CELEX: 51988PC0160(02)
Language: en
Date: 1988-05-04
Title: PROPOSAL FOR A COUNCIL DIRECTIVE ON THE DELIBERATE RELEASE TO THE ENVIRONMENT OF GENETICALLY MODIFIED ORGANISMS

28.7. 88                               Official Journal of the European Communities                            No C 198/19
              Proposal for a Council Directive on the deliberate release to the environment of genetically
                                                     modified organisms
                                              COM (88) 160 final — SYN 131
                              (Submitted by the Commission to the Council on 16 May 1988)
                                                        (88/C 198/09)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                          Whereas the protection of the public and the en-
                                                                  vironment requires that due attention be given to
                                                                  controlling risks from the deliberate release of gen-
Having regard to the Treaty Establishing the European
                                                                  etically modified organisms to the environment;
Economic Community and in particular Article 100A
thereof,
                                                                  Whereas new techniques of genetic modification are
                                                                  defined in Article 2 (2) and Annex I of this Directive;
Having regard to the proposal of the Commission,                  whereas those techniques which have conventionally
                                                                  been used with crop plants and livestock with an
Having regard      to   the  opinion    of   the  European        excellent safety record are not covered by the definition
Parliament,                                                       of Article 2 (2) or Annex I;
Having regard to the opinion of the Economic and                  Whereas it is necessary to establish harmonized
Social Committee,                                                 procedures for the evaluation of the potential risks
                                                                  arising from the intentional introduction, for the purpose
                                                                  of research and development, of genetically modified
Whereas disparity between the regulation of the                   organisms into the environment;
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             Whereas the deliberate release of genetically modified
competition and thus directly affect the functioning of           organisms at the research stage is in most cases a
the common market; whereas, it is therefore necessary to          necessary step in the development of new products
approximate the laws of the Member States in this                 derived from or containing genetically modified
regard, as provided for in Article 100A of the Treaty;            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 measures for the approximation of the
provisions of the Member States which have as their               Whereas it is necessary to establish a Community review
object the establishment and functioning of the internal          and decision-making procedure for the placing on the
market shall, inasmuch as they concern health, safety,            market of the products containing or consisting of gene-
environmental and consumer protection, take a high                tically modified organisms, where the intended use of
level of protection as a base and provide, despite existing       that product involves its deliberate release to the
differences in economies of the Member States, for equal          environment;
standards of protection throughout the Community;
                                                                  Whereas any person, before undertaking a new
Whereas under the Treaty, action by the Community                 deliberate release to the environment of a genetically
relating to the environment shall be based on the                 modified organism, or the placing on the market of a
principle that preventive action shall be taken;                  product containing or consisting of genetically modified
                                                                  organisms where the intended use of that product
Whereas living organisms, whether released to the en-             involves its deliberate release to the environment, shall
vironment in large or small amounts for experimental              submit a notification to the national competent
purposes or as commercial products, may reproduce in              authority;
the environment and cross national frontiers thereby
affecting bordering Member States or the Community as             Whereas that notification should contain a technical
a whole;                                                          dossier of information including a full risk assessment,
                                                                  appropriate safety and emergency response, and in the
                                                                  case of products, precise instructions and conditions for
Whereas it is necessary to ensure the development of
                                                                  use, and proposed labelling and packaging;
industrial products utilizing genetically          modified
organisms which do not cause harm to human health or
the environment; whereas the new biotechnology                    Whereas it is important to follow closely that devel-
promises improvements in health and the environment by            opment and use of genetically modified organisms, and
developing more precise agricultural inputs for                   that in order to do this it is necessary to list all the
protection and nutrition and more effective treatment of         products notified under this Directive, and to provide for
wastes;                                                           subsequent notifications and follow-up information;
 ---pagebreak--- No C 198/20                             Official Journal of the European Communities                                    28. 7. 88
Whereas when a product containing a genetically                    6. Notification means the documents whereby the person
modified organism or a combination of them is placed                   who is to carry out a deliberate release of a G M O or
on the market where the intended use of that product                   a combination of GMOs for the purpose of research
involves its deliberate release to the environment, and                and development, or to place a product on the market
where such a product has been properly notified and                    presents the requisite information to the competent
endorsed under this Directive, a Member State may not                  authority of a Member State. This person shall be
prohibit, restrict or impede the deliberate release of this            referred to as 'the notifier'.
organism on their territory under the conditions set out
in the notification, except under the specific conditions          7. Use means the deliberate release of a product which
of a safeguard procedure, in case of a serious risk to                 has been placed on the market. The persons carrying
human health or the environment,                                       out this use will be referred to as 'users'.
HAS ADOPTED THIS DIRECTIVE:                                                                   Article 3
                                                                   1.     Member States shall adopt the provisions necessary
                  Part A: General provisions                       to ensure that all persons carrying out the deliberate
                                                                   release or placing on the market of GMO(s) shall take
                           Article 1                               all measures reasonably practicable to control any risk of
                                                                   harm to people and the environment.
1.    The objective of this Directive is to approximate
the laws, regulations and administrative provisions of the
Member States and to protect the health of the general             2.     Member States shall designate the competent
population and the environment in relation with:                   authority or authorities responsible for carrying out the
                                                                   requirements of this Directive and its annexes.
— the deliberate release of genetically             modified
    organisms to the environment,                                  Part B: Deliberate release of genetically modified
                                                                   organisms to the environment for research and
— the placing on the market of products containing or
                                                                                       development purposes
    consisting of genetically modified organisms intended
    for subsequent deliberate release to the environment.                                     Article 4
                                                                   Member States shall adopt the provisions necessary to
2.    This Directive does not apply to the carriage of             ensure that:
genetically modified organisms by rail, road, inland
waterway, sea or air.
                                                                   1. Any person, before undertaking a deliberate release of
                                                                       a G M O or a combination of GMOs for the purpose
                           Article 2                                   of research and development, must submit a notifi-
                                                                       cation to the competent authority specified in Article
For the purpose of this Directive:
                                                                       3 (2) of the Member State within whose territory the
                                                                       release is to take place before carrying out the release.
1. Organism includes multicellular and unicellular
   organisms. It also includes subcellular entities capable
   of replication.                                                2. The notification shall include:
2. Genetically modified organism (hereinafter referred to              (a) A technical dossier supplying the information
   as GMO) is an organism in which the genetic material                    specified in Annex II necessary for evaluating the
   is altered in a way that passes the natural barriers of                 foreseeable risks, whether immediate or delayed,
   mating and recombination. Annex I indicates the                         which the GMO(s) may pose to people or the
   techniques by which such genetic alterations can be                     environment, together with the methods used and
   obtained.                                                               the bibliographic reference to them and covering,
                                                                           in particular:
3. Deliberate release means any intentional introduction                   — identification     and    characteristics  of    the
   in the environment of a G M O or a combination of                           GMO(s),
   GMOs without provisions for containment such as                         — the location of the area where the deliberate
   special procedures, equipment and installations, or                         release is to be carried out and the
   facilities that provide physical barriers to prevent their                  predominant meteorological, social, environ-
   spread into the environment.                                                mental and agricultural characteristics of the
                                                                               area,
4. Product means a preparation or formulation consisting
   of or containing a G M O or a combination of GMOs,                      — the purpose and conditions of the release,
   which is placed on the market.                                              including the quantity of the GMO(s) to be
                                                                               released, the size of the area affected, and the
5. Placing on the market mea"ns supplying or making                            duration of the release,
   available to third parties for the purpose of sale or                   — all other information         necessary   for   risk
   commercial distribution.                                                    assessment,
 ---pagebreak--- 28. 7. 88                                 Official Journal of the European Communities                            No C 198/21
        — methods for monitoring the GMO(s) and,                     3.    If the competent authority is not satisfied with the
             when appropriate, proposed techniques for               conditions of the proposed release, it may ask the
             elimination or inactivation of the GMO(s) at            notifier to modify such conditions of the release so as to
             the end of the experiment, and for emergency            bring it into compliance with Article 3 of this Directive.
             response in case of the spread of the GMOs
             beyond the area of release.
                                                                     4.    The notifier may proceed with the release only
    (b) A statement evaluating the impacts and risks                 when he has received the endorsement of the competent
         posed by the GMOs to people or the environment              authority, subject to any conditions required in this
         from the uses envisaged.                                    endorsement.
3. The experimental release of a combination of                      5.    The Member States may provide for derogations
    different GMOs for the same purpose may be notified              from the provisions under Articles 4 and 5 (1) to 5 (4)
    in a single notification.                                        and 6 for deliberate releases carried out by or under the
                                                                     responsibility of a public authority which is designated as
4. In the case of a subsequent release of the same G M O             a competent authority according to Article 3 (2). This
    or combination of GMOs previously notified as part               derogation does not affect the obligation to assess the
    of the same research programme, the notifier shall be            risk posed by the release concerned nor the obligation to
    required to submit a new notification. In this case, the         submit information to the Commission as required in
    notifier may refer to data from previous notifications           Article 7.
    or results from previous releases.
