Proposal for a Council Directive establishing Annex VI to Directive 91/414/EEC concerning the placing of plant protection products on the market
Date: 1997-06-10
Institutions: European Commission
Subjects: environmental protection, groundwater, health policy, marketing, pharmaceutical product

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels,  10.06.1997 
COM(97) 284 final 

Proposal  for a 

COUNCIL  DIRECTIVE 

establishing Annex VI to Directive  91/414/EEC 
concerning the placing of plant protection products on the market 

(presented by the Commission) 

EXPLANATORY MEMORANDUM 

1.Background 

Council Directive 94/43/EC1 of 27 July  1994 established  Annex 
VI to Council Directive  91/414/EEC2 of  15 July  1991  concerning 
the placing-of plant protection products on the market.  Annex 
VI contains the uniform principles to be used by Member  States 
when authorising  plant protection products containing  active 
substances  included  in Annex  I of Directive  91/414/EEC. 

On  18 June  1996 the European Court of Justice  annulled 
Directive  94/43/EC  following  action by the Parliament  against 
the Council on the basis that  it modified  the scope  of the 
basic Directive  91/414/EEC without  following  the  legislative 
procedure prescribed  by the Treaty, which  calls  for Parliament 
to be consulted  (case C-303/94). 

The Court  found  that Directive  94/43/EC modified  the scope of 
the basic directive by: 

- establishing  uniform principles that did not cover all the 
requirements provided  in Article  4 of the basic directive. 
Specifically Article  4 requires that plant protection  products 
must have no unacceptable  influence on the  environment 
including  inter 
refers only to groundwater  intended  for the production  of 
drinking water and not all groundwater. 

alia  groundwater whilst Directive  94/43/EC 

1 OJ No L227,  1.9.1994, p.31 

2 OJ No L230,  19.8.1991, p.l 

-  allowing the issue of conditional  authorizations  for plant 
protection products whose  foreseeable concentrations  in 
groundwater  intended  for the production  of drinking  water 
exceeds the maximum permissable concentration  laid down  in a 
reference measure  (in this case Council Directive  80/778/EEC3 
of  15 July  1980 relating to the quality  of water  intended  for 
human  consumption). 

The need to re-establish  uniform principles  is urgent  given 
that the  first active substances  could be included  in Annex I 
during  Spring  1997.  Without uniform principles  some of the 
main provisions of Directive  91/414/EEC,  including  the high 
level of protection  of human and animal health  and the 
environment required  and the mutual recognition of 
authorizations  between Member  States, cannot be operated. 

2. Aim  and provisions  of the proposal 

The current proposal  intends to establish  a new text  for Annex 
VI to Directive  91/414/EEC. 

In this proposal the provisions relating  to groundwater  are 
amended  and  further restricted  as it was these  provisions 
which were contested  by Parliament  and  found  by the Court not 
to satisfy  the basic provisions of Article  4 of  Directive 
91/414/EEC. The other provisions have not been changed  as they 
were not contested, were agreed  in Council  only  very  recently 
and no elements arose  indicating  that they would  not  satisfy 
the requirements  of the basic directive. 

The  following  specific  changes are proposed  and  further 
explained  in more detail : 

2.1.  EVALUATION 

The proposed  amendments  in section B, Evaluation,  2. Specific 
principles, paragraph  2.5.1.2: 

ensure that the evaluation  covers now all groundwater, 
and not only groundwater  intended  for drinking  water 
production. 

clarify the use of monitoring  data, pending  the  adoption 
of more precise provisions  in the framework  of the new 
water  Directives under preparation. 

2.2. DECISION  MAKING 

The following  regime  is proposed  in section c,  Decision 
making,  2. Specific principles, paragraph  2.5.1.2 : 

3 OJ No L229,  30.8.1980, p.11. 

for  all  plant protection products, containing  either new or 
existing  active  substances  the following  requirement  is 
applied  : no authorization may be granted  if, as a result of 
the use of the plant protection product  under the 
conditions of use  (i.e. the conditions of use that  are 
proposed  to be applied  after  the authorization will have been 
granted),  the expected  concentration  in groundwater  exceeds 
the lower of the two following  limit 

proposed 

values 

: 

(i) the maximum  concentration  laid down  in Directive 
80/778/EEC  related  to the quality of water  intended 
for human consumption  (the so called  "drinking water 
directive").  This standard  has been taken  for the 
reason that  it is precise  and that  it is considered  as 
a high level quality  standard,  and at this time no 
such precise  standard  is provided  for in the  Community 
legislation  for groundwater  itself ; 

(ii) a maximum  concentration which  is based on the 
toxicological  and, where  appropriate,  ecotoxicological 
information  examined by the Commission  and  the Member 
States when the active  substance  is included  in Annex 
I : this maximum  concentration  is either  laid  down 
explicitly by the Commission when the active  substance 
is included  in Annex  I, or when such concentration  has 
not been laid down explicitly by the Commission,  it is 
the concentration extrapolated  from the ADI 
(acceptable daily intake) on the basis  that  10 % of 
the daily  intake  is taking place via the drinking 
water. The ADI  is established  during  the  examination 
of  the above mentioned  toxicological  information, 
before the active  substance  is included  in Annex I. 

The expected  concentrations  in groundwater  are estimated  by 
using  the models  referred  to in part B.  It is however 
acknowledged  that the models currently used do not  always 
enable  a precise  estimation and due to the  included  safety 
factors may overestimate  the concentrations  effectively  found. 
Therefore  the provisions  also provide  for the possibility  that 
authorizations  can be granted when  it is scientifically 
demonstrated,  for example with  field experiments  or 
appropriate  monitoring  data, that  the  lower of  the above 
mentioned  limit values  is not exceeded under relevant  field 
conditions. 

Monitoring  data  should  be '-."" -'-ted and  interpreted  in a 
consistent  scientific  way.  m ey  should normally  cover a 
sufficient  period of time  (not exceeding  one year)  to take 
into account possible  fluctuations. Monitoring  rules and 
procedures  to be  followed will be those  laid down  in existing 
Directives  concerning  the protection of water.  In the  cases 
where particular  concerns arise  specific  action  should be 
considered.  In that case the provisions  of  Directive 
91/414/EEC  apply which means that  such  information  has to be 
sent  to all Member States and the Commission who has to refer 
such information  to the Standing  Committee on Plant Health. 

active  substances  in  situations 

The regime also applies  for plant protection products 
containing  certain  existing 
where,  due  to use of  the product  or other products  containing 
that active  substance  in the past under previous  national 
regulatory  requirements, in practice  the lower of the  limit 
values mentioned under 2.2.a.(i) and  (ii) is already  exceeded 
in groundwater  at least  in certain areas or regions of the 
Member  State concerned.  This situation  is also covered by the 
proposed  text under C 2.5.1.2:  an authorization may only be 
granted  for such products, if the new proposed conditions of 
use are restricted  in such a way that the use under  such 
conditions will not  lead to exceedance  of the lower of the 
limit values mentioned under 2.2  (i) and 2.2  (ii) above, 
without  taking  into account  the already  existing 
concentrations  in groundwater. Therefore, the already  existing 
concentrations  in groundwater  resulting  from previous use will 
not  as such prevent  these plant protection products  from an 
authorization  under this Directive. 

3. 

Evaluation  of  the proposal  in the light  of  the principle 
of  subsidiarity. 

3.1.  What  are the objectives of the proposed  action? 

The proposed  action establishes Annex VI to Council 
Directive  91/414/EEC concerning  the placing of plant 
protection products on the market. 

3.2. Does  the envisaged  action belong  to an exclusive 

Community  competence  or is the competence  shared  between 
the Member States and the  Community? 

The proposed  action belongs to an exclusive  Community 
competence. 

3.3. What  is the Community dimension of the problem? 

Whenever Member States grant  authorizations  for plant 
protection products, containing  an active  substance 
included  in Annex  I to the directive, they must use the 
uniform principles  established  in Annex VI of  Directive 
91/414/EEC  to ensure harmonised  decision making  between 
Member  States.  Without  such harmonised  decision making 
fundamental parts of Directive  91/414/EEC  such as mutual 
recognition of authorizations  between Member  States 
cannot  operate.  Member States may be required  to use 
Annex VI as early as Spring  1997 when  it is expected  that 
the  first  active  substances will be included  in Annex I. 

3.4. What  is the most  efficient  solution  in the light of  the 

possibilities  of.the Community  and the Member  States? 

