CELEX: 51993PC0117
Language: en
Date: 1993-04-20
Title: Proposal for a COUNCIL DIRECTIVE establishing Annex VI of Directive 91/414/EEC concerning the placing of plant protection products on the market

COMMISSION OF THE EUROPEAN COMMUNITIES
                                          C0M(93)117  final
                                          Brussels, 20 April 1993
                          Proposal for a
                        ÇQUNCll PIRECTIVE
                     establishing Annex VI of
                       Directive 91/414/EEC
       concerning the placing of plant protection products
                           on the market.
                  (presented by the Commission)
 ---pagebreak---                              - 2 -
                    EXPLANATORY MEMORANDUM
1. Council Directive 91/414/EEC of 15 July 1991 concerning the
   placing of plant protection products on the market requires
    in article 4 inter alia that Member States shall not
   authorize a plant protection product unless a number of
   requirements mentionned in paragraph (1) (b), (c), (d) and
    (e) are satisfied, pursuant to the uniform principles
   provided for in Annex VI.
   Moreover, according to articles 18 and 23 of the Directive,
   the uniform principles shall be adopted by the Council,
   acting by a qua I if led majority on a proposal from the
   Commission, within one year from the date of notification
   of the Directive.
2. The uniform principles aim to ensure that all Member
   States, in making decisions with respect to authorization
   of plant protection products will apply the requirements of
   Article 4 in an equivalent manner and at the high level of
   protection of human and animal health and of the
   environment seeked by the Directive.
    In this context the Commission would in particular
   underline that the proposal has taken     into consideration
   current Community legislation with regard to protection of
   water and in particular drinking water given the concerns
   expressed during the négociation of Directive 91/414/EEC in
   the Council and Parliament.    The Commission has however the
   intetlon to start a re-examination of Directive 80/778/EEC
   relating to the quality of water intended for human
   consumption.   Where the result of this examination would
   lead to a Commission proposal amending this Directive, or
   other Community regulatory provisions on water
   contamination by plant protection products, the Commission
 ---pagebreak---                             - 3 -
   will examine immediately the consequences thereof with
    regard to the necessity of a corresponding amendment of the
   present proposal, or, where the present proposal would
   already have been adopted by the Council, the necessity of
   amending the relevant provisions of Annex VI by the
   procedures provided therefor In Articles 18 and 19 of
   Directive 91/414/EEC.
3. The Commission considers that, as the uniform principles
   are addressed in the first instance to the public
   authorities in the Member States in charge of plant
   protection products authorization, these principles should
   concentrate on the aspects of the evaluation of the data
   submitted by applicants according to Article 13 of the
   Directive and of decision making on the basis of these
   evaluations.
   The   Commission is however of the opinion that for a proper
   realisation of the objectives mentionned under point 2
   above, the provisions of Annex III should be further
   defined in order to ensure that evaluations can be made on
   the basis of a data package developped according to the
   current state of scientific and technological knowledge.
   Therefore it is the Commission's intention to define,
   according to the procedure provided thereto in the
   Directive, Annex III in such a way that it shall include:
   - the parameters to decide when particular studies or
   information are required;
   - the parameters to decide when particular studies or
   information are not required;
   - the experimental protocols that have to be used to
   generate the required data.
 ---pagebreak---                              - 4-
4.  This proposal conceives the uniform principles in 3 parts :
    1)      a general introduction identifies the alms of the
            uniform principles, the data that have to be taken
             into account for the evaluation and decision making
            and the procedures to evaluate data in order to
            come to a decision;
   2)       the principles concerning the evaluation of the
            available data, composed of some general principles
            and some more specific principles for each of the
            elements provided for in Article 4(1) (b), (c), (d)
            and (e);
   3)       the principles concerning the decision making with
            respect to authorization of plant protection
            products, also composed of some general principles
            and some more specific principles for each of the
            elements provided for in Article 4 (1) (b), (c),
            (d) and (e).
5. The Commission has developped this proposal on the basis of
   highest technical expertise available in the Member States
   with regard to evaluation and decision making on plant
   protection products.
   However, with regard to certain items such as impact of
   plant protection products on non-target plants and on non-
   target aquatic flora   as well as fate of plant protection
   products in air, it has appeared that more experience is
   required before detailed principles on evaluation and
   decision making can be developped. The Commission will
   follow the technical and scientific progress in these
   fields and as soon as possible introduce more detailed
   rules concerning these areas according to the procedures
   provided for in the Directive.
 ---pagebreak---                             - 5 -
6.  In certain cases the use of calculation models is provided
    in this proposal.  However at this moment it is not
   possible for the Commission to provide models which are
   harmonised throughout the Community or to identify all the
   conditions under which certain specified models should be
   used. This is particularly the case for the models
   concerning operator exposure and fate and behaviour of
   plant protection products in the environment.
    It is the intention of the Commission to follow very
   closely the further developments in this area and to
   promote, where possible and within its possibilities,
   further harmonization.   Meanwhile the uniform principles
   provide for some general requirements for the models that
   are to be used.
7. The present proposal concerns the uniform principles for
   evaluation and authorization of chemical plant protection
   products since currently and in the near future almost all
   the plant protection products that are placed or will be
   placed on the market are chemical preparations. As soon as
   possible similar provisions with regard to preparations
   containing micro-organisms or viruses will be developed.
8. This proposal is expected to have a negligie impact on the
   Community budget.
9. The proposal is unlikely to have negative impact on
   business, including SME.
 ---pagebreak---                                - 6-
                            Proposal for a
                          COUNCIL DIRFPTIvp
                       establishing Annex VI of
                         Directive 91/414/EEC
         concerning the placing of plant protection products
                            on the market.
THE COUNCIL OF THE EUROPEAN COMMUNITIES
Having regard to the Treaty establishing the European Economic
Community,
Having regard to Council Directive 91/414/EEC of 15 July 1991
concerning the placing of plant protection products Qn the
market(*), and in particular Article 18.1 thereof;
Having regard to the proposal of the Commission;
(1) 0J N° L 230, 19.08.1991, p. 1.
 ---pagebreak---                                - 7 -
Whereas Annex VI provides for the development of uniform
principles aiming to ensure that the Member States, in deciding
on authorizations of plant protection products, will apply the
requirements of Article 4 (1) (b), (c), (d) and (e) of Directive
91/414/EEC in an equivalent manner and at the high level of
protection of human and animal health and the environment seeked
by the Directive;
Whereas therefor it is necessary to lay down detailed principles
concerning the evaluation of the information submitted by
applicants for a plant protection product and concerning the
decision making on basis of the results of this evaluation, in
view of granting the authorization;
Whereas such principles have to be laid down for each of the
different requirements provided for in Article 4 (1) (b), (c),
(d) and (e);
HAS ADOPTED THIS DIRECTIVE :
                             Article 1
The Annex VI of Directive 91/414/EEC is established by the Annex
to the present Directive.
                             Article 2
Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this Directive
by 25 July 1993 at the latest.
When Member States adopt these measures, they shall contain a
reference to this Directive or shall be accompanied by such
reference on the occasion of their official publication. The
methods of making such a reference shall be laid down by the
Member States.
                             Article 3
This Directive is adrc*ssed to the Member States.
 ---pagebreak---                               - 8 -
                              ANNEX
             UNIFORM PRINCIPLES FOR EVALUATION AND AUTHORIZATION
                   OF PLANT PROTECTION PRODUCTS
       CONTENTS
A.         INTRODUCTION
B.         EVALUATION
1.         General principles
2.         Specific principles
2.1.       Efficacy
2.2.       Absence of unacceptable effects on plants
           or plant products
2.3.       Impact on vertebrates to be controlled
2.4.       Impact on human or animal health
2.4.1.     Arising from the plant protection product
2.4.2.     Arising from residues
2.5.       Influence on the environment
2.5.1.     Fate and distribution in the environment
2.5.2.     Impact on non-target species
2.6.       Analytical methods
2.7.       Physical and chemical properties
 ---pagebreak---                           - 9 -
C.     DECISION MAKING
1.     General principles
2.     Specific principles
2.1.   Efficacy
2.2.   Absence of unacceptable effects on plants or
       plant products
2.3.   Impact on vertebrates to be controlled
2.4.   Impact on human or animal health
2.4.1. Arising from the plant
       protection product
2.4.2. Arising from residues
2.5.   Influence on the environment
2.5.1. Fate and distribution in the environment
2.5.2. Impact on non-target species
2.6.   Analytical methods
2.7.   Physical and chemical properties
 ---pagebreak---                       - 10 -
A. INTRODUCTION
   The principles developped in this Annex aim to ensure
   that  evaluations     and   decisions   with   regard  to
   authorization of plant protection products result in
   the implementation of the requirements of Article 4
   (1) (b), (c), (d) and (e) by all the Member States at
   a high level of protection for man, animals and the
   environment seeked by the Directive.
