DE LA FALSIFICACIÓN DE CERTIFICADOS Artículo 397

This section explains the EU system of regulation as it operated in 2009, including a consideration of the way in which the review of actives is

reducing their availability. Major criticisms of the EU system in terms of timeliness are considered.

It considers the problem of mutual recognition and possible solutions to it. The major revisions to the EU legislation which took place in terms of the review of Directive 91/414/EEC, its repeal with Directive 79/117/EEC and its replacement in 2009 by Regulation 1107/2009, along with the thematic uses strategy for pesticides and the framework directive on sustainable use are considered with particular reference to biopesticides. Reference is also made to the possible implications of the Water Framework Directive (2000/60/EEC) for which the implementing legislation came into force in 2004. There is then a consideration of two member states with very different systems of regulation, Denmark and the Netherlands.

The 91/414 European system

‘Directive 91/414 was a new departure for the Community in several respects. It was one of the fi rst major items of legislation to anticipate not only the principle of subsidiarity, but also the precautionary principle’ (European Commission, 2001: 3). Its basic procedures remain intact in 2006/0136 (COD), but with some important modifi cations. The registration process is divided into two parts: Annex 1 inclusion of active substances and the authorization of plant protection products by member states. An extensive dossier is submitted by a company. It contains all the relevant information on the active substance and at least one representative product. It is submitted to a Rapporteur Member State selected by the company. The pesticide authority in that member state carries out a risk assessment and distributes the Draft Assessment Report (DAR) with a recommendation to the applicant and the other member states. In practice, ‘a signifi cant degree of variation became apparent between review practices among individual Rapporteur Member States. This problem had to be corrected by the development and adoption of a series of guidance documents’ (European Commission, 2001: 5).

Since 2002 the EFSA has been responsible for risk assessment which it carries out through a scientifi c peer review by EFSA scientists and experts from the member states. This leads to the production of a guidance docu- ment which goes to the Working Group (legislation) of the European Commission’s Standing Committee on the Food Chain and Animal Health. Member state civil servants decide whether to approve the active substance and, if successful, it would be added to Annex 1 of Directive 91/414. Product authorizations are considered at a national level using harmonized criteria for data requirements laid down in EU legislation (94/89/EC, Mammalian toxicology, including human exposure; 96/68/EC, Residues, including con- sumer exposure; 94/37/EC, Physical/chemical properties; 95/36/EC, Fate and behaviour; 96/12/EC, Ecotoxicology; 93/71/EEC, Effi cacy). However, as one respondent commented, ‘You have data requirements, member states can interpret them how you wish’. It should be noted that while microbials have a specifi c and uniform set of data requirements at EU level, there has

been no specifi c set of data requirements for plant extracts, pheromones and semiochemicals. Chemical data requirements have been used, but cases could be made for not presenting part of the data.

Loss of active substances through the EU review programme

Many older substances are being removed from the market under the 91/414 review programme, either because they fail to meet the standards of the review or because companies decide for commercial reasons not to support them, which could include a consideration of the costs of re-registration. The MRL programme is likely to reduce the range of available uses. ‘The EU review programme is having a signifi cant impact on the availability of crop protection products. In some cases, there are no effective chemical solutions, as exemplifi ed by the loss of all products for the control of root fl y on swedes and turnips in the UK’ (Richardson, 2005: 237). This does, of course, provide a new opportunity for biopesticides, but biological substitutes are not avail- able for all the withdrawn products and, if they are, may be less effi cacious.

The pesticide review was a protracted process and a new developed database fi nally came on stream in March 2009. About 1000 active substances on the market before 1993 were subjected to a detailed risk evaluation in terms of their effects on human health and the environment. Two hundred and fi fty achieved the harmonized EU safety assessment and 70 substances failed it and were removed from the market. The others were eliminated as dossiers either were not submitted or were withdrawn by industry.

