EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/11135/2015 ANNEX CIS 
(POOL/E3/2015/11135/11135-EN 
ANNEX CIS.doc) […](2015) XXX  draft 
ANNEX 1 
  
ANNEX 
to the 
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
approving C(M)IT/MIT ( 3:1) as an existing active substan ce for use in biocidal products 
for product-types 2, 4, 6, 11, 12 and 13 
  
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 
2 The product assessment shall pay particular attention to the 
exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. 
 The authorisations of biocidal  products are subject to the 
following condition: 
For professional users, safe operational procedures and 
appropriate organisational measures shall be established. 
Products shall be used with ap propriate personal protective 
equipment where exposure cannot be reduced to an acceptable level by other means. 
 The placing on the market of tr eated articles is subject to the 
following condition:  
The person responsible for the placing on the market of a 
treated article treated with or incorporating C(M)IT/MIT (3:1) shall ensure that the label of that treated article provides the 
information listed in the second subparagraph of Article 58(3) 
of Regulation (EU) No 528/2012. C(M)IT/MIT (3:1) IUPAC Name:  
Reaction mass of 5-chloro-2-
methyl-2h-isothiazol-3-one 
and 2-methyl-2h-isothiazol-3-one (3:1) 
EC No: n.a. 
CAS No: 55965-84-9 579 g/kg 
(theoritical 
calculated dry 
weight). 
 
The active 
substance is 
manufactured as a 
technical 
concentrate (TK) 
with different 
solvents and 
stabilizers. 1st July 
2017 30 June 
2027 
4 The product assessment shall pay particular attention to the 
exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. 
 The authorisations of biocidal  products are subject to the 
                                                 
1 The purity indicated in this column was the minimum degree of purity of the active substance us ed for the evaluation made in a ccordance with Article 16(2) of 
Directive 98/8/EC. The active subs tance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the 
evaluated active substance.  
EN 3   EN following conditions: 
(1) For professional users, safe operational procedures and 
appropriate organisational measures shall be established. 
Products shall be used w ith appropriate personal 
protective equipment where exposure cannot be reduced 
to an acceptable level by other means. 
(2) In view of the risks identified for professional users, 
biocidal products shall only be loaded by automated systems, unless it can be demonstrated that risks can be 
reduced to an acceptable level by other means. 
(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 measures 
shall be taken to ensure th at the applicable MRLs are 
not exceeded. 
(4) Products shall not be incorp orated 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 C(M)IT/MIT (3:1) into food or it has been established pursuant to that 
Regulation that such limits are not necessary. 
 The placing on the market of tr eated articles is subject to the 
following condition:  
The person responsible for the placing on the market of a 
                                                                                                                                                                                                                                                    
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 treated article treated with or incorporating C(M)IT/MIT (3:1) 
shall ensure that the label of that treated article provides the 
information listed in the second subparagraph of Article 58(3) 
of Regulation (EU) No 528/2012. 
6 The product assessment shall pay particular attention to the 
exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. 
 The authorisations of biocidal  products are subject to the 
following conditions: 
(1) For industrial or professional users, safe operational 
procedures and appropriate organisational measures 
shall be established. Products shall be used with 
appropriate personal pr otective equipment where 
exposure cannot be reduced to an acceptable level by 
other means. 
(2) In view of the risks to the environment, biocidal 
products shall not be used to preserve pulp and paper processing fluids, unless it can be demonstrated that 
risks can be reduced to an acceptable level. 
 The placing on the market of tr eated articles is subject to the 
following conditions:  
(1) In view of the risks id entified for human health, 
mixtures treated with or incorporating C(M)IT/MIT 
(3:1) and placed on the market for use by the general 
public shall not contain C(M)IT/MIT (3:1) at a concentration triggering classification as skin sensitizer, 
unless exposure can be avoided by other means than the 
wearing of personal protective equipment. 
(2) In view of the risks identified for human health, liquid 
detergents treated with or  incorporating C(M)IT/MIT 
(3:1) and placed on the market for use by professional users shall not contain C(M)IT/MIT (3:1) at a 
concentration triggering classification as skin sensitizer,  
EN 5   EN unless exposure can be avoided by other means than the 
wearing of personal protective equipment. 
(3) In view of the risks id entified for human health, 
mixtures treated with or incorporating C(M)IT/MIT 
(3:1), other than liquid detergents, and placed on the 
market for use by professional users shall not contain 
C(M)IT/MIT (3:1) at a concentration triggering classification as skin sensitizer, unless exposure can be 
avoided, including by the wearing of personal protective 
equipment. 
(4) The person responsible for th e placing on the market of 
a treated article treated with or incorporating 
C(M)IT/MIT (3:1) shall ensure that the label of that 
treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation 
(EU) No 528/2012. 
11 The product assessment shall pay particular attention to the 
exposures, the risks and the efficacy linked to any uses covered 
by an application for authorisation, but not addressed in the 
Union level risk assessment of the active substance. 
 The authorisations of biocidal  products are subject to the 
following conditions: 
(1) For professional users, safe operational procedures and 
appropriate organisational measures shall be established. 
Products shall be used w ith appropriate personal 
protective equipment where exposure cannot be reduced 
to an acceptable level by other means. 
(2) In view of the risks identified for the environment, 
products shall not be authorized for the preservation of photographic processing liquid, of wood treatment 
solution and for the use in large open recirculating 
cooling systems unless it can be demonstrated at that 
risks can be reduced to an acceptable level. 
(3) In view of risks identified for the environment, and 
unless it can be demonstrated that risks can be reduced  
EN 6   EN to an acceptable level, labels and, where provided, 
safety data sheet of products shall indicate that: 
a. For uses in small open recirculating cooling 
systems, risk mitigation measures shall be in place to reduce the direct contamination of terrestrial 
compartment via air deposition. 
b. For uses other than those specified under condition 
(2), release of waste wate r from the facilities shall 
be directed to a sewage treatment plant. 
 
