Proposal for a Council Decision concerning the non-inclusion of diphenylamine 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)
Date: 2009-05-25
Institutions: European Commission
Subjects: dangerous substance, market approval, marketing restriction, pharmaceutical product, plant health legislation, plant health product

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 25.5.2009 
COM(2009) 240 final 

Proposal for a 

COUNCIL DECISION 

concerning the non-inclusion of diphenylamine 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) 

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EXPLANATORY MEMORANDUM 

The  attached  draft  proposal  for  a  Council  Decision  concerns  the  non  inclusion  of 
diphenylamine  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  Ireland,  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  diphenylamine  on  30  September 
2008. 

During  the  evaluation  of  this  active  substance,  a  number  of  concerns  were  identified.  In 
particular, it was not possible to perform a reliable consumer exposure assessment, as data are 
missing on the presence and toxicity of unidentified metabolites of the substance, as well as on 
the  possible  formation  of  nitrosamines  during  storage  of  the  active  substance  and  during 
processing  of  treated  apples.  Moreover,  no  data  was  available  on  the  potential  breakdown  or 
reaction product of diphenylamine residues in processed commodities. 

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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16 Member States voted in favour (165 votes) 

9 Member States voted against (139 votes) 

2 Member States abstained (41 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 diphenylamine 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 diphenylamine. 

For  diphenylamine  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  diphenylamine  the  rapporteur  Member  State  was  Ireland  and  all 
relevant information was submitted on 20 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 diphenylamine4. 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 diphenylamine. 

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  exposure 
assessment, as data are missing on the presence and toxicity of unidentified metabolites 
of the substance, as well as on the possible formation of nitrosamines during storage of 
the  active  substance  and  during  processing  of  treated  apples.  Moreover,  no  data  was 
available  on  the  potential  breakdown  or  reaction  product  of  diphenylamine  residues  in 
processed commodities. Consequently, it was not possible to conclude on the basis of 
the information available that diphenylamine 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  diphenylamine 
satisfy  in  general  the  requirements  laid  down  in  Article  5(1)(a)  and  (b)  of  Directive 
91/414/EEC. 

(7) 

Diphenylamine 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  diphenylamine  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 diphenylamine 
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 
diphenylamine  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 diphenylamine 
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. 

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EFSA  Scientific  Report  (2008)  188,  Conclusion  on  the  peer  review  of  diphenylamine,  finalised 
30 September 2008.  
OJ L 15, 18.1.2008, p. 5–12. 

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(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, 

HAS ADOPTED THIS DECISION: 

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

Article 1 

Member States shall ensure that: 

Article 2 

(a) 

(b) 

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

no authorisations for plant protection products containing diphenylamine 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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