De Kaderrichtlijn Water en Gewasbeschermingsmiddelen

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1 De Kaderrichtlijn Water en Gewasbeschermingsmiddelen Juli 2007 Prof. mr. H.F.M.W. van Rijswick & mr.drs. E.M. Vogelezang-Stoute Centrum voor Omgevingsrecht (UU) en Centrum voor Milieurecht (UvA)

2 Verzorging binnenwerk: Centrum voor Omgevingsrecht en -beleid/m. Walraven 2007 H.F.M.W. van Rijswick en E.M. Vogelezang-Stoute ISBN Alle rechten voorbehouden. Niets uit deze uitgave mag worden verveelvoudigd, opgeslagen in een geautomatiseerd gegevensbestand of openbaar gemaakt, in enige vorm of op enige wijze, hetzij elektronisch, mechanisch, door fotokopieën, opnamen, of enige manier, zonder voorafgaande schriftelijke toestemming van de uitgever. Voor zover het maken van kopieën uit deze uitgave is toegestaan op grond van artikel 16B Auteurswet 1912 jo. het Besluit van 20 juni 1974, Stb. 351, zoals gewijzigd bij het Besluit van 23 augustus 1985, Stb. 471 en artikel 17 Auteurswet 1912, dient men de daarvoor wettelijk verschuldigde vergoedingen te voldoen an de Stichting Reprorecht (Postbus 882, 1180 AW Amstelveen). Voor het overnemen van gedeelte(n) uit deze uitgave in bloemlezingen, readers en andere compilatiewerken (artikel 16 Auteurswet 1912) dient men zich tot de uitgever te wenden. No part of this book may be reproduced in any form, by print, photoprint, microfilm or any other means, without written permission from the publisher. Ondanks alle aan de samenstelling van de tekst bestede zorg, kunnen noch de auteurs, noch de uitgever aansprakelijkheid aanvaarden voor eventuele schade, die zou kunnen voortvloeien uit enige fout, die in deze uitgave zou kunnen voorkomen.

3 Inhoudsopgave Brief summary...7 Summary, conclusions and recommendations Introduction Requirements ensuing from the WFD concerning plant protection products The relationship between the WFD and Directive 91/414/EEC The assessment methods of the two directives Differences between the assessment methods Differentiation of authorisation regime according to region? Differentiation in where the standard applies according to place and scale Scope in the WFD for temporary deterioration of the situation when measures are being taken Reflection of monitoring data in the authorisation decisionmaking How to deal with substances that are also used in contexts other than as plant protection products Application of an environmental quality standard as authorisation standard in the context of Directive 91/ Scope for the independent drawing up of regulations by local or regional authorities Questions and areas that lack clarity regarding the reflection of the WFD in the authorisation decision-making Recommendations...23 Korte samenvatting...27 Samenvatting, conclusies en aanbevelingen Inleiding Vereisten die uit de KRW voortvloeien ten aanzien van gewasbeschermingsmiddelen De verhouding van de KRW tot richtlijn 91/414/EEG De beoordelingsmethoden van beide richtlijnen Verschillen tussen beide beoordelingsmethoden Differentiatie van toelatingsregime naar regio? Differentiatie naar plaats en schaalniveau waar de norm geldt Ruimte in de KRW voor tijdelijke achteruitgang, bij het nemen van maatregelen? Doorwerking van monitoringgegevens in de toelatingsbesluitvorming?

4 4 DE KADERRICHTLIJN WATER EN GEWASBESCHERMINGSMIDDELEN 10. Hoe om te gaan met stoffen die ook in andere toepassingen dan gewasbeschermingsmiddelen gebruikt worden? Toepassing van een milieukwaliteitsnorm als toelatingsnorm in het kader van richtlijn 91/414? Ruimte voor het zelfstandig opstellen van voorschriften door lagere overheden? Onzekerheden en onduidelijkheden met het oog op de doorwerking van de KRW in de toelatingsbesluitvorming Aanbevelingen...43 I Het onderzoek Inleiding Aanleiding voor het onderzoek Doelstelling en onderzoeksvragen Opbouw rapport...51 II. Beantwoording van de onderzoeksvragen Welke verplichtingen vloeien voort uit de KRW ten aanzien van gewasbeschermingsmiddelen? Algemene verplichtingen uit de KRW ten aanzien van gewasbeschermingsmiddelen Kwaliteitsnormen voor verontreinigende stoffen De bepalingen van de Kaderrichtlijn nader onderzocht met het oog op raakvlakken met de Gewasbeschermingsmiddelenrichtlijn Conclusies en aanbevelingen Hoe verhouden de Kaderrichtlijn water en de Gewasbeschermingsmiddelenrichtlijn zich tot elkaar? Inleiding De verhouding van richtlijnen tot elkaar: algemeen Wat zegt de tekst van richtlijn 91/414 over de verhouding tot andere richtlijnen? Wat zegt de tekst van de KRW over de verhouding tot richtlijn 91/414? Eerste uitwerking van deze KRW-bepalingen door de Commissie Conclusies over de verhouding van beide richtlijnen...75 (vragen 2-algemeen en 2c) Hoe is de verhouding tussen beide regelingen bij (dreigende) overschrijding van de kwaliteitsnormen die gelden op grond van de KRW? (vraag 2b) Hoe verhouden de beoordelingsmethoden van richtlijn 91/ 414 en richtlijn 2000/60 zich tot elkaar? (vraag 2d)...79

