National procedure

Registering a new biocidal product

If at least one of the active substances in your biocidal product is not yet approved for all the relevant product types, you must first register the biocidal product before making it available on the Belgian market. In this case, the product will be thoroughly examined and the risks to the environment and the health of users will be evaluated. This may be done via a partial or full evaluation. In case of a full evaluation, the Advisory Committee on Biocidal Products (CAB) will issue a positive or negative opinion. Finally, the application for registration will either be approved or denied.

How do I submit an application?

The application for registration must be submitted electronically through the Gestautor application. Refer to the manual to properly complete and submit the electronic form.

An application for registration must contain the following information:

• Trade name of the biocidal product
• Name of the applicant
• Manufacturer of the biocidal product
• Manufacturer or importer of the active substance(s)
• Distributor
• Product type and intended use
• Various constituents and the quantity of each substance
• Proposed classification and labelling
• Label of the biocidal product
• Safety data sheet of the biocidal product
• Safety data sheet of all ingredients
• Estimated quantity of the biocidal product that will be made
• available on the Belgian market
• Size of the packaging
• Efficacy test(s) of the biocidal product (if the product claims to be effective against specific target organisms or based on a specific standard)

For it to be considered a valid application for registration, the necessary fee must be paid.

Change of registration

To modify the registration data of a biocidal product, you must submit an application for a change of registration through the Gestautor application.

The following changes are processed administratively, without additional evaluation:

• Change of trade name
• Transfer
• Change of the name of the registration holder
• Change of the supplier of the active substance
• Change in the packaging

Other changes require a new scientific evaluation, which may be a partial or full evaluation:

• Change of the composition
• Change of the best-before date
• Change in use
• Change in CLP labelling (Classification, Labelling and Packaging of substances and mixtures)
• Extension or renewal of existing registration

For it to be considered a valid application, the necessary fee must be paid.

Fees and processing times

You are required to pay a fee for registering a biocidal product or for applying for a change of registration. You pay this fee on the basis of the invoice that appears in the Gestautor application following the electronic submission of your file. The invoice shall mention:

• Amount to be paid
• Account number
• Structured payment reference to be indicated by you

You can also look up the amount in advance in the table of fees.

Administrative admissibility

Upon receipt of the fee, the administrative admissibility of the file is verified. This is done within a period of 20 working days.

• If all the information is complete, the application is declared admissible.
• If any information is missing, as the applicant, you will be given 20 working days to complete the missing information. Once the information is complete, the admissibility of the file will be verified within 15 working days. If you do not reply within the specified period or if the additional information is insufficient, the application for registration will be filed away without further action.

Processing times

A file that has been declared admissible may be subjected to a further partial or full evaluation. Additional documents are required in case of a full evaluation. These will be requested by email. The processing times vary depending on the nature of the procedure.

• For an administrative change, the processing time is approximately 45 working days.
• For an application for registration with partial evaluation, the processing time varies between 40 and 125 working days.
• For an application for registration with full evaluation, the processing time is at least 125 working days.This period will be extended by the time needed by the applicant to provide the additional information (40 working days, which may be further extended). The total processing time may amount to 405 working days.

Partial or full evaluation

Partial evaluation

During a partial evaluation, the proposed classification and labelling and - if the product claims to be effective against specific target organisms or based on a specific standard - the efficacy of the biocidal product as well will be evaluated on the basis of the information in the electronic file. This procedure is usually followed if the product meets all the conditions prescribed by law and if there are no further reasons for concern.

Full evaluation

A full evaluation is only required if there is reason to believe that the product may not meet the conditions prescribed by law for making biocidal products available on the market and their use (see Art. 5 of the Royal Decree of 4 April 2019). Possible indications for this are:

• The history of the biocidal product
• A substantiated complaint about the biocidal product, a same biocidal product or a biocidal product family to which the biocidal product belongs
• An inconsistency between the classification, labelling and intended use
• An indication that there may be a risk to humans or the environment (based on data from scientific literature, a report from the Poison Centre or an indication from another Member State)
• A serious indication of microbial resistance based on objective data (data from scientific literature, a report from the Poison Centre or an indication from another Member State)

Filing an appeal

A full evaluation will be presented to the Advisory Committee on Biocidal Products (CAB). The applicant who has submitted the application for registration will be notified about this within 20 working days after receipt of the fee. If you wish to appeal against the decision, you may send a registered letter within 30 working days to the following address:

Biocidal Products Service
Galileelaan 5/2
1210 Brussels
Belgium

The CAB will investigate the complaint and, if explicitly requested in your registered letter, you will be invited for an interview. The CAB will communicate its decision within 60 working days. If the complaint is accepted, the application for registration will be further processed according to the partial evaluation procedure. 

