Board for the Authorisation of Plant Protection Products and Biocides

Annual Report 2016

Foreword

As an organisation very much rooted in society, the Ctgb turns its gaze to the future. Everywhere we look we see an increasingly widespread pursuit of sustainability. We endeavour to find a balance between regulation and innovation, achieve more flexibility in assessment and regulation and deploy technical developments to ensure safety. New techniques can be used to specify the measures that we impose. For example, GPS and precision application techniques make it possible to apply plant protection products with the frequency, quantity and timing needed for best results and lowest environmental impact. And this in turn refines the risk mitigation measures that we impose.

Our decisions also drive technological development. This often has two aspects. On one hand, the autonomous developments in science and technology make innovation possible, and on the other hand our decision-making creates frameworks for innovation. Imposing measures sometimes compels innovation within the sector, as exemplified by our decision-making on the use of imidacloprid. We imposed a temporary prohibition on the use of this product, but we also indicated that its use is justified if growers can purify their wastewater in a demonstrable and verifiable fashion so that no unacceptable levels of residues are present. This resulted in innovation in purification technology.

Besides technical developments, other aspects also promote sustainability, such as the ratio between chemical and nonchemical uses, the increasing use of low-risk products, more attention for prevention, greater use of natural controls, more environmentally benign ('green') products and systematic modification of the guidances. And that also compels us to think about the assessment system and how we can be as supportive as possible – while taking account of the safety of humans, animals and the environment. This is about much more than promoting low-risk products. After all, using fewer chemical products is not a goal in itself. This is a broader societal movement with which the Ctgb and other stakeholders are fully engaged.

Regarding the assessment system, a question for the future is whether we should expand the scope from a narrow product assessment to a broader cultivation approach. This impacts aspects such as the assessment framework, Integrated Pest Management (IPM), whether specific products can be used at affected locations only or on the entire crop, or if chemical products should be used only in the context of the total environmental balance in a system. The entire field of 'greening' and promotion of sustainability is in full motion. We are one link in this entire chain, along with the users, suppliers, manufacturers and applicants. This is why we have chosen innovation as the theme for the next Ctgb client contact day, with a view to the more sustainable and smarter use of techniques, applied to our assessment process and the measures we impose. And I believe that this will remain the central focus for the next few years.

With biocides we are seeing a trend towards prevention and improved hygiene. On one hand, the Biocidal Products Regulation slows the development of new active substances due to the required investments, but on the other hand the Regulation also encourages innovation because it limits the use of existing products. In pest control, we have seen the continued development of Integrated Pest Management (IPM). The use of high-risk products, such as anticoagulants, is still possible, but only as a last resort in a chain that focuses on prevention.
  For other uses of biocides, such as the preservatives, we are seeing a shift towards prevention. With improved hygiene, fewer biocides, or lower concentrations of biocides, are required. Besides the increasingly strict regulations, the demand for biocides by users is a strong impetus for innovation. The in-situ production of low-risk biocides is another area that is characterised by rapid innovation. This type of disinfection is useful not only with biocides, but can possibly also be deployed in plant protection through a separate authorisation.In summary, there are two tracks: innovation makes new things possible, and specific decision-making sometimes promotes innovation. Consequently, contact with all stakeholders in the chain – and we are certainly part of the chain – is crucially important. This contact is currently taking place, we are holding discussions on the pilots with integrated plant protection, concerning the Green Deal, and during the next few years we will continue the discussions on enhancing sustainability.I am also curious about the policy of the new coalition government, in particular its emphasis on enhanced sustainability and 'greening', and how the government can effectively use and promote research in this process. I hope that this will receive an impulse from the new government programme in the near future.The Ctgb has developed into a modern and efficient agency: lean and mean. Two-thirds of management consists of women; this reflects the gender makeup of the organisation as a whole. In this respect, we are a modern, pioneering organisation. We have short and open lines of communication with the outside world, departments, applicants, NGOs, the scientific world and institutes in the Netherlands and abroad. The organisation is characterised by openness and transparency, both internally and externally. The Board is increasingly engaging with the external world, participates in working visits, and the chairman and director are visiting European colleagues and organisations. We are primarily an implementing organisation, but we are also responsible for monitoring developments and communicating them to the departments. We do this by providing solicited and unsolicited advice as appropriate. As part of this policy cycle, consisting of policymakers, policy implementation and monitoring, we also fulfil our role adequately.In 2016, the Ctgb took important steps. It was a good year. The internal processes are in order, the workforce is at the level planned for 2016, and a new planning and operational approach has been initiated to improve the predictability and reduce turnaround times. The year ended with a positive operating result that was above the prognosis at the beginning of the year. This means that we can build equity capital in the coming years, which is important for a healthy organisation.Several years ago we formulated three operational objectives for our organisation: we will accommodate the demand, with acceptable fees and charges, and with the shortest possible turnaround times. We have seen that we are increasingly able to fulfil these three objectives, which are ambitious, but emerge directly from our statutory task. Full compliance with these objectives is a major challenge, but by trial and error we continue to take steps forward. This progress is reflected in our budget, in our operational methods and in our performance as a modern organisation. And this is all thanks to the employees who have made this possible with their tremendous efforts and involvement.Ir. Johan F. de LeeuwChair

