PPP and Yield Enhancer Registration in Hungary
PPP and Yield Enhancer Registration in Hungary
Day two of Kerona Scientific’s virtual Dublin PPP Symposium featured a presentation by Dr Gábor Tőkés on PPP and yield enhancer registration in Hungary. This focused on three main topics: Solutions for PPP authorisation capacity problems, handling borderline cases/non-PPP and parallel authorisation systems for fertilisers.
Dr Tőkés explained that products used in agriculture are divided into three main categories and dealt with under a mixture of legislations including the Plant Protection Products Regulation (EC) No. 1107/2009, the Fertilising Products Regulation (EU) 2019/2009and national legislation.
PPPs are dealt with under Regulation (EC) No. 1107/2009 while non-PPPs such as adjuvants and traps are dealt with under a combination of national legislation and Regulation (EC) No. 1107/2009. The third category is yield-enhancing substances (YES), which are dealt with again under a combination of national legislation and the Fertilising Products Regulation (EU) 2019/2009.
Authorities dealing with the first category (PPPs) have a very wide set of tasks including active substance evaluation, new PPP evaluation/authorisation as zonal rapporteur member state (zRMS)/concerned member state (MS) and/or through mutual recognition (MR), re-registration/renewal, withdrawals, clones, amendments, emergency and parallel import. All these tasks need diversity and capacity within the evaluating authority and as a result, delay is a critical issue almost everywhere. Refit is currently being used in Hungary to increase output by taking on new staff/experts, outsourcing work or establishing an effective organisation.
The second category (non-PPPs) includes products that fall out of scope of the Plant Protection Products Regulation and these include border-line cases, plant care products, signalization traps, macro-organisms for biological protection and at the moment safeners, synergists and adjuvants, which will, later on, be covered within the scope of the Plant Protection Products Regulation (EC) No. 1107/2009 once data requirements are set out. For safeners, synergists, co-formulants, adjuvants, cleaners, stickers and adjuvants, the data required is similar to PPP, however less data is needed, non-GLP is accepted and in the case of well-known substance literature data is accepted. For plant protection tools such as traps, there are simplified data requirements. Macro-organims also fall into this category despite use for plant protection purposes. In Hungary these types of producst are registered at national level.
The third category (YES) includes fertilisers (other than EC fertilisers), organic manures, biostimulants and microorganisms. Generally, there were easy or no registration requirements in most of the EU MS as long as there was no plant protection claim on the label. In Hungary, national registration under national legislation covers fertilisers (except EC fertilisers), organic fertilisers, mineral fertilisers, composts, earthworm humus, soil improvers and growing media, while soil conditioners, microbiological products and plant conditioners are covered as biostimulants in the new Fertilising Products Regulation (EU) 2019/2009. The principles of authorisation for YES products are that they have a positive effect on the plant, yield or soil and that they have no negative effect on the human-animal-plant health and the environment.
The new Fertilising Products Regulation (EU) 2019/2009 is applicable from 16th July 2022 for all YES and also for former EC fertilizers. National authorization is only for products not fulfilling the new requirements or if voluntarily required by the applicant. Optional harmonization is where the applicant can decide between the EU or MS registrations.
Please get in touch with Kerona Scientific if you require any regulatory support for plant protection products or fertilisers in any EU member state (info@kerona.ie) or in GB (info@kerona.co.uk). If you missed the symposium, you can still download the slides at the following link: https://kerona.ie/product/dublin-ppp-symposium-2022-speakers-presentations/