Proposal for a COUNCIL DIRECTIVE amending Council Directive 91/414/EEC to renew the inclusion of carbendazim as active substance
Date: 2011-01-28
Institutions: European Commission
Subjects: confidentiality, exchange of information, marketing standard, plant health product, testing

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EUROPEAN COMMISSION 

Brussels, 28.1.2011 
COM(2011) 27 final 

2011/0012 (NLE) 

Proposal for a 

COUNCIL DIRECTIVE 

amending Council Directive 91/414/EEC to renew the inclusion of carbendazim as active 
substance 

(Text with EEA relevance) 

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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 European Union 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 current scientific and technical knowledge, it is demonstrated 
that they satisfy, in principle, the safety requirements for human health and the environment. 
Council Directive 91/414/EEC provides for risk based decisions, meaning that, apart from the 
intrinsic properties of a substance, also the degree of exposure is a factor that is to be taken 
into  consideration.  It  is  therefore  possible  to  list  in  Annex  I  of  the  Directive  a  hazardous 
substance  providing  that  the  exposure  is  restricted  to  levels  that  can  be  considered  to  be 
acceptable. 

Carbendazim  is  a  substance  that  has  been  included  through  Commission  Directive 
2006/135/EC after lengthy debates and a referral of the dossier to Council. It is a controversial 
substance,  due  to  its  intrinsic  toxicological  properties  (mutagenicity  and  toxicity  to 
reproduction) and therefore this inclusion was highly restrictive and limited in time (3 years 
instead  of  normal  10  years).  Once  the  new  pesticides  regulation  (i.e.  Regulation  (EC) 
1107/2009) will apply, substances of these types cannot be authorised anymore. 

Meanwhile, the notifier made a request for renewal, based on the current legislation The data 
submitted by industry on carbendazim have been initially evaluated by a rapporteur Member 
State, in this case Germany, and afterwards by the European Food Safety Authority (EFSA). 
Both come to the conclusion that it is possible to predict acceptable uses. 

It has appeared from the various examinations made that, in order to achieve the high level of 
protection  of  human  and  animal  health  and  the  environment  chosen  in  the  Union,  plant 
protection products containing carbendazim may be expected to satisfy the requirements laid 
down in Directive 91/414/EEC, provided that adequate risk mitigation measures are applied, 
and the current restrictive approach is maintained. 

For  this  reason,  a  conditional  inclusion  for  the  concerned  substance  was  proposed,  with  the 
following provisions: 

– 

– 

– 

– 

limitation of use of the substance in plant protection products for certain crops only 
that  have  effectively  been  considered  during  the  Union  evaluation.  Carbendazim  is 
only  proposed  for  authorisation  as  an  fungicide  on  cereals,  rape  seed,  sugar  and 
fodder beet and maize; 

restrictions  as  regards  the  application  rates,  in  order  to  ensure  that  impact  on  the 
environment and exposure remains low; 

strict risk mitigation measures set at Union level which will be mandatory in Member 
States; 

limitation of the validity of authorisations to 3.5 years instead of the usual 10 years; 

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– 

– 

The  close  monitoring  of  data  submitted  for  the  assessment  as  a  biocide  and  the 
further  examination  of  the  several  toxicity  studies  that  exist  in  the  public  domain, 
which,  in  the  case  of  adverse  elements,  may  lead  to  the  reconsideration  of  the 
inclusion; 

Submission by the notifier of confirmatory data, in order to provide more robustness 
in certain fields identified during the evaluation process. 

The  review  report  and  the  draft  Directive  were  submitted  on  23  November  2010  to  the 
Standing  Committee  on  the  Food  Chain  and  Animal  Health.  The  result  of  the  vote  was  as 
follows: 

(cid:121) 

(cid:121) 

(cid:121) 

13 Member States in favour (156 votes) 

13 Member States against (160 votes) 

1 Member State abstaining (29 votes) 

The Committee failed to deliver, by qualified majority, an opinion on the draft submitted by 
the Commission. 

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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2011/0012 (NLE) 

Proposal for a 

COUNCIL DIRECTIVE 

amending Council Directive 91/414/EEC to renew the inclusion of carbendazim as active 
substance 

(Text with EEA relevance) 

THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty on the Functioning of the European Union, 

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) 

(5) 

(6) 

1 
2 

The inclusion of carbendazim in Annex I to Directive 91/414/EEC expires on 13 June 
2011. 

On  request  the  inclusion  of  an  active  substance  may  be  renewed  for  a  period  not 
exceeding ten years. On 6 August 2007 the Commission received such a request from 
the applicant regarding the renewal of the inclusion for this substance. 

On 10 January 2008, the applicant submitted to the rapporteur Member State Germany 
data in support of its request for renewal of the inclusion of carbendazim. 

The  rapporteur  Member  State  prepared  a  draft  re-assessment  report  which  was 
commented by the applicant on 13 May 2009 and after its finalisation was submitted 
to the applicant and the Commission on 24 July 2009. In addition to the assessment of 
the  substance,  that  report  includes  a  list  of  the  studies  the  rapporteur  Member  State 
relied on for its assessment. 

