notice to members - European Parliament

European Parliament 2014-2019

Special Committee on the Union’s authorisation procedure for pesticides

26.6.2018

NOTICE TO MEMBERS (1/2018)

Subject:

Mission Report following the PEST Committee mission to the European Food Safety Auhtority (EFSA), Parma, Italy on 7-8 May 2018

Special Committee on the Union’s authorisation procedure for pesticides Members of the mission: Eric ANDRIEU Norbert LINS Miroslav MIKOLASIK Arne GERICKE Bart STAES

(S&D) (Chair) (EPP) (EPP) (ECR) (Greens/EFA)

Local Member of the European Parliament Simona BONAFE (S&D)

Introduction The Special Committee on the Union’s authorisation procedure for pesticides (PEST Committee) was set up on 6 February 2018. According to its mandate, the PEST Committee shall, in particular, analyse and assess the authorisation procedure for pesticides in the Union and come up with a final report (including factual findings and recommendations) by 12 December 2018 (i.e. within its mandate of nine months, running from 12 March 2018, when the Special Committee held its constitutive meeting). To this end, the PEST Committee is mandated to, inter alia, undertake visits to the relevant agencies. On 16 April 2018, the Bureau authorised a mission composed of 11 Members (+ the Chair) to visit the European Food Safety Authority (EFSA) in Parma, Italy, from 7 to 8 May 2018. The delegation was eventually composed of: Mr Eric Andrieu (S&D, Chair and Head of delegation), Mr Norbert Lins (EPP), Mr Miroslav Mikolasik (EPP), Mr Arne Gericke (ECR) and Mr Bart Staes (Greens/EFA). Additionally, Ms Simona Bonafé (S&D) took part in the mission as local Member of the European Parliament. The mission was accompanied by Ms Christina Malmros and Ms Nora Hahnkamper-Vandenbulcke from the PEST Secretariat as well as the following political group advisors: Ms Vittoria Venezia (EPP), Mr Miron Podgorean (S&D) and Ms Joanna Sprackett (Greens/EFA). The meetings were held at the EFSA premises from 14:30 to 18:30 on 7 May 2018 and from 9:00 to 13:00 on 8 May 2018.

Figure 1: From left to right: Mr Tarazona (EFSA, Head of Pesticides Unit), Mr Mikolasik, Mr Url (EFSA Executive Director), Mr Gericke, Mr Staes, Mr Andrieu, Mr De Sèze (EFSA, Head of Scientific Evaluation of Regulated Products Department), Mr Lins, Mr Wolff (EFSA, Institutional liaison, ENCO unit), Ms Victoria Villamar (EFSA, Team leader institutions and stakeholder relations, ENCO unit), James Ramsay (Head of Engagement and Cooperation unit (ENCO unit), Mr. Flavio Fergnani (Team leader Media Relations, ENCO unit)

Summary account of meetings Monday 7 May 2018 Session I - EU risk assessment of pesticides in the food chain: main principles Bernhard Url (EFSA, Executive Director), welcomed the delegation and stressed EFSA’s readiness to support the work of the PEST Committee. He shortly outlined some facts about EFSA: the agency was established in 2002, has approximately 450 members of staff and was supported by more than 1.500 national experts working in scientific panels (supporting EFSA on a voluntary basis during up to 50 days/year). EFSA’s annual budget amounts to 80 Mio. € (exclusively from EU budget), with around 60% currently dedicated to staff (and staff costs constantly increasing). As regards the risk assessment of pesticides, 50 people are currently involved in EFSA’s activities in this area (compared to around 1.000 people at the European Medicine’s Agency/EMA and around 350 employed scientists at the Canadian Pest Management Regulatory Agency/PMRA). In this context, MEPs were particularly interested in knowing which aspects of EFSA’s work in the framework of risk assessment of pesticides could be strengthened and how much additional resources would be needed. Jose Tarazona (EFSA, Head of Pesticides Unit) outlined the following three main areas: 1) assessment of literature research, 2) assessment of plant protection products (an area in which EFSA received a lot of requests from national authorities, but was currently not sufficiently staffed to respond to these requests) and 3) developmental activities (e.g. development of guidance which should be updated at least every 3 years, which was not done at the moment). Mr Url also informed Members that EFSA had - in the context of the ongoing REFIT process of the EU pesticides legislation recently submitted comments on the current risk assessment of pesticides (including reflections on the strengths of the current system and areas for possible improvement) to the Commission (Scientific Advice Mechanism). These comments would be presented at the PEST meeting on 7 June 2018. Moreover, Members inquired about the possibility to introduce fees (such as is the case for EMA). Mr Url - while explaining that the situation was more complex for food than for medicines - acknowledged that this issue would deserve further consideration at political level. The recent Commission proposal to increase EFSA’s budget (proposal of 11 April to amend the General Food Law) was to be welcomed as a further step to increase transparency and public confidence, but would not resolve the current lack of resources EFSA was facing in the pesticides area (as it would only cover the costs of the additional tasks given to EFSA under the new proposal, but not the lack of resources related to EFSA’s current tasks). In his presentation, Mr Url also touched upon the different steps of the risk assessment process of active substances: (1) submission of the dossier by the applicant, (2) assessment by the Rapporteur Member State (RMS), (3) verification (and possibly improvement of the draft assessment report, as was also the case for glyphosate) through peer review and consultations with experts, the public and the applicant, and (4) the final assessment by EFSA (“conclusion”). In relation to EFSA’s key values (transparency of the process, independence of experts and reliability of data), the Executive Director outlined EFSA’s transparency and independence policy. In order to ensure transparency, EFSA published documents related to each of the

steps in the procedure (summary dossier provided by applicant, initial assessment report by the RMS, updated assessment report by the RMS and peer review report by EFSA, as well as the EFSA conclusion). EFSA’s independence from risk managers (European Commission and Member States) and industry was granted through a policy covering all actors and working processes. In relation to the independence of the scientific assessment carried out by EFSA, Mr Url underlined that scientific panels were not used for pesticides, for which a peer review system (with experts from all Member States) was used. It was up to the competent authorities to designate organisations from which experts could be invited to participate in the peer review. For the sake of transparency, EFSA invited Member State experts to submit a Declaration of Interest (DoI), although they were not obliged to do so. These DoIs were made available on EFSA’s website. Mr Url explained that EFSA did not assess the DoIs of Member State experts. The responsibility for ensuring the suitability of the experts nominated to take part in the pesticides peer reviews was with the Member States, based on a relationship of mutual trust and recognition between EFSA and the Member States. However, as of July 2018, following a change of EFSA’s policy, the DoIs of Member State experts would be checked (although this was a delicate exercise as it possibly implied creating different levels of independence). In relation to the independence of EFSA’s experts, their independence was granted (and verified by EFSA’s lawyers, the Management Board and the European Court of Auditors). Mr Url also stressed that EFSA’s civil servants had to submit declarations of interest, which was an additional requirement compared to other EU civil servants. With a view to current divergences between independence policies of EU agencies, Mr Url spoke out in favour of laying down a harmonised independence policy amongst all EU agencies and invited the PEST Committee to come up with a proposal. As regards the reliability of data, Mr Url explained that the assessment of data submitted by industry was standard practice also in other agencies (ECHA and EMA). With regard to the diverging classification of glyphosate by EFSA and the International Agency for Research on Cancer (IARC), Mr Url explained that EFSA and IARC had reached different conclusions because IARC had, in particular, looked at other evidence than EFSA (only publicly available information, either published in peer-reviewed journals or in the form of summaries from industry studies, while EFSA had, on top of open literature, also examined the full industry studies including raw data). Moreover, in line with its mandate, EFSA had not taken into account some evidence reviewed by IARC dealing with formulations. In some cases, EU classification of pesticides was more conservative than the one carried out by IARC. In 2017, EFSA carried out a comparison of 54 pesticides that had been assessed under both the EU and IARC systems. While in most cases (29 active substances), the classification was equivalent between EFSA and IARC, in 14 cases the EU classification was more “stringent” and only in 11 cases (glyphosate + 10) less “stringent”. In response to questions by Members, Mr Url specified that summaries of all studies were published. This was, however, not the case for raw data submitted by industry (which included data protected by EU laws on business confidentiality). In case of glyphosate and the question of whether it was carcinogenic, the EU assessment considered 6 studies in rats and 4 in mice looking at mammalian carcinogenicity as reliable, 3 others were supplementary and 7 inadequate. IARC only evaluated summaries of some of those studies. All studies considered reliable by IARC and EFSA had been commissioned by industry, following OECD guidelines and good laboratory practice (GLP).