   In     evaluating      applications      and     granting
   authorizations Member States shall:
   a) -   be assured that the dossier supplied is in
          accordance to the requirements of Annex III,
          at the latest at the time of finalization of
          the evaluation for the purpose of decision
          making without prejudice, where relevant, of
          the provisions of article 13(1) (a), (4) and
           (6);
     -    be    assured   that   the  data   submitted   are
          acceptable    in   terms   of  extent,    quality,
          consistency and reliability and sufficient to
          permit a proper evaluation of the dossier;
     -    evaluate,     where    relevant,    justifications
          submitted by the applicant for not supplying
          certain data;
 ---pagebreak---                    - 11 -
b)     take   into   account   the   data   of  Annex   II
       concerning   the   active   substance(s)   in   the
       plant protection product     which were submitted
       for the purpose of      inclusion of the active
       substance concerned in Annex I and the results
       of the evaluation of this information, without
       prejudice, where relevant, of the provisions
       of article 13.(1) (b), (2), (3) and (6);
c)     take    into    consideration     other   relevant
       technical    or   scientific    information    made
       avalaible   to    them   with    regard   to    the
       performance of the plant protection product or
       to the potentially      adverse   effects  of the
       plant protection product, its components or
       its residues.
Where  in   the   specific   principles    on  evaluation
reference is made to data of Annex II, this shall be
understood as being the data referred to under point
2(b).
Where the data and information provided is sufficient
to permit completion of the evaluation for one of the
proposed uses, applications must be evaluated and a
decision made for the proposed use(s) for which the
data are sufficient.
Taking account of justifications provided and with
the benefit of any necessary clarifications, Member
States shall reject applications made, where the data
gaps are such that it is not possible to finalize the
evaluation and to perform a reliable decision making
for at least one of the proposed uses.
 ---pagebreak---                     - 12 -
During the process of evaluation and decision making,
Member States shall cooperate with the applicants in
order to    solve where necessary any questions on the
dossier in an early stage or to identify, in an early
stage   additional studies that would be necessary for
a proper evaluation of the dossier, or to amend any
proposed conditions of its envisaged use or to modify
the nature or the composition of the plant protection
product in order to ensure full satisfaction of the
requirements of this Annex or of the Directive.
Member   States  shall  come to  a  justified  decision
normally at the latest 12 months after a technically
complete dossier is available for the Member State. A
technically    complete  dossier  is  a   dossier  that
satisfies all the requirements of Annex III.
The evaluation and decision making process involves
judgments which must be based on sound       scientific
principles and be made with the benefit of expert
advice.
 ---pagebreak---                        - 13 -
B. EVALUATION
1. General principles
   1.     Having    regard    to   current     scientific   and
          technical     knowledge,     Member    States   shall
          evaluate    the   information    referred   to  under
          part A point 2 and in particular :
   a)     assess the performance in terms of efficacy
          and   phytotoxicity     of   the   plant   protection
          product for each use for which authorization
          is sought and
   b)     identify    the   hazards   arising,    assess  their
          significance and make a judgment           as to the
          likely     risks    to   man,     animals    or   the
          environment.
   2.     In the evaluation of applications submitted,
          in accordance with the terms of Article 4,
          which inter alia specify that Member States
          have   regard   to all normal      conditions   under
          which   the   plant   protection    product   may  be
          used,   and   to the   consequences     of  its use,
          Member   States shall ensure that         evaluations
          carried    out   have   regard    to   the   proposed
          practical conditions of use.
          This must include in particular the purpose of
          use,   the   dose,   the   manner,    frequency   and
          timing    of    applications,     the    nature   and
          composition     of   the    preparation.     Whenever
          possible Member States shall also take into
          account the principles of integrated control.
 ---pagebreak---                - 14 -
3.  In the evaluation of applications submitted,
   Member    States   shall   have    regard    to    the
    agricultural,   plant  health    or  environmental
    (including climatic) conditions in the areas
   of the envisaged use.
4.  In interpreting   the results of evaluations,
   Member   States shall take      into consideration
   possible    elements   of    uncertainty    in     the
   information obtained during the evaluation, in
   order to ensure that the chances of failing to
   detect   adverse   effects    are   minimised.     The
   decision making process shall be examined to
   identify critical decision points or items of
   data, for which uncertainties could lead to a
   false classification of risk.
   At first the evaluation shall be based on the
   best  available data or estimates        reflecting
   the realistic conditions of use of the plant
   protection   product,    and   will   result    in   a
   realistic worst case approach. This should be
   followed by a repeat evaluation,taking account
   of  potential   uncertainties     in  the  critical
   data and of a range of use conditions that are
   likely to occur, to determine whether it is
   possible   that  the   initial   estimation    could
   have been significantly different.
 ---pagebreak---               - 15 -
5. Where specific principles of part B section 2
   provide for the use of calculation models in
   the evaluation of a plant protection product,
   these models shall :
   - make   a  best   possible   estimation   of  all
     relevant   processes    involved   taking   into
     account      realistic       parameters      and
     assumptions;
   - be submitted to an analysis as referred to
     under part B point 1.4;
   - be   reliably   validated    with  measurements
     carried out under circumstances relevant for
     the use of the model;
   - be relevant to the conditions in the area of
     the proposed use.
 ---pagebreak---                           - 16
      Specific principles
      Member States shall, for the evaluation of the data
      and information submitted in support of applications,
      implement the following principles.
2.1.  Efficacy
2.1.1 Where the proposed use concerns the control of or the
      protection against an organism, Member States shall
      evaluate the possibility that this organism could be
      harmful   under  the   agricultural,   plant  health  and
      environmental (including climatic) conditions in the
      area of the proposed use.
2.1.2 Where the proposed use concerns another effect than
      the control of or the protection against an organism,
      Member States shall evaluate if significant damage,
      loss   or    inconvenience    could   occur   under   the
      agricultural,     plant    health    and    environmental
      (including climatic) conditions in the area of the
      proposed use if the plant protection product would
      not be used.
2.1.3 Member States shall evaluate the efficacy data on the
      plant protection product as provided for in Annex III
      having regard to the degree of control or the extent
      of  the  effect   desired   and  having   regard  to  the
      relevant experimental conditions such as :
 ---pagebreak---                            - 17 -
              the choice of the crop or cultivar
              the agricultural and environmental (including
              climatic) conditions
              the    presence   and    density    of  the  harmful
              organism
              the development stage of crop and organism
              the   amount   of   the plant    protection  product
              used
              if   required    on   the   label,   the  amount  of
              adjuvant added
              the frequency and timing of the applications
      -       the type of application equipment
2.1.4 Member States shall evaluate the performance of the
      plant protection product in a range of agricultural,
      plant health and environmental         (including climatic)
      condit'ions likely to be encountered in practice in
      the area of proposed use and in particular :
      (i)     the level, duration and consistency of control
              or protection     or other     intended  effects  in
              comparison    with   suitable    reference  products
              and an untreated control;
      (ii)    where relevant the yield response or reduction
              of loss in storage in terms of quantity and/or
              quality in comparison with suitable reference
              products and an untreated control.
 ---pagebreak---                           - 18 -
      A   suitable   reference    product    is   defined    as   an
      authorized plant protection product which has proved
      a   sufficient   performance     in   practice     under   the
      agricultural,     plant     health     and     environmental
       (including   climatic)    conditions    in   the    area   of
      proposed use. In general, formulation type, mode of
      action, working spectrum and method of application
      should   be   close   to   those   of   the   tested     plant
      protection product.
      Where no suitable reference product exists, Member
      States shall evaluate the performance of the plant
      protection   product    to   determine    if    there   is   a
      consistent     and     defined     benefit       under     the
      agricultural,     plant     health     and    environmental
      (including   climatic)    conditions     in   the    area   of
      proposed use.
2.1.5 Where proposed label claims include recommendations
      for use of the plant protection product with other
      plant   protection   products   as   a  tank    mix,   Member
      States shall make the evaluations referred to under
      points 2.1.1 to 2.1.4 above for the tank mix.
