SUBSTITUTION OF HAZARDOUS CHEMICALS IN PRODUCTS AND PROCESSES potx

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 rep

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

22765 Hamburg Germany

20097 Hamburg Germany

Executive Summary

Substitution of hazardous substances by less hazardous alternatives appears to be a

straightforward approach when enterprises consider management and reduction of related risks Substitution is also debated in the context of the future chemicals policy in the

chemical-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

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

be the decision-maker whether substitution takes place or not The cases cover a wide range

of 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

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:

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

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

for implementation

To summarise, the motivation of companies to substitute specific substances differs

significantly from other stakeholders’ attitudes Decisions taken in enterprises are influenced

by policy, regulation and enforcement, technology development, economy and market, scientific finding and the public debate Both environmental legislation and public pressure are seen as relevant external factors

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

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

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 goalsand 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

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

3.2.1 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

Annex II Standardised short descriptions of guidance documents 15 Annex III Standardised short descriptions of the assessment tools 25

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

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

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

OBS Observation List (Sweden)

OHS Occupational health and safety

PER Pollutant Emissions Register

PPP Plant Protection Products

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

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

In order to focus the study, the term “substitution” had to be defined As a working

definition, 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

project has focused on the various influence factors on companies’ internal decisions for or against 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

1.4.4 Examples of substitution policies and management

These 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

The presentations given and views expressed at the conference are documented in Annex V

to 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)

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

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

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:

• The substance oriented Hazard Reduction (HR) approach focuses on the replacement

or 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

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

• 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

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)

Taking into account these considerations about risk reduction strategies, a new working definition 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:

• Legislation (obligatory or indicative), e.g complete or partial bans, market restrictions, control 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

2.1.3 The company as an actor

Substitution 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

market actors

Communication with

administrations

Communication with the public

Small Technicians and

environment/OSH persons /units

One supplier of a

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

From the company point of view legislative requirements from legislative bodies and

authorities 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

Unit

OSH-Transport Unit

Budgeting Unit

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

process) rather than from the single substance which may be in focus of the chemicals regulator 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 sion has to be negotiated between the actors in the company, taking into account outside

deci-influences as legislation enforcement, company image, public pressure etc (see section 2.6)

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

• The authorities take the initiative and launch various kinds of support programs in certain sectors of industry or related to certain types of products, including financial support or specific information tools They leave it however to the enterprises and relevant

stakeholders, to develop and assess better solution and to make the right choice at the end

Chemicals Producers Users of Chemicals

Regulatory Drivers

Enforcement

• Protection of Workers Health

• Prevention of waste, discharge, emission

• General Product Safety

• Registration or Authorisation

• Classification and Labelling

• Restriction on Marketing and Use

EU Minimum Standards Fully Harmonised

The Conceptual Model

Technology Push Demand Pull

Regulatory Push Regulatory Pull

Public Policy

Market Drivers

Players in Supply Chain

Producers of Substances

Users of Chemicals

of Costs

Figure 3 Conceptual model of public policy making and regulatory drivers

Traditional strategies and measures can differ widely, as they can

reduction or prevention and allocate responsibility for risk prevention at company level (SP); for very hazardous (e.g carcinogenic) substances, the preference on substitution may be a formulated as a strong legal requirement (see section 2.2.2);

laid down in different regulative fields, e.g waste management, prevention of emission, protection of workers health, direct marketing and use restrictions (see section 2.2.3);

awareness for the hazard of certain chemicals (see section 2.2.4);

and industry (see section 2.2.5);

• classify and label certain products or substances in order to inform the user in a short form about possible impacts of a substance, preparation or article (see section 2.2.6) and

• introduce financial incentives for substitution, as for example a reduction of taxes for companies having successfully replaced hazardous substances by better alternatives, or introduce a levy which is differentiated according to the level of risk or hazard of the substances in use (see section 2.2.7)

Each of these strategies may promote substitution of hazardous substances in practice The different legislation or programs will be mainly discussed along the categories outlined above, with a focus on legislation at the European level Member States have transposed this legislation into their national legislation These national laws derived from European

legislation will only be covered separately if they include some special regulations about substitution

The standardised short descriptions of the single instruments have been placed into the Annex I

