CELEX: 51988PC0160(01)
Language: en
Date: 1988-05-04
Title: PROPOSAL FOR A COUNCIL DIRECTIVE ON THE CONTAINED USE OF GENETICALLY MODIFIED MICROORGANISMS

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,                           Whereas the development of biotechnology is such as to
                                                                   contribute to the economic expansion of the Member
Having regard to the Treaty establishing the European              States; whereas this implies that genetically modified
Economic Community and in particular Article 100A                  micro-organisms will be used in industrial and non-
thereof,                                                           industrial scale operations;
Having regard to the proposal of the Commission,
Having regard       to  the   opinion    of  the   European        Whereas micro-organisms, whether released in the en-
Parliament,                                                        vironment as air emission, liquid or solid wastes or by
                                                                   accident in the course of their contained use may
Having regard to the opinion of the Economic and                   reproduce and spread crossing national frontiers thereby
Social Committee,                                                  affecting bordering Member States or the Community as
                                                                   a whole;
Whereas disparity between the regulation of the
contained use of genetically modified micro-organisms
which are in effect or in preparation in the Member
                                                                   Whereas the contained use of genetically modified
States may create unequal conditions of competition;
                                                                   micro-organisms must be carried out in such a way as to
whereas these distortive effects are specifically important
                                                                   limit their negative consequences for the health of the
in areas where technical progress of the undertakings
                                                                   general population and the environment giving due
involved largely depends on the conditions under which
                                                                   attention to the prevention of accidents and the control
the operation concerned may legally be carried out;
                                                                   of wastes;
whereas disparities of these conditions in the Member
States thus directly affect the functioning of the internal
market;
                                                                  Whereas it is therefore necessary to approximate legis-
Whereas measures for the approximation of the                      lation in the Member States establishing a common
provisions of the Member States which have as their                procedure for the evaluation of the potential risks arising
object the establishment and functioning of the internal           in the course of the contained use of genetically
market shall, inasmuch as they concern health, safety,             modified micro-organisms in research, development,
environmental and consumer protection, take a high                 manufacture, storage, transport, waste treatment and
level of protection as a base and provide, despite existing       disposal in order to enable the safe development of
differences in economies of the Member States, for equal          biotechnology throughout the Community;
standard of protection throughout the Community;
Whereas under the Treaty, action by the Community
relating to the environment shall be based on the                 Whereas the precise nature and scale of risks associated
principle that preventive action shall be taken;                  with genetically modified micro-organisms are conjectual
                                                                  and the hazards involved must be assessed case by case;
Whereas the Fourth Environmental Action Programme                 whereas particular attention must be given to operations
of 19 October 1987 (') of the European Communities                using certain genetically modified micro-organisms;
declares that measures concerning the evaluation and
best use of biotechnology with regard to the environment
are a priority area where Community action should                 Whereas genetically modified micro-organisms must be
concentrate;                                                      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
C) OJ No C 328, 7. 12. 1987, p. 1.                                criteria for classification; whereas to evaluate hazard for
 ---pagebreak--- No C 198/10                           Official Journal of the European Communities                                  28. 7. 88
human health and the environment it is necessary to              HAS ADOPTED THIS DIRECTIVE:
enumerate certain characteristics of the assessment;
                                                                                           Article 1
Whereas the possible accidents should be obviated at
source by the integration of containment measures at the         For the purposes of this Directive:
various stages of development, construction and
operation;
                                                                 (a) 'Micro-organism' means any microbiological entity,
                                                                     cellular or non-cellular, capable of replication.
Whereas a permanent inventory within each Member
State is necessary in order to follow closely the devel-         (b) 'Genetically modified organism' means any organism
opment of the contained use of genetically modified                  derived from the formation of a new combination of
micro-organisms and to trace the origin of any dele-                 genetic material by the insertion of nucleic acid
terious effect that might arise;                                     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
Whereas any person, before undertaking for the first
                                                                     organism in which they do not naturally occur but in
time the contained use of a genetically modified micro-
                                                                     which they are capable of continued propagation.