 ---pagebreak---                          - 19 -
2.2.  Absence of unacceptable effects on plants or plant
      products
2.2.1 Member States shall evaluate the degree of adverse
      effects on the treated crop after use of the plant
      protection    product    according      to    the     proposed
      conditions of use in comparison, where relevant, with
      suitable   reference    products    and/or     an    untreated
      control :
      a)     This evaluation will take into consideration
             the following information :
      (i)    the   efficacy data provided for in Annex III;
      (ii)   other    relevant    information     on     the    plant
             protection    product    such   as   nature     of   the
             preparation,     application      rate,    method     of
             application,       number      and       timing       of
             applications;
      (iii)  all    relevant    information      on    the    active
             substance    as    provided    for     in    Annex    II
             including   mode    of  action,    vapour     pressure,
             volatility and water solubility.
      b)     This evaluation will include :
      (i)    the nature, frequency, level and duration of
             observed     phytotoxic       effects        and     the
             agricultural, plant health and environmental
             (including   climatic)    conditions      that   affect
             these;
      (ii)   the differences between cultivars with regard
             to their sensitivity to phytotoxic effects;
 ---pagebreak---                           - 20 -
       (iii) the part of the treated crop where phytotoxic
             effects are observed;
       (iv)  the   adverse    impact   on  the   yield   of   the
             treated    crop,   in  terms  of  quantity   and/or
             quality;
       (v)   the adverse impact on treated plants or plant
             products to be used for propagation, such as
             viability, germination, sprouting, rooting and
             establishment;
      (vi)   where highly volatile herbicides, active at a
             very   low   dose,   are  concerned,   the  adverse
             impact on adjacent crops.
2.2.2 Where the available data       indicate that the active
      substance or significant metabolites, degradation and
      reaction products persist in soils and/or in or on
      plants or plant     products, after use of the plant
      protection   product     according    to   the    proposed
      conditions of use, Member States shall evaluate the
      degree of adverse effects on succeeding crops.         This
      evaluation will be carried out as specified           under
      point 2.2.1 above.
2.2.3 Where proposed label claims include recommendations
      for use of the plant protection product with other
      plant  protection     products   as   a  tank   mix,    the
      evaluation as specified under point 2.2.1 above will
      be carried out for the tank mix.
 ---pagebreak---                         - 21 -
2.3. Impact on vertebrates to be controlled
     Where   the  proposed   use   of   the   plant  protection
     product aims to have an effect on vertebrates, Member
     States shall evaluate the mechanism by which           this
     effect is obtained and the effects on the behaviour
     of the target animals; when the intended effect is to
     kill the target animal they shall evaluate the time
     necessary   to obtain the death of the animal and the
     effects on the behaviour of the animal during this
     period.
     This  evaluation   will   take   into   consideration   the
     following information :
     (i)     all relevant   information as provided      for in
            Annex   II  and the results of the evaluation
            thereof,    including    the    toxicological    and
            metabolism studies;
     (ii)   all    relevant    information     on   the   plant
            protection product as provided        for in Annex
            III    including    toxicological     studies    and
            efficacy data.
 ---pagebreak---                              - 22 -
2.4.    Impact on human or animal health
2.4.1.  Arising from the plant protection product
2.4.1.1 Member States shall evaluate the operator exposure to
        the   active    substance     and/or   to    toxicologically
        relevant compounds in the plant protection product
        likely to occur under the proposed conditions of use
        (including in particular dose and application method)
        of the plant protection product using by preference
        realistic data on exposure and, where relevant, a
        suitable calculation model.
        a)     This evaluation will take into consideration
               the following information :
        (i)    the toxicological       and metabolism     studies as
               provided for in Annex II and the results of
               the     evaluation       thereof     including     the
               Acceptable       Operator    Exposure    Level.    The
               Acceptable      Operator   Exposure    Level   is  the
               amount    of   active   substar .e absorbed    by  the
               operator     and   which   will   not   lead   to  any
               adverse health effects. The AOEL is expressed
               as milligrams       of the   chemical   per   kilogram
               body   weight     of  the  operator.    The   AOEL  is
               based   on    the   no-effect   level   in   the  most
               sensitive species or, if appropriate data are
               available, in man.
        (ii)   other    relevant     information    on   the   active
               substances       such   as   vapour    pressure    and
               volatility;
        (iii)  the   toxicological      studies   provided    for  in
               Annex III, including where appropriate dermal
               absorption studies;
 ---pagebreak---                               - 23 -
         (iv)    other relevant information as provided for in
                 Annex III such as :
                 - composition of the preparation
                 - nature of the preparation
                 - container size and design
                 - field of use and nature of crop or target
                 - method of application including handling,
                    loading and mixing of product
                 - exposure reduction measures recommended
                 - protective clothing recommendations
                 - maximum application rate
                 - minimum spray application volume
                 - number and timing of applications.
        b)       This evaluation shall be made for each type of
                 application method and application equipment
                 proposed    for  use  of   the    plant   protection
                 product as well as for the different types and
                 sizes of containers to be used, taking account
                 of mixing, loading operations,       application of
                 the plant protection product and cleaning of
                 application equipment.
2.4.1.2 Member States shall evaluate the suitability of the
        packaging,     including    closures    in   terms    of  its
        strength,      leakproofness,    resistance      to    normal
        transport     and   handling   and   the    safety    of  the
        fastenings for children.
2.4.1.3 Member    States   shall  evaluate   the effectiveness     of
        protective clothing and équipement to be worn or used
        by    those    handling    and  using    plant     protection
        products; they shall evaluate also if these items are
        readily obtainable and if they can be worn with ease,
        taking    into   account  physical    stress   and   relevant
        climatic conditions.
 ---pagebreak---                             - 24 -
2.4.1.4 Member   States   shall   evaluate   the   possibility   of
        exposure   of   other   humans   (bystanders    or  workers
        exposed after the application of the plant protection
        product) or animals to the active substance and/or to
        other toxicologically relevant compounds in the plant
        protection product under the proposed conditions of
        use.
        This  evaluation    will   take  into  consideration    the
        following information :
        (i)    the toxicological      and metabolism    studies on
               the active substance as provided for in Annex
               II and the results of the evaluation thereof;
        (ii)   the   toxicological     studies  provided    for  in
               Annex III including where appropriate dermal
               absorption studies;
        (iii)  other    relevant    information    on   the   plant
               protection product as provided        for in Annex
               III such as :
               - re-entry periods, necessary waiting periods
                  or other precautions to protect humans and
                  animals
               - method     of    application,     in    particular
                  spraying
               - maximum application rate
               - minimum spray application volume
               - composition of the preparation
               - dislodgeable residues
               - further     activities    whereby    workers   are
                  exposed.
 ---pagebreak---                              - 25 -
2.4.2.  Arising from residues
2.4.2.1 Member States shall evaluate the specific information
        on toxicology     as provided     for in Annex       II and in
        particular :
                the   determination      of    an    Acceptable     Daily
                Intake (ADI)
        -       the identification of breakdown and reaction
               products and of metabolites in treated plants
               or plant products
        -       behaviour of residue of the active substance
               and     its    metabolites      from     the    time    of
               application      until   harvest     or   outloading    of
               stored products.
2.4.2.2 Prior   to   evaluating     the    residue     levels    in   the
        reported   trials    or   in   products     of  animal    origin
        Member States shall examine the following
        information :
        -       data    on    the    proposed      good    agricultural
               practice     including     data    on   application     as
               provided for in Annex III and proposed pre-
               harvest     intervals     for    envisaged     uses,    or
               withholding periods or storage periods, in the
               case of post-harvest uses
        -       nature of the preparation
        -       analytical methods and the residue definition
2.4.2.3 Member States shall evaluate the residue levels in
        the reported trials. This evaluation shall be made
        for   each    proposed     use     and     shall    take     into
        consideration :
        (i)    the proposed conditions of use of the plant
               protection product;
        (ii)   the specific information on residues in or on
               treated plants, plant products, food and feed
               as provided for in Annex III;
 ---pagebreak---                            - 26 -
         (iii) the specific information on residues in or on
               treated plants, plant products, food and feed
               as provided for in Annex II and the results of
               the evaluation thereof;
2.4.2.4 Member States shall evaluate the residue levels in
        products of animal origin, taking into consideration
        the information provided for in Annex III, Part A,
        point 8.4.
2.4.2.5 Member States shall estimate the potential    exposure
        of consumers through diet and where relevant other
        ways of exposure using a suitable calculation model.
        This evaluation will take account, where relevant, of
        other sources such as other authorized uses of plant
        protection   products   containing   the same   active
        substance or which give rise to the same residues.
2.4.2.6 Member  States  shall, where   relevant, estimate  the
        exposure of animals, taking into account the residue
        levels in treated plants or plant products intended
        to be fed to animals.
 ---pagebreak---                                 - 27 -
2.5.         Influence on the environment
2.5.1.       Fate and distribution in the environment.
             In the evaluation of the fate and distribution of the
             plant protection product in the environment, Member
             States shall have regard to all compartments of the
             environment, including biota, and in particular to
             the following compartments :
2.5.1.1      Member States shall evaluate the possibility for the
             plant protection product to reach the soil under the
             proposed   conditions   of   use;   if   this   possibility
             exists they shall evaluate the rate and the route of
             degradation in the soil, the mobility in the soil and
             the change of the total concentration          (extractable
             and non-extractable(*)) of the active substance and
             of  relevant   metabolites,    degradation    and  reaction
             products that could be expected in the soil in the
             area  of   envisaged   use    after   use   of   the  plant
             protection    product    according     to    the   proposed
             conditions of use.
