28. 7. 88 Official Journal of the European Communities No C 198/9 
II 
(Preparatory Acts) 
COMMISSION 
Proposal for a Council Directive on the contained use of genetically modified micro-organisms 
COM(88) 160 final — SYN 131 
(Submitted by the Commission to the Council on 16 May 1988) 
(88/C 198/08) 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European 
Economic Community and in particular Article 100A 
thereof, 
Having regard to the proposal of the Commission, 
Having regard to the opinion of the European 
Parliament, 
Having regard to the opinion of the Economic and 
Social Committee, 
Whereas disparity between the regulation of the 
contained use of genetically modified micro-organisms 
which are in effect or in preparation in the Member 
States may create unequal conditions of competition; 
whereas these distortive effects are specifically important 
in areas where technical progress of the undertakings 
involved largely depends on the conditions under which 
the operation concerned may legally be carried out; 
whereas disparities of these conditions in the Member 
States thus directly affect the functioning of the internal 
market; 
Whereas measures for the approximation of the 
provisions of the Member States which have as their 
object the establishment and functioning of the internal 
market shall, inasmuch as they concern health, safety, 
environmental and consumer protection, take a high 
level of protection as a base and provide, despite existing 
differences in economies of the Member States, for equal 
standard of protection throughout the Community; 
Whereas under the Treaty, action by the Community 
relating to the environment shall be based on the 
principle that preventive action shall be taken; 
Whereas the Fourth Environmental Action Programme 
of 19 October 1987 (') of the European Communities 
declares that measures concerning the evaluation and 
best use of biotechnology with regard to the environment 
are a priority area where Community action should 
concentrate; 
C) OJ No C 328, 7. 12. 1987, p. 1. Whereas the development of biotechnology is such as to 
contribute to the economic expansion of the Member 
States; whereas this implies that genetically modified 
micro-organisms will be used in industrial and non-
industrial scale operations; 
Whereas micro-organisms, whether released in the en­
vironment as air emission, liquid or solid wastes or by 
accident in the course of their contained use may 
reproduce and spread crossing national frontiers thereby 
affecting bordering Member States or the Community as 
a whole; 
Whereas the contained use of genetically modified 
micro-organisms must be carried out in such a way as to 
limit their negative consequences for the health of the 
general population and the environment giving due 
attention to the prevention of accidents and the control 
of wastes; 
Whereas it is therefore necessary to approximate legis­
lation in the Member States establishing a common 
procedure for the evaluation of the potential risks arising 
in the course of the contained use of genetically 
modified micro-organisms in research, development, 
manufacture, storage, transport, waste treatment and 
disposal in order to enable the safe development of 
biotechnology throughout the Community; 
Whereas the precise nature and scale of risks associated 
with genetically modified micro-organisms are conjectual 
and the hazards involved must be assessed case by case; 
whereas particular attention must be given to operations 
using certain genetically modified micro-organisms; 
Whereas genetically modified micro-organisms must be 
classified in relation to their hazard; whereas in the 
absence, at the moment, of specifications necessary for 
allocation of these classes it seems appropriate to provide 
criteria for classification; whereas to evaluate hazard for 
No C 198/10 Official Journal of the European Communities 28. 7. 88 
human health and the environment it is necessary to 
enumerate certain characteristics of the assessment; 
Whereas the possible accidents should be obviated at 
source by the integration of containment measures at the 
various stages of development, construction and 
operation; 
Whereas a permanent inventory within each Member 
State is necessary in order to follow closely the devel­
opment of the contained use of genetically modified 
micro-organisms and to trace the origin of any dele­
terious effect that might arise; 
Whereas any person, before undertaking for the first 
time the contained use of a genetically modified micro­
organism must forward to the competent authority a 
declaration of intent allowing the authority to ensure 
that the proposed activity does not present a danger to 
man and the environment; 
Whereas, in the case of industrial operations involving 
certain genetically modified micro-organisms it is 
necessary for the user to provide the competent auth­
orities with information including details of the micro­
organism used, the installation and the operation in 
question, with a view to reducing the hazards of 
accidental release and enabling the necessary steps to be 
taken to reduce their consequences; 
Whereas it is necessary to lay down that any person 
outside the installation liable to be affected by an 
accident should be appropriately and effectively 
informed on all matters relating to safety; whereas area 
and persons liable to be affected are defined by the 
emergency plans of the industrial operation; whereas, in 
order to mitigate the consequences of an accidental 
release the information on potential hazards and 
measures to be taken has to be communicated on an 
active basis to the concerned persons without a request 
being made, through some kind of public information 
media, such as leaflets or information boards; 
Whereas, if an accident occurs, the user must 
immediately inform the competent authority and 
communicate the information necessary for assessing the 
impact of that accident; 
Whereas a continual analysis of the situation throughout 
the Community must be undertaken in order to promote 
both the establishment of lists of activities which ought 
to be subject to special safety measures or the imposition 
of more stringent containment measures; whereas in 
order to enable this analysis the Member States should 
forward to the Commission information regarding 
certain industrial scale operations with genetically 
modified micro-organisms and the accidental releases 
occurring in their territory, HAS ADOPTED THIS DIRECTIVE: 
Article 1 
For the purposes of this Directive: 
(a) 'Micro-organism' means any microbiological entity, 
cellular or non-cellular, capable of replication. 
