Newsletter July

After two years – the event was cancelled in 2020 and last year it was held digitally – we were once again able to hold our Ctgb client contact day at a physical location. It was very enjoyable to see and speak to all our external contacts from very different walks of life! The programme was well-organised and varied, and our Board chairman Johan de Leeuw was able to announce his departure in a lovely way.

The keynote speaker, Cees Leeuwis from WUR, had a message that really got us thinking. He showed us that the transition to sustainability means that we must dare to think even bigger, outside our existing frameworks. And that to achieve true system innovation and make the transition to sustainability, all parties that feel mutually dependent and that are actually dependent on each other must act together. We must dare to put pressure on the existing system – in which we also have a role – and develop new narratives. And of course we must continue to ensure safety. According to Leeuwis, the path to sustainability is diverse, varied, committed and creative. It is not reactive, but creative, whereby all parties with their conflicting interests act together as a coalition and generate the pressure needed to achieve innovation of the entire system.

This means that we have to think bigger. Many ‘outside the box’ solutions are already being developed within our existing frameworks, and we have already achieved a lot with smart solutions – such as the differentiated assessment of biocidal products under transitional legislation – and with our growing expertise on micro-organisms. We have also responded to innovations such as strip cultivation or precision application, but we can go much further by looking for creative solutions outside our familiar box, separate from all existing frameworks and outside European regulations. I do not rule out that we will have to go down that path together (at the European level, of course) in order to establish a completely different system in the future. More than enough food for thought... Daring to think big can also help us with the problem of turnaround times. We will keep you informed.

Ingrid Becks

Secretary / Director of the Ctgb

The Ctgb wants to be transparent in its decision-making and considerations. That is why it has been publishing the agendas and the approved Board reports on its website since the beginning of this year. The agenda is posted on the website in the week prior to the meeting, and the report is generally approved two months after the meeting and is then published. For example, the report of the April meeting was available at the end of June. The report contains all final decisions and considerations with regard to general policy, business operations and the products to be authorised.

Due to the lower demand for telephone support, from 1 July the Service Desk of the Ctgb will be available by telephone between 9 am and 12 noon on Monday through Friday.

We continuously check whether the classification of substances is still in accordance with recent technical and scientific advances. Due to the 18^th ATP, Regulation (EU) 2022/692 has been amended: 17 substances have been re-classified, 39 substances have been included and 1 substance has been removed. This concerns 6 active substances from biocidal products and 13 active substances from plant protection products. As a result, producers may have to change their product label, or there may be consequences for the authorisation. Producers are expected to keep track of these changes themselves. The transition period for existing labels – to allow suppliers to change the labelling and packaging of the products to comply with the new classifications and to sell existing stocks – will run until 23 November 2023.

Classification, Labelling and Packaging

At the beginning of May, the Ctgb published its annual report. As last year, an infographic has been created for this report.

Annual Report 2021

The Ctgb recently decided that plant protection products that are safe for conventional cultivation are also safe for strip cultivation if used correctly. It goes without saying that crop-specific instructions for use apply to all strips on which that crop is grown. This does not require a separate application, assessment or decision.

Greenhouses in other EU Member States are not always the same as the familiar greenhouses in Westland. There are many variations in protected cultivation, especially in the southern European Member States. The EU Member States have now reached an agreement in the IZSC (Interzonal Steering Committee) on the procedure for the risk assessment of applications for various greenhouse uses. High-tech greenhouses and low-tech greenhouses must be assessed interzonally for all three European zones. The other types of protected cultivation, including walk-in tunnels, are included and assessed in the zonal DRR (Draft Registration Report). These requirements are in force for new applications from 1 June 2022.

Agreement of IZSC on the submission of DRR for the application of PPP to be used under greenhouse conditions

A special process will make it possible to add minor uses to authorised low-risk products. This will ensure that these uses are available more quickly and easily for sustainable cultivation. If no assessment is required, the Ctgb will process the requested minor uses administratively as much as possible. If a maximum residue limit (MRL) applies to the active substance, however, an assessment is still required. Other situations in which an assessment is required have been determined per active substance.