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          (c) 'A contained use' is any operation in which micro-
man and the environment;                                             organisms are genetically modified, cultured, stored,
                                                                     transported, destroyed or disposed of and for which
                                                                     physical, chemical or biological barriers are used to
Whereas, in the case of industrial operations involving              limit their contact with people and the environment.
certain genetically modified micro-organisms it is                   It does not include operations with micro-organisms
necessary for the user to provide the competent auth-                to be released in the environment under Council
orities with information including details of the micro-             Directive . . . (deliberate release) or products to be
organism used, the installation and the operation in                 placed on the market unter relevant European
question, with a view to reducing the hazards of                     Community legislation.
accidental release and enabling the necessary steps to be
taken to reduce their consequences;
                                                                 (d) 'Industrial scale operation' is any contained use
                                                                     carried out as part of a manufacturing process,
Whereas it is necessary to lay down that any person                  including uses at the pilot plant stage for the devel-
outside the installation liable to be affected by an                 opment of such processes.
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             (e) 'Non-industrial scale operation' is any other contained
emergency plans of the industrial operation; whereas, in             use including for teaching, research and development
order to mitigate the consequences of an accidental                  purposes.
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          (f) Accident' means: any incident involving significant
being made, through some kind of public information                  and unintended emission of genetically modified
media, such as leaflets or information boards;                       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-
Whereas, if an accident occurs, the user must                        vironment.
immediately inform the competent authority and
communicate the information necessary for assessing the          (g) 'User' means: any natural or legal person responsible
impact of that accident;                                             for the contained use of genetically modified micro-
                                                                     organisms.
Whereas a continual analysis of the situation throughout
the Community must be undertaken in order to promote             (h) 'Notification' means: the presentation of documents
both the establishment of lists of activities which ought            containing the requisite information            to the
to be subject to special safety measures or the imposition           competent authority of a Member State.
of more stringent containment measures; whereas in
order to enable this analysis the Member States should
forward to the Commission information regarding
                                                                                           Article 2
certain industrial scale operations with genetically
modified micro-organisms and the accidental releases             1.    For the purpose of this Directive, genetically
occurring in their territory,                                    modified micro-organisms are classifed as follows:
 ---pagebreak---  28. 7. 88                             Official Journal of the European Communities                            No C 198/11
 Group I: those satisfying the criteria of Annex I                                          Article 6
                                                                  Any person wishing to undertake for the first time in a
 Group II: those other than Group I                               particular installation the contained use of genetically
                                                                  modified micro-organisms shall be required to submit to
                                                                  the competent authority, at least 60 days before
 2.    For non-industrial scale operations, the classifi-         commencing such use, a declaration containing at least
 cation by the user of particular micro-organisms may be          the information listed in Annex IV.A.
 provisional. In this case micro-organisms will be referred
 to as 'equivalent' to the above groups.
                                                                                            Article 7
                           Article 3                              1.    Users of micro-organisms classified in, or equiv-
                                                                  alent to, Group I in non-industrial scale operations shall
 1.    This Directive shall apply without prejudice to the        be required to keep records of the work carried out
provisions of Council Directive . . . on the protection of        which shall be available to the competent authority on
workers from the risks related to exposure to biological          request.
 agents at work.
                                                                  2.    Users of micro-organisms classified in Group I in
2.     Articles 5 to 10 do not apply to the transport of          industrial scale operations shall be required to submit to
genetically modified micro-organisms on public roads,             the competent authority, before commencing such use, a
rail, inland waterway, sea or by air.                             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
                           Article 4                              classification. After submission of the notification the
                                                                  industrial scale operation can proceed.
 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                                    Article 8
prevent their negative consequences for the health of the
                                                                  1.    Users of micro-organisms classified in or equivalent
general population and the environment.
                                                                  to Group II in non-industrial scale operations shall be
                                                                 required to submit to the competent authority, before
2.    To this end, the user shall carry out a prior              commencing such use, a notification containing the
assessment of the contained uses in respect of the bio-          information listed in Annex IV.C. The contained use
logical hazards that they may incur.                              may, in absence of any indication to the contrary from
                                                                 the competent authority, proceed 15 days after
                                                                 submission of the notification.
3.     In making such an assessment the user shall, in
particular, take due account of the relevant parameters
                                                                  2.    Users of micro-organisms classified in Group II in
set out in Annex II for any genetically modified micro-          industrial scale operations shall be required to submit to
organism he is proposing to use.                                 the competent authority before commencing such use, a
                                                                 notification containing:
4.    A record of the safety assessment shall be kept by
the user and made available to the competent authority           — information about the micro-organism(s),
upon request.
