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. 
The preamble and articles are replaced by the following: 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 43 thereof, 
Having regard to the proposal from the Commission, 
Having regard to the opinion of the European Parliament, 
Having regard to the opinion of the Economic and Social 
Committee, 
Whereas plant production has a very important place in the 
Community; 
Whereas plant production yields are continually affected 
by harmful organisms and weeds and whereas it is 
absolutely essential to protect plants against these risks to 
prevent a decline in yields and to help to ensure security of 
supplies; 
Whereas one of the most important ways of protecting 
plants and plant products and of increasing the produc­
tivity of agriculture is to use plant protection products; 
Whereas the use of these plant protection products has 
consequences other than a favourable effect on plant 
production; whereas their use may involve risks for man 
and the environment since, in the main, they are toxic 
substances or preparations with hazardous effects; 
Whereas, in view of the hazards, there are rules in most 
Member States governing the authorization of plant 
protection products; whereas these rules present dif­
ferences which constitute barriers not only to trade in plant 
protection products but also to trade in plant products, and 
thereby directly affect the establishment and operation of 
the common market; 
Whereas it is therefore desirable to eliminate such barriers 
by harmonizing the provisions laid down in the Member 
States; Whereas there must be uniform rules in the Member States 
relating to the conditions and procedure for the acceptance 
of plant protection products; 
Whereas such rules should provide that plant protection 
products should not be put on the market unless they have 
been officially accepted and should be used properly having 
regard to the principles of integrated pest control; 
Whereas it is necessary, at the time when plant protection 
products are accepted, to make sure that, when properly 
applied for the purpose intended, they are sufficiently 
effective and have no unacceptable effect on plants or plant 
products, no unacceptable adverse influence on the 
environment in general and, in particular, no harmful effect 
on human or animal health; 
Whereas acceptance should be limited to plant protection 
products containing certain active substances specified at 
Community level on the basis of their toxicological and 
ecotoxicological properties; 
Whereas it is therefore necessary to establish a Community 
list of permitted active substances; 
Whereas a Community procedure must be laid down for 
assessing whether or not an active substance can be entered 
on the Community list; whereas the information that 
interested parties must submit with a view to admission of a 
substance to the list should be specified; 
Whereas the Community procedure should not prevent 
Member States from authorizing for use in their territory 
for a limited period of time plant protection products 
containing an active substance not yet entered on the 
Community list, provided that the interested party has 
submitted a dossier meeting Community requirements and 
the Member State has concluded that the active substance 
and the plant protection products satisfy the Community 
conditions set in regard to them; 
Whereas, in the interest of safety, substances on the list 
should be reviewed periodically; 
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 as well as of plant protection products that 
acceptance granted by one Member State, and tests carried 
out with a view to acceptance, should be recognized by 
other Member States, unless certain agricultural, plant 
health and environmental conditions relevant to the use of 
the products concerned are not comparable; 
Whereas it is therefore desirable that a system for the 
mutual supply of information should be established and 
that member States should make available to each other the 
particulars and scientific documentation submitted in 
connection with applications for acceptance of plant 
protection products; 
Whereas, however, Member States must be enabled to 
accept plant protection products not complying with the 
abovementioned conditions when it is necessary to do so 
because of an unforeseeable danger threatening plant 
production which cannot be contained by other means; 
whereas such acceptance should be reviewed by the 
Commission in close cooperation with the Member States 
in the framework of the Standing Committee on Plant 
Health; 
Whereas this Directive complements the Community 
provisions on the classification, packaging and labelling of 
pesticides; whereas together with the latter provisions it 
considerably improves the protection of users of plant 
protection products and consumers of plants and plant 
products; whereas it also contributes to the protection of 
the environment; 
Whereas, in order to ensure that the requirements laid 
down in respect of accepted plant protection products are 
satisfied when they are placed on the market, Member 
States must make provision for appropriate inspection 
arrangements; 
Whereas the procedures provided by this Directive are not 
appropriate for evaluation of the risks to the environment 
presented by plant protection products containing or 
composed of genetically modified organisms, but whereas, 
in future, specific procedures will be introduced by 
amendments to this Directive for the evaluation of such 
products; 
Whereas the implementation of this Directive and the 
adaptation of its Annexes to the development of technical 
and scientific knowledge necessitate close cooperation 
between the Commission and the Member States; whereas 
the procedure of the Standing Committee on Plant Health 
offers a suitable basis for this cooperation, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
1. This Directive concerns the acceptance and placing on 
the market within the Community of plant protection products put up in commercial form, and the placing on the 
market within the Community of active substances 
intended for a use as specified in Article 2(1). 
