ChemBiozidDV FAQ 20, When biocidal products are notified, the concentration of the active substance has to be indicated in accordance with §4 of ChemBiozidDV. What concentration has to be indicated for active substances generated in situ or for released active substances?
For biocidal products that are made available on the market to be used for the generartion of active substances on site (in situ), the concentrations of the active substances produced are to be indicated. However, the concentrations of the active substances produced vary depending on the application intended for the biocidal product.
It is now possible to state the concentration range when notifying a biocidal product of this kind. Therefore, please specify the minimum and maximum concentration of the active substance generated that will be reached if the biocidal product is used in accordance with the instructions of use.
For released active substances, please indicate the concentration of the releaser in the biocidal product.
ChemBiozidDV FAQ 21, How do biocidal products have to be notified under the ChemBiozidDV when they consist of two components used for the in situ production of active substances?
Should the two components (to be used to produce an active substance at the site of application/in situ) be made available on the market as a bundle or in one package, they must be notified together as a biocidal product.
If two components are made available separately on the market, they should also be notified as one biocidal product under the Biocide Law Implementation Ordinance (Biozidrechts-Durchführungsverordnung, ChemBiozidDV). However, technical adjustments are necessary when they are notified:
Where applicable, please indicate the different suffixes added to the name for the respective components (e.g. "A" and "B") in brackets after the trade name in the combined notification.
ChemBiozidDV FAQ 22, Does the precursor substance have to be notified if it constitutes the biocidal product subject to authorisation? Or can equipment manufacturers who rent or sell their equipment to customers notify the substance produced in situ? And if so, how?
The mandatory notification of products under the transitional measures laid down in Section 3(1) of the ChemBiozidDV is exclusively linked to "making available on the market". This means that only substances and mixtures made available on the market are relevant for the notification requirements under the ChemBiozidDV. Consequently, the precursor substance must be notified if it constitutes the biocidal product subject to authorisation.
Equipment manufacturers who only sell or rent the equipment for the production of the in situ active substance to customers are not required to notify. Mandatory notification only applies if the precursor substance is also made available on the market in addition to the equipment. Equipment manufacturers may carry out the notification as representatives for the suppliers of the precursor substances, where applicable.
ChemBiozidDV FAQ 28, How does the quantity notification for biocidal products with active substances produced on site (in-situ) or for released active substances work?
Since the quantity notification for the year 2024, it is possible to notify quantities of biocidal products whose active substances are only manufactured on site (in-situ) or for released active substances. The precursor/ releaser concentration has to be stated.
After selecting the active substance, the database automatically displays the precursor/releaser substance, for which the quantity for this active substance must be stated.
The active substance concentration is not necessary for active substances generated in situ or released.
For devices that produce the biocidal active substance without the precursor substance being made available on the market for biocidal purposes (e.g. active chlorine from sodium chloride), no quantity notification is required as no biocidal product is made available on the market.