Proposal for a Council Directive amending Council Directive 91/414/EEC to include methamidophos as an active substance
Date: 2006-06-13
Institutions: European Commission
Subjects: confidentiality, exchange of information, marketing standard, plant health product, testing

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 13.6.2006 
COM(2006) 295 final 

Proposal for a 

COUNCIL DIRECTIVE 

amending Council Directive 91/414/EEC to include methamidophos as an active 
substance 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

The  attached  draft  proposal  for  a  Council  Directive  concerns  the  inclusion  under  strict 
conditions  of  methamidophos  as  active  substance  in  the  positive  list  (Annex  I)  of  Council 
Directive 91/414/EEC concerning the placing of plant protection products on the market. 

Council  Directive  91/414/EEC  creates  a  harmonised  framework  for  the  authorisation  and 
placing  on  the  market  of  plant  protection  products.  Active  substances  to  be  used  as  plant 
protection products are assessed and authorised at Community level and are listed in Annex I 
to  the  Directive.  Individual  plant  protection  products  containing  active  substances  are 
assessed and authorised by Member States under harmonised rules. 

The data submitted by industry have been initially evaluated by a rapporteur Member State, in 
this  case  Italy,  and  afterwards,  on  the  basis  of  their  draft  assessment  report,  by  the 
Commission and all the Member States within the framework of the Standing Committee on 
the Food Chain and Animal Health. 

In  view  of  the  hazardous  profile  of  the  substance,  the  conditions  of  inclusion  provide 
restrictions  to  those  crops  that  have  effectively  been  considered  during  the  Community 
evaluation  and  for  which  acceptable  use  may  be  expected  provided  highly  prescriptive  risk 
mitigation measures are applied. 

The draft Directive was submitted on 3 March 2006 to the Standing Committee on the Food 
Chain and Animal Health. 

5 Member States (79 votes) voted in favour, 
19 Member States (235 votes) voted against and 
1 Member States (7 votes) abstained 

The  Committee  delivered  an  unfavourable  opinion.  Consequently,  pursuant  to  Article  19  of 
Directive 91/414/EEC and in accordance with Article 5 of Council Decision 1999/468/EC, the 
Commission  is  required  to  submit  to  the  Council  a  proposal  relating  to  the  measures  to  be 
taken, the Council having three months in which to act by a qualified majority. 

The draft Directive is not subject to the right of scrutiny of the European Parliament (Article 8 
of Council Decision 1999/468/EC). 

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Proposal for a 

COUNCIL DIRECTIVE 

amending Council Directive 91/414/EEC to include methamidophos as an active substance 

(Text with EEA relevance) 

THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, 

Having  regard  to  Council  Directive 91/414/EEC  of  15 July 1991  concerning  the  placing  of 
plant protection products on the market1, and in particular Article 6(1) thereof, 

Whereas:  

(1) 

(2) 

(3) 

(4) 

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Commission  Regulation  (EEC)  No  3600/92  of  11  December  1992  laying  down  the 
detailed  rules  for  the  implementation  of  the  first  stage  of  the  programme  of  work 
referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of 
plant  protection products on  the market2, establishes a list of active substances to be 
assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. 
That list includes methamidophos. 

For  methamidophos  the  effects  on  human  health  and  the  environment  have  been 
assessed in accordance with the provisions laid down in Regulation (EEC) No 3600/92 
for  a  range  of  uses  proposed  by  the  notifier.  By  Commission  Regulation  (EC) 
No 933/94  of  27  April  1994  laying  down  the  active  substances  of  plant  protection 
products  and  designating  the  Rapporteur  Member  State  for  the  implementation  of 
Commission  Regulation  (EEC)  No  3600/923,  Italy  was  designated  as  Rapporteur 
Member  State.  Italy  submitted  on  30  July  1999  the  relevant  assessment  report  and 
recommendations to the Commission in accordance with Article 7(1)(c) of Regulation 
(EEC) No 3600/92. 

The assessment report has been reviewed by the Member States and the Commission 
within the Standing Committee on the Food Chain and Animal Health.  

The  review  of  methamidophos  revealed  a  number  of  open  questions  which  were 
addressed by the Scientific Panel on Plant health, Plant protection products and their 
Residues (PPR) of the European Food Safety Authority (EFSA). The Scientific Panel 
was asked to define a value for the degree of dermal adsorption scientifically based on 

OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2003/119/EC (OJ L 325, 
12.12.2003, p. 41). 
OJ L 366, 15.12.1992, p. 10. Regulation as last amended by Regulation (EC) No 2266/2000 (OJ L 259, 
13.10.2000, p. 10). 
OJ  L  107,  28.4.1994,  p.  8.  Regulation  as  last  amended  by  Regulation  (EC)  No  2230/95  (OJ  L  225, 
22.9.1995, p. 1). 

