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

    Belgium as the evaluating Member State

    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.

    You may select the Member State that will perform the evaluation, subject to the agreement of the evaluating competent authority (eCA). If you wish to select Belgium as the evaluating Member State, you must contact the Helpdesk of the Biocidal Products Service at least 2 years in advance.

    An application dossier must contain the following elements:

    • Trade name of the biocidal product
    • Names and Chemical Abstracts Service (CAS) Registry Numbers of the active substances
    • Product type(s)
    • Date on which the last active substance for the last product type was approved
    • Application type (national or Union authorisation)
    • Date on which the dossier will be submitted
    • Whether it concerns a single biocidal product or a biocidal product family (for a biocidal product family, you must also indicate the number of product groups and products)
    • Whether any applications for registration are already under consideration for the products concerned within the context of the Belgian transitional measures
    • To apply for a national authorisation (NA-APP) or a simplified authorisation (SA-APP), you must also indicate the Member States for which you want an authorisation

    On the basis of this information, the public service concerned may decide whether Belgium may act as the evaluating authority for your dossier. This information also helps in making a correct estimation of the workload.

    Prepare application

    As soon as the Belgian government accepts its possible role as the eCA, a pre-submission meeting is planned to prepare the dossier. All the necessary meetings are held during the year preceding the submission of the application.

    A fee is requested for the first meeting. If Belgium is chosen as the eCA, you may subsequently deduct this amount from the costs for your application for authorisation.

    In order to prepare for the pre-submission meeting in the best possible manner, the applicant must send, no later than 1 month in advance the most important details:

    • Relevant information about the biocidal product (structure, uses, etc.)
    • Specific issues to be discussed at the meeting

    The eCA provides the applicant with all the information necessary for the proper preparation of the application for authorisation. The applicant remains personally responsible for the content and quality of the dossier. It should noted that an eCA is not a professional consultancy: the provided support has certain limitations and does not guarantee a positive evaluation.

    National authorisation (NA-APP)

    If you want to make a biocidal product available on the market in one country only, it is sufficient to apply for the authorisation of that country. If you want to make the product available on the market in several countries, you may apply for a mutual recognition of the authorisation in each of these countries.

    You may apply for a national authorisation as soon as the last active substance for the relevant product type has been approved. A biocidal product of which all active substances are approved may be made available on the market of a Member State only after it has been granted a national authorisation. For biocidal products of which at least one active substance is pending evaluation, specific transitional measures apply (see Art. 89 of Regulation (EU) No 528/2012).

    Procedure

    The application procedure for a national authorisation is as follows:

    • Firstly, Belgium must be requested to act as the evaluating Member State (eCA).
    • Submit an application for a national authorisation via the European Register for Biocidal Products (R4BP).
    • The specific information for the dossier must be entered via IULCLID.
    • On the European Chemicals Agency (ECHA) website, you can find extra information and recommendations about the types of dossiers you need to prepare.
    • Pay the correct fee for your application for authorisation.
    • The admissibility of the application for authorisation will be confirmed within 30 days, provided that the fee has been paid.
    • After receiving the application for authorisation, the eCA has 90 days to consider whether the dossier is admissible and to validate it.
    • An application that has been declared admissible will be evaluated within a period of 365 days.
    • This period may be extended by up to 180 days, in case additional information is required.
    • At the end of the evaluation phase, the eCA updates all the information on the biocidal product concerned in the R4BP. Depending on the scientific evaluation, the evaluating Member State decides whether or not to authorise the biocidal product.
     

    A national authorisation for a biocidal product is valid for a maximum of 10 years. If the biocidal product contains an active substance that is a candidate for substitution, the national authorisation will be valid for a maximum of 5 years. However, this authorisation can be renewed afterwards. Such a renewal must be requested in time: at least 550 days before the expiry of the authorisation.

    Legal basis, links and other documents

    Union authorisation (UA-APP)

    If you want to make a biocidal product available on the market in the entire European Economic Area (EEA), you must apply for a Union authorisation. In that case, you do not need to apply separately to each country for a national authorisation or a mutual recognition. However, this is subject to the condition that the biocidal product will be used under comparable conditions in all Member States.

