Proposal for a Council Directive amending Council Directive 91/414/EEC to include tetraconazole as active substance
Date: 2009-05-25
Institutions: European Commission
Subjects: marketing standard, pesticide, pharmaceutical product, plant health control, plant health legislation, plant health product

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 25.5.2009 
COM(2009) 242 final 

Proposal for a 

COUNCIL DIRECTIVE 

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

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EXPLANATORY MEMORANDUM 

Council  Directive  91/414/EEC  concerning  the  placing  of  plant  protection  products  on  the 
market  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. 

Article  5  of  the  Directive  provides  for  a  listing  of  active  substances  in  Annex  I  to  the 
Directive  when,  in  the  light  of  the  current  scientific  and  technical  knowledge,  it  is 
demonstrated that they satisfy, in principle, the safety requirements for human health and the 
environment. 

The attached draft proposal for a Council Directive concerns the inclusion of tetraconazole as 
active substance in the positive list (Annex I) of Council Directive 91/414/EEC. 

This  substance  belongs  to  the  3rd  Stage  of  the  work  programme  of  Directive  91/414/EEC. 
Detailed  rules  for  the  implementation  of  the  third  stage  of  the  review  programme  are  laid 
down  in  Regulation  (EC)  No  1490/2002.  This  Regulation  establishes  a  list  of  active 
substances  to  be  assessed,  with  a  view  to  their  possible  inclusion  in  Annex  I  to  Directive 
91/414/EEC  and  foresees  strict  deadlines  for  all  the  parties  involved  in  the  risk  assessment 
and risk management, i.e. the rapporteur Member State, the European Food Safety Authority 
and the Commission. 

The data submitted by industry have been initially evaluated by a rapporteur Member State, in 
this  case  Italy,  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 tetraconazole on 31 July 2008. 

A  draft  Directive  for  an  inclusion  was  submitted  on  26  February  2009  to  the  Standing 
Committee on the Food Chain and Animal Health, where: 

– 

– 

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21 Member States voted in favour (252 votes) 

5 Member States voted against (66 votes) 

1 Member States abstained (27 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 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 tetraconazole 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) 

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 tetraconazole. 

For tetraconazole 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 
tetraconazole the rapporteur Member State was Italy and all relevant information was 
submitted on 15 July 2005.  

The  assessment  report  has  been  peer  reviewed  by  the  Member  States  and  the  EFSA 
and presented to the Commission on 31 July 2008 in the format of the EFSA Scientific 
Report for tetraconazole4. 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 
tetraconazole. 

(4) 

It  has  appeared  from  the  various  examinations  made  that  plant  protection  products 
containing tetraconazole may be expected to satisfy, in general, the requirements laid 
down in Article 5(1) (a) and (b) of Directive 91/414/EEC, in particular with regard to 

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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)  152,  Conclusion  regarding  the  peer  review  of  the  pesticide  risk 
assessment of the active substance tetraconazole (finalised 31 July2008). 

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the uses which have been examined and detailed in the Commission review report. It 
is therefore appropriate to include tetraconazole in Annex I, in order to ensure that in 
all Member States the authorisations of plant protection products containing this active 
substance can be granted in accordance with the provisions of that Directive. 

(5)  Without prejudice to that conclusion, it is appropriate to obtain further information on 
certain specific points. Article 6(1) of Directive 91/414/EEC provides that inclusion of 
a  substance  in  Annex  I  may  be  subject  to  conditions.  Therefore,  it  is  appropriate  as 
regards  tetraconazole,  to  require  that  the  notifier  submits  further  information  on  a 
refined consumer risk assessment, on the specification regarding ecotoxicology, on the 
fate and behaviour of potential metabolites in all relevant compartments, on the refined 
risk  assessment  of  such  metabolites  to  birds,  mammals  aquatic  organisms  and  non-
target  arthropods  and  on  the  potential  for  endocrine  disrupting  effects  to  birds, 
mammals and fish. 

(6) 

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. 

(7)  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 tetraconazole 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. 

(8) 

The experience gained from previous inclusions in Annex I to Directive 91/414/EEC 
of active substances assessed in the framework of 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 
market5  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. 

(9) 

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

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OJ L 366, 15.12.1992, p. 10. 

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(10)  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 2010 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 2010.  

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 
tetraconazole as an active substance by 30 June 2010. 

By  that  date  they  shall  in  particular  verify  that  the  conditions  in  Annex  I  to  that 
Directive relating to tetraconazole 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 of that Directive. 

By way of derogation from paragraph 1, for each authorised plant protection product 
containing  tetraconazole  as  either  the  only  active  substance  or  as  one  of  several 
active  substances  all  of  which  were  listed  in  Annex  I  to  Directive  91/414/EEC  by 
31 December  2009  at  the  latest,  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  tetraconazole.  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. 

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Following that determination Member States shall: 

(a) 

(b) 

in the case of a product containing tetraconazole as the only active substance, 
where necessary, amend or withdraw the authorisation by 30 June 2014 at the 
latest; or 

in  the  case  of  a  product  containing  tetraconazole  as  one  of  several  active 
substances, where necessary, amend or withdraw the authorisation by 30 June 
2014  or  by  the  date  fixed  for  such  an  amendment  or  withdrawal  in  the 
respective  Directive  or  Directives  which  added  the  relevant  substance  or 
substances to Annex I to Directive 91/414/EEC, whichever is the latest. 

This Directive shall enter into force on 1 January 2010. 

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 

" 

No 

Common Name, 
Identification 
Numbers 

"Tetraconazole 

CAS N° 112281-77-3 

CIPAC N° 726 

IUPAC Name 

Purity6 

(RS)-2-(2,4-
dichlorophenyl)-3-
(1H-1,2,4-triazol-1-
yl)-propyl-1,1,2,2-
tetrafluoroethyl ether 

≥ 950 g/kg (racemic 
mixture) 

Impurity toluene: Not 
more than 13g/kg 

Entry into 
force 

Expiration 
of inclusion 

1 January 
2010 

31 
December 
2019 

Specific provisions 

PART A 

Only uses as fungicide in field crops with an application 
of max. 0.100 Kg/ha every third year on the same field 
may be authorised. Uses in apples and grapes must not 
be authorised. 

PART B 

For  the  implementation  of  the  uniform  principles  of 
Annex  VI,  the  conclusions  of  the  review  report  on 
tetraconazole,  and  in  particular  Appendices  I  and  II 
thereof,  as  finalised  in  the  Standing  Committee  on  the 
Food  Chain  and  Animal  Health  on  26  February  2009 
shall be taken into account. 

In  this  overall  assessment  Member  States  must  pay 
particular attention to: 

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- 

the protection of aquatic organisms and non-target 
plants;  in  relation  to  these  identified  risks,  risk 
mitigation measures, such as buffer zones, shall be 
applied where appropriate; 

the protection of the groundwater, when the active 
substance is applied in regions with vulnerable soil 
and/or climatic conditions. 

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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 

The Member States concerned shall request: 

- 

- 

- 

- 

- 

the  submission  of  further  information  on  a refined 
consumer risk assessment 

further  information  on  the  specification  regarding 
ecotoxicology; 

further  information  on  the  fate  and  behaviour  of 
potential metabolites in all relevant compartments; 

the  refined  risk  assessment  of  such  metabolites  to 
birds,  mammals  aquatic  organisms  and  non-target 
arthropods  

further  information  on  the  potential  for  endocrine 
disrupting effects to birds, mammals and fish. 

They  shall  ensure  that  the  notifier  provides  such 
information to the Commission by 31 December 2011 at 
the latest. 

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