ECCO peer review—development since 1996 and future prospects

ECCO peer review—development since 1996 and future prospects

Toxicology Letters 149 (2004) 421–427 ECCO peer review—development since 1996 and future prospects D.J. Flynn a,∗ , J.R. Lundehn b a Pesticides Safe...

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Toxicology Letters 149 (2004) 421–427

ECCO peer review—development since 1996 and future prospects D.J. Flynn a,∗ , J.R. Lundehn b a

Pesticides Safety Directorate, Mallard House, Kings Pool, 3 Peasholme Green, York YO1 7PX, UK b Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Dienststelle Braunschweig, Messeweg 11-12, 38104 Braunschweig, Germany

Abstract Plant protection products have to be evaluated and authorised in the EC-Member States since 1993 in accordance with Directive 91/414/EEC. The programme for evaluating existing active substances (which were on the market before July 1993) involves several steps and stages, stretching over a period of up to formerly 10, and now 15 years. The programme is co-ordinated by the European Commission, with the assistance of the European Community Co-Ordination (ECCO)-Team since 1996. The ECCO-Team consists of two groups; one is situated at the Pesticides Safety Directorate in York (United Kingdom) and the other at the Bundesamt für Verbraucherschutz und Lebensmittelsicherheit—BVL (Federal Office for Consumer Protection and Food Safety) in Braunschweig (Germany). They provide technical and administrative support to the programme for the evaluation of active substances on behalf of the European Commission, and are responsible for the ECCO peer review programme in particular. The programme has been extremely successful, with over 160 active substances having been peer reviewed, facilitating over 100 decisions on the acceptability of those actives at Community level. © 2004 Elsevier Ireland Ltd. All rights reserved. Keywords: Council Directive 91/414/EEC; ECCO; Peer review programme; Evaluation; Authorisation; Plant protection product

1. Introduction Council Directive 91/414/EEC, concerning the placing on the market of plant protection products, was adopted in July 1991 and entered into force on 25 July 1993 (EEC Council, 1991). This Directive formed the framework for a European-wide harmonised regulatory system for the evaluation and authorisation of plant protection products and the active substances in them.

∗ Corresponding author. Tel.: +44-1904-455-898; fax: +44-1904-455-722. E-mail address: [email protected] (D.J. Flynn).

A two-stage registration process has been established through the Directive, with the consideration of the acceptability of active substances being done at community level while the authorisation of specific products and uses is dealt with by the individual Member States. Thus, Annex I to the Directive, the list of active substances deemed acceptable and which may be included in pesticide products for use in the community, is the prime focus of the European regulatory system. In order to demonstrate acceptable uses in terms of risks to users, consumers and the environment, a considerable amount of data must be provided by the manufacturer. The data requirements relating to active substances and plant protection products are given

0378-4274/$ – see front matter © 2004 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.toxlet.2003.12.053

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in Annexes II and III of the Directive respectively, and relate to six discrete areas of the risk assessment; physical and chemical properties, environmental fate and behaviour, ecotoxicology, mammalian toxicology, residues and (Annex III only) efficacy. In the same way that the regulatory procedures relating to the assessment of active substances needed to be harmonised at Community level, so too did the decision making processes relating to the assessment of the safety and efficacy of products at the national level. The basic rules to be observed when conducting risk assessments are established by way of Annex VI of the Directive, which sets out the so-called ‘uniform principles’ for the assessment of the acceptability of products. The details of the uniform principles were published in Directive 97/57/EC (EC Council, 1997). The regulatory procedures, at least in terms of applications for Annex I inclusion, were also standardised. In general terms, a dossier submitted by the applicant/notifier to support the inclusion of an active substance in Annex I of the Directive was evaluated by a single rapporteur Member State on behalf of the others. The rapporteur prepared a draft assessment report (previously referred to as the draft ‘monograph’), which was submitted to the Commission, with a proposal for a decision in relation to Annex I inclusion. This was then further considered by the Commission and all 15 Member States within the framework of the Standing Committee on Plant Health (SCPH, since 2002 superseded by the Standing Committee on the Food Chain and Animal Health, SCFA). It became clear in the early stages of the programme that there was a significant variation in the standard of the initial risk assessments prepared by the different Member States. This could be attributed to several causes; the differing resources, procedures and processes in the different Member States, the different environmental conditions, or the different agricultural practices and needs of the different countries. In order to facilitate the decision making process, some form of peer review process was required in order to obtain a wider, pan-European view of the assessment prior to consideration within the framework of the SCPH. The European Community Co-Ordination (ECCO)-Team was originally established just to organise and run this peer review programme on behalf of the European Commission. It also became clear early on, however, that the European Commis-

sion alone would not be able to co-ordinate the demanding evaluation programme for active substances, particularly the re-evaluation of approximately 800 existing active substances (those already on the market as of 25 July 1993). Consequently, the activities of the ECCO-Team have since expanded to take on other areas of work from the European Commission.

2. The work of the ECCO-Teams In 1996, the ECCO Project was established to organise the expert peer review programme and to provide technical and administrative support to the programme for the evaluation of active substances for the European Commission. The ECCO-Team consists of two groups, one at the Pesticides Safety Directorate in York, United Kingdom, and the other at the Biologische Bundesanstalt für Landund Forstwirtschaft (BBA) in Braunschweig, Germany. Due to re-organisation, the role of the BBA was subsequently taken over by the Bundesamt für Verbraucherschutz und Lebensmittelsicherheit—BVL (Federal Office for Consumer Protection and Food Safety) in February 2003. 2.1. ECCO peer review programme Under four separate contracts covering the last 7 years, the ECCO Teams have been responsible for organisation and running of the ECCO peer review programme. Under this programme, the draft assessment reports prepared by the rapporteur Member States for individual active substances were considered by a small group of scientific experts from different Member States. The programme was organised in a series of ECCO rounds. Each round considered up to eight active substances, and consisted of a series of technical expert meetings followed by a more general ‘Overview’ meeting. At the technical expert ECCO peer review meetings, experts from different Member States and representatives from the European Commission discussed specific sections of the draft assessment reports for the active substances included in that Round. The experts that attended the meetings were selected by the European Commission on the basis of the nominations received by the Member States, with an expert

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from the rapporteur Member State for each substance always being present. The meetings were chaired by senior experts of the BBA (now BVL) and BgVV (Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin; since November 2002 Bundesinstitut für Risikobewertung, BfR) in Germany, and PSD in the UK. To ensure that all views are taken into account, all Member States and manufacturers of the active substances were invited to submit written comments on the draft assessment reports, which were then considered during the meetings. Separate meetings, each lasting up to 5 days, were organised to discuss the following specialised areas of the risk assessment in the draft assessment report: • identity, physico-chemical properties; details of uses and further information; methods of analysis; • impact on human and animal health; • fate and behaviour in the environment; • ecotoxicology; • residues. The task of each ECCO meeting was to agree the risk assessment and identify the key regulatory end-points, to identify any main areas of concern and to confirm any outstanding data requirements to be addressed by the applicant/manufacturer. The meetings also clarified the uses supported by the risk assessment and made recommendations with regard to classification and labelling. A standardised pro-forma for the lists of end-points was developed as part of the programme, which is now a key document in the guidelines for the preparation of dossiers and draft assessment reports. The series of five ECCO peer review meetings was followed by an “Overview Meeting”, where the overall conclusions of the peer review were agreed. Initially attended by a limited number of experts, these were subsequently attended by representatives from all Member States to increase transparency in the procedure. The ECCO-Teams, on behalf of Commission, are responsible for all aspects of the programme. This involves the planning and organisation of the rounds of meetings, selection of experts in liaison with the European Commission and the chairing and reporting of the meetings. It also involves the management and distribution of all the documentation relating to the meetings, including the draft assessment reports, com-

