Inhaltsverzeichnis

1. Allgemeines

​1.1. An wen kann man sich wenden, um den Biozidstatus eines Produkts zu bestimmen?

​1.2. Wie bestimme ich, ob mein Produkt tatsächlich ein Biozidprodukt (Borderline-Produkt) ist?

​1.3. Können Sie mir sagen, ob ein Produkt auf dem belgischen Markt zugelassen ist?

1.4. Wie kann ich melden, dass ein illegales Biozidprodukt auf dem Markt verkauft wird?

1.5. Die Verwendung eines Biozids ist auf dem Etikett oder auf der Zulassungsurkunde, Bekanntmachung oder Registrierung des Produkts nicht vorgesehen. Darf ich das Produkt dennoch auf diese Weise verwenden? Wenn nicht, was kann ich unternehmen, um die Zulassung für die betreffende Verwendung zu beantragen?

​1.6. Welche Regelung/welches Verfahren muss ich befolgen, wenn ich Natriumhypochlorit (Bleichmittel) zum Desinfizieren von Flächen, Schwimmbadwasser oder zur Kontrolle des Algenwuchses in Belgien vermarkten möchte?

1.7. Können wir als Umpacker ein bereits zugelassenes Biozid lose bei unserem Lieferanten kaufen und es anschließend in Behälter abfüllen, auf denen wir unser eigenes Etikett anbringen, unter Angabe des Namens des Produkts und der Zulassungsnummer unseres Lieferanten, oder müssen wir ebenfalls eine Zulassung für die Vermarktung beantragen?

1.8. Sind ätherische Öle (zum Beispiel Zitrone, Kiefer, Lavendel) in Belgien für den Verkauf als Biozidprodukte zugelassen?

1.9. Welche Biozidprodukte sind für die Verwendung in Einrichtungen für die Kinderbetreuung (Krippen, Kindergärten usw.)/in Gemeinschaftsküchen oder Pflegeeinrichtungen zugelassen?

1.10. Dürfen Rodentizide präventiv und/oder innerhalb von Überwachungssystemen eingesetzt werden?

1.11. Ist es möglich eine befallsunabhängige Dauerbeköderung durchzufürhen?

1.12. Fällt die ultraviolette Strahlung in den Anwendungsbereich der Europäischen Verordnung 528/2012 über die Verfügbarkeit und Verwendung von Biozid-Produkten (BPR)?

1.1. An wen kann man sich wenden, um den Biozidstatus eines Produkts zu bestimmen?

Wenn Sie nicht ermitteln können, ob ihr Produkt tatsächlich ein Biozidprodukt ist, können Sie Ihre konkrete Frage an unseren Helpdesk richten und uns folgende Angaben übermitteln: das Etikett, die Gesamtzusammensetzung mit Angabe des Wirkstoffs/der Wirkstoffe, das Sicherheitsdatenblatt sowie eine Beschreibung des Produkts und seiner Wirkungsweise.

1.2. Wie bestimme ich, ob mein Produkt tatsächlich ein Biozidprodukt (Borderline-Produkt) ist?

Bestimmte Produkte (sogenannte „Borderline-Produkte“) befinden sich an der Grenze zwischen einem Biozid, einem Medikament, einem tiermedizinischen Medikament, einem phytopharmazeutischen Produkt (ppp) oder einem kosmetischen Produkt usw.

Die belgische Behörde legt bei der Bestimmung des Status Ihres Produkts die europäischen und nationalen Richtlinien zu Grunde:

  • Biozidrichtlinie/Pflanzenschutzmittel
  • Biozidrichtlinie/Kosmetika
  • Biozidrichtlinie/Humanarzneimittel
  • Biozidrichtlinie/Tierarzneimittel

Wenn bei Grenzfällen zwischen Biozidprodukten und Reinigungsmitteln oder medizinischen Präparaten keine spezifische Richtlinie existiert, wird über den Status eines Produkts nach Beratung zwischen den zuständigen Diensten entschieden.

1.3. Können Sie mir sagen, ob ein Produkt auf dem belgischen Markt zugelassen ist?

Wenn das Biozidprodukt nicht in der Liste der derzeit zugelassenen Biozidprodukte enthalten ist, ist der Verkauf des Produkts auf dem Markt illegal.

Ist das Biozidprodukt in der Liste der derzeit zugelassenen Biozidprodukte enthalten, darf es in Belgien auf den Markt gebracht werden.

1.4. Wie kann ich melden, dass ein illegales Biozidprodukt auf dem Markt verkauft wird?

Um ein illegal verkauftes Biozidprodukt zu melden, kontaktieren Sie uns einfach über unseren Helpdesk mit den folgenden Informationen:

  • Vollständige Handelsbezeichnung des Produkts
  • Name des Herstellers und/oder des Vertreibers des Produkts
  • Name und Adresse des Orts, wo Sie das Produkt gefunden haben
  • Eventuell können Sie ein technisches Datenblatt beifügen, aus dem deutlich hervorgeht, welcher Wirkstoff in dem Produkt enthalten ist und wer der Vertreiber ist.

Anhand dieser Informationen überprüfen wir, ob es sich um ein Biozidprodukt handelt. Wenn das der Fall ist, werden die erforderlichen Maßnahmen getroffen, damit die für die Markteinführung des Produkts in Belgien verantwortlichen Personen die Biozidgesetzgebung einhalten.

1.5. Die Verwendung eines Biozids ist auf dem Etikett oder auf der Zulassungsurkunde, Bekanntmachung oder Registrierung des Produkts nicht vorgesehen. Darf ich das Produkt dennoch auf diese Weise verwenden? Wenn nicht, was kann ich unternehmen, um die Zulassung für die betreffende Verwendung zu beantragen?

Die Verwendung eines Biozidprodukts ist strikt auf denjenigen beschränkt, der in der Zulassungsurkunde, Bekanntmachung oder Registrierung genannt und auf dem Etikett/der Verpackung des Biozidprodukts angegeben ist. Jede andere Verwendung ist illegal und kann die menschliche Gesundheit oder die Umwelt schädigen.

Nur der Inhaber der Zulassung, der Bekanntmachung oder der Registrierung des Biozidprodukts kann einen Antrag für eine neue Verwendung seines bereits zugelassenen Biozidprodukts stellen.  Sie können Kontakt mit dem Zulassungsinhaber (über die Liste der zugelassenen Biozide verfügbar) aufnehmen, damit er auf Wunsch bei uns einen Antrag auf Erweiterung der Benutzung seines Biozidprodukts stellt.

1.6. Welche Regelung/welches Verfahren muss ich befolgen, wenn ich Natriumhypochlorit (Bleichmittel) zum Desinfizieren von Flächen, Schwimmbadwasser oder zur Kontrolle des Algenwuchses in Belgien vermarkten möchte?

Natriumhypochlorit, das für Desinfektionszwecke (oder jede andere Biozidanwendung) verkauft und/oder verwendet wird, muss vom Föderalminister als Biozidprodukt zugelassen, bekannt gemacht oder registriert worden sein, um auf den belgischen Markt gelangen zu können. Die geltende Regelung ist der Königliche Erlass vom 4. April 2019 und die Biozidverordnung 528/2012.

Das Verfahren für die Registrierung eines Produkts finden Sie auf unserer Website unter „Gewerbliche Nutzer > Nationales Verfahren“.

Das Verfahren für die Zulassung eines Produkts auf europäischer Ebene ist auf der ECHA-Website beschrieben.

1.7. Können wir als Umpacker ein bereits zugelassenes Biozid lose bei unserem Lieferanten kaufen und es anschließend in Behälter abfüllen, auf denen wir unser eigenes Etikett anbringen, unter Angabe des Namens des Produkts und der Zulassungsnummer unseres Lieferanten, oder müssen wir ebenfalls eine Zulassung für die Vermarktung beantragen?

In diesem Fall haben Sie zwei Möglichkeiten:

  • Wenn Sie den Namen des Produkts und die Zulassungsnummer Ihres Lieferanten verwenden möchten, müssen Sie dies mit ihm abstimmen. Ihr Lieferant muss einen Antrag für die Hinzufügung neuer Verpackungstypen hinzuzufügen. In diesem Fall übernimmt der Lieferant die vollständige Verantwortung für das Produkt. Sie können Ihren Namen als Vertreiber des Produkts auf dem Etikett angeben. Bitte beachten Sie, dass jedes neu verpackte Produkt unter den Bedingungen verkauft und verwendet werden muss, die in der Zulassungsurkunde/Bekanntmachung/Registrierung des Originalprodukts festgelegt sind.
  • Sie stellen einen Antrag auf Registrierung für ein identisches Produkt. Auch in diesem Fall müssen Sie sich mit Ihrem Lieferanten, dem Zulassungsinhaber für das Hauptprodukt, abstimmen. Sie müssen den Namen des Produkts ändern und es wird eine neue Zulassungsnummer zugewiesen. Für dieses neue Produkt wird eine Registrierung erstellt, in der Sie als Inhaber genannt werden. Sie sind selbst für das Produkt verantwortlich. Sie bestimmen selbst die Abmessungen der Verpackung, die in der Registrierung angegeben werden. Auf dem Etikett des Produkts werden Sie als Registrierungsinhaber und nicht als Vertreiber angegeben.

1.8. Sind ätherische Öle (zum Beispiel Zitrone, Kiefer, Lavendel) in Belgien für den Verkauf als Biozidprodukte zugelassen?

Jedes Biozidprodukt muss beim Föderalminister nach den in der Biozidgesetzgebung definierten Regeln zugelassen, bekanntgemacht oder registriert werden, um in Belgien vermarktet werden zu können. Das gilt auch für ätherische Öle.

Die Definition eines Biozidprodukts wird durch die europäische Verordnung 528/2012 geregelt und ist auf unserer  Website beschrieben.

Wenn ätherische Öle auf dem belgischen Markt als Biozid verkauft werden, müssen sie von unserer Behörde zugelassen worden sein und erscheinen daher in der Liste der zugelassenen Biozide.

Wenn ätherische Öle auf dem Markt als Biozid angeboten werden, jedoch nicht in der Liste der zugelassenen Biozide erscheinen, dürfen sie in Belgien nicht auf den Markt gebracht werden.

