CELEX: 51989PC0034
Language: en
Date: 1989-02-16
Title: AMENDED PROPOSAL FOR A COUNCIL DIRECTIVE CONCERNING THE PLACING OF EEC - ACCEPTED PLANT PROTECTION PRODUCTS ON THE MARKET

No C 89/22                              Official Journal of the European Communities                                  10. 4. 89
               Amended proposal for a Council Directive concerning the placing of EEC-accepted plant
                                               protection products on the market (*)
                                                         COM(89) 34 final
                        (Submitted by the Commission pursuant to Article 149(3) of the EEC Treaty
                                                       on 24 February 1989)
                                                           (89/C 89/02)
               (!) OJ No C 212, 9. 9. 1976, p. 3.
 The words 'EEC-accepted' are deleted from the title.                Whereas there must be uniform rules in the Member States
                                                                     relating to the conditions and procedure for the acceptance
                                                                     of plant protection products;
 The preamble and articles are replaced by the following:
                                                                     Whereas such rules should provide that plant protection
 THE COUNCIL OF THE EUROPEAN COMMUNITIES,
                                                                     products should not be put on the market unless they have
                                                                     been officially accepted and should be used properly having
 Having regard to the Treaty establishing the European               regard to the principles of integrated pest control;
 Economic Community, and in particular Article 43 thereof,
 Having regard to the proposal from the Commission,                  Whereas it is necessary, at the time when plant protection
                                                                     products are accepted, to make sure that, when properly
 Having regard to the opinion of the European Parliament,            applied for the purpose intended, they are sufficiently
                                                                     effective and have no unacceptable effect on plants or plant
                                                                     products, no unacceptable adverse influence on the
 Having regard to the opinion of the Economic and Social             environment in general and, in particular, no harmful effect
 Committee,                                                          on human or animal health;
Whereas plant production has a very important place in the
 Community;                                                         Whereas acceptance should be limited to plant protection
                                                                    products containing certain active substances specified at
Whereas plant production yields are continually affected            Community level on the basis of their toxicological and
by harmful organisms and weeds and whereas it is                    ecotoxicological properties;
absolutely essential to protect plants against these risks to
prevent a decline in yields and to help to ensure security of
supplies;                                                           Whereas it is therefore necessary to establish a Community
                                                                    list of permitted active substances;
Whereas one of the most important ways of protecting
plants and plant products and of increasing the produc-
tivity of agriculture is to use plant protection products;          Whereas a Community procedure must be laid down for
                                                                    assessing whether or not an active substance can be entered
                                                                    on the Community list; whereas the information that
Whereas the use of these plant protection products has              interested parties must submit with a view to admission of a
consequences other than a favourable effect on plant                substance to the list should be specified;
production; whereas their use may involve risks for man
and the environment since, in the main, they are toxic
substances or preparations with hazardous effects;
                                                                    Whereas the Community procedure should not prevent
                                                                    Member States from authorizing for use in their territory
Whereas, in view of the hazards, there are rules in most            for a limited period of time plant protection products
Member States governing the authorization of plant                  containing an active substance not yet entered on the
protection products; whereas these rules present dif-               Community list, provided that the interested party has
ferences which constitute barriers not only to trade in plant       submitted a dossier meeting Community requirements and
protection products but also to trade in plant products, and        the Member State has concluded that the active substance
thereby directly affect the establishment and operation of          and the plant protection products satisfy the Community
the common market;                                                  conditions set in regard to them;
Whereas it is therefore desirable to eliminate such barriers
by harmonizing the provisions laid down in the Member               Whereas, in the interest of safety, substances on the list
States;                                                             should be reviewed periodically;
 ---pagebreak--- 10. 4. 89                              Official Journal of the European Communities                                No C 89/23
Whereas it is in the interest of free movement of plant           products put up in commercial form, and the placing on the
products as well as of plant protection products that             market within the Community of active substances
acceptance granted by one Member State, and tests carried         intended for a use as specified in Article 2(1).
out with a view to acceptance, should be recognized by
other Member States, unless certain agricultural, plant           2. This Directive shall apply without prejudice to the
health and environmental conditions relevant to the use of        provisions of Council Directive 78/631/EEC of 26 June
the products concerned are not comparable;                        1978 on the approximation of the laws of the Member
                                                                  States relating to the classification, packaging and labelling
Whereas it is therefore desirable that a system for the           of dangerous preparations (pesticides) (*), and, where
mutual supply of information should be established and            active substances are concerned, without prejudice to the
that member States should make available to each other the        provisions concerning classification, packaging and label-
particulars and scientific documentation submitted in             ling of Council Directive 67/548/EEC of 27 June 1967 on
connection with applications for acceptance of plant              the approximation of laws, regulations and administrative
protection products;                                              provisions relating to the classification, packaging and
                                                                  labelling of dangerous substances (2).
Whereas, however, Member States must be enabled to
accept plant protection products not complying with the                                      Article 2
abovementioned conditions when it is necessary to do so
because of an unforeseeable danger threatening plant              For the purposes of this Directive the following definitions
production which cannot be contained by other means;              shall apply:
whereas such acceptance should be reviewed by the
Commission in close cooperation with the Member States
in the framework of the Standing Committee on Plant               1.   Plant protection    products
Health;
                                                                       Active substances and preparations containing one or
Whereas this Directive complements the Community                       more active substances, put up in the form in which
provisions on the classification, packaging and labelling of           they are supplied to the user, intended to:
pesticides; whereas together with the latter provisions it
considerably improves the protection of users of plant                  1.1. destroy organisms harmful to plants or plant
protection products and consumers of plants and plant                        products or to prevent the action of such
products; whereas it also contributes to the protection of                   organisms, in so far as such substances or
the environment;                                                             preparations are not otherwise defined below;
Whereas, in order to ensure that the requirements laid                  1.2. influence the life processes of plants, other than
down in respect of accepted plant protection products are                    as a nutrient;
satisfied when they are placed on the market, Member
States must make provision for appropriate inspection                   1.3. preserve plant products, in so far as such
arrangements;                                                                substances or products are not subject to special
                                                                             Council or Commission provisions on preservat-
                                                                             ives;
Whereas the procedures provided by this Directive are not
appropriate for evaluation of the risks to the environment              1.4. destroy undesirable plants; or
presented by plant protection products containing or
composed of genetically modified organisms, but whereas,                1.5. destroy parts of plants or prevent undesired
in future, specific procedures will be introduced by                         growth of plants.
amendments to this Directive for the evaluation of such
products;
                                                                  2.   Residues of plant protection       products
Whereas the implementation of this Directive and the
adaptation of its Annexes to the development of technical              One or more substances present in or on plants or
and scientific knowledge necessitate close cooperation                 plant products, or elsewhere in the environment, and
between the Commission and the Member States; whereas                  resulting from the use of a plant protection product.
the procedure of the Standing Committee on Plant Health
offers a suitable basis for this cooperation,
                                                                  3.     Substances
HAS ADOPTED THIS DIRECTIVE:                                            Chemical elements and their compounds, as they
                                                                       occur naturally or by manufacture, including any
                                                                       impurity inevitably resulting from the manufacturing
                                                                       process.
                          Article 1
1. This Directive concerns the acceptance and placing on          (!) OJ No L 206, 29. 7. 1978, p. 13.
the market within the Community of plant protection               (2) OJ No L 196, 16. 8. 1967, p. 1.
