Appliances: Water Heaters

EAS - European Acceptance Scheme for Construction Products in contact with Drinking Water
by Silvano Pagliuca - IEI Secretary General
EG-CPDW-SG3- NMIM – Glassy Material Expert
EG-CPDW-SG4-AMLP – SG3 Liason Observer/ Water Heater Expert.

1. Reasons for EAS
In Europe there doesn’t exist coherent normative legislation for construction products in contact with drinking water. For the time being each Member State has its own regulatory arrangements together with either Standards or Voluntary Norms. The different regulations and local standards are creating barriers to free trade.

2. Scope of EAS
The EAS will be a coherent and harmonized System in the EC market for regulating and accepting all the Materials/Products coming in contact with water for Human consumption.
The EAS will cover Construction Products of the drinking water supply system from the last downstream point of the water treatment station to the Consumer’s tap (including hot water systems).

3. Major milestones in the development of EAS

1998 Report of the 4 MS feasibility study recommending a harmonized European Acceptance Scheme.
1999 European Community SCC and SCDW accepting recommendations of MS.
2001 DG enterprise issuing the Mandate M 136 to CEN for preparation of Test Methods and harmonized Product Standards. RG-CPDW Interim Report(EAS on paper) issued for consultation.
2003 Research Reports on Test Methods published.
2004 An EAS proposal discussed at Level of RG-CPDW. The draft of EAS setting out all principles of the scheme and covering all operational and management aspects of the directive, submitted to SCC and SCDW for approval and endorsement. Further research on test methods for GCMC and EMG commissioned.
2005 RG-CPDW replaced by EG-CPDW under direct reporting line of SCC and DG Enterprise.

4. EAS - High Level Principles
EAS based on following main principles:
:: High level of consumer protection and sound scientific base for public Health protection.
:: Equal opportunities for all Materials/Products in contact with drinking water on the European market.
:: Transparency of the EAS process.

5. EAS - A risk based approach to Product Assessment
::
Risk in Material Behaviour
The potential risk for the materials in Products to leach harmful substances affecting Drinking water quality in term of:
- Cytotoxicity
- Colour
- Odour
- Turbidity
- General Hygienic Aspects
- Enhancement of microbial growth

The control strategies to be implemented against risks in Material behaviour are:
- full information in composition
- compliance of these Materials with PL (Organic Materials), CL (Metallic Materials), ACL (Cementitious Materials) and OCL (Glassy Materials/ Vitreous Enamels)

:: Risk in Products Performance
The impact of products on drinking water quality will depend also on their form and function.

The control strategies are implementing the evaluation of Products parameters and related functionality such as:
- Surface to Volume ratios (S/V)
- Residence Time
- Lab Test Results vs. Product operating conditions by means of Conversion Factors.

6. EAS – The framework for Materials Testing

The EAS structure of materials testing is built on following 5 pillars:

:: Compliance with PL; CL, ACL, OCL ,as first line of defence for drinking water quality.

:: Organoleptic Assessments consisting of:
- Odour and Flavour
- Colour and tubidity

:: General Hygiene Assessments consisting of:
- Total Organic Carbon
- Chlorine Demand
- Surface Organic Residues (metallic products)

:: Toxic Substances
- DW Parameters according to DWD 98/83/CE.
- Drinking Water Positive List Limits (DWPLL)
- Unsuspected Organic substances (by GCMS)

:: Enhancement of Microbial Growth (EMG)
The behaviour of the material to provide Bio-film for Microbial growth.

Table 1 - Proposal for a matrix for EAS compliance criteria and testing related to material
EAS compliance criteria
Organic Materials
Metallic Materials
Cementitious Materials
Glassy Materials   Vitreous Enamels
Positive lists
Yes
-
Yes
-
Composition lists
-
Yes
-
-
Oxide Composition List
-
-
-
Yes
Approved Constituent list
-
-
Yes
-
Organoleptic tests
Odour and flavour
Yes
-
Yes
-
Colour and Turbidity
Yes
-
Yes
-
General hygiene assessments
TOC
Yes
-
Yes
-
Chlorine demand
Yes
-
To be decided
-
Surface residues (metals)
-
Yes
-
-
Substances posing a risk to health
DWD parameters
Yes
Yes
Yes
Yes
PL substances
Yes
-
Yes
-
Unsuspected substances (GCMS)
Yes
-
Yes
-
CL Compliance
-
Yes
-
-
OCL Compliance
-
-
-
Yes
Enhancement of Microbial Growth
Yes
-
Yes
-

7. EAS and issues in Product testing
The test programmes recognize the different risks and performance characteristics of the different Materials, but the approval and certification process applies to the products and not to Materials.

This is not a problem for single material products (e.g. plastic pipes), while different issues arise for more complex products such as:

- Assembled products, which may require independent components testing.
- Multi-layer products ,which may require independent layer testing, if the layer in contact with drinking water is not acting as a perfect barrier to water and insulating deeper layers.
- Site applied products, require representative samples for testing purposes. (ACL approach trying to simplify the assessment by means of an approved constituents list process)

The assessment of complex products may no require full testing in all circumstances.

When their impact on DW quality is insignificant due to:
- the very low contact surface
- the very high water volume
- very low residence time
- very suitable material type
a Reduced Assessment Procedure (RAP) may be applied.

8. EAS – The legal base

The legal base of the new EAS of products suitable for contact with water for human consumption was found primarily in the CPD 89/106/EEC and for drinking water parameters in DWD 98/83/CE.
CPD 89/106/EEC is under DG Enterprise responsibility, while DWD 98/83/CE is under DG-Environment responsibility.

EAS requested to comply with CPD 89/106/EEC that imply the use of:

- CE marking
- Provision of product information
- harmonized Product Standards (hENs)
- harmonized Test Method
- the highest level of Attestation of Conformity (AoC) system (1+) which involves (table 2):

  1. Third party testing, inspection and certification by Notified Bodies nominated by Member States.
  2. Factory Production Control (FPC) system
  3. Initial Type Testing (ITT)
  4. Audit Surveillance
Table 2 - Attestation of Conformity (AoC) SYSTEMS
System
Task for Manufacturer
Task for Notified Body
Basic foc CE marking
4
ITT of product
FPC
  Declaration of conformity of the manufacturer
3
FPC ITT of product
2
ITT of product
FPC
(testing of samples according prescribed test plan)
Certification of FPC on basins of initial inspection
2+
ITT of product
FPC
(testing of samples according prescribed test plan)
certification FPC on basins of initial inspection and continuous survelliance, assessment and approval of FPC Declaration of conformity of the manufacturer based on certificate of conformity of FPC
1
FPC
testing of samples according prescribed test plan
Product certification basins of:
- ITT of product
- initial inspection of FPC
- Continuous survelliance, assessment and approval of FPC
Declaration of conformity of the manufacturer based on certificate conformity of product
1+
FPC
testing of samples according prescribed test plan
Product certification basins of:
- ITT of product
- initial inspection of FPC
- Continuous survelliance, assessment and approval of FPC
- audit testing of samples

9. Special feature of EAS
The EAS has special features that are not normally found in CPD 89/106/EEC:
:: Requirements to comply with PL,CL,ACL,OCL
:: Use of common test programmes which lead to a single pass/fail outcome
:: Use of common Acceptance Levels
This conflicting area has to be cleared up by EG-CPDW/ SCC/SCDW in the near future.

10. Management of EAS development and operation
The EAS project management is carried out by means of following Work Breakdown Structure (WBS):

European Commission Technical and Administrative Lead under DG-Enterprise Responsibility.
DG-Environment with DW function only giving Advisory positions.
Supervisory Committees Standing Committee on Construction (SCC)
Standing Committee on Drinking Water (Advisory Role)
Advisory Committee Regulators Group for Construction Products in contact with Drinking Water(RG-CPDW),recently replaced by Experts Group for Construction Products in contact with Drinking Water (EG-CPDW).
Working Subgroups Subgroup 1 for Organic Material (SG1-OM )
Subgroup 2 for Metallic Materials (SG2-MM)
Subgroup 3 for Non Metallic Inorganic Material (SG3-NMIM)
(Cementitious and Glassy Materials).
Subgroup 4 for Assembled an Multi-Layer Products
( SG4-AMLP) (including Water Heater).
CEN Preparation of test method standards and harmonized products Standards under formal mandate M136 of EC DG-Enterprise.
CEN working with Its own work breakdown structure with a coordination Technical Committee CEN/TC 164-CPDW and WGs and WSG (AHG i ).
Notified Bodies Testing and Certification. MS requested to nominate NB in their own area of competence and responsibility.
Representative , of already nominated NBs ,participating in developing EAS at EG-CPDW and SGs levels.
Industry Present as Observers/Experts in EG-CPDW and contributing to Sub-Groups activity. Participation in CEN Sub-groups.

