CELEX: 51989PC0034
Language: en
Date: 1989-02-16
Title: Amended proposal for a COUNCIL DIRECTIVE concerning the placing of EEC-accepted plant protection products on the market (presented by the Commission pursuant to Article 149(3) of the EEC Treaty)

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COM (89) 34
Vol. 1989/0012
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                              COM(89 ) 34 final
                                              Brussels , 16 February 1989
                         Amended proposai for a
                            COUNCIL DIRECTIVE
      concerning the placing of EEC-accepted plant protection
                         products on the market
              ( presented by the Commission pursuant to
                   Article 149(3 ) of the EEC Treaty )
                       tel         A\^Sectt
                              A> 'P'i'rrrrrv^t\
 ---pagebreak---                                 2
                     EXPLANATORY MEMORANDUM
1.  The Commission White Paper on completing the internal
    market calls for the adoption by the Council during 1986 of
    this proposal , which was made by the Commission in 1976(1 ).
    The proposal was examined actively by the Council over the
    period 1977-1983 , since when it has remained blocked due to
    reservations by a number of delegations .
2.  The original proposal , which did not provide for total
    harmonisation , envisaged the creation of an optional " EEC-
    acceptance " to operate in parallel with existing national
    arrangements for approving plant protection products . EEC-
    acceptance , if granted by one Member State , was to be
    recognised , subject to certain safeguards , automatically by
    all other Member States normally within a 1 - 2 year
    period . It was to permit the free circulation of the
    product throughout the Community except that Member States
    might , because of local conditions , be authorised by
    derogation under a Community procedure to prohibit its
    circulation in their territory or to restrict or vary its
    field of use . Member States were to be permitted , subject
    to the limitations of Directive 79 / 117 / EEC prohibiting the
    placing on the market and use of plant protection products
    containing certain active substances , to continue to
    approve for marketing in their own territory products
    complying with national provisions .
(1) OJ N° C 212 , 9.9.1976 , p. 3 , C0M(76 ) 437
                                                                   2
 ---pagebreak---                                 3
3. Opposition to the original proposal by certain Member
   States was based on their view that :
   a)      there was a disproportionate burden of proof placed
           on a Member State requesting a national derogation
           ( cf . paragraph 2 ), and
   b)      the envisaged Community procedure for mutual
           recognition and granting of derogations was too
           cumbersome and slow .
   Some Member States also called into question the very
   concept of " EEC-acceptance " , arguing that only Member
   States can judge possible adverse effects of a product ,
   particularly on the environment , under local conditions .
4. To meet these reservations , the Commission is of the
   opinion that the proposal should be modified to :
   a)      simplify the proposed Community procedure by
           limiting it to the establishment of a Community
           positive list of active substances . whose use may
           be considered a priori safe to human and animal
           health and to the environment , and
   b)      give greater flexibility to Member States to judge ,
           in the first instance , the acceptability under
           local conditions , safety , efficacy and
           environmental impact of individual preparations
           containing active substances authorized at
           Community level .
                                                                ">
                                                                Λ
 ---pagebreak---                                 4
    On the other hand , the Commission considers that the
    provisions of the directive should be made applicable to
    all plant protection products marketed in the Community ,
    thus rendering the harmonisation total , and that the
    principle of mutual recognition of national acceptance
    should be maintained . The provisions of the Directive have
    also been strengthened to ensure the proper use of plant
    protection products including the application , where
    appropriate , of the principles of integrated pest control .
    Compared with the original proposal , this modified proposal
    in fact reinforces the envisaged Community regulatory
    regime , so that it corresponds more closely to the
    objectives of the White Paper and contributes to the policy
    on pesticides announced in the Commission 's Green paper ( 2 )
    and the Communication " Environment and Agriculture " ( 3 ) . It
    also takes account of Parliament 's opinion ( 4 ) on the
    original proposal , which :
    a)       approved the proposal only as a transitional
             measure ;
    b)       called on the Commission to introduce more far-
             reaching proposals to bring about total
             standardization and stressed the need for
             flexibility in harmonizing national provisions ,
             particularly with regard to environmental
             protection .
(2) Perspectives for the Common Agricultural Policy , July 1985 ,
    Part IV , item 9
(3) Communication " Environment and Agriculture " of 8.6.1988 ,
    document COM(88)338 final .
(4) OJ H” C 30 . 7.2.1977 , p. 38
                                                                     If-
 ---pagebreak---                               5
5. The proposal does not only cover chemical substances but
   also microorganisms and viruses used as plant protection
   products .
   In June 1988 the Commission introduced to the Council a
   proposal for a Council Directive concerning the deliberate
   release of genetically modified organisms ( GMO ) in the
   environment ( COM(88)160 final ).
   The Commission noticed however that curently GMOs are not
   put on the market and that their use will be very limited
   before 1995 . Moreover , there is only few experience in
   relation to the methodology of risk assessment in this
   area .
   The Commission follows with attention the evolution in
   relation to the development of GMOs which may be marketed
   as plant protection products .
   In this context , the Commission does not exclude that in
   future it will be Induced to propose to the Council the
   introduction in this Directive of complementary and
   specific provisions concerning the risk evaluation and
   acceptance of plant protection products containing or
   composed of GMOs .
6. To facilitate comprehension , the amended proposal is
   presented below in the form of the full text of the
   preamble , enacting terms and annexes now proposed .
                                                              S
 ---pagebreak---                                            -  6
7 . The proposal provides a Regulatory Committee procedure for the establishment
    of standards of composition and purity of active substances , for the inclusion
    of active substances in annex I and for the establishment of uniform
    principles for checking of compliance with the requirements to be satisfied
    for the acceptance of plant protection products . This procedure has also been
    provided for deciding if the decision of a Member State to refuse the placing
    on the market of a plant protection product which has been accepted by another
    Member State or to refuse tests carried out in another Member State in view of
    such acceptance , is effectively justified on the ground that the
    phytosanitary , agricultural and environmental conditions are not comparable in
    the other Member State in comparison with those conditions in his own
    territory .
    The decision to propose this procedure does not prejudice future proposals of
    the Commission concerning decision procedures in this area . Moreover the
    Commission proposed the Advisory Committee procedure for the other management
    acts required for the implementation of the Directive .
                                                                                    C
 ---pagebreak---                                               7
                                      Amended proposal for a
                                        CPU NCI L DIRECTIVE
               concerning the placing of EEC-accepteo plant protection products on
                                             the market
The words 'EEC-accepted' are deleted from the title .
The preamble and articles are replaced by the following :
THE COUNCIL OP THE EUROPEAN COMMUNITIES ,
Having regard to the Treaty establishing the European Economic
Community , and in particular Article 43 thereof .