On the “copy and paste” allegations related to the draft assessment report by the BfR, Mr Url contested these strongly and explained that it was common practice to take up summaries of scientific literature in the draft assessment report, if these summaries had been done correctly (and the RMS, after verification, did not see any need for amendment). This was not to be considered as plagiarism. Members, however, suggested to have a uniform approach in highlighting those parts of the text stemming from the applicant, as practices differed between the national competent authorities. In relation to the so-called “Monsanto papers”, Mr Url pointed out that this was a different issue, as in this case Monsanto had allegedly asked their own employees to ghost-write scientific papers. Should this be true, this would of course be very bad practice. Mr Url noted that amongst the studies included in the Monsanto papers, two so-called review studies (“Kier and Kirkland 2013” and “Williams et al 2000”) were considered in the EU glyphosate risk assessment. These two studies explicitly mentioned the connection of the authors with the companies and therefore, according to EFSA, could not be considered as ghost-written by industry experts. In addition, these two publications were reviews of scientific publications, and were part of a body of evidence of around 700 scientific reviews. Mr Url also stressed that EFSA, as all regulatory agencies, had access to the raw data of all studies and therefore reviews of such literature were of a less relevant weight. Session II - Pesticide evaluations: the peer-review process During this session, EFSA scientific staff led MEPs through the different steps of the pesticides peer-review process, using three examples (s. below). In his introductory words, Mr Tarazona stressed the transparency of the process (including the possibility to submit comments on the draft assessment report during the consultation phase, the highlighting of changes in the revised assessment report and the publication of all comments in the peer review report). In the first presentation, Ms Daniele Court-Marques (EFSA, Team leader - Toxicology Team) leader) explained how EFSA scientists assess scientific evidence on carcinogenicity and, in particular, the weight of evidence approach. Key considerations of this approach were relevance (i.e. the contribution a line of evidence would make to answer a specific question, if reliable), reliability (extent to which the information comprising a line of evidence is correct) and consistency (extent to which the contributions of different lines of evidence are compatible to answer the specific question). Ms Court-Marques illustrated the lines of evidence for hazard identification for carcinogenicity (plausible mode of action, e.g. genotoxicity, animal data on carcinogenicity and epidemiology) of three different active substances (glyphosate, desmedipham and iprodione). She also indicated that the assessment of carcinogenicity was a standard and key element of the EFSA peer-review process, and that it was always evidence- based. In fact, the same process and pool of experts, in EFSA and in the Member States, had suggested classification for carcinogenicity for 21 out of the 76 pesticides assessed since 2015, including two cases for classification in category 1B. In relation to glyphosate, all (acceptable) studies were negative for mutagenicity. Regarding animal studies on genotoxicity, based on 15 out of 16 in vivo studies that were negative, it was also concluded that glyphosate was unlikely to be genotoxic. As to the results of animal studies to assess carcinogenicity of glyphosate, no carcinogenic effect was observed in studies on rats. In studies on mice, no increased incidences of tumours were observed, except

