SUBSTITUTION OF HAZARDOUS CHEMICALS IN PRODUCTS AND PROCESSES potx

Report compiled for the
Directorate General Environment, Nuclear Safety and Civil Protection
of the Commission of the European Communities

Contract No B3-4305/2000/293861/MAR/E1

SUBSTITUTION OF HAZARDOUS CHEMICALS
IN PRODUCTS AND PROCESSES

FINAL REPORT
Hamburg, March 2003
Revision 1

Joachim Lohse
Martin Wirts
Andreas Ahrens
Kerstin Heitmann
Sven Lundie

Lothar Lißner
Annette Wagner
Contact details for further inquiries

Joachim Lohse
Phone +49 – 40 – 391002 – 11
Fax +49 – 40 – 399006 – 33
Email
Ökopol GmbH
Nernstweg 32-34
22765 Hamburg
Germany

Lothar Lißner
Phone +49 – 40 – 2858-640
Fax +49 – 40 – 2858-641
Email
Kooperationsstelle Hamburg
Besenbinderhof 60
20097 Hamburg
Germany
EXECUTIVE SUMMARY

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Executive Summary
Substitution of hazardous substances by less hazardous alternatives appears to be a
straightforward approach when enterprises consider management and reduction of chemical-
related risks. Substitution is also debated in the context of the future chemicals policy in the
EU. At the same time, various stakeholders' perceptions differ widely about the definition of
substitution and concerning the question whether substitution should be a “fundamental
principle”, a “duty to both producers and users of chemicals”, a “preferred risk reduction
strategy” or whether it is “just another tool for managing risk”.
Against this background, the study aims to identify, describe and analyse relevant activities
towards substitution of hazardous chemicals. These activities include political and
administrative strategies and concepts, guidance and assessment tools, as well as practical
substitution “cases”.
Numerous policy programmes and legal texts are presented in the report, covering both 1)
legislation, that is introducing a generic substitution approach while leaving the
implementation to the market players, and 2) specific legislation or technical rules with
detailed requirements on how substitution should be implemented in practice.
The results of a

survey
are presented on practical guidance and assessment tools for
substitution which are publicly available in European Member States. The survey is focussing
on assessment tools that are destined to support decision-making with regard to the selection
of the most appropriate option.
For achieving the general goal of reducing risks from hazardous chemicals, the various
guidance documents suggest a large range of measures, ranging from elimination,
modification or replacement of processes or products to exposure reduction by personal
protection measures. Based on the observation that in the management of chemical risks it is
useful to distinguish between the technical strategies of hazard reduction by emission control
and hazard reduction by substitution, the following
definition of substitution
is suggested:
“Substitution means the replacement or reduction of hazardous substances in products and
processes by less hazardous or non-hazardous substances, or by achieving an equivalent
functionality via technological or organisational measures.”
The key aspect in this definition is the
functional equivalence
, i.e. the achievement of the
same functionality by less hazardous means. Several strategies to achieve an equivalent
functionality fall under this definition, such as elimination of a chemical, replacement of a
hazardous chemical by a less hazardous one, as well as technological or organisational
measures, that lead to a reduction of the quantitative input of the hazardous chemical and /
or enable the use of less hazardous chemicals.
Three studies
describe the effects of specific
policy approaches
in detail, analysing from a
top-down perspective how different policy instruments can influence the behaviour of
companies and promote substitution either directly or indirectly.

However,
substitution practically takes place in enterprises
. Therefore, the main approach
taken in this report is a bottom-up approach with a view from the company perspective, in
which the combined outcome of legislation, administration and other factors is analysed.
Following this rationale,
10 technical case studies
analyse substitution cases from the
perspective of the downstream user of hazardous chemicals or materials who will most likely
EXECUTIVE SUMMARY

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be the decision-maker whether substitution takes place or not. The cases cover a wide range
o
f substances in a variety of products and processes, serving manifold functionalities
including cleaning operations (metal parts, facades, textiles), coating and painting (marine
anti-foulings, wood preservation), fire resistance (flame retardants in printed circuit boards),
lubricants and process fluids (loss lubrication, mould release agents), energy storage
(rechargeable batteries) and plasticisers (phthalates in toys). The case studies give an insight
into typical controversial issues, decision-making and associated time scales.

Each case study starts with a technical description, i.e. the application of a substance in its
technical environment, followed by a presentation of scientific observations about potential
eco-toxicological risks associated with this particular substance. The evolution of
stakeholders’ attitudes and initiatives over time is examined. Stakeholders of interest are
economic actors along the supply chain, authorities, science and research and – in many
cases – the “general public”.
The case studies offer different possibilities of interpretation. It is not intended to judge
whether substitution is the right risk reduction measure or not in a specific case. The purpose

is rather to show how alternatives have been developed, and how it was eventually decided
whether to substitute a hazardous substance or not. In those cases where a market
segmentation was observed, the reasons are examined and discussed why some parts of the
market have shifted to the substitute, while others have not.
Key drivers and barriers
towards substitution are identified particularly with regard to
economic factors, technical functionality, communication and social factors, risk information
and the regulatory framework, that is set by legislation and standardisation. There are some
surprising similarities between completely different substitution cases, although the specific
effect and the relative importance of each of these influence factors varies from one case to
another:
•
Legislation
is found to be one of the most powerful drivers in many cases, often inducing
substitution as a side-effect even where it is not explicitly addressed as the main goal.
• Another strong driver can be serious
public concern
about perceived chemical risks.
• In the absence of such robust drivers, short term
economic considerations
are often the
main barrier, and
• a general tendency of downstream users prevails to stick to well-established
conventional
substances
, rather than undergoing any risks with respect to quality and liability by
experimenting with less hazardous substitutes.
In several cases, there is a considerable
imbalance
between the

available risk information
on
1) substances which have been found to be problematic and thus became subject to
substitution efforts, and 2) their potential substitutes for which less information is available,
partly due to the fact that they have never been used on a similar scale as the conventional
substance. Consequently, this level of information simply does not exist.
Even where functionally equivalent substitutes are readily available, economically viable and
proven to be less hazardous, their
introduction
in a certain process or product
is often
hampered
by the fact that complex communication along the supply chain is a prerequisite
for implementation.
To summarise, the motivation of companies to substitute specific substances differs
significantly from other stakeholders’ attitudes. Decisions taken in enterprises are influenced
EXECUTIVE SUMMARY