1.9. Welche Biozidprodukte sind für die Verwendung in Einrichtungen für die Kinderbetreuung (Krippen, Kindergärten usw.)/in Gemeinschaftsküchen oder Pflegeeinrichtungen zugelassen?

Die Liste der zugelassenen Biozide finden Sie hier.

Um Produkte zu finden, die Sie im Bereich der Desinfektion in Einrichtungen für die Kinderbetreuung einsetzen können, müssen Sie Produkte des Typs 2 oder 4, abhängig von der Art der Verwendung, auswählen. Alle Erläuterungen über diese Typen von Biozidprodukten sind ebenfalls auf unserer Website auf der Seite „Biozide - Allgemeines“ zu finden.
Zur Vervollständigung Ihrer Informationen beachten Sie bitte, dass das ONE 2011 einen Leitfaden mit dem Titel „Die Gesundheit in Betreuungseinrichtungen für Kleinkinder“ veröffentlicht hat. Dieser Leitfaden enthält sinnvolle Hygienepraktiken, insbesondere zur Pflege von Räumen und zur Verwendung von Desinfektionsmitteln in Kinderbetreuungseinrichtungen.

1.10. Dürfen Rodentizide präventiv und/oder innerhalb von Überwachungssystemen eingesetzt werden? 

Rodentizide, die nach der EU-Verordnung Nr. 528/2012 über Biozidprodukte zugelassen sind, dürfen nicht präventiv oder innerhalb von Überwachungssystemen eingesetzt werden, ob von nichtberufsmäßigen oder berufsmäßigen Verwendern.

Nichtchemische Methoden wie das Aufstellen von Fallen sind stets zu bevorzugen. Es sind außerdem die einzigen zugelassenen Präventions- und Überwachungsmethoden. Rodentizide sind nur zur Bekämpfung bereits anwesender Nagetiere zugelassen. Bei nachgewiesenem Befall können also Rodentizide vorübergehend eingesetzt werden.

Unter Einsatz zu präventiven Zwecken ist Folgendes zu verstehen: Einsatz von Rodentiziden an Orten, wo es voraussichtlich oder vermutlich Nagetiere vorkommen.

Unter Überwachung ist das Feststellen von Nagetieren zu verstehen. Dies umfasst:  

  • die Beobachtung zu Ortungszwecken: wird innerhalb eines Bereichs vorgenommen, um bestimmen zu können, ob da Schädlinge anwesend sind (oder nicht);
  • die Beobachtung zu Abgrenzungszwecken: zielt darauf ab, die Grenzen des Bereichs festzulegen, der als von Schädlingen befallen bzw. frei von Schädlingen gilt; 
  • ​die Beobachtung zu Überwachungszwecken: kontinuierliche Beobachtung zwecks Ermittlung der Eigenschaften einer Schädlingspopulation.

 1.11. Ist es möglich, eine befallsunabhängige Dauerbeköderung durchzuführen?

In einigen Fällen ist es möglich, eine befallsunabhängige Dauerbeköderung mit Rodentiziden durchzuführen.  Es handelt sich dabei weder um eine präventive Bekämpfungsmaßnahme noch um eine Methode zur Überwachung von Nagetierpopulationen, sondern um eine Methode zur Behandlung problematischer Stätten. Eine befallsunabhängige Dauerbeköderung darf nur mit für diese Verwendung zugelassenen Produkten (siehe SPC), und nur unter folgenden Bedingungen verwendet werden:

  • von berufsmäßigen Verwendern, mit nachgewiesenen fortgeschrittenen Fähigkeiten ("geschultes Fachpersonal");
  • an Orten mit einer hohen Gefahr eines Wiederbefalls;
  • wenn sich andere Methoden zur Schadnagerkontrolle (nichtchemische Methoden und vorübergehender Einsatz von Rodentiziden) als unzureichend erwiesen haben;
  • Eine befallsunabhängige Dauerbeköderung als Strategie ist regelmäßig im Rahmen der integrierten Schädlingsbekämpfung und der Beurteilung der Gefahr eines Wiederbefalls zu überprüfen.

Zudem ist mit den folgenden Wirkstoffen ist keine Dauerbeköderung erlaubt: Brodifacoum, Chlorphacinon, Coumatetralyl, Difethialon, Flocoumafen, Warfarin.

 1.11. Fällt die ultraviolette Strahlung in den Anwendungsbereich der Europäischen Verordnung 528/2012 über die Verfügbarkeit und Verwendung von Biozid-Produkten (BPR)?

Die UV-Desinfektion an sich fällt nicht in den Geltungsbereich der BPR, da sie eine „physikalische“ Maßnahme ist.

Wenn es sich bei dem verwendeten System jedoch tatsächlich um ein System handelt, das unter der Einwirkung von UV-Strahlung aus einer Beschichtung freie Radikale erzeugt, dann liegt das System durchaus im Rahmen der BPR.

Das ist das typische Beispiel aus „case type 3“, indent 1, wie im CA -May-19-4.6a , Punkt 3.1 (8).a. definiert. Im letzteren Fall ist während der Übergangszeit ein Antrag auf Registrierung erforderlich. Sobald der Wirkstoff auf EU-Ebene zugelassen ist, muss ein gültiger europäischer Antrag gestellt werden.

