The position of the Plant Protection Products and Fertilisers Department of the Belgian Federal Public Service for Public Health, Food Chain Safety and Environment

On 16 January 2019, the European Parliament (EP) adopted a Resolution on the authorisation procedure for pesticides in the European Union. The starting point for this resolution was a report by the so-called PEST Committee of the EP. Over a period of several months, the PEST Committee heard many actors and stakeholders about their views on the EU's pesticide policy.

The resolution contains 117 'general comments', many of which are recommendations to one or more actors. These include the European Commission, the European Food Safety Authority (EFSA) and the Member States.

Our Department has analysed the recommendations to the Member States. The results of this analysis are outlined below. Some of the recommendations addressed to the Commission, for which Belgium has already developed an initiative, are also covered.

Analysis of the recommendations addressed to the Member States

The numbering given is that of the 'general remarks' of the resolution.

4. The EP calls on the Commission and the Member States to allocate sufficient resources and appropriate expertise to the assessment of active substances and plant protection products and to ensure independent, objective and transparent assessment in light of current scientific and technical knowledge.

Position from the Department:

The number of Department staff involved in the evaluation of active substances and plant protection products is constantly growing. Further recruitment is planned. However, the growth of the Department must be controlled in order to be able to accommodate the new colleagues in an appropriate manner. In 1991, when the first EU legislation on plant protection products (Directive 91/414/EEC) was adopted, 6 officials were active in the field of the authorisation of plant protection products. Today, there are 53. Continued growth was possible thanks to the Budgetary Fund for raw materials and products. By increasing the fees payable for applications for authorisation, the Fund's revenue was gradually increased.

In application of the Act of 21 December 2013 strengthening the transparency, independence and credibility of decisions and recommendations in the field of health, health insurance, the safety of the food chain and the environment, an implementing decree is currently being drawn up by the FPS Public Health, Food Chain Safety and Environment. Once this has come into force, the officials involved in the evaluation of plant protection products will have to submit a declaration of interests.  This will make it possible to assess the independence of these evaluators.

The officials involved in the evaluation process of the active substances and who therefore participate in a meeting of experts organised by the EFSA are already required by the latter organisation to demonstrate the absence of a conflict of interest by means of a declaration of interests.

However, since only officials are involved in the evaluation of plant protection products in Belgium, it can already be assumed that this is done in a sufficiently independent and objective manner.

The transparency of the evaluations of the active substances is guaranteed: the draft assessment reports drawn up by the Member State rapporteurs are made public by the EFSA. We are not that far advanced with regard to the evaluations within the framework of national authorisations. After all, we are dealing with a large number of applications, dossiers and evaluations of all kinds, about one thousand a year, and currently still prepared in a variety of different formats. In order to be properly published, a new IT programme, which is currently being developed, must first be operational. Only then can a systematic publication of the evaluation reports be carried out. The Department is investigating how to deal with this.  In the meantime, however, the evaluations are already available on request.

The Plant Protection Products and Fertilisers Department is constantly monitoring the availability of sufficient expertise. Staff members of the FPS Public Health, Food Chain Safety and Environment have a constant supply of both generic and technical training courses at their disposal. In fact, tailor-made training courses are even organised on request. Participation in national or international workshops and meetings is encouraged. Maximum use is also made of offers in the context of the European programme 'Better Training for Safer Food'. Participation in the peer reviews for the active substances allows for the exchange of experiences with international colleagues. Within the Department, the experts within the same evaluation domain ensure knowledge is transferred and a uniform evaluation method is obtained.

5. The EP calls on the Commission and the Member States to ensure full and uniform application of the hazard-based cut-off criteria for active substances that are mutagenic, carcinogenic or toxic for reproduction, or that have endocrine-disrupting properties.

Position from the Department:

The Belgian positions in the Standing Committee on Plants, Animals, Food and Feed always move towards a consistent application of exclusion criteria. Two examples illustrate this:

• The report of the Standing Committee of 24-25 January 2019 states the following:
  “Ipconazole (amended review report to take note)
  Two Member States did not consider the risk to granivorous birds to be satisfactorily resolved. In addition to the confirmatory information aspect, three Member States expressed their view that an early review under Article 21 of Regulation (EC) No 1107/2009 should be initiated for ipconazole given the classification as toxic for reproduction, Category 1B and the fact that renewal was several years away.
  Given the views expressed, the note taking was put on hold. The Commission informed that it would reflect on the way forward.”
  Belgium was one of the three countries that called for a review of the approval of this active substance in view of its classification as R1B.
• The same report reports under item B.04 on the discussion on the possible first approval of the new active substance flutianil. In its conclusion, the EFSA had raised some uncertainty about the endocrine disrupting properties of this substance. Most Member States considered this uncertainty to be negligible and did not consider it necessary to go into more detail. The report reads "Three Member States indicated that they would only support the proposal if a request for confirmatory information was added on the assessment of the ED potential of flutianil. The Commission informed that it will consider adding such request for confirmatory information and that a vote will be rescheduled as soon as possible.”
  Once again, Belgium was one of the three Member States that adopted a strict attitude with regard to the exclusion criteria, which led to the European Commission effectively amending the proposal for approval.