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by policy, regulation and enforcement, technology development, economy and market,
s
cientific finding and the public debate. Both environmental legislation and public pressure
are seen as relevant external factors.
Government and authorities
can play an important role in goal setting and promoting of
substitution as one relevant option for risk reduction, not only by preparing legislation but
also by sending to industry informal regulatory signals e.g. in the form of guidance and
recommendations. Government-funded research and development programmes are an
important tool to support the development of substitutes, especially in cases where this relies

on close co-operation of economic actors in
networks
, that require efforts and resources
going significantly beyond the core business of enterprises.
Substitution should be based on comparative assessment of alternatives
which requires
reliable information on the hazard of substitutes and the associated risk of using them
instead of the conventional substance. The current situation is often described as
unsatisfactory in this respect. If in the future public policy will ensure that, as a pre-requisite
for informed choices, comparable risk-related information on conventional substances and
their substitutes is available, this will bear significant potential to accelerate substitution of
hazardous substances in products and processes. Industry-specific innovation networks can
contribute substantially to these informed choices.
Substitution requires qualification
. Therefore, education and training of industrial and
professional users of chemicals is needed in order to have appropriate skills to assess
available information and to “ask the right questions” to suppliers.
In any case, enterprises need
clarity about strategic policy goals

and legislation
on
substitution of hazardous substances, as well as trust in the enforcement capacity of
authorities. If enterprises have trust in future market developments, they will invest in
innovative substituting technologies. Political visions, like the commitment to significantly
reduce toxic substances in the environment, can support such trends.

TABLE OF CONTENTS
1 Goals, scope and methodology of the study _____________________1

1.1 Goals ___________________________________________________ 1
1.2 Scope___________________________________________________ 1
1.3 Methodology _____________________________________________ 1
1.4 Structure of each section ____________________________________ 3
1.4.1 General substitution possibilities _____________________________________________ 3
1.4.2 Status analysis – legislation, policy and programs in the EU _______________________ 3
1.4.3 Practical guidance and assessment tools on substitution at various levels ____________ 3
1.4.4 Examples of substitution policies and management ______________________________ 4
1.4.5 Case studies _____________________________________________________________ 4
1.4.6 European conference on substitution of hazardous substances _____________________ 4
1.4.7 Summary and overall conclusions ____________________________________________ 5
2 Substitution – policies, status, guidance, assessment and experiences 6

2.1 General substitution possibilities ______________________________ 6
2.1.1 General risk reduction strategies _____________________________________________ 6
2.1.2 The role of political actors __________________________________________________ 9
2.1.3 The company as an actor__________________________________________________ 11
2.2 Status analysis: legislation, policy and programs in the EU _________ 14
2.2.1 Frameworks for substitution________________________________________________ 14
2.2.2 Introduction of substitution preferences into legislation__________________________ 16
2.2.3 Prohibition of certain substances in certain uses (ProSub)________________________ 18
2.2.4 Listing substances (LiSub) _________________________________________________ 20
2.2.5 Promoting substitution by voluntary European-wide agreements (SubVol)___________ 23
2.2.6 Promoting substitution by obligatory or voluntary labelling _______________________ 23
2.2.7 Promoting substitution by financial incentives (IncSub) __________________________ 25
2.3 Practical guidance on substitution ____________________________ 26
2.3.1 Types of guidance on substitution and their general structure ____________________ 26
2.3.2 Description of selected guides ______________________________________________ 28
2.3.3 Short list of substance, product or process specific guides _______________________ 34
2.4 Assessment tools on substitution at various levels _______________ 36

2.4.1 Basic principles of decision aid methods ______________________________________ 36
2.4.2 Assessment tools for substance risk assessment _______________________________ 39
2.4.3 Assessment tools for evaluation of risk reduction measures ______________________ 42
2.4.4 Assessment tools used by industry __________________________________________ 46
2.4.5 Assessment tools from eco-labels for consumer products ________________________ 48
2.5 Examples of substitution policies and management_______________ 53
2.5.1 Procedure for granting of discharge permits in the Netherlands and Denmark________ 53
2.5.2 Substitution policy: Lists and licenses in Sweden and Ireland _____________________ 58
2.5.3 The case “Oeko-Tex-Standard” - Substitution policy via voluntary labels ____________ 65
2.6 Case studies_____________________________________________ 72
2.6.1 Methodology ____________________________________________________________ 72
2.6.2 Summaries of the 10 individual case studies___________________________________ 74
2.6.3 Key factors influencing substitution __________________________________________ 85
3 RESULTS AND CONCLUSIONS ______________________________94

3.1 Definition of substitution ___________________________________ 94
3.2 The enterprise as the place for substitution_____________________ 94
3.2.1 Core requirements of enterprises in the substitution process _____________________ 94
3.2.2 Motivation to consider substitution in an operating process_______________________ 95
3.2.3 Assessment of options by decision makers ____________________________________ 97
3.2.4 Driving factors for substitution______________________________________________ 98
3.2.5 Actors involved in practical implementation of substitution ______________________ 101
3.3 The role of authorities ____________________________________ 103
3.4 Overall conclusions ______________________________________ 104
3.4.1 Conceptual considerations on substitution ___________________________________ 104
3.4.2 Public policy framework __________________________________________________ 105
3.4.3 Trade and industries’ tools to support informed choices ________________________ 105
3.4.4 Factors driving substitution at company level _________________________________ 106
References_______________________________________________107

References of section 2.1 ______________________________________ 107
References of section 2.2 ______________________________________ 107
References of section 2.4 ______________________________________ 107
References of section 2.5.1 _____________________________________ 108
References of section 2.5.2 _____________________________________ 108
References of section 2.5.3 _____________________________________ 109
Annexes
Annex I Legislation, policy and programs in the EU:
Standardised short descriptions 2
Annex II Standardised short descriptions of guidance documents 15
Annex III Standardised short descriptions of the assessment tools 25
Annex IV Extended case descriptions 40
Annex V Conference proceedings 176
List of Tables
Table 1 Example: losses from consumer products – risk reduction strategies 7

Table 2 Example: emission from processes– risk reduction strategies 8
Table 3 Communication in substitution cases 11
Table 4 Restrictive policies 18
Table 5 List of substance-, product- or process-specific guides 35
Table 6 Classification of substances in the Dutch concept (RIZA 97) 55
Table 7 Comparison of substance-oriented limit values required for Oeko-Tex vs. official
Eco-labels for textiles 68

Table 8 Analytical categories for evaluation of case studies 73
Table 9 Definition of characterising factors 74
Table 10 Key influence factors promoting or hindering substitution 86
Table 11 Communication requirements of enterprises depending on size of substitution case
98

TABLES OF FIGURES
Figure 1 Risk reduction approaches for different use pattern of substance to achieve a
common risk reduction level (originally based on AHRENS 2001) 8

Figure 2 Company view and political view 12
Figure 3 Conceptual model of public policy making and regulatory drivers 15
Figure 4 Typical steps in guidance for substitution 27
Figure 5 Scheme of the assessment proposed in the GDS 32
Figure 6 Concept of the Dominance Analysis 37
Figure 7 Concept of Positional Analysis 38
Figure 8 Concept of Elimination by Aspects (EBA) procedure 38
Figure 9 Schematic Scheme of the “Quick Scan” for substances proposed in the Netherlands
40

Figure 10 Assignment of PBT criteria to levels of concern 41
Figure 11 Assignment of “in principle” measures on the basis of level of concern 41
Figure 12 Schematic draw of the Risk Benefit Analysis 43
Figure 13 Example of presentation of results in eco-efficiency analysis 47
Figure 14 Eco-label-criteria concerning the presence of hazardous substances during the
lifetime of a product 49

Figure 15 Illustrative examples of Öko-Tex Standards 66
Abbreviations
B2B Business to business
BAT Best available technology
BATNEEC Best available technology not entailing excessive costs
COSHH Control of substances hazardous to health
EBA Elimination by Aspects
EC Treaty Treaty establishing the European Community
EMAS Eco-management and audit scheme

ELVs Emission limit values
EPER European pollutants emission register
HOCNF Harmonised Offshore Chemicals Notification Format
HSE Health, Safety and Executive
IPC Integrated Pollution Control
NGO Non-governmental organisation
OBS Observation List (Sweden)
OHS Occupational health and safety
PER Pollutant Emissions Register
PPP Plant Protection Products
SDS Safety data sheet
SME Small and medium size enterprises
SOMS Strategy on management of substances (NL)
TRI Toxic Release Inventory
TRGS 440 Technische Regeln für Gefahrstoffe (D)
WEEE Waste from Electrical & Electronic Equipment

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1 Goals, scope and methodology of the study
1.1

Goals
The present study aims to identify, describe and analyse practical activities towards
substitution of hazardous chemicals. These activities include political and administrative
concepts and strategies, assessment and guidance tools as well as practical substitution
“cases”. The analysis covers the motivation, practical action and the success of relevant
stakeholders as far as possible.
The findings of the study aim at an increased understanding of influencing factors of a

substitution process. The results have been discussed at a conference with stakeholders and
actors which was held in Hamburg in June 2002 (see Annex V for details). A short version of
the report will be distributed to relevant stakeholders and to the public. The findings of this
project might be used by all stakeholders in order to improve and accelerate substitution
which might become one of their strategies to reduce the risks connected with chemicals.
1.2

Scope
The study is designed to analyse the issue substitution from various perspectives.
Substitution is an issue in several fields of legislation and policy, and it is referred to in
numerous assessment tools and practical guidance instruments by a wide range of authors.
Although in many cases substitution of chemicals is not directly addressed by legislation and
policies, often it appears to be an indirect outcome of environmental legislation, research
programmes, liability legislation etc. All these instruments have a generic character which
can support or hinder substitution.
The report includes case studies of substitution to obtain insight into the typical development
of a substitution case over time, from the early stages of initial awareness of a potential risk
to the final step of implementation of an adequate risk reduction measure. Three studies
highlight political strategies to promote and stimulate substitution efforts in companies (see
Section 2.5). Ten technical studies focus on technical aspects of chemical or technological
substitution efforts in certain industrial applications (see section 2.6). The purpose of these
case studies is to examine the PROS and CONS of substitution from the various perspectives,
and to identify the relevant key drivers and barriers.
1.3

Methodology
Since substitution can be analysed in various ways, methodological decisions had to be made
in the course of the project as regards approach, definition and perspective.
Approach and definition:
The findings of this study are based on literature reviews and stakeholder consultation.

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In order to focus the study, the term “substitution” had to be defined. As a working
d
efinition, the analysis started with the definition of “substitution” as given in the terms of
reference of the service contract:
“Substitution should be understood as an active choice between and including combinations
of chemical substances, preparations, other materials and technical solutions in order to
reduce the exposure to hazardous substances by human beings and the environment”.
Later on a narrower definition was attained by a separation between emission control
measures and substitution (or hazard reduction) measures.
In this sense, the emission control approach aims to eliminate emission, losses and
discharges by keeping the hazardous substances in a “closed-loop” process or product
system. The focus of this approach is on setting up technical and organisational barriers in
order to avoid the release of substances from a technical system into the environment.
During the further course of the project, emission control measures were not considered as
substitution. Substitution has been defined for the purpose of this study as:
“Substitution means the replacement or reduction of hazardous substances in products and
processes by less hazardous or non-hazardous substances, or by achieving an equivalent
functionality via technological or organisational measures.”
It has to be emphasised that this definition comprises of two substitution strategies:
1 replacement of a hazardous chemical by a less hazardous one, and
2 technological or organisational measures which lead to a reduction of the input of the
hazardous chemical and / or enable the use of less hazardous chemicals.
The first case of substitution, i.e. direct replacement of a hazardous substance by a less
hazardous one, is straight forward. In many cases, however, the assessment of the risk
reduction by substitution will not give unambiguous results, e.g. when the environmental
problem caused by atmospheric emissions of volatile organic substances is shifted to the
aquatic environment by introduction of non-volatile, water miscible chemicals. In such cases

more advanced tools for comparative assessment are required.
In many cases technological measures are able to reduce the amount of hazardous
chemicals significantly. Better technical equipment and better effectiveness might fulfil such
demands.
Organisational measures may contribute to substitution by improved working procedures
reducing the use of hazardous substances. An example is the use of hazardous substances in
facade cleaning. With appropriate organisational measures, it is often possible to replace
common hazardous all-purpose cleaners by less aggressive cleaning agents which are
specifically adapted to effectively clean a particular type of dirt.
The key aspect in this definition is the functional equivalence, i.e. the achievement of a same
functionality by less hazardous means. An equivalent functionality for the industrial or private
user can be achieved in many ways, such as elimination of a chemical, use of a slightly less
hazardous chemical etc.
Perspective:
Another important methodological decision needs to be highlighted: since companies are
considered as the most relevant group of actors during implementation of substitution, the
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project has focused on the various influence factors on companies’ internal decisions for or
a
gainst the implementation of substitution. However, other aspects of political decision
making, scientific research, public communication and implementation problems of local or
regional authorities are taken into account as well.
1.4

Structure of each section
1.4.1 General substitution possibilities
Section 2.1 describes the background of the study referring to the use of the term
“substitution” in recent official EU documents in which “substitution” is discussed as one

possible strategy towards risk reduction. An impression is given on the different perspectives
of political and economic actors on this subject. A terminology is developed to distinguish
between the risk reduction strategies of “substitution” and “emission control”.
The roles of various actors and their involvement in the debate on substitution, including
interactions e.g. between administration and enterprises, are described.
Additionally, this section highlights the importance of companies where substitution needs to
be decided upon and implemented in practice, giving a first overview of the numerous
aspects which must be evaluated before an enterprise can take its internal decision whether
to substitute a certain substance or not.
1.4.2 Status analysis – legislation, policy and programs in the EU
In the EU and its Member States efforts towards substitution of hazardous substances can be
found in numerous pieces of legislation and government programmes.
Different types of typical legal instruments are distinguished, such as
• generic introduction of the substitution concept in legislation without specifying the way
of implementation;
• strict legislation such as ban or restriction of hazardous substances and
• softer legislation aiming at substitution as one option of prevention, e.g. by using lists of
hazardous substances for orientation, or by promoting substitution by certain information
requirements (e.g. mandatory labelling) or financial tools (e.g. incentives or levies).
The standardised short descriptions of single instruments are given in Annex I.
1.4.3 Practical guidance and assessment tools on substitution at various levels
Sections 2.3 and 2.4 describe publicly available practical guidance and assessment tools for
substitution in European Member States. A distinction between guidance and assessment
documents is not always possible because both aspects are often combined: Guidance needs
assessment in advance - if assessment leads to alternative options of practical handling, then
guidance is needed. The focus of these sections is on assessment tools supporting decision-
making with regard to the selection of the most appropriate option.
The documents referred to in Sections 2.3 and 2.4 are presented in some more detail in
Annexes II and III.
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1.4.4 Examples of substitution policies and management
T
hese three ‘policy and management’ cases introduce various policy frameworks and
approaches promoting and stimulating substitution efforts in companies:
• The emission approach applied by the Dutch and Danish water authorities when granting
discharge permits includes the inventory and assessment of chemicals used in the
company and which could be possibly present in the waste water.
• The Swedish governance approach sets up a general “duty of consideration” which
requires every company to make themselves aware whether or not hazardous chemicals
could be replaced by more environmentally sound alternatives. The Irish Government
programme introduced a commitment to adopt both the "precautionary" and the
"polluter pays" principles in all policy areas and at all levels of Government.
• The Oeko-Tex concept is based on a voluntary scheme applied in the textile supply
chain. It facilitates informed choices among textiles depending on the presence of
hazardous components in the textile product.
1.4.5 Case studies
Section 2.6 contains the summaries of the ten individual case studies. The selected cases
cover chemicals in a variety of products and processes, serving a range of functionalities
including cleaning operations (metal parts, facades, textiles), coating / painting / inking
operations (marine anti-foulings, wood preservation), fire resistance (flame retardants in
printed circuit boards), lubricants and process fluids (loss lubrication, mould release agents),
energy storage (rechargeable batteries) and plasticisers (phthalates in toys).
Key factors which are relevant for all case studies are identified and conclusions are drawn
from the cases. The case studies illustrate that there are various ways of substitution.
Consequently, the case studies offer different possibilities of interpretation. Beyond the
companies’ classical internal criteria focusing on technology and economic aspects, external
considerations such public concern about health and environmental risks come into view.
In all case studies, quite a number of stakeholders were involved. These include, besides

companies along the supply chain, government and administration, science and research in
the field, and in most cases also “the public” (media, politicians, NGOs).
Each case study starts with a factual description of the technical case, i.e. the application of
a substance in its technical environment, followed by a presentation of scientific evidence
about potential risks associated with this particular substance. The development of the
various stakeholders’ attitudes and initiatives over time is examined, eventually leading to
the development of alternatives which in turn have certain implications for business practice.
Extended case descriptions are laid down in Annex IV.
1.4.6 European conference on substitution of hazardous substances
On 13-14 June 2002 the European conference on Substitution of Hazardous Substances was
held in Hamburg. The conference was organised in order to raise awareness on substitution
as a policy and management concept, and to stimulate dialogue and understanding on how
successful substitution looks like in practice. A wide range of stakeholders, including experts
from industry, policy makers, scientists and the public, participated in the conference.
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The presentations given and views expressed at the conference are documented in Annex V
t
o this study. They have been further used as a valuable basis for the guide on substitution
which will be separately published.
1
1.4.7 Summary and overall conclusions
Section 3 summarises the most relevant aspects and influence factors which are driving
substitution. These results are based on reviewed documents from legislation, policies,
programmes, guides and assessment tools that have been described and analysed in a
structured and comparable manner in the section 2.
At first, the definition of substitution is presented (see section 3.1), followed by most
relevant aspects for enterprises based on the results of the ten technical case studies (see
section 3.2). The analysis identifies companies’ requirements and needs, motivations and

drivers, time horizons and procedural aspects of substitution.
Section 3.3 highlights the role of authorities and their possible contributions with regard to
goal setting, promoting, regulating and enforcement of substitution.
In Section 3.4 conceptual considerations on the role of substitution are summarised as a
“prevention at source” strategy for risk reduction, which however is not necessarily the “one
and only” strategy for risk reduction. Concerning the question how substitution happens in
practice, conclusions are drawn with respect to the policy framework, private sector-based
tools to support informed choices, and, last but not least, a short list of factors driving
substitution at company level, as they were identified in the course of this study.

1
“What makes substitution of hazardous chemicals happen?” – Summary for the Public (2003).
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Kooperationsstelle Hamburg
2 Substitution – policies, status, guidance, assessment and
experiences
2.1

General substitution possibilities
The EU „White Paper on a Strategy for a future Chemicals Policy“ states the general goal
that
“EU chemicals policy must ensure a high level of protection of human health and the
environment as enshrined in the
Treaty establishing the European Community (EC Treaty)
both for the present generation and future generations while also ensuring the efficient
functioning of the internal market and the competitiveness of the chemical industry.”
The starting point of this new policy initiative was an increasing concern, that the current EU
chemicals policy does not provide sufficient protection for human health and the

environment. Evaluation and assessment of the existing legal instruments in the field of
chemical legislation, i.e. Directives on packaging and labelling of substances (67/548/EEC)
and preparations (1999/45/EC), the Regulation (793/93/EEC) on existing substances and the
Directive (76/769/EEC) on market restrictions for dangerous substances and preparations,
resulted in the conclusion that a new strategy was necessary, which is now outlined in the
“Commissions White Paper”.
As one integrated part of the new strategy, the White Paper mentions the objective to
encourage the substitution of dangerous by less dangerous substances where suitable
alternatives are available as one of the concepts to prevent adverse health effects for
consumers and workers as well as environmental pollution. In the White Paper the
Commission states further that “
the increased accountability of downstream users and
better public information will create a strong demand for substitute chemicals that have been
sufficiently tested and that are safe for the envisaged use.“

While the Commission understands that substitution is an objective of the new chemicals
policy, the European Parliament states (COM(2001) 88 – C5-0258/2001 – 2001/2118(COS)),
that
“ the substitution principle – the promotion of safer practices and substances to
replace hazardous practices and substances – should be fully applied in the new policy as
key drivers to stimulate innovation towards a sustainable chemical industry, ”
. The EU
Parliament “Asks the Commission to produce a consistent and clear definition in European
law of the so-called “substitution principle” (ibid.). Furthermore the European Parliament
states that “ substitution should become a duty for manufacturers and downstream users to
avoid risks to workers as well as to health and environment in general; ” (ibid.)
Thus the objective of this study is to provide more clarity with respect to the concept of
“substitution”: Is it a principle or rather an objective of chemicals policy, and is it a principal
duty or merely a tool for risk management during manufacture and use of chemicals? To
open the debate, this section will, based on structural considerations, describe the general

substitution possibilities in the wider context of risk reduction strategies, and analyse how
they are perceived from the different perspectives of political actors vs. actors at the
company level.
2.1.1 General risk reduction strategies
For achieving the general goal of risk reduction two main concepts can be found in practice:
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• The substance oriented Hazard Reduction (HR) approach focuses on the replacement
o
r reduction of hazardous substances in products and processes by less hazardous or
non-hazardous substances or by replacing the function of the hazardous substance by
technological or organisational measures.
• The Emission Control (EC) approach aims to eliminate emission, losses and discharges
by keeping the hazardous substances in a “closed” process or product system. The focus
is on setting up technical and organisational barriers between the technical system and
the environment.
Both concepts can to a smaller or greater extent imply elimination, modification or
replacement of processes, products and services. Although the two approaches are often
intermingled with each other (see below for examples), this project’s focus is on substitution
as the main aspect of the hazard reduction approach and not on emission control. In specific
cases, it may however be important to assess the substitution option with alternative options
for emission control in a comparative way, taking into account potential trade-offs between
conflicting targets (such as e.g. risk reduction by substituting a certain solvent by aqueous
systems vs. increased energy demand for drying operations when water is used instead of
more volatile solvents).
The variety of possible strategies and the complex relations between them can be illustrated
with an example from the field of consumer products
:

Table 1 Example: losses from consumer products – risk reduction strategies
The current draft EU risk assessment under Reg. 793/93/EEC draws the conclusion that there is an
unacceptable risk for children caused by a reprotoxic plasticisers (DEHP) in indoor air. One of the
sources contributing to the indoor pollution are floor coverings. Each of the following strategies may
be successful in reduction of the actual exposure to a hazardous substance, however there are major
differences:
Strategy 1
: Substitution by less toxic plasticisers
This Strategy needs good knowledge on the intrinsic properties of the substitutes. For many potential
substitutes the necessary data are not available or could be only made available by extensive testing.
Strategy 2
: Substitution by less mobile plasticisers
The replacement of a mobile hazardous substance by a less mobile hazardous substance may be
further strategy to limit the risk with a focus on reduction of losses.
Strategy 3
: Emission control by chemical containment
Based on the idea of a “chemical containment” the flooring material may be sealed with a coating
reducing losses of plasticisers. The hazardous substance leaves the “containment” only in negligible
amounts during use.
Strategy 4
: Meeting the same functionality with an alternative solution
This strategy substitutes the whole product by an alternative flooring material e.g. natural fibre or a
different polymer without plasticisers.
At the process level, risk reduction again may be achieved by either closing the system, or
by the substitution of chemicals, which usually also implies modification of processes. The
different options illustrate the broad range of understanding of what “substitution” means.

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Table 2 Example: emission from processes– risk reduction strategies
Options to reduce exposure are described in a model for metal cleaning operations. There is a
considerable number of principal options aiming at VOC emission reduction in order to prevent
summer smog, to protect workers health and to minimise hazardous waste.
Exposure prevention by
Emission Control Hazard Reduction Process modification in order to elimi-
nate the need to use certain chemicals
Reduce or avoid the contact of the material
with dirt, e.g. no temporary surface
conservation, use a micro lubrication system
for drilling and cutting operations
• Effective use and
recycling
• Improved effective-
ness of the cleaning
devices
• Semi-automatic,
semi-closed cleaning
devices
• Fully closed cleaning
devices
• Substitution of
chlorinated hydrocarbons
• Use of less volatile
hydrocarbons
• Use of less toxic
chemicals
• Use of low volatile
agents

• Use of supercritical CO2

Use advanced mechanical cleaning
technologies (blasting, high pressure water
cleaning, plasma cleaning)

Whether the HR or the EC approach will be chosen in a specific case will be influenced both
by the type of process and the use pattern of the substance. For intermediate products
which are used on-site, in many cases an emission control approach may be a reasonable
route, whereas for products and substances used in private households or by untrained
professional users the HR approach may be favoured in order to comply with the
precautionary principle (see Figure 1), which on a long term basis will lead to inherently
safer products after all dangerous substances have gradually been substituted by less
hazardous products / ingredients.
Risk Reduction Strategies /
Use Pattern
Hazard
Reduction
Emission
Control
Risk Level
Intermediate products
(on site)



Industrial application
few plants




Application in businesses
many users / plants



Use in private households



Figure 1 Risk reduction approaches for different use pattern of substance to
achieve a common risk reduction level (originally based on AHRENS 2001)

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Taking into account these considerations about risk reduction strategies, a new working
d
efinition of substitution has been developed:
New Working Definition:
“Substitution means the replacement or reduction of hazardous substances in products and
processes by less hazardous or non-hazardous substances, or by achieving an equivalent
functionality via technological or organisational measures.”

Two main players in substitution are the legislative bodies or the administration on the one
hand and the companies on the other hand, beside others like end-users, non-governmental
organisations, the public etc. The views of these two groups of actors are significantly
different, but a comparative approach will enable a deeper analysis of the barriers and
opportunities of both sides. The influence of the other groups of actors will be discussed in

