1. 1 SANITARY SURVEILLANCE OF MATERIALS IN CONTACT WITH WATER INTENDED FOR CONSUMPTION assessment of impact on water quality and health safety in Poland dr Janusz Świątczak Head of Communal Hygiene Department National Institute of Public Health – National Institute of Hygiene Transition Facility PL 06/IB/EN/01 Warsaw, 19 September 2008

2. 2 Sanitary supervision of materials and products in contact with water intended for consumption - National Institute of Hygiene in mid-1970’s indicated the need for a uniform and systematic impact assessment of products and materials on water quality. The assessment was deemed necessary due to: potential negative impact of materials and products on water quality, the need to fulfil ever more strict water quality requirements set out in the legislation.

3. 3 Sanitary supervision of materials and products in contact with water intended for consumption National Institute of Hygiene has been carrying out hygienic assessment of general purpose construction materials since mid 1970’s. (the reason for this were cases of application of materials polluting air in confined spaces with toxic substances, and substances causing odour complaints. Removal of the materials from thousands of apartments required very costly refurbishment works). Materials and products submitted for hygienic assessment included those intended for use in drinking water treatment, collection and distribution installations. These required hygienic assessment against different criteria.

4. 4 NIH’s hygienic assessment of materials and products in contact with water intended for consumption: introduced in 1984, before formal regulatory obligation – investors obliged tenderers to submit hygienic assessment in course of tendering procedures state field sanitary inspectors required hygienic assessment for materials and products to be presented in course of the procedure before granting consent for use of new or modernised collective water supply devices, Building Research Institute’s granting of a technical approval for a product used in contact with water intended for consumption was conditional on submission of its hygienic assessment

5. 5 Sanitary supervision of materials and products in contact with water intended for consumption – hygienic certification – a historical outline NIH prepares a methodological document „Methodology of testing plastics in direct contact with drinking water”. 1980 commencement of sanitary testing of materials and products and issuance of certificates attesting that the material or product has no negative impact on the quality of water it is in contact with. HYGIENIC ASSESSMENT – a NIH document issued without an end-date; instead, it included a clause stipulating that it becomes void automatically where recipe, or production technology changes. 1984 - 1994 from 1995 HYGIENIC CERTIFICATE – replaced the hygienic assessment. A NIH document with, initially, a 10-year validity period, from 2000, a 5-year validity period. 1984

6. 6 Sanitary supervision of materials and products in contact with water intended for consumption – current scheme HYGIENIC CERTIFICATION (NIZP- PZH) analysis of contents/ materials migration tests (NIH, VSES, other) other sanitary certificates manufacturer’s or distributor’s application ++ + Assessment of State District Sanitary Inspector - for a specific building (INVESTOR’S APPLICATION – DESIGN DOCUMENTATION + HYGIENIC CERTIFICATE) + water testing before building is approved for use POSITIVE RESULT– product may be used NEGATIVE RESULT – product may not be used ASSESSMENT REGISTER (PPIS)

7. 7 National Institute of Public Health – National Institute of Hygiene unit authorised to inspire and coordinate actions in the field of developing laboratory network necessary to assess impact of products from organic materials on quality of water intended for human consumption. EAS System Implementation of the EU Directive 89/106/EEC on construction materials and Directive 98/83/EC on quality of water intended for human consumption. Marking of products approved for use under CE-EAS Main objectives: To ensure that materials in contact with water will not deteriorate the quality of drinking water, thus will not pose a health hazard To harmonise approval systems in EU countries, and consequently to remove barriers in trade of these products (ensure equal competition conditions)

8. 8 (EAS) procedures Procedures approving contact with water intended for consumption for: organic materials (e.g. plastics) metal products cement products Stage I test Assessment of impact of the material on organoleptic qualities of water Assessment of impact of the material on microorganism multiplication Assessment of total organic substances migrating to water by determining TOC (total organic carbon) Stage II test Determine „unexpected” substances by means of gas chromatography and mass spectrometry Determine cytotoxicity of substances whose presence in drinking water is connected with material composition and „unexpected” substances Determine impact of disinfecting chlorine on the quality of water in contact with the product

9. 9 Assessment of biofilm susceptibility of materials in contact with water – testing procedure developed by Communal Hygiene Dept. NIPH - NIH Biomass growth assessment (susceptibility of the material to biofilm formation) on the basis of ATP/cm 2 measurements in a dynamic test using a flow device. Forecasted date of implementation – 01.01.2009 Flow device

10. 10 Testing impact of materials on water quality Laboratory of CHD NIPH-NIH VSES Laboratories ICP - AES ICP - MSGC – FID - ECD HPLC HPIC GC - MS

11. 11 Sanitary supervision of materials and products in contact with water intended for consumption - legislation Directive 98/83/EC, OJ L 330.5.12.1998 Art. 10 Act of 7 June 2001 on public water supply and public wastewater removal (OJ PL of 2006, no 123, item 858 with subsequent changes), art. 12.1-3. and 13 Regulation of the Minister of Health of 29 March 2007 on quality of water intended for human consumption (OJ PL of 2007, no. 61, item 417), §18.1-6.

12. 12 Sanitary supervision of materials and products in contact with water intended for consumption - legislation Directive 98/83/EC Art. 10 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 remain in water intended for human consumption in concentrations higher than is necessary for the purpose of their use and do not, either directly or indirectly, reduce the protection of human health provided for in this Directive. Interpretative documents and technical specifications referred to in Art. 3 and 4 of the Directive 89/106/EEC of 21 December 1988 on the approximation of laws, regulations and administrative provisions of the Member States relating to construction products shall take into the account requirements of this directive.

13. 13 The use of new treatment technologies for water intended for human consumption requires an approval from a state voivodship sanitary inspector Sanitary supervision of materials and products in contact with water intended for consumption – legislation [continued] Act of 7 June 2001 on public water supply and public wastewater removal (OJ of 2006, no. 123, item 858 with subsequent changes): Supervision of the quality of water intended for consumption shall be exercised by units of the State Sanitary Inspection following rules set out in the SSI provisions. Art. 12.1 Each material and product used in treatment of water intended for human consumption shall be accompanied by a positive hygienic assessment of the state district sanitary inspector. Art. 12.2 Art. 12.3 Art. 13 p. 6 Competent minister of health (…) shall set out by way of a regulation the method of supervision of materials and products used in water treatment and distribution processes.

14. 14 (the regulation became void on entry into force of the amendment to the Act on public water supply and public wastewater removal of 22 April 2005) Sanitary supervision of materials and products in contact with water intended for consumption – legislation [continued] Regulation of the Minister of Health of 19 November 2002 setting out quality requirements for water intended for human consumption (OJ PL of 2002, no. 203, item 1718). §8. 3. Each material, product and preparation, including desinfectants, used in water treatment and distribution systems and devices must obtain an approval from competent state district sanitary inspector issued on the basis of a NIH hygienic certificate.

15. 15 Regulation of the Minister of Health of 29 March 2007 on quality of water intended for human consumption (OJ PL of 2007, no. 61, item 417). Sanitary supervision of materials and products in contact with water intended for consumption – legislation [continued] § 18. 1. The use of a water treatment and distribution material or product is conditional on obtaining a hygienic assessment from a competent state district sanitary inspector (SDSI), or state border sanitary inspector (SBSI). § 18. 2. The assessment referred to in par. 1 shall be issued on the basis of design documentation. § 18. 3. The documentation referred to in par. 2 shall include: 1.Name and address of the facility where the assessed material or product is to be used, 2.Types of used materials, and preparations accompanied by up-to-date hygienic certificates from a unit authorised to issue such certificates, 3.Stipulation of the place and application of materials, products and preparations used in the water treatment and distribution process, 4.In the case of biocidal products, also a document approving the product for marketing, including description of its application. § 18. 4. Assessment referred to in par. 1 must be accompanied by the result of water test performed by competent SDSI or SBSI (…).

16. 16 Regulation of the Minister of Health of 29 March 2007 on quality of water intended for human consumption (OJ PL of 2007, no. 61, item 417). Sanitary supervision of materials and products in contact with water intended for consumption – legislation [continued] § 18. 4. Competent state district sanitary inspector or state border sanitary inspector shall keep a register of issued assessments of water treatment and distribution materials and products. § 18. 5. Competent state district sanitary inspector or state border sanitary inspector shall keep a register of parameters that need to be monitored in water delivered to service recipients in connection with water treatment and distribution materials and products.

17. 17 HYGIENIC CERTIFICATION IN NIPH-NIH IS ONLY A PART OF THE SUPERVISION SYSTEM OF MATERIALS AND PRODUCTS used to treat and distribute water intended for consumption; the key element of the system are controls performed by field units of SSI. Sanitary supervision of materials and products in contact with water intended for consumption HYGIENIC CERTIFICATION OF MATERIALS AND PRODUCTS IN CONTACT WITH WATER IS OBLIGATORY – where the hygienic certificate is absent, the material or product may not be used in public water supply systems. This has influence on requirements used to assess the product. NIPH-NIH accepts and issues hygienic certificates on the basis of tests performed in other certifying units:

18. 18 Sanitary supervision of materials and products in contact with water intended for consumption TZW/ DVGW (Germany), where testing procedure includes hygienic ass. Hygiene-Institut des Ruhrgebiets (Germany) WRC Water Research Centre (Great Britain) WRAS Water Regulation Advisory Scheme (Great Britain) DWI Drinking Water Inspectorate (Great Britain) Institut Pasteur (France) INSTITUTIONS CERTIFYING PRODUCTS IN CONTACT WITH WATER INTENDED FOR CONSUMPTION, whose test results and certificates are accepted by NIPH-NIH CRECEP Centre de recherche d’expertise et de controle des eaux de Paris (France) Institut Fresenius (Germany)

19. 19 INSTITUTIONS CERTIFYING PRODUCTS IN CONTACT WITH WATER INTENDED FOR CONSUMPTION, whose test results and certificates are accepted by NIPH-NIH (continued) Sanitary supervision of materials and products in contact with water intended for consumption KIWA (Netherlands) NSF National Sanitation Foundation (USA) UL Underwriters Laboratories (USA) WQA Water Quality Association (USA)

20. 20 Sanitary supervision of materials and products in contact with water intended for consumption

21. 21 water pipelines (17,3%) water reservoirs (7,5%) fittings, couplings (11,4%) valves, flanges, hydrants, bands (17,9%) sealing (5,3%) protective coatings (4,4%) mortars (4,4%) water filters (6,1%) taps (9,7%) filter beds (4,4%) water treatment and disinfection preparations (9,2%) other (2,4%) Materials and products in contact with water intended for consumption subject to hygienic certification in NIH (2005-2006) pipes Reservoirs and tanks Fittings and couplings taps Water filters Valves, flanges Filter beds Water treatment preparations mortars coatings sealings (412 products) other

22. 22 THANK YOU FOR YOUR ATTENTION