5 INHOUDSOPGAVE Inleiding De beoordelingsmethode van richtlijn 91/ De beoordelingmethode van de KRW Verschillen beoordeling richtlijn 91/414 en de beoordeling op grond van de KRW Staat de Gewasbeschermingsmiddelenrichtlijn toe dat voor het bereiken van de waterkwaliteitsdoelstellingen voor individuele wateren op grond van de KRW met betrekking tot het gebruik van gewasbeschermingsmiddelen aanvullende regels worden gesteld (regionale differentiatie). (vraag 2E) Inleiding Regionale differentiatie binnen richtlijn 91/ Aanvullende regels voor het gebruik, voor het bereiken van KRW-doelstellingen in individuele wateren? In hoeverre bieden richtlijn 91/414 en de Kaderrichtlijn water ruimte voor differentiatie In hoeverre biedt richtlijn 91/414 ruimte voor differentiatie naar bijvoorbeeld de plaats waar de norm (ten aanzien van oppervlaktewateren/of grondwater) geldt alsmede naar schaalniveau; zo ja, tot welk schaalniveau strekt de werking van de richtlijn zich uit? In hoeverre biedt de Kaderrichtlijn water ruimte voor differentiatie naar bijvoorbeeld de plaats waar de norm (ten aanzien van oppervlaktewater en/of grondwater) geldt alsmede naar schaalniveau; zo ja, tot welke schaalniveau strekt de werking van de richtlijn zich uit? Algemene conclusie en aanbevelingen Staat de KRW toe dat bij de vaststelling van normoverschrijding en de naar aanleiding daarvan te nemen maatregelen rekening wordt gehouden met herstel van een waterlichaam en welke tijdschaal geldt daarbij? Tijdelijke achteruitgang Overschrijding milieukwaliteitsnormen voor stoffen Overgangsgebied voor overschrijding Overige normen voor de goede ecologische toestand Conclusie Stel dat uit monitoringgegevens blijkt dat kwaliteitsnormen o.g.v. de KRW ten aanzien van een werkzame stof worden overschreden in een bepaald oppervlaktewater- of grondwaterlichaam. 5

6 DE KADERRICHTLIJN WATER EN GEWASBESCHERMINGSMIDDELEN Welke randvoorwaarden kent de KRW in dat geval om via het toelatingsinstrument de overschrijding ongedaan te maken? Inleiding Doorwerking kwaliteitsnorm op grond van de KRW in de beoordeling op basis van richtlijn 91/ De rol van monitoringgegevens in de toelatingsbeoordeling en besluitvorming De instrumenten De vraag naar de causaliteit De betekenis van de milieubeginselen Conclusies en aanbevelingen Hoe bij de toetsing in het kader van richtlijn 91/414 om te gaan met werkzame stoffen die niet alleen als gewasbeschermingsmiddel bijdragen aan de belasting van het oppervlaktewater maar die ook op andere wijze op de markt zijn en gebruikt worden (en in het oppervlaktewater komen) Inleiding Andere toepassingen van een stof en de vraag naar de causaliteit Andere toepassingen en op grond van de KRW te nemen maatregelen Conclusies Staat richtlijn 91/414 toe dat in de KRW dochterrichtlijn vastgestelde milieukwaliteitsnormen worden gehanteerd als norm voor het toelaten van gewasbeschermingsmiddelen, zowel in het geval wanneer de milieukwaliteitsnorm strikter is als in het geval dat deze minder stringent is? Is er ruimte voor het zelfstandig opstellen van voorschriften door de lagere overheden: gemeenten, provincies en waterschappen? En zo ja, wat zijn daarbij de grenzen? Inleiding Richtlijn 91/414 en de organisatie van de uitvoering door de lidstaten Ruimte voor het stellen van voorschriften door lagere overheden Conclusies III. Conclusies en aanbevelingen IV Achtergronddocument

7 Brief summary This report contains the results of a study of the relationship between the Water Framework Directive ( WFD ) and the Council Directive concerning the placing of plant protection products on the market (Directive 91/414/EEC). This study forms the first phase in a project for drawing up a methodology for the authorisation criterium risk for water organisms, known as the water decision tree. The study was carried out on the instructions of the Ministry of Housing, Spatial Planning and the Environment, by Utrecht University s Centre for Environmental Law and Policy/NILOS and the Universiteit van Amsterdam s Centre for Environmental Law. The objective of the study was to gain an understanding of the relationship between the two directives and, in particular, in the way in which the WFD is reflected in the authorisation policy and in the preconditions resulting from the WFD for the water decision tree. The research question of the study covers the following areas: the requirements of the WFD concerning plant protection products, the relationship between the WFD and Directive 91/414/EEC, including the assessment methods, the possibilities for regulating individual waters and the possibilities for regional differentiation, the scope for the differentiation of standards and, in the event of exceedance of standards, for taking the recovery of a water body into account, the reflection of monitoring data in the authorisation policy, the assessment of contamination by plant protection products if the substances in question also cause water contamination as a result of other applications, the use of an environmental quality standard from the WFD in the authorisation of a plant protection product, the scope for local or regional authorities to draw up regulations independently. By virtue of the WFD, the water in the European Union must, in principle, have a good status by This good status is expressed in environmental quality standards, which must be met by the Member States. In order to achieve the WFD objectives, a combined approach has to be taken at na- 7

