Jun. 5, 2008
EU member states and industry stakeholders cannot continue to work in isolation if they are to rise to the challenges posed by depleting food stocks, climate change, a rising population and the migration of food to fuel crops. Terry Tooby, regulatory affairs director at UK consultancy JSC International, sounded this warning at the Informa Life Sciences 15th “Registration of Agrochemicals in Europe” conference on May 13th-14th in Brussels, Belgium. The proposed revision of the EU agrochemical registration Directive (91/414), due to come into force in 2010, may provide an opportunity to take some steps towards this goal of greater co-operation in the region.
One area that could improve matters is the "zonal approach" to work-sharing. The European Commission's proposal sees the EU region divided into three zones - northern, central and southern Europe - that would provide the legal basis and joint procedures within the zones for the submission of product approval applications. Most member states would fall within the central zone (Austria, Belgium, the Czech Republic, Germany, Hungary, Ireland, Luxembourg, the Netherlands, Poland, Romania, Slovenia, Slovakia and the UK). The southern zone would have the second largest membership (Bulgaria, Greece, Spain, France, Italy, Cyprus, Malta, Portugal); while the northern zone would have the fewest members (Denmark, Estonia, Latvia, Lithuania, Finland, Sweden).
Many view the zonal approach as a workable solution to work-sharing in the EU as agricultural, plant health and environmental factors are comparable within zones. However, such commonalities are limited. "Environmental or agricultural circumstances specific to the territory of a member state might require that, on application, member states recognise the authorisation issued by another member state, amend it, or refrain from authorising the plant protection product in their territory," said Kostas Markakis, of the Greek Ministry of Rural Development and Food, at the conference. He was speaking on the latest proposed changes in the ongoing discussions on the revision of Directive 91/414 by EU Ministers and the European Parliament.
There are no major changes compared to the original proposal from the Commission despite the fact that there some member states do not accept this division, Mr Markakis said. However, some amendments are under debate on a number of issues. Some member states object to the idea that they would be unable to refuse authorisations granted by other member states in the same zone. EU Ministers are considering a compromise that would allow countries some flexibility to allow for local conditions. Other proposals would ban mutual recognition for products containing active ingredients that are classified as candidates for substitution.
To apply for zonal approval, companies would have to submit Annex III dossier documents containing data for the product. Other documents would accompany these, such as a list of intended uses in the zone; the name of the member state(s) where the applicant has made, or intends to make, an application; a proposal as to which member state is expected to evaluate the application; as well as assessment of equivalence, where necessary.
Applications would then be examined by the member state that applicants have proposed. In some cases, to ensure a fair division of labour within zones, another member state would be able to take on applications. "The other member state(s) to which an application has been submitted shall refrain from proceeding with the file pending the assessment by the member state examining the application," Mr Kostas commented. Some applicants may submit to more than one of the three zones. In such cases, member states would have to agree on the evaluation data that is independent of zonal commonalities, such as environmental and agricultural conditions.
The examinations would be based on "current scientific and technical knowledge" and with reference to "guidance documents available at the time of application", Mr Kostas pointed out. Member states that fall within the authorising zone would be able to comment. The examination would have to be concluded within a year of application. "If additional data are requested, an additional time period to a maximum of six months is given."
Once a member state has granted approval, this will have clear consequences for other member states within the zone. "Other member states that have received an application shall authorise the plant protection products concerned under the same conditions as the member state examining the application," Mr Kostas pointed out.
In special cases, where applications included specific requirements, applicants would have to send the summary report and the complete Annex III dossier to the other member states if requested. Special cases would include agrochemicals used in greenhouses, post-harvest applications, treatment of empty storage rooms and seed treatments. Mutual recognition, in special cases, would be voluntary and could be based on: authorisations that member states of a different zone have granted; products that contain ais that are candidates for substitution, with reference to cut-off criteria; and provisional authorisations.
A member state would only be able to refuse to register a product "if due to its very specific environmental or agricultural circumstances, it has substantial reasons to consider that the product in question poses a serious risk to human or animal health or the environment," Mr Kostas added. However, even in such cases, applicants could choose to challenge such a decision by a member state in national courts.
If, after approval, a member state withdrew or amended an authorisation, it would have to inform the other zonal member states, the Commission and the respective authority. The other member states in that zone would take national conditions and risk mitigation measures into account before withdrawing or amending the authorisation, except if the product posed "a serious risk".