    A Union authorisation will not be granted if:

    • The product contains an active substance that falls under the exclusion criteria of Regulation (EU) No 528/2012
    • The product belongs to product types 14, 15, 17, 20 or 21

    Procedure

    The application procedure for a Union authorisation is as follows:

    • Firstly, Belgium must be requested to act as the evaluating Member State (eCA).
    • Request a preliminary meeting with the European Chemicals Agency (ECHA). This meeting must take place no later than 6 months before the submission of the application.
    • Submit an application for a Union authorisation via the European Register for Biocidal Products (R4BP). The specific information for the dossier must be entered via IULCLID. On the European Chemicals Agency (ECHA) website, you can find an overview of all the steps you need to take and the types of dossiers you need to prepare.
    • Pay the correct fee for your application for authorisation to the ECHA and the eCA.
    • The admissibility of the application for authorisation will be confirmed by the ECHA within 30 days, provided that the fee has been paid.
    • If the ECHA declares the application for authorisation admissible, the eCA has 30 days to validate the dossier. Any incomplete dossier must be completed within 90 days.
    • An application that has been declared admissible will be evaluated within a period of 365 days. This period may be extended by up to 180 days, in case additional information is required.
    • The evaluation is sent to the applicant who has 30 days to submit written comments.
    • The ECHA examines whether the evaluation by the eCA is thorough and complete.
    • Subsequently, the dossier is sent to the Biocidal Products Committee (BPC), which consists of peers.
    • The Committee submits an opinion to the European Commission within 180 days.
    • On the basis of this opinion, the European Commission takes a decision on the authorisation of the biocidal product throughout the territory of the European Union.
     

    A Union authorisation for a biocidal product is valid for a maximum of 10 years. However, this authorisation can be renewed afterwards. Such a renewal must be requested in time: at least 550 days before the expiry of the authorisation.

    Legal basis, links and other documents

    Simplified authorisation (SA-APP)

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

    A simplified authorisation may only be applied for 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

    In case of a simplified authorisation procedure, you will need to provide less extensive information and your application will be evaluated within a shorter period of time.

    • Firstly, you must request Belgium to act as the evaluating Member State (eCA)
    • Submit an application for a simplified authorisation via the European Register of Biocidal Products (R4BP).
    • Pay the correct fee for your application for authorisation.
    • An application that has been declared admissible will be evaluated within a period of 90 days. This period may be extended by up to 90 days, in case additional information is required.
    • On the basis of the evaluation, the competent authority decides whether the biocidal product may be made available on the Belgian market and whether any restrictions are to be imposed.

    A simplified authorisation for a biocidal product is valid for a maximum of 10 years. If the simplified authorisation is granted, you may also make the product available on the market in other European Member States, without mutual recognition. However, for this you must notify the Member States concerned 30 days in advance (notification for placing on the market). The biocidal product must be labelled and accompanied by instructions for use in the official language/languages of the Member State concerned.

    Legal basis, links and other documents

    Same biocidal product authorisation (BBP or BBS)

    Each Member State may grant an authorisation for a biocidal product that is identical to another authorised product (or to a product for which an authorisation is expected to be granted).The same applies to biocidal product families.The aim of the procedure is to make it possible for same biocidal products or biocidal product families to be made available on the market multiple times under a different name or by a different authorisation holder.

    • A same biocidal product authorisation may only be applied for if:
    • The active substance(s) in the biocidal product is (are) approved
    • There is a valid Union authorisation, national authorisation or simplified authorisation (UA-BBS, NA-BBS, SA-BBS) for the reference product
    • A valid application has been submitted for a Union authorisation, national authorisation or simplified authorisation for the reference product, where the decision on the authorisation of the same biocidal product depends on the decision on the reference product (UA-BBP, NA-BBP, SA-BBP)

    If the reference product is a biocidal product of which not all the active substances have yet been evaluated at the European level, the Belgian transitional measures will apply to the identical product.

    Procedure

    • Submit an application for authorisation for a same biocidal product via the European Register of Biocidal Products (R4BP). On the European Chemicals Agency (ECHA) website, you can find an overview of all the steps of the procedure.
    • Pay the correct fee for your application for authorisation.
    • If a national or simplified authorisation exists for the reference product, the evaluating Member State is responsible for validating the dossier. It also takes the decision on the authorisation.
    • If a Union authorisation exists for the reference product, the ECHA is responsible for validating the dossier. The Biocidal Products Committee (BPC) submits an opinion to the European Commission within 30 days.
    • The European Commission will take a decision on the authorisation on the basis of this opinion.

    An application for authorisation for a same biocidal product leads to an independent authorisation.The authorisation is identical to that for the reference product, except with regard to the requested changes. The authorisation for the same biocidal product will be issued with a different authorisation number and can be modified or cancelled independently of the authorisation for the reference product.

    An authorisation for a same biocidal product is valid for a maximum of 10 years. However, this authorisation can be renewed afterwards.The authorisation will expire on the same date as the authorisation of the reference product (or the reference family).

    Legal basis, links and other documents

    Minor or major scientific changes (MIC or MAC)

    The conditions for the authorisation of an approved biocidal product may change due to an application 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

    • Submit an application for a scientific change 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. 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.
    • If Belgium is the evaluating Member State, you must enclose a supporting document with your application listing the details of all the Member States concerned.
    • Pay the correct fee for your application for authorisation.

    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.

