oSIST prEN 16637-1:2021

SLOVENSKI STANDARD
oSIST prEN 16637-1:2021
01-marec-2021
Gradbeni proizvodi - Ocenjevanje sproščanja nevarnih snovi - 1. del: Navodilo za
določanje preskusov izluževanja in dodatnih korakov preskušanja
Construction products - Assessment of release of dangerous substances - Part 1:
Guidance for the determination of leaching tests and additional testing steps

Bauprodukte - Bewertung der Freisetzung von gefährlichen Stoffen - Teil 1: Leitfaden für

Produits de construction - Evaluation de l'émission de substances dangereuses - Partie

1 : Guide pour la spécification des essais de lixiviation et des étapes supplémentaires

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee

If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations

which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other

language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without

© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 16637-1:2021 E

European foreword ...................................................................................................................................................... 4

Introduction .................................................................................................................................................................... 5

1 Scope .................................................................................................................................................................... 6

2 Normative references .................................................................................................................................... 6

3 Terms and definitions ................................................................................................................................... 7

3.1 Sampling and products ................................................................................................................................. 7

3.2 Release and laboratory testing ................................................................................................................ 10

4 Symbols and abbreviations ....................................................................................................................... 15

4.1 Symbols ............................................................................................................................................................ 15

4.2 Abbreviations ................................................................................................................................................. 15

5 Determination of the appropriate release test method.................................................................. 15

5.1 Principles and general review of the test methods .......................................................................... 15

5.2 Product properties and test conditions for the determination of the relevant test

method .............................................................................................................................................................. 16

5.3 Determination of the appropriate test method ................................................................................. 18

6 Adoption of modules for the product specific leaching standard ............................................... 19

6.1 Overview of the modules ............................................................................................................................ 19

6.2 Product sampling and transport to the laboratory .......................................................................... 21

6.2.1 Introduction on sampling .......................................................................................................................... 21

6.2.2 Objective of sampling .................................................................................................................................. 21

6.2.3 Preparation of a sampling plan and sampling strategy .................................................................. 21

sampling plan ................................................................................................................................................. 24

6.2.5 Packaging and transport of laboratory sample ................................................................................. 24

6.2.6 Sample description and marking of laboratory sample and sampling report ....................... 25

6.2.7 Chain of custody report .............................................................................................................................. 25

6.2.8 Dispatch of product samples, time schedule ...................................................................................... 25

6.2.9 Report on sampling ...................................................................................................................................... 26

6.3 Preparation of the laboratory sample ................................................................................................... 26

6.4 Collection of eluates ..................................................................................................................................... 26

6.4.1 Dynamic surface leaching test .................................................................................................................. 26

6.4.2 Up-flow percolation test ............................................................................................................................. 27

7 Indirect methods ........................................................................................................................................... 28

7.1 Definition ......................................................................................................................................................... 28

7.2 Requirements for indirect methods....................................................................................................... 28

7.3 Examples of indirect methods .................................................................................................................. 28

Annex A (informative) Release scenarios and impact assessment ......................................................... 29

Annex B (informative) Different types of leaching tests ............................................................................. 33

Annex C (informative) Key concepts for product sampling ....................................................................... 35

Annex D (informative) Example form of a chain of custody report ........................................................ 47

Annex E (informative) Example form for the sampling report ................................................................ 48

Annex F (informative) Metallic products ......................................................................................................... 49

Annex G (informative) Guidance on how to identify and handle unexpected test results and

how to recognize heterogeneous products ......................................................................................... 50

Bibliography ................................................................................................................................................................. 53

This document (prEN 16637-1:2021) has been prepared by Technical Committee CEN/TC 351

“Construction Products: Assessment of release of dangerous substances”, the secretariat of which is

— Addition of guidance on how to identify and handle unexpected test results and how to recognize

This document has been prepared under a mandate given to CEN by the European Commission and the

This document deals with the determination and use of test methods for leaching of construction

products taking specific situations into account. It specifies preconditions under which leaching tests

EN 16637, Construction products: Assessment of release of dangerous substances, consists of the

— Part 1: Guidance for the determination of leaching tests and additional testing steps,

Background information on characterization of leaching behaviour of construction products can be

found in Technical Reports provided by CEN/TC 351 (i.e. CEN/TR 16098 [1], CEN/TR 16496 [2]).