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ments for the meetings, reports of the meetings and full reports for the active substances. To date, 14 ECCO rounds have been organised by the ECCO-Team, with a total of 140 ECCO meetings having been held in Braunschweig and in York. One hundred and twenty of those meetings were true ECCO peer review meetings, organised in order for specialist experts from different Member States to consider the draft assessment reports prepared under 91/414/EEC. In all, these meetings have involved 1560 separate invitations being sent to 400 different experts from the different MS and accession countries. At these meetings, a total of 162 draft assessment reports have been peer reviewed (Table 1), facilitating the decision making for over 100 active substances for which decisions on Annex I inclusion or non-inclusion have been taken. For existing active substances, 87 draft assessment reports were submitted to the Commission, of which 84 have been peer reviewed. Sixty decisions on Annex I inclusion have been taken by European Commission and Member States, with 32 active substances being included and 28 not. For new active substances, 102 dossiers have been submitted for Annex I inclusion, 97 have been deemed ‘complete’ and are, therefore, under evaluation. Nine of these are for micro-organisms. Seventy-eight draft assessment reports have been peer reviewed and 45 decisions on Annex I inclusion have been taken, with 43 new active substances included and two not included. 2.2. Guidance documents Another key element of the work of the ECCO-Team has been in the preparation of guidance documents. As well as the expert peer review meetings arranged to discuss the risk assessments for active substances, a further 20 meetings were arranged specifically to develop guidance documents. These often came about through specific requests from the earlier ECCO expert meetings, where a problem was identified in a meeting and the report of the meeting recommended that guidance was urgently required. Where possible, meetings to develop guidance documents were arranged to coincide with scheduled ECCO meetings to make best use of experts and resources. Guidance documents relating to setting AOELs, terrestrial and aquatic ecotoxicology, residues and the criteria for Annex I inclusion were developed in ECCO

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Table 1 Active substances discussed in ECCO peer review meetings Active substances

Existing or newa

Rapporteur member state

Category

Annex I

2,4-D 2,4-DB Acephate Acetamiprid Acibenzolar-s-methyl Alachlor Alanycarb Aldicarb Alpha-cypermethrin Amitraz Amitrole Ampelomyces quisquails strain AQ10 Atrazine Azafenidin Azimsulfuron Azinphos-methyl Azoxystrobin Bacillus subtilis strain QST 713 Beflubutamid Benalaxyl Benomyl Bentazone Benzoic acid Beta-cyfluthrin Bifenazate Boscalid Bromoxynil Carbendazim Carfentrazone Carvone Chlorfenapyr Chiorothalonil Chiorpropham Chlorpyrifos Chlorpyrifos-methyl Chlortoluron Chlozolinate Cinidon-ethyl Coniothyrium minitans Cyazofamid Cyclanilide Cyfluthrin Cyhalofop-butyl Cyhalothrin Cypermethrin Daminozide Deltamethrin Desmedipham Dimethenamid-p Dinocap Dinoterb Diquat DNOC Endosulfan Esfenvalerate

Existing Existing Existing New New Existing New Existing Existing Existing Existing New Existing New New Existing New New New Existing Existing Existing New Existing New New Existing Existing New New New Existing Existing Existing Existing Existing Existing New New New New Existing New Existing Existing Existing Existing Existing New Existing Existing Existing Existing Existing Existing

Greece Greece Italy Greece France Spain France United Kingdom Belgium Austria France France United Kingdom Spain Italy Germany Germany Germany Germany Portugal Germany Germany Germany Germany The Netherlands Germany France Germany France The Netherlands Spain The Netherlands The Netherlands Spain Spain Spain Greece United Kingdom Germany France Greece Germany Italy Sweden Belgium The Netherlands Sweden Finland Germany Austria France United Kingdom France Spain Portugal

Herbicide/growth regulator Herbicide Insecticide Insecticide Fungicide Herbicide Insecticide Acaricide/insecticide/nematicide Insecticide Insecticide/acaricide Herbicide Fungicide Herbicide Herbicide Herbicide Acaricide/insecticide Fungicide Bactericide/fungicide Herbicide Fungicide Fungicide Herbicide Bactericide/fungicide Insecticide Acaricide Fungicide Herbicide Fungicide Herbicide Growth regulator Acaricide/insecticide Fungicide Herbicide growth regulator Acaricide/insecticide Insecticide/acaricide Herbicide Fungicide Herbicide Fungicide Fungicide Growth regulation Acaricide/insecticide Herbicide Insecticide Insecticide Growth regulation Insecticide Herbicide Herbicide Fungicide Herbicide Herbicide Insecticide/fungicide/herbicide Insecticide Insecticide

Yes Yes No Open Yes Open Open No Open Yes Yes Open Open No Yes Open Yes Open Open Open No Yes Open Yes Open Open Open Open Yes Open No Open Open Open Open Open No Yes Yes Yes Yes Yes Yes No Open Open Yes Open Yes Open No Yes No Open Yes

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Table 1 (Continued ) Active substances

Existing or newa

Rapporteur member state

Category

Annex I

Ethofumesate Ethoxysulfuron Etoxazole Famoxadone Fenamidone Fenarimol Fenhexamid Fenthion Fentin acetate Fentin hydroxide Ferric phosphate Flazasulfuron Florasulam Flufenacet Flumioxazine Flupyrsulfuron-methyl Fluroxypyr Flurtamone Flusilazole Foramsulfuron