 ---pagebreak---  No C 89/24                              Official Journal of the European Communities                                   10. 4. 89
 4.   Active substances                                                                         Article 3
      Substances, micro-organisms and viruses having
                                                                    1. Member States shall prescribe that plant protection
      general or specific action:
                                                                    products may be placed on the market for use in their
      4.1. against harmful organisms, or                            territory only if they have accepted the product in
                                                                    accordance with this Directive.
      4.2. on plants, parts of plants or plant products.
                                                                    2. Member States shall not, on the grounds that a plant
                                                                    protection product is not accepted for use in their territory,
 5.    Preparations                                                 impede the storage or movement of such products intended
                                                                    for use in another Member State, provided that:
      Mixtures or solutions composed of two or more
      substances of which at least one is an active substance,
      intended for use as plant protection products.                — the product is accepted in another Member State, and
6.    Plants                                                        — the operators in question satisfy the inspection
                                                                        requirements laid down by the Member States in order
      Live plants and live parts of plants, including fresh             to ensure compliance with paragraph 1.
      fruit and seeds.
                                                                    3. Member States shall prescribe that plant protection
                                                                   products must be used properly and in accordance with any
7.   Plant products                                                 conditions laid down pursuant to this Directive. Proper
                                                                    use, hall include application of the principles of integrated
     Products in the unprocessed state or having undergone         pest control.
     only simple preparation such as milling, drying or
     pressing, derived from plants, but excluding plants
     themselves as definied in point 6.                            4. Member States shall prescribe that active substances
                                                                   may not be placed on the market unless:
8.   Harmful    organisms
                                                                   — they are classified, packaged and labelled in accordance
     Pests of plants or plant products belonging to the                 with the provisions of Directive 67/548/EEC, and
     animal or plant kingdom, and also viruses, mycoplas-
     mas and other pathogens.                                      — when the active substance was not on the market before
                                                                       the date of application of this Directive, a dossier is
                                                                       transmitted to the Member States and to the Commis-
9.     Animals                                                         sion, in accordance with Article 6, with the declaration
                                                                       that the active substance is intended for a use as
     Animals belonging to species normally fed and kept or             specified in Article 2(1).
     consumed by man.
10. Placing on the market
                                                                                               Article 4
     Any handing over, whether in return for payment or
     free of charge, other than for storage followed by            1. Member States shall provide that a plant protection
     consignment from the territory of the Community.              product may be accepted only if:
     Importation into the territory of the Community shall
     be deemed to be placing on the market for the
    purposes of this Directive.                                    (a) its active substances are listed in Annex I and any
                                                                       conditions laid down therein are fulfilled;
11.    Environment                                                 (b) it is established, in the light of current scientific and
                                                                       technical knowledge that, when properly applied for the
    Water, air and land and any inter-relationship                     purpose intended, and having regard to all foreseeable
    between them, as well as any relationship with living              conditions under which it may be used:
    organisms.
                                                                       (i) it is sufficiently effective;
12. Integrated pest control
                                                                       (ii) it has no unacceptable effect on plants or plant
    The rational application of a combination of bio-
                                                                             products;
    logical, chemical, cultural or plant breeding measures
    whereby the use of chemical plant protection products
    is limited to the necessary minimum.                               (iii) it has no harmful effect on human or animal health;
 ---pagebreak--- 10. 4. 89                               Official Journal of the European Communities                                No C 89/25
    (iv) it has no unacceptable adverse influence on the           — appear before the Committee.
         environment;
(c) the nature and quantity of its active substances and,          4. The procedure laid down in Article 18 shall be
    where appropriate, their toxic impurities can be               followed for taking a decision to include an active
    determined by methods in general use.                          substance in Annex I and for setting any conditions in
                                                                   connection therewith.
2. Member States shall ensure that compliance with the
requirements set out in paragraph 1 is established by              5. Paragraphs 1 to 4 shall also apply to the amendment of
official or officially recognized tests and analyses carried       any conditions included in Annex I in connection with an
out under agricultural, plant health and environmental             active substance.
conditions relevant to use of the plant protection product in
question and representative of those prevailing where the
product is intended to be used, within the territory of the        6. Paragraphs 3 and 4 shall apply if, after inclusion of an
Member State concerned.                                            active substance in Annex I, facts emerge that cast doubt on
                                                                   its conformity with the requirements indicated in Ar-
                                                                   ticle 5(1).
                           Article 5
1. An active substance shall be included in Annex I for an
initial period not exceeding 10 years and only if:
                                                                                               Article 7
(a) its residues in edible plant products, edible livestock
    products or the environment do not have any harmful            Member States shall prescribe that the holder of an
    effects on human or animal health or on the environ-           acceptance must notify to the competent authority all
    ment and, if constituting a potential hazard, can be           information on the harmful effects of any substance listed
    measured by methods in general use;                            in Annex I or of its residues on human or animal health or
                                                                   on unacceptable adverse effects on the environment.
(b) it may be expected, on the basis of scientific and             Member States shall notify this information to the other
    technical data, that preparations manufactured from it         Member States and to the Commission, which shall refer
    will meet the requirements of Article 4(l)(b)(iii) and         the information to the Standing Committee on Plant
    (iv).                                                          Health.
2. The inclusion of a substance in Annex I may be
renewed on one or more occasions for periods not
exceeding five years in each case.
                                                                                               Article 8
                           Article 6                               By way of derogation from Article 4, a Member State may:
1. A Member State or the Commission shall, in order to
obtain the inclusion of an active substance in Annex I,            1. in very special circumstances, authorize for a period
ensure that a dossier satisfying the requirements of Annex              not exceeding 120 days the placing on the market of
II is transmitted by the interested party of the other                  plant protection products not complying with Article 4
Member States and to the Commission.                                    if such a measure appears necessary because of an
                                                                        unforeseeable danger threatening plant production
The Commission shall refer the dossier for examination by               which cannot be contained by other means. In this case,
the Standing Committee on Plant Health.                                 the Member State concerned shall immediately inform
                                                                        the other Member States and the Commission of its
2. At the request of a Member State it may, not less than               action. It shall be decided without delay, in accordance
three months after the date of referral, be found by the                with the procedure laid down in Article 18, whether
                                                                        and, if so, under what conditions the action taken by
procedure laid down in Article 19 that the dossier satisfies
                                                                        the Member State may be continued or repeated;
the requirements of Annex II.
Such a finding shall be without prejudice to subsequent            2.   permit, for a period not exceeding three years, the
application of paragraph 3, should this be required in                  placing on the market of plat protection products
connection with assessment of the dossier.                              containing an active substance not listed in Annex I and
                                                                        not yet available on the market on the date of
3. As part of the procedure for assessing the dossier the               implementation of this Directive, provided that:
interested party may be invited by the Commission to:
— provide any further information deemed necessary for                   (a) following application of Article 6(1) and (2) it is
    the purpose of assessing whether the active substance                    found that the dossier on the active substance
    satisfies the requirements indicated in Article 5(1),                    satisfies the requirements of Annex II;
 ---pagebreak--- No C 89/26                               Official Journal of the European Communities                                  10. 4. 89
     b) the Member State establishes that the active                — the name and address of the manufacturer, if different
         substance satisfies the requirements of Article 5(1)           from the applicant,
         and that the plant protection product satisfies the
         requirements of Article 4(1) (b) and (c).
                                                                    — the designation or trade name or code number of the
                                                                        plant protection product,
     In such cases the Member State shall immediately
     inform the other Member State and the Commission of
     its assessment of the dossier and of the terms of              — the type of preparation,
     acceptance.
