Proposal for a Council Decision concerning the non-inclusion of methomyl in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance
Date: 2007-06-08
Institutions: European Commission
Subjects: dangerous substance, marketing restriction, pharmaceutical product, plant health legislation, plant health product, withdrawal from the market

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 8.6.2007 
COM(2007) 290 final 

Proposal for a 

COUNCIL DECISION 

concerning the non-inclusion of methomyl in Annex I to Council Directive 91/414/EEC 
and the withdrawal of authorisations for plant protection products containing that 
substance  

(presented by the Commission) 

EN 

   EN 

 
 
 
  
EXPLANATORY MEMORANDUM 

The attached draft proposal for a Council Decision concerns the non inclusion of methomyl as 
active  substance  in  the  positive  list  (Annex  I)  of  Council  Directive  91/414/EEC  and  the 
withdrawal  of  plant  protection  products  containing  that  substance.  The  proposal  for  a  non 
inclusion  is  based  on  a  number  of  concerns  identified  during  the  evaluation  of  this  active 
substance. 

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 the United Kingdom, which submitted a draft assessment report. The European Food 
Safety  Authority  has  organised  a  peer  review  of  the  initial  evaluation  and  has  provided  the 
Commission with a conclusion of the risk assessment for methomyl on 23 June 2006. 

During  the  evaluation  of  this  active  substance,  a  number  of  concerns  were  identified.  In 
particular, based on the available information, the operator exposure would exceed the AOEL 
(acceptable  operator  exposure  level)  and  it  has  not  been  demonstrated  that  the  worker  and 
bystander exposure is acceptable. Moreover, with regard to ecotoxicology, there are concerns 
due to a high risk for birds and mammals, aquatic organisms, bees and non target arthropods. 

The  draft  decision  for  a  non  inclusion  was  submitted  on  16  March  2007  to  the  Standing 
Committee on the Food Chain and Animal Health, where: 

– 

– 

– 

18 Member States voted in favour (199 votes) 

7 Member States voted against (107 votes) 

2 Member States abstained (39 votes) 

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

EN 

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   EN 

 
Proposal for a 

COUNCIL DECISION 

concerning the non-inclusion of methomyl in Annex I to Council Directive 91/414/EEC 
and the withdrawal of authorisations for plant protection products containing that 
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  the  fourth  subparagraph  of 
Article 8(2) thereof, 

Whereas: 

(1) 

(2) 

(3) 

Article  8(2)  of  Directive  91/414/EEC  provides  that  a  Member  State  may,  during  a 
period of 12 years following the notification of that Directive, authorise the placing on 
the  market  of  plant  protection  products  containing  active  substances  not  listed  in 
Annex  I  of  that  Directive  that  are  already  on  the  market  two  years  after  the  date  of 
notification,  while  those  substances  are  gradually  being  examined  within  the 
framework of a programme of work. 

Commission  Regulations  (EC)  No  451/20002  and  (EC)  No  703/20013  lay  down  the 
detailed  rules  for  the  implementation  of  the  second  stage  of  the  programme  of  work 
referred  to  in  Article  8(2)  of  Directive  91/414/EEC  and  establish  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 methomyl. 

For methomyl the effects on human health and the environment have been assessed in 
accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) 
No 703/2001 for a range of uses proposed by the notifier. Moreover, those Regulations 
designate the rapporteur Member States which have to submit the relevant assessment 
reports  and  recommendations  to  the  European  Food  Safety  Authority  (EFSA)  in 
accordance  with  Article  8(1)  of  Regulation  (EC)  No  451/2000.  For  methomyl  the 
rapporteur  Member  State  was  the  United  Kingdom  and  all  relevant  information  was 
submitted on 3 May 2004. 

1 

2 

3 

OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2007/.../EC (OJ L ..., ... 
2007, p. ...). 
OJ L 55, 29.2.2000, p. 25. Regulation as last amended by Regulation (EC) No 1044/2003 (OJ L 151, 
19.6.2003, p. 32). 
OJ L 98, 7.4.2001, p. 6. 

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(4) 

(5) 

(6) 

The  assessment  report  was  peer  reviewed  by  the  Member  States  and  the  EFSA  and 
presented to the Commission on 23 June 2006 in the format of the EFSA conclusion 
regarding  the  peer  review  of  the  pesticide  risk  assessment  of  the  active  substance 
methomyl4.  This  report  was  reviewed  by  the  Member  States  and  the  Commission 
within the Standing Committee on the Food Chain and Animal Health. 

During the evaluation of this active substance, a number of concerns were identified. 
In particular, based on the available information, the operator exposure would exceed 
the AOEL (acceptable operator exposure level) and it has not been demonstrated that 
the  worker  and  bystander  exposure  is  acceptable.  Moreover,  with  regard  to 
ecotoxicology,  there  are  concerns  due  to  a  high  risk  for  birds  and  mammals,  aquatic 
organisms, bees and non target arthropods. 

The Commission invited the notifier to submit its comments on the results of the peer 
review  and  on  its  intention  or  not  to  further  support  the  substance.  The  notifier 
submitted  its  comments  which  have  been  carefully  examined.  However,  despite  the 
arguments  advanced,  the  above  concerns  remained  unsolved,  and  assessments  made 
on  the  basis  of  the  information  submitted  and  evaluated  during  the  EFSA  expert 
meetings  have  not  demonstrated  that  it  may  be  expected  that,  under  the  proposed 
conditions of use, plant protection products containing methomyl satisfy in general the 
requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC. 

(7)  Methomyl should therefore not be included in Annex I to Directive 91/414/EEC. 

(8)  Measures  should  be  taken  to  ensure  that  authorisations  granted  for  plant  protection 
products containing methomyl are withdrawn within a fixed period of time and are not 
renewed and that no new authorisations for such products are granted. 

(9) 

Any period of grace granted by a Member State for the disposal, storage, placing on 
the  market  and  use  of  existing  stocks  of  plant  protection  products  containing 
methomyl, should be limited to twelve months in order to allow existing stocks to be 
used  in  one  further  growing  season,  which  ensures  that  plant  protection  products 
containing methomyl remain available to farmers for 18 months from the adoption of 
this Decision. 

(10)  This  decision  does  not  prejudice  the  submission  of  an  application  for  methomyl 
according  to  the  provisions  of  Article  6  (2)  of  Directive  91/414/EEC  in  view  of  a 
possible inclusion in its Annex I. 

(11)  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 DECISION: 

Methomyl shall not be included as an active substance in Annex I to Directive 91/414/EEC. 

Article 1 

4 

EFSA  Scientific  Report  (2006)  83,  1-73,  Conclusion  regarding  the  peer  review  of  pesticide  risk 
assessment of methomyl. 

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Member States shall ensure that: 

Article 2 

(a) 

(b) 

authorisations  for  plant  protection  products  containing  methomyl  are  withdrawn  by 
[…  INSERT  DATE  6  MONTHS  FROM  THE  DATE  OF  ADOPTION  OF  THIS 
DECISION]; 

no  authorisations  for  plant  protection  products  containing  methomyl  are  granted  or 
renewed from the date of publication of this Decision. 

Article 3 

Any  period  of  grace  granted  by  Member  States  in  accordance  with  the  provisions  of 
Article 4(6)  of  Directive  91/414/EEC,  shall  be  as  short  as  possible  and  shall  expire  on  [… 
INSERT DATE 18 MONTHS FROM ADOPTION OF THIS DECISION] at the latest.  

Article 4 

This Decision is addressed to the Member States. 

Done at Brussels, 

For the Council 
The President 

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