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Return to 1. General


2. National procedures for the provision of products on the market

2.1. Does the entry into force of the Royal Decree of 4 April 2019 on registration procedures have an impact on authorisations and notifications already granted?

No, authorisations and notifications granted in application of the Royal Decree of 8 May 2014 remain valid until the date mentioned in the authorisation or notification report.

However, any application for the change, renewal or extension of an authorisation or notification will have the effect of replacing the authorisation or notification by a registration. Registration is granted with a new registration number for the product. To eliminate products bearing the existing authorisation or notification number, a six-month deferment is granted so that the existing stocks can be placed on the market. A second six-month period is granted for the elimination and/or use of the existing stocks.


2.2. New registration applications


  • 2.2.1. How can an electronic application be submitted? How can I install the "ApplicationFormGenerator" on my computer?

In order to create the electronic dossier, you need to install the ApplicationFormGenerator IT app on your computer. Go to the page "Professionals > National procedure" to consult the installation instructions for your operating system: Windows 2000 version and Windows 7 version.

Once the installation is completed, the electronic dossier has to be compiled. Please bear the following in mind:

  • consult the manual in order to fill in the electronic dossier correctly;
  • ensure that the required email addresses are correct, as they will be used throughout the dossier evaluation process.

A complete electronic dossier encompasses three files:

  • the xml_temp file (electronic file containing the added data),
  • the xml_product name file (the electronic dossier is complete after 'file, complete') and
  • the CTD Folder (documents added to the electronic dossier).
  • 2.2.2. May I use an existing authorisation in another European Member State to register my product in Belgium?

Only an authorisation granted by a Member State carrying out a comparable evaluation as Belgium can be taken into account, as it is the case in the Netherlands for a range of product types. Administrative notifications granted in France or in Germany cannot be taken into account.

The dossier manager examines case by case if the existing authorisation granted abroad can be taken into account and if a limited evaluation can be performed. If so, the deadline for processing your application can be shortened.

The procedure to be followed is consistent with the procedure for a new registration application: see page "Professionals > National procedure"

Select type C15m1 in the ApplicationFormGenerator (existing authorisation abroad).

The required fee is identical to the ordinary registration application fee, namely €1,000.

  • 2.2.3. What are the conditions to be able to submit a registration application for a biocidal product which is identical to a product already authorised in Belgium?

A biocidal product can only be authorised as an identical product for the Belgian market if it is deemed to be identical to a reference biocidal product, and if this reference product is already authorised in Belgium.

A biocidal product is only considered identical to a reference product if each of the following conditions is met:

  • both products are made using the same production process by the same company, an associated company or a company working under licence;
  • the specifications and content of the active substances and the type of formulation are identical;
  • the non-active substances are identical; and
  • the packaging size, material and shape are identical or equivalent with regard to the product's possible harmful effects on human or animal health or the environment.
  • 2.2.4. A biocidal product is made in Belgium but is intended for sale in another Member State. It is therefore neither placed on the market nor used in Belgium. In this case, is it necessary to apply for an authorisation for this product?

If the biocidal product is made in Belgium to be immediately exported abroad, and if it is neither placed nor used in the Belgian market, no authorisation, notification or registration application needs to be submitted for this product in Belgium.

(Reference: "Concepts of placing and making available on the market in the context of Regulation (EU) No 528/2012". (CA-Sept15-Doc.7.6-Final). https://circabc.europa.eu/)

  • 2.2.5. Is there a procedure to acquire an authorisation to place a biocidal product on the market for Belgium, the Netherlands and Luxembourg simultaneously, or do separate authorisation applications need to be submitted in each of these countries?

As long as the active substance(s) is/are not approved at the European level, the national procedures for this product are still applicable for each country. The authorisation for placing the product on the market must be applied for separately in each country.

In this specific case, we can however confirm that the procedure for granting authorisations in the Netherlands is similar to the Belgian procedure. As a result, an application submitted in Belgium for a product which already has a Dutch authorisation is sometimes processed more swiftly than a new traditional application.

The application procedure is described on the page "Professionals > National procedure".

  • 2.2.6. Do the analyses of the concentrations of active substances and stability for a biocidal product need to be carried out according to the standards of Good Laboratory Practice (GLP)?

If a product requires an in-depth evaluation, the analyses of the concentrations of active and stability substances must be submitted.

The analysis of concentrations of active substances needs to be carried out in an independent laboratory which is external from the company applying for the registration. In this case, there are no GLP requirements. If the analysis is carried out by a laboratory which is internal to the company applying for the registration, this analysis must be carried out according to GLP standards in order to be accepted, and the laboratory in question must be officially recognised as applying GLP.

Regarding stability, the test required at the Belgian level may be carried out at a laboratory which is internal or external to the company applying for the registration. There are no GLP requirements to demonstrate the stability of a product according to the Belgian national procedure.

  • 2.2.7. What are the criteria for transferring effectiveness tests to formulations whose compositions are almost equivalent?

In principle, all the tests must always be carried out on the end product (= on the final commercial formulation) for which the registration application was submitted.


2.3. Applications for changes, extension or renewal of authorisation/notification/registration


  • 2.3.1. Our firm’s registered office address has changed, how do we have to register this change for all of our records?

