Options for amendment of Article 10

Transcription

1 Options for amendment of Article 10 Towards a common framework for acceptance of materials, products and treatment chemicals in contact with drinking water Wennemar Cramer On behalf of Article 10 Subgroup of the Drinking Water Committee

2 Remit of Subgroup Set up by Drinking Water Committee 8 May meetings between June and October 2007 Remit: To prepare a working document discussing options for the amendment of Article 10 of Drinking Water Directive in view of clarification and improvement of legal basis for materials, products and treatment chemicals in contact with drinking water 2

3 Members Subgroup John Ashworth Jan Cortvriend Wennemar Cramer Manfred Fuchs Katerina Hantzi Sophie Herault Tuija Kaunisto Birgit Mendel Drinking Water Inspectorate (UK) EC DG Environment Ministry of Environment (Netherlands) EC DG Enterprise Ministry of Environment (Denmark) Ministry of Health (France) Vesi-instituutti / Prizztech Oy (Finland) Bundesministerium für Gesundheit Report reflects expert opinion of members. It does not constitute a formal position of Member States and EC 3

4 Drinking Water Directive 98/83/EC (DWD) Article 10: Quality assurance of treatment, equipment and materials Member States shall take all measures to ensure that materials and treatment chemicals do not impair the drinking water quality input into drinking water not higher than necessary for the purpose no reduction in protection level DWD Consequently: need for national acceptance scheme (NAS) Technical specifications on basis of the Construction Products Directive (CPD) shall respect requirements of the DWD 4

5 Protection level of Drinking Water Directive Protection level is more than just 46 parametric values: Drinking water: wholesome and clean No substances or micro-organisms in concentrations or numbers, which constitute a potential danger to human health (Article 4) Drinking water quality standards, based on scientific knowledge and the precautionary principle Point of use is point of compliance (tap directive) Performance specifications of analytical methods Accreditation of laboratories (DWD Annex III) 5

6 Construction Products Directive (89/106/EEC) Objective: accomplishment of internal market Essential requirements of products to be tested for Nr 3: Health and hygiene Product standards, test standards & CE-marking related to intended use Technical specifications on basis of the CPD shall respect requirements of the DWD (= DWD Article 10) 6

7 EAS Proposal Control of performance of substances and materials Lists of acceptable substances (PL, CL and ACL) Full formulation information provided by manufacturers Product testing (initial type testing) Product standards, supporting test standards (CEN) Auditing Pre-certificate audit of internal quality control systems Post-certificate auditing of systems and products (including audit testing) 7

8 Conclusions RG-CPDW (2005) Broad support for EAS Proposal amongst regulators and stakeholders DWD should be amended to provide legal basis for EAS in addition to CPD EAS requires management, technical and administrative capabilities at EU level Commission later questioned the feasibility of implementation of the proposed EAS 8

9 4 MS review Representatives of France, Germany, Netherlands and UK met in October 2007 with Commission to seek solution for regulatory requirements for supporting test standards (solving the CEN problem ) Report ready and sent to Commission, CEN/TC164 and drinking water regulators Review of national schemes Recommendations for supporting test standards Course aiming for convergency of practices Presentation of report in Expert Group CPDW (15 mei) 9

10 Subgroup: Options for amendment of DWD Article 10 Status quo plus clarification of scope (option I) Water supply system from source to tap Not only chemical parameters, but also enhancement of microbial growth and organoleptic aspects Option I plus requirement for Member States to use authorisation scheme complying with framework set out in new annex to DWD (options II, III, IV) Variations differing in extent of detailing Full EAS (option V) See EAS Proposal (2005) Common lists and other acceptance criteria annex to DWD 10

11 Evaluation criteria Coverage of products Quality of products (consumer protection) Flexibility Member States Transparency for stakeholders Possibility to check compliance with DWD Promotion of internal market Competitive Europe Minimising operational costs for Member States Minimising operational costs for EC Minimising certification costs See table in report for evaluation (scores) 11

12 Conclusions and recommendations (1) Art.10 needs amendment to repair linguistic error and to clarify the scope Source to tap (note: CPD only partly covers scope!) Chemical substances, enhancement of microbial growth, organoleptic aspects Art.10: obligation for Member States to control input of substances from materials and treatment chemicals DWD does not provide a framework for such a control Current situation would lead to diverging national approaches 12

13 Conclusions and recommendations (2) Providing a framework in the DWD would be a major improvement (use Comitology for details and updating!!) Convergency of national approaches Specification of protection level (binding for technical specifications under the CPD) A common scheme (EAS) will have further advantages in terms of minimising costs and improving transparency A common scheme may be contrary to the proportionality principle Short term: further development of options II-IV in terms of possible wording for amendment of DWD 13

14 ENDWARE Statement In its meeting of 5-6 November 2007, ENDWARE discussed the state of play with respect to the development of the European Acceptance Scheme (EAS). The group took note of the interim results of the work undertaken by the Article 10 subgroup of the Standing Committee on Drinking Water. The meeting concluded that the assessment of the materials and chemicals in contact with drinking water should be an important issue in the revision process of the Drinking Water Directive. It was pointed out that the large investments in the infrastructure in the coming years underlines the urgency of having adequate legal instruments and technical specifications in place to control the quality of the products in view of protecting human health. Against this background, the meeting expressed the opinion that the preferred option for the revision would be a common approach along the lines set out in the EAS proposal. 14