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 "TO TRANSITIONAL MEASURES NOTIFICATION OVERVIEW" (ZUR ÜBERSICHT ÜBERGANGSREGELUNGEN).

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 five steps: "indication of trade name", "active substance", "product type", "Article 95", and "overview".

Step 1 of 5 - Trade name

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

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 5 - Active substance

This step involves selecting an active substance.

First enter the "Active substance concentration (g/kg)" (Wirkstoffkonzentration (g/kg)) for the active substance you want to add in this step. The entry can only be made in this unit and should be a number > 0 with a maximum of five decimal places. It is not possible to enter letters (e.g. alternative units) in this field.

Note:

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

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 5 - 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 4" (zu Schritt 4).

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 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 4 of 5 - Article 95

In step 4, 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 5 of 5 - 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 4 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 "TO TRANSITIONAL MEASURES NOTIFICATION OVERVIEW" (ZUR ÜBERSICHT ÜBERGANGSREGELUNGEN).

 

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, confirm, and deactivate 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 notification

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

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

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.

Additional information required under the Biocide Law Implementation Ordinance (Biozidrechts-Durchführungsverordnung, ChemBiozidDV) must be entered and confirmed in the "Confirm product" form that then opens. The following information has to be entered:

• Active substance concentration
• Active substance source/Article 95
• Manufacturer data (if necessary for the product)
• Application details (if necessary for the product)
• Confirmation of the attributed effect

The information "Active substance concentration" (Wirkstoffkonzentration) and "Active substance source" (Wirkstoffquelle) are entered for each active substance contained in the product. You can open the form for this step by clicking on "Edit active substance" (Wirkstoff bearbeiten).

After you have completed the information, you can save it by clicking on "Edit" (Bearbeiten) and will then be taken back to the product data sheet.

From the product data sheet, please launch the confirmation process again by clicking on "Confirm" (Bestätigen). You will then be able to see the information you entered previously.

Please now add the missing information to your notification. You can then complete this process 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).

A magnifying glass icon is located at the right end of each notification data record displayed there. Clicking on it will take you to the product data sheet for the selected notification data record.

Note on finding the detailed view:

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 "TO TRANSITIONAL MEASURES NOTIFICATION OVERVIEW" (ZUR ÜBERSICHT ÜBERGANGSREGELUNGEN).

 

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 products" (Deaktivierte Produkte) from the menu.

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