Proposal for a COUNCIL DIRECTIVE establishing Annex VI of Directive 91/414/EEC concerning the placing of plant protection products on the market
Date: 1993-04-20
Institutions: European Commission
Subjects: environmental impact, marketing, plant health control, plant health product, product safety, public health

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) 

-  2 -

EXPLANATORY  MEMORANDUM 

1. 

Council  Directive 91/414/EEC of  15 July  1991 concerning the 

placing of plant protection products on  the market  requires 

in article 4  inter alia that Member  States shall  not 

authorize a plant  protection product unless a number of 

requirements mentionned  in paragraph  (1) (b), (c), (d) and 

(e) are satisfied, pursuant  to the uniform principles 

provided  for  in Annex VI. 

Moreover, according  to articles 18 and 23 of  the Directive, 

the uniform principles shall  be adopted by  the Council, 

acting by a qua I if led majority on a proposal  from  the 

Commission, within one year  from  the date of  notification 

of  the Directive. 

2. 

The uniform principles aim to ensure that all Member 

States,  in making decisions with  respect  to authorization 

of plant protection products will  apply  the requirements of 

Article 4  in an equivalent manner  and at  the high  level of 

protection of human and animal  health and of  the 

environment  seeked by  the Directive. 

In this context  the Commission would  in particular 

underline that  the proposal  has taken  into consideration 

current  Community  legislation with  regard  to protection of 

water  and  in particular  drinking water given  the concerns 

expressed  during  the négociation of Directive 91/414/EEC  in 

the Council  and Parliament.  The Commission has however  the 

intetlon to start a re-examination of Directive  80/778/EEC 

relating  to the quality of water  intended  for  human 

consumption.  Where  the result of  this examination would 

lead to a Commission proposal  amending  this Directive, or 

other Community  regulatory provisions on water 

contamination by plant protection products, the Commission 

-  3 -

will  examine  immediately  the consequences  thereof  with 

regard  to the necessity of  a corresponding  amendment  of  the 

present  proposal, or, where  the present  proposal  would 

already  have been  adopted  by  the Council,  the necessity  of 

amending  the  relevant  provisions of Annex  VI  by  the 

procedures  provided  therefor  In Articles  18 and  19 of 

Directive  91/414/EEC. 

3. 

The Commission  considers  that, as  the uniform  principles 

are addressed  in the  first  instance  to the public 

authorities  in the Member  States  in charge of  plant 

protection  products  authorization,  these principles  should 

concentrate  on  the aspects of  the evaluation  of  the  data 

submitted  by applicants according  to Article  13 of  the 

Directive and of  decision making  on  the basis of  these 

evaluations. 

The  Commission  is however  of  the opinion  that  for  a proper 

realisation of  the objectives mentionned under  point  2 

above,  the provisions of Annex  III  should  be  further 

defined  in order  to ensure  that  evaluations  can  be made  on 

the basis of  a data  package  developped  according  to  the 

current  state of  scientific  and  technological  knowledge. 

Therefore  it  is the Commission's  intention  to define, 

according  to the procedure  provided  thereto  in the 

Directive, Annex  III  in such  a way  that  it shall  include: 

-  the parameters  to decide when  particular  studies or 

information are  required; 

-  the parameters  to decide when  particular  studies or 

information  are not  required; 

-  the experimental  protocols  that  have  to be used  to 

generate  the  required  data. 

- 4 -

4. 

This proposal  conceives  the uniform  principles  in 3 parts  : 

1) 

a general  introduction  identifies the alms of  the 

uniform  principles,  the data  that  have  to be  taken 

into account  for  the evaluation and  decision  making 

and  the procedures  to evaluate data  in order  to 

come  to a  decision; 

2) 

the principles  concerning  the evaluation  of  the 

available data, composed  of  some general  principles 

and  some more  specific principles for each of  the 

elements  provided  for  in Article  4(1)  (b), (c), (d) 

and (e); 

3) 

the principles concerning  the decision  making  with 

respect  to authorization of  plant  protection 

products, also composed  of  some general  principles 

and  some more  specific principles  for  each of  the 

elements  provided  for  in Article  4  (1) (b), (c), 

(d) and (e). 

5. 

The Commission  has developped  this proposal  on  the basis of 

highest  technical  expertise available  in the Member  States 

with  regard  to evaluation and  decision making  on  plant 

protection  products. 

However, with  regard  to certain  items such  as  impact  of 

plant  protection  products on non-target  plants and on  non-

target  aquatic  flora  as well  as  fate of  plant  protection 

products  in air,  it has appeared  that  more experience  is 

required  before detailed principles on evaluation  and 

decision  making  can be developped. The Commission  will 

follow the  technical  and  scientific progress  in these 

fields and  as soon  as possible  introduce more  detailed 

rules concerning  these  areas according  to the  procedures 

provided  for  in the Directive. 

-  5  -

6. 

In certain  cases  the use of  calculation  models  is provided 

in this proposal.  However  at  this moment  it  is not 

possible  for  the Commission  to provide models which  are 

harmonised  throughout  the Community  or  to  identify  all  the 

conditions under  which  certain  specified models  should  be 

used.  This  is particularly  the case  for  the  models 

concerning  operator  exposure  and  fate  and  behaviour  of 

plant  protection products  in the  environment. 

It  is the  intention of  the Commission  to follow  very 

closely  the  further  developments  in this area  and  to 

promote, where  possible  and within  its possibilities, 

further  harmonization.  Meanwhile  the uniform  principles 

provide  for  some  general  requirements  for  the models  that 

are  to be  used. 

7. 

The  present  proposal  concerns  the uniform  principles  for 

evaluation  and  authorization of  chemical  plant  protection 

products  since  currently  and  in the near  future  almost  all 

the  plant  protection  products  that  are  placed  or  will  be 

placed  on  the market  are  chemical  preparations. As  soon  as 

possible  similar  provisions  with  regard  to  preparations 

containing  micro-organisms or  viruses will  be  developed. 

8. 

This  proposal  is expected  to have  a negligie  impact  on  the 

Community  budget. 

9. 

The  proposal  is unlikely  to have  negative  impact  on 

business,  including  SME. 

- 6 -

Proposal  for a 

COUNCIL DIRFPTIvp 

establishing Annex VI of 

Directive 91/414/EEC 

concerning the placing of plant protection products 

on the market. 

THE COUNCIL OF THE EUROPEAN COMMUNITIES 

Having regard to the Treaty establishing the European Economic 

Community, 

Having regard to Council Directive 91/414/EEC of 15 July 1991 

concerning the placing of plant protection products Qn the 

market(*), and in particular Article 18.1 thereof; 

Having regard to the proposal of the Commission; 

(1) 0J N° L 230, 19.08.1991, p. 1. 

- 7 -

Whereas Annex VI provides for the development  of uniform 

principles aiming to ensure that the Member  States, in deciding 

on authorizations of plant protection products, will apply the 

requirements of Article 4  (1) (b), (c), (d) and  (e) of Directive 

91/414/EEC in an equivalent manner and at the high level of 

protection of human and animal health and the environment  seeked 

by the Directive; 

Whereas therefor it is necessary to lay down detailed principles 

concerning the evaluation of the information submitted by 

applicants for a plant protection product  and concerning the 

decision making on basis of the results of this evaluation, in 

view of granting the authorization; 

Whereas such principles have to be laid down for each of the 

different  requirements provided  for in Article 4  (1) (b), (c), 

(d) and (e); 

HAS ADOPTED THIS DIRECTIVE : 

The Annex VI of Directive 91/414/EEC is established by the Annex 

to the present Directive. 

Article 1 

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. 

This Directive is adrc*ssed to the Member States. 

Article 3 

- 8 -

ANNEX 

UNIFORM PRINCIPLES FOR EVALUATION AND AUTHORIZATION 

OF PLANT PROTECTION PRODUCTS 

CONTENTS 

A. 

INTRODUCTION 

B. 

EVALUATION 

1. 

2. 

2.1. 

2.2. 

2.3. 

2.4. 

General principles 

Specific principles 

Efficacy 

Absence of unacceptable effects on plants 

or plant products 

Impact on vertebrates to be controlled 

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. 

2.7. 

Analytical methods 

Physical and chemical properties 

C. 

DECISION MAKING 

- 9 -

1. 

2. 

2.1. 

2.2. 

2.3. 

2.4. 