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the  different  results  of  the  studies  submitted  by  the  notifier  to  be  used  in  the 
assessment  of  human  risk  arising  from  the  dermal  route  of  exposure.  Moreover,  the 
Scientific Panel was asked to review the estimates of avoidance, time spent foraging in 
treated areas and proportion of contaminated diet obtained in treated areas, and advise 
on their implications for estimates of acute, short and long term exposure of birds and 
mammals  to  the  insecticide  methamidophos.  In  its  opinion  on  the  first  question  the 
PPR Panel concluded4 that, on the basis of the available data the best estimated dermal 
adsorption  of  the  diluted  preparation  is  considered  to  be  about  5%.  On  the  second 
question, the PPR Panel concentrated its assessment on two species considered by the 
notifier and Rapporteur Member State, yellow wagtail and wood mouse, as they make 
substantial use of the crops supported for methamidophos. The PPR Panel disagreed5 
with the values proposed by the notifier and the Rapporteur Member State as regards 
the proportion of contaminated diet set for yellow wagtails and the estimates used in 
dietary composition for yellow wagtails and wood mouse. The PPR Panel noted that 
these  values  would  under-estimate  acute  exposure  of  individual  animals.  The  PPR 
Panel developed an alternative approach for assessing the potential role of avoidance. 
The mechanisms involved are complex but it appears possible that both yellow wagtail 
and wood mouse might feed quickly enough for mortality to occur in field conditions. 
The PPR Panel identified several options for laboratory or field studies, which could 
be considered to assess these risks with more certainty. 

It  has  appeared  from  the  various  examinations  made  that  plant  protection  products 
containing methamidophos may be  expected to satisfy the requirements laid down in 
Article 5(1)(a) and (b) of Directive 91/414/EEC, with regard to the uses which were 
examined and detailed in the Commission review report, provided that adequate risk 
mitigation measures are applied. As methamidophos is a hazardous substance, its use 
should  not  be  unrestricted.  In  particular,  there  are  concerns  about  its  intrinsic  toxic 
effects.  Although 
the  hazards  posed  by 
is  scientific  consensus  on 
methamidophos, there may be different views on the risks. This is a question of risk 
management  rather  than  science  which  depends  on  the  level  of  risk  which  is 
acceptable  for  a  given  society.  In  order  to  achieve  the  high  level  of  protection  of 
human  and  animal  health  and  the  environment  chosen  in  the  Community,  risk 
mitigation measures should be imposed. 

there 

Articles 5(4) and 6(1) of Directive 91/414/EEC provide that inclusion of a substance 
in Annex I may be subject to restrictions and conditions. In this case, restrictions on 
the inclusion period and on the authorised crops are measures deemed necessary. The 
restriction  of  the  inclusion  period  means  that  Member  States  will  give  priority  to 
reviewing plant protection products already on the market containing methamidophos. 
In order to avoid discrepancies in the high level of protection sought, the inclusion in 
Annex I to Directive 91/414/EEC should be limited to the uses of methamidophos that 
have  been  actually  assessed  within  the  Community  evaluation  and  for  which  the 
proposed  uses  were  considered  to  comply  with  the  conditions  of  Directive 

Opinion  of  the  Scientific  Panel  on  Plant  Health,  Plant  Protection  Products  and  their  Residues  on  a 
request from the Commission related to the evaluation of methamidophos in toxicology in the context 
of Council Directive 91/414/EEC (The EFSA Journal (2004), 95, 1-15) Adopted on 14 September 2004.  
Opinion  of  the  Scientific  Panel  on  Plant  Health,  Plant  Protection  Products  and  their  Residues  on  a 
request  from  the  Commission  related  to  the  evaluation  of  methamidophos  in  ecotoxicology  in  the 
context  of  Council  Directive  91/414/EEC(The  EFSA  Journal  (2004),  144,  1-50)  Adopted  on 
14 December 2004.  

(5) 

(6) 

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91/414/EEC. This means that other uses, which were not or only partially covered by 
this assessment, must first be subject to a complete assessment, before their inclusion 
in Annex I of Directive 91/414/EEC can be considered. Finally, due to the hazardous 
nature of methamidophos, it is necessary to provide for a minimum harmonisation at 
Community level of certain risk mitigation measures that are to be applied by Member 
States when granting authorisations. 

(7) 

(8) 

The  risks  mitigation  measures  in  this  Directive  are  considered  sufficient  to  limit  the 
risks resulting from the use of the substance to an acceptable level. 

Since it appears possible to identify adequate risk mitigation measures, to be applied 
within  well-described  situations  and  under  strict  conditions, 
it  would  be 
disproportionate to refuse the inclusion of this active substance in Annex I to Directive 
91/414/EEC. 

(9)  Without  prejudice  to  the  conclusion  that  plant  protection  products  containing 
methamidophos  may  be  expected  to  satisfy  the  requirements  laid  down  in  Article 
5(1)(a) and (b) of Directive 91/414/EEC, it is appropriate to obtain further information 
on certain specific points. Article 6(1) of Directive 91/414/EC provides that inclusion 
of a substance in Annex I may be subject to conditions. Therefore, it is appropriate to 
require that methamidophos should be subjected to further testing for confirmation of 
the risk assessment for birds and mammals and that such studies should be presented 
by  the  notifiers.  In  addition,  Member  States  should  require  authorisation  holders  to 
provide  information  on  the  use  of  methamidophos  including  any  information  on 
incidences on operator health. 

(10)  As  with  all  substances  included  in  Annex  I  to  Directive  91/414/EEC,  the  status  of 
methamidophos could be reviewed under Article 5(5) of that Directive in the light of 
any new data becoming available 

(11)  The experience gained from previous inclusions in Annex I to Directive 91/414/EEC 
of active substances assessed in the framework of Regulation (EEC) No 3600/92 has 
shown  that  difficulties  can  arise  in  interpreting  the  duties  of  holders  of  existing 
authorisations  in  relation  to  access  to  data.  In  order  to  avoid  further  difficulties  it 
therefore appears necessary to clarify the duties of the Member States, especially the 
duty  to  verify  that  the  holder  of  an  authorisation  demonstrates  access  to  a  dossier 
satisfying  the  requirements  of  Annex  II  to  that  Directive.  However,  this  clarification 
does  not  impose  any  new  obligations  on  Member  States  or  holders  of  authorisations 
compared to the directives which have been adopted until now amending Annex I.  

(12)  A reasonable period should be allowed to elapse before an active substance is included 
in  Annex  I  in  order  to  permit  Member  States  and  the  interested  parties  to  prepare 
themselves to meet the new requirements which will result from the inclusion. 

(13)  Without  prejudice  to  the  obligations  defined  by  Directive  91/414/EEC  as  a 
consequence  of  including  an  active  substance  in  Annex  I,  Member  States  should  be 
allowed  a  period  of  six  months  after  inclusion  to  review  existing  authorisations  of 
plant  protection  products  containing  methamidophos  to  ensure  that  the  requirements 
laid  down  by  Directive  91/414/EEC,  in  particular  in  its  Article  13  and  the  relevant 
conditions  set  out  in  Annex  I,  are  satisfied.  Member  States  should  vary,  replace  or 
withdraw, as appropriate, existing authorisations. in accordance with the provisions of 

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Directive 91/414/EEC. By derogation from the above deadline, a longer period should 
be provided for the submission and assessment of the complete Annex III dossier of 
each  plant  protection  product  for  each  intended  use  in  accordance  with  the  uniform 
principles  laid  down  in  Directive  91/414/EEC.  Given  the  hazardous  properties  of 
methamidophos, the period for Member States to verify whether the plant protection 
products,  which  contain  methamidophos  as  the  only  active  substance  or  in 
combination  with  other  authorised  active  substances,  comply  with  the  provisions  of 
Annex VI should not exceed three years. 

(14) 

It is therefore appropriate to amend Directive 91/414/EEC accordingly. 

(15)  The  measures  provided  for  in  this  Directive  are  not  in  accordance  with  the  opinion 
delivered  by  the  Standing  Committee  on  the  Food  Chain  and  Animal  Health;  they 
must  therefore,  by  virtue  of  Article 19(2)  of  Directive  91/414/EEC,  be  adopted  by 
the Council. 

HAS ADOPTED THIS DIRECTIVE: 

Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. 

Article 1 

Article 2 

Member States shall adopt and publish by 30 June 2007 at the latest the laws, regulations and 
administrative  provisions  necessary  to  comply  with  this  Directive.  They  shall  forthwith 
communicate to the Commission the text of those provisions and a correlation table between 
those provisions and this Directive.  

They shall apply those provisions from 1 July 2007. 

When Member States adopt those provisions, they shall contain a reference to this Directive 
or be accompanied by such a reference on the occasion of their official publication. Member 
States shall determine how such reference is to be made. 

Article 3 

1. 

Member  States  shall  in  accordance  with  Directive  91/414/EEC,  where  necessary, 
amend  or  withdraw  existing  authorisations  for  plant  protection  products  containing 
methamidophos as an active substance by 30 June 2007. 

