Difficult Path to Harmonized EU Acceptance Criteria For Materials in Contact with Drinking Water
By Keller and Heckman LLP’s Packaging Practice Group
The regulatory picture applicable to materials in contact with drinking water in the European Union (EU) is complex. It involves consideration of existing EU Directives, national approval programs, and a forthcoming scheme to harmonize acceptance criteria for substances that contact drinking water. Faced with the absence of full harmonization in this area, companies should consider recourse to some legal principle, such as the principle of mutual recognition, to gain market access.
The subject of materials in contact with drinking water, among other topics related to drinking water, is under increased scrutiny as the European Council's Drinking Water Directive 98/83/EC (DWD) of Nov. 3, 1998 is approaching its five-year mark for review and possible amendment. At the end of October 2003, a stakeholder seminar for all the current Member States and new candidate countries organized by the European Commission Directorate-General for the Environment, Water, the Marine and Soil Unit, was held in Brussels, Belgium to address the upcoming revision of the DWD. One of the topics of this meeting was the regulation of materials in contact with drinking water, which is addressed in Article 10 of the DWD. Specifically, the DWD mandates that "Member States shall take all measures necessary to ensure that no substances or materials for new installations used in the preparation or distribution of water intended for human consumption or impurities associated with such substances, or materials for new installations remain in water intended for human consumption in concentrations higher than is necessary for the purpose of the use, and do not, either directly or indirectly, reduce the protection of human health provided for in this Directive."
Materials and products used for the storage and distribution of water intended for human consumption that are permanently incorporated in construction works also are addressed by another EU Directive; the Construction Products Directive 89/106/EEC (CPD), as amended. This Directive applies to products that are manufactured for permanent incorporation into buildings and civil engineering works (e.g., plumbing installations), and sets forth essential requirements for ensuring the safety of water supply networks and "CE" (European Community) marking (which is intended to ensure the free movement of goods throughout the EU). The CPD states that the essential requirements constitute both the general and specific criteria applicable to construction products, and are the basis for the preparation of harmonized European standards. The Directive provides for conformity assessment procedures for construction products, and although contemplating a role for national authorities ("approved bodies") in evaluating compliance with the essential requirements, mandates in Article 6 that products satisfying the Directive not be prevented from free circulation among the Member States. Thus, it would appear that the DWD and CPD together set out the legal and technical requirements applicable to materials in contact with drinking water.
However, many of the EU Member States, taking their cue in part from Article 10 of the DWD, have developed independent national approval schemes for materials and substances used in contact with drinking water. For example, in the United Kingdom (U.K.), materials in contact with drinking water must be the subjects of governmental approval pursuant to Regulations 25-28 of the Water Supply (Water Quality) Regulations of 1989. The Secretary of State issues approvals for materials in contact with drinking water, with technical and administrative support for the approval process provided by the U.K. Drinking Water Inspectorate (DWI) and the Committee on Products and Processes for Use in Public Water Supply (CPP). Approvals are based on a demonstration of compliance with British standards (and European standards when available). Similar systems exist in many other Member States.
In practice (and contrary to the mutual recognition provisions of the CPD), national approvals, such as those granted by the U.K. authorities, are often not accepted in other Member States. Consequently, these national schemes are creating obstacles to the free movement of goods, and have prompted the European Commission to initiate efforts to establish a shared regulatory approach for these construction products in the EU. More specifically, the European Acceptance Scheme (EAS) for water pipes, taps, and fittings in contact with drinking water is an attempt by the European authorities to harmonize requirements for materials in contact with drinking water, which includes a research program to resolve issues raised by regulators in the Member States. According to statements made in the October 2003 seminar, the EAS (i.e., its regulatory framework, guidance documents, harmonized product and test standards) is intended to be completed in 2006. However, some stakeholders consider the timetable for completion to be unrealistic, so one should not have high expectations that the EAS will solve all existing problems in the years to come.
In the meantime, companies continue to face divergent national approval systems. This is not acceptable in today's Europe. Under the CPD, but also under the EC Treaty, drinking water pipe materials that are lawfully produced and marketed in a Member State should be able to lawfully circulate throughout the EU. The principle of "mutual recognition" is a right that is granted to private parties in the EC Treaty, as interpreted by the European Court of Justice, and that is enforceable in the courts. While a legal action may not be the solution in each and every case, companies should certainly consider using the principle of mutual recognition as an alternative to repeated national approvals. This may be the best way to force this remaining national fortress to surrender to EU harmonization.