2016 in a nutshell

The Board for the Authorisation of Plant Protection Products and Biocidal Products (Ctgb) is the competent authority in the Netherlands for plant protection products and biocidal products. Its most important tasks are to assess plant protection products and biocidal products regarding their safety and to make decisions about their authorisation, so that these products can become available for agriculture, disinfection in hospitals, household use and other purposes. When a product is authorised by the Ctgb, society must have confidence that – if used correctly – it is safe for people, animals and the environment.

For the Ctgb, 2016 was a year in which the organisation could benefit from steps taken in past years in nearly all fields: The internal processes and workforce are in order, and the year ended with a positive financial result. Our efforts to improve the operational planning have begun to bear fruit, and employees have responded positively to the new planning method, which offers more room for them to organise their own work and is based more on teamwork. The staff survey that was held at the end of 2016 also showed a substantial improvement in how employees experience the organisation. On most components, we are now at or above the national benchmark level. For the outsider, the effect is not yet visible, but we are convinced that the effects of these efforts will soon become visible in terms of completion of applications. In 2016, much energy was invested in the training and familiarisation of the new colleagues. The number of applications continued to increase, especially for biocidal products. We also saw that the effects of the Biocidal Products Regulation are becoming visible: The Ctgb, ECHA, other Member States and applicants must still become accustomed to the new procedures and the new relationships between stakeholders. As a result of these changes, the applications require more attention, more consultation is required and the dossiers are not always adequate. We have seen that this has led to delays in processing. For plant protection products, the backlog was not reduced in 2016, but it did not increase either.

To ensure safety, the EU and the Ctgb will continue to modify the assessment standards in accordance with the latest scientific advances. New active substances are authorised for 15 years following assessment. After this period has elapsed, an active substance must again go through the authorisation process based on the most recent scientific insights. Products expire on the expiration date of the corresponding active substance. In other words, when the authorisation of an active substance expires, the authorisations of the products containing this substance also expire. As a result, the regulations require attention to new insights into safety. Despite the societal debate and the political decision-making about its use, a substance such as glyphosate has remained on the market because it continues to comply with safety criteria based on scientific grounds. In contrast, the authorisation for the co-formulant polyethoxylated tallow amine (POEA) has been withdrawn because studies have shown that it is more toxic than glyphosate. At the European level, the workload is heavy and the timelines are short. All competent authorities, including the Ctgb, are struggling with this situation.

