Annual Report 2020

Annual report | 26-05-2021

Preface

To close the year, I have previously expressed a word of thanks to our employees for their efforts. This year I would like to first express my gratitude for the flexibility and tremendous commitment that everyone has shown during the corona pandemic. And this time we also fondly remember two valued colleagues, Kartika Liotard and Rick Peters, who sadly lost their lives last year. This loss – understandably – had a substantial impact on the organisation. It is also fitting for the Board to reflect on this loss.

During the year under review, the corona pandemic has largely determined how we operate as an organisation and as a Board, and continues to do so today. I believe that the Ctgb has dealt with this admirably. And despite the pandemic, our applicants continued to provide everything needed for assessment and decision-making. Partly because of this, we can report that the Ctgb had another good year in 2020, with a positive financial result.

We worked digitally in the past year and are now thinking about striking a new balance between being physically present in the office and working digitally in the office and at home. We are trying to keep the good things we have learned during this time. I believe that this is feasible and is cost-effective, for example due to less travel. We are listening to our employees to arrive at a new hybrid approach that is also more motivating for them.

As a governmental organisation, the Ctgb is in principle in favour of processing applications at acceptable rates and with the shortest possible turnaround times. The pressure on the organisation and on the assessment process has grown enormously in recent years. This is due to aspects such as Brexit, the increasing complexity of our work, the large quantity of underlying studies, additional refinements, the increasing number of guidances, and the growing size of biocidal product families. We expect that all these aspects will only increase in the future, even though the framework of legislation and regulations does not provide any more space for the statutory timelines.

During the past six years, the Ctgb has grown rapidly as an organisation. This growth was made possible by our rate structure, the structure of our organisation and our authoritative and credible operational method. We operate with the concept of 'controlled growth', which enabled the Ctgb to assess more applications from more clients. Has the Ctgb become a victim of its own success?

All of the above aspects have resulted in a certain tension and pressure that is no longer bearable with the current approach, nor can it be resolved with controlled growth alone. That is why we decided to slow down in 2020. This means that we have been reluctant to accept new applications in a number of categories. But we will continue to expand the organisation through controlled growth where it is necessary and responsible. We are returning to the correct balance between supply and demand in order to remain reliable and be more predictable.

Today, every organisation is asked to contribute to sustainability, partly to combat climate change. We are doing this as part of the Implementation Programme for the Vision of the Future of Plant Protection 2030 (Toekomstvisie Gewasbescherming 2030) and with a new biocidal products policy. In view of the role of the Ctgb, it is very important to keep a close eye on the distinction between the authorisation and the use of plant protection products and biocidal products. The largest contribution to sustainability and climate objectives is made by reducing use, and not by reducing the number of authorisations. These two aspects are often conflated, which is confusing and incorrect. The Ctgb stands for responsible authorisation based on scientific substantiation and factual information. At the same time, we will also be asked to contribute to the reduction of use based on our knowledge, with a different intention than simply assessing the mitigating measures currently required in the assessment. We will be asked to do so not as part of the assessment process, but because of the increasing importance of embedding this process in society. In addition, the Ctgb is equipped and available to assess the growing number of applications for 'green' active substances, biopesticides and low-risk products for plant protection and biocidal uses.

Due to the corona situation, we carried out risk assessments for the exemptions from many disinfectants, such as hand gels for professional use. Moreover, the products are also being used by consumers. Similar to antibiotics, for example, this substantially increased use can greatly increase the risk of resistance development. In this case it is important to keep an eye on this as part of the signalling task of the Ctgb. Initially the exemptions were temporary, but now that the products are being used extensively – also by consumers – we must also continue to warn about the risk of resistance. It is much better and more responsible to wash your hands with soap and water than to make extensive use of disinfectant hand gels, albeit authorised ones. We should not allow the exception to become a rule. The scope of authorised use must remain limited. We will continue to warn about this in an appropriate manner at the right times.

