Proposal for a Council Directive amending Council Directive 91/414/EEC to include flusilazole as active substance
Date: 2006-09-14
Institutions: European Commission
Subjects: confidentiality, exchange of information, marketing standard, plant health product, testing

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 14.09.2006 
COM(2006) 536 final 

Proposal for a 

COUNCIL DIRECTIVE 

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

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

Conclusions: 

The  attached  draft  proposal  for  a  Council  Directive  concerns  the  inclusion  under  strict 
conditions of flusilazole 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. It amends and 
restricts the initial Proposal that has been submitted to Council earlier. 

The concerns expressed by several Member States in the framework of the ongoing debates at 
Council  reflect  their  judgement  that  the  risk  mitigation  measures  envisaged  by  the 
Commission  are,  in  their  practice,  not  sufficient  to  reduce  or  minimize  the  risk  to  an 
acceptable level in this particular case. In order to correctly reflect the high level of protection 
of  human  and  animal  health  and  a  sustainable  environment  sought  in  the  Community,  the 
Commission consider appropriate, in addition to the conditions and risk mitigation proposed 
earlier, to further reduce the period of inclusion to 18 months instead of seven years, which 
emphasizes the need for a priority re-assessment of this substance. 

History: 

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  Ireland,  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  provided 
restrictions  to  those  crops  that  had  effectively  been  considered  during  the  Community 
evaluation and for which acceptable use had been expected provided highly prescriptive risk 
mitigation measures were applied. 

The draft Directive was submitted on 03 March 2006 to the Standing Committee on the Food 
Chain and Animal Health. 

5 Member States (92 votes) voted in favour, 
18 Member States (193 votes) voted against and 
2 Member States (36 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. 

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The  Commission  forwarded  to  Council  a  draft  Proposal  for  a  Directive  which  followed  the 
same  approach,  i.e.  the  inclusion  of  the  substance  under  very  restrictive  conditions.  In  the 
light  of  the  recent  debates  at  Council,  however,  the  Commission  considers  appropriate  to 
revise its initial proposal by restricting further the period of inclusion to 18 months. 

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 flusilazole 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) 

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 flusilazole. 

For flusilazole 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, Ireland was designated as Rapporteur Member State. 
Ireland  submitted  the  relevant  assessment  report  and  recommendations  to  the 
Commission on 30 April 1996 in accordance with Article 7(1)(c) of Regulation (EEC) 
No 3600/92. 

(3) 

The assessment report has been reviewed by the Member States and the Commission 
within the Standing Committee on the Food Chain and Animal Health.  

1 

2 

3 

OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2006/74/EC (OJ L 238, 
30.8.2006, p. 17). 
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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(4) 

(5) 

(6) 

As  regards  flusilazole  two  questions  were  submitted  to  the  Scientific  Committee  on 
Plants (“the Scientific Committee”). The first concerned the adequacy of the proposed 
NOEC (No Observed Effect Concentration) for ensuring a sufficient protection from 
adverse effects on reproduction and, more generally, the comparative sensitivity of the 
early  life  stage  test  compared  to  the  full  fish  life  cycle  study.  The  second  question 
related  to  the  potential  impact  on  organic  matter  decomposition.  In  both  cases,  the 
recommendations of the Scientific Committee4 have been taken into consideration in 
formulating this Directive and the relevant review report. 

It  has  appeared  from  the  various  examinations  made  that  plant  protection  products 
containing  flusilazole  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 flusilazole is a hazardous substance, its use should 
not  be  unrestricted.  In  particular  there  are  concerns  about  its  intrinsic  toxic  effects, 
including  potential  endocrine  disrupting  properties.  There  is  at  present  no  scientific 
consensus  on  the  exact  extent  of  the  risk.  Applying  the  precautionary  principle,  and 
taking into account the current state of scientific knowledge, risk mitigation measures 
should  be  imposed  in  order  to  achieve  the  high  level  of  protection  of  human  and 
animal health and the environment chosen in the Community. 

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  deemed  necessary.  The  original 
measures presented to the Standing Committee on the Food Chain and Animal Health, 
proposed  the  restriction  of  the  inclusion  period  to  seven  years,  which  means  that 
Member States would give priority to reviewing plant protection products already on 
the market containing flusilazole . In order to avoid discrepancies in the high level of 
protection sought, the inclusion in Annex I to Directive 91/414/EEC was intended to 
be  limited  to  the  uses  of  flusilazole  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. This implies that other uses, which were not 
or  only  partially  covered  by  this  assessment,  had  first  to  be  subject  to  a  complete 
assessment,  before  their  inclusion  in  Annex  I  of  Directive  91/414/EEC  could  be 
considered.  Finally,  due  to  the  hazardous  nature  of  flusilazole  ,  it  was  considered 
necessary to provide for a minimum harmonisation at Community level of certain risk 
mitigation  measures  that  were  to  be  applied  by  Member  States  when  granting 
authorisations. 

4 

Opinion of the Scientific Committee on Plants on specific questions from the Commission concerning 
the evaluation of Flusilazole in the context of Council Directive 91/414/EEC (Opinion adopted by the 
Scientific Committee on Plants on 18 July 2002). 

