The note "Currently not marketable" (aktuell nicht verkehrsfähig) appears in my notification. What do I have to do?
If the note "Currently not marketable" (aktuell nicht verkehrsfähig; grey font) appears, you must update or confirm the information on your product.
According to Section 6(2) of the Biocide Law Implementation Ordinance (Biozidrechts-Durchführungsverordnung, ChemBiozidDV), the correctness of the information for notifications must be confirmed every two years by 31 March at the latest. If the information is not confirmed within the period specified in the first sentence of Section 6(2), the biocidal product may not be made available on the domestic market until the data have been confirmed.
You can find help on how to confirm information in our user guide.
ChemBiozidDV FAQ 11
You have submitted an application in due time for a product currently under evaluation for authorisation under the BPR. Do the new provisions of the ChemBiozidDV also apply to the notification and updating of products that are currently subject to a decision-making process?
The submission of a notification, its updating, and its regular confirmation under the ChemBiozidDV are also required for products that are currently subject to an ongoing authorisation procedure in Germany.
In order to comply with these provisions, any existing notification for this biocidal product must be updated (i.e. supplemented with the notification information required under Section 4(2) ChemBiozidDV). Alternatively, if no notification has yet been submitted for the biocidal product, this must be done subsequently. The notification must be updated as long as the notified products can still be made available on the market without an authorisation.
ChemBiozidDV FAQ 13
Does the notification also have to be confirmed if the biocidal product is no longer being manufactured?
Confirmation is required as long as the products are made available on the market, that is while they are on sale (third sentence of Article 6(2) ChemBiozidDV). It is therefore advisable to continue to confirm the notification as long as the product is still being made available on the market by other persons along the supply chain in order to avoid any confusion as far as possible.
ChemBiozidDV FAQ 14
How is the attributed effect mentioned in indent 7 of Section 4(2) of the ChemBiozidDV "confirmed" under the transitional measures for existing active substances?
As regulated in Section 4 of the ChemBiozidDV, the notification includes, among other things, a confirmation of the effect attributed to the biocidal product.
Technically, this is confirmed during the notification procedure by "clicking" in a confirmation box. This is a self-disclosure that is not checked within the scope of the notification procedure. However, the notifier must be able to present the relevant information to the responsible authorities upon request.
For biocidal products placed on the market under the national transitional measuresit is the responsibility of those placing products on the market to provide a safe and efficacious product. Accordingly, those placing the product on the market must have evidence of efficacy to support the claims made for it.
General requirements for evidence of efficacy can be found in Volume II of the Guidance on the Biocidal Products Regulation, which also sets out the basis for the efficacy studies to be submitted during the biocidal product authorisation process.
ChemBiozidDV FAQ 15
Can I change the active substances and product types specified in the notification?
It is not possible to change or add an active substance or product type in an existing notification.
Please re-register the product in question with the changed active substance(s) and/or product type(s) and display the new registration number (N-number) on the label.
ChemBiozidDV FAQ 16
I could not confirm the notification for my biocidal product authorised under the Biocidal Products Regulation in the eBIOMELD database. The note "Currently not marketable" (aktuell nicht verkehrsfähig) now appears in the notification. What can I do?
The notification procedure under the ChemBiozidDV is only to be carried out for those biocidal products that can be marketed without authorisation under the national transitional measures. Biocidal products authorised under Regulation (EU) No 528/2012 (Biocidal Products Regulation) therefore do not have to be notified or confirmed. This is why it is not possible to confirm the old notification.
The marketability of these biocidal products follows from the existing authorisation. Failure to confirm the notification under the ChemBiozidDV therefore has no legal consequences.
In order to avoid misunderstandings, however, we recommend deactivating the old notification submitted during the period before the authorisation was granted.
ChemBiozidDV FAQ 17
Should I also confirm or update my deactivated notifications?
It is not necessary to confirm and update deactivated notifications.
If such a notification were to be reactivated at a later date, the further information required under the ChemBiozidDV would then have to be confirmed and completed.
ChemBiozidDV FAQ 18
What do I need to do, if all active substances contained in my notified biocidal product have been approved?
Generally, you have to submit an application for product authorisation until the approval date of the last active substance in your biocidal product. You can find additional information under "Background Information on the Authorisation Procedure".
Furthermore, you have to insert the information on your product authorisation application in your notification in eBIOMELD to ensure that the marketability is visible. Please see FAQ No 8.
ChemBiozidDV FAQ 27