Proposal for a Council Directive amending Council Directive 91/414/EEC to include vinclozolin as active substance
Date: 2006-06-13
Institutions: European Commission
Subjects: confidentiality, exchange of information, marketing standard, plant health product, testing

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 13.6.2006 
COM(2006) 297 final 

Proposal for a  

COUNCIL DIRECTIVE 

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

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

The  attached  draft  proposal  for  a  Council  Directive  concerns  the  inclusion  under  strict 
conditions  of  vinclozolin  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. 

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  France,  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  provide 
restrictions  to  those  crops  that  have  effectively  been  considered  during  the  Community 
evaluation  and  for  which  acceptable  use  may  be  expected  provided  highly  prescriptive  risk 
mitigation measures are applied. 

The draft Directive was submitted on 3 March 2006 to the Standing Committee on the Food 
Chain and Animal Health. 

3 Member States (68 votes) voted in favour, 
19 Member States (205 votes) voted against and 
3 Member States (48 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. 

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 vinclozolin 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) 

(4) 

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2 

3 

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 vinclozolin. 

For vinclozolin 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, France was designated as Rapporteur Member State. 
France  submitted  the  relevant  assessment  report  and  recommendations  to  the 
Commission  on  24  March  1997  in  accordance  with  Article  7(1)(c)  of  Regulation 
(EEC) No 3600/92. 

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

As  regards  vinclozolin  three  matters  were  submitted  to  the  Scientific  Committee  on 
Plants (“the Scientific Committee”). The Scientific Committee was asked to comment 
on  whether  there  was  enough  scientific  evidence  to  support  the  assumption  that 
reproductive  effects  observed  in  rats  would  not  occur  at  significantly  lower  doses  in 

OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive … (OJ L …, …, p. …). 
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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humans  i.e.  that  humans  might  be  significantly  more  sensitive4.  The  Scientific 
Committee concluded that the results of these studies do not indicate that humans will 
be affected by such substances at significantly lower doses, i.e. there is no reason to 
expect that humans would be more sensitive to vinclozolin than rats. Subsequently, the 
Committee was requested to comment particularly on the possible increased sensitivity 
of  infants  and  children  to  these  effects.  The  Committee  observed  that  the  effects 
induced  in  rats  by  vinclozolin  during  the  development  period  are  irreversible.  This 
contrasts with the situation in adult animals where the effects have been shown to be 
reversible. Furthermore, the effects occur at lower doses during development than in 
adults.  In  this  context,  the  Committee  concludes  that  the  situation  in  humans  would 
not be expected to be different from that seen in rats. Finally, it was asked whether the 
reproductive effects of vinclozolin were mediated via an acute or via chronic exposure 
response.  The  Committee  stated  that,  in  the  case  of  vinclozolin,  it  is  unlikely  that  a 
single dose would induce a developmental effect due to the known mode of action of 
the  substance,  the  fact  that  humans  are  not  more  sensitive  than  laboratory  animal 
models  and  the  realistic  level  of  a  single  exposure.  The  results  of  the  above  works 
permitted the allocation of an Acceptable Daily Intake (ADI). 

In  a  second  question,  the  Scientific  Committee  considered  the  appropriate  No 
Observed  Effect  Concentration  (NOEC)  of  vinclozolin  in  birds  and  wild  mammals5. 
The  Scientific  Committee  concluded  that  the  possible  long-term  risk  to  birds  and 
mammals could not be excluded. As a result it was considered appropriate to impose 
risk mitigation measures.  

Finally,  the  Scientific  Committee  was  requested  to  comment  on  the  biological  and 
ecological significance of the effects observed in the fish life-cycle study with fathead 
minnow6. In the latter case the Committee states that the study made available did not 
measure  or  attempt  to  assess  reproductive  effects  in  fish.  Consequently,  additional 
studies  have  been  provided  by  the  notifier.  These  were  assessed  by  the  Rapporteur 
who  concluded  that  the  active  substance  and  its  metabolites  may  act  as  weak  anti-
androgens  and  consequently  a  NOEC  level  has  been  determined  for  them.  Based  on 
this  level  and  the  application  of  appropriate  management  measures,  it  is  considered 
that the long term risk to fish is acceptable. 

Consequently, it is concluded that in the above cases, the recommendations from the 
Scientific Committee 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  vinclozolin  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 

Opinion  of  the  scientific  Committee  on  Plants  regarding  reproductive  effects  of  vinclozolin  in  the 
context  of  Council  Directive  91/414/EEC  concerning  the  placing  of  plant  protection  products  on  the 
market (Opinion expressed on 28 October 1999 - SCP/VINCLO/019-Final dd 19.11.1999). 
Opinion  of  the  scientific  Committee  on  Plants  regarding  the  evaluation  of  reproductive  effects  of 
vinclozolin  in  te  context  of  Council  Directive  91/414/EEC  concerning  the  placing  of  plant  protection 
products on the market (Opinion adopted on 17 March 2000 - SCP/VINCLO/021-Final dd 31.3.2000). 
Opinion of the scientific Committee on Plants on additional questions from the Commission concerning 
the  evaluation  of  vinclozolin  in  the  context  of  Council  Directive  91/414/EEC  (Opinion  adopted  on 
18 July 2002 - SCP/VINCLO-TER/002-Final). 

