CELEX: 51988PC0160
Language: en
Date: 1988-05-04
Title: Proposal for a COUNCIL DIRECTIVE on the contained use of genetically modified microorganisms#Proposal for a COUNCIL DIRECTIVE on the deliberate release to the environment of genetically modified organisms#(submitted by the Commission)

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COM (88) 160
Vol. 1988/0048
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                        COM(88 ) 160 final - SYN 131
                                        Brussels , 4 May 1988
                                Proposai for a
                               COUNCIL DIRECTIVE
        on the contained use of genetically modified microorganisms
                                Proposai for a
                               COUNCIL DIRECTIVE
              on the deliberate release to the environment of
                       genetically modified organisms
                        ( submitted by the Commission )
 ---pagebreak---                  PROPOSAL
                  FOR A
COUNCIL DIRECTIVE ON THE CONTAINED USE
OF GENETICALLY MODIFIED MICROORGANISMS
 ---pagebreak---                          EXPLANATORY_ MEMORANDUM
I.   INTRODUCTION
1 . In its Communication to the Council "A Community Framework for the
Regulation    of Biotechnology "   ( Com ( 86)573 final ), the Commission
signaled its intention to introduce proposals for Community Regulation
of biotechnology which would address two distinct aspects of the use
of genetic engineering :
A . Levels of physical and biological containment ,       accident   control
    and waste management in industrial applications ;
B . Authorization    of  planned   release      of  genetically     modified
    organisms to the environment .
2 . The detailed rules for the containment of genetically modified
microorganisms which are pathogenic to humans are laid down in the
proposal for a Council Directive on the protection of workers from the
risks related to exposure to biological agents at work . These rules
have    worker protection    as their       primary  objective     and   are
complementary     to the proposals on contained use of genetically
modified microorganisms accompanying this memorandum .
3 . A further proposal deals with the release of genetically modified
organisms to the environment , and together with this proposal and the
worker protection proposal forms a coherent legal framework to deal
with questions of genetically modified organisms .
4 . It is obviously necessary that installations carrying out work with
genetically modified microorganisms do this in a manner which presents
or minimizes any potential risk to man and the environment and while
it is recognized that in the majority of cases the microorganisms used
will constitute a minimal risk and require only that good operating
practices are respected , there will be other cases where by virtue of
the presumed pathogenicity or other properties of the microorganism in
question , special measures for containment and , if necessary , accident
response    procedures will be appropriate .        Therefore , regulatory
measures are needed to ensure that the use of genetically modified
microorganisms is undertaken with the degree of security ( control )
commensurate with the potential risk involved .
5 . In 1986 , the OECD Council issued a Recommendation on safety
considérations for applications of Recombinant DNA .         The Commission
and    the Member States participated in the préparation of this
Recommendation .
 ---pagebreak---                                        2
The technical control     of the Commission's proposals are based on this
OECD Recommendation .                             ; .          ;
6 . As ' the development and industrial application of the new techniques
of genetic engineering continue to expand very rapidly the Commission
considers- that , both from the viewpoint of avoiding the “ fragmentation
of the market and of ensuring a high and . consistent 0 standard of
protection for man and the environment , regulatory measures should be
introduced at a Community level in relation to the contained use of
genetically modified microorganisms . -                                r
II . THE CONTAINED USE OF GENETICALLY MODIFIED MICRQORGANISMS
1 . LEGISLATION IN THE MEMBER STATES OF THE EUROPEAN         COMMUNITIES
Several Member States have been reviewing existing regulations and
some have issued specific rules concerning the contained use of
biotechnology .
In Bel q.i um a 'rDNA Advisory Committee' is in creation , in order to
channel biotechnology-related issues to the competent authorities .
There is no specific regulation in the field of biotechnology but it
is estimated that a number of existing rules would apply .               These
include systems of authorizations for production , and for liquid and
solid waste transport and disposal as well as legislation on worker
protection .
In Denmark the Folketing adopted in May 1986 a bill on 'Environment
and Gene Technology' .     Concerning workers' safety an order on " Gene
Technology and Working Environment " was issued in September 1987 .
Research can be carried out only in laboratories classified for the
purpose by the National Labour Inspection , and each experiment has to
be notified and registered . Production in industry must be previously
licenced by the competent authorities . This involves the review of a
risk     assessment study and the approval of the containment and
emergency measures proposed by the applicant .
In the Federal Republic of Germany the contained use of genetically
modified microorganisms is subject to several provisions .           Research
activities are subject to guidelines ; the disposal of liquid wastes
from production and utilization of genetically modified microorganisms
are subject to authorization , as is the establishment and functioning
of industrial installations producing medicinal products or their
intermediates using biotechnology .
Moreover     the Association     ( Beruf sgenossenschaf t ) of the chemical
industry has prepared a recommendation for accident prevention in
laboratories and industrial installations using biotechnologies . The
Minister for Social Affairs has given his agreement and the different
associations will now implement these) .recommendations in their own
sector .
                                                                              6
 ---pagebreak---                                       1
In France there are guidelines for research with genetic technologies
which     provides for voluntary notification of certain high risk
projects     to a    scientific committee ( Commission de Classement ) .
Industrial activities using genetically modified microorganisms are
subject to the Law on 'Classified Installations for Environmental
Protection' and at present must be authorized before beginning to
work .    An interdepartmental working group , meeting by initiative of
the Prime Minister , is evaluating whether industrial activities should
be distinguished on the basis of the microorganism used and submitted
to declaration when using low risk microorganisms .
Greece     has set    up an interdepartmental Committee , the 'Ad-Hoc
Committee on Biohazards' which is responsible for the coordination of
biosafety activities in relation to research projects .
In Ireland a statutory Recombinant DNA Committee has been set up to
receive and examine notifications for research projects falling within
categories of high risk .      The Committee also receives proposals for
industrial large scale work and issues case by case recommendations to
the local authorities on conditions to be met regarding the plant 's
design , the containment measures and the safety of workers .
In Italy . Spain and Portugal no specific guidelines or rules apply to
the contained use of biotechnology ; however , a number of existing
regulations related to products are applicable .
In     Luxembourg there    are no     specific laws     with    respect   to
biotechnology .      At   present , both    laboratories and      industrial
installations using genetic technologies fall under the general rules
for    'Classified Installations'   where authorization   is needed   before
beginning to work .
In the Netherland s guidelines have been set up for research and
industrial production .     Also , genetically manipulated microorganisms
are regulated under the Nuisance Act which requires a licence for
hazardous installations .     The licence could specify the provisions to
be adopted for containment and emergency response .          The licence is
given by the Community Council and is normally based on advice of the
Recombinant DNA Committee .
In  the United'   Kingdom the  general requirements   of   the   Health  and
Safety at Work Act and the Genetic Manipulation Regulations , issued
under this Act , apply to researchers and industries using genetic
technologies .    Notification of activities is required , and Guidelines
on     Safe Work are issued by the Advisory Committee on Genetic
Manipulation , while the Health and Safety Executive inspectors carry
out active controls for enforcement . The Health and Safety Commission
is planning to propose statutory notification for the large scale use
and planned release of genetically modified microorganisms , because at
present such notifications are on a voluntary basis .
 ---pagebreak---                                         4
2 . COMMENTS ON THIS PROPOSAI, FOR A DIRECTIVE
A. ££narâl
This proposal deals with the contained use of genetically modified
microorganisms including questions of waste and accident prevention .
While some naturally occurring microorganisms may also be of concern
in that they may present dangers to plants , animals or the environment
in general , the Commission considers that in the first instance
priority    should be   given to a legal framework which will both provide
adequate protection and at the same time allow society to benefit from
this rapidly evolving technology .
The   Commission is    however working towards the development of coherent
methods   of risk    assessment in    this field   and   will   on   this . basis
examine if and how the accompanying proposal could be modified                 or
extended to cover non-genetically modified microorganisms .
Genetically modified microorganisms can be released to the environment
in the course of their contained use in two different ways :
- routine release in normal operating conditions e.g . as              wastes or
   in airborne émissions ,
- accidentai      release    in    abnormal     operating     conditions     i.e .
   significant release in the environment following an event which
   causes the activity to get out of control .
In certain cases such releases will pose risks to human health and the
environment ; it is therefore necessary to :
1 ) Identify these cases ,
2 ) Adopt working practices and containment measures               corresponding
    to the hazard the microorganism represents ,
3 ) Prevent the accidental release of hazardous microorganisms and
    limit the consequences of any such accident which may occur .
This proposai for a directive covers the steps from 1 to 3 .
For the purp.ose of this directive genetically modified microorganisms
are divided in two groups :
microorganisms      presenting a      minimal hazard ( Group I ) to which
relatively simple rules of good hygiene and safety practice shall be
applied , and other microorganisms ( Group II ) where containment , waste
control and in some cases emergency response procedures are essential .
In all cases users have to declare the fact that they are carrying out
operations involving genetically manipulated microorganisms to the
responsible authorities and carry out a hazard assessment .
A    system   of    notification   to     the  competent   authority    is   then
established ,    to   allow   effective     monitoring   and   control   of   the
correctness    of the   classification and     of  the   containment    measures
applied .
 ---pagebreak---                                        5
The time schedule and the content of the notification is dependent
upon the classification of the microorganism and on the scale of the
operation involved . In respect of the latter the Commission considers
more appropriate to adopt a flexible approach and distinguish the
activities      on the    basis of     their purpose .     'Industrial scale
operations' would include manufacturing processes , and pilot plants
whereas 'non-industrial scale operations' would include teaching ,
research and development activities .
In order to ensure that the probability of accidental release                  is
reduced to a minimum , the proposal envisages special provisions               in
such cases of higher risk or incertitude .          These are represented by
the industrial scale operations using microorganisms belonging to
group II . The notification in this case will be more detailed and the
user will       prove that he has studied possible causes of accidents ,
anticipating      the combination of events which might lead to an
unintended release and adopted safety measures and emergency response
plans where appropriate .       The user must also forward to the competent
authority the information necessary to set up an emergency plan for
the area surrounding the installation , should an accident occur .
In addition , the proposal for a Directive provides for the competent
authorities to be notified of accidental releases occurring in their
territory and for an effective preventive and monitoring system to be
set up at Community level .
General provisions are      made for   the adapting   of   the   directive     to
technical progress .
Technical annexes laying down containement        and    waste   measures     are
largely drawn from the OECD Recommendation .
B. P articular     comments  on    certain   articles     of   the    proposed
  , nixQCtlvg .
ARTICLE 1
The   définition of    'microorganism' is   intended to    cover   microscopie
                                                                        scopie
living entities , cellular or non cellular , with capacity of              self
                                                                           self
perpétuation .       Microorganisms    can be viruses , prokaryotes        (( for
                                                                              for
example , bacteria ) eucaryotes ( for example , fungi ) or protista .      This
                                                                           This
définition includes mammalian and plant cell cultures .
The definition of 'genetically modified microorganism' is intended to
be broad so as . to include present and future techniques . It excludes
deletion , mutagenesis , con jugation , transformation , transduction or
any other process if they are carried under normal physiological
conditions and do not involve the use of recombinant DNA techniques or
genetically modified organisms .
                                                                                  G
 ---pagebreak---                                       6
The definition of contained use relies upon the degree to which both
physical and biological methods are used to t control or restrict
dissemination    of microorganisms .        For this purpose 'biological
barriers 'are those characteristics the microorganisms possess which
limit their ability to survive .        'Physical and chemical barriers'
consist of a set of equipment , operating procedures and practices and
facility design which restrict dissemination of the microorganism into
the unrestricted environment .      This approach is purposely flexible :
there are a large number of combinations of biological , physical and
chemical barriers that could be deployed to prevent release into the
environment .
ARTICLE 2 , ARTICLE 4 AND ARTICLE 5
These   articles   represent    the  general   provision   of   the  proposed
Directive .   Article   2 sets out the criteria for the classification of
genetically manipulated microorganisms , Article 4 the obligation to
carry out a prior safety assessment of the operation and to keep it
under  review , Article    5 establishes   the containment    measures to  be
applied for each group of microorganism .
This article provides for an initial declaration to be forwarded by
all persons wishing to work with genetically modified microorganisms .
Each declaration will refer to a particular installation or building .
A 60 day waiting period is established in order to allow the competent
authority receiving the declaration to carry out effective inspection
of the installation concerned and enforce the specific duties placed
on the users under this proposed Directive .              This declaration ,
requiring a minimum set of particulars ( listed in Annex IV A ) will
enable the competent authority to know at least where the contained
uses are being undertaken .
ARTICLE 7
This article establishes the requirements for users of microorganisms
from Group I according to the scale of use :
- non-industrial scale operations : record of work must be          available
  upon request of the competent authority ;
- industrial scale operations : prior notification of the         information
  listed in Annex IV . B , work can proceed    immediately .
ARTICLE 8
This Article establishes the requirements for users of microorganisms
from Group II according to the scale of use :
- non-industrial    scale operations :      prior notification      of    the
  information listed in Annex IV . C with a 15 days      waiting period ;
- industrial scale operations : prior notification of the         information
  listed in Annex IV . D with a 60 days waiting     period .
 ---pagebreak---                                       7
ARTICLE J)
This article establishes the requirements for the updating of the
notification where the users shall inform the competent authority as
soon as possible of all information or modifications which could
affect the notification already made . This would include a change in
the microorganism or in the techniques used or in the number of
personnel involved in the operation , thus enabling the competent
authority to be informed of all ending activities .
ARTICLE 10 and ARTICLE 11
These    articles    specify   the  responsibilities   of  the   competent
authorities   who shall    receive the declarations and the notifications .
In    particular they      will examine    the notification ,   carry out
inspections and checks , and take all requisite measures with a view of
preventing accidents or limit the consequences of such accidents ,
including drawing up of external emergency plans .
This article concerns the information which the users must give to the
competent authority in the event of an accident and the consequent
action that shall be taken by the latter .
ARTICLE 13
This article specifies the information which the Member States are to
send to the Commission : extracts from the notifications concerning
industrial    scale operations      with Group    II   microorganism   and
information about accidents occurring . This article also provides for
the organization of exchange of information and the setting up of a
data base to which the Member States are to have access .
ANN EX I and AN N EX II
These    annexes provide      the criteria    whch must be followed in
classifying a genetically manipulated microorganism and in assessing
the risks for human health and the environment which may be entailed
by its contained use . Both these annexes are based on the principles
outlined in the OECD Report cited in 1.5 .
Tn bot.h these annexos , unloss it is differently specified , the
defin.ition of pathogen applying is the sanie as that outlined in the
OECD report i.e .:
Pathogenicity is the potential ability of living organisms and viruses
to cause diseuse in man , animais an plants .
                                                                           8
 ---pagebreak---                                             - 8 -
                                           PROPOSAL
                                            FOR A
                       £QUEQlL-niR£Kn,.IYÉ-.QN- THE CONTAINE R . USE
                      OF GENETTCALI.Y MQDIFIED MICROORGANISHS .
THE COUNCIL OF THE EUROPEAN COMMUNITIES ,
Having       regard to the Treaty establishing the                 European   Economic
Community and in particular Article 100 A therof ,
Having regard to the proposal of the Commission ( 1 ),
Having regard to the opinion of the European Parliament ( 2 ),
Having regard to the opinion of the Economic and Social Committee ( 3 ),
Whereas disparity between the regulation of the contained use of
genetically         modified microorganisms          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 depend 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 differencies 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 1937
 ( 4 ) 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 ;
Whereas the development of biotechnology is such as to contribute to
the economic expansion of the Member States , whereas this implies that
genetically modified microorganisms               will bo  used in     industrial  and
non-industrial scale operations ;
Wh or O:' :- r or- --organisms , whether released in the envjj ronme  ronment  as  a: r
émission ,     liquid OJ: solid wastes or by accident in thee cour     course cf their
contained      use may reproduce and spread crossing nati.onal frontiers
thereby affecting bordering Member States or the Community as a whole ;
 (1)
 ( 2 )
 < 3 )
 (4 )  0                   7 . 12
 ---pagebreak---                                      9
Whereas the contained use of genetically modified microorganisms must
be carried out in such 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 legislation 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   microorganisms   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 microorganisms are conjectual and the hazards
involved must be assessed case by case , whereas particular attention
must    be given to operations using certain genetically modified
microorganisms ;
Whereas genetically modified microorganisms 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 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 development of the contained use of
genetically modified microorganisms and to trace the origin of any
deleterious effect that might arise ;
Whereas     any person , before undertaking for the first time the
contained use of a genetically modified microorganism 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 microorganisms it is necessary for the user to
provide the competent authorities with information including details
of the microorganism 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 ;
                                                                           ίο
 ---pagebreak---                                          10
Whereas it is necessary to lay down that any person outside the
installation        liable to     be affected     by ah 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 ,
though some kind of public information media , such as leaflets of
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 microorganisms and the accidental releases
occcurring in their territory ,
HAS ADOPTED THIS DIRECTIVE :
1 . For the purposes of this Directive :
 ( a ) " Kicroorganism " means any microbiological entity , cellular or non -
cellular , capable of réplication .
 ( 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 microorganisms 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 microorganisms to be released in the
 environment       under   Council  Directive   ...   ( deliberate  release )  or
 products to be placed on the market under relevant EC 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 development of such processes .
  ( e ) " Non-industrial    scale operation " is any other contained          use
 including for teaching , research and development purposes .
 ---pagebreak---                                         11
( f ) " Accident "  means : any     incident   ir.volving   significant   and
unintended émission of genetically modified microorganism in the
course of their contained use that .leads to a serious danger ,
immédiate or delayed , to the heaith of the general population or the
environment .
( g ) " User " means : any natural or legal person responsible       for  the
contained use of genetically modified microorganisms .
( 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
microorganisms are classifed as follows :
Group I : Those satisfying the criteria of Annex I
Group II : Those other than Group I
2 . For non-industrial scale operations , the classification by the user
of particular microorganisms may be provisional .              In this case
microorganisms will be         referred to as 'equivalent' to the above
groups .
                                   ARTICLE–2
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 microorganisms 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 microorganisms shall be carried
out in such a way as to prevent their negative consequences for the
health of the genera ], population and the environment .
2 . To this end , thè user shall carry out a          prior assessment of thè
contai.ned uses in respect of thè biological          hazards that they may
incur .