Based on new insights, the Ctgb also intervenes in existing authorisations if required. This happened with products containing imidacloprid that are used in greenhouses. Studies on the quality of surface water showed that the wastewater from greenhouses, despite regulations, was still being discharged. The Ctgb therefore decided to prohibit the use of imidacloprid in greenhouses unless the wastewater could be demonstrably and verifiably purified to 99.5%. In 2016, the Ctgb was also involved with the Deltaplan Waterkwaliteit (comprehensive water quality plan) of the Ministry of Infrastructure and the Environment. In this comprehensive plan, many stakeholders work together to improve the water quality in the Netherlands.

During the year under review, the emphasis of the Ctgb policy was on European harmonisation, improved sustainability and increased predictability. The Ctgb was able to take important steps on all these aspects.

Harmonisation

The Ctgb and the competent authorities in the other Member States of the EU aim at harmonisation, including equal implementation of European legislation and equal assessment of dossiers for plant protection products and biocidal products. This endeavour came under some pressure in 2016 because the assessing Member States shifted several aspects – such as components of the assessments concerning birds and mammals – to the national level.

During the assessment of biocidal products, the guidance turned out to offer room for differences in interpretation, which slowed the processing of applications. Additionally, the Member States had difficulty reaching agreement about the assessment methodology for various DEET products.

The Ctgb tries to deal with such problems in consultation with other Member States. For example, during the year under review the Ctgb chaired the Coordination Group for biocidal products, which aims to find solutions for substantive disagreements between the Member States. For plant protection products the Ctgb is involved in establishing a central secretariat for the Central Zone to provide administrative support to various steering groups. And in the autumn, the Ctgb organised the first workshop for lawyers, because the lawyers of the various competent authorities were encountering the same questions and problems. During the workshop a platform was established for sharing insights and solutions. For the directors of the European competent authorities for biocidal products, the Ctgb also organised a workshop at the European Chemicals Agency (ECHA), during which the directors specified bottlenecks and proposed joint solutions.

Improved sustainability

The Ctgb was one of the participants in the Green Deal for environmentally benign plant protection products, which was completed in 2016. In this framework, the Ctgb authorised six new ‘green’ plant protection products. Green Deal products must comply with the same safety and environmental requirements as chemical products, because ‘green’ products are not safe by definition. For the assessment criterion ‘efficacy’, however, the requirements have been relaxed to enable the development of environmentally benign innovations. In the spring, the Ctgb held a workshop to make European-wide agreements on these green assessment criteria and to embed this development effectively in existing legislation. These agreements are being used to develop a new EPPO Directive. Now that the Green Deal has been completed, the Ctgb has maintained its Green Team to continue to make maximum use of this experience when assessing future ‘green’ applications. In 2016, three additional low-risk products were authorised that were not part of the Green Deal.

The Ctgb is exchanging expertise with the US Environmental Protection Agency (EPA) about the assessment of green products, expertise that the Ctgb is aiming to include in the assessment of green products in Europe. However, the pursuit of sustainability is not limited to a focus on green products. In the context of Integrated Pest Management (IPM), the entire cultivation process must be taken into consideration: the systems approach. We are looking for ways to include this approach in the assessment process. In this respect, the Ctgb is participating in the project group for systems approach pilot projects under the direction of LTO (national agriculture and horticulture association).

Predictability

Internally, the Ctgb has examined its primary process. It aims to improve the predictability of the application process. The project group on planning therefore developed a new planning concept for the primary process. This concept not only requires a new approach to planning, but also an effective, digitally supported system. These two tracks were established during the year under review. A number of teams have been working on giving shape to the new planning concept, and at the end of the year a supplier was selected to initiate a proof-of-concept phase before making a definitive choice for a supporting ICT system. Internally, the positive effects on the process are already visible; for applicants they will become apparent in the somewhat longer term.

To ensure that the Ctgb remains up-to-date regarding the procedural and substantive agreements in Europe, two coordinators were appointed in 2016. They are responsible, respectively, for the implementation of the procedural and substantive assessment frameworks and for the external communication on this process. To this end, the Evaluation Manuals for plant protection products and biocidal products have been revised and Registration Manuals have been developed. Both of these types of manuals are now available electronically on our website.