     If, on assessment of the dossier as provided for in            — the name and amount of each active substance
     Article 6(3), it is found that the active substance does           contained in it,
     not satisfy the requirements of Article 5(1), a decision
     may be taken by the procedure laid down in Article 18
                                                                    — the use for which it is intended and the directions for
     requiring the Member State to withdraw the accept-
                                                                        using it.
     ance;
3.   for a period of 10 years from the date of implemen-            6. Member States shall ensure that a dossier is compiled
     tation of this Directive, without prejudice to Directive       on each application. Each dossier shall contain at least a
     79/117/EEC, authorize the placing on the market in its         copy of the application, a record of the administrative
     territory of plant protection products containing active       decisions taken by the Member State concerning the
     substances not listed in Annex I that were already on          application and the particulars and technical documen-
     the market before that date.                                   tation laid down in Article 12(1), together with a summary
                                                                    of the latter. Member States shall on request make available
     The Commission shall draw up a programme of work               to the other Member States and to the Commission the
     for the gradual examination of these active substances         dossiers provided for in this paragraph; they shall supply to
     during that period. In implementing this programme             them on request all information necessary for full
     the Commission may require interested parties to               comprehension of applications.
     submit all requisite data to the Commission and the
     Member States within a prescribed period.
     During this period it may, following examination by                                      Article 10
     the Standing Committee on Plant Health of such an
     active substance, be decided, by the procedure laid
     down in Article 18, that the substance can be included         1. At the request of the applicant, a Member State to
     in Annex I or that the Member State must withdraw the          which an application is made for the acceptance of a plant
     authorization referred to above within a prescribed           protection product already accepted in another Member
     period.                                                       State must:
                                                                   — unless certain agricultural, plant health or environ-
                            Article 9                                   mental conditions relevant to the use of the product are
                                                                        not comparable in the regions concerned, refrain from
1. Application for acceptance of a plant protection                     requiring the repetition of tests and analyses already
product may be made by the manufacturer, the importer or                carried out in connection with the acceptance of the
the distributor, if the plant protection product is to be               product in that Member State, and
placed on the market in the first instance by a distributor.
2. Every applicant shall be required to have a permanent           — unless certain agricultural, plant health or environ-
office within the Community.                                            mental conditions relevant to the use of the product are
                                                                        not comparable in the regions concerned, authorize
                                                                        placing on the market in its territory.
3. Member States may require that applications for
acceptance be submitted in their national or official
languages or one of those languages.                               2. Member States shall inform the Commission of cases
                                                                   where they have required repetition of a test and of cases
4. Each Member State shall agree to consider any                   where they have refused to accept a plant protection
application for acceptance made to it and shall decide             product already accepted in another Member State, in
thereon within a reasonable period.                                respect of which the applicant had claimed that the
                                                                   agricultural, plant health and environmental conditions
5. Within 45 days of the receipt of an application the             relevant to use of the product in the regions concerned in
Member State concerned shall inform the other Member               the Member State where the test was carried out or for
States and the Commission thereof and shall at the same            which acceptance was granted were comparable to those in
time provide the following particulars of the application:         their own territory. They shall notify the Commission of
                                                                   the ground on which repetition of the test was required or
— the name and address of the applicant,                           acceptance was refused.
 ---pagebreak--- 10. 4. 89                               Official Journal of the European Communities                               No C 89/27
3. In accordance with the procedure laid down in Article           residue studies submitted with a view to the inclusion of the
18, it may be decided that a Member State which has                active substance in Annex I by a person other than the
refused to recognize comparability should accept the tests         applicant for acceptance, unless:
and analyses or should authorize the placing on the market
of the product in the regions concerned in its territory.
                                                                   — either the applicant has agreed with the other person
                                                                       that recourse may be had to these data,
                          Article 11
                                                                   — or the application for acceptance is made at least 15
                                                                       years after the first acceptance in a Member State of a
1. Member States shall inform the other Member States
                                                                       plant protection product containing the active subst-
and the Commission immediately in writing of each plant
                                                                       ance in question.
protection product accepted in accordance with this
Directive, indicating the conditions and the period of
validity of such acceptance and attaching a copy of the label      3. Member States shall inform the Commission if, on
under which the plant protection product is to be placed on        examination of an application for acceptance, they
the market. They shall also inform the other Member States         consider as being listed in Annex I active substances which
and the Commission immediately of any subsequent                   have been produced by a person or manufacturing process
revocation or non-renewal of the acceptance or alteration          other than those specified in the dossier on the basis of
of the conditions of an acceptance.                                which the active substance was first included in Annex I.
                                                                   They shall transmit to it all data regarding the identity and
2. Each Member State shall draw up an annual list of the           impurities of the active substance.
plant protection products accepted in its territory and shall
communicate that list to the other member States and the
Commission.
                                                                                              Article 13
3. By means of the procedure laid down in Article 19 a
standardized information system shall be set up to facilitate      Member States and the Commission shall ensure that
the application of paragraphs 1 and 2 and also of                  information involving industrial and commercial secrets is,
Article 9(5).                                                      if the party wishing to have an active substance included in
                                                                   Annex I or the applicant for acceptance of a plant
4. Acceptance shall be cancelled or modified if it is              protection product so requests, treated as confidential.
established that:
                                                                   Industrial and commercial secrecy shall not apply t o :
(a) the requirements for acceptance are not or are no longer
    satisfied;
                                                                   — the names and composition of the active substance or
(b) false or misleading particulars were supplied concerning           plant protection product,
    the facts on the basis of which authorization was
    granted.                                                       — physico-chemical data concerning the active substance
                                                                       or plant protection product,
                          Article 12                               — any ways of rendering the active substance or plant
                                                                       protection product harmless,
1. Member States shall require that applicants for
acceptance of a plant protection product submit with their
application:                                                       — the interpretation of the results of the tests to establish
                                                                       efficacy and harmlessness to animals, plants and the
                                                                       environment, and the name of the body responsible for
(a) a dossier satisfying the requirements set out in
                                                                       the tests,
    Annex III; and
(b) for each active substance in the product other than those      — recommended methods and precautions to reduce
    referred to in the first subparagraph of Article 8(3), a           handling, storage, transport, fire or other hazards,
    dossier satisfying the requirements set out in Annex II.
                                                                   — decontamination procedures to be followed in the case
2. By way of derogation from paragraph 1, applicants                    of accidental spillage or leakage,
may, if the active substance is already listed in Annex I and
does not differ substantially in degree of purity and nature
of impurities, be exempted from supplying the information          — first aid and medical treatment to be given in the case of
required under paragraph 1(b), except for that identifying              injury to persons.
the active substance.
                                                                   If the interested party or applicant himself subsequently
Such exemption may not, however, be granted in respect of          discloses previously confidential information, he shall be
data from toxicological, metabolic, ecotoxicological and           required to inform the competent authority accordingly.
 ---pagebreak--- No C 89/28                               Official Journal of the European Communities                                  10. 4. 89
                           Article 14                                    (h) safety precautions in the form of standard phrases
                                                                              selected appropriately from those listed in
                                                                              Annex V;
Article 5(1) of Directive 78/631/EEC shall apply to all plant
protection products within the meaning of this Directive.