(b) 'Genetically modified organism' means any organism 
derived from the formation of a new combination of 
genetic material by the insertion of nucleic acid 
molecules produced by whatever means outside the 
cell, into any virus, bacterial plasmid or other vector 
system so as to allow their incorporation into a host 
organism in which they do not naturally occur but in 
which they are capable of continued propagation. 
(c) 'A contained use' is any operation in which micro­
organisms are genetically modified, cultured, stored, 
transported, destroyed or disposed of and for which 
physical, chemical or biological barriers are used to 
limit their contact with people and the environment. 
It does not include operations with micro-organisms 
to be released in the environment under Council 
Directive . . . (deliberate release) or products to be 
placed on the market unter relevant European 
Community legislation. 
(d) 'Industrial scale operation' is any contained use 
carried out as part of a manufacturing process, 
including uses at the pilot plant stage for the devel­
opment of such processes. 
(e) 'Non-industrial scale operation' is any other contained 
use including for teaching, research and development 
purposes. 
(f) Accident' means: any incident involving significant 
and unintended emission of genetically modified 
micro-organisms in the course of their contained use 
that leads to a serious danger, immediate or delayed, 
to the health of the general population or the en­
vironment. 
(g) 'User' means: any natural or legal person responsible 
for the contained use of genetically modified micro­
organisms. 
(h) 'Notification' means: the presentation of documents 
containing the requisite information to the 
competent authority of a Member State. 
Article 2 
1. For the purpose of this Directive, genetically 
modified micro-organisms are classifed as follows: 
28. 7. 88 Official Journal of the European Communities No C 198/11 
Group I: those satisfying the criteria of Annex I 
Group II: those other than Group I 
2. For non-industrial scale operations, the classifi­
cation by the user of particular micro-organisms may be 
provisional. In this case micro-organisms will be referred 
to as 'equivalent' to the above groups. 
Article 3 
1. This Directive shall apply without prejudice to the 
provisions of Council Directive ... on the protection of 
workers from the risks related to exposure to biological 
agents at work. 
2. Articles 5 to 10 do not apply to the transport of 
genetically modified micro-organisms on public roads, 
rail, inland waterway, sea or by air. 
Article 4 
1. The Member States shall take the necessary steps to 
ensure that the contained use of genetically modified 
micro-organisms shall be carried out in such a way as to 
prevent their negative consequences for the health of the 
general population and the environment. 
2. To this end, the user shall carry out a prior 
assessment of the contained uses in respect of the bio­
logical hazards that they may incur. 
3. In making such an assessment the user shall, in 
particular, take due account of the relevant parameters 
set out in Annex II for any genetically modified micro­
organism he is proposing to use. 
4. A record of the safety assessment shall be kept by 
the user and made available to the competent authority 
upon request. 
Article 5 
1. For micro-organisms in Group I the principles of 
good microbiological practice as laid out in Council 
Directive 80/1107/EEC shall be applied. 
2. In addition to these principles, the containment 
measures set out in Annex III shall be applied, as appro­
priate, to contained uses of micro-organisms in Group II 
so as to ensure a high level of safety. 
3. The containment measures applied shall be period­
ically reviewed to take into account new scientific or 
technical knowledge relative to risk management and 
waste disposal. Article 6 
Any person wishing to undertake for the first time in a 
particular installation the contained use of genetically 
modified micro-organisms shall be required to submit to 
the competent authority, at least 60 days before 
commencing such use, a declaration containing at least 
the information listed in Annex IV.A. 
