
Article 1 
Iodine, including polyvinylpyrrolidone iodine, shall be approved as an active substance for use in biocidal products for product-types 1, 3, 4 and 22, 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, 31 January 2014.
For the Commission
The President
José Manuel BARROSO
ANNEX

Common Name IUPAC Name Identification Numbers Minimum degree of purity of the active substance Date of approval Expiry date of approval Product type Specific conditions
Iodine (including polyvinylpyrrolidone iodine) IUPAC Name:IodineEC No: 231-442-4CAS No: 7553-56-2IUPAC Name:Polyvinylpyrrolidone iodineEC No: n.a.,CAS No: 25655-41-8 995 g/kg of iodineFor polyvinylpyrrolidone iodine: the iodine content shall have a purity of 995 g/kg 1 September 2015 31 August 2025 1 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.
3 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.Authorisations are subject to the following conditions: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 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.Authorisations are subject to the following conditions:
((1)) 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 or Regulation (EC) No 396/2005 shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.
((2)) Products containing iodine 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 iodine into food or it has been established pursuant to that Regulation that such limits are not necessary.
22 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 adressed in the Union level risk assessment of the active substance.Authorisations are subject to the following condition:For professional users, safe operational procedures and appropriate organizational measures shall be established. Where exposure cannot be reduced to an acceptable level by other means, products shall be used with appropriate personal protective equipment.