    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 procedure on the European Chemicals Agency (ECHA) website. If the product is on the market in several European Member State, 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 the evaluating Member State, request a meeting with the Biocidal Products Service in time to discuss the dossier and the procedure. Along with the application, you must send the latest available information that is relevant to the dossier. You must also indicate whether the conclusions of the previous evaluation of the biocidal product are still valid and provide supporting data for this.
    • For the renewal of a national authorisation, the evaluating Member State (eCA) decides whether a full evaluation of the application is required. This decision is taken within 90 days after the validation of the application. If a full evaluation is required, the statutory time limits for evaluating a national authorisation apply. If not, the eCA takes a decision on the renewal within 180 days.
    • For the renewal of a Union authorisation, the evaluating Member State (eCA) decides whether a full evaluation of the application is required. This decision is taken within 30 days after the validation of the application.If a full evaluation is required, the statutory time limits for evaluating a Union authorisation apply. If not, the eCA submits an opinion to the ECHA within 180 days. Subsequently, the ECHA submits an opinion to the European Commission within 180 days. The European Commission will take a decision on the authorisation based on this opinion.

    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 renewal is subject to a fee.

    Legal basis, links and other documents

    Administrative change (ADC)

    Regulation (EU) No 528/2012 provides the option of making administrative changes to an existing European authorisation.This includes:

    • A change in the trade name
    • Addition or removal of an additional trade name
    • Change or addition of a manufacturer of the active substance or substances in the biocidal product
    • Change of address of the authorisation holder
    • Etc.

    NA-ADC applications are handled by the European Member State, while applications for simplified authorisation (SA-APP) or applications for Union authorisation (UA-APP) are handled by the European Chemicals Agency (ECHA).

    Procedure

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

    Grouping of changes

    It is possible to combine several administrative changes in a single application. Indicate this clearly in the application and provide the information as indicated in the Annex to the Regulation on changes to authorised biocidal products.The changes are divided into two sections:

    • Section 1 contains the administrative changes to be notified BEFORE implementation
    • Section 2 contains the administrative changes to be notified AFTER implementation

    If you want to group together different administrative changes, it is recommended that the changes be grouped on the basis of these two sections. 

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    Transfer of authorisation holder (TRS)

    Regulation (EU) No 528/2012 provides the option of transferring an existing European authorisation to a new authorisation holder. An application for such a transfer can be submitted via the European Register of Biocidal Products (R4BP). The evaluating Member State will validate and evaluate the application within 30 days, provided that the fee has been paid.

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    Tests and experiments

    Regulation (EU) No 528/2012 provides the option of conducting tests and experiments with unapproved active substances or unauthorised biocidal products. Such tests may only be carried out in the context of scientific research and are subject to a number of conditions:

    • If you perform the experiment or test, you must prepare and maintain detailed written records.The competent authority may request this information.
    • If you want to perform a test or experiment that may release a biocidal product into the environment, you must notify, in advance, the competent authority of the country in which the experiment is to take place. The notification must be sent at least 45 days before the test or experiment takes place and must include the following elements:
      • Identity of the biocidal product or active substance
      • Chemical composition of the mixture, in the form of a complete list of the constituents and their concentrations
      • Labelling information
      • Quantities to be used in the experiment or test
      • Purpose and protocol of the experiment or test
      • Place where the experiment or test is to be performed
      • Person, persons, companies or organisations performing  the experiment or test
      • All available information on the potential effects on the environment or on human and animal health
      • Expected results of the experiment or test

    The competent authority must issue an opinion regarding the notification within 45 days. If no opinion is issued, the test or experiment may be carried out. The submission of a notification for the test or experiment is subject to a fee.

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    Parallel import (PP)

    The term ‘parallel import’ refers to the import of biocidal products that are already authorised elsewhere in the European Union. A product may be imported into Belgium as a parallel biocidal product if:

    • It is already authorised in the Member State of origin, according to Regulation (EU) No 528/2012
    • 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 at the same time as the authorisation for the reference product

    All the rules to be followed for making a biocidal product available on the market in Belgium, including the classification and labelling rules and specific rules for the Belgian market, also apply to the imported products.

    Procedure

    Submit an application for parallel import via the European Register for Biocidal Products (R4BP). This must include the following details:

    • Name and authorisation number of the product in the Member State of origin
    • Name and address of the competent authority in the Member State of origin
    • Name and address of the authorisation holder in the Member State of origin
    • Original label and instructions for use accompanying the product in the Member State of origin (at the request of the competent authority of the importing Member State)
    • Name and address of the applicant
    • Name to be assigned to the product in the importing Member State
    • A draft label for the product in the importing Member State, in the official languages of that Member State
    • A sample of the product to be imported (if deemed necessary by the competent authority of the importing Member State)
    • Name and authorisation number of the reference product in the importing Member State

    An application for parallel import is subject to a fee.

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