anecdotal form at a later stage in the case studies.
2.1.2 The role of political actors
Clearly, the technical measures aiming at risk reduction can exclusively be undertaken by the
companies. Legislative bodies or the administration can be seen as indirect actors in this
field, setting the main legal conditions for the activities of companies and establishing certain
framework conditions which may lead to an action of the manufacturer towards one of the
above-mentioned risk reduction measures.
Legislation is a compromise between different interests, ranging from risk reduction to
technological demands and economic considerations. In all EU Member States, legislation on
chemicals covers a wide range of laws, acts, directives, ordinances, regulations, technical
rules etc. Several pieces of legislation, mainly in the field of pesticides regulations and
substance related regulations in the field of environmental protection and workers health,
pursue the goal to use the least dangerous chemicals wherever technically possible and
economically reasonable.
Thus “substitution” is generally the replacement of hazardous chemicals by less hazardous /
dangerous chemicals as it is outlined e.g. in [NHP 2000]:
“ anyone conducting an operation or taking measures must avoid using or selling chemical
products that might entail risks to human health or the environment if they can be replaced
with such chemical products as may be assumed to be less hazardous.”
Legislators and administration use the term “substitution” in various contexts, leading to
different consequences as there are:
• Substitution as a causal argument for a market restriction aiming at relative risk
reduction;
• Substitution as a continuous duty for producers to evaluate the used substances and
alternatives and assess / compare the evaluated risk;
• Substitution as an integrated part of a management system at the enterprise level;
• Substitution as a general policy guideline without specific instrumentation.
The political strategy to realise substitution can refer to different political instruments, not all
of which are addressing substitution directly. Widely used instruments are:
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• Legislation (obligatory or indicative), e.g. complete or partial bans, market restrictions,
c
ontrol duties, registration duties, classification and labelling duties, information and
reporting duties.
• Voluntary environmental or OSH-agreements between associations, authorities and
associations, inside branches etc.
• Support for better chemicals management, as e.g. awards for environmental
management systems, guides etc.
• Financial incentives for companies, e.g. lower fees for less hazardous waste
• Research and innovation programmes, e.g. for cleaner technologies
• Information and dissemination campaigns, e.g. information about regulation, about
simple chemical management rules.
As it is stated in the White Paper that “the allocation of responsibilities between these two
main actors is inappropriate because authorities are responsible for the assessment instead
of enterprises which produce, import or use the substances”, there are attempts to
reorganise the system in such a way that the responsibility for assessment actually lies with
the industrial companies involved.
This proposed “system change” is a consequence of the concept of “producer/importer/user
responsibility” and is therefore substantially different to traditional legislative measures.
In the chemicals policy sector risk reduction approaches from different areas are merged.
From a historical point of view two main regulative fields can be found: Legislation from the
field of safety and health for workers and the younger legislation addressing the
environmental protection. For both fields the substitution of hazardous substances is an
important issue. More recently, legislation on the protection of consumers has emerged as a
third main regulative field addressing risk reduction.
Further, preparatory work aiming to develop the “Health and Environment” policy sector
needs an integrative approach taking into account the different media. Many hazardous

substances have an impact on the environment, workers health and consumers health at the
same time. For example:
• Solvents emitted from industrial production processes and chemical products may have
direct health effects or may contribute to the formation of summer smog thereby
indirectly affecting human health and plants.
• Persistent, toxic and bioaccumulative substances may have toxic effects on sediment
organisms, wildlife and may reach the breastfed human baby via the food chain
(secondary poisoning).
• Textile finishing agents and dyes which do not sufficiently completely bind to the fibre
are a waste water problem as well as a problem for workers in the textile industry and
for textile users, e.g., with regard to sensitisation.
Consequently, aspects of worker’s health and consumer’s health have to be taken into
account wherever they are relevant in relation to the environmental objectives of water
protection, process control and waste management.
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2.1.3 The company as an actor
S
ubstitution in practice can be described as a company activity in a complex environment of
economic and technological conditions, existing and expected regulations, and a number of
different actors. With increasing size of the substitution cases more outside actors play a role
and influence the outcome of a substitution initiative.
a) Typical actors inside a company
: Units or - in smaller companies - persons such as
technicians, environmental and occupational safety and health units (persons), financial
departments, purchase and sales people or workers representatives.
b) Outside market actors
: the suppliers of the chemical to be substituted, the supplier of the

substitute, the suppliers of the equipment concerned, customers etc.
c) Local or regional administrations
according to legislative requirements
d) Non-governmental organisations (NGO)
: In cases with high public interest environmental
and consumer NGOs may also be involved and can act as pressure groups
e) Industry associations
: In cases with high impact on one industry sector also associations
may be involved and can act as pressure group / initiator.
Concerning the scope of a particular case, the term “substitution” can cover a wide range of
activities. A minimum case is that the substitution is not more than a change from one
chemical to another with less dangerous properties. Such a substitution may even be done in
full consensus among the major actors - and with no or very few technical, economical or
regulative problems (e.g. substitution of a toxic façade cleaner to a less harmful one, see
section 2.6.2.2). At the other extreme, a large substitution case means a long lasting
process, possibly with conflicts inside and outside the company and including important
technical changes, economic impacts and regulatory consequences (e.g. organostannic
compounds as anti-fouling products, see section 2.6.2.4). The larger the efforts necessary to
accomplish substitution (i.e. the larger the “innovation depth”) the more barriers are present
(see Table 3).
Table 3 Communication in substitution cases
Complexity
of
substitution
cases
Communication
inside companies
Communication
outside with
market actors

Communication
with
administrations
Communication
with the public
Small Technicians and
environment/OSH
persons /units
One supplier of a
substitute




Medium important units /
persons (technicians,
finances,
environment/OSH
persons /units)
Suppliers of
substitute, other
chemicals, equip-
ment, consultants

Some relevant
administrations


Large All important units /
persons (finances,

marketing, environ-
ment/OSH persons
/units, workers rep)
Suppliers of the
substitute, other
chemicals, equip-
ment, customers,
consultants,
scientists

All possibly
concerned
administrations
Communication
with press, non-
governmental
groups, trade
unions
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From the company point of view legislative requirements from legislative bodies and
a
uthorities are manifold and may affect, besides the content of chemicals in the final
product, various aspects like e.g. waste, waste water, process emissions, recycling,
transport, storage, risk of fire or explosion, and occupational safety and health. Furthermore
other important influence factors besides legislation may exist (see section 2.2).
Normally the legislative or administrative bodies focus on one of the above aspects (e.g.
chemical safety) but the industry sectors for which they are responsible are manifold. The

complementary views are illustrated by the double pyramid in Figure 2.

