Due to regulatory changes in Great Britain (GB), Byotrol products containing the active substance Polyhexamethylene Biguanide (PHMB), are being transferred to an alternative formulation to enable their continued sale to our valued customers.
Why is the change required?
The change is due to the withdrawal of support from the active substance supplier, and consequently the removal of the active substance from the GB Article 95 list. Great Britain’s official exit from the EU on 1st January 2021, triggered all EU biocidal regulations to be duplicated into GB legislation, which has resulted in some active substance suppliers exiting the GB market. The active substance supplier of Polyhexamethylene Biguanide (PHMB / CAS 27083-27-8) has declared to their customers that PHMB will no longer be supported in Great Britain from 31st December 2022.
When does the change come into effect?
Whilst PHMB continues to be suitable for use in biocidal products in the European Union (EU), from the 31st December 2022, biocidal products containing Polyhexamethylene Biguanide (PHMB / CAS 27083-27-8) must not be sold in Great Britain. The supply of biocidal products containing PHMB into the European Union, including Northern Ireland, can continue as normal.
Products currently within the GB distribution network will remain legally compliant up until the end of 2022. The Health & Safety Executive (HSE) has advised that there is no grace period for stock to be sold through after this date. Therefore, PHMB (CAS 27083-27-8) can no longer be legally used in biocidal products in Great Britain after 31st December 2022.
Which Byotrol products are affected by the change?
This change impacts Byotrol’s quat-free Surface Sanitiser and Surface Sanitising Wipes which are used extensively in the facilities management sector, particularly for catering environments, due to their exceptional efficacy against Listeria at low temperatures.
This regulation governs only products marketed as biocidal products. Products that are classified as medical devices are exempt from the change. Therefore, the sale of Byotrol’s Trionic Medical Device Disinfectant products will continue as normal.
The following current Byotrol products will therefore be transitioned to our alternative formulation and will not be available in their current form after 30th September 2022.
| Item Code | Product Name |
| SLC0005 | Byotrol Surface Sanitiser 5Ltr |
| SLC0020 | Byotrol Surface Sanitiser 20Ltr |
| SWB1500 | Byotrol Surface Sanitising Wipes (Blue) 1500 wipes |
| SWW0100F | Byotrol Surface Sanitising Wipes (White) 100 wipes |
The replacement products will continue to benefit from the exceptional antimicrobial efficacy that you would expect from a Byotrol product. Our team plans to ensure a smooth transition for our customers to minimise disruption.
Byotrol account managers will be in touch with all our current customers to discuss further details of the introduction of the replacement products.
If you have any questions or require further information about our new products or the regulations affecting products that contain PHMB, then please contact us.