EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/305/2024 
(POOL/E4/2024/305/305 -EN.docx)  
[…](2024) XXX  draft  
 
COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
not renewing the approval of sulfuryl fluoride for use in biocidal products of product -
types 8 and 18 in accordance with Regulation (EU) No 528/2012 of the European 
Parliament and of the Council  
(Text with EEA relevance)    
EN 1  EN COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
not renewing the approval of sulfuryl fluoride for use in biocidal products of product -
types 8 and 18 in accordance with Regulation (EU) No 528/2012 of the European 
Parliament and of the Council  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the 
Council of 22 May 2012 concerning the making available on the market and use of biocidal 
products1, and in particular Article 14( 4), first subparagraph, point (b),  thereof,  
Whereas:  
(1) Sulfuryl fluoride  was included in Annex I to Directive 98/8/EC of the European 
Parliament and of the Council2 as an active substance for use in bio cidal products of 
product -types 8 and 18 . Pursuant to Article 86 of Regulation (EU) No 528/2012 , it was 
therefore considered approved until 31 December 2018 for use in biocidal products of 
product -type 8 and until 30 June 2021  for use in biocidal products of product -type 18  
under that Regulation subject to the requirements  set out in Annex I to Directive  
98/8/EC.  
(2) On 28 June 2017, application s were  submitted in accordance with Article 13(1) of 
Regulation (EU) No 528/2012 for the renewal of the approval  of sulfuryl fluoride  for 
use in biocidal products of product -types 8 and 18 (‘the application s’). The 
applications were evaluated by the competent authority of Sweden  (‘the evaluating 
competent authority’).  
(3) On 14 February 2018, the evaluating competent authority informed the Commission 
that it had decided, pursuant to Article 14(1) of Regulation (EU) N o 528/2012, that a 
full evaluation of the applications was necessary.  In accordance with Article 14(2) of 
that Regulation, where the evaluating competent authority decides that a full 
evaluation of an application is necessary, the evaluation is to  be carri ed out in 
accordance with Article 8 (1), (2) and (3) , of that Regulation.  
(4) Pursuant to Commission Implementing Decision (EU) 2018/14793, the expiry date of 
approval of sulfuryl fluoride for use in biocidal products of product -type 8 has been 
postponed to 30 June 2021, in order to allow sufficient time for the examination of the 
                                                 
1 OJ L 167, 27.6.2012, p. 1, ELI:  http://data.europa.eu/eli/reg/2012/528/oj . 
2 Directive 98/8/EC of the European Parliament and of the Council of 16 Febru ary 1998 concerning the 
placing of biocidal products on the market (OJ L 123, 24.4.1998, p.1, ELI: 
http://data.europa.eu/eli/dir/1998/8/oj ). 
3 Commission Implementing Decision (EU) 2018/1479 of 3 October 2018 postponing the expiry date of 
approval of sulfuryl fluoride for use in biocidal products of product -type 8 (OJ L 249, 4.10.2018, p. 16 , 
ELI: http://data.europa.eu/eli/dec_impl/2018/1479/oj ).  
EN 2  EN application. Commission Implementing Decision (EU) 2021/7134 further postponed 
the expiry date of the approval of sulfuryl fluoride for use in biocidal products of 
product -types 8 and 18 to 31 December 2023. That expiry was again postponed by 
Commission Implementing Decision (EU) 2023/21015 to 31 December 2024.  
(5) On 12 December  2022, the evaluating competent authority submitted 
recommendations on the renewal  of the approval of sulfuryl fl uoride to the European 
Chemicals Agency (‘the Agency’).  
(6) In accordance with Article 14(3) of Regulation (EU) No 528/2012, on 13 September  
2023 the Agency adopted the opinion s6,7 formulated by its Biocidal Products 
Committee, having regard to the conclusions of the evaluating competent authority.  
(7) In its opinions t he Agency  concluded  that the information provided in the applications 
was not sufficient to assess whether sulfuryl flu oride meet s the criteria  set out in  
Article 5(1) , point (c) , of Regulation (EU) No 528/2012 , with regard to reproduct ion 
toxicity , and Article 5(1), point (d), of that Regulation , with regard to endocrine -
disrupting properties that may cause adverse effect s in humans.  Furthermore, the 
information provided in the applications was not sufficient to assess whether sulfuryl 
fluoride meets the condition for being considered a candidate for substitution  set out in 
Article 10(1), point (e),  of Regulation (EU) No 528/2012  with regard to  endocrine -
disrupting properties that may cause adverse effects in non -target organisms.  
(8) Pursuant to Article 8(2) and Article 6(2),  second subparagraph , of Regulation (EU) No 
528/2012, the evaluating competent authority requested the applicant to provide 
sufficient data in order to make it possible to determine whether sulfuryl fluoride 
meets the criteria referred  to in Article 5(1), points (c) and (d), of Regulation (EU)  No 
528/2012 . However, the requisite information and data hav e not been submitted by the 
applicant  within the period prescribed by the evaluating competent authority . 
Therefore, Article 6(2), second subparagraph , of Regulation (EU) No 528/2012 has 
not been complied with , making it impossible to determine whether sul furyl fluoride 
meets the criteria  referred to in Article 5(1) , points (c) and (d), of that Regulation , and 
subsequently it is not possible to determine whether sulfuryl fluoride may meet the 
conditions set out in  Article 5  of that Regulation.  
(9) Since the applicant did not submit the requisite information and data requested by the 
evaluating competent authority within the period prescribed  with regard to Article 
5(1), point (d), of Regulation (EU) No 528/2012 , concerning endocrine -disrupting  
prope rties that may cause adverse effects in humans , the evaluating competent 
authority  did not make a further request for data needed to assess whether sulfuryl 
fluoride meets the condition for being considered a candidate for substitution set out in 
                                                 
