Market freeze on authorisations, as much as possible, limited
In its meeting on 22 June 2016, the Board clarified its policy regarding biocide authorisations during the transition from Dutch law to the Biocidal Products Regulation. The Board has sought to utilise the maximum flexibility offered in the legislation and the Ctgb operational process.
Between the European approval of biocidal substances and the authorisation of the corresponding products in the Netherlands (based on the inclusion of the substances), there is a sort of 'No man's land'; during the interim period, how can applications and amendments be processed? According to previous policy, from the date of European approval of a biocidal substance, the Ctgb stops processing applications for derived authorisations and amendments that are related to that substance. This has caused difficulties for industry, which experiences this as a ‘market freeze’. This problem is partly inherent to the authorisation system. However, the Ctgb has sought to make a concession to applicants regarding the most important bottlenecks in the system. To limit the duration of this market freeze, the Ctgb has used the maximum space offered by the law to continue to accept applications for amendments and derived authorisations.
Specifically, the Board has formulated three recommendations for applicants and authorisation holders about when it is still sensible to submit an application under transitional legislation in the Netherlands. In these recommendations, the Board took account of a realistic period for assessment and decision-making within the Ctgb. Under transitional legislation in the Netherlands,
- Applications for authorisation of a new biocidal product and applications for major amendments to existing authorisations can be submitted to the Ctgb up to 78 weeks before the date of European approval of the last PT-substance combination for the corresponding biocidal product.
- Applications for a derived authorisation and minor amendments of existing authorisations can be submitted up to 90 days before the date of re-registration of the original authorisation.
- Administrative amendments can be submitted until immediately before re-registration.