ANNEX II
Review of National Regulatory Approval/Certification Schemes for Products
for use with Water Intended for Human Consumption (drinking water)
Version 1
1st April 2008
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Contents
Section
Tables
Title
1
Introduction
2
Regulatory Issues, including approval/certification systems
1
Products covered and basis of assessment
2
Regulatory aspects
3
Approved products: Audit and re-assessment requirements
3
Organic Materials/Products
4
Current methods of leachate preparation
5
Basis of current analytical methods used
6
Organoleptic assessment: sample rinsing and leachate preparation
7
Organoleptic assessment: odour and flavour – analysis
8
Organoleptic assessment: appearance – analysis
9
Migration studies: sample rinsing and leachate preparation
10
Migration studies: Evaluation of test results
11
Migration studies: existing Member State conversion factors
4
Metallic Materials/Products
12
5
Metallic materials requirements
Cementitious Materials/Products
13
Cementitious product requirements – in preparation
1
Introduction
Several previous attempts have been made to gather together details of the established approval systems for products used in contact with water intended for
human consumption (drinking water), as currently operated within EU Member States. These studies have failed to cover all aspects and details of the existing
established regulatory schemes within these Member States 1 .
TPF
FPT
In October 2007 the Commission asked Member State Drinking Water Regulators from France, Germany, the Netherlands and UK, together with the CEN Water
Rapporteur, to consider the potential for “harmonisation” of those schemes currently operated by these four Member States for the approval of products for use with
drinking water. With the full co-operation of all four Member States Drinking Water Regulators, together with detailed scientific and technical input from their
respective technical experts, the following set of tables has now been assembled covering all aspects of the existing approval scheme, together with possible ways
forward to achieve, at least in the first instance, harmonisation of test practices.
These sets of table are divided into four sections –
•
Comparison of Regulatory approval & certification systems (Tables 1 to 3) – these tables provide an overview of how the approval schemes are
operated in the respective Member States, including the products covered, how they are tested, what is the involvement of the National Regulator and
associated bodies in the various parts of the process, and how approved products are audited. Note – consideration has not yet been given to how requests
for changes in products are currently handled by Member States.
•
Current testing details for products containing organic materials (Tables 4 to 11) – these tables set out the similarities and differences between the
approaches adopted to the testing of products (or components of assembled products) made from organic materials in contact with drinking water in France,
Germany, the Netherlands, and in the United Kingdom, and include a set of common proposals aimed at providing the basis for the harmonisation of existing
test practices in the four Member States. These tables reflect the three steps in the evaluation of these products –
1) sample rinsing and leachate preparation
2) analytical methods used for test leachates
3) evaluation of test results (including conversion of test results) against Member State acceptance criteria
•
Current requirements for metallic materials (Table 12) – this table covers requirements for products containing metallic materials. At present each of the
4 Member States has some requirement(s) concerning the composition of metallic materials used for products in contact with drinking water. Additionally
Germany has specific requirements on the composition of the specific drinking waters suitable for use with certain metallic material types, and a test
procedure to approve compositions of metallic materials for their use in products in contact with drinking water; recently, the first part of a series of new CEN
standards for the long-term assessment of metallic materials (EN 15664-1), based on the German test, has been published.
•
Current testing details for Cementitious materials/products (Table 13). Currently the comparison of the approach to testing of these products/materials
in the four Member States is being collated.
To simplify the use of these tables, different colours have been applied for the requirements in each Member State. Where the Member State Regulators have
agreed on a common proposal for future work, or on areas where further agreement is still needed, these are highlighted in bold red text within Tables 6 to 10
inclusive, and the appropriate table notes.
TP
1
The most comprehensive study to date is that of Fielding, Rogers and Wilson (Effects of Materials on Water Quality: Inventory of European Approval Scheme for products for use in contact with drinking
water – published by WRc-NSF Ltd, 2001).
PT
TABLE 1
PRODUCTS COVERED AND BASIS OF ASSESSMENT
Member
State
Products covered
France
All
Responsible Body 1
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Health Ministry (DGS)
“Notified” (by DGS)
laboratories (4 labs)
Based on which national
laws/regulation
Basic (test) requirements
Drinking water regulation
(Code de la Santé
Publique, latest revision in
2007)
AS set in regulation (PL, compositions
lists, test requirements, pass/fail criteria)
Arrêté du 29 mai 1997
Arrêtés du 24 juin 1998,
13 janvier 2000, 22 août
2002 et du 16 septembre
2004
(See EG CPDW 225 for
exhaustive list of texts)
Approval /
Certification 2
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French standards for testing (fitness for
contact with DW) :
XP P 41250, parts 1 to 3 (organolpetic
parameters, general migration and
cytotoxicity for organic materials)
XP P 41 250, parts 1 to 3 organolpetic
parameters, general migration and
cytotoxicity for cementitious materials)
XP P 41280 for ancillaries (to be
published)
Cementitious materials: present regulation
only based on composition criteria,
without testing requirement. Revised
assessment rules, including testing are
being developed.
Metallic materials : no testing
requirements, assessment based only on
composition rules
Germany
All
Based on a formulation check
plus testing, if required.
- Umweltbundesamt (UBA):
KTW-Guidelines (gov.)
- DVGW: standards (priv.)
- DIN: standards (priv.)
Certification body (priv.) –
Deutsche Vereinigung des
Gas- und Wasserfaches
Cert. GmbH (DVGW)
Drinking Water Ordinance
Section 17- Basic
requirements including a
link to the “generally
acknowledge technical
standards”
DVGW product standards include
hygienic requirements as:
• KTW-Guideline (UBA) for organic
materials
http://www.umweltbundesamt.de/wass
er-e/themen/drinkingwater/pruefleitlinie.htm
• DVGW W 270 (Microbial growth)
• DIN 50930-6 for metallic materials
• DVGW W 347 for cementitious
materials
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Yes
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Member
State
Products covered
The
Netherlands
“All”
Responsible Body 1
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Minister of Spatial Planning,
Housing and Environment VROM - advised by
“Commision of Experts”
Based on a formulation check
plus testing, if required.
List of approved products is
published on www.kiwa.nl/ATA
Non-metallic materials and
products used in building
water systems
United
Kingdom –
England and
Wales
Notified body Kiwa
Certification & Inspection
Water Regulations Advisory
Scheme (WRAS)4
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Based on which national
laws/regulation
Basic (test) requirements
-Drinking Water Decree
Article 4
- Regulation of December
7, 2002, nr.
BWL/2002095022
•
Water Supply (Water
Fittings) Regulations
1999* – Schedule 2,
sections 2 & 3
BS 6920 –
• Odour, flavour, colour and turbidity
• Enhancement of microbial growth
• Leaching of metals and cytotoxic
substances
Approved materials and products
listed by WRAS on their website
- http://www.wras.co.uk/directory/
Similar
requirements
apply in
Scotland & in
Northern
Ireland
HTU
Approval /
Certification 2
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•
(Regulation of December 7, 2002, nr.
BWL/2002095022,
EC notification number 2001/0122/NL,
in revision)
CEN Test methods
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Yes
Products – Yes
(for some
aspects only –
does not
necessarily
cover fitnessfor-purpose)5
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Materials – No
Metallic materials and
products used in building
water systems
Non-metallic products used by
public water suppliers
Drinking Water Inspectorate
(DWI)
Water Supply (Water
Quality) Regulations
20003 P
P
No materials test requirements – testing
limited to mechanical and functional
requirements
The UK does not have a positive list of
ingredients – product ingredients
considered on a case-by-case basis
n/a
1. Small surface area contact,
and/or
transient contact time – see
Advice Sheet 8 –
http://www.dwi.gov.uk/31/pdf/Adv
icesheet8.pdf
Regulation 31(4)(b)
BS 6920 –
• Odour and flavour
• Enhancement of microbial growth
• Leaching of metals if appropriate
No
2. Normal – all other products
Approval process detailed in
Advice Sheet 1 –
http://www.dwi.gov.uk/31/pdf/Adv
icesheet1.pdf
Regulation 31(4)(a)
BS 6920 –
• Odour, flavour, colour and turbidity
• Enhancement of microbial growth
• Leaching of metals and cytotoxic
substances
PLUS
• Total organic carbon (TOC)
• GC-MS General Scan
• Ingredient related specific compounds
on a case-by-case basis.
Note – analytical requirements take into
Approval
given, but no
certification.
Aprpoval is
dependent
upon use in
accordance
with the
“Instructions
for
Use”documen
HTU
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HTU
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The “List of Approved Products”
is published on the DWI website
http://www.dwi.gov.uk/31/approv
edproducts/soslist.shtm
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Member
State
Products covered
Responsible Body 1
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Based on which national
laws/regulation
Basic (test) requirements
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account issues such as water type,
proposed usage, and the detailed
“Instructions for Use” document supplied
to the end-user with the product.
Fitness for purpose assumed, but no test
requirements. See Section 4.3 of Advice
Sheet 8 for specific products.
Metallic products used by
public water suppliers
Approval /
Certification 2
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t issued with
the product,
and does not
include
fitness-forpurpose.
No
HTU
NOTES:
1 - Who sets requirements and who approves /certifies products
2 - includes testing of technical fitness
3 - regulations notified to the Commission
4 - the Water Regulations Advisory Scheme (WRAS) acts on behalf of and is accountable to water suppliers in the UK. The Scheme works to promote knowledge of the Water supply
(Water Fittings) Regulations and their implementation; it is accountable to them. Full details about the Constitution of the Scheme are available from http://www.wras.co.uk/PDF_Files/WRAS%20Constitution%20Issue%206%20Feb%2006.pdf
5 - details of assessment criteria for products and materials are available from the WRAS website - http://www.wras.co.uk/.
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TABLE 2
REGULATORY ASPECTS – APPROVAL SCHEMES
France
STEP
Germany
The Netherlands
United Kingdom
Applicant
Competent
Authority
Notified
Body
Applicant
Competent
Authority
Certification
Body
Applicant
Competent
Authority
Notified
Body
Applicant
Competent Authority
(DWI)
See
Note 1
1. Application, full
formulation, production
process details
X
-
-
X
-
-
X
-
-
X – results
of
preliminary
testing to
BS 6920
also
submitted
-
-
2. Check on details of
application
-
-
X
-
-
X
-
-
X
-
X
-
3.1 – F, D, NL. Check on
compliance with Regulations
(eg. PL, CL, ACL)
-
-
X
-
-
Test lab
-
X
-
-
Not required – no
PL etc.
-
3.1 – UK. Obtain expert
toxicological advice on any
ingredients of concern to
health
-
-
-
-
-
-
-
-
-
-
X
-
3.2. Assessment protocol in
case of non-compliance with
regulations (eg PL, CL, ACL)
-
-
-
-
-
-
-
X
-
-
No requirement
-
4. Pre certificate auditing of
factory products control
system and sampling of
initial type testing
-
-
-
-
-
X
-
-
X
-
No requirement –
test samples
submitted by
applicant to
designated test
laboratory. Details
of manufacturer’s
quality system
required.
-
5. Laying down of test
protocol
-
-
X
-
X–
Product
standards
(DVGW –
standards
incl. UBA
guidelines,
DIN
standards)
-
X
X
-
X
-
6. Initial type testing
-
Test lab
-
DWI and experts
UBA
guidelines
-
X
-
-
General tests plus
specific ingredients
on basis of
toxicological
Review
-
X
-
X
DWI designated
test laboratories
-
France
STEP
7. Report of test results
Germany
The Netherlands
United Kingdom
Applicant
Competent
Authority
Notified
Body
Applicant
Competent
Authority
Certification
Body
Applicant
Competent
Authority
Notified
Body
Applicant
-
-
X
-
-
Test lab
-
-
X
-
Competent Authority
(DWI)
See
Note 1
X
-
Sent to DWI by test
laboratory
8. Evaluation of test results.
Check against acceptance
levels
-
-
-
-
-
Test lab +
certifying
body
-
-
X
-
No fixed
assessment levels
– results reviewed
by toxicological
experts & reported
to DWI
-
9. Certification with logo
-
-
No
certification
-
-
X
-
-
X
-
No certification –
approval letter, with
approval
conditions, issued
by DWI
-
No logo
Sanitary
attestation
(ACS)
10. Protocol post certificate
auditing
Voluntary
-
-
-
-
X
-
-
X
-
No requirement
-
11. Post certificate auditing
(audit testing)
Voluntary
-
-
-
-
X
-
-
X
-
No requirement
-
-
X
-
-
-
X
-
-
-
-
X – on DWI
website – see note
2
-
12. Public listing of
approved products
NOTES.