11. EAS and Mandate M136 to CEN
DG Enterprise commissioned the mandate M136 to CEN/CENELEC in 2001.
The Mandate deals with two areas of work:
- Supporting Standards (EAS Supporting test methods)
- harmonized product standards (hEN)

The test methods are being developed by CEN/TC 164 WG3 dealing with Drinking Water Materials
Behaviour and in liaison with EG-CPDW subgroups (1,2,3,4).

The work structure of CEN/TC 164 WG3 breaking down in:

- AHG1 - subgroup,developing Organoleptic Tests
- AHG2 - subgroup,developing test for NMIM
- AHG3 - subgroup,developing Microbial Growth Test
- AHG5 - subgroup,developing MM tests
- AHG6 - subgroup,developing Cementitious tests
- AHG7 - subgroup,developing GC/MS analyses methods for unsuspected substances.

Among other CEN/CT 164 WGn , WG10 has to be also quoted because dealing with product standards of Tanks and Boilers for cold and hot water inside buildings.

For the harmonized product standards the Mandate indicated :

- The Products/Materials to be covered
- The Product performance Characteristics (Essential Requirements)
- The System of Attestation of Conformity

The harmonized product standards will have a Z/A annex for Essential Requirements
(CPD 89/106/EC), also giving details of the attestation of conformity system (1+) and product marking requirements. It is not clear at present how the detailed and complex testing and approval procedures are to be incorporated into product standards

12. EAS and IEI contribution and strategy
IEI has been participating at the works of EAS as Observer on behalf of the European Enamelling Industry at RG-CPDW from the very beginning.

Several Working documents were   developed aiming at showing Vitreous Enamel Fitness for contact with water for human consumption.

When EG-CPDW replaced RG-CPDW, IEI sitting in

- SG3 - NMIM as Expert of Glassy Material/Vitreous enamel

- SG4 - AMLP as liaison for SG3 and expert for Hot Waters Heaters.

IEI strategy has been to develop working documents to support:

- a Vitreous Enamel Oxide Composition List
- an Accepted Without Testing procedure 
- a Reduced Assessment Product approach for water heaters

Nowdays, IEI admitted to present working documents directly at EG-CPDW plenary meeting ,for   

discussion, guidelines before EG-CPDW submitting it to SCC for decisions, support and implementation.

Very soon, IEI will present a Migration test study of 10 Hot Water Tank Enamels to EG-CPDW to prove fitness of V.E. for drinking water contact in support of above reported strategy

Bibliography end previous CPDW Documentation on Vitreous Enamels:

  1. RG-CPDW 115:   Comments concerning Enamelled Products
  2. RG-CPDW 123: "Comparative Bacteriological Studies";
  3. RG-CPDW 165: "Detailed Boiler Presentation"
  4. CEN/TC164/WG3, document N 617: "WG3 Matrix".
  5. EG-CPDW 200, 'RG-CPDW186 Final EAS
  6. EG-CPDW 223 'Glassy Material - EAS Approach Proposal I.E.I. Working Document".
  1. Revised Mandate M 136 to CEN/CENELEC - Brussel, March,2006- G3 RK D (2005)
  2. TG-CPDW 06-007 (RS 036 rev.5) "Accepted Without Testing /Without further Testing (draft) Procedural Aspects."
List of Abbreviations
Acronym Full Name
ACL Approved Constituent Llist for the European Acceptance Scheme
ATP Adenosine Tri-Phosphate
AoC   Attestation of Conformity; refers to the CPD system for attesting the conformity of construction products to European Technical Specifications
AWT-AWFT Accepted Without Testing-Accepted   Without Further Testing
CEN Comité Européen de Normalisation (European Committee for Standardisation)
CL Composition Lists for the European Acceptance   Scheme
CPD Construction Product Directive (Directive 89/106/EC)
CPDW   Construction Products in contact with Drinking Water
DG Directorate General of European Commission
DWD Drinking Water Directive (Directive 98/83/EC)
EAS European Acceptance   Scheme for CPDW
EC European Commission
EFSA European Food Safety Authority
EN European Standard
EG-PDW Experts Group on CPDW
EOTA European Organisation for Technical Approvals
EMG Enhanced Microbial Growth
ETA European Technical Approval
EU European Union
FPC Factory Production Control
GCMS Gas Chromatography Mass Spectrometry - (analytical technique for identifying chemicals in leachates)
GNB Group of Notified Bodies
hEN harmonised European Standard
ITT Initial Type Testing
MS Member State of the EU
MTC Maximum Tolerable Concentration
NAS National Acceptance Scheme for construction products in contact with drinking water
NB Notified Body (i.e. certification, inspection or testing bodies)
NCB Notified Certification Body
NOAEL No Observed Adverse Effect Level
NPD No Performance Determined
NTL Notified Testing Laboratory
OCL   Oxide Composition List of Vitreous Enamels for European Acceptance Scheme
PL Positive List for the European Acceptance Scheme
RG-CPDW Regulators Group on CPDW
RT Residential Time
SCC Standing Committee on Construction (CPD Article 19)
SCDW Standing Committee on Drinking Water (DWD Article 12)
SCHER Scientific Committee on Health and Environment Risks
SG1-OM Experts Subgroup 1- Organic Materials
SG2-MM

