Proposal for a Council Decision concerning the non-inclusion of triazoxide in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance
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) 244 final 

Proposal for a 

COUNCIL DECISION 

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

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EXPLANATORY MEMORANDUM 

The attached draft proposal for a Council Decision concerns the non inclusion of triazoxide 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 triazoxide on 26 September 2009. 

During  the  evaluation  of  this  active  substance,  a  number  of  concerns  were  identified.  In 
particular  it  was  not  possible  to  perform  a  reliable  consumer  risk  assessment  as  data  are 
missing  to  determine  the  nature  of  residues  in  plant  commodities  and  the  possible  transfer  of 
residues  in  animal  products.  Moreover,  the  available  data  did  not  demonstrate  that  the  long 
term risk to mammals, birds, fish and earthworms are acceptable. 

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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17 Member States voted in favour (186votes) 

8 Member States voted against (137 votes) 

2 Member States abstained (22 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 triazoxide 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 triazoxide. 

For triazoxide 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 
triazoxide  the  rapporteur  Member  State  was  the  United  Kingdom  and  all  relevant 
information was submitted on 25 June 2007. 

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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.  

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(4) 

(5) 

(6) 

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 
30 September 2008 in the format of the EFSA conclusion regarding the peer review of 
the pesticide risk assessment of the active substance triazoxide4. This report has been 
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 triazoxide. 

During  the  evaluation  of  this  active  substance,  a  number  of  concerns  have  been 
identified.  In  particular  it  was  not  possible  to  perform  a  reliable  consumer  risk 
assessment as data are missing to determine the nature of residues in plant commodities 
and the possible transfer of residues in animal products. Moreover, the available data did 
not  demonstrate  that  the  long  term  risk  to  mammals,  birds,  fish  and  earthworms  are 
acceptable.  Consequently,  it  was  not  possible  to  conclude  on  the  basis  of  the 
information  available  that  triazoxide  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 triazoxide satisfy 
in  general  the  requirements  laid  down  in  Article  5(1)(a)  and  (b)  of  Directive 
91/414/EEC. 

(7) 

Triazoxide 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 triazoxide 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  triazoxide 
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 
triazoxide 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  triazoxide 
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 33/20085, 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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EFSA  Scientific  Report  (2008),  193.  Conclusion  regarding  the  peer  review  of  the  pesticide  risk 
assessment of the active substance triazoxide finalised 26 September 2008. 
OJ L 15, 18.1.2008, p. 5–12. 

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HAS ADOPTED THIS DECISION: 

Article 1 

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

Member States shall ensure that: 

Article 2 

(a) 

(b) 

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

no  authorisations  for  plant  protection  products  containing  triazoxide  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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