Health and Safety Executive

Laboratory Disinfectant & The Biocidal Products Regulations

  • Safety notice:  01/2007
  • Issue date: January 2007

Background

1  Laboratories have recently informed HSE of difficulties in obtaining several commonly used laboratory disinfectants (e.g. Hycolin, Stericol and Clearsol).

2  From 1st September 2006[1] certain disinfectants, that contain active substances, which are not supported as part of the Biocidal Products Directive review programme, cannot be placed on the EU market or subsequently stored for any purpose (except for export and disposal). The Directive is implemented in the UK as the Biocidal Products Regulations 2001 (BPR). Since 2003, industry has been aware of the need to take appropriate action to ensure a timely phase-out of stocks of products through the supply chain. It is industry’s responsibility to ensure that all biocidal products containing unsupported active substances do not remain on the EU market after 1st September 2006.

3 The phenolic-based Hycolin disinfectant, commonly used for inactivation of Mycobacterium tuberculosis and contaminated materials, contain active substances (including 2,4,6-trichlorophenol and xylenol), which have not been supported as part of the biocides review and as such this formulation of Hycolin is no longer available from suppliers and manufacturers or for use. Other disinfectants (e.g. Stericol and Clearsol) have been similarly affected.

Action Required

4  Laboratory users need to review their current disinfectants, to ensure their use is in line with the requirements of BPR 2001. Where disinfectants do not meet these requirements, users should:

  • Review the purpose for which the disinfectant is used (e.g. surface decontamination, liquid or consumable discard regimens) and whether an alternative method of inactivation is equally effective (e.g. autoclaving combined with a safe system for transport);
  • Where necessary, identify an effective replacement disinfectant i.e. with demonstrated efficacy, using an approved or peer-reviewed methodology, against the pathogens (or appropriate surrogates) being used in the laboratory – this information can be obtained from manufacturers, suppliers or disinfectant testing laboratories;
  • Be mindful that alternative disinfectants (e.g. virusolve+, Nu-Cidex, Tristel, TriGene, Sodium dichloroisocyanurate (NaDCC)), which are purported to have efficacy of inactivation against particular pathogens (e.g. Mycobacteria spp), are used for a purpose and in a manner reflective of the efficacy test conditions used for that disinfectant;
  • Where necessary, commission disinfectant efficacy testing either in-house or through a laboratory, which has the necessary expertise and experience in disinfectant testing.

5  Where users have existing stocks of disinfectants, which do not comply with BPR 2001, users are advised that continued use of these products for disinfection purposes is in breach of the BPR 2001 legislation and should cease. In the rare situations that laboratories cannot safely implement an alternative method of inactivation (e.g. autoclaving) and have not identified an alternative effective disinfectant, then the temporary use of the disinfectant should only be undertaken for a period sufficient to achieve this purpose. HSE as regulators in this sector will raise this issue as part of their inspections.

6  Where it is necessary to dispose of unused stocks of unauthorised disinfectants, the Environment Agency are best placed to advise on how this can be achieved, to ensure that there is no harm to the environment.

7  Sources of further information on biocidal products are:


[1] as published in Commission Regulation (EC) No 2032/2003 (the Second Review Regulation) of 4 November 2003. Further information can be found at: www.hse.gov.uk/biocides/


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Updated 25.07.11