6. The EP calls on the the Commission and the Member States in their role as risk managers to duly apply the precautionary principle when, following an assessment of the available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, by adopting provisional risk management measures necessary to ensure a high level of protection of human health.

Position from the Department:

The Department is aware that Article 1(4) of Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market requires Member States to apply the precautionary principle where there is scientific uncertainty. The Department is of the opinion that the Authorisation Committee (the Committee that advises on applications for authorisation of plant protection products in Belgium) applies this principle correctly. It often happens that the applicant receives the message that, before an authorisation can be granted, the dossier must be completed because in one area or another, the data are insufficient to reduce the uncertainty to a negligible level. The Committee prefers this approach to that suggested by the EP, which consists of taking provisional risk control measures in the event of uncertainty.

9. The EP considers that, within the EU system, greater attention should be paid to the widespread use, and prophylactic use when inappropriate, of plant protection products and the effects thereof on human health, animal health and the environment, as well as to the build-up of resistance in the target organism.

Position from the Department:

In Belgium, this matter falls within the remit of the Regions. The Regions will be made aware of this recommendation through the Authorisation Committee in which they are represented.

In all likelihood, this recommendation refers to the so-called 'prophylactic' treatment of seed. Farmers would be able to buy almost only seeds that had already been treated with plant protection products in advance, while the pests and diseases to which the crop would be exposed would not be known beforehand. However, the Flemish and Walloon Region expressly support seed treatment as a sustainable use. Seed treatment permits much more efficient disease control with significantly lower quantities of plant protection products. Moreover, on the basis of his past experience, the farmer can estimate relatively well which diseases and pests are to be expected, and adjust the seed treatment to this in terms of choice of dose and crop protection product.

As for other applications of plant protection products, the consequences of sowing treated seeds for human and animal health and for the environment are investigated, as well as the possible development of resistance by the target organism.

10. The EP stresses the importance of full implementation of Directive 2009/128/EC, given its link to the authorisation system, in particular the provisions with regard to integrated pest management and adequate training for farmers therein; points out that Parliament’s ongoing work on this matter may be referred to for further details.

Position from the Department:

The implementation of integrated plant protection is the responsibility of the Regions. The Regions will be made aware of this recommendation through the Authorisation Committee in which they are represented. Several projects initiated in the framework of ‘NAPAN’ (the Belgian national action plan for the reduction of pesticides) also contribute to facilitating integrated plant protection, such as the accelerated authorisation procedure for 'biopesticides'.

As far as the training of farmers is concerned, this is a competence of Belgium's Communities and Regions. In this area, the Department works with them within the framework of the ‘phytosanitary certificate', which is the licence that users must have in order to gain access to plant protection products for professional use. In order to obtain the phytosanitary certificate, the applicant must have received sufficient training and must undergo continuous compulsory further training; this training focuses on the practice of integrated crop protection.

11. The EP calls on the Commission and the Member States to ensure consistency of purpose between the approval of active substances and authorisation of plant protection products under this Regulation and the purpose of Directive 2009/128/EC.

Position from the Department:

Directive 2009/128/EC establishes a framework for achieving a sustainable use of pesticides by reducing the risks and impacts of pesticide use on human health and the environment and by promoting the use of integrated pest management and alternative approaches or techniques, such as non-chemical alternatives to pesticides.

The Department is of the opinion that the objectives of Directive 2009/128/EC are indeed taken into account in the authorisation of plant protection products. This is mainly done by involving the Regions in the federal authorisation procedure, because the objectives concern both federal and regional competences.

The separation of authorisations of plant protection products for professional use on the one hand and non-professional use on the other hand allows the risk reduction policy options to be optimised according to the target group, which is also in the spirit of the Directive. For products for professional use, the policy can favour risk-reduction measures that require a certain amount of know-how on the part of the user, since the latter has been trained. For the non-professional user, the path of support (by means of framework measures) towards and limitation (by means of legal measures) to intrinsically less dangerous alternatives is preferable. An example of this is the Royal Decree of 16 September 2018, in which the non-professional user's access to herbicides was gradually restricted to low-risk products or products of natural origin.

12. The EP calls on the Commission and the Member States to no longer approve active substances or plant protection products for desiccation.

Position from the Department:

In order to properly comprehend this recommendation, it is important to be aware of the consideration underlying it. This recital reads as follows: "whereas desiccation by means of plant protection products (i.e. the pre-harvest treatment of the actual crop plantation in order to speed up ripening and facilitate harvesting) is not desirable'.

