EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/12397-2015 […](2015) XXX  draft 
  
COMMISSION IMPLEMEN TING DECISION 
of XXX  
pursuant to Article 3(3) of Regulation (EU) No 528/2012 of  the European Parliament 
and of the Council on propan -2-ol containing products used for hand disinfection 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING DECISION 
of XXX  
pursuant to Article 3(3) of Regulation (E U) No 528/2012 of the European Parliament 
and of the Council on propan-2-ol containi ng products used for hand disinfection 
(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 Article 3(3) thereof, 
Whereas: (1) In the context of an applica tion under the Union authorisa tion procedure referred to in 
Article 41 of Regulation (EU) No 528/ 2012, on 3 December 2015 Germany requested 
the Commission to decide, pursuant to Articl e 3(3) of that Regul ation, whether a group 
of ready to use propan-2-ol containing produc ts placed on the market to be used for 
hand disinfection (‘the products’) and to be aut horised as a biocidal product family as 
defined in Article 3(1)(s) of  that  Regulation, are biocidal products. 
(2) Germany considered that the products are medicinal products in accordance with 
Directive 2001/83
2, arguing that the intended uses of the products show that they aim 
at preventing diseases in humans, as they can be used in areas and situations where 
disinfection is medically reco mmended. According to Germany, this is particularly the 
case when the products are used by health professionals as a preoperative treatment 
procedure to prevent the risk of transmi ssion of microorganisms into the surgical 
wound.  
(3) The products are intended to control a num ber of bacteria, viruses and fungi, which 
meet the definition of ‘harmful organism’ provided under Article 3(1)(g) of 
Regulation (EU) No 528/2012 si nce they may have a detrimental effect on humans. 
(4) Since destroying, deterring, rendering harmle ss, preventing the action of, or otherwise 
exerting a controlling effect on any harmfu l organism is a biocidal function, the 
products meet the definition of a biocidal  product provided under Article 3(1)(a) of 
that Regulation. 
(5) In accordance with Article 2(2) of Regula tion (EU) No 528/2012 it is important to 
consider whether the products may fall with in the scope of Dir ective 2001/83/EC of 
the European Parliament and of the Council if  they meet the definition of a medicinal 
product as provided under Articl e 1(2) of that Directive. 
                                                 
1 OJ L 167, 27.6.2012, p. 1. 
2 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the 
Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67.).  
EN 3   EN (6) When the products are not used with a view  to restoring, correcting or modifying 
physiological functions by exerting a pharm acological, immunological or metabolic 
action, or to making a medical diagnosis in  humans, and when the products are not 
presented either as having properties for tr eating or preventing any human diseases but 
to reduce the microorganism load on hands and thus the risk of transmitting microorganisms from potentially contaminat ed hands, the products do not meet the 
definition of a medicinal product as pr ovided under Article 1(2) of Directive 
2001/83/EC and therefore fall under the sc ope of Regulation (EU) No 528/2012. 
(7) Since product-type 1, as defi ned in Annex V to Regula tion (EU) No 528/2012, covers 
products used for human hygiene purposes, a pplied on or in contac t with human skin 
or scalps for the primary purpos e of disinfecting the skin or  scalp, the products belong 
to product-type 1.  
(8) The measures provided for in this Decision are in accordance with the opinion of the 
Standing Committee on Biocidal Products. 
HAS ADOPTED THIS DECISION: 
Article 1 
Propan-2-ol containing products to be used in hand disinfec tion for the purpose of reducing 
the risk of transmission of microorganisms sh all be considered as biocidal products in 
accordance with Article 3(1)(a) of Regulatio n (EU) No 528/2012 and shall fall within 
product-type 1 as defined in Annex V to that Regulation. 
Article 2 
This Decision shall enter into force on the twen tieth day following that of its publication in 
the Official Journal of  the European Union . 
Done at Brussels, 
 For the Commission 
 The President 
 Jean-Claude JUNCKER