EN    EN EN EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels,  
  
  
Draft 
COMMISSION DIRECTIVE ../…/EC 
of […] 
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 
EN EN 2   EN Draft 
COMMISSION DIRECTIVE ../…/EC 
of  
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 
(Text with EEA relevance) 
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing the European Community, 
Having regard to Directive 98/8/EC of the European Parliament and of the Council of 
16 February 1998 concerning the placing of  biocidal products on the market1, and in 
particular the second subparagraph of Article 16(2) thereof, 
Whereas: (1) Commission Regulation (EC)  No 1451/2007 of 4 December 2007 on the second phase 
of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of 
the European Parliament and of the Counc il concerning the pl acing of biocidal 
products on the market
2 establishes a list of active substances to be assessed, with a 
view to their possible inclusion in Annex I, IA or IB to Directiv e 98/8/EC. That list 
includes sulfuryl fluoride. 
(2) Commission Directive 2006/140/EC3 included sulfuryl fluoride as an active substance 
in Annex I to Directive 98/8/EC for use in  product-type 8, wood preservatives, as 
defined in Annex V to Directive 98/8/EC. 
(3) Pursuant to Regulation (EC) No 1451/2007, sulf uryl fluoride has now been evaluated 
in accordance with Article 11(2) of Direc tive 98/8/EC for use in product-type 18, 
insecticides, as defined in Annex V to that Directive. 
(4) Sweden was designated as Rapporteur Member State and submitted the competent 
authority report, together with a reco mmendation, to the Commission on 19 June 2007 
in accordance with Article 14(4) a nd (6) of Regulation (EC) No 1451/2007. 
(5) The competent authority report was re viewed by the Member States and the 
Commission. In accordance with Article 15 (4) of Regulation (EC) No 1451/2007, the 
                                                 
1 OJ L 123, 24.4.1998, p. 1. Directive as last amended by Directive 2008/31/EC of the European 
Parliament and of the Council (OJ L 81, 20.03.2008, p. 57). 
2 OJ L 325, 11.12.2007, p. 3. 
3 OJ L 414, 30.12.2006, p. 78 EN 3   EN findings of the review were incorporated, within the Standing Committee on Biocidal 
Products on 19 September 2008, in an assessment report. 
(6) It appears from the examinations made that biocidal products used as insecticides and 
containing sulfuryl fluoride may be expected  to satisfy the requirements laid down in 
Article 5 of Directive 98/8/EC. It is theref ore appropriate to incl ude sulfuryl fluoride 
in Annex I, in order to ensure that in al l Member States authorisations for biocidal 
products used as insecticides and contai ning sulfuryl fluorid e can be granted, 
modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC.  
(7) In the light of the conclusions of the assessmen t report, it is approp riate to require that 
products containing sulfuryl fluoride and used  as insecticides be authorised only for 
use by trained professionals in accordance  with Article 10(2)(i)(e) of Directive 
98/8/EC, and that specific risk mitigation measures are applied at product authorisation level to ensure the sa fety of operators and of bystanders. 
(8) In addition, it is appropriate to require cont inuous monitoring of sulfuryl fluoride in 
remote tropospheric air and to  require results of such monitoring to be regularly 
reported to the Commission.  
(9) It is important that the provisions of this Directive be applied simultaneously in all the 
Member States in order to ensure equal tr eatment of biocidal products on the market 
containing the active substance sulfuryl fluoride and also to facilitate the proper 
operation of the biocidal pr oducts market in general. 
(10) A reasonable period should be allowed to elap se before an active substance is included 
in Annex I in order to permit Member Stat es and the interested parties to prepare 
themselves to meet the new requirements enta iled and to ensure that applicants who 
have prepared dossiers can benefit fully fr om the 10-year period of data protection, 
which, in accordance with Artic le 12(1)(c)(ii) of Directive 98/8/EC, starts from the 
date of inclusion. 
(11) After inclusion, Member States should be allowed a reasonable period to implement 
Article 16(3) of Directive 98/8/EC, and in  particular, to grant, modify or cancel 
authorisations of bioc idal products in produ ct-type 18 containing su lfuryl fluoride to 
ensure that they comply with Directive 98/8/EC. 
(12) Directive 98/8/EC should therefore be amended accordingly. 
(13) The measures provided for in this Directiv e are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Annex I to Directive 98/8/EC is amended in a ccordance with the Annex to this Directive. EN 4   EN Article 2  
1. Member States shall adopt and publish, by  31 January 2010 at th e 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 thos e provisions and this Directive. 
They shall apply those provi sions from 1 February 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 determin e how such reference is to be made. 
2. Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 
Article 3 
This Directive shall enter into force on the tw entieth day following that of its publication in 
the Official Journal of  the European Union . 
Article 4 
This Directive is addressed to the Member States. 
Done at Brussels, […] 
 For the Commission 
 Stavros Dimas  Member of the Commission  
EN 5   EN ANNEX  
The following is added to entry ‘No. 1’  in Annex I to Directive 98/8/EC:   
No Common Name 
 IUPAC Name 
Identification 
Numbers Minimum purity of 
the active 
substance in the 
biocidal product as 
placed on the 
market Date of 
inclusion Deadline for compliance with Article 16(3) 
(except for products containing more than one 
active substance, for which the deadline to comply 
with Article 16(3) shall be the one set out in the 
last of the inclusion decisions relating to its active 
substances) Expiry 
date of 
inclusion Product 
type Specific provisions (*)  
EN 6   EN    "994 g/kg 1 February 
2011 31 January 2013 31 
January 2021 18 Member States shall ensure that authorisations 
are subject to the following conditions: 
(1) Products shall only be sold to and used 
by professionals trained to use them. 
(2) Appropriate measures to protect 
fumigators and bystanders during 
fumigation and venting of treated 
buildings or other enclosures must be 
taken.  
(3) Labels and/or safety-data sheets of 
products shall indicate that, prior to 
fumigation of any enclosure, all food items must be removed. 
(4) Concentrations of sulfuryl fluoride in 
remote tropospheric air are monitored. 
(5) Member States shall also ensure that 
reports of the monitoring referred to in 
point (4) are transmitted by 
authorisation holders directly to the 
Commission every fifth year, starting 
at the latest five years after the 
authorisation. The limit of detection for 
the analysis shall be at least 0.5 ppt 
(equivalent to 2.1 ng sulfuryl 
fluoride/m
3 of tropospheric air)." 
(*) For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on  the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm