New national notification procedure for biocidal products in Germany
On August 25, a new executive regulation on the notification and dispensing of biocidal products was published in the German Federal Law Gazette (Bundesgesetzblatt). This regulation replaces the old Biocide Notification Regulation of 2005 and poses new challenges for the distributors of biocidal products in Germany.
The ChemBiozidDV revises the notification procedure for products containing existing active substances that are eligible for the national transitional arrangements. Existing notifications will be transferred to the new system and must be supplemented with the added information as part of the first confirmation of the notification data.
For products notified to the BAuA before August 26, 2021, this confirmation must be made by March 31, 2022. Notifications after the deadline must be updated in the second calendar year following the notification. Thereafter, reports must be confirmed every two years by March 31 of that year.
In addition to the information that already had to be submitted to the BAuA under the old notification procedure, additional information must be submitted for all new notifications:
- Indication of the active substance concentration in the biocidal product,
- information on the application according to § 28 ChemG (national product authorization),
- information on Article 95 of the Biocidal Products Ordinance,
- confirmation of the attributed efficacy of the biocidal product.
If the notifications are not updated or confirmed in due time, the product may not be placed on the market until the accuracy of the information is confirmed.
In extension, a notification procedure is introduced for the annual quantities of biocidal products made available on the market or exported in Germany. This notification must be made annually by March 31 for each biocidal product.
In addition to the expanded notification requirements, the implementing regulation also newly regulates the dispensing of biocidal products in various product types. To this end, self-service bans are established and requirements for dispensing persons (dispensing discussions, expertise, etc.) are defined. However, these regulations will not come into force until January 1, 2025.
From our point of view, both the information on Art. 95 CPD and the confirmation of the advertised efficacy of the product appear to be problematic in one or the other case. In both cases, the corresponding documents do not have to be submitted together with the notification. In the context of monitoring, however, it must be possible to submit them upon request of the authority.
Especially in the case of longer or more complicated supply chains, we see difficulties in obtaining a corresponding certificate from the Art. 95 listed supplier.
In respect of the efficacy certificates, there may be bottlenecks in the capacities of the laboratories, as for many products the corresponding certificates have not been issued. Furthermore, there may be problems in some product types, as there are still no/few standards for efficacy verification that have been coordinated at the European level.
Again, it is important to note that the test evidence does not have to be provided as part of the notification, but the reports must be made available upon request by the monitoring authority.
If either of these items of information are not available, they should be sought immediately as failure to provide/availability of this information is an administrative offense under the Chemicals Act and will additionally result in suspension of the marketability of the product.
If you have any further questions on the subject or would like our professional assistance, please do not hesitate to contact us.