9. 9. 76 Official  Journal  of the  European  Communities No C 212/3 
II 
(Preparatory  Acts) 
COMMISSION 
Proposal  for a Council  Directive  concerning  the placing  of EEC-accepted  plant 
protection  products  on the market 
(Submitted  by the Commission  to the Council  on 4 August  1976) 
THE  COUNCIL  OF THE  EUROPEAN  COMMUNITIES, 
Having  regard  to  the  Treaty  establishing  the 
European  Economic  Community,  and  in particular 
Article  100 thereof, 
Having  regard  to the proposal  from  the Commission, 
Having  regard  to the  opinion  of the  European 
Parliament, 
Having  regard  to the opinion  of the Economic  and 
Social  Committee, 
Whereas  plant  production  has a very  important  place 
in the European  Communities; 
Whereas  the yield  from  that  production  is continually 
being  affected  by harmful  organisms  and  weeds  and 
whereas  it is absolutely  essential  to protect  plants 
against  these  risks  to prevent  a fall  in yields  and 
thereby  help  to assure  the availability  of supplies; 
Whereas  one  of the  most  important  methods  of 
protecting  plants  and  plant  products  and  of 
increasing  the  productivity  of agriculture  is to use 
plant  protection  products; 
Whereas  the effects  of these  plant  protection  products 
may not  be wholly  favourable  for plant  production 
and their  use  may  involve  risks  for  man  and  the 
environment  since,  in the  main,  they  are  toxic 
substances  or preparations  having  dangerous  effects; Whereas,  there  are  rules  in most  Member  States 
governing  approval  to  place  plant  protection 
products  on  the  market  and  whereas  these 
regulations  contain  differences  which  constitute  an 
obstacle  to trade  and  thereby  directly  affect  the 
establishment  and  functioning  of the  common 
market; 
Whereas  it is therefore  desirable  to eliminate  this 
obstacle  by aligning  the  relevant  provisions  laid 
down  in the  Member  States  by law,  regulation  or 
administrative  provision  to  create  conditions 
permitting  the  free  circulation  of plant  protection 
products  in the Community; 
Whereas  a large  number  of plant  protection  products 
are already  in circulation  in the Member  States  and 
whereas  a considerable  proportion  of these  are 
intended  only  for  local  or regional  circulation  to 
meet  local  or regional  agricultural  and  ecological 
conditions  and  needs;  whereas  it therefore  seems 
desirable  that  Member  States  remain  free  to regulate 
in accordance  with  national  provisions  plant 
protection  products  intended  for circulation  in their 
own territory; 
Whereas  in a first  stage  the need  for harmonization 
will be satisfied  by the  creation  of the  type  of an 
EEC-accepted  plant  protection  product  which  may  be 
placed  freely  on the market  within  the  Community 
and whereas  all  EEC-accepted  plant  protection 
products  are to be listed  in a 'Common  catalogue  of 
EEC-accepted  plant  protection  products'; 
Whereas  there  must  be uniform  rules  in the Member 
States  relating  to the  conditions  and  procedure  for 
EEC-acceptance; 
No C 212/4 Official  Journal  ot the European  Communities 9. 9. 76 
Whereas  it is necessary,  at the  time  when  plant 
protection  products  are EEC-accepted,  to make  sure 
that when  properly  applied  for the purpose  intended 
they are  sufficiently  effective  and  have  no 
unacceptable  effect  on plants  or plant  products,  no 
unreasonable  adverse  influence  on the environment  in 
general  and,  in particular,  no harmful  effect  on 
human  or animal  health; 
Whereas,  in a first  stage,  EEC-acceptance  shall  be 
limited  to plant  protection  products  containing 
certain  active  substances  laid  down  at Community 
level; 
Whereas  EEC-accepted  plant  protection  products 
shall  after  expiry  of a certain  period  be subject  to no 
restrictions  on placing  them  on the market  within  the 
Community  for  reasons  related  to the  requirements 
laid down  in this  Directive  and  the Annexes  thereto; 
Whereas  it is desirable  to give  Member  States  the 
right  through  a special  procedure  to raise  any 
objections  they  may  have  to a plant  protection 
product  and  its inclusion  in the Common  catalogue 
as well  as prohibit  a plant  protection  product  already 
included  in the aforementioned  Catalogue  or limit  its 
use; 
Whereas  it is desirable  that  the Commission  should 
ensure  that  plant  protection  products  to be included 
in the  Common  catalogue  of EEC-accepted  plant 
protection  products  be published  in the  Official 
Journal  of the European  Communities; 
Whereas  this  Directive  complements  the  Council 
Directive  of ... on the  approximation  of the  laws, 
regulations  and  administrative  provisions  of Member 
States  relating  to the  classification,  packaging  and 
labelling  of pesticides  in respect  of the packaging  and 
labelling  of EEC-accepted  plant  protection  products; 
whereas,  together  with  the  latter  Directive,  it 
considerably  improves  the  protection  given  to the 
users  of plant  protection  products  and  to the 
consumers  of plants  and  plant  products  and  whereas 
it also  contributes  to  the  protection  of  the 
environment; 
Whereas  in order  to ensure  that  the requirements  laid 
down  in respect  of EEC-accepted  plant  protection 
products  are  satisfied  when  placed  on the  market, 
Member  States  must  make  provision  for appropriate 
control  arrangements; 
Whereas  official  investigations  of EEC-accepted  plant 
protection  products  to check  their  compliance  with the provisions  of this  Directive  shall  be carried  out in 
accordance  with  Community  methods  of sampling 
and analysis; 
Whereas  the implementation  of this  Directive  and  the 
adaptation  of its Annexes  to the  development  of 
technical  and  scientific  knowledge  necessitates  a close 
cooperation  between  the  Commission  and  Member 
States;  whereas  the  procedure  of the  Standing 
Committee  on Plant  Health  offers  a suitable  basis  for 
this, 
HAS  ADOPTED  THIS  DIRECTIVE: 
Article  1 
This  Directive  concerns  the  placing  on the  market 
within  the  Community  of  EEC-accepted  plant 
protection  products  put up in commercial  form. 
Article  2 
For the  purposes  of this  Directive  the  following 
definitions  shall  apply: 
1. Plant  protection  products 
Active  substances  and  preparations  containing 
one ore more  active  substances  intended: 
1.1. to destroy  organisms  harmful  to plants  or 
plant  products  or to protect  them  from  such 
organisms,  in so far as such  substances  or 
preparations  are not defined  in the following 
provisions; 
1.2. to influence  the  life  processes  of plants, 
other  than  as a nutrient; 
1.3. to preserve  plant  products,  in so far as they 
are not  subject  to special  Council  or 
Commission  provisions  on preservatives; 
1.4. to destroy  undesired  plants;  or 
1.5. to destroy  parts  of plants  or to prevent 
undesired  growth  of plants. 
2. Plant  protection  products  put  up in commercial 
form 
Plant  protection  products  in the  form  in which 
they are supplied  to the user. 
3.. Residues  of plant  protection  products 
Residues  of plant  protection  products  and  of 
their  toxic  metabolites  or breakdown  products. 
9. 9. 76 Official  Journal  of the European  Communities No C 212/5 
4. Substances 
Chemical  elements  and  their  compounds,  as they 
occur  naturally  or by manufacture. 
5. Preparations 
Mixtures  or solutions  composed  of two  or more 
substances,  or of micro-organisms  or viruses  used 
as plant  protection  products. 
6. Active  substances 
Substances,  micro-organisms  and  viruses,  having 
general  or specific  action: 
6.1. against  harmful  organisms;  or 
6.2. on plants,  parts  of plants  or plant  products. 
7. Plants 
Live plants  and  live  parts  of plants,  including 
fresh  fruit  and seed. 
8. Plant  products 
Products,  in the  unprocessed  state  or having 
undergone  only  simple  preparation  such  as 
milling,  drying,  or pressing,  derived  from  plants, 
but excluding  plants  themselves  as defined  in 7. 
9. Harmful  organisms 
Pests  of plants  or of plant  products,  belonging  to 
the animal  or plant  kingdoms  and  viruses. 
10. Animals 
Animals  belonging  to species  normally  nourished 
and kept  or consumed  by man. 
11. Placing  on the market 
Any handing  over  whether  in return  for payment 
or free  of charge. 
Article  3 
Member  States  shall  provide  that  plant  protection 
products  'may  be placed  on the  market  with  the 
description  'EEC-accepted'  only  if they  have  been 
officially  accepted  in accordance  with  the provisions 
of this  Directive. 
Article  4 
1. Member  States  shall  provide  that  plant 
protection  products  may  be 'EEC-accepted'  only  if, in so far as can  be ascertained  in the light  of current 
scientific  and technical  knowledge: 
1.1. when  properly  applied  for the purpose  intended 
and having  regard  to all foreseeable  conditions 
under  which  they  will  be used 
1.1.1.  they  are sufficiently  effective, 
1.1.2.  they  have  no unacceptable  effect  on plants 
or plant  products, 
1.1.3.  they  have  no harmful  effect  on human  or 
animal  health, 
1.1.4.  they  have  no  unreasonable  adverse 
influence  on the environment; 
1.2. the nature  and  quantity  of  their  active 
substances  can  be  measured  by  methods  in 
general  use. 
2. Uniform  principles  for  checking  compliance 
with  the requirements  listed  in paragraph  1.1 shall  be 
established  in accordance  with  the  procedure  laid 
down  in Article  20. 
3. The  active  substances  whose  inclusion  in 
EEC-accepted  plant  protection  products  is permitted 
are listed  in Annex  I. 
Article  5 
1. Application  for  'EEC-acceptance'  of a plant 
protection  product  may  be made  by: 
1.1. the manufacturer; 
1.2. the distributer,  if the plant  protection  product  is 
to be first  placed  on the  market  within  the 
Community  by a distributer;  or 
1.3. the importer  into  the Community. 
2. Each  applicant  shall  be required  to have  a 
permanent  office  within  the Community. 
Article  6 
1. Each  application  for  EEC-acceptance  may  be 
made  to only  one  Member  State. 
2. Each  Member  State  shall  receive  and  decide 
within  a reasonable  period  on any  application  for 
EEC-acceptance  made  to it. 
3. Within  one  month  of the  receipt  of each 
application  the Member  State  concerned  shall  inform 
the other  Member  States  and  the Commission  thereof 
and shall  at the  same  time  provide^the  following 
particulars  of the application: 
No C 212/6 Official  Journal  of the European  Communities 9. 9. 76 
— the  name  and  address  of the applicant, 
— the  name  or experimental  designation  of the plant 
protection  product, 
— its physical  nature, 
— the  names  and  corresponding  contents  of all 
active  substances  contained  in it, 
— the  uses  for which  it is intended. 
Article  7 
1. The  Member  States  shall  provide  that,  when  an 
application  for EEC-acceptance  of a plant  protection 
product  is made,  at least  those  particulars  which  are 
set out in Annex  II shall  be supplied. 
2. The  applicant  shall  normally  be required  to 
submit  scientific  documentation  relating  to the 
particulars  supplied. 
3. Member  States  and  the  Commission  shall 
ensure  that  information  involving  business  or 
manufacturing  secrets  is, if the applicant  so requests, 
treated  as confidential. 
Article  8 
Member  States  shall  ensure  that  satisfaction  of the 
requirements  for EEC-acceptance  set out in Article  4 
(1) is established  by official  or officially  recognized 
and scientifically  valid  tests  and  analyses. 
Article  9 
1. Member  States  shall  be  responsible  for 
compiling  a file  on  each  EEC-accepted  plant 
protection  product.  Each  such  file  shall  contain  at 
least  a copy  of the  application,  a record  of the 
administrative  actions  taken  by the Member  State  in 
deciding  on the  application  and  all the  essential 
results  of the tests  and  analyses  on which  acceptance 
was based. 
2. Member  States  shall  inform  die other  Member 
States  and  the Commission  immediately  in writing  of 
each  plant  protection  product  EEC-accepted  in 
accordance  with  this  Directive,  indicating  the terms 
and the  period  of validity  of such  acceptance  and 
attaching  copies  of each  different  label  or draft  label 
under  which  the  plant  protection  product  is to be 
placed  on the market  within  the Community.  It shall 
also inform  the  other  Member  States  and  the 
Commission  immediately  of  any  subsequent alteration,  not  constituting  a separate  acceptance,  of 
these  terms. 
3. Any  amendment  of the  particulars  prescribed 
under  items  12, 13 and  14 of paragraph  3.1 of Article 
15 on the label  of an EEC-accepted  plant  protection 
product  shall  be  considered  as  a separate 
EEC-acceptance. 
Article  10 
Member  States  shall,  if so requested,  make  available 
to the other  Member  States  and  to the Commission 
the files  provided  for  under  Article  9 (1) and  shall 
supply  to them  on request  and  to the extent  possible 
all information  necessary  for an understanding  of the 
acceptances. 
Article  11 
1. Member  States  shall  provide  that  EEC-accep-
tance  shall  expire  not  later  than  10  years  from 
31 December  in the year  in which  it is granted.  On 
such expiry,  it may  be renewed  for a further  period 
not exceeding  10 years  and  for  successive  periods 
thereafter  not exceeding  10 years. 
2. Acceptance  shall  be cancelled  or amended  if: 
2.1. it is established  that  the  requirements  for 
acceptance  are not or no longer  satisfied; 
2.2. false  or misleading  particulars  were  supplied 
concerning  the  facts  on the  basis  of which 
acceptance  was  granted. 
3. Acceptance  shall  be cancelled  at any  time  on 
request  in writing  by the  acceptance-holder  to the 
Member  State  which  granted  the acceptance. 
Article  12 
1. With  effect  from  31 December  of the  year 
following  the year  of EEC-acceptance,  the  Member 
States  may  not,  for  reasons  related  to  the 
requirements  laid  down  in this  Directive  and  the 
Annexes  thereto,  refuse,  prohibit  or restrict  the 
placing  on  the  market  of  EEC-accepted  plant 
protection  products  which  comply  with  the 
requirements  of this  Directive  and  the  Annexes 
thereto. 
2. By  way  of derogation  from  paragraph  1 a 
Member  State  may  apply,  not less  than  three  months 
before  expiry  of the  prescribed  time  limit  under  the 
procedure  laid  down  in Article  20, for authorization 
to prohibit  totally  or partially  the placing  of a plant 
9. 9. 76 Official  Journal  of the  European  Communities No C 212/7 
protection  product  on the market  within  its territory 
or to restrict  or vary  its field  of use. 
3. Such  authorization  as provided  for in paragraph 
2 may  be granted  only  if a plant  protection  product 
fails to fulfil  any one  of the requirements  of Article  4, 
paragraph  1.1,  in the territory  of the Member  State 
making  the application.  This  shall  be established  in 
official  or officially  recognized  and  scientifically  valid 
tests  unless  such  failure  is already  evident  from  the 
particulars  in the application. 
4. If  a Member  State  does  not intend  to make  an 
application  under  the  provisions  of paragraph  2 in 
respect  of a plant  protection  product,  it shall  notify 
the Commission  or make  a statement  to that  effect  to 
the Standing  Committee  on Plant  Health. 
5. If  all the Member  States  submit  such  statements 
or inform  the  Commission  as provided  for  in 
paragraph  4, the time  limit  prescribed  in paragraph  1 
shall  no longer  apply  and  Article  13 (1) shall  apply. 
6. The  time  limit  prescribed  in paragraph  1 may  be 
extended  before  its expiry  under  the procedure  laid 
down  in Article  20 if sound  reasons  exist. 
Article  13 
1. The  Commission  shall  publish,  if possible 
before  the end  of each  year,  a list of all the  plant 
protection  products  which  may  be placed  on the 
market  within  the  Community  with  the  description 
'EEC-accepted'  during  the  following  year.  The  list 
shall  be published  in the  Official  journal  of  the 
European  Communities  under  the  title  'Common 
catalogue  of EEC-accepted  plant  protection  products' 
and shall  specify  the year  to which  it relates.  Should 
there  be any  discrepancy  between  the Catalogue  and 
the particulars  of any  acceptance,  the  particulars 
given  in the acceptance  shall  prevail. 
2. Each  Member  State  shall  draw  up an annual  list 
of the  plant  protection  products  EEC-accepted  in 
accordance  with  this  Directive  and  of their  uses 
provided  for within  its territory. 
Article  14 
If it is established  that  in the territory  of a Member 
State  an EEC-accepted  plant  protection  product  when 
properly  applied  for a use  which  has  been  provided 
for, 
1. gives  rise  to harmful  effects  on human  or animal 
health,  or 2. gives  rise  to unacceptable  effects  on plants  or 
plant  products,  or 
3. has  unreasonable  adverse  influence  on  the 
environment, 
the Member  State  may  apply  under  the  procedure 
laid down  in Article  20 for authorization  to prohibit 
totally  or partially  the placing  of this  plant  protection 
product  on the  market  within  its territory  or to 
restrict  its use. 
Article  15 
1. The  Council  Directive  of  ...  on  the 
approximation  of  the  laws,  regulations  and 
administrative  provisions  relating  to the classification, 
packaging  and  labelling  of pesticides  shall  apply  to 
the classification,  packaging  and  labelling  of 
EEC-accepted  plant  protection  products. 