General principles 

Specific principles 

Efficacy 

Absence of unacceptable effects on plants or 

plant products 

Impact on vertebrates to be controlled 

Impact on human or animal health 

2.4.1. 

Arising from the plant 

protection product 

2.4.2. 

Arising from residues 

2.5. 

2.5.1. 

2.5.2. 

2.6. 

2.7. 

Influence on the environment 

Fate and distribution in the environment 

Impact on non-target species 

Analytical methods 

Physical and chemical properties 

A. 

INTRODUCTION 

- 10 -

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; 

- 11 -

b) 

take  into  account  the  data  of  Annex  II 

concerning  the  active  substance(s)  in  the 

plant protection product  which were submitted 

for  the  purpose  of  inclusion  of  the  active 

substance concerned in Annex I and the results 

of the evaluation of this information, without 

prejudice,  where  relevant,  of  the  provisions 

of article 13.(1) (b), (2), (3) and (6); 

c) 

take  into  consideration  other  relevant 

technical  or  scientific  information  made 

avalaible  to  them  with  regard  to  the 

performance of the plant protection product or 

to  the  potentially  adverse  effects  of  the 

plant  protection  product,  its  components  or 

its residues. 

Where  in  the  specific  principles  on  evaluation 

reference is made to data of Annex  II, this shall be 

understood as being the data referred to under point 

2(b). 

Where the data and information provided is sufficient 

to permit completion of the evaluation for one of the 

proposed  uses, applications  must  be evaluated  and a 

decision made  for the proposed  use(s) for which the 

data are sufficient. 

Taking  account  of  justifications  provided  and  with 

the benefit  of  any  necessary  clarifications,  Member 

States shall reject applications made, where the data 

gaps are such that it is not possible to finalize the 

evaluation  and to perform a reliable decision making 

for at least one of the proposed uses. 

-  12 -

During the process of evaluation and decision making, 

Member  States  shall  cooperate with  the applicants  in 

order to  solve where necessary  any questions on  the 

dossier  in an early stage or to identify,  in an early 

stage  additional studies that would be necessary  for 

a  proper  evaluation  of  the  dossier,  or  to  amend  any 

proposed conditions of its envisaged use or to modify 

the nature or the composition of the plant  protection 

product  in  order  to  ensure  full  satisfaction  of  the 

requirements of this Annex or of the Directive. 

Member  States  shall  come  to  a  justified  decision 

normally  at the  latest  12 months after  a technically 

complete dossier is available for the Member State. A 

technically  complete  dossier  is  a  dossier  that 

satisfies all the requirements of Annex III. 

The  evaluation  and  decision  making  process  involves 

judgments  which  must  be  based  on  sound  scientific 

principles  and  be  made  with  the  benefit  of  expert 

advice. 

-  13 -

B. 

1. 

EVALUATION 

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. 

- 14 -

3. 

In  the  evaluation  of  applications  submitted, 

Member  States  shall  have  regard  to  the 

agricultural,  plant  health  or  environmental 

(including  climatic)  conditions  in  the  areas 

of the envisaged use. 

4. 

In  interpreting  the  results  of  evaluations, 

Member  States  shall  take  into  consideration 

possible  elements  of  uncertainty  in  the 

information obtained during the evaluation, in 

order to ensure that the chances of failing to 

detect  adverse  effects  are  minimised.  The 

decision  making  process  shall  be  examined  to 

identify  critical  decision  points or  items of 

data,  for which  uncertainties  could  lead to a 

false classification of risk. 

At  first  the evaluation  shall be based  on the 

best  available  data  or  estimates  reflecting 

the  realistic  conditions  of  use  of  the  plant 

protection  product,  and  will  result  in  a 

realistic  worst  case  approach. This  should  be 

followed by a repeat evaluation,taking account 

of  potential  uncertainties  in  the  critical 

data and of a range of use conditions that are 

likely  to  occur,  to  determine  whether  it  is 

possible  that  the  initial  estimation  could 

have been significantly  different. 

-  15 -

5. 