Shortcomings in the EU system of registration

The length of time it takes to complete registrations is a major consideration for SMEs as they wish to generate a cash fl ow as soon as possible and start to recoup the costs of research and development. ‘The industry complains that the current registration period for [microbial biological control agents] in the EU is costly and time-consuming. Long registration periods are a severe problem, because they delay the onset of the returns for the investments made during research and development’ (REBECA, 2008: 19). Seven exam- ples of biological control agents considered by the REBECA project showed that the time period from the month of dossier submission to the month of inclusion on Annex 1 or granting of national registration was a mean of 87.7 months with a range of 57–121 months (REBECA, 2008: 19). The mean time for registration in the EU was 75 months compared with 28 months in the USA (Hokkanen and Menzler-Hokkanen, 2008). There was also considerable variation in reported registration times between member states. Britain and Germany were regarded by our respondents as having relatively effi cient registration agencies. A number of complaints were made about Spain, one respondent commenting, ‘waiting two years from submission, such a backlog of products’.

In an internal market, one would hope that once a product was approved in one member state, it could then easily be registered in other member states. As one manufacturer commented, ‘Hopefully, once done a registration in one country, just a rollout to other European countries. Everyone is looking for mutual recognition routes. Have a lot of trouble with mutual recognition.’ The Commission accepts that ‘Mutual recognition does not function well and national authorisations of products leads to duplication of work in Member States and to differences in the availability of plant protection products across the European Union’ (European Commission, 2005).

Some of these problems have arisen because of the existence of 27 regula- tory authorities across the EU with varying and often inadequate levels of resources available to them and following their own particular procedures. Some member states are uneasy about the principle of mutual recognition. A Danish Environmental Protection Agency (EPA) offi cial commented in inter- view: ‘Mutual recognition would seek to undermine standards. We really feel that.’ The slowness of getting Annex 1 listings has also been a factor and the drive to speed things up led to substances being approved for single rather than multiple uses. A more underlying tension is, as one respondent put it, ‘Regulators united in commitment to carrying on regulation on a member state basis, policy makers likely to favour a more harmonised approach’.

To some extent, regulators have been developing their own informal links, both through EU and OECD committees and on a bilateral basis. One participant in the EU expert meetings noted that Belgium, Denmark, Germany, the Netherlands, Sweden and the UK were regular in attendance with France and Hungary coming occasionally. These links can be used as a basis for information exchange and have led to work sharing of the Rappor- teur role. A PSD offi cial commented, ‘Try to get an air of pragmatism, work sharing, where we can support each other, where we can support each other to cut down on data requirements. We used to know frighteningly little about how others did effi cacy.’ PSD sees itself as ‘trying to push pragmatism into Europe. [We are] trying to push pragmatism into other member states.’

One available mechanism for harmonization is to make use of the EPPO. Founded in 1951, EPPO is an intergovernmental organization with 50 members and a secretariat of 12 based in Paris, funded by contributions from the member governments. In the plant protection area, EPPO has developed a number of standards for use by national registration authori- ties. PSD has taken certain UK procedures and has turned them into EPPO ones, particularly in the effi cacy area, for example trials guidelines and minimum effective dose. One respondent suggested that EPPO had more effective dissemination mechanisms than the EU.

Although the EU is supposedly an internal market, it is geographically diverse and pesticides that work in one set of climate conditions will not necessarily work in another or at least not as well. A proposed solution has been to devise climatic zones in which mutual recognition could occur. This idea originated with a paper by the UK Crop Protection Association that out- lined a northern European region with a climate comparable to the UK. This paper was accepted by the ACP and ‘provided an opportunity for companies

to use northern European data in regulatory submissions without the need to provide for each trial a specifi c justifi cation that climate conditions were relevant to the UK’ (Richardson, 2005: 235). More generally, ‘The climate within a zone can be considered comparable for the purposes of effectiveness data, and should aid the acceptance of effi cacy data between countries within a zone’ (Richardson, 2005: 235). However, as will be evident from the fol- lowing discussion of EU reform proposals, zoning met with considerable political resistance and many problems connected with its implementation have to be resolved.

The reform of the EU regulatory system

This revolves around three main proposals: the amendment of Directive 91/414; the EU Thematic Strategy; and the Sustainable Use Directive, but also discusses the Water Framework Directive. In this section the main elements of each proposal are considered and then their progress through the co-decision process of the EU. There is also a draft regulation on the collection of data on pesticides sale and use, but that is not considered further here.

The amendment of Directive 91/414

A steer for the revision of the directive was provided by the 2001 report to the Parliament and the Council on how the directive was working. It was admit- ted that ‘Decision-making was slow between 1993, when the Directive entered into force, and 1999 … An already complex piece of legislation became progressively more complex in application as expectations mounted on all sides, ensuring that standards and criteria were not only maintained at a high level but were effectively raised’ (European Commission, 2001: 8). It took another 5 years for the Commission to produce a set of proposals for amendment. Part of the reason for the delay was no doubt the extensive consultations held with a range of stakeholders, including the IBMA. The other principal stakeholder groups consulted were: agriculture and food organizations, six; agrochemical and chemical organizations, four; environ- mental organizations, four; animal welfare organizations, two; retailers, one; consumers, one. This gives the indication of the range of confl icting interests involved and helps to explain why it was so diffi cult to get the proposals through the Parliament. Despite the time taken in the preparation of the proposal, one regulator commented, ‘It is not the best thought out proposal. Born of frustration that mutual recognition has not taken off.’

A central consideration for the Commission was that ‘The large difference in authorisation of existing active substances shows that without further har- monisation the protection levels in Member States may vary a lot’ (European Commission, 2006a: 9). The whole approach of the document was informed by the application of the precautionary principle to ‘ensure that industry demonstrates that substances or products produced or placed on the market do not adversely affect human health or the environment’ (European Commission, 2006a: 14). The document also endorsed the principle of IPM,

but recognized that it would require a transition period of unspecifi ed length before it could be applied, although the accompanying Thematic Strategy targeted 2014.

The main proposals included provisions to encourage a move from national to zonal-level authorizations with obligatory mutual recognition between member states of the same zone. This solution to the mutual recognition prob- lem had proved particularly controversial during the stakeholder consultations and continued to be so subsequently. Some stakeholders opposed any further harmonization, while others favoured full centralization. ‘The proposed system is a compromise between the current situation and a fully centralised authorisation’ (European Commission, 2006a: 7). Like many compromises, it pleased relatively few with only Austria and the UK being clear supporters among the member states with France and Germany opposed. One consider- ation was that states with national testing systems, such as France, did not want the job losses associated with greater centralization.

A key plank of the proposals was risk-based comparative assessment and substitution to encourage the replacement of more hazardous substances and/or products with alternatives. This was good news for advocates of biopesticides, and has been called for by the IBMA in its 2005 ‘white paper’ on the regulation of biologicals, but the infl uential ECPA was opposed in princi- ple to regulatory substitution at any level. Farmer organizations were also opposed because they were concerned about the reduced availability of prod- ucts. Hazard triggers would be used to exclude from Annex 1 carcinogens, mutagens or reproductive toxins.

The Commission proposed bringing to an end the system whereby member states could grant provisional national authorizations for new active substances pending a decision on Annex 1 listing. This was thought to pro- vide a welcome element of fl exibility in the system, but the Commission’s view was that it was incompatible with a harmonized system for establishing MRLs and would be offset by strict deadlines for assessing an active sub- stance. Whether deadlines such as completing the DAR within 12 months of notifi cation of the completeness check are achievable is another matter. Resource constraints and the availability of specialized personnel have been a continuing constraint for the European pesticides regulation regime.