                                                                                                Article 6
5. The notifier may also refer to data or results form
    notifications previously submitted by other notifiers,           On the completion of a release the notifier shall send to
    provided that the latter have given their agreement in           the competent authority an assessment of the result of
    writing.                                                         the release in respect of any risk to man or the en-
                                                                     vironment, with particular reference to any product that
6. In the event of any modification of the deliberate                he intends to notify.
    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                                          Article 7
    risks, either while the notification is being examined           1.    The Commission shall set up a system of exchange
    by the competent authorities or after the endor-                 of the information contained in the notifications. The
    sement, the notifier shall:                                      competent authorities shall send to the Commission a
                                                                     summary of each notification received within 15 days of
    (a) revise the measures specified in Article 4 (2),              its receipt.
    (b) inform the     competent authority of the modifi-
         cation, in    advance or as soon as the new                 2.    The Commission shall forward these summaries to
         information   is available, in so far as it affects the     the other Member States.
         information   contained in the notification.
                                                                     3.    If a competent authority wants more information
                            Article 5                                relative to releases carried out in other Member States, it
                                                                     may ask the competent authority of this Member State to
 1.    The competent authority shall:
                                                                     provide them with further information.
— evaluate the risk posed by the release in the light of
     the notifier's risk assessment,                                 4.    The competent authority of the other Member
                                                                     States may suggest to the competent authority which
— state its conclusions in writing,                                  received the original notification any modifications to
                                                                     the conditions of the release.
     and, if necessary,
— ask the notifier to provide further information or                 Part C: Placing on the market of products containing
     verification tests, explaining the reasons for it,                             genetically modified organisms
— carry out such tests as may be necessary for control                                          Article 8
     purposes.
                                                                     Articles 9 to 16 of this Directive do not apply to:
2.     The competent authority shall respond to the noti-
fication within 90 days of its receipt, either deciding on           — medicinal products,
its endorsement or indicating the further information
required or measures to be taken.
                                                                     — veterinary products,
 ---pagebreak--- No C 198/22                             Official Journal of the European Communities                                  28. 7. 88
— foodstuffs, feedingstuffs and their additives,                                            Article 10
                                                                   1.     On receipt of the notification referred to in Article
— plants and animals produced or used in agriculture,
                                                                   9, the competent authority shall examine it for
     horticulture, forestry, husbandry and fisheries, the
                                                                   compliance with this Directive, giving particular
     reproductive material thereof and the products
                                                                   attention to the risk assessment and the recommended
     containing these organisms,
                                                                   precautions related to the safe use of the product.
— or to any products covered by Community legislation
                                                                   2.    The competent authority may ask the notifier for
     which includes a specific risk assessment.
                                                                   additional information or suggest further tests to carry
                                                                   out or changes in the conditions of placing on the
                           Article 9                               market so as to bring these conditions into compliance
                                                                   with the Directive.
1.     Before a G M O or a combination of GMOs are
placed on the market as or in a product, the manu-                 3.    "When the competent authority is satisfied that the
facturer or the importer to the Community shall submit a           placing on the market of the product under the
notification to the competent authority of the Member              conditions specified in the notification is in compliance
State where they are to be placed on the market for the            with this Directive, it shall send to the Commission a
first time. This notification shall contain:                       dossier including a summary of the notification together
                                                                   with a statement of the conditions under which it
— the information required in Annex II, extended as                proposes to endorse the placing on the market of the
     necessary to take into account the diversity of sites of      product.
     use of the product, and an assessment of any risks for
     man and/or the environment related to the GMO(s)              4.    The competent authority shall respond to the noti-
     contained in the product,                                     fication within 90 days of receipt, either by indicating
                                                                   the need for further information and evaluation, or
— the conditions for the placing on the market of the              measures to bring it into compliance with this Directive,
     product, including specific conditions of use and             or forwarding the dossier referred to in Article 10 (3) to
     handling and a proposal for labelling and packaging           the Commission.
     which should comprise at least the requirements laid
     down in Annex III.
