Table of contents

1. Introduction

The evaluation of biocides is performed in order to guarantee a high health protection level  to users and to the environment. The Royal Decree of 4 April 2019 regulates the national procedure for placing biocidal products on the market according to the Regulation (EU) nr. 528/2012. This Decree abolishes the provisions of the Royal Decree of 8 May 2014 concerning the  authorisation and notification procedure. From now on, there is only one national procedure to place a biocidal product ont the Belgian market: the registration. Depending on the case, the registration requests will be submitted to a restricted evaluation or to a full evaluation.

It is also possible to introduce specific requests for parallel trade, scientific experiments or tests, or certificates of free sale.

Please follow the links to access the Royal Decree of 4 April 2019 and the Royal Decree of 27 February 2019 amending the Royal Decree of 13 November 2011 establishing the fees and annual contibutions to the Budgetary Fund for raw materials and products.

ATTENTION

  • Following the publication of the Royal Decree of 4 April 2019 version 9 of the ApplicationFormGenerator (AFG) has now been made available. We recommend that you use the new version for the submission of your requests. Version 8 of the AFG remains valid until 1 October 2019. Beyond that date any requests submitted through version 8 or previous versions will be refused.
  • Impact of the BREXIT on the biocides sector (10/2018)
  • Modification of the fees and annual contributions (01/2018)
  • The following deadlines must be met:
    • new national registration request should be introduced ultimately  1 year BEFORE the date of approval defined on EU level;
    • a request for modifying a national registration or notification should be introduced ultimately 6 months BEFORE the date of approval defined on EU level;
    • new national registration request for an identical product should be introduced ultimately 3 months BEFORE the date of approval defined on EU level.

Any application submitted after the deadline will be rejected.


2. REGISTRATION PROCEDURE

2.1. New registration request

2.2. Installing the IT application

2.3. Completing the electronic file

2.4. Sending the registration request

2.5. Paying the fee

2.6. Modifying your registration

2.7.  For a request for a product identical to one already registered in Belgium

2.8. For a new product based on an existing authorisation in another EU country (and provided that the assessment procedure complies with the Belgian requirements)

2.9. Processing Time

2.1. New registration request

You must submit a file in electronic format by using an IT application (ApplicationFormGenerator (AFG)). Your request will be assessed in terms of the risks of the product to health and the environment. According to the criteria established in the Royal Decree, a restricted or a full evaluation is performed. In the case of a full evaluation, the Advisory Committee on Biocidal Products (CAB) will issue a positive or negative recommendation on this product. Subsequently, the registration is approved or disapproved taking this recommendation into account. In the event you do not agree with the decision taken (refusal of registration, particular conditions imposed, modification or withdrawal of a registration), you can introduce an objection with the biocides service.

2.2. Installing the IT application

You must first install the IT application on your computer in order to submit an electronic file.

2.3. Contents of the electronic file

Consult the instruction manual to ensure that you complete the electronic form correctly (Annex 1. A).

For a new registration request, this form has to include the following information :

  • the commercial name of the biocidal product;
  • the requestor;
  • manufacturer of the biocidal product;
  • manufacturer or importer of the active substance;
  • the distributor;
  • product type and intended application;
  • exact qualititative and quantitative composition;
  • classification and labelling proposition;
  • label of the biocide product;
  • security data sheet of the biocidal product;
  • security data sheet of all ingredients of the biocidal product;
  • estimated quantity of the biocidal product to be made available on the Belgian market;
  • size of the packing;
  • efficiency tests of the biocidal product for which a registration request is submitted (only if the latter claims efficiency against a specific target organism or according to a specific norm).

Correctly indicate the requested email addresses – they will be used during the whole assessment procedure of the file.

To be complete, the electronic file must contain three files:

  1. the xml_temp file (electronic file containing the added data),
  2. the xml_product name file (the electronic file is complete after 'file, complete') and
  3. the CTD Folder (documents added to the electronic file).

2.4. Sending the registration request

The sending procedure of an electronic file is described under the ‘And Finally’ section of the abovementioned user manual.

All requests must be sent to the email address  info.gestautor@health.fgov.be.

2.5. Paying the fee

You must pay a fee. This fee must be paid when you receive the automatic email acknowledging receipt of the file. This automatic email will indicate the amount of the fee to be paid, the account number and the structured reference to be indicated when the payment is made.