It is not, therefore, a question of haulm killing by desiccation of the potato crop prior to harvest, the aim of which is to prevent the transmission of the potato disease to the tubers and not to facilitate harvesting.  In Belgium, some products are authorised for this use. On the basis of EP's comments, the Department considers that it can be deduced that EP did not refer to this practice. Plant protection products which dry out the crop in order to facilitate harvesting are no longer authorised in Belgium.

13. The EP calls on the Commission and the Member States to no longer allow the use of plant protection products in areas used by the general public or by vulnerable groups, as defined in Article 12(a) of Directive 2009/128/EC.

Position from the Department:

The proposed measure concerns the protection of public health from exposure via the environment. It is, therefore, a matter that falls within the remit of the Regions. They have already taken measures to this effect.  In any case, the Regions will be made aware of this recommendation through the Authorisation Committee in which they are represented.

14. The EP calls on the Commission to take the necessary action to ensure that sales statistics concerning pesticides are publicly available per active substance and per Member State, and that pesticide use statistics are further improved so as to provide full information for the environmental risk assessment as well as the comparative assessment under the Regulation.

Position from the Department:

The Department supports the EP's call to the Commission and would welcome harmonised rules on how sales statistics are made public. However, the Department has not waited for such an initiative at EU level: sales data are already made public.

Statistics on use are the responsibility of the Regions.

21. The EP considers it essential that research and innovation continue to be developed in the Union, and therefore calls for Horizon Europe, other Union financial instruments and the Member States to provide sufficient funding to promote:
(a) independent research on the effects of plant protection products on human and animal health, the environment and agricultural production;
(b) research into alternatives to plant protection products, including non-chemical methods, and low-risk pesticides, with a view to presenting farmers with new solutions for sustainable agriculture, and research into agro-ecological and precision farming techniques with a view to minimising external input and optimising pest control in a targeted and sustainable manner.

Position from the Department:

The scientific research referred to in the Recommendation is the responsibility of the Regions.  The recommendation will be brought to their attention.

26. The EP Calls for full implementation of the 3Rs principle (replacement, reduction and refinement of animal testing).

Position from the Department:

The Department supports this call. However, Member States are bound to apply the data requirements laid down in Regulations (EU) No 283/2013 (for the active substances) and No 284/2013 (for the plant protection products). Where necessary, they should therefore be adapted on the initiative of the European Commission. Moreover, Articles 61 and 62 of Regulation (EC) No 1107/2009 already provide for rules to avoid studies on vertebrate animals as much as possible. The processing of applications for plant protection products is subject to strict monitoring of their application.

27. The EP calls for the application of non-animal tests and technologies in the testing of active substances, safeners, synergists, other co-formulants and product formulations, and for the assessment of cumulative and mixture effects of active substances and plant protection products, wherever such tests and technologies are available.

Position from the Department:

The Department supports this call. However, Member States are required to apply the data requirements laid down in Regulations (EU) No 283/2013 (for the active substances) and No 284/2013 (for the plant protection products). Where necessary, they should therefore be adapted on the initiative of the European Commission.

With regard to cumulative and mixed effects, the Department also requests that a methodology for evaluating these effects be developed by the EFSA as a matter of urgency. Initially, the EFSA is currently developing a method to evaluate cumulative effects of plant protection product residues.

31. The EP on the Commission and the Member States to ensure effective controls of the agricultural products imported from third countries with a view to ensuring a high level of protection and a level playing field for European food production.

Position from the Department:

In Belgium, this aspect is the responsibility of the Federal Agency for the Safety of the Food Chain (FASFC). Foodstuffs on the Belgian market, independent of the origin of production, have to respect the maximum residue limits (MRL) for pesticides as established by European regulation (EC) N° 396/2005. Foodstuffs that are not complying with these MRL are not allowed to be placed on the market.

The FASFC has put a risk-based control program in place for pesticide residues, foreseeing sampling and analysis of foodstuffs produced in the EU and imported from third countries. Of the 2818 samples that were analysed in 2018, 23,4 % were imported from third countries. An overview of the enforcement results for pesticide residues of the FASFC is available on their website.

32. The EP calls on the Member States and the Commission to engage in increased efforts to stop the trade of illegal plant protection products, as these products undermine the objectives of Union legislation in this area.

Position from the Department:

In Belgium, this aspect is the responsibility of the Federal Agency for the Safety of the Food Chain (FASFC). The FASFC has different types of enforcement in place in order to detect the trade of illegal plant protection products.

On the one hand, regular inspections are carried out of operators that are active in the placing on the market of plant protection products (producers, packaging companies, distributors, importers,…) as well as of the professional users of these products (farmers,  contractors,…). During these inspections, it is exactly checked whether the present plant protection products are authorised in Belgium.  Besides these inspections, also specific enforcement actions happen at the import of plant protection products and active substances, more precisely in the harbour of Antwerp, in order to verify if the legal requirements for these products are respected. Finally, an analytical program is going on for the plant protection products on the Belgium market allowing verification of the respect of the authorisation conditions of these products (o.a. content on active substance, relevant metabolites, and physical-chemical properties). 

An overview of the FASFC enforcement results for plant protection products is available on their website.

35. The EP calls on the Commission to ensure that only Member States that can guarantee a high quality of assessment and that have effective procedures for assessing conflicts of interest become reporting Member States (RMSs).

Position from the Department:

The national experts involved in the evaluation of active substances for which Belgium is the reporting Member State must complete a declaration of interest, which will be assessed by the EFSA for conflicts of interest, in order to be able to take part in the peer review meetings organised by the EFSA. For most of our experts, the declaration of interests can be consulted on the EFSA website. For some of them this is not the case, because they have not recently taken part in an EFSA expert meeting.

The Belgian system to identify conflicts of interest (see response to recommendation no 4), which is still under development, does not provide for the obligation to submit a declaration of interests for the national experts referred to in the previous paragraph. Nevertheless, they will also be invited to submit such a declaration of interests.

As regards the quality of the evaluation: the EFSA has repeatedly cited the Belgian evaluation reports as examples to be followed. It can therefore be satisfactorily assumed that Belgium has a sufficiently high quality of assessment as a Member State rapporteur. In other words, the Department does its utmost to maintain or even improve this quality, as explained in recommendation 4.

37. The EP further calls on the Member States to responsibly carry out their auditing of GLP certified laboratories, and calls on the Commission to create a Union verification system for Member State audits led by itself.>

Position from the Department:

This aspect is the responsibility of the Sciensano in Belgium. The recommendation will be brought to the attention of this institution.

46. The EP insists that the RMS should strictly apply Article 9 of the Regulation, so as to ensure that applications are complete before they are deemed admissible.

Position from the Department:

The Department fully agrees with this recommendation. Belgium, as rapporteur Member State, always carries out an in-depth examination of the admissibility of a dossier, not only for the new active substances in application of Article 9 of Regulation (EC) No 1107/2009, but also for the applications for renewal of the approval in application of Regulation (EU) No 844/2012. Moreover, as rapporteur Member State, Belgium always organises a meeting with the producer of the active substance well in advance of its submission in order to clarify the data requirements at the earliest possible stage.

47 The EP stresses that the assessment should include a thorough evaluation of the raw data, as well as data related to final product formulations as available at that stage of the evaluation; calls on the RMS to clearly demonstrate in the DAR that all studies have been properly checked for their relevance, scientific quality and validity, and if necessary to include further studies that were considered as not relevant by the applicant; points out that dismissing data reporting adverse effects should be based only on scientific evidence-based justification, for example the proper application of relevant OECD guidance documents.

Position from the Department:

The Department agrees with the recommendation, which is already being fully implemented by Belgium. In addition, Belgium, as rapporteur Member State, always carries out its own literature review. This is done independently of the literature review that the applicant has to integrate in his application dossier.

50. The EP recommends that the RMS should limit reproducing paragraphs to a minimum and only to justified and duly reported cases; insists that, as long as the assessment is made by the applicant, should passages be taken from the application dossier a clear distinction should be made between the assessment of the authority and the assessment of the applicant.

Position from the Department:

Belgium, as rapporteur Member State, follows in this respect the approach agreed at EU level (template for the preparation of assessment reports, noted by the Standing Committee on Plants, Animals, Food and Feed on 22 March 2019). This approach is as follows: “The RMS is the author of the Assessment Report. The Assessment Report is based on the validation by the RMS, and the verification during the EFSA peer-review process, of the information submitted by the Applicant in the dossier, including the Applicant’s assessments provided in the summary dossier. As a consequence, data and information including assessments and conclusions, validated and verified by the RMS experts, may be taken from the applicant’s (summary) dossier and included as such or adapted/modified by the RMS in the Assessment Report. For reasons of efficiency, the Assessment Report should include the information validated/verified by the RMS, without detailing which elements have been taken or modified from the Applicant’s assessment. As the Applicant’s summary dossier is published, the experts, interested parties, and the public may compare both documents for getting details on which elements of the Applicant’s dossier have been validated/verified and which ones have been modified by the RMS. Nevertheless, the views and conclusions of the RMS should always be clearly and transparently reported; the conclusions from the applicant should be included as an Applicant’s statement for every single study reported at study level; and the RMS should justify the final assessment for each endpoint in all cases, indicating in a clear way the Applicant’s assessment and the RMS reasons for supporting or not the view of the Applicant.”