8 DE KADERRICHTLIJN WATER EN GEWASBESCHERMINGSMIDDELEN tional level for point and diffuse sources of pollution. If multiple environmental quality standards are applicable, the emission control measures necessary to achieve these objectives must be focused on the strictest one. The WFD contains no requirements specifically regarding plant protection products. The regulation realised via authorisation of plant protection products is one of the control measures within the context of the WFD. The measures within the context of Directive 91/414 must therefore be included in the programme of measures to be drawn up by Member States. This means that contamination from both point and diffuse sources must be tackled if it becomes apparent that the objectives cannot be met. The WFD contains various measures that Member States can use to tackle any such sources of contamination. These measures are divided into basic (minimum requirements) and supplementary measures. Examples of basic measures for point sources are the tightening of permits or general rules, and for diffuse sources, prevention or control of the introduction of the pollutants, tightening of authorisation and prohibitory provisions. More generally, the WFD requires that priority be given to tackling contamination at the source. The preconditions ensuing from the WFD must have consequences for the authorisation of plant protection products. These preconditions particularly concern fitting the water quality standards into the authorisation assessment whereby, in principle, the quality standards apply to all waters and there is only scope for possible relaxation. This relaxation has to be within the WFD exceptions. Given the requirements of Art. 10 para 3 of the WFD, the environmental quality standards from the WFD must be reflected in the authorisation decision-making. However, the directives do not contain any clear procedures for how this is to be realised. The Uniform Principles for the authorisation of plant protection products do reflect the standards from the water directives, but this is less clearly regulated for surface water quality. The objectives and authorisation criteria provide scope for this reflection of water quality standards, but there are no procedural regulations to this end. The assessment methods of the two directives vary. The points of departure of the WFD are the water quality standards and those of Directive 91/414 are the application of the product and the resulting exposure. Monitoring data is central to the WFD, but Directive 91/414 works with models and monitoring data have no clear place. In view of the differences between the assessment systems, and the case law of the European Court of Justice, the conclusion of this study is that the two sets of standards should be applied alongside one another. 8

9 BRIEF SUMMARY The WFD provides for a system of monitoring obligations with a view to meeting the WFD water quality standards. Appropriate measures must be taken on the basis of the monitoring results to ensure that the standards are actually met. Different measures have to be taken depending on the cause of the exceedance. In view of the WFD requirements of prevention and control of contamination at the source, if the exceedance of the standards is caused by the use of authorised plant protection products, measures concerning the revision or tightening of authorisation would seem to be most sensible. When authorising new plant production products, the WFD requirements will have to be used in the assessment. The conclusion of the study is that there are no procedures in either the WFD or Directive 91/414 to enable the reflection of the quality standards and monitoring data in the authorisation assessment. The research question of the study also concerned the possibilities the directives provide for deviating from water quality standards, in the sense of differentiation according to time or place where the standards apply. The findings of the study show that neither the WFD nor Directive 91/414/EEC provide a general possibility for this. The WFD only contains the general exceptional provisions and provisions for the protection of certain areas that need extra protection. Furthermore, the WFD assumes that the Member States lay down the quality requirements for a good ecological status themselves, a distinction being made between different types of waters. Directive 91/414 does not have any possibilities for differentiation according to time or place where the standard applies. The above leads to the general conclusion that the WFD sets requirements on the water quality and that, if these requirements are not met because of the use of plant protection products that have been authorised or are to be authorised, measures have to be taken concerning this authorisation. To this end, it is necessary to gear authorisation to the requirements and quality standards set by the WFD. This study shows that this is not only required and desirable but also that it is possible pursuant to current legislation. No absolute restrictions have been found that stand in the way of better harmonisation between the WFD and Directive 91/414. However, the harmonisation between the two directives requires improvement on a number of points. Recommendations are made to this end in this study. These concern the procedures for reflecting the quality standards in the assessment and decision-making involved in authorising plant protec- 9

10 DE KADERRICHTLIJN WATER EN GEWASBESCHERMINGSMIDDELEN tion products, in particular. Some of the recommendations concern the national level and some the European level. In this study, an inventory has been made of any questions ensuing from the two directives, so that more clarity can be obtained on the scope and obligations ensuing from the WFD regarding plant protection products at a followup stage. 10