2. This Directive shall apply without prejudice to the 
provisions of Council Directive 78/631/EEC of 26 June 
1978 on the approximation of the laws of the Member 
States relating to the classification, packaging and labelling 
of dangerous preparations (pesticides) (*), and, where 
active substances are concerned, without prejudice to the 
provisions concerning classification, packaging and label­
ling of Council Directive 67/548/EEC of 27 June 1967 on 
the approximation of laws, regulations and administrative 
provisions relating to the classification, packaging and 
labelling of dangerous substances (2). 
Article 2 
For the purposes of this Directive the following definitions 
shall apply: 
1. Plant protection products 
Active substances and preparations containing one or 
more active substances, put up in the form in which 
they are supplied to the user, intended to: 
1.1. destroy organisms harmful to plants or plant 
products or to prevent the action of such 
organisms, in so far as such substances or 
preparations are not otherwise defined below; 
1.2. influence the life processes of plants, other than 
as a nutrient; 
1.3. preserve plant products, in so far as such 
substances or products are not subject to special 
Council or Commission provisions on preservat­
ives; 
1.4. destroy undesirable plants; or 
1.5. destroy parts of plants or prevent undesired 
growth of plants. 
2. Residues of plant protection products 
One or more substances present in or on plants or 
plant products, or elsewhere in the environment, and 
resulting from the use of a plant protection product. 
3. Substances 
Chemical elements and their compounds, as they 
occur naturally or by manufacture, including any 
impurity inevitably resulting from the manufacturing 
process. 
(!) OJ No L 206, 29. 7. 1978, p. 13. 
(2) OJ No L 196, 16. 8. 1967, p. 1. 
No C 89/24 Official Journal of the European Communities 10. 4. 89 
4. Active substances 
Substances, micro-organisms and viruses having 
general or specific action: 
4.1. against harmful organisms, or 
4.2. on plants, parts of plants or plant products. 
5. Preparations 
Mixtures or solutions composed of two or more 
substances of which at least one is an active substance, 
intended for use as plant protection products. 
6. Plants 
Live plants and live parts of plants, including fresh 
fruit and seeds. 
7. Plant products 
Products in the unprocessed state or having undergone 
only simple preparation such as milling, drying or 
pressing, derived from plants, but excluding plants 
themselves as definied in point 6. 
8. Harmful organisms 
Pests of plants or plant products belonging to the 
animal or plant kingdom, and also viruses, mycoplas­
mas and other pathogens. 
9. Animals 
Animals belonging to species normally fed and kept or 
consumed by man. 
10. Placing on the market 
Any handing over, whether in return for payment or 
free of charge, other than for storage followed by 
consignment from the territory of the Community. 
Importation into the territory of the Community shall 
be deemed to be placing on the market for the 
purposes of this Directive. 
11. Environment 
Water, air and land and any inter-relationship 
between them, as well as any relationship with living 
organisms. 
12. Integrated pest control 
The rational application of a combination of bio­
logical, chemical, cultural or plant breeding measures 
whereby the use of chemical plant protection products 
is limited to the necessary minimum. Article 3 
1. Member States shall prescribe that plant protection 
products may be placed on the market for use in their 
territory only if they have accepted the product in 
accordance with this Directive. 
2. Member States shall not, on the grounds that a plant 
protection product is not accepted for use in their territory, 
impede the storage or movement of such products intended 
for use in another Member State, provided that: 
— the product is accepted in another Member State, and 
— the operators in question satisfy the inspection 
requirements laid down by the Member States in order 
to ensure compliance with paragraph 1. 
3. Member States shall prescribe that plant protection 
products must be used properly and in accordance with any 
conditions laid down pursuant to this Directive. Proper 
use, hall include application of the principles of integrated 
pest control. 
4. Member States shall prescribe that active substances 
may not be placed on the market unless: 
— they are classified, packaged and labelled in accordance 
with the provisions of Directive 67/548/EEC, and 
— when the active substance was not on the market before 
the date of application of this Directive, a dossier is 
transmitted to the Member States and to the Commis­
sion, in accordance with Article 6, with the declaration 
that the active substance is intended for a use as 
specified in Article 2(1). 