2.2.2 Introduction of substitution preferences into legislation

In the new Swedish Guidelines on Chemicals Policy the duty to prevent risks from hazardous chemicals is formulated in general words [NHP 00]: “ 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

product aims at reduction of risk to human health and environment

A “substitution principle” can be introduced as an obligation for companies to (continuously) check whether less hazardous substitutes exist, or it might be part of the authorisation

process for a specific group of products like for example biocides or plant protection

products

2.2.2.1 Substitution as preferred risk prevention measure at company level

The first approach could be found at national and EU-level, mainly in the legislation related

to workers health The general rule of substitution applies for workplaces in all EU Member States:

If a less hazardous substance is available and can be introduced with reasonable means it has to be introduced Article 6 of the EU Chemicals Agent Directive (98/24/EC)

sets up a hierarchy of measures to prevent or reduce risks arising from chemical agents at work:

• substitution of hazardous substances by non hazardous or less hazardous agents or processes

• minimise releases by engineering control including closed systems

• take collective protection measures , like general ventilation

• take individual protection measures

The main differences between Member States arise from the different interpretation of the

“reasonability” of such a substitution The two main questions might be:

• How to assess, whether a chemical is the less hazardous?

• Which level of technical, economical or practical efforts or disadvantages for the

companies are regarded reasonable?

As one example the German Dangerous Substances Ordinance (Gefahrstoffverordnung) applies a “substitution principle” as it mentions an obligation to substitute hazardous

substances where this is necessary for preventing harm to workers health, provided that the less harmful alternative can be applied with reasonable (economical and practical) efforts Additionally, the processes which are emitting hazardous substances should be substituted

by processes from which no or less hazardous substances are emitted, where such measure

is regarded as reasonable

The described evaluation process has a continuous character as the substances used have to

be evaluated on a regular basis

SP 1 (see Annex 1)

Some other national legislation on environment and workers health also address an

obligation for risk reduction and specifies thereafter possible measures how to proceed Generally, control hierarchies are defined, and substitution can often be found at the top of the preferred measures No document could be found however, which evaluates the degree

of enforcement of the measures given in the control hierarchies For example, in the Austrian Regulation of Water Protection Act, substitution is mentioned as one technical option beside others to prevent contamination due to industrial waste water discharge The criteria

mentioned for the substitute are “less hazardous” and “high biodegradability” However, no obligation to substitute is mentioned

SubOp 1 (Annex 1)

Other examples for such legislation are national laws and ordinances as COSSH -Control of Substances Hazardous to Health Regulations (UK), Chemicals Act and Dangerous Substances Ordinance (DE) , Environmental Code and Chemical Products Act (SE), Environmentally Hazardous Substances Act (NL) etc

For substances with very hazardous properties like carcinogenic or mutagenic substances, the legal requirements to substitute are more stringent compared to the general preference,

as described above Directive 90/394/EEC on the protection of workers from the risk related

to exposure to carcinogens at work for example, includes an obligation to substitute

carcinogen substances if technically possible Consequently, if the use if the carcinogen is maintained, the employer must provide justification to the authority upon request If

replacement is technically not possible a closed system is required If this is not possible either, obligations to decrease the exposure as much as possible and some kind of

monitoring must be applied

The high efforts to be undertaken for maintaining the use of carcinogens may also work as

an economical inventive to avoid the use of such hazardous substances at all (saving risk management costs)

Osub 1, 2 (Annex 1)

The Directive 99/13/EEC on the limitation of emissions of volatile organic compounds related

to the use of organic solvents in certain activities and installations (VOC-Directive) includes a similar obligation to substitute solvents meeting the criteria for CMR category 1 and 2 Osub 3 (Annex 1)

2.2.2.2 “Substitution” within authorisation

The introduction of the “substitution principle” into authorisation processes is the second strategy found here In this strategy, substitution is not the user’s obligation and it is also

not continuous task It is may be applied by the Competent Authorities once during

substance or product authorisation or re-evaluation after specified time intervals

Directive 98/8/EEC on placing biocidal products on the market is a regulative instrument in which an option for comparative assessment is described The Directive (article 10 (5)) sets also criteria which have to be fulfilled by the substitute, like e.g i) ensuring adequate

chemical diversity to prevent resistance of micro-organisms, ii) ensuring same functionality, iii) presenting significantly less risk, iv) avoiding economical and practical disadvantages SP2 (Annex 1)

2.2.3 Prohibition of certain substances in certain uses (ProSub)

The substitution in this context can be categorised in two hazard reduction (HR) approaches: 2.2.3.1 Complete ban of substances or groups of substances

This is the strictest form of the HR-approach - the total ban of a substance or a group of substances Well known examples are asbestos, PCP and PCB as well as organic lead Only a few exemptions for very special purposes are made