If this concerns only an address change of your registered office WITHOUT other changes (e.g. name change of your firm) you just have to notify your address change by email to info.gestautor@environment.belgium.be. A transfer application (C6) is not needed. Your address will be changed in our database and the change will be applied to all your dossiers and records.

  • 2.3.2. Which procedure should we follow if we want to place a new packaging size on the market for an identical biocidal product which is already authorised?

It does not matter if the packaging of an identical product is different from that of the mother product, but the packaging must always comply with what is described in the authorisation report or registration.

Send a Packaging Modification application (C18) to add a new packaging to the authorisation report or registration for the identical product and/or mother product. To submit an application, consult the page "Professionals > National procedure".

  • 2.3.3. Which procedure should we follow to request the transfer or modification of the name of the holder of the authorisation for a biocidal product which is already authorised?

You must submit an electronic dossier (via ApplicationFormGenerator) by selecting the dossier "Transfer/modification of the name of the holder of an existing authorisation (C6)". The following documents are required for this type of application:

  • if it only involves a modification of the name of the authorisation holder: a letter clarifying the modification of the name of the authorisation holder
  • if it involves a change of the authorisation holder: a letter transferring the current authorisation holder to the new authorisation holder

If you get a receipt mail for the application, a 150 Euro retribution with a structured reference must be paid. This application is treated administratively without a scientific evaluation. The treatment terms are 14 working days for the administrative check and 30 working days for the assessment of the application.

  • 2.3.4. The product identification number has been modified following a change to an authorisation or notification. Why? What are our obligations regarding product labelling?

Article 43 of the Royal Decree of 4 April 2019 allows for transitional provisions for authorisations and notifications. Any application for change, renewal or extension will have the effect of replacing the authorisations or notifications with registrations. The product will be given a new registration number to replace the old authorisation or notification number.

To eliminate products bearing the existing authorisation or notification number, a six-month deferment is granted so that the existing stocks can be placed on the market. A second six-month period is granted for the elimination and/or use of the existing stocks.


2.4. Transition period for the European level


  • 2.4.1. What are the criteria for obtaining a post-appendix I extension?

A post-appendix I extension is granted for a product if the following conditions are met:

  • the Belgian authorisation, notification or registration must be valid on the approval date of the active substance, and
  • a European application for the product must have been submitted to the R4BP-3 before the approval date of the active substance, and
  • the invoice from the ECHA and the evaluating Member State must have been paid.
  • 2.4.2. If a national authorisation expires after the date on which the decision was taken to approve the active substance, but before the actual date of the authorisation, is it possible to submit a renewal application?

If it has been decided at the European level to approve an active substance for which the actual approval date (indicated in the annex of the authorisation decree) generally occurs two years later, it is still possible to submit authorisation extension or renewal applications up to six months before this effective date. It is therefore still possible to submit an application in the period between the decision regarding the authorisation and its actual date, but any change application must be submitted six months before the approval date.

  • 2.4.3. When must the competent Belgian authority be informed of the intention of submitting a first authorisation application?

If you choose Belgium as evaluating Member State for your biocidal product, you must contact the Biocides service at least one year before the authorisation of the (last) active substance for the last PT (product type).

You must then wait for confirmation of official acceptance before submitting the application to R4BP-3. This official confirmation may be attached to the application in R4BP-3. Six months before the dossier is submitted, it is also advisable to hold a pre-submission meeting with the dossier manager to ensure the dossier is prepared correctly.

  • 2.4.4. Can I submit a change of composition for a Belgian national authorisation once the active substance has been approved at EU level for the type of product in question?

No, it is no longer possible to modify Belgian national authorisations once the European procedure applies.

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Return to 2. National procedure for the provision of products on the market


3. European procedures for the provision of products on the market

3.1. General


3.2. New applications for the provision of products on the market


  • 3.2.1. How to submit an application for a biocidal product for which the active substance and the PT (product type) have already been evaluated at the European level? Should Gestautor still be used for this kind of application?

As soon as an active substance has been evaluated and approved for certain PTs, it is added to the list of approved active substances. From the moment that it is included on this list, the European procedure needs to be followed (set out in the Biocide Regulation 528/2012) to submit an authorisation application pertaining to a biocidal product which contains this substance and which falls within an approved PT. This implies that you should only use the R4BP-3 application on the ECHA website (European database for the management of authorisation applications for biocidal products) to submit this application.

  • 3.2.2. Where can I find guidance on submitting an application in R4BP-3 and which form should I use?

For any questions about R4BP, please refer to the ECHA manuals for R4BP, which you can find on the following page: ECHA.

  • 3.2.3. Can an MRS (mutual recognition in sequence) application in Belgium include several trade names?

Yes, provided that the authorisation holder is the same for each name.


3.3. Applications for changes, extension or renewal


  • 3.3.1. In accordance with Regulation No 354/2013 on changes to biocidal products, is it possible to combine several administrative changes (e.g. addition of a new manufacturer AND change of an existing manufacturer's production site address) in a single application and thus only pay €150 once?

Several administrative changes can be grouped together in a single application and sent to the Member State affected by these changes. However, it is important for these changes to be clearly specified in the application and for the information required to be provided as indicated in the regulation on modifications to authorised biocidal products.

For administrative changes, however, please refer to the appendix to this regulation, whose heading 1 contains the list of possible administrative changes. These changes are divided into two sections. One (Section 1) lists the administrative modifications that must be notified BEFORE they are implemented and the second (Section 2) lists the administrative modifications that may be notified AFTER implementation.
If you want to group several administrative changes together in a single application, it is advisable to group them per section.

  • 3.3.2. Do I have to submit a change application at European level when the supplier of a non-active substance changes?

No, you do not have to submit an administrative change application (NA-ADC) in R4BP-3 to change the supplier of one of the non-active substances.

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Return to 3. European procedures for the provision of products on the market


4. European procedures for the approval of active substances

4.1. Are there specific conditions or restrictions (for example, concentrations) applicable to the substances (listed in (EG) Regulation 1062/2014, Annex II, part 1) used as non-active co-formulants (for example, ethanol or isopropanol as solvents, lactic acid as a pH stabilizer) in the biocides formulations? More specifically, if such a substance was refused for a certain PT as an active substance, can that substance nevertheless be used with another function in the formulation of a biocidal product used for the concerned PT?

4.2. In the context of Regulation 528/2012 on biocidal products and Delegated Regulation 1062/2014 on the work programme, I would like to know if, when a notification is made for an active substance under the work programme, it is also possible to submit an authorisation application for this same active substance in the context of Article 7 of Regulation 528/2012. In other words, can these procedures take place in parallel for the same active substance?

4.3. In the context of Regulation 528/2012 on biocidal products and Delegated Regulation 1062/2014 on the work programme, I would like to know if an authorisation application under Article 7 of Regulation 528/2012 can be transferred to a different party, to allow this party to continue the procedure if the initial applicant decides to abandon the application. In the context of the work programme, there is a regulation that allows a procedure to be continued.

4.4. Are any active substances or groups of active substances classified as "problematic" that will probably not be approved and thus be banned in the future for use in biocidal products?

4.5. Wirkstoff ist auf europäischer Ebene neu definiert worden. Welches Verfahren sollten wir als Inhaber befolgen?

4.1. Are there specific conditions or restrictions (for example, concentrations) applicable to the substances (listed in (EG) Regulation 1062/2014, Annex II, part 1) used as non-active co-formulants (for example, ethanol or isopropanol as solvents, lactic acid as a pH stabilizer) in the biocides formulations? More specifically, if such a substance was refused for a certain PT as an active substance, can that substance nevertheless be used with another function in the formulation of a biocidal product used for the concerned PT?

Such questions are treated case by case.

The answer depends on the purpose for which the substance is added in the formulation of the biocidal product, on the concentration and the function of the substance in the formulation. If that substance is present in such a concentration that it contributes to the biocidal effect of the product, the substance has to be considered as being an active substance. For one specific substance there are no threshold concentrations that are authorised for all biocidal products, as that depends on the substance considered.

According to the Belgian procedure, during the transition period, the applicant has to indicate the function of all substances used in the formulation of his biocidal product in Gestautor. If the substance is considered to be a non-active substance, a security card is needed.

As far as the European records are concerned, if they pertain a substance of concern as described in Art. 3, 1 (f) of the (EU) Regulation No 528/2012, a more detailed record may be necessary and a risk assessment will have to be performed.

4.2. In the context of Regulation 528/2012 on biocidal products and Delegated Regulation 1062/2014 on the work programme, I would like to know if, when a notification is made for an active substance under the work programme, it is also possible to submit an authorisation application for this same active substance in the context of Article 7 of Regulation 528/2012. In other words, can these procedures take place in parallel for the same active substance?

Both the procedures mentioned have a different scope of application.

Notification with the subsequent submission of a dossier in accordance with Regulation 1062/2014 is for existing substances (= a substance that was already on the market as an active substance of a biocidal product on 14/5/2000). If the ECHA accepts the notification the substance is included in the work programme. In this event, the substance can remain on the market pending a decision on its approval.

The submission of a dossier for approval under Article 7 of the RBP is for new substances. These substances can only be placed on the market after approval.

Notification is the first step in the procedure if a substance comes under one of the conditions of Article 15 of Regulation 1062/2014 and is therefore considered for inclusion in the work programme. The applicant has two years to submit a complete dossier from the date the substance is accepted by the ECHA and included in the work programme. The requirements for the dossier are identical to those in the Article 7 procedure, i.e. those set out in Article 6 of the RBP. The procedure is described in Article 3-9 of Regulation 1062/2014, but takes place in a very similar way to that described in Article 6-9 of the RBP.

4.3. In the context of Regulation 528/2012 on biocidal products and Delegated Regulation 1062/2014 on the work programme, I would like to know if an authorisation application under Article 7 of Regulation 528/2012 can be transferred to a different party, to allow this party to continue the procedure if the initial applicant decides to abandon the application. In the context of the work programme, there is a regulation that allows a procedure to be continued.

It is true that there is a specific system for substances in the work programme, i.e. Article 10 of Regulation 1062/2014. The RBP says nothing about this for a new substance. Although it seems logical for the same procedure to be applied in this case, this is a question that should be taken up with the evaluating Member State. The question can also be asked via the ECHA helpdesk.