3 . In making such an assessment thè user shall , in particular , take
due account of thè relevant parameters set out in Annex II for any
genetically modified microorganism 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 .
                                                                              \г
 ---pagebreak---                                        12
                                 ARTICLE 5
1 . For    microorganisms    in    Group   I    thè   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 appropriate , to contained uses of
microorganisms in Group II so as to ensure a high level of safety .
3 . The containment measures applied shall be periodically 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 microorganisms
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 microorganisms classified in , or equivalent 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 microorganisms 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 ‘microorganisms 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 microorganisms 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 microorganism ( s ) ,
    Information about personnel ,
    Information about the installation ,
    Information about waste management ,
    Information about accident prévention and emergency response plans ,
    The safety assessment referred to in Article 4 ,
the details of which dire listed in Annex IV . D.
                                                                             43
 ---pagebreak---                                        13
The    contained use   may , in  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 .
                                  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 consequences
for the risk posed by the contained use , or which affects the contents
of the original declaration and notification .
                                  ARTICLE 1Q
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 appropriate , 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 .
The competent^ authority is also responsible for :
- organ.iz.ing '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 information    shall be  commmunicated to  the
above    mentioned persons    without  their   request  and  shall  also  be
published .
 ---pagebreak---                                        14
                                  ARTICLE -1 2
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
immediately inform the competent authority specified in Article 10 and
provide the following information :
    the circumstances of the accident ,
    the identity and quantities of the microorganism ( 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 recommendations for the avoidance
and the limitation of the      effects of similar accidents in the future .
1 . Member States shall :
a ) ensure that in thè case of contained uses notified under Artide
8.2 , thè competent authority sends thè following information to thè
Commission within 60 days of receipt of thè notif ication :
    - the identity , proposed uses and potential risks of the
      microorganism ( 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 implémentation 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 microorganisms
released ,    the emergency      response measures        employed and    their
effectiveness ,      and    an   analysis      of    the   accident   including
recommendations     for the limitation 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 paragraph 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 .
 ---pagebreak---                                      15
                               ARTICLE... 11
1 . Every three years , Member States shall send the Commission a
summary report on their experience with this Directive , the first time
being on 1st September 1991 .
2 . Every three years , the Commission shall publish a summary based on
the report referred to in paragraph 1 , the first time being in 1992 .
3 . The Commission may publish general statistical information on the
implémentation of this Directive and related matters , as long as it
contains no information likely to cause substantial harm to the
compétitive position of a user .
                               ARTICLE_.1.5
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 ail
laws ,    régulations   and    admistrative      provisions    adopted  in
implémentation of this Directive .
This Directive  is addressed to the Member States .
 ---pagebreak---                                               ANNEX I
 CRITERIA     FOR CLASSIFYING   GENETICALLY   MANIPULATED    MICROORGANISMS   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
     conséquences in environment .
Vector / Insert
 - Well characterised 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 construct in the
     environment ( unless that is a requirement of intended       function ),
 - Should be poorly mobilisable ,
 - Should not transfer any resistance markers to microorganisms not
     known    to acquire     them naturally     ( if such acquisition could
     compromise use of drug to control disease agents ) .
-G .enetically manipulated microorganism
 - Non-pathogenic ,
 - As safe in the reactor or fermenter as host or parental organism ,
     but     with   limited survival without adverse conséquences in the
     environnent .
Other classes of microorganisms that          could be included in Group I if
they are not pathogenic are :
- those       constructed entirely      from a     single    prokaryotic    host
     ( including .its indegenous 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 .
 ---pagebreak---                                           2
                                                         ANNEX    II
Points     to consider in conducting the safety       assessment referred to in
Article 4 .
A. Characteristics of the parental microorganism(s )
B. Characteristics of the modified microorqanism
C.  Health considérations
D.  Environmental considerations
A. Characteristics of the parental microorganism ( s )
    Names and designation ,
    Degree of relatedness ,
    Sources of the microorganism ( s )
    Information     on reproductive         cycles ( sexual / asexual )     of    the
    parental     microorganism ( s ) or ,     where applicable , of the host
    microorganism ,
    History of prior genetic manipulations ,
    Stability of parental or of recipient microorganism in term 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 microorganism
    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
    microorganism ,
    Stability of the microorganism in term of genetic traits ,
    Frequency     of mobilisation      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 considérations
    Allergenic and toxic hazard of the protein                 or    of   non-viable
    microorganism ,
    Comparison     of    the modified         microorganism      to     the    parent
    microorganism regarding pathogenicity ,
    Capacity for colonisation ,
 ---pagebreak---                                        3
    If    the    microorganism    is   pathogenic     to    humans   who   are
    immunocompétent :
    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 of human host ,
    f)  Presence of vectors or means of dissémination ,
    g)  Biological stability ,
    h)  Antibiotic-resistance patterns ,
    i)  Allergenicity ,
    j)  Availibity of appropriate thérapies .
■ . EnvirQimen£al_-CQnsideratiQns
    Factors affecting survival and multiplication of the engineered
    microorganism in the environment ,
    Available      techniques    for     detection ,     identification    and
    monitoring of the engineered microorganism ,
    Available techniques for detecting transfer of the new genetic
    material to other organisms ,
    Known and predicted habitats of the engineered microorganism ,
    Description of ecosystems to which the microorganism could be
    accidentally disseminated ,
    Anticipated     mechanism and     result of interaction between the
    engineered     microorganism and      the organisms or microorganisms
    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---                                      4
                                        ANNEX III .
The containment measures for microorganisms from Group II shall be
chosen by the user from the categories below as appropriate to the
microorganism 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
spécifie circumstances of smaller-scale operations .
                                             CONTAINMENT CATEGORIES
        SPECIFICATIONS _                   12                         3
1 . Viable microorganisms should          yes          yes          yes
in a System which physically
separates the process from the
environment ( closed system )
2 . Exhausted gases from the closed    Minimise      Prevent     Prevent
System should be treated so as to :    release       release     release
3 . Sample collection , addition of    Minimise      Prevent     Prevent
materials to a closed system and       release       release     release
transfer of viable microorganisms
to another closed system , should be
performed so as to :
4 . Bulk culture fluids should not     Inactived    Inactived Inactived
be removed from the closed system      by           by        by
unless the viable microorganisms       validated    validated validated
have been :                            means        Chemical  Chemical
                                                    or        or
                                                    physical  physica 1
                                                    means     means
5 . Seals should be designed so        Minimise     Prevent      Prevent
as to :                                release      release      release
                                                              ./.
                                                                         îo
 ---pagebreak---                                      5
6 . Closed Systems should be           Optional  Optional    Yes , and
    located 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
    nominated personnel only                                 airlock
c ) Personnel should wear protective   Yes work  Yes       A complete
    clothing                           clothing              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 inactived
    before release
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       No        Optional    Yes
    the 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    Inactived Inactived  Inactived
    discharge                          by        by         by
                                       validated validated  validated
                                       means     chemical   physical
                                                 or         means
                                                 physical
                                                 means
 ---pagebreak---                                          б
                                               ANNEX IV'
PART     A   - Information      required   for  the   déclaration  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 microorganism ( 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 déclaration referred to in Article 6 ;
- the parental microorganism ( 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
- description       of the      sections of     the    installation ,    of     the
   prédominant 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 techn.ically possible or if it does not appear necessary
to give the information specifi.ed 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 subinission of the déclaration referred to in        Article 6
    and the name of the responsible person(s )
                                                                                    ^2
 ---pagebreak---                                           7
                                                                                    v
b ) information about the microorganism ( s ) :
    - the identity and characteristics of the microorganism ( 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 microorganism ( 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 microorganisme s ) to the environment ;
    - substances which are or may be produced in the course of the use
       of the microorganism ( 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
       microorganism ( s ) .
d ) information about the installation :
    -  the activity in which the microorganism ( 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 , quantifies , and potential hazards of wastes arising from
       the use of the microorganism ( s ) ,
    - waste management techniques used , including recovery , liquid or
       solid wastes ,
    - ultimate form and destination of inactivated wastes .
f ) information       about    accident   prévention    and   emergency  response
    plans :
    - the    sources of      hazards  and   conditions   under   which  accidents
       inight 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 assessmont ( referred to in Article 4 ) of the
potential hazards and risks which might arise from the proposed
contained use .
                                                                                 26
 ---pagebreak---                            PROPOSAI.
                            FOR A
PROPOSAL FOR A COUNCIL DIRECTIVE ON THE DELIBERATE RELEASE TO
      THE ENVIRONMENT OF GENETICALLY MODIFIED ORGANISMS
 ---pagebreak---                  EXPLANATORY MEMORANDUM
INTRODUCTION
In its     Communication to       the Council "A Community
Framework    for      the    Regulation     of   biotechnology "
( Com(86)573 final ), the Commission signaled its intention
to introduce       proposals for Community Regulation of
biotechnology which would address two distinct aspects of
the use of genetic engineering :
A. Levels of       physical and      biological    containment ,
    accident control and waste management in industrial
    applications ;
B . Authorization of      planned release       of genetically
    engineered organisms into the environment .
The current proposal concerns the release into the
environment ( aspect B ) . Industrial applications ( aspect
A ) will be the subject of separate proposals .
