Source

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. )

Implementing Regulation (EU) 2018/613 · Regulation · 3 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

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PHMB (1415; 4.7) is approved as an active substance for use in biocidal products of product-types 2 and 4, subject to the specifications and conditions set out in the Annex.

Article 2

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This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Supplementary provisions

ANNEXSupplementary provisions

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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 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: (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) in view of the risks identified for the uses assessed, the product assessment shall pay particular attention to: (a) professional users; (b) non-professional users; (c) secondary exposure of the general public and toddlers; (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. 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: (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) in view of the risks identified for the uses assessed, the product assessment shall pay particular attention to: (a) professional users; (b) non-professional users; (c) secondary exposure of the general public; (d) environment: surface water, sediment and soil; (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 ( 2 ) or Regulation (EC) No 396/2005 of the European Parliament and of the Council ( 3 ) shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded; (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. ( 1 ) The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance. ( 2 ) Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council ( OJ L 152, 16.6.2009, p. 11 ). ( 3 ) Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC ( OJ L 70, 16.3.2005, p. 1 ).

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