Proposal for a Council Decision concerning the non-inclusion of metam 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)
Date: 2009-05-25
Institutions: European Commission
Subjects: dangerous substance, environmental protection, health risk, market approval, marketing standard, pharmaceutical product, plant health product

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 25.5.2009 
COM(2009) 243 final 

Proposal for a 

COUNCIL DECISION 

concerning the non-inclusion of metam 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) 

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EXPLANATORY MEMORANDUM 

The attached draft proposal for a Council Decision  concerns the non  inclusion  of metam 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  Belgium,  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 metam on 26 November 2008. 

During  the  evaluation  of  this  active  substance,  a  number  of  concerns  were  identified.  In 
particular,  inadequate  residues  studies  and  lack  of  information  on  a  toxicologically  relevant 
impurity  N,N'-dimethylthiourea  (DMTU)  did  not  permit  to  demonstrate  the  acceptability  of 
consumer  exposure.  Furthermore,  due  to  the  high  rate  of  application,  a  large  amount  of  the 
impurity DMTU is released in the environment and the lack of data with respect to its behavior 
in the environment give rise to concern. 

The  draft  decision  for  a  non  inclusion  was  submitted  on  26  February  2009  to  the  Standing 
Committee on the Food Chain and Animal Health, where: 

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11 Member States voted in favour (100 votes) 

11 Member States voted against (139 votes) 

5 Member States abstained (106 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). 

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Proposal for a 

COUNCIL DECISION 

concerning the non-inclusion of metam 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  to  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 1490/20023 lay  down the 
detailed  rules  for  the  implementation  of  the  third  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 metam. 

For  metam  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  1490/2002  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  10  (1)  of  Regulation  (EC)  No  1490/2002.  For 
metam  the  rapporteur  Member  State  was  Belgium  and  all  relevant  information  was 
submitted on 10 September 2007. 

(4) 

The  assessment  report  has  been  peer  reviewed  by  the  Member  States  and  the  EFSA 
within  its  Working  Group  Evaluation  and  presented  to  the  Commission  on 
26 November 2008 in the format of the EFSA conclusion regarding the peer review of 
the  pesticide  risk  assessment  of  the  active  substance  metam4.  This  report  has  been 

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OJ L 230, 19.8.1991, p. 1. 
OJ L 55, 29.2.2000, p. 25. 
OJ L 224, 21.8.2002, p. 23. 
EFSA  Scientific  Report  (2008)  203,  Conclusion  regarding  the  peer  review  of  the  pesticide  risk 
assessment of the active substance metam, finalised 26 November 2008. 

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(5) 

(6) 

reviewed by the Member States and the Commission within the Standing Committee 
on the Food Chain and Animal Health and finalised on 26 February 2009 in the format 
of the Commission review report for metam. 

During  the  evaluation  of  this  active  substance,  a  number  of  concerns  have  been 
identified.  In  particular,  inadequate  residues  studies  and  lack  of  information  on  a 
toxicologically  relevant  impurity,  N,N'-dimethylthiourea  (DMTU),  did  not  permit  to 
demonstrate the acceptability of consumer exposure. Furthermore, due to the high rate 
of application, a large amount of the impurity DMTU is released in the environment 
and  the  lack  of  data  with  respect  to  its  behavior  in  the  environment  give  rise  to 
concern. Consequently, it was not possible to conclude, on the basis of the information 
made  available  within  the  deadlines,  that  metam  met  the  criteria  for  inclusion  in 
Annex I to Directive 91/414/EEC. 

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 put forward by the notifier, the concerns identified could not be eliminated, 
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 metam satisfy in 
general  the  requirements  laid  down  in  Article  5(1)  (a)  and  (b)  of  Directive 
91/414/EEC. 

(7)  Metam 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  metam  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  metam 
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 
metam 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  metam 
according  to  the  provisions  of  Article  6  (2)  of  Directive  91/414/EEC,  the  detailed 
implementation rules of which have been laid down in Commission Regulation (EC) 
No  33/2008  of  17  January  2008  laying  down  detailed  rules  for  the  application  of 
Council  Directive  91/414/EEC  as  regards  a  regular  and  an  accelerated  procedure  for 
the  assessment  of  active  substances  which  were  part  of  the  programme  of  work 
referred to in Article 8(2) of that Directive but have not been included into its Annex I5 
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, 

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OJ L 15, 18.1.2009, p. 5. 

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HAS ADOPTED THIS DECISION: 

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

Article 1 

Member States shall ensure that: 

Article 2 

(a) 

(b) 

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

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

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 3 

This Decision is addressed to the Member States. 

Done at Brussels, 

Article 4 

For the Council 
The President 

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