Where  specific  principles of part  B section 2 

provide  for  the  use  of  calculation  models  in 

the evaluation  of  a plant  protection  product, 

these models shall : 

- make  a  best  possible  estimation  of  all 

relevant  processes  involved  taking  into 

account 

realistic 

parameters 

and 

assumptions; 

- be  submitted  to  an  analysis  as  referred  to 

under part B point  1.4; 

- be  reliably  validated  with  measurements 

carried out under circumstances relevant  for 

the use of the model; 

- be relevant to the conditions in the area of 

the proposed use. 

- 16 

Specific principles 

Member  States  shall,  for  the  evaluation  of  the  data 

and information submitted  in support of applications, 

implement  the following principles. 

2.1. 

Efficacy 

2.1.1 

Where the proposed use concerns the control of or the 

protection  against  an  organism,  Member  States  shall 

evaluate  the possibility  that  this organism  could  be 

harmful  under  the  agricultural,  plant  health  and 

environmental  (including  climatic)  conditions  in the 

area of the proposed use. 

2.1.2 

Where  the  proposed  use  concerns  another  effect  than 

the control of or the protection against an organism, 

Member  States  shall  evaluate  if  significant  damage, 

loss  or  inconvenience  could  occur  under  the 

agricultural, 

plant 

health 

and 

environmental 

(including  climatic)  conditions  in  the  area  of  the 

proposed  use  if  the  plant  protection  product  would 

not be used. 

2.1.3 

Member States shall evaluate the efficacy data on the 

plant protection product as provided  for in Annex III 

having  regard  to the degree of control or the extent 

of  the  effect  desired  and  having  regard  to  the 

relevant experimental  conditions such as : 

-  17 -

the choice of the crop or cultivar 

the  agricultural  and  environmental  (including 

climatic) conditions 

the  presence  and  density  of  the  harmful 

organism 

the development  stage of crop and organism 

the  amount  of  the  plant  protection  product 

used 

if  required  on  the  label,  the  amount  of 

adjuvant added 

the frequency and timing of the applications 

- 

the type of application  equipment 

2.1.4 

Member  States  shall  evaluate  the  performance  of  the 

plant  protection  product  in a range of  agricultural, 

plant  health  and  environmental  (including  climatic) 

condit'ions  likely  to  be  encountered  in  practice  in 

the area of proposed use and in particular : 

(i) 

the level, duration and consistency of control 

or  protection  or  other  intended  effects  in 

comparison  with  suitable  reference  products 

and an untreated control; 

(ii)  where relevant the yield response or reduction 

of loss in storage in terms of quantity and/or 

quality  in  comparison  with  suitable  reference 

products and an untreated control. 

-  18 -

A  suitable  reference  product  is  defined  as  an 

authorized  plant protection  product which  has proved 

a  sufficient  performance  in  practice  under  the 

agricultural, 

plant 

health 

and 

environmental 

(including  climatic)  conditions  in  the  area  of 

proposed  use.  In  general,  formulation  type, mode  of 

action,  working  spectrum  and  method  of  application 

should  be  close  to  those  of  the  tested  plant 

protection product. 

Where  no  suitable  reference  product  exists,  Member 

States  shall  evaluate  the  performance  of  the  plant 

protection  product  to  determine  if  there  is  a 

consistent 

and 

defined 

benefit 

under 

the 

agricultural, 

plant 

health 

and 

environmental 

(including  climatic)  conditions  in  the  area  of 

proposed use. 

2.1.5 

Where  proposed  label  claims  include  recommendations 

for  use  of  the  plant  protection  product  with  other 

plant  protection  products  as  a  tank  mix,  Member 

States  shall  make  the  evaluations  referred  to  under 

points 2.1.1 to 2.1.4  above for the tank mix. 

-  19 -

2.2. 

Absence  of  unacceptable  effects  on  plants  or  plant 

products 

2.2.1 

Member  States  shall  evaluate  the  degree  of  adverse 

effects  on  the  treated  crop  after  use  of  the  plant 

protection  product  according  to  the  proposed 

conditions of use in comparison, where relevant, with 

suitable  reference  products  and/or  an  untreated 

control : 

a) 

This  evaluation  will  take  into  consideration 

the following  information : 

(i) 

the  efficacy data provided  for in Annex III; 

(ii)  other  relevant  information  on  the  plant 

protection  product  such  as  nature  of  the 

preparation,  application  rate,  method  of 

application, 

number 

and 

timing 

of 

applications; 

