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French Agency for Food, Environmental and Occupational Health & Safety

ECHA launches a public consultation on substitution of the active biocidal substance PHMB

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News of 19/03/2015

On 9 February 2015, the European Chemicals Agency (ECHA) launched a public consultation on its web site regarding substitution of the active biocidal substance PHMB, used mainly as a disinfectant and preservative. This consultation follows on from the assessment conducted by ANSES on PHMB, considered to be very persistent (vP) and toxic (T), two conditions which lead to its being considered a candidate for substitution, in accordance with Article 10 of Regulation (EU) 528/2012 concerning the making available on the market and use of biocidal products. The goal of this public consultation, which is open through 10 April 2015, is to gather relevant information on this substance, and in particular on available substitutes.

France is the rapporteur Member State for assessment of approval applications for the active substance polyhexamethylene biguanide (PHMB) for use as a disinfectant and preservative. 

In fact, in 2010 ANSES had already drafted a file for revision of PHMB classification, and the opinion issued on 9 September 2011 by ECHA's Risk Assessment Committee was based on this. The harmonised classification of PHMB was adopted on 2 October 2013.

PHMB is assessed in the framework of Regulation (EU) 528/2012 concerning the making available on the market and use of biocidal products, used as a:

  • disinfectant for human hygiene purposes (product-type 1);
  • disinfectant not intended for direct application to humans or animals (product-type 2);
  • disinfectant used for veterinary hygiene purposes (product-type 3);
  • disinfectant for surfaces in contact with food or feed (product-type 4);
  • preservative for products during storage (product-type 6);
  • preservative for fibres, leather, rubber and polymerised materials (product-type 9);
  • Products used for the preservation of liquids used in cooling and processing systems (product-type 11).

Based on the information contained in the assessment reports for this active biocidal substance that were prepared by ANSES for the above types of products, PHMB fulfils the following two criteria required for being considered as a PBT substance (persistent, bioaccumulative and toxic), and a candidate for substitution: vP (very persistent) and T (toxic).

ECHA launched a public consultation on its website on 9 February 2015 in order to gather information on this substance, notably on available substitutes, technical and economic feasibility, the hazards and risks of alternatives, their availability, etc.

Interested parties can therefore submit any information they consider relevant up through 10 April 2015.

Following this consultation, and based on all the data available, ECHA's Biocidal Products Committee (BPC) will issue a final opinion and send it to the European Commission for an approval or disapproval decision on PHMP used as an active biocidal substance.