In situ-generated biocidal products
If active substances are generated on site for biocidal purposes, authorisation may be required for the use of the substances, or for the sale of the precursors with which the substances are generated.
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 concept of in situ-generation means that active substances are generated on site, in order to function as biocidal products against harmful organisms. The generation can take place from chemicals that have been purchased for the purpose (so-called precursors), or substances that are in water or air with the help of technical equipment. In situ-generated active substances and their precursors must be approved or evaluated in the EU Review Programme for the relevant product type in order for them to be used and provided. If the active substances have been approved at EU level, product authorisation is required according to the EU Biocides Regulation. The requirement for product authorisation applies to the sale of precursors sold with a biocidal claim or the use that takes place of active substances that have been generated on site with the help of technical equipment.
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.
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.
For what is authorisation required and who is responsible for the application?
It is either the precursors or the in situ-generated substance that is regarded as the biocidal product and requires authorisation. Authorisation is not required for the technical equipment used for the generation. The precursors are regarded as biocidal products if they are sold with a biocidal claim. In cases where the precursors are the biocidal product, it is for these that you apply for approval. It is the company that manufactures or make the the precursors available on the market for the first time (the primary supplier) that applies for authorisation. The generated active substances are regarded as biocidal products if they are generated from precursors that are not sold with a biocidal claim or generated from water or air. In cases where the generated substance is the biocidal product, it is the use of the substance that requires authorisation according to the rules. In practice, however, it can be difficult for users to apply for authorisation. Therefore, it is anticipated that it will often be the supplier of the technical equipment who will choose to be responsible for the application for authorisation for the use that will take place with the customers.
For in situ products, a distinction is made between different categories prior to the authorisation procedure:
Case type 1 - one or more precursors that generate active substances by mixing, without using a generator (e.g. active bromine generated from sodium bromide and sodium hypochlorite).
Case type 2 - one or more precursors that generate active substances using technical equipment (e.g. active bromine generated from sodium bromide by electrolysis).
Case type 3 - coating containing one or more catalysts which generate free radicals after activation.
Case type 4 - active substances generated in situ from precursors not supplied on the market for biocidal purposes and technical equipment (e.g. ozone generated from ambient air by an ozone generator or active chlorine generated from salt not supplied for biocidal purposes by electrolysis through a device).
Which in situ substances must be on the Article 95 list?
In addition to the authorisation rules, it is required that substance or product suppliers for biocides shall be included in the so-called Article 95 list. It is a list referred to in Article 95 (1) of the EU Biocides Regulation for the supply of a biocidal product containing a relevant substance. A substance is considered relevant if a complete dossier for the precursor has been validated by a Member State, in connection with the application for approval of the active substance. An actor can be included on the list if he has submitted a complete dossier for the relevant substance, or by a permit that gives access to such a complete dossier for a substance (a so-called Letter of Access, LoA), or by a reference to such a dossier for which all data protection periods have expired. A Letter of Access is a special document that actors can purchase from those who have submitted the documentation required for the evaluation.
In the case of in situ-generation, the requirement in Article 95 therefore only applies to precursors sold with a biocidal claim, if a complete dossier for the precursor has been validated by a Member State. However, all active substance applications for in situ generation have not yet been validated. As long as applications for precursors with biocidal claim have not yet been validated, despite the fact that the application has been submitted in time, the requirement for the substance supplier to be on the Article 95 list for these products do not yet apply.
Precursors sold as commodity chemicals without a biocidal claim are not covered by the Article 95 requirement. Nor is technical equipment, or the use of in situ generated substances.
Do you have questions about in situ-generated biocidal products?
You can ask us questions through our questionnaire, Ask the Swedish Chemicals Agency Helpdesk