In situ-generated biocidal products

Content:

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 generated 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 generated on site, both with or without the use of other chemical substances (precursors).

The exceptions for certain products have expired - apply for approval of active substances

Certain combinations of active substance and precursors/method for generation were not covered by past regulations on biocides. 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.

Since the current regulations include all in situ-generated active substances, a stakeholder 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. In order to use or make such substances or products available on the market, an authorisation is required.

Read more about the current regulations on ECHA's website on in situ generated active substances.external link

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 are no longer covered by the ongoing evaluation in the Review Programme.

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 needs authorisation in Sweden to be sold and used, others not.

You can find information about which products need to be authorised here.

Do you have questions about in situ-generated biocidal products?

You can ask us questions through our questionnaire, Ask the Swedish Chemicals Agency Helpdesk

Rules for biocidal products

ECHA’s guidance and information:


ECHA's information on in situ-generated substancesexternal link

Document from meeting with competent authorities about free radicals as active substances in biocidesexternal link

Guide for data requirements for the application for approval for free radicalsexternal link

Last published 25 September 2020