1 – the UK does not have either a notified body or certification authority involved in these product approvals; the Drinking Water Inspectorate carries out most of these functions,
relating to the approval of CPDWs.
2 – the UK list of approved products is available at – http://www.dwi.gov.uk/31/approvedproducts/soslist.shtm
HTU
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TABLE 3
APPROVED PRODUCTS: AUDIT & RE-ASSESSMENT REQUIREMENTS
Country
Validity/Duration of
Approvals
(years)
France
5 years
French ACS does not include audit
procedure
Basis of Retesting
Complete or limited retesting depending on changes in the formulation.
Any change in the 5 years validity period must also be submitted to the laboratory
(10 years for NF
certified PE pipes)
Circulaire DGS/VS 4 n°2000-232 du 27 avril 2000 – gives a list of possible changes and re-testing
procedures.
T
5 (+5) years
(KTW guideline test
report)
Germany
12 months
The Netherlands
Ministerial Regulation of December 7,
2002, nr. BWL/2002095022,
T
A third party (DVGW) certifies products. The certifying process includes also technical requirements and
depends on the product.
Attestation of Conformity: level 1 (including treatment chemicals) - according to Commission Decision
2002/359 and chapter 4 of the Ministerial Regulation including :
1. Prototype testing
Testing of samples taken by auditor (TOC, odour-flavour-colour assessment, specific determinands)
Pre-certification audit
Factory Producton Control (FPC) check by auditor raw materials (recipe or formulation); production process; test equipment; internal transport and storage;
management of complaints; responsibilities of staff; obilgation to report any change in the composition of
the product
EC notification number 2001/0122/NL
2. Post-certification (annually)
Audit of FPC; check on chemical composition of the product; full product-retesting of samples taken by
auditor during the audit visit (TOC, odour-flavour-colour assessment, specific determinands)
3. Reporting of results to producer /supplier.
4. Annual reporting of all audit results to the Ministry of Spatial Planning, Housing and Environment.
5. In case of nonconformities: measures will be taken ranging from an official warning to immediate
withdrawal of the approval
United Kingdom
BS 6920
Regulation 31
leachate study
5 years
No current requirement
Submission of details of any changes, followed by limited re-testing – usually odour and flavour
assessment, plus any other test that gave a “border-line” response at the previous test period.
All original approvals, more than 5 years old, have now been audited – this involved a factory surveillance
visit and subsequent limited testing of samples taken during the visit, and review of the Instructions for Use.
It was assumed that the EAS audit requirements would follow on from this initial audit.
Note: we are currently considering further follow-up actions to this audit process.
TABLE 4
CURRENT METHODS OF LEACHATE PREPARATION (2007)
Determinand(s)
France
Germany
The Netherlands
U.K.
odour
XP P41250-1
EN 1420-1 or EN
14395-1
EN 1420-1 or EN
14395-1
BS 6920-2.2
flavour
XP P41250-1
EN 1420-1 or EN
14395-1
EN 1420-1 or EN
14395-1
BS 6920-2.2
PH
-
-
-
-
conductivity
-
-
-
-
nitrites
-
-
-
-
ammonia
-
-
-
-
Kjeldahl nitrogen
-
-
-
-
permanganate value
-
-
-
-
total organic carbon
XP P41250-2
EN 12873-1 or 2
EN 12873- 1 or 2
EN 12873-1 or 2
Chlorine demand
XP P41250-1
-
-
-
colour
-
EN 12873-1 or 2
EN 13052-1*
BS 6920-2.3
turbidity
-
EN 12873-1 or 2
EN 13052-1*
BS 6920-2.3
aluminium
XP 41250-2
+
+
BS 6920-2.6
antimony
XP 41250-2
+
+
BS 6920-2.6
arsenic
XP 41250-2
+
+
BS 6920-2.6
barium
-
+
+
BS 6920-2.6
cadmium
XP 41250-2
+
+
BS 6920-2.6
chromium
XP 41250-2
+
+
BS 6920-2.6
copper
-
+
+
-
iron
-
+
+
BS 6920-2.6
lead
XP 41250-2
+
+
BS 6920-2.6
mercury
XP 41250-2
+
+
BS 6920-2.6
nickel
XP 41250-2
+
+
BS 6920-2.6
selenium
XP 41250-2
+
+
BS 6920-2.6
silver
-
+
+
-
Tin
-
+
+
-
zinc
-
+
+
-
PAHs
XP P41250-2
+
+
-
organic solvents
XP P41250-2
+
+
-
plasticisers
XP P41250-2
+
+
-
THMs
XP P41250-2
+
+
-
VCM (PVC-U)
XP P41250-2
+
EN 12873-1 or 2
-
-
DVGW W 270(A)
NVN 1225**
BS 6920-2.4
cytotoxicity
XP P41250-3
-
-
BS 6920-2.5
GC-MS general survey
XP P41250-2
Under consideration
Under consideration
EN 12873-1 or 2
Product/formuation related
determinands
XP P41250-2
EN 12873-1 or 2+
EN 12873-1 or 2
EN 12873-1 or 2
Microbial growth
Notes:
The Netherlands –
* - For the reason of avoiding extra costs, in practice EN 12873-1 is used
** - Not applied yet.
Germany and the Netherlands –
+ - EN 12873-1 or 2 applied if substances present in the formulation
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TABLE 5
BASIS* OF THE CURRENT ANALYTICAL METHODS USED
Determinand(s)
France
Germany
The Netherlands
U.K.