Having regard to the proposal from the Commission ,
Having regard to the opinion of the European Parliament ,
Having regard to the opinion of the Economic and Social
Committee ,
Whereas plaint production has a very important place in the
Coiiimuni ty ;
Whereas plant production yields are continually affected by
harmful organisms and weeds and whereas it is absolutely
essential to protect plants against these risks to prevent a
decline in yields and to help to ensure security of supplies ;
Whereas one of the most important ways of protecting plants and
plant products and of increasing the productivity of agriculture
is to use plant protection products ;
 ---pagebreak---                                    3
Whereas the use of these plant protection products has
consequences other than a favourable effect on plant production ;
whereas their use may involve risks for man and the environment
since , in the main , they are toxic substances or preparations
with hazardous effects ;
Whereas , in view of the hazards , there are rules in most Member
States governing the authorization of plant protection products
and whereas these rules present differences which constitute
barriers not only to trade in plant protection products but also
to trade in plant products , and thereby directly affect the
establishment and operation of the common market ;
Whereas it is therefore desirable to eliminate such barriers by
harmonizing the provisions laid down in the Member States ;
Whereas there must be uniform rules in the Member States relating
to the conditions and procedure for the acceptance of plant
protection products ;
Whereas such rules should provide that plant protection products
should not be put on the market unless they have been officially
accepted and should be used properly having regard to the
principles of integrated pest control ;
Whereas it is necessary , at the time when plant protection
products are accepted , to make sure that , when properly applied
for the purpose intended , they are sufficiently effective and
have no unaooeptable effect on plants or plant products , no
unacceptable adverse influence on the environment in general and ,
in particular , no harmful effect on human or animal health ;
 ---pagebreak---                                   9
Whereas acceptance should be limited to plant protection products
containing certain active substances specified at Community level
on the basis of their toxicological and ecotoxicological
properties ;
Whereas it is therefore necessary to establish a Community list
of permitted active substances ;
Whereas a Community procedure must be laid down for assessing
whether or not an active substance can be entered on the
Community list ; whereas the information that interested parties
must submit with a view to admission of a substance to the list
should be specified ;
Whereas the Community procedure should not prevent Member States
from authorizing for use in their territory for a limited period
of time plant protection products containing an active substance
not yet entered on the Community list , provided that the
interested party has submitted a dossier meeting Community
requirements and the Member State has concluded that the active
substance and the plant protection products satisfy the Community
conditions set in regard to them ;
Whereas , in the interest of safety , substances on the list should
be reviewed periodically ;
Whereas it is in the interest of free movement      of plant
products as well as of plant protection products that acceptance
granted by one Member State , and tests carried out with a view to
acceptance , should be recognized by other Member States, unless
certain agricultural , plant health and environmental conditions
relevant to the use of the products concerned are not comparable ;
 ---pagebreak---                                 - 10
Whereas it is therefore desirable that a system for the mutual supply
of information should be established and that member States
should make available to each other the particulars and
scientific documentation submitted in connection with applications
for acceptance of plant protection products ;
Whereas , however , Member States must be enabled to accept plant
protection products not complying with the abovementioned
conditions when it is necessary to do so because of an
unforeseeable danger threatening plant production which cannot be
contained by other means ; whereas such acceptance should be
reviewed by the Commission in close co-operation with the Member
States in the framework of the Standing Committee on Plant
Health ;
Whereas this Directive complements the Community provisions on
the classification , packaging and labelling of pesticides ;
whereas together with the latter provisions it considerably
improves the protection of users of plant protection products and
consumers of plaints and plant products , and whereas it also
contributes to the protection of the environment ;
Whereas , in order to ensure that the requirements laid down in
respect of accepted plant protection products are satisfied when
they are placed on the market , Member States must make provision
for appropriate inspection arrangements ;
Whereas the procedures provided by this Directive are not
appropriate for evaluation of the risks to the environment
presented by plant protection products containing or composed of
genetically modified organisms , but whereas , in future , specific
procedures will be introduced by amendments to this Directive for the
evaluation of such products ;
                                                                      J0
 ---pagebreak---                                     11
Whereas the implementation of this Directive and the adaptation
of its Annexes to the development of technical and scientific
knowledge necessitate close co-operation between the Commission
and the Member States ; whereas the procedure of the Standing
Committee on Plant Health offers a suitable basis for this co-operation,
HAS ADOPTED THIS DIRECTIVE :
                               Article 1
1.    This Directive concerns the acceptance and placing on the
      market within the Community of plant protection proucts put
      up in commercial form , and the placing on the market within
      the Community of active substances intended for a use as
      specified in Article 2(1 ).
2.    This Directive shall apply without prejudice to the
      provisions of Council Directive 78 / 631 / EEC of 26 June 1978
      on the approximation of the laws of the Member States
      relating to the classification , packaging and labelling of
      dangerous preparations ( pesticides ) ( 1 ), and , where active
      substances are concerned , without prejudice to the
      provisions oonoerning classification , packaging and
      labelling of Council Directive 67 / 548 / EEC of 27 June 1967
      on the approximation of laws , regulations and
      administrative provisions relating to the classification ,
      packaging and labelling of dangerous substances ( 2 ).
                               Article 2
For the purposes of this Directive the following definitions
shall apply :
(1)   OJ N° L 206 , 29.7.1978 , p. 13
(2)   OJ N 8 L 196 , 16.8.1967 , p. 1
                                                                      M
 ---pagebreak--- Plant protection products
Active substances and preparations containing one or more
active substances , put up in the form in which they are
supplied to the user , intended to :
1.1      destroy organisms harmful to plants or plant products or to
         prevent the action of such organisms , in so far as
         such substances or preparations are not otherwise
         defined below ;
1.2      influence the life processes of plants , other than
         as a nutrient ;
1.3      preserve plant products , in so far as such
         substances or products are not subject to special
         Council or Commission provisions on preservatives ;
1.4      destroy undesirable plants , or
1.5      destroy parts of plants or prevent undesired growth
         of plants .
Residues ol plant protection products
One or more substances present in or on plants or plant products, <
elsewhere in the environment , and resulting from the use of
a plant protection product .
Substances
Chemical elements and their compounds , as they occur
naturaLlly or by manufacture , including any impurity
inevitably resulting from the manufacturing process .
 ---pagebreak---                                  13
4.   Active substances
     Substances , micro-organisms and viruses having general or
     specific action :
     4.1 .    against harmful organisms , or
     4.2      on plants , parts of plants or plant products .
5.   Préparations
     Mixtures or solutions composed of two or more substances of
     which at least one is an active substance , intended for use
     as plant protection products .
6.   Plants
     Live plants and live parts of plants , including fresh fruit
     and seeds .
7.   Plant products
     Products in the unprocessed state or having undergone only
     simple preparation such as milling , drying or pressing ,
     derived from plants , but excluding plants themselves as
     defined in point 6 .
8.   Harmful organisms
     Pests of plaints or plant products belonging to the animal
     or plarnt kingdom , amd also viruses , mycoplasmas and other
     pathogens .
9.   Animais
     Animals belonging to species normally fed and kept or
     consumed by mam .
10 . Placing sm the market
     Any handing over , whether in return for payment or free of
     charge , other than for storage followed by consignment from
     the territory of the Community . Importation into the
     territory of the Community shall be deemed to be placing on
     the market for the purposes of this Directive .
 ---pagebreak---                                    14 -
   11 . Environment
        Water „ air and land and any inter-relationship between
        them , as well as any relationship with living organisms .
   12 . Integrated pest control
        The rational application of a combination of biological ,
        chemioal , cultural or plant breeding measures whereby the
        use of chemical plant protection products is limited to the
        necessary minimum .
                               Article £
   1.   Member States shall prescribe that plant protection
        products may be placed on the market for use in their
        territory only if they have accepted the product in
        accordance with this Directive .
   2.   Member States shall not , on the grounds that a plant
        protection product is not accepted for use in their
        territory , impede the storage or movement of such products
        intended for use in another Member State , provided that :
        -        the product is accepted in another Member State ,
                 and
                 the operators in question satisfy the inspection
                 requirements laid down by the Member States in
                 order to ensure compliance with paragraph 1 .
   3.   Member States shall prescribe that plant protection
        products must be used properly and in accordance with any
        conditions laid down pursuant to this Directive . Proper
        use shall inolude application of the principles of
        integrated pest control .
I*                                                   ■> ?*     fV   &
 ---pagebreak---  Member States shall prescribe that active substances may
 not be placed on the market unless :
          they are classified , packaged and labelled in
          accordance with the provisions of Directive
          67 / 548 / EEC , and
          when the active substance was not on the market
          before the date of application of this Directive , a
          dossier is transmitted to the Member States auid to
          the Commission , in accordance with Article 6 , with
          the declaration that the active substance is
          intended for a use es specified in Article 2(1 ).
                             Article 1
 Member States shall provide that a plant protection product
 may be accepted only if :
(a)       its active substances are listed in Annex I and any
          conditions laid down therein are fulfilled ,
(b)       it is established , in the light of current
          scientific and technical knowledge that , when
          properly applied for the purpose intended , and
          having regard to all foreseeable conditions under
          which it may be used :
        ( i)          it is sufficiently effective
        ( ii )        it has no unacceptable effect on plants or
                      plant products
 ---pagebreak---                                   16 _
              (iii )    it has no harmful effect on human or animal
                        health ,
            . dv )      it has no unacceptable adverse influence on
                        the environment ,
   ( c)        the nature and quantity of its active substances
               and , where appropriate , their toxic impurities can
               be determined by methods in general use .