                                                                        (i) the type of action of the plant protection product
                                                                              (e.g. insecticide, growth regulator, weedkiller,
                                                                              etc.);
                           Article 15
                                                                        (j) the type of preparation (e.g. wettable powder,
Member States shall take the necessary measures to ensure                     emulsifiable concentrate, etc.);
that the packaging of plant protection products satisfies the
following requirements as to labelling:                                 (k) the uses for which the plant protection product has
                                                                             been accepted;
1. All packages must show clearly and indelibly the
     following:                                                         (1) directions for use and the dose rate, expressed in
                                                                             metric units, for each use provided for under the
     (a) the trade name or designation of the plant                          terms of the acceptance;
         protection product;
                                                                        (m) where necessary, the safety interval for each use
     (b) the name and address of the holder of the                           between application and:
         acceptance and the registration number of the plant
         protection product and, if different, the name and                  — sowing or planting of the crop to be protected,
         address of the person placing the plant protection
         product on the market;
                                                                             — sowing or planting of succeeding crops,
     (c) the name and amount of each active substance
                                                                             — harvesting,
         expressed:
                                                                             — use or consumption;
         — for plant protection products which are solids,
             aerosols, volatile liquids (maximum boiling
             point 50° C) or viscous liquids (lower limit 1 Pa          (n) particulars of possible phytotoxicity, varietal
             at 20° C): as a percentage by weight,                           susceptibility, tainting of produce and any other
                                                                             adverse side effects, together with the intervals to
                                                                             be observed between application and sowing or
         — for other liquids: as a percentage by weight and                  planting of:
             in grams per litre at 20° C,
                                                                             — the crop in question, or
         — for gases: as a percentage by volume.
                                                                             — subsequent crops;
         The name must be as given in the list contained in
         Annex I to Directive 67/548/EEC or, if not included
         therein, its ISO common name. If the latter is not             (o) if accompanied by a leaflet, as provided for in
         available, the active substance shall be designated                 paragraph 2, the sentence 'Read accompanying
         by its chemical designation according to IUPAC or                   instructions before use'.
         the nomenclature published by the journal 'Chemi-
         cal Abstracts';                                           2.  Member States may permit the requirements in
                                                                       paragraph 1(1) and (n) to be indicated on a separate
                                                                       leaflet accompanying the package if the space available
    (d) the net quantity of the plant protection product
                                                                       on the package is too small. Such a leaflet shall be
         given in legal units of measurement;
                                                                       regarded as part of the label for the purposes of this
                                                                       Directive.
    (e) the batch number;
                                                                   3.  Member States shall stipulate that the labels of
    (f) the indications required under Article 6 of Directive          accepted plant protection products which are not
         78/631/EEC, in particular those mentioned in                  intended for domestic use shall also bear the statement
         paragraphs 2(d), (g), (h) and (i), 3 and 4 of that            'unsuitable for domestic use'.
         Article;
                                                                   4.  In no case may the label of the packaging of a plant
    (g) the nature of any special risks by means of standard           protection product bear the indications 'non-toxic',
         phrases selected appropriately from those listed in           'harmless' or similar indications. However, the leaflet
         Annex IV;                                                     mentioned in paragraph 2 may state that it is harmless
 ---pagebreak--- 10. 4. 89                                 Official Journal of the European Communities                                No C 89/29
     to bees or to any other specified organisms provided            The Commission shall adopt the measures envisaged if they
     that such indications refer to normal use.                      are in accordance with the opinion of the Committee.
5.   Member States may make the placing of plant                     If the measures envisaged are not in accordance with the
     protection products on the market in their territories          opinion of the Committee, or if no opinion is delivered, the
     subject to the use of the national language or languages        Commission shall, without delay, submit to the Council a
     in the labelling thereof.                                       proposal relating to the measures to be taken. The Council
                                                                     shall act by a qualified majority.
                                                                     If, on the expiry of a period of three months from the date
                           Article 16
                                                                     of referral to the Council, the Council has not acted, the
                                                                     proposed measures shall be adopted by the Commission.
Member States shall make suitable arrangements for plant
protection products which have been placed on the market
to be officially checked by sampling to see whether they
comply with the requirements of this Directive.                                                Article 19
                                                                     Where the procedure laid down in this Article is to be
                                                                     followed, matters shall be referred by the chairman, either
                           Article 17                                on his own initiative or at the request of a Member State, to
                                                                     the Standing Committee on Plant Health set up under
1. The following shall be established, having regard to              Decision 76/894/EEC, hereinafter referred to as 'the
current scientific and technical knowledge, in accordance            Committee'.
with the procedure laid down in Article 18:
                                                                     The representative of the Commission shall submit to the
— any standards for the composition, purity and charac-              Committee a draft of the measures to be taken. The
    teristics of active substances listed in Annex I found to        Committee shall deliver its opinion on the draft, within a
    be necessary,                                                    time limit which the chairman may lay down according to
                                                                     the urgency of the matter, if necessary by taking a vote.
— any necessary amendments to Annex I,
                                                                     The opinion shall be recorded in the minutes; in addition,
— uniform principles for checking compliance with the                each Member State shall have the right to ask to have its
    requirements set out in Article 4(l)(b).                         position recorded in the minutes.
                                                                     The Commission shall take the utmost account of the
2. The following shall be established, having regard to
                                                                     opinion delivered by the Committee. It shall inform the
current scientific and technical knowledge, in accordance
                                                                     Committee of the manner in which its opinion has been
with the procedure laid down in Article 19:
                                                                     taken into account.
— any necessary amendments to Annexes II, III, IV and V,
                                                                                               Article 20
— explanatory notes covering the particulars set out in
    Annexes II and III.
                                                                     1.   Without prejudice to the provisions of paragraphs 2
                                                                     and  3, plant protection products may be used in research
                                                                     and   development work only under controlled conditions
                           Article 18                                and   in limited quantities.
Where the procedure laid down in this Article is to be               2. Member States shall require any person intending to
followed, matters shall be referred without delay by the             conduct in their territory any research, experiment or test
chairman, either on his own initiative or at the request of a        involving the release into the environment of a plant
Member State, to the Standing Committee on Plant Health              protection product containing as an active substance a
set up by Council Decision 76/894/EEC, hereinafter                   living micro-organism or virus to notify their competent
referred to as 'the Committee'.                                      authorities at least 45 days before the start of the proposed
                                                                     research, experiment or test. Those authorities shall be
The representative of the Commission shall submit to the             given with the notification any information necessary to
Committee a draft of the measures to be taken. The                   enable them to evaluate the safety of the proposed research,
Committee shall deliver its opinion on the draft within a            experiment or test. This provision shall not apply to
time limit which the chairman may lay down according to              genetically modified organisms covered by Directive ... on
the urgency of the matter. The opinion shall be delivered by         the deliberate release to the environment of genetically
the majority laid down in Article 148 (2) of the Treaty. The         modified organisms.
votes of the representatives of the Member States within the
Committee shall be weighted in the manner set out in that            If the proposed research, experiment or test is liable to have
Article. The chairman shall not vote.                                harmful effects on human or animal health or have an
 ---pagebreak--- No C 89/30                                      Official Journal of the European Communities                                               10. 4. 89
unacceptable adverse influence on the environment, the                                                           Article 21
Member State concerned may either prohibit it or permit it
subject to such conditions as it considers necessary to                            Member States shall bring into force the laws, regulations
prevent those consequences.                                                        and administrative provisions necessary to comply with
                                                                                   this Directive within two years of the date on which it is
                                                                                   adopted. They shall immediately inform the Commission
                                                                                   thereof. The provisions referred to in the third indent of
3. Common conditions for the application of this Article,                          Article 17(1) shall be adopted within the same period.
in particular the maximum quantities of pesticides that
may be released in experimental work as mentioned in
                                                                                                                 Article 22
paragraph 1, shall be adopted with the procedure laid
down in Article 18.                                                                This Directive is addressed to the Member States.
