EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11865/2017 Rev. 1 
(POOL/E4/2017/11865/11865R1 -
EN.doc)  
[…](2017) XXX  draft 
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving PHMB (1415; 4.7) as an existing active substance for use in biocidal products 
of product -types 2 and 4  
(Text with EEA relevance)    
EN 2  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving PHMB (1415; 4.7) as an existing active substance for use in biocidal products  
of product -types 2 and 4  
(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 con cerning the making available on the market and use of biocidal 
products1, and in particular the third subparagraph of Article  89(1) thereof , 
Whereas:  
(1) Commission Delegated Regulation (EU) No 1062/20142 establishes a list of existing 
active substances to be evaluated for their possible approv al for use in biocidal 
products. That list includes PHMB ( 1415; 4.7 ). 
(2) PHMB ( 1415; 4.7 ) has been evaluated for use in  products of product -type 2, 
disinfectants and algaecides not intended for direct application to humans or animals , 
and product -type 4, food and feed area , as describ ed in Annex V to Regulation (EU) 
No 528/2012.  
(3) France  was designated as evaluating competent authority and submitted the 
assessment report s together with its recommendations  on 13 December 2016.  
(4) In accordance with Article 7 (2) of Delegated  Regulation (EU) No  1062/2014 , the 
opinion s of the European Chemicals Agency w ere formulated on 4 October 2017  by 
the Biocidal Product s Committee , having r egard to the conclusions of the evaluating 
competent authority.  
(5) According to th ose opinion s, biocidal products of product -types 2 and 4  containing  
PHMB (1415; 4.7)  may be expected to satisfy the criteria of Article  19(1)(b) of 
Regulation (EU) No  528/2012,  provided that certain specifications and conditions 
concerning their use are complied with . 
(6) It is therefore appropriate to approve PHMB ( 1415; 4.7 ) for use in  biocidal products of 
product -types 2 and 4 , subject to compliance with certain specifications an d 
conditions . 
(7) The opinions conclude that PHMB ( 1415; 4.7 ) meets the criteria for being a  very 
persistent (vP) and toxic (T)  substance  in accordance with Annex XIII to Regulation 
                                                 
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).  
EN 3  EN (EC) No 1907/2006 of the Europea n Parliament and of the Council3. PHMB ( 1415; 
4.7) therefore meets the conditions set out in point (d) of Article  10(1) of Regulation 
(EU) No  528/2012  and should be considered a candidate for substitution.  
(8) Pursuant to  Article 10(4) of that Regulation, t he approval of an active substance that is 
consid ered as a candidate for substitution should be for a period not exceeding 7  years .  
(9) For the use in product -type 4, the evaluation did not address the incorporation of 
biocidal products containing PHMB ( 1415; 4.7 ) in materials and articles intended to 
come into contact directly or indirectly with food  within the meaning of Article  1(1) of 
Regulation (EC) No 1935/2004 of the European Parliament and of the Council4. Such 
materials may require the establishment of specific limits on the migration into food, 
as referred to in Article  5(1)(e) of Regulation (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 . 
(10) Since PHMB ( 1415; 4.7 ) meets the criteria for being very persistent  (vP) according to 
Annex XIII to Regulation (EC) No 1907/2006 , treated articles treated with or 
incorporating PHMB ( 1415; 4.7 ) should be appropriately labelled when placed on the 
market . 
(11) 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 the new requirements . 
(12) The measures provided for in this Regulation are in accorda nce with the opinion of the 
Standing  Committee on Biocidal Product s, 
HAS ADOPTED THIS REGULATION:  
Article  1 
PHMB ( 1415; 4.7 ) is approved as an active substance for use in biocidal products of product -
types 2 and 4 , subject to the specifications and conditi ons 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.  
                                                 
3 Regulation (EC) No 1907/2006 of the European P arliament and of the Council of 18 December 2006 
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), 
establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council 
Regulation (EEC) No  793/93 and Commission Regulation (EC) No 1488/94 as well as Council 
Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 
2000/21/EC (OJ L 396, 30.12.2006, p. 1) . 
4 Regulation (EC) No 1935/2004 of the European Parliament and o f 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).  
EN 4  EN Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER