EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SCBP41-Doc.xx 
[…](2014) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving propan-2-ol as an active substance for use in biocidal products for product-
types 1, 2 and 4 
(Text with EEA relevance) 
 EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving propan-2-ol as an active substan ce for use in biocidal products for product-
types 1, 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 concerning the making av ailable 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 Regul ation (EU) No XX/2014
2 establishes a list of active 
substances to be evaluated with a view to  their possible approval for use in biocidal 
products or inclusion into A nnex I to Regulation (EU) No  528/2012. That list includes 
propan-2-ol. 
(2) Propan-2-ol has been evaluated in accordan ce with Article 90(2) of Regulation (EU) 
No 528/2012 for use in biocidal products for product-type 1, human hygiene disinfectants, product-type 2, disinfectants and algaecides  not intended for direct 
application to humans or animals, and produc t-type 4, food and feed  area disinfectants, 
as defined in Annex V to  Regulation (EU) No 528/2012. 
(3) Germany was designated as evaluating competent authority and submitted the 
assessment reports, together with its re commendations, to the Commission on 5 
November 2012 in accordance with paragra phs 4 and 6 of Article 14 of Commission 
Regulation (EC) No 1451/2007
3. 
(4) The opinions of the European Chemicals Ag ency were formulated on 18 June 2014 by 
the Biocidal Product Committee, having regard  to the conclusions of the evaluating 
competent authority.  
(5) According to those opinions, biocidal produc ts used for product-types 1, 2 and 4 and 
containing propan-2-ol may be  expected to satisfy the requirements laid down in 
Article 5 of Directive 98/8/EC of the European Parliament and of the Council4 
provided that certain specifi cations and conditions relating to its use are satisfied.  
                                                 
1 OJ L 167, 27.6.2012, p. 1. 
2 Commission Delegated Regulation (EU) No XX/2014 of XXXX 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 XX, XXX, p. X). 
3 Commission Regulation (EC) No 1451/2007 of 4 Decem ber 2007 on the second phase of the 10-year 
work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3). 
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) . EN 3   EN (6) It is therefore appropriate to approve pr opan-2-ol for use in biocidal products for 
product-types 1, 2 and 4 subject to complia nce with certain specifications and 
conditions.  
(7) Since the evaluations did not address nanom aterials, the approvals should not cover 
such materials in accordance with Arti cle 4(4) of Regula tion (EU) No 528/2012. 
(8) For the use in product-type 4, the evalua tion did not address th e incorporation of 
biocidal products containing propan-2-ol in materials and articles intended to come 
into contact directly or indi rectly with food within the meaning of Article 1(1) of 
Regulation (EC) No 1935/2004 of the Eur opean Parliament and of the Council5. 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.  
(9) A reasonable period should be allowed to elapse before an active substance is 
approved, in order to permit interested pa rties to take the preparatory measures 
necessary to meet th e new requirements.  
(10) 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 
Propan-2-ol shall be approved as  an active substance for use in  biocidal products for product-
types 1, 2 and 4, subject to the specifica tions 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 
  
                                                 
5 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).