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

éG -
ISSN 0254-1475 
COM (93) 117 final 
DOCUMENTS 
EN 03 05 
Catalogue number : CB-CO-93-154-EN-C 
ISBN 92-77-54006-0 
Office for Official Publications of the European Communities 
Lr29S5 Luxembourg