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) 
Whereas the. principle of good 
microbiological practice and the principles 
of safety and health at work laid down in 
the relevant Community laws should apply 
to all activities in which genetically 
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) "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 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 genetically modified micro- or any activity 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 
used to limit their contact with the general these types, are used to provide a high 
population and the environment;" level of safety for the general population 
and the environment;" 
G 
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 for human health and the 
environment. Such types of genetically 
modified micro-organisms and their 
characteristics are listed in Annex II, Part 
B 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 for human health and the 
environment. Such types of genetically 
modified micro-organisms and their 
characteristics are listed in Annex II, Part 
Band Part C: 
Article 6 (3) 
3. The assessment should result in the 
categorization of the contained-use 
activities in the following four classes of 
risk: 3. The assessment shall result in the final 
categorization of the 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 and environmental 
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 and environmental 
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 the information 
listed in Annex V, Part B shall be 
submitted. 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) 
2a. The applicant can, however, himself 
request a decision on a formal 
authorization from the competent 
authority. This decision must be made 
within a maximum of 45 days from the 
notification. 
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 consent of the 
competent authority. The competent 
authority shall communicate its decision in 
writing at the latest 90 days after 
submission of the notification. 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 consent of the 
competent authority. The competent 
authority shall communicate its decision in 
writing at the latest 90 days after 
submission of the notification. 
Article 10a (3) 
3. If a previous notification has been 
submitted for Class 3 or a higher class of 
activities and the associated consent 
requirements have been satisfied, the 
contained use may in absence of any 
indication to the contrary from the 
competent authority proceed 45 days after 
submission of the new notification, or 
earlier with the agreement of the 
competent authority." 3. If a previous notification has been 
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 the latest 45 days after 
submission of the notification. 
Article 14(b) 
(b) Information on emergency 
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. (b) Information on emergency plans 
and relevant safety measures 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. 
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 
laid down in accordance with Article 
130Slofthe EC Treaty. 
Article 21 
3. The Commission shall adopt 
measures which shall apply immediately. 
Howeverr if these measures are not in 
accordance with the opinion of the 
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 from the date of such 
communication-
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 
B. Types of genetically modified B. Criteria establishing the safety of 
micro-organisms wliich have j)een shown genetically modified micro-organisms to 
to be safe for luman health and the human health and the environment, 
environment ; nd which are, therefore, 
excluded front the Directive:" 
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 
2. a. The assessment referred to in 
Article 6 should be based on the 
following: 
(i) the recipient micro-organism; 
(ii) the inserted (donated) genetic 
material; 
(iii) the vector; 
(iv) the donor micro-organism (if the 
donor micro-organism is used during the 
operation); 
(v) the resulting genetically modified 
micro-organisms. 
b. The severity of the potentially 
harmful effects. 
c. The likelihood of the potentially 
harmful effects being realized. 2. The assessment referred to in Article 
6 should be based on the following: 
a. The identification of any potentially 
harmful effects of the operation in 
particular any potentially harmful effects 
caused by: 
(i) the recipient micro-organism; 
(ii) the inserted (donated) genetic 
material; 
(iii) the vector; 
(iv) the donor micro-organism (if the 
donor micro-organism is used during the 
operation); 
(v) the resulting genetically modified 
micro-organisms. 
b. The severity of the potentially 
harmful effects. 
c. The likelihood of the potentially 
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 
Article 6, the user may take into 
consideration the risk class of the 
recipient, the vector and, if applicable, 
donor micro-organism as given in other 
Community legislation, international or 
national schemes (e.g. WHO, NIH etc.). 
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). 3. In order to arrive at the categorization 
of a particular activity, as referred to in 
Article 6, the user may take into 
consideration the risk class of the 
recipient, the vector and, if applicable, 
donor micro-organism as given in other 
Community legislation, in 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. 
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 animals, and on the severity and 
schemes give only a provisional indication transmissibility of the disease likely to be 
of the risk class of the activity and the caused. Directive 90/679/EEC classifies 
corresponding set of containment and micro-organisms, as biological agents, into 
control measures required. 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 invariably apply to genetically 
modified micro-organisms: 
(a) when necessary, tests shall be 
carried out to ascertain the presence of 
viable used organisms outside the physical 
boundaries within which they are 
primarily contained: 
(b) provision shall be made for basic 
and regular further training of personnel; 
(c) biological safety committees or 
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) 
Table I a (line 12) 
12 Washing and decontamination 
provisions for personnel 
Containment levels 
1 yes 
2 yes 
3 yes 
4 yes 12 Handwashing and decontamination 
provisions for personnel 
Containment levels 
1 yes 
2 yes 
3 yes 
4 yes 
Table II (line 9) 
Surfaces resistant to acids, alkalis, 
solvents, disinfectants 
Containment levels 
1 
2 
3 
4 
walls) optional 
optional 
yes (bench if any, floor) 
yes (bench, floor, ceiling, Surfaces resistant to water, acids, 
alkalis, solvents, disinfectants, 
decontamination agents and which are 
easy clean 
Containment levels 
1 yes (bench if any) 
2 yes (bench if any) 
3 yes (bench if any, floor) 
4 yes (bench if any, floor, 
OJ No. L183, 29.6.1989, p.l. 
1£ 
ceiling, walls) 
Table II (line 16) 
16 Washing and decontamination 16 Handwashing and decontamination 
provisions for personnel provisions for personnel 
Containment levels Containment levels 
1 yes 1 yes 
2 yes 2 yes 
3 yes 3 yes 
4 yes 4 yes 
*% 

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COM(97) 240 final 
DOCUMENTS 
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