Biguanide Changes

News | 23 October 2013

Poly hexamethylene biguanide hydrochloride (PHMB) has been used for many years as a broad spectrum biocide in food processing, industrial, institutional, agricultural and domestic disinfection applications. The substance has been formulated into a number of disinfectant products; for instance: hand and surface sanitising wipes, hand sanitisers, surface disinfectants and water treatment disinfectants.

In 2010 the European Chemical Agency (ECHA) received a proposal for the harmonised classification and labelling of PHMB that included reference to potential carcinogenic properties.  This was based on scientific studies using animals.  The recommendations were reviewed and the CLP amending regulation EU No 944/2013 (2 October 2013) has reclassified Poly hexamethylene biguanide hydrochloride.
 

New Classification - for Poly Hexamethylene Biguanide Hydrochloride CAS No. 27083-27-8 or 32289-58-0 (according to CLP).

Carc. 2                   H351 – Suspected of Causing Cancer

Acute Tox. 4           H302 – Harmful if Swallowed

Eye Dam. 1             H318 – Causes Serious Eye Damage

Skin Sens. 1B           H317 – May Cause Allergic Skin Reaction

STOT RE 1 (respiratory tract inhalation) H372 – Causes Damage to the Respiratory Tract through prolonged or repeated exposure by inhalation

Aquatic Acute 1 M Factor = 10       H400  - Very Toxic to Aquatic Life

Aquatic Chronic 1 M Factor = 10     H410 – Very toxic to aquatic life with Long Lasting Effects         

Holchem Position

Biguanide (specifically PHMB with CAS no. 27083-27-8 or 32289-58-0) has been used by Holchem and other producers of disinfectants in the food industry for many years with no reported ill effects. The reclassification is based on the scientific data submitted to ECHA.

Holchem strive to always minimise the risk to our own staff, to customers (users of our products), consumers and to the environment. We act on best scientific knowledge at any point in time even if not required by legislation.

Holchem only market one product that contains PHMB - Chill Shield. The level of PHMB in Chill Shield is such that from 2015 we would be required to label the product according to the CLP Regulation.

Holchem applies the principle that as soon as new information becomes available which may affect risk management measures, or the classification of product, then that information should be acted upon and passed on.  With the above in mind Holchem have decided to:

•        Remove the raw material PHMB from our site.

•        Suspend sales of Chill Shield.

•        Send warehouse stock of Chill Shield for disposal.

•        Make available a replacement for Chill Shield to our customers. Cold Shield is the recommended direct replacement; it utilises a QAC (Quat) as the biocide within a gel style formulation.

 

What should Users do?

Although the requirement for publishing the new MSDS and re-labelling (for formulated products) will not apply until 2015 we recommend that, as the information is in the public domain, a risk assessment is carried out before using products that contain Poly hexamethylene biguanide hydrochloride (with CAS no. 27083-27-8 or 32289-58-0). PHMB would be listed in Section 3 of the material safety data sheet if present in the product.