Technical equivalence of an active substance: biocides
What technical equivalence is
The purpose of technical equivalence is to ensure that the active substance contained in a biocidal product does not have significantly more hazardous properties than the substance which was evaluated for the purpose of approval (the reference source).
When technical equivalence is assessed
Technical equivalence needs to be assessed when there has been a change in regard to the source of the active substance:
- when the substance is produced from a source different to the reference source
- when the substance is produced from the same reference source but following a change to the manufacturing process or location
Who assesses technical equivalence
HSE is responsible for assessing technical equivalence for Great Britain under the GB Biocidal Products Regulation (GB BPR).
If you need to have technical equivalence assessed for Northern Ireland, this is done by the European Chemicals Agency (ECHA) under the EU Biocidal Products Regulation (EU BPR).
How to apply for an assessment
Companies interested in applying for technical equivalence assessment should email [email protected].
The assessment is divided into 2 tiers.
In Tier 1, substance identity, chemical composition, analytical profile of 5 representative batches, description of the analytical method used for the determination of the substance and absorption spectra are assessed. If we cannot establish technical equivalence based on Tier 1, you may ask HSE to perform a Tier 2 assessment based on the hazard profile using toxicological and eco-toxicological data.
Normally we would expect to receive a Tier 1 application in the first instance. If you think that a Tier 2 assessment will be necessary, you should discuss this with us before carrying out any experimental work.
The approximate timeframe for a technical equivalence application is 90 days from payment of the fees. However, this timeframe may be suspended if you are asked to submit additional information.
Please note that if we do not hold the relevant data for the reference source, we may not be able to process your application.
Once the assessment is complete, you will be given the opportunity to comment regarding the outcome before HSE takes the final decision.
Technical equivalence and biocidal products
When you apply for product authorisation under GB BPR or EU BPR, if you are not using the reference source, you must make sure that the active substance you are using has technical equivalence.
For products that are already authorised, if the active substance source or manufacturing process changes, you must make sure that the active substance produced from this source or manufacturing process has technical equivalence before you start using it in your product. You must also notify us of these changes before you start using the new or amended source in your product.