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Commission Implementing Regulation (EU) 2016/125 of 29 January 2016 approving PHMB (1600; 1.8) as an existing active substance for use in biocidal products for product-types 2, 3, 11 (Text with EEA relevance)

Implementing Regulation (EU) 2016/125 · 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 (1600; 1.8) is approved as an active substance for use in biocidal products for product-types 2, 3, and 11, 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 (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 2024 2 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) For industrial or 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) In view of the risks identified for human health and the environment, products shall not be authorised for the treatment of swimming pools, unless it can be demonstrated that risks can be reduced to an acceptable level. (3) In view of the risks identified for human health and the environment, products shall not be authorised for disinfection of medical equipment by dipping, unless it can be demonstrated that risks can be reduced to an acceptable level. (4) In view of the risks identified for human health, ready-to-use wipes shall not be authorised for non-professionals, unless it can be demonstrated that risks can be reduced to an acceptable level. (5) 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. 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. 3 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) 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) In view of the risks identified for human health, products shall not be authorised for disinfection of equipment by dipping, unless it can be demonstrated that risks can be reduced to an acceptable level. In addition, in case products are authorised, in view of the risks identified for the environment, labels, and where provided, safety data sheets shall indicate that no release to sewage treatment plants shall be allowed, unless it can be demonstrated that risks can be reduced to an acceptable level by other means. (3) 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. (4) 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. 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. 11 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) For industrial or 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) In view of the risks identified for human health, labels and, where provided, safety data sheets shall indicate that loading of product into the cooling system shall be automated, that the pump shall be rinsed before cleaning and that appropriate personal protective equipment shall be worn during the cleaning phase, unless it can be demonstrated that risks can be reduced to an acceptable level by other means. (3) In view of the risks identified for water, sediments and soil, labels and, where provided, safety data sheets shall indicate that disposal of preserved liquids following drainage of the closed recirculating system shall be handled as hazardous waste, unless it can be demonstrated at product authorisation that risks to the environment can be reduced to an acceptable level by other means. 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. ( 1 ) The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market ( OJ L 123, 24.4.1998, p. 1 ). The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with 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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