The most  efficient  solution  is to establish Annex VI of 
Directive  91/414/EEC as soon as possible  and as matter of 
urgency. 

3.5. What  is the added value of the envisaged action, and what 

are the consequences of non action? 

Action  is required  to ensure the full operation of 
Directive  91/414/EEC.  Non action would prevent  the 
operation of the most  important provisions of  Directive 
91/414/EEC. 

3.6. What  are the means  for Community  action? 

The proposed  directive  to establish Annex VI of  Directive 
91/414/EEC. 

3.7. Is harmonisation necessary or is it possible  to adopt a 

framework  directive  containing general principles  leaving 
the application  to the Member  States? 

The harmonization  is necessary and must be as precise  as 
possible. 

4. 

Financial  implications 

The proposal  is expected  to have a negligible  impact  on 
the Community budget. 

5. 

Impact  on industry,  including  SMEs 

See separate  evaluation. 

COUNCIL  DIRECTIVE  / 

/EC 

of 

establishing  Annex  VI  to  Directive  91/414/EEC 
concerning  the  placing  of  plant  protection  products  on  tr 

on  products  on  the  market 

THE  COUNCIL  OF  THE  EUROPEAN  UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community, 

Having  regard  to  Council  Directive  91 /414/EECf1)  of  1 5  July  1991  concerning  the  placing  of 
plant  protection  products  on  the  market,  and  in  particular  Article  18(1)  thereof, 

Having  regard  to  the  proposal  from  the  Commission, 

Whereas  by  the  judgement  of  the  European  Court  of  Justice  of  18  June  1996(2)  Council 
Directive  94/43/EC(3)  of  27  July  1 9 9 4,  establishing  Annex  VI  to  Directive  91/414/EEC,  was 
annulled; 

Whereas  Annex  VI  to  Directive  91/414/EEC  lays  down  uniform  principles  aiming  to  ensure 
that  the  Member  States,  in  deciding  on  authorizations  for  plant  protection  products,  apply  the 
requirements  of  Article  4(1 )(b),  (c),  (d)  and  (e)  of  that  Directive  in  an  equivalent  manner  and 
at  the  high  level  of  protection  of  human  and  animal  health  and  the  environment  sought  by  the 
Directive; 

Whereas  it  is  therefore  necessary  to  lay  down  detailed  principles  concerning  the  evaluation  of 
information  on  plant  protection  products  supplied  by  applicants  and  the  decision  to  be  made 
on  authorization  on  the  basis  of  the  results  of  that  evaluation; 

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); 

Whereas,  initially,  it  is  possible  to  lay  down  at  this  stage  uniform  principles  for  chemical  plant 
protection  products  only;  whereas  therefore  it  remains  for  the  uniform  principles  for  products 
containing  micro-organisms  to  be  laid  down  in  accordance  w i th  the  same  procedure  as 
provided  for  in  Article  18(1)  of  the  Directive  91/414/EEC;  whereas  such  approach  is  in  line 
w i th  Directive  91/414/EEC,  and  in  particular  article  23  (2)  thereof; 

Whereas  in  particular  for  all  plant  protection  products  a  high  level  of  protection  for  all 
groundwater  must  be  satisfied  under  the  conditions  of  use  which  will  be  laid  d o wn  in  the 
authorization;  whereas  therefore  it  must  be  provided  that  plant  protection  products  may  only 
be  authorized  w h en  it  is  adequately  demonstrated  that  their  use  in  accordance  w i th  the 
conditions  to  be  laid  d o wn  in  the  authorization  will  not  lead  to  concentrations  of  the  active 
substance  or  of  relevant  metabolites,  d e g r ^ d M ^"  ~r  reaction  products  in  groundwater  which 

C)  OJ  No  L 2 3 0,  1 9 . 8 . 1 9 9 1,  p.  1.  Directive  as  last  amended  by  Directive  96/68/EC  (OJ  No  L 
2 7 7,  3 0 . 1 0 . 1 9 9 6,  p.  25). 
(2)  Case  C - 3 0 3 / 94 
(3) OJ  No  L 2 2 7,  1.9.1994,  p.  3 1. 

exceed  the  lower  of  the  limit  values  for  groundwater  referred  to  in  this  Directive;  whereas  this 
applies  as  well  for  plant  protection  products  containing  active  substances,  already  on  the 
market  t wo  years  after  notification  of  Directive  91/414/EEC, which  means  that  for  such 
products  an  authorization  can  only  be  granted  where  it  is  adequately  demonstrated  that, 
under  the  new  conditions  of  use  which  will  be  laid  down  in  the  authorization,  the  expected 
concentrations  resulting  exclusively  from  the  new  use  will  not  exceed  the  lower  of  the  limit 
values  referred  to  in  this  Directive; 

Whereas  the  provisions  of  this  Directive  concerning  the  protection  of  water,  including  the 
provisions  related  to  monitoring,  are  without  prejudice  to  Member  States'  obligations  under 
the  Directives  concerning  the  protection  of  water,  and  in  particular 
Directives  75/440/EEC  (4),  80/68/EEC  (5) and  80/778/EEC  (6); 

Whereas  a  review  of  the  abovementioned  Directives  is  in  progress,  and  where  necessary  wil 
have  to  be  followed  by  an  adaptation  of  the  present  Directive; 

Whereas  a  short  implementation  period  is  justified  given  that  in  the  light  of  the  decision  of  the 
European  Court  of  Justice  of  18  June  1996  only  those  provisions  concerning  groundwater 
have  been  reviewed; 

HAS  ADOPTED  THIS  DIRECTIVE: 

Article  1 

Annex  VI  to  Directive  91/414/EEC  is  hereby  established  as  set  out  in  the  Annex  to  this 
Directive. 

Article  2 

Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative  provisions 
necessary  to  comply  w i th  this  Directive  not  later  than  1  October  1 9 9 7. 

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  reference  shall  be  laid  d o wn  by  the  Member  States. 

Article  3 

This  Directive  shall  enter  into  force  on  the  date  of  its  publication  in  the  Official  Journal  of  the 
European  Communities. 

(4)  Council  Directive  75/440/EEC  of  16  June  1975  concerning  the  quality  required  of  surface 
water  intended  for  the  abstraction  of  drinking  water  in  the  Member  States  (OJ  No  L  194, 
2 5 . 7 . 1 9 7 5.  p.  2 6.  Directive  as  last  amended  by  Directive  91/692/EEC  (OJ  No  L  3 7 7, 
3 1 . 1 2 . 1 9 9 1,  p.  4 8 ). 
(5)  Council  Directive  80/68/EEC  of  17  December  1 9 79  on  the  protection  of  groundwater 
against  pollution  caused  by  certain  dangerous  substances  (OJ  No  L 2 0,  2 6 . 1 . 1 9 8 0,  p.  43). 
Directive  as  last  amended  by  Directive  91/692/EEC  (OJ  No  L 3 7 7,  3 1 . 1 2 . 9 1,  p.  4 8 ). 
(6)  Council  Directive  80/778/EEC  of  15  July  1 9 80  relating  to  the  quality  of  water  intended  for 
human  consumption  (OJ  No  L 2 2 9,  3 0 . 8 . 1 9 8 0,  p.  11).  Directive  as  last  amended  by 
Directive  91/692/EEC  (OJ  No  L 3 7 7,  3 1 . 1 2 . 1 9 9 1,  p.  4 8 ). 

This  Directive  is  addressed  to  the  Member  States. 

Article  4 

Done  at  Brussels, 

For  the  Council, 
The  Presidentt 

8 

"ANNEX  VI 

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. 
2.5. 
2.6. 
2.7. 

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 
Influence  on  the  environment 
Analytical  methods 
Physical  and  chemical  properties 

DECISION-MAKING 

1. 

2. 

2 . 1. 

2.2. 
2.3. 
2.4. 
2.5. 
2.6. 
2.7. 

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 
Influence  on  the  environment 
Analytical  methods 
Physical  and  chemical  properties 

INTRODUCTION 

1.  The  principles  developed  in  this  Annex  aim  to  ensure  that  evaluations  and  decisions 

w i th  regard  to  authorization  of  plant  protection  products,  provided  they  are  chemical 

preparations,  result  in  the  implementation  of  the  requirements  of  Article  4(1 )(b),  (c), 

(d)  and  (e)  of  this  Directive  by  all  the  Member  States  at  the  high  level  of  protection 

of  human  and  animal  health  and  the  environment. 

