How to apply?

Which application procedure should you follow?

Find the applicable type of application by answering the questions below.

1. Start

   1. Upon submission of an application, the first step is to determine whether the active substances contained in the product have already been authorised in Europe. This can influence the subsequent procedures.

   2. Step 1Does your product need authorisation?

      • Is this product a biocidal product ?
      • is this product an in situ generated product?
      • Is this product a treated article ?

      All biocidal products on the Dutch market require authorisation by Ctgb, either under the BPR or under national legislation (Wgb):

      • For products based on active substances pending in the EU review programme, the BPR allows Member states to continue to authorise biocidal products and place them on the market applying national practice.  This is a temporary transitional measure.
      • For biocidal products based on active substances that have been approved within the EU review programme, the regulatory legal frame work defined in the BPR applies.

      Therefore, a company that wishes to place a biocidal product on the market, will first have to determine the status of the active substance.  An application for authorisation can be submitted within either the national legal framework or the EU legal framework

      To check (1) which substance/product type combinations are included in the Review Programme and (2) are still under review, see the ECHA website.

      If the active substance is obtained either from a source different to the reference source in the EU authorisation, or from the reference source, but following a changed manufacturing process and/or location, you may apply for an assessment of Technical Equivalence at ECHA

      For information on applications that do not refer to a request for authorisation, please refer to:

      • Inquiry to share data for biocidal product
      • Export certificate
      • Notification of unexpected or adverse effects (see Practical guide biocides National authorisation, page 46)

   3. Step 2Is the product not authorised in the Netherlands?

      If the active substance is approved, you can apply for :

      • a national product authorisation;
      • a national product authorisation through mutual recognition (either in parallel or in sequence);
      • an union authorisation. (If you wish to place your biocidal product on the market in the entire European Union);

      If the approved active substance is classified as Candidate for Substitution, any product authorisation will be preceeded by an evaluation of available alternatives. Therefore a product application with this active substance should be accompanied by:

      • a comparative assessment;

      Is the active substance included in the Review Programme and still pending?

      • a limited assessment procedure is the standard procedure under transitional legislation for an application for a new authorisation, amendment or renewal of authorisations

      • in case a limited assessment is not possible then appy for a full assessment procedure under transitional legislation (when the active substance in your product is being evaluated in the EU Review Programme for that product type)

      If the active substance appears in Annex I of the BPR 528/2012 and the biocidal product complies with art 25 of the BPR, a biocidal product is eligible for a simplified authorisation procedure. The simplified authorisation procedure aims to encourage the use of biocidal products that have a more favourable environmental or human and animal health profile.

   4. Step 3Is the product already authorised in the Netherlands?

      If the active substance is approved and you are the holder or represent the holder of a product authorisation, you might be interested to apply for:

      • a re-registration of a product authorisation (you can apply for renewed authorisation according to the BPR when all the active substances in your product have been approved)
      • a renewal of a product authorisation
      • a major change to a product authorisation
      • a minor or administrative change to a product authorisation
      • a same biocidal product authorisation
      • an additional name for a product
      • an immediate notification of harmful of unacceptable effects
      • a withdrawal a product authorisation

      If your product is authorised in another Member State in the EU and it is identical to a product that is approved in NL, it is possible to apply for:

      • a parallel trade permit in NL

      If an identical product is already authorised in NL and you have permission of the holder of a product authorisation, you might be interested to apply for:

      • a derived authorisation

      If the active substance is included in the Review Programme and still pending and you are the holder or represent the holder of a product authorisation:

      • a re-registration of a product authorisation under transitional legislation (following approval of the active substance)
      • a renewal of a product authorisation (after expiration of product authorisation period)
      • a minor administrative change to a product authorisation under transitional legislation
      • a major change to a product authorisation under transitional legislation
      • a withdrawal a product authorisation
      • If you have a group of very similar products with the same use and user type it may be possible to apply for authorisation of a frame formulation.​

   5. Step 4If the active substance is NOT approved?

      Only products with approved active substances can be authorised under the BPR.

      If the active substance is NOT approved (and not included in the EU Review Programme) you might be interested to apply for:

      • an active substance approval at ECHA

      If the application for active substance approval is submitted, you might be interested to put already a product on the market and apply for:

      • an authorisation under transitional legislation limited assessment procedure; see under Step 2
      • an authorisation under transitional legislation with the full assessment procedure; see under Step 2
      • a provisional authorisation

   6. Step 5Do you need to apply for a derogation?

      You can apply for a derogation of the requirements to have the biocidal product authorised in an emergency situation or for research and development.

      • Derogation for an emergency situation (art. 55)
      • Derogation for Research and Development (art. 56)