The   deliberate     release    into    the    environment   of
genetically modified organisms ( GMOs ) has given rise to
particularly intense debate about the possible risks
involved . The application of these organisms in the open
environment is       very broad :     pesticides , herbicides ,
nitrogen fixation ( in microorganisms or in crop-plants ),
plants and animals resistant to pests and diseases ,
adapted to extreme meteorological conditions or scarcity
of resources , degradation of toxic chemicals and oil
spills , enhanced oil recovery , metal leaching of low-
grade ores , and many others .
 ---pagebreak---                               2
At the same time , however , the intentional release of
organisms having a combination of traits that nature may
have never produced increases uncertainty as regards the
behaviour of the organism and the possibility of a
deleterious impact on the environment . Not only known or
predicted traits of the organism ( such as pathogeniticy ,
etc .) may raise questions but also the possibility of
displacement of         natural populations ,      alteration of
ecological cycles         and interactions ,      and    undesired
transference of novel genetic traits to other species
( i.e. , pesticide-resistance of a crop-plant passed on to
weeds ). This makes it necessary to proceed with the
releases in a         careful manner . Therefore , regulatory
measures are     needed to    ensure that    these    releases   be
carried out        only under     conditions of        human    and
environmental safety which are as high as reasonably
practicable .
It must also be adknowledged that the use of GMOs could
lead to improvements in helath and the environment by
permitting the development of more precise agricultural
inputs for protection and nutrition and more effective
treatment of waste .
A    recent     OECD     report   ( " Recombinant     DNA    safety
considerations ", 1986 ) recognized        the risks mentioned
above and concluded that they can be assessed , to some
extent , by       analogy with information about existing
organisms . However , there is insufficient experience at
this stage provide a basis for coherent standards for
testing and regulations . Instead , the Report recommends a
prior case - by - case evaluation of all deliberate releases .
The Commission believes that the rapid elaboration of a
Community framework of biotechnolgy regulation               is of
crucial importance         to the development of this new
technology in the Community . Citizens and the environment
throughout the         Community need to be provided with
adequate protection from any potential hazards arising
from the application of genetic engineering . The internal
market arguments for Community-wide regulation in this
field are clear and , from an environmental viewpoint ,
organisms are no respecters of national frontiers , and
nothing short of Community-wide regulation can offer the
necessary human and environmental protection .
Because international experience in deliberate release is
still limited , it is not possible to propose any general
guidelines or testing requirements for the time being .
The Commission is therefore proposing a case -by- case
notif ication - and - endorsement procedure       which will be
mandatory for industry and research institutions , in line
with the recommendation of the OECD report .
 ---pagebreak---                                   3
II . LEGISLATION IN THE MEMBER STATES OF THE EUROPEAN
     COMMUNITY
     Several Member        States have been reviewing existing
     regulations and generally assessing the risks to humans
     and the environment from the release of genetically
     engineered organisms .
     In the     Federal Republic of Germany a general ban on the
     deliberate release of genetically modified organisms
     ( GMOs ) has been established . Exemptions are on a case-by¬
     case basis , without any formal authorization procedures .
     The German authorities are currently deciding whether a
     legal framework is neceesary to regulate the deliberate
     release of GMOs , taking into account a recent Bundestag
     report on the subject .
     In Ita ] y ,     no specific      regulation applies    to the
     delibérate release of GMOs . A first proposal for release
     is being examined under pesticide legislation .
     In The Netherlands , regulations for environmental release
     are in preparation . At present , there is no ban on the
     release of GMOs ; the Government allows experiments to
     proceed where adequate review has been provided .
     In France .   the Ministry of Agriculture has established a
     commission     ( Commission    de   Génie   Biomoléculaire ) to
     examine case - by- case the deliberate release of GMOs .
     Belgium is covering GMOs under existing legislation ,
     having gained some experience with a proposed release of
     genetically modified potato plants .
     Luxembourg is examining closely the deliberate release of
     GMOs . The possibility of ad hoc authorizations will be
     examined by the Ministry of the Environment .
     In the United Kingdom . guidelines for the deliberate
     relase of GMOs were approved in April 1986 . These
     guidelines , prepared by the Advisory Committee on Genetic
     Manipulation ( ACGM ) establish a framework for the case -
     by-case consideration of proposals by an expert national
     body and relevant governmental departments , and has set
     up a sub-committee to oversee individual notifications .
     This scheme is at present voluntary , but the ACGM has
     proposed statutory notification for deliberate releases .
 ---pagebreak---                             4
The guidelines ,   which will apply to organisms obtained
through genetic    manipulation , will cover releases to the
environment in large scale and field trials under non -
contained conditions . It is envisaged that when GMOs
developed for release have been fully assessed by ACGM ,
HSE and other relevant governemental departments , routine
use will be exempt from the notification procedure .
In Denmark f the Danish Folketing adopted in May 1986 a
bill on genetic engineering and other technologies ,
including agricultural and environmental uses of GMOs and
products containing them . The provisions of the law
state :
- release of GMOS may not take place even for research
  purposes ; the Ministry of the Environment may approve
  such releases in special cases ;
- applicant in these cases must , if so required by the
  Authorities , provide information and test results in
  accordance with certain guidelines and at certain
  laboratories . The Ministry of the Environment may lay
  down detailed rules on the implementations of the
  approval arrangements ;
The law covers :
- inspection , information      on accidents ,      prohibition
  after authorization       has   been    granted ,    imported
  substances ,    local authorities and the possiblity of
  appeal against     decisions taken under the law .
Ireland has set up a Recombinant DNA Committee and an
Institutional Biosafety Committee . Deliberate releases
will require review and approval by these Committees ,
which will follow the OECD recommendations . In addition ,
provisions of a number of Irish laws are relevant in the
cases of      deliberate releases ,     including the Water
Pollution Act , the Dangerous Substances Act and the
Destructive Insects and Pests Act .
In Greece r   there are   no specific   regulations    in  this
field , but   an 'Ad  hoc Committee of Biohazards' has been
set up      with responsibility    in   the  coordination    of
biosafety activities .
In Spain , no specific regulations apply to deliberate
release of GMOs , but a committee is being set up to be
responsible of these activities
In Portugal ,   there are   no specific   regulations in    the
field but the Secretariat of State of Environment will be
responsible for the subject .
 ---pagebreak---                              5
COMMENTS ON THIS PROPOSAL FOR A DIRECTIVE
1 . General
The possible hazards from the release to the environment
of genetically modified organisms are of various types :
- pathogenicity to humans , animais or plants ;
- disruptive effects on ecosystems : displacement of
    natural populations , alteration of ecological cycles
    and interactions ;
- transfer of     the novel    genetic traits to other species
    with undesired effects ;
- excessive     dependence     on  species   lacking     genetic
    variation .
However , public concern about genetic engineering is
growing , and it is easy to imagine the public 's response
in case of harm to people or the environment caused by a
GMO     deliberately     introduced    in   the     environment .
Moreover , genetic engineering will sharply increase the
number of organisms with new traits introduced in the
environment . These reasons make it urgently necessary to
provide protection to people and the environment from the
possible risks related to these new techniques .
The present       approach , which     focusses on      the new
techniques of genetic engineering , is the first and most
urgent step in the regulatory process ; however , this will
not impede evolution towards a more organism-related
approach . Thus , the Commission will , as experience and
knowledge on the matter build-up , undertake to regulate
the release of certain categories of naturally-occuring
organisms , such       as known     human , plant     or animal
pathogens , and      non-indigenous     organisms .    Moreover ,
different categories of organisms and / or techniques may
be established ,       allowing different requirements for
organisms of different levels of risk .
This Directive will establish a case -by- case notification
and endorsement procedure for the deliberate release of
GMOs . Before      carrying out      a release ,     the person
responsible for it shall submit a notification to the
Competent Authority of his Member State , including a
detailed risk assessment where the possible hazards
associated with the release must be identified .
 ---pagebreak---                              6
However , understanding that there is a clear quantitative
difference in the level of risk between experimental
releases ( carried out under very controlled conditions ,
strictly limited in space and time , closely monitored )
and commercial ones ( with limitations only in areas and
conditions of use ), two different procedures will be
established : one for experimental releases where each
competent authority is fully responsible for the releases
carried out in its Member State , and a second one for the
placing on the market of genetically modified organisms
for a given use , where consultation and agreement with
the other Member States is needed before the product is
endorsed for its placing on the market .
The endorsement procedure has the advantage over an
authorization procedure , that it leaves responsibility
with the notifier . Moreover , in a field largely unknown
like this , the decisions as to the safety of a release
and its conditions must be the result of           a dialogue
between notifier and Competent Authority .
In a largely unexplored field like this , the exchange of
information is likely to play an essential role in
gaining experience . Therefore , provision is made for
information exchange among the Member States through the
Commission . This information sharing will be without
restriction for      the Commission     and the      Competent
Authorities , provided that absolute confidentiality is
guaranteed for these data . The experience from the
chemicals sector ,       where notification units for new
chemical substances have been working for years with
excellent results , encourages the Commission to pursue
this goal .
On the other hand , given the public concern about genetic
engineering , it     is considered     essential that       the
information necessary        for evaluating     the risk and
adopting safety measures , be made available to the
public .