"The division of the EU into three zones is something completely new," commented Mr Markakis. The new view of Europe is also bringing new ways to view ais across the region. From a system "that required applicants to prove the comparability of conditions, we are moving to a system in which conditions are by definition assumed comparable," he pointed out. Work-sharing is also becoming the rule, rather than the exception. "From voluntary work-sharing initiatives, we are moving to compulsory schemes," Mr Markakis pointed out.
However, despite the adjustments already made from the experience of work-sharing pilot projects, more changes would be needed to make the system run "smoothly". Competent authorities need: better co-ordination; changes in their administrative structures, and organisations and working practices; as well as estimating specific national data requirements. Mr Markakis recommended that companies should: rationalise good agricultural practices (GAPs) and products that are supported at zonal level to ensure success; change the structure and organisation of national registration teams, so as to reflect the "zonal rapporteur system”, as well as Annex III submissions to "reflect the 'risk envelope' approach”; and submit joint applications where possible "to reduce workload".
"Under these circumstances, the criteria of a steering group managed by the Commission with the participation of all stakeholders that will deal with zonal authorisation issues … seems to be appropriate," Mr Markakis said.
While Mr Markakis' experience concerns work-sharing in southern Europe, Eija-Leena Hynninen of the Finnish Food Safety Authority, Evira, spoke of initiatives in the northern European region.
Work-sharing projects began in this zone three years ago, when Denmark, Estonia, Finland, Latvia, Lithuania, Norway and Sweden co-operated. For the first round of the pilot project, the countries selected products containing only new ais already included in Annex I of Directive 91/414. This criterion saw a diversity of work-sharing on different products in the first and second rounds.
The first round included Stähler's insecticide, Mospilan (Nippon Soda's acetamiprid), Kumiai Chemical's fungicide, Frupica SC (mepanipyrim), BASF's fungicide, Signum (boscalid + pyraclostrobin), Syngenta's fungicide Acanto (picoxystrobin) and Bayer CropScience's insecticide, Calypso 480 SC (thiacloprid).
The second round covered DuPont's herbicide, Granstar Preemia 50 SX (tribenuron-methyl), Aventis' (now Bayer) herbicide, Nortron 50 SC/Tramat 50 SC (ethofumesate), AgriChem's herbicide, Partner (ethofumesate), Makhteshim-Agan Industries fungicide, Bumper 25 EC (propiconazole), Bayer CropScience's insecticide, Decis Mega 50 EW (deltamethrin), BASF's fungicide, Ranman TwinPack (cyazofamid), BASF's herbicide, Stomp 330 EC, 400 SC (pendimethalin), and BASF's herbicide, Pico 75 WG (picolinafen).
Member states have held five meetings since the first one in 2005. These have proven that co-operation was both "productive and useful", Ms Hynninen said. However, she noted divergent GAP and time schedules as well as financial problems ahead. The northern zone plans to publish the results and material, for the benefit of other member states, as well as facilitate information exchange between different zones, hold additional discussions with the industry and develop template and guidance documents.
"The journey to a common understanding and networking between experts of the participating countries in the field of evaluating plant protection products has begun," Ms Hynnien assured delegates. If she is right, the proposed zonal approach may help substantially cut down on the workload that looms ahead with the revision of Directive 91/414.
However, some see the process as a slow one. "Mutual recognition is still a minor option in most countries in the central zone," said Pavel Minář, head of the plant protection section at the Czech Republic's State Phytosanitary Administration (SPA). In his country, for example, of 160 standard applications for a new product, only 12 have been assessed through mutual recognition.
Current work-sharing projects in the central zone include co-ordinated processes to check product compliance, as well as evaluating zonal GAP and making information on risk assessments available. Some factors pose challenges for work-sharing projects in the zone, such as short deadlines, organising a joint peer review and boosting its capacity for an increased number of cases. To respond to these challenges, Mr Minář recommended "industry should co-ordinate its applications by different member states by harmonising GAPS – if possible – ... [and] precise informing on applications and authorisations in other countries."
He envisions a "more favourable situation" for countries willing to subscribe to mutual recognition after 2010, due to "less dependency" on applicants' activities and "better solutions" for minor uses. This is based on the assumption that the zonal approach has come into force in the EU. Member states would be obliged to authorise products under the "same" conditions and restrictions, taking account of additional health safety restrictions and of specific risk mitigation measures. Products authorised in a member state of the same zone would have the same uses and the agricultural practices will be comparable.
While work-sharing and mutual recognition pilot projects in some regions have fared better than others, participants from all three proposed zones have acknowledged an increasing need for such co-operation in future. As Mr Minář pointed out: "It seems that work-sharing was voluntary. Now it is necessary [due to the volume of applications and data required for each]. And in future it will become obligatory."