Existing New New New New Existing New Existing Existing Existing New New New New New New Existing New Existing New

Sweden Italy France France France United Kingdom United Kingdom Greece United Kingdom United Kingdom Germany Spain Belgium France France France Germany France Ireland Germany

Yes Yes Open Yes Yes Open Yes No No No Yes Open Yes Yes Yes Yes Yes Yes Open Yes

Forchlorfenuron Fosthiazate Gliocladium catenulatum strain J 1446 Glyphosate Imazalil Imazamox Imazosulfuron Indoxacarb Iodosulfuron Ioxynil Iprodione Iprovalicarb Isoproturon Isoxaflutole Kresoxim-methyl Lambda-cyhalothrin Lindane Linuron Maleic hydrazide Mancozeb Maneb MCPA MCPB Mecoprop Mecoprop-p Mepanipyrim Mesosulfuron-methyl Mesotrione Metalaxyl Metalaxyl-m Methamidophos Methoxyfenozide Metiram Metsulfuron-methyl

New New New Existing Existing New New New New Existing Existing New Existing New New Existing Existing Existing Existing Existing Existing Existing Existing Existing Existing New New New Existing New Existing New Existing Existing

Spain United Kingdom Finland Germany Luxemburg France Germany The Netherlands Germany France France Ireland Germany The Netherlands Belgium Sweden Austria United Kingdom Denmark Italy Italy Italy Italy Denmark Denmark Italy France United Kingdom Portugal Belgium Italy United Kingdom Italy France

Herbicide Herbicide Insecticide/acaricide Fungicide Fungicide Fungicide Fungicide Insecticide Fungicide Fungicide Molluscicide Herbicide Herbicide Herbicide Herbicide Herbicide Herbicide Herbicide Fungicide Growth regulator/herbicidel/ insecticide nematicide Growth regulator Nematicide Fungicide Herbicide Fungicide Herbicide Herbicide Insecticide Herbicide Herbicide Fungicide Fungicide Herbicide Herbicide Fungicide Insecticide Insecticide/rodenticide Herbicide Growth regulator Fungicide Fungicide Herbicide Herbicide Herbicide Herbicide Fungicide Herbicide Herbicide Fungicide Fungicide Acaricide/insecticide Insecticide Fungicide Herbicide

Open Yes Open Yes Yes Yes Open Open Yes Open Yes Yes Yes Yes Yes Yes No Yes Yes Open Open Open Open Yes Yes Open Open Yes No Yes Open Open Open Yes

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Table 1 (Continued ) Active substances

Existing or newa

Rapporteur member state

Category

Annex I

Milbemectin Molinate Monolinuron Oxadiargyl Oxasulfuron Paecilomyces fumosoroseus apopka strain 97 Paraquat Parathion Parathion-methyl Pendimethalin Permethrin Pethoxamid Phenmedipham Picolinafen Picoxystrobin Procymidone Profoxydim Prohexadione-calcium Propiconazole Propineb Propoxycarbazone-sodium Propyzamide Prosulfuron Pseudomonas chlororaphis strain MA342 Pymetrozine Pyraclostrobin Pyraflufen-ethyl Pyrazophos Pyridate Quinoxyfen Quintozene s-Metolachlor Silthiofam Simazine Spinosad Spiroxamine Spodoptera exigua nuclear polyhedrosis virus Sulfosulfuron Tecnazene Tepraloxydim Thiabendazole Thiacloprid Thiamethoxam Thifensulfuron(-methyl) Thiophanate-methyl Thiram Triasulfuron Trifloxystrobin Tritosulfuron Vinclozolin Warfarin Ziram Zoxamide

New Existing Existing New New New Existing Existing Existing Existing Existing New Existing New New Existing New New Existing Existing New Existing New New New New New Existing Existing New Existing New New Existing New New New New Existing New Existing New New Existing Existing Existing Existing New New Existing Existing Existing New

The Netherlands Portugal United Kingdom Italy Italy Belgium United Kingdom Italy Italy Spain Ireland Germany Finland Germany Ireland France Spain France Finland Italy Germany Sweden France Sweden Germany Germany Belgium The Netherlands Austria United Kingdom Greece Belgium Ireland United Kingdom The Netherlands Germany Netherlands Ireland United Kingdom Spain Spain United Kingdom Spain France Germany Belgium France United Kingdom Germany France Ireland Belgium United Kingdom

