Annual Report 2021
Again this year I would like to express my gratitude for the flexibility and tremendous commitment that everyone has shown during the corona pandemic. Our employees and the Board continued to work mainly from home and digitally. This was not always easy for employees with small children or those who were alone at home all this time without their usual contact with colleagues. But our productivity has not suffered as a result. Despite the restrictions of the pandemic, everyone was still prepared to submit dossiers and assessments to the Board for decision-making. As a result, hardly any additional delays were incurred. At the same time, we are of course pleased that we can go back to normal a bit more and can again consult with each other in person. This also applies to applicants, for example when submitting applications and providing further information. Here as well, in-person consultations with the account managers have again become possible, and this can be done in a more relaxed manner.
During the corona period we also learned about new approaches to work, and we want to give them a place in a hybrid method and create a new balance between physical and digital working. The trick is to do this together, and this process will take shape in the near future. That also applies to the Board. We will also start meeting in person again on occasion, while at the same time – also in Europe – we will continue to work digitally.
This search for balance also applies to the budget and the organisation as a whole. Fortunately, we ended the year with a small positive result, even though the budget and the available assessment capacity were not in balance. That was due in part to the time and energy that was required by the glyphosate dossier – especially from the single review team that was involved – and in part to unexpected staff turnover. Besides the quantitative aspect, i.e. the number of staff, the balance between the various teams also needs to be restored because they depend on each other. And that imbalance has an impact throughout the European Union. All in all, the assessment capacity at the Ctgb and our counterpart organisations in Europe is inadequate. This is partly related to the financing system, whereby the European Commission and the coalition government in the Netherlands also believe that the Ctgb system should be an example for other countries. This would enable the capacity to be increased more easily. Indeed, more assessment capacity in Europe is a precondition for restoring balance.
In this regard, we have been creative at the Ctgb with differentiated assessments and a cluster-based approach, such as the exemptions for disinfectants and the transitional law for biocidal products. This all contributes to being as balanced as possible and achieving maximum performance as an organisation.
We have a robust assessment system in Europe, which means that products are placed on the market only after they have been assessed as safe and after a decision-making process that often stipulates mitigating measures. The system is constantly being maintained, varying from the development of guidances to anticipating new scientific information. Based on the Regulations for biocidal products and plant protection products, applicants are also required to raise the alarm themselves if new facts or circumstances become known that affect their authorised products and their uses. And that in turn gives the Ctgb the opportunity to anticipate this if necessary. Responding alertly to new information thus ensures the reliability of our assessments.
We also respond alertly to new information by making appraisals – often at the request of the Department or on our own behalf – such as the studies conducted by Meten=Weten and the azoles issue, in which much has been set in motion on the basis of our alertness and actions, not only in the Netherlands with the flower bulb consultation, but also at the EU level. And this was shown more recently with the phosphine issue, in which we have shared knowledge in the same way. This was not limited to our sphere of activity, but has taken place throughout the chain, and this is also being followed up in the EU. We have contributed to the activities for the bee guideline in Europe and identified the risks of possible neurodegenerative effects of plant protection products in Europe and at the Department. And that will be followed up in method development. Last year in the Netherlands, we advised on the management of pest control, among other things. These are good examples of how we operate according to a reliable system and remain alert to new developments and scientific information. The Ctgb is also transparent about this. On our website the documentation system has continued to grow. It provides access not only to our decisions, but also to more and more of our formal advice and appraisals. The Board agenda and reports are now also available.
In recent years, many discussions about biodiversity and sustainability have taken place. What can the Ctgb do about these aspects? What can the Netherlands do about them? What do we ask of Europe and what do we expect from the authorisation system? New guidances have been published on several topics and updates on existing topics are in development. Over the longer term, this will also depend on discussions about the possible reformulation of the objectives related to protection. In consultation with the Department, we are looking specifically at the short-term priority for European guidances in line with developments to achieve a reduction in use. We now have a good picture of strip cultivation – one of the topics on the sustainability agenda. We have looked closely at this aspect from the perspective of the authorisation system and made a decision that we can go forward with. Authorised products can be used in strip cultivation, with the following points for attention: phytotoxicity, residues and effects on natural enemies in the adjacent strips. Using a similar approach, we are also going to investigate how we can give precision techniques a useful role in modern, sustainable crop protection. In this way we continue to respond to new developments.
ir. Johan F. de Leeuw, chairman
1. Annual overview: 2021 in a nutshell
The Board for the Authorisation of Plant Protection Products and Biocidal Products (Ctgb) is de competent authority in the Netherlands for plant protection products and biocidal products. It is a semi-autonomous agency (abbreviated in Dutch as ZBO) that assesses the risks of products and active substances and takes decisions within the European frameworks of the Plant Protection Products Regulation and the Biocidal Products Regulation. These regulations are based on the precautionary principle: a product may only be placed on the market if it has been shown to be safe. For these risk assessments, the Ctgb works closely in the EU with the European Food Safety Authority (EFSA), the European Chemicals Agency (ECHA), the competent authorities of the other Member States and in the Netherlands with various ministries, the Dutch Food and Consumer Product Safety
Authority (NVWA), the Human Environment and Transport Inspectorate (ILT) and research institutes such as the National Institute for Public Health and the Environment (RIVM) and Wageningen University & Research (WUR).
For the implementation of European regulations, guidance documents are developed and regularly updated to take account of the latest advances in science and technology. The Ctgb actively contributes to this process. Our organisation remains critical and vigilant, keeps track of current developments, is open to scientific assessment and strives to be as up-to-date as possible and prepared for the demands that new developments will impose. The assessment framework and risk assessment process are therefore constantly evolving, due to continuous refinement and adaptation to new scientific insights and societal developments. The Ctgb also provides solicited and unsolicited advice to various ministries.
Decisions and advice
In 2021, the Board made 140 decisions on applications for plant protection products and 88 decisions for biocidal products. These decisions often covered more than one authorised use of the product. Of the decisions taken, the Board completely rejected six applications for plant protection products and seven applications for biocidal products. Incidentally, if the Board authorises a specific product, this does not necessarily mean that all uses in the application are also authorised. Some of the requested uses (15% for plant protection products and 1% for biocidal products) were rejected or withdrawn by the applicant because of risks identified by the Ctgb. In addition, the instructions for use have been made more restrictive in many existing authorisations; this applies to 50% of the plant protection products and 68% of the biocidal products. The Board advised the Ministries of Agriculture, Nature and Food Quality (LNV) and Infrastructure and Water Management (IenW) on, among other things, 48 exemptions (39 for plant protection products, 9 for biocidal products).
Trends in authorised products and active substances
The Ctgb reports annually how many products are authorised in the Netherlands and how many different active substances they contain. For plant protection products, a downward trend in the number of active substances has become apparent, while for biocidal products the number of active substances has remained stable. See the figures below. However, these figures provide only limited information on the number and types of products available per sector.
Autorised Plant Protection Products and Biocides
|Biocidal products||Plant Protection Products||Active subsances PPP||Active substances Biocides|
Exemptions due to the corona pandemic
In early 2020, the Ctgb had to perform many risk assessments in a short time at the request of the Ministry of Infrastructure and the Environment. These assessments were related to exemptions for disinfectants. In 2021, the Ministry granted exemptions for disinfectants only if a corresponding application for regular authorisation had been submitted to the Ctgb before 1 February 2021. These applications were assessed as a cluster by the Ctgb in accordance with the differentiated assessment under transitional law, which entails a new accelerated assessment procedure (see below). At the beginning of 2022, a decision will be made on this set of more than 50 applications. With this accelerated assessment, the Ctgb can make a timely decision, so that a subsequent extension of the exemptions is no longer necessary. As long as the applications are pending, the products in question are exempt from the authorisation requirement. The products may remain on the market and be used until the formal decision on authorisation has been issued.
Accelerated assessment of biocidal products under transitional legislation in the Netherlands
In 2020, the Ctgb developed a differentiated assessment route under transitional legislation (GBO) for products containing an active substance that has not yet been approved at the European level. Once the substance has been approved, these products fall under the Biocidal Products Regulation. The basic principle for a GBO assessment is that the application can be assessed in a short time through comparison with another product that was previously authorised. This reference product must contain the same active substance and be comparable in terms of concentration and legal conditions for use. Due to the shorter procedure, the costs are lower and the Ctgb can make a decision more quickly. It is expected that the majority of biocidal product applications under transitional legislation in the Netherlands will be eligible for this accelerated procedure. At the end of October, for example, four biocidal products were authorised after an accelerated assessment procedure. For three of them, the application was submitted in 2021 and the decision could therefore be taken within a year.
