EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10560/2016 (POOL/E4/2016/10560/10560-EN.doc) […](2016) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving citric acid as an existing active substance for use in b iocidal products of 
product-type 2 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving citric acid  as an existing active substance for use in biocidal products of 
product-type 2 
(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 avai lable on the market and use of biocidal 
products
1, and in particular the third subpa ragraph of Article 89(1) thereof, 
Whereas: (1) Commission Delegated Re gulation (EU) No 1062/2014
2 establishes a list of existing 
active substances to be evaluated for thei r possible approval for use in biocidal 
products. That list in cludes citric acid. 
(2) Citric acid has been evaluate d in accordance with Article 16(2) of Directive 98/8/EC 
of the European Parliament and of the Council3 for use in products of product-type 1, 
human hygiene biocidal products, as defined in Annex V to that Directive, which 
corresponds to product-type 1 as defi ned in Annex V to Regulation (EU) 
No 528/2012. 
(3) The evaluation covered an anti-viral tissue impregnated with citric acid which would 
be placed on the market with the claim "kills 99,9% of cold & flu viruses in the 
tissue". In accordance with Article 1 of  Commission Implementing Decision (EU) 
2015/19854, such anti-viral tissue is to be cons idered as a biocidal product falling 
within product-type 2 as defined in Annex V to Re gulation (EU) No 528/2012. 
Therefore, any approval of citr ic acid as an existing activ e substance should only cover 
its use in biocidal products of product-type 2, disinfectants and al gaecides not intended 
for direct application to  humans or animals. 
(4) Belgium was designated as evaluating competent authority and submitted the 
assessment report together with its recommendations on 23 August 2013. 
(5) In accordance with Article 7(2) of De legated Regulation (EU) No 1062/2014, the 
opinion of the European Chemicals Agency was formulated on 16 February 2016 for 
                                                 
1 OJ L 167, 27.6.2012, p. 1. 
2 Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for 
the systematic examination of all existing active substan ces 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 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). 
4 Commission Implementing Decision (EU) 2015/1985 of 4 November 2015 pursuant to Article 3(3) of 
Regulation (EU) No 528/2012 of the European Parliament and of the Council on an anti-viral tissue 
impregnated with citric acid (OJ L 289, 5.11.2015, p. 26).  
EN 3   EN use in products of product-type 2 by the Biocidal Products Committee, having regard 
to the conclusions of the ev aluating competent authority. 
(6) According to that opinion, biocidal products of product-type 2 cont aining citric acid 
may be expected to satisfy the requireme nts of Article 5 of Directive 98/8/EC, 
provided that certain specifications and conditions concerning their use are complied with. 
(7) It is therefore appropriate to approve citric  acid for use in biocidal products of product-
type 2, subject to compliance with cer tain specifications and conditions. 
(8) A reasonable period should be allowed to elapse before an active substance is 
approved in order to permit interested parties to take the preparatory measures 
necessary to meet th e new requirements. 
(9) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Citric acid is approved as an active substance for use in biocid al products of product-type 2, 
subject to the specifications and conditions set out in the Annex. 
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  Jean-Claude JUNCKER