By  that  date  they  shall  in  particular  verify  that  the  conditions  in  Annex  I  to  that 
Directive relating to methamidophos are met, with the exception of those identified 
in  part  B  of  the  entry  concerning  that  active  substance,  and  that  the  holder  of  the 
authorisation has, or has access to, a dossier satisfying the requirements of Annex II 
to that Directive in accordance with the conditions of Article 13. 

2. 

By  derogation  from  paragraph  1,  for  each  authorised  plant  protection  product 
containing  methamidophos,  Member  States  shall  re-evaluate  the  product  in 

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accordance  with  the  uniform  principles  provided  for  in  Annex  VI  to  Directive 
91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that 
Directive  and  taking  into  account  part  B  of  the  entry  in  Annex  I  to  that  Directive 
concerning  methamidophos.  On  the  basis  of  that  evaluation,  they  shall  determine 
whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) 
of Directive 91/414/EEC. 

Following 
that  determination  Member  States  shall  for  products  containing 
methamidophos,  where  necessary  amend  or  withdraw  the  authorisation  by  31 
December 2009. 

This Directive shall enter into force on 1 January 2007. 

Article 4 

Article 5 

This Directive is addressed to the Member States. 

Done at Brussels,  

For the Council 
The President

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The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC: 

ANNEX I 

“No 

Common Name, 
Identification 
Numbers 

XX  Methamidophos 
CAS No 10265-
92-6 
CIPAC No 355 

IUPAC Name 

Purity6 

Entry into 
force 

Expiration of 
inclusion 

Specific provisions 

O, S dimethyl 
phosphoramidothioate 

> 680 g/kg 

1 January 
2007 

31 December 
2013 

PART A 

Only use as insecticide on potato may be authorised.  

The following conditions of use must be respected:  

– 

– 

At rates not exceeding 0,5 kg active substance per hectare 
per application 

Maximum 3 applications per season. 

The following uses must not be authorised: 

– 

– 

– 

air application; 

knapsack  and  all  handheld  applications,  neither  by 
amateur nor by professional users;  

home gardening. 

Member  States  shall  ensure  that  all  appropriate  risk  mitigation 
measures  are  applied.  Particular  attention  must  be  paid  to  the 
protection of: 

– 

birds  and  mammals.  Conditions  of  authorisation  shall 
include  risk  mitigation  measures,  such  as  a  judicious 
timing  of  the  application  and  the  selection  of  those 
formulations  which,  as  a  result  of 
their  physical 
presentation  or  the  presence  of  agents  that  ensure  an 
the 
adequate  avoidance,  minimise 
concerned species; 

the  exposure  of 

6 

Further details on identity and specification of active substance are provided in the review report. 

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“No 

Common Name, 
Identification 
Numbers 

IUPAC Name 

Purity6 

Entry into 
force 

Expiration of 
inclusion 

Specific provisions 

– 

– 

aquatic  organisms  and  non 
target  arthropods.  An 
appropriate  distance  must  be  kept  between  treated  areas 
and  surface  water  bodies  as  well  as  margins  of  the  crop. 
This  distance  may  depend  on  the  application  or  not  of 
drift reducing techniques;  

operators, who  must  wear  suitable  protective  clothing,  in 
particular  gloves,  coveralls,  rubber  boots  and  respiratory 
protective  devices  during  mixing-loading  and  gloves, 
coveralls,  rubber  boots  and  face  protection  or  safety 
glasses during application and cleaning of equipment. The 
above  measures  must  be  applied,  unless  the  exposure  to 
the  substance  is  adequately  precluded  by  the  design  and 
construction of the equipment itself or by the mounting of 
specific protective components on such equipment. 

PART B 

For  the  implementation  of  the  uniform  principles  of  Annex  VI,  the 
conclusions  of  the  review  report  on  methamidophos,  and  in 
particular Appendices I and II thereof, shall be taken into account.  

Member  States  must  ensure  that  the  authorisation  holders  report  at 
the  latest  on  31  December  of  each  year  on  any  reported  effect  on 
operator  health.  Member  States  may  require  that  elements,  such  as 
sales  data  and  a  survey  of  use  patterns,  are  provided  so  that  a 
realistic picture of the use conditions and the possible toxicological 
impact of methamidophos can be obtained.  

Member  States  shall  request  the  submission  of  further  studies  to 
confirm  the  risk  assessment  for  birds  and  mammals.  They  shall 
ensure  that  the  notifiers  at  whose  request  methamidophos  has  been 
included  in  this  Annex  provide  such  studies  to  the  Commission 
within 2 years from the entry into force of this Directive. 

” 

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