Notification procedure (transitional measures for existing active substances)

Notification procedure

An overview of the active notification data records can be viewed in tabular form in the product administration area, which is reached by clicking on the menu item "Transitional measures notification" (Übergangsregelungen), then the menu heading "Notification management" (Meldungsverwaltung).

The magnifying glass icon at the end of the line for each product opens the detailed overview of the selected notification, which can be used to edit, confirm, and deactivate this notification.

You can start the notification process for a (new) biocidal product by clicking on "Notify product" (Produkt melden).

The "Export entire list" (Gesamte Liste exportieren) button allows you to export an entire list of the notifications stored in your user account in ".CSV" format.

Notify product

A biocidal product is notified in the following six steps: "indication of trade name", "active substance", “active substance concentration”, "product type", "Article 95", and "overview".

Step 1 of 6 - Trade name

In this step, enter the intended trade name for your product in the field "Trade name" (Handelsname).

Note:
For two-component products, please refer to FAQ ChemBiozidDV Nr. 21.

If you are not the manufacturer of the biocidal product, please tick the "Notifier is not manufacturer" (Melder ist nicht der Hersteller) box and fill in the information on the manufacturer in the fields below.

To confirm, click on "To step 2" (zu Schritt 2) in the bottom left of the window.

Use the "Cancel" (Abbrechen) button to end the process and return to the Start page.

 

Step 2 of 6 - Active substance

This step involves selecting an active substance.

You can narrow down the selection of active substances displayed by using the "Search" (Suche) field. A search via CAS or EC number would be possible as well.

To select the desired active substance, mark the applicable entry by clicking on the circle at the right end of the corresponding line. Only one entry can be selected in this step. It is possible to add another active substance in step 5, "Overview" (Übersicht).

Confirm your selection by clicking on "Go to step 3" (zu Schritt 3).

Step 3 of 6 - Active substance concentration

First enter the "Active substance concentration" (Wirkstoffkonzentration) for the active substance you want to add in this step.

The selection of the “unit of concentration” (Einheit der Konzentration) is possible via a drop-down menu next to the field “active substance concentration” (Wirkstoffkonzentration).

Note:
For active substances produced/released by the biocidal product at the site of application, please refer to FAQ ChemBiozidDV Nr. 20.

Step 4 of 6 - Product type

In this step, you select the product type(s) for the active substance you have previously set.

 

To make your selection, mark the product type(s) by ticking the box(es) to its/their left. Please select all desired product types for the active substance at this point. Please bear in mind that this list only includes product types for which the selected active substance has been or will be evaluated under the review programme for existing active substances.

Confirm your selection by clicking on "Go to step 5" (zu Schritt 5).

The following restrictions apply, limiting the options for the notification:

• Active substances assigned to product types 6 and 7 cannot be combined with active substances of other product types, as they usually do not contribute to the actual biocidal function of a product and, as "silent" active substances, do not influence how long it will be marketable for.
• As a rule, disinfectants for human hygiene cannot also be used as protective agents, while products of product type 22 for the preservation of cadavers (parts of corpses) or animal carcasses cannot be used as disinfectants of product types 2 to 5.
• If an active substance is assigned to product types with an antimicrobial target, all other active substances added to the product must also be marketable for the same product types, as it can usually be assumed that the active substances exert their effect in several product types and would therefore be considered as active substances in these product types.
• Active substances of product type 14 can no longer be selected (FAQ ChemBiozidDV Nr. 44) and therefore cannot be combined with active substances of other product types, as in this case combination products assigned to other product types cannot usually be present.

If the restrictions mentioned above do not apply to your product, please explain clearly why  they do not apply and contact the Federal Office for Chemicals (Bundesstelle für Chemikalien):

chembioziddv@baua.bund.de  

Step 5 of 6 - Article 95

In step 5, the active substance source (Article 95 Biocidal Products Regulation) for the active substance currently under consideration is added to the notification.

 

Please select the applicable entry(ies) from the available alternatives by selecting the checkbox(es) to its/their left.

Confirm your selection by clicking on "Go to step 5" (zu Schritt 5).

Step 6 of 6 - Overview

In this step, the information you have previously entered is displayed. You can see what the status of the product would be under "Note" (Hinweis).

If the entry for the active substance is incorrect, you might want to remove it from the notification by clicking on "Delete active substance" (Wirkstoff löschen).

If your product contains one or more additional active substances, please click on "Add additional active substance" (Weiteren Wirkstoff hinzufügen). You can go through steps 2 to 5 for each additional active substance.

