New EU pesticide legislation the view of a manufacturer

Aspects of Applied Biology 106, 2011 Crop Protection in Southern Britain New EU pesticide legislation the view of a manufacturer By J C WILLIAMS Bayer CropScience Ltd, 230, Cambridge Science Park, Milton Rd, Cambridge CB4 0WB Summary The new pesticide legislation mainly discussed in this paper are the Plant Protection Products Regulation 1107/2009 and the Sustainable Use Directive 2009/128/EC. These pieces of European legislation are essential elements of the Thematic Strategy on Pesticides. Other pesticide relevant pieces of legislation briefly covered in this paper are the Maximum Residue Level Regulation 396/2005 and the Water Framework Directive 2000/60/EC. Regulation 1107/2009 entered into force on 14 December 2009 and Directive 91/414/EEC will be repealed on 14 June 2011. One of the main elements of the Regulation, unlike the Directive, is that it provides the possibility to reject active substances on the basis of their intrinsic properties. A concept commonly known as hazard-based cut-off criteria. The Sustainable Use Directive 2009/128/EC covers the use of pesticides in the EU and will come into force in stages from 2011 to 2020. The UK is well positioned regarding many of the aspects of this legislation, however some new controls will be required to be introduced. Key words: Thematic strategy, legislation, 1107/2009, 2009/128/EC, Water Frame Directive, pesticide Introduction The current main piece of legislation dealing with the registration of plant protection products (PPP) is 91/414/EEC which came into force in 1993. The review process under this legislation for existing active substances (a.s.) has seen the loss of over 600 a.s. For many, the view is that PPP are already highly regulated and we are already experiencing some serious problems controlling weeds, diseases and pest problems, especially in minor crops. The new legislation published in December 2009 which forms the European Union Thematic Strategy on Pesticides is composed of four elements; 1. Plant Protection Products Regulation 1107/2009 2. Sustainable Use Directive (SUD) 2009/128/EC 3. Machinery Directive 2009/127/EC which sets out standards for new equipment 4. Statistics Regulation 1185/2009 The key elements of this regulation are the provision of annual sales data and the provision of data every five years on usage on crops and the pesticides used. Other relatively recent pieces of legislation also considered in this paper are the Maximum Residue Level (MRL) Regulation 396/2005 and the Water Framework Directive (WFD) 2000/60/ EC. 269

1107/2009 The first thing to point out about this regulation is that it is a regulation, not a directive, and as such is directly applicable in all member states (MS). It does not need to be transposed into UK national legislation. The regulation will be directly applicable on 14 June 2011. In order to provide a small amount of background information; the preceding legislation was the Plant Protection Products Directive (also known as the Authorisations Directive), 91/414/EEC. 91/414/EEC came into force in 1993 and was transposed into UK law as the Plant Protection Product Regulations in 1995. Under 91/414/EEC, registration of a.s. was conducted at EU level, resulting in Annex I listing of the a.s. This was subsequently followed by registration (in the case of new a.s.) or re-registration (in the case of existing a.s.) of PPP at Member State level. One important aspect of this legislation was that evaluations and decisions were essentially riskbased. Hazard-based cut-off criteria One of the main issues for industry of 1107/2009 is the introduction of hazard-based cut-off criteria, whereby a.s. will be eliminated from the evaluation process purely as a result of their classification (Table 1). No risk-based evaluations will be conducted for a.s. that fail the hazardbased cut-off criteria, irrespective of exposure or risk and whether safe uses can be identified (except in the case of some limited exclusions, discussed later in this paper). Table 1. Criteria for the approval of active substances Human Health Carcinogen C1A & C1B Mutagen M1A & M1B Toxic for Reproduction R1A & R1B Endocrine disruptor Environmental PBT (Persistent, Bioaccumulative & Toxic) POP (Persistent Organic Pollutant) vpvb (very Persistent, very Bioaccumulative) Endocrine disruptor It is important to note that some questions remain over the interpretation of some of the criteria and the cut-off criteria will only take effect on renewal of each a.s. (most taking place between 2016 and 2019). Endocrine disruptors As can be seen in Table 1, one of the criteria that will be used as a cut-off will be endocrine disruption. Currently there is no agreed definition of an endocrine disruptor and the Commission has been tasked to come forward with proposals by 14 December 2013. There is no date in the legislation for the adoption of such proposals and therefore a temporary definition will be used in a transitional period. It should be noted that despite the emotive association of endocrine activity and human reproduction, endocrine disruptors are not intrinsically bad for human health or dangerous to the environment. Many foods are associated with having endocrine active properties, some of which are used in holistic medicine to reduce menopausal symptoms. Soy beans, chick peas, and lentils are examples of commonly consumed foods which are considered to provide good sources of endocrine disruptors. Birth control pills are specifically designed to disrupt naturally occurring endocrine systems and as a result, normal female hormone cycles. They are used daily by millions of women, all over the world and they are widely found in water. A number of a.s. can under certain circumstances exhibit endocrine activity. Every regulatory approval decision is based on scientifically sound evidence on whether a substance is safe to humans and the environment. 270