4 Commission Implementing Decision (EU) 2021/713 of 29 April 2021 postponing the expiry date of 
approval of sulfuryl fluoride for use i n biocidal products of product -types 8 and 18 (OJ L 147, 
30.4.2021, p. 21 , ELI: http://data.europa.eu/eli/dec_impl/2021/713/oj ). 
5 Commis sion Implementing Decision (EU) 2023/2101 of 28 September 2023 postponing the expiry date 
of the approval of sulfuryl fluoride for use in biocidal products of product -types 8 and 18 in accordance 
with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 241, 
29.9.2023, p. 147 , ELI: http://data.europa.eu/eli/dec_impl/2023/2101/oj ). 
6 Biocidal Products Committee (BPC) opinion on the application for renewal of the approval of the active 
substance: sulfuryl fluoride , Product type: 8, ECHA/BPC/3 89/2023, adopted on 13 September  2023. 
7 Biocidal Products Committee (BPC) opinion on the applic ation for renewal of the approval of the active 
substance: sulfuryl fluoride, Product type: 18, ECHA/BPC/3 90/2023, adopted on 13 September 2023.   
EN 3  EN Article 1 0(1), point (e), of that Regulation with regard to endocrine -disrupting 
properties that may cause adverse effects in non -target organisms . 
(10) Furthermore, due to the missing information, it is not possible to evaluate the  risks for 
both human health and the e nvironment for the representative biocidal product s 
containing sulfuryl fluoride  for use in biocidal products of product -types 8 and 18  in 
order to determine if sulfuryl fluoride still meets the conditions of approval laid down 
in Article 4(1) of Regulatio n (EU) No 528/2012 . Therefore, it has ultimately not been 
demonstrated that the representative biocidal product s containing sulfuryl fluoride  for 
use in biocidal products of product -types 8 and 18  may be expected to not have 
unacceptable effects themselves , or as a result of their residues, on human health and 
on the environment, and thus that they may be expected to satisfy the criteria set out in 
Article 19(1), point s (b)(iii) and (b)(iv), of Regulation (EU) No 528/2012.   
(11) Consequently , given the  opinion s of the Agency, t aking into account that the applicant 
did not provide the requisite information and data prescribed by the evaluating 
competent authority needed to assess whether  sulfuryl fluoride  meets the criteria 
referred to in Article 5(1) , points (c) and (d) , of Regulation (EU) No 528/2012  and 
subsequently to assess  whether sulfuryl fluoride may meet the conditions set out in 
Article 5 of that Regulation , and since it has not been demonstrated that the criteria 
laid down in  Article 19(1), point s (b)(iii) and (b)(iv), of Regulation (EU) No 528/2012 
are met, it cannot be determined whether the conditions laid down  in Article 4(1) of 
that Regulation are still satisfied . Thus, the condition  for renewal of the approval  of an 
active substance  set out in  Article 12(1) of Regulation (EU) No 528/2012  is not 
fulfilled . 
(12) It is therefore appropriate not to renew the approval of sulfuryl fluoride  for use in 
biocidal products of product -types 8 and 18.  
(13) The measures provided for in this Decision are in accordance  with the opinion of the 
Standing Committee on Biocidal Products,  
HAS ADOPTED THIS DECISION:  
Article 1  
The approval of sulfuryl fluoride  as an active substance for use in bioc idal products of 
product -types 8 and 18  is not renewed.  
Article 2 
This Decision shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
Done at Brussels,  
 For the Commission  
 The President  
 Ursula V ON DER LEYEN