Biocidal products at the EU level
In 2021, the Ctgb examined processes not only nationally, but also at European level. For example, the Ctgb has started a pilot study with ECHA and an applicant into a 'smarter' process sequence for substances that do not meet the authorisation requirements but are conditionally approved due to their societal importance (see box on next page). The idea is to initiate the substantive risk assessment for such substances only if their societal importance has been demonstrated. This saves assessment time later in the process. Furthermore, the Ctgb continues to share its knowledge with Member States that are less experienced in the risk assessment of biocidal products. With RIVM as a partner, the Ctgb has invested a lot of time into the development and harmonisation of the assessment methodology. Corresponding measures have also been taken, such as distributing the workload more evenly among Member States where possible and limiting new tasks.
Plant protection products at the EU level
In Europe, continuous work is being done on the framework for risk assessment to keep it as up-to-date as possible with the latest advances in science and technology. However, the available capacity for this is limited, which means that the European Commission, EFSA and the Member States have to set priorities. The Ctgb has played an important role in this process and indicated that priority should be given to the assessment framework for low-risk products, for bees and other insects, for neurodegenerative disorders and precision techniques. Our organisation advised the Ministry of Agriculture, Nature and Food Quality regarding the discussion between the European Ministers of Agriculture on determining the protection targets for honeybees. Furthermore, the Ctgb actively contributed to the development of the revised guidance document on birds and mammals, the assessment framework for micro-organisms and the revision of the EFSA bee guidance. The Ctgb has assigned these tasks to one of its scientific evaluators.
In collaboration with the German Federal Office of Consumer Protection and Food Safety (BVL), the Ctgb arranged a workshop at the beginning of November for the Member States, the European Commission and EFSA on IT architecture in the context of the Plant Protection Products Regulation. During this workshop the Member States gave each other a glimpse into their organisation and IT environment. The competent authorities in the EU all use different IT systems and it is not yet possible to link them to a single European system (such as IUCLID or PPPAMS). There was great interest in the workshop, with more than 60 participants from 19 countries, the European Commission, EFSA and ECHA. National and EU plans were discussed and future visions shared about open data, data exchange and desired developments. EFSA and the European Commission explained their IT roadmap, including the IUCLID system for submitting applications for active substances and MRLs. It became clear that the EU is aiming for a future where data is entered once and can then be used securely across the Union.
Substance assessment glyphosate
Due to the extensive application dossier for renewing approval of the active substance glyphosate, the EU decided previously that a group of four Member States would jointly conduct the risk assessment. To this end, France, Hungary, the Netherlands and Sweden are working together in the Assessment Group on Glyphosate (AGG). On 15 June 2021 they sent the draft risk assessment to EFSA and ECHA, who published the draft report and the classification and labelling proposal and submitted it for public consultation and for consultation with the Member States. Before approval of substance can be renewed in the EU, the many studies in the dossier must demonstrate that the substance is safe. The presentations and reports of consultations with the applicant companies and the summary of the assessment process with the main findings have been published on the European AGG website.
In 2020, the European Union and the Netherlands presented ambitious plans with the Farm to Fork Strategy and the Implementation Programme of the Vision for Plant Protection in 2030. The role of the Ctgb is to contribute to the availability of low-risk products and optimise the assessment framework, for example with the possibility of incorporating innovative techniques or uses into integrated crop protection. The first steps were taken in 2021. Based on a WUR overview of precision techniques that are ready for practice, the Ctgb analysed the bottlenecks that can be expected during the assessment. For strip cultivation – in which lower quantities of plant protection products are needed for the same yield – the Ctgb investigated which changes this requires in the risk assessment. The European framework for the assessment of micro-organisms such as bacteria, viruses and fungi has taken shape with new guidance documents for the entire EU to be used when assessing micro-organisms.