According to the Department, this approach offers sufficient guarantees of transparency. Nevertheless, if the Commission were to develop an initiative to further develop the template in the sense suggested by the EP, Belgium would participate constructively.

51. The EP calls on the Commission and the Member States to ensure that key tests (e.g. up-to-date ecotoxicological tests for soil organisms, assessment of environmental concentration and residues in dust, wind, air and water, and tests addressing long-term toxic effects, in particular for vulnerable groups) and up-to-date scientific and technological developments in methods are included in the risk assessment.

Position from the Department:

The Department considers that the implementation of this recommendation is addressed primarily to the Commission and not to the Member States.

There are three interlinked aspects to this recommendation:

• The data requirements for the active substances and the plant protection products. These were developed in the 1990s (in the context of Directive 91/414/EEC) and were initially adopted as Implementing Regulations (EU) No 544/2011 and No 545/2011. Subsequently, the data requirements were substantially revised, resulting in Implementing Regulations (EU) No 283/2013 and No 284/2013.As such, the data requirements have been revised relatively recently.
• Communications 2013/C 095/01 and 2013/C 095/02, which complement Implementing Regulations (EU) No 283/2013 and (EU) No 284/2013, and which lay down which test methods and guidelines apply for each of the data requirements of these Implementing Regulations. Since the Implementing Regulations have been adopted, no adjustments have been made to these Communications. It is therefore high time that this was done. Belgium has during the meetings of the Standing Committee on Plants, Animals, Food and Feed repeatedly urged the Commission to update the Communications.
• The technical and scientific guidelines for the evaluation of the studies. These guidelines are generally developed by the EFSA, but the OECD can also play a role here.

60. The EP calls on the Commission and the Member States, in the Standing Committee on Plants, Animals, Food and Feed (PAFF Committee), to adopt without delay any pending guidance, including the updated bee guidance used by EFSA in its recent review of three neonicotinoids.

Position from the Department:

Belgium, within the Standing Committee on Plants, Animals, Food and Feed, has consistently supported a rapid and far-reaching implementation of the EFSA guideline for the assessment of effects on pollinators. Unfortunately, to date, a significant number of Member States have opposed the implementation. In view of this the Belgian authorities have considered that it is necessary to apply the EFSA guideline at least partially in the procedure for the national authorisation of plant protection products. This document explains how we deal with this. Belgium always supports the adoption of EFSA Guidelines by the Standing Committee on Plants, Animals, Food and Feed.

Several other guidelines are still under revision, for which an update has been awaited for a long time in order to bring the evaluation methodologies into line with the current state of scientific knowledge. For some, the EFSA has already received a mandate to carry out this work, for others this is in the pipeline. Delays in updating or adopting these guidelines mean that the evaluation of plant protection products is not carried out in accordance with the latest scientific knowledge. Care should be taken to ensure that they are regularly updated in line with the scientific consensus.

63. The EP calls on EFSA, the Commission and the Member States to apply an extra safety factor when calculating the ‘safe’ doses of exposure, with a view to addressing potential mixture toxicity in cases of high remaining uncertainty which could not be decreased by additional tests of mixtures.

Position from the Department:

Belgium cannot apply additional safety factors unilaterally. The safety factors are laid down at EU level, in particular in Regulation (EU) No 546/2011 implementing Regulation (EC) No 1107/2009 as regards uniform principles for evaluation and authorisation of plant protection products. Those uniform principles were taken unchanged from Annex VI to Directive 91/414/EEC. They therefore need to be updated as a matter of urgency. Belgium has already pointed this out during the discussions on the so-called Refit of Regulation (EC) No 1107/2009. In the meantime, Belgium is obliged to apply the calculations of the safe exposure doses laid down in Regulation (EC) No 546/2011. Moreover, a unilateral deviation by Belgium from this would constitute a serious obstacle to the application of the mutual recognition procedure for national authorisations and would therefore make it more difficult to implement the general remark no 91, by which the EP calls on the Member States to apply this procedure more effectively.

65. The EP calls on the Member States to ensure that they are properly represented in EFSA by independent national experts; recommends that the Member States engage with EFSA in constructive ways.

Position from the Department:

Belgium is always represented at the EFSA's Pesticide Steering Network meetings. A Belgian expert is also always present at the expert meetings at which an active substance is discussed for which Belgium has acted as Member State rapporteur. If EFSA organises an expert meeting on more general issues, Belgium is always represented. During an expert meeting at which no active substance is discussed for which Belgium is the Member State rapporteur, there is usually no Belgian expert present. On the one hand, there is insufficient capacity available within the Department to guarantee such systematic participation and, on the other hand, it is doubtful whether the presence of an expert from each of the Member States would contribute to the effectiveness of these meetings.