11 Summary, conclusions and recommendations 1. Introduction This report contains the results of a study into the relationship between the Water Framework Directive (WFD) and the Council Directive concerning the placing of plant protection products on the market (Directive 91/414/EEC). The study forms the first phase in a project for drawing up a methodology for the authorisation criterium risk for water organisms, known as the water decision tree The study was carried out on the instructions of the Ministry of Housing, Spatial Planning and the Environment, by Utrecht University s Centre for Environmental Law and Policy/NILOS and the Universiteit van Amsterdam s Centre for Environmental Law. The objective of the study was to gain an understanding of the relationship between the two directives and, in particular, in the way in which the WFD is reflected in the authorisation policy and in the preconditions resulting from the WFD for the water decision tree. The research question of the study covers the following areas: the requirements of the WFD concerning plant protection products, the relationship between the WFD and Directive 91/414/EEC, including the assessment methods, the possibilities for regulating individual waters (regional differentiation), the scope for the differentiation of standards and, in the event of exceedance of standards, for taking the recovery of a water body into account, the reflection of monitoring data in the authorisation policy, the assessment of contamination by plant protection products if the substances in question also cause water contamination as a result of other applications, the use of an environmental quality standard from the WFD in the authorisation of a plant protection product, the scope for local authorities to draw up regulations independently. 11

12 DE KADERRICHTLIJN WATER EN GEWASBESCHERMINGSMIDDELEN 2. Requirements ensuing from the WFD concerning plant protection products No specific obligations regarding plant protection products ensue from the WFD. Insofar as plant protection products contain pollutants, the same regime applies to them as to other pollutants. If quality standards have been laid down for specific pollutants, these standards must be met. If priority substances are concerned, quality standards are laid down at Community level which must then be transposed into statutory provisions by Member States. These statutory provisions must stipulate that the quality standards may not be exceeded. As regards non-priority substances and the other ecological objectives, Member States are obliged to lay down quality standards in the law at national level. These standards must also be met. In principle, Member States have a high degree of freedom as regards how these quality standards are met. If the objectives are not met, or there is a risk that they will not be met, an investigation must be carried out to ascertain the cause. The investigation is based on monitoring data. If it becomes apparent that the standards are exceeded as a result of the use of authorised plant protection products, appropriate measures must be taken so that the objectives and standards are met. If the monitoring data show that the standards are exceeded due to illegal usage (the usage of nonauthorised substances or usage that violates the instructions for use) then it goes without saying that enforcement should be tightened or use should be made of initial regulations in the field of water protection. As regards other reasons for (imminent) exceedance of the standards, Art.10 of the WFD indicates that the objectives must be achieved by means of a combined approach of point and diffuse sources. Article 11 introduces a programme of measures that contains some obligatory and some supplementary measures. The instruments from Directive 91/414/EEC also fall under the programme of measures. The measures to be taken can be divided into measures to regulate point sources and measures to regulate diffuse sources. Plant protection products ending up in the water originate from both point and diffuse sources, and protection of the water quality against pollution by plant protection products therefore requires measures for regulating both types of sources. 12

13 SUMMARY, CONCLUSIONS AND RECOMMENDATIONS Tackling point sources primarily makes use of instruments from the WFD, such as taking emission control measures. Examples of such measures are the issuing or tightening of permits and the setting of general rules etc. When tackling pollution resulting from diffuse sources relating to pesticide use, instruments ensuing from Directive 91/414/EEC, such as the revision of authorisations, must primarily be used. Not only are individual Member States subject to obligation when tackling the pollution of European bodies of water. If a member state is confronted with problems it is unable to solve on its own, it may ask the Commission to take action. The Commission is also subject to its own obligations. It is up to the Commission to select and regulate priority substances. This regulation consists of laying down environmental quality standards and proposals for the most appropriate emission control measures and product and process control measures. If product control measures entail testing of the relevant agreements given on the basis of Directive 91/414/EEC or the Biocides Directive, testing takes place in accordance with the provisions of these directives. The Commission does not meet its obligations in respect of laying down emission control measures for priority substances. The legal consequences of the Commission, or any other community institution, not meeting its obligations pursuant to the WFD are not clear. More specifically, it is not clear whether this has consequences for the obligations to which the Member States are subject. 3. The relationship between the WFD and Directive 91/414/EEC In view of the EC legislative system and the interconnection clauses of Directive 91/414 and the WFD, no conclusions can be drawn as to which of the two directives prevails, in the sense that either one always takes precedence from the start. Following from the considerations of the Uniform Principles (based on Directive 91/414/EEC), the standards set for groundwater, drinking water and surface water are directly reflected as standards for authorisation. Two of the directives reflected here are to be replaced by the WFD. The text of the Uniform Principles does not explicitly entail the reflection of the Water Directive 76/464/EEC in the authorisation assessment. It can however be concluded that the Ub provides scope for this, by including the term particu- 13

