In situ-generated active substances and their precursors should be approved or evaluated for the relevant product type in order to be sold and used. Companies using active substances manufactured in situ should review what kind of approval the substances require. The alternative is to review the possibility of replacing existing methods.
The term in situ refers to the production of active substances manufactured on site, both with or without the use of other chemical substances (precursors).
The exceptions for certain products expire - apply for approval of active substances
Certain combinations of active substance and precursors/method for generation were not covered by past regulations on biocides. Since the current regulations include all in situ-generated active substances, those who are interested must have submitted an application for approval of these active substances no later than 1 September 2016. If no such application was submitted in time, the active substances may not be used or supplied after 1 September 2017.
Examples of such substances are radicals generated in situ for use as biocides and active substances generated on site by chemicals not sold as biocides.
You can find further information on how this might affect your company and what you need to do to adapt to the current regulations on ECHA's website on in situ generated active substances.
Redefining in situ-generated substances
Many active substances generated in situ have been redefined and have new names in the Review Programme. The new names describe both the generated active substance and the precursor chemicals used. As a result, certain combinations of precursor chemicals and active substances will no longer be covered by the ongoing evaluation in the Review Programme.
In spring 2016 there was an opportunity to submit a notification of interest to take over the role of stakeholder in the review program for some of the redefined combinations of active substance and precursors/method of generation. The Commission will decide on non-approval for the combinations in which nobody has expressed interest in. Once decisions on non-approval have been made, it will also be stated how long these in situ-generated biocides may be sold and used.
What is the Review Programme?
Active substances in biocidal products are evaluated in a European Review Programme if there is one or more stakeholders supporting the evaluation by financing it. The substances included in the Review Programme are included in Annex II to Regulation (EU) No 1062/2014. These substances may still be placed on the market in accordance with current practice and national rules as long as the evaluation is in progress. This means that some products need to be approved in Sweden to be sold and used, others not.
Do you have questions about in situ-generated biocidal products?
You can ask us questions through our questionnaire, Ask the Swedish Chemicals Agency Helpdesk