2.2.3.2 HR 2: Partial ban of chemicals depending on the type of use

This is a much more common form of hazard reduction The restriction of the use is

executed for those applications with high risks Typical restriction criteria can be seen in Table 4

Table 4 Restrictive policies

Risk of a hazardous

substance

Use accepted in

Risk of a hazardous substance

Use not accepted in

Examples

Closed handling Open handling Chlorinated Hydrocarbons

Industrial / Commercial use Private use Pesticides, TBT,

CMRs in general Special industrial application General industrial use Cyanides in galvanic

processes or mining

Restriction on certain substances can be found in legislation from a variety of contexts and aim different goals to achieve Main contexts and goals are:

• Prevention of water pollution,

• Legislation in the context of waste management to prevent contamination of waste,

• Prevention of exposure of workers to certain hazardous substances and

• Keep products free of hazardous substances in order to prevent health risk for users or contamination of the environment

Many national Water Acts or the secondary legislation based on it traditionally restrict the discharge of certain specified hazardous substances in certain industrial sectors

Examples for substances of concern prohibited for specific industrial sectors by the Austrian Water Protection Act (Wasserrechtsgesetz, WRG) are shown in the Annex This can be seen

as the result of an evaluation procedure within these sectors by referring to the prevention techniques generally available (Best Available Technique)

ProSub 1 (Annex 1)

Based on Directive 96/61/EC concerning Integrated Pollution Prevention and Control (IPPC) the ongoing Sevillia Process establishes Best Available Techniques for the most common industrial processes in Europe Definition of BAT includes options to prevent pollution by ”the use of less hazardous substances” in the processes.4

SubOp 2 (Annex 1)

Council Directive 75/442/EEC on waste, establishes the “Polluter Pays Principle” and the possibility for Member States to develop market restrictions for products leading to waste problems upon disposal

ProSub 3 (Annex 1)

Along the same lines, the German Recycling and Waste Directive mentions the option to prohibit certain products if the product leads to unacceptable effects upon waste disposal or treatment

ProSub 4 (Annex 1)

A concrete example of prohibition of substances related to waste management can be found

in Directive 2000/53/EC on end-of-life vehicles which specifies obligations to collect and recycle scrap cars, including technical rules to avoid the diffusion of hazardous substances from treatment operations Furthermore, Art 4 1 (a) of the Directive calls on Member States

to encourage vehicle manufacturers, in liaison with material and equipment manufacturers,

to limit the use of hazardous substances and to reduce them as far as possible, to prevent their release into the environment, making recycling easier, and avoid the need to dispose of hazardous waste More specifically, Art 4 2 (a) generally prohibits the use of lead,

cadmium, mercury and hexavalent chromium in car manufacturing, with certain exemptions from the general prohibition laid down in Annex II to the Directive.5This Annex has to be amended on a regular basis according to technical and scientific progress This makes the process towards substitution of the four elements lead, cadmium, mercury and hexavalent chromium rather dynamic

4 Similar requirements have been laid down earlier in existing legislation of Member States, e.g in the Principal Requirements for Plant Operators in the German Technical Guideline for Emission Control (TA Luft, 1986, N° 3.1.2).

5 The upcoming Directives on Waste Electrical and Electronic Equipment (WEEE) and Restrictions of Hazardous Substances (ROHS) are very similar to the concept of Directive 2000/53 and are therefore not discussed in detail

ProSub 2 (Annex 1)

2.2.4 Listing substances (LiSub)

Setting up lists of (hazardous) substances is one of the most widely used strategies to

facilitate risk prevention or risk reduction Such lists can be long or short, can be based on transparent and widely accepted criteria or they can be just an instant collection of

substances The lists may contain substance names only or they include detailed information

on the substance properties

The purpose of such lists may vary as well: “Positive Lists” contain substances which are recommended for use “Black Lists” flag substances for risk reduction measures, e.g

rigorous containment or replacement by less hazardous solutions “Priority lists” often flag substances of concern for which the extent of concern and the need of specific measures shall be determined as a matter of urgency A forth type of list contains substances with known or suspected (very) dangerous properties which need particular attention when used 2.2.4.1 Internationally accepted lists

Annex 1 to Directive 67/548/EC on classification, labelling and packaging contains about

5000 dangerous substances with harmonised classification and labelling requirements The substance list (annex 1), the classification criteria (annex 5) and the testing methods (annex 6) are continuously updated, 28 times up till now Classification as CMR of category 1 and 2 for example means at the same time that these substances are prohibited in consumer applications and must be labelled with cross-bones in professional applications Substances occurring on annex 1, in particular if they are classified as CMR or as sensitiser, are usually subject to market driven substitution

The substances listed on annex 1 represent only a subgroup of substances meeting the classification criteria For all other dangerous substances, the producer or importer is

responsible to assign appropriate preliminary classification (article 6 of Directive 67/548) However, due to the large gaps of knowledge on the properties of substances having been placed on the EU market before 19816, it is assumed that many classifiable substances remain in market without proper classification In order to facilitate availability of information

on potentially hazardous properties, the Danish Environmental Agency has carried out a modelling based screening exercise on 47.000 substances, resulting in the “Advisory list for self-classification of dangerous substances” About 20,600 of the 47,000 substances under investigation are deemed to require classification for one or more dangerous properties The list can be used when substances are to be assessed which are not listed in annex 1 to Directive 67/548 and for which sufficient hazard information is not available It should help the suppliers and users of chemicals in Denmark to classify substances Although not

binding, the Danish EPA calls upon importers or manufacturers to use the advisory list as a tool in their own assessment

Within the EU Existing Substance Program (regulation 793/93), the available data on about

2500 high volume chemicals have been screened, and four priority list for risk assessment on Community level (total of 140 substances) have been published by now Based on a

modelling based risk ranking procedure, risk assessment of these substances is highly

6 This is more than 99% of the current market volume

expected to have regulatory outcome However, whether or not substitution is the preferred risk reduction strategy cannot be concluded based on these lists, since a risk reduction strategy will be worked out by the member states only after conducting the risk assessment The Water Framework Directive (WFD) 2000/60/EC requires in its Article 16(5) the establish-ment of a priority substance list The substances of EU-wide of concern were selected in a monitoring and modelling based risk ranking procedure and decided upon separately in Decision 2455/2001/EC Presently 33 substances (substance groups) are on the priority list, and the Commission will make proposals for measures by 2004 The measures may also include substitution of these substances in products and processes Furthermore, the

member states are requested to establish also for other chemical substances river specific priorities, taking into account the regional environmental circumstances and

basin-industrial sectors present Hence, in future additional priorities to minimise or cease releases

of hazardous substances in certain river basins may be set up by the water authorities in order be implemented by the companies

Already before the Water Framework Directive entered into force, lists of possible concern, priority lists for measures and also positive lists have been set up for the EU marine area or

at global level:

• Under the Stockholm Convention Persistent Organic Pollutants are listed, aiming at a global cessation of use and/or releases 12 substances have been listed so far, the list will be extended in future These substances are, as far as contained in marketed

products top candidates for phase out of production and use

• The OSPAR list of priority substances for action (OSPAR Strategy with regard to

hazardous substances, Annex 2, 1998, latest update 2002) contains 36 substances or groups of substances, for which measures have been worked out under OSPAR, aiming

at cessation of emission, discharges an losses Such measures include substitution

• OSPAR’s list of substances of possible concern (latest update 2002) has been set up based on intrinsic properties only It contains about 390 substances suspected to be persistent, toxic and liable to bioaccumulate or suspected to have endocrine properties

• OSPAR’s PLONOR-List is a positive list of chemicals used in offshore-installations, which are considered to pose little or no risk to the Environment” (PLONOR) The substances

on this list are mainly inorganic alkali or earth alkali salts and organic substances with rapid biodegradation like short chain alcohol’s For use of chemicals mentioned on this list, data requirements are lower than for other non listed substances

2.2.4.2 National lists and industry sector lists

A strategy to promote substitution is the publication of

i) names of “undesired” substances,

ii) lists of substances which need particular attention or

iii) lists of preferred chemicals (positive lists)

These lists may be published by national authorities or by other organisations like

associations or other non-governmental organisations Also large industrial companies e.g in the automobile or electronic sector, do actually circulate informal lists among their suppliers, highlighting preferred and unwanted substances as a purchasing criteria Most lists

mentioned have no legally binding character but are recommendations or informal regulatory

signals In some cases - if such lists are issued by governmental agencies -, a company which follows the recommendations can be released from some administrative burden or control measures Examples of a sector specific voluntary initiative of associations can be found in

• the Attachment to the „Voluntary Commitment regarding the classification of textile agents according to their relevance for water systems“ by TEGEWA (Federation of

manufacturers of textiles, leather, tanning agents and detergents)

• “the Guidance Document on the Appliance of Substances under special attention in Electric & Electronic – Products” which was published in 2000 in co-operation of the European Chemical Industry Council (CEFIC), associations from the electric and

electronic sector and the European association of Metals (EUROMETAUX) In this

document 14 substances are listed, and it covers information about the chemical use pattern, established properties and results of toxicological studies, the status of

assessment currently under way, and including information on eco-labels It aims to give users and companies comprehensive and practical information about chemicals

More general lists of substances which may be of particular concern have been issued by e.g the authorities in Denmark, Sweden or Finland:

• The Danish Environmental Protection Agency has published the List of undesirable

including chemicals with possible future risks, independent of the production figures The list of undesirable chemicals (75 substances) describes more in detail those chemicals from the effect list with an annual production over 100 tons Both lists are indicative and show the supplier and the user which substances might become more strictly regulated

in near future The lists provide an information tool that enables e.g enterprises or authorities to get aware of substances of concern which are not yet or not sufficiently regulated or which are subject to further investigations

LiSub 2 (Annex 1)

• Swedish Chemicals Inspectorate [KEMI] has published the Observation List (1998), a list

of 250 particular hazardous chemicals, for which the KEMI recommends to seriously reconsider the use in products and processes For each substance in this list, i) the criteria why it was selected, ii) the product types and applications of concern and iii) the frameworks in which it is already regulated are provided The list was set up based on information available in the Swedish national register on chemical products

LiSub 1 (Annex 1)

• In Finland the “first priority list of hazardous substances in Finland” (FEI 01) was

published in 2001 in order to “evaluate the hazard potential of chemicals and also to support the substitution principle” The proposal contains 80 chemicals of which 57 are industrial chemicals, 17 and 13 are biocidal and pesticidal active substances, respectively The selection is based on the PBT (persistent, bioaccumulative and toxic) criteria under special considerations of the specific conditions in Finland concerning climate, soil, lakes and Baltic Sea In addition, also 7 endocrine disrupting substances and 8 metals have been included Substances for investigation have been selected from the Finnish register

of chemical products (KETU) thereby taking the specific industrial sectors present in Finland into account On the one hand this list serves as a basis for identification of

relevant substances for the purpose of the national implementation WFD and 76/464/EC, but on the other hand also has to be used as guide for the permit procedure for

industrial plants under the IPPC Directive (96/61/EC) in order to consider this national priority substance list in the Finish environmental permits procedure laid down in the Finish Environmental Protection Act 86/2000 and the Environmental Protection Decree 169/2000 to determine for which chemicals there have to be limit values The

environmental permit scheme in Finland includes all industry sectors irrespective of their size and amount of substances discharged Therefore also downstream users and small SMEs are included in the system The substance list furthermore lays down a basis for the obligatory reporting of the MS to the Commission with respect to environmental pollution emission register (EPER)

• In 1999, the German Federal Institute for Safety and Health (FIOSH) published a positive list of recommendable new colorants It is directed to enterprises using textile, paper plastic or leather dyes or producing pigments for paints, lacquers, inks etc The list should be used by these enterprises to be in accordance with the substitution principle of Hazardous Substances Ordinance § 16 Section 2, which requires the user of chemicals to employ substitutes for hazardous chemicals and preparations wherever possible and appropriate The List contains more than 60 substances, which have been notified as new substances in accordance with the Chemicals Act until 1998 Due to the fact that for the same purpose substances with different hazard profile were notified, the German FIOSH felt responsible, to publish the products with the least hazardous properties This approach, well functioning with new substances usually does not work well with existing substances since often systematic comparison fails due to the incomparability of data

Li Sub 3 (Annex 1)

2.2.5 Promoting substitution by voluntary European-wide agreements (SubVol)

In the printing industry the UV-Technology is seen as a method to improve the effectiveness

of printing and parallel the environmental performance UV-Curing inks contain no or

negligible amounts of VOC However, this new technology bears new risks as exposure to ionisation, strong UV-light and ozone, electric beams) Mainly the acrylates necessary for the curing can cause serious skin diseases

To support the safe introduction of a generally favourable technology, Health and Safety Authorities form Germany (BG), the UK (HSE); France (CNAMTS) and Italy (ISPESL) agreed voluntarily on a “JOINT BG/HSE/CNAMTS/ISPESL – PROTOCOL ON IMPROVED CONDITIONS

