Annex

IUPAC Name:

CoPoly(bisiminoimidocarbonyl, hexamethylene hydrochloride), (iminoimidocarbonyl, hexamethylene hydrochloride)

EC No: n.a.

CAS No: 27083-27-8 and 32289-58-0

956 g/kg (calculated dry weight specification).

The active substance as manufactured is an aqueous solution of 20 % w/w of PHMB (1600; 1.8)

PHMB (1600; 1.8) is considered a candidate for substitution in accordance with Article 10(1)(d) of Regulation (EU) No 528/2012.

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. (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. (2)

   In view of the risks identified for human health and the aquatic and soil compartments, products shall not be authorised for use as disinfectant of utensils by dipping, unless it can be demonstrated that risks can be reduced to an acceptable level.

3. (3)

   In view of the risks identified for human health and the aquatic compartment, products shall not be authorised for surface disinfection by mopping, unless it can be demonstrated that risks can be reduced to an acceptable level.

4. (4)

   In view of the risks identified for human health, labels, and where provided, safety data sheets of ready-to-use wipes shall indicate that the use is restricted to areas not accessible to the general public, unless it can be demonstrated that risks can be reduced to an acceptable level by other means.

5. (5)

   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^f2 or Regulation (EC) No 396/2005 of the European Parliament and of the Council^f3 shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.

6. (6)

   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 PHMB (1600; 1.8) 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 PHMB (1600; 1.8) 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.