Contents

1. General

1.1. Wh​o can determine the biocidal status of a product?

1.2. How can I determine if my product is a biocidal product (borderline product)?

1.3. Can you tell me if a product is authorised for the Belgian market?

1.4. How can I report an illegal biocidal product being sold on the market?

1.5. The purpose for which I want to use a biocidal product is not listed on the label, authorisation report, notification report or registration for the product. Am I still authorised to use the product for that purpose? If not, which steps do I need to take to apply for an authorisation for the use in question?

1.6. Which regulations/procedures do I have to follow if I want to place sodium hypochlorite (bleach) on the Belgian market to disinfect surfaces or pool water or to contain algal growth?

1.7. As the repacker 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 put our own label, mentioning the name of the product and the authorisation number of our supplier, or do we also need to submit an application to place it on the market?

1.8. ​Can essential oils (e.g. lemon, pine, lavender) be sold in Belgium as biocidal products?

1.9. Which biocidal products are authorised for use within childcare environments (crèches, nurseries, etc.)/in collective kitchens or care homes?

1.10. Can rodenticides  be used preventively and/or in monitoring systems?

1.11. Is permanent baiting allowed?

1.12. Do ultraviolet rays (UV) fall within the scope of EU Regulation No 528/2012 concerning the making available on the market and use of biocidal products (BPR)?

1.1. Who can determine the biocidal status of a product?

If you cannot determine whether your product is a biocidal product, please send your question to our helpdesk, clearly mentioning the label, the full composition mentioning the active substance(s), the SDS sheet and a description of the product and of its mode of action.

1.2. How can I determine if my product is a biocidal product (borderline product)?

Some products (called “borderline products”) are halfway between a biocidal product and a (veterinary) medicinal product, a plant protection product, a cosmetic product, etc.

The Belgian authorities refer to European and national guidance documents to determine the status of your product:

  • biocides guidance/PPP
  • biocides guidance/cosmetics
  • biocides guidance/human medicines
  • biocides guidance/veterinary medicines

Regarding borderline cases between biocidal products and detergents or medical devices, there is no guidance document available but the status of the product has been determined in consultation with the different departments involved.

1.3. Can you tell me if a product is authorised for the Belgian market?

If the biocidal product is not included in the list of authorised biocidal products, the product is being sold on the market illegally.

If the biocidal product is included in the list of authorised biocidal products, it can be found on the Belgian market.

1.4. How can I report an illegal biocidal product being sold on the market?

To report a biocidal product being sold illegally, please contact us via our helpdesk and provide the following information:

  • the full trade name of the product
  • the name of the producer and/or distributor of the product
  • the exact location where you found the product (name and address)
  • if possible also a technical data sheet in order for us to clearly identify the active substance contained in the product as well as the distributor of the product.

On the basis of that information, we will verify whether this is a biocidal product. If the product is found to be a biocidal product, the necessary measures will be taken in order to ensure that the people responsible for placing this product on the Belgian market will be brought into conformity with the legislation on biocidal products.

1.5. The purpose for which I want to use a biocidal product is not listed on the label, authorisation report, notification report or registration for the product. Am I still authorised to use the product for that purpose? If not, which steps do I need to take to apply for an authorisation for the use in question?

The use of a biocidal product is strictly limited to what is mentioned in the authorisation report, notification report or registration and shown on the label/packaging of the biocidal product. All other uses are illegal and constitute a risk to human health or the environment.

Only the holder of the authorisation, notification or registration of the biocidal product can submit an application for a new use of his/her biocidal product which is already authorised. You can contact the authorisation holder (available via list of authorised biocidal products) in order for him/her to submit, if he/she wish, an extension application with our services concerning the use of his/her biocidal product.

1.6. Which regulations/procedures do I have to follow if I want to place sodium hypochlorite (bleach) on the Belgian market to disinfect surfaces or pool water or to contain algal growth?

Sodium hypochlorite sold and/or used for disinfection (or other biocidal purposes) must be authorised, notified or registered with the federal minister to be allowed on the Belgian market. The regulation in force is the royal decree of 4 April 2019 and Biocide Regulation 528/2012.

The procedure for registering a product can be found on the page "National procedure".

The procedure for authorising a product at European level can be found on the ECHA website.