As a reminder, the amount including the various fees can be found in this table of fees.

2.6. Modifying your registration

In the electronic file, you can also request modifications for biocidal products that are already registered in Belgium. All modifications must be submitted via ApplicationFormGenerator (AFG). You must also pay a fee, as described in the table of fees.

The following are processed administratively : name change, transfer, extension or renewal submitted before the expiry date of the existing authorisation.

Our services will carry out a restricted or full scientific assessment of the file in the following cases: extension or renewal submitted after the expiry date of the existing authorisation, change of composition, change of shelf life, extension of use, or CLP-SGH labelling.  The restricted or full evaluation decision is taken according to the same stipulations as new registration requests as mentioned in point 4.

The documents required depend on the modification request.

2.7. For a request for a product identical to one already registered in Belgium

You must submit a file in electronic format (via ApplicationFormGenerator (AFG), by choosing "new registration/identical product (C7)" as your file type. A letter of access of the holder of the already registered product or a declaration of honour (if you are the holder of the already registered product) are required.
You must also pay a fee, as set out in the table of fees. This request is processed administratively without a scientific assessment.

2.8. For a new product based on an existing authorisation in another EU country (and provided that the assessment procedure complies with the Belgian requirements)

You must submit a file in electronic format (via ApplicationFormGenerator (AFG)), by choosing the file "new authorisation/Europe identical/same use (C15m1) ». Other documents are also requested in the electronic file.

You must also pay a fee, as set out in the table of fees.

This type of request is processed administratively, but it is not excluded that a restricted or full scientific assessment be performed. This decision is made on a case-by-case basis, depending on the product concerned, and the country in which the product was originally authorised.

2.9. Administrative maintainability deadlines

After receiving the fee, the administrative maintainability is checked within 20 business days. If the file is not administratively maintainable the missing data are asked. The requestor then has 20 business days to deliver them. After receiving the missing data, the maintainability is treated within 15 business days. If the requestor does not reply within the given deadlines or if the additional data are insufficient, the request is classified without result.

If the file is found maintainable, the request will be submitted to either a restricted or a full evaluation. In the latter case, additional documents will be asked by email.


3. RESTRICTED EVALUATION

3.1. Contents of the evaluation

3.2. Processing time

3.1. Contents of the evaluation

If the file is administratively maintainable, the classification and the labelling of the biocidal product are established. If the product claims any efficiency against a specific target organism, (race, species or equivalent) or according to a specific norm, its efficiency is evaluated according to the data submitted in the electronic file.

3.2. Processing time

The registration is granted within 20 business days. If all the requested data are not included in the file, the biocides service informs the requestor of the missing data. From then on the requestor has 20 business days to deliver the missing data. These will be evaluated within 20 business days after reception. If the requestor does not deliver these data on deadline, or if the information received is insufficient, the request is classified without result.


4. FULL EVALUATION

4.1. Decision to perform a full evaluation

4.2. Appeal possibility

4.3. Administrative maintainability

4.4. Processing time

4.1. Decision to perform a full evaluation

If there are reasons to believe that the biocidal product does not meet the conditions mentioned in article 5 of the Royal Decree of 4 April 2019 concerning the placing on the market and use of biocidal products, the request is transmitted to the CAB in view of a full evaluation. The requestor is informed of the situation by registered post within 20 business days from reception of the fee.

The indicators or elements thereof may include:

  1. the historical background of the biocidal product;
  2. a founded complaint against the biocidal product concerned, against a particularly similar biocidal product or a biocidal group to which the biocidal product belongs;
  3. incompatibility between the classification, the labelling and the intended use;
  4. data from scientific literature, a notification from the poison centre or an indication from another Member State susceptible to establish  a potential danger to man or environment;
  5. data from scientific literature, a notification from the poison centre or an indication from another Member State susceptible to establish an objectified microbial resistance.

4.2. Appeal possibility

The requestor can launch an appeal against the decision by addressing a registered letter within 30 business days to the following address:

Services Biocides
Eurostation | Place Victor Horta 40/10
1060 Bruxelles
Belgique
 

The appeal is examined by the CAB and the requestor can be heard if he asks to be. The CAB renders its conclusion within a delay of 60 business days and notifies the requestor by registered letter.

If the appeal is accepted the registration request is treated according to the restricted evaluation procedure.

