Annex

IUPAC Name:

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

EC No: not available

CAS No: 32289-58-0 and 1802181-67-4

943g/kg (calculated dry weight specification).

The active substance as manufactured is an aqueous solution of 20 % w/w of PHMB (1415; 4.7)

PHMB (1415; 4.7) is considered a candidate for substitution in accordance with point (d) of Article 10(1) Regulation (EU) No 528/2012.

The authorisations of biocidal products are subject to the following conditions:

1. (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;

2. (2)

   in view of the risks identified for the uses assessed, the product assessment shall pay particular attention to:

   1. (a)

      professional users;

   2. (b)

      non-professional users;

   3. (c)

      secondary exposure of the general public and toddlers;

   4. (d)

      environment: surface water, sediment and soil.

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 (1415; 4.7) 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.

PHMB (1415; 4.7) is considered a candidate for substitution in accordance with point (d) of Article 10(1) Regulation (EU) No 528/2012.

The authorisations of biocidal products are subject to the following conditions:

1. (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;

2. (2)

   in view of the risks identified for the uses assessed, the product assessment shall pay particular attention to:

   1. (a)

      professional users;

   2. (b)

      non-professional users;

   3. (c)

      secondary exposure of the general public;

   4. (d)

      environment: surface water, sediment and soil;

3. (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^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;

4. (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 PHMB (1415; 4.7) 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 (1415; 4.7) 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.