Biocides must be notified in order to be marketable under the transitional arrangements.
Biocidal products with existing active substances that can take advantage of the transitional arrangements are marketable even without authorisation. However, for this transitional period, it is necessary to give notification of the biocidal product in accordance with the Biocide Notification Ordinance (ChemBiozidMeldeV), among other requirements.
iThe marketability of the aforementioned biocidal products is regulated according to paragraph 28(8) of the Chemicals Act (ChemG).
Information on the transitional arrangements and on other necessary steps for a product to be market-able are available on the website of the REACH-CLP-Biozid Helpdesk.
The information below relates to notifications pursuant to the Biocide Notification Ordinance (ChemBiozidMeldeV).
Notified biocidal products can be found in the publicly accessible Database of notified biocidal products (in German) along with the available information.
A secure area of this database (in German) is available to the national authorities responsible for monitoring.
In accordance with the Biocide Notification Ordinance, a registration number is allocated to products that are marketable within the framework of the transitional arrangements and that have been notified. The registration number consists of a letter (N-) and a five-digit number.
Biocidal products may only be placed on the market within the framework of the transitional arrangements if a registration number is applied to the relevant product. The application for the registration number issued within the framework of the notification procedure can be submitted by manufacturers, importers or parties operating using their own trade name. These two provisions are set out in paragraph 2(1) of the Biocide Notification Ordinance.
The notification of biocidal products is free of charge and is performed for each trade name. If a biocidal product is marketed under different trade names, therefore, a separate notification is required for each trade name.
The following information is required for the notification of a biocidal product:
An online notification form (in German) is available for submitting the notification.
You will need a user account in order to enter the data for your biocidal product(s).
Once you have entered all of the data successfully and your product is marketable, you can view your registration number directly on the screen and will receive an email confirming this registration number.
In general, the marketability of biocidal products depends on the active substances contained for the respective product-type. Information on the approval process for biocidal active substances can be found on the website of the REACH-CLP-Biozid Helpdesk.
Your user account will display the date on which your biocidal product's marketability ends, or the date by which an application for authorisation must be submitted in the case of a decision on approval, so that your biocidal product remains marketable without interruption. Please check the date shown here regularly as it may change, for example when a decision is made regarding approval.
If a decision is reached not to approve at least one of the biocidal active substances in your biocidal product, and if the so-called "phase-out date" has already passed, you will not receive a registration number when submitting the notification of the product. The product is then not marketable.
If the "phase-out date" lies in the future, you will receive a registration number for your product. The date on which the product's marketability ends will be displayed in your user account.
A user's guide is available describing the individual steps in the notification procedure using the online form.
If you have entered a product incorrectly and wish to delete the registration number that was allocated, please send an email to BAuA stating the registration number to be deleted, the trade name, and details of the manufacturer/importer/person placing the product on the market.
The database on which the notification procedure is based contains biocidal active substances that are included in Annex II to Delegated Regulation (EU) No 1062/2014. It takes account of previous decisions made in relation to biocidal active substances that were published in the form of EU regulations.
The list of approved substances and the list of non-approval decisions can be found on the website of the REACH-CLP-Biozid Helpdesk.
Notification pursuant to the Biocide Notification Ordinance is a provision at the national level in Germany.
The registration numbers issued under the notification procedure therefore have no effect on the marketability of biocidal products within the framework of the transitional arrangements in other EU Member States (e.g. France, Belgium, the Netherlands).
Please contact the competent authorities in the corresponding countries for information on their requirements for marketability within the framework of the transitional arrangements.
A list of the competent authorities and national help desks can be found on the website of the European Chemicals Agency (ECHA).