2. 

In  evaluating  applications  and  granting  authorizations  Member  States  shall: 

(a) 

-  ensure  that  the  dossier  supplied  is  in  accordance  w i th  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,  to  the 

provisions  of  Article  13(1)(a),  (4)  and  (6)  of  this  Directive; 

-  ensure  that  the  data  submitted  are  acceptable  in  terms  of  quantity,  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; 

(b) 

take  into  account  the  Annex  II  data  concerning  the  active  substance  in  the 

plant  protection  product,  submitted  for  the  purpose  of  inclusion  of  the  active 

substance  concerned  in  Annex  I,  and  the  results  of  the  evaluation  of  those 

data,  without  prejudice,  where  relevant,  to  the  provisions  of  Article  13(1 )(b), 

(2),  (3)  and  (6)  of  this  Directive; 

(c) 

take  into  consideration  other  relevant  technical  or  scientific  information  they 

can  reasonably  possess  w i th  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. 

10 

3.  Where  in  the  specific  principles  on  evaluation  reference  is  made  to  Annex  II  data, 

this  shall  be  understood  as  being  the  data  referred  to  in  point  2(b). 

4.  Where  the  data  and  information  provided  are  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. 

Taking  account  of  justifications  provided  and  w i th  the  benefit  of  any  subsequent 

clarifications,  Member  States  shall  reject  applications  for  which  the  data  gaps  are 

such  that  it  is  not  possible  to  finalize  the  evaluation  and  to  make  a  reliable  decision 

for  at  least  one  of  the  proposed  uses. 

5.  During  the  process  of  evaluation  and  decision-making,  Member  States  shall 

cooperate  w i th  the  applicants  in  order  to  resolve  any  questions  on  the  dossier 

quickly  or  to  identify  at  an  early  stage  any  additional  studies  necessary  for  a  proper 

evaluation  of  the  dossier,  or  to  amend  any  proposed  conditions  for  the  use  of  the 

plant  protection  product  or  to  modify  its  nature  or  its  composition  in  order  to  ensure 

full  satisfaction  of  the  requirements  of  this  Annex  or  of  this  Directive. 

Member  States  shall  normally  come  to  a  reasoned  decision  within  12  months  of 

receiving  a  technically  complete  dossier.  A  technically  complete  dossier  is  one  that 

satisfies  all  the  requirements  of  Annex  III. 

6.  The  judgments  made  by  the  competent  authorities  of  the  Member  States  during  the 

evaluation  and  decision-making  process  must  be  based  on  scientific  principles, 

preferably  recognized  at  international  level  (for  example,  by  the  EPPO),  and  be  made 

w i th  the  benefit  of  expert  advice. 

1  1 

B. 

EVALUATION 

1.  General  principles 

1.  Having  regard  to  current  scientific  and  technical  knowledge,  Member  States 

shall  evaluate  the  information  referred  to  in  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  humans,  animals  or  the  environment. 

2. 

In  accordance  w i th  the  terms  of  Article  4  of  this  Directive,  which  inter  alia 

specifies  that  Member  States  shall  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  and  in  particular  to  the  purpose  of  use, 

the  dose,  the  manner,  frequency  and  timing  of  applications,  and  the  nature  and 

composition  of  the  preparation.  Whenever  possible  Member  States  shall  also 

take  into  account  the  principles  of  integrated  control. 

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  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  or  of  under-estimating  their  importance  are  reduced  to  a 

minimum.  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. 

12 

The  first  evaluation  made  shall  be  based  on  the  best  available  data  or  estimates 

reflecting  the  realistic  conditions  of  use  of  the  plant  protection  product. 

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  and  resulting  in  a  realistic  worst-case  approach,  to  determine  whether 

it  is  possible  that  the  initial  evaluation  could  have  been  significantly  different. 

5.  Where  specific  principles  of  Section  2  provide  for  the  use  of  calculation  models 

in  the  evaluation  of  a  plant  protection  product,  those  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  in  B,  point  1.4; 

-  be  reliably  validated  w i th  measurements  carried  out  under  circumstances 

relevant  for  the  use  of  the  model; 

-  be  relevant  to  the  conditions  in  the  area  of  use. 

6.  Where  metabolites,  degradation  or  reaction  products  are  referred  to  in  the 

specific  principles,  only  those  that  are  relevant  for  the  proposed  criterion  shall 

be  taken  into  consideration. 

13 

2. 

Specific  principles 

Member  States  shall,  for  the  evaluation  of  the  data  and  information  submitted 

in  support  of  applications,  and  without  prejudice  to  the  general  principles  of 

Section  1, implement  the  following  principles. 

2 . 1. 

Efficacy 

2 . 1 . 1.  Where  the  proposed  use  concerns  the  control  of  or  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  an  effect  other  than  the  control  of  or 

protection  against  an  organism,  Member  States  shall  evaluate  whether 

significant  damage,  loss  or  inconvenience  could  occur  under  the  agricultural, 

plant  health  and  environmental  (including  climatic)  conditions  in  the  area  of 

proposed  use  if  the  plant  protection  product  were  not  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: 

- 

the  choice  of  the  crop  or  cultivar; 

- 

the  agricultural  and  environmental  (including  climatic)  conditions; 

14 

- 

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) 

conditions  likely  to  be  encountered  in  practice  in  the  area  of  proposed  use  and 

in  particular  : 

(i) 

the  level,  consistency  and  duration  of  the  effect  sought  in  relation  to  the 

dose  in  comparison  w i th  a  suitable  reference  product  or  products  and  an 

untreated  control; 

(ii)  where  relevant,  effect  on  yield  or  reduction  of  loss  in  storage,  in  terms  of 

quantity  and/or  quality,  in  comparison  w i th  a  suitable  reference  product  or 

products  and  an  untreated  control. 

Where  no  suitable  reference  product  exists,  Member  States  shall  evaluate  the 

performance  of  the  plant  protection  product  to  determine  whether  there  is  a 

consistent  and  defined  benefit  under  the  agricultural,  plant  health  and 

environmental  (including  climatic)  conditions  in  the  area  of  proposed  use. 

15 

2.1.5.  Where  the  product  label  includes  requirements  for  use  of  the  plant  protection 

product  w i th  other  plant  protection  products  and/or  w i th  adjuvants  as  a  tank 

mix,  Member  States  shall  make  the  evaluations  referred  to  in  points  2.1.1 

to  2.1.4  in  relation  to  the  information  supplied  for  the  tank  mix. 

Where  the  product  label  includes  recommendations  for  use  of  the  plant 

protection  product  w i th  other  plant  protection  products  and/or  w i th  adjuvants 

as  a  tank  mix,  Member  States  shall  evaluate  the  appropriateness  of  the  mix  and 

of  its  conditions  of  use. 

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,  w i th  a  suitable  reference  product  or 

products,  where  they  exist,  and/or  an  untreated  control. 

(a)  This  evaluation  will  take  into  consideration  the  following  information: 

(t) 

the  efficacy  data  provided  for  in  Annex  III; 

(ii)  other  relevant  information  on  the  plant  protection  product  such  as 

nature  of  the  preparation,  dose,  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. 

16 

(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  main  cultivars  w i th  regard  to  their  sensitivity 

to  phytotoxic  effects; 

(iii) 

the  part  of  the  treated  crop  or  plant  products  where  phytotoxic 

effects  are  observed; 

(iv) 

the  adverse  impact  on  the  yield  of  the  treated  crop  or  plant  products 

in  terms  of  quantity  and/or  quality; 

(v) 

the  adverse  impact  on  treated  plants  or  plant  products  to  be  used  for 

propagation,  in  terms  of  viability,  germination,  sprouting,  rooting  and 

establishment; 

(vi)  where  volatile  products  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 

plant  substances  in  significant  quantities  after  use  of  the  plant  protection 

product  according  to  the  proposed  conditions  of  use,  Member  States  shall 

evaluate  the  degree  of  adverse  effects  on  subsequent  crops.  This  evaluation 

will  be  carried  out  as  specified  in  point  2 . 2 . 1. 

17 

2.2.3.  Where  the  product  label  includes  requirements  for  use  of  the  plant  protection 

product  w i th  other  plant  protection  products  or  w i th  adjuvants  as  a tank  mix, 

the  evaluation  as  specified  in  point  2.2.1  will  be  carried  out  in  relation  to  the 

information  supplied  for  the  tank  mix. 

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  observed  effects  on  the  behaviour  and  health  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 

conditions  under  which  death  occurs. 

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 

18 

2 . 4 . 1. 

Arising  from  the  plant  protection  product 

2 . 4 . 1 . 1.  Member  States  shall  evaluate  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, 

application  method  and  climatic  conditions)  using  by  preference  realistic  data 

on  exposure  and,  if  such  data  are  not  available,  a  suitable,  validated  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  (AOEL).  The  acceptable 

operator  exposure  level  is  the  maximum  amount  of  active 

substance  to  which  the  operator  may  be  exposed  without  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  highest  level  at  which  no  adverse  effect  is 

observed  in  tests  in  the  most  sensitive  relevant  animal  species 

or,  if  appropriate  data  are  available,  in  humans; 

(ii)  other  relevant  information  on  the  active  substances  such  as 

physical  and  chemical  properties; 

(iii) 

the  toxicological  studies  provided  for  in  Annex  III,  including 

where  appropriate  dermal  absorption  studies; 

19 

(iv)  other  relevant  information  as  provided  for  in  Annex  III  such  as: 

-  composition  of  the  preparation; 

-  nature  of  the  preparation; 

-  size,  design  and  type  of  packaging; 

- 

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  stated  on  the  label; 

-  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  and  routine  maintenance  of 

application  equipment. 

20 

2 . 4 . 1 . 2.  Member  States  shall  examine  information  relating  to  the  nature  and 

characteristics  of  the  packaging  proposed  w i th  particular  reference  to  the 

following  aspects: 

the  type  of  packaging; 

its  dimensions  and  capacity; 

the  size  of  the  opening; 

the  type  of  closure; 

its  strength,  leakproofness  and  resistance  to  normal  transport  and 

handling; 

its  resistance  to  and  compatibility  w i th  the  contents. 

2 . 4 . 1 . 3.  Member  States  shall  examine  the  nature  and  characteristics  of  the  protective 

clothing  and  equipment  proposed  w i th  particular  reference  to  the  following 

aspects: 

obtainability  and  suitability; 

ease  of  wearing  taking  into  account  physical  stress  and  climatic 

conditions. 

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. 

21 

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, 

including  the  acceptable  operator  exposure  level; 

(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; 

maximum  spray  application  volume; 

- 

composition  of  the  preparation; 

excess  remaining  on  plants  and  plant  products  after  treatment; 

further  activities  whereby  workers  are  exposed. 

22 

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  metabolites, degradation  and reaction products in 

treated  plants or plant products; 

behaviour  of  residues of the  active  substance  and its  metabolites 

from the time of  application  until harvest,  or in the  case of 

post-harvest  uses, until outloading  of  stored plant 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  ill  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. 

23 

2 . 4 . 2 . 3.  On  the  basis  of  suitable  statistical  models  Member  States  shall  evaluate  the 

residue  levels  observed  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  and  the 

distribution  of  residues  between  edible  and  non-edible  parts; 

(iii) 

the  specific  information  on  residues  in  or  on  treated  plants,  plant 

products,  food  and  feed  as  provided  for  in  Annex  II  and t he  results  of 

the  evaluation  thereof; 

(iv) 

the  realistic  possibilities  of  extrapolating  data  from  one  crop  to 

another. 

2 . 4 . 2 . 4.  Member  States  shall  evaluate  the  residue  levels  observed  in  products  of  animal 

origin,  taking  into  consideration  the  information  provided  for  in  Annex  III,  Part 

A,  point  8.4  and  residues  resulting  from  other  uses. 

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  of 

information  such  as  other  authorized  uses  of  plant  protection  products 

containing  the  same  active  substance  or  which  give  rise  to  the  same  residues. 

24 

2.4.2.6.  Member  States  shall,  where  relevant,  estimate  the  exposure  of  animals,  taking 

into  account  the  residue  levels  observed  in  treated  plants  or  plant  products 

intended  to  be  fed  to  animals. 

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  aspects  of  the 

environment,  including  biota,  and  in  particular  to  the  following: 

2 . 5 . 1 . 1.  Member  States  shall  evaluate  the  possibility  of  the  plant  protection  product 

reaching  the  soil  under  the  proposed  conditions  of  use;  if  this  possibility  exists 

they  shall  estimate  the  rate  and  the  route  of  degradation  in  the  soil,  the 

mobility  in  the  soil  and  the  change  in  the  total  concentration  (extractable  and 

non-extractable  f  )  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  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  cannot  be  extracted  by  methods  which  do  not 
significantly  change  the  chemical  nature  of  these  residues.  These  non-extractable 
residues  are  not  considered  to  include  fragments  through  metabolic  pathways  leading  to 
natural  products. 

25 

(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  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. 

26 

2 . 5 . 1 . 2.  Member  States  shall  evaluate  the  possibility  of  the  plant  protection  product 

reaching  the  groundwater  under  the  proposed  conditions  of  use;  if  this 

possibility  exists,  they  shall  estimate,  using  a  suitable  calculation  model 

validated  at  Community  level, the  concentration  of  the  active  substance  and  of 

relevant  metabolites,  degradation  and  reaction  products  that  could  be  expected 

in  the  groundwater  in  the  area  of  envisaged  use  after  use  of  the  plant 

protection  product  according  to  the  proposed  conditions  of  use. 

As  long  as  there  is  no  validated  Community  calculation  model,  Member  States 

shall  base  their  evaluation  especially  on  the  results  of  mobility  and  persistence 

in  soil  studies  as  provided  for  in  Annexes  II  and  III. 

This  evaluation  will  also  take  into  consideration  the  following  information: 

(i) 

the  specific  information  on  fate  and  behaviour  in  soil  and  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; 

27 

vapour  pressure; 

volatilization  rate; 

hydrolysis  rate  in  relation  to  pH  and  identity  of  breakdown 

products; 

dissociation  constant; 

(iii) 

all  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; 

(vii) 

where  relevant,  monitoring  data  on  the  presence  or  absence  of  the 

active  : jc5tanc3  and  rsievar.t  ,~staboiites,  ciegraaaiion  or  reaction 

products 

in  groundwater  as  a  result  of  previous  use  of  plant 

protection  products  containing  the  same  active  substance  or  which 

give  rise  to  the  same  residues;  such  monitoring  data  shall  be 

interpreted  in  a  consistent  scientific  way. 

28 

2.5.1.3.  Member  States  shall evaluate the  possibility  of the  plant  protection  product 

reaching surface  water  under the  proposed conditions  of  use; if this  possibility 

exists they  shall estimate,  using a suitable  calculation  model validated  at 

Community level, the short-term  and long-term predicted  concentration  of  the 

active  substance  and of  metabolites, degradation  and reaction  products  that 

could  be expected  in the  surface  water  in the  area  of  envisaged  use  after  use 

of the  plant protection product  according to the proposed conditions  of use. 

If  there  is no validated  Community calculation  model, Member  States shall 

base their  evaluation  especially  on the  results of  mobility  and persistence  in 

soil studies  and the  information on run-off  and drift  as provided for in 

Annexes  II  and III.  This evaluation  will also take  into consideration the 

following information: 

(i) 

the  specific  information on fate  and behaviour  in soil and 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; 

29 

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) 

possible  routes  of  exposure: 

drift; 

run-off; 

overspray; 

discharge  via  drains; 

leaching; 

deposit  in  the  atmosphere; 

(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; 

30 

(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  of  the  plant  protection  product 

being  dissipated  in  the  air  under  the  proposed  conditions  of  use;  if  this 

possibility  exists  they  shall  make  the  best  possible  estimation,  using  where 

appropriate  a  suitable,  validated  calculation  model,  of  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  fate  and  behaviour  in  soil,  water  and  air  as 

provided  for  in  Annex  II  and  the  results  of  the  evaluation  thereof; 

(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; 

31 

(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  procedures  for  destruction  or 

decontamination  of  the  plant  protection  product  and  its  packaging. 

2.5.2. 

Impact  on  non-target  species 

When  calculating  toxicity/exposure  ratios  Member  States  shall  take  into 

consideration  toxicity  to  the  most  sensitive  relevant  organism  used  in  the 

tests. 