Authorisable active substances per year

Products and substances 1990 2016

Organisation and finances

In 2016, the Ctgb organisation experienced controlled growth. Due to the influx of applications and the turnover of staff due to an improving employment market, in 2015 there was a shortage of personnel, resulting in a risk of increasing turnaround times and backlog. While 2015 was characterised by an equal influx of outflow of employees, resulting in a stable workforce, in 2016 the required increase in capacity was realised, and the Ctgb again grew rapidly in size. We actively recruited new personnel and the workforce increased by more than 18%, from 125 staff (113.6 FTE) at the end of 2015 to 148 staff (134.8 FTE) at the end of 2016. This growth took place primarily within the primary processes, which alleviated the risk of increasing turnaround times and backlogs.

However, the influx of new employees did impact the existing organisation; the corresponding training/familiarisation increased the workload of existing staff. Now that the workforce and the changes to the organisation structure and job positions are in order, we can focus on realising the objectives for the years to come. In 2016, we established a solid foundation for this. The concept of controlled growth, i.e. not growing any faster than the organisation can handle, will be applied in the years to come if required.

Financial results

The year 2016 ended with a positive operating result of €207,000. The original budget included a positive operating result of €300,000, but this was changed at the beginning of 2016 to €150,000. This change was implemented in the updated plan of approach (Strengthening Equity Capital) because the accountant determined that corrections were required on several components of the lease calculation. The year ended with a result that exceeded the prognosis in part because the number of authorised products on the reference date was higher than predicted, resulting in more income. In addition, sufficient provisions were made to cover applications with financially negative results and sufficient billable hours were generated due to the influx of new employees. Much time and energy has been invested in the training and familiarisation of new employees so that they can participate more quickly in the primary process and consequently generate more billable hours.

The operating result for 2016 was credited to the general reserve; as a result, the negative equity capital declined. The desired general reserve is 10% of the average annual turnover during the past three years.

Communication with the societal environment

Positive or negative decisions on the authorisation of plant protection products and biocidal products by the Ctgb have become increasingly interesting to various stakeholders in society. At the same time there is more spontaneous attention for specific cases than for the factual story that underlies the cases. More journalists are contacting the Ctgb. In 2015/2016, the communication team of the Ctgb was expanded. Our communication policy is based on explaining the authorisation system and clarifying our standpoints and decisions. Authorisations that received a great deal of attention in 2016 included those for glyphosate and imidacloprid. During the course of the year, the implementation by the Ctgb of the European ban on the use of POEA in glyphosate-containing products was the focus of substantial media attention.

In its communication, the Ctgb wants to actively enhance the knowledge of the press and public about our work. More than before, this also means that we take action if incorrect information is published. A public, written reaction to the suggestion that a strict authorisation policy would be disastrous for the Dutch potato export was published in its entirety by the relevant trade journals. Based on the same communication policy, an agreement has been made with the digital version of the trade journal De Boerderij about an ‘expert blog’.
To provide an accurate picture of the position of the Ctgb, transparency is important. As a result, in 2016 we decided to publish received viewpoints (anonymised) in their entirety on the website of the Ctgb.

Ctgb stakeholders day

On 9 June 2016 the annual Ctgb client contact day was held, with more than 200 visitors. The themes ‘increased sustainability’ and ‘harmonisation’ in the practice of authorisation were the focus of the programme. The participation and interaction demonstrated great engagement in the sphere of operation of the Ctgb, including a diversity of images and ideas from various groups of stakeholders. Chairman Johan de Leeuw therefore closed the Ctgb client contact day by expressing the desire to cooperate with the various stakeholders when implementing the requirements for the products of the future.

Online information channels

The Ctgb website has a large number of repeat visitors (68% of the total of 117,182). The percentage of visitors from abroad has fluctuated for several years between 20% and 25%. The majority of the visitors to the website consult multiple authorisations in the authorisation data bank, which was used more than 1.125 million times. Since the end of 2016, the up-to-date versions of the Evaluation Manual and a new Registration Manual have been online. The manuals have been viewed more than 8000 times.

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