14 DE KADERRICHTLIJN WATER EN GEWASBESCHERMINGSMIDDELEN larly in the considerations, but this has not been elaborated in section C of the Uniform Principles (the decision-making principles). Given the requirements of the WFD, the standards set for achieving water quality standards must also be reflected in the programme of measures, which the system of Directive 91/414/EEC and, in turn, the Uniform Principles are part of. After all, where necessary, quality objectives or standards must be reflected in the emission control measures and, in turn, in authorisation decisions. The combined approach to point and diffuse sources can also include Directive 91/414/EEC because the WFD speaks of other relevant sources ). If a quality objective or standard requires stricter conditions for emission control measures than those ensuing from the combined approach, this must lead to stricter measures. This may entail a tightening of regulations or another form of prior regulation (Art. 10 paras 2 and 3 in conjunction with Art.11 para 3 under h). Measures pursuant to Directive 91/ 414/EEC must be a part of the WFD programmes of measures (Annex VI). Measures leading to the non-inclusion of active substances in Annex I of Directive 91/414/EEC are deemed by the Commission as product control measures for the purposes of the WFD. This is in accordance with Art. 16 para 6 of the WFD. According to the Commission communication concerning the control of surface water pollution, the Commission provides a lot of scope for Member States to draw up their own measures, both for priority substances and other pollutants. It is not clear precisely how the Commission sees the relationship between the national and Community measures. Laying down a procedure for Member States for the exchange of information as the basis for Community action has, however, been included as an action in the Commission communication but this has not been incorporated into the Commission proposal itself. If the authorisation of a plant protection product in accordance with Directive 91/414/EEC leads to an (imminent) exceedance of an environmental quality standard pursuant to the WFD, Art. 10, paras 2 and 3 of the WFD apply to it. A situation then arises in which an environmental quality standard requires a stricter condition than the emission control measures set within the context of Directive 91/414/EEC. Pursuant to Art. 10 para 3 of the WFD, stricter emission control measures must be laid down in this case. These measures can vary depending on the question of whether the standards are exceeded as a result of point or diffuse sources. The directives do not give the procedures to be followed when taking stricter emission control measures. 14

15 SUMMARY, CONCLUSIONS AND RECOMMENDATIONS 4. The assessment methods of the two directives Directive 91/414 contains relatively vague legal criteria for the authorisation assessment by Member States, including for the protection of water. These criteria are elaborated in the Uniform principles for assessment and decisionmaking. More detailed elaboration is, however, required for the concept no unacceptable effect on surface water, in particular. For drinking water and groundwater this concerns concentration standards. Further elaboration of the assessment and decision-making has been laid down in the dossier requirements (Annexes II and III of Directive 91/414), in policy documents such as a Guidance Document, the status of which is not very clear, and other technical/scientific documents. At national level in the Netherlands there is a ministerial regulation and a Pesticides Approval Committee ( CTB ) Manual. The involvement of the Maximum Acceptable Risk ( MTR ) in the authorisation assessment means that an environmental quality standard is applied in product assessment. The choices to be made as regards assessment methods and models in the assessment and decision-making are decisive factors in the outcomes. The latter might, for example, depend on whether emission routes should be included or the place and duration of exposure. Authorisation assessment is a risk assessment that focuses on the application of the plant protection product, and on exposure and risk in relation to this application. Assessment often takes place on the basis of models. There is no clear place for monitoring data in the assessment. The first assessment step for water organisms (Uniform Principles C ) is limited to a few coefficients and a bioconcentration factor. This step contains no general standard as regards unacceptable effects. In view of this elaboration, the requirement to meet the quality standards pursuant to the WFD adds an extra requirement to this first step. Testing against unacceptable effects is, however, included in the subsequent steps ( unlessprovisions, if the first step is not met). The quality standards pursuant to the WFD can also be counted as such. The requirements the WFD sets in respect of the chemistry relate to substances and are expressed as a certain maximum concentration of substances that may be present in the water. The standards for active substances in plant protection products are also laid down in the form of a maximum acceptable concentration of substances in the context of the WFD. The WFD bases its standards for the maximum concentration of priority substances on both an 15

16 16 DE KADERRICHTLIJN WATER EN GEWASBESCHERMINGSMIDDELEN annual average of the measurements and a maximum acceptable concentration. The standards for priority substances pursuant to the WFD are laid down at EC level. In principle, the standards for the chemical quality, which concerns the priority substances apply to all surface waters. The standards for ecological quality also apply to all surface waters. This can be derived from the general coordinating objective of the WFD, the meaning of the environmental objectives as explained by the European Court of Justice in case C- 32/05 and, finally, from the fact that the WFD determines that the current protection level may not be lower. The standards for both priority and nonpriority substances from the older water directives also applied to all surface waters (Directive 76/464/EC), unless the directive only concerned specific designated waters like for example fishing water, bathing water, shellfish water, water intended for drinking water extraction. It naturally makes a difference whether it concerns standards for natural waters where a good ecological status must be met or heavily modified or artificial waters where a good ecological potential will do. The monitoring system of the WFD is differentiated according to the objective of the monitoring, the most important types being trend, status and operational monitoring. Stricter requirements apply for the benefit of protected areas for drinking water and protected habitats. For groundwater, the quantity also has to be monitored. The monitoring obligations pursuant to the WFD link up with the obligatory measures to be taken from Article 11 of the WFD, whereby a distinction is made in the monitoring of, and measures for, pollution from point and diffuse sources. In order to be able to take the most appropriate measures in the event that the environmental quality standards are not met, information based on the monitoring data must be available on the causes of the pollution. If the monitoring data shows that the standard is not being met, or if it becomes apparent that this will not be achieved on time, suitable measures have to be taken depending on the cause of the pollution. 5. Differences between the assessment methods The methods of assessment of Directive 91/414/EEC and the WFD differ from one another on many points as they have different points of departure: the application of a product for Directive 91/414/EEC and the quality of the water for the WFD. One characteristic difference is that the assessment of Directive 91/414/EEC focuses on the application of products and on the ensuing exposure and subsequently the risk. This is based on the usage of the products in question in accordance with the regulations or normal conditions