                                                                                            Article 11
If, on the basis of the results of any release notified            1.     On receipt of the dossier referred to in Article 10,
under Part B of this Directive, or on substantive,                 the Commission shall forward to all Member States:
reasoned scientific grounds, a notifier considers that the
placing on the market and use of a product do not pose             — the summary of the dossier,
any risk to man and/or the environment, he may
propose not to comply with one or more of the                      — any other information it has collected pursuant to
requirements of Annex III.B.                                           this Directive.
                                                                   2.     For a period of three months after the Commission
2.     Subject to the agreement of the competent                   has circulated the dossier with the summary of the notifi-
authority, the notifier may refer in this notification to          cation and the proposed conditions for placing on the
data or experiences from releases of the same GMO(s)               market, other competent authorities may request the
previously notified at the research and development level.         competent authority which proposes the endorsement to
                                                                   provide further information or change the conditions for
3.     The notifier may also refer to data or results from         placing on the market, giving their reasons for such
notifications previously submitted by other notifiers,             requests.
provided that the latter have given their agreement in
writing.                                                           3.     If the competent authority which proposed the
                                                                   endorsement fails to comply with the requests of other
4.     Each new product which, containing or consisting            authorities regarding further information, the risk
of the same G M O or combination of GMOs, is intended              assessment or the conditions of placing on the market, it
for a different use, shall be notified separately.                 shall give its reasons to the competent authority
                                                                   concerned.
5.     If new information has become available with                4.     Should it not be possible for the competent auth-
regard to the risks of the product to people or the en-            orities concerned to reach an agreement, and should any
vironment, either before or after the endorsement, the             competent authority feel, on the basis of scientific
notifier shall:                                                    evidence, that the placing on the market of the product
                                                                   may pose risks to people or the environment, within this
— revise the measures specified in Article 9 ( 1 ) , and           period of three months, the Commission shall take a
                                                                   decision in accordance with the procedure laid down in
— inform the competent authority immediately.                      Article 20.
 ---pagebreak--- 28. 7. 88                              Official Journal of the European Communities                             No C 198/23
5. When the competent authority that received the                 the use of all products placed on the market under this
original notification has provided a satisfactory response        Directive.
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            2. The Commission shall send to the European
in the case of Article 11 (4), it shall endorse the notifi-       Parliament every three years a report on the control by
cation so that the product may be placed on the market.           the Member States of the products placed on the market
                                                                  under this Directive.
6. Once a product has been endorsed, it may be used
without further notification throughout the European
Community in so far as the specific conditions of use                                Part D: Final provisions
and the environments and/or geographical areas
stipulated in the conditions are strictly adhered to.                                       Article 17
                                                                  1. The notifier may indicate the information in the
7. Member States shall adopt all necessary measures               notifications submitted under Articles 4 and 9 of this
to ensure that users comply with the conditions of use            Directive, the disclosure of which might harm his
specified in the endorsement.                                     competitive position, that should be kept secret. Veri-
                                                                  fiable justification must be given in such cases.
                         Article 12
Member States shall take all necessary measures to                2. The competent authority shall decide on its own
ensure that products containing or consisting of GMOs             responsibility which information will be kept secret.
will be placed on the market after endorsement only if
their labelling and packaging is that endorsed under
Article 11.                                                       3. In no case may the following information be kept
                                                                  secret:
                         Article 13
                                                                 — identity of the GMO(s), name and address of the
The Member States may not, on grounds relating to the                 notifier, purpose of the release or of the product, and
notification and endorsement of a deliberate release                  site of release, or areas of use,
under this Directive, prohibit, restrict or impede the
placing on the market of products containing or
consisting of GMOs which comply with the requirements            — the evaluation of foreseeable effects, in particular any
of this Directive.                                                    pathogenic and ecologically disruptive effects,
                         Article 14                              — for experimental releases: methods and plans for
                                                                      monitoring the GMO(s), for decontaminating the
 1. Where a Member State has evidence that a product                  area(s) of release, and for emergency response,
which has been properly notified and endorsed under
this Directive constitutes a serious risk to people or the
environment, it may provisionally restrict or prohibit the       — for placing on the market: methods for monitoring
use or sale of that product on its territory. It shall                the GMO(s) contained in the product and for
immediately inform the Commission and the other                       emergency response in case of misuse.
Member States of such action and give reasons for its
decision.
                                                                  4. Confidential information brought to the attention
                                                                 either of the Commission or of a competent authority
2. The Commission shall take a decision on the                    shall be kept secret.
matter, within three months following the procedure laid
down in Article 20.