2 . Particular   comments_ou_certain_articles_ci_the
    Directive
    The proposal     is divided in four parts :        Part   A
    ( articles 1 to 3 ) on general provisions ,        Part   B
    ( articles 4  to 7 )   on the deliberate release of GMOs
    for research     and development     purposes , Part      C
    ( articles 8 to 16 ) on the placing on the market of
    products containing or consisting of GMOs , Part D
    ( articles 17 to 23 ) on final provisions .
                                                                3o
 ---pagebreak---                           7
PART A : GENERAL PROVISIONS
Article 2
The definition of " organism " encompasses viruses and
other subcellular entities as well as higher plants
and animals .     It is understood that these organisms
are living ones , including inactive forms such as
seeds , spores , and the like .
Annex I , which will be updated as necessary , indicates
the techniques by which the genetically modified
organisms can be obtained .
" Deliberate   release "    is  defined   in  opposition    to
" contained   use " .  As   the  borderline   between    these
concepts is not clear-cut , particularly in the case of
greenhouses and stables ( which can be considered
contained or non-contained depending on the adoption
of particular measures or on certain characteristics ),
and taking into account the need to establish clear
criteria to       trigger the notification under this
Directive ,    the     Commission    will    elaborate ,    in
consultation     with the Member states , guidelines for
containment in        greenhouses ,   stables    and     other
facilities , which will clarify which activities will
be considerd as deliberate release .
PART B : DELIBERATE RELEASES FOR EXPERIMENTAL PURPOSES
Article 4
This Article establishes the obligation to notify all
releases in the research and development phase and
outlines the content of the notification .
One of the most important features of the procedure of
notification is that it promotes the dialogue between
notifier and Competent Authority . This dialogue will
serve to clarify all those cases where the application
of the Directive is in doubt .
Article 5
This Article       establishes that national Competent
Authorities will be in charge of the review of the
notifications and      their endorsement .   The  Commission
may establish    regular contacts and interchanges among
the different    Competent Authorities , or carry out any
other relevant activities in order to ensure a uniform
and high-quality review by all Competent Authorities .
 ---pagebreak---                            8
Article 6
This   Article     establishes   the  endorsement    of  a
notification for        an experimental release by the
national Competent Authority . The Competent Authority ,
in order to endorse a notification , will have to be
satisfied not only with the formal compliance of the
dossier with the Directive but , above all , will have
to consider     the   risk   associated  with  the release
acceptable .
Article 7
This article establishes the procedure for information
exchange among Competent Authorites
PART C :  PLAC ING   ON THE MARKET OF PRODUCTS CONTAINING
          OR CONSISTING OF GMOs
Art icl e 9 a nd-LÛ
In these articles , the procedure for notification and
endorsement for the placing on the market of products
consisting of or containing GMOs is laid down .         As
these products must be able to circulate in the
Community without        trade barriers , provisions for
consultation among Member States are considered , so
that no product shall be endorsed without all Member
States having had the right to object .
However , taking into account the high specificity
expected for most of these products , and the diversity
of environments within the Community , the endorsement
is made valid only for the use of the product under
very specific conditions and , where relevant , in
specific geographical areas .
In cases where the experimental phase has demonstrated
that the product to be notified is very safe , the
notifier may ask not to comply with some notification
reguirements so as to simplify the endorsement of the
product .
Article 12
This article     establishes that products endorsed under
this Directive must be commercialized under conditions
which ensure their proper and safe use .
 ---pagebreak---                            9
Artide 13
This   Article      establishes    the   free  circulation   of
products containing genetically modified              organisms
which have been properly endorsed .
Article 14
This is the safeguard clause , which allows Member
Sates to         impose   provisional      measures    on   the
commercialization of products containing GMOs , until
the Commission takes a Community-wide decision . The
reasons for a national ban should in any case be
scientific ones .
PART D :   FINAL PROVISIONS
Ar ticle . 1 7
This article establishes the right of the notifier to
determine , to a certain extent , the information within
the notification which is to be kept secret ( except
for the Commission and the Competent Authorities ) in
order to safeguard his competitive position . But , at
the same time , it establishes a minimum set of data
that , in any case , has to be made available to the
public .       This accounts for the citizen 's right to
information about potentially harmful activities , and
will also help to promote public 's confidence in the
development of genetic engineering .
Article . 18
This Article establishes the commitment to update the
Directive to technical progress as necessary , given
the rapid scientific development of this field .
Artide 19
This article       establishes    the   Committee   which  will
advise     the    Commission   in   the   application   of  the
Article 14 , the adaptation of the annexes to technical
progress and         the resolution       of disputes before
endorsement .
                                                                33
 ---pagebreak--- Annex I
This Annex is intended to provide , through a periodical
update , as a clarification of what techniques can make an
organism " genetically modified " within the meaning of
this Directive . The techniques not covered are those that
have long been used with crop plants and livestock with
an excellent safety record .
Annex II
This Annex sets out the information requirements for the
notification . It is not a checklist , for not all items
are relevant in every case . Instead , it is intended as a
comprehensive list of different aspects relevant for the
evaluation of the risk , from which each notifier will
pick those items which are relevant to their case .
The level of detail of the information to be provided and
its quality will be a function of the type of release : a
field test is likely to rely heavily on bibliographic
data and assumptions , whereas a notification for a
product should     be based    on experimental evidence .
Competent Authorities     will   therefore   examine   the
information requirements in a flexible manner .
Annex III
This Annex spécifiés the additional information required
in the notification dossier in the case of the placing on
the market of GMOs .
 ---pagebreak---                                PROPOSAL
                                FOR A
      COUNCIL DIRECTIVE ON THE DELIBERATE RELEASE INTO THE
          ENVIRONMENT. OF GENETICALLY MODIFIED ORGANISMS
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 ( 1 ),
Having regard to the opinion of the European Parliament ( 2 ),
Having regard to       the  opinion    of the  Economic  and  Social
Committee ( 3 ) ,
Whereas , disparity between the regulation of the deliberate
release to the environment of genetically modified organisms
which are in effect or in preparation in the Member States may
create unequal conditions of competition and thus directly
affect the functioning of the common market ; whereas , it is
therefore necessary to approximate the laws of the Member
States in this regard , as provided for in Article 100A of the
Treaty ;
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 ( 5 ) and
provide , despite existing differences in economies of the
Member    States , for   equal standards   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 , ( 4 )
(1 )
( 2)
( 3 )
(4 )
(5 ;
 ---pagebreak---                                   2
Whereas living organisms , whether released to the environment
in large or small amounts for experimental purposes or as
commercial products , may reproduce in the environment and
cross national frontiers thereby affecting bordering Member
States or the Community as a whole ,
Whereas      it is   necessary to      ensure the development of
industrial products utilizing genetically modified organisms
which do not cause harm to human health or the environment ,
whereas the new biotechnology promises improvements in health
and the environment by developing more precise agricultural
inputs    for protection     and nutrition and more effective
treatment of wastes .
Whereas the protection of the public and the environment
requires that due attention be given to controlling risks from
the deliberate release of genetically modified organisms to
the environment ,
Whareas new techniqes of genetic modification are defined in
Article 2.2 and Annex I of this Directive ; whereas those
techniques which have conventionally been used with crop
plants and livestock with an excellent safety record are not
covered by the definition of Article 2.2 or Annex I ;
Whereas it is necessary to establish harmonized procedures    for
the    evaluation of the potential risks arising from         the
intentional introduction , for the purpose of research        and
development ,     of gentically     modified organisms  into  the
environment ,
Whereas ,     the deliberate    release of genetically modified
organisms at the research stage is in most cases a necessary
step in the development of new products derived from or
containing genetically modified organisms ; and whereas the
regulatory requirements under which these releases take place
are likely to have important impacts on the final cost of such
products ; ,
Whereas it it necessary to establish a Community review and
decisionmaking procedure for the placing on the market of the
products containing or consisting of genetically modified
organisms , where the intended use of that product involves its
deliberate release to the environment ,
Whereas     any person , before undertaking a new deliberate
release to the environment of a genetically modified organism ,
or the placing on the market of a product containing or
consisting      of genetically    modified organisms   where the
intented use of that product involves its deliberate release
to   the environment , shall submit a notification to the
national competent authority ,
 ---pagebreak---                                    3
Whereas     that notification   should contain   a technical dossier
of information including a full risk assessment , appropriate
safety and emergency response , and in the case of products ,
precise instructions and conditions for use , and proposed
labelling and packaging
Whereas , it is important to follow closely the development and
use of genetically modified organisms , and that in order to do
this it is necessary to list all the products notified under
this Directive , and to provide for subsequent notifications
and follow-up information ,
Whereas , when a product containing a genetically modified
organism or a combination of them is placed on the market
where the intended use of that product involves its deliberate
release to the environment , and where such a product has been
properly notified and endorsed under this Directive , a Member
State may not prohibit , restrict or impede the deliberate
release      of this     organism on their territory      under the
conditions set out in the notification , except           under the
specific conditions of a safeguard procedure , in         case of a
serious risk to human health or the environment ;
HAS ADOPTED THIS DIRECTIVE :
PART A :   GENERAL PROVISIONS
                              ARTICLE 1
 1 . The objective of this Directive is to approximate the laws ,
     régulations and administrative provisions of the Member
     States and to protect the health of the general population
     and the environment in relation with :
     - the   deliberate release   of genetically modified organisms
        to the environment ,
     - the placing on the market of products containing or
        consisting of genetically modified organisms intended for
        subséquent deliberate release to the environment .