17 SUMMARY, CONCLUSIONS AND RECOMMENDATIONS of use. The assessment of the WFD, on the other hand, focuses on the chemical and ecological quality of surface water in river basins. Monitoring data have an important position in the WFD system because the measures taken to ensure that the environmental objectives and quality standards are met on time are determined on the basis of this data. The position of monitoring data in the assessment system of Directive 91/414/EEC is, however, much less clear. In this directive, assessment takes place primarily on the basis of models. 6. Differentiation of authorisation regime according to region? Directive 91/414/EEC (including the Uniform Principles) does not recognise the concept of regional differentiation. The Uniform Principles, on the other hand, does have an area specific approach. The decision-making principles (part C of the Uniform Principles) may even require an area specific authorisation, with specific conditions and restrictions for use and where necessary, a decision not to authorise a particular substance in certain areas. The considerations mentioned for area specific authorisation are agricultural, plant health and environmental conditions. In Directive 91/414/EEC s system, environmental conditions also include water. It is therefore possible within the authorisation system of Directive 91/414/EEC to set regionally-oriented restrictions and regulations or, if necessary, to refuse authorisation in cases where the condition of certain waters so require. In principle, supplementary WFD regulations concerning use for individual waters are possible because Directive 91/414 does not regulate the use of authorised substances exhaustively. If achievement of the WFD objectives is concerned, achieving the environmental quality standards in question must be reflected in the measures to be taken, including the decisions regarding authorisation as an example of emission control measures. The Nederhoff judgment by the European Court of Justice shows that environmental quality standards can lead to restriction in the use of a product. Whether this would similarly apply to situations from Directive 91/414 is likely, certainly once Directive 76/464 has been replaced by the WFD; this will ultimately be decided by the European Court of Justice. In the situation envisaged by the Commission, with a directive for sustainable use on the basis of Art. 175 EC, supplementary WFD regulations will be possible because Member States will then, in principle, be able to take further measures, if required. 17

18 18 DE KADERRICHTLIJN WATER EN GEWASBESCHERMINGSMIDDELEN 7. Differentiation in where the standard applies according to place and scale In Directive 91/414 (including Annexes) there is no question of a differentiation according to the place where the standard applies or scale. In principle, the standard applies to groundwater and surface water in general. For surface water, the various emission routes must be taken into account here. Directive 91/414 only designates a certain scale for which the standard applies for surface water intended for drinking water. The ditch next to the plot approach (sloot-naast-perceel-bena-dering) has been developed in the Netherlands during practical investigation and assessment, and concerns the assessment methodology. On the basis of the underlying objective of the WFD, the level of protection of the older water directives, the case law of the European Court of Justice and the exceptional provisions concerning the environmental quality standards included in the WFD and the daughter directive, it can be concluded that the WFD does not provide any general possibility for differentiation according to the place where the standards apply. This is as opposed to the general authority that Member States have to lay down ecological quality requirements themselves. These requirements will be dependent on the type of water to which they apply and the possibility of invoking the exceptional provisions. The WFD and daughter directive concerning environmental quality standards provide the possibility for the Member States to invoke certain exceptional situations concerning all substances, or the possibility of designating transitional areas where the standards for priority substances do not have to be met. The WFD does not have any explicit regulation for the designation of transitional areas for non-priority substances. It is not clear whether Member States can designate such areas themselves under the same conditions that apply for priority substances including the condition that transitional areas are only possible for point source discharges). The WFD also has a differentiation regarding the places where the standards apply in respect of areas that require extra protection, such as water bodies that are used for the extraction of drinking water (then both the standards of the WFD and of the Drinking Water Directive apply) and certain habitat areas. Because the standards for other (water) directives also have to be met, the standards of the Bathing Water Directive also apply for certain bathing waters. The requirements of Directive 91/414/EEC must, in any case, also be met.

