Annual Report 2023

Annual report | 30-04-2024

Preface

In 2023, the Ctgb and its activities were in the spotlight. There were discussions about sustainability and understandable concerns about possible health effects of plant protection products and biocides. This resulted in media attention and calls for more detailed assessments. However, the increasing complexity of assessments also put pressure on the turnaround times of submitted applications. This affects the Ctgb, and rightly so, because we are responsible for important societal tasks.

In view of these challenges, the new multi-year strategy focuses on turnaround times, enhanced sustainability and greater understanding of long-term health effects. In the area of enhanced sustainability, an accelerated procedure based on an administrative route for applications for authorisation of low-risk products came into force on 1 January 2023. A new methodology has been developed for the comparative assessment of substances with "candidate for substitution" status (effective 1 from January 2024). This accelerates replacement with safer alternatives. We also established a separate enhanced sustainability desk that prioritises the processing of applications for plant protection products that contribute to sustainable agriculture. All these activities help to accelerate the availability of products that are less harmful to humans, animals and the environment.

During the year under review we rejected 6% of applications for plant protection products and 10% of applications for biocidal products in their entirety, which was more than in previous years. In addition, some of the uses that were applied for were rejected by the Ctgb or withdrawn by the applicant (applications usually include multiple uses). The conditions under which an authorisation is issued were also tightened in a large number of cases. In existing authorisations for phosphides and rodenticides, we placed additional restrictions on the use of these products. We value this secure assessment of substances and products because ensuring the safety of humans, animals and the environment has always been our mission.

In 2023, the periodic (five-yearly) assessment of the scientific and legal quality of our work was conducted by an independent International Audit Committee, this time chaired by Professor Anthony Hardy. We are proud of this committee's positive assessment of the quality of our work.

Among other improvements to reduce turnaround times, an organisational change of the Ctgb secretariat was implemented in the autumn of 2023. Preparing for this change and keeping the new work processes running smoothly has demanded a lot from all employees. The excessive turnaround times are also the result of the inadequate assessment capacity in other Member States and the increasing complexity of assessment frameworks and associated regulations. Therefore, the Ctgb has prepared an analysis for consultation with departments, the European Commission and other Member States on possible modifications and simplifications. These consultations take place at many levels. Although changes in the European system are not easy to achieve, we consider our international commitment to this process to be of great importance.

In 2023, much public and political attention focused on the authorisation and use of plant protection products and biocides. The European approval of glyphosate was especially in the spotlight. A number of national newspapers published interviews with the Ctgb on this topic. In these interviews we not only provided a detailed explanation about the tasks and responsibilities of the Ctgb, but also clarified the limits of our competences. In addition, we explained how the European frameworks that we work with come about and how we apply them. This is in line with our more proactive communication strategy, in which we prioritise openness and transparency.

I would like to close by expressing my appreciation to all our staff, with special thanks to our departing Board member Corné Kempenaar and to all our partners. We look forward to renewing our acquaintance with all stakeholders at the annual Ctgb Client Contact Day on 12 June next.

Rob van Lint

Board Chairman

Besides working on the applications, the Ctgb advised the ministries of Agriculture, Nature and Food Quality (LNV) and Infrastructure and Water Management (IenW) on policy questions about plant protection products and biocides, respectively. For both policy areas, we prepared an analysis of national and EU bottlenecks that were identified as relevant by the ministries and ourselves. At the EU level, we consulted with DG Sante, ECHA (biocides) and EFSA (plant protection products). For both plant protection products and biocides, we also addressed proportional distribution of activities and workload in the EU, and we contributed to framework development. With an important contribution to the course Better Training for Safer Food (BTSF) for European colleagues, the Ctgb helped to enhance knowledge about micro-organisms in plant protection products.

Plant protection products

Administrative route for low-risk products

When a plant protection product is used, some of it (via drift, for example) enters the environment. The Implementation Programme for the Vision on Plant Protection 2030 assumes sustainable production with resilient plants and cultivation systems that can avoid the use of plant protection products as much as possible. If plant protection products are used, this is done in accordance with the principles of integrated crop management, with virtually no emissions to the environment and virtually no residues. This principle is an important starting point for Ctgb policy. The Ctgb wants to simplify and accelerate the availability of low-risk products. Since 1 January 2023, an administrative route has therefore been established for extending the authorisation of low-risk products with minor uses, which will accelerate processing and decision-making. This means that no assessment (partial or otherwise) is done for the newly requested minor uses; the decision to authorise these uses is based entirely on the assessment of the previously authorised uses. For first time in April 2023, 12 additional uses in fruit and vegetable crops were authorised for a first low-risk product based on this procedure.

Azole resistance

For a number of years, healthcare has been faced with a fungus that is resistant to azoles, which are also used in anti-fungal medicines. Among other factors, this resistance can be caused by contact with azole-based fungicides in, for example, plant protection products or wood preservatives. In 2023, the Ctgb concluded on the basis of new research that the problem cannot be solved by authorisation policy alone and that a broader approach is needed. As a result, the Ctgb withdrew the previously adopted 'azoles protocol'. The Ctgb asked the Ministry of Agriculture, Nature and Food Quality to include this resistance problem in the ongoing national and international research into effective control measures for this problem.

Delays in assessment of plant protection products

For plant protection products, the assessment framework has been expanded both in terms of content and procedure in recent years. As a result, the workload per application has increased enormously and the statutory deadlines are no longer commensurate with that workload. This is due, for example, to the introduced requirement for full reassessment as part of substance and product renewal, instead of just reviewing new data and a new assessment framework. New components were also added to the assessment framework (such as endocrine disruption and prohibited co-formulants) and guidelines were revised, which made the process more complex. This complexity is increasing not only because of new scientific insights, but also to enable increasingly refined assessments. This makes the assessment process more time-consuming.

