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April 2012
France, Germany, the Netherlands and the United Kingdom (4MS) work together in the
framework of the 4MS Common Approach. This common approach aims for convergence of
the respective national approval schemes for materials and products in contact with drinking
water.
The 4MS have adopted this document as a common basis for implementing the concept of
assessing cementitious materials in their national regulations. The document is subject to
revisions agreed by the 4MS.
As a next step, the 4MS will prepare common Positive Lists for organic and inorganic
substances and a List of Recognised Generic Constituents.
Further information may be obtained from any of the competent authorities of the 4MS.
Bundesministerium fr Gesundheit (Deutschland)
Ministre du Travail, de LEmploi et de la Sant (France)
Ministerie van Infrastructuur en Milieu (Nederland)
Department for Environment, Food and Rural Affairs (United Kingdom)
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Index
Abbreviations
Definitions
Background
1. Introduction
2. Scope and Coverage
3. Further Development Work
Overview
10
13
10
10
10
11
11
D1 Rationale
D2 Approval procedure
Process Diagrams
14
TABLES
Table 1 Conversion Factors
Table 2 List of Accepted Generic Constituents Specification and Testing
Table 3 Combined limit for metals in cements and additions
Table 4 Test methods and Requirements for assessing cementitious products
and constituents
16
17
19
20
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Abbreviations
AoC
CAP
CEN
CEN TC
CF
CPD/CPR
DW
Drinking water
DWD
DWPL
DWPLL
EC
European Commission
EFSA
EG-CPDW
EMG
FTU
GC-MS
JMC
MTCtap
MS
PDW
PL-CM
PL-OM
SG-CM
SG-EMG
S/V
TOC
TFN
TON
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Definitions
Term
Definition
Constituent where all organic and inorganic substances are listed as generic
constituents in Table 2 columns 1 and 2 of this document
Finely divided material used in concrete in order to improve certain properties
or to achieve special properties. EN 206-1 Concrete Part 1: Specification,
performance, production and conformity deals with two types of inorganic
additions:
- nearly inert additions (type 1)
- pozzolanic or latent hydraulic additions (type 2)
Material added during the mixing process of concrete in small quantities
related to the mass of cement to modify the properties of fresh or hardened
concrete
Granular mineral material suitable for use in concrete. Aggregates may be
natural, artificial or recycled from material previously used in construction
NOTE. Source material would need to be assessed for recycled material to
ensure no introduction of contamination.
Constituent product tested and approved in accordance with Part C of this
document
addition
admixture
aggregate
approvals body
cementitious material
cementitious product
constituents
(and constituent products)
List of substances that have been assessed with respect to their toxicological
characteristics and can be used for the manufacture of a constituent from
which a cementitious product is (partly) made
microbiological characteristic
of a product, material or
constituent
Notified Body
organoleptic characteristic of
a product, material or
constituent
substance
(and primary substance)
Chemical element and its compounds in the natural state or obtained by any
manufacturing process, including any additive necessary to preserve its
stability and any impurity deriving from the process used, but excluding any
solvent which may be separated without affecting the stability of the substance
or changing its composition
NOTE: Definition taken from the REACH Regulation.
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Overview
At the level of principles the assessment approach for cementitious products will follow that adopted for
other materials. However, a feature of the preparation of cementitious products is that they comprise
some combination of constituents, which can themselves be mixtures (preparations) of primary
substances and minerals*. There will be controls on the substances and constituents that can be
accepted for use. Final products will be subject to compliance testing. It is accepted that prior approval
of constituents produced as products by manufacturers can allow the testing of the final product to be
reduced. This Report therefore distinguishes the various elements of assessment that can be involved
in product certification.
1) Control of Primary Substances
Substances that are acceptable in manufactured cementitious constituents and products will be
itemised in Positive Lists, distinguishing between organic and inorganic substances. Part A of the
report deals with the establishment of such Lists and the requirements for compliance. The potential
for release of metals is also a matter of concern as regards the impact on drinking water, and
provisions related to content levels and test requirements are set out in Part C.
2) Control of Constituents
The constituents of cementitious products comprise a variety of substances, not all of which can, or
need to, appear on Positive Lists. The 4MS Common Approach accepts that constituents
themselves can be assessed for their suitability for drinking water applications. The control
approach acknowledges that:
a. There are constituents that can be described and accepted at a generic level.(Accepted
Generic Constituents)
b. Manufacturers can create and place on the market constituents from mixtures of substances
and minerals, and these Constituent Products can themselves be tested to establish
satisfactory performance in contact with drinking water.(Approved Constituent Products)
a. Accepted Generic Constituents
The Common Approach accepts that it will be helpful for manufacturers if regulators schedule
generic constituents which, based on past experience, will be accepted for use in cementitious
products. Part B of the report identifies these constituents and introduces the specifications to be
met to allow acceptance in final products
b. Approved Constituent Products
The report goes on to detail in Part C the arrangements that can be made for individual
manufacturers constituent products to be granted a certificate of (drinking water) conformity.
Possession of such a certificate will be taken into account in the testing of the final product. Under
the Common Approach product conformity certificates granted in one country can be used in any of
the 4MS countries, but no central list of the certificates will be maintained.