             This ' evaluation   will   take   into   consideration   the
             following information:
             (i)     the specific information on fate and behaviour
                     in the soil as provided for in Annex II and
                     the results of the evaluation thereof;
(*) non-extractable residues (sometimes referred to as "bound" or
"non-extracted" residues)     in plants and     soils are defined     as
chemical species originating from pesticides, used according to
good agricultural practice, that are unextracted by methods which
do  not   significantly   change   the   chemical    nature    of  these
residues.   These   non-extractable    residues    are   considered   to
exclude fragments through metabolic pathways leading to natural
products.
 ---pagebreak---                             - 28 -
         (ii)   other   relevant    information    on   the    active
                substance such as :
                - molecular weight
                - solubility in water
                - octanol/water partition coefficient
                - vapour pressure
                - volatilization rate
                - dissociation constant
               - photodegradation      rate    and     identity     of
                  breakdown products
               - hydrolysis    rate    in   relation    to    pH   and
                  identity of breakdown products;
         (iii) all    relevant    information     on     the    plant
               protection product as provided         for in Annex
               III including the information on distribution
               and dissipation in soil;
        (iv)   where relevant, other authorized uses of plant
               protection products in the area of proposed
               use , containing the same active substance or
               which give rise to the same residues.
2.5.1.2 Member States shall evaluate the possibility for the
        plant protection product to reach the ground water
        under  the    proposed   conditions    of    use;    if   the
        possibility exists that the plant protection product
        can reach the ground water they shall estimate, using
        where appropriate a suitable calculation model, the
        concentration of the active substance and of relevant
        metabolites, degradation and reaction products that
        could be expected in the ground water in or from the
        areas  of   envisaged   use   after   use   of    the   plant
        protection    product    according    to    the     proposed
        conditions of use.
 ---pagebreak---                      - 29 -
This  evaluation     will   take    into   consideration      the
following information :
(i)     the   specific    information      on   the    fate   and
        behaviour     in   the    soil    and    in   water    as
        provided for in Annex II and the results of
        the evaluation thereof;
(ii)    other    relevant    information      on    the   active
        substance    such as:
        - molecular weight
        - solubility in water
        - octanol/water partition coefficient
        - vapour pressure
        - volatilization rate
        - hydrolysis     rate    in   relation      to   pH   and
          identity of breakdown products
      - - dissociation constant
(iii)   all    relevant     information       on    the     plant
        protection product as provided for in Annex
        III including the information on distribution
        and dissipation in      soil and water;
(iv)    where relevant, other authorized uses of plant
        protection products in the area of envisaged
        use containing the same active substance or
       which give rise to the same residues ;
(v)     where relevant, data on dissipation including
        transformation     and sorption in the saturated
        zone;
(vi)    where   relevant,    data on     the procedures       for
        drinking water abstraction and treatment               in
        the area of envisaged use.
 ---pagebreak---                             - 30 -
2.5.1.3 Member States shall evaluate the possibility for the
        plant protection product to reach surface water under
        the proposed conditions of use ; if this possibility
        exists they shall estimate, using where appropriate a
        suitable calculation model,        the short term and long
        term  predicted    environmental     concentration   of   the
        active   substance     and    of    relevant    metabolites,
        degradation and reaction products after use of the
        plant protection product according to the proposed
        conditions of use.
        This evaluation will take into consideration, where
        relevant, the following information:
        (i)    the    specific      information     on    fate    and
               behaviour in the soil and in water as provided
               for   in   Annex   II   and    the  results   of   the
               evaluation thereof;
        (ii)   other    relevant    information    on    the   active
               substance such as :
               - molecular weight
               - solubility in water
               - octanol/water partition coefficient
               - vapour pressure
               - volatilization rate
               - hydrolysis     rate    in   relation    to  pH   and
                 identity of breakdown products
               - dissociation constant;
        (iii)  all    relevant     information     on    the    plant
               protection product as provided          for in Annex
               III including the information on distribution
               and dissipation in soil and water;
 ---pagebreak---                            - 31 -
        (iv)   possible routes of exposure :
               - drift
               - run-off
               - overspray
               - discharge via drains
               - leaching
               - atmospheric deposition;
        (v)    where relevant, other authorized uses of plant
               protection products in the area of envisaged
               use containing the same active substance or
               which give rise to the same residues;
        (vi)   where   relevant, data    on the procedures   for
               drinking water abstraction      and treatment  in
               the area of envisaged use.
2.5.1.4 Member States shall evaluate the possibility for the
        plant protection product     to be dissipated    in the
        air under the proposed conditions of use; if this
        possibility exists they shall estimate, using where
        appropriate    a   suitable   calculation   model,   the
        concentration of the active substance and of relevant
        metabolites, degradation and reaction products that
        could be expected in the air after use of the plant
        protection    product   according    to   the   proposed
        conditions of use.
        This  evaluation   will  take   into  consideration  the
        following information :
        (i)    the   specific   information   on  the  fate  and
               behaviour in the soil, water and in air as
               provided for in Annex II and the results of
               the evaluation thereof;
 ---pagebreak---                            - 32 -
         (ii)  other   relevant    information  on   the  active
               substance such as :
               - vapour pressure
               - solubility in water
               - hydrolysis    rate   in  relation   to  pH   and
                 identity of breakdown products
               - photochemical degradation in water and air
                 and identity of breakdown products
               - octanol/water partition coefficient;
        (iii)  all   relevant     information   on   the    plant
               protection product as provided      for in Annex
               III including the information on distribution
               and dissipation in air.
2.5.1.5 Member States shall evaluate the suitability of the
        procedures for destruction or decontamination of the
        plant protection product and its packaging.
2.5.2.  Impact on non-target species
2.5.2.1 Member  States   shall   evaluate   the  possibility   of
        exposure of birds and other terrestrial vertebrates
        to the plant protection product under the proposed
        conditions of use; if this possibility exists they
        shall evaluate the degree of short term and long term
        risk, including on the reproduction, to be expected
        for these organisms after use of the plant protection
        product according to thé proposed conditions of use.
 ---pagebreak---                   - 33 -
a)    This evaluation will take into consideration
      the following information :
 (i)  the    specific     information     relating     to
      toxicological   studies on mammals and to the
      effects   on    birds    and   other    non-target
      terrestrial vertebrates including effects on
      the    reproduction      and    other     relevant
      information    on   the   active    substance    as
      provided for in Annex II and the results of
      the evaluation thereof;
(ii)  all   relevant    information    on    the    plant
      protection product as provided for in Annex
      III including the information on effects on
      birds   and    other    non-target     terrestrial
      vertebrates;
(iii) where relevant, other authorized uses of plant
      protection products in the area of envisaged
      use containing the same active substance or
      which give rise to the same residues.
b)    This evaluation will include :
(i)   the    fate     and    distribution      including
      persistence and bioconcentration of the active
      substance    and    of   relevant    .metabolites,
      degradation   and   reaction   products    in   the
      relevant compartments of the environment after
      application of the plant protection product;
 ---pagebreak---                             - 34 -
         (ii)  the estimated      exposure of the species likely
               to be at risk at the time of application or
               during the period that residues are present,
               taking   into account     all  relevant     routes of
               exposure such as ingestion of the formulated
               product    or     treated    food,    prédation      on
               invertebrates,      feeding  on   vertebrate      prey,
               contact    by    overspraying    or    with    treated
               vegetation, inhalation or grooming;
        (iii)  a calculation of the acute,         short term and,
               where necessary, long term        toxicity/exposure
               ratio.   The    toxicity/exposure       ratio's     are
               defined    as    respectively    the    quotient     of
                             or
               LD50,   LC50       NOEC expressed     on   an   active
               substance   basis     and the  estimated      exposure
               expressed in mg/kg body weight.
