If you sell or you are planning to sell or use biocides in Germany, then this information is crucial for your business.
From January 1, 2022 a new notification procedure applies to biocides, which is set out in the German Biocide Law implementing Ordinance - Verordnung über die Meldung und die Abgabe von Biozid-Produkten sowie zur Durchführung der Verordnung (EU) Nr. 528/2012 – also known as ChemBiozidDV.
The new procedure is set out for biocidal products that fall under the transitional regulations for existing active substances.
For instance, if you use ethanol as an active substance in your hand disinfectant product, this will fall under the new procedure as well.
So, what has changed in the procedure itself?
Under the previous law you were required to submit:
- trade name of the biocidal product,
- names, CAS numbers and EC numbers of the biocidal active substances and
- the product type(s) for each contained biocidal active substance.
Under the new law, you will have to submit additional information:
- concentration of active substance(s) in the product
- information on the authorisation procedure in case the active substance(s) has already been approved (application for mutual recognition, application for approval) – stating the case number if the application is submitted via ECHA’s R4BP.
- information on Article 95 of Regulation (EU) No 528/2012 (“BPR”) - A confirmation of the information by the named active substance or product supplier is not necessary with the notification, but it must be possible to prove to the supervisory authorities in a suitable manner.
- confirmation of efficacy of the biocidal product - This is a self-disclosure that is not checked as part of the notification. On request, however, those subject to the duty to report must be able to provide the inspection with relevant information.
As you can see, the procedure requires a lot more of information. Luckily there are still no fees charged for the notification via the BAUA’s online portal.
What will happen to the existing notifications which were submitted under the previous law?
The existing notifications will be transferred to the updated system with new notification procedure.
Update and confirmation of the notification
In future, those subject to the obligation to notify will have to update their notifications if there are changes to the information provided.
In addition, it is necessary to confirm the information provided in the notification every two years.
If the data is not confirmed, the notifier may not make the biocidal product available on the market until they have confirmed the accuracy of the information.
What are the deadlines for updating the existing notifications?
For biocidal products that were notified before August 26, 2021, confirmation is required for the first time by March 31, 2022.
For biocidal products that were notified after August 26, 2021, by March 31 of the second calendar year following the notification.
What else is new?
Annual quantity of biocidal products made available or in Germany or exported from Germany is to be reported. Manufacturers or importers who make biocidal products available on the market in Germany or who export them have the obligation to report.
The notification is made annually until March 31 to the Federal Office for Chemicals (Bundesstelle für Chemikalien) electronically using an electronic form provided on the website of the Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin).
As you can now see, this information is of utmost importance for your biocides’ business in Germany.
In the worst-case scenario, you will not be able to place your product on the market in Germany if you do not act in time.
Yet there is still enough time left to act, our advice is not to wait for the deadline but start gathering the missing information as soon as possible.
If you need a hand with meeting these new demands, we can help you. Just send me an e-mail at email@example.com and we will discuss the challenges you are facing and find a solution.