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  extent  of  the 

short-term  and  long-term  risk  to  be  expected  for  these  organisms,  including 

their  reproduction,  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  toxicological  studies  on 

mammals  and  to  the  effects  on  birds  and  other  non-target 

terrestrial  vertebrates,  including  effects  on  reproduction,  and 

other  relevant  information  concerning  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; 

32 

(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,  breakdown  and  reaction  products  in  the  various 

parts  of  the  environment  after  application  of  the  plant  protection 

product; 

(ii) 

the  estimated  exposure  of  the  species  likely  to  be  exposed  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  w i th  treated  vegetation; 

(iii)  a  calculation  of  the  acute,  short-term  and,  where  necessary, 

long-term  toxicity/exposure  ratio.  The  toxicity/exposure  ratios 

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. 

33 

[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; 

(ii)  other  relevant  information  on  the  active  substance  such  as: 

-  solubility  in  water; 

-  octanol/water  partition  coefficient; 

-  vapour  pressure; 

-  volatilization  rate; 

-  KOC; 

-  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; 

34 

(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,  breakdown  and reaction products in 

water,  sediment  or fish; 

(ii)  a calculation  of the  acute  toxicity/exposure  ratio for  fish and 

Daphnia.  This ratio  is defined  as the quotient  of  respectively 

acute  LC50 or EC50 and the  predicted  short-term  environmental 

concentration; 

(iii)  a calculation of the  algal growth inhibition/exposure  ratio for 

algae.  This ratio  is defined  as the  quotient  of the  EC50 and the 

predicted  short-term  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  NOEC and the  predicted  long-term  environmental 

concentration; 

(v)  where  relevant,  the  bioconcentration  in fish  and possible 

exposure  of  predators of  fish,  including humans; 

35 

(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; 

(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); 

36 

(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  expressed in 

grammes of  active  substance  per  hectare  and the  contact  and 

oral  LD50 expressed  in /;g of  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,  colony  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  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 the  lethal 

and sublethal effects  on these  organisms to  be expected  and the  reduction in 

their  activity  after  use of the  plant  protection  product  according to the 

proposed conditions  of use. 

37 

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 Annex  III such as: 

effects  on beneficial  arthropods  other than bees; 

toxicity  to honeybees; 

available  data  from  biological  primary screening; 

38 

maximum  application  rate; 

maximum  number  and  timetable  of  applications. 

(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. 

2.5.2.5.  Member  States  shall  evaluate  the  possibility  of  exposure  of  earthworms  and 

other  non-target  soil  macro-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  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  non-target  soil 

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: 

-  solubility  in  water; 

-  octanol/water  partition  coefficient; 

39 

-  Kd for adsorption; 

-  vapour pressure; 

-  hydrolysis  rate  in relation to  pH and identity  of  breakdown 

products; 

-  photodegradatior* rate  and identity  of  breakdown products; 

-  DT50 and DT90 for  degradation  in the soil; 

(iii)  all relevant  information on the  plant  protection  product as 

provided for  in Annex  III, including the  effects  on earthworms 

and other  non-target  soil 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; 

40 

(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)  where  relevant,  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  of  the  plant  protection  product 

reaching  the  soil  under  the  proposed  conditions  of  use,  evaluate  the  impact  on 

microbial  activity  such  as  the  impact  on  nitrogen  and  carbon  mineralization 

processes  in  the  soil  after  use  of  the  plant  protection  product  according  to  the 

proposed  conditions  of  use. 

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  non-target  soil  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  ill,  including  the  effects  on  non-target  soil 

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. 

(iv) 

all  available  information  from  biological  primary  screening. 

41 

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,  ecotoxicologically  or 

environmentally  significant  impurities  and  co-formulants. 

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  as  provided  for  in  Annex  III  and  in 

particular: 

the  specificity  and  linearity  of  the  proposed  methods; 

the  importance  of  interferences; 

the  precision  of  the  proposed  methods  (intra-laboratory 

repeatability  and  inter-laboratory  reproducibility); 

(iii) 

the  limit  of  detection  and  determination  of  the  proposed  methods  for 

impurities; 

42 

2.6.2. 

for  residue  analysis: 

the  residues  of  the  active  substance,  metabolites,  breakdown  or  reaction 

products  resulting  from  authorized  uses  of  the  plant  protection  product  and 

w h i ch  are  of  toxicological,  ecotoxicological  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  as  provided  for  in  Annex  III  and  in 

particular: 

the  specificity  of  the  proposed  methods; 

the  precision  of  the  proposed  methods  (intra-laboratory 

repeatability  and  inter-laboratory  reproducibility); 

the  recovery  rate  of  the  proposed  methods  at  appropriate 

concentrations; 

(iii) 

the  limit  of  detection  of  the  proposed  methods; 

(iv) 

the  limit  of  determination  of  the  proposed  methods. 

43 

2.7. 

Physical and chemical  properties 

2.7.1. 

Member  States  shall evaluate  the  actual  active  substance  content  of 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 suitable  FAO specification  exists, the  physical  and chemical 

properties  addressed  in that  specification; 

where  no suitable  FAO specification  exists, 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: 

(i) 

the data  on the  physical and chemical properties  of the  active 

substance  as provided for  in Annex  II and the  results  of the 

evaluation  thereof; 

(ii) 

the  data  on the  physical and chemical properties  of the  plant 

protection  product  as provided for  in Annex III. 

2.7.3. 

Where  proposed  label claims include  requirements  or recommendations for 

use of the  plant  protection  product  with other  plant  protection  products or 

adjuvants  as a tank  mix, the  physical  and chemical compatibility  of the 

products  in the  mixture  must  be evaluated. 

44 

C. 

DECISION-MAKING 

1.  General  principles 

1.  Where  appropriate,  Member  States shall impose conditions  or restrictions 

with the  authorizations they grant.  The  nature  and severity  of these 

measures must be selected on the  basis of,  and be appropriate  to, the 

nature  and extent  of the  expected  advantages  and the  risks likely to arise. 

2.  Member  States shall ensure that,  where  necessary,  decisions taken  with 

respect to the granting of  authorizations  take  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 number  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  rates 

and the  number of  applications  may not give rise to  undesirable  effects  such 

as the development  of  resistance. 

4.  Member  States  shall ensure that  decisions respect the  principles of 

integrated  control if the  product  is intended to  be used in conditions  where 

these  principles  are relied on. 

45 

5.  Since the  evaluation  is to  be based on data  concerning  a limited number of 

representative  species,  Member  States  shall ensure that  use of  plant 

protection  products does not have  any long-term repercussions  for the 

abundance  and diversity  of  non-target  species. 

6.  Before  issuing an authorization,  Member  States shall ensure that  the  label of 

the  product: 

fulfils the  requirements  of  Article  16 of this  Directive; 

also contains the  information on protection of  users required by 

Community  legislation on worker protection; 

specifies  in particular  the  conditions or restrictions  under  which the 

plant  protection  product  may or may not  be used as referred to in 

points  1 , 2 , 3 ,4  and 5 above. 

The  authorization  shall mention the  particulars  indicated  in Article  6(2)(g) 

and  (h),  (3)  and  (4)  of  Council  Directive  78/631 /EEC of  26  June  1978 on the 

approximation  of the  laws of the  Member  States  relating to the 

classification,  packaging  and labelling of  dangerous  preparations 

(pesticides)  C) and in Article  16(g) and (h) of  Directive  91/414/EEC. 

7.  Before issuing  authorizations,  Member  States shall: 

(a) 

ensure that  the  proposed packaging  is in accordance  with the 

provisions  of  Directive  78/631/EEC; 

[1)  OJ No L 206,  29.7.1978, p.  13.  Directive  as last  amended by Directive  92/32/EEC 

(OJ  No L 154,  5.6.1992, p.  1). 

46 

(b) 

ensure  that: 

the  procedures  for  destruction  of  the  plant  protection  product; 

the  procedures  for  neutralization  of  the  adverse  effects  of  the 

product  if  it  is  accidentally  dispersed; 

the  procedures  for  the  decontamination  and  destruction  of  the 

packagings, 

are  in  accordance  w i th  the  relevant  regulatory  provisions. 

8.  No  authorization  shall  be  granted  unless  all  the  requirements  referred  to  in 

Section  2  are  satisfied.  However: 

(a) 

when  one  or  more  of  the  specific  decision-making  requirements 

referred  to  in  Part  C,  points  2 . 1, 2.2,  2.3  or  2.7,  are  not  fully 

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. 

