From 1 January 2022, a new notification procedure will apply to biocides, which is regulated in the Biocide Law Implementation Ordinance.
Biocidal products with existing active substances that can make use of the transitional arrangements can also be marketed without authorisation. However, for this transitional period, among other things, a notification of the biocidal product to the Federal Institute for Occupational Safety and Health (BAuA) is required in accordance with the Biocide Law Implementation Ordinance - ChemBiozidDV. In addition, the notification of biocidal products made available on the market will be required in the future.
The "Ordinance on the Notification and Dispensing of Biocidal Products and on the Implementation of Regulation (EU) No 528/2012 (Biocide Law Implementation Ordinance) - ChemBiozidDV" was published in the Federal Law Gazette (BGBl. I 2021, No 57) on 25 August 2021 and entered into force on 26 August.
The existing delegated regulations of the Biocide Authorisation Ordinance and the Biocide Notification Ordinance are merged with the newly created regulations on the supply of biocidal products and on the notification of biocidal products made available on the market in this ordinance.
The new notification procedure for biocidal products covered by the transitional arrangements for existing active substances continues to be under the competence of the Federal Chemicals Agency. It replaces the previous notification procedure under the Biocide Notification Ordinance and expands it to include a notification procedure for biocidal products made available on the market. .
The notification for biocidal products that fall under the transitional arrangements for existing active substances is regulated in Section 2 of the Biocidal Products Implementation Ordinance. This section applies from 01 January 2022 (Section 18(1) ChemBiozidDV) and replaces the previous notification procedure for biocidal products of the Biocide Notification Ordinance. The previous regulations have been adapted to the current legal status and further developed.
Existing reports are transferred to the new reporting procedure. They will be supplemented by the newly added information as part of the first confirmation by the notifiers. For biocidal products notified before 26 August 2021, this confirmation must be made for the first time by 31 March 2022, for all biocidal products notified after this date by 31 March of the second calendar year following the notification. Thereafter, a confirmation of the notification must be submitted every two years by 31 March.
Due to the further development of the notification procedure for biocidal products that fall under the transitional arrangements for existing active substances, additional information will become mandatory with the notification in future. This concerns in particular:
In future, notifiers will have to update their notifications if there are changes to the information provided (Section 6(1) ChemBiozidDV).
In addition, it will be necessary to confirm the information provided in the notification every two years (Section 6(2) ChemBiozidDV). If the data are not confirmed, the person required to notify may not make the biocidal product available on the market until he has confirmed the accuracy of the information.
For biocidal products notified before 26 August 2021, confirmation is required for the first time by 31 March 2022 (Section 18 (2) ChemBiozidDV).
The Biocide Law Implementing Regulation will require some changes to the existing electronic form and the database behind it. Work on this is currently underway and the changes will be available at the beginning of next year.
The previous electronic form for notification of biocidal products is no longer available since the start of the changeover phase to the new electronic form www.ebiomeld.de (in German)
The Biocide Law Implementation Ordinance introduces a notification procedure according to which the annual quantity of biocidal products made available on the market or exported in Germany (Section 16 ChemBiozidDV) has to be notified. Manufacturers or importers who make biocidal products available on the market in Germany or export them are obliged to notify. The notification is made electronically to the Federal Chemicals Agency by 31 March each year using an electronic form provided on the website of the Federal Institute for Occupational Safety and Health. The notification obligation serves to create a data basis for the targeted design of measures to reduce risks and for the tailor-made development of monitoring programmes.
The electronic form for notification of biocidal products made available on the market can be found in the eBIOMELD notification portal at www.ebiomeld.de.
When can the notifications according to ChemBiozidDV be updated? Will all biocidal products already notified under the Biocide Notification Ordinance be automatically transferred to the new database?
The notification form is available again. As the database and the online portal of the BAuA ("eBIOMELD") have only been updated, the previous notifications of biocidal products remain valid. You will have until the end of 31.03.2022 to fill in and complete the new mandatory fields for your products already notified before 26.08.2021.
Does the ChemBiozidDV require notifiers to have a registered office within the EU?
Companies with their registered office outside the European Union (EU), the European Economic Area (EEA) or Switzerland cannot submit notifications according to ChemBiozidDV. Corresponding companies require a legal representative within the European Union (EU), the European Economic Area (EEA) or Switzerland.
How is the "confirmation" of the attributed effect listed under section 2, § 4 number 7 ChemBiozidDV carried out under transitional regulations for existing active substances?
As regulated in § 4 ChemBiozidDV, the notification includes, among other things, a confirmation of the effect attributed to the biocidal product. This regulation applies to new notifications from 01.01.2022. For biocidal products notified to the Federal Chemicals Agency before 26.08.2021, the confirmation must be made for the first time by the end of 31.03.2022.
Technically, the confirmation takes place during the notification by "clicking" in a confirmation field. This is a self-disclosure which is not checked as part of the notification. However, upon request, the notifier must be able to provide the enforcement authorities with the relevant information. Wrongfully declaring this effect constitutes an administrative offense.
