
Article 1 
C(M)IT/MIT (3:1) is approved as an active substance for use in biocidal products for product-types 2, 4, 6, 11, 12 and 13, subject to the specifications 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, 1 February 2016.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX

Common Name IUPAC NameIdentification Numbers Minimum degree of purity of the active substance Date of approval Expiry date of approval Product type Specific conditions
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/aCAS No: 55965-84-9 579 g/kg (theoretical calculated dry weight).The active substance is manufactured as a technical concentrate (TK) with different solvents and stabilisers. 1 July 2017 30 June 2027 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 appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means.The placing on the market of treated 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.
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 following conditions:
((1)) For professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with 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 or Regulation (EC) No 396/2005 of the European Parliament and of the Council shall be verified, and any appropriate risk mitigation measures 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 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 treated 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.
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 protective 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 treated articles is subject to the following conditions:
((1)) In view of the risks identified 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 sensitiser, 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 sensitiser, unless exposure can be avoided by other means than the wearing of personal protective equipment.
((3)) In view of the risks identified 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 sensitiser, unless exposure can be avoided, including by the wearing of personal protective equipment.
((4)) 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.
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 with 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 the preservation of photographic processing liquid, preservation of wood treatment solution and for the use in large open recirculating cooling systems unless it can be demonstrated 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 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 water from the facilities shall be directed to a sewage treatment plant.The placing on the market of treated 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 with 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 contain C(M)IT/MIT (3:1) at a concentration triggering classification as skin sensitiser, unless safe operational procedures and appropriate organisational measures 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 industrial release from the facilities into the watercourse after mechanical/chemical treatment or after treatment in a sewage treatment plant, unless it can be demonstrated that risks can be reduced to an acceptable level by other means.The placing on the market of treated 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 with 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 level by other means.
((3)) In view of the risks identified for professional users, labels and, where provided, safety data sheets shall indicate that the products shall not be used in metal working fluids at a concentration triggering classification as skin sensitiser, unless it can be demonstrated that risks can be reduced to an acceptable level by other means.The placing on the market of treated 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.