2.5.2.2 Member  States   shall     evaluate  the    possibility     of
        exposure of aquatic organisms to the plant protection
        product under the proposed conditions of use; if this
        possibility exists they shall evaluate the degree of
        short term and long term risk to be expected               for
        aquatic organisms after use of the plant protection
        product according to the proposed conditions of use.
        a)     This evaluation will take into consideration
               the following information :
        (i)    the   specific     information   relating      to   the
               effects on aquatic organisms as provided for
               in Annex II and the results of the evaluation
               thereof;
 ---pagebreak---                  - 35 -
(ii)  other   relevant   information     on   the   active
      substance such as :
      - solubility in water
      - octanol/water partition coefficient
      - vapour pressure
      - volatilization rate
      - Kd for adsorption
      - biodégradation in aquatic systems and in
        particular the ready biodegradability
      - photodegradation     rate    and     identity    of
        breakdown products
      - hydrolysis    rate   in  relation     to   pH   and
        identity of breakdown products;
(iii) all   relevant    information     on     the   plant
      protection product as provided        for in Annex
      III and in particular the effects on aquatic
      organisms;
(iv)  where relevant, other authorized uses of plant
      protection products in the area of envisaged
      use, containing the same active substance or
      which give rise to the same residues.
b)    This evaluation will include ;
(i)   the fate and distribution of residues of the
      active substance and of relevant metabolites,
      degradation   and - reaction products      in water,
      sediment or aquatic organisms;
(ii)  a    calculation      of     the      short      term
      toxicity/exposure ratio     for fish and Daphnia.
      The  short   term   toxicity/exposure      ratio   is
      defined as the quotient of respectively acute
      LC50 or   EC50 and the     short    term   predicted
      environmental concentration;
 ---pagebreak---                             - 36 -
         (iii) the     calculation     of     the     algal    growth
               inhibition/exposure       ratio    for    algae.   This
               exposure ratio is defined as the quotient of
               the    EC50    and   the    short    term    predicted
               environmental concentration;
         (iv)  a      calculation      of      the      long      term
               toxicity/exposure ratio for fish and Daphnia.
               The    long   term   toxicity/exposure       ratio   is
               defined as the quotient of the N0EC and the
               long        term      predicted         environmental
               concentration;
        (v)    where relevant, the bioconcentration in fish
               and possible exposure of predators of fish,
               including man;
        (vi)   if   the   plant   protection    product    is  to   be
               applied directly to surface water, the effect
               on the change of surface water quality, such
               as pH or dissolved oxygen content..
2.5.2.3 Member   states   shall   evaluate    the   possibility     of
        exposure   of    honeybees    to   the   plant     protection
        product under the proposed conditions of use             ; if
        this possibility exists they shall evaluate the short
        term and long term risk to be expected for honeybees
        after use of the plant protection product according
        to the proposed conditions of use.
        a)     This evaluation will take into consideration
               the following information :
        (i)    the    specific    information     on    toxicity    to
               honeybees as provided for in Annex II and the
               results of the evaluation thereof;
 ---pagebreak---                  • - 37 -
 (ii) other    relevant   information     on   the    active
      substance such as :
      - solubility in water
      - octanol/water partition coefficient
      - vapour pressure
      - photodegradation      rate    and     identity    of
        breakdown products
      * mode     of   action     (e.g.     insect     growth
        regulating activity);
(iii) all    relevant    information     on     the    plant
      protection product as provided for in Annex
      III including    the toxicity to honeybees;
(iv)  where relevant, other authorized uses of plant
      protection products in the area of envisaged
      use, containing the same active substance or
      which give rise to the same residues.
b)    This evaluation will include :
(i)   the ratio between the maximum application rate
      in gramme of active substance per hectare and
      the   contact   and   oral   LD50     in   pg   active
      substance per bee (hazard quotients) and where
      necessary the persistence of residues on or,
      where relevant, in the treated plants;
(ii)  where   relevant,    the    effects     on    honeybee
      larvae,   honeybee   behaviour,    qqlony     survival
      and   development    after    use    of    the   plant
      protection product according to the proposed
      conditions of use.
 ---pagebreak---                             - 38 -
2.5.2.4 Member   States   shall   evaluate    the   possibility   of
        exposure    of    beneficial     arthropods     other   than
        honeybees to the     plant protection product under the
        proposed   conditions    of   use;   if   this   possibility
        exists they will assess lethal and sublethal effects
        on these organisms to be expected after use of the
        plant protection product according to the proposed
        conditions of use.
        This  evaluation    will   take   into   consideration   the
        following information :
        (i)    the    specific    information     on   toxicity   to
               honeybees and other beneficial arthropods as
               provided for in Annex II and the results of
               the evaluation thereof;
        (ii)   other    relevant    information    on   the   active
               substance such as :
               - solubility in water
               - octanol/water partition coefficient
               - vapour pressure
               - photodegradation       rate    and    identity   of
                  breakdown products
               - mode     of    action     (e.g.    insect    growth
                  regulating activity);
        (iii)  all    relevant     information     on    the   plant
               protection product as provided for in Annexe
               III such as :
               - the effects on beneficial arthropods other
                  than bees
               - the toxicity to honeybees
               - available     data    from    biological    primary
                  screening in summary form
               - the maximum application rate;
 ---pagebreak---                              - 39 -
        (iv)   where relevant, other authorized uses of plant
               protection products in the area of envisaged
               use, containing the same active substance or
               which give to the same residues.
2.5.2.5 Member   States    shall   evaluate    the   possibility   of
        exposure   of   earthworms    and   other   soil   non-target
        macro-organisms to the plant protection product under
        the proposed conditions of nee; if thif possibility
        exists they shall evaluate the degree of short term
        and long term risk to be expected to these organisms
        after use of the plant protection product according
        to the proposed conditions of use.
        a)     This evaluation will take into consideration
               the following information :
        (i)    the    specific    information     relating    to  the
               toxicity of the active substance to earthworms
               and to other soil non-target macro-organisms
               as provided for in Annex II and the results of
               the evaluation thereof;
        (ii)   other    relevant    information      on  the   active
               substance such as i
               - solubility in water
               - octanol/water partition coefficient
               - Kd for adsorption
               - vapour pressure
               - hydrolysis      rate   in   relation    to   pH  and
                  identity of breakdown products
               - photodegradation        rate    and    identity   of
                  breakdown products
               - DT5Q     and   DT90    for   degradation     in  the
                  soil;
 ---pagebreak---                             - 40 -
        (iii)   all   relevant     information     on    the   plant
                protection product as provided for in Annex
                III including    the effects on earthworms and
                other soil non-target macro-organisms;
        (iv)    where relevant, other authorized uses of plant
                protection products in the area of envisaged
                use, containing the same active substance or
                which give rise to the same residues.
        b)      This evaluation will include :
        (i)     the lethal and sublethal effects;
        (ii)    the    predicted     initial     and     long   term
                environmental concentration;
        (iii)   a calculation of the acute toxicity/exposure
                ratio   (defined as the quotient of LC 5 0 and
                Predicted initial environmental concentration)
                and of the long term toxicity/exposure ratio (
                defined   as  the   quotient    of   the   NOEC  and
                Predicted       long      term         environmental
                concentration);
        (iv)    the   bioconcentration     and     persistence    of
                residues in earthworms.
2.5.2.6 Member States shall, where the evaluation carried out
        under part    B point    2.5.1.1  does not exclude the
        possibility for the plant protection product to reach
        the   soil  under   the   proposed   conditions     of  use,
        evaluate the impact on the microbial activity such as
        the impact on the nitrogen and carbon mineralisation
        processes   in   the   soil   after   use    of   the  plant
        protection    product     according    to     the   proposed
        conditions of use.
 ---pagebreak---                   - 41 -
This  evaluation  will  take  into  consideration  the
following information :
(i)    all   relevant   information   on  the   active
       substance including the specific information
       relating to the effects on soil non-target
       micro-organisms as provided for in Annex II
       and the results of the evaluation thereof;
(ii)   all   relevant   information    on  the   plant
       protection product as provided for in Annex
       III including the effects on soil non-target
       micro-organisms;
(iii) where relevant, other authorized uses of plant
       protection products in the area of proposed
       use, containing the same active substance or
       which give rise to the same residues.
 ---pagebreak---                          - 42 -
2.6   Analytical methods
      Member States shall evaluate the analytical methods,
      proposed for post-registration control and monitoring
      purposes, to determine :
2.6.1 for formulation analysis :
      the nature and quantity of the active substance(s) in
      the plant protection product and, where appropriate,
      any toxicologically or ecotoxicologically significant
      impurities and co-formulants;
2.6.2 for residue analysis :
      the residues of the active substance, metabolites,
      degradation  or   reaction   products,   resulting   from
      authorized uses of the plant protection product, and
      which   are   of    toxicological    or    environmental
      significance.
      This  evaluation   will  take   into  consideration   the
      following information :
      (i)    the data on analytical methods as provided for
             in Annex II   and the results of the evaluation
             thereof;
      (ii)   the data on analytical methods provided for in
             Annex III and in particular :
             - the specificity of the proposed methods
             - the recovery rate of the proposed methods
             - the   precision   of    the   proposed   methods
               (intra-laboratory    repeatability   and  inter-
               labor atorry reproducibility);
 ---pagebreak---                   - 43 -
(iii) the   limit   of   detection of  the proposed
      methods;
(iv)  the  limit of determination   of the proposed
      methods.