Article 7 
1. Users of micro-organisms classified in, or equiv­
alent to, Group I in non-industrial scale operations shall 
be required to keep records of the work carried out 
which shall be available to the competent authority on 
request. 
2. Users of micro-organisms classified in Group I in 
industrial scale operations shall be required to submit to 
the competent authority, before commencing such use, a 
notification containing the information listed in Annex 
IV.B. The information shall be sufficient to enable the 
competent authority to assess the correctness of the 
classification. After submission of the notification the 
industrial scale operation can proceed. 
Article 8 
1. Users of micro-organisms classified in or equivalent 
to Group II in non-industrial scale operations shall be 
required to submit to the competent authority, before 
commencing such use, a notification containing the 
information listed in Annex IV.C. The contained use 
may, in absence of any indication to the contrary from 
the competent authority, proceed 15 days after 
submission of the notification. 
2. Users of micro-organisms classified in Group II in 
industrial scale operations shall be required to submit to 
the competent authority before commencing such use, a 
notification containing: 
— information about the micro-organism(s), 
— information about personnel, 
— information about the installation, 
— information about waste management, 
— information about accident prevention and 
emergency response plans, 
— the safety assessment referred to in Article 4, 
the details of which are listed in Annex IV.D. 
The contained use may, in the absence of any indication 
to the contrary from the competent authority, proceed 
60 days after submission of the notification or earlier, 
with the agreement of the competent authority. 
No C 198/12 Official Journal of the European Communities 28. 7. 88 
Article 9 
The competent authority shall be informed as soon as 
possible and the declaration and the notification under 
Articles 6, 7 and 8 shall be modified when the user 
becomes aware of new information or modifies the 
contained use in a way that could have significant conse­
quences for the risk posed by the contained use, or 
which affects the contents of the original declaration and 
notification. 
Article 10 
1. Member States shall designate the competent 
authority or authorities who shall ensure that this 
Directive is correctly applied and shall receive the 
declaration and the notifications referred to in Articles 6, 
7 and 8. 
2. The competent authority shall examine the 
conformity of the declaration and the notification with 
the requirements of this Directive, the accuracy and 
completeness of the information given and, where appro­
priate, the adequacy of the waste management, safety, 
and emergency response measures. 
3. If necessary, the competent authority may ask the 
user to provide further information or to introduce 
modifications to the conditions of the proposed 
contained use. 
4. In this case the relevant waiting period is extended 
until the notifier complies with the request of the 
competent authority and has informed them thereof. 
Article 11 
The competent authority is also responsible for: 
— organizing inspections and other control measures to 
ensure the user's compliance with this Directive, 
-— ensuring that, where necessary, before an operation 
commences an emergency plan is drawn up to deal 
with biological hazards outside the installation in the 
event of an accident and that the emergency services 
are aware of the hazards and are informed of such in 
writing, 
— ensuring that all persons liable to be affected by an 
accident are informed in an appropriate manner of 
the emergency response measures and of the correct 
behaviour to adopt, sending to the other Member 
States concerned the same information as that which 
is disseminated to their own nationals. The infor­
mation shall be communicated to the above 
mentioned persons without their request and shall 
also be published. 
Article 12 
1. Member States shall take the necessary measures to 
ensure that, if an accident occurs which can endanger 
the health of the general population and the environment, the user shall be required to inform immediately the 
competent authority specified in Article 10 and provide 
the following information: 
— the circumstances of the accident, 
— the identity and quantities of the micro-organism (s) 
released, 
— any information necessary for the assessment of the 
effects of the accident on the health of the general 
population and the environment, 
— the emergency measures taken. 
2. The Member States shall: 
— ensure that any emergency, medium and long-term 
measures which may prove necessary are taken, and 
immediately alert any Member State which could be 
affected by the accident, 
— collect, where possible, the information necessary for 
a full analysis of the accident and make recommen­
dations for the avoidance and the limitation of the 
effects of similar accidents in the future. 
Article 13 
1. Member States shall: 
(a) ensure that in the case of contained uses notified 
under Article 8 (2), the competent authority sends 
the following information to the Commission within 
60 days of receipt of the notification: 
— the identity, proposed uses and potential risks of 
the micro-organism(s), 
— a summary of the containment measures applied, 
— a summary of the emergency plans referred to in 
Article 11; 
(b) consult with other Member States likely to be 
affected in case of an accident in the drawing-up and 
implementation of emergency plans; 
(c) 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 micro-organisms 
released, the emergency response measures employed 
and their effectiveness, and an analysis of the 
accident including recommendations for the limi­
tation of its effects and the avoidance of similar 
accidents in the future. 