for malignant lymphoma and haemangiosarcomas as well as kidney tumours. However, as to the former, they were either within the historical control data (i.e. tumour incidences of control animals in earlier studies) or there was a low incidence in the same range as controls in other studies. As to kidney tumours, they were only observed at high doses (>4000 mg/kg bw per day). Moreover, there was a lack of pre-neoplastic lesions and a lack of consistency. As to epidemiology, there was only very limited evidence for an association between glyphosate-based formulations and Non-Hodgkin Lymphoma and the overall evidence was inconclusive for a causal link between glyphosate and cancer in human studies. Based on this evidence, it was concluded that glyphosate would not need to be classified as carcinogenic. Ms Court-Marques also explained the assessment of two other pesticides, presenting the evidence used during the EFSA peer review for suggesting the classification of iprodione as carcinogenic category 1B and of desmedipham as carcinogen category 2. She highlighted that all three cases were based on the same criteria and methodology, and applied by the same pool of experts in EFSA and the Member States. In the debate, one Member inquired whether the weight of evidence approach had indeed been properly applied in case of glyphosate (referring, in particular, to an article published in March 2018 by Clausing, Robinson and Burtscher-Schaden, claiming that glyphosate should have been classified as probably carcinogenic (category 1b), had the statistical methods and weight of evidence criteria been applied in accordance with guideline documents). Ms CourtMarques replied that one had to distinguish between statistical significance and biological relevance. Accordingly, when the biological relevance was considered, EFSA experts had not confirmed the statistical significance (i.e. the observed increases in tumour incidences) and, thus, a link between exposure to glyphosate and the appearance of tumours could not be established. Also, something that was statistically relevant may be biologically irrelevant. Mr Guilhem de Sèze (EFSA, Head of Scientific Evaluation of Regulated Products Department) added that, according to OECD guidance, the statistical method had to be defined before the tests were being carried out, and not afterwards. In a second presentation, Mr Juan Manuel Parra Morte (EFSA, Scientific Officer Toxicology Team) explained the different steps of human health risk assessment (hazard identification, a dose-response relationship, exposure and risk characterisation) and, in particular, the risk assessment carried out in case of three active pesticide substances (glyphosate, diquat and thiophanate-methyl). In practice, the scientific evidence consisted of industry studies and public literature. Based on this, and considering any adverse effects as well as the dose at which it is observed, the safe dose in animals, not causing effects, and the dose causing effects, were determined. Based on the safe dose in animals, human reference levels (HRLs) were set (=safe dose in animal at least divided by 100), unless there was evidence suggesting that the pesticide was mutagenic/genotoxic. In case the exposure of consumers, workers etc. (according to an exposure assessment) was below the HRL, there was no reason for concern. In case of glyphosate, the evidence consisted of more than 700 studies (including published literature). Adverse effects (abortions in rabbits) were observed and the safe dose in rabbits was established at 50 mg/kg/day (with human reference levels set at 0.5 mg/kg/day). Further to an exposure assessment (of adults and children), it was concluded that there was no reason for concern as the exposure was expected to be below the acute reference dose (ARfd). Mr Parra Morte also explained that no ARfD had been set in the past (in 2001) as this reference value was a new concept at the time. At present, however, an ARfD was established (although it had not initially been proposed by the RMS, it was proposed following the peer

review by MS and was finally agreed at an expert meeting, although the applicant did not consider it necessary). In case of diquat, more than 40 studies had been considered. Adverse effects (cataracts in dogs) had been observed and in 2018, a reassessment of the available data led to a revision of the reference value and a more accurate exposure assessment indicating concern (with which the applicant did not agree). In case of thiophanate-methyl, reference values were set in the past (2005) because safe doses were identified. Due to new guidance on genotoxicity, more sensitive assays and new evidence available, the initial assessment was reviewed. As a consequence, no HRLs have been set for this active substance as mutations (genotoxicity) were observed in rats (and the risk related to exposure was high as genotoxicity is associated with degenerative diseases, reproductive toxicity or cancer). In this context, Members inquired whether it was standard practice that the Commission asked EFSA to reassess certain active substances, which Mr Tarazona confirmed (specifying, however, that this did not happen very often). In a third presentation, Ms Domenica Auteri (EFSA, Team leader - Ecotoxicology Team) explained the environmental risk assessment carried out in relation to pesticides. Main factors to be considered were the environmental fate and behaviour of the active substances (in the soil, surface and groundwater, and in the air) as well as the ecotoxicology (i.e. the impact on non-target organisms such as birds and mammals, aquatic and soil organisms, bees and plants). The main outcome of the risk assessment of glyphosate was that its use represented a high risk for birds and mammals. In addition, indirect effects on biodiversity were considered as an important risk management issue and mitigation measures (including no-spray buffer zones) were needed. In case of diquat (which was more toxic than glyphosate), a high reproductive risk for birds and mammals as well as for aquatic organisms, earthworms and other soil organisms was identified. While for glyphosate, no critical areas of concern were identified, this was the case for diquat in relation to birds and mammals. In the following debate, Members were interested in knowing how the impact on soil organisms was tested (with EFSA replying that it did not carry out tests itself, but that when a high risk for soil organisms was identified, this often triggered higher-tier studies with a wider range of species). Other issues discussed were, inter alia, the impact of pesticides (in particular neonicotinoids) on bees, the link between genetically modified crops and the significantly increased use of pesticides (with EFSA referring to a huge study that was currently ongoing for assessing the levels of glyphosate residues in food and feed and its potential risk for human and animal health) as well as the use of pesticides outside the agricultural uses (e.g. use of glyphosate-based pesticides by Deutsche Bahn to keep weed off its tracks which, according to EFSA, was an issue for consideration and enforcement by Member States authorities, as identified in the EFSA conclusion).

Tuesday 8 May 2018 Session III - Assessment of pesticides: ongoing developments In the first presentation on the improvement of health assessments, Ms Federica Crivellente

(EFSA, Scientific Officer - Mammalian Toxicology Team) gave an overview of ongoing activities in the area of epidemiological studies. At present, the data requirements for active substances were laid down in Regulation 283/2013. Accordingly, relevant epidemiological studies had to be submitted by the applicant where available. In relation to EFSA’s recent and future activities in this area, Ms Crivellente pointed to two Scientific Opinions issued by EFSA in March and October 2017 respectively. While one of these opinions focused on improving the use of epidemiological studies in pesticide risk assessment (and included several recommendations concerning, in particular, the design of such studies and the methodology to integrate epidemiological data with toxicological studies and other evidence), the other one was a case study to investigate the plausible involvement of pesticide exposure as a risk factor in Parkinson’s disease and childhood leukaemia (using the “Adverse Outcome Pathway” (AOP) concept to assess biological plausibility1). Ms Crivellente also explained that both opinions were a follow-up of a comprehensive review of epidemiological studies, published by EFSA in 2013, investigating the link between pesticide exposure and many health outcomes. Despite a considerable amount of epidemiological information available, the review only found significant associations between pesticide exposure, mostly related to already banned pesticides, and Parkinson’s disease as well as childhood leukaemia (which was, in particular, due to the low quality of much of the available evidence). In November 2017, EFSA also organised a Scientific Conference on the use of epidemiological studies in pesticides risk assessment. Other follow-up activities were, however, currently on hold because of a lack of budget and human resources. In the following, Members inquired about the possible link between professional diseases (including premature puberty and fertility problems) and the use of pesticides (on which there were, inter alia, studies ongoing in France), and asked about the existence of national inventories. Ms Crivellente replied that this was a complex issue (inter alia because it was extremely difficult to measure/determine the exposure to pesticides, as, amongst others, questionnaires filled in by workers/farmers were not harmonised and thus prone to bias) and that one should thus be very careful before drawing any firm conclusions. Although positive correlations between the use of pesticides and certain diseases had been observed, these only related to groups of pesticides rather than to specific active substances. Due to a lack of resources, EFSA did, at present, not collaborate with national social systems. Also, EFSA was currently not involved in any phytopharmacovigilance activities (such as EMA). Should this become a political priority in the future (and on condition that EFSA was provided with the necessary resources), this could possibly be done in the future. When asked about the (additional) money needed to carry out phytopharmacovigilance activities and to coordinate epidemiological studies at EU level, Mr Url replied that it was difficult to come up with concrete numbers at this point. However, the upcoming Scientific Opinion of the Commission’s Scientific Advice Mechanism High Level Group, to be adopted soon and to be presented at the PEST meeting on 7 June 2018, would probably be useful in this context. The “Adverse Outcome Pathway (AOP)” was developed by the scientific community and implemented through the OECD to improve understanding of how chemicals induce adverse effects (i.e. to establish whether there is a plausible link between the cause – a chemical coming into contact with and affecting an organism at cellular level – and a subsequent chain of events leading to the effect i.e. disease) and consequently identify chemicals that need to be considered as potential risk factors for a disease. The AOP concept is thus intended to improve the use of epidemiological data in risk assessment. 1