Any  restrictions  on  use  of  the  product  relating  to  non-compliance 

w i th  some  of  the  aforementioned  requirements  must  be  mentioned  on 

the  label,  and  non-compliance  w i th  the  requirements  referred  to  in 

point  2.7  must  not  compromise  proper  use  of  the  product.  These 

advantages  can  be  in  terms  of: 

advantages  for  and  compatibility  w i th  integrated  control 

measures  or  organic  farming; 

47 

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,  e.g.  for  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  referred  to  in  Part  C,  point  2.6,  are  not  fully 

satisfied  because  of  limitations  in  current  analytical  science  and 

technology,  authorization  shall  be  granted  for  a  limited  period  if  the 

methods  submitted  prove  adequate  for  the  purposes  intended. 

In  this 

case  the  applicant  shall  be  given  a time  limit  in  which  to  develop  and 

submit  analytical  methods  that  are  in  accordance  w i th  the  criteria 

referred  to  above.  The  authorization  will  be  reviewed  on  expiry  of  the 

time  limit  accorded  to  the  applicant; 

(c) 

where  the  reproducibility  of  the  submitted  analytical  methods  referred 

to  in  Part  C,  point  2.6,  has  only  been  verified  in  t wo  laboratories,  an 

authorization  shall  be  granted  for  one  year  to  permit  the  applicant  to 

demonstrate  the  reproducibility  of  those  methods  in  accordance  w i th 

agreed  criteria. 

9.  Where  an  authorization  has  been  granted  according  to  the  requirements 

provided  for  in  this  Annex,  Member  States  may,  by  virtue  of  Article  4(6): 

(a) 

define,  where  possible,  preferably  in  close  co-operation  w i th  the 

applicant,  measures  to  improve  the  performance  of  the  plant 

protection  product,  and/or 

48 

(b) 

define,  where  possible,  in  close  co-operation  w i th  the  applicant, 

measures  to  reduce  further  the  exposure  that  could  occur  during  and 

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. 

2. 

Specific  principles 

The  specific  principles  shall  apply  without  prejudice  to  the  general  principles 

referred  to  in  Section  1. 

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  on  the 

basis  of  experience  acquired  or  scientific  evidence  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  those  conditions,  no  authorization  shall  be  granted  for  those 

uses. 

2 . 1 . 2. 

The  level,  consistency  and  duration  of  control  or  protection  or  other  intended 

effects  must  be  similar  to  those  resulting  from  the  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,  consistency  and 

duration  of  control  or  protection  or  other  intended  effects  under  the 

agricultural,  plant  health  and  environmental  (including  climatic)  conditions  in 

the  area  of  proposed  use. 

49 

2.1.3.  Where  relevant,  yield  response  when  the  product  is  used  and  reduction  of  loss 

in  storage  must  be  quantitatively  and/or  qualitatively  similar  to  those  resulting 

from  the  use  of  suitable  reference  products. 

If  no  suitable  reference  product 

exists,  the  plant  protection  product  must  be  shown  to  give  a  consistent  and 

defined  quantitative  and/or  qualitative  benefit  in  terms  of  yield  response  and 

reduction  of  loss  in  storage  under  the  agricultural,  plant  health  and 

environmental  (including  climatic)  conditions  in  the  area  of  proposed  use. 

2.1.4.  Conclusions  as  to  the  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  or  particular  growing 

conditions). 

2.1.5.  Where  proposed  label  claims  include  requirements  for  use  of  the  preparation 

w i th  other  specified  plant  protection  products  or  adjuvants  as  a tank  mix,  the 

mixture  must  achieve  the  desired  effect  and  comply  w i th  the  principles  referred 

to  in  points  2.1.1  to  2.1.4. 

Where  proposed  label  claims  include  recommendations  for  use  of  the 

preparation  w i th  other  specified  plant  protection  products  or  adjuvants  as  a 

tank  mix,  Member  States  shall  not  accept  the  recommendations  unless  they  are 

justified. 

2.2. 

Absence  of  unacceptable  effects  on  plants  or  plant  products 

2 . 2 . 1. 

There  must  be  no  relevant  phytotoxic  effects  on  treated  plants  or  plant 

products  except  where  the  proposed  label  indicates  appropriate  limitations  of 

use. 

50 

2 . 2 . 2. 

There  must  be  no  reduction  of  yield  at  harvest  due  to  phytotoxic  effects  below 

that  which  could  be  obtained  without  the  use  of  the  plant  protection  product, 

unless  this  reduction  is  compensated  for  by  other  advantages  such  as  an 

enhancement  of  the  quality  of  the  treated  plants  or  plant  products. 

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  unacceptable  adverse  effects  on  treated  plants  or  plant 

products  used  for  propagation  or  reproduction,  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  or  reproduction. 

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  requirements  for  use  of  the  preparation 

w i th  other  plant  protection  products  or  adjuvants,  as  a  tank  mix,  the  mixture 

must  comply  w i th  the  principles  referred  to  in  points  2.2.1  to  2.2.6. 

51 

2.2.8. 

The  proposed  instructions  for  cleaning  the  application  equipment  must  be 

both  practical  and  effective  so  that  they  can  be  applied  w i th  ease  so  as  to 

ensure  the  removal  of  residual  traces  of  the  plant  protection  product  which 

could  subsequently  cause  damage. 

2.3. 

Impact  on  vertebrates  to  be  controlled 

An  authorization  for  a  plant  protection  product  intended  to  eliminate 

vertebrates  shall  be  granted  only  w h e n: 

death  is  synchronous  w i th  the  extinction  of  consciousness,  or 

death  occurs  immediately,  or 

vital  functions  are  reduced  gradually  without  signs  of  obvious 

suffering. 

For  repellant  products,  the  intended  effect  shall  be  obtained  without 

unnecessary  suffering  and  pain  for  the  target  animals. 

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). 

52 

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/EECof  27  November  1980 on the  protection  of  workers 

from the  risks  related  to  exposure  to  chemical, physical  and  biological 
agents  at  work  (2) and  in accordance  with  Council  Directive  90/394/EEC of 

28  June  1990 on the  protection  of  workers  from  the  risks  related  to 
exposure  to  carcinogens  at  work  (3). 

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  those  items 

are  effective  and  in accordance  with  the  relevant  Community  provisions  and 

are  readily  obtainable  by the  user  and  unless  it  is feasible  to  use  them  under 

the  circumstances  of  use  of  the  plant  protection  product,  taking  into  account 

climatic  conditions  in  particular. 

2.4.1.3.  Plant  protection  products  which  because  of  particular  properties  or  if 

mishandled  or  misused  could  lead to  a high  degree  of  risk  must  be subject  to 

particular  restrictions  such  as restrictions  on the  size  of  packaging,  formulation 

type,* distribution, use  or  manner  of  use.  Moreover,  plant  protection  products 

which  are  classified  as very  toxic  may  not  be authorized  for  use  by  non 

professional  users. 

(2)  OJ  No  L 327,  3.12.1980, p.  8.  Directive  as last  amended  by  Directive  88/642/EEC 

(OJ  No L 356,  24.12.1988,p.  74). 

(3)  O J N o L 1 9 6 , 2 6.  7.1990, p.  1. 

53 

2 . 4 . 1 . 4.  Waiting  and  re-entry  safety  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  any  limit  values  established  for  those  compounds  in  accordance 

w i th  the  Community  provisions  referred  to  in  point  2 . 4 . 1 . 1. 

2 . 4 . 1 . 5.  Waiting  and  re-entry  safety  periods  or  other  precautions  must  be  established  in 

such  a  w ay  that  no  adverse  impact  on  animals  occurs. 

2 . 4 . 1 . 6.  Waiting  and  re-entry  periods  or  other  precautions  to  ensure  that  the  AOEL 

levels  and  limit  values  are  respected  must  be  realistic;  if  necessary  special 

precautionary  measures  must  be  prescribed. 

2 . 4 . 2. 

Arising  from  residues 

2 . 4 . 2 . 1.  Authorizations  must  ensure  that  residues  occurring  reflect  the  minimum 

quantities  of  the  plant  protection  product  necessary  to  achieve  adequate 

control  corresponding  to  good  agricultural  practice,  applied  in  such  a  manner 

(including  pre-harvest  intervals  or  withholding  periods  or  storage  periods)  that 

the  residues  at  harvest,  slaughter  or  after  storage,  as  appropriate,  are  reduced 

to  a  minimum. 

54 

2 . 4 . 2 . 2.  Where  no  Community  MRL  ( * *)  or  provisional  MRL  (at  national  or  at 

Community  level)  exists,  Member  States  shall  establish  a  provisional  MRL 

in accordance  with  Article  4(1 ){f)  of  this  Directive;  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  and  frequency 

or  manner  of  use. 

