EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10094/2016 ANNEX (POOL/E4/2016/10094/10094-EN ANNEX.doc) […](2016) XXX  draft 
ANNEX 1 
  
ANNEX 
to the 
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
approving Amines, N-C10–C16-alkyltrime thylenedi-, reaction products with 
chloroacetic acid as an existing active subs tance for use in biocidal products of product-
types 2, 3 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 Prod
uct 
type Specific conditions 
2 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: 
a) professional users; 
b) children for products used in institutional areas; 
c) surface water and sediment for products used in 
industrial or institutional areas; 
d) soil for products used in industrial areas. 
 Amines, N-
C10–C16-alkyltrimethylenedi-, reaction 
products with 
chloroacetic 
acid IUPAC Name:  
Amines, N-C10–C16-
alkyltrimethylenedi-, reaction 
products with chloroacetic acid 
 
EC No: N/A 
CAS No: 139734-65-9 The theoretical 
calculated dry 
weight 
specification: 1000 
g/kg (100,0 %, by 
wt). 
 
The active 
substance as 
manufactured is an 
aqueous solution of 
160-220 g/kg of 
Amines, N-C10–
C16-
alkyltrimethylenedi
-, reaction products 
with chloroacetic 
acid (16-22 %, by 
wt). 1 January 
2018 31 December 
2027 
3 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: 
a) professional users; 
b) surface water and sediment fo r products used for : i) 
                                                 
1 The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in a ccordance with Article 89(1) of Regulation 
(EU) No 528/2012. The active substance in the product placed on the market can be of equal or di fferent purity if it has been p roven technically equivalent with the 
evaluated active substance.  
EN 3   EN the disinfection of animal housing; ii) the disinfection 
of vehicles used for animal transport; iii) the 
disinfection of footwear and animals' hooves; 
c) soil for products used for the disinfection of vehicles 
used for animal transport; 
d) micro-organisms of the sewage treatment plant for 
products used for the disinfection of footwear and 
animals' hooves. 
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 Council
2 or Regulation (EC) No 396/2005 of the European 
Parliament and of the Council3 shall be verified, and any 
appropriate risk mitigation m easures shall be taken to 
ensure that the applicable  MRLs are not exceeded. 
 
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, the 
product assessment shall pay particular attention to: 
a) professional users; 
b) surface water and sediment fo r products used in: i) 
food, drink and milk industry sites; ii) milking parlours; iii) slaughterhouses and butcheries and iv) 
                                                                                                                                                                                                                                                    
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).  
EN 4   EN large scale catering kitchens and canteens; 
c) soil for products used in i) food, drink and milk 
industry sites; ii) slaughterhouses and butcheries and 
iii) large scale catering kitchens and canteens. 
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 Council or Regulation (EC) No 396/2005 of the European 
Parliament and of the Council shall be verified, and any 
appropriate risk mitigation m easures shall be taken to 
ensure that the applicable  MRLs are not exceeded. 
4) Products shall not be incorporated in materials and articles 
intended to come into contact with food within the 
meaning of Article 1(1) of Regulation (EC) No 1935/2004, unless the Commission has established 
specific limits on the migration of peracetic acid into food 
or it has been established pursuant to that Regulation that such limits are not necessary.