2.   Member States shall ensure that compliance with the
     requirements set out in paragraph 1 is established by
     official or officially-recognized tests and analyses
     carried out under agricultural , plant health and
     environmental conditions relevant to use of the plant
     protection product in question and representative of those
     prevailing where the product is intended to be used , within
     the territory of the Member State concerned .
                              Article 3.
1.   An active substance shall be included in Annex I for an
     initial period not exceeding ten years and only if :
   (a )        its residues in edible plant products , edible
               livestock products or the environment do not have
               any harmful effects on human or animal health or on
               the environment and , if constituting a potential
              hazard , can be measured by methods in general use ;
                                                                   A
 ---pagebreak---                                 17
   (b )     it may be expected , on the basis of scientific and
             technical data , that preparations manufactured from
            it will meet the requirements of Article
            4(l)(b)(iii ) and Civ ).
2.  The inclusion of a substance in Annex I may be renewed on
    one or more occasions for periods not exceeding five years
    in each case .
                           Article fi
1. A Member State or the Commission shall , in order to obtain
   the inclusion of an active substance in Annex I , ensure that a
   dossier satisfying the requirements of Annex II is
   transmitted by the interested party to the other Member
   States and to the Commission .
   The Commission shall refer the dossier for examination by
   the Standing Committee on Plant Health .
2. At the request of a Member State it may , not less than
   three months after the date of referral , be found by the
   procedure .laid down in Article 19 that the dossier
   satisfies the requirements of Annex II .
   Such a finding shall be without prejudice to subsequent
   application of paragraph 3 , should this be required in
   connection with assessment of the dossier .
3. As part of the procedure tor assessing the dossier the
   interested party may be Invited by the Commission to :
            provide any further information deemed necessary
            for the purpose of assessing whether the active
            substance satisfies the requirements Indicated in
            Article 5(1 ),
 ---pagebreak---                                    ιε
               appear before the Committee .
4.    The procedure    Laid down in Article 18 shall be followed for
      taking a decision to include an active substance in Annex I
      and for setting any conditions in connection therewith .
5.    Paragraphs 1 to 4 shall also apply to the amendment of any
      conditions included in Annex I in connection with an active
      substance .
6.    Paragraphs 3 and 4 shall apply if , after Inclusion of an
      active substance in Annex I , facts emerge that cast doubt
      on its conformity with the requirements indicated in
      Article 5(1 ).
                               Article Z
Member States shall prescribe that the holder of an acceptance
must notify to the competent authority all information on the
harmful effects of any substance listed in Annex I or of its
residues on human or animal health or on unacceptable adverse
effects on the environment . Member States shall notify this
information to the other Member States and to the Commission ,
which shall refer the information to the Standing Committee on
Plant Health .
                              Article 3.
By way of derogation from Article 4 , a Member State may :
1.    in very special circumstances , authorize for a period not
      exceeding 120 days the placing on the market of plant
      protection products not complying with Article 4 if such a
      measure appears necessary because of an unforeseeable
      danger threatening plant production which cannot be
      contained by other means . In this case , the Member State
 ---pagebreak---                                  19
   concerned shall Immediately inform the other Member States
   and the Commission of its action .     It shall be decided
   without delay , in accordance with the procedure laid down
   in Article 18 , whether and , if so , under what conditions
   the action taken by the Member State may be continued or
   repeated ;
2. permit , for a period not exceeding three years ,    the
   placing   on    the   market  of  plat  protection  products
   containing an active substance not listed in Annex I and
   not yet available on the market on the date of implementation
   of this Directive , provided that :
   (a)      following application of Article 6(1 ) and ( 2 ) it is
            found that the dossier on the active substance
            satisfies the requirements of Annex II ,
   (b )     the Member State establishes that the active
            substance satisfies the requirements of Article
            5(1 ) and that the plant protection product
            satisfies the requirements of Article 4(l)(b ) and
            ( o ).
   In such cases the Member State shall immediately inform the
   other Member State and the Commission of its assessment of
   the dossier and of the terms of acceptance .
   If , on assessment of the dossier as provided for in Article
   6(3 ), it is found that the active substance does not
   satisfy the requirements of Article 5(1 ), a decision may be
   taken by the procedure laic down in Article 18 requiring the
   Member State        to withdraw the acceptance ;
                                                                 AH
 ---pagebreak---                                20
3. for a period of 10 years from the date of implementation of
   this Directive , without prejudice to Directive 79 / 117 / EEC ,
   authorize the placing on the market in its territory of
   plant protection products containing active substances not
   listed in Annex I that were already on the market before
   that date .
   The Commission shall draw up a programme of work for the
   gradual examination of these active substances during that
   period . In implementing this programme the Commission may
   require interested parties to submit all requisite data to
   the Commission and the Member States within a prescribed
    period .
   During this period it may , following examination by the
   Standing Committee on Plant Eealth of such an active
    substance ,   be decided ,  by  the  procedure  laid  down in
   Article 18 , that the substance can be included in Annex I
   or that the Member State must withdraw the authorization
   referred to above within     a  prescribed  period .
                           Article â
1. Application for acceptance of a plant protection product
   may bd made by the manufacturer , the importer or the
    distributor , if the plant protection product is to be
                                                        *
    placed on the market in the first instance by a
    cistributor .-
2. Every applicant shall be required to have a permanent
   office within the Community .
                                                                    %
 ---pagebreak---                                21
3. Member States may require that applications for acceptance
   be submitted in their national or official languages or one
   of those languages .
4. Each Member State shall agree to consider any application
   for acceptance made to it and shall decide thereon within a
   reasonable period .
5. Within 45 days of the receipt of an application the Member
   State concerned shall inform the other Member States and
   the Commission thereof and shall at the same time provide
   the following particulars of the application :
           the name and address of the applicant ;
           the name and address of the manufacturer , if
           different from the applicant ;
           the designation or trade name or code number of the
           plant protection product ;
           the type of preparation ;
           the name and amount of each active substance
           contained in it ;
           the use for which it is intended and the directions
           for using it .
6. Member States shall ensure that a dossier is compiled on
   eaoh application . Each dossier shall contain at least a
   oopy of the application , a reoord of the administrative
   decisions taken by the Member State concerning the
   application and the particulars and technical documentation
   laid down in Artiole 12 ( 1_), together with a
   summary of the latter . Member States shall on request make
   available to the other Member States and to the Commission
   the dossiers provided for in this paragraph ; they shall
   supply to them on request all information necessary for
   full comprehension of applications .
                                                              21
 ---pagebreak---                                  22
                            Article 10
1. At the request of the applicant , a Member State to which an
   application is made for the acceptance of a plant
   protection product already accepted in another Member State
   must :
   -unless certain agricultural , plant health or environmental
   conditions relevant to the use of the product are not
   comparable in the regions concerned , refrain from requiring
   the repetition of tests and analyses already carried out in
   connection with the acceptance of the product in that
   Member State ; and
   -unless certain agricultural , plant health o r environmental
   conditions relevant to the use of the product are not
   comparable in the regions concerned , authorize placing on
   the market in its territory .
2. Member States shall inform the Commission of cases where
   they have required repetition of a test and of cases where
   they have refused to accept a plant protection product
   already accepted in another Member State , in respect of
   which the applicant had claimed that the agricultural ,
   plant health and environmental conditions relevant to use
   of the product in the regions concerned in the Member State
   where the test was carried out or for which acceptance was
   granted were comparable to those in their own territory .
   They shall notify the Commission of the ground on which
   repetition of the test was required or acceptance was
   refused .
3. In accordance with the procedure laid down in Article 18 ,
   it may be decided that 3 Member State which has refused to recognize
   comparability should accept the tests and analyses or
   should authorize the placing on the market of the product
   in the regions oonoerned in its territory .
                                                                     11
 ---pagebreak---                              - 23 -
                           Article 11
1.  Member States shall inform the other Member States and the
    Commission immediately in writing of each plant protection
    product accepted in accordance with this Directive ,
    indicating the conditions and the period of validity of
    such acceptance and attaching a copy of the label under
    which the plant protection product is to be placed on the
    market . They shall also inform the other Member States and
    the Commission immediately of any subsequent revocation or
    non-renewal of the acceptance or alteration of the
    conditions of an acceptance .
2.  Each Member State shall draw up an annual list of the plant
    protection products accepted in its territory and shall
    communicate that list to the other Member States and the
    Commission .
3.  By means of the procedure laid down in Article 19 a
    standardized Information system shall be set up to
    facilitate the application of paragraphs 1 and 2 and also
    of Article 9(5 ).
4.  Acceptance shall be cancelled or modified if it is
    established that :
   (a )      the requirements for acceptance are not or are no
          *  longer satisfied ;
   (b )      false or misleading particulars were supplied
             concerning the faots on the basis of which
            authorization was granted .
                          Article 12
1.  Member States shall require that applicants for acceptance
    of a plant protection product submit with their
    application :
                                                               2 3
 ---pagebreak---                               _ 24 _
   ( a)      a dossier satisfying the requirements set out in
             Annex III , and
   ( b)      for each active substance in the product other than
             those referred to in the first subparagraph of
             Article 8(3 ), a dossier satisfying the requirements
             set out in Annex II .
2.   By way of derogation from paragraph 1 , applicants may , if
     the active substance is already listed in Annex I and does
     not differ substantially in degree of purity and nature of
     impurities , be exempted from supplying the information
     required under paragraph 1(b ), except for that identifying
     the aotive substance .
     Such exemption may not , however , be granted in respect of
     data from toxicological , metabolic , ecotoxicological and
     residue studies submitted with a view to the inclusion of
     the aotive substance in Annex I by a person other than the
     applicant for acceptance , unless :
             either the applicant has agreed with the other
             person that recourse may be had to these data ;
             or the application for acceptance is made at least
             15 years after the first acceptance in a Member
             State of a plant protection product containing the
             active substance in question .
3.   Member States shall inform the Commission if , on
     examination of an application for acceptance , they consider
     as being listed in Annex I active substances which have
     been produced by a person or manufacturing process
     other   than those specified in the dossier on the basis of
     whloh the aotive substance was first inoluded in Annex I .
                                                                 34
 ---pagebreak---                                   25
      They shall transmit to it all data regarding the identity
      and impurities of the active substance .
                              Article 13
Member States and the Commission shall ensure that Information
involving industrial and commercial secrets is , if the party
wishing to have an active substance included in Annex I or the
applicant for acceptance of a plant protection product so
requests , treated as confidential .
Industrial and commercial secrecy shall not apply to :
      the names and composition of the active substance or plant
      protection product ;
      physico-chemical data concerning the active substance or
      plant protection product ;
      any ways of rendering the active substance or plant
      protection product harmless ;
      the interpretation of the results of the tests to establish
      efficacy and harmlessness to animals , plants and the
      environment , and the name of the body responsible for the
      tests ;
      recommended methods and precautions to reduce handling ,
      storage , transport , fire or other hazards ;
                                                                 2^
 ---pagebreak---                                     26
      decontamination procedures to be followed in the case of
      accidental spillage or leakage ;
      first aid and medical treatment to be given in the case of
      injury to persons .
If the interested party or applicant himself subsequently
discloses previously confidential information , he shall be
required to inform the competent authority accordingly .
                             Article 14
Article 5(1 ) of Directive 78 / 63 1 / EEC shall apply to all plant
protection products within the meaning of this Directive .
                             Article 15
Member States shall take the necessary measures to ensure that
the packaging of plant protection products satisfies the
following requirements as to labelling :
1.    All packages must show clearly and indelibly the following :
     (a)       the trade name or designation of the plant
               protection product ;
     Cb )   '  the name and address of the holder of the
               acceptance and the registration number of the plant
               protection product and , if different , the name and
               address of the person placing the plant protection
               product on the market ;
     (c )      the name and amount of each active substance
               expressed :
 ---pagebreak---                             27
      - for plant protection products vhich are solids ,
      aérosols , volatile liquids ( maximum boiling point
      50°C ) or viscous liquids ( lover limit 1 Pa at
      20 °C ): as a percentage by weight ;
      - for other liquids : as a percentage by weight and
      in grams per litre at 20 'C ;
      - for gases : as a percentage by volume .
      The name must be as given in the list contained in
      Annex I to Directive 67 / 548 / EEC or , if not included
      therein , its ISO common name .     If the latter is not
      available , the active substance shall be designated
      by its chemical designation according to IUPAC or
      the nomenclature published by the journal " Chemical
      Abstracts " ;
 <d ) the net quantity of the plant protect i on product
      given in legal units of measurement ;
 <e ) the batch number ;
 <f ) the indications required under Article 6 of
      Directive 78 / 631 / EEC , in particular those mentioned
      in paragraphs 2(d ), ( g ), ( h ) and ( i ), 3 and 4 of
      that Article ;
 <«)  the nature of any special risks by means of
      standard phrases selected appropriately from those
      listed in Annex IV ;
( h)  safety precautions in the form of standard phrases
      selected appropriately from those listed in
      Annex V ;
(i)   the type of aotion of the plant protection product
      ( e.g. Insecticide , growth regulator , weedkiller ,
      eto . ) ;
 (J ) the type of préparation ( e.g . wet table povder ,
      emulsifiable concentrate , etc. ) ;
                                                              2 1
 ---pagebreak---                                _ 28 _
   (k)        the uses for which the plant protection product has
              been accepted ;
   (l)        directions for use and the dose rate , expressed in
              metric units , for each use provided for under the
              terms of the aooeptance ;
   (m)        where necessary , the safety interval for each use
              between application and :
                      sowing or planting of the crop to be
                      protected ,
                      sowing or planting of succeeding crops ,
                      harvesting ,
                      use or consumption ;
   (n)        particulars of possible phytotoxicity , varietal
              susceptibility , tainting of produce and any other
              adverse side effects , together with the intervals
              to be observed between application and sowing or
              planting of
              -       the crop in question , or
                      subséquent crops ;
   (o)        if accompanied by a leaflet , as provided for in
              paragraph 2 , the sentence “ Read accompanying
              instructions before use ".
2.  Member States may permit the requirements in paragraph 1(1 )
    and ( n ) to be indicated on a separate leaflet accompanying
    the package if the space available on the package is too
    small . Such a leaflet shall be regarded as part of the
    label for the purposes of this Directive .
                                                                  '2Ï
 ---pagebreak---                                   29
3.    Member States shall stipulate that the labels of accepted
      plant protection products which are not intended for
      domestic use shall also bear the statement “ unsuitable for
      domestic use ".
4.    In no case may the label of the packaging of a plant
      protection product bear the indications 'non-toxic' ,
       'harmless' or similar indications .  However , the leaflet
      mentioned in paragraph 2 may state that it is harmless to
      bees or to any other specified organisms provided that such
      indications refer to normal use .
5.    Member States may make the placing of plant protection
      products on the market in their territories subject to the
      use of the national language or languages in the labelling
      thereof .
                              Article lfi
Member States shall make suitable arrangements for plant
protection products which have been placed on the market to be
officially checked by sampling to see whether they comply with
the requirements of this Directive .
                              Article 17
1.    The following shall be established , having regard to
      current scientific and technical knowledge , in accordance
      with the procedure laid down in Article 18 :
                any standards for the composition , purity and
                characteristics of active substances listed in
                Annex I found to be necessary ;
                                                                  79
 ---pagebreak---                                       30
                   any necessary amendments to Annex I ;
                   uniform principles for checking compliance with the
                   requirements set out in Article 4(l)(b ).
 2.      The following shall be established , having regard to
         current scientific and technical knowledge , in accordance
         with the procedure laid down in Article 19 :
                   any necessary amendments to Annexes II , III , IV and
                   V;
                   explanatory notes covering the particulars set out
                   in Annexes II and III ;
                                 Article 18
Where the procedure laid down in this Article is to be followed ,
matters shall be referred without delay by the Chairman , either
on his own initiative or at the request of a Member State , to the
Standing Committee on Plant Health set up by Council Decision
76 / 894 / EEC , hereinafter referred to as “ the committee ".
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 .
The opinion shall be delivered by the majority laid down in
Artiole 148(2 ) of the Treaty .     The votes of the representatives
of the Member States within the committee shall be weighted in
the manner set out in that Artiole .        The chairman shall not
vote .
The Commission shall adopt the measures envisaged if they are in
aocordanoe with the opinion of the Committee .
 ---pagebreak---                                   31
 If the measures envisaged are not in accordance with the opinion
 of the committee , or if no opinion is delivered , the Commission
shall , without delay , submit to the Council a proposal relating
 to the measures to be taken . The Council shall act by a
qualified majority .
If , on the expiry of a period of three months from the date of
referral to the Council , the Council has not acted , the proposed
measures shall be adopted by the Commission .
                              Article 19
Where the procedure laid down in this Article is to be followed ,
matters shall be referred by the chairman , either on his own
initiative or at the request of a Member State , to the Standing
Committee on Plant Health set up under Decision 76 / 894 / EEC ,
hereinafter referred to as " the   committee ".
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 .
 ---pagebreak---                                 32
                           Article 20
1. Without prejudice to the provisions of paragraphs
    2   and 3,  plant   protection   products  in ay be
   used in research and development work only under controlled
   conditions and in limited quantities .
2. Member States shall require any person intending to conduct
   in their territory any research , experiment or test
   involving the release into the environment of a plant
   protection product containing as an active substance a
   living micro-organism or virus to notify their competent
   authorities at least 45 days before the start of the
   proposed research , experiment or test . Those authorities
   shall be given with the notification any information
   necessary to enable them to evaluate the safety of the
   proposed research , experiment or test . This provision
   shall not apply to genetically modified organisms covered
   by Directive       /   / KEG on the deliberate release to the
   environment of genetically modified organisms .
   If the proposed research , experiment or test is liable to
   have harmful effeots on human or animal health or have an
   unacceptable adverse influence on the environment , the
   Member State concerned may either prohibit it or permit it
   subject to such conditions as it considers necessary to
   prevent those consequences .
   Common conditions for the application of this Article , in
   particular the maximum quantities of pesticides that may be
   released in experimental work as mentioned in paragraph 1 ,
   shall be adopted with the procedure laid down in Article
   18 .
 ---pagebreak---                                    33 -
                              Article 21
 Member      States shall bring into force the laws , regulations
and administrative provisions necessary to comply with this
Directive within two years of the date on which it is adopted .
 They shall immediately inform the Commission thereof . The
 provisions referred to in the third indent of Article 17(1 )
 shall be adopted within the same period .
                             Article 22
This Dlreotlve is addressed to the Member States .
  Done at Brussels                       For the Council
                                                                  33
 ---pagebreak---                                      ANNEX I
                  Actiyg_sybsiances_authorised_for_iocoiporatign
                           in plant protection products
To be established according to the procedure of Article 6(4 ) and Article 8 ,
point 3 , third indent .
 ---pagebreak---                               ANNEX II
        Requirements for ihe dossier in be Introduced lor
         the Inclusion nl an active substance in ATUIPT I
INTRODUCTION
The information required shall include :
      a technical dossier supplying the information necessary for
      evaluating the foreseeable risks , whether immediate or
      delayed , which the substance may entail for man and the
      environment and containing at least the information and
      results of the studies referred to here below , together
      with a detailed and full description of the studies
      conducted and of the methods used or a bibliographical
      reference to them ;
      the proposed classification and labelling of the substance
      in accordance with Directive 67 / 548 / EEC of the Council of
      27 June 1967 on the approximation of the laws , regulations
      and administrative provisions relating to the
      classification , packaging and labelling of dangerous
      substanoes and its amendments .
If it is not technically possible or if it does not appear
necessary to give an information , the reasons should be stated .
                                                                    ?s
 ---pagebreak--- Tests must be conducted according to the methods described in
Annex V of Directive 79 / 831 / EEC ( 1 ) or in the event of a method
being inappropriate or not described , other methods used must be
justified . Tests must be conducted in accordance with the
provisions provided for in Directive 86 / 609 / EEC ( 2 ).
(1)   Council Directive amending for the sixth time Directive
      67 / 548 / EEC on the approximation of the laws , regulations
      and administrative provisions relating to the
      classification , packaging and labelling of dangerous
      substances . O.J. N° L 259 , 15.10.1979 , p. 10 , as completed
      in Commission directives 84 / 449 / EEC ( O.J. N° L 251 ,
      19.9.1984 , p. 1 ) and 87 / 302 / EEC ( O.J. N° L 133 , 30.5.1988 ,
      p. 1 ) •
(2)   Counoil Directive on the approximation of laws , regulations
      and administrative provisions of the Member States
      regarding the protection of animals used for experimental
      and other scientific purposes , O.J. N° L 358 , 18.12.1986 ,
      P- 1
                   J
 ---pagebreak---  Part A : Chemical substances
 1 .   IDENTITY OF THE ACTIVE SUBSTANCE
 1.1   Common name proposed or accepted by ISO and synonyms
 1.2   Chemical name ( IUPAC nomenclature )
1.3    Applicant ( name , address , etc .)
1.4    Manufacturer ( name , address , etc .)
1.5    Manufacturer ' s development code number(s )
1.6    CAS and EEC members ( if available )
1.7    Empirical and structural formula and molecular weight
1.8    Manufacture of the active substance
1.9    Minimum and maximum pure active substance content in % w / w
1.10   Identity and amount of isomers , impurities and other by ¬
       products , together with information on the possible range
       expressed as % w / w
2.     PHYSICO-CHEMICAL PROPERTIES OF THE ACTIVE SUBSTANCE
2.1    Melting point , boiling point , specific gravity , refractive
       index
2.2    Vapour pressure in mm Hg at 20°C , volatility
2.3 *  Appearanoe ( physical state , colour and odour )
2.4 *  Absorption spectra - ultra-violet , visible and infra-red
2.5 *  Solubility in water and organic solvents at 20°
2.6 *  Fat solubility
2.7    Partition coefficient - N-octanol / water
2.8    Stability in water , hydrolysis rate , identity of breakdown
       product ( s )
2.9    Stability in air , photolysis rate , identity of breakdown
       product ( s )
2.10   Stability in organic solvents used in preparations
* This data must be supplied for both active substance and pure
active substance
 ---pagebreak---                                    5
2.11   Stability in acidic and alkaline environments
2.12   Thermal degradation including identity of breakdown
       products
2.13   Molar extinction at relevant wavelengths
2 . 14 Flammability including auto-flammability
2.15   Flash point
2 . 16 Surface tension
2.17   Explosive properties
2.18   Oxidizing properties
2.19   Reactivity towards container materials
2 . 20 Storage
3.     FURTHER INFORMATION ON THE ACTIVE SUBSTANCE
3.1    Types of uses envisaged , eg field , glasshouse , food or feed
       storage , etc .
3.2    Function , eg fungicide herbicide , insecticide , etc .
3.3    Effects on pests , eg contact , inhalation poison , stomach
       poison , fungitoxic or fungistatic etc ., systemic or not in
       plants
3.4    Pests controlled and crops or products protected or treated
3.5    Mode of aotion
3.6    Information on the occurrence or possible occurrence of the
       development of resistance
3.7    Rate of application
3.8    Number and timing of application and duration of protection
3.9    Methods of application ( eg high or low volume spraying
       etc . )
3.10   Phytotoxicity : necessary waiting periods to avoid
       phytotoxio effeots in the case of soil fumigants and
       persistent herbioides or other plant protection products
3.11   Reoommended methods and precautions concerning : handling ,
       storage , transport or fire
3.12   In case of fire , nature of reaction product , eg combustion
       gases , etc .
 ---pagebreak---                                 6
3.13 Emergency measures in the case of an accident
3.14 Possibility of rendering the active substance harmless
     3.14.1  Possibility of recovery
     3.14.2  Possibility of neutralization
     3.14.3  Controlled discharge
     3.14.4  Incineration
     3.14.5  Water purification
     3.14.6  Others .
4.   ANALYTICAL METHODS
4.1  Analytical methods for the active substance which must
     include methods for the determination of inactive isomers
     and impurities
4.2  Analytical methods including recovery and the lower limits
     of determination for residues in the following :
     4.2.1   Foodstuffs , feedingstuffs
     4.2.2   Soil
     4.2.3   Concentrations in water and air
5.   TOXICOLOGICAL AND METABOLISM STUDIES
5.1  Acute toxicity in mammals
     5.1.1   Oral single dose toxicity LD50 - rat and at least
             one other mammalian species
     5.1.2   Percutaneous - at least rat
     5.1.3   Inhalation - at least rat
 ---pagebreak---     5.1.4   Intraperitoneal - at least rat
    5.1.5   Other peritoneal routes
    5.1.6   Skin and eye irritation - rabbit
    5.1.7   Skin sensitization
5.2 Short term toxicity
    5.2.1   Oral administration - 2 species , one rodent and one
            non-rodent ( 1 / 10 of life span , i.e 90 days for rat )
    5.2.2   Other routes
5.3 Chronlo toxioity
    5.3.1   Long term toxicity and/ or carcinogenicity ( at least
            rat ) including an estimation of a No effect level
            (NOEL ) thereby enabling the estimation of an
            Acceptable daily intake (ADI )
5.4 Supplementary toxicological studies
    5.4.1   Mutagenicity studies covering appropriate genetic
            endpoints ( at least two short term tests including
            at least one bacterial and one non-bacterial test
            system )
    5.4.2   Reproduction studies - 3 generation test
            (preferably in rats )
    5.4.3   Teratogenicity studies - at least in two rodent
            species , one being the rabbit
    5.4.4   Neurotoxicity studies - adult hens
    5.4.5   Metabolic studies - animals and plants
    5.4.6   Toxic effects of metabolites from treated plants in
            cases where different from animal metabolites
5.5 Medical data
    5.5.1   Medical surveillance on manufacturing plant
            personnel
    5.5.2   Direct observation , eg , clinical cases
    5.5.3   Health records , both from industry and agriculture
    5.5.4   Fatal / suicidal etc poisoning cases
    5.5.5   Observations on exposure of the general population
    5.5.6   Diagnosis of poisoning , specific signs of
            poisoning , clinical tests
    5.5.7   Sensitization/ allergenicity
                                                                    ko
 ---pagebreak---                                  8
    5.5.8    Proposed treatment : first aid measures , antidotes ,
             medical treatment
    5.5.9    Prognosis
6.  RESIDUES IN OR ON TREATED PRODUCTS
6.1 Behaviour of the residue of the pure active substance and
    its metabolites from the time of application until harvest
    - distribution in the plant , kinetics of disappearance ,
    binding to the plant constituents , etc .
6.2 Overall material balance for the applied active substance
6.3 Sufficient residue data from supervised trials to
    demonstrate that residues likely "to arise from the
    envisaged treatments would not be of concern for human and
    animal health
6.4 Residue monitoring data for products in the distribution
    chain
6.5 Effects of industrial processing and / or household cooking
    on residues
6.6 Taint , odour or taste due to residues on or in fresh or
    processed products .
7.  ECOTOXICOLOGICAL STUDIES
7.1 Effoots on organisms
    7.1.1    Oral single dose toxicity LD5Q for at least two
             bird species
    7.1.2    Acute LC50 . 96-hours exposure for one fish
             species , eg rainbow trout , zebra fish , guppi
                                                                   WI
 ---pagebreak---                                g
    7.1.3   Subacute toxicity for fish ( at least 14 days )
    7.1.4   Acute LC50 . 48-hour exposure for one suitable
            fish-food species eg Daphnia
    7.1.5   Subacute toxicity for Daphnia ( at least 14 days )
    7.1.6   Bio - accumulation
    7.1.7   Algal test - Acute LD50 - 9 hours exposure
            Scenedosmus species
    7.1.8   Effects to beneficial arthropods ( honey bees and
            other beneficial arthropods eg predators and
            parasites )
    7.1.9   Effect on soil non- target macro-organisms , eg
            earthworms - laboratory and field tests
    7.1.10  Effect on other non-target macro-organisms
    7.1.11  Effect on soil non-target micro-organisms ( eg soil
            respiration , nitrification , nitrogen fixation and
            degradation of organic matter )
    7.1.12  Leaf litter breakdown
7.2 Fate in the environment
    7.2.1   Degradation in soil - at least 3 natural soil types
    7.2.2   Adsorption and desorption in soil - at least 3
            natural soil types
    7.2.3   Persistence in soil - at least 3 natural soil types
    7.2.4   Mobility in soil - at least three natural soil
            types
    7.2.5   Degradation in the aquatic environment
    7.2.6   Laboratory tests on biodegradation , hydrolysis and
            photolysis
    7.2.7   Field testing for degradation
                                                                <4 2
 ---pagebreak---                                           10
Part B : Microorganisms and viruses             . not genetically modified in
            the sense of Directive ../.../ EEC )   (')
1.       IDENTITY OF THE ORGANISM
1.1      Systematic name and strain for bacteria , protozoa and
         fungi , whether a mutant strain ; for viruses the taxonomic
         designation of the agent , serotype , strain or mutant
1.2      Common name or alternative and superseded names
1.3      Applicant ( name , address , etc .)
1.4      Manufacturer ( name , address , etc .)
1.5      The appropriate test procedures and criteria used for
         identification ( eg . morphology , biochemistry . serology )
1.6      Composition - microbiological purity , nature and identity
         of any impurities and oontent of extraneous organisms
2.       BIOLOGICAL PROPERTIES OF THE ORGANISM
2.1      Target host ( species of pest ).           Pathogen! city or antagonism
         to host , infective dose , transmissibllity and Information
         on mode of action
2.2      History of the organism and its uses . Natural occurrence
         and geographical distribution
2.3      Host specificity range and effects on species other than
         the target pest f nni nri f ng species most closely related to
         the target species - to include infectivity , pathogenicity
         and transmissibllity
( 1 ) Council Directive ( proposed ) on the deliberate release to the environment
      of genetically modified organisms ( doc . C0M(S8)160)
                                                                                  4^
 ---pagebreak---                                  11
 2.4  Infectivity and physical stability in use by the proposed
      application method . Effect of temperature , exposure to air
      radiation etc . Persistence under the likely environmental
      conditions of use
2.5  Whether the organism is closely related to a crop pathogen
      or to a pathogen of a non-target vertebrate species
2.6  Laboratory evidence of genetic stability ( ie mutation rate )
     under environmental conditions of proposed use
2.7  Presenoe , absence or production of toxins as well as their
     nature and identity
3.   FURTHER INFORMATION ON THE ORGANISM
3.1  Method of production with descriptions of the techniques
     used to ensure a uniform product and of assay methods for
     its standardization .  In the case of a mutant , detailed
     information should be provided on its production and
     isolation , together with all known differences between the
     mutant and the parent wild strains .
3.2  Methods for establishing the identity and purity of seed
     stock from which batches are produced , and results obtained
     including information on variability .
3.3  Methods used to show microbiological purity of the final
     product and showing that contaminants have been controlled
     to an acceptable level , results obtained and information on
     variability
3.4  Methods to show the organism being free from any human and
     mammalian pathogen
3.5  Methods to prevent loss of virulenoe of seed stock
3.6  Methods for determining storage stability and shelf-life
     stability ( if appropriate ) after reconstitution of the
     active agent , and results obtained
 ---pagebreak---                                       12
3.7    Field of use : agriculture / horticulture ( including food
       storage ) and forestry
3.8    Pests controlled
3.9    Crop protected
3.10   Application rate
3.11   Number and timing of applications
3.12   Method of application ( eg high or low volume spraying ,
       release of infected host , etc .)