 ---pagebreak---                           - 44 -
2.7   Physical and chemical properties
2.7.1 Member States shall evaluate the actual content of
      the active substance in the plant protection product
      and its stability during storage.
2.7.2 Member   States   shall     evaluate   the   physical   and
      chemical properties of the plant protection product
      and in particular:
             where   a   FAO   specification    exists  for   the
             active    substance     contained   in   the   plant
             protection product, the physical and chemical
             properties addressed in these specifications;
             where   no   FAO  specification    exists   for  the
             active    substance     contained   in   the   plant
             protection product, all the relevant physical
             and chemical properties for the formulation as
             referred to in the "Manual on the development
             and   use   of   FAO    specifications   for   plant
             protection products".
      This  evaluation   will   take    into  consideration   the
      following information     :
             the data on physical and chemical properties
             of the active substance as provided          for in
             Annex  II and the results of the evaluation
             thereof;
      -      the data on physical and chemical properties
             of the plant protection product as provided
             for in Annex III.
 ---pagebreak---                         - 45 -
2.7.3 Where proposed label claims include recommendations
      for use of the plant protection product with other
      plant protection products as a tank mix, the physical
      and chemical compatibility   of the products   in the
      mixture must be evaluated.
 ---pagebreak---                             - 46 -
C.    DECISION MAKING
1.    General Principles
1.    Member   States      shall    impose,    where    appropriate,
      conditions     or     restrictions     with     authorizations
      granted.   The nature and severity of these measures
      must be selected on the basis of, and be appropriate
   " "tor the nature and extent of the expected advantages
      and the risks likely to arise.
2.    Member States shall ensure that decisions, taken with
      respect   to   the granting      of   authorizations, take,
     where necessary, account of the agricultural, plant
      health    or     environmental        (including      climatic)
      conditions    in   the   areas    of   envisaged     use.  Such
      considerations may result in specific conditions and
      restrictions     of    use,    and,   where     necessary,   in
      authorization being granted for some but not other
      areas within the Member State in question.
3.   Member    States     shall    ensure    that   the    authorized
      amounts,    in    terms     of    rates     and    numbers   of
      applications, are the minimum necessary to achieve
     the desired effect even where higher amounts would
      not result in     unacceptable risks to human or animal
      health or to the environment. The authorized amounts
     must    be    differentiated       according      to,   and   be
      appropriate    to the     agricultural, plant        health or
      environmental (including climatic) conditions in the
      various areas for which an authorization is granted.
      However the amounts to be used may not give rise to
      undesirable    effects     such    as   the   development    of
      resistance.
4.    Member   States    shall    ensure    that   decisions    take,
     whenever possible, into account the principles of
      integrated control.
 ---pagebreak---                    - 47 -
Member States shall ensure that the authorization
implies   an approval of the      label provided   for a
plant protection product, being established according
to the requirements of Article        16. Moreover, the
label shall contain the information on protection of
users required from the implementation of Community
legislation on worker protection. In particular the
label shall contain the conditions or restrictions
under which the plant protection product may be used
or may not be used as identified under points (1),
(2), (3) or (4) above.
Member States shall ensure that the authorization
implies an approval of the proposed packaging and of
the   proposed     procedures    for    destruction    or
decontamination of the plant protection product and
its packaging.
The packaging must be designed -in accordance with the
provisions of article 15 and fulfil the requirements
of the tests made in accordance with the provisions
of Annex III part A point 4.
The   proposed     procedures    for    destruction    or
decontamination of the plant protection product and
its packaging must be both practical and effective.
No authorization    shall be granted     unless all the
requirements as referred to under part C section 2
are satisfied. However :
a)      when one or more of the specific decision
        making requirements as referrred to under part
        C   points  2.1,   2.2,  2.3   or  2.7  are   not
        satisfied,   authorizations   shall  be  granted
        only where the advantages of the use of the
        plant protection product under the proposed
        conditions   of   use   outweigh   the  possible
        adverse effects of its use.     These advantages
        can be in terms of :
 ---pagebreak---               - 48 -
   advantages for and compatibity with integrated
   control measures or organic farming;
   facilitating strategies to minimize the risk
   of development of resistance;
   the need for a greater diversity of types of
   active  substances   or  biochemical  modes of
   action such as for the use in strategies to
   avoid accelerated breakdown in the soil;
   reduced risk for operators and consumers;
   reduced contamination of the environment and
   reduced impact on non-target species.
b) where the criteria as referred to under part C
   point  2.6   are   not  satisfied   because of
   limitations in current analytical science and
   technology, an authorization shall be granted
   for a limited period if the methods submitted
   have been justified as being adequate for the
   purposes intended. In this case a time limit
   shall be given to the applicant in order to
   develop and submit analytical methods that are
   in accordance with the criteria as referred to
   above.  The authorization will be reviewed at
   the expiry of the time limit accorded to the
   applicant.
 ---pagebreak---                        - 49 -
8. Member States may, where an authorization has been
   granted according to the requirements provided for in
   this Annex in close cooperation with the applicant :
   a)     identify, where possible, measures to improve
          the   performance     of   the  plant    protection
          product, and/or
   b)     identify, where possible, measures to reduce
          further the exposure that could occur after
          use of the plant protection product.
   Member States shall inform applicants of any measures
   identified under a) or b) and shall invite applicants
   to provide any     supplementary   data and    information
   necessary  to    demonstrate   performance  or   potential
   risks arising under the changed conditions.
              •K Vr.v
 ---pagebreak---                            - 50
2.    Specific principles
2.1   Efficacy
2.1.1 Where the proposed uses include recommendations for
      the control of or protection against organisms which
      are   not   considered     to   be    harmful   under   normal
      agricultural,      plant      health     and     environmental
      (including    climatic)     conditions     in  the   areas  of
      proposed use or where the other intended effects are
      not    considered     to    be    beneficial     under   these
      conditions,    no authorization       shall be granted     for
      these uses.
2.1.2 The level, duration, and consistency of control or
      protection or other intended effects must be similar
      to those resulting       from use of suitable        reference
      products.    If no suitable       reference product     exists
      the plant protection product must be shown to give a
      defined benefit in terms of the level, duration and
      consistency     of   control     or   protection     or  other
      intended effects under the agricultural, plant health
      and environmental (including climatic) conditions in
      the area of proposed use.
2.1.3 Where relevant, yield response and reduction of loss
      in storage, in terms of quantity and/or quality, must
      be at a similar level as that resulting- from use of
      suitable     reference      products.     If    no    suitable
      reference    product     exists,     the   plant    protection
      product   must   be   shown    to   give   a  consistent   and
      defined benefit in terms of, where relevant,             yield
      response and reduction of loss in storage in terms of
      quantity and/or quality under the agricultural, plant
      health    and     environmental       (including     climatic)
      conditions in the area of proposed use.
 ---pagebreak---                            - 51 -
2.1.4 Conclusions as to performance of the preparation must
      be valid for all areas of the Member State in which
      it   is  to   be   authorized,   and   must  hold   for   all
      conditions under which its use is proposed, except
      where    the    proposed    label    specifies    that    the
      preparation is intended for use in certain specified
      circumstances     (e.g.  light  infestations,    particular
      soil types, particular growing conditions).
2.1.5 Where proposed label claims include recommendations
      for   use    of   the   preparation     with  other     plant
      protection products as a tank mix, the principles
      referred    to in points 2.1.1 to 2.1.4 above must be
      satisfied for the preparation applied in the mixture.
2.2   Absence of unacceptable effects on plants or plant
      products
2.2.1 There must be absence of relevant phytotoxic effects
      on treated plants or plant products except where the
      proposed label indicates appropriate limitations of
      use.
2.2.2 There must be no reduction of yield at harvest below
      that which could be obtained without the use of the
      plant protection product, unless at the same time,
      the quality of the treated plants or plant products
      is capable of being enhanced.
2.2.3 There must be no unacceptable adverse effects on the
      quality of treated plants or plant products, except
      in the case of adverse effects on processing where
      proposed   label claims specify that the preparation
      should   not   be   applied  to   crops   to  be   used   for
      processing purposes.
 ---pagebreak---                            - 52 -
2.2.4 There   must   be   no   unaceptable    adverse    impact   on
      treated    plants     or    plant    products     used     for
      propagation,      such    as    effects     on    viability,
      germination, sprouting, rooting, and establishment,
      except where proposed label claims specify that the
      preparation should not be applied to plants or plant
      products to be used for propagation.
2.2.5 There must be no unacceptable impact on succeeding
      crops,   except where proposed       label claims specify
      that particular crops which would be affected, should
      not be grown following the treated crop.
2.2.6 There must    be   no unacceptable     impact   on   adjacent
      crops, except where proposed         label claims      specify
      that  the   preparation    should   not   be   applied    when
      particular sensitive adjacent crops are present.