Waste
Unit
Waste
Water
Unit
Chemical
Safety
Unit
OSH-
Unit
Transport
Unit
Budgeting
Unit

Sector I Sector II Sector III

Enterprise I
Enterprise II
Enterprise III
Enterprise IV
Enterprise V
Enterprise VI
Enterprise VII
Enterprise VIII
Enterprise IX

Figure 2 Company view and political view
On the other hand, for the analysis this means that a general view on chemicals legislation
alone will not be sufficient to understand difficult and complex substitution cases.
It is the task of local, regional and national administrations to deal in practice with this highly
complex regulative situation - from interpretation to enforcement (see sections 2.3 and 2.4).
To analyse this rather complex field more deeply, two main routes can be followed: A
bottom-up approach, in which the outcome of combined legislation and other factors is
analysed with a view from the enterprise level, and a top-down approach in which different
policy instruments are analysed for their effectiveness (see section 2.5). This report will
follow mainly the company view of substitution, and the effects of administrative or
legislative activities are mainly evaluated from this perspective in order to interpret how
these activities work in practice.
Adopting the company view implies at the same time a slight change of perspective, starting
from the functionality of a substance in the system of its complex application (product or
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process) rather than from the single substance which may be in focus of the chemicals
r
egulator. Consequently our case studies (see section 2.6 and Annex IV) focus on such an
integrated product (or process) approach, which is in accordance to the EU-Commissions’
Green Paper on Integrated Product Policy (IPP), that states
“Rising consumption of products
is at the origin of most of the pollution and depletion of resources our society causes.“

and claims for
“ a strategy to strengthen and refocus product-related environmental
policies to promote the development of a market for greener products“.
When considering the substitution of a chemical/material, companies typically evaluate

substitute materials along requirements such as:
• Technical functionality of the substitute (product or process),
• Quality of the final product,
• Process integration,
• Environmental risks,
• Health risks,
• Economy,
• Availability of the substitute,
• Marketing aspects as design (optical effects, gloss),
• Qualification of employees,
• Safety aspects,
• Guarantee and liability regulations and
• Country specific aspects.
The materials or chemicals conventionally used have the principal advantage that they have
proved their technical functionality already in the past. Only in very simple substitution cases
all necessary information on the possible substitute(s) is easily available. The information
sources may be just as wide-spread as the parameters to consider, and it is a hard task to
obtain a full picture. The potential and the motivation to get and interpret all the information
differs of course from company to company. External consultants and local administrations
are often used as advisors, for small companies mainly the suppliers of chemicals take the
function of the basic information source.
There exist also a number of process or sector specific substitution support guides. These
tools claim to help companies with a full assessment of a chemical substitution including
technology, economy, instruction/qualification needs and risk assessment methods (see
sections 2.3 and 2.4).
A company’s internal priority setting obviously depends on the available options and depends
on the impact of the various influence factors. If the market moves fast towards products
which do not contain a certain chemical, then there is no chance to set any other priority
than on substitution. The same is valid if a strict ban is enforced.
The more common case for substitution is, that there are several options and the real deci-

sion has to be negotiated between the actors in the company, taking into account outside
influences as legislation enforcement, company image, public pressure etc. (see section 2.6).
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2.2

Status analysis: legislation, policy and programs in the EU
2.2.1 Frameworks for substitution
In the EU and its member states efforts towards substitution of hazardous substances can be
found in numerous pieces of legislation and public programs. As outlined in section 2.1.2
public policy can make use of different strategies to promote substitution of hazardous
substances by less hazardous solutions. In principle, one can identify five main, but not
exclusive options. Figure 3 may facilitate better understanding how public policy (including
regulations) can influence the behaviour of companies in the market.
• Substitution of hazardous substances is introduced as a policy goal or as a “duty of
consideration”, however the duty to consider less hazardous alternatives and to make
good choices remains at company level. The authorities may check from time to time the
efforts made by industry to actively screen the market for better solutions.
• Policy makers concentrate their regulatory activity on setting up the pre-conditions for
informed choices in the markets. This includes mechanisms to increase the availability
and accessibility of good quality product information (e.g. harmonised classification and
labelling rules) and
internalisation of external costs into market prices (e.g. by liability
laws triggering ensurance requirements, tax laws). Subsidies to improve the
competitiveness of less hazardous solution would be regarded here as politically intended
externalisation. To this end, public policy aims to make use of market drivers in order to
achieve substitution of hazardous chemicals. However such policy driven market
mechanisms may compete with purely economical market drivers as illustrated by the

case studies in section 2.6.
• The authorities set up restrictions on marketing and use, and by this promote the search
for substitutes in the market. These restriction can be directly laid down in chemicals
legislation (EU “harmonised legislation”)
2
, addressing the producers and importers of
chemicals. Two general mechanisms are used for such restrictions: 1) Substances e.g.
intended to manipulate biological processes (plant protection products, pharmaceuticals,
biocides) may only be marketed and used after authorisation. 2) Very hazardous
substances can be banned for use in those applications where they pose an unacceptable
risk. For biocides, authorisation or marketing and use restrictions already include socio-
economic analysis with regard to the societal need for the substance and available
alternatives. By imposing marketing and use restrictions the authorities direct the market
towards alternative solutions.
• Indirect marketing and use restrictions can be set by “down-stream legislation” (EU
“minimum standard legislation” related to environment or occupational health)
3
. For
certain product groups or applications, the national authorities take the lead to work out
detailed requirements and recommendation on the available substitutes, like for example
in the German TRGS 600 series. In addressing the users of chemicals by regulatory
measures authorities trigger a pull towards development of less hazardous chemicals by
the chemical manufacturers.

2
based on article 95 of the Amsterdam Treaty
3
based on article 138 and 175 of the Amsterdam Treaty