Proposal for a COUNCIL DECISION concerning the non-inclusion of 1,3-dichloropropene in Annex I to Council Directive 91/414/EEC
Date: 2010-09-01
Institutions: European Commission
Subjects: dangerous substance, marketing restriction, pharmaceutical product, plant health legislation, plant health product, withdrawal from the market

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EUROPEAN COMMISSION 

Brussels, 1.9.2010 
COM(2010) 444 final 

2010/0239 (NLE) 

Proposal for a 

COUNCIL DECISION 

concerning the non-inclusion of 1,3-dichloropropene in Annex I to Council Directive 
91/414/EEC  

(Text with EEA relevance) 

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EXPLANATORY MEMORANDUM 

The  attached  draft  proposal  for  a  Council  Decision  concerns  the  non-inclusion  of  1,3-
dichloropropene  as  active  substance  in  the  positive  list  (Annex  I)  of  Council  Directive 
91/414/EEC.  The  proposal  for  a  non-inclusion  is  based  on  a  number  of  concerns  identified 
during the second evaluation of this active substance, which is not approved since September 
2007. 

Directive 91/414/EEC concerning the placing of plant protection products on the market sets 
up  a  harmonised  framework  for  the  authorisation  and  placing  on  the  market  of  plant 
protection products. Article 8(2) of this Directive provides a programme to be carried out over 
a  period  of  12  years  for  the  gradual  examination  of  the  active  substances  contained  in  the 
pesticides, which are on the market for the inclusion in Annex I of the Directive. Regulation 
(EC)  No  451/2000  and  Regulation  (EC)  No  1490/2002  lay  down  the  detailed  rules  for  the 
implementation of the second and third stages of the above mentioned programme of work. 

1,3-dichloropropene is one of the active substances covered by the second stage of this work 
programme.  It  had  been  non-included  in  Annex  I  of  Directive  91/414/EEC  by  Commission 
Decision 2007/619/EC, in particular due to the release in the environment of large amounts of 
known  and  unknown  polychlorinated  impurities,  for  which  no  information  on  persistency, 
toxicological  behaviour,  uptake  from  crops,  accumulation,  metabolic  fate  and  residue  level 
were available, as well as to the inconclusive nature of the consumer risk assessment and to the 
risk of groundwater potential contamination, for birds, mammals, aquatic organisms and other 
non target organism. 

In June 2008, the notifier of the active substance re-submitted a new dossier according to the 
accelerated  procedure  provided  for  in  Regulation  (EC)  No  33/2008.  This  dossier  has  been 
evaluated  by  the  designated  rapporteur  Member  State  (Spain)  and  by  the  European  Food 
Safety Authority (EFSA), which delivered on 30 September 2009 its conclusions on the risk 
assessment for 1,3-dichloropropene. 

However,  the  additional  data  and  information  provided  by  the  notifier  did  not  permit  to 
eliminate  all  the  specific  concerns  that  led  to  the  first  non-inclusion.  Therefore,  on  9  July 
2010, the Commission submitted to the Standing Committee on the Food Chain and Animal 
Health a draft Commission Decision concerning the non-inclusion of 1,3-dichloropropene in 
Annex I to Council Directive 91/414/EEC. 

The Committee delivered no opinion and the results of the vote were the following: 

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14 Member States voted in favour (150 votes) 

11 Member States voted against (154 votes) 

2 Member States abstained (41 votes) 

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 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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2010/0239 (NLE) 

Proposal for a 

COUNCIL DECISION 

concerning the non-inclusion of 1,3-dichloropropene in Annex I to Council Directive 
91/414/EEC  

(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  the  fourth  subparagraph  of 
Article 8(2) thereof, 

Whereas: 

(1) 

(2) 

By  Commission  Decision  2007/619/EC2  it  was  decided  not  to  include  the  active 
substance  1,3-dichloropropene  in  Annex  I  to  Directive  91/414/EEC.  That  Decision 
was  taken  within  the  framework  of  the  second  stage  of  the  programme  of  work 
provided for in Commission Regulations (EC) No 451/20003 and (EC) No 703/20014 
which  lay  down  the  detailed  rules  for  the  implementation  of  the  second  stage  of  the 
programme  of  work  referred  to  in  Article  8(2)  of  Directive  91/414/EEC  and  which 
establish  a  list  of  active  substances  to  be  assessed,  with  a  view  to  their  possible 
inclusion in Annex I to Directive 91/414/EEC.  

