The notification of biocidal products before they are placed on the market and quantity notification of sales volumes for biocidal products made available on the market in Germany or exported in accordance with the Biocide Law Implementation Ordinance (Biozidrechts-Durchführungsverordnung, ChemBiozidDV) can be submitted free of charge on BAuA's online portal (eBIOMELD).

ChemBiozidDV FAQ 1

The responsibility for the implementation of titles 2 (Notification of biocidal products), 4 (Restriction of authorisation of certain types of biocidal products), and 5 (Notification of biocidal products made available on the market) of the ChemBiozidDV lies with the Federal Office for Chemicals (Bundesstelle für Chemikalien) at the Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin, BAuA). Questions about these titles can be addressed to BAuA ( chemg@baua.bund.de ).

The responsibility for monitoring the above-mentioned areas and the arrangements for the supply of biocidal products (Title 3 ChemBiozidDV) lies with the authorities of the federal states (Bundesländer) entrusted with these functions. Questions about this topic can be addressed to the competent local authority (which can be found using the ICSMS). Information on the arrangements for the supply of biocidal products can be found here (only in German).

ChemBiozidDV FAQ 2

In principle, the company’s details can be amended in the user account. You will find help on how to do this in the User Guide.

ChemBiozidDV FAQ 3

Companies with their registered office outside the European Union (EU), the European Economic Area (EEA), or Switzerland can submit notifications under the ChemBiozidDV provided that they enter an authorised representative (Bevollmächtigten) based within the European Union (EU), the European Economic Area (EEA) or Switzerland in the user account's personal data (“Eigene Daten”).

ChemBiozidDV FAQ 4

According to Section 4 of the ChemBiozidDV, the following information must be provided when notifying a biocidal product:

• Trade name of the biocidal product
• Name, address, and email address of the person required to notify and, if different, the name, address, and email address of the manufacturer
• Product type(s) to which the biocidal product is to be assigned
• Name(s) of the active substance(s) contained in the biocidal product with active substance concentration and CAS and EC number (if available)
• Date of application for authorisation and associated case number, if such an application has been made
• Indication of who is acting as substance supplier of the active substance or product supplier of the biocidal product in accordance with Article 95
• Confirmation that the biocidal product has the effect attributed to it

Information on Article 95 claims is not publicly available.

ChemBiozidDV FAQ 5

According to Article 4(2) of the ChemBiozidDV, it is not only necessary to indicate the person required to notify (i.e. the person who makes the biocidal product available on the market for the first time) in the notification with their contact details. If a person other than the distributor or another company manufactures the biocidal product, this person must also be indicated in the notification with their name, address and email address.

Please take into account that the "manufacturer" of a biocidal product within the meaning of the ChemBiozidDV (indent 2 of Article 4(2) ChemBiozidDV) is always the "physical" or actual manufacturer, not the distributor.

The background to this is that the manufacturer of a biocidal product has certain obligations that serve to protect humans, animals, and the environment. For example, a manufacturer must document the manufacturing process and keep samples of the manufacturing batches (Article 65 Biocidal Products Regulation). The indication of the actual product manufacturer with their name and address is necessary for effective market surveillance.

Please also refer to ChemBiozidDV FAQ 23 "Am I allowed to place a notified product with my own trade name on the market?".

If an application for authorisation has already been submitted for the product in question, the notification is also to include the case number assigned for the authorisation procedure (R4BP case number) and the date on which the application was submitted. Should the manufacturer have submitted the application for authorisation, the distributors and the manufacturer must exchange this information in due time so that all parties concerned can keep their notification complete and up to date. Please also bear in mind that Article 95 compliance must also be ensured and information on this issue must be passed along the supply chain.

Please also refer to ChemBiozidDV FAQ 19 "How should the active substance supplier be indicated in the notification pursuant to the ChemBiozidDV? Is it sufficient to indicate the company here, or is a letter from the supplier of the active substance(s) required? How is conformity with Article 95 of the Biocidal Products Regulation confirmed?".

ChemBiozidDV FAQ 6

A biocidal product continues to be marketable under the transitional measures until the last active substance contained in the product has been approved (or a decision not to approve has been taken for one of the active substances).

The note "Active substance decision pending" (Wirkstoffentscheidung ausstehend) means that no approval decision has yet been taken for at least one of the active substances in the biocidal product in respect of the relevant product type(s) for which the product containing that active substance has been notified and no non-approval decision has been taken for any of the active substances. As soon as the relevant (non-)approval decisions are published by the European Commission, the data in the "Note" column will be updated by the Federal Office for Chemicals.

ChemBiozidDV FAQ 7

If the date displayed under "Note" (Hinweis) is coloured orange, it is the approval date of the (most-recently approved) active substance in respect of the relevant product type(s) for which the product containing this active substance has been notified. If no application for the authorisation of the product has been submitted by this date, the biocidal product may only be made available on the market for 180 days or used for 365 days. The notifier has to add the information on a product authorisation application submitted in due time until that date to the notification. This application data is displayed in the public database in the product data sheet below the orange note. Additionally, it is possible to see whether an application for authorisation has been submitted on the page "Marketable and authorised biocidal products" (Verkehrsfähige und zugelassene Biozidprodukte) in the list "Biocidal products subject to decision-making process" (Biozidprodukte im Entscheidungsverfahren). If the product is already authorised, this can be found in the "Information on biocides" database on the European Chemicals Agency (ECHA) website. In this case we recommend the notifiers to deactivate their notification. However, in the database there might still be active notification of already authorised biocidal products. This can lead to contradictory information, as there is no official comparison between authorised products and notified products in eBIOMELD.