                                                                 — information about personnel,
                           Article 5                             — information about the installation,
 1.   For micro-organisms in Group I the principles of
good microbiological practice as laid out in Council             — information about waste management,
Directive 80/1107/EEC shall be applied.
                                                                 — information        about     accident   prevention   and
                                                                      emergency response plans,
2.    In addition to these principles, the containment
measures set out in Annex III shall be applied, as appro-        — the safety assessment referred to in Article 4,
priate, to contained uses of micro-organisms in Group II
so as to ensure a high level of safety.
                                                                 the details of which are listed in Annex IV.D.
3.    The containment measures applied shall be period-          The contained use may, in the absence of any indication
ically reviewed to take into account new scientific or           to the contrary from the competent authority, proceed
technical knowledge relative to risk management and              60 days after submission of the notification or earlier,
waste disposal.                                                  with the agreement of the competent authority.
 ---pagebreak--- No C 198/12                           Official Journal of the European Communities                                 28. 7. 88
                          Article 9                              the user shall be required to inform immediately the
                                                                 competent authority specified in Article 10 and provide
The competent authority shall be informed as soon as             the following information:
possible and the declaration and the notification under
Articles 6, 7 and 8 shall be modified when the user              — the circumstances of the accident,
becomes aware of new information or modifies the
contained use in a way that could have significant conse-        — the identity and quantities of the micro-organism (s)
quences for the risk posed by the contained use, or                  released,
which affects the contents of the original declaration and
notification.                                                    — any information necessary for the assessment of the
                                                                     effects of the accident on the health of the general
                         Article 10                                  population and the environment,
1.    Member States shall designate the competent                — the emergency measures taken.
authority or authorities who shall ensure that this
Directive is correctly applied and shall receive the
                                                                 2.    The Member States shall:
declaration and the notifications referred to in Articles 6,
7 and 8.
                                                                 — ensure that any emergency, medium and long-term
                                                                     measures which may prove necessary are taken, and
2.    The competent authority shall examine the                      immediately alert any Member State which could be
conformity of the declaration and the notification with              affected by the accident,
the requirements of this Directive, the accuracy and
completeness of the information given and, where appro-          — collect, where possible, the information necessary for
priate, the adequacy of the waste management, safety,                a full analysis of the accident and make recommen-
and emergency response measures.                                     dations for the avoidance and the limitation of the
                                                                     effects of similar accidents in the future.
3.    If necessary, the competent authority may ask the
user to provide further information or to introduce
                                                                                           Article 13
modifications to the conditions of the proposed
contained use.                                                   1.     Member States shall:
4.    In this case the relevant waiting period is extended       (a) ensure that in the case of contained uses notified
until the notifier complies with the request of the                   under Article 8 (2), the competent authority sends
competent authority and has informed them thereof.                    the following information to the Commission within
                                                                      60 days of receipt of the notification:
                         Article 11
                                                                      — the identity, proposed uses and potential risks of
The competent authority is also responsible for:                          the micro-organism(s),
                                                                      — a summary of the containment measures applied,
— organizing inspections and other control measures to
    ensure the user's compliance with this Directive,                 — a summary of the emergency plans referred to in
                                                                          Article 11;
-— ensuring that, where necessary, before an operation
    commences an emergency plan is drawn up to deal              (b) consult with other Member States likely to be
    with biological hazards outside the installation in the           affected in case of an accident in the drawing-up and
    event of an accident and that the emergency services              implementation of emergency plans;
    are aware of the hazards and are informed of such in
    writing,                                                     (c) inform the Commission as soon as possible of any
                                                                      accident within the scope of this Directive, giving
— ensuring that all persons liable to be affected by an               details of the circumstances of the accident, the
    accident are informed in an appropriate manner of                 identity and quantities of the micro-organisms
    the emergency response measures and of the correct                released, the emergency response measures employed
    behaviour to adopt, sending to the other Member                   and their effectiveness, and an analysis of the
    States concerned the same information as that which               accident including recommendations for the limi-
    is disseminated to their own nationals. The infor-                tation of its effects and the avoidance of similar
    mation shall be communicated to the above                         accidents in the future.
    mentioned persons without their request and shall
    also be published.                                           2.     The Commission shall establish a procedure for the
                                                                 exchange of information under 1 above. It shall also set
                         Article 12                              up and keep at the disposal of the Member States a
                                                                 register of the accidents which have occurred under the
 1.   Member States shall take the necessary measures to         Directive, including an analysis of the causes of the
ensure that, if an accident occurs which can endanger            accidents, experience gained, and measures taken to
the health of the general population and the environment,        avoid similar accidents in the future.