Article 4 
1. Member States shall provide that a plant protection 
product may be accepted only if: 
(a) its active substances are listed in Annex I and any 
conditions laid down therein are fulfilled; 
(b) it is established, in the light of current scientific and 
technical knowledge that, when properly applied for the 
purpose intended, and having regard to all foreseeable 
conditions under which it may be used: 
(i) it is sufficiently effective; 
(ii) it has no unacceptable effect on plants or plant 
products; 
(iii) it has no harmful effect on human or animal health; 
10. 4. 89 Official Journal of the European Communities No C 89/25 
(iv) it has no unacceptable adverse influence on the 
environment; 
(c) the nature and quantity of its active substances and, 
where appropriate, their toxic impurities can be 
determined by methods in general use. 
2. Member States shall ensure that compliance with the 
requirements set out in paragraph 1 is established by 
official or officially recognized tests and analyses carried 
out under agricultural, plant health and environmental 
conditions relevant to use of the plant protection product in 
question and representative of those prevailing where the 
product is intended to be used, within the territory of the 
Member State concerned. 
Article 5 
1. An active substance shall be included in Annex I for an 
initial period not exceeding 10 years and only if: 
(a) its residues in edible plant products, edible livestock 
products or the environment do not have any harmful 
effects on human or animal health or on the environ­
ment and, if constituting a potential hazard, can be 
measured by methods in general use; 
(b) it may be expected, on the basis of scientific and 
technical data, that preparations manufactured from it 
will meet the requirements of Article 4(l)(b)(iii) and 
(iv). 
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 6 
1. A Member State or the Commission shall, in order to 
obtain the inclusion of an active substance in Annex I, 
ensure that a dossier satisfying the requirements of Annex 
II is transmitted by the interested party of the other 
Member States and to the Commission. 
The Commission shall refer the dossier for examination by 
the Standing Committee on Plant Health. 
2. At the request of a Member State it may, not less than 
three months after the date of referral, be found by the 
procedure laid down in Article 19 that the dossier satisfies 
the requirements of Annex II. 
Such a finding shall be without prejudice to subsequent 
application of paragraph 3, should this be required in 
connection with assessment of the dossier. 
3. As part of the procedure for assessing the dossier the 
interested party may be invited by the Commission to: 
— provide any further information deemed necessary for 
the purpose of assessing whether the active substance 
satisfies the requirements indicated in Article 5(1), — appear before the Committee. 
4. The procedure laid down in Article 18 shall be 
followed for taking a decision to include an active 
substance in Annex I and for setting any conditions in 
connection therewith. 
5. Paragraphs 1 to 4 shall also apply to the amendment of 
any conditions included in Annex I in connection with an 
active substance. 
6. Paragraphs 3 and 4 shall apply if, after inclusion of an 
active substance in Annex I, facts emerge that cast doubt on 
its conformity with the requirements indicated in Ar­
ticle 5(1). 
Article 7 
Member States shall prescribe that the holder of an 
acceptance must notify to the competent authority all 
information on the harmful effects of any substance listed 
in Annex I or of its residues on human or animal health or 
on unacceptable adverse effects on the environment. 
Member States shall notify this information to the other 
Member States and to the Commission, which shall refer 
the information to the Standing Committee on Plant 
Health. 
Article 8 
By way of derogation from Article 4, a Member State may: 
1. in very special circumstances, authorize for a period 
not exceeding 120 days the placing on the market of 
plant protection products not complying with Article 4 
if such a measure appears necessary because of an 
unforeseeable danger threatening plant production 
which cannot be contained by other means. In this case, 
the Member State concerned shall immediately inform 
the other Member States and the Commission of its 
action. It shall be decided without delay, in accordance 
with the procedure laid down in Article 18, whether 
and, if so, under what conditions the action taken by 
the Member State may be continued or repeated; 
2. permit, for a period not exceeding three years, the 
placing on the market of plat protection products 
containing an active substance not listed in Annex I and 
not yet available on the market on the date of 
implementation of this Directive, provided that: 
(a) following application of Article 6(1) and (2) it is 
found that the dossier on the active substance 
satisfies the requirements of Annex II; 
No C 89/26 Official Journal of the European Communities 10. 4. 89 
b) the Member State establishes that the active 
substance satisfies the requirements of Article 5(1) 
and that the plant protection product satisfies the 
requirements of Article 4(1) (b) and (c). 