The effect attributed to the product is confirmed by ticking the corresponding checkbox "Confirmation of attributed effect*" (Bestätigung der zugeschriebenen Wirkung*). It is mandatory to complete this field.

Notification of products containing only active substances that have already been approved

If an application has already been submitted for the product and the relevant date for its approval has been reached, the boxes headed  "Application submitted" (Antragstellung) can be filled in. The information on the application procedure must be completed accordingly or it must be indicated that an application has not been submitted or has not been submitted on time by ticking the corresponding checkbox "Application has not been submitted/not submitted on time" (Antrag wurde nicht/nicht fristgerecht gestellt).

Note:
The "R4BP number" is assigned by the ECHA in the R4BP (Register for Biocidal Products) system. This information is requested as part of the notification procedure so the notification can be allocated to an application procedure.

If all the entries are correct, you can complete the notification by clicking on "Register product" (Produkt registrieren).

You will be able to review the details of the product. You will also be sent a confirmation email.

Detailed product view

An overview of the active notification data records can be viewed in tabular form in the product administration area, which can be reached by clicking on the menu item "Transitional measures notification" (Übergangsregelungen), then the menu heading "Notification management" (Meldungsverwaltung).

The magnifying glass icon at the end of the line for each product opens the detailed overview of the selected notification.

The information submitted on a biocidal product is displayed in the detailed product view.

You can edit the product (Produkt bearbeiten) and active substance (Wirkstoff bearbeiten) information, confirm (Bestätigen) and deactivate (Deaktivieren) the notification record in this view.

You can print out the data sheet by clicking on "Print data sheet" (Datenblatt drucken).

First, a window opens with the view of the data sheet to be printed. Here, you have the option of selecting the printer to be used before you confirm the print request by clicking on "Print" (Drucken).

Edit product

You can start amending your tradename, manufacturer, application and efficacy details by clicking on the "Edit product" (Produkt Bearbeiten) button in the product data sheet.

After you have entered the desired amendments, you can complete this process by clicking on "Save" (Speichern).

Edit active substance

By clicking on the button “Edit active substance” (Wirkstoffe bearbeiten) field in the product data sheet, you can change your notification details for the active substance(s) contained.

The first step is to select the active substance contained in the product for which you want to make a change. If more than one active substance is contained in the product, you can make a selection by opening the drop-down menu under “Select product active substance” (Produkt-Wirkstoff auswählen) and clicking on the desired active substance.

After you have selected the desired active substance, you can go to the next step by clicking on the “Next” (Weiter) button.

In the second step, you can edit the information about the active substance supplier (Artikel95-Quellen ändern) and the active substance concentration (Wirkstoffkonzentration).

After you have entered the desired changes, you can complete this process by clicking on the "Save" (Speichern) button.

Confirm notification

The notifications that still require confirmation are shown on the start page. You can start confirming a notification by clicking on the link provided.

Note:
If you do not see a confirmation prompt on your start page, but still want to confirm a product, you can do so by going to the product administration area and clicking on the magnifying glass icon.

You can also start the confirmation process by clicking on the "Confirm" (Bestätigen) button that can be seen in the product data sheet.

In the following overview, you can see the information currently stored for your product. If the information provided is correct, you can complete this process by clicking on "Confirm product" (Produkt bestätigen).

If you want to make changes to the information about the product or the active substance, you can start these steps using the "Edit product" (Produkt bearbeiten) and/or "Edit active substance" (Wirkstoff bearbeiten) buttons in the product data sheet. You can then continue by clicking on "Confirm product" (Produkt bestätigen).

If the system determines that necessary information is missing, you will be informed of the information that is still missing and where these editing steps can be carried out. Once you have added the information, you can continue by clicking on "Confirm product" (Produkt bestätigen).

Deactivate notification

It is possible to deactivate a notification in its detailed view. The process is started by clicking on "Deactivate" (Deaktivieren).

You will see the view shown below. Here, you can click on "Deactivate" (Deaktivieren) to complete the process or "Cancel" (Abbrechen) to end the process without deactivating the notification.

Note:
Please bear in mind that it is not possible to restore a deactivated notification in your user account. Should it be necessary to cancel the deactivation of a notification, please contact the Federal Office for Chemicals (email address: chembioziddv@baua.bund.de ).

An overview of the deactivated notifications can be viewed under "Transitional measures notification" (Übergangsregelungen). Please select "Deactivated notifications" (Deaktivierte Meldungen) from the menu.

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