(iii)  all  relevant  information  on  the  active 

substance  as  provided  for  in  Annex  II 

including  mode  of  action,  vapour  pressure, 

volatility and water  solubility. 

b) 

This evaluation will  include : 

(i) 

the  nature,  frequency,  level  and  duration  of 

observed 

phytotoxic 

effects 

and 

the 

agricultural,  plant  health  and  environmental 

(including  climatic)  conditions  that  affect 

these; 

(ii)  the differences  between  cultivars with  regard 

to their sensitivity to phytotoxic effects; 

- 20 -

(iii)  the part  of  the treated  crop where  phytotoxic 

effects are observed; 

(iv)  the  adverse  impact  on  the  yield  of  the 

treated  crop,  in  terms  of  quantity  and/or 

quality; 

(v) 

the  adverse  impact  on treated  plants or plant 

products  to  be  used  for  propagation,  such  as 

viability, germination, sprouting, rooting and 

establishment; 

(vi)  where  highly  volatile  herbicides,  active  at a 

very  low  dose,  are  concerned,  the  adverse 

impact on adjacent crops. 

2.2.2 

Where  the  available  data  indicate  that  the  active 

substance or significant metabolites, degradation and 

reaction  products  persist  in  soils  and/or  in  or  on 

plants  or  plant  products,  after  use  of  the  plant 

protection  product  according  to  the  proposed 

conditions  of  use,  Member  States  shall  evaluate  the 

degree of  adverse  effects  on  succeeding  crops.  This 

evaluation  will  be  carried  out  as  specified  under 

point 2.2.1 above. 

2.2.3 

Where  proposed  label  claims  include  recommendations 

for  use  of  the  plant  protection  product  with  other 

plant  protection  products  as  a  tank  mix,  the 

evaluation  as  specified  under point  2.2.1  above will 

be carried out  for the tank mix. 

2.3. 

Impact on vertebrates to be controlled 

- 21 -

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. 

2.4. 

Impact on human or animal health 

- 22 -

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; 

(iv)  other  relevant  information  as provided  for  in 

- 23 -

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. 

2.4.1.4 

Member  States  shall  evaluate  the  possibility  of 

- 24 -

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. 

2.4.2. 

Arising  from residues 

- 25 -

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; 

- 26 -

(iii)  the  specific  information  on residues  in or on 

treated  plants, plant  products,  food  and  feed 

as provided  for in Annex  II and the results of 

the evaluation thereof; 

2.4.2.4 

Member  States  shall  evaluate  the  residue  levels  in 

products of  animal  origin,  taking  into  consideration 

the  information  provided  for  in  Annex  III,  Part  A, 

point 8.4. 

2.4.2.5 

Member  States  shall  estimate  the potential  exposure 

of  consumers  through  diet  and  where  relevant  other 

ways of exposure using  a suitable calculation model. 

This evaluation will take account, where relevant, of 

other  sources  such as other authorized  uses of plant 

protection  products  containing  the  same  active 

substance or which give rise to the same residues. 

2.4.2.6 

Member  States  shall,  where  relevant,  estimate  the 

exposure of  animals, taking  into  account  the  residue 

levels  in  treated  plants  or  plant  products  intended 

to be fed to animals. 

2.5. 

Influence on the environment 

- 27 -

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. 

- 28 -

(ii)  other  relevant  information  on  the  active 

substance such as : 

- molecular weight 

- solubility  in water 

- octanol/water partition  coefficient 

- vapour pressure 

- volatilization  rate 

- dissociation constant 

- photodegradation  rate  and  identity  of 

breakdown products 

- hydrolysis  rate  in  relation  to  pH  and 

identity of breakdown products; 

(iii)  all  relevant 

information  on  the  plant 

protection  product  as  provided  for  in  Annex 

III  including  the  information  on  distribution 

and dissipation  in soil; 

(iv)  where relevant, other authorized  uses of plant 

protection  products  in  the  area  of  proposed 

use  , containing  the same active  substance  or 

which give rise to the same residues. 

