Welcome to this special edition of the Biological Agents eBulletin. Users of disinfectants are alerted to two key developments concerning EU requirements for supply and authorisation of use of disinfectants (including formaldehyde).

Supply of disinfectants

From the 1st September 2015, only suppliers of disinfectants (within scope of the Biocidal Products Regulation (BPR)), who are registered on an approved list of suppliers will be able to market and supply them. Given that these are widely used for disinfection or decontamination of equipment and facilities working with microorganisms, users need to ensure that their disinfectant suppliers are registered with the European Chemicals Agency (ECHA) to avoid problems in obtaining supplies of disinfectants.

HSE advises users to make their disinfectant suppliers aware of the imminent deadline for supplier registration by forwarding the information in this ebulletin.

NOTE: Only where the disinfectant or biocidal substance is supplied for use as a biocidal product does the supplier need to be on the approved list. If users are unclear whether this applies to their supplier they should contact the HSE biocides helpdesk at biocidesenquiries@hse.gsi.gov.uk

Use of formaldehyde as a biocide

Formaldehyde is used in laboratories for room or equipment decontamination (eg microbiological safety cabinets). It has recently been classified as a Category 1b carcinogen under the Classification, Labelling and Packaging (CLP) Regulation, which takes effect from January 2016. This means that use of formaldehyde will be restricted to professional use only. Current use of formaldehyde in laboratories is considered to be professional use as it involves written safety procedures, undertaken by trained and competent people using appropriate precautions to protect health, safety and the environment. Users should review their risk assessment in light of the new classification, to ascertain whether additional precautions are necessary.

The classification also has significant implications for the approval of formaldehyde as an active substance under BPR. In effect, whilst the short term use (next 3-5 years) is unlikely to be affected, the long term use of formaldehyde may be subject to further restrictions if and when suitable replacements are identified. HSE therefore recommends that users start to look into the development of alternative gaseous disinfectants for rooms and equipment, whilst there is time to do so. HSE has published research on the efficacy of a range of gaseous disinfectants that users may find helpful.

Timescales

The systematic authorisation process through the European Commission is underway, with an expected decision on the authorisation of formaldehyde towards the middle of 2016. Due to its classification as a Category 1b carcinogen, biocidal products containing formaldehyde can only be authorised for use for a maximum period of five years initially. Products may be authorised for a further period of time if no suitable alternatives have been identified.