4.4. Are any active substances or groups of active substances classified as "problematic" that will probably not be approved and thus be banned in the future for use in biocidal products?

For substances still included in the revision programme, a separate evaluation will be carried out for each active substance (therefore not per group). If this evaluation results in a negative decision, this substance must be gradually abandoned (following a respite period). However, it is not possible to predict these evaluations. Then, Article 5 of Regulation 528/2012 lists certain criteria for the non-approval of active substances, but the second paragraph of this article states several exceptions. If these substances are approved despite everything, it will be for a shorter period (five years instead of ten). In this case and in the case of other substances of concern, they are considered for substitution with an obligation to perform a comparative evaluation of the product. All this is described in Articles 5, 10 and 23 of the Regulation on biocidal products.

4.5. Ein Wirkstoff ist auf europäischer Ebene neu definiert worden. Welches Verfahren sollten wir als Inhaber befolgen?

Wenn die Bewertung eines Wirkstoffs ergibt, dass er nicht genau der Identität des Stoffes entspricht, die in das Überprüfungsprogramm aufgenommen wurde (Teil 1 von Anhang II der Verordnung über das Überprüfungsprogramm für Wirkstoffe) wird die Identität des Stoffes von der zuständigen Bewertungsbehörde neu definiert. Der Stoff, dessen Identität neu definiert wurde, wird dann anstelle des Wirkstoffs, dessen Identität nicht richtig war, in das Überprüfungsprogramm aufgenommen.

Auf belgischer Ebene müssen alle Urkunden von Biozidprodukten, die den neu definierten Wirkstoff enthalten, geändert werden.

Dazu müssen Sie eine Wirkstoffänderung (Akte C11 im Application Form Generator; gegen Gebühr von 1000 Euro) einsenden, damit die Änderung durchgeführt werden kann. Wird der Wirkstoff nicht verändert, läuft die Registrierung, Zulassung oder Benachrichtigung des Produkts mit dem Datum des Inkrafttretens der Neudefinitionsentscheidung im Amtsblatt der Europäischen Union ab. Gemäß Artikel 89 Absatz 2 der Verordnung (EG) Nr. 528/2012 wird ab diesem Datum eine Nachfrist von 12 Monaten für die Bereitstellung des Biozids auf dem Markt und eine Nachfrist von 18 Monaten für die Verwendung des Biozids gewährt.

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Return to 4. European procedures for the approval of active substances


5. Annual contributions

Will the information on the website of the compulsory declaration of the quantities sold annually be confidential?

The data from the annual sales declarations will be treated confidentially. This data is never published.

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6. Closed circuit

Please consult the website www.circuitbiocide.be.

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7. Labelling and packaging

7.1. My biocidal product is individually packaged and subsequently put in a box for sale. In this context, where must the identification number for placing the product on the market be applied?

The authorisation, notification or registration number has to be mentioned on both packages, i.e. on the single product package as well as on the product box, as it allows the product to be correctly identified.

For small packages (<125 ml), not all information from the authorisation report, notification or registration can be mentioned on the package. On these, the following data must be mentioned:

  • the name of the product;
  • the authorisation, notification or registration number;
  • the name of the active substance and its concentration;
  • the purpose for which the product is meant (e.g. rodenticide);
  • the danger pictograms if applicable;
  • the H- and P-phrases if applicable.

7.2. Is it obligatory to mention first aid instructions on the label if there is no information sheet or additional package?

In such case, the first aid instructions must be mentioned on the product label, as there is no separate information sheet or package on which these can be mentioned.

Since the CLP Regulation entered into force, the safety recommendations (P-phrases) include most of the first aid instructions. If these instructions are included in the safety recommendations, there is no specific need to repeat them elsewhere on the label.

7.3. In which languages does the label of biocidal products on the Belgian market have to be written?

The rules about the language of the label and the safety data sheet of biocidal products are established in the Royal Decree of 7/09/2012, as well as in the Royal Decree of 19/03/2015 (Royal Decree modifying the Royal Decree of 7/09/2012).

The Royal Decree of 7/9/2012 stipulates that the SDS and the label of a biocidal product, and more in particular the information meant in Article 17, Section 1, of Regulation (EC) No 1272/2008, has to be formulated at least in Dutch, French and German.

The Royal Decree of 19/03/2015 allows an exception to this rule for the industrial/professional use of a biocidal product, but only in the context of internal use within the company. In such cases, the information only has to be formulated in the language or languages of the linguistic region where the product is made available on the market.

Concretely, for biocidal products, as German is compulsory in accordance with CLP regulations, we request a German version of all documents (such as the label and SDS) where the CLP labelling must be stated; this applies to all biocidal products needing authorisation, notification or registration.

7.4. As a repackager of a biocidal product that is already authorised, can we purchase a biocidal product in bulk from our supplier and then transfer it to containers on which we place our own label, indicating the name of the product and the authorisation number of our supplier, or do we also need to submit an authorisation?