In such cases the Member State shall immediately 
inform the other Member State and the Commission of 
its assessment of the dossier and of the terms of 
acceptance. 
If, on assessment of the dossier as provided for in 
Article 6(3), it is found that the active substance does 
not satisfy the requirements of Article 5(1), a decision 
may be taken by the procedure laid down in Article 18 
requiring the Member State to withdraw the accept­
ance; 
3. for a period of 10 years from the date of implemen­
tation of this Directive, without prejudice to Directive 
79/117/EEC, authorize the placing on the market in its 
territory of plant protection products containing active 
substances not listed in Annex I that were already on 
the market before that date. 
The Commission shall draw up a programme of work 
for the gradual examination of these active substances 
during that period. In implementing this programme 
the Commission may require interested parties to 
submit all requisite data to the Commission and the 
Member States within a prescribed period. 
During this period it may, following examination by 
the Standing Committee on Plant Health of such an 
active substance, be decided, by the procedure laid 
down in Article 18, that the substance can be included 
in Annex I or that the Member State must withdraw the 
authorization referred to above within a prescribed 
period. 
Article 9 
1. Application for acceptance of a plant protection 
product may be made by the manufacturer, the importer or 
the distributor, if the plant protection product is to be 
placed on the market in the first instance by a distributor. 
2. Every applicant shall be required to have a permanent 
office within the Community. 
3. Member States may require that applications for 
acceptance be submitted in their national or official 
languages or one of those languages. 
4. Each Member State shall agree to consider any 
application for acceptance made to it and shall decide 
thereon within a reasonable period. 
5. Within 45 days of the receipt of an application the 
Member State concerned shall inform the other Member 
States and the Commission thereof and shall at the same 
time provide the following particulars of the application: 
— the name and address of the applicant, — the name and address of the manufacturer, if different 
from the applicant, 
— the designation or trade name or code number of the 
plant protection product, 
— the type of preparation, 
— the name and amount of each active substance 
contained in it, 
— the use for which it is intended and the directions for 
using it. 
6. Member States shall ensure that a dossier is compiled 
on each application. Each dossier shall contain at least a 
copy of the application, a record of the administrative 
decisions taken by the Member State concerning the 
application and the particulars and technical documen­
tation laid down in Article 12(1), together with a summary 
of the latter. Member States shall on request make available 
to the other Member States and to the Commission the 
dossiers provided for in this paragraph; they shall supply to 
them on request all information necessary for full 
comprehension of applications. 
Article 10 
1. At the request of the applicant, a Member State to 
which an application is made for the acceptance of a plant 
protection product already accepted in another Member 
State must: 
— unless certain agricultural, plant health or environ­
mental conditions relevant to the use of the product are 
not comparable in the regions concerned, refrain from 
requiring the repetition of tests and analyses already 
carried out in connection with the acceptance of the 
product in that Member State, and 
— unless certain agricultural, plant health or environ­
mental conditions relevant to the use of the product are 
not comparable in the regions concerned, authorize 
placing on the market in its territory. 
2. Member States shall inform the Commission of cases 
where they have required repetition of a test and of cases 
where they have refused to accept a plant protection 
product already accepted in another Member State, in 
respect of which the applicant had claimed that the 
agricultural, plant health and environmental conditions 
relevant to use of the product in the regions concerned in 
the Member State where the test was carried out or for 
which acceptance was granted were comparable to those in 
their own territory. They shall notify the Commission of 
the ground on which repetition of the test was required or 
acceptance was refused. 
10. 4. 89 Official Journal of the European Communities No C 89/27 
3. In accordance with the procedure laid down in Article 
18, it may be decided that a Member State which has 
refused to recognize comparability should accept the tests 
and analyses or should authorize the placing on the market 
of the product in the regions concerned in its territory. 
Article 11 
1. Member States shall inform the other Member States 
and the Commission immediately in writing of each plant 
protection product accepted in accordance with this 
Directive, indicating the conditions and the period of 
validity of such acceptance and attaching a copy of the label 
under which the plant protection product is to be placed on 
the market. They shall also inform the other Member States 
and the Commission immediately of any subsequent 
revocation or non-renewal of the acceptance or alteration 
of the conditions of an acceptance. 
2. Each Member State shall draw up an annual list of the 
plant protection products accepted in its territory and shall 
communicate that list to the other member States and the 
Commission. 
3. By means of the procedure laid down in Article 19 a 
standardized information system shall be set up to facilitate 
the application of paragraphs 1 and 2 and also of 
Article 9(5). 
4. Acceptance shall be cancelled or modified if it is 
established that: 
(a) the requirements for acceptance are not or are no longer 
satisfied; 
(b) false or misleading particulars were supplied concerning 
the facts on the basis of which authorization was 
granted. 
Article 12 
1. Member States shall require that applicants for 
acceptance of a plant protection product submit with their 
application: 
(a) a dossier satisfying the requirements set out in 
Annex III; and 
(b) for each active substance in the product other than those 
referred to in the first subparagraph of Article 8(3), a 
dossier satisfying the requirements set out in Annex II. 
2. By way of derogation from paragraph 1, applicants 
may, if the active substance is already listed in Annex I and 
does not differ substantially in degree of purity and nature 
of impurities, be exempted from supplying the information 
required under paragraph 1(b), except for that identifying 
the active substance. 
Such exemption may not, however, be granted in respect of 
data from toxicological, metabolic, ecotoxicological and residue studies submitted with a view to the inclusion of the 
active substance in Annex I by a person other than the 
applicant for acceptance, unless: 
— either the applicant has agreed with the other person 
that recourse may be had to these data, 
— or the application for acceptance is made at least 15 
years after the first acceptance in a Member State of a 
plant protection product containing the active subst­
ance in question. 
3. Member States shall inform the Commission if, on 
examination of an application for acceptance, they 
consider as being listed in Annex I active substances which 
have been produced by a person or manufacturing process 
other than those specified in the dossier on the basis of 
which the active substance was first included in Annex I. 
They shall transmit to it all data regarding the identity and 
impurities of the active substance. 
Article 13 
Member States and the Commission shall ensure that 
information involving industrial and commercial secrets is, 
if the party wishing to have an active substance included in 
Annex I or the applicant for acceptance of a plant 
protection product so requests, treated as confidential. 
Industrial and commercial secrecy shall not apply to: 
— the names and composition of the active substance or 
plant protection product, 
— physico-chemical data concerning the active substance 
or plant protection product, 
— any ways of rendering the active substance or plant 
protection product harmless, 
— the interpretation of the results of the tests to establish 
efficacy and harmlessness to animals, plants and the 
environment, and the name of the body responsible for 
the tests, 
— recommended methods and precautions to reduce 
handling, storage, transport, fire or other hazards, 
— decontamination procedures to be followed in the case 
of accidental spillage or leakage, 
— first aid and medical treatment to be given in the case of 
injury to persons. 
If the interested party or applicant himself subsequently 
discloses previously confidential information, he shall be 
required to inform the competent authority accordingly. 
No C 89/28 Official Journal of the European Communities 10. 4. 89 
Article 14 
Article 5(1) of Directive 78/631/EEC shall apply to all plant 
protection products within the meaning of this Directive. 
Article 15 
Member States shall take the necessary measures to ensure 
that the packaging of plant protection products satisfies the 
following requirements as to labelling: 
1. All packages must show clearly and indelibly the 
following: 
(a) the trade name or designation of the plant 
protection product; 
(b) the name and address of the holder of the 
acceptance and the registration number of the plant 
protection product and, if different, the name and 
address of the person placing the plant protection 
product on the market; 
(c) the name and amount of each active substance 
expressed: 
— for plant protection products which are solids, 
aerosols, volatile liquids (maximum boiling 
point 50° C) or viscous liquids (lower limit 1 Pa 
at 20° C): as a percentage by weight, 
— for other liquids: as a percentage by weight and 
in grams per litre at 20° C, 
— for gases: as a percentage by volume. 
