SIST-TP CEN/TR 15858:2009
(Main)Construction products - Assessment of the release of regulated dangerous substances from construction products based on the WT, WFT/FT procedures
Construction products - Assessment of the release of regulated dangerous substances from construction products based on the WT, WFT/FT procedures
This CEN Technical Report describes a procedure for assessing construction products with regards to their release/emission of regulated dangerous substances (RDS) into the environment in accordance with Essential Requirement Number 3 of the Construction Products Directive (CPD), as far as these construction products fall under the responsibility of CEN.
NOTE 1 For the purpose of this document and mandate M/366, the release of regulated dangerous substances from construction products is limited to two main environmental compartments:
soil, groundwater and surface water;
indoor air.
NOTE 2 It should be noted that construction products falling under the CPD and these environmental compartments are the subject of other European Union regulations, e.g. REACH, and they may also be the subject of Member State regulations.
This Technical Report defines how the mandated characteristics expressed in terms of mandated RDSs for each construction product can be assessed by an individual manufacturer using the ‘Without Testing’ (WT) procedure and/or the ‘Without Further Testing’ (WFT) and ‘Further Testing’ (FT) procedures after an initial type assessment and how the corresponding information accompanying the CE marking can be expressed in terms of declared values or RDS classes.
This report describes:
under which conditions a RDS class for a construction product may be declared by the individual manufacturer using the ‘Without Testing (WT)’ assessment procedure;
if all relevant mandated RDSs are assessed by this Without Testing procedure, how a set of RDS classes for a construction product may also be declared by the manufacturer without the need for testing of their specific products;
how to establish RDS classes for a construction product using a Without Further Testing procedure once sufficient information has been obtained from initial type testing;
when and how to undertake Further Testing as part of factory production control;
Bauprodukte - Bewertung der Freisetzung von regulierten gefährlichen Stoffen aus Bauprodukten auf der Grundlage der WT-, WFT- und FT-Verfahren
Produits de construction - Evaluation de la libération des substances dangereuses - Méthodologies applicables aux cas "Sans essai" (SE) et "Sans essai supplémentaire" (SES)
Gradbeni proizvodi - Ocenjevanje sproščanja reguliranih nevarnih snovi iz gradbenih proizvodov na osnovi postopkov brez preskušanja (WT), brez nadaljnjega preskušanja (WFT) in z nadaljnjim preskušanjem (FT)
General Information
Standards Content (Sample)
SIST-TP CEN/TR 15858
SLOVENSKI
STANDARD
november 2009
Gradbeni proizvodi – Ocenjevanje sproščanja reguliranih nevarnih snovi iz
gradbenih proizvodov na osnovi postopkov brez preskušanja (WT), brez
nadaljnjega preskušanja (WFT) in z nadaljnjim preskušanjem (FT)
Construction products – Assessment of the release of regulated dangerous
substances from construction products based on the WT, WFT/FT procedures
Produits de construction – Evaluation de la libération des substances
dangereuses – Méthodologies applicables aux cas "Sans essai" (SE) et "Sans
essai supplémentaire" (SES)
Bauprodukte – Bewertung der Freisetzung von regulierten gefährlichen Stoffen
aus Bauprodukten auf der Grundlage der WT-, WFT- und FT-Verfahren
Referenčna oznaka
ICS 91.100.01 SIST-TP CEN/TR 15858:2009 ((sl)en)
Nadaljevanje na straneh II in od 1 do 37
© 2009-11. Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST-TP CEN/TR 15858 : 2009
NACIONALNI UVOD
Tehnično poročilo SIST-TP CEN/TR 15858 ((sl)en), Gradbeni proizvodi – Ocenjevanje sproščanja
reguliranih nevarnih snovi iz gradbenih proizvodov na osnovi postopkov brez preskušanja (WT), brez
nadaljnjega preskušanja (WFT) in z nadaljnjim preskušanjem (FT), 2009, ima status slovenskega
tehničnega poročila in je z metodo ponatisa z nacionalnim dodatkom privzeto evropsko tehnično
poročilo CEN/TR 15858:2009.
NACIONALNI PREDGOVOR
Evropsko tehnično poročilo CEN/TR 15858:2009 je pripravil tehnični odbor Evropskega komiteja za
standardizacijo CEN/TC 351 Gradbeni proizvodi – Ocenjevanje sproščanja nevarnih snovi.
Pripravo tega dokumenta sta Evropska komisija in Evropsko združenje za prosto trgovino poverila
CEN. Ta evropski dokument ustreza bistvenim zahtevam direktiv EU.
