Methods and procedures
Before a plant protection product or biocidal product can be sold and used in the Netherlands, the person who wants to place this product on the market must have an authorisation from the Ctgb.
Applying for an authorisation
The applicant submits an application dossier to the Ctgb that complies with Europe and national regulations. For example, the information in the dossier must be obtained from studies conducted by independent laboratories that meet the criteria for “Good Laboratory Practice” and “Good Experimental Practice”. The Ctgb conducts a critical assessment about whether all the studies provided by the applicant meet these criteria.
All documents required for the assessment must be present in the dossier and must comply with the substantive requirements. The actual assessment begins only after the application dossier is complete.
During the assessment, the possible exposures to substances for humans, animals and the environment are calculated. These calculated exposures are then compared with the safe values. In this way, the risks of using the product are specified. If the assessment indicates that the product can be used safely and that it is effective, then the Board will decide to authorise the product.
The Ctgb assesses the risks in accordance with European law (regulations and directives). We refer to this as the assessment framework. The framework applies to all EU Member States. However, country-specific rules and requirements may also apply.
This determines the implementation of the assessment framework, including the risks and how these should be assessed and reviewed according to the prevailing laws and regulations. The adoption of these laws and regulations is a political process.
After the Secretariat has prepared a decision, a draft decision is submitted to the Board. The Board checks the draft decision and makes a decision on the application (whether or not to authorise the product). All decisions concerning an authorisation can be appealed.
Legal conditions for use
As part of the authorisation process, legal conditions for use are approved, which must be included on the label of the product. In addition, the Ctgb assigns an authorisation number (e.g. 12345 N or NL-1234567) that must also be included on the packaging, so users can see whether the product has indeed been authorised in the Netherlands.
Overview of authorisations
Most of the assessments of authorised products conducted by the Ctgb are publicly accessible. In this way, everyone can see the studies on which the Ctgb based its decision to grant an authorisation and the considerations that played a role in this process.