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
1
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.
2
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.
3
NIH’s hygienic assessment of materials and products
in contact with water intended for consumption:
introduced in 1984, before formal regulatory obligation –
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,
investors obliged tenderers to submit hygienic assessment in
course of tendering procedures
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
4
Sanitary supervision of materials and products in contact with
water intended for consumption – hygienic certification – a
historical outline
1980
NIH prepares a methodological document „Methodology of testing
plastics in direct contact with drinking water”.
1984
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.
1984 1994
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.
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.
5
Sanitary supervision of materials and products in contact with water intended for
consumption – current scheme
manufacturer’s
or distributor’s
application
+
analysis of
contents/
materials
+
migration
tests (NIH,
VSES, other)
+
other sanitary
certificates
HYGIENIC CERTIFICATION (NIZP- PZH)
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
NEGATIVE RESULT –
product may not be
used
ASSESSMENT
REGISTER
(PPIS)
POSITIVE RESULT–
product may be used
6
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)

7
(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
8
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/cm2 measurements in a dynamic test using a flow device.
Forecasted date of implementation – 01.01.2009
Flow device
9
Testing impact of materials on water quality
Laboratory of CHD NIPH-NIH
ICP - MS
HPLC
GC – FID - ECD
ICP - AES
GC - MS
HPIC
VSES Laboratories
10
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.
11
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.
12
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):
Art. 12.1
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. 12.2
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. 12.3
The use of new treatment technologies for water intended for human consumption
requires an approval from a state voivodship sanitary inspector
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.
13
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.
(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)
14
Sanitary supervision of materials and products in contact with water intended for
consumption – legislation [continued]
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. 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 (…).
15
Sanitary supervision of materials and products in contact with water intended for
consumption – legislation [continued]
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. 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.
16
Sanitary supervision of materials and products in contact with water
intended for consumption
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.
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:
17
Sanitary supervision of materials and products in contact with water intended for
consumption
INSTITUTIONS CERTIFYING PRODUCTS IN CONTACT WITH WATER INTENDED
FOR CONSUMPTION,
whose test results and certificates are accepted by NIPH-NIH
TZW/ DVGW (Germany), where testing procedure includes hygienic ass.
Hygiene-Institut des Ruhrgebiets (Germany)
Institut Fresenius (Germany)
DWI Drinking Water Inspectorate (Great Britain)
WRC Water Research Centre (Great Britain)
WRAS Water Regulation Advisory Scheme (Great Britain)
CRECEP Centre de recherche d’expertise et de controle des eaux de
Paris (France)
Institut Pasteur (France)
18
Sanitary supervision of materials and products in contact with water intended for
consumption
INSTITUTIONS CERTIFYING PRODUCTS IN CONTACT WITH WATER INTENDED
FOR CONSUMPTION,
whose test results and certificates are accepted by NIPH-NIH (continued)
KIWA (Netherlands)
NSF National Sanitation Foundation (USA)
UL Underwriters Laboratories (USA)
WQA Water Quality Association (USA)
19
Sanitary supervision of materials and products in contact with water intended for
consumption
20
Materials and products in contact with water intended for consumption
subject to hygienic certification in NIH (2005-2006)
water pipelines (17,3%)
water reservoirs (7,5%)
fittings, couplings (11,4%)
valves, flanges, hydrants, bands
Water
(17,9%)
filters
mortars
sealing (5,3%)
protective coatings (4,4%) coatings
mortars (4,4%)
sealings
water filters (6,1%)
taps (9,7%)
filter beds (4,4%)
water treatment and disinfection Water
treatment
preparations (9,2%)
preparations
other
taps
pipes
Fittings and
couplings
Reservoirs
and tanks
Filter beds
Valves,
flanges
other(2,4%)
(412 products)
21
THANK YOU FOR YOUR ATTENTION
22