(**)  A  Community  MRL  will  mean  an  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  O,  Council  Directive  86/362/EEC  of 
24  July  1 9 86  on the  fixing  of  maximum  levels  for  pesticide  residues  in  and  on 
cereals  (b),  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  (c),  Council  Regulation 
(EEC)  No  2 3 7 7 / 90  of  26  June  1990  laying  down  a  Community  procedure  for  the 
establishment  of  maximum  residue  limits  of  veterinary  medicinal  products  in  foodstuffs 
of  animal  origin  (d),  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  (•)  or  Council  Directive  91/132/EEC  of  4  March  1991 
amending  Directive  74/63/EEC  on  undesirable  substances  and  products  in 
feedingstuffs  (f). 

(a)  OJ No L 340, 9.1 2.1976, p.  26.  Directive  as last amended  by Directive  96/32/EC  (0J 

No L144;  18.6.1996, p.  12). 
OJ  No  L  2 2 1,  7.  8 . 1 9 8 6,  p.  3 7.  Directive  as  last  amended  by  Directive  96/33/EC 
(OJ  No  L  1 4 4,  1 8 . 6 . 1 9 9 6,  p.  35). 
O J N o L 2 2 1,  7.  8 . 1 9 8 6,  p.  4 3.  Directive  as  last  amended  by  Directive  96/33/EC 
(OJ  No  L  1 4 4,  1 8 . 6 . 1 9 9 6,  p.  35). 
OJ  No  L  2 2 4,  18.  8 . 1 9 9 0,  p.  1.  Regulation  as  last  amended  by  Commission 
Regulation  (EEC)  No  9 5 5 / 94  (OJ  No  L  108,  2 9 . 4 . 1 9 9 4 , p.  8). 
OJ  No  L 3 5 0,  14.1 2.1 9 9 0,  p.  7 1.  Directive  as  amended  by  Directive  96/32/EC 
(OJ  No  L  144,  1 8 . 6 . 1 9 9 6,  p.  12). 
OJ  No  L  6 6,  13.  3 . 1 9 9 1,  p.  16. 

(b) 

(c) 

(d) 

(a) 

(f) 

55 

2 . 4 . 2 . 3.  Where  the  new  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  previously,  Member  States  shall  not 

grant  an  authorization  for  the  plant  protection  product  unless  the  applicant  can 

provide  evidence  that  its  recommended  use  will  not  exceed  that  MRL  or  unless 

a  new  provisional  MRL  has  been  established  by  the  Member  State  or  the 

Commission  in  accordance  w i th  Article  4(1 )(f)  of  this  Directive. 

2 . 4 . 2 . 4.  Where  a  Community  MRL  exists  Member  States  shall  not  grant  an  authorization 

for  the  plant  protection  product  unless  the  applicant  can  provide  evidence  that 

its  recommended  use  will  not  exceed  that  MRL,  or  unless  a  new  Community 

MRL  has  been  established  in  accordance  w i th  the  procedures  provided  for  in 

the  relevant  Community  legislation. 

2 . 4 . 2 . 5.  In  the  cases  referred  to  in  points  2.4.2.2  and  2 . 4 . 2 . 3,  each  application  for  an 

authorization  must  be  accompanied  by  a  risk  assessment  taking  into  account 

worst-case  potential  exposure  of  consumers  in  the  Member  State  concerned  on 

the  basis  of  good  agricultural  practice. 

Taking  into  account  all  registered  uses,  the  proposed  use  cannot  be 

authorized  if  the  best  possible  estimate  of  dietary  exposure  exceeds  the 

acceptable  daily  intake  (ADI). 

2 . 4 . 2 . 6.  Where  the  nature  of  residues  is  affected  during  processing,  a  separate  risk 

assessment  may  need  to  be  carried  out  under  the  conditions  provided  for  in 

point  2 . 4 . 2 . 5. 

2 . 4 . 2 . 7.  Where  the  treated  plants  or  plant  products  are  intended  to  be  fed  to  animals, 

residues  occurring  shall  not  have  an  adverse  effect  on  animal  health. 

56 

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 

significance  from  the  toxicological,  ecotoxicological  or  environmental  point  of 

view,  metabolites  and  breakdown  or  reaction  products,  after  use  of  the  plant 

protection  product  under  the  proposed  conditions  of  use: 

during  tests  in  the  field,  persist  in  soil  for  more  than  one  year  (i.e. 

D T9 0>  1 year  and  D T5 0>3  months),  or 

during  laboratory  tests,  form  not  extractable  residues  in  amounts 

exceeding  7 0%  of  the  initial  dose  after  100  days  w i th  a 

mineralization  rate  of  less  than  5%  in  100  days, 

unless  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  points  2 . 5 . 1 . 2, 

2 . 5 . 1 . 3,  2 . 5 . 1 . 4.  and  2.5.2. 

57 

2.5.1.2  (a)  No  authorization  shall  be  granted  if  the  concentration  of  the  active 

substance  or  of  relevant  metabolites,  degradation  or  reaction  products  in 

groundwater,  may  be  expected  to  exceed,  as  a  result  of  use  of  the  plant 

protection  product  under  the  proposed  conditions  of  use,  the  lower  of  the 

following  limit  values: 

(i) 

the  maximum  permissible  concentration  laid  d o wn  by  Council  Directive 

80/778/EEC(4)  of  15  July  1980  relating  to  the  quality  of  water  intended 

for  human  consumption,  or 

(ii) 

the  maximum  concentration  laid  d o wn  by  the  Commission  when  including 

the  active  substance  in  Annex  I,  on  the  basis  of  appropriate  data, 

in  particular  toxicological  data,  or,  where  that  concentration  has  not  been 

laid  d o w n,  the  concentration  corresponding  to  one  tenth  of  the  ADI  laid 

d o wn  when  the  active  substance  was  included  in  Annex  I 

unless  it  is  scientifically  demonstrated  that  under  relevant  field  conditions 

the  lower  concentration  is  not  exceeded. 

2 . 5 . 1 . 3.  No  authorization  shall  be  granted  if  the  concentration  of  the  active  substance  or 

of  relevant  metabolites,  breakdown  or  reaction  products  to  be expected  after  use 

of  the  plant  protection  product  under  the  proposed  conditions  of  use  in  surface 

water: 

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 

Council  Directive  75/440/EEC  of  1 6  June  1975  concerning  the  quality 

required  of  surface  water  intended  for  the  abstraction  of  drinking  water 

in  the  Member  States  (5),  or 

has  an  impact  deemed  unacceptable  on  non-target  species,  including 

animals,  according 

to 

the 

relevant 

requirements  provided 

for 

in 

point  2 . 5 . 2. 

(4)  OJ  No  L  2 2 9,  3 0 . 8 . 1 9 8 0,  p.  1 1.  Directive  as  last  amended  by  Directive  91 /692/EEC 
(OJ  No  L  3 7 7,  3 1 . 1 2 . 1 9 9 1,  p.  4 8 ). 
(5)  OJ  No  L  1 9 4,  2 5 . 7 . 1 9 7 5,  p.  3 4.  Directive  as  last  amended  by  Directive  91/692/EEC 

(OJ  No  L  3 7 7,  3 1 . 1 2 . 1 9 9 1,  p.  48). 

58 

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 reduced to  a minimum. 

2.5.1.4.  No  authorization  shall  be  granted  if  the  airborne  concentration  of  the  active 

substance  under the  proposed conditions  of  use is such that  either  the  AOEL or 

the  limit  values  for  operators,  bystanders  or  workers  as  referred  to  in  Part C, 

point  2.4.1,  are exceeded. 

59 

2 . 5 . 2. 

Impact  on  non-target  species 

2 . 5 . 2 . 1.  Where  there  is  a  possibility  of  birds  and  other  non-target  terrestrial  vertebrates 

being  exposed,  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  on  the  basis  of  LD50  or  the 

long-term  toxicity/exposure  ratio  is  less  than  5,  unless  it  is  clearly 

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  occur  -  directly  or 

indirectly  -  after  use  of  the  plant  protection  product  according  to  the 

proposed  conditions  of  use. 

