Report compiled for the Directorate General Environment, Nuclear Safety and Civil Protection of the Commission of the European Communities Contract No B3-4305/2000/293861/MAR/E1 SUBSTITUTION OF HAZARDOUS CHEMICALS IN PRODUCTS AND PROCESSES FINAL REPORT Hamburg, March 2003 Revision 1 Joachim Lohse Martin Wirts Andreas Ahrens Kerstin Heitmann Sven Lundie Lothar Lißner Annette Wagner Contact details for further inquiries Joachim Lohse Phone +49 – 40 – 391002 – 11 Fax +49 – 40 – 399006 – 33 Email Lohse@oekopol.de Ökopol GmbH Nernstweg 32-34 22765 Hamburg Germany Lothar Lißner Phone +49 – 40 – 2858-640 Fax +49 – 40 – 2858-641 Email lissner_koop@public.uni-hamburg.de Kooperationsstelle Hamburg Besenbinderhof 60 20097 Hamburg Germany EXECUTIVE SUMMARY i Kooperationsstelle Hamburg Executive Summary Substitution of hazardous substances by less hazardous alternatives appears to be a straightforward approach when enterprises consider management and reduction of chemical- related risks. Substitution is also debated in the context of the future chemicals policy in the EU. At the same time, various stakeholders' perceptions differ widely about the definition of substitution and concerning the question whether substitution should be a “fundamental principle”, a “duty to both producers and users of chemicals”, a “preferred risk reduction strategy” or whether it is “just another tool for managing risk”. Against this background, the study aims to identify, describe and analyse relevant activities towards substitution of hazardous chemicals. These activities include political and administrative strategies and concepts, guidance and assessment tools, as well as practical substitution “cases”. Numerous policy programmes and legal texts are presented in the report, covering both 1) legislation, that is introducing a generic substitution approach while leaving the implementation to the market players, and 2) specific legislation or technical rules with detailed requirements on how substitution should be implemented in practice. The results of a survey are presented on practical guidance and assessment tools for substitution which are publicly available in European Member States. The survey is focussing on assessment tools that are destined to support decision-making with regard to the selection of the most appropriate option. For achieving the general goal of reducing risks from hazardous chemicals, the various guidance documents suggest a large range of measures, ranging from elimination, modification or replacement of processes or products to exposure reduction by personal protection measures. Based on the observation that in the management of chemical risks it is useful to distinguish between the technical strategies of hazard reduction by emission control and hazard reduction by substitution, the following definition of substitution is suggested: “Substitution means the replacement or reduction of hazardous substances in products and processes by less hazardous or non-hazardous substances, or by achieving an equivalent functionality via technological or organisational measures.” The key aspect in this definition is the functional equivalence , i.e. the achievement of the same functionality by less hazardous means. Several strategies to achieve an equivalent functionality fall under this definition, such as elimination of a chemical, replacement of a hazardous chemical by a less hazardous one, as well as technological or organisational measures, that lead to a reduction of the quantitative input of the hazardous chemical and / or enable the use of less hazardous chemicals. Three studies describe the effects of specific policy approaches in detail, analysing from a top-down perspective how different policy instruments can influence the behaviour of companies and promote substitution either directly or indirectly. However, substitution practically takes place in enterprises . Therefore, the main approach taken in this report is a bottom-up approach with a view from the company perspective, in which the combined outcome of legislation, administration and other factors is analysed. Following this rationale, 10 technical case studies analyse substitution cases from the perspective of the downstream user of hazardous chemicals or materials who will most likely EXECUTIVE SUMMARY ii Kooperationsstelle Hamburg be the decision-maker whether substitution takes place or not. The cases cover a wide range o f substances in a variety of products and processes, serving manifold functionalities including cleaning operations (metal parts, facades, textiles), coating and painting (marine anti-foulings, wood preservation), fire resistance (flame retardants in printed circuit boards), lubricants and process fluids (loss lubrication, mould release agents), energy storage (rechargeable batteries) and plasticisers (phthalates in toys). The case studies give an insight into typical controversial issues, decision-making and associated time scales. Each case study starts with a technical description, i.e. the application of a substance in its technical environment, followed by a presentation of scientific observations about potential eco-toxicological risks associated with this particular substance. The evolution of stakeholders’ attitudes and initiatives over time is examined. Stakeholders of interest are economic actors along the supply chain, authorities, science and research and – in many cases – the “general public”. The case studies offer different possibilities of interpretation. It is not intended to judge whether substitution is the right risk reduction measure or not in a specific case. The purpose is rather to show how alternatives have been developed, and how it was eventually decided whether to substitute a hazardous substance or not. In those cases where a market segmentation was observed, the reasons are examined and discussed why some parts of the market have shifted to the substitute, while others have not. Key drivers and barriers towards substitution are identified particularly with regard to economic factors, technical functionality, communication and social factors, risk information and the regulatory framework, that is set by legislation and standardisation. There are some surprising similarities between completely