More information needed

For a full evaluation, additional information and documents are required.These will be requested through the Gestautor application. If you do not file an appeal against the full evaluation or if your appeal has been denied, you will be given 30 working days to provide the following additional information: 

• An analysis of the percentage of active substances: if the analysis is performed by the applicant’s in-house laboratory, it must meet the Good Laboratory Practice (GLP) requirements, whereas this is not necessary in case of an independent laboratory
• A stability test
• A letter of access for the active substance(s)
• A summary of the toxicological and ecotoxicological data:
• this is only necessary if the European assessment report of the active substance(s) is not yet available or if a letter of access for the active substance(s) cannot be submitted
• Efficacy tests for all intended uses
• A residue test: this is only necessary if residues may end up in food

If you do not reply within the specified period or if the additional information is insufficient, the application for registration will be filed away without further action.

Processing times

The processing times range from 45 to 405 working days, depending on the nature of the procedure.

Registering a same biocidal product

If a particular biocidal product is already registered in Belgium, a second applicant may refer to the information relating to the first registration in order to register a same biocidal product. To do this, the second applicant must have the written consent of the first applicant. Specifically, this is a ‘letter of access’ that gives the second applicant the right to use the confidential information about the first registered product. However, if you are the registration holder of the first product that has already been registered and you want to re-register that product, for example, under a different name, a declaration on honour will suffice.

How do I submit an application?

The application for registration of a same biocidal product is submitted electronically through the Gestautor application. Choose ‘New registration/same biocidal product (C7)’ as the file type. As in the case of a normal application for registration, the necessary fee must be paid. The application is processed administratively, without scientific evaluation.

Permanently linked

A same biocidal product is registered under the same conditions and with the same end date as the original product. Moreover, the two products are permanently linked to one another. The registration of the second, same biocidal product may, therefore, only be changed if the authorisation holder of the first product first changes the registration of the first product.

Parallel trade

The term ‘parallel trade’ means to make products available on the market that are identical to products that are already authorised elsewhere in the European Union. A biocidal product may be made available on the Belgian market under a parallel trade permit if:

• It is already authorised in the Member State of origin
• It is completely identical to a product already registered in Belgium, where the existing product is called the ‘reference product’
• It has an authorisation for import from the Member State where the product is already recognised
• The authorised uses of the product are absolutely identical to the authorised uses of the reference product
• The authorisation for the imported product expires at the latest by the same date as the authorisation for the reference product

All the mandatory rules for making a biocidal product available on the Belgian market, including the classification and labelling rules and the specific rules for the Belgian market, also apply to products made available under a parallel trade permit.

How do I submit an application?

As an exception, the application for a parallel trade permit is NOT submitted through the Gestautor application but by post. The application must meet all the submission conditions prescribed by law (see Art. 19 of the Royal Decree of 4 April 2019), include a completed parallel trade form and all the information necessary to demonstrate that the new biocidal product is identical to the reference product.You may send your application to the following address:

Biocidal Products Service
Galileelaan 5/2
1210 Brussels
Belgium

For it to be considered a valid application, the necessary fee must be paid.

Tests and experiments

In order to develop or research new biocidal products, it may be necessary to conduct tests or experiments. If you want to obtain an authorisation for a test or experiment, you must meet the legal criteria for making biocidal products available on the market and their use (see Art. 26 of the Royal Decree of 4 April 2019).

Register

To perform a test or experiment with a biocidal product, you must first prepare a register that contains the following information:

• Identity of the biocidal product or active substance
• Labelling information
• Quantities to be used in the experiment or test
• Place where the experiment or test is to be performed
• Person(s), companies or organisations performing the experiment or test

You must keep the register up to date and also prepare a file containing all the available information on possible effects on the environment and on human and animal health.

If you want to perform a test or experiment that may release a biocidal product into the environment, you must notify the competent authority of this in advance. You may do this by sending the appropriate form by email to info.gestautor@health.gov.be.

Reasons for refusal

The federal government may prohibit experiments and tests or only allow these to be performed under certain conditions if they have harmful effects on human or animal health or if they have unacceptable adverse effects on humans, animals or the environment.

Certificate of Free Sale

The Certificate of Free Sale is a document that facilitates the export of biocidal products to countries outside the European Union/European Economic Area. It confirms that the product for which it is issued complies with the rules applicable to biocidal product and that it is authorised or registered in Belgium. You must send your application by email to info.gestautor@health.fgov.be. For the payment terms and conditions, you may refer to the table of fees.