Insecticide Herbicide Herbicide Herbicide Herbicide Insecticide Herbicide Insecticide/repellent Repellent/insecticide Herbicide Insecticide Herbicide Herbicide Herbicide Fungicide Fungicide Herbicide Growth regulator Fungicide Fungicide Herbicide Herbicide Herbicide Fungicide Insecticide Fungicide Herbicide Fungicide Herbicide Fungicide Fungicide Herbicide Fungicide Herbicide Insecticide Fungicide Insecticide Herbicide Growth regulator/fungicide Herbicide Fungicide Insecticide Insecticide Herbicide Fungicide Fungicide Herbicide Fungicide Herbicide Fungicide Rodenticide Fungicide/repellent Fungicide

Open Yes No Yes Yes Yes Open No No Yes No Open Open Yes Yes Open Open Yes Yes Yes Open Yes Yes Yes Yes Open Yes No Yes Open No Open Yes Open Open Yes Open Yes No Open Yes Open Open Yes Open Yes Yes Yes Open Open Open Yes Open

a Existing active substance, on the market on or before 25 July 1993. New: new active substance, application for first inclusion in Annex I made after 25 July 1993.

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meetings specifically arranged to prepare such guidance. ECCO has also co-ordinated the further consideration of documents that were initially prepared by individual authorities, e.g. the persistence and plant strengthener guidance documents developed by the Netherlands, the dermal absorption document developed by France and the criteria for assessment of micro-organisms originally developed by Sweden. 2.3. Administrative support to the programme The role of the ECCO-Team in terms of the administrative support provided to the European Commission in the management and co-ordination of the whole evaluation programme has increased considerably over the past 7 years. As the number of active substances being considered in the programme has increased, the simple task of managing the programme has become increasingly complicated, with various active substances being considered in the different stages of the process, sometimes being peer reviewed using different procedures. Much of this management/co-ordination role is now undertaken by the ECCO-Team. The Teams are also now responsible for the preparation and handling of not only the documentation relating to the peer review, but also the documentation relating to the subsequent consideration of the active substance within the framework of the SCFA. This expanded role now involves the uploading and management of all the documents onto the Commission’s internet platform CIRCA, the provision of administrative support to the Commission Working Groups, and the preparation of draft Review Reports for each of the active substances. As many as 250 different documents may be handled by the ECCO-Team each week. The importance of this increased administrative support role should not be underestimated, and similar support will be required in the future if the increased workloads arising from the review programme are to be successfully managed.

3. Conclusions The ECCO peer review programme has been an incredible success, providing for the peer review

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of all the draft assessment reports that were available and facilitating the decision making on over 100 active substances with respect to their inclusion or non-inclusion in Annex I of 91/414/EEC. It has also fulfilled a valuable training role, bringing together experts of the same field from the different Member States to raise and standardise the level of expertise in the different Member States. In addition, several guidance documents have been prepared under the ECCO programme, to further improve and harmonise the risk assessments across EU Member States. With the accession of ten new countries to the Community next year the first two roles, i.e. peer review and training, will become even more important. As well as being responsible for the organisation of the peer review programme, and as a direct result of that work, the ECC-Team has also instrumental in developing the current evaluation procedure, constantly reviewing the processes and procedures to further improve quality, transparency and efficiency. With the foundation of the European Food Safety Authority (EFSA), risk assessment and risk management have been separated (EC Parliament and Council, 2002). The responsibility for risk assessment has moved from the European Commission to EFSA, and so too has the responsibility for the peer review of active substances under 91/414/EEC. It is clear that this important step in the evaluation process must continue, at least for the foreseeable future, and PSD and BVL are fully prepared to continue to provide support to the programme.

References EC Council, 1997. Directive 97/57/EC of 22 September 1997 establishing Annex VI to Council Directive 91/414/EEC concerning the placing of plant protection products on the market. Off. J. Eur. Commun. L265, 87–109. EC Parliament and Council, 2002. Regulation (EC) 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. Off. J. Eur. Commun. L31, 1–24. EEC Council, 1991. Directive 91/414 of 15 July 1991 concerning the placing of plant protection products on the market. Off. J. Eur. Commun. L230, 1–32 (corrigenda: Off. J. Eur. Commun. No. L170 (25 June 1992), 40).