 2 . This    Directive   does   not  apply    to  the   carriage  of
     genetically modified     organisms   by   rail , road ,  inland
     waterway , sea or air .
For the purpose of this Directive :
1 . Organism includes multicellular and unicellular organisms .
     It    also    includes   subcelluiar    entities   capable   of
     replication .
 ---pagebreak---                                   4
2 . Geneti c ally modified organism ( hereinafter referred to as
    GMO ) is an organism in which the genetic material is
    altered in a way that passes the natural barriers of mating
    and recombination .     Annex I indicates the techniques by
    which such genetic alterations can be obtained .
3 . Deliberate    release means  any intentional   introduction  in
    the environment    of a  GMO or   a combination of GMOs without
    provisions     for containment such as spécial procedures ,
    equipment and installations , or facilities that provide
    physical     barriers to    prevent their     spread into the
    environment .
4 . Product means a preparation or formulation consisting of or
    containing a GMO or a combination of GMOs , which is placed
    on the market .
5 . Placinq on the market means supplying or making available
    to third      parties   for     the   purpose    of   sale   or
    commercial distribution .
6 . Notification means the documents whereby the person who is
    to    carry out     a deliberate     release of a GMO or a
    combination     or GMOs for the purpose of research and
    development , or to place a product on the market presents
    the requisite information to the competent authority of a
    Member State .     This person shall be referred to as " the
    notif ier "
7 . Use means the deliberate release of a product which have
    been placed on the market .       The persons carrying out this
    use will be referred to as " users ".
                             ARTICLE 3
1 . Member States shall adopt the provisions necessary to
    ensure ' that all persons carrying out the deliberate release
    or placing on the market of GMO(s ) shall take all measures
    reasonably practicable to control any risk of harm to
    people and the environment .
2 . Member States shall designate the competent authority or
    authorities responsible for carrying out the requirements
    of this Directive and its annexes .
                                                                    58
 ---pagebreak---                                       5
PART    B : DELIBERATE RELEASE OF GENETICALLY MODIFIED ORGANISMS
           TO    THE ENVIRONMENT        FOR RESEARCH AND DEVELOPMENT
           PURPOSES
                                ARTICLE 4
Member     States shall    adopt the     provisions necessary to ensure
that :
1 . Any person , before undertaking a deliberate release of a
    GMO or a combination of GMOs for the purpose of research
    and development ,      must    submit     a notification    to   the
    competent authority specified in Article 3.2 of the Member
    State within whose territory the release is to take place
    before carrying out the release .
2 . The notification shall include :
a ) A technical dossier supplying the information specified in
    Annex II necessary for evaluating the foreseeable risks ,
    whether immediate or delayed , which the GMO(s ) may pose to
    people or the environment , together with the methods used
    and the bibliographic reference to them and covering , in
    particular :
    - identification and characteristics of the GMO(s ),
    - the     location of   the area where the deliberate release is
       to be carried out and the prédominant meteorological ,
       social , environmental and agricultural characteristics of
       the area ,
    - the purpose and conditions of the release , including the
       quantity of the GMO(s ) to be released , the size of the
       area affected , and the duration of the release ,
    - ail other information necessary for risk assessment ,
    - methods for monitoring the GMO(s ) and , when appropriate ,
       proposed techniques for elimination or inactivation of
       the GMO(s )    at   the    end    of  the  experiment ,  and  for
       emergency    response in    case of    the spread  of   the  GMOs
       beyond the area of release .
b ) A statement evaluating the impacts and risks posed by the
    GMOs to people or the environment from the uses envisaged .
3 . The    experimental release of a combination of different GMOs
    for     the same      purpose may       be notified in a single
    notification .
 ---pagebreak---                                      6
4 . In the case of a subséquent release of the same GMO or
    combination of GMOs previously notified as part of the same
    research programme , the notifier shall be required to
    submit a new notification . In this case , the notifier may
    refer to data from previous notifications or results from
    previous releases .
5 . The notifier may also refer to data or results from
    notifications       previously submitted by other notifiers ,
    provided that the latter have given their agreement in
    writing .
6 . In the event of any modification of the deliberate release
    of GMO(s ) which could have consequences with regard to the
    risks for people or the environment or if new information
    has become available on such risks , either while the
    notification is being examined by the competent authorities
    or after the endorsement , the notifier shall :
    a ) revise the measures specified in Article 4.2
    b ) inform thè competent authority of thè modif ication , in
        advance or as soon as thè new information is available ,
        in    so far as it affects thè information contained in thè
        notif ication .
                               ARTICLE 5
1 . The competent authority shall :
    - evaluate      the risk  posed by     the release   in the light of
       the notifier' s risk assessment ,
    - State its conclusions in writing ,
       and , if necessary ,
    - ask    ■ the   notifier  to   provide    further   information   or
       vérification tests , explaining the reasons for it ,
    - carry     out such   tests as    may be    necessary   for  control
       purposes .
2 . The competent authority shall respond to the notification
    within 90 days of its receipt , either deciding on its
    endorsement or indicating the further information required
    or measures to be taken .
3 . If the competent authority is not satisfied with the
    conditions of the proposed release , it may ask the notifier
    to modify such conditions of the release so as to bring it
    into compliance with Article 3 of this Directive .
4 . The    notifier may    proceed with the release only when he has
    received       the  endorsement     of   the   competent   authority ,
    subject to any conditions required in this endorsement .
                                                                           4(9
 ---pagebreak---                                    7
5 . The   Member States   may provide    for   dérogations   f rom  the
    provisions    under articles   4 and   5.1   to  5.4   and   6  for
    deliberate releases       carried    out    by   or    under    the
    responsibility of a public authority which is designated as
    a competent authority according to articles 3.2 .              This
    dérogation does not affect the obligation to assess the
    risk posed by the release concerned nor the obligation to
    submit information to the Commission as required in Article
    7.
                              ARTICLE 6
On the completion of a release the notifier shall send to the
competent authority an assessment of the result of the release
in respect of any risk to man or the environment , with
particular reference to any product that he intends to notify .
                              ARTICLE 7
1 . The Commission shall set up a system of exchange of the
    information contained in the notifications . The competent
    authorities shall send to the Commission a summary of each
    notification received within 15 days of its receipt .
2 . The   Commission shall    forward these    summaries to the other
    Member States .
3 . If a competent authority wants more information relative to
    releases carried out in other Member States , it may ask the
    competent authority of this Member State to provide them
    with further information .
4 . The competent authority of the other Member States may
    suggest to the competent authority which received the
    original notification any modifications to the conditions
    of the release .
        : PLACING    ON THE     MARKET    OF    PRODUCTS    CONTAINING
          GENETICALLY MODIFIED ORGANISMS
                              ARTICLE 8
Articles 9 to 16 of this Directive , do not apply to :
- médicinal products ,
- veterinary products ,
- foodstuffs , f eedingstuf f s and their additives ,
 ---pagebreak---                                     8
- plants      and animals      produced or     used in agriculture ,
   horticulture , - forestry , husbandry       and . fisheries ,    the
   reproductive material thereof and the products containing
   these organisms ,
- or to any products covered by Community           legislation which
   includes a specific risk assessment .
                               ARTICLE 9
1 . Before . a GMO or a combination of GMOs are placed on the
    market as or in a product , the manufacturer or the importer
    to     the Community shall submit a notification to the
    competent authority of the Member State where they are to
    be     placed on the market for the first time .               This
    notification shall contain :
    - the     information required       in Annex II , extended as
       necessary to take into account the diversity of sites of
       use of the product , and an assessment of any risks for
       man    and / or  the   environment   related   to  the    GMO(s )
       contained in the product ,
    - the conditions for the placing on the market of the
       product ,     including specific     conditions of     use and
       handling and a proposal for labelling and packaging which
       should comprise at least the requirements laid down in
       Annex III .
If , on the basis of the results of any release notified under
Part     B of       this Directive , or on substantive , reasoned
scientific grounds , a notifier considers that the placing on
the market and use of a product do not pose any risk to man
and / or the environment , he may propose not to comply with one
or more of the requirements of Annex III.B.
2 . Subject to the agreement of the competent authority , the
    notifier     may refer      in this notification to data or
    expériences from releases of the same GMO(s ) previously
    notified at the research and development level .
3 . The notifier may also refer to data or results from
    notifications       previously submitted by other notifiers ,
    provided that the latter have given their agreement in
    writing .
4 . Each new product which , containing or consisting of the
    same     GMO or combination of GMOs , is intended for a
    different use , shall be notified separately .
 ---pagebreak---                                   9
5 . If new information has become available with regard to the
    risks of the product to people or the environment , either
    before or after the endorsement , the notifier shall :
    - revise the measures specified in Article 9.1 , and
    - inform the competent authority immediately .
                             ARTICLE 10
1 . On receipt of the notification referred to in Article 9 ,
    the competent authority shall examine it for compliance
    with this Directive , giving particular attention to the
    risk assessment and the recommended precautions related to
    the safe use of the product .
2 . The competent authority may ask the notifier for additional
    information or suggest further tests to carry out or
    changes in the conditions of placing on the market so as to
    bring these conditions into compliance with the Directive .