19 SUMMARY, CONCLUSIONS AND RECOMMENDATIONS As regards the WFD, the question of whether differentiation according to scale is possible is difficult to answer. On the one hand, in principle the standards apply to all surface waters, unless one of the exceptional situations described above is the case. The designation of certain waters that need extra protection can, furthermore, be seen as a differentiation according to scale. This does not alter the fact that the terminology of the WFD is not clear. The terms river basins, waters, surface waters, groundwaters and water bodies are used when discussing objectives, standards, designation of areas, exceptional provisions and monitoring obligations. And above that the European Court of Justice has added the concept of water masses. Summarising, it can be concluded that neither Directive 91/414/EEC nor the WFD provide a general possibility for differentiating standards according to place or scale. The situation is only different where the directives mention specific exceptions and for areas requiring extra protection. 8. Scope in the WFD for temporary deterioration of the situation when measures are being taken The WFD, along with its daughter directive, gives no scope for standards being exceeded, unless this falls within the frameworks indicated by the directive(s), such as the exceptional provisions of Art. 4 of the WFD, or within the annual average which has to be guaranteed and stays under the MAC standard, or there is a case of an exceedance due to point source discharges of priority substances within a transitional area designated by the member state. As mentioned earlier, it is not clear whether the WFD provides a possibility for the designation of transitional areas for non-priority substances. The WFD has no provisions indicating that account can be taken of the recovery of a water body and neither does it contain any provisions for a timescale applying to any such case. It must be assumed that the possibility of recovery must fall within the exceptional provisions discussed above. The standards for a good ecological status are that the ecosystem must function and the objectives must be achieved. It is not clear whether there is a possibility for recovery within this latter requirement. 19

20 DE KADERRICHTLIJN WATER EN GEWASBESCHERMINGSMIDDELEN 9. Reflection of monitoring data in the authorisation decisionmaking Contrary to the situation with the WFD, there is no clear place for monitoring data in Directive 91/414. The latter s authorisation assessment concentrates primarily on models. In the first instance, the authorisation decisionmaking focuses on the use in accordance with the use requirements rather than the effects that arise in practice. After authorisation, there is no structured feedback or link with the monitoring results. In other words, there is no post-registration monitoring. Monitoring does not have a clear place in the context of the Uniform Principles either. Because of the system s focus on use in accordance with the regulations, and on assessment on the basis of dossier data, based on models, the reflection of monitoring data is a laborious process. If standards are exceeded, an investigation will first have to be carried out, both in the context of Directive 91/414 and the WFD. How comprehensive this procedure will have to be will depend on the degree to which the indications can be substantiated and on the severity of the exceedance. The WFD does require likelihood (plausibility), but not certainty, with regard to a causal link between the use of a substance and the pollution before measures have to be taken. Measures must, after all, be taken for sources that can cause pollution. There will, however, have to be a certain amount of insight into this link, in view of the proportionality requirement of any measure that has to be taken. This sets requirements on monitoring data. There is no clear regulation for the reflection of WFD monitoring data in the authorisation decisions in the context of Directive 91/ How to deal with substances that are also used in contexts other than as plant protection products With a view to the proportionality of any measure proposed, other applications of substances will also have to be taken into account in the search for causes if standards are exceeded. The WFD does not require that the precise part played by the substance in question in the pollution is determined. Where necessary, measures must also be taken for substances that are used for purposes other than as plant protection products in order to achieve the WFD objectives; these measures must be included in the programme of measures. In principle, the WFD requires the same measures for a substance used for any other application as for plant protection products. 20

21 SUMMARY, CONCLUSIONS AND RECOMMENDATIONS The WFD is not clear on the distinction between basic and supplementary measures, including due to the differences between Art. 11 para 3 and Annex VI part A. There is no mention in the WFD of prioritization of measures. Measures for substances in plant protection products and for nitrate may have a certain priority because these regulatory frameworks are mentioned in Annex VI part A and must, therefore, in any case be included in the programme of measures. Furthermore, plant protection products are named as product group in the indicative list of most important pollutants. 11. Application of an environmental quality standard as authorisation standard in the context of Directive 91/414 In view of the differences between the objectives and assessment systems of the two directives, both standards have to be applied for plant protection products. To this end, when taking authorisation decisions, a fixed environmental quality standard for a priority substance will have to be applied in addition to the standard in the context of Directive 91/414. Moreover, if an environmental quality standard is less stringent than a standard in the context of Directive 91/414/EEC, the strictest quality standard must be deemed decisive for any emission control measures to be drawn up. An environmental quality standard cannot, therefore, serve as a replacement of the Directive 91/414/EEC standards. 12. Scope for the independent drawing up of regulations by local or regional authorities The question of whether there is scope for local regulators to independently draw up regulations relating to authorised plant protection products is more a question about national law than EC law. Directive 91/414/EEC does not give any pronouncements on this matter. It must be assumed that it is not excluded, provided: any such regulations do not impair the authorisation regulation system; they do not concern topics that are exhaustively regulated in Directive 91/414/EEC, such as labelling regulations; the intended objective of the regulations also ensues from other EC legislation or national legislation that is in accordance with EC frameworks; the authority fits within the national regulatory system. 21