3.13   Compatibility or incompatibility with other products likely
       to be used on the crop or to be recommended for such use ,
       e.g. chemical plant protection products which have been
       shown to be mutagens in bacterial or viral systems must not
       be mixed with these biological preparations
3 . 14 Phytopathogenicity
3.15   Phytotoxlclty
3.16   Recommended methods and precautions concerning handling ,
       storage , transport or fire
3.17   Possibility of rendering the substance harmless
4.     TOXICOLOGICAL AND INFECTIVITY STUDIES
4.1    Bacteria , fungi , protozoa and neoplectana
       4.1.1    Aoute toxicity and infectivity
                4 . 1.1.1 Oral single dose - at least mouse and rat
                4 . 1.1 . 2 In the oase where a single dose LD50
                            determination is not appropriate to assess
                            pathogenicity , a set of range-finding tests
                            must be carried out to reveal highly toxic
                            agents and infectivity
                4 . 1.1 . 3 Subcutaneous single dose - at least mouse
                            and guinea pig
 ---pagebreak---                                     13
            4 . 1.1.4 Inhalation single dose -at least rat and
                          guinea pig
            4 . 1.1 . 5 Intraperitoneal single dose -at least mouse
                          and guinea pig
            4 . 1.1 . 6 Eye irritation test - rabbit
    4.1.2   Short term toxicity
            4 . 1.2.1 Oral administration - rat
            4 . 1 . 2 . 2 Inhalatlon - guinea pig
    4.1.3   Special toxlcological studies .
            Where the use of any product is likely to result in
            residues in food and / or where the results of acute
            and short-term tests so indicate , the following
            further tests are required :
            4 . 1.3.1 Long-term toxicity
            4 . 1.3.2 Neurotoxiclty
            4 . 1.3.3 Reproduction (3 generations )
            4 . 1 . 3 . 4 Animal excretion and metabolism
    4.1.4   Further toxicological studies .
            For an organism which produces a toxin , the
            following is required :
            4 . 1.4.1 Chemical structure and stability of toxin
            4 . 1.4 . 2 Toxicity - brine shrimp larvae
            4 . 1.4 . 3 Mutagenicity - prokaryotic and / or
                          eukaryotic micro-organisms
            4 . 1.4 . 4 Potential tumourigenicity - a test based
                          on in vitr o cell transformation
            4 . 1.4 . 5 Teratogenicity
            4 . 1.4 . 6 Caroinogenicity
            4 . 1 . 4 . 7 Allergenicity
            4 . 1.4.8 Infactivity under immunosuppression
4.2 Viruses
    4.2.1   Acute toxicity and infectivity
            Data as outlined under 4.1.1 and cell culture
            studies using purified infective virus and primary
            oell cultures of mammalian , avian and fish cells
                                                                   ЧС
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    4.2.2   Short term toxicity
            Data as outlined under 4.1.2 and tests for
            infectivity carried out by insect bioassay or on a
            suitable cell culture at least 7 days after the
            last administration to the animals
    4.2.3   Special toxicological studies .
            Where the use of any product is likely to result in
            residues in food and / or where the results of acute
            and short-term tests so indicate , the tests
            outlined under 4.1.3 are required
    4.2.4   Further toxicological studies .
            Depending on the results of acute and subacute
            toxicity and infectivity studies , the following may
            be required :
            4.2.4 . 1 Mutagenicity
            4 . 2 . 4 . 2 Tumourigenicity
            4 . 2 . 4 . 3 Teratogenicity
            4 . 2 . 4 . 4 Carcinogenicity
4.3 Medioal data
    4.3.1   Medical surveillance on manufacturing plant
            personnel
    4.3.2   Direct observation , eg , clinical cases
    4.3.3   Health records , both from industry and agriculture
    4.3.4   Observations on exposure of the general population
    4.3.5   Diagnosis of poisoning , specific signs of
            poisoning , clinical tests
    4.3.6   Sensitization/ allerogenicity
    4.3.7   Proposed treatment : first aid measures , antidotes ,
            medical treatment
    4.3.8   Prognosis
                                                                  ч ;
                                                                    i
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5.   RESIDUES IN FOOD AND FEED
5.1  Identification of viable and non-viable ( eg toxins )
     residues in treated crops , the viable residue by culture or
     bio-assay and the non-viable by appropriate techniques
5.2  Likelihood of multiplication of the active agent in or on
     crops or food together with a report on any effect on food
     quality
5.3  Extent of indirect contamination of adjacent non-target
     crops , wild plants , soil and water
5.4  In cases where residues of toxins remain on an edible crop ,
     data as outlined tinder item 6 of Annex II , Part A will be
     required
6.   ECOTOXICOLOGICAL STUDIES
6. 1 Effects on organisms and fate in the environment including
     infeotlvity
     6.1.1    Important parasites and predators of target species
     6.1.2    Honey bees : acute toxicity and infectivity
     6.1.3    Earthworms
     6.1.4    Other non-target organisms believed to be at risk
     6.1.5    Fish - at least one indigenous species
     6.1.6    Birds - acute toxicity on at least two species
     6.1.7    Effects on livestock including immunological
              response
     6.1.8    Spread in air , soil and water
     6.1.9    Persistence in air , soil and water
     6.1.10   Possible fate in food chains
     6.1.11   Effeots on flora and fauna
 ---pagebreak---                                  16
                             ANNEX III
           Requirements for the dossier     h& Introduced
         for the acceptance Q£_ a plant protection product
INTRODUCTION
The information required shall include :
      a technical dossier supplying the information necessary for
      evaluating the effloaclty and the foreseeable risks ,
      whether immediate or delayed , which the preparation may
      entail for man and the environement and containing at least
      the information and results of the studies referred to here
      below , together with a detailed and full description of the
      studies conducted and of the methods used on a
      bibliographical reference to them ;
      the proposed classification and labelling of the
      preparation in accordance with the relevant Community
      Directives .
If it is not technically possible or if it does not appear
necessary to give information , the reasons should be stated .
 ---pagebreak---                                     17
Tests must be conducted according to the methods described in
Annex V of Directive 79 / 831 / EEC CD or in the even of a method
being inappropriate or not described , other methods used must be
Justified . Tests must be conducted in accordance with the
provisions provided in Directive 86 / 609 / EEC ( 2 )
Cl )  Council Directive amending for the sixth time Directive
      67 / 548 / EEC on the approximation of the laws , regulations
      and administrative provisions relating to the
      classification , packaging and labelling of dangerous
      substances . O.J. N * L 259 , 15.10.1979 , p. 10 , as completed
      in Commission directives 84 / 449 / EEC CO.J. N° L 251 ,
      19.9.1984 , p. 1 ) and 87/ 302/ EEC CO.J. N * L 133 , 30.5.1988 ,
      p. 1 ).
C2 )  Counoil Directive on the approximation of laws , regulations
      and administrative provisions of the Member States
      regarding the protection of animals used for experimental
      and other soientifio purposes , O.J. N * L 358 , 18.12.1986 ,
      p. 1
 ---pagebreak---                                   18
Part A :       Chemical préparations
1.    IDENTITY OF THE PREPARATION
1.1   Trade name or proposed trade name
1.2   Applicant ( name and address , etc .)
1.3   Manufacturer ( name and address , etc . incl . location of
      plant )
1.4   Use category ( herbicide , insecticide , etc .)
1.5   Detailed quantitative / qualitative information on the
      composition of the preparation ( active substance(s ) ) ,
      impurities , adjuvants , inert components , etc .)
1.6   Physical state and nature of the preparation ( emulsif iable
      concentrate , vettable powder , solution , etc .)