Authorisations for non-professional use of plant protection products are regularly applied for. This involves a wide range of products such as sticks for flower pots, granules and powders, and sprays for use both indoors and outdoors. For non-professional uses, a specific, harmonised approach to assess ecotoxicological risks is not yet available. A spray for non-professional use is therefore initially assessed for professional use. However, this generic approach has not worked very well, because home gardening and arable farming (professional monoculture) cannot be compared. Until a harmonised approach becomes available, the Ctgb therefore follows an internal policy line for non-professional use of sprays that is based on a decision tree. This simplifies the authorisation process, especially regarding the ecotoxicology assessment for certain low-risk products. For other applications for non-professional uses – such as uses based on granulates, drenching treatments or sticks – an assessment will be performed in accordance with the current framework and then submitted to the Board.

Non-professional spray applications of plant protection products, a new approach to the higher tier assessment (ecotoxicology)

Chapter 7 Ecotoxicology; terrestrial; non-target arthropods – EU part – of the Evaluation Manual has been updated. Point 7 in the decision tree in Appendix 1 has been updated to reflect the current state of knowledge and expert judgement used in the higher tier risk assessment for non-target arthropods based on field studies. For off-field studies with small plots (checkerboard design), the ‘no observed effect rate’ for the population (population NOER) together with a safety factor of 2 is considered to be the relevant endpoint (the regulatory acceptable concentration – RAC) for risk assessment. For studies with larger plots (≥1 ha) in which the test substance is applied according to the intended use, a choice is being made on a case-by-case basis between the population NOER (no observed effect rate) or the NOAER (no observed adverse effect rate, i.e. including recovery) until additional guidelines are available.

The current risk assessment framework for non-target arthropods (Guidance Document on Terrestrial Ecotoxicology (Sanco/10329/2002 rev 2 final) and ESCORT 2) lacks specific guidelines on the endpoints and trigger values to be used in field studies; they are for this reason based on expert judgement. However, including this in the EM as a structural approach creates a dilemma because the methodology has already been used in specific cases. This causes inconsistency when entering a start date. The current update therefore applies to both current and future dossiers.

7. Ecotoxicology

The Evaluation Manual, EU part and NL part, Chapter 6 Fate and behaviour in the environment: behaviour in soil; leaching, has been amended in version 2.6. In June 2021, new versions of the FOCUS PELMO and FOCUS PEARL models were released. These models are used in the first tier of the risk assessment for leaching to groundwater. The new versions of the models, FOCUS PEARL 5.5.5 and FOCUS PELMO 6.6.4, also make it possible to calculate concentrations in the soil and pore water according to the new guidance from EFSA for calculating exposure of soil organisms. This new guidance is not yet in force, but the new versions must now be used in the first tier of the risk assessment for leaching to groundwater. The website of FOCUS DG SANTE, where the models are made available, states that FOCUS PEARL 5.5.5 and FOCUS PELMO 6.6.4 should be used for applications submitted after 1 January 2022.

Simultaneously with the release of the new models, an amended version of the guidance document “Generic Guidance for Tier 1 FOCUS Ground Water Assessments” was published. The most important change is the additional guidance for the parameter derivation in cases where degradation and sorption in the soil is dependent on pH or other soil properties. The new version of this guidance document (version 2.3) is also in force for dossiers submitted after 1 January 2022.

6. Environmental Fate & Behaviour

From 1 June, the Fate and Behaviour team has made a slight change in its procedure for assessing dossiers – national, zonal and interzonal:

• The applicant text will not be changed (except for minor editorial aspects).
• The RMS (NL) evaluation – comments, revisions and (if necessary) recalculations – will be placed in a grey text box at the bottom of the assessment.
• The final conclusion about the risk and the expected concentrations in the environment (PEC values) will be clearly shown in this box.
• Additional questions, if needed, will be included in the text box.
• The procedure has changed only for Part B.8. For Part A, Part B.0 and Part B.10, it has not changed.

The Ctgb has implemented this change to make its operational method more efficient and transparent. In addition, it is now more in line with the procedure used in many other Member States to process the dRR format for the fate section. Because no other changes to the template or assessment framework were required, this procedure has been in effect since 1 June 2022.

Last year, the Ctgb introduced the validation checklist for biocidal products. For new applications, the list shows the points on which the Ctgb assesses biocide dossiers. The list thus provides applicants with an overview of the requirements that an application must meet when it is submitted. Due to the overlap, the validation checklist has made the biocidal products priority list superfluous. It is thus no longer in use and has been removed from the Ctgb website. Applicants are requested to use the validation checklist when preparing and submitting new applications for biocidal products.

Validation list BPR