odour
EN 1622
EN 1622
EN 1622
BS 6920-2.2
flavour
EN 1622
EN 1622
EN 1622
BS 6920-2.2
pH
-
-
-
-
conductivity
-
-
-
-
nitrites
-
-
-
-
ammonia
-
-
-
-
Kjeldahl nitrogen
-
-
-
-
permanganate value
-
-
-
-
total organic carbon
EN 1484
EN 1484
EN 1484
EN 1484 1
chlorine demand
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EN ISO 7393-2
-
-
-
colour
-
Visual comparison
EN ISO 7887, Section 4
EN ISO 7887: section 4
turbidity
-
Visual comparison
EN ISO 7027
EN ISO 7027
EN 11885 (2)
+
+
aluminium
antimony
EN 17294-2/EN 15886 (2)
+
1
P
P
+
1
1
arsenic
EN 17294-2/EN 15886 (2)
+
+
barium
-
+
+
P
P
P
P
1
P
P
cadmium
EN 17294-2/EN 15886 (2)
+
+
1
chromium
EN 17294-2/EN 15886 (2)
+
+
-
-
+
+
-
+
1
copper
iron
-
+
P
P
P
P
lead
EN 17294-2/EN 15886 (2)
+
+
1
mercury
EN 17294-2/EN 15886 (2)
+
+
1
1
P
P
P
P
nickel
EN 17294-2/EN 15886 (2)
+
+
selenium
EN 17294-2/EN 15886 (2)
+
+
silver
-
+
+
-
tin
-
+
+
-
zinc
-
+
+
-
EN 17993
+
+
-
EN 11423-1, XP P41250-2
+
+
-
EN 6468 (PCBs)
+
+
-
EN 10301
+
+
-
PAHs
organic solvents
plasticisers
THMs
P
P
1
P
P
VCM (PVC-U)
-
+
Specifically developed
-
Microbial growth
-
DVGW W270 (A)
NVN 12253
BS 6920-2.4
cytotoxicity
XP P41250-3
-
-
GC-MS general survey
XP P41250-2
-
Under consideration
BS 6920-4
-
Either existing methods,
or developed for the
specific determinand
Either existing methods,
or developed for the
specific determinand
Either existing methods,
or developed for the
specific determinand
Product/formuation related
determinands
P
P
BS 6920-2.5
NOTES:
* – deviations from the published methods are noted elsewhere
+ - Germany and the Netherlands – either existing methods or developed if the specific substances present in the formulation
1 – UK - test laboratories free to use BS or BS EN methods, Standing Committee of Analysis (SCA) methods for the water industry, or other
suitable methods capable of equivalent or better performance.
2 – France - other methods can be used provided they have equivalent or better performance
3 – the Netherlands – not applied yet
TABLE 6
ORGANOLEPTIC ASSESSMENT: SAMPLE RINSING & LEACHATE PREPARATION (*CEN Standards EN 1420-1, EN 13052-1 & EN 14395-1)
Process
Pre-test sample
treatment
France
Germany
The Netherlands
UK
Common proposal
1 h in flowing tap water,
24 h in chlorine free test
water + 3 test water
rinses
(1 sample with
disinfection treatment 50 mg Cl2/l)
As in EN 1420-1(*) - except
no pre-test disinfection
treatment
Flushing: 1 h
Stagnation: 24 h
Flushing: 1 h
As in EN 1420-1 (*),
except no pre-test
disinfection treatment
used. One specimen of
the product is prepared for
a single migration test.
As in BS 6920-2.2.1 - 10
minutes rinse in test water
As in EN 1420-1 (*).
UK and France to work on
making the change from their
current methods. Provide
clarification on pre-test
treatments.
B
B
Agreement to request removal
of pre-test disinfection option
from the standard and to
combine EN 1420-1 with EN
13052-1 & 14395-1, plus new
test sample requirements for
(g)
Site Applied Products
P
Test Water
Number of test
samples/leachate
series tested
Glass bottled mineral
water
1. Chlorine free
2. Chlorinated (1 mg/l)
Chlorine-free tap water
Single testing in each
water type
As in EN 1420-1(*).Duplicate
+ blank test
0.03 to 2.4 dm
depending on the final
intended use
P
Single testing in each water
type plus blank test as in EN
1420-1 (*) – see general
comment on duplication at the
end of table 6.
As in EN 1420-1 (*) (except
as below – see notes j & k)
Pipes filling: min 2.5 dm-1(k)
Fittings+Ancillaries: 1.5dm-1
Seals: 0.2 dm-1
Tanks: 2.5 dm-1 (j)
Pipes & tanks: 5-40 dm-1(i)
Fittings:
Sealings:
1.5 dm-1
As in EN 1420-1 (*).
Clarification on precision may
be required
(via guidance). For pipes this is
determined solely by the
(f)
internal diameter.
As in EN 1420-1 (*) (except
as below – see note h)
3 x 72 hours (23°C)
plus, if required
3x24h , 1x72h and 3x24h (h)
at either 60 or 85°C(c)
3 x 72 hours (23°C)
or
3 X 24 hours (either 60 or
85°C)(d)
3 x 24 hours
1 x 72 hours
3 x 24 hours (cold water)
Cold water as in EN 1420-1 (*)
Hot water, where required – to
be decided (e).
As in EN 1420-1 (*) (except
as below – see note h)
All three leachates (23°C)
Leachates 1, 6 & 7 (h) (60 or
85ºC)
All three leachates
1st leachate, and if
necessary, the 7th leachate
All three leachates as in EN
1420-1 (*). Allow option to
assess additional leachates if
required.
4 x 24 hours (20°C)
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
PB
P
B
Notes – see next page
P
P
P
P
P
P
Leaching sequence
P
Duplicate – one for each
water type
P
All 4 leachates (20ºC),
and if necessary the 5th
th
to 7 leachates
Chlorinated and/or chlorine-free
dependent upon individual
Member State – additional
testing may be required (a) if
only chlorine-free test water
used
Single testing – one
leachate series of one
specimen of the product (b)
P
P
Leachates analysed
1. Chorine free tap water
2. Chlorinated (1 mg/l) tap
water
P
-1
S/V test ratio
Chlorine-free tap water
P
P
P
P
P
P
Notes for Table 6
a - this could be requested by the applicant at the time of testing
b - if the specimen fails a second specimen is prepared for the odour and flavour assessment
c - only required if product is used for warm (60°C) and/or hot water (85°C) – only undertaken if cold water test also undertaken
d - not yet decided for the final implementation in the approval system – it is planned to approve the product to be used also for cold water if the product to be
used for hot water has passed for TON/TFN at 85°C
e - when Member States experience of a standard shows problems/concerns then revision/research will be required by CEN – see general background note 1
under Table 4.
f - inserts are not used in the preparation of leachates from pipes for odour and flavour assessment – the smallest diameter of pipes for which approval is required
is used
g - all test sample types would then be covered by one test method, e.g. pipes, tanks, coatings etc.
h - EN 1420-1, 13052-1 and EN 14395-1 specify three 24 hour sequential leaching periods for hot water testing
-1
j - EN 14395-1 specifies an S/V test ratio of 0.5 to 1.0 dm
k - this S/V test ratio differs from the pipe diameter determined variable test ratio specified in EN 1420-1 and may require the use of an arrangement such as that set out in Figure
B.2 of Annex B of EN 12873-1 in order the achieve this increased S/V for large diameter pipes
P
P
TABLE 7
ORGANOLEPTIC ASSESSMENT: ODOUR & FLAVOUR – ANALYSIS
France
Germany
The Netherlands
UK
Common Proposal
Test method – EN 1622
Test method - EN 1622
Test methods: EN 1622
TON < 2
Paired test with unforced
choice;
minimum 3 panellists
Paired test with forced choice,
8 panellists
Test method – BS
6920-2.2
EN 1622, using one method of
assessment, e.g. paired unforced
OR paired forced*.
