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Editor-in-chief: Maurizio Roncaccia
Editors: Paul Trouth and Päivi Jokiniemi
Article related to: Biocides
In situ generated active substances notified in 2016 – deadlines approaching
A biocidal active substance that is generated where it is used is called an “in situ generated” active substance. If yours is not being evaluated under the Review Programme, but you notified it in 2016, then the next step is to submit an active substance application to ECHA. This must be done within two years of the acceptance of your notification. Read what to keep in mind when preparing your application.
Deadlines approaching and work to be done
If you market an in situ generated active substance which is not under evaluation in the Review Programme, then you should have notified it to ECHA already in 2016, where possible.
If you did that in time, you were given two years to submit a full application for an active substance approval.
That application will allow you to continue using the in situ generated active substance until the evaluation of the substance in the Review Programme has been completed.
If you have not already started to prepare your application, it is time to start now.
The deadline for submitting the active substance application was specified in the letter that confirmed the compliance of your notification. You can also find the deadline in the list of compliant notifications.
What if my substance is not on the list?
If you failed to notify ECHA about your substance, you may still apply for its approval. However, you cannot market or use such a precursor/in situ active substance combination until the approval has been granted and the biocidal product has been authorised.
If your precursor/in situ active substance combination is listed but you do not submit the application for active substance approval by the given deadline, the European Commission will give a non-approval decision.
This means that you will not be allowed to market or use your precursor/in situ active substance combination from the date indicated in the legislation.
Where can I find advice?
You need to assess the risks of your substance (and the manufacturing process) on human health and the environment. Details on what information you need to provide can be found in BPR Annex II.
If you need one-to-one advice, you can contact the competent authority that has agreed to evaluate your active substance application.
Collect and evaluate the existing data on your substances. If any data is missing, can you generate it through, for example, reading across from a similar substance or group of substances? If not, you need to send an inquiry to ECHA before carrying out any new tests.
Describe the process by which the active substance is generated in situ. This needs to include the conditions and their variations, and how these affect the composition of the technical active substance generated in situ.
When preparing the risk assessment, you need to assess both the pure active substance generated in situ as well as all the substances from which you make the active substance (the precursors) and any reaction by-products. You do not need to do risk assessments for precursors that are substances or mixtures that cannot themselves be authorised as biocidal products, for example, air or seawater.
You need to assess the risk to humans. Workers may be exposed to the precursors (before and during in situ generation) and the substances generated in situ (during and after in situ generation). You need to assess the risks to human health at all these stages. You also need to assess if the unreacted precursors or any of the reaction by-products affect the toxicity of the active substance generated in situ. Consider too whether any members of the public could be exposed to the in situ generated substance during the production process – perhaps there is a release to the air?
You also need to assess the risk to the environment. The environment is exposed to the precursors mainly after the generation of the in situ active substance, if they remain unreacted. Nonetheless, it is important to assess if any of the components of the technical active substance generated in situ are toxic to the environment. However, under certain conditions, you may not need to do the risk assessment for some of the components. The recommendation of the BPC Working Groups explains these exceptions.
Once you have your information, put it in a IUCLID dossier, export it and submit it to ECHA through R4BP 3. Remember that you need to create a separate substance dataset for the in situ generated active substance, each of the precursors and any of the reaction by-products.
Communication related to your application happens through R4BP 3, so remember to log in also after you have finalised your submission.
In situ generation – where one or more substances (precursors) react together to generate a new technical active substance in the same place where it will be used.
In situ generated active substance – the pure active substance generated.
Technical active substance generated in situ – the pure active substance, as well as reaction by-products, unreacted precursors and other impurities (e.g. contaminants from precursors).
Precursor – a substance or a mixture from which the active substance is generated in situ. Unreacted precursors may be present as impurities in the composition of the technical active substance generated in situ.
Review Programme – the programme of review of biocidal active substances that were on the market in biocidal products on 14 May 2000.
Reaction by-products – formed during generation of the active substance, considered as impurities.