OF USE OF UV-TECHNOLOGY IN THE PRINTING INDUSTRY IN GERMANY, THE UNITED KINGDOM, FRANCE, ITALY AND OTHER INTERESTED MEMBER STATES OF THE EUROPEAN UNION” The selection of the least hazardous acrylates is done by using a list of acrylates according to the requirements of 67/548/EEC and 88/379/EEC It has been prepared by CEFIC UV/EB group, which consists of nine chemical producers of acrylates

SubVol1 (Annex 1)

2.2.6 Promoting substitution by obligatory or voluntary labelling

When products are labelled with risk phrases, this can

• raise the awareness of the hazard of this product and thus make sure that the

appropriate security measures are applied

• raise the awareness and initiate the search for alternatives e.g by eco-labelling

The core of legislation for classification and labelling is the directive 67/548/EEC Council Directive of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances This Directive had been amended 8 times and adapted to technical progress 28 times till now In 1999 the new Directive 99/45/EC on classification and labelling of dangerous

preparations entered into force, i) complementing the classification and labelling system for chemical products with an element related to the environment and ii) setting up an

obligation to inform customers on request on all dangerous substances present in a

preparation

LabSub1 (Annex 1)

The Directive 2001/58/EC on Safety Data Sheets (SDS) amends the existing format to

provide safety data sheets for dangerous substances and preparations Since summer 2002 this includes also preparations dangerous to the environment The Directive contains a detailed standard format how the relevant information have to be reported It is the most relevant source of hazard and safety related information for professional users The

information covers aspects as identity of the substance or preparation, including quantitative information on dangerous ingredients It provides a basic hazard identification, information about physical and chemical properties, stability and reactivity, toxicological information, ecological information and information on disposal The usual exposure controls and personal protection measures have to be provided At the same time, SDSs are a first aid document in cases of accidents It contains information about handling and storage, transport and

relevant regulations applying to the particular chemical

Manufacturers, importers or distributors of substances or preparations (“persons responsible for placing on the market”) are obliged to prepare an SDS for all their products containing dangerous substances including preparations which are not classified as dangerous (but which contain dangerous substances > 1%) The SDS is made for professional users, not for the consumer

Safety data sheets could be one of the basic tools for qualitative comparison of hazards posed by chemicals and hence could facilitate a systematic comparative assessment At present a fair comparison is often not possible due to the insufficient quality of many safety data sheets

LabSub2 (Annex 1)

The official labelling and classification is a very effective information for users of a chemical because it is directly visible on the packaging Especially for chemically non-qualified users and for SME outside the chemical sector the legally required labelling is the basic short information In this way it promotes substitution in a broad sense, since it raises awareness and allows for comparison of danger symbols and the risk phrases of products

In the case of eco-labelling, the absence of certain hazardous substances is frequently a key criterion Thus the eco-label award is given to those products where substitution of the hazardous substance has been successfully achieved Prominent examples of labels are the German Blue Angel, the Nordic Swan, the Euroflower of the EU, the Danish Mal-code system for lacquer (see section 2.4) or the textile label Ökotex 100 (see section 2.5.3)

2.2.7 Promoting substitution by financial incentives (IncSub)

Another approach to promote substitution is to charge a levy on hazardous chemicals in order to generate an economical advantage for non- or less hazardous chemicals On the other hand taxes for companies that comply with certain non legally binding regulations / indicative rules can be lowered

Such taxation systems can address a product group, a specific substance or a group of substances and it may be related to certain sectors of industry

One example of a product related taxation system is the levy system on pesticides that was introduced in Norway in 1999 It lays down an environmental tax for pesticides, determined

by the adjacent health and environmental risk of the chemical

Although the use of Plant Protection Products (PPP) is comparatively low in Norway, cold climate and heavy rainfall create a great awareness of this topic The calculation system for levies is based on both, exposure and intrinsic data The “basic fee” for each pesticide

product is multiplied by a factor between 1 and 8 depending on the assigned environmental / health risk Therefore more hazardous products will be more expensive than those one with low or no hazardous properties

Overall this strategy may lead to the use of less hazardous pesticides and to a limitation of quantities used due to the higher costs of these products It is a dynamic because it works with the help of economic incentives According to the Inspectorate the system was

introduced in 1999 but has not yet been evaluated It was stated that farmers have changed attitude since introduction of levies and chose PPP with low levies in the case they have a choice (Agricultural Inspectorate, pers comm.)