If the date in the "Note" (Hinweis) field is coloured red,

• a non-approval decision has been taken for at least one of the active substances in the product or
• an approval has not been renewed (the latter is only relevant if at least one other active substance in the product is still subject to the evaluation procedure, as products containing only approved active substances already have to be authorised and a notification would not be sufficient) or,
• if all active substances contained in the biocidal product have already been approved, no information on a submitted product authorisation application have been added to the notification.

Marketing under the transitional measures after the date shown is no longer allowed (The sales phase out deadlines have already been taken into account in this date).

Note: In case of notifications of biocidal products with only approved active substances and a product authorisation application in due time the marketability can be re-established by adding the information on the product authorisation application to the notification.

In addition to the notes that appear in the notification, the approval decisions and non-approval decisions on the active substances are also published on the REACH-CLP Biocides Helpdesk pages (German).

ChemBiozidDV FAQ 8

An overview of the transitional measures for biocidal products can be found on the REACH-CLP Biocides Helpdesk pages (German).

ChemBiozidDV FAQ 9

If biocidal products with the notified trade names are covered by a current application for authorisation in Germany (i.e. are included as part of the biocidal product family in an application submitted in due time), they must be/have been notified under the ChemBiozidDV before it is allowed for them to be made available on the market.

Notification under the ChemBiozidDV is not possible for biocidal products subsequently notified in the biocidal product family after the date specified in the second subparagraph of Article 89(3) of the BPR. They are not marketable until a positive authorisation decision has been issued.

ChemBiozidDV FAQ 10

For the indication of the active substance source, a selection of the data stored in the system is provided on the basis of the Article 95 list administered by the ECHA.
At the time of notification, at least one of the entries available here must be selected for each active substance/product type combination included in the notification. It is not necessary to confirm the supplier(s).

Please have appropriate evidence ready to present to the supervisory authorities upon request. Please update your notifications if the supplier(s) of the active substance(s) has/have changed.

ChemBiozidDV FAQ 19

The following applies to biocidal products that can be made available on the German market without authorisation on the basis of national transitional measures pursuant to Article 89 of the Biocidal Products Regulation in conjunction with Section 28(8) of the Chemicals Act (Chemikaliengesetz):

If you place a biocidal product on the market which is already notified and you wish to change information on the label, such as the trade name, a new notification is required in accordance with the ChemBiozidDV. In this case, you are the distributor.

The biocidal product must be notified with the relevant data and the registration number received (N-XXXXXX) must be stated on the new label.

If you receive a biocidal product and are provided with the label by the other operator and (re)sell the product under their trade name, no new notification is required. The other operator must then have already notified the biocidal product and state the N-number on the label provided.

Please also refer to ChemBiozidDV FAQ 6 "What do manufacturers of biocidal products and pure distributors have to consider with regard to the notification of their products under the ChemBiozidDV?" for the use of the term "manufacturer" within the meaning of the ChemBiozidDV.

ChemBiozidDV FAQ 23

Your user name is the email address you entered in the first step when registering your user account. It cannot be changed. It is only possible to create a new user account under a new user name.

The email address stored under "Details of distributor/manufacturer/importer" (Angaben zum Inverkehrbringer/Hersteller/Importeur) is used to contact you (e.g. with the confirmation email after a notification). You can change this email address in your user account under "User data" (Eigene Daten). However, this does not change the user name you use to log in.

ChemBiozidDV FAQ 24

If it is possible to find out the user name, you can create a new password for this user account using the "Forgotten password" (Passwort vergessen) function (see user guide ).

If the user name for a user account is no longer available or identifiable, the only option is to set up a new user account with a new user name.

ChemBiozidDV FAQ 25

The following product notifications have been or are deactivated via the system:

1. Product notifications for which no confirmation has been received by 31.03. of the corresponding year for more than two years (for confirmation please see here). These notifications are automatically deactivated on the 01.04. of the corresponding year.
2. Product notifications which include active substance identities that have been redefined in the course of the evaluation process and therefore are not up to date and you have not updated your notification with the correct information on the active substance despite having received an e-mail-alert.

Please notify your product with the up to date information again and use the new registration number (e.g. "N-12345"). In exceptional and justified cases, please contact chembioziddv@baua.bund.de and give a detailed explanation why it was not possible to confirm the notification timely or why it was not possible to update the information on the substance identity in time.

ChemBiozidDV FAQ 26

Generally, you can still notify biocidal products which contain active substances for which a decision on approval has already been taken but the approval date is in the future.

When completing the notification process you will be asked to fill out obligatory information regarding the authorisation application or tick the box “Antrag nicht/nicht fristgerecht gestellt” (Authorisation application not submitted/not submitted in time).

If you do not have information on the authorisation application (yet), please check the box “Antrag nicht/nicht fristgerecht gestellt”, even if you plan to submit an authorisation application in due time later one. As soon as you have submitted the authorisation application you have to add the information on this application and remove the check in the check box, in order to ensure that the marketability of your product is displayed correctly (see also ChemBiocideDV No. 8 and 27).

ChemBiozidDV FAQ 43

All biocidal active substances of product type 14 that were evaluated within the framework of the Review Programme for existing active substances have already been approved for more than 10 years (Approved substances product type 14). It can therefore be assumed that all biocidal products used in product type 14 are already subject to authorisation and/or have been authorised. Marketability under transitional regulations is therefore no longer given.

ChemBiozidDV Nr. 44