EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/11178/2020 
(POOL/E4/2020/11178/11178 -EN.doc)  
[…](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 citric acid 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 . 
Citric acid has been assessed as an existing active substance within the review 
programme set out in Article 89(1) of the BPR established by Regulation (EU) No 
1062/2014 (the Review Regulation)  for use in biocidal products of product -type n°2 
“disinfectants and algaecides not intended for direct application to humans or 
animals ”. 
In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the 
Biocidal Product Committee of ECHA  adopted its opinion on  16 February 2016  
(ECHA/BPC/088/2016 ), conclud ing that biocidal products of product -type n°2 
containing citric acid 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 citric acid in accordance with Article 90(2) of Regulation 
(EU) No 528/2012 . Citric acid was therefore approved as an active substance for use 
in biocidal products  of pro duct-type n°2 by Commission Imp lementing Regulation 
(EU) 2016/1938 of 4 November 2016 .  
The opinion of ECHA also concluded that that citric acid  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 November 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 te rm its previous approval made by Commission Implementing 
Regulation (EU) No 2016/1938 of 4 November 2016. Such inclusion would in 
particular reduce the administrative burden , facilitate the placing on the EU market 
of biocidal products presenting lower con cerns for human health, an imal health and 
the environment , and promote innovation for such biocidal products.  
The opinion  of ECHA of 16 February 2016 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 citric acid 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 European Chemicals Agency, of the biocides industry and of the 
civil society  during  the meeting of 22-25 September 20 20. 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 citric acid 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 528/2012 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 28(1) thereof,  
Whereas:  
(1) Citric acid has been assessed as an existing active substance within the review 
programme  set out in Article 89(1) of Regulation (EU) No 528/2012 established by 
Commission Delegated Regula tion (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 16 
February 2016  by the  Biocidal Products Committee3, having regard to the conclusions 
of the evaluating competent authority.  That opinion  concluded that biocidal products 
of product -type 2  containing citric acid may be expected to fulfill  the requirements of 
Article 5 of Directive 98/8/EC  of the European Parliament and of the Co uncil4 which 
were the requirements applicable to the examination of the application for approval of 
citric acid in accordance with Article 90(2) of Regulation (EU) No 528/2012 . 
(3) Citric acid was therefore approved as an active substance for use in biocidal p roducts 
of pr oduct -type 2 by Commission Im plementing Regulation (EU) 2016/19385. 
(4) The opinion of the Agency also concluded that citric acid  does not give rise to concern 
and is eligible for inclusion in Annex I to Regulation (EU) No 528/2012 . 
(5) Taking into ac count the opinion of the Agency , it is therefore appropriate to include 
citric acid  in Annex I to Regulation (E U) No 528/2012 . As citric acid has been 
assessed based on a n active substance  dossier satisfying  the requirement s laid down  in 
                                                 
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 i n 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 substance : Citric 
acid, Product type: 2, ECHA/BPC/088/2016 , adopted on  16 February 2016.  
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) 2016/1938 of 4 November 2016  approving citric acid as an 
existing active substance for use in biocidal products of product -type 2  (OJ L 299, 5.11.2016, p. 54 ). EN 4  EN Article 11(1) of Directive 98/8/EC , citric acid  should be included in category 6 of 
Annex I to 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 
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  
 Ursula VON DER LEYEN  