The European Standards prEN 16637-1, prEN 16637-2 and prEN 16637-3 are developed to assess the

release of regulated dangerous substances (RDS) from construction products into soil, surface water

and groundwater in the framework of Mandate M/366. The horizontal test methods developed under

the Mandate M/366 are intended to be used to show compliance with notified regulations. The tests

cover the release of substances from construction products and in particular, those that are regulated in

prEN 16637-1 specifies how the CEN Technical Product Committees and EOTA experts should

determine the appropriate leaching test for the determination of the release of RDS from a construction

product into soil, surface water and groundwater. prEN 16637-1 gives background information for

a) description of the intended conditions of use of the construction product (e.g. above ground

exposed to the precipitation, or shielded from direct infiltration, in surface or groundwater) with

b) identification of main release mechanisms, and the appropriate leaching test for a given

prEN 16637-2 specifies a horizontal test to assess surface dependent release from monolithic, plate-like

prEN 16637-3 specifies a horizontal test to assess release from granular construction products.

The test methods can be used for both steps in the hierarchy (type testing (TT) and factory production

control (FPC)) and form the reference tests for the intended uses and conditions specified in

prEN 16637-1. In this hierarchy of testing conditionally “indirect tests” can be used, but are not

The release of substances upon contact with water results in a potential risk to the environment during

the intended use of construction products. The intent of these tests is to identify the leaching behaviour

of construction products and thereby allow assessments of the release of RDS from such products to

soil, surface water and groundwater under intended conditions of use in relation to CE marking and

This document does not address impact assessment. However, since the test methods described in the

document may be used in the context of impact assessments and regulation based on impact

assessments, some guidance on this issue is provided in this document, Annex A (informative).

In addition to existing validation results, in 2011 CEN/TC 351 began an extensive research program on

robustness validation of the existing tank leaching and percolation tests. This was carried out by a

consortium of European experts on 20 construction products to unify differences from the protocols of

the different CEN Members and to check the influence of testing conditions on the test result (e.g.

temperature, flow rate, renewal scheme). The results ([3], [4]) of the research program confirmed the

robustness of the horizontal tests known from former works. Conclusions from the program have been

implemented into the Technical Specifications for the test methods. The performance of the leaching

tests regarding repeatability and reproducibility was deduced from a second validation step and

(1) This document allows the identification of the appropriate leaching test method for the

determination of the release of RDS from construction products into soil, surface water and

groundwater. This document provides a stepwise procedure for the determination of appropriate

(2) Furthermore, this document gives general guidance for CEN Technical Product Committees and

EOTA WGs on basic aspects (sampling, sample preparation and storage, eluate treatment, analysis of

eluates and documentation) to be specified in the relevant product standards or ETAs.

(3) Metallic products and coatings on metallic products are not considered in the determination scheme

of this document since the test methods in prEN 16637-2:— (tank test) and prEN 16637-3:—

(column test) are not appropriate for the testing of these construction products due to a different

(4) It is assumed that intermittent contact with water (e.g. exposure to rainwater) is tested – by

convention – as permanent contact. For some coatings, (e.g. some renders with organic binders

according to EN 15824 [7]) in intermittent contact to water, physical and chemical properties might be

altered in permanent contact with water. These products are not considered in the determination

scheme of this document since the test method in prEN 16637-2 is not appropriate for the testing of

these construction products (in this case EN 16105 [8] might be an alternative method).

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

prEN 16637-2:— , Construction products: Assessment of release of dangerous substances – Part 2:

prEN 16637-3:— , Construction products: Assessment of release of dangerous substances – Part 3:

EN 16687:2015, Construction products: Assessment of release of dangerous substances – Terminology

For the purposes of this document, the terms and definitions given in EN 16687 and the following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

granular product with a low permeability, due to very small pores between the particles

Note 1 to entry: Compacted granular products are usually tested by a test method for granular construction

products with low hydraulic conductivity, because the percolation test is not applicable due to the low

permeability of the products (e.g. fine aggregates that do not allow significant percolation of water through the

sample that consists of two or more increments, put together in appropriate portions, from which the

hardening of freshly prepared mixtures under well-defined conditions (time, temperature, humidity,

minimal time defined necessary for curing before a release/emission test can be executed to obtain test

product composed of solid particles with a particle size smaller than a specified size or grading

individual portion of product collected by a single operation of a sampling device which will not be

tested as a single entity, but will be mixed with other increments in a composite sample

Note 1 to entry: When the laboratory sample is further prepared by subdividing, cutting, sawing, coring, mixing,

drying, grinding, and curing or by combinations of these operations, the result is the test sample. When no

preparation of the laboratory sample is required, the laboratory sample is the test sample. A test portion is

removed from the test sample for the performance of the test/analysis or for the preparation of a test specimen.