In relation to glyphosate, Members also pointed to the current confusion between the active substance and the plant protection products containing it. Acknowledging this, Mr Url added that an EU risk assessment of plant protection products might be needed (while continuing to involve, however, the Member States). Still in the area of improving health assessments, Mr Andrea Terron (EFSA, Senior Scientific Officer - Pesticides Unit) held a second presentation on developmental neurotoxicity (“DNT” including autism, attention deficit hyperactivity disorder (ADHD), dyslexia etc.) in which case the brain in development was affected by environmental chemicals. Mr Terron stressed the lack of adequate DNT data which was, in particular, due to the fact that there was no obligation for pesticides to be tested for DNT and to current limitations of the test system. In this context, the goal of EFSA’s ongoing project was to develop non-animal alternatives (invitro test methods) for screening DNT effects, as animal studies were considered as insufficient. Moreover, the standard testing only used endpoints, while the consideration of a mechanistic perspective (although time-consuming) would be a huge improvement. Should EFSA be provided with more budget, this process could, however, be accelerated. EFSA was leading the development of a science based solution at international (OECD) level. In this context, one Member suggested to oblige industry to participate in the funds dedicated to research. Members were also interested in research carried out by OECD. In a third presentation, Mr Luc Mohimont (EFSA, Deputy Head of Pesticides Unit) explained EFSA’s activities in relation to cumulative risk assessment. According to Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed, cumulative and synergistic effects (including pesticide residues arising from other sources than current plant protection uses of active substances and residues from such uses, i.e. multiple pesticide residues) had to be taken into account when setting Maximum Residue Levels (MRLs), as and when methodologies to assess such effects would be available. Those methodologies, as well as the data (monitoring results from national competent authorities, food consumption surveys and pesticide dossiers reviewed by EFSA) were now available. Consequently, a pilot assessment – looking at the cumulative effects of exposure to pesticides in food on the human nervous and thyroid systems – was already underway and expected to be finalised by end of 2018 (with further assessments of cumulative/synergistic effects in relation to other organs, tissues and systems, such as liver, kidneys, eyes, and the reproductive and developmental systems, foreseen in the coming years). All results of the pilot assessments would be published in a Scientific Report and should pave the way to implement cumulative risk assessments as required by legislation. The pilot assessments had been made possible by the so-called “Monte Carlo Risk Assessment” (MCRA) tool, a software program developed by the Dutch National Institute for Public Health and the Environment (RIVM) in cooperation with the Wageningen University. The tool had been adapted to perform assessments of cumulative exposure from pesticides as part of an ongoing partnership between EFSA and the RIVM. In the following debate, Members raised concerns in relation to the application of the precautionary principle, stressed that politicians needed clear information on the state of research and asked for a definition of the precautionary principle. Mr Mohimont underlined that it was up to risk managers, not risk assessors, to apply the precautionary principle in case of scientific uncertainty. The European Commission had set up a working group in this context in order for risk managers to better define the problem as well as the protection goals (i.e. the thresholds that should not be exceeded). Mr Mohimont highlighted that EFSA was

only looking at dietary exposure, while outside of this area something should be done as well (which was, however, not possible at the moment due to, again, a lack of resources). In a fourth presentation, Mr Chris Lythgo (EFSA, Team leader - Chemistry & Environmental exposure Team) outlined EFSA’s vision for using landscape characteristics in environmental risk assessment (ERA). While the current ERA of pesticides focused on assessing environmental fate and behaviour as well as ecotoxicology, EFSA envisaged a landscape based ERA in which additional data would be integrated in the model calculations, thereby enabling a more precise calculation of the environmental impact of pesticides and, possibly, more sustainable farming. While the technology to develop such tool was available, EFSA’s resources to do so were limited. In the debate, Members asked about the impact of environmental requirements (Article 4 of Regulation (EC) No 1107/2009) on pesticide authorisations and the current use of derogations (Article 53) by the Member States. Mr Tarazona explained that many approvals of active substances included recommendations to the Member States to take mitigation measures, where specific uses had been identified as representing a possible risk for the environment. He also pointed out that the actual impact of pesticides on the environment was currently not known. The landscape based ERA, once developed, would be a useful tool in this context. Session IV - Wrap-up of session II and III Included under previous points. Session IV - Assessment of pesticides residues in food and consumers risk Ms Hermine Reich (Senior Scientific Officer) presented EFSA’s role in the dietary risk assessment of pesticide residues and the setting of EU Maximum Residue Levels (MRLs). In particular, she explained the different steps of dietary risk assessment in order to assess residue behaviour of the pesticide and possible consumer health risks from residues in food (hazard identification, hazard characterisation, exposure assessment and risk characterisation). Chronic (long-term) and acute (short-term) dietary consumer exposure to pesticide residues were estimated using a calculation model developed by EFSA (PRIMo – Pesticide Residue Intake Model). The model was based on national food consumption data and unit weights provided by Member States. Ms Reich went on to describe the setting of MRLs. Provided that EFSA’s risk assessment did not identify any unacceptable risks to consumers, EU-harmonised MRLs were set. MRLs represented the upper levels of pesticide residues that were legally permissible in or on food or animal feed (based on good agricultural practice and the lowest consumer exposure necessary to protect vulnerable consumers). In this context, Ms Reich, however, underlined that the exceedance of a MRL did not necessarily entail any adverse health impacts. As regards actual compliance with the MRLs in the Member States, EFSA draws up annual reports. According to the 2015 report on pesticide residues, more than 97% of food samples collected across the EU were within the legal limits, with over 53% free of detectable residues. In the following discussion, main issues touched upon were the independence of competent authorities (with Mr Url stressing the importance of maintaining a strict separation between risk assessors and managers) and residue levels of pesticides in imported GMOs (in

particular, whether such - herbicide-resistant - GMOs contained higher pesticide residues due to the increased use of herbicides such as glyphosate, with Ms Reich replying that GMOs were generally not found to have higher pesticide residues than conventional crops, but that the spectrum of residues found in genetically modified crops was different).