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(7) 

(8) 

(9) 

Under  the  procedures  laid  down  by  Directive  91/414,  the  approval  of  active 
substances,  including  the  definition  of  risk  management  measures,  is  decided  by  the 
Commission.  Member  States  bear  the  responsibility  for  the  implementation, 
application  and  control  of  the  measures  intended  to  mitigate  the  risks  generated  by 
plant protection products. Concerns expressed by several Member States reflect their 
judgment that additional restrictions are necessary to reduce the risk to a level that can 
be considered acceptable and consistent with the high level of protection that is sought 
within  the  Community.  At  present,  it  is  a  question  of  risk  management  to  set  the 
the  continued  production, 
adequate 
commercialisation and use of flusilazole  

safety  and  protection 

level  of 

for 

As a consequence of the above, the Commission re-examined its position . In order to 
correctly  reflect  the  high  level  of  protection  of  human  and  animal  health  and  a 
sustainable  environment  sought  in  the  Community,  it  considered  appropriate,  in 
addition to the principles set out in recital 6, to further reduce the period of inclusion 
to  18  months  instead  of  seven  years.  This  further  reduces  any  risk  by  ensuring  a 
priority re-assessment of this substance.  

It  may  be  expected  that  plant  protection  products  containing  flusilazole  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 
and providing that the necessary risk mitigation measures are applied. 

(10)  Without  prejudice  to  the  conclusion  that  plant  protection  products  containing 
flusilazole 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.  The  potential  endocrine  disrupting  properties  of  flusilazole 
have  been  assessed  in  tests  which  follow  the  best  currently  available  practice.  The 
Commission  is  aware  that  the  Organisation  for  Economic  Cooperation  and 
Development  (OECD)  is  developing  test  guidelines  in  order  to  further  refine  the 
assessment of potential endocrine disrupting properties. Therefore it is appropriate to 
require  that  flusilazole  should  be  subjected  to  such  further  testing  as  soon  as  agreed 
OECD Test Guidelines exist and that such studies should be presented by the notifier. 
In  addition,  Member  States  should  require  authorisation  holders  to  provide 
information  on  the  use  of  flusilazole  including  any  information  on  incidences  on 
operator health. 

(11)  As  with  all  substances  included  in  Annex  I  to  Directive  91/414/EEC,  the  status  of 
flusilazole  could  be  reviewed  under  Article  5(5)  of  that  Directive  in  the  light  of  any 
new data becoming available. Equally, the fact that the inclusion of this substance in 
Annex  I  expires  on  a  particular  date  does  not  prevent  the  inclusion  being  renewed 
according to the procedures laid down in the Directive. 

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(12)  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.  

(13)  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. 

(14)  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 flusilazole 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 
flusilazole, the period for Member States to verify whether plant protection products 
containing flusilazole, alone or in combination with other authorised active substances, 
comply with the provisions of Annex VI should not exceed 18 months  

(15) 

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

(16)  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.  

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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 
flusilazole  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 flusilazole 
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  flusilazole,  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 
flusilazole. 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 flusilazole, 
where necessary, amend or withdraw the authorisation by 30 June 2008. 

This Directive shall enter into force on 1 January 2007. 

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 entries shall be added at the end of the table in Annex I to Directive 91/414/EC. 

ANNEX 

No 

XX 

Common Name, 
Identification 
Numbers 

IUPAC Name 

Flusilazole 
CAS N° 
85509-19-9 
CIPAC N°435 

Bis(4-
fluorophenyl)(methyl) 
(1H-1,2.4-triazol-1-
ylmethyl) silane 

Purity5 

925 g/kg 

Entry into 
force 

Expiration 
of inclusion 

Specific provisions 

1 January 
2007 

30 June 2008  PART A 

Only  uses  as  fungicide  on  the  following  crops  may  be 
authorised: 

– 

– 

– 

– 

cereals other than rice 

maize 

rape seed 

sugarbeet 

at rates not exceeding 200 g active substance per hectare 
per application. 

The following uses must not be authorised: 

– 

– 

– 

air application; 

knapsack and 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: 

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. An appropriate distance must 
be kept between treated areas and surface water 
bodies.  This  distance  may  depend  of 
the 
application or not of drift reducing techniques or 
devices; 

and  mammals. 

of 
Conditions 
birds 
authorisation  shall 
include  risk  mitigation 
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 

operators,  who  must  wear  suitable  protective 
clothing,  in  particular  gloves,  coveralls,  rubber 
boots  and  face  protection  or  safety  glasses 
during mixing, loading, application and cleaning 
of  the  equipment,  unless  the  exposure  to  the 
substance is adequately precluded by the design 
and construction of the equipment itself or 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 
flusilazole, and in particular Appendices I and II thereof, 
shall be taken into account.  

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No 

Common Name, 
Identification 
Numbers 

IUPAC Name 

Purity5 

Entry into 
force 

Expiration 
of inclusion 

Specific provisions 

Member States must ensure that the authorisation holders 
report  at  the  latest  on  31  December  of  each  year  on 
incidences  of  operator  health  problems.  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 flusilazole can be obtained. 

Member  States  shall  request  the  submission  of  further 
studies  to  address  the  potential  endocrine  disrupting 
properties  of  flusilazole  within  two  years  after  the 
adoption  of  the  Test  Guidelines  on  endocrine  disruption 
by  the  Organisation  for  Economic  Cooperation  and 
Development (OECD). They shall ensure that the notifier 
at  whose  request  flusilazole  has  been  included  in  this 
Annex provide such studies to the Commission within 2 
years of the adoption of the above test guidelines. 

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