COMMISSION IMPLEMENTING REGULATION (EU) 2018/613
of 20 April 2018
approving PHMB (1415; 4.7) as an existing active substance for use in biocidal products of product-types 2 and 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 (1415; 4.7) (polyhexamethylene biguanide hydrochloride with a mean number-average molecular weight (Mn) of 1415 and a mean polydispersity (PDI) of 4.7) |
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) |
1 November 2019 |
31 October 2026 |
2 |
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:
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. |
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4 |
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:
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