmful  effects  being  realized. 

Procedure 

Annex  III par. 3 
Procedure 

3.  In order to arrive  at the  categorization 
of  a  particular  activity,  as  referred  to  in 
into 
Article  6, 
the  user  may 
the 
consideration 
recipient,  the  vector  and,  if  applicable, 
donor  micro-organism  as  given  in  other 
Community 
international  or 
legislation, 
national  schemes  (e.g. WHO, NIH etc.). 

take 
class  of 

risk 

the 

These classification  schemes 

concern natural micro-organisms  and are 
usually  based  on the ability  of micro 
organisms  to cause disease  to humans or 
animals, and  on the severity  and 
transmissibiiity  of the disease  likely  to be 
caused. The  user may  also  take  into 
consideration  classification  schemes 
referring  to plant  pathogens (which  are 
usually  established  on a national  basis). 

the 

risk 

legislation, 

take 
class  of 

3.  In order to arrive at the  categorization 
of  a  particular  activity,  as  referred  to  in 
into 
Article  6, 
the  user  may 
the 
consideration 
recipient,  the  vector  and,  if  applicable, 
donor  micro-organism  as  given  in  other 
Community 
particular 
Directives  90/679/EEC~  on  the  protection 
of  workers  from  risks  related  to  exposure 
to  biological  agents  at  work  as  amended 
by  Directive  93/88/EEC"  and  adapted  to 
technical  progress  by  Directive  95/30/EC". 
Internationa!  or  national  schemes  (e.g. 
Wl 10, NIH  etc.)  and  their  revisions  due  to 
new  scientilic  knowledge  and  technical 
progress  may  also be considered. 

in 

These classification  schemes 

concern  natural  micro-organisms  and are 
usually  based  on the ability  of micro 
organisms  to cause disease to humans or 

OJ  No  L  374  31.12.1990  p.l 
OJ  No  L  268  29.10.1993  p.  0071 
OJ  No  L  155  06.07.1995  p.  0041 

The above mentioned classification 
schemes give only a provisional indication 
of the risk class of the activity and the 
corresponding set of containment and 
control measures required. 

animals, 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 categorization of the contained use 
activities in the four Classes of  risk 
referred to in Article 6(3).  The user may 
also take into consideration  classification 
schemes referring to plant pathogens 
(which are usually established on a 
national basis). The above mentioned 
classification  schemes give only a 
provisional indication of the risk class of 
the activity and the corresponding set of 
containment and control measures 
required. 
Annex 111  par.5b (new) 

5b.  Risk assessments for human health 
and the environment may give rise to 
different  classifications  of the contained 
use.  Where this occurs, the final 
classification  will be the higher of the two 
classifications  with its accompanying 
containment and control measures. 

Annex IV Preface (new paragraphs) 

As  a  minimum,  in  addition  to  specific 
safety  measures,  the  following  principles 
of  good  microbiological  practice  at  work 
shall 
to  genetically 
modified  micro-organisms: 

invariably  apply 

(a) 
when  necessary,  tests  shall  be 
carried  out  to  ascertain  the  presence  of 
viable used organisms outside the physical 
boundaries  within  which 
are 
primarily contained: 

they 

provision  shall  be  made  for  basic 

(b) 
and regular further training of personnel; 

biological  safety  committees  or 
(c) 
subcommittees shall be set up according to 
requirements: 

(d) 

internal  practical  rules  of  conduct 

-i/| 

shall be  drawn  up  and  enforced  to  ensure 
the safety of personnel. 

The  application  of  'Good  microbiological 
practice'  shall  be  reviewed  by  the  user 
periodically.  The  persons  employed  in 
this  area  shall  take  part  in  the  review, 
without  prejudice 
to  Article  11  of 
Directive  89/391/HEC on  the  introduction 
of measures to encourage improvements in 
the safety and health of workers at work-. 

Table I a (line 3) 

Surfaces resistant to acids, alkalis, 
solvents,  disinfectants 
Containment levels 
1  yes (bench) 
2  yes (bench) 
3  yes (bench, floor) 
4  yes (bench, floor, ceiling, walls) 

3  Surfaces resistant to water, acids, 
alkalis, solvents, disinfectants, 
decontamination agents and which 
are easy to clean 
Containment levels 
1  yes(bench) 
2  yes(bench) 
3  yes (bench, floor) 
4  yes (bench, floor, ceiling, walls) 

12  Washing and decontamination 
provisions for personnel 
Containment levels 
1  yes 
2  yes 
3  yes 
4  yes 

Table I a (line 12) 

12  Handwashing and decontamination 

provisions for personnel 
Containment levels 
1  yes 
2  yes 
3  yes 
4  yes 

Surfaces resistant to acids, alkalis, 

Surfaces resistant to water, acids, 

Table II (line 9) 

solvents, disinfectants 
Containment  levels 
1 
2 
3 
4 
walls) 

optional 
optional 
yes (bench if any, floor) 
yes (bench, floor, ceiling, 

alkalis, solvents, disinfectants, 
decontamination agents and which are 
easy clean 

Containment levels 
1 
2 
3 
4 

yes (bench if any) 
yes (bench if any) 
yes (bench if any,  floor) 
yes (bench if any,  floor, 

OJ  N o.  L 1 8 3, 

2 9 . 6 . 1 9 8 9, 

p . l. 

1£ 

ceiling, walls) 

Table II (line 16) 

16  Washing and decontamination 

16 

Handwashing and decontamination 

provisions for personnel 
Containment levels 
yes 
1 
yes 
2 
yes 
3 
yes 
4 

provisions for personnel 
Containment levels 
yes 
1 
yes 
2 
yes 
3 
yes 
4 

*% 

ISSN 0254-1475 

COM(97) 240  final 

DOCUMENTS 

EN 

05  14  15 

Catalogue number  :  CB-CO-97-232-EN-C 

ISBN 92-78-19877-3 

Office  for Official  Publications of the European Communities 

L-2985 Luxembourg 

Ay