IncSub 1 (Annex 1)

A substance related taxation system is proposed by the Danish Ministry of the Environment

in their “ Action Plan for reducing and phasing out phthalates in soft plastics“ published in

1999 The proposed taxation is one of the main instruments mentioned in the action plan The tax shall apply to phthalates in a number of selected product groups for which the tax system was applicable The tax system has a qualitative basis as the tax does not vary in relation to the exact phthalate content On the one hand this helps to keep the tax more simple, but on the other hand will force manufacturers to choose alternative materials or plasticisers so that substitution ensures a complete elimination from the products It is stated

in the action plan that from a technical point of view the reduction the percentage of

phthalates in the products is not a reasonable route anyway

It is proposed that the tax should be restricted to apply only to certain plastic goods where it

is deemed possible that the tax will work, and where the products are homogenous so that a standard-rate tax based on weight can be calculated on the basis of expected PVC and phthalate contents The taxes are reimbursed in connection with exports to keep

competitiveness of Danish enterprises on the export markets

In effect, the taxes on phthalates in selected product groups may lead to lower total sales due to price rises This downturn in sales for each of the relevant product categories

depends on the price increase and its impact on demand (price elasticity) Therefore the tax may lead to an effective substitution enforced by economic incentives Also substitutes with higher prices than the presently used materials / phthalates may find better opportunities to enter the market The qualitative nature of the tax model will make emission control

measures unfavourable for companies

Another instrument mentioned in the action plan is to support the development of

alternatives to phthalate plasticisers by subsidies From this the availability of alternative materials / plasticisers can be enhanced and might at the same time motivate manufacturers

to start development of substitutes

IncSub 2 (Annex 1)

Since 2001 all Danish companies have to pay a work environment tax (Arbejdsmiljøafgift) Companies can get a bonus if they are certified as a company with a good working

environment This certification is a general rule and covers all aspects of the work

environment In the process of certification substitution will play a role, the certification process will start in 2002

IncSub 3 (Annex 1)

2.3 Practical guidance on substitution

This section describes publicly available practical guidance and assessment tools for

substitution in European Member States A combined description of documents on guidance and assessment appears to be the best way of presenting these two issues, because both tools are in most of the cases combined: Guidance needs assessment in advance - if

assessment leads to alternative options of practical handling, then guidance is needed Therefore assessment tools form an integrative part of guidance documents, and thus are either directly included or cross-reference is given to appropriate tools

For an analytical distinction we define assessment tools as “tools laying down or proposing a specific methodology, which is applicable to one individual step in an evaluation process” In this report we will focus primarily on assessment tools supporting the choice to make the last step, i.e help finding the most appropriate way out of several optional measures Therefore assessment tools are an integrative part of the guidance document and are directly included

or reference is given to appropriate tools

At a first glance, guidance for substitution is very simple The general rule of substitution applies for workplaces in all EU Member States:

If a less dangerous substance is available and can be introduced reasonably it has to be introduced (according to e.g Dir 89/391/EEC, 98/24/EC)

The main difficulties arise from the practical interpretation of terms such as “less dangerous” and “reasonability” in the different contexts

The assessment and the drawing of appropriate conclusions is in practice not easy To help companies and all actors in this field, national competent bodies developed different models for this practical assessment Companies themselves made internal guidance documents A number of assessment tools for the handling of dangerous substances have been developed

by scientists (SÖRENSEN 1992) The following description is focused on those models issued

by relevant authorities or by companies

2.3.1 Types of guidance on substitution and their general structure

From the literature survey of this study several guidance documents could be identified in which a general or concrete route how to substitute hazardous substances against less

hazardous substances is laid down The guidance documents found can be divided in three main categories according to the addressee targeted:

• Governmental Guidance which is addressed to members of official governmental

institutions which have to carry out risk analysis and decide about risk reduction

measures for certain substances / products / processes The aim is to apply the best possible methodology to find the appropriate general (legislative) measures for enforcing risk reduction

• Administrative Guidance which is addressed to (local) authorities being responsible for the implementation of legislation in order to find the appropriate way how to proceed within this legislation This guidance is mainly prepared by federal or national authorities, respectively

• Practical Guidance which is addressed to enterprises as users of chemicals and to

distributors/producers of chemicals and describes a methodology which aims at

identification and prevention of risks caused by hazard substances in products /

processes etc and to identify the appropriate technical / organisational measure

All guidance documents evaluated follow a general route shown in Figure 4 where also the

political and practical guidance are shown However, not all guidance documents cover all steps Typically the guides put an emphasis either on risk assessment (steps 1 to 4) or on risk reduction measures (steps 5 to 7)

Figure 4 Typical steps in guidance for substitution

There is a huge number of guides available which are dealing with the replacement of

substances, but many of them are restricted to a specific group of products in a certain industrial or working process Some of the countries with a high rate of internet connections started to have such guide only available on the Internet (list of examples in section 2.3.3) The problems to be tackled by the companies are manifold Some characteristic ones might be:

• What is the practical interpretation of terms as “less dangerous” and “reasonability”?