3) Product Testing and Approval
The tests that are relevant for cementitious products are:
Organoleptic effects (colour, odour, taste, turbidity, foaming)
Migration of metals
Migration of organics by TOC
Migration of PL substances
GC-MS
Enhanced Microbial Growth (EMG)
Part D describes the acceptance criteria for approval of both constituents and final products. It
shows that tests are related to the nature of the constituents in the final product.
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A review will be made of inorganic substances currently subject to controls in the 4MS, and proposals
will be developed for the evaluation and acceptance of such substances.
A2 Transitional Arrangements
The current MS positive (and equivalent) lists will be consolidated in a Combined List as the starting
point for the transition to common lists. The first step will be to identify substances that appear in current
lists that it is agreed can be transferred to a common Core List. After that items on existing lists must
be either validated by a toxicological evaluation (and then transferred to the Core List), or eliminated as
no longer acceptable.
This will not be such a demanding exercise as it is for organic materials, since the lists are likely to have
something under 400 entries.
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Reduced testing for migration of metals can be applied only if (for each metal) the sum of the content of
the metals in the cement plus any additions is less than the values given in Table 3. Otherwise the final
cementitious product shall be fully tested in accordance with Part D and Table 4.
Note: Content testing is not a valid control for aluminium migration but experience shows that while aluminium
may be at or close to the permitted value of 20 ug/l (10% of DWD parametric value for Al) for some cements after
3 migration cycles, it always falls within this value before 10 cycles.
The content of these metals by mass of cement or addition shall be given on the Drinking Water
Certificates of Conformity for the cement or addition.
Test method references:
EN 13656:2002. Characterisation of waste Microwave assisted digestion with hydrofluoric (HF), nitric
(HNO3) and hydrochloric (HCl) acid mixture for subsequent determination of elements in waste
EN ISO 11969:1996. Water quality Determination of arsenic Atomic absorption spectrometric
method (hydride technique)
EN ISO 11885:2009. Water quality Determination of selected elements by inductively coupled plasma
optical emissions spectrometry (ICP_OES)
EN ISO 17294-2:2003. Water quality- Application of inductive coupled plasma mass spectrometry (ICPMS) Part 2: Determination of 62 elements
EN ISO 5961:1994. Determination of cadmium by atomic absorption spectrometry
EN 1233:1997. Determination of chromium. Atomic absorption spectrometric methods
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If a series of different products is made from the same raw and ancillary materials under the
same manufacturing process (a so-called product family) and the product with the largest in
use S/V is assessed and approved, then the whole series of products is allowed to be used
for all application areas within the product group without further testing
A clause will be required in certificates and product approvals to indicate the CF used and its
implications for the conditions of use.
The acceptance procedure for final products shall follow sections C3 - C5.
Further consideration is to be given to the use of GC-MS testing for certain cementitious products. (See
also C2)
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no
no
yes
yes
yes
Compliance with PL-CM1
no
Rejected
List of testing parameters for product testing
(according specification for each individual constituent)
Product testing
(EN 14944)
TON-TFN + TOC always required as a minimum
(See Table 1 for Conversion Factors)
no
yes
Approved
Compliance to
requirements (Table 4)
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Description:
Application conditions (max concentration in product, product
type, product CF)
Detailed composition
yes
yes
no
Compliance with PL-CM
Rejected
yes
requirements (Table 4
Approved
no
Compliance to
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Table 1
For cementitious products and constituents, the following CFs shall apply to substances determined during testing for general migration according
to Table 4
Product group
CF in d/dm*
10
5
4
1
4
0.04
1
0.01
Table 2
Cement
Inorganic
additions
Aggregates
Note
EMG
Specific organic
Determinants
PL-CM requirements
GC-MS
(1)
TOC
Technical specifications
Metals
Constituent
Organoleptic
Testing parameters
YES
For organic substances used
in cement preparation (e.g.
grinding aids)
(2)
(4)
Not currently
approved in NL
YES
For organic substances used
in preparation (e.g. grinding
aids)
No
(2)
(4)
See note 3 re
recycled
aggregates
Admixtures
Fibres
Note
No
YES
Inorganic and organic
substances
YES
For organic substances
Polymer
modifiers
To be proposed by SG-CM
YES
For organic substances
Formwork
release agents
To be proposed by SG-CM
YES
Curing
compounds
GC-MS
TOC
PL-CM requirements
Metals
(1)
EMG
Mixing water
Technical specifications
Organoleptic
Constituent
Specific organic
Determinants
Testing parameters
Combined limit for metals in cement and additions (see Note 2 of Table 2 above)
Metal
As
Cd
Cr
Ni
Pb
Table 3
Assessment
test
Testing procedure
Analytical method
Requirement
Notes
Organoleptic
parameters
General
Migration
Enhanced
Microbial Growth
Part B, Table 2
EN 14944-1 for
Products
prEN 14944-2 for
constituents
(Note 1)
EN 14944-3 for
Products
prEN 14944-4 for
constituents
(Note 1)
Foaming: visual
observation
TOC: EN 1484
Metals as appropriate:,
see section C5
Specific determinates
(PL substances) :
appropriate to substance
NOTE 2: EMG see C4. Further work being done on selection of test method from the alternatives available by the SG-CM in the light of any work
on the application of EMG tests to products.