2.    PHYSICO-CHEMICAL AND TECHNICAL PROPERTIES OF THE
      PREPARATION
2.1   Appearance ( physical state , colour and odour )
2.2   Explosivity and oxidising properties
2.3   Flash point and other indications of flammability or
      spontaneous ignition
2.4   Acidity/ alkalinity
2.5   Surface tension
2.6   Speoifio gravity
                                                                   C
 ---pagebreak---                                 19
2.7 Storage stability - stability and shelf-life .    Effects of
    light , temperature , humidity , etc .
2.8 Vapour pressure in mm Hg at 20 °C , volatility
2.9 Technical characters of the preparation
    2.9.1     Vettability
    2.9.2     Persistent foam
    2.9.3     Suspensibility
    2.9.4     Vet sieve test
    2.9.5     Dry sieve test
    2.9.6     Size range of granules or particles and content of
              fines
    2.9.7     Emulsion stability
    2.9.8     Corrosiveness
    2.9.9     Compatibility with other plant protection products
              with which its use is recommended
    2.9.10    Compatibility with proposed packaging materials
    2.9.11    Vetting and adherence to crops and products
3.  ANALYTICAL METHODS
3.1 Analytical methods for determining the composition of the
    preparation .
4.  FURTHER TECHNICAL INFORMATION ON THE PREPARATION
4.1 Details of intended use , eg types of pests controlled
    and / or plants or plant products to be protected
4.2 Application rate
4.3 Concentration of active substance in material used(eg %
    concentration in the diluted spray )
4.4 Method of application ( low volume ( LV ), ultral low volume
    ( ULV ) eto .)
4.5 Number and timing of application
                                                                 SI
 ---pagebreak---                                 20
4.6 Specific phytotoxicity : necessary waiting periods to avoid
    phytotoxic effects arising from soil - fumigants ,
    herbicides , etc .
4.7 Packaging
4.8 Destruction or decontamination of the preparation and
    packaging
4.9 Model of the label and , if need be . of the separate leaflet
    accompanying the package .
5.  EFFICACY DATA
5.1 Laboratory experiments - effect on the target organism
5.2 Field experiments - results under practical conditions of
    use - reliability , duration and consistency of protection
    or other intended effect ( s ) appropriate to the desired crop
    protection objective at the various development stages of
    the pest and / or of the crop , crop product , etc .
5.3 Effects on the quantity or quality of treated plants or
    plant products
5.4 Safety considerations , to target plants ( including
    different cultivars ), or to target plant products
5.5 Comparison with reference products or normally accepted
    practice
5.6 Possible advantages of the produot or its method of
    application in comparison with other products ( duration or
    consistency of protection , etc .)
5.7 Undesirable or unintended side-effects , eg on beneficial
    and other non- target organisms , on succeeding crops , other
    plants or parts of treated plants used for propagating
    purposes ( eg seeds , cuttings , runners ).
5.8 Compatibility with different cultural practices and other
    crop protection measures under the conditions of use
    envisaged
                                                                   <>
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5.9 Effeot of variables -    climate , temperature , humidity ,
    soil , etc .
6.  TOXICOLOGICAL STUDIES ON THE PREPARATION
6.1 Acute toxicity in mammals
    6.1.1    Oral single dose toxicity LD5Q - rat and at least
             one other mammalian species
    6.1.2    Percutaneous ( acute and sub-acute ) - at least rat
    6.1.3    Inhalation ( acute and sub-acute ) - at least rat
    6.1.4    Shin and eye irritation - rabbit
    6.1.5    Shin sensitization
7.  RESIDUES IN FOOD AND FEED
7.1 Residue data concerning the active substance including data
    from supervised trials in crops , food or feedingstuf fs for
    which use is proposed , giving all experimental conditions
    and details . Data should be available for the range of
    different climatic and agronomic conditions encountered in
    the area of proposed use .
7.2 Pre-harvest intervals for proposed uses
7.3 Proposed maximum residue levels ( MRLs ) and justification of
    the aooeptability of these residues
7.4 Taint , odour or taste due to residues on or in fresh or
    processed products
8.  EXISTING CLEARANCES
8.1 Information on clearances in other countries
8.2 Information on established maximum residue limits ( MRL ) in
    other countries
 ---pagebreak---                                    22
Part B : Preparations of microorganisms or viruses
 1.    IDENTITY OF AND INFORMATION ON THE PREPARATION
1.1   Trade name or proposed trade name
1.2   Applicant ( name , address , etc .)
1.3   Manufacturer ( name , address , etc .)
1.4   Use category ( insecticide , fungicide , etc .)
1.5   Detailed quantitative and qualitative information on the
      composition of the preparation ( active organism(s ), inert
      components , extraneous organisms , etc . )
1.6   Physical state and nature of the preparation
1.7   Stability of the preparation , effects of temperature
      change , method of packaging and storage , and retention of
      biological activity in storage
1.8   Methods for establishing storage stability
2.    FURTHER TECHNICAL INFORMATION ON THE PREPARATION
2.1   Details of intended use , eg . types of pests controlled and
      plants or plant products to be protected
2.2   Application rate
2.3   Concentration of active substance in material used ( eg %
      concentration in the diluted spray )
2.4   Method of application ( eg . low volume , ultra low volume ,
      release of infeoted host )
2.5   Number and timing of application
                                                                   SS
 ---pagebreak---                                 23
2.6 Packaging
2.7 Destruction or decontamination of the preparation and
    packaging
2.8 Model of the label and , if need be , of the separate leaflet
    accompanying the package .
3.  ANALYTICAL METHODS
3.1 Analytical methods for determining the composition of the
    preparation .
4.  EFFICACY DATA
4.1 Laboratory experiments - effect on the target host
4.2 Field experiments - results under practical conditions of
    use - reliability , duration and consistency of protection
    or other intended effect ( s ) appropriate to the desired crop
    protection objective at the various development stages of
    the pest and / or of the crop , crop product , etc .
4.3 Information on the occurrence or possible occurrence of the
    development of resistance
4.4 Effects on the quantity or quality of treated plants or
    plant produots
4.5 Comparison with reference products or normally accepted
    praotloe . Advantages of the agent over conventional methods
    of control currently in use , with particular reference to
 ---pagebreak---                                  24
    hazards to operators , to consumers of treated produce , and
    to the environment
4.6 Compatibility with different cultural practices and other
    crop protection measures under the conditions of use
    envisaged ( including those for other pests of the crop to
    be treated ) .
4.7 Effect of variables -     climate , temperature , humidity ,
    soil , etc .
4.8 Undesirable or unintended side-effects , eg . on beneficial
    and other non- target organisms , on succeeding crops , other
    plants or parts of treated plants used for propagation
    purposes ( eg . seeds , cuttings , runners )
5.  TOXICITY AND INFECTIVITY STUDIES
5.1 Acute toxicity and infectivity
    5.1.1    Oral single dose LD50 - at least mouse and rat
    5.1.2    Sub-cutaneous single dose - at least mouse and rat
    5.1.3    Inhalation single dose - at least rat and guinea
             Pig
    5.1.4    Eye irritation test - rabbit
    5.1.5    Sensitization studies
6.  RESIDUES IN FOOD AND FEED
6.1 Residue data oonoerning the active substance Including data
    from supervised trials in crops , food or feedingstuf fs for
                                                                  S' (
 ---pagebreak---                                25
    which use is proposed , giving all experimental conditions
    and details . Data should be available for the range of
    different climatic and agronomic conditions encountered in
    the area of proposed use .
6.2 Pre-harvest intervals for proposed uses .
6.3 Proposed maximum residue levels ( MRLs ) and the
    justification of the acceptability of these levels ( for
    toxins )
6.4 Taint , odour or taste due to residues on or in fresh or
    processed products
7.  EXISTING CLEARANCES
7.1 Information of clearances in other countries
7.2 Information on established maximum residue limits ( MRL ) in
    other countries .
                                                                 '5
 ---pagebreak---                                 26
                             ANNEX IY
           Standard phrases ol nature            rlshs
Contents of Annex III of the proposai of 4.8.1976 .
 ---pagebreak---                                 27
                             ANNEX X
                Standard phrases of. saf£i3 adxi££
Contents of Annex IV of the proposal of 4.8 . 1976 .