                                                                         ANNEX I
                     ACTIVE SUBSTANCES AUTHORIZED FOR INCORPORATION IN PLANT PROTECTION
                                                                        PRODUCTS
              To be established according to the procedure of Article 6(4) and of the third indent of point 3 of Article 8.
                                                                         ANNEX 11
                    REQUIREMENTS FOR THE DOSSIER TO BE INTRODUCED FOR THE INCLUSION OF AN
                                                        ACTIVE SUBSTANCE IN ANNEX I
                                                                   INTRODUCTION
             The information required shall include:
             — a technical dossier supplying the information necessary for evaluating the foreseeable risks, whether
                   immediate or delayed, which the substance may entail for man and the environment and containing at least
                  the information and results of the studies referred to here below, together with a detailed and full description
                  of the studies conducted and of the methods used or a bibliographical reference to them,
             — the proposed classification and labelling of the substance in accordance with Directive 67/548/EEC of the
                  Council of 27 June 1967 on the approximation of the laws, regulations and administrative provisions
                  relating to the classification, packaging and labelling of dangerous substances and its amendments.
             If it is not technically possible or if it does not appear necessary to give an information, the reasons should be
             stated.
             Tests must be conducted according to the methods described in Annex V to Directive 79/831/EEC (1) or in the
             event of a method being inappropriate or not described, other methods used must be justified. Tests must be
             conducted in accordance with the provisions provided for in Directive 86/609/EEC (2).
                  Council Directive amending for the sixth time Directive 67/548/EEC on the approximation of the laws, regulations and
                  administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ No L 259,
                  15. 10. 1979, p. 10), as completed in Commission Directives 84/449/EEC (OJ No L 251,19. 9. 1984, p. 1) and 87/302/EEC
                  (OJ No L 133, 30. 5. 1988, p. 1).
                  Council Directive on the approximation of laws, regulations and administrative provisions of the Member States regarding
                  the protection of animals used for experimental and other scientific purposes (OJ No L 358, 18. 12. 1986, p. 1).
 ---pagebreak--- 10. 4. 89                                Official Journal of the European Communities                                     No C 89/31
                                                                  Part A
                                                           Chemical substances
          1.          IDENTITY OF THE ACTIVE SUBSTANCE
          1.1.        Common name proposed or accepted by ISO and synonyms.
          1.2.        Chemical name (IUPAC nomenclature).
          1.3.        Applicant (name, address, etc.).
          1.4.        Manufacturer (name, address, etc.).
          1.5.        Manufacturer's development code number(s).
          1.6.        CAS and EEC numbers (if available).
          1.7.        Empirical and structural formula and molecular weight.
          1.8.        Manufacture of the active substance.
          1.9.        Minimum and maximum pure active substance content in % w/w.
          1.10.       Identity and amount of isomers, impurities and other by- products, together with information on the
                      possible range expressed as % w/w.
          2.          PHYSICO-CHEMICAL PROPERTIES OF THE ACTIVE SUBSTANCE
          2.1.        Melting point, boiling point, specific gravity, refractive index.
          2.2.        Vapour pressure in mm Hg at 20°C, volatility.
          2.3. (*)    Appearance (physical state, colour and odour).
          2.4. (*)    Absorption spectra — ultra-violet, visible and infra-red.
                J
          2.5. ( )    Solubility in water and organic solvents at 20°C.
          2.6. (*)    Fat solubility.
          2.7.        Partition coefficient — N-octanol/water.
          2.8.        Stability in water, hydrolysis rate, identity of breakdown product(s).
          2.9.        Stability in air, photolysis rate, identity of breakdown product(s).
          2.10.       Stability in organic solvents used in preparations.
          2.11.       Stability in acidic and alkaline environments.
          2.12.       Thermal degradation including identity of breakdown products.
          2.13.       Molar extinction at relevant wavelengths.
          2.14.       Flammability including auto-flammability.
          2.15.       Flash point.
          2.16.       Surface tension.
          2.17.       Explosive properties.
          2.18.       Oxidizing properties.
          2.19.       Reactivity towards container materials.
          2.20.       Storage.
          3.          FURTHER INFORMATION ON THE ACTIVE SUBSTANCE
          3.1.        Types of uses envisaged, e.g. field, glasshouse, food or feed storage, etc.
          3.2.        Function, e.g. fungicide, herbicide, insecticide, etc.
          3.3.        Effects on pests, e.g. contact, inhalation poison, stomach poison, fungitoxic or fungistatic etc.,
                      systemic or not in plants.
          3.4.        Pests controlled and crops or products protected or treated.
          3.5.        Mode of action.
          3.6.        Information on the occurrence or possible occurrence of the development of resistance.
          3.7.        Rate of application.
          3.8.        Number and timing of application and duration of protection.
          3.9.        Methods of application (e.g. high or low volume spraying etc.).
          (!) This data must be supplied for both active substance and pure active substance.
 ---pagebreak--- No C 89/32                           Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                  10. 4. 89
           3.10.   Phototoxicity: necessary waiting periods to avoid phytotoxic effects in the case of soil fumigants and
                   persistent herbicides or other plant protection products.
           3.11.   Recommended methods and precautions concerning: handling, storage, transport or fire.
           3.12.   In case of fire, nature of reaction product, e.g. combustion gases, etc.
           3.13.   Emergency measures in the case of an accident.
           3.14.   Possibility of rendering the active substance harmless.
           3.14.1. Possibility of recovery.
           3.14.2. Possibility of neutralization.
           3.14.3. Controlled discharge.
           3.14.4. Incineration.
           3.14.5. Water purification.
           3.14.6. Others.
           4.      ANALYTICAL METHODS
           4.1.    Analytical methods for the active substance which must include methods for the determination of
                   inactive isomers and impurities.
           4.2.    Analytical methods including recovery and the lower limits of determination for residues in the
                   following:
           4.2.1.  Foodstuffs, feedingstuffs.
           4.2.2.  Soil.
           4.2.3.  Concentrations in water and air.
           5.      TOXICOLOGICAL AND METABOLISM STUDIES
           5.1.    Acute toxicity in mammals
           5.1.1.  Oral single dose toxicity LD 5 0 — rat and at least one other mammalian species.
           5.1.2.  Percutaneous — at least rat.
           5.1.3.  Inhalation — at least rat.
           5.1.4.  Intraperitoneal — at least rat.
           5.1.5.  Other peritoneal routes.
           5.1.6.  Skin and eye irritation — rabbit.
          5.1.7.   Skin sensitization.
          5.2.     Short term toxicity
          5.2.1.   Oral administration — two species, one rodent and one non-rodent (one-tenth of life span, i.e.
                   90 days for rat).
          5.2.2.   Other routes.
          5.3.     Chronic toxicity
          5.3.1.   Long term toxicity and/or carcinogenicity (at least rat) including an estimation of a No effect leval
                   (NOEL) thereby enabling the estimation of an Acceptable daily intake (ADI).
          5.4.     Supplementary toxicological studies
          5.4.1.   Mutagenicity studies covering appropriate genetic endpoints (at least two short term tests including
                   at least one bacterial and one non-bacterial test system).