A guidance document for antimicrobial resistance came into effect in May and one for assessing microbial metabolites in November, after which the evaluation manual for bio-pesticides was also updated. The Green Team of the Ctgb, which specialises in the assessment of micro-organisms, made a significant contribution to the development of these new guidance documents. In addition, it provided two tutors for training future assessors (see box).
The current trend towards ‘greening’ of the product assortment was also apparent in 2021 in the active substance applications assessed by the Ctgb. Of the six new substance applications that were submitted, four concerned a micro-organism, a 'green substance'.
Products authorised within the EU and by the Ctgb are safe, if used according to instructions. They have been assessed according to the current assessment framework and are regularly reassessed, within the timelines established by the regulations. However, due to advancing insights or new developments, new information can always emerge about approved substances or authorised products. Authorisation holders are obliged to report these insights or developments, and such a report can also come from a third party, such as the NVWA or ILT, the NVIC (National Poisons Information Centre) or from an operator. But it can also involve a publication in a scientific journal or information from an article in a newspaper. The European Union and the Ctgb therefore keep a finger on the pulse even after approval and authorisation.
All this new information must be studied to assess whether there is a risk that the approved active substance or authorised product no longer meets the safety requirements. In such a case, it may be that the approval or
There have long been suspicions and indications of a possible relationship between plant protection products used in the past and the development of neurodegenerative disorders such as Parkinson's disease. The active substances in question are no longer approved in Europe and are no longer being used, but this raised the question whether there are also such connections with substances that are currently approved. The Commission therefore sent EFSA a letter in early 2021 asking it to screen the currently approved substances for possible relationships with the development of neurodegenerative disorders.
Measure against stacking
The levels of the active substances abamectin, deltamethrin, esfenvalerate and chlorantraniliprole in surface water have exceeded the authorisation standard for several years. There were indications that these exceedances are caused in part by stacked use. 'Stacking' means that you first use one product on a parcel plot up to the maximum number of permitted uses and then use another product with the same active substance. This higher application frequency and dosage of the same active substance were not included in the assessment of these products. The risk assessment therefore does not cover stacking. Research by Wageningen University (WUR) has shown that exceedance of the standards due to stacking poses a risk to surface water and the associated aquatic organisms, which necessitates intervention. After a consultation round on the proposal, the Commission decided at the end of July to include a restriction sentence against the stacked use of plant protection products containing these substances. The Minister of Agriculture, Nature and Food Quality then requested the European Commission to tackle stacking on a European scale.
Lung infections with the fungus Aspergillus fumigatus are a dangerous complication for ICU patients in hospital – also those with Covid-19. This is especially concerning now that the fungus is becoming increasingly resistant to medical azoles, which are the most effective drugs for treatment of lung infections with the fungus. Research by the RIVM has shown, among other things, that waste heaps from bulb cultivation, in which azoles are also used, are an important breeding ground for resistant fungi. In order to prevent the development of resistance, the Ctgb imposed restrictions on the storage and processing of flower bulb waste at growers in 2021, and it also informed the European Commission about this. Additional research by the CLM (Centre for Agriculture and the Environment) also found hotspots of azole-resistant Aspergillus fumigatus in green waste and treated wood waste, and based on exploratory research, possibly also in the cultivation of strawberries, potatoes and onions. The Ctgb therefore advised the Ministries of LNV and IenW to enter into discussions with the sectors and to develop a generic approach for these chains with safeguards in environmental regulations and monitoring. Because the Netherlands and Denmark have raised the issue azole resistance at the EU level, the problem is definitely on the agenda there too. During the reassessment of the various azoles, EFSA will look critically at resistance, and five European agencies (ECHA, EFSA, ECDC, EMA and EEA) will be commissioned by the European Commission in 2022 to acquire scientific information about the development and risks of azole resistance and to advise on action at the EU level.