Slovensko tehnično poročilo SIST-TP CEN/TR 15858:2009 je dne 1. oktobra 2009 po pooblastilu
Strokovnega sveta SIST za splošno področje sprejel tehnični odbor SIST/TC NES Nevarne snovi.
NACIONALNI DODATEK
Proizvajalci gradbenih proizvodov lahko uporabljajo samo surovine, ki ne vsebujejo prepovedanih
snovi, za omejene snovi pa morajo upoštevati omejitve iz Priloge XVII k Uredbi (ES) št. 1907/2006
Evropskega parlamenta in Sveta o registraciji, evalvaciji, avtorizaciji in omejevanju kemikalij (REACH).
Člen 67 Uredbe (ES) št. 1907/2006 določa, da se snovi, zmesi ali izdelki ne smejo proizvajati, dajati v
promet ali uporabljati, če ne izpolnjujejo pogojev iz kakršne koli omejitve zanje iz Priloge XVII. Ta
uredba je v celoti zavezujoča in se neposredno uporablja v vseh državah članicah EU.
Proizvajalci gradbenih proizvodov morajo spremljati spremembe in dopolnitve Uredbe (ES)
št. 1907/2006 Evropskega parlamenta in Sveta o registraciji, evalvaciji, avtorizaciji in omejevanju
kemikalij (REACH). Prva sprememba Priloge XVII k Uredbi (ES) št. 1907/2006 je 1. junija 2009
razveljavila in nadomestila Direktivo 76/769/EGS o približevanju zakonov in drugih predpisov držav
članic v zvezi z omejitvami pri trženju in uporabi nekaterih nevarnih snovi in pripravkov.
Za zaščito gradbenih proizvodov se lahko uporabljajo le priglašeni oziroma avtorizirani ali registrirani
biocidni proizvodi na podlagi Zakona o biocidnih proizvodih (ZBioP) (Uradni list RS, št. 61/06).
Več informacij dobite na spletni strani Urada Republike Slovenije za kemikalije: http://www.uk.gov.si/.
OPOMBI
– Povsod, kjer se v besedilu uporablja izraz “evropsko tehnično poročilo”, v SIST-TP CEN/TR
15858:2009 to pomeni “slovensko tehnično poročilo”.
– Nacionalni uvod in nacionalni predgovor nista sestavni del evropskega tehničnega poročila.
II
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SIST-TP CEN/TR 15858:2009
TECHNICAL REPORT
CEN/TR 15858
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
March 2009
ICS
English Version
Construction products - Assessment of the release of regulated
dangerous substances from construction products based on the
WT, WFT/FT procedures
Produits de construction - Evaluation de la liberation des Bauprodukte - Bewertung der Freisetzung von regulierten
substances dangereuses - Methodologies applicables aux gefährlichen Stoffen aus Bauprodukten auf der Grundlage
cas 'Sans essai' (SE) et 'Sans essai supplementaire' (SES) der WT-, WFT- und FT-Verfahren
This Technical Report was approved by CEN on 3 February 2009. It has been drawn up by the Technical Committee CEN/TC 351.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 15858:2009: E
worldwide for CEN national Members.
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CEN/TR 15858:2009 (E)
Executive summary
Most EU Member States protect their environment by general regulatory requirements not to pollute. Some
place requirements on the RDS content within the environment, e.g. within the indoor air, and a few Member
States place requirements in notified regulations on the release/emission of RDSs from construction products.
As these Member State regulations may be regarded as a barrier to trade in construction products, the
European Commission is seeking a way to provide the information these Member States require in a
transparent way based on European standard test methods. Consequently, the European Commission will
revise the mandates for all construction products to require information on the release/emission of RDSs
under the CE marking where this is required by European or Member State regulations. Where there are no
specific requirements, manufacturers may use the No Performance Determined declaration when placing their
products on those markets.
Where a Member State regulates release from construction products, they identify for each product a set of
RDSs and for each one assign a regulatory level, i.e. a maximum level of release. This CEN/TR suggests that
the harmonised European Standard (hEN) corresponding to the product provides technical classes for the
release/emission of RDSs, referred to as ‘RDS classes’ that coincide with the different regulatory levels. As
different Member State regulations have different sets of RDSs and different regulatory levels, this CEN/TR
also proposes to simplify this complexity by providing in the hEN sets of RDS classes. Each set of RDS
classes would, in principle, satisfy a particular Member State’s regulations, but there may be also a set that
satisfies all Member State regulations. As an alternative, this CEN/TR mentions also the possibility to provide
in the hEN the declared value concept for each mandated RDS.
