The notification procedures for biocidal products are regulated in Title 2 and Title 5 of the Biocide Law Implementation Ordinance (Biozidrechts-Durchführungsverordnung, ChemBiozidDV).
Biocidal products containing existing active substances that qualify for national transitional measures can still be marketed in Germany without authorisation under the Biocidal Products Regulation (Regulation (EU) No 528/2012, BPR). For this transitional period it is necessary, among other things, to submit a notification (Meldung) for the biocidal product to the Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin, BAuA) before it is placed on the market in accordance with the German Biocide Law Implementation Ordinance. In addition, as in the case of authorised biocidal products, quantity notifications of the sales volumes for biocidal products made available on the market (Mengenmitteilung) have to be submitted as well.
ChemBiozidDV
The Ordinance on the Notification and Distribution of Biocidal Products and on the Implementation of Regulation (EU) No 528/2012 (Biocide Law Implementation Ordinance) was published in the Federal Law Gazette (Bundesgesetzblatt; I 2021, No 57) on 25 August 2021 and entered into force on 26 August 2021.
The previous secondary legislation, the Biocide Authorisation Ordinance (Biozid-Zulassungsverordnung) and the Biocide Notification Ordinance (Biozid-Meldungsverordnung) were combined and expanded in this ordinance together with newly adopted provisions on the distribution of biocidal products and the quantity notification of sales volumes for biocidal products made available on the market.
Notification procedure for biocidal products under the transitional measures
The notification of biocidal products covered by the transitional measures for existing active substances is governed by Title 2 of the Biocide Law Implementation Ordinance.
The information required for notification before placing on the market and the prerequisites for the issue of a registration number are listed in the ordinance (sections 3 to 5 ChemBiozidDV).
Notifiers must update their notifications if there are changes in their notification data (Section 6 (1) ChemBiozidDV).
In addition, it is necessary to confirm the correctness of the notification data every two years (Section 6 (2) ChemBiozidDV). If the notifier fails to confirm these data, the biocidal product may not be made available on the market until the correctness of the information has been confirmed. The first confirmation must be made by 31 March of the second year following the notification.
The electronic form for the notification of biocidal products can be found on the eBIOMELD notification portal (German).
An overview of the transitional measures for biocidal products can be found on the REACH-CLP Biocides Helpdesk pages (German).
Quantity notification of sales volumes for biocidal products made available on the market
Title 5 of the Biocide Law Implementation Ordinance regulates the notification procedure under which the annual quantity of biocidal products made available on the market or exported from Germany must be notified (Section 16 ChemBiozidDV).
Manufacturers or importers who make biocidal products available on the market in Germany or export them are required to notify the quantities sold. The notification is to be submitted electronically to the Federal Office for Chemicals (Bundesstelle für Chemikalien) by 31 March each year using an electronic form provided on the website of the Federal Institute for Occupational Safety and Health.
Mandatory notification serves to create a data basis for the targeted design of measures to mitigate risks and the tailored development of monitoring programs.
The electronic form for the quantity notification of the volumes of biocidal products made available on the market can be found on the eBIOMELD notification portal (German).
Quantity notification according to §16 ChemBiozidDV for the year 2023
By 31 March 2024, manufacturers and importers of biocidal products that are made available on the market in Germany or manufactured in Germany for export are obliged to report the type and quantity of these biocidal products manufactured or imported in 2023 and the active substances they contain in eBIOMELD.
The quantities of all manufactured or imported biocidal products must be reported, regardless of whether they are still marketable under transitional regulations or have already been authorised.