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Approval of active substances

In Belgium, only biocidal products that contain approved active substances may be made available on the market and used. Biocidal products with existing active substances, which are still undergoing the EU Review Programme, may be made available on the market if they fall under the transitional measures of Regulation (EU) No 528/2012.

    Types of active substances

    To produce biocidal products, you may use two types of active substances:

    Existing active substances

    Existing active substances are substances which were made available on the market before 14 May 2000 but which are pending evaluation at the European level. Biocidal products with existing active substances are subject to the Belgian transitional measures, i.e. the registration procedure according to the Royal Decree of 4 April 2019. These products may remain on the market until the European Commission has taken a decision on the substance concerned. If a biocidal product contains several active substances, the transitional measures remain applicable until all the active substances contained in that biocidal product have been evaluated at the European level.

    Once all the active substances for the relevant product types have been approved and included in the Union list of approved active substances, the transitional measures cease to apply and the European procedures become applicable to these products. Subsequently, an application for authorisation must be submitted at the European level for the relevant product types before the approval date of the last active substance.

    If an active substance is not approved, the biocidal product must be withdrawn from the European market within the periods of grace laid down in Regulation (EU) No 528/2012. The periods of grace only apply to biocidal products that have undergone the EU Review Programme.

    I. Evaluation of existing active substances (on the market before 14/5/2000)   II. Evaluation of biocidal products
    STATUS (OR DECISION)   STATUS
    At least one active substance is under evaluation for the relevant product type ⇒
    • Transitional measures apply (Art. 89 of the BPR) to biocidal products with at least one active substance under evaluation.
    • In Belgium, the Royal Decree of 4 April 2019 applies.
    • To make a biocidal product available on the Belgian market, an application for registration must be submitted according to the national registration procedure.
    All active substances have been or are approved for the relevant product type ⇒
    • The authorisation procedures laid down in Regulation (EU) No 528/2012 are applicable.
    • If, before the date of approval of the last active substance, a European application for authorisation has been submitted for biocidal products already registered in Belgium under the national procedure, the registration of these products will be extended by 3 years in Belgium (post-Annex I extension).
    • If, before the date of approval of the last active substance, no European application for authorisation has been submitted for biocidal products already registered in Belgium under the national procedure, the following periods of grace will apply: 180 days for making the product available on the market and 365 days for using up existing stocks.
    At least one active substance is not approved for the relevant product type ⇒ For biocidal products already registered in Belgium and which contain an active substance that has not been approved, the following periods of grace apply: 12 months for making the product available on the market and 18 months for using up existing stocks, starting from the rejection date. After the expiry of these periods of grace, the biocidal products may no longer be made available on or used in the European market.

    New active substances

    New active substances are not subject to the transitional measures. They may not be incorporated into biocidal products and made available on the market unless they are included in the Union list of approved active substances.

    • The authorisation of active substances is granted at the European level.
    • The authorisation of biocidal products can only take place after the active substances have been approved. This authorisation is granted by the Member States, unless it involves a Union authorisation.

    Active substances are normally authorised for a period of 10 years unless they are candidates for substitution. In that case, the authorisation of an active substance is valid for a maximum of 7 years. If the active substance also meets one or more exclusion criteria, the authorisation is valid for a maximum of 5 years. Authorised active substances are included in the Union list of approved active substances. Thereafter, an application for authorisation may be submitted only for biocidal products with approved active substances.

    If you want to make a new active substance available on the market for use in biocidal products that are not yet authorised (or are under evaluation), you must submit an application for approval to the European Chemicals Agency (ECHA). If you select Belgium as the evaluating Member State for the evaluation of your new active substance, you must contact the Belgian Biocidal Products Service at least 2 years in advance. 
     

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