Experience has shown that the majority of construction products pose no significant risk to the environment,
so this CEN/TR provides two assessment procedures for providing, when required, this information on the
release/emission of RDSs. Where there is a dossier of information that has been accepted by the Commission
showing the release/emission of all or some of the mandated RDSs remains with time under relevant
regulatory levels, these classes can be assigned by the manufacturer without testing (WT). The conditions for
applying this procedure will be specified in the product standard. All the other mandated RDSs are subjected
to an initial type testing (ITT) as specified in the relevant product standard. Based on the results of the ITT, the
release/emission is then either assessed ‘Without Further Testing’ (WFT) or as requiring ‘Further Testing’ (FT).
The WFT procedure is for the situation where the ITT shows that the release/emission from the product is
significantly lower than the RDS class limit and, where this is not the case, the FT procedure is required to
show conformity to the RDS class.
Both assessment procedures include ongoing factory production control (FPC) as specified in the relevant
hEN and operated by the manufacturer. In the case of the WT procedure, the provisions for the FPC comprise
all actions to be taken by the manufacturer, which result from the conditions under which the dossier has been
approved by the European Commission.
In the case of the WFT/FT procedure, the FPC may or may not include further testing depending on the
results of the ITT assessment.
This CEN Technical Report sets out the framework for the system described above and identifies appropriate
supporting standards and guidance documents that should be worked out in CEN/TC 351 for the horizontal
approach, and guidance on the provisions that Product TCs should include in their hENs. If the European
Commission accepts the principles set out in this CEN Technical Report, it is intended to provide some
examples of the application of the system, e.g. in a Part 2 of this document.
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Contents Page
Executive summary . 2
Foreword . 4
1 Introduction . 6
2 Scope . 7
3 Terms and definitions . 8
4 General procedure . 13
5 Basic principles . 14
5.1 Introduction . 14
5.2 Construction Product Directive . 16
5.3 Scope of Mandate M/366 . 17
5.4 Constituents, materials, products . 18
5.5 Regulations and Directives placing requirements on the environment . 18
5.6 Regulatory levels, RDS classes and sets of RDS classes . 19
5.7 Assessment procedures . 20
5.8 Combining construction products into a single assessment. 23
5.9 Construction Products covered by Member State Regulations but not covered under
CPD-ETS . 23
6 Release/emission scenarios . 23
7 Identification of relevant regulated dangerous substances . 24
8 Setting of RDS classes by Product TCs. 25
9 Initial Type Assessment. 28
10 Conformity to a class limit on the basis of a WT procedure. 29
10.1 General . 29
10.2 Dossier of information . 29
10.3 Assessment of the dossier . 31
10.4 Application of the WT procedure . 31
11 Evaluation of conformity . 32
12 Factory production control of RDSs . 32
12.1 General . 32
12.2 Routine control of production . 32
13 Recommended delivery of the proposed system . 33
13.1 List of mandated RDSs . 33
13.2 Statistical basis for the system . 33
13.3 RDS classes and sets of RDS classes . 33
13.4 WT procedure . 34
13.5 WFT procedure . 34
13.6 FT procedure . 34
13.7 Evaluation of conformity . 35
Annex A (informative) Implementation of the proposed system by a manufacturer of a product . 36
References . 37
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Foreword
This document (CEN/TR 15858:2009) has been prepared by Technical Committee CEN/TC 351 “Construction
products: Assessment of release of dangerous substances”, the secretariat of which is held by NEN.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
This CEN Technical Report describes a technical procedure for providing information on the release/emission
of regulated substances in accordance with Essential Requirement No. 3 (ER 3) of the Construction Products
Directive (CPD) and in particular the provision of this information using the ‘Without Testing’ and ‘Without
Further Testing’ procedures. An overall description of all options for testing construction products with respect
to ER3 is given. Within the overall framework and criteria, flexibility is built into the system to permit CEN
technical committees (CEN/TCs) and individual manufacturers to select the optimal solutions for their
construction products. The system is designed to cope with changes to construction products and to allow for
further optimization when there are data to justify such optimization.
This CEN Technical Report applies to construction products under the responsibility of CEN, i.e. those that
conform to European product standards. However, many of the principles and concepts described in this
report could be applied to construction products covered by a European Technical Approval.
This report describes how Regulated Dangerous Substance classes (RDS classes) for each mandated
Regulated Dangerous Substance (RDS) are developed and how sets of these RDS classes may be grouped
for user convenience. It introduces the idea of an Initial Type Assessment (ITA) as the first step in the
technical process. This Initial Type Assessment brings a more flexible approach to satisfying the
requirements of ER3 and may/may not include any testing using a European test method depending on the
quality of the product information already available. Where the ITA identifies that the construction product
satisfies the criteria set out in the product standard with either no, a limited amount, or in specific cases more
extensive testing using European test methods, the construction product may be deemed-to-conform to one or
more RDS classes. Where all relevant RDS classes are satisfied by these procedures, the construction
product may be deemed-to-conform to a set of RDS classes. The technical procedure(s) for establishing a
deemed-to-conform approach to satisfying ER3, and its informational requirements, is described in this CEN
Technical Report.
