GB and NI Biocides Regulation – Sodium Azide as a preservative (PT6) in mixtures and in treated articles enquiry – HSE response

Following a recent member enquiry regarding the current status of Sodium Azide when used as a preservative in mixtures, and in treated articles, BIVDA placed an enquiry with the HSE Biocides team, regarding both GB and NI respectively. Note that NI continues to follow EU Biocides legislation, and GB the UK Biocides legislation.

Note also that finished IVDs are out of the scope of both legislations, however, Research Use Only, Vet Use Only and intermediates/raw materials using Sodium Azide as a preservative are in the scope of the Biocides legislation(s).

The response can be seen below:

Based on the information provided, since the exit from the EU, GB (England, Scotland and Wales) has a different timeline to the EU (including Northern Ireland (NI)) for the BPR active substance review programme. This means that there can be divergence in the status of an active substance in GB and NI.

The current status of Sodium Azide for product type PT 6 use under the GB Biocidal Products Regulations – GB BPR (England, Scotland and Wales) and EU Biocidal Products Regulations – EU BPR (Northern Ireland) are as follows:

GB BPR

EU BPR

You can find sodium azide listed on the BPR active substance lists for GB and NI – Biocides – HSE and clicking on the relevant tab (GB or NI) for the relevant market and searching by active substance name, CAS/EC number etc.

As the approval/assessment status ‘Under assessment’ and the regulatory process is ‘New active substance’ this means that:

If any of the active substances in the relevant product type is a new active substance, you will need to:

• apply for GB or EU BPR product authorisation by the approval date for the last active substance/product type combination
• receive authorisation before the biocidal product can be made available on the Great Britain or Northern Ireland markets

Therefore, biocidal products containing sodium azide for PT 6 use cannot be made available on the GB or NI markets.

Treated Articles (TA) containing sodium azide for PT 6 use can be placed on the GB or NI markets, provided any requirements are complied with in the earlier TA, see weblink provided.

Regarding your second question, unfettered access does not apply until BPR product authorisation is granted. Further information on supplying biocidal products to NI is available at Biocides regulation: Northern Ireland – Biocides – HSE.

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