Determinand
Odour
th
After the 4 test period
th
or after the 7 test
period if a decrease of
TFN is observed
P
P
P
P
rd
TON < 2 for 3 test period
(23°C)
P
P
P
P
th
TON ≤ 4 for 7 test period (60
and 85°C)
(corresponds to TON < 16)
Test method – EN 1622
Test method - EN 1622
Test methods: EN1622
TFN < 2
Paired test with unforced
choice;
minimum 3 panellists
Paired test with forced choice,
8 panellists
P
P
Flavour
≤ 5 panellists select the 15-fold
diluted leachate of the 3rd period as
the sample with the biggest odour
th
After the 4 test period
th
or after the 7 test
period if a decrease of
TFN is observed
P
P
P
P
TON < 2 for 3rd test period
(23°C)
P
P
th
TON ≤ 4 for 7 test period (60
and 85°C)
P
P
Final leachates
(extracts)
free from odour
≤ 5 panellists select the 15-fold
diluted leachate of the 3rd period as
the sample with the biggest odour
P
P
(corresponds to TFN < 16)
Test method – BS
6920-2.2
First 1:1 dilution of final
leachates (extracts)
free from flavour
Interpretation of results and
choice of method determined by
National Requirements.*
Further work needed to
harmonise the results, including
the method for choice of
assessors, and possible
inclusion of AQC into the
assessment method.
Views of CEN TC164/WG3/AHG1
to be sought.
Amend EN 1420-1 to specify the
precise test conditions in EN
1622 to be applied to product
leachates, e.g. unforced paired
test.
General Background Notes on Organoleptic Assessments.
1. Hot water testing – national practices –
a. France – no clear policy at present
b. Germany – Products for warm (60°C) and hot (85°C) have to be tested with hot or warm water plus with cold water. The reason for this is that high volatile
substances causing odour or taste may only be present in the cold migration water.
c. The Netherlands – only required if product is used for warm (60°C) and/or hot water (85°C) – only undertaken if cold water test also undertaken. It is
currently planned to approve a product to be used at a lower water temperature if the product to be used has been tested and has passed TON/TFN at a higher
temperature, e.g. satisfactory test results at 85ºC will mean it is also acceptable for warm and cold water (60 and 23ºC), but has to be tested at 85ºC if it is also
planned to be used in hot water (85ºC).
d. UK – Evidence gained over 25 years of using the BS 6920 organoleptic test assessment methods clearly shows that if a product fails for odour and flavour
under cold water conditions, it will also fail under the more demanding hot water conditions test , and usually to a far greater extent. We have no evidence that
products that meet the hot water test requirements of BS 6920 (Part 3 – hot water tests) will give any failures in cold water tests. On this basis, if a
material/product has been tested using hot water (between 30 and 85ºC permitted) it is treated as suitable for use at any LOWER temperature. Thus a
satisfactory test outcome using water at 85ºC would cover use at all lower temperatures.
Continued ……
2. Testing of duplicates – UK practice.
There is concern about the numbers of test sample leachates that can be assessed for odour and flavour in any one day by a panel of assessors, before fatigue
is encountered and the value of the results obtained diminished. Therefore, for organisational reasons, the UK adopted single testing of product leachates,
prepared using test water with and without added chlorine. The use of chlorinated water, in addition to chlorine-free test water, effectively supplies duplicate test
results for all materials/product, apart from those that can leach substances into water that can react with chlorine to produce additional odours and flavours.
Testing of duplicates – common proposal
This still needs to be clarified, In particular, for one test sample (which could be made up of several test pieces) –
a. are leachates to be prepared in duplicate for each test water type, or will only one leachate be prepared for each test water type?
b. will the analysis be carried out in duplicate on each leachate, or will a single analysis on each leachate be adequate?
TABLE 8
ORGANOLEPTIC ASSESSMENT: APPEARANCE – ANALYSIS.
France
Germany
The Netherlands
Determinand
Colour
UK
Common Proposal
BS 6920 appearance test
-
Visual observation - no
increase compared with
the test water
Test method: EN-ISO 7887
section 4
Any increase limited to 10
mg/l Pt/Co
Test method – BS 6920-2.3
Any increase limited to <5
Hazen units
Use EN ISO 7887, using one
method of test*. National
Regulators to set MS
requirements, including test
method to be used.*
Revise EN 13052-1 and
14395-1 to specify section 4
of EN-ISO 7887, as currently
used in the Netherlands and
the UK, or agree that all MSs
shall use the more
demanding (costly) three
wavelength method specified
in Section 3 of EN-ISO 7887.
Turbidity
Foaming
-
-
Note * - the DWD states “no change”
Visual observation – no
increase compared with
the test water
Test method: EN-ISO 7027
Visual observation - no
increase compared with
the test water
Not required
Any increase limited to 1
FTE
Test method – BS 6920-2.3
Any increase limited to <0.5
FTU
Use EN ISO 7027 – National
Regulators to set MS
requirements*
Not currently required in
the UK but has been
considered as a future test
requirement.
Currently only required by
Germany – can give a useful
(quick and cheap) indication
of gross migration of organic
substances into water.
TABLE 9
MIGRATION STUDIES: SAMPLE RINSING & LEACHATE PREPARATION
Process
France
Germany
The Netherlands
UK
Common proposal
Pre-test sample
treatment
1 h in flowing tap water,
24 h in chlorine free test
water + 3 test water
rinses (1 sample with
disinfection treatment 24 h in 50 mg Cl2/l)
As in EN 12873-1&2,
except no pre-test
disinfection treatment.
As in EN 12873-1& 2,
except no pre-test
disinfection treatment
used.
As in EN 12873 series of
standards, except no pretest disinfection treatment
used.