Possible exemptions 1. Negligible exposure There is provision in Annex II Point 3 of Regulation 1107/2009 which allows the approval of an a.s. that fails the hazard-based cut-off criteria if the exposure to humans under realistic proposed condition of use, is negligible. It defines negligible exposure as residue concentrations in food or feed below the default concentration of 0.01 mg kg -1. However, negligible exposure is not fully defined in the non-dietary area and work is ongoing to try to define under what circumstances this exemption could be used. 2. Derogation if a serious danger to plant health Article 4.7 of 1107/2009 provides the possibility for the approval of an a.s. that fails the cut-off criteria if it is necessary to control a serious danger to plant health, that no (chemical or nonchemical) alternatives are available, that mitigation measures can be identified to limit exposure of humans and the environment, and that appropriate MRLs exist. The main limitations to such an approval are that the approval has to be approved by other MS and the Commission and that the approval is only valid for a maximum of 5 years. An industry proposal has been made that any decision on whether an a.s. is necessary to control a serious danger to plant health should be made case-by-case on the basis of the evidence provided by the applicant and reviewed by the MS. Industry recommends that particular attention should be given to maintaining a chemical diversity to ensure a sustainable agriculture in Europe and to minimise the development of resistance. The impact of withdrawing existing a.s. on minor crops/uses must be taken into account when evaluating whether alternatives are suitable or not (if they exist). Industry also recommends that non-chemical methods be evaluated using the same guidance, criteria (including efficacy) and safety standards as chemical methods. Comparative assessment & substitution Under Article 24 of 1107/2009, a.s. which meet certain specified criteria will be identified by the Commission as Candidates for Substitution. For these a.s., approvals will be only granted for seven years and any PPP containing that a.s. will be required to undergo Comparative Assessment at MS level (Article 50). This new process aims to compare a PPP with other approved PPP and non-chemical methods of control or prevention, and substitute the more hazardous with a safer alternative. It is well recognised that this will not be an easy process as for example, one PPP may pose more of a risk to earthworms and the other more of a risk to birds which is the safer? Any potential for the replacement of a PPP by a non-chemical method not only requires an evaluation of the efficacy of the technique, but also a full assessment of the true cost in terms of safety and economics. It is planned that this process will take place at MS level, each time a product containing a Candidate for Substitution is registered. This means that any PPP containing more than one a.s. will be reviewed many times. The MS will be required to consider the availability of alternatives (including minor uses), resistance pressures, economics and practicality. Zonal evaluation Under 1107/2009, the EU is divided into three zones; Northern, Central & Southern. The concept is that once a PPP approval is granted in one MS, other MS in that zone are able to use the evaluation to grant an approval (a process commonly known as Mutual Recognition), as long as any national specific data requirements and risk assessments have been completed. This process is intended to speed-up decision making and to encourage a level playing field within a zone in terms of pesticide availability. In order to achieve this, it is important that any national specific data requirements and risk assessments are minimised. 271

Loss of provisional authorisations 1107/2009 provides set timelines and a clear process for the evaluation of new a.s. (Articles 7 to 13). In the event that these timelines are not met and the evaluation has not been completed within 30 months, Article 30 contains a derogation allowing MS to grant National Provisional Authorisations (NPA s), as long as an appropriate MRL has been set. NPA s under 91/414/EEC represent an important safety net for the R&D industry, ensuring the rapid entry onto the market of PPP containing a new a.s. This process has been well used in the UK and the loss of this option is important to industry. It should, however, be stressed that industry s preference is to ensure a process that supports and ensures rapid approval decisionmaking on new a.s., which in turn will allow PPP containing these new a.s. to be fully authorised throughout Europe. A clear process for the granting of NPA s is however not provided in the new Regulation. Using the timelines in 1107/2009, the first NPA may be expected 30 36 months after submission to the Rapporteur Member State (RMS). It should be noted that this is significantly longer than current timelines under Directive 91/414/EEC where the first NPA may be granted 12 18 months after the submission of the a.s. dossier to the RMS. MRL Regulation 396/2005 The MRL Regulation came into force on 1 September 2008 and requires MRL s to be set at EU level before any approval can be granted in a MS. The process requires a dossier to be submitted to a RMS, and evaluation takes place over a period of approximately 3 12 months. The resulting report is then evaluated by the European Food Safety Authority (EFSA) over a period of 3 6 months. For both evaluations the time taken really depends on the complexity of the dossier and whether a new a.s. in involved. Following their evaluation, EFSA makes a recommendation to the Commission and a vote takes place at an appropriate Commission meeting (approximately 3 months). The approval for the use of the PPP cannot be granted until publication (approximately 4 9 months). The setting of the MRL is a potential rate-limiting step for the introduction of new a.s. and it is a major obstacle to the introduction of additional crops to PPP, especially for minor uses. The crop protection industry s preference would be for a streamlined regulatory process that removes unnecessary regulatory barriers and provides the economic incentives for industry to invest; minimising the need for specific rules and exemptions for minor uses. Sustainable Use Directive 2009/128/EC Unlike 1107/2009, 2009/128/EC is a directive and therefore it requires transposition into national legislation. The SUD covers the use of pesticides in the EU and will come into force in stages from 2011 to 2020. The UK is well positioned regarding many of the aspects of this legislation, however some new controls will be required to be introduced. The UK Government (via DEFRA) published an initial consultation on the implications of the SUD in May 2010 and a summary of the responses was published in December 2010. The plan is that a consultation on the drafting legislation will be published in early 2011, in order that the legislation can be in place for the required deadline of 26 November 2011. Further information on what Industry considers to be the key articles of the SUD is provided below. 272