ir. Johan F. de Leeuw, chairman

Annual overview: 2020 in a nutshell

The past year started with a milestone. On 1 January 2020 it was exactly 20 years ago that the Board for the Authorisation of Plant Protection Products and Biocidal Products (Ctgb) was awarded the status of a semi-autonomous agency. As an independent competent authority, the Ctgb operates between consumers, industry, agriculture and horticulture, environmental organisations and the government. It assesses plant protection products and biocidal products for safety and efficacy, and then takes decisions whether or not to authorise them. This concerns a wide variety of products, such as plant protection products for agriculture and horticulture, disinfectants for hospitals, the food industry and swimming pools, and products that are in everyone's kitchen cupboard or garden shed, such as ant bait, mosquito repellents and wood preservatives. When the Ctgb authorises a product, this means that it is effective and safe for humans, animals and the environment if used according to instructions. As a result, consumers can be confident about the safety of plant protection products and biocidal products that are used in agriculture and horticulture, in their living environment and in their homes.

In addition to the task of assessing the risks of plant protection products and biocidal products and taking authorisation decisions, the Ctgb provides solicited and unsolicited advice to various ministries.

Corona pandemic and working from home

For the Ctgb, 2020 was a very unusual and turbulent year. It started in January with the sudden vulnerability of the Citrix servers, as a result of which employees of government agencies, institutions and organisations, as well as the Ctgb, were restricted in working remotely for a number of days. Soon after, the corona pandemic reached Europe and the Netherlands. As a result, from mid-March almost everyone was required to work remotely. Almost all Ctgb employees and Board members did so for the rest of the year, while a handful of employees provided the essential services in the office. Consultations took place by telephone or via WebEx. From the first lockdown, everyone in the organisation made every effort to adapt and keep things running as smoothly as possible. As a result, the hours worked in the primary assessment process were almost according to the work plan, and the Ctgb remained financially healthy. Applicants indicated that it was a challenge to have all the studies required for the application dossier completed on time. In the end, we only had to grant a few postponements due to delays caused by the corona pandemic.  

Decisions and advice

In 2020, the Board made 123 decisions on applications for plant protection products and 71 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 ten 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 (13% for plant protection products and 9% 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 62% of the biocidal products. This was done so that consumers and growers can be confident that the products they buy and use are safe when used as directed.

The Board also advised the Ministries of Agriculture, Nature and Food Quality (LNV) and Infrastructure and Water Management (IenW) about 57 exemptions (36 for plant protection products and 21 for biocidal products, especially disinfectants).

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. A downward trend appears to have begun for active substances, see the figures

below. However, these figures provide only limited information on the number of products available per sector. Some sectors have reported a deterioration of the product assortment. For example, potato growers appear to have difficulty with the withdrawal of the sprout inhibitor chlorpropham. An additional problem is that residues from walls, floors or crates are still detected in potatoes in small quantities due to the frequent use of this substance in storage sheds in recent decades. At the end of September, the SCoPAFF (Standing Committee on Plants, Animals, Food and Feed) therefore decided on a temporary maximum residue limit (MRL) of 0.4 mg/kg. This MRL is so low that consumers are protected and illegal use is impossible, but is high enough to enable the use of existing storage facilities.

Europe

As the Dutch competent authority, the Ctgb operates within the European frameworks of the Plant Protection Products Regulation and the Biocidal Products Regulation. Guidance documents are constantly being developed and refined for further elaboration of these European regulations. The Ctgb actively contributes to this process and works closely in Europe with the European Food Safety Authority (EFSA), the European Chemicals Agency (ECHA), the competent authorities of the other European Member States, and in the Netherlands with various ministries, the Netherlands 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).

Crop protection

For example, a great deal of work has been done in the European working group for biopesticides on the development of the assessment framework for micro-organisms. The Ctgb made a significant contribution to the guidance documents that have since been adopted for the assessment of antimicrobial resistance and for the production of metabolites by micro-organisms. Work is also ongoing on revising the data requirements for micro-organisms – a discussion in which the Ctgb is closely involved. A scientific evaluator from the Ctgb has been seconded almost year round to support EFSA in the revision of the bee guidance, and this will continue until 2022. The Ctgb also seconded an employee to EFSA in Parma for more than six months.

Biocidal products

In 2020 various guidance documents for the risk assessment of biocidal products were under development in Europe, although no new guidance documents were published. However, a Q&A appendix was added to the guidance for biocidal product families and the specification of this procedure has taken shape in more and more Member States (see also page 17). Agreements have been made in the European working groups for several expertises. These agreements have been published in new TAB versions (Technical Agreements on Biocides). In most cases, these were further explanations of existing guidances. Pending the finalisation of the new guidance for the risk assessment of arthropod pollinators, a hazard phrase for bees was approved, especially for neonicotinoids in PT18 applications. Agreements have also been made on the listing of substances of concern (SoCs) in an SPC (Summary of Product Characteristics).

Sustainability

In May, the European Commission presented the Farm to Fork Strategy. Frans Timmermans, Executive Vice-President of the European Commission, described this as follows: “The corona crisis has shown how vulnerable we are and how important it is to restore the balance between human activity and nature. As key points of the Green Deal, the Biodiversity Strategy and the Farm to Fork Strategy point the way to a new and better balance between nature, food systems and biodiversity; to protect the health and well-being of our people while making the EU more competitive and resilient. These strategies are indispensable for the great transition that is now imminent.”

In addition, the European Commission published its Biodiversity Strategy and Chemicals Strategy for sustainability. These strategies are also part of the overarching European Green Deal and will influence our work in the coming years.

In the Netherlands, the Minister of Agriculture, Nature and Food Quality presented the Implementation Programme for the ‘Vision of the Future of Plant Protection 2030’ to the Lower House of parliament in the autumn. The parties involved in this – including the Ctgb "work together on agricultural and horticultural practices that are connected with nature: only plant protection products are used that have virtually no emissions to the environment and leave virtually no residues on food products.” The role of the Ctgb in the implementation programme focuses in part on optimising the assessment framework, with the option of including innovative techniques or uses within integrated plant protection, and contributing to the availability of low-risk products.

The Ctgb was also commissioned by the European Union, together with the French consultant organisations AETS and AINIA, to provide training for all European competent authorities in the risk assessment of micro-organisms, and thus to disseminate its specialist expertise. We will provide two of the four experts for this training programme. The programme aims to increase the knowledge about micro-organisms among the EU Member States and will also contribute to a harmonised approach to the assessment of micro-organisms and the development of guidance documents for this purpose. The risk assessment of biological products requires a completely different approach than that of chemical agents because the risks of bacteria, fungi or viruses differ from those of chemical substances.

Even before the corona pandemic, the Ctgb held a meeting for journalists to update them on the authorisation of green products, with presentations by the members of the Green Team.

Pesticides Exemption Scheme (RUB)

In October, the Ctgb published the amended RUB list in the Government Gazette (Staatscourant). In the past, these products were placed on the market without an assessment under the RUB, but are now subject to European legislation. To this end, applicants have to compile a dossier for their product, which is assessed by the Ctgb for safety and efficacy. After two years, applicants have now submitted dossiers for 16 of the 57 RUB products. These are currently being assessed by the Ctgb, or an assessment in another Member State is pending. Until their assessments are completed, the products will remain on the RUB list and may be used. After 1 January 2021, products for which the active substance has been approved, but for which no dossier has been submitted, are no longer authorised. These have therefore been removed from the RUB list. When used for the disinfection of pruning knives, milk is still on the published list, but is now authorised as a basic substance and can be used throughout Europe for this purpose. Following a subsequent change, milk will therefore be removed from the RUB list.

Notifications

Authorised products are safe, if used according to instructions. Nevertheless, it can happen that 'something' is found to be unsafe about the product. In that case, the Ctgb receives a notification from an authorisation holder, a third party or other source. Such a third party or source can be the NVWA, the ILT, the NVIC, or a user of a product; it can also be a publication in Science or information from an article in the newspaper. In short, such a notification concerns new information (Article 56 Reg 1107/2009 and Article 47 Reg 528/2012) that must be investigated to assess whether there is a risk and the authorised product no longer complies with the requirements. In such a case, the authorisation may have to be amended, for example by changing the conditions of authorisation. Ultimately, such new information may even lead to the authorisation being withdrawn. For some time now, a process has been in place at the Ctgb, and a team (the MIC team) has been formed to process this wide range of new information. In 2020, about 20 notifications were received that concerned the above-mentioned Articles.