3 . When the competent authority is satisfied that the placing
    on the market of the product under the conditions specified
    in the notification is in compliance with this Directive ,
    it shall send to the Commission a dossier including a
    summary of the notification together with a statement of
    the conditions under which it proposes to endorse the
    placing on the market of the product .
4 . The competent authority shall respond       to the notification
    within 90 days of receipt , either by        indicating the need
    for further    information  and   evaluation ,   or  measures   to
    bring   it into compliance with this Directive , or forwarding
    the dossier referred to in Article 10.3 to the Commission .
1 . On   receipt of   the dossier   referred to    in Article 10 , the
    Commission shall forward to ail Member States :
    - the summary of the dossier ,
    - any   other information   it has   collected pursuant to this
       Directive .
 ---pagebreak---                                  10
2 . For a period of three months after the Commission has
    circulated      the   dossier with    the summary    of   the
    notification and the proposed conditions for placing on the
    market ,   other competent authorities    may   request   the
    competent    authority which proposes    the endorsement to
    provide further information or change the conditions for
    placing on the market , giving their reasons for such
    requests .
3 . If the competent authority which proposed the endorsement
    fails to comply with the requests of other authorities
    regarding further information , the risk assessement or the
    conditions of placing on the market , it shall give its
    reasons to the competent authority concerned .
4 . Should it not be possible for the competent authorities
    concerned to reach an agreement , and should any competent
    authority feel , on the basis of scientific evidence , that
    the placing on the market of the product may pose risks to
    people or the environment , within this period of three
    months , the Commission shall take a decision in accordance
    with the procedure laid down in Article 20 .
5 . When the competent authority that received the original
    notification has provided satisfactory response to the
    requests of the other competent authorities , or if no
    suggestions have been made within the 60-day period , or
    when the   Commission has  taken a favourable decision in the
    case of Art . 11.4 , it shall endorse the notification     so
    that the product may be placed on the market .
6 . Once a product has been endorsed , it may be used without
    further    notification throughout the European Community
    insofar    as the    specific conditions     of use and the
    environments and / or geographical areas stipulated in these
    conditions are strictly adhered to .
7 . Member States shall adopt all necessary measures to ensure
    that users comply with the conditions of use specified in
    the endorsement .
                            ARTICLE 12
Member States shall take all necessary measures to ensure that
products containing or consisting of GMOs will be placed on
the market after endorsement only if their labelling and
packaging is that endorsed under Article 11 .
 ---pagebreak---                                             11
                                     ARTICLE 13
The       Member       States   may   not ,    on   grounds  relating   to   the
notificaiton           and endorsement      of a    deliberate  release    under
this directive , prohibit , restrict or impede the placing on
the market of products containing or consisting of GMOs which
comply with the requirements of this Directive .
1 . Where a Member State has evidence that a product which has
    been properly notified and endorsed under this Directive
    constitues a serious risk to people or the environment , it
    may provisionally restrict or prohibit the use or sale of
    that product on its territory . It shall immediately inform
    the     Commission and        the other       Member States of such action
    and give reasons for its decision .
2 . The Commission shall take a decision on the rnatter , within
    3 months following the procedure laid down in Article 20 .
The Commission shall publish in the Official Journal a list of
all       the products receiving final endorsement under this
Directive .          For each product , the GMO(s ) contained therein and
the use(s ) shall be clearly specified .
                                     ARTICLE 16
1 . Member      States shall        send to     the Commission , at the end of
    each year , a brief factual report on the control of the use
    of all products placed on the market under this Directive .
2   T he)   C omm i. s s ion shall send to the European Parliament , every
    three years , a report on the control by the Member States
    of the products placed on the market under this Directive .
 ---pagebreak---                                          12
PART Di       FINAL PROVISIONS
1 . The          notifier   may   indicate     the    information     in   the
      notifications        submitted under this Articles 4 and 9 of this
      Directive ,       the disclosure        of which      might harm     his
      compétitive         position , that      should    be    kept    secret .
      Vérifiable justification must be given in such cases .
2 . The          competent authority      shall     décidé     on    its   own
      responsibility which information will be kept secret .
3 . In no case may the following information be kept secret :
      - identity of the GMO(s ), name and address of the notifier ,
         purpose of the release or of the product , and site of
         release , or areas of use .
      - the       evaluation of    foreseeable effects , in particular any
         pathogenic and ecologically disruptive effects .
      - for        experimental releases :       methods and       plans   for
         monitoring the GMO(s ), for decontaminating the area(s ) of
         release , and for emergency response .
      - for placing on the market :            methods for monitoring the
         GMO(s )      contained in      the    product and for emergency
       ■ response in case of misuse .
 4 . Confidential information brought to the attention either of
      the Commission or of a competent authority shall be kept
      secret .                              '       .
                                    AE1I£U5-19
According to the procedure laid down in Article 20 , the
Commission shall adapt the annexes of this Directive to
 technical progress by :
 - by amending new           techniques to     be covered    or   deleting  as
     appropriate
     amending the notification requirements set out in Annexes II
• v and . Ill to take into . account the potential hazard of the
   > GMO ( s ) .
 ---pagebreak---                                       13
                                 ARTICLE 19
1 . The Commission shall be assited by a Committee of an
    advisory nature composed of the representatives of the
    Member States and chaired by the representative of the
    Commission .
2 . The     Commission     shall   function   in   accordance   with    the
    procedures laid down in Article 20 .
                                 ARTICLE 20
1 . Where the procedure laid down in this Article is followed ,
    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 have the right 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 21
1 . Member States and the Commission shall meet regularly and
    exchange information on the experience acquired with regard
    to the prevention of risks related to the release of GMOs
    to the environment .
2 . Every three years , Member States shall send the Commission
    a report on the measures taken to implement the provisions
    of this Directive , the first time being on lst September
    1991 .   *
3 . Every      three years , the Commission shall publish a summary
    based      on the reports referred to in paragraph 2 , the first
    time being in 1992 .
                                 ARTICLE 22
1 . Member States shall bring into force the laws , regulations
    and administrative provisions necessary to comply with this
    Directive       within a      period of      18 months     from     its
    notification .
2 . The Member States shall immediately inform the Commission
    of     all laws regulations and administrative provisions
    adopted in implementation of this Directive .
 ---pagebreak---                                14
                          ARTICLE 23
This Directive is addressed to the Member States .
 ---pagebreak---                                              ANNEX I
Genetically modified organisms are organisms which can be
obtained by such techniques as recombinant DNA , micro -
injection , macroinjection microencapsulation , nuclear and
organel transplantation or genetic manipulation of viruses .
 ---pagebreak---                                           ANNEX II
The notifications  for a   deliberate   release  referred to  in
Article 4 and for placing on the market referred          to  in
Article 9 must provide the information set out below .
Not all the points included will apply to every case . It is to
be expected , therefore , that individual notifications will
address only    the particular     subset of issues that are
appropriate to individual situations .     In each case where it
is not technically possible or it does not appear necessary to
give the information , the reasons shall be stated .
The level of detail required in response to each subset of
considérations is also likely to vary according to the nature
and the scale of the proposed release .
The description of the methods used or the reference to
standardized or internationally recognized methods shall also
be mentioned in the dossier , together with the name of the body
or bodies responsible for carrying out the studies .
 ---pagebreak--- 1 . IDENTIFICATION AND CHARACTERISTICS OF THE pRGANISM
    a ) Information relating to the parental organisms
           Scientific name
           Taxonomy
           Other    names    ( usual   name ,   strain     name ,  cultivar
           name , etc . ) .
           Phenotypic and genetic markers .
    b ) Information relating to the récipient organism
           Description      of     identification         and     détection
           techniques
           Sensitivity , reliability ( in quantitative terms ) and
           specificity      of     detection       and      identification
           techniques
           Description of thè geographic distribution and of thè
           naturai habitat of thè organism including information
           on    naturai       predators ,    preys ,      parasites    and
           competitors and symbionts
           Potential for       genetic   transfer     and   exchange   with
           other organism
           Vérification of        the genetic       stability      of   the
           organisms and factors affecting it
           Pathological , ecological       and physiological      traits of
           the organism :
           * Classification      according     to   existing      Community
              rules
           *   Generation time in natural         ecosystems , sexual and
               asexual reproductive cycle
           *   Information on survival , including seasonality and
               the ability to form survival structures e.g. :
               seeds , spores or sclerotia
           *   Pathogenicity :         infectivity ,          toxigenicity ,
               virulence , allergenicity ,        carrier ( vector )     of
               pathogen , possible vectors , host range including
               non-target organisms .          Possible activation of
               latent viruses ( proviruses ).         Ability to colonize
               other organisms
 ---pagebreak---         *
        *    Antibiotic resistance , and potential use of these
             antibiotics in humans and domestic organisms for
             prophylaxis and therapy
        *    Involvement in environmental processes : primary
             production , nutrient turn-over , decomposition of
             organic matter , respiration , etc ..
c ) Information relating to the genetic modification
        Methods used for the modification
        Methods used      to construct and introduce the insert(s )
        into the recipient
        Purity of the insert from any unknown sequence
        Functional identity         and location of the       altered
        inserted nucleic acid segment ( s ) in question
        Description of any new genetic trait ( s ) or phenotypic
        characteristics which may be expressed or no longer
        expressed
        History of previous genetic         manipulations   with  the
        parental organisms .