National Action Plans Article 4 of the SUD requires MS to develop National Action Plans (NAP) designed to reduce the risks relating to the use of pesticides and to reduce their use wherever possible. In the UK, the development of the NAP involved many stakeholders (a requirement of SUD) and have already been published (Anon., 2008). There are existing UK National Action Plans on Biodiversity, Amenity, Availability, Water, Human Health and Amateur use. Training Article 5 of the SUD requires MS to ensure that all professional users, distributors and advisors have access to appropriate training by 26 November 13. In the UK, there are already extensive training opportunities in place, including certification bodies. It is expected that the new regulations will require some modification to the existing systems and encompass more people, including the removal of grandfather rights. Aquatic environment and links to the Water Framework Directive (WFD) 2000/60/EC Article 11 of the SUD requires MS to ensure that appropriate measures are adopted in order to protect the aquatic environment and drinking water supplies. This Article links into the WFD and it is likely that measures taken to implement the directive could result in restrictions or prohibitions on the use of PPP on a local or national basis. The WFD has resulted in many EU Priority substances and UK Specific Pollutants being identified, for which action is required to be taken. Under the WFD, there is a possibility for a loss of PPP causing WFD non-compliance, but it is more likely that risk mitigation measures such as the use of low drift nozzles and buffer zones and enhanced voluntary measures will be adopted to address any localised issues. Integrated Pest Management (IPM) Article 14 of the SUD requires MS to take all necessary measures to promote low pesticide-input pest management, giving priority to non-chemical methods. It should be noted that the concept of IPM, or more correctly Integrated Crop Management (ICM), has been and is fully supported by the agrochemical industry. Industry only ask that when considering the use of non-chemical methods of pest control the true cost, both in terms of safety and economics, needs to be fully considered alongside the crop protection product. Discussion The new legislation is now in place and we all (industry and regulators) have to find a way to make it work to the advantage of all stakeholders. Under this legislation, there is a potential for the loss of active substances and products. The challenge is to ensure that any losses are only due to safety reasons and are not of an arbitrary nature. The toolbox of crop protection products (and modes of action) is reducing and it is important to remember that we still have to feed the world. World-wide, there is increasing awareness of the requirement for food security and the maintenance of not only the staple food supply, but also the variety of crops. In order to show the true value of crop protection to the UK food chain and living standards, the Crop Protection Association has recently sponsored a report, which concludes that without pesticides to keep weeds, pests and diseases in check, crop yields would fall to half their current levels and food prices would rise by 40%, an increase to UK consumers of some 70 billion per year in food costs (Rickard, 2010). Relevant Legislation and Documents Consultation on the implementation of EU pesticides legislation, Defra, HSE, Welsh Assembly Government, Scottish Executive and Department for Agriculture and Rural Development February 2010. 273

Consultation on the implementation of EU pesticides legislation; summary and government response, Defra, HSE, Welsh Assembly Government, Scottish Executive and Department for Agriculture and Rural Development December 2010. Council Directive 91/414/EEC concerning the placing of plant protection products on the market. Directive 2009/128/EC of the European Parliament and of the Council establishing a framework for Community action to achieve the sustainable use of pesticides. Directive 2000/60/EC of the European Parliament and of the Council establishing a framework for Community action in the field of water policy. Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. Regulation (EC) No 396/2005 of the European Parliament and of the Council on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC. References Anon. 2008. UK Pesticides Strategy: A Strategy for the Sustainable Use of Plant Protection Products, HSE, PSD, Defra, Welsh Assembly Government, Scottish Executive and Department for Agriculture and Rural Development. www.defra.gov.uk. Rickard S. 2010. The Value of Crop Protection An Assessment of the Full Benefits for the Food Chain and Living Standards. Report for the UK Crop Protection Association, Peterborough. 37 pp. 274