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Application for single biocidal product - Belgium as the Member State concerned

    Belgium as the Member State concerned

    To make a biocidal product available on the market in the European Union, you must have either a national or Union authorisation. An application for such an authorisation is evaluated by a single Member State. The ‘Member States concerned’ are not the Member States that evaluate the application, but the Member States in which the applicant wants to obtain an authorisation for a biocidal product.

    You may select the Member State that will perform the evaluation, subject to the agreement of the evaluating competent authority (eCA). If you want to select Belgium as the evaluating Member State, you must contact the Helpdesk of the Biocidal Products Service at least 1 year in advance. If not, Belgium will serve as the Member State concerned.

    Mutual recognition (MRP-MRS)

    If you want to place a product on the market in several Member States of the European Union, you must submit an application for product authorisation by mutual recognition. Here, you can choose between mutual recognition in sequence or in parallel.

    Mutual recognition in parallel

    For a mutual recognition in parallel, you must apply for a product authorisation to the evaluating Member State. At the same time, you must submit a request to other Member States to recognise the authorisation once it has been granted by the evaluating Member State.

    If the product is already on the market in Belgium when you submit the application for mutual recognition in parallel, the existing authorisation will be temporarily extended. The extension is valid for the duration of the evaluation period, for a maximum period of 3 years. It can only be granted if you submit the application before the official approval date of the last approved active substance for the product type concerned.

    Mutual recognition in sequence

    For a mutual recognition in sequence, the product must first be authorised by the evaluating Member State. Subsequently, you may request other Member States (= Member States concerned) to recognise the authorisation. You may only make the product available on the Belgian market if the authorisation procedure has been completed and Belgium, as the Member State concerned, has recognised the authorisation of the evaluating Member State.

    Procedure

    Submit an application for mutual recognition via the European Register for Biocidal Products (R4BP). On the European Chemicals Agency (ECHA) website, you can find an overview of all the steps of the procedure. The recognition process takes approximately 5 months from the time the application is validated by the Member State concerned. An application for mutual recognition is subject to a fee.

     

    Legal basis, links and other documents

    Minor or major scientific changes (MIC or MAC)

    Do you want to change the authorisation conditions of an approved biocidal product? If so, you must apply for a scientific change. There are two types of scientific changes:

    • Minor change (MIC) that does not affect the authorisation conditions of the biocidal product
    • Major change (MAC) that has an impact on the authorisation conditions and therefore makes it necessary to re-evaluate the risks and efficacy of the biocidal product

    Procedure

    An application for a scientific change can be submitted via the European Register of Biocidal Products (R4BP). You can find the full procedure on the European Chemicals Agency (ECHA) website. When submitting the application, you must include the necessary scientific data to support the requested change: stability studies, efficacy studies, toxicological or ecotoxicological test reports, etc.

    Only the competent authority that has granted the original authorisation may modify this authorisation. If the product is already available on the market in several Member States - via the mutual recognition system - the authorisation holder must apply for the change in each Member State separately. Applications must be submitted simultaneously in all Member States. If Belgium is only acting as one of the Member States concerned and not the evaluating Member State, the authorisation holder must enclose a supporting document with his application listing the details of the evaluating Member State and of all the other Member States concerned.

    An application for a scientific change is subject to a fee.

    Legal basis, links and other documents

    Renewal (RNL)

    The authorisations for biocidal products are valid for a limited period of time. However, Regulation (EU) No 528/2012 allows for the renewal of national and Union authorisations, so that the product may remain on the market for a longer period of time. A renewal may only be applied for if the biocidal product still meets all legal and scientific conditions. Such a renewal must also be applied for in time: at least 550 days before the expiry of the authorisation.

    Procedure

    • Submit an application for renewal via the European Register for Biocidal Products (R4BP).You can find the correct application procedure on the European Chemicals Agency (ECHA) website. If the product is on the market in several European Member States (via a mutual recognition), you must submit the application to all the Member States concerned simultaneously. You may select the Member State that will perform the evaluation, subject to the agreement of the competent authority. The Member State that carried out the original evaluation will be given preference.
    • If Belgium is acting as the Member State concerned, you must enclose a supporting document with your application mentioning the evaluating Member State, the reference product and all products linked to the reference product. The validity period of the renewed authorisation will never be longer than that of the original authorisation and may be a maximum of 10 years. If the authorisation holder does not apply for renewal or if the application is denied, the biocidal product will be removed from the market. This will be done no later than 180 days after the expiry date of the original authorisation. An application for a renewal is subject to a fee.

    Legal basis, links and other documents

    Notification (SN-NOT)

    A notification procedure is a simplified authorisation procedure for biocidal products that are less harmful to the environment and to human and animal health. Via the system of notifications, the European Union wants to encourage the production of harmless biocidal products.

    A notification is only possible if the biocidal product meets the conditions set out in Article 25 of Regulation (EU) No 528/2012:

    • All the active substances in the biocidal product are listed in Annex I and comply with the specified restrictions
    • The biocidal product does not contain any substances of concern
    • The biocidal product does not contain any nanomaterials
    • The biocidal product is sufficiently effective
    • No personal protective equipment is required while using the biocidal product

    Procedure

    For a notification procedure, you will need to provide less extensive information and your application will be evaluated within a shorter period of time.

    A notification can be submitted via the European Register for Biocidal Products (R4BP). The evaluating Member State will validate and evaluate the application within 30 days, provided that the fee has been paid.

    The biocidal product must be labelled and accompanied by instructions for use in the official language(s) of the Member State concerned.

    Legal basis, links and other documents

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