You have two options:

  • If you wish to use the name of the product and the authorisation number of your supplier, you must agree this with the supplier. If the new packaging does not comply with the product authorisation report, your supplier will have to apply for an extension to its authorisation report with the addition of new types of packaging. In this case, the supplier remains the holder of the authorisation and bears the entire responsibility of the product. You may add your name to the label in the capacity of distributor of the product.
  • If you want to submit an authorisation application for an identical product, you need to agree with your supplier who is the holder of the authorisation of the mother product. You will have to modify the name of the product. We will assign a new authorisation number, and will draw up an authorisation report in which you will be indicated as being the holder of the authorisation. You will be responsible for the product yourself. You will determine the dimensions of the packaging yourself, which will be indicated in the report. You will be indicated on the label as the holder of the authorisation and not as a distributor.

7.5. In accordance with Article 69 of the BBP, the label of a biocidal product must mention the identity of each active substance. For small packages (e.g. an aerosol), is it possible to use an abbreviation (such as IPBC, CMIT/MIT) instead of the full chemical name of the substance (IUPAC name)?

To ensure the text on small packaging is legible, it is acceptable to give abbreviations provided that they are mentioned in the list relating to Article 95 for active substances. Abbreviations such as IPBC and CMIT/MIT are included on this list and can be used on small packages. However, the CAS number for each active substance must be clearly stated on the label, regardless of the size of the packaging.

7.6. Is promotional packaging (such as 500 ml + 20% free, as well as promotional actions) allowed for biocidal products?

Article 36 of the Royal Decree of 4 April 2019 sets out the conditions for the classification, packaging and labelling of authorised biocidal products.

Article 37 of the same Royal Decree prohibits any form of advertising for biocidal products that cannot be placed on the market.
The Royal Decree does not contain any provisions on promotional packaging. However, the packaging must meet the requirements of Article 36.

This means that advertising can only be included for authorised biocidal products, but the labelling cannot mislead about the risks of the biocidal product to human and animal health or the environment, or its efficacy; in no event can it state "low-risk biocidal product", "non-toxic", "harmless", "natural" "environmentally-friendly" "animal-friendly" or similar claims.

7.7. If a product really is of 100% natural origin, may this fact be mentioned on the label?

Articles 69 (2) and 72 (3) of Regulation 528/2012 (RBP) state respectively that labels or advertising for biocidal products cannot be misleading in respect of the risks from the product to human health, animal health or the environment and, in any event, do not mention the indications ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’, ‘natural’, ‘environmentally friendly’, ‘animal friendly’ or similar claims.

The claims "natural" and a fortiori "100% natural" are therefore not authorised in accordance with the legislation. However, mentioning the ingredients, whether or not they are of natural origin, is obviously permitted.

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Return to 7. Labelling and packaging


8. Borderlines

8.1. Do anti-lice products fall under the legislation on biocidal products?

Given that these are products that are applied to human skin, we make a distinction between the following products:

  • products that kill lice are medicines,
  • preventive or repellent products are biocidal products,
  • products that repel or kill lice in the environment are biocidal products.

8.2. When must a bleach-based product be considered a biocidal product?

Bleach-based solutions available to the general public without any claims are not automatically considered biocidal products once they have more than a certain active chlorine content. These products are evaluated on a case-by-case basis. This evaluation considers not only the claim on the label, but also all the marketing information (advertising, website, illustrations on the label, target users, etc.). If it is found that the aim of a product is to act as a disinfectant or combat green deposits or algae - or is used for these purposes, it will be considered a biocidal product. Products intended exclusively to whiten will not be considered biocidal products.

If a manufacturer is keen to position their product as a detergent, they are advised to clearly state on the label that the product cannot be used as a disinfectant or to combat algae/green deposits.

8.3. Can I place an animal food on the market as a repellent without local authorisation?

Yes, the product is excluded from the RBP if it can be established that the product comes under Regulation (EC) No 767/2009 (animal feed), Regulation (EC) No 1831/2003 (additives for use in animal nutrition) or any other legislation mentioned in Art. 2.2 of Regulation (EU) No 528/2020 (biocides regulation - RBP). The product must then meet the criteria of this specific legislation before it can be placed on the market, and in this way any claims as a biocidal product can be authorised up to a certain level, without authorisation as a biocidal product.

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Return to 8. Borderlines


9. Treated articles

Can an article treated with a biocidal product be withdrawn from the market if the active substance in the biocidal product with which the article was treated has not yet been approved? Does this also apply to importers of articles treated with biocidal products?

In accordance with Article 94 of the RBP, a dossier had to be submitted by 1 September 2016 at the latest for the active substance present in the biocidal product with which the article has been treated. If no dossier had been submitted by this time, a product treated with this substance - or with a biocidal product based on this substance if it was treated outside the EU - could still be placed on the market until 1 March 2017. If a dossier was submitted on 1 September 2016, the treated article may remain on the market while the dossier is evaluated and until the active substance is approved. If the application is rejected or the active substance not approved, the treated article may still be placed on the market at the latest six months after the date of the decision. The same rules apply to importers of treated articles.

You can find out whether an active substance is being evaluated or has been approved on the ECHA website: add a link to the list of substances approved by ECHA.

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10. Inspection

Which Belgian legislation includes the sanctions applicable if the 2012 Regulation on biocidal products is violated? More specifically, what sanctions are applicable if a product without an identification number is placed on the market?

The sanctions are listed in Article 17 of the law on product standards.

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Do you have any further questions? Go to www.helpdeskdppc.be.

See also Biocides FAQ (General).

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