Experts Subgroup 2 - Metallic Materials

SG3-NMIM Expert s Subgroup 3 - Non-Metallic Inorganic Materials (including Glassy Materials)

SG4-AMLP Experts Subgroup 4- Assembled Multi-Layers Products
S/V Surface vs. Volume Rate
TC Technical Committees of CEN
TDI Tolerable Daily Intake
TOC Total Organic Carbon
UAP Unique Acceptance Procedure
WHO World Health Organisation
CAS Chemical Abstracts Service
EINECS European Inventory of Existing Commercial Chemical Substances
p.p.b. Parts per billion equivalent to ?g/l
HWT Hot Water Tank (= Water Heater = Boiler)
MAC Maximum Allowed Concentration
M n T Migration Rate at T°C for n th   period
HSM Hot Stage Microscope
n.a. not available
n.r. not reported


A few Useful Definitions
Term Definition
Vitreous Enamel /Porcelain Enamel B orosilicate glassy structured material, whose chemical composition can be expressed   only in term of oxide com-position and is almost insoluble in water because all elements are linked mainly with covalent   chemical bonds V.E./P.E. defined by:
•  EINECS N. 266-047- 6;
•  CAS N. 65997-18- 4.
Oxide Composition List List of components/oxides that have been accepted for use in glassy or metallic products (Vitreous Enamels) with respect to toxicological, organoleptic, migration of metals and hygienic characteristics.

Accepted Without Testing
(AWT)

P roduct or material that is accepted as being fit for use in contact with drinking water due to its composition and other requirements placed on the product/material; obviating the need for testing of the finished product/material
NOTE This concept is applied to cementitious , glassy and metallic materials
Accepted Without Further Testing (AWFT) Product, material or constituent that has been tested and has been   shown to be sufficiently below the limits in this EAS to be accepted without further testing
NOTE See text of EAS for criteria

Single Material   Product

Product made with one single homogeneous   material. Such products are relatively straightforward to test, using either the product itself, or a representative sample in the case of a large item.

Assembled   Product These products comprise two or more components, possibly of different materials. Where the components are of different materials, it may be necessary to separately measure their impacts on water quality. This may require the product to be dismantled , but in some situations it will be proper to test the complete unit in its intended conditions of use.

Multi-Layers   Product
(including Coatings)

Product made with more than one layer.
Where there is a foreseeable   possibility that the layers not initially intended to be in contact with water may - within the expected life of the product ,eventually have an impact on water quality, each layer should be independently tested. (This situation might arise from migration through layers, or by the long-term deterioration of the layer intended to be in contact.) Where such an indirect action is not possible, e.g. because of the existence of a functional barrier (es. V.E.), the layers that will not be in contact need not be tested .
Water Heater / Boiler/Hot Water Tank Factory made product intended to produce   and store hot water in buildings merging the indoor drinking water   distribution system . The hot water is produced by means of electricity, gas or fuels   and/or indirect exchange hot fluids.  
Substance Chemical or mixture of related chemicals used to make a material
Constituent Ingredient used to make a material or product
Material Prepared form of a substance, or of a combination of substances, suitable for use in a manufacturing process
Material type Category of materials of similar physical/chemical characteristics (e.g. organic, metallic, vitreous enamels).
Product Item made from a material or combination of materials or material types, in the form in which it is placed on the market

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