Status of zonal authorisations in the Central Zone
At the virtual Dublin Plant Protection Symposium held on 1-2 December 2020, Dr. Katja Bidovec, Head of the Plant Protection Products Sector at the Ministry of Agriculture, Forestry and Food in Slovenia, presented the status of zonal authorisations in the Central Zone.
Dr. Bidovec opened her presentation by describing the plans of the Central Zone Steering Committee (CZSC) to organise an interzonal directors consultation group meeting, allowing for increased cooperation between the various zonal authorities. Dr. Bidovec then moved on to outline the current zonal challenges.
The first issue described by Dr. Bidovec was the challenges arising from Brexit, which has resulted in a greatly increased workload leading to issues with capacity for the competent authorities. Another factor in this is the mutual recognition transition period, as products registered in the UK can no longer be registered in the EU under mutual recognition.
Dr. Bidovec then outlined the delays associated with the requirement for an endocrine disruptor (ED) assessment. The “stop the clock” mechanism of the ED assessment has delayed the work involved in the renewal and approval of applications, especially Article 43 applications. COVID-19 was also identified as causing delays, as some applicants could not perform the tests required and member states lacked optimum conditions to perform the evaluations.
Dr. Bidovec then focused on the capacity issues experienced by competent authorities. She highlighted the increasing numbers of applications for minor composition changes to Slovenia, as well as applications for mutual recognition filed right before the conclusion on renewal of active substances. The burden associated with comparative assessment was also outlined. Dr. Bidovec explained that comparative assessment, in its current form, is not effective as the number of active substances is declining. The increase in the number of emergency authorisations was also mentioned as having an impact on capacity.
Regarding harmonisation in the central zone, Dr. Bidovec mentioned the interpretation of the Regulation pertaining to Article 34 assessment, where it is not clear what should be assessed and data protection issues also arise where products could be out of protection in the zRMS but not in the cMS. There are also problems with reaching an agreement regarding the inter-zonal core assessment of protected crops. The last issue Dr. Bidovec touched on was the extension of submission deadlines due to the implementation of the new software such as IUCLID for active substance approval. Inter-zonal issues were also discussed such as the requirement for an environmental assessment for greenhouses and seed treatment.
Dr. Bidovec concluded by proposing some solutions to the problems identified, proposing that more cooperation on a strategic level with COM and EFSA and more comprehensive and elaborate guidance documents are required. In addition, allowing for the conclusion of evaluations and then making a confirmatory data request, preparation of higher quality dossiers for generics, and additional training in order to standardise evaluation procedures and reduce differences in evaluation would help to solve some of the issues at a zonal level.
If you missed the PPP Symposium, a copy of all the presentations is available on the publications section of the Kerona website; https://kerona.ie/product/dublin-plant-protection-symposium-2020-speaker-presentations/
If you have any questions in relation to the zonal authorisation of plant protection products please do not hesitate to contact our team in Kerona.