When do I have to notify the quantity of my biocidal products in accordance with the Biocidal Products Implementation Ordinance (ChemBiozidDV)?
The quantity notification is made annually by the end of 31 March for the previous calendar year. The corresponding form in the eBIO-MELD reporting database is activated at the beginning of the year.
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When will the quantity notification be activated?
The quantity notification form in eBIOMELD is usually activated in the first week of the year. The quantity notification must then be submitted by 31 March.
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Is a company obliged to notify under § 16 of the ChemBiozidDV if it purchases its biocidal products from external manufacturers?
A company that obtains its biocidal products from a manufacturer based in Germany is not subject to the notification requirement under Section 16 of the ChemBiozidDV. Section 16 ChemBiozidDV regulates the obligation to notify the annual quantity of biocidal products made available on the market or exported from the market within the scope of this Ordinance. According to Section 16 (1) No. 1 ChemBiozidDV, manufacturers or importers are obliged to report the type and quantity of biocidal products that they have supplied to recipients resident or domiciled in Germany or that they have exported.
If the company purchases the product from an external manufacturer, it is only obliged to notify if it imports the product into Germany itself.
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As a manufacturer of biocidal products, do I also have to include the quantities exported by my customers in my own notification?
Section 16 ChemBiozidDV regulates the obligation to notify the annual quantity of biocidal products made available on the market or exported in Germany. According to § 16 (1) No. 1 ChemBiozidDV, you as a manufacturer are obliged to notify the biocidal products you have made available on the market or exported in Germany.
Accordingly, you must notify the quantity of product you have made available on the market as a manufacturer and your customer must notify the quantity he has exported.
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Do I have to notify zero quantities of biocidal products that have not been made available on the market in the last year?
The obligation to notify the annual quantity does not apply if the product was not made available on the market in the corresponding calendar year. A ‘zero notification’ within the scope of Section 16 ChemBiozidDV is possible, but not required.
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Which number do I have to enter in the quantity notification?
There are different forms for the quantity notification depending on whether the active substances contained in the product have not yet been approved for all of the corresponding product type(s) and the product is therefore still marketable in accordance with the transitional regulations (‘Übergangsregelungen’ form) or whether an application for authorisation has already been submitted or the product has already been authorised (‘Beantragte / zugelassene Produkte’ form). Accordingly, different numbers are requested in the forms.
For biocidal products in the transitional procedure for which an application for authorisation has not yet been submitted, the quantity notification requires the trade name, the registration number (as an example: N-123456) and the product quantity to be entered.
For biocidal products or biocidal product families for which an application for authorisation has already been submitted but no decision has yet been made on this application, the registration number (as an example: N-123456) and the case number (R4BP3 Case Number) (as an example: BC AB1234567) must be entered.
For biocidal products that have already been authorised, please only state the authorisation number in the format DE-1234567-12 or EU-1234567-0000.
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Which number (case number or authorisation number) do I enter in the quantity notification if the product I manufacture was authorised last year?
Please use the authorisation number in the quantity notification for the year in which your biocidal product was authorised.
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How do I report the total quantity of biocidal products exported?
Product quantities that you manufacture for export are stated in the separate ‘Export’ form. If you only manufacture a biocidal product for export, only the trade name and the exported product quantity must be stated in the quantity notification. A separate quantity notification must be submitted for each biocidal product.
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How do I notify the quantity of my biocidal product family?
For a biocidal product family, the quantities of the individual family members must be notified individually. If part of the member's quantity has been exported, two quantity notifications are required for the relevant member of the family (1x ‘Beantragte/ zugelassene Produkte’ and 1x ‘Export’).
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How can I enter an active substance whose approval expired last year and which is no longer included in the eBIOMELD database selection list?
By entering the name of the active substance or the CAS number, the active substance can be found and the quantity notification for the corresponding biocidal product can be carried out.
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What should I do if I have made a mistake in the quantity notification?
If you have made a mistake in the quantity notification, please edit your notification yourself.
If you have selected the wrong form for the quantity notification (export, transitional regulation, applied for/authorised), please send an e-mail to
chembioziddv@baua.bund.de stating the trade name of the product, the ID of the quantity notification and requesting this quantity notification to be deleted. You can then make a new notification for the biocidal product.
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How do I notify the quantities made available on the market for my biocidal product if it is a precursor used for on-site (in-situ) manufacturing when several active substance names are involved?
Please complete a notification with the correct product quantity. Then select the relevant active substance names (e.g. ‘Active bromine generated from sodium bromide and sodium hypochlorite’ and ‘Active bromine generated from sodium bromide by electrolysis’). You will then be asked to enter the concentration for the corresponding precursor (in the above example only for ‘sodium bromide’). It is not necessary to estimate how much of the product is used in which in-situ system. Please enter the same concentration several times for this precursor, as it is queried several times (once for each active substance name) for technical reasons.
Please note: If several notifications or subsequent authorisations for the individual systems are affected, you can still only enter one registration number or authorisation number. We recommend that you enter the registration/authorisation number of the most commonly used system.
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Only applies to quantity notifications for exported biocidal products that contain releaser/precursors for the in-situ generation of active substances: What releaser/precursor concentration must be included in the quantity notifications for self-created active substances?
For active substances generated/ released at the site of use, the releaser/ precursor concentration of the substance containing the ‘active element’ must be indicated (e.g. for active chlorine, the chlorinated precursor). There are also cases in which this allocation is not possible. In any case, the active substance name should be chosen so that the substance for which the concentration is given is listed last (e.g. the concentration of ammonium phosphate should be given for the biocidal active substance ‘monochloramine, generated from sodium hypochlorite and ammonium phosphate’, which is currently not marketable in Europe).
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