In the technical procedure, there is a hierarchy of testing using reference test methods for the determination of
release/emission, alternative test procedures and screening tests. These may be used in the Initial Type
Testing (ITT) and in the further testing (factory production control and evaluation of conformity) to assess the
constituents or materials and approve the construction product. The overall objective of this report is to set out
a framework for an effective, appropriate and cost effective system for providing when required information on
the release/emission of regulated dangerous substances from construction products under ER3. The NPD
option is retained for CEN Member States who protect the environment with a different approach.
NOTE As the general CEN/TC 351 document on terminology is still under development, this document has its own
clause on terms and definitions. Those are incorporated in the draft general document. It is expected that in the final
technical report (after the approval of CEN/TC 351), this clause will be replaced by reference to the general CEN/TC 351
document.
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CEN/TR 15858:2009 (E)
Abbreviations
CEN European Committee for Standardization
CEN/TR European Committee for Standardization Technical Report
CPD Construction Products Directive
EGDS European Commission's Expert Group on Dangerous Substances
EN European Standard
ER3 Essential Requirement No. 3: Hygiene, health and the environment
ETA European Technical Approval
ETS European Technical Specification, i.e. a hEN or ETA
FT Further Testing
hEN Harmonised European standard
ITA Initial Type Assessment
ITT Initial Type Testing
NPD No Performance Determined
REACH European regulation on the Registration, Evaluation, Authorisation and
restriction of Chemicals
RDS Regulated dangerous substance
RDSs Regulated dangerous substances
TC Technical Committee
WFT Without Further Testing
WT Without Testing
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SIST-TP CEN/TR 15858:2009
CEN/TR 15858:2009 (E)
1 Introduction
Mandate M/366 EN [1]
Development of horizontal standardized assessment methods for harmonised approaches relating to
dangerous substances under the Construction Products Directive (CPD) [2] introduces, with respect to
compliance with EU or Member State Regulations, procedures for classification of construction products using
a 'Without Testing procedure' (WT procedure) and a 'Without Further Testing procedure' (WFT procedure) in
addition to the normal 'Further Testing' approach (FT procedure).
Work Package 1 given in the mandate to CEN requests, amongst other things, that a Technical Report on
“Without Testing (WT)” and “Without Further Testing (WFT)” be developed.
Text abstracted from Mandate M/366:
This Technical Report shall develop criteria for classifying products as WT/WFT. It must define the criteria a
product or material has to fulfil, in order to be accepted as WT/WFT. The mandated Technical Report will
need to make it possible for the European Expert Group on Dangerous Substances to develop a concept, how
these products will be selected, and which the European Commission Services intends to use for further
measure, with the endorsement of the Standing Committee on Construction.
The TR should consider the viability of two lists, i.e. a) products or materials regarded as WT/WFT based on
generally accepted knowledge on the constituents and release behaviour, and b) products regarded as WFT
based on verification of their emission or content of regulated dangerous substances (measured/tested in
accordance with the harmonised measurement/testing standards).
Mandate M/366 also states in 1.2 sub-clause 5:
It should be possible to demonstrate, for a larger number of products, that they do not contain any regulated
dangerous substances or do not have the ability of releasing dangerous substances into soil, ground or
surface water, or to indoor air, in quantities above the limits regulated in any Member State of the EU.
During the second half of 2006 and the first months of 2007 there was considerable discussion over various
concepts and the evolution of ideas. In order to clarify matters, a delegation from CEN/TC 351 held a meeting
with the Construction Unit on the 2 March 2007. The main outcome of this meeting was a confirmation that in
the future CEN product standards would have to provide a system for manufacturers to provide information on
the release/emission of relevant regulated dangerous substances related to release scenarios, as far as this
information is required by EU regulations or MS regulations where the construction product is placed on the
market. Where there are no specific regulations with respect to release/emission of regulated dangerous
substances, the manufacturer may use the ‘No performance determined (NPD)’ option. At this same meeting,
it was also clarified that the WT and WFT procedures are ‘substance based’. This means that each relevant
RDS is assessed individually to determine if the WT, WFT or FT procedure applies to the classification of the
particular RDS.