 ---pagebreak--- 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                  Where the procedure laid down in this Article is
Commission a summary report on their experience with                    followed, the representative of the Commission shall
this Directive, the first time being on 1 September 1991.               submit to the committee a draft of the measures to be
                                                                        taken. The committee shall deliver its opinion on the
2.     Every three years, the Commission shall publish a                draft, within a time limit which the chairman may lay
summary based on the report referred to in 1 above, the                 down according to the urgency of the matter, if
first time being in 1992.                                               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
3.     The Commission may publish general statistical                   in the minutes. The Commission shall take the utmost
information on the implementation of this Directive and                 account of the opinion delivered by the Committee. It
related matters, as long as it contains no information                  shall inform the committee of the manner in which its
likely to cause substantial harm to the competitive                     opinion has been taken into account.
position of a user.
                                                                                                Article 17
                           Article 15                                   1.    Member States shall bring into force the laws,
                                                                        regulations and administrative provisions necessary to
1.     The Commission shall be assisted by a committee                  comply with this Directive by . . . .
of an advisory nature composed of the representatives of
the Member States and chaired by the representative of                  2.    The Member States shall immediately inform the
the Commission.                                                         Commission of all laws, regulations and administrative
                                                                        provisions adopted in the implementation of this
2.     Amendments made to the annexes of this Directive                 Directive.
to adapt them to technical progress shall be adopted by                                         Article 18
the Commission in accordance with the procedure laid
down in Article 16.                                                     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).
 ---pagebreak--- N o C 198/14                             Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s           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,
 ---pagebreak--- 28. 7. 88                             Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s          N o 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.
 ---pagebreak--- N o C 198/16                                 Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                  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.
                                                                                          Containment Categories
                              Specifications
                                                                            1                         2                  3
            1. Viable micro-organisms should exist                 Yes                      Yes                  Yes
               in a system which                 physically
               separates the process from the en-
               vironment (closed system)
           2. Exhausted gases from the closed                       Minimise release        Prevent release      Prevent release
               system should be treated so as to:
           3. Sample        collection,      addition    of         Minimise release        Prevent release      Prevent release
               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                     Inactivated by          Inactivated by       Inactivated by
               removed from the closed system                      validated means          validated            validated
               unless the viable micro-organisms                                            chemical or          chemical or
               have been:                                                                   physical means       physical means
           5. Seals should be designed so as to:                    Minimise release        Prevent release      Prevent release
           6. Closed systems should be located                      Optional                Optional             Yes, and
               within a controlled area                                                                          purpose-built
               (a) Biohazard signs should be posted                 Optional                Yes                  Yes
               (b) Access should be restricted to                   Optional                Yes                  Yes, via airlock
                   nominated personnel only
               (c) Personnel should wear protective                Yes, work                Yes                  A complete
                   clothing                                         clothin                                      change
               (d) Decontamination and washing                     Yes                      Yes                  Yes
                   facilities should be provided for
                   personnel
               (e) Personnel should shower before                   No                      Optional             Yes
                   leaving the controlled area
               (f) Effluent from sinks and showers                  No                      Optional             Yes
                   should be collected and inac-
                   tivated before release
 ---pagebreak--- 28. 7. 88                                   Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                N o C 198/17
                                                                                         Containment Categories
                             Specifications
                                                                           1                         2                  3
             (g) The controlled area should be                     Optional                Optional             Yes
                  adequately ventilated to minimise
                  air contamination
             (h) The controlled area should be                     No                      Optional             Yes
                  maintained at an air pressure
                  negative to atmosphere
             (i) Input air and extract air to the                 No                       Optional             Yes
                  controlled area should be HEPA
                  filtered
             (j) The controlled area should be                    No                       Optional             Yes
                  designed to contain spillage of
                  the entire contents of the closed
                  system
             (k) The controlled area should be                    No                       Optional             Yes
                  sealable to permit fumigation
          7. Effluent      treatment      before     final        Inactivated by           Inactivated by       Inactivated by
             discharge                                            validated means          validated            validated
                                                                                           chemical or          physical means
                                                                                           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,
 ---pagebreak--- N o C 198/18                             Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                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.