Registration Process

Confirmation of receipt

A written confirmation of receipt of the application including payment of the application fees is sent within two weeks to the applicant. In this confirmation, the Ctgb reports the application number.

Intake

During the intake the Ctgb determines whether the application form has been filled in completely, and whether all required attachments are included. The Ctgb considers whether the application and the submitted data and documents are of sufficient quality to conduct an assessment. If the application proves to be not ‘valid and logical’, the applicant is notified about which aspects are incomplete and is given once the opportunity to supply the missing data, within a term established by the Ctgb. N.B. ambiguities and missing data will delay the processing of the application. Following receipt and evaluation of the missing data, or the expiration of the given term, the Ctgb decides either to conduct the assessment or not to take the application into consideration.

Assessment

Based on the submitted dossier, the Ctgb conducts a risk assessment of the biocidal product by determining whether the product is sufficiently effective and whether all relevant physical and chemical properties are known and whether the risks for humans and the environment arising from the use of the biocidal product comply with requirements for authorisation.

Additional questions

It is possible that the Ctgb concludes that ‘a safe use’ or ‘sufficient efficacy’ is not demonstrated. In that case, through additional questions supplementary data will be asked for refinement of the assessment. The applicant will be notified in writing (within 34 weeks after receipt of the payment for summarisation and assessment costs), and will be asked to submit the supplementary data within a term established by the Ctgb. After receipt of the missing data, the Ctgb informs the applicant in writing about whether the data will be taken into consideration. If so, an invoice for summarisation and assessment of the supplementary data is included.

Decision by the Board

After the Secretariat has prepared the assessment report, a draft decision is submitted to the Board. Finally the Board decides on the application to authorise the product. As a rule, the Board will decide to approve the authorisation, if the assessment indicates that the product is effective and can be used safely.

Timeline National Authorisation under Transitional Legislation

National legislation (Bgb, art. 7 and ‘Besluit bestuursreglement regeling toelating gewasbeschermingsmiddelen en biociden’, - in Dutch - Ctgb 2018) sets legal deadlines for handling of an application under transitional legislation. The visualisation of the activities in the registration process in the graph below, is based on these legal deadlines. Well organized dossiers however, may contribute to substantially shorter processing times.