2. Member  States  shall  take  all necessary  steps  to 
ensure  that  plant  protection  products  which  have 
been  accepted  in accordance  with  the  provisions  of 
this Directive  can not be placed  on the market  unless 
their  packaging  satisfies  the following  requirements: 
2.1. the  packages  must  be so constructed  and  sealed 
that their  contents  cannot  escape;  this 
requirement  does  not apply  where  special  safety 
devices  are prescribed; 
2.2. the materials  constituting  the  packages  and 
closures  must  not  be.  liable  to attack  by the 
contents  or liable  to form  harmful  or dangerous 
compounds  with  the contents; 
2.3. the  packages  and  closures  must  be sufficiently 
strong  and  solid  throughout  to ensure  that  they 
cannot  come  apart  and  will  safely  withstand  the 
stresses  and  strains  of normal  handling. 
Packages  meeting  these  requirements  shall  be 
regarded  as satisfactory. 
3. Member  States  shall  provide  that  in addition  to 
the labelling  provisions  of paragraph  1 the packaging 
of EEC-accepted  plant  protection  products  shall 
satisfy  the following  requirements  as to labelling: 
3.1. All packages  must  show  clearly  and  indelibly  the 
following: 
3.1.1.  the proprietary  name  or designation  of the 
plant  protection  product; 
No C 212/8 Official  Journal  of the European  Communities 9. 9. 76 
3.1.2.  the  words  'EEC-accepted'  together  with 
the abbreviation  for  the  Member  State, 
which  has  accepted  the plant  protection 
product,  of the  international  code  used 
for motor  vehicles; 
3.1.3.  the  name  and  address  of the  holder  of 
the EEC-acceptance  and  the  registration 
number  of the plant  protection  product; 
the number  shall  immediately  follow  the 
abbreviation  for  the  Member  State  as 
provided  for in paragraph  3.1.2; 3.1.10.  advice  for  the  protection  of  the 
environment  in general  and  of man  and 
animals  in particular.  Such  safety  advice 
shall  normally  be given  in the  form  of 
standard  phrases  selected  appropriately 
from  these  listed  in Annex  IV of this 
Directive  and  in Annex  IV of the Council 
Directive  67/548/EEC  of 27 June  1967; 
3.1.11.  the type  of plant  protection  product 
(e.g.,  insecticide,  growth  regulator, 
herbicide  etc...  .); 
3.1.4.  if different  from  3.1.3,  the  name  and 
address  of the  person  first  placing  the 
plant  protection  product  on the market; 
3.1.5.  the  names  and  corresponding  contents  of 
all active  substances  contained  in the 
plant  protection  product,  each  active 
substance  being  mentioned  separately  by 
the name  or one  of the names  given  for 
it in Annex  I and  each  corresponding 
content  being  expressed  in terms  of pure 
active  substance  as follows: 
— for  plant  protection  products  which 
are solids,  aerosols,  volatile  liquids 
(boiling  point  maximum  50°  C) or 
viscous  liquids  (lower  limit  1000 
centipoises  at 20°  C): as a percentage 
by weight, 
— for  other  liquids:  as a percentage  by 
weight  and  in g/1 at 20° C, 
— for  gases:  as a percentage  by volume; 
3.1.6.  the  weight  or volume  of the  contents, 
expressed  in metric  units; 
3.1.7.  identification  of the  quantity  manufac-
tured  during  a specified  period; 3.1.12.  the uses  of the plant  protection  product; 
3.1.13.  directions  for  use  and  timing  of 
application; 
3.1.14.  the dose  rate,  expressed  in metric  units, 
for each  use; 
3.1.15.  where  necessary,  the  safety  interval 
between  application  and 
(a) sowing  or planting, 
(b) harvesting, 
(c) use  or consumption,  or 
(d) sowing  or planting  succeeding  crops 
for each  use; 
3.1.16.  warnings  concerning  possible  phytotoxi-
city, varietal  susceptibility,  tainting  of 
produce  and  any  other  adverse  side 
effects,  together  with  the intervals  to be 
observed  between  application  and 
sowing  or planting: 
(a) the  crop  in question,  or 
(b) succeeding  crops; 
3.1.8.  the  physical  nature  of the  preparation 
(e.g.,  wettable  powder,  emulsifiable 
concentrate  etc....); 
3.1.9.  indication  of the nature  of special  risks, 
if any,  to the environment  in general  and 
to man  and  animals  in  particular. 
Indication  of such  risks  shall  normally  be 
given  in the  form  of standard  phrases 
selected  appropriately  from  those  listed 
in Annex  III of this  Directive  and  in 
Annex  III  of the  Council  Directive 
67/548/EEC  of 27 June  1967; 3.1.17.  if accompanied  by a leaflet  as provided 
for in paragraph  3.5 the sentence  'Read 
accompanying  instructions  before  use'. 
In no case  may  wording  on the  label  on plant 
protection  products  accepted  in accordance  with 
the provisions  of this  Directive  bear  such 
indications  as  'non-toxic'  or  'harmless'. 
However,  labels  may  state  that  a plant 
protection  product,  for example,  is harmless  to 
bees or to any  other  specified  organisms  (pests, 
fish,  game,  beneficial  species  etc.)  provided  that 
such  indications  refer  to the  normal  use  of the 
plant  protection  product. 
9. 9. 76 Official  Journal  of the European  Communities No C 212/9 
3.2. The  label  required  in accordance  with  the 
provisions  of paragraph  3.1  must  be so affixed 
to one  or more  surfaces  of the  package  that  it 
can be read  horizontally  when  the package  is set 
down  normally.  The  dimensions  of the  label 
must  be as follows: 
Package  contents 
— less  than  or 
equal  to 3 1 Dimensions 
if possible  at least 
52 x 74 mm, 
— greater  than  3 1, and 
not exceeding  50 1, at  least  74 x 105  mm, 
— geater  than  50 1, and 
not exceeding  500  1 at least  105  x 148  mm, 
— greater  than  500  1 at  least  148  x 210  mm. 
The entire  surface  of the  label  must  adhere  to 
the immediate  packaging  of the plant  protection 
product. 
3.3. A label  shall  not  be  required  where  the 
particulars  are  clearly  shown  on the  package 
itself  in a manner  satisfying  the requirements  of 
paragraph  3.2. 