1.7. As the repacker 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 put our own label, mentioning the name of the product and the authorisation number of our supplier, or do we also need to submit an application to place it on the market?

In this case, 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. Your supplier must send an application to add new types of packaging. In this case, the supplier always bears the entire responsibility of the product. You may add your name to the label in the capacity of distributor of the product. Please note that any repacked product must be sold and used according to the conditions set out in the authorisation report/notification report/registration of the original product.
  • You submit a registration application for an identical product. In this case too, you must agree with your supplier, who is the holder of the mother product. You must modify the name of the product, which will be assigned a new authorisation number. A registration will be created for this new product, and you will be mentioned as the holder. You will be responsible for the product yourself. You will determine the dimensions of the packaging yourself, which will be indicated in the registration. You will be mentioned on the label as the holder of the registration and not as a distributor.

1.8. Can essential oils (e.g. lemon, pine, lavender) be sold in Belgium as biocidal products?

Biocidal products have to be authorised, notified or registered with the federal authorities in accordance with the rules as stipulated in the biocide regulations in order to be placed on the Belgian market. This also applies to essential oils.

The definition of a biocidal product is governed by European Regulation 528/2012 and is outlined on our website.

If essential oils are sold on the Belgian market with a biocidal claim, they have to be authorised by our services and listed as authorised biocidal products.

Essential oils with biocidal claims that are not included in the list of authorised biocidal products, must not be placed on the Belgian market.

1.9. Which biocidal products are authorised for use within childcare environments (crèches, nurseries, etc.)/in collective kitchens or care homes?

The list of authorised biocidal products can be found here.

To find the products which you could use for disinfecting childcare environments, you should select product types 2 or 4 depending on the type of use. All the explanations regarding the types of biocidal products can also be found on our website, on the page" Biocides - Generalities".
To supplement this information, be aware that the Office of Birth and Childhood (ONE) published a report in 2011 entitled "La santé dans les milieux d’accueil de la petite enfance" (Health in childcare environments). This guide includes good hygiene practice, in particular on the upkeep of premises and the use of disinfectants in crèches.

1.10. Is it allowed to use rodenticides preventively and/or in monitoring systems?

Rodenticides approved under EU Regulation 528/2012 should never be used preventively or in monitoring systems whether it be by a private individual or a professional user.

Non-chemical methods such as trapping (mousetraps) should always be favoured for a preventive use or for monitoring. Rodenticides are only allowed when fighting rodents already present. In case of proven infestation, the temporarily use of rodenticides is thus allowed.

By preventive use we mean the use of rodenticides on sites where the presence of rodents is likely or suspected.

By monitoring we mean the detection of rodents. This encompasses:

  • a detection survey: “conducted in an area to determine if pests are present (or absent)”.
  • a delimiting survey: “conducted to establish the boundaries of an area considered to be infested by or free from a pest”.
  • a monitoring survey: “Ongoing survey to verify the characteristics of a pest population”

1.11. Is permanent baiting allowed?

In some cases permanent baiting with rodenticides is allowed. Permanent baiting is neither a preventive control method nor a monitoring system but rather a curative control method restricted to problematical sites. Permanent baiting is exclusively to be performed with products approved for this specific use (cf. SPC) and only under the following conditions:

  • By trained professionals with proven advanced qualifications;
  • On sites with a high potential for reinfestation;
  • When other control methods (non-chemical methods, temporary use of rodenticides) have proved ineffective;
  • Permanent baiting must be periodically reassessed as part of an integrated pest control system while considering the risk of reinfestation.

Moreover, it is not allowed to use the following active substances for permanent baiting: Brodifacoum, Chlorophacinone, Coumatetralyl, Difethialone, Flocoumafen and Warfarin.

 1.12. Do ultraviolet rays (UV) fall within the scope of EU Regulation No 528/2012 concerning the making available on the market and use of biocidal products (BPR)?

UV disinfection, as such, does not fall under the BPR as it is a “physical” action. 

However, if the system used actually generates free radicals by UV radiation through coating, it does fall within the scope of the BPR.

It is a showcase example of “case type 3”, indent 1, as defined in the CA-May-19-4.6a , point 3.1 (8).a. In the latter case, you need to apply for registration during the transition period. When the active substance is approved at EU level, a valid request must be made at EU level.

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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. May I use an existing authorisation in another European Member State to register my product in Belgium?

