Quantity notification procedure (biocidal products made available on the market)

The Biocide Law Implementation Ordinance (Biozidrechts-Durchführungsverordnung, ChemBiozidDV) introduced a notification procedure under which the annual quantity of biocidal products made available on the market in Germany or exported must be notified. Manufacturers or importers who make biocidal products available on the market in Germany or export them are required to notify the relevant quantities. The notification is to be submitted annually by 31 March for the previous year.

Quantity notifications for biocidal products that can be marketed under the transitional measures are requested in two forms.

Quantity notifications for biocidal products for which an application was not yet required are carried out under “Quantity notification (transitional regulations)” (Mengenmitteilung (Übergangsregelungen)).

For biocidal products for which an application for authorisation has already been submitted/had to be submitted, quantity notifications are carried out using the “Quantity notification (applied for/approved)” (Mengenmitteilung (Beantragt/ Zugelassen) form.

Quantity notification management

The quantity notifications you have previously submitted are listed under "Quantity notification management" (Mitteilungsverwaltung).

The "Export entire list" (Gesamte Liste exportieren) button allows you to export an entire list of the quantity notifications of the respective year submitted with your user account in the ".CSV" format. (Note: You can download this list only in the timeframe where you can submit quantity notifications until 31.03. of each year.)

Quantity notification (transitional measures)

For biocidal products that can currently be placed on the market in Germany under the transitional measures this form must be used for the quantity notification. This means biocidal products that contain existing active substances of which at least one has not been approved yet for the corresponding product type(s). Therefore, there was no need to submit an application for authorisation yet.

In the first step, the trade name (Handelsname), the registration number (Registriernummer) (N-XXXXXX), and the product quantity (Produktmenge) in the selected unit of product quantity (Einheit der Produktmenge) are entered. The "Next" (Weiter) button is used to continue to the second step.

In the second step, select the desired active substance by marking the relevant entry by clicking on the circle on the right at the end of the corresponding line.

By clicking on the "Next" (Weiter) button, the quantity notification goes to the third step, in which the active substance concentration (Wirkstoffkonzentration) and the unit of concentration (Einheit der Konzentration) are specified.

Click on "Next" (Weiter) to continue from the quantity notification to the fourth step, in which the associated product type(s) is/are selected.

The product type(s) is/are selected here by ticking the checkbox(es) to its/their left.

Click on "Next" (Weiter) to reach the step where you conclude or extend the procedure. Here, you have the options of reviewing the information entered, deleting the active substance entered (Wirkstoff löschen), adding another active substance (Weiteren Wirkstoff hinzufügen), or submitting the notification by clicking on "Send quantity notification" (Mengenmeldung abschicken).

To add another active substance, please click on the "Add another active substance" (Weiteren Wirkstoff hinzufügen) button. You will then go through the steps described above again.

Quantity notification (applied for authorisation/authorised)

This form must be used to submit the quantity notification for biocidal products that are subject to an ongoing product authorisation application that has already been submitted in due time or for which an authorisation has already been granted.

In the first step please enter:

• the trade name,
• for which an application for authorisation has been submitted but a decision has not yet been taken
  • the notification number (Registriernummer) and
  • the R4BP case number

or

• for biocidal products
• for authorised biocidal products
  • the authorisation number (Zulassungsnummer),
• and the product quantity in the selected unit of product quantity (Einheit der Produktmenge)

Click on "Next" (Weiter) to continue to the second step.

In the second step, select the desired active substance by marking the relevant entry by clicking on the circle on the right at the end of the corresponding line.

By clicking on the "Next" (Weiter) button, the quantity notification goes to the third step, in which the active substance concentration (Wirkstoffkonzentration) and the unit of concentration (Einheit der Konzentration) are specified.

The "Next" (Weiter) button takes you to the fourth step, in which the associated product type(s) is/are selected.

Here, the product type(s) is/are selected by ticking the correct checkbox(es) to its/their left.

The "Next" (Weiter) button takes you to the step where you conclude or extend the procedure. 

Here, you have the options of reviewing the information entered, deleting the active substance entered (Wirkstoff löschen), adding another active substance (Weiteren Wirkstoff hinzufügen), or submitting the notification by clicking on "Send quantity notification" (Mengenmeldung abschicken).

To add another active substance, please click on "Add another active substance" (Weiteren Wirkstoff hinzufügen). You will then go through the steps described above again.

Quantity notification (export)

A separate form is available for the quantity notification of biocidal products that were manufactured in Germany and exported in the past year.

In the first step, the trade name, the registration number (Registriernummer) (if available), the R4BP case number and/or authorisation number (Zulassungsnummer) (if available), and the product quantity in the selected unit of product quantity (Einheit der Produktmenge)  are entered. Click on "Next" (Weiter) to continue to the second step.

In the second step, select the desired active substance by marking the relevant entry by clicking on the circle on the right at the end of the corresponding line.

In this form, it is possible to store information on a user-defined active substance. This allows you to specify active substances in the notification procedure that have not been or will not be approved under the Biocidal Products Regulation and are therefore not available in the selection list.

By clicking on the "Next" (Weiter) button, the quantity notification goes to the third step, in which the active substance concentration (Wirkstoffkonzentration) and the unit of concentration (Einheit der Konzentration) are specified.

The "Next" (Weiter) button takes you to the fourth step, where the associated product type(s) is/are selected. 

Here, the product type(s) is/are selected by ticking the correct checkbox(es) to its/their left.

The "Next" (Weiter) button takes you to the step where you conclude or extend the procedure. 

Here, you have the options of reviewing the information entered, deleting the active substance entered (Wirkstoff löschen), adding another active substance (Weiteren Wirkstoff hinzufügen), or submitting the notification by clicking on "Send quantity notification" (Mengenmeldung abschicken).

To add another active substance, please click on "Add another active substance" (Weiteren Wirkstoff hinzufügen). You will then go through the steps described above again.

Edit quantity notification 

As long as the deadline for quantity notification (31. March for the previous year) has not yet expired, you can change the quantities and information you have entered for the biocidal product. To do this, please click on the "Notification management" (Mitteilungsverwaltung) button in the "Quantity notification" (Mengenmitteilung) tab. This will open the notification management, which contains a list of the quantity notifications you have already made.

Select the product for which you want to edit the quantity notification by clicking on the magnifying glass on the right in the product row.

The quantity notification data sheet will then open. You can now change the name of the biocidal product, the registration number or the product quantity by selecting the "Edit" (Bearbeiten) button under the block with the information on trade name, product status and product quantity.

It is not possible to change the product status. If you have selected the wrong form for the quantity notification, please write an email to chembioziddv@baua.bund.de stating the trade name of the product, the ID of the quantity notification (you can find this in the overview in the notification management) and the request to delete this quantity notification. The incorrect quantity notification will then be deleted and you can submit it again accordingly.

If you have assigned the wrong product type to the active substance, please select the "Edit active substance" (Wirkstoff bearbeiten) button under the relevant active substance. You can then change the active substance concentration, the unit of the active substance concentration and the product type.

If you have selected the wrong active substance, please select the “Delete active substance” (Wirkstoff löschen) button and then add it again using the “Add active substance” (Wirkstoff hinzufügen) button in the quantity notification data sheet.

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