NOTE Although European and Member State Regulations require a substance based assessment of the possible
leaching/emission from construction products at some fixed distance from the construction works, the corresponding
information to be provided under CE marking refers to the construction product as defined in the European Technical
Specification (ETS) and determined only on the basis of harmonised European laboratory test procedures.
As requirements for the regulatory level of release/emission of RDSs vary between Member States, this report
introduces a system for splitting each RDS into RDS classes.
These RDS classes will be established in product standards as ‘technical classes’ under the CPD, as
described in Commission Services' Guidance Paper E [3].
The technical experts in CEN/TC 351 believe that this CEN Technical Report should:
a) describe the basis of the normal CPD approach (herein referred to as FT) to providing the information
required in the product standard under essential requirement No. 3 (ER 3);
b) describe how the WT and WFT procedures lead to a 'deemed to conform' approach that may reduce the
amount of testing needed to supply the informational requirements;
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c) explain the detail how the WT, WFT and FT procedures may be used to determine in which RDS class
each relevant substance within a construction product can be declared to lie;
d) include as much of the overall process as possible bearing in mind that matters that are strictly
administrative are outside the remit of CEN and this CEN Technical Report.
At this stage (April 2008), this report focuses on the main points, main procedures and the structure of the
system. The criteria cannot be finalised until there is a fundamental decision on the level of risk acceptable
with each of the procedures. This report notes that CEN/TC 351 has agreed to hold a Workshop on the 27
October 2008 to review this issue and makes a recommendation via CEN/TC 351 to the European
Commission. Once the level of risk is agreed by the European Commission, this report should be revised to
reflect that decision and to provide further elaboration and examples. It would be helpful to users if the
technical procedures described in this document and the complementary administrative procedures to be
developed by the European Commission were to be combined into a single document.
This CEN Technical Report is for the European Commission Services and their expert bodies (DG Enterprise
and the Expert Group on Dangerous Substances), the Standing Committee for Construction, construction
product technical committees and all mirror groups including environmental legislators, representatives of
manufacturers organisations, notified bodies and laboratories concerned with the development and use of test
methods for measuring the release/emission of regulated dangerous substances into soil, groundwater,
surface water and indoor air in harmonised construction product standards. Guidance is provided for other
CEN/TC 351 Working Groups and Task Groups showing how their specific activities fit within the overall
framework. This Technical Report is also aimed at construction product technical committees to provide
guidance on how ER3 with respect to the release/emission of RDSs should be addressed in future revisions of
their product standards.
This CEN Technical Report is not aimed at individual manufacturers of construction products.
2 Scope
This CEN Technical Report describes a procedure for assessing construction products with regards to their
release/emission of regulated dangerous substances (RDS) into the environment in accordance with Essential
Requirement Number 3 of the Construction Products Directive (CPD), as far as these construction products
fall under the responsibility of CEN.
NOTE 1 For the purpose of this document and mandate M/366, the release of regulated dangerous substances from
construction products is limited to two main environmental compartments:
1) soil, groundwater and surface water;
2) indoor air.
NOTE 2 It should be noted that construction products falling under the CPD and these environmental compartments
are the subject of other European Union regulations, e.g. REACH, and they may also be the subject of Member State
regulations.
This Technical Report defines how the mandated characteristics expressed in terms of mandated RDSs for
each construction product can be assessed by an individual manufacturer using the ‘Without Testing’ (WT)
procedure and/or the ‘Without Further Testing’ (WFT) and ‘Further Testing’ (FT) procedures after an initial
type assessment and how the corresponding information accompanying the CE marking can be expressed in
terms of declared values or RDS classes.
This report describes:
a) under which conditions a RDS class for a construction product may be declared by the individual
manufacturer using the ‘Without Testing (WT)’ assessment procedure;
b) if all relevant mandated RDSs are assessed by this Without Testing procedure, how a set of RDS classes
for a construction product may also be declared by the manufacturer without the need for testing of their
specific products;
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c) how to establish RDS classes for a construction product using a Without Further Testing procedure once
sufficient information has been obtained from initial type testing;
d) when and how to undertake Further Testing as part of factory production control;
e) how to evaluate conformity of the construction product to one or more RDS classes;
f) how to create and declare a set of RDS classes using one or a combination of the WT, WFT and FT
procedures.
For construction products that have to be tested, horizontal European release/emission test methods are the
reference methods, but this report also describes under which conditions screening tests may be used. The
use of alternative tests is part of the standard CPD procedure and therefore the use of alternative tests is not
described in this report.
NOTE A manufacturer is free to use an alternative test calibrated against the reference method. However, data
based on the reference method has precedence if there is conflicting information.
The procedures described in this CEN Technical Report are intended to be applied for placing products on the
market; it includes the 'no performance determined' o
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