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

Select type C15m1 in the Gestautor application (existing authorisation abroad).

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

2.2.2. 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.

2.2.3. 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/)

2.2.4. 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 "National procedure".

2.2.5. 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.

2.2.6. 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.

Select type C6 (change of name/address) in the Gestautor application for each of the products to be adapted.
To submit an application, please consult the page « National procedure ».
A fee of 150 € is charged per product.
 

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 "National procedure".

2.3.3. Which procedure should we follow to request the transfer of an authorisation for a biocidal product already authorised from/to another authorisation holder?

You must submit an electronic dossier through the Gestautor application. Select type C61 or C62 (depending on the transfer's direction) A letter transferring the authorisation to the new authorisation holder, signed by mutual agreement, is required.

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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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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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. An active substance has been redefined at EU level. What do I have to do as an authorisation holder?

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. An active substance has been redefined at EU level. What do I have to do as an authorisation holder?

Where the evaluation of an active substance demonstrates that it does not exactly match the identity of the substance as originally included in the Review Programme (Part 1 of Annex II of the biocides Review Regulation), the substance identity will be redefined by the evaluating competent authority.  The newly redefined substance will then be included in the Review Programme, replacing the active substance whose identity was not correct.

In Belgium, all authorisation certificates of biocidal products containing the redefined AS need to be modified.

To do this, you have to apply for a change of active substance (dossier C11 in the Gestautor application, including the payment of a EUR 1,000 fee) in order for the change to be made. If the active substance is not modified, the registration, authorisation or notification of the product shall expire on the date of entry into force of the decision of redefining the AS in the Official Journal of the European Union. Pursuant to Article 89(2) of Regulation 528/2012, a 12-month period of grace will be granted from that date for the making available on the market of the biocidal product, and a 18-month period of grace for the use of the biocide.

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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?

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

7.3. In which languages do the safety data sheets and labels of biocidal products placed on the Belgian market have to be drafted?

7.4. Is it essential that the safety data sheet is written in all three national languages?

7.5. Is it essential that the label is written in all three national languages?

7.6. What does internal use of a product within a company mean? In which language(s) do the labels have to be drafted in this case?

7.7. 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?

7.8. 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)?

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

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

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 do the safety data sheets and labels of biocidal products placed on the Belgian market have to be drafted?

The Royal Decree of 7/09/2012, amended by the Royal Decree of 19/03/2015, defines the use of the languages in which the labels and safety data sheets of substances and mixtures are to be drafted.

During the procedure for the registration, authorisation or notification of a biocidal product, the labels and safety data sheets are to be submitted in Dutch, French and German, given that the placing on the market is valid for the whole territory.

7.4. Is it essential that the safety data sheet is written in all three national languages?

The Royal Decree of 7/09/2012 prescribes that the safety data sheet of a substance or mixture have to be drafted in at least the language(s) of the linguistic region where the substances or mixtures are to be placed on the market.

However, during the procedure for the registration, authorisation or notification procedure of a biocidal product, the safety data sheets must be submitted in Dutch, French and German, given that the placing on the market is valid for the whole territory.

7.5. Is it essential that the label is written in all three national languages?

The Royal Decree of 7/9/2012 prescribes that the label of substances and mixtures, and specifically the information referred to in Article 17, paragraph 1, of Regulation (EC) No 1272/2008, have to be drafted at least in Dutch, French and German.

The special case of internal use within a company is clarified below.

7.6. What does internal use of a product within a company mean? In which language(s) do the labels have to be drafted in this case?

According to the Royal Decree of 19/03/2015, substances or mixtures are considered as being used internally within a company if they are used for the manufacture of another product. Among other things, they are not considered as being used internally within a company when they are placed back on the market by the purchaser without modification of the substances or mixtures in question, or of the label.

The Royal Decree of 19/03/2015 specifies that the information that must appear on the label is to be drafted in at least the language(s) of the linguistic region where the placing on the market is to happen, when the substances or mixtures in question are placed on the market exclusively intended for internal use by one (or more) companies.

In any case, during the procedure for the authorisation, registration or notification of a biocidal product, both the label and safety data sheet will have to be sent to the Biocidal Products Service in all three national languages, given that the placing on the market is valid for the whole territory.

7.7. 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.

7.8. 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.

7.9. 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.

7.10. 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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