EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/12438/2020 
(POOL/E4/2020/12438/12438 -EN.docx)  
[…](2020) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Regulation (EU) No 528/2012 of the European Parliament and of the Council 
to include potassium sorbate as an active substance in Annex I thereto  
 
(Text with EEA relevance)   EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
Article 28(1) of Regulation (EU) No 528/2012 (the BPR) empowers the Commission 
to adopt delegated acts in order to include an active substance into Annex I to the 
BPR after receiving the opinion of the European Chemicals Agency (ECHA), 
provided that there is evidence that the active substance do not give rise to concern 
according to the condi tions set out in Article 28(2) of that Regulation.  A simplified 
authorisation procedure is provided in Chapter V of the BPR for biocidal products 
containing active substances  listed in Annex I to the BPR and fulfilling other 
conditions set out in Article 2 5 of that Regulation . 
Potassium sorbate has been assessed as an existing active substance within the 
review programme set out in Article 89(1) of the BPR established by Commission 
Delegated Regulation (EU) No 1062/2014 (the Review Regulation)  for use in 
biocidal products of product -type 8 “wood preservatives ”. 
In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the 
Biocidal Product Committee of ECHA  adopted its opinion on  4 December 2014   
(ECHA/BPC/ 37/2014 ), conclud ing that biocidal products of product -type 8 
containing potassium sorbate  may be expected to satisfy the requirements of Article 
5 of Directive 98/8/EC  which were the requirements applicable to the examination of 
the application for approval of potassium sorb ate in accordance with Article 90(2) of 
Regulation (EU) No 528/2012 . Potassium sorbate was therefore approved as an 
active substance for use in biocidal products of pro duct-type 8 by Commission 
Implementing Regulation (EU) 2015/1729 of 28  September 2015 .  
The opinion of ECHA also concluded that potassium sorbate does not give rise to 
concern and is eligible for inclusion in Annex I to Regulation (EU) No 528/2012.   
During the 81st meeting of Member States’ Competent Authorities on biocidal 
products in Novemb er 2018, Member States’ Competent Authorities agreed that this 
active substance could be included into Annex I to the BPR, with the view to replace 
in the long term its previous approval made by Commission Implementing 
Regulation (EU) 2015/1729 of 28  Septe mber 2015 . Such inclusion would in 
particular reduce the administrative burden , facilitate the placing on the EU market 
of biocidal products presenting lower concerns for human health, an imal health and 
the environment , and promote innovation for such bioc idal products.  
The opinion  of ECHA of 4 December 2014  is considered as an opinion of the 
Agency pursuant to Article 28(1) of  Regulation (EU) No 528/2012 . 
This draft Delegated Regulation therefore proposes to include potassium sorbate  in 
Annex I to Regulation (EU) No 528/2012 . 
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
The Commission has consulted an expert group (the 'Biocides CA meeting') 
consisting of representatives of Member States' competent authorities for biocidal 
products, of the Euro pean Chemicals Agency, of the biocides industry and of the 
civil society  during the meeting of 8 December  2020. During this consultation , no 
concerns were raised.   EN 2  EN 3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The delega ted Regulation  amends Annex I to Regulation (EU) No 528/2012 . The 
legal basis  is Article 28(1) of that Regulation.  EN 3  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Regulation (EU) No 528/2012 of the European Parliament  and of the Council 
to include potassium sorbate as an active substance in Annex I thereto  
 
(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 528/201 2 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 28(1) thereof,  
Whereas:  
(1) Potassium (E,E) -hexa -2,4-dienoate  (potassium sorbate ) has been ass essed as an 
existing active substance included in  the work  programme  for the systematic 
examination of all existing active substances , referrred to  in Article 89(1) of 
Regulation (EU) No 528/2012 and carried out in accordance with  Commission 
Delegated Regu lation (EU) No 1062/20142. 
(2) In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the 
opinion of the European Chemicals Agency (‘the Agency ’) was adopted  on 4 
December  2014 by the  Biocidal Products Committee3, having regard to the 
conclusions of the evaluating competent authority.  As the evaluation of the competent 
authority was completed on 20  October 2010, the application for approval of 
potassium sorbate was examined in accordance with Directive 98/8/EC  of the 
European Parliament  and of the Council4, as provided for in Article 90(2) of 
Regulation (EU) No 528/2012 , and  the Agency  concluded in its opinion that biocidal 
products of product -type 8 containing potassium sorbate  may be expected to fulfill  the 
requirements of Article 5 of  Directive 98/8/EC.  
(3) Potassium sorbate  was therefore approved as an active substance for use in biocidal 
products of pr oduct -type 8 by Commission Im plementing Regulation (EU) 
2015/17295.  
                                                 
1 OJ L 167, 27.6.2012 , p. 1.  
2 Commission Delegated Regula tion (EU) No 1062 /2014 of 4 August 2014  on the work programme for 
the systematic examination of all existing active substances contained in biocidal products referred to in 
Regulation (EU) No 528/2012 of the European Parliament and of the Council  (OJ L 294, 10.10.2014 , 
p. 1). 
3 Biocidal Products Committee  Opinion on the application for approval of the active subs tance : 
Potassium sorbate , Product type: 8, ECHA/BPC/ 37/2014 , adopted on  4 December 2014 . 
4 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the 
placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).  
5 Commission Implementing Regulation (EU) 2015/1729  of 28 September 2015  approving potassium 
sorbate  as an existing active substance for use in biocidal products of product -type 8 (OJ L 252, 
29.9.2015 , p. 24). EN 4  EN (4) Potassium sorbate is still included  in the work  programme for the systematic 
examination of all existing active substances  for its use in biocidal products of 
product -type 6. 
(5) In the opinion of 4 December 2014 , the Agency  also concluded that potassium sorbate  
fulfils the criteria  for inclusion in Annex I to Regulation (EU ) No 528/2012 . 
(6) Taking into account the opinion of the Agency , it is appropriate to include potassium 
sorbate  in Annex I to Regulation (E U) No 528/2012 . As potassium sorbate  has been 
assessed on the basis of  an active substance  dossier that has been accepted  in 
accordance with  Article 11(1) of Directive 98/8/EC , potassium sorbate  should be 
included in category 6 of Annex I to Regulation  (EU) No 528/2012 .  
(7) Article 89(3) of Regulation (E U) No 528/2012 contains transitional measures where 
an existing act ive substance included in the work programme for the systematic 
examination of existing active substances is approved in accordance with that 
Regulation. With respect to potassium sorbate  for product -type 6, the date of approval 
for the purposes of Article  89(3) of that Regulation should be set at  1 February 2023, 
in order to allow sufficient time for applications for authorisation to be submitted in 
accordance with the second subparagraph of Article 89(3) of that Regulation , 
HAS ADOPTED THIS REGULATION:  
Article 1 
Annex I to Regulation (E U) No 528/2012  is amended in accordance with the  Annex to this 
Regulation . 
Article 2 
For the purposes of Article 89(3) of Regulation (E U) No 528/2012, the date of approval of 
potassium sorbate for product -type 6 is 1 February 2023 . 
Article  3 
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 St ates. 
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN  