What if a maximum residue limit has not yet been established?
An application may be made for authorisation of a plant protection product in the Netherlands or in a zone in Europe, while no maximum residue limit has yet been set at the EU level for use of a particular substance on a particular crop. What does the Ctgb do in such cases?
For the purpose of clarification, an overview of existing policy is given below. Based on Regulation (EC) No 1107/2009 concerning plant protection products, and a European Commission decision, the Ctgb applies the following procedures for maximum residue limits under each of the following scenarios:
1. A maximum residue limit applies
The maximum residue limit is laid down by law (is applicable) and used as the standard by enforcers and trade organisations. The Ctgb may authorise the product.
2. A maximum residue limit is in force
If a maximum residue limit is in force – the limit has been published but not yet applied – the Ctgb may authorise the plant protection product. The applicant must however be informed of this, as there is a risk to growers that certain parties, such as a supermarket chain with a quality department, will not purchase their product. There is no risk as far as enforcement in the Netherlands is concerned, as the Netherlands Food and Consumer Product Safety Authority will also apply the date from which the maximum residue limit comes into force.
3. The maximum residue limit is not yet in force but is known
If the value of a required maximum residue limit is known – which means that the procedure has reached a point at which this will no longer change – and the European Food Safety Authority (EFSA) has published a recommendation naming a limit that covers the intended use, the Ctgb will make use of this maximum residue limit in its assessment. This is because the limits recommended by the EFSA are not usually changed. However, the Ctgb may not yet authorise use of the product.
Once the maximum residue limit has come into force, the applicant has four months within which to apply for an administrative change to extend authorisation for the use concerned. After all, the use has already been taken into consideration in the assessment and the length of time between the assessment and the moment at which the maximum residue limit came into force is limited. The ‘original’ application still falls within the authorisation deadline, and therefore so too does the extension. The authorisation application must be resubmitted if the new authorisation covers just one use.
4. The maximum residue limit is not yet known
If the value of the maximum residue limit is not yet known, the applicant may submit an application for a zonal extension at a later stage or, if the new authorisation covers just one use, resubmit the authorisation application.
Maximum residue limits: applications for minor uses (NLKUG)
In the case of an application for minor use, a maximum residue limit must also be established that covers the requested extension. There is also a specific requirement that the extension of use being applied for falls within the ‘risk envelope’. This means the Ctgb will establish that the risks of the extended use being applied for are no greater than the risks of the previously authorised uses.
Maximum residue limits: re-registration and renewal applications
It is possible that, in the case of substance renewals, the definition of the residue changes and therefore the maximum residue limits also need to be changed. In this case, the European Commission may ask the EFSA to re-assess the maximum residue limits. Until the re-assessed maximum residue limits come into force, the existing standards will apply in accordance with the old residue definition. If this covers the use in the re-registration or product renewal application, the Ctgb will apply the existing standards as these are legally valid at the time of application. The Ctgb will however apply the new residue definition when assessing the exposure risk to consumers. If the use is not covered by existing standards, the procedure described above will be followed (1–4). This situation is not expected to be seen very often in practice as re-assessments are usually conducted for substance renewals, and new residue definitions are established in the renewal process.