EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10850/2017 ANNEX (POOL/E4/2017/10850/10850-EN ANNEX.doc) […](2017) XXX  draft 
ANNEX 1 
  
ANNEX 
to the 
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
approving propan-1-ol as an ex isting active substance for us e in biocidal products of 
product-types 1, 2 and 4 
  
EN 2   EN ANNEX 
Common Name IUPAC Name 
Identification Numbers Minimum degree 
of purity of the 
active substance1 Date of 
approval Expiry date of 
approval Product 
type Specific conditions 
Propan-1-ol IUPAC Name:  
Propan-1-ol 
 EC No: 200-746-9 CAS No: 71-23-8 ≥ 995 g/kg 1 May 
2019 30 April 2029 1 The authorisations of biocidal products are subject to the 
following conditions: 
1) The product assessment shall pay particular attention 
to the exposures, the risks and the efficacy linked to 
any use covered by an application for authorisation, but not addressed in the Union-level risk assessment 
of the active substance. 
2) In view of the risks identified for the uses assessed, 
the product assessment shall pay particular attention to professional users. 
 
2 The authorisations of biocidal products are subject to the 
following condition: 
The product assessment shall pay particular attention to 
the exposures, the risks and the efficacy linked to any use 
covered by an application for authorisation, but not 
addressed in the Union-level risk assessment of the active substance. 
 
4 The authorisations of biocidal products are subject to the 
following conditions: 
1) The product assessment shall pay particular attention 
to the exposures, the risks and the efficacy linked to 
any use covered by an application for authorisation, 
but not addressed in the Union-level risk assessment of the active substance. 
2) In view of the risks identified for the uses assessed, 
                                                 
1 The purity indicated in this column was the minimum degree of purity of the active substance ev aluated. The active substance i n the product placed on the market can be of 
equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.  
EN 3   EN the product assessment shall pay particular attention 
to professional users. 
3) For products that may lead to residues in food or feed, 
the need to set new or to amend existing maximum 
residue levels (MRLs) in accordance with Regulation 
(EC) No 470/2009 of the European Parliament and of 
the Council2 or Regulation (EC) No 396/2005 of the 
European Parliament and of the Council3 shall be 
verified, and any appropriate risk mitigation measures 
shall be taken to ensure that the applicable MRLs are 
not exceeded. 
 
 
                                                 
2 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for t he establishment of residue limits of 
pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European 
Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.200 9, p. 11). 
3 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pes ticides in or on food and feed of plant 
and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).