The name must be as given in the list contained in 
Annex I to Directive 67/548/EEC or, if not included 
therein, its ISO common name. If the latter is not 
available, the active substance shall be designated 
by its chemical designation according to IUPAC or 
the nomenclature published by the journal 'Chemi­
cal Abstracts'; 
(d) the net quantity of the plant protection product 
given in legal units of measurement; 
(e) the batch number; 
(f) the indications required under Article 6 of Directive 
78/631/EEC, in particular those mentioned in 
paragraphs 2(d), (g), (h) and (i), 3 and 4 of that 
Article; 
(g) the nature of any special risks by means of standard 
phrases selected appropriately from those listed in 
Annex IV; (h) safety precautions in the form of standard phrases 
selected appropriately from those listed in 
Annex V; 
(i) the type of action of the plant protection product 
(e.g. insecticide, growth regulator, weedkiller, 
etc.); 
(j) the type of preparation (e.g. wettable powder, 
emulsifiable concentrate, etc.); 
(k) the uses for which the plant protection product has 
been accepted; 
(1) directions for use and the dose rate, expressed in 
metric units, for each use provided for under the 
terms of the acceptance; 
(m) where necessary, the safety interval for each use 
between application and: 
— sowing or planting of the crop to be protected, 
— sowing or planting of succeeding crops, 
— harvesting, 
— use or consumption; 
(n) particulars of possible phytotoxicity, varietal 
susceptibility, tainting of produce and any other 
adverse side effects, together with the intervals to 
be observed between application and sowing or 
planting of: 
— the crop in question, or 
— subsequent crops; 
(o) if accompanied by a leaflet, as provided for in 
paragraph 2, the sentence 'Read accompanying 
instructions before use'. 
2. Member States may permit the requirements in 
paragraph 1(1) and (n) to be indicated on a separate 
leaflet accompanying the package if the space available 
on the package is too small. Such a leaflet shall be 
regarded as part of the label for the purposes of this 
Directive. 
3. Member States shall stipulate that the labels of 
accepted plant protection products which are not 
intended for domestic use shall also bear the statement 
'unsuitable for domestic use'. 
4. In no case may the label of the packaging of a plant 
protection product bear the indications 'non-toxic', 
'harmless' or similar indications. However, the leaflet 
mentioned in paragraph 2 may state that it is harmless 
10. 4. 89 Official Journal of the European Communities No C 89/29 
to bees or to any other specified organisms provided 
that such indications refer to normal use. 
5. Member States may make the placing of plant 
protection products on the market in their territories 
subject to the use of the national language or languages 
in the labelling thereof. 
Article 16 
Member States shall make suitable arrangements for plant 
protection products which have been placed on the market 
to be officially checked by sampling to see whether they 
comply with the requirements of this Directive. 
Article 17 
1. The following shall be established, having regard to 
current scientific and technical knowledge, in accordance 
with the procedure laid down in Article 18: 
— any standards for the composition, purity and charac­
teristics of active substances listed in Annex I found to 
be necessary, 
— any necessary amendments to Annex I, 
— uniform principles for checking compliance with the 
requirements set out in Article 4(l)(b). 
2. The following shall be established, having regard to 
current scientific and technical knowledge, in accordance 
with the procedure laid down in Article 19: 
— any necessary amendments to Annexes II, III, IV and V, 
— explanatory notes covering the particulars set out in 
Annexes II and III. 
Article 18 
Where the procedure laid down in this Article is to be 
followed, matters shall be referred without delay by the 
chairman, either on his own initiative or at the request of a 
Member State, to the Standing Committee on Plant Health 
set up by Council Decision 76/894/EEC, hereinafter 
referred to as 'the Committee'. 
The representative of the Commission shall submit to the 
Committee a draft of the measures to be taken. The 
Committee shall deliver its opinion on the draft within a 
time limit which the chairman may lay down according to 
the urgency of the matter. The opinion shall be delivered by 
the majority laid down in Article 148 (2) of the Treaty. The 
votes of the representatives of the Member States within the 
Committee shall be weighted in the manner set out in that 
Article. The chairman shall not vote. The Commission shall adopt the measures envisaged if they 
are in accordance with the opinion of the Committee. 
If the measures envisaged are not in accordance with the 
opinion of the Committee, or if no opinion is delivered, the 
Commission shall, without delay, submit to the Council a 
proposal relating to the measures to be taken. The Council 
shall act by a qualified majority. 
If, on the expiry of a period of three months from the date 
of referral to the Council, the Council has not acted, the 
proposed measures shall be adopted by the Commission. 