2.5.1.2 

Member  States  shall evaluate the possibility  for the 

plant  protection  product  to  reach  the  ground  water 

under  the  proposed  conditions  of  use;  if  the 

possibility  exists that  the plant  protection  product 

can reach the ground water they shall estimate, using 

where  appropriate  a  suitable  calculation  model,  the 

concentration of the active substance and of relevant 

metabolites,  degradation  and  reaction  products  that 

could  be expected  in the ground water  in or  from the 

areas  of  envisaged  use  after  use  of  the  plant 

protection  product  according  to  the  proposed 

conditions of use. 

- 29 -

This  evaluation  will  take  into  consideration  the 

following  information : 

(i) 

the  specific  information  on  the  fate  and 

behaviour  in  the  soil  and  in  water  as 

provided  for  in  Annex  II  and  the  results  of 

the evaluation thereof; 

(ii)  other  relevant  information  on  the  active 

substance  such as: 

- molecular weight 

- solubility  in water 

- octanol/water partition  coefficient 

- vapour pressure 

- volatilization rate 

- hydrolysis  rate  in  relation  to  pH  and 

identity of breakdown products 

- - dissociation  constant 

(iii)  all  relevant  information  on  the  plant 

protection  product  as  provided  for  in  Annex 

III  including  the  information  on  distribution 

and dissipation in  soil and water; 

(iv)  where relevant, other authorized uses of plant 

protection  products  in  the  area  of  envisaged 

use  containing  the  same  active  substance  or 

which give rise to the same residues ; 

(v) 

where  relevant,  data  on  dissipation  including 

transformation  and  sorption  in the  saturated 

zone; 

(vi)  where  relevant,  data  on  the  procedures  for 

drinking  water  abstraction  and  treatment  in 

the area of envisaged use. 

2.5.1.3 

Member  States  shall evaluate the possibility  for the 

- 30 -

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; 

- 31 -

(iv)  possible routes of exposure : 

- drift 

- run-off 

- overspray 

- discharge via drains 

-  leaching 

- atmospheric  deposition; 

(v) 

where relevant, other authorized uses of plant 

protection  products  in  the  area  of  envisaged 

use  containing  the  same  active  substance  or 

which give rise to the same residues; 

(vi)  where  relevant,  data  on  the  procedures  for 

drinking  water  abstraction  and  treatment  in 

the area of envisaged use. 

2.5.1.4 

Member  States  shall evaluate the possibility  for the 

plant  protection  product  to  be  dissipated  in  the 

air  under  the  proposed  conditions  of  use;  if  this 

possibility  exists  they  shall  estimate,  using  where 

appropriate  a  suitable  calculation  model,  the 

concentration of the active substance and of relevant 

metabolites,  degradation  and  reaction  products  that 

could  be expected  in  the  air  after  use  of  the  plant 

protection  product  according  to  the  proposed 

conditions of use. 

This  evaluation  will  take  into  consideration  the 

following  information : 

(i) 

the  specific  information  on  the  fate  and 

behaviour  in  the  soil,  water  and  in  air  as 

provided  for  in  Annex  II  and  the  results  of 

the evaluation thereof; 

- 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. 

2.5.2.4 

Member  States  shall  evaluate  the  possibility  of 

- 38 -

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. 

2.6 

Analytical methods 

- 42 -

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. 

2.7 

Physical and chemical properties 

-  44 -

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. 

C. 

1. 

1. 

- 46 -

DECISION MAKING 

General Principles 

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 

2. 

Specific principles 

- 50 

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. 

2.1.4 

Conclusions as to performance of the preparation must 

- 51 -

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. 

2.2.4 

There  must  be  no  unaceptable  adverse  impact  on 

- 52 -

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. 

2.4. 

Impact on human or animal health 

- 53 -

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 

2.4.1.4 

Waiting  and  re-entry  periods  or  other  precautions 

- 54 -

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. 

2.4.2.2 

Member  States  shall, where  no Community  MRL(*)  nor a 

-  55 -

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. 

D T90 >  * 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 

2.5.2. 

Impact on non-target species 

- 59 -

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. 

2.6 

Analytical methods 

- 62 -

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 

0.1 

1 

>1 

0.005 

0.025 

0.125 

50 

25 

12.5 

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 

Difference 

Difference 

mg/kg 

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 

2.7 

Physical and chemical properties 

- 64 -

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 

250 - 500 g/kg or g/1 

±6 % 

±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