- 07 Apr
PHMB – Setting the record straight
One of the chemicals used in Byotrol technology is Polyhexamethylene biguanide hydrochloride (PHMB), a biocide that has been used widely for decades providing valuable disinfection, cleaning and hygiene functions in a wide selection of products such as cosmetics, deodorant, contact lenses solutions, fabric softeners, water treatments and wound care products. PHMB is an effective public health biocide supported under the Biocidal Products Directive in Europe and REACh*.
ECHA has reviewed all available data for PHMB including 30 year old rat feeding studies, where rats ingested 5 times their body weight of PHMB, and recommended that PHMB be classified and labelled on products where PHMB is included at >1% as H351 - suspected of causing cancer. This classification is for biocidal (not cosmetic where it is permitted at certain levels for certain uses, or medical device) products in Europe and will not apply across other parts of the world.
One manufacturer of PHMB has stated they believe this decision is based on an incorrect interpretation of the data. PHMB has a long history of safe use in many applications and this change in classification does not change the safety of PHMB for use in such applications”. This view is consistent with evaluations conducted by regulatory authorities around the world and also by leading independent experts. Risk assessments, including those by the US EPA and Australia’s APVMA, continue to allow the use of PHMB products at all current use levels without any additional labelling requirements.
As the number of commercially available biocides is being reduced Byotrol plc believes it is imperative that we retain effective antimicrobial products to provide solutions to everyday hygiene needs. Our vast formulation and micro testing experience clearly demonstrates that PHMB is one of, if not the, most effective biocides at very low levels compared to other biocidal actives and combinations of actives. It has one of the lowest Minimum Biocidal Concentration (MBC) value of available biocides against a range of bacteria, particularly Listeria, E. coli and Salmonella.
Byotrol plc formulates products with the lowest efficacious levels of biocides possible so that there is no additional risk passed onto users whilst addressing the fundamental needs for foodborne pathogen management. Whilst the original Byotrol concentrate used in industry, where the logistics and economics of shipping ready to use products are not viable, will now be labelled H351 (suspected of causing cancer), this change to the hazard classification, triggered by the change in classification for PHMB doesn’t increase the risk to users when used in a safe and responsible manner, (with PPE) as directed following workplace safety assessments. When diluted to 1% the in use liquid is well below the threshold for any H351 labelling requirements and therefore any hazard or risk.
Additionally, Byotrol plc have developed alternative products, for industry, should an alternative be sought, still based on PHMB and through rebalancing actives, in our Sanitiser+ and QFS Sanitiser+ (QAC free) ranges, PHMB is included in concentrate form below the 1% threshold for labelling whilst still delivering the long-lasting antimicrobial control on surfaces our customers experience with the original formulation.
As a responsible supplier we are keen though to ensure that there is a good understanding of the changes. PHMB is an excellent biocide which we believe will continue to be used in wide ranging consumer and industrial products and by many market leading companies. Byotrol believes that the safety of PHMB in our products is unchanged and at the levels it is used in our products, there is no additional risk.
* European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of Chemicals (REACh).
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