3.4. Member  States  may  make  the  placing  on the 
market  in their  territories  of plant  protection 
products  accepted  in  accordance  with  the 
provisions  of this  Directive  subject  to the 
requirement  that  such  plant  protection  products 
be labelled  in an least  one  of their  official 
languages. 
3.5. Member  States  may  permit  the  particulars 
required  under  items  13 and  16 of paragraph  3.1 
be indicated  on a separate  leaflet  accompanying 
the package  if the space  available  on the package 
is too  small  to allow  labelling  in accordance 
with  the  provisions  of paragraph  3.2.  Such  a 
leaflet  shall  be regarded  as part  of the label  for 
the purpose  of this  Directive. 
4. Member  States  shall  provide  that  toxic 
EEC-accepted  plant  protection  products  must  be 
strikingly  coloured. 
Article  16 
1. The  Member  States  may  not for reasons  related 
to colour,  packaging  or labelling,  prohibit,  restrict  or 
impede  the placing  on the market  of plant  protection 
products  which  comply  with  the requirements  of this 
Directive  and  the Annexes  thereto. 2. The  provisions  of paragraph  1 shall  be without 
prejudice  to the right  of Member  States  to require: 
2.1. reference  to be  made  on  the  label  that 
EEC-accepted  plant  protection  products  are 
subject  to additional  national  provisions  relating 
to the protection  of the  user  or to the persons 
permitted  to place  them  on the market; 
2.2. a statement  on the label  that  EEC-accepted  plant 
protection  products  may  not  be  used  for 
purposes,  or in a manner,  not  provided  for on 
the label. 
3. Member  States  shall  inform  the other  Member 
States  and  the Commission  of any  implementation  of 
paragraph  2. 
Article  17 
Member  States  shall  make  suitable  arrangements  for 
EEC-accepted  plant  protection  products,  which  have 
been  placed  on the market,  to be officially  controlled, 
at least  by check  sampling,  as regards  their  compliance 
with  the requirements  of this  Directive. 
Article  18 
Member  States  shall  take  all steps  necessary  to ensure 
that official  controls  of  EEC-accepted  plant 
protection  products  to check  their  compliance  with 
the requirements  laid  down  by law,  regulation  or 
administrative  provision  are  carried  out  in 
accordance  with  Community  methods  of sampling 
and analysis. 
Article  19 
1. The  following  shall  be  established,  having 
regard  to current  scientific  and  technical  knowledge, 
in accordance  with  the  procedure  laid  down  in 
Article  20: 
1.1. criteria  for  the  composition,  purity  and 
condition,  where  these  are  found  necessary,  of 
the active  substances  listed  in Annex  I; 
1.2. explanatory  notes  covering  the  particulars  set 
out in Annex  II; 
1.3. any  necessary  amendments  to Annexes  I, II, III 
and IV; 
1.4. the methods  of sampling  and  analysis  referred  to 
in Article  18. 
2. Active  substances  shall  be included  in Annex  I 
only if: 
No C 212/10 Official  Journal  of tne European  Communities 9. 9. 76 
2.1. on the  basis  of the  results  presented  it may  be 
expected  that  plant  protection  products 
manufactured  from  them  will  meet  the 
requirements  of Article  4 (1); 
2.2. their  residues,  if constituting  a danger  to human 
or animal  health,  can  be measured  by methods 
in general  use. 
Article  20 
1. Where  the procedure  laid  down  in this  Article  is 
to be followed,  matters  shall  be referred  without 
delay  by the chairman,  either  on his own  initiative  or 
at the  request  of a Member  State,  to the  Standing 
Committee  on Plant  Health  set up by the  Council 
Decision  of .. . hereinafter  called  the 'Committee'. 
2. Within  the Committee,  the votes  of the Member 
States  shall  be weighted  as provided  in Article  148  (2) 
of the Treaty.  The  charman  shall  not vote. 
3. The  representative  of the  Commission  shall 
submit  a draft  of the  measures  to be adopted.  The 
Committee  shall  deliver  its opinion  on such  measures 
within  a time  limit  set by the chairman  according  to 
the urgency  of the  matters.  Opinions  shall  be 
delivered  by a majority  of 41 votes. 
4. The  Commission  shall  adopt  the measures  and 
implement  them  forthwith  where  they  are  in accordance  with  the  opinion  of the  Committee. 
Where  they  are not in accordance  with  opinion  of the 
Committee,  or if no  opinion  is delivered,  the 
Commission  shall  without  delay  propose  to the 
Council  the  measures  to be adopted.  The  Council 
shall  adopt  the measures  by a qualified  majority. 
If the Council  has  not  adopted  any  measures  within 
three  months  of the proposal  being  submitted  to it, 
the Commission  shall  adopt  the  proposed  measures 
and implement  them  forthwith. 
Article  21 
1. The  Member  States  shall  bring  into  force  the 
provisions  necessary  to comply  with  this  Directive 
within  18  months  of its  notification  and  shall 
forthwith  inform  the Commission  thereof. 
2. On  notification  of this  Directive  Member  States 
shall  inform  the Commission,  in time  to enable  it to 
put forward  its  comments,  of all  draft  laws, 
regulations  or administrative  provisions  which  they 
contemplate  adopting  in the  field  covered  by this 
Directive. 
Article  22 
This  Directive  is addressed  to the Member  States. 