The Thematic Strategy for Pesticides and the Sustainable Uses Directive

This arose from the 6th Environmental Action Programme, which called for a reduction in the impact of pesticides on human health and the environment and the need to achieve a more sustainable use of pesticides. However, the strategy document acknowledged that ‘The potential risks associated with their use are accepted to a certain extent by society given the related economic benefi ts since inter alia plant protection products contribute to ensuring supplies of affordable and healthy agricultural products of high quality’ (European Commission, 2006b: 3). The Commission noted with concern that ‘Despite the increasing costs involved in [the registration] process and the decreasing number of active substances on the market, actual consumption and use of pesticides in the EU have not decreased in the last ten years. At the

same time, the percentage of food and feed samples where residues of pesti- cides exceed maximum regulatory limits is not declining, but remains around 5%’ (European Commission, 2006c: 3). As with the proposal to amend Directive 91/414, the Commission expressed its concern about policy variability between member states, which in their view required harmonizing action at EU level: ‘Over the last fi fteen years, signifi cant but uneven changes in pesticide use have been observed amongst Member States. Whilst pesticide use declines in some Member States, a sharp increase has been observed in others’ (European Commission, 2006c: 3).

The Commission declared its support for forms of agriculture that restricted or better targeted ‘the use of plant protection products, such as organic farming, integrated pest management or the use of less susceptible varieties’ (European Commission, 2006b: 6). No mention is made of biopest- icides, refl ecting their low profi le at EU level. This is evident in internal SANCO documents which examine extensively the reaction of the ECPA to proposals, but make no mention of the IBMA. During the debates in the Parliament, lobbying efforts by the IBMA raised the profi le of biological solutions, but the toehold they obtained in the legislation was subsequently removed.

The preparation of the Thematic Strategy identifi ed the need for a Sustain- able Use Directive as several of the envisaged measures could not be integrated into existing legislation or policies. This directive was passed in 2009 and will be implemented by 2011. It was centred around the creation of National Action Plans to identify areas of risk, the reduction of risk and use, the minimization of impacts on human health and environment, responsible use and IPM. It would set up systems of training for distributors and users, require member states to set up systems for inspection of application equipment, and prohibit aerial spraying.

The battle in the Parliament

In its plenary vote in November 2007, the Parliament substantially toughened up the proposals put forward by the Commission. As they stood, the Com- mission proposals on active substance approval criteria would remove the main control for major diseases of wheat in the UK with potential yield losses of 20–30% and would have signifi cant implications for crops such as carrots, parsnips and onions because the majority of approved herbicides might no longer be available. The Parliament proposals would mean ‘effectively no herbicide options for control of weeds in horticultural crops; chemical con- trol of black-grass in cereals would become virtually impossible with severe economic impacts … potatoes – seed potato growing unlikely; ware potato yields severely reduced … many horticultural crops would be uneconomic to grow’ (PSD, 2008b: 11–12).

The discussion of the Parliamentary debate focuses on two proposals that are particularly relevant to biopesticides: the zoning scheme and an amendment proposing distinct regulatory arrangements for biopesticides. The scheme to divide the EU into northern, southern and central zones for mutual recognition purposes had attracted opposition as soon as it was

proposed. There were concerns that the proposed zones did not represent homogeneous regions in terms of climate, pests or agricultural production and practices, although truly homogeneous zones would be diffi cult to devise. Hungary in particular pressed for a fourth zone which would pre- sumably cover Eastern Europe. There was concern that products might be withdrawn from the market unnecessarily because of a conservative assess- ment by one member state. Denmark, which takes a relatively rigorous stance on pesticide regulation, expressed concern that a plant protection product ‘approved in one Member State could have a highly adverse effect in other Member States of the same zone’ (Anon., 2007). From a different perspective, an industry spokesman commented that ‘Introducing a zonal system often takes away national fl exibility, instead of a lowest common denominator system which is often talked about in Europe, going to end up with potential for highest common denominator in granting an authorisation. Any member state that has an issue with something imposes that condition.’

It was always possible to criticize the arbitrary nature of the zones, particularly given that it was not politically feasible to divide countries as might have been climatically sensible for northern and southern France.