Rats and mice
In 2021, the KPMB foundation – in close collaboration with branch organisations, trainers, certifiers, the Ctgb, the inspectorate and the relevant ministries – published a new IPM Rodent Control Handbook (HIK) based on principles established by the Ctgb. The manual is in force from 1 January 2023 for the control of rodents – rats and mice, both indoors and outdoors – according to the principles of IPM. This completes a process that was initiated 10 years ago by the Ctgb to arrive at a fully-fledged and certified IPM system for professional rodent control. (See box on societal interest)
The Ctgb currently makes a lot of information publicly available, especially via its website. All authorisation decisions and their substantiation can be found in the authorisations database, and all completed Wob requests can also be found on the website. The call for transparency is getting stronger, not only in the Netherlands – partly due to the benefits scandal – but also in the EU. The General Food Law has now been revised in accordance with the Transparency Regulation (Regulation (EU) No. 2019/1381) – a response to the European Parliament's demand for greater transparency. Studies demonstrating the safety of an active substance are now made publicly available at the start of the application process by
the European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA). This enables everyone to monitor the approval of active substances for plant protection products.
The Ctgb is participating in this development towards optimal transparency. 'Transparency and communication' was also the theme of the 2021 Ctgb client contact day. Due to the corona measures, it was held as a digital event this year from the 'Ctgb studio' in Ede. With 196 online participants, the turnout was comparable to other years. Various perspectives were presented. An important conclusion was that transparency is not possible without clear explanation. Putting data online without explanation creates confusion; you have to clarify the meaning of this data.
In the Netherlands, the Open Government Act will come into effect in May 2022. The new legislation requires active disclosure and thus goes a step further than the Government Information (Public Access) Act. For the implementation of this legislation, the Ctgb dovetails with the National Sustainable Digital Government scheme with its programmes Open op orde for information management and Goed bewaard as a guideline for employees. As a result, the Ctgb now meets most of the requirements of the new legislation. In 2022 it will also start publishing the agenda and minutes of the Board meetings. (See also Chapter 5.)
In 2021, the Ctgb was again compelled to take account of the waves of the corona pandemic and corresponding measures, and remained financially healthy. As in
2020, nearly all Ctgb employees and Board members worked from home, while a small number ensured staffing of essential facilities at the office. Consultations took place by telephone or via WebEx. Team days were planned in the office as soon as this was possible and plans were made to start working in a hybrid manner in 2022. As a result, the balance between working from home and working at the office will be different than before, while retaining the benefits of both. At the end of 2021, a minor renovation of the office was started so that it will be ready for a new, future-proof, hybrid form of working by early 2022.
Experiences in recent years have shown how complicated it is to reduce the backlog and become more predictable as an organisation. This also applied to 2021. Nevertheless, efforts to realise the work plan were reasonably successful, despite the fact that the Ctgb had less risk assessment capacity than budgeted and employees were obliged to work from home for long periods. It was also a year of ‘standing still’ in terms of controlled growth to give the organisation more space. This space was needed to effectively train new employees, to increase and broaden the knowledge of the teams, to improve the consistency and quality of the work and to enhance the decision-making skills within the departments to accelerate the processes. However, due to an unexpected, relatively large outflow of employees, while at the same time it proved difficult to attract new employees due to the tight labour market and the corona situation, this space was not available.
As a result, the Ctgb remains vulnerable in terms of assessment capacity, which affects the balance between the various teams and thus the progress of the work. Capacity will therefore continue to be a point of attention.
Despite a policy to limit the influx of applications for plant protection products and biocidal products and a steady improvement in the number of applications processed, the backlog has increased. This is partly due to a greater capacity shortage than expected in 2021 and a larger influx of non-regulatory applications for biocidal products (NL transitional law applications for disinfectants and CMS applications). Moreover, due to increasingly complex applications, old applications being reopened, discussions about refinements and many active substance dossiers, it remained difficult to complete tasks on time – for biocidal products as well as plant protection products.
The organisation was faced with an imbalance between the various risk assessment expertises, as a result of which some employees had too little work and others had too much due to training new staff, unfilled vacancies and large active substance dossiers. For example, the re-assessment of glyphosate primarily involved only one team mainly because the other parts of that assessment were performed by other Member States. The magnitude of this substance dossier required this team to invest a lot of assessment time, so it could not work on other applications, while the role of the other teams in this dossier was limited to checking the assessment of the other Member States. Due to these factors, it remains difficult to achieve a balance between the various expertises that are needed to make sufficient progress on the applications.