The Commission communicated the draft re-assessment report to the European Food 
Safety  Authority  (hereinafter:  ‘the  Authority’)  and  to  the  Member  States  on  28  July 
2009 for comments. 

At the request of the Commission, the draft re-assessment report was peer reviewed by 
the  Member  States  and  the  Authority  and  commented  by  the  applicant  on 
14 December 2009. The Authority presented its conclusion on the peer review of the 
risk  assessment  of  carbendazim2  to  the  Commission  on  30  April  2010.  After  the 
applicant  had  been  given  the  possibility  to  comment  and  taking  into  account  its 

OJ L 230, 19.8.1991, p. 1.  
European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the 
active substance carbendazim EFSA Journal 2010; 8(5):1598. 

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(7) 

(8) 

comments delivered on 31 May 2010, the draft re-assessment report and the conclusion 
from  the  Authority  were  reviewed  by  the  Member  States  and  the  Commission  within 
the  Standing  Committee  on  the  Food  Chain  and  Animal  Health  and  finalised  on 
23 November 2010 in the format of the Commission review report for carbendazim. 

It  has  appeared  from  the  various  examinations  made  that  plant  protection  products 
containing carbendazim may be expected to continue to satisfy the requirements laid 
down  in  Article  5(1)(a)  and  (b)  of  Directive  91/414/EEC,  as  regards  the  uses  which 
were  examined  and  detailed  in  the  Commission  review  report.  It  is  therefore 
appropriate  to  renew  the  inclusion  of  carbendazim  in  Annex  I  to  Directive 
91/414/EEC,  in  order  to  ensure  that  plant  protection  products  containing  this  active 
substance  may  continue  to  be  authorised  where  they  comply  with  that  Directive.  In 
addition  to  the  uses  supported  for  the  first  inclusion,  the  applicant  supports  in  its 
renewal dossier the use on fodder beet. Taking into consideration the additional data 
submitted by the applicant, the use on fodder beet should be added to the list of uses 
that may be authorised. 

Article 5(4) of Directive 91/414/EEC provides that inclusion of a substance in Annex I 
may be subject to restrictions. In order to correctly reflect the high level of protection 
of human and animal health and the environment sought in the Union, it is necessary 
to limit the uses of carbendazim to those that have actually been assessed and which 
are considered to comply with the conditions of Article 5(1) of Directive 91/414/EEC. 
This implies that uses which are not part of the list of uses set out in Annex I to that 
Directive may not be authorised unless they are first added to that list. It is appropriate 
to  set  maximum  limits  for  the  presence  of  two  relevant  impurities  2-amino-3-
hydroxyphenazine 
in  commercially 
manufactured carbendazim. 

(AHP)  and  2,3-diaminophenazine 

(DAP) 

(9)  Without  prejudice  to  the  conclusion  set  out  in  recital  8,  it  is  appropriate  to  obtain 
further  information  on  certain  specific  points.  Article  6(1)  of  Directive  91/414/EC 
provides  that  inclusion  of  a  substance  in  Annex  I  may  be  subject  to  conditions. 
Therefore, it is appropriate to require that the applicant submits further information as 
regards, the aerobic degradation in soil, the long term risk to birds and the relevance of a 
third  impurity,  for  confidentiality  reasons  referred  to  as  AEF037197.  In  addition,  the 
applicant should be requested to examine the studies included in the list in the draft re-
assessment report of 16 July 2009 (Volume 1, Level 4 "Further information", pp. 155 – 
157). 

(10)  Several Member States have expressed concerns as regards the hazard profile of this 
substance.  Similar  concerns  were  expressed  at  the  time  of  the  first  inclusion.  The 
renewal  dossier  is,  in  part,  based  on  toxicity  data  used  during  the  assessment  of  the 
dossier submitted for the initial inclusion of this substance. The original inclusion was 
limited  to  a  period  of  three  years.3  Account  should  also  be  taken  of  the  progressive 
understanding  of  the  need  to  ensure  a  high  level  of  protection  of  human  and  animal 
health  and  the  sustainable  environment.  Therefore,  it  is  appropriate  to  limit  the 
renewal period of the inclusion to three and half years. 

3 

Commission Directive 2006/135/EC of 11 December 2006 amending Council Directive 91/414/EEC to 
include carbendazim as active substance, OJ L 349, p. 37. 

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(11)  As  with  all  substances  included  in  Annex  I  to  Directive  91/414/EEC,  the  status  of 
carbendazim could be reviewed under Article 5(5) of that Directive in the light of any 
new  data  becoming  available,  such  as  its  currently  ongoing  evaluation  in  the 
framework  of  Directive  98/8/EC  of  the  European  Parliament  and  the  Council  of 
16 February  1998  concerning  the  placing  of  biocidal  substances  on  the  market4  and 
from the review of relevant scientific literature. 

(12)  A  reasonable  period  should  be  allowed  to  elapse  before  the  inclusion  of  an  active 
substance in Annex I to Directive 91/414/EEC is renewed in order to permit Member 
States and the interested parties to prepare themselves to meet the new requirements 
resulting from the renewal. 

(13)  Without  prejudice  to  the  obligations  defined  by  Directive  91/414/EEC  as  a 
consequence  of  renewing  the  inclusion  of  an  active  substance  in  Annex  I  thereof, 
Member  States  should  be  allowed  a  period  of  six  months  after  renewal  to  review 
authorisations of plant protection products containing carbendazim to make sure that 
the  requirements  laid  down  in  Directive  91/414/EEC,  in  particular  in  its  Article  13, 
and  the  relevant  conditions  set  out  in  Annex  I  to  that  Directive,  continue  to  be 
satisfied.  As  appropriate,  Member  States  should  renew,  where  appropriate  with 
modifications,  or  refuse  to  renew  authorisations.  By  way  of  derogation  from  that 
deadline, a longer period should be provided for the submission and assessment of the 
update  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. 

(14) 

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

(15)  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 in accordance with the Annex to this Directive. 

Article 1 

Article 2 

Member  States  shall  adopt  and  publish  by  30  November  2011  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 December 2011. 

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. 

4 

OJ L 123, 24.4.1998, p. 1.  

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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 
carbendazim as an active substance by 1 December 2011. 

By  that  date  they  shall  in  particular  verify  that  the  conditions  in  Annex  I  to  that 
Directive relating to carbendazim 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 carbendazim 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 1 June 
2011 at the latest, Member States shall, where necessary, re-evaluate the products, to 
take  into  account  developments  occurred  in  the  scientific  and  technical  knowledge 
and 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  carbendazim.  On  the  basis  of  that  evaluation,  they  shall  determine 
whether the product still 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, 
where necessary, amend or withdraw the authorisation by 1 December 2013. 

This Directive shall enter into force on 1 June 2011. 

Article 4 

Article 5 

This Directive is addressed to the Member States. 

Done at Brussels,  

For the Council 
The President 

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" 

No 

Common Name, 
Identification 
Numbers 

149  Carbendazim 

CAS N° 10605-21-7 

CIPAC N° 263 

In Annex I to Directive 91/414/EC, row No 149 is replaced by the following: 

ANNEX 

IUPAC Name 

Purity5 

Entry into 
force 

Expiration 
of inclusion 

Specific provisions 

Methyl benzimidazol-2-
ylcarbamate  

≥ 980 g/kg 

1 June 2011 

Relevant impurities 

2-amino-3-
hydroxyphenazine 
(AHP): not more 
than 0.0005 g/kg 

2,3-
diaminophenazine 
(DAP): not more 
than 0.003 g/kg 

30 November 
2014 

PART A 

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

-  cereals 

- 

rape seed 

-  sugar and fodder beet 

-  maize 

at rates not exceeding: 

-  0,25  kg  active  substance  per  hectare  per  application 

for cereals and rape seed; 

-  0,075  kg  active  substance  per  hectare  per  application 

for sugar and fodder beet; 

-  0,1 kg active substance per hectare per application for 

maize. 

The following uses must not be authorised:  

-  air application; 

-  knapsack  and  handheld  applications  neither  by 

amateur nor by professional users; 

-  home gardening. 

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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 

Purity5 

Entry into 
force 

Expiration 
of inclusion 

Specific provisions 

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

-  aquatic  organisms.  Appropriate  drift  mitigation 
measures must be applied to minimise the exposure of 
surface  water  bodies.  This  should  include  keeping  a 
distance  between  treated  areas  and  surface  water 
bodies  alone  or  in  combination  with  the  use  of  drift-
reducing techniques or devices; 

-  earthworms 

other 

soil  macro-organisms. 
and 
Conditions  of  authorisation 
risk 
mitigation measures, such as the selection of the most 
appropriate  combination  of  numbers  and  timing  of 
application,  and, 
the  degree  of 
if  necessary, 
concentration of the active substance; 

include 

shall 

-  birds (long term risk). Depending on the results of the 
risk  assessment  for  specific  uses,  targeted  mitigation 
measures  to  minimise  the  exposure  may  become 
necessary;  

-  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 
carbendazim,  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 

The  Member  States  concerned  shall  request  that  the 
applicant provides the following to the Commission:  

-  by  1  December  2011  at  the  latest,  information  as 
toxicological  and  ecotoxicological 

regards 
relevance of the impurity AEF037197; 

the 

-  by  1  June  2012  at  the  latest,  the  examination  of  the 
studies  included  in  the  list  in  the  draft  re-assessment 
report  of  16  July  2009  (Volume  1,  Level  4  "Further 
information", pp. 155 – 157); 

-  by  1  June  2013  at  the  latest,  information  on  the  fate 
and  behaviour  (route  of  aerobic  degradation  in  soil) 
and the long term risk to birds." 

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