National application and major changes

All biocidal products require an authorisation before they can be placed on the market, and the active substances contained in that biocidal product must be previously approved. There are, however, certain exceptions to this principle, addressed in the transitional measures of the BPR 528/2012, which entered into force september 1st 2013. For example, biocidal products based on an existing active substance(s) under review for that product type in the EU Review programme are subject to national law and will be placed on the market and used by a continuation of national rules and practices, pending the final decision on the approval of the active substance.

The national application under transitional legislation is the procedure of choice for:

  • the authorisation of a new biocidal product containing an active substance under evaluation in the review program;
  • amendments (eg. new use) of existing authorisations of biocidal products containing an active substance under evaluation in the review program;
  • major changes in the authorisation of biocidal products containing an active substance under evaluation in the review program.