2. The Commission shall establish a procedure for the 
exchange of information under 1 above. It shall also set 
up and keep at the disposal of the Member States a 
register of the accidents which have occurred under the 
Directive, including an analysis of the causes of the 
accidents, experience gained, and measures taken to 
avoid similar accidents in the future. 
28. 7. 88 Official Journal of the European Communities No C 198/13 
Article 14 Article 16 
1. Every three years, Member States shall send the 
Commission a summary report on their experience with 
this Directive, the first time being on 1 September 1991. 
2. Every three years, the Commission shall publish a 
summary based on the report referred to in 1 above, the 
first time being in 1992. 
3. 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 substantial harm to the competitive 
position of a user. 
Article 15 
1. The Commission shall be assisted by a committee 
of an advisory nature composed of the representatives of 
the Member States and chaired by the representative of 
the Commission. 
2. Amendments made to the annexes of this Directive 
to adapt them to technical progress shall be adopted by 
the Commission in accordance with the procedure laid 
down in Article 16. Where the procedure laid down in this Article is 
followed, the representative of the Commission shall 
submit to the committee a draft of the measures to be 
taken. The committee shall deliver its opinion on the 
draft, within a time limit which the chairman may lay 
down according to the urgency of the matter, if 
necessary by taking a vote. The opinion shall be 
recorded in the minutes; in addition, each Member State 
shall have the right to ask to have its position recorded 
in the minutes. The Commission shall take the utmost 
account of the opinion delivered by the Committee. It 
shall inform the committee of the manner in which its 
opinion has been taken into account. 
Article 17 
1. Member States shall bring into force the laws, 
regulations and administrative provisions necessary to 
comply with this Directive by .... 
2. The Member States shall immediately inform the 
Commission of all laws, regulations and administrative 
provisions adopted in the implementation of this 
Directive. 
Article 18 
This Directive is addressed to the Member States. 
ANNEX I 
Criteria for classifying genetically manipulated micro-organisms in Group I 
Host or parental organism 
— non-pathogenic, 
— no adventitious agents, 
— proven history of extensive safe use, or 
— built-in environmental limitations permitting optimal growth in the reactor or fermenter but limited 
survival without adverse consequences in the environment. 
Vector/insert 
— well characterized and free from known harmful sequences, 
— limited in size as much as possible to the DNA required to perform the intended function, 
— should not increase the stability of the resulting organism in the environment (unless that is a 
requirement of intended function), 
— should be poorly mobilisable, 
— should not transfer any resistance markers to micro-organisms not known to acquire them naturally (if 
such acquisition could compromise use of drugs to control disease agents). 
No C 198/14 Official Journal of the European Communities 28. 7. 88 
Genetically manipulated micro-organism 
— non-pathogenic, 
— as safe in the reactor or fermenter as host or parental organism, but with limited survival without 
adverse consequences in the environment. 
Other classes of micro-organisms that could be included in Group I if they are not pathogenic are: 
— those constructed entirely from a single prokaryotic host (including its indigenous plasmids and viruses) 
or from a single eukariotic host (including its chloroplasts, mitochondria, plasmids, but excluding 
viruses), 
— those that consist entirely of DNA segments from different species that exchange DNA by known 
physiological processes. 
ANNEX II 
Points to consider in conducting the safety assessment referred to in Article 4 
A. Characteristics of the parental micro-organism(s) 
B. Characteristics of the modified micro-organism 
C. Health considerations 
D. Environmental considerations 
A. Characteristics of the parental micro-organistn(s) 
— names and designation, 
— degree of relatedness, 
— sources of the micro-organism(s) 
— information on reproductive cycles (sexual/asexual) of the parental micro-organism(s) or, where 
applicable, of the host micro-organism, 
— history of prior genetic manipulations, 
— stability of parental or of recipient micro-organisms in terms of relevant genetic traits, 
— nature of pathogenicity and virulence, infectivity, toxicity and vectors, 
— host range, 
— other potentially significant physiological traits, 
— stability of these traits, 
— natural habitat and geographic distribution. Climatic characteristics of original habitats, 
— significant involvement in environmental processes, 
— interaction with and effects on other organisms in the environment, 
— ability to form survival structures. 