                                                                                            Article 18
                         Article 15
                                                                 According to the procedure laid down in Article 20, the
The Commission shall publish in the Official Journal of          Commission shall adapt the annexes of this Directive to
the European Communities a list of all the products              technical progress by:
receiving final endorsement under this Directive. For
each product, the GMO(s) contained therein and the
use(s) shall be clearly specified.                               — amending new techniques to be covered or deleting
                                                                      as appropriate,
                         Article 16
                                                                 — amending the notification requirements set out in
1. Member States shall send to the Commission, at the                 Annexes II and III to take into account the potential
end of each year, a brief factual report on the control of            hazard of the GMO(s).
 ---pagebreak--- N o C 198/24                             Official Journal of the European Communities                                        28. 7. 88
                          Article 19                                                                Article 21
1.    The Commission shall be assisted by a Committee                   1.     Member     States and the Commission shall meet
of an advisory nature composed of the representatives of                regularly and     exchange information on the experience
the Member States and chaired by the representative of                  acquired with    regard to the prevention of risks related to
the Commission.                                                         the release of   GMOs to the environment.
                                                                        2.     Every three years, Member States shall send the
2.    The Commission shall function in accordance with                  Commission a report on the measures taken to
                                                                        implement the provisions of this Directive, the first time
the procedures laid down in Article 20.
                                                                        being on 1 September 1991.
                                                                        3.     Every three years, the Commission shall publish a
                          Article 20                                    summary based on the reports referred to in paragraph
                                                                        2, the first time being in 1992.
Where the procedure laid down in this Article is
followed a representative of the Commission shall submit                                            Article 22
to the Committee a draft of the measures to be taken.
                                                                         1.    Member States shall bring into force the laws,
The Committee shall deliver its opinion on the draft,
                                                                        regulations and administrative provisions necessary to
within a time limit which the chairman may lay down
                                                                        comply with this Directive within a period of 18 months
according to the urgency pf the matter, if necessary by
                                                                        from its notification.
taking a vote. The opinion shall be recorded in the
minutes; in addition, each Member State shall have the                  2.     The Member States shall immediately inform the
right to have its position recorded in the minutes. The                 Commission of all laws, regulations and administrative
Commission shall take the utmost account of the opinion                 provisions adopted in implementation of this Directive.
delivered by the Committee. It shall inform the
                                                                                                    Article 23
Committee of the manner in which its opinion has been
taken into account.                                                     This Directive is addressed to the Member States.
                                                               ANNEX I
             Genetically modified organisms are organisms which can be obtained by such techniques as recombinant
             DNA, micro-injection, macro-injection, micro-encapsulation, nuclear and organal transplantation or
             genetic manipulation of viruses.
                                                               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 notifi-
            cations 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 considerations 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--- 28. 7. 88                               Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s             N o C 198/25
          1. Identification and characteristics of the organism
             (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 recipient organism:
                 — description of identification and detection techniques,
                 — sensitivity, reliability (in quantitative terms) and specificity of detection and identification tech-
                      niques,
                 — description of the geographic distribution and of the natural habitat of the organism including
                      information on natural predators, preys, parasites and competitors and symbionts,
                 — potential for genetic transfer and exchange with other organisms,
                 — verification of the genetic stability of the organism 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,
                     — 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, decompo-
                          sition 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.
          2. 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 affect survival, multiplication and
                     dissemination (wind, water, soil, etc.),
                 — sensitivity to specific agents.
 ---pagebreak--- N o C 198/26                            Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                 28. 7. 88
              (b) Interactions of the G M O with the biological systems:
                  — predicted habitat of the G M O ,
                  — 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 dispersal of genetic material,
                  — 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 characteristics,
                   — 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. Conditions of the deliberate release
              (only for notifications under Article 4)
              (a) description of the proposed deliberate release, including the programme and the purpose(s) or
                   objective(s),
              (b) preparation 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.
 ---pagebreak--- 28. 7. 88                               Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s            N o C 198/27
          5. Control and emergency response plans
             (a) Monitoring techniques:
                 — methods for tracing the GMO(s), and for monitoring its effects,
                  — detection 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 undesirable
                     effect.
             (c) 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.
                                                                 ANNEX      III
          A. The following information shall be provided in the notification for placing in the market of products, in
              addition to that of Annex II:
              1. Name of the product and name(s) of GMO(s) contained therein.
              2. Name of the manufacturer or distributor, and his legal 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(l), A(2), A(3), B(l) and B(2) of this Annex.