2.2.7 Where proposed label claims include recommendations
      for   use   of   the    preparation     with   other     plant
      protection products as a tank mix, the principles
      referred to in points 2.2.1 to 2.2.6 above must be
      satisfied for the preparation applied in the mixture.
2.2.8 The  proposed     instructions     for   cleaning     of   the
      application   equipment    must   be   both  practical     and
      effective so that they can be applied with ease and
      that the removal of       residual traces of the plant
      protection product, which could         subsequently     cause
      damage, is ensured.
2.3.  Impact on vertebrates to be controlled
      The intended effect on vertebrates to be controlled
      shall be obtained without unneccessary suffering and
      pain for these animals.
 ---pagebreak---                                 - 53 -
2.4.         Impact on human or animal health
2.4.1.      Arising from the plant protection product
2.4.1.1     No authorization shall be granted if the extent of
            operator exposure     in handling and using the plant
            protection product under the proposed conditions of
            use, including dose and      application method,     exceeds
            the Acceptable Operator Exposure Level (AOEL).
            Moreover, the conditions of the authorization shall
            be in compliance with the Limit Value established for
            the active substance and/or toxicologically relevant
            compound(s) of the product in accordance with Council
            Directive 80/1107/EEC on the protection of workers
            from   the  risks   related   to   exposure   to   chemical,
            physical and biological agents at work(^) , and in
            accordance with Council Directive 90/394/EEC on the
            protection   of  workers    from   the   risks   related  to
            exposure to carcinogens at work(2) .
2.4.1.2     Where the proposed conditions of use require use of
            items   of  protective    clothing     and   equipment,   no
            authorization shall be granted unless these items are
            effective, readily obtainable to the user and unless
            it is feasible to use them under the circumstances of
            use of the plant protection product.
2.4.1.3     Plant    protection    products,      which    because    of
            particular properties and, if mishandled or misused,
            could lead to a high degree of risk must be subject
            to   particular   restrictions    such    as  the   size  of
            packaging or formulation type, the distribution, the
            use or the manner of use.      Moreover, plant protection
            products which are classified as very toxic may not
            be supplied to nor used by non professional users.
(1) O.J. N° L 327, 03.12.80, p.8
(2) O.J. N° L 196, 26.07.90, p. 1
 ---pagebreak---                            - 54 -
2.4.1.4 Waiting and re-entry periods or other precautions
        must  be such that the exposure of bystanders or
        workers exposed after the application of the plant
        protection product does not exceed the AOEL levels
        established     for    the   active     substance      or
        toxicologically   relevant compound(s)    in the plant
        protection product nor the Limit values where they
        were established for these compounds according to the
        Community   provisions  as  referred   to   under   point
        2.4.1.1 above.
2.4.1.5 Waiting and re-entry periods or other precautions
        must  be  such   that  no adverse  impact    on   animals
        occurs.
2.4.1.6 Waiting and re-entry periods or other precautions
        ensuring that the AOEL levels and Limit values are
        respected must be realistic; if necessary         special
        precautionary measures must be foreseen.
2.4.2   Arising from residues
2.4.2.1 Residues occuring should reflect minimum quantities
        of the plant protection product necessary to achieve
        adequate  pest   control, applied   in  such    a manner
        (including the largest feasable pre-harvest intervals
        or withholding periods or storage periods) that the
        residues at harvest, collection, slaughter or after
        storage, as appropriate, are as low as practicable.
 ---pagebreak---                                    - 55 -
2.4.2.2       Member States shall, where no Community MRL(*) nor a
              provisionnai MRL (at national or at Community           level)
              exists establish a provisional MRL; conclusions as to
              the levels fixed must be valid for all circumstances
              which could influence the residue levels in the crop
              such as timing of application, application            rate or
              manner of use.
2.4.2.3       Member    States   shall,   where   the   good   agricultural
              practice or the circumstances under which the plant
              protection product is to be used do not correspond to
              those under which a provisional         MRL (at national or
              at Community     level) was established,        not  grant  an
              authorisation for the plant protection product unless
              the applicant can provide evidence that this MRL will
              not   be  exceeded   by   the   recommended    use  of  it  or
              unless a new provisional MRL is established.
(*)   A  Community   MRL   will  mean  a MRL    established     pursuant  to
Council Directive 76/895/EEC of 23 November 1976 relating to the
fixing of maximum levels for pesticide residues in and on fruit
and   vegetables,    Directive   86/362/EEC    of  24   July   1986  on  the
fixing of maximum levels for pesticide residues in and on cereals
( 1 ), Council Directive 86/363/EEC of 24 July 1986 on the fixing
of maximum levels for pesticide residues in and on foodstuffs of
animal origin( 2 ) , Council Directive 90/642/EEC of 27 November
1990 on the fixing of maximum levels for pesticide residues in
and   on  certain   products of    plant   origin,   including    fruit  and
vegetables^3)     or Council Directive 91/132/EEC of 4 March            1991
amending    Directive     74/63/EEC   on    undesirable    substances    and
products in animal nutrition^ ) ; it is envisaged that the data
for the establisment       of such levels will be available after a
period not normaly exceeding 3 years.
(1) O.J. N° L. 221, 07.08.86, p. 37
(2) O.J. N° L. 221, 07.08.86, p. 43
(3) O.J. N° L. 350, 14.12.90, p. 71
(4) O.J. N° L.     66, 13.03.91, p. 16
 ---pagebreak---                           - 56 -
2.4.2.4 Member States shall, where a Community MRL         exists
        not grant an authorisation for the plant protection
        product unless the applicant      can provide evidence
        that this MRL will not be exceeded by the recommended
        use of it.
2.4.2.5 In the cases referred to under points 2.4.2.2 and
        2.4.2.3 above, each application for an authorisation
        roust be accompanied by a risk assessment taking into
        account worst case potential exposure of consumers in
        the Member State concerned.
        Taking into account all registered uses, the proposed
        use  can  hot  be   authorized   if  the best    possible
        estimate of dietary exposure exceeds      the ADI.
2.4.2.6 When during processing the nature of residues is
        affected, a separate risk assessment may need to be
        carried out under the conditions as provided          for
        under point 2.4.2.5 above.
2.4.2.7 When  the   treated   plants   or   plant   products  are
        intended to be fed to animals, residues occuring
        shall not have an adverse effect on animal health.
2.5.    Influence on the environment
2.5.1.  Fate and distribution in the environment-
2.5.1.1 No  authorization   shall be granted      if the   active
        substance, and where they are of toxicological or
        environmental significance, metabolites, degradation
        or reaction products after use under the proposed
        conditions of use of the plant protection product,
 ---pagebreak---                                   - 57 -
                    persist in soil for more than one year            (i.e.
                    DT    >
                       90     * year and DT50 > 3 months) or
            -        form bound residues in amounts exceeding 50 %
                    of initial dose after 30 days or 70 % after
                     100 days connected with mineralisation rate
                    less than 5 % within 100 days
            This   does     not    apply    if   it   is   scientifically
            demonstrated that       under field conditions there is no
            accumulation in soil at such levels that unacceptable
            residues    in   succeeding     crops   occur,   and/or    that
            unacceptable phytotoxic effects on           succeeding crops
            occur, and/or      that there is an      unacceptable impact
            on   the    environment,      according    to   the   relevant
            requirements provided for in part C points 2.5.1.2,
            2.5.1.3, 2.5.1.4 and 2.5.2.
2.5.1.2     No    authorization       shall     be    granted     if    the
            concentration of the active suBstance or of relevant
            metabolites,     degradation     or   reaction   products    in
            water intended for human consumption, as defined by
            Directive 80/778/EEC of 15 July 1980 relating to the
            quality of water intended for human consumption^),
            may be expected, without special treatment, not to
            comply with the provisions of that Directive after
            use   of   the    plant    protection    product    under   the
            proposed conditions of use
2.5.1.3     No    authorization       shall     be    granted     if    the
            concentration of the active substance or of relevant
            metabolites, degradation or reaction products to be
            expected after use of the plant protection product
            under   the proposed       conditions of use       in surface
            water:
(1) O.J. N°. L. 229, 30.08.80, p.11
 ---pagebreak---                               - 58 -
                   exceeds, where the surface water in or from
                   the area of envisaged use is intended for the
                   abstraction   of  drinking   water,   the    values
                   fixed by Directive 75/440/EEC of 16 June 1975
                   concerning   the   quality    of   surface    water
                   intended for the abstraction of drinking water
                   in the Member States(^) or
                   has  an  impact  deemed   unacceptable    on non-
                   target species, including animals, according
                   to the relevant requirements provided for in
                   part C point 2.5.2.