9. 9. 76 Official  Journal  of the  European  Communities No C 212/11 
ANNEX  I 
Active  substances  permitted  in EEC-accepted  plant  protection  products 
alachlor carbaryl 
alachlore carbaril 
alaclor 
alachloor carbophenothion 
carbophenothion 
aldicarb carbofenotion 
aldicarbe carbofenothion 
aluminiumphosphid chloraniformethan 
aluminium  phosphide chloraniformethane 
phosphure  d'aluminium cloraniformetano 
fosfuro  di alluminio chloraniformethaan 
aluminiumfosfide 
chlorbufam 
anthraquinon chlorbufame 
anthraquinone clorbufam 
antrachinone chloorbufam 
anthrachinon 
chlorodimeform 
asulam chlordimeform 
asulame chlordimeforme 
clordimeform 
atrazin chloordimeform 
atrazine 
atrazina chlorfenvinphos 
chlorfenvinfos 
azinphos-methyl chloorfenvinfos 
azinphos-methyl 
azinfos-metile 
azinfos-methyl chloroxuron azinfos-methyl 
cloroxuron 
barban 
barbane chlorpropham 
chlorprophame 
benomyl clorprofam 
benomyl chloorprofam 
benomil 
chlorpyrifos 
bentazon chlorpyriphos 
bentazone clorpirifos 
chloorpyrifos 
benzoylprop-ethyl 
chlorthiamid Benzoylprop-athyl chlorthiamid 
benzoylprop-ethyl chlorthiamide 
benzoilprop-etile clortiamid benzoilprop-etile 
chloorthiamide 
binapacryl 
chlortoluron binapacril chlortoluron binapacril 
clortoluron 
chloortoluron 
bromacil 
bromacile coumatetralyl 
coumatetralyl 
bromophos cumatetralil 
bromofos cumatetralyl 
captafol crimidin captafol 
crimidine 
captan crimidina 
captane 
cycluron captano cycluron captano 
cicluron 
No C 212/12 Official  Journal  of the European  Communities 9. 9. 76 
cyhexatin 
ciexatin 
2,4-D  n 
desmetryn 
desmetryne 
desmetryne 
desmetrina 
dalapon  Na-salt 
Dalapon-Natriumsalz 
dalapon-sodium 
dalapon  sale  di sodio 
dalapon-natrium 
dazomet 
demeton-S-methylsulfon 
demeton-S-methylsulphone 
demeton-S-methylsulphone 
demeton-S-metilsulfone 
diazinon 
diazinone 
dicamba  (2) 
dichlobenil 
dichlobenil 
diclobenil 
dichlofluanid 
dichlofluanide 
diclofluanide 
dichlorprop  (2) 
diclorprop 
dichloorprop 
dichlorpropan 
dichloropropane 
dicloropropano 
dichloorpropaan 
dichlorvos 
diclorvos 
dichloorvos 
dicofol 
dimethirimol 
dimethirimol 
dimetirimol 
(') Kun  tilladt  som  salte  og estere. 
Nur als Salze  und  Ester  zugelassen. 
Admis  seulement  comme  sels  et esters. 
Permitted  only  as salts  and  esters. 
Ammesso  solo  come  sali  e esteri 
Enkel  toegelaten  als zouten  en esters. 
(') Kun  tilladt  som  salte. 
Nur als Salze  zugelassen. 
Permitted  only  as salts. 
Admis  seulement  comme  sels. 
Ammesso  solo  come  sali. 
Enkel  toegelaten  als zouten. dimethoat 
dimethoate 
dimethoate 
dimetoato 
dimethoaat 
dinocap 
dinoseb  og dets  ammonium  og amin  salte 
Dinoseb  und  seine  Ammonium-  und  Aminsalze 
dinoseb  and  its ammonium  and  amine  salts 
dinosebe  et ses sels d'ammonium  et sels d'amine 
dinoseb  e suoi  sali d'ammonio  e d'ammine 
dinoseb  en zijn  ammonium  — en amine  zouten 
dinoseb  acetat 
Dinosebacetat 
dinoseb  acetate 
dinosebe  : ester  acdtique 
dinoseb  acetato 
dinosebacetaat 
diquat  dibromid 
Deiquat  dibromid 
diquat  dibromide 
diquat  dibromuro 
diuron 
DNOC 
dodemorph 
dodemorph 
dodemorf 
dodin 
dodine 
doguadine 
dodina 
endosulfan 
EPTC 
fenazaflor 
fenazaflor 
fenazafloor 
fenitrothion 
fenitrothion 
fenitrotion 
fenthion 
fention 
ferbam 
ferbame 
ferrosulfat 
Eisen-II-sulfat 
ferrous  sulphate 
sulfate  de fer 
ferro  solfato 
ferrosulfaat 
folpet 
folpel 
9. 9. 76 Official  Journal  of the  European  Communities No C 212/13 
fonofos 
formetanat 
formetanate 
formetanate 
formetanato 
formetanaat 
ioxynil  (J) 
Joxynil 
kobberoxychlorid 
Kupferoxychlorid 
copper  oxychloride 
oxychlorure  de cuivre 
ossicloruro  di rame 
koper  oxychloride 
lenacil 
lenacile 
lindan 
lindane 
lindano 
lindaan 
linuron 
malathion 
malation 
mancozeb 
mancozebe 
maneb 
manebe 
MCPA  (2) 
mechlorprop  (2) 
mecoprop 
mecoprop 
metaldehyd 
metaldehyde 
metaldehyde 
metaldeide 
methabenzthiazuron 
methabenzthiazuron 
metabenztiazuron 
methidathion 
methidathion 
metidation 
H Kun  tilladt  som  alkalisalte  og octansyre-estere. 
Nur als Alkalisalze  und  Octanoat  zugelassen. 
Permitted  only  as alkali  metal  salts  and  octanoic  ester. 
Admis  seulement  comme  sels  alcalins  et ester 
octanoique. 
Ammesso  solo  come  sali  alcalini  ed estere  ottanoico. 
Enkel  toegelaten  als alkalimetaalzouten  en octanoaat. 
(2) Kun  tilladt  som  salte. 
Nur als Salze  zugelassen. 
Permitted  only  as salts. 
Admis  seulement  comme  sels. 
Ammesso  solo  come  sali. 