OTHER INFORMATION NECESSARY FOR RISK EVALUATION
a ) Characteristics of the genetically modified organism
    ( GMO ) affecting survival , multiplication and dispersion
        Biological        features      which    affect     survival ,
        multiplication and dispersion
        Behaviour in simulated natural environments , such as
        microcosms , growth rooms , greenhouses , etc .
        Known or predicted environmental conditions which may
        a'ffect survival ,       multiplication and dissemination
         ( wind , water , soil , etc .)
        Sensitivity to specific agents
b ) Interactions of the GMO with the biological Systems :
        Predicted habitat of the GMO
        Genetic transfer capability
        Likelihood of        post-release selection       of genetic
        transfer leading to the expression of undesirable
        effects in the organisms released or / and in any other
        organism in the environment
        Measures employed         to ensure     genetic    stability ,
        Description of genetic traits which may           prevent  or
        minimise dispersai of genetic material
 ---pagebreak---            Routes of biological dispersal , known or potential
           modes of interaction with the disseminating agent ,
           including inhalation ,       ingestion , surface contact ,
           burrowing , etc .
           Potential for     excessive population      increase    in   the
           environment
           Identification and description of the target organism
           Anticipated    mechanism     and   result      of   interaction
           between the released GMO(s ) and the target            organism
           Identification      and     description       of     non-target
           organisms which may be affected unwittingly
           Known or predicted effects on non-target organisms in
           the environment        impact on      population levels of
           competitors , preys ,      hosts , symbionts ,       predators ,
           parasites and pathogens
           Other potentially significant interactions with              the
        environment .
3 . GEOGRAPHICAL LOCATION OF THE SITE OF RELEASE ( in the case of
    notifications for placing on the market , the site(s ) of
    release will be the intended areas of use of the product )
    a ) Geographical location of the site(s ), including :
           Physical or biological proximity to humans
           Size of local population
           Economic activities      of local    populations     which   are
           based on the natural resources of the area
    b ) Description of the site , including :
           Climatic characteristics
           Geographical ,    geological     and   pedological      charac ¬
           teristics
           Flora and      fauna ,   including    crops ,    livestock   and
           migratory species
           Surrounding ecosystems      to which    the    organism    could
           spread
    c ) A comparison of the natural habitat of the               recipient
        organism with the proposed site(s ) of release .
4 . CONDI TIONS OF T HE DELIP ERATK . RELEASE ( only for notifications
    under Article 4 )
 ---pagebreak---     a ) Description     of      the    proposed      deliberate       release ,
        including       the      program     and     the' purpose(s )       or
        objective ( s )
    b ) Préparation of the site previous to the release
    c ) Size of the site
    d ) Method , amount , frequency and duration of the release
    e ) Methods of      human intervention           ( mining ,   cultivation
        methods , etc ..) on the site .
    f ) Worker safety measures during the release
    g ) Post-release treatment of the site
5 . CONTROL AND EMERGENCY RESPONSE PLANS
    a ) Monitoring techniques
           Methods for     tracing the      GMO(s ), and    for    monitoring
           its effects
           Détection       and       identification        techniques       to
           distinguish the GMO(s ) from the parental organisms
           Specificity     ( to     identify     the     GMO(s ),     and   to
           distinguish       them      from    the       parental       ones ),
           sensitivity     and      reliability      of    the     monitoring
           techniques
           Techniques for detecting transfer               of   the    donated
           genetic material to other organisms
           For experimental       releases , duration      and frequency of
           the monitoring
    b ) Response plans     in case     of an   unexpected spread        of the
        organism
           Methods and procedures for            controlling      the   GMO(s )
           in case of unexpected spread
           Methods for decontamination of            the   areas    affected ,
           e.g. eradiction of the GMO(s )
           Methods for        disposal or        sanitation of         plants ,
           animals , soils , etc ., that       were exposed during or
           after the spread
           Methods for     the isolation of the area affected by the
           spread
           Plans for    protecting human       and environmental        health
           in case of the occurrence of an undes.irable effect
 ---pagebreak--- ) Control of   the release  ( only in case of notifications
  under Article 4 )
     Methods and procedures to minimize the spread of the
     GMO(s ) beyond the site of release
     Methods and procedures to protect the       site  from
     intrusion by unauthorized individuals .
 ---pagebreak---                                                            ANNEX   III
A. The following             information   shall     be provided       in thè
    notification for placing on            thè market of products , in
    addition to that of Annex II :
    1 . Name of       the product     and  name(s )   of  GMO(s )   contained
        there in
    2 . Name of       the man                2 . Name of  the manufacturer    or di
        address in the Community
    3 . Specificity of the product , exact conditions of use
        including , when appropriate , the type of environment
        and / or the geographical area(s ) of the Community for
        which the product is suited
    4 . Type of expected use : industry , agriculture and skilled
        trades , consumer use by public at large .
B . The following information shall be provided , when relevant ,
    in addition to that of Annex III . A , in accordance with
    Article 9 .
    1 . Measures       to    take  in   case    of  unintended    release  or
        misuse .
    2 . Specific instructions          or recommendations for storage and
        handling
    3 . Estimated production and / or imports to the Community
    4 . Proposed packaging .          This must be appropriate so as to
        avoid unintended release of the GMO(s ) during storage ,
        or at a later stage
    5 . Proposed labelling .          This must include , at        least in
        summarized form , the information referred to               in points
        A . 1 , A. 2 , A. 3 , B.l and B.2 of this Annex .
                                                                                ^6
 ---pagebreak---          DRAFT COUNCIL DIRECTIVE ON THE DELIBERATE RELEASE
      TO THE ENVIRONMENT OF GENETICALLY MODIFIED ORGANISMS .
COMPETITIVENESS AND EMPLOYMENT IMPACT ASSESSMENT
I.    WHAT IS THE MAIN REASON FOR INTRODUCING THE MEASURE
      To approximate     the Member States' laws and administrative
      provisions regarding        the deliberate       release to the
      environment of genetically modified organisms ( GMOs ) to
      the environment ,    and to ensure that these releases , for
      experimental and commercial purposes , will take place
      under conditions of human and environmental safety which
      are as high as reasonably practicable .           These releases
      will involve , for example , microorganisms to be used as
      pesticides , toxic Chemical degraders , etc , as well as
      plants or      animais adapted        to adverse environmental
      conditions , or résistant to diseases .          As some Member
      States are introducing régulations on this matter , the
      élaboration of a Community directive is essential to avoid
      fragmentation of the market .
II .  FEATURES OF THE BUSINESSES IN QUESTION
      This a high-technology field , in which most activities are
      developped by       large chemical       manufacturers , and by
      research institutions very often supported by these large
      industries .    The number    of PMEs is small at this moment ,
      and they      are located in well-developped areas , not
      eligible for regional aid or the ERDF .              However , the
      number of PMEs is potentially high in the future , as this
      currently expensive technology becomes more affordable .
      Many of the applications envisaged are products taylored
      for very specific uses : the sort of products appropriate
      for SMEs .
III . WHAT   DIRECT   OBLIGATIONS    DOES    THIS   MEASURE   IMPOSE      ON
      BUSINESS ?
      The   directive     requires   the     researcher     and / or   . the
      manufacturer    to    take   measures     to   ensure   human      and
      environmental safety ,     and to    submit a   notification to a
      national competent      authority .    The notification      will be
       submitted in   all cases of releases of GMOs , as the little
      knowledge and    experience on      possible risks do not allow ,
      at this    moment , the   exemption of    certain categories        of
      organisms .    This notification ,     however extensive , should
      not require      burdensome additional         work : it       should
      essentially consist of the information already available
      for the business in order to ensure the safety of the
      release .    These notificatons will not be required of the
      final users of the product , i.e. farmers , environmental
      clean-up companies , etc .
 ---pagebreak---                                        2
IV .  WHAT INDIRECT      OBLIGATIONS ARE LOCAL AUTHORITIES LIKELY TO
      IMPOSE ON BUSINESSES ?
      To keep a high level of public information .
V.    ARE THERE ANY SPECIAL MEASURES IN RESPECT OF SMEs ?
      No .
VI .  WHAT IS THE LIKELY EFFECT ON :
      ( a ) the competitiveness of businesses ,
      ( b ) employment ?
      ( a ) The harmonization of procedures at Community level
            should have a positive effect on the competitiveness
            of SMEs . On the other hand , the necessary adoption of
            safety measures ( i . e ., fencing of the areas of release ,
            further testing and the like ) in order to make the
            releases as safe as possible may , in some occasions ,
            be rather      expensive .       These costs    could   be ,
            proportionally , more burdensome for SMEs .
      (b)   None .
VII . HAVE BOTH SIDES OF INDUSTRY BEEN CONSULTED ?
      This proposal        has been discussed with the European
      Biotechnology        Coordination        group ,   composed    of
      representatives       from     different    European   Industry 's
      organisations : AMFEP , CEFIC , CIAA , EFPIA , GIFAP .        The
      employee 's side , however , has not been consulted .
      Industry 's view is that Community-wide harmonization of
      procedures is        badly needed ,      but it    expressed its
      reservation to an endorsement by regulatory bodies prior
      to the releases .