            The  proposed  instructions    for  use   of   the   plant
            protection product, including procedures for cleaning
            application   equipment   must    be    such   that    the
            likelihood  of  accidental   contamination    of   surface
            water is minimized.
2.5.1.4     The airborne concentration of the active substance
            should be such that with respect to the realistic
            conditions of use neither the AOEL nor Limit values
            for operators, bystanders or workers as referred to
            under part C point 2.4.1. are exceeded.
(1) O.J. N°. L. 194, 25.07.75, p. 34
 ---pagebreak---                             - 59 -
2.5.2.  Impact on non-target species
2.5.2.1 If there is a possibility of exposure for birds and
        other     non-target    terrestrial       vertebrates      no
        authorization shall be     granted if :
               the acute and      short   term   toxicity/exposure
               ratio     for   birds     and    other     non-target
               terrestrial    vertebrates     is    less   than   10,
                and the long term toxicity/exposure ratio is
                less than 5 unless it is cleary established
               through an appropriate risk assessment that
               under field conditions no unacceptable impact
               occurs    after  use   of   the   plant    protection
               product according to the proposed conditions
               of use;
               the bioconcentration factor (BCF, related to
              * fat tissue) is greater than 1 unless it is
               clearly    established   through     an   appropriate
               risk assessment that under field conditions no
               unacceptable effects - directly or indirectly
               - occur after use of the plant protection
               product according to the proposed conditions
               of use.
2.5.2.2 If there is a possibility of exposure. for aquatic
        organisms no authorization shall be granted if :
               the    toxicity/exposure    ratio     for   fish   and
               DAPHNIA    is less than 100 for acute exposure
                and less than 10 for chronic exposure,        unless
                it    is   clearly    established      through     an
               appropriate risk assessment that under field
                conditions the viability of aquatic species is
               not    threatened    after    use    of   the    plant
               protection product according to the proposed
               conditions of use;
 ---pagebreak---                              - 60 -
                the algal growth inhibition/exposure ratio is
                 less than 10 unless it is clearly established
                through   an appropriate       risk assessment     that
                under field conditions        the viability of algae
                is   not  threatened      after   use  of    the  plant
                protection product according to the proposed
                conditions of use;
                the maximum bioconcentration factor (BCF) is
                greater     than    1000    for    plant    protection
                products which are readily biodegradable or
                greater   than    100   for   those   which    are  not
                readily   biodegradable,       unless   it   is  cleary
                established      through     an    appropriate     risk
                assessment     that   under    field   conditions    no
                unacceptable      impact    on   the    viability    of
                exposed    species,     directly     and    indirectly
                (predators), occurs       after   use of the plant
                protection product according to the proposed
                conditions of use.
2.5.2.3 If there is a possibility of exposure for honeybees,
        no  authorization     shall    be  granted    if   the   hazard
        quotients for oral or contact exposure of honeybees
        are greater than 50 unless it is clearly established
        through   an appropriate      risk   assessment    that   under
        field conditions      there are no unacceptable effects
        on   honeybee    larvae,     honeybee    behaviour,      colony
        survival   and   development     after   use   of   the   plant
        protection     product     according     to    the     proposed
        conditions of use.
2.5.2.4 If there is a possibility of exposure of beneficial
        arthropods    other    than   honeybees    no   authorization
        shall be granted unless it is clearly              established
        through an appropriate risk assessment             that under
        field conditions there is        no unacceptable impact on
        these organisms, taking into account their ability to
        recover, after use of the plant protection product
        according to the proposed conditions of use.
 ---pagebreak---                              - 61 -
        If there is a possibility of exposure of beneficial
        arthropods other than honeybees no authorization for
        use in integrated pest management systems shall be
        granted if more than 30% of the test-organisms are
        affected    in  lethal    or  sublethal    laboratory    tests
        conducted at the maximum proposed application rate,
        unless    it    is   clearly     established     through     an
        appropriate      risk    assessment    that     under     field
        conditions there is      no unacceptable impact on these
        organisms after use of the plant protection product
        according    to the proposed      conditions    of   use.   Any
        claims   for   selectivity    and   proposals    for   use   in
        integrated     pest    management      systems     shall     be
        substantiated by appropriate data.
2.5.2.5 If there is a possibility of exposure for earthworms,
        no   authorization    shall    be  granted    if   the   acute
        toxicity/exposure ratio for earthworms is           less than
        10 and the long term toxicity/exposure ratio is less
        than 5, unless it is clearly established through an
        appropriate     risk    assessment     that     under    field
        conditions    earthworm    populations    are   not   at   risk
        after use of the plant protection product according
        to the proposed conditions of use.
2.5.2.6 If there is a possibility of exposure of soil non-
        target   micro-organisms     no   authorization      shall   be
        granted. - if the nitrogen      and   carbon   mineralisation
        processes in laboratory studies        are affected by more
        than   25%   after   100   days,   unless    it   is   clearly
        established    through an appropriate       risk   assessment
        that under field conditions there is no unacceptable
        impact on the microbial activity after use of the
        plant protection product according to the proposed
        conditions of use.
 ---pagebreak---                           - 62 -
2.6   Analytical methods
      To enable the validition of the analytical methods
      proposed for post-registration control and monitoring
      purposes,   the following criteria must be met        :
2.6.1 for formulation analysis :
      the method must be able to determine and to identify
      the active substance(s) and where appropriate, any
      toxicologically    or   ecotoxicologically      significant
      impurities and co-formulants.
2.6.2 for residue analysis :
      (i)     the  method   must  be   able   to  determine    and
              confirm    residues     of     toxicological      or
              environmental significance
      (ii)    the mean recovery rates should be between 70%
              and 110% with a relative standard deviation of
              < 20%.
      (iii)   the  repeatability    must    be   less   than   the
              following values :
      Residue level               Difference          Difference
         mg/kg                       mg/kg          in %
         0.01                     0.005                   50
         0.1                      0.025                   25
         1                        0.125                   12.5
        >1                                                12.5
      Intermediate values are determined by interpolation
      from a log-log graph.
 ---pagebreak---                    - 63 -
(iv)   the   reproducibility  must   be  less  than  the
       following values :
Résidu level               Difference        Difference
mg/kg                      mg/kg             in %
0.01                       0.01               100
0.1                        0.05                50
1                          0.25                25
>1                                             25
Intermediate values are determined by interpolation
from a log-log graph.
(V)    In the case of residue analysis       in treated
       plants,      plant    products,       foodstuffs,
       feedingstuffs or products of animal origin,
       except where the MRL or the proposed MRL is et
       the limit of determination, the sensitivity of
       methods proposed must     satisfy the   following
       criteria :
       Proposed, provisional    Limit of Determination
       or Community MRL
         mg/kg                    mg/kg
         > 5                       0.5
         5 - 0.5                   0.5 - 0*1
         0.5 - 0.05                0.1 - 0.02
         < 0.05                    MRL X 0.5
 ---pagebreak---                            - 64 -
2.7   Physical and chemical properties
2.7.1 Where   a   FAO   specification   exists  for  the   active
      substance contained in the plant protection product,
      these specifications must be met.
2.7.2 Where  no    FAO   specification   exists for  the   active
      substance contained in the plant protection product
      the physical and chemical properties must meet the
      following :
      a) Chemical properties :
      The difference between        the  stated and  the  actual
      content    of    the   active   substance  in   the   plant
      protection product must, throughout the         shelf-life
      period   not exceed the following values :
              Content(*)                          Tolerance
              < 25 g/kg or g/1                       ±15 %
              25 - 100 g/kg or g/1                   ±10 %
              100 - 250 g/kg or g/1                   ±6 %
              250 - 500 g/kg or g/1                   ±5 %
              > 500 g/kg or g/1                      ±25 g/kg or
                                                     9/1
              (*) in each range
              the upper limit is not
              included
 ---pagebreak---                            - 65 -
      b) Physical properties :
      The   plant    protection    product   must   fulfill   the
      physical    criteria     (including   storage   stability)
      specified for the relevant formulation type in the
      "Manuel   on     the    development   and   use    of   FAO
      spec!fleetions for plant protection products".
2.7.3 Where proposed label claims include recommendations
      for   use   of    the   preparation   with   other    plant
      protection products as a tank mix and/or where the
      proposed     label     includes    indications    on    the
      compatibility of the preparation        with other    plant
      protection products as a tank mix, these products
      must be physically and chemically compatible in the
      tank mix.
 ---pagebreak---  ---pagebreak---                                      éG -
                                                                      ISSN 0254-1475
                                                               COM (93) 117 final
                                                       DOCUMENTS
EN                                                                          03 05
                                 Catalogue number : CB-CO-93-154-EN-C
                                                             ISBN 92-77-54006-0
Office for Official Publications of the European Communities
Lr29S5 Luxembourg