Immediate notification by the authorisation holder
Under Article 56 of Regulation 1107/2009, the authorisation holder of a plant protection product has a legal obligation to report new information to the Ctgb on the authorisation as soon as there are indications of harmful or unacceptable effects concerning the specified plant protection product, the active substance or its metabolites, a safener, synergist or co-formulant in that plant protection product which suggest that the plant protection product no longer complies with the criteria set out in Article 29 and Article 4, respectively. The authorisation holder is obliged to immediately report this new information to the Ctgb. This applies to all authorisations issued by the Ctgb. The assumption is that the plant protection product has been used under the authorised conditions.
The authorisation holder is obliged to inform the Ctgb of all potentially harmful or unacceptable effects on:
- the health of humans and animals,
- the groundwater,
- plants or plant products,
- the environment.
To this end, the authorisation holder must ‘record and report all suspected adverse reactions in humans, animals and the environment related to the use of the plant protection product’. The notification obligation also relates to decisions or assessments taken by international organisations or public bodies that authorise plant protection products or approve active substances in third countries. The notification must include an assessment of whether and how the new information would result in the plant protection product or the active substance, its metabolites, a safener, or synergist or co-formulant no longer complying with the requirements set out in Article 29 and Article 4 or Article 27, respectively.
The ‘Immediate Notification’ form can be used for this purpose. This form must be e-mailed. The Ctgb then assesses the report on the basis of the applicable criteria. The fees for submitting an immediate notification are shown in the Ctgb Tariffs Decree under Obligatory Notification (IKV). Depending on the outcome of the assessment, it will be determined whether measures are necessary and whether the authorisation needs to be amended.
If the authorisation holder has a proposal for amending the authorisation, they simultaneously submit a request for amendment.
Examples of situations that require immediate notification
- Incidents with humans - all negative, unexpected and unforeseen incidents that occur with people, which may be associated with the use of a plant protection product.
The Ctgb must be notified as soon as these incidents are known to the authorisation holder. Based on the available data, the Ctgb assesses whether the reported effects can be attributed to the specific plant protection product.
- Incidents with animals – immediate notification is required even if the effects are not widespread.
- Contamination of groundwater – reports of active substances or relevant metabolites being detected in the Netherlands at levels that exceed the European threshold value (0.1 μg/L for active substance), originating from company reports or official water monitoring programmes that are not accessible to the public.
- Impact on the environment – potentially harmful or unacceptable effects on soil, water or air quality, aquatic ecosystems, non-target organisms (e.g. beneficial insects, vertebrates) or other environmental compartments or systems that are possibly caused by the use of an authorised plant protection product where it is plausible that the conditions of the authorisation are no longer complied with.
- New data – unsubmitted data on the active substance or plant protection product from technical studies, or from studies required by law, demonstrating that the product no longer complies with the authorisation criteria of the active substance (Article 4) or plant protection product (Article 29).
- Official decisions or assessments by international organisations or government bodies – if these could be relevant for the decision of the Ctgb to authorise the plant protection product and which have been brought to the attention of the authorisation holder. Such decisions may originate from non-EU legislators or international organisations involved in the evaluation of plant protection products, such as the FAO and the WHO. An example of such a decision is the reduction of the Allowable Daily Intake (ADI) by the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) to a substantially lower value than that set by the EU; the decision was based on data that has not yet been evaluated by the EU.