Newsletter December 2021

In collaboration with the German Federal Office of Consumer Protection and Food Safety, the BVL (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit), the Ctgb arranged a workshop at the beginning of November for the member states, the European Commission and EFSA on the IT architecture in the context of the Plant Protection Products Regulation. The member states used it to allow each other a peek into their organisation and IT environment. The large differences were the first thing to stand out. The competent authorities all use different IT systems – a fact that does not make things easier for applicants. And it’s not possible – in any event at the moment – to link the national IT systems to the European (for example IUCLID, PPPAMS). In addition, this means considerable investment from each member state. This is more than adequate reason to look together at the developments in the IT field needed at the European level.

There has long been a need for a joint vision on IT and cooperation. Arranging this strategic IT workshop was for this reason agreed at the high level meeting of the directors of the competent authorities, European Commission and EFSA and others in December last year. Information technology is the lubricant for our modern society, organisations and business. When assessing the risks of plant protection products, we follow IT and IT developments closely, but we have not to date exchanged our vision and ideas on this in existing EU discussions. Until now. We would like moreover to link up as far as possible to the IT systems of the European Union, EFSA and ECHA.

There was great interest, with more than 60 participants from 19 countries, the European Commission, EFSA and ECHA. National and EU plans were discussed, EFSA and the European Commission set out their IT roadmap, including the IUCLID system for submitting applications for active substances and MRLs, and various member states presented their visions for the IT of the future. The participants conducted a lively discussion on open data, data exchange and desirable developments. Contact has been established, and ideas and visions exchanged. It was clear to all that we aim in the European future towards inputting data just once for subsequent use across the entire EU. To be continued!

Ingrid Becks

Secretary/Director of the Ctgb

From 1 January 2022, we will change the invoicing of service desk questions. Until now, questions requiring more than four (4) hours for the organisation to answer are billed. From 1 January, we will distinguish between whether the question can be answered by service desk staff and whether it has to be passed to back office staff. In the latter case, all the hours required, from the back office and the service desk, will be billed. If a service desk staff member is able to answer the question, this will in all cases be free of charge. In addition, questions that have been answered will no longer be billed per question; the applicant will instead receive a monthly combined invoice for the questions answered.

There were two reasons for this change. Firstly, the clear distinction between service desk hours and back office hours leads to less internal administration, which in turn leads to a small reduction in administration costs for the applicant. Secondly, the scientific assessors in the back office usually work on applications on a paid basis. If they answer a question from the pre-application process instead of that work, it is clear that these hours also have to be billed in full.

The Ctgb is constantly working to improve the quality and expertise of the service desk staff. In accordance with this aim, more than 50% of the service desk questions are answered by the staff themselves.

This change in rates will be included in the 2022 Tariffs Decree that will be made available on our website in December.

Introduction of the Wageningen Drift Calculator (WDC) will make various changes to the Ctgb work method necessary. With applications for mutual recognition and zonal authorisation for which the Netherlands is the relevant member state, the Ctgb is now still restricting the national assessment for environmental aspects with exposure via spray drift. For surface water (Step 1-2 and Step 3), non-target plants and non-target arthropods (only for fruit), the risk assessment in the Core Assessment suffices, as long as no drift-restricting measures are stipulated in it. The Ctgb is investigating whether this will still suffice, if the Wageningen Drift Calculator is used for the national assessment after 1 January 2022. It will make known whether the approach above will have to be altered or will be retained as soon as possible.

The Evaluation Manual Biopesticides version 1.3 has recently been published. This means that the description of the national assessment systems for plant protection products on the basis of microbial, botanical and semi-chemical active substances is once again up to date. The Evaluation Manual has been brought into line with EU guideline SANCO/2020/12258 for the risk assessment of metabolites produced by microbially active substances for plant protection products. The guideline applies for applications submitted from 1 November 2021 onwards.

Evaluation Manual Biopesticides

Following a differentiated assessment under transitional law (GBO), authorisation was extended for four biocides. This accelerated assessment is allowed only for agents using a substance not yet approved by the EU. The starting point for a GBO assessment is that the application can be assessed in a short time through comparison with another agent that has previously been authorised. This reference agent must contain the same active substance and be comparable with respect to its concentration in use and directions for use.

Since 2021, a concentration limit of 0.1% for so-called PBT and vPvB substances has applied for biocidal product products, in line with the REACH legislation. This was decided by the competent authorities (CA-June21-Doc.4.3 Final). PBT and vPvB are abbreviations for (extremely) persistent, bioaccumululative and/or toxic, and consequent cause for environmental concern. The ECHA website has up-to-date lists of substances with their properties: pbt and candidate list. If a biocidal product contains more than one substance of this kind, then the limit for the combined concentrations applies. Companies are under a best-effort obligation to replace PBT and vPvB substances by alternatives with a lower risk – even if the substance is below the concentration limit.