Delays in assessment of biocidal products

In the case of the historically 'younger' assessment framework for biocidal products, the issue is that it is not yet complete and finalised in terms of both content and procedure. As a result, further specification takes place during the assessment, with the goalposts sometimes shifting during the game, so to speak. Coupled with the fact that we have to consider the latest scientific insights, this means that we sometimes have to redo parts of the assessment, which greatly slows down processing. More pragmatic, risk-based choices from the European Commission and Member States could help accelerate the assessment of biocidal products.

Reassessment of glyphosate

No substance reassessment has resulted in as much controversy as that for glyphosate. In 2023, this renewal procedure ended with the European Commission's decision to renew the approval of this active substance for 10 years. The publication of the EFSA conclusion and the Commission's proposal led to much attention in the Lower House of Parliament and the media. The Ctgb advises the minister on the reassessment of glyphosate, and the minister decides on the position of the Netherlands in EU decision-making. The Secretary-Director of the Ctgb was interviewed in various national media about the procedure for re-approving glyphosate and for an explanation of the EFSA opinion. She also participated in a round-table discussion on this topic that was organised by the Lower House of Parliament. This discussion included societal concerns about a possible link between substances such as glyphosate and neurodegenerative diseases such as Parkinson's disease. However, no assessment methodology is yet available to specifically assess the risk of neurodegenerative diseases. In order to assess such risks in the future, in its multi-year strategy 2024-2027 the Ctgb has prioritised research into the long-term health effects of plant protection products and biocides.

Court ruling on case involving lily grower and local residents

In a summary judgement involving a lily grower and local residents, in 2023 a court prohibited the use of legally authorised products for the first time. On appeal, the trial court partially reversed the summary judgement. Although the Ctgb was not explicitly involved as a party to these proceedings, we took time to answer media questions about this case.

Organisation and organisational development

Ctgb wants to remain on a steady course and be prepared for the future. During the year under review, we worked in several areas to prepare for the 2024-2027 policy period, which is derived from the multi-year strategy 2024-2027. Based on various analyses, evaluations and a round-table discussion with representatives of interest groups, ministries, NVWA, CLM, RIVM and NGOs, the Board formulated three priorities for the new policy period:

• commit to reducing application turnaround times;
• facilitate the sustainability of the substance and product assortment;
• commit to greater insight into the long-term health effects of plant protection products and biocides.

It follows from these priorities, and other aspects, that we are investing in reducing turnaround times. One result of this was the organisational development during 2023. In 2024/2025, we will give applicants better insight into the status of their applications.

We are also establishing a separate desk for applications that contribute to enhanced sustainability. Finally, based on our role and expertise, we are contributing to the development and feasibility of methodologies for assessing cumulative exposure and neurodegenerative diseases.

To stay on course and ensure that we have an accurate picture of our performance, the Ctgb regularly reflects on itself with initiatives such as the 2022 stakeholder survey, which was published in early 2023. In this survey, the Ctgb scored high on expertise, quality and reliability, but it also showed dissatisfaction with the long turnaround times. The signals from the survey have been taken into account in the new multi-year strategy.

The aim of the organisational development implemented on 2 October is to balance the quality-time-money triangle effectively and to strengthen integral collaboration in the process chain. This should lead to reduced backlogs and shorter turnaround times. However, this does not mean that the Ctgb will meet the statutory deadlines for all types of applications (as explained above). The main effect of the organisational development is that an application is assessed and dealt with as efficiently as possible by a single collaborating team in which all areas of expertise are represented.

On 2 October, Minister Adema of Agriculture, Nature and Food Quality also visited the Ctgb. It was his first visit to the Ctgb, for which his ministry bears responsibility in the Lower House of Parliament. After a short speech to all Ctgb employees, the minister conducted a discussion with the Board Chairman and other executives.

Annual Ctgb Client Contact Day

On 15 June, the Ctgb held the annual Ctgb Client Contact Day, which was attended by more than 200 interested stakeholders. The theme – Authorisation and Enforcement – was addressed from various perspectives by representatives from ministries, enforcement agencies, the public prosecutor's office and NGOs. The consensus at the end of the day was the following: for a sustainable living environment, we need each other and must continue to seek cooperation to ensure effective connection in the chain of authorisation, compliance and enforcement, especially with regard to new developments.

Journalists' meeting

For journalists from trade journals and regional and national daily newspapers who report on science, health or the environment, the Ctgb holds annual meetings. The journalists in attendance are given more in-depth information on the assessment process. The focus this year was on the toxicological assessment. Journalists from over 10 publications and/or editorial boards participated in the meeting. They expressed their appreciation for the initiative and the presentations made by the Ctgb staff.

Labour market communication

To attract sufficiently skilled new employees, the Ctgb updated its website with labour market information. This included a short video (recorded with our own employees) to show how appealing and exciting it is to work at the Ctgb.

Trends in authorised products and active substances

The Ctgb reports every year on how many products are authorised in the Netherlands and how many different active substances they contain. Regarding the number of active substances for plant protection products, a decreasing trend was shown, although the total number of products has grown slightly. For biocidal products, the number of active substances has remained stable, and the total number of products has continued to decrease slightly; see the figures below.

However, these figures provide only limited information on the number and types of products available per sector. Chapter 3 Applications, assessments and authorisations discusses this in more detail.