For biocidal products placed on the market under national transitional arrangements, no proof of efficacy has to be submitted to the Federal Institute for Occupational Safety and Health – in contrast to the authorisation procedure. It is the responsibility of the distributor to provide a safe and effective product on the market. Accordingly, the person placing the product on the market must have proof of efficacy to support the corresponding claims.
General requirements for efficacy evidence can be found in the efficacy guidelines, which are also the basis for the efficacy studies to be submitted in the biocidal product authorisation procedure: Guidance on the Biocidal Products Regulation
You have submitted an application for authorisation according to BPR 528/2012 for a product in due time, which is currently being evaluated: Do the new regulations of the ChemBiozidDV also apply to the notification and updating of products that are currently in the decision-making process?
The ChemBiozidDV will also require the notification and updating of notifications for products that are currently in an ongoing decision-making process in Germany.
In order to comply with these regulations, an existing notification for this biocidal product must be updated, i.e. supplemented with the new notification information or, if there is not yet a notification for this biocidal product, it must be prepared in accordance with the new notification requirements. The notification shall be updated as long as products are still on the market without being authorised.
How is the notification according to ChemBiozidDV of products from third party companies regulated? Your product is distributed via different distributors under other trade names. These trade names have all been submitted with the application for authorisation. In addition, all these products are also registered in the biocide register by the respective companies and have corresponding N-numbers of the BAuA. What do these companies now have to do in order to comply with the above-mentioned regulation?
The distributors must also confirm the notifications available for the biocidal product after they have been updated, and this must be done at the time specified in Section 18(2) ChemBiozidDV. A notification must then also contain the indication of the case number from the authorisation procedure. If an application for authorisation covers several products on the market, it is possible to state the same case number. As a contract manufacturer, please inform your distribution partners of the case number in good time so that these companies can also update the reports in good time.
How can products previously notified under the Biocide Notification Ordinance be updated in accordance with the ChemBiozidDV?
Changes to the notifications can be made in the respective user account. Further information is available in the user guide in chapters 2.3 and 2.4.
How can products be "subsequently notified" in accordance with the ChemBiozidDV that were previously marketable without notification under the transitional arrangements in the ongoing authorisation procedure and for which no notification was required under the Biocide Notification Ordinance?
With the update of the notification form, it is now possible to notify biocidal products whose active substance(s) has/have reached the date of authorisation.
How can a company's details be changed for a biocidal product that has already been notified?
In principle, the details of the company can already be changed in the user account. These data stored in the user account apply to all messages of this user account.
How should the supplier of the active substance be named in the notification according to ChemBiozidDV? Is naming the company sufficient here, or is a letter from the supplier of the active substance required? How is the confirmation of conformity with Article 95 of the Biocidal Products Ordinance carried out?
For the naming of the active substance supplier, a data selection stored in the system is provided on the basis of the Article 95 list maintained at ECHA.
At the time of notification, one of the entries available there must be selected for each active substance-product type combination contained in the notification. A confirmation of the supplier is therefore not necessary. Please have appropriate evidence ready to present to the monitoring authorities upon request.
Which fees are charged for a notification according to ChemBiozidDV?
The notification of biocidal products according to ChemBiozidDV is possible free of charge via the online portal of the BAuA ("eBIOMELD").
To which authority/ies can questions about the ChemBiozidDV be directed?
The responsibility for the implementation of Sections 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 Chemicals Agency of the Federal Institute for Occupational Safety and Health (BAuA). Questions concerning these sections can be addressed to the BAuA: email@example.com.
The responsibility for monitoring the above-mentioned areas as well as the regulations on the supply of biocidal products (Section 3 of the ChemBiozidDV) lies with the Länder authorities responsible for monitoring. Questions on this topic can be addressed to the respective local competent authority ICSMS.
When must reports be updated that are or have been filed between 8/26/2021 and 12/31/2021?
The confirmation for products notified after 26.8.2021 but before 31.12.2021 is not obligatory until 31.03.2023 according to § 6 para. 2 ChemBiozidDV. The transitional period of § 18 para. 2 ChemBiozidDV does not apply to these products, as they were notified after 26.08.2021. However, it is of course already possible before this date - presumably from 26.01.2022 when the new system is running - to supplement the reporting data with the additional data required under the Biocide Law Implementing Regulation. If you yourself report/have reported a biocidal product in this period, we recommend that you make the additions to these reports as early as possible in order to provide your customers with the best possible information and to avoid enquiries from you.
When I make a notification, do I also have to comply with the notification obligations under Article 16?
No, the notification of a biocidal product which is marketable due to transitional arrangements and the notification of quantities placed on the market are independent procedures. Notifiers under Section 4(1) are not necessarily obliged to notify under Section 16. Where appropriate, notification and communication for the same product may be carried out by two different companies. If, for example, a contract manufacturer X manufactures a product for company Y which is placed on the market by company Y under its own name, company X would be obliged to notify and notify and company Y would only be obliged to notify.