B. Characteristics of the modified micro-organism 
— the nature of the modification, 
— the function of the genetic manipulation or of the new nucleic acid, 
— nature and source of the vector 
— structure and amount of any vector and/or donor nucleic acid remaining in the final construction of 
the modified micro-organism, 
— stability of the micro-organism in terms of genetic traits, 
28. 7. 88 Official Journal of the European Communities No C 198/15 
— frequency of mobilization of inserted vector and/or genetic transfer capability, 
— rate and level of expression of the new genetic material, 
— activity of the expressed protein. 
C. Health considerations 
— allergenic and toxic hazard of the protein or of non-viable micro-organisms, 
— comparison of the modified micro-organism to the parent micro-organism regarding pathogenicity, 
— capacity for colonisation, 
— if the micro-organism is pathogenic to humans who are immunocompetent: 
(a) diseases caused and mechanism of pathogenicity including invasiveness and virulence, 
(b) communicability, 
(c) infective dose, 
(d) host range, possibility of alteration, 
(e) possibility of survival outside human host, 
(f) presence of vectors or means of dissemination, 
(g) biological stability, 
(h) antibiotic-resistance patterns, 
(i) allergenicity, 
(j) availibity of appropriate therapies. 
D. Environmental considerations 
— factors affecting survival and multiplication of the engineered micro-organism in the environment, 
— available techniques for detection, identification and monitoring of the engineered micro-organism, 
— available techniques for detecting transfer of the new genetic material to other organisms, 
— known and predicted habitats of the engineered micro-organism, 
— description of ecosystems to which the micro-organism could be accidentally disseminated, 
— anticipated mechanism and result of interaction between the engineered micro-organism and the 
organisms or micro-organisms which might be exposed in case of release to the environment, 
— known or predicted effects on plants and animals such as pathogenicity, infectivity, toxicity, 
virulence, vector of pathogen, allergenicity, colonisation, 
— known or predicted involvement in biogeochemical processes, 
— availability of methods for decontamination of the area in case of release to the environment. 
No C 198/16 Official Journal of the European Communities 28. 7. 88 
ANNEX III 
The containment measures for micro-organisms from Group II shall be chosen by the user from the 
categories below as appropriate to the micro-organism and the operation in question in order to ensure the 
protection of the public health of the general population and the environment. 
Industrial uses shall be considered in terms of their unit operations. The characteristics of each operation 
will dictate the physical containment to be used at that stage. This will allow selection and design of 
process, plant and operating procedures best fitted to assure adequate and safe containment. Two 
important factors to be considered when selecting the equipment needed to implement the containment are 
the risk of, and the effects consequent on, equipment failure. Engineering practice may require increasingly 
stringent standards to reduce the risk of failure as the consequence of that failure becomes less tolerable. 
Containment measures for non-industrial scale operations shall be derived from the containment categories 
below, bearing in mind the specific circumstances of smaller-scale operations. 
Specifications 
1. Viable micro-organisms should exist 
in a system which physically 
separates the process from the en­
vironment (closed system) 
2. Exhausted gases from the closed 
system should be treated so as to: 
3. Sample collection, addition of 
materials to a closed system and 
transfer of viable micro-organisms to 
another closed system, should be 
performed so as to: 
4. Bulk culture fluids should not be 
removed from the closed system 
unless the viable micro-organisms 
have been: 
5. Seals should be designed so as to: 
6. Closed systems should be located 
within a controlled area 
(a) Biohazard signs should be posted 
(b) Access should be restricted to 
nominated personnel only 
(c) Personnel should wear protective 
clothing 
(d) Decontamination and washing 
facilities should be provided for 
personnel 
(e) Personnel should shower before 
leaving the controlled area 
(f) Effluent from sinks and showers 
should be collected and inac­
tivated before release Containment Categories 
1 
Yes 
Minimise release 
Minimise release 
Inactivated by 
validated means 
Minimise release 
Optional 
Optional 
Optional 
Yes, work 
clothin 
Yes 
No 
No 2 
Yes 
Prevent release 
Prevent release 
Inactivated by 
validated 
chemical or 
physical means 
Prevent release 
Optional 
Yes 
Yes 
Yes 
Yes 
Optional 
Optional 3 
Yes 
Prevent release 
Prevent release 
Inactivated by 
validated 
chemical or 
physical means 
Prevent release 
Yes, and 
purpose-built 
Yes 
Yes, via airlock 
A complete 
change 
Yes 
Yes 
Yes 
28. 7. 88 Official Journal of the European Communities No C 198/17 
Specifications 
(g) The controlled area should be 