As in EN 12873-1 & 2
1. Chlorine free
demineralised water
2. Chlorinated (1 mg/l)
Chlorine-free ultrapure
water
Chlorine-free ultrapure
water
1. Chorine free ultrapure
2. Chlorinated (1 mg/l)
ultrapure water
Chlorinated and or chlorinefree dependent upon individual
Member State – additional
testing may be required (a) if
only chlorine-free test water
used
B
Test Water
Amend standards to remove
pre-test disinfection option.
B
P
Number of test
samples tested
Single testing for each
water type
plus blank test
As in EN 12873-1&2
Duplicate + blank test
S/V test ratio
0.03 to 2.4 dm-1
depending on final
intended use
As in EN 12873-1&2
1
Pipes filling: min 5 dm
Fittings+Ancillaries: 5 dm-1
Sealings: 5 dm-1
Tanks: 5 dm-1
P
P
Duplicate
Duplicate – one for each
water type – see comment
below
Duplicate testing for each
water type except for GC-MS
Pipes: 5 – 40 dm-1
-1
Fittings: 2.5 dm
Sealings: 1 volume of
sealing material + 10
volumes of water
Tanks: 5 – 40 dm-1
As in the BS EN 12873
standards
As in EN 12873-1 & 2
As in EN 12873-1&2
3 x 72 hours (23°C)
plus, if required (b),
3x24h, 1x72h, 3x24 h
(60 or 85°C) (e)
3 x 72 hours (23°C)
(c)
or
3 x 24 hours (85°C)
As in EN 12873 – i.e.
three sequential 72 hour
contact periods – cold
water only. The UK does
not currently do hot water
migration studies on
products.
As in EN 12873-1 & 2
As in EN 12873-1&2
All 3 leachates (23°C)
Leachates 1, 6 & 7 (60 or
85°C) – also leachates 2
and 3 for TOC
All 3 leachates
All 3 leachates
As in EN 12873-1 & 2 – further
leachates (maximum 7 extra)
tested, if required, for die-away
studies.
P
P
P
P
P
B
PB
P
P
P
P
P
P
P
Leaching sequence
1 x 24 hours (20ºC)
P
P
Leachates analysed
Analysis
Notes – see next page
1st for all determinands
P
P
P
P
P
P
P
P
P
(d)
P
(f)
P
See General Background Note
1 under Table 4 concerning hot
water testing.
See Table 5
Notes for Table 9
a – this could be requested by the applicant at the time of testing
b - only required if product is used for warm (60°C) and/or hot water (85°C)
c - not yet decided; it is planned to approve the product to be used also for cold water if the product to be used for hot water has passed for hot water (85°C)
d - if concentrations of specific determinands in the leachate (migration water) show a decrease from 1st to 3rd migration period it is allowed to use a correction
by 0.1 of the concentration of specific determinands in leachate (migration water) of the 3rd migration period to determine the virtual concentration of the specific
determinand in the leachate (migration water) after 10 migration periods.
P
P
P
P
P
P
e - only required if product is used for warm (60°C) and/or hot water (85°C) – only undertaken if cold water test also undertaken
f – these standards state what leachates are analysed – Annex C demonstrated how this could be achieved, but this will change with laboratory operational
requirements, sample preparation and curing regimes etc.
g – further consideration is required concerning the need of a cytotoxicity test and of the appropriate method(s) for assessing the enhancement of
microbial growth test
Testing of duplicates – UK practice.
Interpretation of results from the GC-MS general survey can be very time-consuming for some products/materials types (several man-days). Therefore, to keep
costs to a reasonable level, the UK has adopted the principle of only preparing and analysing two leachates, one prepared with chlorine-free test water and one
prepared using chlorinated test water. To do each of these tests in duplicate could add significant costs to this work, with little justifiable result.
Testing of duplicates – common proposal
This still needs to be clarified, In particular, for one test sample (which could be made up of several test pieces) –
a. are leachates to be prepared in duplicate for each test water type, or will only one leachate be prepared for each test water type?
b. will the analysis be carried out in duplicate on each leachate, or will a single analysis on each leachate be adequate?
TABLE 10
MIGRATION STUDIES: EVALUATION OF TEST RESULTS
France
Conversion of
measured
concentrations
No requirement, since the
tests are performed at
“realistic” surface area to
volume test ratios.
Germany
The Netherlands
FC
S
V t
c tap = c
c tap = c
Where:
t: stagnation time in the
migration test
t: stagnation time in the
migration test
B
c: measured concentration
of the migration water
FC: conversion factor
B
B
Conversion factors
FC see separate table
B
Acceptable increasing of
the analysed leachates:
defined in circular date 12
April 1999.
TOC: 1 mg/l
GC-MS screening: 1 µg/l
Sum parameters
Individual
substances
according to the
Positive Lists
No requirement
S/V: surface to volume in
the migration test
B
1.
B
B
B
Regulatory issues to be
decided by the national
regulators –
P
P
B
FC see separate table
Guidance – good
practice
B
No requirement
B
Ctap ≤DWPLL
ctap ≤ DWPLL
B
B
B
B
Presence of any
substance of concern [or
unknown or unsuspected
substance(s) identified in
the GC-MS general
survey] in product
leachates could lead to
refusal of approval of the
product, on a case-bycase basis.
B
for the last migration period
(3rd for 23°C, 7th for 60°C or
80°C)
P
P
P
P
2. no increasing c of the
analysed leachates
TOC-DWPLL: 0.5 mg/l
1. Directive 2002/72/EC
DWPLL = SML/20***
Common Proposal
x 0.1*
Where:
ctap: calculated
concentration at the
tap
c: measured concentration
in the migration
rd
water of the 3
migration period
FC: conversion factor
S/V: surface to volume in
the migration test
ctap: calculated
concentration at the
tap
Requirements
FC
S
V t
UK
Harmonised common
approach
Indication of that such a
scheme could look like
Clear statement of what
is regulatory and what is
technical
TOCtap <2.0 mg/l
B
B
National positive list – **
See comments above
2. Synoptic Document
DWPLL = R(SML)/20***
3. National positive lists
Notes:
*: (NL) - If concentrations of specific determinands in the leachate (migration water) show a decrease from 1st to 3rd migration period it is allowed to use a correction by 0.1 of the
rd
concentration of specific determinands in leachate (migration water) of the 3 migration period to determine the virtual concentration of the specific determinand in the leachate
(migration water) after 10 migration periods.
**: (NL) if substance is not listed on the National Positive List the Group of toxicologist of the Commission of Experts prepares a proposal for the Ministry to decide the assessment
protocol (the so called ‘letter of the Ministry’) - working documents to be used e.g. Directive 2002/72/EC and Synoptic documents (DWPLL= SML/20)
P
P
P
P
P
P
TABLE 11
11.1
MIGRATION STUDIES: EXISTING MEMBER STATE CONVERSION FACTORS
Overview main conversion factors in The Netherlands
Product group
Conversion
factor
FC in d/dm
B
B
A: Storage
Drinking water tanks
Repair systems
0,1
0,0005
B: Distribution
Pipes (trunk mains)
Fittings with ancillaries
Ancillaries
3
0,33
0,033
C: Domestic installation
Domestic main (diameter DN = 20 mm, l = 10 m)
Shut-off valve
Water meter
Drain tap
0,1
1E-05
0,0001
1E-09
Installation pipes (diameter DN 13 mm, ltotaal = 90 m)
Hot water (reservoirs, e.g. kitchen boiler)
Vent and expansion pipe
Surge suppressor
Flexible hose (diameter = 4,6 mm, l = 70 cm)
Faucet (kitchen, bathroom, toilet, etc.)
Tap (others)
Aerator
Shower accessories (included flexible hose, l = 150 cm)
Connector
20
1
0,001
0,1
20
6
0,01
0,1
1
0,0001
B
11.2
B
Product groups with conversion factors in Germany
Product group
Conversion
factor
FC in d/dm
20
10
5
4
2
1
0.4
0.2
0.1
4
B
Pipes of diameter DN < 80 mm (domestic installation)
Pipes of diameter 80 mm ≤ DN < 300 mm (service and distribution pipes)
Pipes of diameter DN ≥ 300 mm (trunk mains)
Fittings and ancillaries for pipes of diameter DN < 80 mm (installation in buildings)
Fittings and ancillaries for pipes of diameter 80 mm ≤ DN < 300 mm (supply pipes)
Fittings and ancillaries for pipes of diameter DN ≥ 300 mm (water mains)
Sealings for pipes of diameter DN < 80 mm (installation in buildings)
Sealings for pipes of diameter 80 mm ≤ DN < 300 mm (supply pipes)
Sealings for pipes of diameter DN ≥ 300 mm (water mains)
Tanks installed in buildings and repair systems for such tanks
Tanks and reservoirs not installed in buildings and repair systems for such tanks and
reservoirs
B
1
TABLE 12
METALLIC MATERIALS REQUIREMENTS
Material
France
(see Note e)
Germany
The Netherlands
(see Note c)
UK
Copper
Yes
Yes
Yes
Copper pipes to conform
with BS EN 1057; copper
fittings with BS EN 1254
Requirements on
composition
Total Impurities < 0,1%
As in EN 1057:
Composition (d):
Copper + Silver: min. 99.9%
0,015% ≤ P ≤ 0.040%
Copper ≥ 99.9 %
Phosphorus ≤ 0.04%
Impurities (total) ≤ 0.1 %
+
residual surface carbon
< 0.1 mg/dm2
P
P
None
Tinned Copper
No
Requirements on
composition
pH ≥ 7.4
P
P
residual surface carbon < 0.2
2
mg/dm
P
Requirements on
composition of
drinking water in
contact with this
material
Common proposal
P
None (b)
None
P
P
or
7.0 ≤ pH < 7.4 and
TOC ≤ 1.5 g/m³
Yes
Pipe:
As in EN 1057
Tin layer:
Tin + Copper ≥ 99,9%
Yes
None
(d)
Composition :
Pipe:
Copper + Tin ≥ 99.9 %
Tin layer:
Tin ≥ 90
Copper < 10 %
P
P
None
Impurities:
Antimony ≤ 0.01%
Arsenic ≤ 0.01%
Bismuth ≤ 0.01%
Cadmium ≤ 0.01%
Chromium ≤ 0.01%
Lead ≤ 0.01%
Nickel ≤ 0.01%
Requirements on
composition of
drinking water in
contact with this
material
None
None
None (b)
P
P
Material
France
(see Note e)
Germany
The Netherlands
(see Note c)
UK
Galvanized Steel
Yes
Only for cold water
Only in combination with
coating/lining (e.g. epoxy or
cementmortar)
No direct contact with
drinking water
None
Requirements on
composition
Lead ≤ 1%
Cadmium ≤ 0,1 %
Tot. (other) impurities < 0,5
%
Antimony ≤ 0.01%
Arsenic ≤ 0.02%
Bismuth ≤ 0.01%
Cadmium ≤ 0.01%
Lead ≤ 0,25%
-
None (b)
KB8,2 ≤ 0.5 mol/m³
-
None
Requirements on
composition of
drinking water in
contact with this
material
Stainless Steel
Requirements on
composition
Not set in the regulation
but in technical documents
(DTU 60.1 / NF P 40-201)
with different restrictions for
cold and hot water
KS4,3 ≥ 1.0 mol/m³
Yes
Yes
Based on regulation for
materials in contact with
th
foodstuff (arrêté of 13
January 1976) :
P
P
Chromium ≥ 13 %
Nickel and Manganese (no
limit value given)
Aluminium ≤ 4.0 %
Copper ≤ 4.0 %
Molybdenum ≤ 4.0 %
Titanium ≤ 4.0 %
B
B
B
Common proposal
P
P
(b)
P
P
B
Yes
Yes
(d)
1.4401
1.4571
1.4404
1.4436
1.4435
Niobium ≤ 1.0 %
Tantalum ≤ 1.0 %
Zirconium ≤ 1.0 %
Composition :
Carbon ≤ 0.08 %
Chromium 16.0-27.0 %
Nickel ≤ 30.0 %
Molybdenum ≤ 7.0 %
Nitrogen ≤ 0.6 %
Titanium ≤ 0.8 %
Niobium ≤ 1.0 %
Copper ≤ 2.5 %
Tungsten ≤ 1.0 %
Phosphorus ≤ 0.045 %
Silicon ≤ 1.5 %
Manganese ≤ 6.5 %
Sulphur ≤ 0.03 %
Selenium: Not specified
Iron: Remainder
P
Yes – a range of approved
grades – Annex 5 of Advice
Sheet 5 http://www.dwi.gov.uk/31/pdf
/Advicesheet5.pdf
P
HT
TH
Impurities:
Antimony ≤ 0.02 %
Arsenic ≤ 0.02 %
Cadmium ≤ 0.02 %
Requirements on
composition of
drinking water in
contact with this
material
None
None