          5.4.2.   Reproduction studies — three generation test (preferably in rats).
          5.4.3.   Teratogenicity studies — at least in two rodent species, one being the rabbit.
          5.4.4.   Neurotoxicity studies — adult hens.
          5.4.5.   Metabolic studies — animals and plants.
          5.4.6.   Toxic effects of metabolites from treated plants in cases where different from animal metabolites.
 ---pagebreak--- 10. 4. 89                           Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                    No C 89/33
          5.5.    Medical data
          5.5.1.  Medical surveillance on manufacturing plant personnel.
          5.5.2.  Direct observation, e.g. clinical cases.
          5.5.3.  Health records, both from industry and agriculture.
          5.5.4.  Fatal/suicidal etc. poisoning cases.
          5.5.5.  Observations on exposure of the general population.
          5.5.6.  Diagnosis of poisoning, specific signs of poisoning, clinical tests.
          5.5.7.  Sensitization/allergenicity.
          5.5.8.  Proposed treatment: first aid measures, antidotes, medical treatment.
          5.5.9.  Prognosis.
          6.      RESIDUES IN OR O N TREATED PRODUCTS
          6.1.    Behaviour of the residue of the pure active substance and its metabolites from the time of application
                  until harvest — distribution in the plant, kinetics of disappearance, binding to the plant constituents,
                  etc.
          6.2.    Overall material balance for the applied active substance.
          6.3.    Sufficient residue data from supervised trials to demonstrate that residues likely to arise from the
                  envisaged treatments would not be of concern for human and animal health.
          6.4.    Residue monitoring data for products in the distribution chain.
          6.5.    Effects of industrial processing and/or household cooking on residues.
          6.6.    Taint, odour or taste due to residues on or in fresh or processed products.
          7.      ECOTOXICOLOGICAL STUDIES
          7.1.    Effects on organisms
          7.1.1.  Oral single dose toxicity LD 5 0 for at least two bird species.
          7.1.2.  Acute LC 50 , 96-hour exposure for one fish species, e.g. rainbow trout, zebra fish, guppi.
          7.1.3.  Subacute toxicity for fish (at least 14 days).
          7.1.4.  Acute LC 50 , 48-hour exposure for one suitable fish-food species, e.g. Daphnia.
          7.1.5.  Subacute toxicity for Daphnia (at least 14 days).
          7.1.6.  Bio-accumulation.
          7.1.7.  Algal test — Acute LD 5 0 — nine hours exposure Scenedosmus species.
          7.1.8.  Effects to beneficial arthropods (honey bees and other beneficial arthropods, e.g. predators and
                  parasites).
          7.1.9.  Effect on soil non-target macro-organisms, e.g. earthworms — laboratory and field tests.
          7.1.10. Effect on other non-target macro-organisms.
          7.1.11. Effect on soil non-target micro-organisms (e.g. soil respiration, nitrification, nitrogen fixation and
                  degradation of organic matter).
          7.1.12. Leaf litter breakdown.
          7.2.    Fate in the environment
          7.2.1.  Degradation in soil — at least three natural soil types.
          7.2.2.  Absorption and desorption in soil — at least three natural soil types.
          7.2.3.  Persistence in soil — at least three natural soil types.
          7.2.4.  Mobility in soil — at least three natural soil types.
          7.2.5.  Degradation in the aquatic environment.
          7.2.6.  Laboratory tests on biodegradation, hydrolysis and photolysis.
          7.2.7.  Field testing for degradation.
 ---pagebreak--- No C 89/34                               Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                    10. 4. 89
                                                                          PartB
                             Micro-organisms and viruses (not genetically modified in the sense of Directive ...) (J)
            1.         IDENTITY OF THE ORGANISM
            1.1.       Systematic name and strain for bacteria, protozoa and fungi, whether a mutant strain; for viruses the
                       taxonomic designation of the agent, serotype, strain or mutant.
            1.2.       Common name or alternative and superseded names.
            1.3.       Applicant (name, address, etc.).
            1.4.       Manufacturer (name, address, etc.).
            1.5.       The appropriate test procedures and criteria used for identification (e.g. morphology, biochemistry,
                       serology).
            1.6.       Composition — microbiological purity, nature and identity of any impurities and content of
                       extraneous organisms.
           2.         BIOLOGICAL PROPERTIES OF THE ORGANISM
           2.1.       Target host (species of pest). Pathogenicity or antagonism to host, infective dose, transmissibility
                      and information on mode of action.
           2.2.       History of the organism and its uses. Natural occurrence and geographical distribution.
           2.3.       Host specificity range and effects on species other than the target pest including species most closely
                      related to the target species — to include infectivity, pathogenicity and transmissibility.
           2.4.       Infectivity and physical stability in use by the proposed application method. Effect of temperature,
                      exposure to air radiation etc. Persistence under the likely environmental conditions of use.
           2.5.       Whether the organism is closely related to a crop pathogen or to a pathogen of a non-target
                      vertebrate species.
           2.6.       Laboratory evidence of genetic stability (i.e. mutation rate) under environmental conditions of
                      proposed use.
           2.7.       Presence, absence or production of toxins as well as their nature and identity.
           3.         FURTHER INFORMATION ON THE ORGANISM
           3.1.       Method of production with descriptions of the techniques used to ensure a uniform product and of
                      assay methods for its standardization. In the case of a mutant, detailed information should be
                      provided on its production and isolation, together with all known differences between the mutant
                      and the parent wild strains.
           3.2.       Methods for establishing the identity and purity of seed stock from which batches are produced, and
                      results obtained including information on variability.
           3.3.       Methods used to show microbiological purity of the final product and showing that contaminants
                     have been controlled to an acceptable level, results obtained and information on variability.
          3.4.       Methods to show the organism being free from any human and mammalian pathogen.
          3.5.       Methods to prevent loss of virulence of seed stock.
          3.6.       Methods for determining storage stability and shelf-life stability (if appropriate) after reconstitution
                     of the active agent, and results obtained.
          3.7.       Field of use: agriculture / horticulture (including food storage) and forestry.
          3.8.       Pests controlled.
          3.9.       Crop protected.
          (l) Council Directive (proposed) on the deliberate release to the environment of genetically modified organisms [Doc.
               COM(88) 160].
 ---pagebreak--- 10. 4. 89                            Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                     No C 89/35
          3.10.    Application rate.
          3.11.    Number and timing of applications.
          3.12.    Method of application (e.g. high or low volume spraying, release of infected host, etc.).
          3.13.    Compatibility or incompatibility with other products likely to be used on the crop or to be
                   recommended for such use, e.g. chemical plant protection products which have been shown to be
                   mutagens in bacterial or viral systems must not be mixed with these biological preparations.
          3.14.    Phytopathogenicity.
          3.15.    Phytotoxicity.
          3.16.    Recommended methods and precautions concerning handling, storage, transport or fire.
          3.17.    Possibility of rendering the substance harmless.
          4.       TOXICOLOGICAL AND INFECTIVITY STUDIES
          4.1.     Bacteria, fungi, protozoa and neoplectana
          4.1.1.   Acute toxicity and infectivity
          4.1.1.1. Oral single dose — at least mouse and rat.
          4.1.1.2. In the case where a single dose LD 5 0 determination is not appropriate to assess pathogenicity, a set of
                   range-finding tests must be carried out to reveal highly toxic agents and infectivity.