adequately ventilated to minimise 
air contamination 
(h) The controlled area should be 
maintained at an air pressure 
negative to atmosphere 
(i) Input air and extract air to the 
controlled area should be HEPA 
filtered 
(j) The controlled area should be 
designed to contain spillage of 
the entire contents of the closed 
system 
(k) The controlled area should be 
sealable to permit fumigation 
7. Effluent treatment before final 
discharge Containment Categories 
1 
Optional 
No 
No 
No 
No 
Inactivated by 
validated means 2 
Optional 
Optional 
Optional 
Optional 
Optional 
Inactivated by 
validated 
chemical or 
physical means 3 
Yes 
Yes 
Yes 
Yes 
Yes 
Inactivated by 
validated 
physical means 
ANNEX IV 
PART A 
Information required for the declaration referred to in Article 6: 
— name of person(s) responsible for carrying out the contained use, 
— description of the education and training received by the persons who will carry out the work, of the 
persons who will take part in them, of the persons who will be responsible for supervision, monitoring 
and safety and of the person responsible for carrying out the safety assessment, 
— the address of the installation, 
— a description of the nature of the work which will be undertaken and in particular the classification of 
the micro-organism(s) to be used and the likely scale of the operation. 
PART B 
Information required for the notification referred to in Article 7 (2): 
— the date of submission of the declaration referred to in Article 6, 
— the parental micro-organism(s) used or, where applicable the host-vector system(s) used, 
— the source(s) and the intended function(s) of the genetic material(s) involved in the manipulation(s), 
— the purpose of the contained use including the expected results, 
— the culture volumes to be used. 
PART C 
Information required for the notification referred to in Article 8 (1): 
— the information required in Part B, 
No C 198/18 Official Journal of the European Communities 28. 7. 88 
— description of the sections of the installation, of the predominant meteorological conditions and of the 
potential sources of danger arising from the location of the installation, 
— description of the protective and supervisory measures to be applied throughout the duration of the 
contained use, 
— the safety precautions and containment measures to be adopted including waste treatment provisions. 
PART D 
Information required for the notification referred to in Article 8 (2): 
If it is not technically possible or if it does not appear necessary to give the information specified below, 
the reasons shall be stated. The level of detail required in response to each subset of considerations is likely 
to vary according to the nature and the scale of the proposed contained use. In the case of information 
already submitted to the competent authority under the requirements of this Directive, reference can be 
made to this information by the user. 
(a) the date of submission of the declaration referred to in Article 6 and the name of the responsible 
person(s); 
(b) information about the micro-organism(s): 
— the identity and characteristics of the micro-organism(s), 
— the purpose of the contained use or the nature of the product, 
— the host-vector system to be used (where applicable), 
— the volumes to be used, 
— behaviour and characteristics of the micro-organism(s) in the case of changes in the conditions of 
containment or of release to the environment, 
— overview of the potential hazards associated with the release of the micro-organisms to the en­
vironment, 
— substances which are or may be producted in the course of the use of the micro-organism(s) other 
than the intended product; 
(c) information about personnel: 
— the maximum number of persons working in the installation and the number of persons who work 
directly with the micro-organism(s); 
(d) information about the installation: 
— the activity in which the micro-organism(s) is to be used, 
— the technological processes used, 
— a description of the sections of the installation, 
— the predominant meteorological conditions, and sources of danger arising from the location of the 
installation; 
(e) information about waste management: 
— types, quantities, and potential hazards of wastes arising from the use of the micro-organism(s), 
— waste management techniques used, including recovery, liquid or solid wastes, 
— ultimate form and destination of inactivated wastes; 
(f) information about accident prevention and emergency response plans: 
— the sources of hazards and conditions under which accidents might occur, 
— the preventive measures applied such as safety equipment, alarm systems, containment methods and 
procedures and available resources, 
— a description of information provided to workers, 
— the information necessary for the competent authority to enable them to draw up or establish the 
necessary emergency response plans for use outside the installation in accordance with Article 11. 
(g) a comprehensive assessment (referred to in Article 4) of the potential hazards and risks which might 
arise from the proposed contained use.