Session V - Conclusions In his concluding remarks, Mr Url reiterated, in particular, EFSA’s independence (from risk managers - the European Commission and Member States - as well as from private interests) which was granted through an independence policy covering all actors and working processes. EFSA’s efforts in this area resulted in a cost of around 1 Mio € a year. Being under permanent scrutiny by the European Court of Auditors, the European Commission and the European Parliament, Mr Url considered the question as solved, underlining that it would be difficult to go any further in this context. While not resolving EFSA’s lack of resources, the recent Commission proposal on the General Food Law was of major importance in order to improve the transparency of the authorisation procedure as well as risk communication. Mr Andrieu, head of the PEST delegation, thanked Mr Url and his colleagues for the interesting visit. In his view, the discussions had revealed several aspects to be considered further in the future work of the PEST Committee. These were, in particular, the distribution of roles between the European and national level (considering a stronger focus on the effects of the final products rather than on those of active substances), the efficiency of cooperation between EU agencies (avoiding a “silo approach”), the agency’s budget (and the need to increase EFSA’s budget in order to properly carry out current, but also additional future tasks) as well as the question of conflicts of interest (while the outcome of discussions were rather reassuring, this still needed to be looked at more closely).

PEST COMMITTEE DELEGATION TO EFSA (PARMA, ITALY) 7-8 MAY 2018 COMPOSITION OF THE DELEGATION

Members of the European Parliament Eric ANDRIEU (Chair and Head of Delegation)

(FR)

S&D

Norbert LINS

(DE)

EPP

Miroslav MIKOLASIK

(SK)

EPP

Arne GERICKE

(DE)

ECR

Bart STAES

(BE)

Greens/EFA

(IT)

S&D

Local Member of the European Parliament Simona BONAFE

Staff ENVI Secretariat Christina MALMROS

Head of Secretariat

Nora HAHNKAMPER VANDENBULCKE

Administrator

Political advisors Vittoria VENEZIA

EPP

Miron PODGOREAN

S&D

Joanna SPRACKETT

Greens

Press Jan BERNAS

S&D (Press officer)

Interpreters Mireille GASTALDI

(FR)

Johanna Eleanor McCALMONT

(EN)

Ludovic SLOVENEC

(FR)

Visit of a delegation from the PEST Committee to EFSA Meeting date:

7-8 May 2018

Meeting venue:

Auditorium, EFSA, Parma, Italy

Meeting hours:

07/05: 14:30 – 18:30 08/05: 9:00 – 14:00

Chair:

Bernhard Url – EFSA’s ED

Final Programme Monday, 7 May 2018 Time

No.

Items

Presenters

13:00

Arrival of the delegation at EFSA’s premises

13:15

Lunch

14:30

1

Opening and welcome

- Bernhard Url, EFSA’s Executive Director - Eric Andrieu, Chair of the PEST Committee

Session I –EU risk assessment of pesticides in the food chain: main principles * 14:45

2



How EFSA works: structure and scientific decision making process



EFSA’s key values: -

transparency of the process

-

independence of experts reliability of the data



Interagency and international cooperation (e.g. ECHA, OECD, USEPA, WHO, IARC)



Follow-up on first working session of the PEST Committee on 12 April 2018 in Brussels: possible further questions

- Bernhard Url, EFSA’s Executive Director

Exchange of views 16:45

Break Picture opportunity and Coffee/tea

* It should be clear that each presented items is meant to generate an open and interactive dialogue, with the aim for members of the delegation to take the opportunity to raise questions at any moment and seek further

clarifications.