None
None (b)
P
P
Material
France
(see Note e)
Germany
The Netherlands
(see Note c)
UK
Non-alloyed and
Low-alloyed Steel
Fitting and ancillaries
Only when constant throughflow and laminar/turbulent
flow
Only in combination with
coating/lining (e.g. epoxy or
cementmortar)
None
(Only small surfaces in
contact with water)
Common proposal
No direct contact with
drinking water
Requirements on
composition
Molybdenum ≤ 4.0 %
Chromium ≤ 3.0 %
Nickel ≤ 5.0 %
Tot. Other impurities < 0,5 %
-
None (b)
c(O2) > 3 g/m³
pH > 7
KS4.3 > 2 mol/m³
c(Ca) > 0.5 mol/m³
-
None
(b)
(b)
P
P
Requirements on
composition of
drinking water in
contact with this
material
None
Brass
For Fittings and Ancillaries
For Fittings and Ancillaries
For Fittings and Ancillaries
None
Requirements on
composition
Lead ≤ 5 %
Arsenic ≤ 0.1% / 0.15% (a)
Lead < 2.2% / 3.5%(a)
Composition (d):
Copper ≥ 57.0 %
Zink: Remainder
Lead ≤ 3.5 %
Aluminium ≤ 1.0 %
Iron ≤ 0.5 %
Silicon ≤ 1.0 %
Tin ≤ 0.5 %
None (b)
B
B
Nickel ≤ 1 %
Arsenic and Antimony ≤ 0.2 %
Tot. Other impurities < 0,5 %
B
P
P
B
P
P
Aluminium ≤ 0.8%
Iron ≤ 0.3%
Manganese ≤ 0.1%
Tin ≤ 0.3%
Others(each) ≤0.02%
Others(total) ≤ 0.25%
P
P
P
P
P
P
P
P
Impurities:
Antimony ≤ 0.02 %
Arsenic ≤ 0.02 %
Bismuth ≤ 0.02 %
Cadmium ≤ 0.02 %
Chromium ≤ 0.02 %
Nickel ≤ 0.2 %
residual surface carbon
2
< 0.2 mg/dm
P
Requirements on
composition of
drinking water in
contact with this
material
None
None
None
P
None (b)
P
P
Material
France
(see Note e)
Germany
The Netherlands
(see Note c)
Dezincification
Resistant Brass
No specific requirement, only
1 brass category
For Fittings and Ancillaries
For Fittings and Ancillaries
See brass
Composition (d):
Copper ≥ 61.0 %
Zink: Remainder
Arsenic ≤ 0.15 %
Lead ≤ 2.2 %
Aluminium ≤ 1.0 %
Iron ≤ 0.5 %
Silicon ≤ 1.0 %
Tin ≤ 0.5 %
Requirements on
composition
P
P
Impurities:
Antimony ≤ 0.02 %
Bismuth ≤ 0.02 %
Cadmium ≤ 0.02 %
Chromium ≤ 0.02 %
Nickel ≤ 0.2 %
residual surface carbon < 0,2
2
mg/dm
P
Requirements on
composition of
drinking water in
contact with this
material
None
None
P
UK
Common proposal
Material
Gunmetal
Requirements on
composition
France
(see Note e)
(Bronze)
For Fittings and Ancillaries
Germany
The Netherlands
(see Note c)
UK
For Fittings and Ancillaries
For Fittings and Ancillaries
None
Lead ≤ 6%
Nickel ≤ 0.6%
Lead < 3.0%
Composition (d):
Zinc ≤ 6.5 %
Tin ≤ 13.0 %
Lead ≤ 3.0 %
Nickel ≤ 0.6 %
None (b)
Nickel ≤ 3 %
Antimony≤ 0.5%
Tot. Other impurities < 0,5 %
Arsenic ≤ 0.03%
Antimony ≤ 0.1%
Iron ≤ 0.3%
Phosphorus ≤ 0.04%
Sulphur ≤ 0.04%
Others(each) ≤0.02%
Others(total) ≤ 0.25%
P
P
Common proposal
(b)
P
P
P
P
Impurities:
Aluminium ≤ 0.01 %
Antimony ≤ 0.1 %
Arsenic ≤ 0.03 %
Bismuth ≤ 0.02 %
Cadmium ≤ 0.02 %
Chromium ≤ 0.02 %
Iron ≤ 0.3 %
Silicon ≤ 0.01 %
residual surface carbon < 0,2
2
mg/dm
P
Requirements on
composition of
drinking water in
contact with this
material
None
Other Materials
(See note f)
Test procedure
Evaluation by experts
(AFSSA) for addition on new
materials / new composition
on the list (final decision by
health authorities)
None
P
None
New compositions
Long-term test acc.
DIN 50931-1
Long-term test according to
prEN 15664
DIN 50930-6
Based on values in Dutch
regulation (Drinking Water
Decree)
Guidelines published by
AFSSA (Avis du 4 juillet
2006)
Test requirements
Notes – see next page
None (b)
P
P
Notes for Table 1
a. Germany - For parts with low surface contact (4%) with drinking water
b. UK – fitness for proposed use and compatibility with the particular water type – to be assessed before use. Also “pipes of different metallic materials are not to be connected
unless suitable precautions are taken to ensure that corrosion through galvanic action cannot take place”.
c. The Netherlands – the requirements are based on the technical draft of the revised version of the Ministerial Regulation of December 7, 2002, nr. BWL/2002095022,
EC notification number 2001/0122/NL (Regeling Materialen en Chemicaliën) that will be published late 2008/early 2009.
d. The Netherlands - Based on document 'construct 06/768 rev.1'
e. France - according to arrêté of 29th May 1997. The list of composition for metallic materials is under revision in particular for better alignment with the compositions proposed
by the EAS subgroup when applicable.
f. France - other materials are listed in the French composition list: Copper-Aluminium alloys, Cast Iron, Titanium steel, Aluminium and magnesium anodes for cathodic
protection and Chromium-nickel plating (Arrêté of 22 August 2002)
TP
TP
PT
P
P
PT
A common Proposal for metallic materials & products has yet to be developed.
TABLE 13
Material
CEMENTITIOUS PRODUCT REQUIREMENTS
France
(see Note e)
Germany
The Netherlands
(see Note c)
UK
Common proposal