EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10117/2017 (POOL/E4/2017/10117/10117-EN.doc) […](2017) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving active chlorine rele ased from sodium hypochlori te as an existing active 
substance for use in biocidal products of product-types 1, 2, 3, 4 and 5 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving active chlorine released from sodi um hypochlorite as an existing active 
substance for use in biocidal products of product-types 1, 2, 3, 4 and 5 
(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 includes active chlori ne released from sodium hypochlorite 
(hereafter referred to as  ‘sodium hypochlorite’). 
(2) Sodium hypochlorite has been evaluated in accordance with Article 16(2) of Directive 
98/8/EC of the European Pa rliament and of the Council3 for use in products of 
product-type 1, human hygiene biocidal produ cts, product-type 2, private area and 
public health area disinfectants  and other biocidal products , product-type 3, veterinary 
hygiene biocidal products, product-type 4, food and feed area disinfectants, and 
product-type 5, drinking water di sinfectants, as defined in Annex V to that Directive, 
which correspond respectively to product-type s 1, 2, 3, 4 and 5 as defined in Annex V 
to Regulation (EU) No 528/2012. 
(3) Italy was designated as evaluating compet ent authority and submitted the assessment 
reports together with its recommendations on 17 May 2010. 
(4) In accordance with Article 7(2) of De legated Regulation (EU) No 1062/2014, the 
opinions of the European Chemicals Agen cy were formulated on 14 December 2016 
by the Biocidal Products Committee, havi ng regard to the conclusions of the 
evaluating competent authority. 
(5) According to those opinions, biocidal products of product-types 1, 2, 3, 4 and 5 
containing sodium hypochlorite may be expect ed to satisfy the requirements of Article 
5 of Directive 98/8/EC, provide d that certain specifications  and condition s concerning 
its use are complied with. 
                                                 
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).  
EN 3   EN (6) It is therefore appropriate to approve sodi um hypochlorite for use in biocidal products 
of product-types 1, 2, 3, 4 and 5, subject to complia nce with certain sp ecifications and 
conditions. 
(7) For the use in biocidal produc ts of product-type 4, the ev aluation did not address the 
incorporation of biocidal products containing sodium hypo chlorite in materials and 
articles intended to come into contact directly or indirectly with food as re ferred to in 
Regulation (EC) No 1935/2004 of the Eur opean Parliament and of the Council4. Such 
materials and articles may require the establishment of specific limits on the migration into food, as referred to in Article 5(1)(e) of Regulatio n (EC) No 1935/2004. The 
approval should therefore not cover such use unless the Commission has established 
such limits or it has been established pursuant to that Regulation that such limits are not necessary. 
(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 
Active chlorine released from s odium hypochlorite is approved as  an active substance for use 
in biocidal products of product-types 1, 2, 3, 4 and 5, 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  
                                                 
4 Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on 
materials and articles intended to come into contact  with food and repealing Directives 80/590/EEC and 
89/109/EEC (OJ L 338, 13.11.2004, p. 4).