http://www.legislation.gov.uk/eur/2018/613Commission 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)Commission Implementing Regulation (EU) 2018/613Commission 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)2020-12-12King's Printer of Acts of Parliamenthttps://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32018R0613texttext/xmlen2018-04-20

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)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products

OJ L 167, 27.6.2012, p. 1.

, and in particular the third subparagraph of Article 89(1) thereof,

Whereas:

(1)

Commission Delegated Regulation (EU) No 1062/2014

Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).

establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes PHMB (1415; 4.7).

(2)

PHMB (1415; 4.7) has been evaluated for use in products of product-type 2, disinfectants and algaecides not intended for direct application to humans or animals, and product-type 4, food and feed area, as described in Annex V to Regulation (EU) No 528/2012.

(3)

France was designated as evaluating competent authority and submitted the assessment reports together with its recommendations on 13 December 2016.

(4)

In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinions of the European Chemicals Agency were formulated on 4 October 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.

(5)

According to those opinions, biocidal products of product-types 2 and 4 containing PHMB (1415; 4.7) may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.

(6)

It is therefore appropriate to approve PHMB (1415; 4.7) for use in biocidal products of product-types 2 and 4, subject to compliance with certain specifications and conditions.

(7)

The opinions conclude that PHMB (1415; 4.7) meets the criteria for being a very persistent (vP) and toxic (T) substance in accordance with Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

. PHMB (1415; 4.7) therefore meets the conditions set out in point (d) of Article 10(1) of Regulation (EU) No 528/2012 and should be considered a candidate for substitution.

(8)

Pursuant to Article 10(4) of that Regulation, the approval of an active substance that is considered as a candidate for substitution should be for a period not exceeding 7 years.

(9)

For the use in product-type 4, the evaluation did not address the incorporation of biocidal products containing PHMB (1415; 4.7) in materials and articles intended to come into contact directly or indirectly with food within the meaning of Article 1(1) of Regulation (EC) No 1935/2004 of the European Parliament and of the Council

Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).

. Such materials may require the establishment of specific limits on the migration into food, as referred to in Article 5(1)(e) of Regulation (EC) No 1935/2004. The approval should therefore not cover such use unless the Commission has established such limits or it has been established pursuant to that Regulation that such limits are not necessary.

(10)

Since PHMB (1415; 4.7) meets the criteria for being very persistent (vP) according to Annex XIII to Regulation (EC) No 1907/2006, treated articles treated with or incorporating PHMB (1415; 4.7) should be appropriately labelled when placed on the market.

(11)

A reasonable period should be allowed to elapse before an active substance is approved, in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.

(12)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1

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

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

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 20 April 2018.

For the Commission

The President

Jean-Claude Juncker

ANNEX

Common Name	IUPAC NameIdentification Numbers	Minimum degree of purity of the active substance 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.	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 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). or Regulation (EC) No 396/2005 of the European Parliament and of the Council 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). 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.

Common Name

IUPAC NameIdentification Numbers

Minimum degree of purity of the active substance

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.

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

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.

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)

(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

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).

or Regulation (EC) No 396/2005 of the European Parliament and of the Council

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).

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.