Enkel  toegelaten  als zouten. methomyl 
methomyl 
metomil 
methoprotryn 
methoprotryne 
metoprotryne 
metoprotrin 
methoprotryne 
methoxychlor 
methoxychlore 
metossicloro 
methoxychloor 
methylbromid 
Methylbromid  (Brom-methan) 
bromomethane  (methyl  bromide) 
bromure  de methyle  (bromomethane) 
bromuro  di metile  (bromometano) 
methylbromide  (broommethaan) 
metiram 
metirame 
metirame-zinc 
metobromuron 
metobromuron 
metoxuron 
metoxuroni 
metribuzin 
metribuzin 
mercaptodimethur 
methiocarb 
methiocarbe 
metiocarb 
mevinphos 
mevinphos 
mevinfos 
monolinuron 
monuron 
natrium  chlorat 
Natriumchlorat 
sodium  chlorate 
chlorate  de soude 
sodio  clorato 
natrium  chloraat 
nicotin 
Nikotin 
nicotine 
nicotina 
nikotine 
nicotinsulfat 
Nikotinsulfat 
nicotine  sulphate 
sulphate  de nicotine 
solfato  di nicotina 
nicotinsulfaat 
No C 212/14 Official  Journal  of the  European  Communities 9. 9. 76 
nitrofen 
nitrofene 
nitrofeen 
omethoat 
omethoate 
omethoate 
ometoato 
omethoaat 
oxydemeton-methyl 
oxydemeton-methyl 
essidemeton-metile 
paraquat  dichlorid  og di-(methylsulfat) 
Paraquat  dichlorid  und  di-(methylsulfat) 
paraquat  dichloride  and di-(methylsulphate) 
paraquat  dichloride  et di-(methylsulfate) 
paraquat  dicloro  e di-(metilsolfato) 
paraquat  dichloride  en di-(methylsulfaat) 
parathio 
paration 
pentachlorphenol 
pentachlorophenol 
pentachlorophenol 
pentaclorofenolo 
pentachloorphenol 
pentachloorfenol 
pentachlorphenol  Na-salt 
N atrium-pentachlorphenolat 
sodium  pentachlorphenate 
pentachlorophenate  de sodium 
pentaclorofenato  di sodio 
natrium  pentachloorfenolaat 
phenmedipham 
phenmediphame 
fenmedifam 
phosalon 
phosalone 
fosalone 
phosmet 
fosmet 
phosphamidon 
fosfamidone 
fosfamidon 
pirimicarb 
pirimicarbe 
prometryn 
prometryne 
prometryne 
prometrina 
propachlor 
propachlore 
propaclor 
propachloor 
propham 
prophame 
profam propineb 
propin&be 
propyzamid 
propyzamide 
propizamide 
pyrazon 
pyrazone 
pirazon 
pyrethriner  (*) 
Pyrethrine 
pyrethrins 
pyrethrines 
pirethrine 
pyrethrinen 
chinomethionat 
quinomethionate 
chinomethionate 
chinometionato 
chinomethionaat 
rotenon 
rotenone 
rotenone 
simazin 
simazine 
simazina 
svovl 
Schwefel 
sulphur 
soufre 
zolfo 
zwavel 
sulfotep 
TCA 
TCA  sodium 
terbuthylazin 
terbuthylazine 
terbutylazine 
terbutilazina 
terbutylazin 
terbutryn 
terbutryne 
terbutrin 
tetradifon 
tetradifon 
(4) Kun  sammen  med  piperonyl  butoxyd. 
Nur zusammen  mit  Piperonylbutoxid. 
Only  together  with  piperonyl  butoxide. 
Seulement  avec  piperonyl  butoxide. 
Solo  con  piperonilbutossido. 
Enkel  met  piperonylbutoxide. 
9. 9. 76 Official  Journal  of the European  Communities No C 212/15 
thallium  sulfat trichlorfon 
Thalliumsulfat triclorfon 
thallium  sulphate trichlorphon 
sulfate  de thallium trichloorfon 
tallio  solfato 
thallium  sulfaat trichloronat 
trichloronate 
thiometon tricloronato 
thiometon trichloronaat 
tiometon 
tridemorph 
thiophanat tridemorphe 
Thiophanat-athyl tridemorph 
thiophanate-ethyl tridemorf 
thiophanate-ethyl 
thiophanate triforin 
tiofanato triforine 
thiofanaat-ethyl 
vamidothion 
thiophanat-methyl vamidotion 
thiophanate-methyl 
thiophanate-methyl warfarin 
methylthiophanate warfarine 
tiofanato  metile coumafene 
thiofanaat-methyl 
zineb 
thiram zin&be 
thirame 
tiram zinkphosphid 
zinc phosphide 
tri-allat zinc (phosphure  de 
Triallat zinco  (fosfuro  di .. 
tri-allate zinkfosfide 
triallate 
tri-allaat ziram 
zirame 
No C 212/16 Official  Journal  of the  European  Communities 9. 9. 76 
ANNEX  11 
MODEL 
Application  form  for the EEC-acceptance  of a plant  protection  product 
(hereinafter  referred  to as 'the product') 
Name  of responsible  authority: 
Date  received: 
Ref. No 
N.B:  If there  is insufficient  space  under  any  heading,  the particulars  may  be supplied  in a 
separate  numbered  document  attached  to the form.  In such  cases,  a summary  of the 
particulars  must  be given  under  the heading  in question  on the form  together  with  the 
reference  to the numbered  document. 
1. (a) Name  of applicant: 
(b) Address  and  telephone  number  of per-
manent  office  in the Community: 
2. (a) Proprietary  name  of the product: 
(b) Experimental  designation: 
3. Name  and address  of manufacturer: 
4. Physical  condition  and  nature  of the product 
(e.g. wettable  powder,  emulsifiable  concen-
trate,  granules  etc. ....): 
9. 9. 76 Official  Journal  of the  European  Communities No C 212/17 
5. Detailed  composition  of the product: 
5.1 
Names  of all ingredients  (') Contents  (*) Equivalent  content  of 
each active  substance 
on pure  basis 
(') Each  ingredient  must  be indicated  by its ISO  common  name  or,  if not  available,  by its chemical  designation 
according  to 1UPAC  nomenclature  and,  in the  case  of an active  substance,  by its empirical  and  structural 
formula;  in the  case  of an ingredient  not  chemically  definable,  it should  be indicated  by other  appropriate 
characterization. 