The amendment of the General Food Law (European Regulation No 178/2002 of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety) by Regulation (EU) 2019/1243 of 20 June 2019 provides for representation of all Member States on the EFSA's Management Board.

A constructive cooperation with the EFSA receives Belgium's full backing and, as a member of the central zone, Belgium has also supported the recent initiative to set up additional consultation platforms precisely in order to further improve cooperation.

76. The EP strongly regrets the numerous delays at Member State and Commission level before and after peer review by EFSA, in particular the delays in the assessment of substances that meet the cut-off criteria, and urges the RMSs and the Commission to meet their deadlines as laid down in the Regulation.

Position from the Department:

The Department regrets that Belgium, as rapporteur Member State, has not always been able to complete the evaluation reports within the deadlines laid down in the Regulation. In our opinion, however, efforts to comply with the deadline should not be at the expense of the thoroughness of the evaluation. Belgium, as rapporteur Member State, has a realistic programme for the coming years, and the Department is therefore confident that it will be able to meet the set deadlines in future.

77. The EP stresses the need to ensure political accountability for the adoption of implementing acts using the comitology procedure; expresses its concern at the lack of transparency in the PAFF Committee; calls on the Commission and the Member States to increase the overall transparency of the procedures, including by providing detailed minutes on the comitology discussions and the respective positions, in particular by explaining and justifying the PAFF Committee’s decisions and by making public the votes of the Member States.

Position from the Department:

The Department agrees with this recommendation and has asked the Commission to discuss it in the Standing Committee. In the message by which Belgium asked the Commission for this discussion, Belgium has already indicated that it is in favour of making the votes public.

78. The EP calls on the Commission and the Member States to endorse an independence policy and to ensure that Members of the Standing Committee on Plants, Animals, Food and Feed have no conflicts of interest.

Position from the Department:

The representative of the Member State in the Standing Committee is not a personal member of the Committee. Of course, the Belgian representative receives instructions from his hierarchy regarding the positions to be taken. Moreover, the Department has no objection to the requirement for Member States' representatives on the Standing Committee to submit a declaration of interests.

79. The EP calls on the Commission and the Member States to strictly apply Article 4 of the Regulation and to adopt clear scientifically based criteria for what constitutes unacceptable effects on the environment, taking into account real-life exposure (acute and chronic) to multiple plant protection products.

Position from the Department:

Belgium strictly adheres to the criteria set out in Article 4. The criteria for what is meant by unacceptable effects on the environment are laid down by the uniform principles (Regulation (EU) No 546/2011; see also the reaction to general remark 64). Belgium supports the EP's call with regard to multiple plant protection products; the methodology in this respect is not yet sufficiently developed.

89. The EP considers the mutual recognition procedure as vital for sharing the workload and facilitating compliance with deadlines; regrets the delays in the assessments by the Member States examining the applications for authorisation and implementation problems associated with the mutual recognition principle; calls on the Commission to work with Member States to improve the functioning of the zonal system; underlines that the full implementation of the existing legislation should have the aim of avoiding duplication of work and making new substances available to farmers without unnecessary delays.

Position from the Department:

Belgium is using the mutual recognition procedure. Nevertheless, experience has shown that a national review remains necessary. The evaluation reports prepared by some Member States do not fully meet expectations in terms of quality. In addition, there are still considerable differences between Member States, including within a zone, in terms of environmental and agricultural conditions. While mutual recognition is an important principle, priority should be given to ensuring an acceptable level of health and environmental safety.

Nevertheless, the Department will examine the possibility of streamlining the mutual recognition procedure.  This is, moreover, an action that was also recommended following an internal audit.

90. The EP urges the Member States to meet the deadlines for the evaluation of plant protection products and the provisions relating to mutual recognition, as laid down in the Regulation.

Position from the Department:

In this context, reference can be made to the reply to general observation No 4. Successive increases in the fees payable by applicants for authorisation have led to a steady increase in the Department's fees, which must, however, be monitored to ensure that newly recruited staff can be properly supported and trained.  In any case, further recruitment is planned. Nevertheless, it must be acknowledged that it is unlikely that strict compliance with the deadlines will be achieved in the near future.

92. The EP calls on the Member States to ensure that all plant protection products undergo proper assessments, including exposure scenarios, on the basis of data obtained for the plant protection product itself, and considers that extrapolation of data on plant protection products should not be done from data obtained on active substances, unless this is scientifically justified and confirmed as reliable by post-market monitoring.