2 . 5 . 2 . 2.  Where  there  is  a possibility  of  aquatic  organisms  being  exposed,  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  long-term  exposure,  or 

the  algal  growth  inhibition/exposure  ratio  is  less  than  10,  or 

the  maximum  bioconcentration  factor  (BCF)  is  greater  than  1 0 00  for 

plant  protection  products  containing  active  substances  w h i ch 

are  readily  biodegradable  or  greater  than  100  for  those 

which  are  not  readily  biodegradable, 

60 

unless  it  is clearly  established through  an appropriate  risk  assessment 

that  under  field  conditions  no  unacceptable  impact  on the  viability  of 

exposed species (predators) occurs  -  directly or indirectly -  after use of 

the  plant  protection  product  according  to  the  proposed  conditions  of 

use. 

2.5.2.3.  Where there is a possibility of honeybees being exposed, 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,  or colony  survival  and development  after 

use of the plant  protection product  according to the  proposed conditions of use. 

2.5.2.4.  Where  there  is a possibility  of  beneficial  arthropods  other than  honeybees  being 

exposed, no authorization 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 

those  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.  Where there  is a possibility of  earthworms being exposed, no authorization shall 

be granted  if the  acute toxicity/exposure  ratio for earthworms  is less than  10 or 

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. 

61 

2 . 5 . 2 . 6.  Where  there  is  a possibility  of  non-target  soil  micro-organisms  being  exposed,  no 

authorization  shall  be  granted  if  the  nitrogen  or  carbon  mineralization  processes 

in  laboratory  studies  are  affected  by  more  than  2 5%  after  100  days,  unless  it  is 

clearly  established  through  an  appropriate  risk  assessment 

that  under 

field 

conditions  there  is  no  unacceptable  impact  on  microbial  activity  after  use  of  the 

plant  protection  product  according  to  the  proposed  conditions  of  use,  taking 

account  of  the  ability  of  micro-organisms  to  multiply. 

2.6. 

Analytical  methods 

The  methods  proposed  must  reflect  the  state  of  the  art.  The  following  criteria 

must  be  met  in  order  to  permit  validation  of  the  analytical  methods  proposed 

for  post-registration  control  and  monitoring  purposes: 

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, ecotoxicologically  or  environmentally 

significant  impurities  and  co-formulants; 

2.6.2. 

for  residue  analysis: 

(i) 

the  method  must  be  able 

to  determine  and  confirm 

residues  of 

toxicological,  ecotoxicological  or  environmental  significance; 

(ii) 

the  mean  recovery  rates  should  be  between  7 0%  and  1 1 0%  w i th  a 

relative  standard  deviation  of  <_  2 0 %; 

62 

(iii) 

the  repeatability  must be less than the  following values  for  residues in 

foodstuffs: 

Residue level 

Difference 

mg/kg 

mg/kg 

Difference 

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; 

(iv) 

the reproducibility must be less than the following values for residues in 

foodstuffs: 

Residue level 

Difference 

mg/kg 

mg/kg 

Difference 

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; 

63 

(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  at  the  limit  of  determination,  the 

sensitivity  of the  methods proposed must satisfy  the  following  criteria 

Limit  of  determination  in  relation  to  the  proposed  provisional  or 

Community MRL: 

MRL  (mg/kg) 

limit of determination  (mg/kg) 

>  0,5 

0,5  - 0 , 05 

<  0,05 

0,1 

0,1  -  0,02 

MRL  x 0 , 5. 

2.7. 

Physical  and chemical  properties 

2.7.1. 

Where an appropriate FAO specification exists, that specification must be met. 

2.7.2. 

Where  no  appropriate  FAO specification  exists,  the  physical  and  chemical 

properties  of the  product  must meet the following  requirements: 

(a) 

Chemical properties: 

Throughout the shelf-life period, the difference  between the stated and 

the  actual  content  of  the  active  substance  in  the  plant  protection 

product  must  not exceed the following values: 

64 

Declared  content  in 

g/kg  or  g/l  at  20°C 

Tolerance 

up  to  25 

±  1 5%  homogeneous  formulation 

±  2 5%  non-homogeneous  formulation 

more  than  25  up  to  100 

more  than  100  up  to  2 50 

more  than  2 50  up  to  5 00 

± 1 0% 

±  6% 

±  5% 

more  than  5 00 

±  25  g/kg  or  ±  25  g/l 

(b) 

Physical  properties: 

The  plant  protection  product  must  fulfil  the  physical  criteria  (including 

storage  stability)  specified  for  the  relevant  formulation  type 

in  the 

"Manual  on  the  development  and  use  of  FAO  specifications  for  plant 

protection  products". 

2 . 7 . 3. 

Where  the  proposed  label  claims  include  requirements  or  recommendations  for 

use  of  the  preparation  with  other  plant  protection  products  or  adjuvants  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,  those  products  or  adjuvants  must  be physically  and chemically  compatible 

in  the  tank  mix." 

65 

IMPACT ASSESSMENT FORM 

THE IMPACT OF THE PROPOSAL ON BUSINESS 

with special reference  to small and medium  sized  enterprises 

Title of proposal: 

Proposal  for  a  Council  Directive  to  establish  Annex  VI  of  Council 

directive  91/414/EEC  concerning  the  placing  of  plant  protection 

products on the market 

The proposal 

1. 

Taking account of the principle of subsidiarity, why is Comunity legislation necessary 

in this area and what are it main aims? 

Council Directive 91/414/EEC provides in article  18 par.  1 that uniform  principles 

for  the  evaluation  and  decision  making  on  plant  protection  products  have  to  be 

established  as Annex VI to the Directive. The uniform  principles aim to ensure that 

all  Member  States  will  apply  the  requirements  of  the  Directive  in  an  equivalent 

manner  and  at  the high level  of  protection  of  human  and  animal  health  and  of  the 

environment  saught by the Directive. 

The impact on business: 

2.  Who will be affected  by the proposal? 

which  sectors of business 

which sizes of business (what is the concentration of small and medium sized 

firms) 

are there particular geographical areas of the Community where these business 

Cc 

are  found? 

All  companies  applying  for  the authorisation  of  plant protection  products  will have 

to ensure that their products meet the criteria established  in the uniform  principles. 

3.  What will business have to do to comply with the proposal? 

Companies will have to meet the data requirements set already in Annexes II and III 

of the Directive in order to demonstrate that under the proposed conditions of use the 

plant protection product  to be authorized  meets the requirements  of the Directive. 

4.  What economic effects  is the proposal  likely to have? 

on employment 

on investment  and the creation of new business 

on the competitive position of business 

The  proposal,  and  in  particular  the  provisions  concerning  the  protection  of 

groundwater,  will have an impact on industry,  including agriculture.  Authorizations 

of certain plant protection products already on the market in certain Member States, 

may  have  to  be  withdrawn  or  restricted,  so  that  the  use  of  some  products  with  an 

interesting use pattern for agriculture may disappear or be restricted because they are 

not considered  to be acceptable any more according  to the criteria established  in the 

current proposal.  Certain new products with  interesting use characteristics  may  for 

the same reasons not reach the EC market.  This may in particular affect  EC industry 

and  agriculture  in  their  competitivity  with  third  countries  where  less  stringent 

requirements  apply. 

However Council Directive 91/414/EEC requires a high level of protection of human 

and animal  health and  the environment.  This proposal  for  uniform  principles  has to 

make this requirement operational with the consequence that the E.U. will take a lead 

position towards a sustainable use of plant protection products  in its territory. 

O 

Does the proposal contain measures to take account of the specific  situation of small 

and medium sized firms  (reduced or different  requirements etc.)? 

There are no specific  provisions for  small and medium sized  firms. 

Consultation 

List the organisation which have been consulted about the proposal and outline their 

main views. 

European Crop Protection Association (ECPA) and European Crop Care Association 

(ECCA) 

contest the scientific basis for the very strict critérium applied for groundwater 

(0,1/xg/l) 

propose that time-weighted avarages for the concentrations in groundwater be 

used and that the weaknesses of model calculations are taken into account; 

want  a  derogation  for  compounds  which  present  unequivocal  advances  in 

protection of human health and the environment but which do occasionally not 

meet the groundwater  requirement 

COPA and COGECA 

supports  in general the approach of DG VI to progress the proposal  for new 

uniform  principles as rapidly  as possible 

supports  ECPA  concerning  the  approach  for  the  protection  of  groundwater 

(see comments of ECPA above). 

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ISSN 0254-1475 

COM(97) 284 final 

DOCUMENTS 

EN 

05  10  15 

Catalogue  number  :  CB-CO-97-274-EN-C 

ISBN 92-78-21143-5 

Office  for  Official  Publications of the European  Communities 

L-2985  Luxembourg 

£9