COMMISSION IMPLEMENTING REGULATION (EU) 2016/124
of 29 January 2016
approving PHMB (1600; 1.8) as an existing active substance for use in biocidal products for product-type 4
(Text with EEA relevance)
Article 1
Article 2
ANNEX
Common Name |
IUPAC Name Identification Numbers |
Minimum degree of purity of the active substance(1) |
Date of approval |
Expiry date of approval |
Product type |
Specific conditions |
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PHMB (1600; 1.8) (polyhexamethylene biguanide hydrochloride with a mean number-average molecular weight (Mn) of 1600 and a mean polydispersity (PDI) of 1.8) |
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) |
1 July 2017 |
30 June 2027 |
4 |
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:
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. |