Cumulative effects

At the end of April, EFSA published the results of the assessment of the cumulative effects of active substances from plant protection products on the nervous system and the thyroid gland. The assessment – conducted by RIVM, among others – showed that consumers were not at risk from food. Consequently, changes to the maximum residue limits for specific substances or changes to existing authorisations were not necessary. In the coming years, assessments of cumulative toxicological effects on other organs and systems will be carried out by EFSA.

Parkinson’s disease

In the summer, the Health Council of the Netherlands reported that research in other countries had indicated a possible link between exposure to plant protection products and the risk of developing Parkinson’s disease. The results of research in the Netherlands have been less pronounced, but they cannot allay the concerns and, according to the Council, the authorisation procedure for such products can never eliminate all potential health risks. Via the Ministry of Agriculture, Nature and Food Quality, the Ctgb, together with the RIVM, urged that the data requirements for plant protection products be adjusted accordingly throughout Europe. This has already happened with biocidal products. The Council recommended that precautionary measures be intensified by striving to reduce the use of chemical plant protection products, continuing to improve the authorisation procedure, and focusing on information about safe working practices and enforcement, registering use and periodically measuring exposure. In this context, the Board also invited professor and physician Bas Bloem, a renowned Parkinson’s expert, to share his expertise. A follow-up appointment is scheduled for early 2021.

Stacking products

In May, the MEB discussed a proposed measure against the 'stacking of plant protection products', which was then presented for consultation. This proposal was based on concerns that 'stacked use' of different plant protection products with the same active substance could lead to accumulation of that substance in the environment. If these agents are used in succession to control one or more pests on the same parcel, the active substances in those products can end up in the environment in hazardous quantities. Monitoring data has shown that some active substances have exceeded the authorisation standard in surface water for several years. Based on agricultural practice, the NVWA has designated four substances as 'stacking-sensitive'. To prohibit stacked use in an enforceable manner, the intention is to include a restriction sentence on the instructions for all authorised plant protection products that are based on one of these active substances.

Rats and mice

For the expansion of the existing IPM system to an integrated system for the control of rats and mice both outdoors and indoors (by professionals only), in 2020 work began on the adaptation of the Manual on IPM Rodent Control (HIK). This required a lot of consultation between the parties involved, including user organisations, the programme manager, the inspectorate, various ministries and the Ctgb. Those adaptations are now almost ready. A new version of the Manual is expected to be available this spring.

Organisation

Assessing applications

Our basic principle is to accommodate demand within the concept of controlled capacity growth. This means that the growth depends on the capacity of the departments and various teams to take on more work as well as the balance between the teams. We have seen increased demand in Europe and have responded to this in recent years, but most other Member States have increased their capacity only slightly, if at all. Brexit has further exacerbated the shortage of European assessment capacity. Due to the controlled growth policy, the Ctgb has for years accepted more than its 'fair share' of applications for plant protection and biocidal products and active substances, which could also have been assessed by other Member States. That is why we aim for a more equitable distribution of European applications between the Member States. Increasing the assessment capacity and enhancing the development of expertise and experience in the Member States is crucial for a high-quality peer review process in Europe. This forms the basis for European decision-making. The Ctgb is therefore prioritising this issue in various European consultations.

In 2020, the influx of applications (in absolute numbers) turned out to be lower than budgeted for plant protection and biocidal products. Nevertheless it has not been possible to reduce backlogs and shorten turnaround times: these have not decreased for either biocidal products or plant protection products. This was in line with our expectations for biocidal products. This is because the dossiers have become larger and more complex, as was also noted by the applicants. In the case of biocidal products, the dossiers for large families in particular are complex and extensive. The quality of dossiers is often poor, and in some cases a harmonised assessment framework is not yet available. To achieve safe use, applications for plant protection agents require increasingly higher tier refinements. In addition, the European procedures are becoming increasingly intensive and challenging. Notable examples of this are the assessments of endocrine-disrupting properties and neurotoxicity. Furthermore, an increase in the number of pending substance applications also requires a relatively large amount of assessment capacity. The Ctgb has also continued to grow as an organisation (where necessary, some teams even exceeded controlled growth) and part of the available capacity has therefore been used for training new employees. In 2020, moreover, the Ctgb also had to contend with an imbalance in available capacity between the various expertises. Due to all these factors, the goals of processing applications in accordance with the budget and reducing turnaround times have not been realised. This is despite the measures taken to train new employees as effectively as possible during the corona pandemic, to make employees more flexible, to limit the influx of biocidal product applications and to outsource work to external parties.

