The Interplay Between the EU Water Framework Directive, The List of Priority Substances and Sector-Specific Legislation

Claudio A. Mereu
McKenna Long & Aldridge, LLP

Introduction
Several pieces of legislation regulate the marketing of chemical products in the European Union (EU), each covering a different commercial sector (e.g., industrial chemicals, plant protection products, biocides, and pharmaceuticals) or specific activities involved in placing products on the market (e.g., hazard classification, packaging, and labeling). Since the adoption of the so-called Dangerous Substances Directive (67/548/EEC) in 1967, the EU has updated its chemicals legislation regularly, sometimes substantially. The 1990s were a particularly active decade. In 1991, the Plant Protection Products Directive (91/414/EEC) harmonized the pre-market evaluation and re-registration of agricultural pesticides. A year later, the Seventh Amendment to the Dangerous Substances Directive (93/32/EEC) significantly modified pre-market notification procedures for "substances" (substances defined as "chemical elements and their compounds in the natural state or obtained by any production process…"). In 1998, the Biocidal Products Directive (98/8/EC) harmonized the review of non-agricultural pesticides ("biocides") along the same lines as the Plant Protection Products Directive (with certain notable differences though).

The present decade also has seen significant regulatory activity in the area of chemical products. Specifically, the EU's "White Paper on the Strategy for a Future Chemicals Policy" outlines a radically new system for the comprehensive registration, evaluation and authorization of chemicals in the EU, and the Water Framework Directive (2000/60/EC) sets forth an all-inclusive water policy for the EU member states.

The purpose of this article is to describe the principal implications of the Water Framework Directive (WFD) and its interplay with sector-specific legislation, using the Plant Protection Products Directive (PPPD) as an example. In brief, the article shows that the WFD and PPPD can effectively coexist only to the extent that the WFD does not jeopardize and takes into account the evaluation of agricultural products ongoing under the PPPD. In this regard, the article identifies fundamental legal and methodological flaws that exist in the EU's recent adoption of a list of "priority substances" under the WFD. These flaws result from the EU's failure to observe selection criteria expressly prescribed by the WFD, specifically, the work now taking place under the PPPD.

The Water Framework Directive and List of Priority Substances
The stated objective of the WFD is to "establish a framework for the protection of inland surface waters, transitional waters, coastal waters and groundwater" through measures intended to progressively reduce discharges, emissions, and spills of "priority substances" and eliminate the presence of "priority hazardous substances" in the aquatic environment. The WFD was adopted following a proposal by the environmental directorate of the European Commission (DG Environment) and a majority vote of the European Parliament and Council under the so-called "co-decision" legislative procedure established by the Treaty constituting the European Community (the "EC Treaty").

In order to achieve its objectives, the WFD directed the European Commission to create a list of "priority substances" using the selection criteria set forth in Article 16(2) of the WFD. Specifically, the Commission is instructed to prioritize substances "on the basis of risk to or via the aquatic environment, identified by: (a) risk assessment carried out under Council Regulation n. 793/93, Council Directive 91/414/EEC, and Directive 98/8/EC of the European Parliament and Council, or (b) target risk-based assessment (following the methodology of Council Regulation 793/93) focusing solely on aquatic ecotoxicity and on human toxicity via the aquatic environment." Thus, the basic methodology for selecting priority substances is risk-based. In addition, the Commission must take into account the risk assessment performed under other applicable EU legislation. This means, for example, that an agricultural pesticide may be listed as a priority substance under the WFD, but only if the risk assessment carried out under the PPPD showed that the pesticide presented a "significant risk to or via the aquatic environment."

Once the list of priority substances is compiled in accordance with the above criteria, the Commission also must identify among the listed substances those presenting an especially high level of risk, or the priority hazardous substances, taking into account "the selection of substances of concern undertaken in the relevant Community legislation regarding hazardous substances or relevant international agreements" (Article 16(3) of the WFD). The difference between priority substances and priority hazardous substances was not present in the initial text of the WFD presented by the Commission. However, it was inserted in the final text as a result of a political compromise between the European Council and the Parliament during the final stage of the legislative procedure, leading to the adoption of the WFD ("co-decision"). With this political compromise, the Parliament agreed not to phase-out all priority substances but only those which are identified as priority hazardous substances. The list of priority substances, and its sub-category of priority hazardous substances, is intended to be incorporated in and form Annex X to the WFD.

The list of priority substances adopted under the WFD is a dynamic list, which the Commission must update "at least every four years" (Article 16(4)). When necessary to meet the foregoing timetable, the Commission may list new substances using a simplified risk-assessment procedure, as provided by Article 16(2). However, this procedure is only available to the Commission to "review the adopted list" (emphasis added). In other words, the Commission cannot adopt a first priority list using simplified risk-assessment procedures. Remarkably, while new substances can be added to the list regularly, the WFD does not provide for a "de-listing" mechanism. As a result, inclusion in the list seems to be an irreversible decision for any particular substance.

Within this context, on Dec. 15, 2001, the EU adopted Decision 2455/2001/EC establishing the first list of priority substances under the WFD. The list contained 10 priority hazardous substances and 23 priority substances, 14 of which are included in a sub-category of "under review," and may be re-assigned as priority hazardous substances within 12 months. The presence of priority substances in the aquatic environment must approach background values for naturally occurring substances and be close to zero for synthetic (man-made) substances over a period of maximum 20 years, while priority hazardous substances must be eliminated or phased-out, also within 20 years.

The much debated adoption of the first list of priority substances raises three major issues. First, the methodology used to select priority substances does not observe the appropriate risk-based criteria prescribed by the WFD. Instead, substances were listed using a summary hazard-based assessment procedure called "combined monitoring and modeling-based priority setting" (COMMPS). Second, the list of priority substances contains the new sub-category of "priority substances under review," which is not provided in the WFD and whose underlying rationale is unclear and probably politically-driven. Third, when selecting priority substances the Commission ignored the EU legislation identified in Article 16(2) of the WFD. In this regard, many agricultural pesticides have been listed without any required consideration of the results of their risk assessment under the PPPD. Furthermore, the inclusion of agricultural pesticides in the first priority list directly and adversely affects end-use products, to the extent that their application to crops entails potential "discharges, emissions and losses" to the aquatic environment, including inevitable spray drift and run-off.

Conclusion
The stated aim of the WFD is to establish an European Union-wide system to control water pollution, but the recent adoption of a list of priority substances achieves the foregoing aim at the expense of products already undergoing comprehensive risk assessment under other, more specific EU legislation, especially agricultural pesticides being evaluated for continued safe and effective use under the PPPD. The list of priority substances, which will have serious effects on the agro-business, is based on a fundamental methodological flaw. In addition, the list of priority substances is legally flawed, because it fails to observe the selection criteria expressly prescribed by the WFD and the risk assessment results of sector specific legislation, such as the PPPD. In this respect, the list of priority substances clashes with a fundamental principle of EU law requiring the institutions to ensure a coherent application of EU legislation and to avoid any possible conflict between "horizontal" and sector-specific legislation.