The original notifier submitted a new application pursuant to Article 6(2) of Directive 
91/414/EEC and Commission Regulation (EC) No 33/2008 of 17 January 2008 laying 
down detailed rules for the application of Council Directive 91/414/EEC as regards a 
regular  and  an  accelerated  procedure  for  the  assessment  of  active  substances  which 
were  part  of  the  programme  of  work  referred  to  in  Article  8(2)  of  that  Directive  but 
have not been included into its Annex I5. It requested the application of the accelerated 
procedure  pursuant  to  Chapter  III  of  Regulation  (EC)  No  33/2008  and  submitted  an 
updated dossier. The application was submitted to Spain, which had been designated 
rapporteur Member State by Regulation (EC) No 451/2000.  

(3) 

That  application  complies  with  the  substantive  and  procedural  requirements  of 
Article 15 of Regulation (EC) No 33/2008 and was submitted within the time period 
provided for in the second sentence of Article 13 of that Regulation.  

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OJ L 230, 19.8.1991, p. 1. 
OJ L 249, 25.9.2007, p. 11. 
OJ L 55, 29.2.2000, p. 25.  
OJ L 98, 7.4.2001, p. 6. 
OJ L 15, 18.1.2008, p. 5. 

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(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

Spain evaluated the new information and data submitted by the notifier and prepared 
an additional report on 15 April 2009. 

The additional report was peer reviewed by the Member States and the European Food 
Safety  Authority,  hereinafter 
the  Commission  on 
30 September  2009  in  the  format  of  the  EFSA  Conclusion  for  1,3-dichloropropene6. 
This  report  was  reviewed  by  the  Member  States  and  the  Commission  within  the 
Standing  Committee  on  the  Food  Chain  and  Animal  Health  and  finalised  on  9  July 
2010 in the format of the Commission review report for 1,3-dichloropropene. 

'EFSA',  and  presented 

to 

The  new  assessment  by  the  rapporteur  Member  State  and  the  new  conclusion  by  the 
EFSA concentrated on the concerns that lead to the non-inclusion, which were due to the 
release in the environment of large amounts of known and unknown polychlorinated 
impurities,  for  which  no  information  on  persistency,  toxicological  behaviour,  uptake 
from crops, accumulation, metabolic fate and residue level were available, as well as 
to the inconclusive nature of the consumer risk assessment and to the risk of groundwater 
potential  contamination,  for  birds,  mammals,  aquatic  organisms  and  other  non  target 
organism. 

New  data  and  information  were  submitted  by  the  notifier  in  the  updated  dossier  to 
address the concerns which lead to the non-inclusion, in particular as regards the identity 
of a number of impurities, the level of residues expected in crops, the risk to groundwater 
contamination  and  the  risk  to  birds,  mammals,  aquatic  organisms  and  non-target 
organisms. A new assessment was performed, as included in the additional report and in 
the EFSA Conclusion for 1,3-dichloropropene. 

However, the additional data and information provided by the notifier did not permit 
to eliminate all the specific concerns that led to the non-inclusion.  

In  particular,  there  is  a  concern  for  the  consumer  exposure  in  relation  to  eleven 
unidentified  manufacturing  impurities.  Furthermore,  the  potential  contamination  of 
groundwater in relation to 1,3-dichloropropene, its relevant toxic breakdown  product 
(EZ)-3-chloroacrylic  acid  and  eleven  unidentified  manufacturing  impurities  were  not 
adequately  addressed  and  there  is  a  potential  for  long-range  transport  through  the 
atmosphere  of  ten  manufacturing  impurities.  In  addition,  the  risk  to  non-target 
organisms was not demonstrated to be acceptable. 

(10)  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.  Furthermore,  in 
accordance  with  Article  21(1)  of  Regulation  (EC)  No  33/2008,  the  Commission 
invited  the  notifier  to  submit  comments  on  the  draft  review  report.  The  notifier 
submitted its comments, which have been carefully examined. 

(11)  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 

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European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the 
active  substance  (EZ)-1,3-dichloropropene  on  request  from  the  European  Commission.  EFSA  Journal 
2009; 7(10):1341. [102 pp.]. doi:10.2903/j.efsa.2009.1341. Available online: www.efsa.europa.eu. 

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products containing 1,3-dichloropropene satisfy in general the conditions laid down in 
Article 5(1)(a) and (b) of Directive 91/414/EEC. 

(12) 

1,3-dichloropropene  should  therefore  not  be  included  in  Annex  I  to  Directive 
91/414/EEC.  

(13)  Decision 2007/619/EC should be repealed. 

(14)  This  Decision  does  not  prejudice  the  submission  of  a  further  application  for  1,3-
dichloropropene  pursuant  to  Article  6(2)  of  Directive  91/414/EEC  and  Chapter  II  of 
Regulation (EC) No 33/2008.  

(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 DECISION: 

1,3-dichloropropene  shall  not  be  included  as  active  substance  in  Annex  I  to  Directive 
91/414/EEC. 

Article 1 

Decision 2007/619/EC is repealed. 

Article 2 

Article 3 

This Decision is addressed to the Member States. 

Done at Brussels, 

For the Council 
The President 

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