Note 2 to entry: The laboratory sample is the final sample from the point of view of sample collection but it is the

granular product with specific requirements on the grain size distribution to be tested in the dynamic

product which has certain minimum dimensions and physical and mechanical properties that ensure its

Note 1 to entry: Monolithic products are usually tested by a dynamic surface leaching test.

product formed as a semi-rigid or rigid plate, which has certain minimum dimensions and physical and

mechanical properties that ensure its integrity over a certain period of time in the intended conditions

Note 1 to entry: Plate-like products are usually tested by a dynamic surface leaching test.

Note 1 to entry: The manner of selection of the sample should be described in a sampling plan.

Note 2 to entry: The term “sample” is often accompanied by a prefix (e.g. laboratory sample, test sample)

specifying the type of sample and/or the specific step in the sampling process to which the obtained material

predetermined procedure for the selection, withdrawal, on-site pre-treatment, preservation and

minimum quantity (mass or volume) of the product for which test results are obtained

Note 1 to entry: Information on characteristics of the product, including emission and variations therein, for a

product formed as a flexible or semi-flexible sheet, which has certain minimum dimensions and

physical and mechanical properties that ensure its integrity over a certain period of time in the

Note 1 to entry: Sheet-like products are usually tested by the dynamic surface leaching test.

EXAMPLE Consider a continuous production process that results in a specific product. The population for

that product is all the individual products produced between the moment the production process started (this

may be years ago) and the moment the production process ends (this may be years ahead). From the perspective

of testing, this definition does not provide a practical concept. Products produced in the past are no longer

available for testing, while products that might be produced in the (far) future are also not available. The term

sub-population provides a workable alternative, as the ‘start’ and ’end’ of the sub-population can be defined in a

practical way. For the same product, already in production for a number of years, the sub-population might be the

production for a year, the production for a month, or another definition that is practical.

amount of the test sample taken directly for testing/analysis purposes, usually of known weight or

EXAMPLE A bag of aggregates is delivered to the laboratory (the laboratory sample). For test purposes a

certain amount of the aggregate is dried, the result is the test sample. Afterwards the column for a percolation test

sample, prepared from the laboratory sample from which test portions are removed for testing or for

test portion specially prepared for emission/release/radiation testing in a test facility in order to

simulate the emission/release/radiation behaviour of the product under intended conditions of use

EXAMPLE Cement is used in construction as a constituent of concrete. For testing purposes, a test specimen

of concrete is prepared for the release test, using cement and adding additional constituents (like aggregates) with

release test method in which a granular construction product with low hydraulic conductivity is

exposed with one defined surface to a leachant renewed at subsequent time intervals

release test method in which a monolithic, sheet-like or plate-like product is immersed in a leachant

general term for the entire process of assessing the concentrations of regulated dangerous substances

or parameters, at the point of compliance based on the leaching test results, the source term, (or, where

applicable, the façade emission function) and the modelling of environmental transport taking into

Note 1 to entry: The final step after the impact assessment is the comparison of the predicted environmental

concentrations with the environmental limit values at the point(s) of compliance, see “impact evaluation”.

Note 2 to entry: Impact assessment is not part of the standardization work in CEN/TC 351. The regulator is

responsible for the definition of relevant intended conditions of use, modelling of the environmental transport, the

comparison of (predicted) environmental concentrations of substances/parameters with regulatory

limit values (or other assessment criteria) in soil, surface water or groundwater at a point of

Note 1 to entry: Such predictions are based on the results of release tests which are translated to intended

Note 2 to entry: The translation of test results to environmental concentrations is not part of standardization

intended use of the construction product as defined in the applicable harmonised standard or European

conditions that a product may undergo during service life and that influence its release/emission

Note 1 to entry: These conditions are expressed in parameters such as temperature, amount of water during

exposure, wetting/drying; intended conditions of use may vary for instance as a function of time, location,

orientation, geographical location, etc. For simplification, intended conditions of use are transferred into release

liquid that is brought into contact with the test portion in the leaching procedure

Note 1 to entry: Usually demineralized water is used as leachant for laboratory leaching tests.

release and change with time in release from a solid product in contact with a leachant as a function of