H For  products  which  are  solids,  aerosols,  volatile  liquids  (b.p.  ^ 50  °C),  or viscous  liquids  (—  1 000 centipoises 
at 20 °'C),  as a percentage  by weight;  for  other  liquids,  as a percentage  by weight  and  in g/1  at 20 °C; for 
gases,  as a percentage  by volume. 
5.2 Indicate  any  active  substance  not  listed 
in Annex  I: 
5.3 For  each  distinct  source  of each  tech-
nical  active  substance  used  in manu-
facture,  its composition  (i.e.,  purity  in 
percentage,  nature  and  percentages  of 
impurities,  isomers,  secondary  products): 
6. Chemical  properties  of each  active  sub-
stance: 
7. Physical  properties  of 
7.1 each  active  substance: 
7.2 the  product: 
8. Method(s)  of analysis  for  the  composition 
of the product 
8.1 Method(s)  for qualitative  and  quantitive 
determination  of the  active  substance(s) 
in the product: 
8.2 Other: 
No C 212/18 Official  Journal  of the  European  Communities 9. 9. 76 
9. Application  (x) 
9.1 Mode  of action: 
9.2 Types  of pest  controlled  and  types  of 
crops  protected  or other  purpose  of 
application: 
9.3 Application  rate(s): 
9.4 Number  and  timing  of applications: 
9.5 Methods  of application: 
10. Specific  phytotoxicity,  including  necessary 
waiting  periods  to avoid  phytotoxic  effects, 
e.g., with  soil  fumigants,  persistent  herbi-
cides: 
11. Experimental  data  to demonstrate  efficacy 
of the product  for the uses  proposed  and 
under  the conditions  of use envisaged: 
12. Residues 
12.1 Method(s)  for residue  analysis: 
12.2 Proposed  method  for  the  official 
control  of residues  in named  edible 
crops/animal  products  of each  active 
substance: 
12.3 Residue  data: 
12.4 Proposed  maximum  permissable  residue 
of each  active  substance  in named 
edible  crops/animal  products: 
12.5 Proposed  safety  interval(s),  including 
necessary  waiting  periods  following 
fumigation  of edible  crops: 
(*) The  applicant  must  attach  copies  of each  different  label  or draft  label,  including  leaflets  forming  part  of the 
label  as provided  for  in Article  IS paragraph  3.5,  under  which  the  product  will  be placed  on the  market  within 
the Community. 
9. 9. 76 Official  Journal  of the European  Communities No C 212/19 
13. Nature  of packaging  in which  the  product 
will be placed  on the  market  and  the  size 
range  of packages: 
14. Stability  of the product  in the packaging  in 
which  it will  be placed  on the market: 
15. Experimental  data  on toxicity  in animals: 
16. Proposed  classification  of  the  products 
according  to risk  (*): 
17. Medical  data: 
18. Environment 
18.1 Information  giving  all the data  permit-
ting an assessment  to be made  of the 
foreseeable  risks,  whether  immediate  or 
delayed,  that  the  product  may  present 
for the  environment  as a function,  in 
particular,  of its toxicological  charac-
teristics,  biodegradability,  potential  for 
bioaccumulation  and  volume  of pro-
duction  envisaged: 
18.2 Production  envisaged: 
19. Has  application  for  EEC-acceptance  been 
made  to another  Member  State? 
(') In accordance  with  the  provisions  of the  Council  Directive  of on  the  approximation  of the 
laws,  regulations  and  administrative  provisions  relating  to the  classification,  packaging  and  labelling  of pesticides 
(OJ ). 
Place  Signature 
Date 
No G 212/20 Official  Journal  of the European  Communities 9. 9. 76 
ANNEX  III 
Standard  phrases  of nature  of special  risks 
1. Dangerous  to livestock  / game  / wild  birds  / wild  animals  / wild  flowers  / bees  / fish. 
2. Harmful  to livestock  / game  / wild  birds  / wild  animals  / wild  flowers  / bees  / fish. 
3. (Active  substance)  is one  of the more  persistent  constituents  of plant  protection  products  and 
its repeated  application  may  lead  to the  contamination  of the  environment  with  possible 
detrimental  effects. 
ANNEX  IV 
Standard  phrases  of safety  advice 
1. Not  to be used  on any  edible  crop. 
2. May  only  be used  on (named  crops  or foodstuffs). 
3. Not  to be applied  to (named  crops  or foodstuffs)  at a rate  in excess  of (dosage  rate  in 
terms  of active  substances)  per application. 
4. Not  more  than  (number)  application(s)  to be made  on (crops  or foodstuffs)  per  season. 
5. Not  to be used  later  than  (date). 
6. Allow  at least  (days/weeks)  between  (last)  application  and  harvesting. 
7. Wear  (state  item  or items)  if handling  (crop  or crops)  within  (interval)  of treatment. 
8. Post  warning  telling  unprotected  persons  to keep  out  of treated  areas  for  (state  period). 
9. Keep  all livestock  out of treated  areas  for at least  (interval). 
10. Keep  all livestock  away  from  treated  water  for at least  (interval). 
11. Do not  apply  at flowering  stage.  Keep  down  flowering  weeds. 
12. Do not contaminate  ponds,  waterways  and  ditches  with  product  or used  container. 
13. Keep  tightly  closed/in  a cool  place/locked  up/out  of reach  of children/away  from  food-
stuffs/away  from  feedingstuffs/away  from  heat/away  from  flame. 
14. Neutralize  waste  material  with  /wash  out  container  thoroughly/and  dispose  of 
safely  by /burying. 
15. Empty  container  completely  and  burn. 
16. Dispose  of rinsings  from/container/equipment  away  from  ponds,  waterways,  ditches  and 
wells. 
17. Do not enter/greenhouse/glasshouse/mushroom  house/warehouse/ship's  hold  within  (interval) 
of treatment  unless  wearing/full  protective  clothing/respirator.