But important steps have also been taken: the application process for biocidal products under the Regulation is steadily improving; more national and union applications – including applications for biocidal product families – were on the agendas of the Board meetings. The first transitional applications that have been assessed under the GBO policy have been completed, and the large cluster project of applications for disinfectants that came in as a result of last year's corona exemptions is being finalised (see page 10).
Tools have been developed to make time and cost estimates for processing applications – for plant protection products and biocidal products – and the first experiences have been gained with using these tools. And to increase flexibility and capacity, the number of Evaluating Bodies will be expanded in 2021. It has also been noted that optimisation of the planning methodology is necessary to enable the organisation to look ahead and distribute the work more efficiently. This is an important point that the Ctgb will be working on in 2022.
The Ctgb had formulated four possible business risks for 2021 that could affect the realisation of the work plan:
- The impact of the corona pandemic and measures
- Maintaining capacity in relation to the workload
- Data security
- In processing Objections and Appeals, the prioritisation is increasingly determined by events in our surroundings, with increasing notices of default (due to late decisions) and provisional measures
The impact of the corona pandemic
The corona crisis has obviously impacted our organisation. The financial impact and the consequences on the influx of applications and on the realisation of the work plan were limited for the time being, but the corona pandemic and the corresponding measures clearly impacted our employees and their well-being. This was due, for example, to a lack of face-to-face contact with colleagues or a sense of isolation. In addition, new employees have scarcely had the opportunity to become acquainted with the organisation. This gives rise to concerns about declining engagement with the organisation, even if there are no concrete indications for this.
Last year, the organisation attempted to maintain sufficient attention for the well-being of its employees, to provide customisation where possible and to facilitate working from home. During the year, a cautious course was followed for returning to the office. As a result, there was less disappointment about the government tightening the measures after easing them, and drastic intervention was not necessary.
Retention of capacity in relation to workload
In recent years, substantial investments have been made in expanding the workforce. For 2021, the Ctgb intended to ‘stand still’ while expanding the workforce in order to give the organisation more space. However, in the end this did not happen due to unforeseen staff turnover (see page 14). To absorb the turnover and give shape to the expected growth in capacity in 2022, a number of vacancies above budget were nevertheless created in 2021. In addition, we explored whether there may be other possibilities in the planning and the associated imbalance in personnel between the various teams.
The Ctgb possesses and processes highly confidential information from applicants, on which it bases its decision-making. The risk of this information falling into the wrong hands or ‘getting out on the street' must therefore be strictly avoided. The types of threats that the organisation recognises in terms of data security include: loss of information carriers, theft of information, manipulation (hacking) of data and information, information falling into the wrong hands and physical accessibility.
Measures have therefore been taken in various areas. For example, the Ctgb is working with a new information and information security policy in accordance with the National Information Security Baseline (BIR2017). And strict house rules have been drawn up that everyone must adhere to. The Ctgb works in accordance with the General Data Protection Regulation (GDPR) and its workplaces and infrastructure are adequately secured.
Company applications are strictly separated from the public website, and all automated actions of employees are logged. The patch and archive rooms are secured and an external data security audit is performed periodically. The office is physically secured and there is an identification requirement for visitors who must visibly wear a pass. The role of security officer is adequately structured and this officer knows how to act.
Data security is therefore continuously on the agenda and is tightened when necessary, especially because more and more employees are working from home, partly due to the corona pandemic. A reduction of the current application landscape (OBSO programme) is planned and investments are being made in new systems and increasingly secure software and connections. At the same time, role-based access to functionalities and data will be further tightened. Finally, we focus continuously on informing employees about the policy and rules.
Prioritisation within Objections and Appeals
During 2021, the prioritisation within Objections and Appeals was increasingly determined by the environment, with increasing notices of default (due to failure to make decisions on time) and provisional measures. As a result, the legal capacity required to deal with this cannot be used for older cases that have been pending for some time. There was a tendency that more and more capacity was needed for these types of cases.
The capacity of the legal team has been increased in recent years, which has enabled considerable progress in reducing the backlog of objections, appeals and Wob requests. It is estimated that the remaining backlog can be eliminated in 2022. All this had consequences for the planned budget for objections, appeals and publication. Good agreements could be made about this with the ministries involved.