Is confirmation of notification also required if the biocidal product is no longer manufactured?
The confirmation is required as long as the products are made available on the market by the notifier, i.e. also during the sale (§ 6 para. 2 sentence 3 ChemBiozidDV). It is therefore recommended to carry out the confirmation also as long as the product is made available on the market by other persons along the supply chain in order to avoid possible irritations.
Can new products for which a marketing authorisation application has been submitted as part of a product family also be notified?
If biocidal products are covered by a current application for authorisation in Germany, i.e. if they are included as part of the family in the application for the biocidal product family submitted in due time, they must be/have been notified under the ChemBiozidDV in order to be allowed to make them available on the market. For biocidal products subsequently notified to the biocidal product family after the date specified in Article 89(3)(2) of the Biocidal Products Ordinance, notification under the Biocidal Products Implementing Regulation is no longer possible, as was previously the case. They are then also not marketable until a possible positive authorisation decision.
Does the precursor have to be reported when it becomes the authorised biocidal product? Or can equipment manufacturers who lease or sell their equipment to customers report the substance generated? And if so, how?
§ Section 3 (1) ChemBiozidDV for products under the transitional arrangements is exclusively linked to "making available on the market". This means that only substances and mixtures made available on the market are relevant for the notification obligations under the ChemBiozidDV. This means that the precursor must be reported if it becomes the authorised biocidal product. Equipment manufacturers who sell or lease equipment to customers cannot carry out this notification.
When you notify biocidal products, the concentration of active substances must be stated in accordance with the ChemBiozidDV. What concentration must be stated for active substances generated in situ?
For biocidal products that are used on site (in situ) for the generation of active substances, the concentration of the generated active substances must be stated. However, the generated active substance concentration varies depending on the application / use of the biocidal product. When notifying a corresponding biocidal product, for technical reasons it is only possible to specify one concentration value and not a concentration range. Therefore, please indicate the minimum concentration of the generated active substance in g/kg that is achieved when the biocidal product is used according to the conditions of the instructions for use.
The message "currently not marketable" ("aktuell nicht verkehrsfähig") is displayed in my notification. What do I have to do?
If the message "currently not marketable" ("aktuell nicht verkehrsfähig"; grey font) is displayed, you must update or confirm the information on your product. According to paragraph 6, section 2 of the ChemBiozidDV, the correctness of the information must be confirmed for notifications every two years by 31 March at the latest. If the information is not confirmed within the period pursuant to sentence 1, the person obliged to notify may not make the biocidal product available on the market until the data has been confirmed.
For assistance in carrying out your required confirmation, please refer to our user guide in chapters 2.3 and 2.4.
I could not confirm the notification for my biocidal product authorised under the Biocidal Products Regulation in the eBIOMELD database. The notification now says "currently not marketable" ("aktuell nicht verkehrsfähig"). What can I do?
The notification procedure according to the Biocide Law Implementation Ordinance is only to be carried out for biocidal products that can be marketed without authorisation within the framework of the national transitional measures. Biocidal products authorised under Regulation (EU) No 528/2012 (Biocidal Products Regulation) therefore do not have to be notified or confirmed. A confirmation of the old notification is therefore not possible.
The marketability of these biocidal products follows from the existing authorisation. The lack of confirmation therefore has no legal consequences.
However, to avoid misunderstandings, we recommend to deactivate the old notification originatingfrom times before the authorisation was granted.
For a registered product according to ChemBiozidDV it says under "Note" ("Hinweis"): "Active substance decision pending" ("Wirkstoffentscheidung ausstehend"). What does this mean?
Ultimately, the marketability of a biocidal product under transitional measures continues 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 indication "active substance decision pending" ("Wirkstoffentscheidung ausstehend") means that for at least one of the active substances in the biocidal product, in the relevant product type(s) for which the product containing that active substance has been notified, no approval decision has yet been taken 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" ("Hinweis") column will be adjusted by the Federal Office for Chemicals.
For a registered product according to ChemBiozidDVan orange or red note text is shown. What does this mean?
If the date displayed under "Note" ("Hinweis") is coloured orange, the date displayed is the approval date of the active substance (last to be approved) in the relevant product type(s) for which the product containing this active substance was notified. If no application for 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. Whether an application for authorisation has been submitted can be seen on the page "Authorised biocidal products" (in the "List of biocidal products that may be made available and used on the market in Germany on the basis of an ongoing decision procedure" (only in the German version of the website as "Liste der Biozidprodukte, die in Deutschland aufgrund eines laufenden Entscheidungsverfahrens auf dem Markt bereitgestellt und verwendet werden dürfen"). If the product is already authorised, this can be viewed in the database linked on the same page.
If the date under "Note" ("Hinweis") is coloured red, a non-approval decision has been taken or an approval has not been renewed for at least one of the active substances in the product (the latter is only relevant if at least one other active ingredient in the product is still in the evaluation process, since products containing only approved active substances must already be authorised and a notification would not be sufficient). Marketing according to the transitional measures after the indicated date is no longer permitted.