4.3. Administrative validity

If the decision taken after the full evaluation is maintained or if no appeal has been submitted, the requestor has to deliver the following additional data within 30 days:

  • analysis of the active substance concentration (this analysis must be performed by an independent laboratory and has to be linked to the name of the product concerned.  A GLP analysis is not requested. However, if the analysis is done by the internal laboratory of the requestor’s firm, the analysis must be submitted according to GLP standards);
  • stability test;
  • access letter for the active substance(s);
  • review of toxicological and eco-toxicological data  if the European evaluation report of the active substance(s) is not available yet or if no access letter for the active substance(s) can be submitted;
  • efficiency test(s) for each intended use;
  • residual test if residues are possible in food.

As soon as the data are received the administrative validity is evaluated within 15 business days. If data are missing, the biocides service informs the requestor thereof, and the latter has 20 business days to give an answer. After reception of the data, the administrative evaluation is made within 15 business days. If the requestor does not submit the data within the given deadlines or if the information received is insufficient, the request is classified without result.

4.4. Processing time

If the request is administratively maintainable the advice concerning the registration is transmitted within 125 business days. If additional data are required, the biocides service informs the requestor thereof and the 125 days’ counter is suspended until their receipt.

The requestor has a renewable delay of 40 business days  to transmit the additional data. After this delay, extended or not, the request is classified without result.


5. MODIFYING THE REGISTRATION

The holder can ask to modify the registration. To that end he restarts the procedure described under point 2.6.

If the request concerns an administrative modification an advice has to be rendered within 20 business days.

If the request concerns a scientific modification the procedure described under point 3 and 4 is applicable and the requestor has to submit the necessary data.


6. IDENTICAL PRODUCT

For a product already registered in Belgium the registration of an identical product can be granted to another requestor if the latter refers to the data submitted by the holder of the first registration. The request is then submitted following the procedure described under point 2.7.

The second requestor must in advance dispose of a written consent of the first requestor in the form of an access letter, authorising him to use the confidential information regarding the product registered initially.

An advice has to be rendered within 20 business days from the administrative maintainability of the request. The product is then registered under the same conditions and with the same expiring date as the preceding registration. Moreover a permanent link will unite the two products and no  modification of the second registration can be made if the first requestor does not carry out the same modification beforehand.


7. PARALLEL TRADE

In order to obtain a parallel trade authorisation in Belgium, the product must previously be:

  • authorised in a EU Member State;         
  • identical to a product already registered in Belgium in the sense of art. 53 of (EU) Regulation Nr. 528/2012;     

This request must be submitted by post, together with the appropriate documents and in accordance with the submission process described in Article 19 of the Royal Decree of 8 May 2014, that is the form for parallel trade, as well as all the information required to prove that the biocidal product is identical to the reference product.
To see the payment methods, please consult the table of fees.
An annual contribution will be asked.


8. OBJECTION

In the event you do not agree with the decision taken (refusal of registration, particular conditions imposed, modification or withdrawal of a registration), you can introduce an objection within 30 business days to the following address:

Biocides Service
Eurostation | Place Victor Horta 40/10
1060 Bruxelles
Belgium
 

The objection is transmitted to the High Health Council which will have to examine the case within 60 days, extended by 90 days to render an advice. During the procedure you will be called by the Council in order to enforce your position. It is not allowed to include new studies when an objection is introduced. This type of objection involves the payment of a fee.


9. TEST or EXPERiment AUTHORISATION

To obtain authorization for a test or experiment to be carried out for research or development purposes on unregistered biocidal products, you must satisfy the criteria described in article 26 of the Royal Decree of 4 April 2019 on the placing on the market and use of biocidal products.

If you intend to carry out  experiments or tests that may involve or result in the biocidal product being released into the environment, this must be notified in advance to the competent service by e-mail, using the following form: Annex 3.

The experiments and tests may be forbidden or conditionally authorised if harmful effects may occur on human or animal health, or if there may be a risk of adverse impacts on the environment, human beings or animals.

The persons that carry out the experiments or tests draw up a register including the particularities regarding :

  • The identity of the biocidal product or of the active substance,
  • The labelling data,
  • The quantities delivered
  • Names and addresses of the persons who received the product or substance.

They keep this register up to date and establish a file containing all available data regarding the potential effects on human or animal health or regarding the environmental impact. They make this information available, on request by the minister.