(5) 

(6) 

(7) 

(8) 

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(9) 

examined and detailed in the Commission review  report, provided  that adequate risk 
mitigation  measures  are  applied.  As  vinclozolin  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/EC 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  measures  deemed  necessary.  The 
restriction  of  the  inclusion  period  means  that  Member  States  will  give  priority  to 
reviewing  plant  protection  products  already  on  the  market  containing  vinclozolin.  In 
order  to  avoid  discrepancies  in  the  high  level  of  protection  sought,  the  inclusion  in 
Annex I to Directive 91/414/EEC should be limited to the uses of vinclozolin 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/EEC.  This 
means  that  other  uses,  which  were  not  or  only  partially  covered  by  this  assessment, 
must  first  be  subject  to  a  complete  assessment,  before  their  inclusion  in  Annex  I  of 
Directive  91/414/EEC  can  be  considered.  Finally,  due  to  the  hazardous  nature  of 
vinclozolin,  it  is  necessary  to  provide  for  a  minimum  harmonisation  at  Community 
level of certain risk mitigation measures that are to be applied by Member States when 
granting authorisations. 

(10)  The  risk  mitigation  measures  in  this  Directive  are  considered  sufficient  to  limit  the 

risks resulting from the use of the substance to an acceptable level. 

(11)  Since it appears possible to identify adequate risk mitigation measures, to be applied 
within  well-described  situations  and  under  strict  conditions, 
it  would  be 
disproportionate to refuse the inclusion of this active substance in Annex I to Directive 
91/414/EEC.  

(12)  Without  prejudice  to  the  conclusion  that  plant  protection  products  containing 
vinclozolin  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  vinclozolin 
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 vinclozolin 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  vinclozolin  including  any  information  on  incidences  on 
operator health. 

(13)  As  with  all  substances  included  in  Annex  I  to  Directive  91/414/EEC,  the  status  of 
vinclozolin could be reviewed under Article 5(5) of that Directive in the light of any 
new data becoming available. 

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(14)  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. 

(15)  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. 

(16)  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  vinclozolin  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 
vinclozolin, the period for Member States to verify whether plant protection products 
containing  vinclozolin,  alone  or  in  combination  with  other  authorised  active 
substances, comply with the provisions of Annex VI should not exceed three years. 

(17) 

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

(18)  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.  

They shall apply those provisions from 1 July 2007. 

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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. 

1. 

2. 

Article 3 

Member  States  shall  in  accordance  with  Directive  91/414/EEC,  where  necessary, 
amend  or  withdraw  existing  authorisations  for  plant  protection  products  containing 
vinclozolin  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 
vinclozolin  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  vinclozolin,  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 
vinclozolin. 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 
vinclozolin,  where  necessary,  amend  or  withdraw 
31 December 2009. 

that  determination  Member  States  shall  for  products  containing 
the  authorisation  by 

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/EEC: 

ANNEX 

“No 

Common Name, 
Identification 
Numbers 

XX  Vinclozolin 

CAS N° 
50471-44-8 
CIPAC N°280 

IUPAC Name 

Purity7 

(R,S)3-(3,5-
dichlorophenyl)-5-
methyl-5-vinyl-1,3-
oxazolidine-2,4-dione  

960 g/kg  

Entry into 
force 

Expiration 
of inclusion 

1 January 
2007 

31 December 
2013 

Specific provisions 

PART A 

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

– 

– 

– 

rape seed 

ornamentals 

chicory (root treatment) 

at rates not exceeding  

– 

– 

– 

0,75  kg  active  substance  per  hectare  per 
application for rape seed; 

0,25  kg  active  substance  per  hectare  per 
application (spray) and 0,5 kg active substance 
per  hectoliter  water  per  application  (dip)  for 
ornamentals; 

0,0175  kg  active  substance  per  1000  kg  per 
application  (spray  on  belt),  0,015  kg  active 
substance  per 10  m2  per  application  (spray  on 
forcing  boxes)  and  0,06  kg  active  substance 
per  hectolitre  water  per  application  (dip)  for 
chicory. 

The following uses must not be authorised:  

– 

air application; 

7 

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 

Purity7 

Entry into 
force 

Expiration 
of inclusion 

Specific provisions 

– 

– 

knapsack  and  handheld  applications  by 
amateur users; 

home gardening. 

Member  States  shall  ensure  that  all  appropriate  risk 
mitigation  measures  are  applied.  Particular  attention  must 
be paid to the protection of: 

– 

– 

– 

relevant, 

organisms.  Where 

aquatic 
an 
appropriate  distance  must  be  kept  between 
treated  areas  and  surface  water  bodies.  This 
distance  may  depend  on  whether  or  not  drift 
reducing techniques or devices are used; 

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  equipment,  unless 
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. 

the  exposure 

to 

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“No 

Common Name, 
Identification 
Numbers 

IUPAC Name 

Purity7 

Entry into 
force 

Expiration 
of inclusion 

Specific provisions 

PART B 

For  the  implementation  of  the  uniform  principles  of 
Annex  VI,  the  conclusions  of  the  review  report  on 
vinclozolin, and in particular Appendices I and II thereof, 
shall be taken into account.  

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 vinclozolin can be obtained. 

Member  States  shall  request  the  submission  of  further 
studies  to  address  the  potential  endocrine  disrupting 
properties  of  vinclozolin  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  vinclozolin  has  been  included  in  this 
Annex provides such studies to the Commission within 2 
years of the adoption of the above test guidelines.  

” 

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