EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/973/2022 
(POOL/E4/2022/973/973 -EN.docx)  
[…](2022) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
cancelling the approval of tolylfluanid  as an active substance for use in biocidal products 
of product -type 7 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 REGULATION (EU) …/...  
of XXX  
cancelling the approval of tolylfluanid  as an active substance for use in biocidal products 
of product -type 7 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 15(1) thereof,  
Whereas:  
(1) Tolylfluanid was approved  as an active substance for use in biocidal products of 
product -type 7, film preservatives, as described in Annex V  to Regulation (EU) No 
528/2012 , by Commission Implementing Regulation (EU) 2016/10872, subject to 
compliance with certain conditions  (‘the approval’) . 
(2) On 2 March 20 20, Denmark requested  that the Commission should  initiate a review of 
the approval pursuant to Article 15(1) of Regulation (EU) No 528/2012 , on the basis 
of significant indications that the use of the active substance in biocidal products or 
treated articl es raises significant concerns about the safety of such biocidal products or 
treated articles . In more detail, a metabolite  of tolyflu anid, dimethylsulfamid , has been 
found in a great number of Danish drinking water supplies , and these contaminations  
can b e linked with use of paints  treated with tolylfluanid . Where  ground water is 
ozonated in water treatment  for the production of drinking water , dimethylsulfamid 
may turn into N -nitrosodimethylamine which is genotoxic, mutagenic and 
carcinogenic. Denmark therefore requested a revis ion of  the evaluation of  the 
groundwater risk assessment  for tolylfluanid for product -type 7 , with the view to 
restrict the use of tolylfluanid in outdoor paint s treated with tolylf luanid . 
(3) On 5 July 2021 , the Commission announced to the initial applicant  for approval  of 
tolylfluanid its intention to start the procedure for the review of the approval of th at 
active substance for product -type 7  in accordance with Article 15(1) of Regulation 
(EU) No 528/2012 , and provided an opportunity for the initial applicant to submit 
comments . Moreover, t he Commission made  publicly available the information that it 
is carrying out this review on the website of the Directorate -General Health and Food 
Safety i n accordance  with Article 15(1) of Regulation (EU) No 528/2012 . 
(4) On 7 October 2021, the initial applicant  for the approval  of tolylfluanid indicated that 
it stopped the production of the active substance  and the placing on the market of 
                                                 
1 OJ L 167, 27.6. 2012, p. 1 . 
2 Commission Implementing Regulation (EU) 2016/1087 of 5 July 2016 approving tolylfluanid as an 
existing active substance for use in biocidal products of product -type 7 (OJ L 180, 6.7.2016, p. 18).  EN 2  EN biocidal products containing it , and will not  seek the renewal of approval of the 
substance . The initial applicant for the approval of tolyfluanid is the only substance  
supplier  within the meaning of Article 95 (1), first subparagraph,  of Regulation (EU) 
No 528/2012  included in the list r eferred to in that subparagraph,  for that active 
substance and product -type, published on the European Chemicals Agency’s website.  
Furthermore, n o biocidal product containing tolylfluanid for product -type 7 is 
authorised in the Union.  
(5) Given that there are no other suppliers of the substance , that no biocidal product  
containing tolyfluanid for product -type 7 is authorised in the Union and that the initial 
applicant  will not  seek the renewal of approval of the substance , the Commission did 
not consult  the European Chemicals Agency pursuant to Article 15(2) of Regulation 
(EU) No 528/2012 .  
(6) After having reviewed the information provided, the Commission considers that the 
use of tolyfluanid in biocidal products and treated articles raises significant concerns 
about the safety of such biocidal products and treated articles . Given the fact that there 
are no other suppliers of the substance, that no biocidal product containing tolyfluanid 
for product -type 7 is authorised in the Union and that the initial applicant  will not seek 
the renewal of approval of the substance, the Commission considers appropriate to 
cancel the approv al of tolylfluanid as an active substance  for use in bi ocidal products 
of product -type 7.  
(7) Implementing Regulation (EU) 2016/1087  should there fore be repealed.  
(8) As economic operators need time to adapt to the cancellation of the approval, it should 
be allowed to continue placing on the Union market treated articles  treated with or 
incorporating tolylfluanid  for product -type 7 for some time . 
(9) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee  on Biocidal Products , 
HAS ADOPTED THIS REGULATION:  
Article 1  
The approval of t olylfluanid  as an active substance for use in biocidal products of produ ct-
type 7  is cancelled .  
Article 2 
Implementing Regulation (EU) 2016/1087 is repealed  with effect from … [OP: please insert 
the date of entry into force of this Regulation ]. 
Article 3 
Treated articles treated with or incorporating tolylfluanid for product -type 7 shall no t be 
placed on the Union market from …[ OP: please insert the date = 6 months after the date of 
entry into force of this Regulation ]. 
Article 4 
This Regulation shall enter into force on the twentieth  day following that of its publication in 
the Official Journal of the European Union . EN 3  EN This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN