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Frequently asked questions

Biocidal products

What is the difference between a biocidal product and a pesticide?

 Difference between a biocidal product and a pesticide

‘Pesticides’ is a collective term for both biocidal products and plant protection products. They are used for deterring, rendering harmless or destroying unwanted organisms via chemical or biological means.

Plant protection products are pesticides for agricultural use. They are products used to protect crops or plants. More information on plant protection products can be found on Phytoweb.

Biocidal products are pesticides that do not relate to crops or plants, but are used for the protection of human health and property. For example: 

  • Antibacterial soap
  • Insecticides against ants or flies
  • Mouse poison pellets
  • Wood preservatives

You will often recognise a biocidal product by its label. For example, the following indications implicitly refer to a biocidal function: 

  • ‘Kills 99.9% of all bacteria’
  • ‘Disinfectant’
  • ‘Germicidal’

A biocidal product may only be made available on the market  if it has been authorised or registered by the Federal Minister for the Environment. 

The use of biocidal products is not free from risks. Therefore, the safety precautions must be strictly followed.

May private individuals also use biocidal products?

All biocidal products must receive official approval in Belgium before they may be made available on the market. Approved biocidal products can be recognised by their authorisation or registration number displayed on the label: XXXXB or BE-20XX-XXXX or XX/IP or NOTIFXXX or BE-REG-XXXXX.

Whether a biocidal product may be used by private individuals, professionals or both can be checked in several places:

Biocidal products that may be used by the general public are mostly free-circuit products. Closed-circuit biocidal products are mainly reserved for professional users.

On this site you will mostly find information intended for professional users. Are you a private individual? If so, please visit our site for private individuals.

What is the impact of Brexit on the biocidal products sector?

You can find all the relevant information in this document from the European Commission.

 

 

Regulations and procedures

In which languages must I draw up the safety data sheet and the label if I want to make biocidal products available on the Belgian market? And for internal use?

For the registration or authorisation procedure of a biocidal product, the safety data sheets and labels must be provided in Dutch, French and German, since the products will made available on the market throughout Belgium.

Once they are made available on the market, the labelling information, as referred to in Article 17(1) of Regulation (EC) No 1272/2008 (CLP or Classification, Labelling and Packaging of substances and mixtures) for substances or mixtures, must be drawn up in the three national languages (Dutch, French and German).

By way of derogation, labels of substances or mixtures used within the company to manufacture another product (= internal use) may be drawn up in the language(s) of the linguistic region in which the products are to be made available on the market. It should be noted that, if these substances or mixtures are made available on the market again by the buyer without any change in the substances or mixtures in question or in the label, this will not be considered internal use.

The safety data sheet of substances and mixtures must be drawn up in, least, in the language(s) of the linguistic region in which the substances or mixtures are to be made available on the market.

More information:

As a private individual, do I have to register in the closed circuit to use a closed-circuit biocidal product in a private swimming pool?

In general, the users of closed-circuit biocidal products must register. However, an exception can be stated in the authorisation certificate of the product (see paragraph 8 in the authorisation certificate). In that case, the certificate mentions that registration is not obligatory for private users of the biocide as far as it is used in their private swimming pool. You can find the certificate of authorisation through the list of authorised biocides.

 

Do I have to register in the closed circuit if I use a biocidal product?

If you use closed-circuit biocidal products, you have to register in the closed circuit. This applies mainly to professional users.

If you only use free-circuit products, the registration obligation does not apply.

To find out whether a biocidal product belongs to the closed circuit, you may refer to the list of authorised biocidal products. For each product, this list indicates whether it belongs to the closed or free circuit.

In some cases, an exemption from the registration obligation is granted for closed-circuit products. In that case, private individuals may also use a closed-circuit biocidal product. This exception is stated in the list of authorised biocidal products.

Which products are considered to be legal/illegal on the Belgian market?

Only a biocidal product that is included in the list of authorised biocidal products may be made available on the Belgian market. In all other cases, it is considered to be illegal on the market.

To report a biocidal product being sold illegally, you may contact our helpdesk. The following information must be mentioned when making a report:

  • Full trade name of the product
  • Name of the manufacturer and/or distributor of the product
  • Name and address of the place where you have found the product

If necessary, you can also send a technical data sheet, so that we know which active substance is incorporated in the product and the name of the distributor.

On the basis of this information, we will check whether it involves a biocidal product. If so, we will take the necessary measures to ensure that those who make the product available on the Belgian market comply with their legal obligations.

The purpose for which I want to use a biocidal product is not mentioned on the label or the Certificate of Authorisation or Certificate of Registration. May I still use the product? If not, how do I request authorisation for this?

The use of a biocidal product is strictly limited to what is stated on the Certificate of Authorisation or Certificate of Registration and on the label/packaging of the biocidal product. Any other use is illegal and may harm our health and the environment.

Only the authorisation or registration holder of the biocidal product may apply for a new use of the already authorised biocidal product. 

You may contact the authorisation holder (who can be found via the list of authorised biocidal products) to submit, if he/she wishes, an application to our services for an extension of the use of his/her biocidal product.

As the repackager of an already authorised biocidal product, may we purchase the product in bulk and fill it into drums/cans bearing our own label, mentioning the product name and authorisation number of our supplier? Or do we also have to submit an application seeking permission to make this available on the market?

There are two options:

  1. If you want to use your supplier’s product name and authorisation or registration number, you must enter into an agreement with your supplier for this. Your supplier may then submit an application to add new types of packaging. In this case, the supplier remains fully responsible for the product. Subsequently, you may have your name added to the label as a distributor of the product.

    Please note that any repackaged product must be sold and used under the conditions set out in the Certificate of Authorisation/Certificate of Registration of the original product.
  1. If you decide to apply for registration of an identical product (click here for the European procedure and here for the national procedure), you must enter into an agreement with your supplier, who is the authorisation holder of the parent product. You must change the name of the product and a new registration number will be assigned to the product. The new product will be registered and you will be indicated as the authorisation holder. In that case, you become responsible for the product. You are free to decide on the packaging sizes to be mentioned in the registration. On the product label, you will be indicated as the authorisation holder, and not as the distributor.

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

No. The authorisations granted and notifications issued according to the Royal Decree of 8 May 2014 will remain valid until the date mentioned on the Certificate of Authorisation or in the notifications.

Any application to change, renew or extend an authorisation or notification will result in the authorisation or notification being replaced by a registration. Upon registration, a new registration number will be assigned to the product.

Thereafter, the products with the existing authorisation or notification number may no longer be made available on the market. A 6-month period of grace will be granted for making existing stocks of these products available on the market. Subsequently, a second 6-month period of grace will be granted for disposing of and/or using up the remaining stocks.

May I use an authorisation that already exists in another European Member State to register my product in Belgium?

Only an authorisation granted by a Member State that performs a similar evaluation as Belgium (as is the case for a number of product types in the Netherlands) will be taken into consideration. Administrative notifications issued in France or Germany are not eligible for this.

The dossier manager makes a case-by-case assessment of the eligibility of the existing authorisation abroad and whether a limited evaluation can be performed. If this is the case, the processing time of your application may be reduced.

The procedure that you must follow is the same as for a new application for registration. For this, you must select type C15m1 (existing authorisation abroad) in the Gestautor application.

The applicable fee can be found in the table of fees.

A biocidal product is produced in Belgium but intended for sale in another Member State. This means that it is not made available on the market or used in Belgium. Does this product require a Belgian registration?

If the biocidal product is produced in Belgium and thereafter immediately exported abroad (and therefore not made available on the market or used in Belgium), no registration is required for this product in Belgium. See Article 3(1)(k) of the Biocidal Products Regulation (definition of use) and the Royal Decree of 4 April 2019.

Is there a procedure for making a biocidal product simultaneously available on the market in Belgium, the Netherlands and Luxembourg or do I have to submit a separate application in each country?

This depends on the status of the active substance(s) in the biocidal product:

  • As long as the active substance(s) of the biocidal product has (have) not yet been approved at the European level, national procedures apply in each country. In this case, the authorisation for making the product available on the market must be applied for separately in each country.

    However, Dutch authorisations are granted on the basis of a very similar procedure as in Belgium. That is why the application in Belgium for a product that already has a Dutch authorisation is sometimes processed more quickly than a regular new application for registration.

 

  • If all the active substances of the biocidal product are approved at the European level, you must follow the European procedure. If there is a European authorisation for your product in one Member State, you may submit an application for mutual recognition to the other Member States. Via the Union authorisation, it is also possible to make a biocidal product available on the market throughout the European Economic Area. In that case, it is no longer necessary to apply for a national authorisation or mutual recognition in each country separately.
 

 

Do the analyses of the concentrations of active substance and of the stability of a biocidal product have to be performed according to the Good Laboratory Practice (GLP) standards?

For a thorough evaluation of a product, analyses of the concentrations of active substances and of the stability of a biocidal product are required.

Analysis of the concentrations of active substances

  • If the analysis of the concentrations of active substances is performed by an independent laboratory outside the company that is applying for the registration, there are no Good Laboratory Practice (GLP) requirements.
  • If the analysis is performed by a laboratory within the company that is applying for the registration, the analysis must be performed according to the GLP standards and the laboratory in question must have an official GLP accreditation.

Analysis of the stability of the product

  • The test required at the Belgian level may be performed by a laboratory within or outside the company that is applying for registration. There are no GLP requirements.

What are the criteria for transferring the efficacy test results to formulations with quasi-equivalent compositions?

In principle, all the tests must always be performed on the final product (= the final commercial formulation) for which the application for registration is submitted.

Why was the authorisation or notification number of a product changed after a change in the authorisation or notification? Does this also have to be indicated on the label?

Article 43 of the Royal Decree of 4 April 2019 provides for transitional provisions for authorisations and notifications. As a result, for each application for a change, renewal or extension, the authorisations and notifications are replaced by registrations. The product is assigned a new registration number to replace its former authorisation or notification number.

From then on, the label must display the new registration number.

Thereafter, the products with the existing authorisation or notification number may no longer be made available on the market. A 6-month period of grace will be granted for making existing stocks of these products available on the market. Subsequently, a second 6-month period of grace will be granted for disposing of and/or using up the remaining stocks.

What are the criteria for obtaining a post-Annex I extension?

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

  • The Belgian authorisation, notification or registration is valid on the date of approval of the active substance
  • A European application has been submitted for the product in R4BP-3 before the date of approval of the active substance
  • The invoices of the European Chemicals Agency (ECHA) and the evaluating Member State have been paid

Do I have to submit an application for a change at the European level if the supplier of a non-active substance changes?

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

Are there any specific conditions or restrictions for substances (listed in Regulation (EC) No 1062/2014, Annex II, Part 1) that are used as non-active co-formulants in biocidal product formulations?

More specifically: if approval has been denied for the use of such a substance as an active substance for a given product type, may that substance be used with a different function in the formulation of a biocidal product used for the product type in question? Examples:

  • Ethanol or isopropanol as solvents
  • Lactic acid as pH stabiliser

Such questions are dealt with on a case-by-case basis.

The answer depends on the purpose for which the substance is added and the concentration and biocidal function of the substance in the formulation of the biocidal product. If the substance is present in a sufficiently high concentration, such that it contributes to the biocidal function of the product, it must be considered an active substance. Whether or not the concentration is considered ‘sufficiently high’ depends on the individual substance; no general limit concentrations are defined.

During the transitional period, according to the Belgian procedure, it is the applicant’s responsibility to declare, in Gestautor, the biocidal function of all the substances used in the formulation of the biocidal product. If the substance is considered an active substance, a safety data sheet is required.

For European dossiers: if it concerns a substance of concern (as described in Article 3(1)(f) of Regulation (EU) No 528/2012), a more detailed dossier may be required and a risk assessment must be performed.

May an application for approval of a new active substance be transferred to another party, as is possible for existing active substances within the Review Programme?

It is true that a specific arrangement is provided for existing substances within the Review Programme (Article 10 of Delegated Regulation (EU) No 1062/2014). However, Regulation (EU) No 528/2012 does not provide for any separate arrangement for new substances. Although it seems logical that the same procedure should also apply here, this is a question best discussed with the evaluating Member State. The question may also be sent to the European Chemicals Agency (ECHA) Helpdesk.

The identity of an active substance has been redefined at the European level. What procedure must I follow as an authorisation holder?

If the evaluation of an active substance shows that its identity does not fully correspond to that of the substance included in the Review Programme (Part 1 of Annex II of the Regulation for the review of active substances), the identity of this substance is then redefined by the evaluating authority. The substance whose identity has been redefined will subsequently be included in the Review Programme, as replacement of the active substance whose identity was incorrect.

As a result, at the Belgian level, all biocidal product certificates containing the redefined active substance must be modified. To do this, you must submit an application for change of an active substance (Dossier C11 in the Gestautor application) and pay the necessary fee.

If the identity of the active substance is not redefined, the registration, authorisation or notification of the product will expire on the date of entry into force of the redefinition decision as published in the Official Journal of the European Union. From that date onwards, a 12-month period of grace is granted for making the biocidal product available on the market and an 18-month period of grace for using up the biocidal product (Article 89(2) of Regulation (EU) No 528/2012).

My biocidal product is individually packaged and then placed in a box for sale. So where should the registration/authorisation number be displayed?

The registration/authorisation number must be displayed on both packaging elements:

  • On the individual packaging AND
  • On the box containing the product

This makes it possible to identify the product properly.

In case of small packages (<125 ml), all the registration/authorisation data may not fit on the packaging. The following details must be displayed on such packages:

  • Trade name of the product

  • Registration/authorisation number

  • Name of the active substance and its concentration

  • Intended use of the product (e.g. rodenticide)

  • Hazards pictograms (if applicable)

  • Hazard (H) and precautionary (P) statements (if applicable)

More information about the label

 

Are promotional bonus packs (e.g. 500 ml + 20% free as well as other promotional packs) for biocidal products allowed?