Due to the increasing turnaround times, the assessment process of EU dossiers for biocidal products was scrutinised during the past year. In doing so, we found that the Biocidal Products Regulation (BPR) offers possibilities that we have scarcely utilised before. For example, the BPR makes a 'Pre Submission Meeting' (PSM) mandatory and stipulates that an assessment cannot begin until all the necessary data for the risk assessment has been provided. This means that a dossier can be declared valid only if that requirement is met. The Ctgb will strictly monitor this requirement for dossiers submitted from 1 March 2021. In addition, the possibilities were examined to offer a consultation with the applicant while the assessment process is ongoing. Such a 'follow-up meeting' or 'Post Submission Meeting' can be used if the assessment process of a dossier threatens to become stalled. This approach has now been used for a number of dossiers.

For biocidal products, mainly due to the restriction on the influx since 2018 and the controlled growth over the years, the work backlog (in hours) has decreased and we have seen a stabilisation in the number of assessments in progress. The first steps to shorten the turnaround times in the longer term have therefore been taken, but given the enormous work backlog, we still have to be patient. For plant protection products, the work backlog (in hours) has remained stable. Besides limiting the influx of applications for biocidal products, Ctgb has therefore decided to also limit the influx of plant protection products. Only in this way will it be possible to become more predictable and reduce work backlogs. Due to current commitments, in practice this means that a restriction will be imposed on the influx of applications for plant protection products from 2022.

Risk management

For 2020, the Ctgb formulated two possible business risks that could affect the realisation of the work plan: the amount of equity capital and the available capacity.

Amount of equity capital

Equity accrual is progressing well. The Ctgb closed 2020 with a positive operating result. The operating result for 2020 was credited to the general reserve, which increased the equity.

Available capacity not in line with the demand

Due to an unpredictable job market and the natural turnover of existing staff, it remains difficult to fill staff vacancies and keep the balance between the teams at the desired level.

During the corona pandemic we managed to recruit new employees, we partly compensated for the turnover of current employees and where possible we deployed external capacity, with maximum internal flexibility, but there was still an imbalance between the teams.

Multi-year programmes and organisation programmes

Predictability & Turnaround Times (VSDL) Programme

In the longer term the Ctgb wants to shorten the turnaround times for assessing applications for authorisation of plant protection products and biocidal products with the ultimate aim of making decisions on these applications within the statutory or agreed timelines. VSDL is a multi-year programme that focuses initially on gaining insight into the backlog and the size of the dossiers, and on improving the processes and planning methodology, with the aim of reducing the backlog and becoming more predictable. As soon as we are more predictable and the backlog has been reduced, we can start to focus on reducing the turnaround times. The latter goal therefore requires more time before the results are visible. The basic principles here are that the balance between teams is/remains in order and the size of the dossiers remains somewhat stable. Within VSDL two major activities were implemented in 2020: an updated and (where necessary) optimised planning policy and planning process, and timeline monitoring. A number of activities, such as a total overview with management information for safeguarding progress as input for the OBSO programme and a clarification of the assessment process for biocidal products, have been completed, with the results serving as input for follow-up activities in 2021. In 2020 the various activities within VSDL also resulted in more insight into the magnitude of the backlog and the required capacity per dossier.

Organisation-wide collaboration environment (OBSO)

The multi-year OBSO programme provides an organisation-wide ICT collaboration environment, a reduction of the currently outdated complex application landscape and investments in new systems and applications. Existing applications such as the MST (Products Substances Authorisations) will be linked to the new systems to prevent unnecessary and double data entry. The OBSO programme was launched in 2020 and is progressing well. At the beginning of 2020, a new technology for the case management system was chosen that is even better suited to the wishes of the Ctgb. The technical environment was also delivered and the software installed for the SharePoint (document management system) and PowerBI (management information tool) applications, and provided with the initial structure. In December, employees were given the first 'sneak preview' of SharePoint. In addition, the first steps have been taken for data conversion/migration and making the links between the various applications. Finally, research was conducted into the wishes for and functionalities of the new customer portal and CRM (Customer Relationship Management), which is planned for installation in 2021.