• How is the practical risk assessment done?

• Which risk is connected to which risk reduction measure?

• If the alternative substance has risk sentences different from the substance now in use: Which risks have a higher priority than others?

• If there are any new risks produced, how is the assessment done?

• Does the substitution lead to other conflicts, e.g with the environmental or economic practices and policies of the company?

socio-• How many technical, economic or practical disadvantages for the company are

2.3.2 Description of selected guides

This section will present governmental and administrative guidance documents Overall 10 guidance documents were chosen for deeper analysis The documents represent a variety of guidance from different contexts These are:

G 1 Risk Reduction for Existing Substances (UK Gov / Industry Working Group)

G 2 Technical Guidance Document on Development of Risk Reduction Strategies

G 3 The Technical Rule for Hazardous Substances Nr 440 (TRGS 440)

G 4 The Column Model - a help tool for risk assessment of chemicals and options

for substitutes (acc to § 16 Dangerous Substances Act and TRGS 440 - German BIA: Institute for occupational safety)

G 5 Draft Guidance Document on Substitution of Hazardous Chemical Substances

(GDS)

G 6 COSHH ESSENTIALS: Easy steps to control chemicals

G 7 GISBAU Information system for dangerous substances in the construction

industry

G 8 The complete idiot’s guide to CHIP (CHIP = Chemicals Hazard Information and

Packaging for Supply)

G 9 Guidance Manual for Formulators and Other Professional Users of Chemicals

G 10 Environmental Label as guidance for enterprises

The document on the Risk Reduction for Existing Substances G1 by the UK Government is

addressed to rapporteurs of Member States who work in the field of risk management for the EU-Commission The document gives guidance for finding a risk reduction strategy under Regulation 793/93/EEC on existing substances If the risk assessment resulted in a concern for a substance, the rapporteur is advised to suggest a risk reduction strategy In this

guidance document a proposal is made how to proceed, starting from identification of

potential risk reduction strategies, how to implement these in voluntary or regulatory

measures and how to make the choice of selecting the most appropriate measure with the help of decision aid methods The authors primarily propose to use the risk benefit analysis, which is described in detail in an additional report by the same group of authors

At the legislative level, this proposal aims at harmonising the procedure of evaluation of risk reduction strategies within the EU This UK report can be seen as a first proposal for a EU guidance document on development of risk reduction strategies, which was actually

published by the Commission in 1997

The steps recommended in the guidance are here shortly described:

1 Identify Risks: In the first step the possible risks from the emission of the substance of concern to human health and the environment are identified on a technical basis, i.e make an exposure / emission analysis and assess the adjacent risks Risk / exposure is analysed along the complete product life cycle from the substance during processing, distribution, use and disposal

2 Identify sources: After this status analysis the most important sources for risk can be identified

3 Work out risk reduction measures: Different options for risk reduction measures can be worked out from this and proposals are made in this report for all levels mentioned above Options proposed are substitution, control of emission to air (threshold limits), limit of use etc In the next step the guidance discusses the question, how to implement these measures into legislation / voluntary activities and the adjacent legislation are given (summary of possible political / legislative instruments)

4 Choice making: For the last step, the choice making for the best option, criteria laid down on a rather general basis, e.g measures should result in proportion to the risk and costs and all these measures should be compared and the minimum necessary burden should be imposed For detailed analysis the reader is referred to literature on

assessment tools

In this methodology substitution is one of several practical options for risk reduction

Therefore this document can be seen as a general guidance for risk reduction measures rather than a guidance exclusively concerned with substitution A guidance how to cope with the difficulties that might arise when the recommended measures are introduced in practice are not addressed directly but must be evaluated and used as the basis for decision

The Technical Guidance Document on Development of Risk Reduction Strategies G2 of the

EU Commission is the official document for the development of risk reduction strategies under Regulation 793/93/EEC on existing substances and is addressed to rapporteurs of the