The Royal Decree of 4 April 2019 does not contain any provisions regarding promo pack offers. However, the packaging must meet the requirements of Article 28 of the Royal Decree. This means that the label:

  • Must not contain misleading information about the hazards of the product with respect to the environment and human and animal health
  • Must not contain misleading information about its efficacy
  • Must not, under any circumstances, contain indications such as ‘non-toxic’, ‘harmless’, ‘natural’, ‘environmentally friendly’, ‘animal friendly’, ‘low-risk biocidal product’ or any such similar indication

Article 29 of the same Royal Decree prohibits any form of advertising of biocidal products that are not authorised to be made available on the market. Therefore, only authorised biocidal products may be advertised.

In case of a 100% natural-origin product, may I mention ‘100% natural’ on the label?

No, that is not allowed.

Article 69(2) and Article 72(3) of the Biocidal Products Regulation (Regulation (EU) No 528/2012) and Article 28 of the Royal Decree of 4 April 2019 stipulate that a label of or an advertisement for biocidal products must not be misleading about the hazards posed by the product to the environment and human and animal health. Indications such as ‘non-toxic’, ‘harmless’, ‘natural’, ‘environmentally friendly’, ‘animal friendly’, ‘low-risk biocidal product’ and other similar indications are strictly prohibited.

Therefore, an indication such as ‘natural’ or ‘100% natural’ is not allowed.

Of course, the listing of ingredients, whether or not of natural origin, is allowed.

Penalties

Which Belgian legislation sets out the penalties for non-compliance with the Biocidal Products Regulation (Regulation (EU) No 528/2012), e.g. for making a product available on the market without an authorisation number?

The penalties are specified in Article 17 of the Belgian Law on Product Standards.

Microbial-based cleaning products (MBCPs)

What are microbial-based cleaning products?

Microbial-based cleaning products are cleaning agents containing microorganisms. These can be cleaning agents to use in and around your home, as well as personal care products to clean your skin or hair (however, in that case they are considered as cosmetics!). The bacteria are for example added because they produce enzymes that can break down dirt or stains.

Are microbial-based cleaning products subject to the Detergent Regulation (Regulation (EC) No 648/2004)?

Detergents should conform to the Detergent Regulation (Regulation (EC) No 648/2004). In this regulation, detergents are defined as followed:

any substance or mixture containing soaps and/or other surfactants intended for washing and cleaning processes. Detergents may be in any form (liquid, powder, paste, bar, cake, moulded piece, shape, etc.) and marketed for or used in household, or institutional or industrial purposes.

Other products to be considered as detergents are:

  • ‘Auxiliary washing mixture’, intended for soaking (pre-washing), rinsing or bleaching clothes, household linen, etc.;
  • ‘Laundry fabric-softener', intended to modify the touch of fabrics in processes which are complementary to washing them;
  • ‘Cleaning mixture’, intended for domestic all-purpose cleaners and/or other cleaning surfaces (e.g.: materials, products, machinery, mechanical appliances, means of transport and associated equipment, instruments, apparatus, etc.);
  • ‘Other cleaning and washing  mixtures’, intended for any other washing and cleaning processes.

The presence of one or more microorganisms (such as bacteria, phages, yeasts, or moulds) does not influence the definition of a substance or a mixture as a detergent.

What is the current regulatory status of cleaning products with living microorganisms as active ingredients?

Microbial-based cleaning products can fall under the scope of different regulations (the Biocidal Products Regulation or the Detergent Regulation). The intended use (claim) and the mode of action determine which scope of regulation such a product falls under.

If a product makes biocidal claims/has biocidal intent and contains an active substance that is acting directly or indirectly by means other than purely physical or mechanical, then the product should be considered as a biocidal product.

If the active substance consists of one or more types of bacteria, enzymes or other biological constituents, the product should still be considered as a biocidal product. This was clarified by a case at the Court of Justice of the European Union (Case-592/18) concerning  the question on the definition of a biocidal product; whether or not it also applies to substances which consist of one or more types of bacteria, enzymes, or other constituents, and that have, due to the specific way in which they act, no direct effect on the harmful target organism itself, but have an influence on the creation or maintenance of the potential habitat of that harmful organism.

Can a microbial-based cleaning product be a biocide as well as a detergent?

Yes, the Biocidal Products Regulation does not exclude the Detergent Regulation.

When placed on the market, detergents shall conform to the conditions, characteristics and limits laid down with any other relevant Community legislation.

If surfactants are also active substances, and are used as disinfectant, they are exempt from the biodegradability provisions of the Detergent Regulation (Annexes II, III, IV and VIII).

This means that a product can be a detergent or a biocidal product or both. For example, a microbial-based cleaning product is a detergent. If it also has a biocidal claim, it is a detergent as well as a biocidal product. The Detergent Regulation then applies together with the Biocidal Products Regulation. If there is no biocidal claim, the product is only to be considered as a detergent. The following tree chart illustrates the possible cases:

chart biocide or detergent

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