EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE -2015 -12459 rev. 3  
[…](2016) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending Implementing Regulation (EU) No 540/2011 as regards the conditions of 
approval of the active substance sulfuryl fluoride   EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending  Implementing Regulation (EU) No 540/2011 as regards the conditions of 
approval of the active substance sulfuryl fluoride  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard  to Regulation (EC) No 1107/2009 of the European Parliament and of the 
Council of 21 October 2009 concerning the placing of plant protection products on the market 
and repealing Council Directives 79/117/EEC and 91/414/EEC1, and in particular the second 
alternative o f Article 21(3) and Article 78(2) thereof,  
Whereas:  
(1) Commission Directive 2010/38 /EU2 of 18 June 2010 amending Council Directive 
91/414/EEC to include sulfuryl fluoride as active substance  provide s further 
confirmatory information on estimates of  sulfuryl fluoride atmospheric lifetime, the 
tropospheric concentrations of sulfuryl fluoride and the milling conditions , necessary  
to ensure that residues of fluoride ion in cereals  do not exceed the natural background  
levels . 
(2) Active substances included i n Annex I to Directive 91/414/EEC are deemed to have 
been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the 
Annex to Commission Implementing Regulation (EU) No 540/20113. 
(3) The notifier submitted additional information with a view t o confirm the risk 
assessment for the fate of sulfuryl fluoride in the atmosphere  and for the residue s of 
fluoride ion in milling products present in the machinery during the fumigation.  
(4) The United Kingdom assessed the additional information submitted by the notifier. It 
submitted its assessment, in the form of an addend um to the draft assessment report, to 
the other Member States, the Commission, and the European Food Safety Authority, 
hereinafter ‘the Authority’, on 4 June 2015 . 
(5) The Commission considered that according to the additional information provided by 
the notifier , it could not be excluded that the residue levels in milling products present 
in the machinery during the fumigation will exceed the natural background 
concentration for fluoride ion  or will not meet the relevant maximum residue levels . 
Therefore the conditions of approval should be amended to ensure that milling 
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Directive 2010/38/EU of 18 June 2010 amending Council Directive 91/414/EEC  to 
include sulfuryl fluoride as active substance ( OJ L 154, 19.6.2010, p. 21 ).  
3 Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation 
(EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active 
substances  (OJ L 153, 11.6.2011, p. 1). EN 3   EN products present in the treated facilities always comply w ith provisions of 
Regulation  (EC) No 396/2005.  
Furthermore  it considered that  the information submitted  has not demonstrated  the 
steady state of sulfuryl fluoride  in troposphere ; consequently  there is also a need for 
further monitoring of its tropospheric concentrations  until the steady state is fully 
proven . It is also appropriate to provide for the further monitoring the tropospheric 
concentrations of sulfuryl fluoride and to submit information in this regard to the 
Commission, Member States  and the Europ ean Food Safety Authority  on regular 
basis , every fifth year.  
(6) Sulfuryl fluoride is also approved as a biocidal active substance according to 
Commission Directive 2009/84/EC4 of 28 July 2009 amending Directive 98/8/EC of 
the European Parliament and of the C ouncil to include sulfuryl fluoride as an active 
substance in Annex I thereto . Due to the same concerns about the environmental fate 
of sulfuryl fluoride as for the pesticidal uses, additional information including a 
monitoring of the tropospheric concentr ations has been required. Submission  dates  of 
information should be the same , in order to avoid redundant work and rationalize the 
evaluation process . 
(7) The Annex to Implementing Regulation (EU) No 540/2011 should therefore be 
amended accordingly.  
(8) The applicant was given the possibility to submit comments on the review report.  
(9) Member States should be provided with time to amend or withdraw authorisations for 
plant protection products containing sulfuryl fluoride  which are not complying with 
the restrict ed conditions of approval . 
(10) For plant protection products containing sulfuryl fluoride, where Member States grant 
any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, this 
period should expire at the latest 18 months after the ent ry into force of this 
Regulation.  
(11) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Amendment to Implementing Regulation (EC) No 540/2011  
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the 
Annex to this Regulation.  
                                                 
4 Commission Directive 2009/84/EC of 28 July 2009 amending Directive 98/8/EC of the European 
Parliament and of the Council to include sulfuryl fluoride as an active substance in Annex I thereto  (OJ 
L 197, 29.7.2009, p. 67 ) EN 4   EN Article 2 
Transitional measures  
Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary 
amend or with draw existing authorisations for plant protection products containing sulfuryl 
fluoride  as active substance by [6 months after EIF] . 
Article 3 
Grace period  
Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) 
No 1107/2 009 shall be as short as possible and shall expire 12 months after restriction o r 
withdrawal  of the respective authorisation at the latest . 
Article 4 
Entry into force  
This Regulation shall enter into force on the twentieth  day following that of its publication in 
the Official Journal of the European Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude Junker