22 22 DE KADERRICHTLIJN WATER EN GEWASBESCHERMINGSMIDDELEN 13. Questions and areas that lack clarity regarding the reflection of the WFD in the authorisation decision-making There are a number of areas regarding the reflection of the WFD in the authorisation decision-making that lack clarity. It would be advisable to clarify these areas. In some cases, consultation at European level will be necessary if clarity is to be achieved. Further research may be required in others. Finally, it must be noted that in the case of a number of questions, a definitive answer will only be obtained once the court, either the national court or the European Court of Justice, has judged on the matter. There is also insufficient clarity regarding the definitions of the following WFD concepts, at least regarding the meaning in relation to environmental objectives and quality standards: river basins, waters, surface waters, groundwaters, water bodies, water masses, pollution, point source, diffuse source, discharge and point source discharge. Clarity regarding these concepts is essential for a good understanding of the scope of the WFD as well as the relationship between the WFD and Directive 91/414/EEC. Because the WFD terminology is ambiguous, the question of whether differentiation according to scale is possible is difficult to answer. It is not clear whether a good ecological status and the standard that the ecosystem must function, entail a possibility for taking recovery of the surface waters into account. The WFD uses annual averages for ecological standards. The Member States may lay down MAC values for substances that fall under this good ecological status. It is not clear whether the Member States have the authority to come to an arrangement by analogy with the transitional areas that can be designated for the point source discharge of priority substances. Further research is necessary into the possible implementation of environmental quality standards, and in particular into the way in which the environmental quality standards must be reflected in the decision-making in other policy areas. There is no procedure for the reflection of WFD monitoring data within Directive 91/414. There is no procedure for information exchange between Member States and the Commission as a basis for Community action. The scope of the obligations that community institutions are subjected to pursuant to the WFD and the consequences of not meeting these community obligations for the obligations for the Member States (to produce certain results), are not clear.

23 SUMMARY, CONCLUSIONS AND RECOMMENDATIONS Neither the daughter directive nor the proposals for the daughter directive concerning the laying down of quality standards elaborate on procedures to be followed for laying down stricter emission control measures. 14. Recommendations This study has resulted in a number of recommendations that can be divided into recommendations at national and at Community level. Recommendations at national level 1. All environmental quality standards that must be laid down pursuant to the WFD must be included in a statutory provision. The statutory provision must be implemented such that it guarantees that the required environmental status and the environmental quality standards set are met on time. This implies that environmental quality standards must be seen as obligations to produce certain results. However, this does not mean that these limit values must automatically be taken into account for every decision or every permit to be issued. It would be advisable to find out how the environmental quality standards must be implemented to meet both the obligations pursuant to the WFD and retain sufficient flexibility for, for example, regional differentiation. 2. The Member States will have to take different measures, depending on the source or cause of the pollution, to meet the quality standards. The most obvious measures to be taken in the case of pollution by point sources are emission control measures such as the tightening of permits and/or general rules. If the pollution is caused by diffuse sources due to the use of plant protection products, taking source-oriented product control measures, such as the revision of approvals (authorisations) would seem most obvious. If the tightening of an authorisation does not lead to the required result, or if the authorisation assessment gives reason (see below), other product control measures will have to be taken possibly regionally-oriented ones. 3. When taking product control measures, it would be advisable to relate the agreements pursuant to Directive 91/414/EEC or the Biocides Directive to the quality standards the WFD sets for pollutants. This would ensure that the regimes of the WFD and Directive 91/414/EEC are better 23

24 DE KADERRICHTLIJN WATER EN GEWASBESCHERMINGSMIDDELEN geared to one another and this choice would then be in line with the combined approach of the WFD. 4. The quality standards of the WFD must be given a clear position in the authorisation assessment to enable a source- and prevention-oriented authorisation policy (i.e. prevention of standard exceedance). 5. It would be advisable to lay down points of departure and agreements for the reflection of WFD monitoring data in authorisation decision-making in a regulation that clearly describes authorities, procedures, terms and measures concerning monitoring data and the place of these data in authorisation decision-making. 6. Although at the level of objectives and criteria it is clear that quality standards pursuant to the WFD must and can be reflected in the authorisation decision-making, they are not reflected in the elaboration of the assessment methodology, for example in Uniform Principles C (water organisms). It would be advisable to elaborate these at national level in policy rules or in a ministerial regulation in combination with technical documents. 7. There are no procedures, for example on terms for the delivery of data or decision-making, to enable this reflection of quality standards in the authorisation decision-making. With a view to the legal certainty of interested parties it would also be advisable to elaborate procedures for this in policy rules or ministerial regulations. Recommendations at European level: 8. The directives do not go into the assessment and decision-making procedures to be followed when standards are exceeded or exceedances are imminent. For the sake of clarity and from the point of view of legal certainty and uniformity of legislation, it would be advisable to include a provision comparable to that of Art. 60 para 5 of REACH in the proposals for the new regulation for plant protection products. This provision creates the authority to re-examine authorisations again if the WFD objectives are not met. Similarly, a provision could be included in the Plant protection products regulation on the basis of which, if the quality standards pursuant to the WFD are not (or no longer) met, the reexamination of an admission (by the Commission) or an authorisation 24