Article 19 
Where the procedure laid down in this Article is to be 
followed, matters shall be referred by the chairman, either 
on his own initiative or at the request of a Member State, to 
the Standing Committee on Plant Health set up under 
Decision 76/894/EEC, hereinafter referred to as 'the 
Committee'. 
The representative of the Commission shall submit to the 
Committee a draft of the measures to be taken. The 
Committee shall deliver its opinion on the draft, within a 
time limit which the chairman may lay down according to 
the urgency of the matter, if necessary by taking a vote. 
The opinion shall be recorded in the minutes; in addition, 
each Member State shall have the right to ask to have its 
position recorded in the minutes. 
The Commission shall take the utmost account of the 
opinion delivered by the Committee. It shall inform the 
Committee of the manner in which its opinion has been 
taken into account. 
Article 20 
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 
and in limited quantities. 
2. Member States shall require any person intending to 
conduct in their territory any research, experiment or test 
involving the release into the environment of a plant 
protection product containing as an active substance a 
living micro-organism or virus to notify their competent 
authorities at least 45 days before the start of the proposed 
research, experiment or test. Those authorities shall be 
given with the notification any information necessary to 
enable them to evaluate the safety of the proposed research, 
experiment or test. This provision shall not apply to 
genetically modified organisms covered by Directive ... on 
the deliberate release to the environment of genetically 
modified organisms. 
If the proposed research, experiment or test is liable to have 
harmful effects on human or animal health or have an 
No C 89/30 Official Journal of the European Communities 10. 4. 89 
unacceptable adverse influence on the environment, the 
Member State concerned may either prohibit it or permit it 
subject to such conditions as it considers necessary to 
prevent those consequences. 
3. Common conditions for the application of this Article, 
in particular the maximum quantities of pesticides that 
may be released in experimental work as mentioned in 
paragraph 1, shall be adopted with the procedure laid 
down in Article 18. Article 21 
Member States shall bring into force the laws, regulations 
and administrative provisions necessary to comply with 
this Directive within two years of the date on which it is 
adopted. They shall immediately inform the Commission 
thereof. The provisions referred to in the third indent of 
Article 17(1) shall be adopted within the same period. 
Article 22 
This 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). 
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. 
2.5. (J) 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. 
No C 89/32 Official Journal of the European Communities 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 LD50 — 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. 
10. 4. 89 Official Journal of the European Communities 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 ON TREATED PRODUCTS 
6.1. Behaviour of the residue of the pure active substance and its metabolites from the time of application 
until harvest — distribution in the plant, kinetics of disappearance, binding to the plant constituents, 
etc. 
6.2. Overall material balance for the applied active substance. 
6.3. Sufficient residue data from supervised trials to demonstrate that residues likely to arise from the 
envisaged treatments would not be of concern for human and animal health. 
6.4. Residue monitoring data for products in the distribution chain. 
6.5. Effects of industrial processing and/or household cooking on residues. 
6.6. Taint, odour or taste due to residues on or in fresh or processed products. 
7. ECOTOXICOLOGICAL STUDIES 
7.1. Effects on organisms 
7.1.1. Oral single dose toxicity LD50 for at least two bird species. 
7.1.2. Acute LC50, 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 LC50, 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 LD50 — 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. 
No C 89/34 Official Journal of the European Communities 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]. 
10. 4. 89 Official Journal of the European Communities 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 LD50 determination is not appropriate to assess pathogenicity, a set of 
range-finding tests must be carried out to reveal highly toxic agents and infectivity. 
4.1.1.3. Subcutaneous single dose — at least mouse and guinea pig. 
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. 
No C 89/36 Official Journal of the European Communities 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. 
10. 4. 89 Official Journal of the European Communities No C 89/37 
ANNEX III 
REQUIREMENTS FOR THE DOSSIER TO 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). 
No C 89/38 Official Journal of the European Communities 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 ON 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 LD50 — 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. 
10. 4. 89 Official Journal of the European Communities 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 ON 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. 
No C 89/40 Official Journal of the European Communities 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 LD50 — at least mouse and rat. 
5.1.2. Sub-cutaneous single dose — at least mouse and rat. 
5.1.3. Inhalation single dose — at least rat and guinea pig. 
5.1.4. Eye irritation test — rabbit. 
5.1.5. Sensitization studies. 
6. RESIDUES IN FOOD AND FEED 
6.1. Residue data 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.