          4.1.1.3. Subcutaneous single dose — at least mouse and guinea pig.
          4.1.1.4. Inhalation single dose — at least rat and guinea pig.
          4.1.1.5. Intraperitoneal single dose — at least mouse and guinea pig.
          4.1.1.6. Eye irritation test — rabbit.
          4.1.2.   Short term toxicity
          4.1.2.1. Oral administration — rat.
          4.1.2.2. Inhalation — guinea pig.
          4.1.3.   Special toxicological   studies
                   Where the use of any product is likely to result in residues in food and/or where the results of acute
                   and short-term tests so indicate, the following further tests are required:
          4.1.3.1. Long-term toxicity.
          4.1.3.2. Neurotoxicity.
          4.1.3.3. Reproduction (three generations).
          4.1.3.4. Animal excretion and metabolism.
          4.1.4.   Further toxicological    studies
                   For an organism which produces a toxin, the following is required:
          4.1.4.1. Chemical structure and stability of toxin.
          4.1.4.2. Toxicity — brine shrimp larvae.
          4.1.4.3. Mutagenicity — prokaryotic and/or eukaryotic micro-organisms.
          4.1.4.4. Potential tumourigenicity — a test based on in vitro cell transformation.
          4.1.4.5. Teratogenicity.
          4.1.4.6. Carcinogenicity.
          4.1.4.7. Allergenicity.
          4.1.4.8. Infectivity under immunosuppression.
          4.2.     Viruses
          4.2.1.   Acute toxicity and infectivity
                   Data as outlined under 4.1.1 and cell culture studies using purified infective virus and primary cell
                   cultures of mammalian, avian and fish cells.
 ---pagebreak--- No C 89/36                             Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                 10. 4. 89
           4.2.2.   Short term toxicity
                    Data as outlined under 4.1.2 and tests for infectivity carried out by insect bioassay or on a suitable
                    cell culture at least seven days after the last administration to the animals.
           4.2.3.   Special toxicological    studies
                    Where the use of any product is likely to result in residues in food and/or where the results of acute
                    and short-term tests so indicate, the tests outlined under 4.1.3 are required.
           4.2.4.   Further toxicological    studies
                    Depending on the results of acute and subacute toxicity and infectivity studies, the following may be
                    required:
           4.2.4.1.  Mutagenicity.
           4.2.4.2.  Tumourigenicity.
           4.2.4.3.  Teratogenicity.
           4.2.4.4.  Carcinogenicity.
           4.3.     Medical data
           4.3.1.   Medical surveillance on manufacturing plant personnel.
           4.3.2.   Direct observation, e.g. clinical cases.
           4.3.3.   Health records, both from industry and agriculture.
           4.3.4.   Observations on exposure of the general population.
           4.3.5.   Diagnosis of poisoning, specific signs of poisoning, clinical tests.
           4.3.6.    Sensitization/allerogenicity.
           4.3.7.   Proposed treatment: first aid measures, antidotes, medical treatment.
           4.3.8.   Prognosis.
           5.       RESIDUES IN FOOD AND FEED
           5.1.     Identification of viable and non-viable (e.g. toxins) residues in treated crops, the viable residue by
                    culture or bio-assay and the non-viable by appropriate techniques.
           5.2.     Likelihood of multiplication of the active agent in or on crops or food together with a report on any
                    effect on food quality.
           5.3.     Extent of indirect contamination of adjacent non-target crops, wild plants, soil and water.
           5.4.     In cases where residues of toxins remain on an edible crop, data as outlined under item 6 of Annex II,
                    Part A, will be required.
           6.       ECOTOXICOLOGICAL STUDIES
           6.1.     Effects on organisms and fate in the environment including infectivity
           6.1.1.   Important parasites and predators of target species.
           6.1.2.   Honey bees: acute toxicity and infectivity.
           6.1.3.   Earthworms.
           6.1.4.   Other non-target organisms believed to be at risk.
           6.1.5.   Fish — at least one indigenous species.
           6.1.6.   Birds — acute toxicity on at least two species.
           6.1.7.   Effects on livestock including immunological response.
           6.1.8.   Spread in air, soil and water.
           6.1.9.   Persistence in air, soil and water.
           6.1.10.  Possible fate in food chains.
           6.1.11.  Effects on flora and fauna.
 ---pagebreak--- 10. 4. 89                                    Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                      No C 89/37
                                                                      ANNEX III
               REQUIREMENTS FOR THE DOSSIER T O BE INTRODUCED FOR THE ACCEPTANCE OF A
                                                       PLANT PROTECTION PRODUCT
                                                                  INTRODUCTION
          The information required shall include:
          — a technical dossier supplying the information necessary for evaluating the efficacity and the foreseeable
                risks, whether immediate or delayed, which the preparation may entail for man and the environment and
                containing at least the information and results of the studies referred to here below, together with a detailed
                and full description of the studies conducted and of the methods used on a bibliographical reference to them,
          — the proposed classification and labelling of the preparation in accordance with the relevent Community
                Directives.
          If it is not technically possible or if it does not appear necessary to give information, the reasons should be stated.
          Tests must be conducted according to the methods described in the Annex to Directive 79/831/EEC (*) or in the
          event of a method being inappropriate or not described, other methods used must be justified. Tests must be
          conducted in accordance with the provisions provided in Directive 86/609/EEC (2).
                                                                        Part A
                                                               Chemical preparations
          1.             IDENTITY OF THE PREPARATION
          1.1.           Trade name or proposed trade name.
          1.2.           Applicant (name and address, etc.).
          1.3.           Manufacturer (name and address, etc., including location of plant).
          1.4.           Use category (herbicide, insecticide, etc.).
          1.5.           Detailed quantitative/qualitative information on the composition of the preparation [active
                         substance(s), impurities, adjuvants, inert components, etc.].
          1.6.           Physical state and nature of the preparation (emulsifiable concentrate, wettable powder, solution,
                         etc.).
          2.             PHYSICO-CHEMICAL AND TECHNICAL PROPERTIES OF THE PREPARATION
          2.1.           Appearance (physical state, colour and odour).
          2.2.           Explosivity and oxidizing properties.
          2.3.           Flash point and other indications of flammability or spontaneous ignition.
          2.4.            Acidity/alkalinity.
          2.5.           Surface tension.
          2.6.           Specific gravity.
          2.7.            Storage stability — stability and shelf-life. Effects of light, temperature, humidity, etc.
          2.8.            Vapour pressure in mm Hg at 20°C, volatility.
          2.9.            Technical characters of the preparation
          2.9.1.          Wettability.
          2.9.2.          Persistent foam.
          2.9.3.          Suspensibility.
          2.9.4.          Wet sieve test.
           (!) Council Directive amending for the sixth time Directive 67/548/EEC on the approximation of the laws, regulations and
                administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ No L 259,
                 15. 10. 1979, p. 10), as completed in Commission Directives 84/449/EEC (OJ No L 251,19. 9. 1984, p. 1) and 87/302/EEC
                (OJ No L 133, 30. 5. 1988, p. 1).
            2
           ( ) Council Directive on the approximation of laws, regulations and administrative provisions of the Member States regarding
                the protection of animals used for experimental and other scientific purposes (OJ No L 358, 18. 12. 1986, p. 1).
 ---pagebreak--- No C 89/38                            Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                    10. 4. 89
            2.9.5.  Dry sieve test.
           2.9.6.   Size range of granules or particles and content of fines.
           2.9.7.   Emulsion stability.
           2.9.8.   Corrosiveness.
           2.9.9.   Compatibility with other plant protection products with which its use is recommended.
           2.9.10.  Compatibility with proposed packaging materials.
           2.9.11.  Wetting and adherence to crops and products.
           3.       ANALYTICAL METHODS
           3.1.     Analytical methods for determining the composition of the preparation.
           4.       FURTHER TECHNICAL INFORMATION O N THE PREPARATION
           4.1.     Details of intended use, e.g. types of pests controlled and/or plants or plant products to be protected.
           4.2.     Application rate.
           4.3.     Concentration of active substance in material used (e.g. % concentration in the diluted spray).
           4.4.     Method of application [low volume (LV), ultra low volume (ULV) etc.].
           4.5.     Number and timing of application.
           4.6.     Specific phytotoxicity: necessary waiting periods to avoid phytotoxic effects arising from soil —
                   fumigants, herbicides, etc.
           4.7.     Packaging.
           4.8.    Destruction or decontamination of the preparation and packaging.
           4.9.    Model of the label and, if need be, of the separate leaflet accompanying the package.
           5.      EFFICACY DATA
           5.1.    Laboratory experiments — effect on the target organism.
           5.2.    Field experiments — results under practical conditions of use — reliability, duration and consistency
                   of protection or other intended effect(s) appropriate to the desired crop protection objective at the
                   various development stages of the pest and/or of the crop, crop product, etc.
           5.3.    Effects on the quantity or quality of treated plants or plant products.
           5.4.    Safety considerations, to target plants (including different cultivars), or to target plant products.
           5.5.    Comparison with reference products or normally accepted practice.
           5.6.    Possible advantages of the product or its method of application in comparison with other products
                   (duration or consistency of protection, etc.).
           5.7.    Undesirable or unintended side-effects, e.g. on beneficial and other non-target organisms, on
                   succeeding crops, other plants or parts of treated plants used for propagating purposes (e.g. seeds,
                   cuttings, runners).
          5.8.     Compatibility with different cultural practices and other crop protection measures under the
                   conditions of use envisaged.
          5.9.     Effect of variables — climate, temperature, humidity, soil, etc.
          6.       TOXICOLOGICAL STUDIES ON THE PREPARATION
          6.1.     Acute toxicity in mammals
          6.1.1.   Oral single dose toxicity LD 5 0 — rat and at least one other mammalian species.
          6.1.2.   Percutaneous (acute and sub-acute) — at least rat.
          6.1.3.   Inhalation (acute and sub-acute) — at least rat.
          6.1.4.   Skin and eye irritation — rabbit.
          6.1.5.   Skin sensitization.
 ---pagebreak--- 10. 4. 89                         Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                No C 89/39
          7.    RESIDUES IN FOOD AND FEED
          7.1.  Residue data concerning the active substance including data from supervised trials in crops, food or
                feedingstuffs for which use is proposed, giving all experimental conditions and details. Data should
                be available for the range of different climatic and agronomic conditions encountered in the area of
                proposed use.
          7.2'. Pre-harvest intervals for proposed uses.
          7.3.  Proposed maximum residue levels (MRLs) and justification of the acceptability of these residues.
          7.4.  Taint, odour or taste due to residues on or in fresh or processed products.
          8.    EXISTING CLEARANCES
          8.1.  Information on clearances in other countries.
          8.2.  Information on established maximum residue limits (MRL) in other countries.
                                                                   PartB
                                             Preparations of micro-organisms or viruses
          1.    IDENTITY OF AND INFORMATION ON THE PREPARATION
          1.1.  Trade name or proposed trade name.
          1.2.  Applicant (name, address, etc.).
          1.3.  Manufacturer (name, address, etc.).
          1.4.  Use category (insecticide, fungicide, etc.).
          1.5.  Detailed quantitative and qualitative information on the composition of the preparation [active
                organism(s), inert components, extraneous organisms, etc.].
          1.6.  Physical state and nature of the preparation.
          1.7.  Stability of the preparation, effects of temperature change, method of packaging and storage, and
                retention of biological activity in storage.
          1.8.  Methods for establishing storage stability.
          2.    FURTHER TECHNICAL INFORMATION O N THE PREPARATION
          2.1.  Details of intended use, e.g. types of pests controlled and plants or plant products to be protected.
          2.2.  Application rate.
          2.3.  Concentration of active substance in material used (e.g. % concentration in the diluted spray).
          2.4.  Method of application (e.g. low volume, ultra low volume, release of infected host).
          2.5.  Number and timing of application.
          2.6.  Packaging.
          2.7.  Destruction or decontamination of the preparation and packaging.
          2.8.  Model of the label and, if need be, of the separate leaflet accompanying the package.
          3.    ANALYTICAL METHODS
          3.1.  Analytical methods for determining the composition of the preparation.
          4.    EFFICACY DATA
          4.1.  Laboratory experiments — effect on the target host.
          4.2.  Field experiments — results under practical conditions of use — reliability, duration and consistency
                of protection or other intended effect(s) appropriate to the desired crop protection objective at the
                various development stages of the pest and/or of the crop, crop product, etc.
          4.3.  Information on the occurrence or possible occurrence of the development of resistance.
          4.4.  Effects on the quantity or quality of treated plants or plant products.
 ---pagebreak--- No C 89/40                             Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                10. 4. 89
           4.5.      Comparison with reference products or normally accepted practice. Advantages of the agent over
                     conventional methods of control currently in use, with particular reference to hazards to operators,
                     to consumers of treated produce, and to the environment.
           4.6.      Compatibility with different cultural practices and other crop protection measures under the
                     conditions of use envisaged (including those for other pests of the crop to be treated).
           4.7.      Effect of variables — climate, temperature, humidity, soil, etc.
           4.8.      Undesirable or unintended side-effects, e.g. on beneficial and other non-target organisms, on
                     succeeding crops, other plants or parts of treated plants used for propagation purposes (e.g. seeds,
                     cuttings, runners).
           5         TOXICITY AND INFECTIVITY STUDIES
           3.5.1.    Acute toxicity and infectivity
           5.1.1.    Oral single dose LD 5 0 — at least mouse and rat.
           5.1.2.    Sub-cutaneous single dose — at least mouse and rat.
           5.1.3.    Inhalation single dose — at least rat and guinea pig.
           5.1.4.    Eye irritation test — rabbit.
           5.1.5.    Sensitization studies.
           6.        RESIDUES IN FOOD AND FEED
           6.1.      Residue data concerning the active substance including data from supervised trials in crops, food or
                     feedingstuffs for which use is proposed, giving all experimental conditions and details. Data should
                     be available for the range of different climatic and agronomic conditions encountered in the area of
                     proposed use.
           6.2.      Pre-harvest intervals for proposed uses.
           6.3.      Proposed maximum residue levels (MRLs) and the justification of the acceptability of these levels
                     (for toxins).
           6.4.      Taint, odour or taste due to residues on or in fresh or processed products.
           7.        EXISTING CLEARANCES
           7.1.      Information of clearances in other countries.
           7.2.      Information on established maximum residue limits (MRL) in other countries.
                                                                ANNEX      IV
                                   STANDARD PHRASES OF NATURE OF SPECIAL RISKS
           Contents of Annex III to the proposal of 4 August 1976.
                                                                ANNEX       V
                                          STANDARD PHRASES OF SAFETY ADVICE
           Contents of Annex IV to the proposal of 4 August 1976.