Session II –Pesticide evaluations: the peer-review process 17:00

3

EFSA scientific staff will lead the MEPs through the different steps of the pesticides peer-review process:

Introductory remarks by Jose Tarazona, Head of Pesticides Unit

1. Scientific check and evaluation of scientific studies (weight of evidence for carcinogenicity)

1. Daniele Court-Marques, Team Leader Toxicology

2. Setting toxicological reference values (concluding on Human health assessment)

2. Juan Parra Morte, Scientific Officer Toxicology

3. Concluding on Environmental Risk Assessment

3. Domenica Auteri, Team Leader Ecotoxicology

End of the afternoon session

18:30

Evening Monday, 7 May 18:30

Light dinner at EFSA

19.45

Shuttles ready for pick-up

Tuesday, 8 May 2018 Time

No.

Items

Presenters

07:30

Leave the hotel

08:45

Arrival at EFSA and welcome coffee Session III – Assessment of pesticides: on going developments *

9:00

4

EFSA scientific staff will lead the MEPs through the different key EFSA activities in the area of pesticides, such as 1. Epidemiological studies 2. Cumulative Risk Assessments 3. Landscape environmental assessment

Introductory remarks by Jose Tarazona, Head of Pesticides Unit 1. Federica Crivellente and Andrea Terron, Scientific Officers Toxicology 2. Luc Mohimont, deputy Head Pesticides Unit 3. Chris Lythgo, Team Leader Chemistry and Environmental Exposure

Session IV – Wrap-up of sessions II and III 10:30

11:00

5



Wrap up of 2 previous sessions



Open question round Coffee/tea break

Session IV – Assessment of pesticides residues in food and consumers risk 11:15

6

Pesticides Residues: setting maximum residue levels of pesticides in food and reporting of data

Hermine Reich, EFSA Scientific Leader for Pesticides Residues

on pesticide residue levels in food and related human exposure Question round and exchange of views Session V - Conclusions 12:30

7

Concluding Remarks

-

Bernhard Url, EFSA’s Executive Director

-

Eric Andrieu, Chair of the PEST Committee

Lunch 13:00 14:00

Lunch at EFSA premises

End of visit - shuttle leaving Parma to airports

List of participants Delegation of the European Parliament Special Committee on EU Pesticides authorisation procedure (PEST) Mr Eric Andrieu

Head of the delegation, Chair of the PEST Special Committee,

Mr Norbert Lins

Member of the PEST Special Committee, EPP (Co-Rapporteur)

Mr Miroslav Mikolasik

Member of the PEST Special Committee, EPP

Ms Simona Bonafe

Member of the PEST Special Committee, S&D

Mr Arne Gericke

Member of the PEST Special Committee, ECR

Mr Bart Staes

Member of the PEST Special Committee, Greens/EFA (Co-Rapporteur)

Ms Christina Malmros

Head of the Secretariat of the PEST Committee

Ms Nora Hahnkamper-

Administrator, Secretariat of the PEST Committee

Vandenbulcke Ms Vittoria Venezia

Political group advisor, EPP

Mr Miron Podgorean

Political group advisor, S&D

Ms Joanna Sprackett

Political group advisor, Greens/EFA

Mr Jan Bernas

Press officer, S&D

3 interpreters

Languages covered: English and French

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EFSA participants Mr Bernhard Url

Executive Director

Mr Guilhem de Sèze

Head of Scientific Evaluation of Regulated Products (REPRO) Department

Mr José Tarazona

Head of the Pesticides Unit

Mr Luc Mohimont

Deputy Head of Pesticides Unit

Ms Hermine Reich

EFSA Scientific Leader for Pesticides Residues, Pesticides Unit

Ms Domenica Auteri

Team Leader Ecotoxicology, Pesticides Unit

Mr Chris Lythgo

Team Leader Chemistry and Environmental Exposure, Pesticides Unit

Ms Daniele Court-Marques

Team Leader Toxicology, Pesticides Unit

Ms Federica Crivellente

Scientific Officer Toxicology, Pesticides Unit

Mr Andrea Terron

Scientific Officer Toxicology, Pesticides Unit

Mr Juan Parra Morte

Scientific Officer Toxicology, Pesticides Unit

Mr Dirk Detken

Head of Legal and Assurance Unit

Mr Flavio Fergnani

Team Leader Media Relations – Engagement and Cooperation (ENCO) Unit

Ms Victoria Villamar

Team leader institutions and Stakeholders Relations– ENCO Unit

Mr Christophe Wolff

Policy Officer – Institutional Liaison – ENCO Unit

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