The placing on the market of tr eated articles is subject to the 
following condition:  
The person responsible for the placing on the market of a 
treated article treated with or incorporating C(M)IT/MIT (3:1) shall ensure that the label of that treated article provides the 
information listed in the second subparagraph of Article 58(3) 
of Regulation (EU) No 528/2012. 
12 The product assessment shall pay particular attention to the 
exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. 
 The authorisations of biocidal  products are subject to the 
following conditions: 
(1) For professional users, safe operational procedures and 
appropriate organisational measures shall be established. Products shall be used w ith appropriate personal 
protective equipment where exposure cannot be reduced 
to an acceptable level by other means. 
(2) In view of the risks identified for the environment, 
products shall not be authorised for use in off-shore 
installations, unless it can be demonstrated that risks can 
be reduced to an acceptable level. 
(3) In view of the risks identified for human health, labels 
or safety data sheets of products authorised for off-shore 
installations shall indicate that drilling mud shall not  
EN 7   EN contain CMIT/MIT (3:1) at a concentration triggering 
classification as skin sensiti zer, unless safe operational 
procedures and appropriate organisational can be established for workers. 
(4) In view of the risks identified for the environment, 
labels or safety data sheets of products authorised for 
use in paper mills shall indicate the need for an appropriate dilution of the in dustrial release from the 
facilities into the watercourse after mechanical/chemical 
treatment or after treatment in a sewage treatement plant, unless it can be demonstrated that risks can be 
reduced to an acceptable level by other means. 
 The placing on the market of tr eated articles is subject to the 
following condition:  
The person responsible for the placing on the market of a 
treated article treated with or incorporating C(M)IT/MIT (3:1) 
shall ensure that the label of that treated article provides the 
information listed in the second subparagraph of Article 58(3) 
of Regulation (EU) No 528/2012. 
13 The product assessment shall pay particular attention to the 
exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the 
Union level risk assessment of the active substance. 
 The authorisations of biocidal  products are subject to the 
following conditions: 
(1) For professional users, safe operational procedures and 
appropriate organisational measures shall be established. 
Products shall be used w ith appropriate personal 
protective equipment where exposure cannot be reduced 
to an acceptable level by other means. 
(2) In view of the risks identified for professional users, 
loading of the products into metalworking fluids shall be semi-automated or automated, unless it can be 
demonstrated that risks can be reduced to an acceptable  
EN 8   EN level by other means. 
(3) In view of the risks identified for professional users, 
and, where provided, safety data sheets shall indicate 
that the products shall not be used in metal working fluids at a concentration trig gering classification as skin 
sensitizer, unless it can be demonstrated that risks can 
be reduced to an acceptable level by other means. 
 The placing on the market of tr eated articles is subject to the 
following condition:  
The person responsible for the placing on the market of a 
treated article treated with or incorporating C(M)IT/MIT (3:1) 
shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) 
of Regulation (EU) No 528/2012.