Position from the Department:

This general remark relates to the impact that the presence of co-formulants may have on the properties of the plant protection product.  The Commission is preparing a Regulation establishing Annex III to Regulation (EC) No 1107/2009 (list of unacceptable co-formulants). Moreover, Belgium has long had a national list of unacceptable co-formulants. Regulation (EU) No 284/2013 (data requirements for plant protection products) largely determines the extent to which extrapolation on the basis of data obtained on active substances is possible. The Department certainly supports a critical analysis of this aspect at the time of the next revision of the data requirements. However, it is important to remain proportionate and to find a balance that takes into account the objective set by the EP in its general remark No 27, i.e. to reduce animal testing.

94. The EP calls on the Member States to ensure that any decision on the authorisation of plant protection products is based on a proper risk assessment of the real-life exposure, acute and chronic, of vulnerable groups, and for the corresponding EFSA Guidance to be amended accordingly.

Position from the Department:

The EFSA guideline on exposure of operators, workers, bystanders and residents is used by the Belgian evaluators. It is the latest tool we have at our disposal. It is true that there are still some gaps in the EFSA guideline, but the EFSA has started the activities that should lead to a revised and extended version of the guideline.

95. The EP stresses the need to require applicants to provide all studies to the Member State examining the application for authorisation, including the raw data, in a machine-readable format.

Position from the Department:

Full study reports, including raw data, and of course in a machine-readable format, must always be submitted to our Department.

96. The EP calls for public access to be granted to the above studies, including all supporting data and information relating to applications for authorisation, in a machine-readable format and in their entirety in order to ensure transparency, thus allowing for timely independent scrutiny while protecting personal data and ensuring that those who requested the studies can only use them for non-commercial purposes, so as to safeguard the relevant intellectual property rights.

Position from the Department:

Today, anyone who asks the Department can have access to the studies that were submitted in order to obtain the authorisation (after the authorisation was issued). The Department points out that making all the studies in support of applications public would require considerable resources, which may have to be used as a matter of priority for the implementation of other recommendations of the EP. Nevertheless, the Department is willing to think constructively if an initiative is developed to this end by the Commission in the context of a revision of Regulation (EC) No 1107/2009.

98. The EP urges the Member States to increase efficiency through greater zonal and inter-zonal coordination, in order to better share the workload and make the best use of each Member State’s resources, and to grant derogations under Article 53 of the Regulation only where existing requirements are strictly complied with.

Position from the Department:

Article 53 of the Regulation deals with emergency plant protection situations and allows Member States to grant authorisations for plant protection products that have not gone through the regular authorisation procedure.  In other words, it is possible to deviate from the data requirements and standards established at European level.

The Department is of the opinion that the coordination within the central zone is going well.  Belgium is an active participant in the meetings of the Central Zonal Steering Committee and the Interzonal Steering Committee.

With regard to Article 53, the existing obligations are strictly complied with.

99. The EP considers that the system of inter-zonal mutual recognition must be improved.

Position from the Department:

Belgium is open to mutual recognition of authorisations granted by Member States of other zones. There are already examples of this (mutual recognition of French and Danish authorisations).  Initiatives for further improvement will be supported by Belgium.

100. The EP calls on the Member States to better implement the authorisation procedures at national level in order to limit the derogations and extensions granted under Article 53 of the Regulation to actual emergency situations; calls on the Member States to strictly apply Article 53 of the Regulation, to only accept and examine completed applications for derogations, and to only submit completed notifications of derogations to the Commission and other Member States.

Position from the Department:

Article 53 of the Regulation deals with emergency plant protection situations and allows Member States to grant authorisations for plant protection products that have not gone through the regular authorisation procedure. In other words, it is possible to deviate from the data requirements and standards established at European level.

Article 51 concerns the extension of authorisations for so-called "minor uses" or "minor crops". The volumes of crop protection products used for this purpose are too small to allow the authorisation holders to go through an authorisation procedure, which provided for the possibility for the Member States to initiate the authorisation procedure themselves. These extensions must, however, comply with the European data requirements and standards, with the exception of efficacy.

The Department pursues an active policy with regard to the authorisation of plant protection products in small crops, in application of Article 51. This makes it possible to limit the number of authorisations in application of Article 53.

Applications in accordance with Article 53 are refused if they are incomplete.

The Department is certainly not opposed to the use of the possibilities offered by Article 53(2) and (3) in order to curb any unjustified application of this Article. These paragraphs provide that the Commission may ask the EFSA for an opinion and that the Commission may propose to withdraw to modify or to forbid repetition or prolongation. The Commission requested the EFSA, in application of Article 53(2), to examine the validity of a number of authorisations for plant protection products based on neonicotinoids. As indicated by the EP in its recital ‘CK’ for a number of these authorisations, the EFSA found that the conditions of Article 53(1) were not fully satisfied. The Commission subsequently drew up proposals for decisions to ensure that the Member States concerned may not repeat the measure. The Commission asked the Member States what they thought of this.  Belgium has replied that it agrees in principle with the proposed measure.

