Proposal for a Council Directive amending Council Directive 91/414/EEC to include azinphos-methyl as 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) 290 final 

Proposal for a 

COUNCIL DIRECTIVE 

amending Council Directive 91/414/EEC to include azinphos-methyl as 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  azinphos-metyl  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  Germany,  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 to the Standing Committee on the Food Chain 
and Animal Health. 

4 Member States (50 votes) voted in favour, 
18 Member States (223 votes) voted against and 
3 Member States (48 votes) abstained 

The  Committee  delivered  no  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 azinphos-methyl as 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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2 

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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 azinphos-methyl. 

For  azinphos-methyl  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, Germany was designated as Rapporteur 
Member  State.  Germany 
report  and 
recommendations  to  the  Commission  on  11  October  1996  in  accordance  with 
Article 7(1)(c) of Regulation (EEC) No 3600/92. 

relevant  assessment 

submitted 

the 

This 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  azinphos-methyl  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  indicate  the  time  for  non-target  arthropods  populations  living  in  the 

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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treated fields to recover to an ecologically sustainable state after specific conditions of 
application of the substance. Moreover, the Scientific Panel was asked to comment on 
the adequacy of the risk assessment carried out for birds by the Rapporteur Member 
State. In its opinion on the first question the PPR Panel concluded that from available 
data  that  given  a  realistic  combination  of  unfavourable  conditions,  the  densities  of 
arthropod populations would still be reduced at the end of the season of treatment and 
possibly at the start of the next growing season. Recovery would be facilitated by an 
unsprayed  zone  but  further  information  would  be  required  to  estimate  the  time  to 
recovery  more  precisely.  On  the  second  question,  the  PPR  Panel  concluded  that  a 
more refined risk assessment was required. The PPR Panel identified some options for 
refining the risk assessment4. 

It  has  appeared  from  the  various  examinations  made  that  plant  protection  products 
containing azinphos-methyl 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 azinphos-methyl is a hazardous substance, its use 
should  not  be  unrestricted.  In  particular,  there  are  concerns  about  its  intrinsic  toxic 
effects.  Although  there  is  scientific  consensus  on  the  hazards  posed  by  azinphos-
methyl,  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. 

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 azinphos-methyl. 
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  azinphos-methyl 
that have been actually assessed within the Community evaluation and for which the 
proposed  uses  were  considered  to  comply  with  the  conditions  of  Directive 
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 azinphos-methyl, 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.  

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 
it  would  be 
within  well-described  situations  and  under  strict  conditions, 

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  azinphos-methyl  in  the  context  of  Council 
Directive 91/414/EEC (The EFSA Journal (2003), 5, 1-20) Adopted on 3 November 2003.  

(5) 

(6) 

(7) 

(8) 

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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 
azinphos-methyl  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 azinphos-methyl should be subjected to further testing for confirmation of 
the  risk  assessment  for  some  non-target  organisms  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  azinphos-methyl  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 
azinphos-methyl 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 6 months after inclusion to review existing authorisations of plant 
protection  products  containing  azinphos-methyl  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 
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 
azinphos-methyl, the period for Member States to verify whether the plant protection 
products,  which  contain  azinphos-methyl  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. 

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(15)  The Standing Committee on the Food Chain and Animal Health has not delivered an 

opinion within the time-limit laid down by its Chairman. 

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. 

2. 

Member  States  shall  in  accordance  with  Directive  91/414/EEC,  where  necessary, 
amend  or  withdraw  existing  authorisations  for  plant  protection  products  containing 
azinphos-methyl 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 azinphos-
methyl  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. 

By  derogation  from  paragraph  1,  for  each  authorised  plant  protection  product 
containing  azinphos-methyl,  Member  States  shall  re-evaluate  the  product  in 
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  azinphos-methyl.  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 azinphos-
methyl, where necessary, amend or withdraw the authorisation by 31 December 2009. 

This Directive shall enter into force on 1 January 2007. 

Article 4 

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Article 5 

This Directive is addressed to the Member States. 

Done at Brussels,  

For the Council 
The President 

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

ANNEX  

“No 

Common Name, 
Identification 
Numbers 

XX  Azinphos-methyl  
CAS N° 86-50-0   
CIPAC N° 37 

IUPAC Name 

Purity5 

>900 g/kg 

S-(3,4-dihydro-4-
oxobenzo[d][1,2,3]triaz
in-3-yl-methyl)-O,O-
dimethyl-
phosphorodithioate 

Entry into 
force 

Expiration 
of inclusion 

1 January 
2007 

31 December 
2013 

Specific provisions 

PART A 

Only use as insecticide on potato may be authorised.  

The following conditions of use must be respected:  

– 

– 

at rates not exceeding 0,12 kg active substance 
per hectare per application 

Maximum 2 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: 

– 

and  mammals.  Conditions 

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

selection  of 

5 

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 

Purity5 

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 of 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 
azinphos-methyl,  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 
azinphos-methyl can be obtained.  

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“No 

Common Name, 
Identification 
Numbers 

IUPAC Name 

Purity5 

Entry into 
force 

Expiration 
of inclusion 

Specific provisions 

to  confirm 

Member  States  shall  request  the  submission  of  further 
studies 
the  risk  assessment  for  birds, 
mammals,  aquatic  organisms  and  non  target  arthropods. 
They  shall  ensure  that  the  notifiers  at  whose  request 
azinphos-methyl 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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