102. The EP calls on the Member States to ensure that public consultation of relevant stakeholders is undertaken prior to the granting of any emergency authorisation under Article 53, without creating unnecessary delays in the granting of emergency authorisations and ensuring that all relevant stakeholders are informed in a timely manner whether the emergency authorisation is granted or refused.

Position from the Department:

Article 53 of the Regulation deals with emergency plant protection situations and allows Member States to grant authorisations for plant protection products that have not gone through the regular authorisation procedure. In other words, it is possible to deviate from the data requirements and standards established at European level.

The Department considers that the EP's proposal to conduct a public consultation before granting an emergency authorisation under Article 53 is difficult to reconcile with the fact that many of these applications are of an urgent nature. The EP is aware of this, as it insists on avoiding undue delay in granting the relevant authorisation. In Belgium, these applications are always dealt with quickly and, if possible, discussed at the next meeting of the Approval Committee for Pesticides for Agricultural Use. The authorisations are published on our website Fytoweb as soon as they have been issued.  By means of a press release, also posted on Fytoweb, all interested parties can take note of the authorisation.

103. The EP calls on all Member States to publish the completed application forms they receive requesting an emergency authorisation under Article 53, whether the authorisation is granted or refused.

Position from the Department:

Article 53 of the Regulation deals with emergency plant protection situations and allows Member States to grant authorisations for plant protection products that have not gone through the regular authorisation procedure. In other words, it is possible to deviate from the data requirements and standards established at European level.

The Department will examine the most efficient way of responding to this recommendation, as well as any legal obstacles such as those relating to confidentiality and language legislation.

105. The EP calls on the Member States to inform each other, the Commission and the public concerning the authorisation and withdrawal of plant protection products, as well as mitigation measures, in order to ensure an EU-wide overview of plant protection products on the market and the risk management pertaining to them.

Position from the Department:

All the information referred to by the EP in this note is publicly available on our website:

• The full content of all authorisations, including risk mitigation measures;
• For each withdrawal of an authorisation, a press release is drawn up, announcing the grace periods for placing on the market and for using existing stocks.

106. The EP calls on the Commission and the Member States to improve their data exchange on safer plant protection products which could replace plant protection products containing candidates for substitution, in order to facilitate the comparative assessment of plant protection products.

Position from the Department:

The Department supports this call and will participate constructively in any such initiative.

108. The EP calls on the Commission and the Member States to promote the development and use of sustainable and ecological alternatives to plant protection products, integrated pest management measures and low-risk pesticides, as an important measure for reducing the adverse impacts of pest management; acknowledges the need for more research into and development of these products; calls on the Commission, therefore, to assess options to stimulate innovation in this field.

Position from the Department:

In Belgium, this matter falls largely within the competence of the Regions, in particular as rgards the promotion of the development and use of ecological and sustainable alternatives to plant protection products, as well as integrated pest management measures. The Regions will be made aware of this recommendation through the Authorisation Committee in which they are represented. With regard to the promotion of low-risk crop protection products, the Department contributes by facilitating the submission of applications for the authorisation of these products. The Department provides the applicant with concrete advice before, during and after the submission of his application.

The Belgian national action plan for the reduction of pesticides (NAPAN) provides for the identification of low-risk pesticides of natural origin, in application of all legal provisions, so that it is clear which pesticides are involved.

112. The EP calls for a harmonised definition of ‘minor use’ in order to promote a level playing field, and recommends creating a single EU list of major crops.

Position from the Department:

Efforts have already been made in the past to achieve such a definition, including through EPPO (European and Mediterranean Plant Protection Organisation). These efforts have not led to a satisfactory outcome. A crop that is certainly an important crop in one Member State may be marginal in another. An example of this is the vine in France and Belgium.  The Department does not consider this a priority issue.

113. The EP calls on the Commission, EFSA and the Member States to ensure that all relevant stakeholders, including the public, are included in any stakeholder activities on pesticides, as provided for in Directive 2003/35/EC and the Aarhus Convention.

Position from the Department:

All relevant stakeholders are represented in the NAPAN (the Belgian national action plan for the reduction of pesticides) Advisory Board. A meeting of the Board is held every three months to follow up and discuss the various NAPAN projects. For several projects (such as the elaboration of communication campaigns, knowledge certificates, elaboration of the NAPAN five-year programme), stakeholders are even more closely involved through participation in ad hoc groups involved in the realisation of these projects. The public is officially consulted on NAPAN on the occasion of the preparation of the five-year programme.

114. The EP calls on the Commission and the Member States to ensure that the requirements in the Regulation for the prioritisation of non-chemical methods are properly implemented.

Position from the Department:

In Belgium, this matter falls within the remit of the Regions. The Regions will be made aware of this recommendation through the Authorisation Committee in which they are represented.