different substitution cases, although the specific effect and the relative importance of each of these influence factors varies from one case to another: • Legislation is found to be one of the most powerful drivers in many cases, often inducing substitution as a side-effect even where it is not explicitly addressed as the main goal. • Another strong driver can be serious public concern about perceived chemical risks. • In the absence of such robust drivers, short term economic considerations are often the main barrier, and • a general tendency of downstream users prevails to stick to well-established conventional substances , rather than undergoing any risks with respect to quality and liability by experimenting with less hazardous substitutes. In several cases, there is a considerable imbalance between the available risk information on 1) substances which have been found to be problematic and thus became subject to substitution efforts, and 2) their potential substitutes for which less information is available, partly due to the fact that they have never been used on a similar scale as the conventional substance. Consequently, this level of information simply does not exist. Even where functionally equivalent substitutes are readily available, economically viable and proven to be less hazardous, their introduction in a certain process or product is often hampered by the fact that complex communication along the supply chain is a prerequisite for implementation. To summarise, the motivation of companies to substitute specific substances differs significantly from other stakeholders’ attitudes. Decisions taken in enterprises are influenced EXECUTIVE SUMMARY iii Kooperationsstelle Hamburg by policy, regulation and enforcement, technology development, economy and market, s cientific finding and the public debate. Both environmental legislation and public pressure are seen as relevant external factors. Government and authorities can play an important role in goal setting and promoting of substitution as one relevant option for risk reduction, not only by preparing legislation but also by sending to industry informal regulatory signals e.g. in the form of guidance and recommendations. Government-funded research and development programmes are an important tool to support the development of substitutes, especially in cases where this relies on close co-operation of economic actors in networks , that require efforts and resources going significantly beyond the core business of enterprises. Substitution should be based on comparative assessment of alternatives which requires reliable information on the hazard of substitutes and the associated risk of using them instead of the conventional substance. The current situation is often described as unsatisfactory in this respect. If in the future public policy will ensure that, as a pre-requisite for informed choices, comparable risk-related information on conventional substances and their substitutes is available, this will bear significant potential to accelerate substitution of hazardous substances in products and processes. Industry-specific innovation networks can contribute substantially to these informed choices. Substitution requires qualification . Therefore, education and training of industrial and professional users of chemicals is needed in order to have appropriate skills to assess available information and to “ask the right questions” to suppliers. In any case, enterprises need clarity about strategic policy goals and legislation on substitution of hazardous substances, as well as trust in the enforcement capacity of authorities. If enterprises have trust in future market developments, they will invest in innovative substituting technologies. Political visions, like the commitment to significantly reduce toxic substances in the environment, can support such trends. TABLE OF CONTENTS 1 Goals, scope and methodology of the study _____________________1 1.1 Goals ___________________________________________________ 1 1.2 Scope___________________________________________________ 1 1.3 Methodology _____________________________________________ 1 1.4 Structure of each section ____________________________________ 3 1.4.1 General substitution possibilities _____________________________________________ 3 1.4.2 Status analysis – legislation, policy and programs in the EU _______________________ 3 1.4.3 Practical guidance and assessment tools on substitution at various levels ____________ 3 1.4.4 Examples of substitution policies and management ______________________________ 4 1.4.5 Case studies _____________________________________________________________ 4 1.4.6 European conference on substitution of hazardous substances _____________________ 4 1.4.7 Summary and overall conclusions ____________________________________________ 5 2 Substitution – policies, status, guidance, assessment and experiences 6 2.1 General substitution possibilities ______________________________ 6 2.1.1 General risk reduction strategies _____________________________________________ 6 2.1.2 The role of political actors __________________________________________________ 9 2.1.3 The company as an actor__________________________________________________ 11 2.2 Status analysis: legislation, policy and programs in the EU _________ 14 2.2.1 Frameworks for substitution________________________________________________ 14 2.2.2 Introduction of substitution preferences into legislation__________________________ 16 2.2.3 Prohibition of certain substances in certain uses (ProSub)________________________ 18 2.2.4 Listing substances (LiSub) _________________________________________________ 20 2.2.5 Promoting substitution by voluntary European-wide agreements (SubVol)___________ 23 2.2.6 Promoting substitution by obligatory or voluntary labelling _______________________ 23 2.2.7 Promoting substitution by financial incentives (IncSub) __________________________ 25 2.3 Practical guidance on substitution ____________________________ 26 2.3.1 Types of guidance on substitution and their general structure ____________________ 26 2.3.2 Description of selected guides ______________________________________________ 28 2.3.3 Short list of substance, product or process specific guides _______________________ 34 2.4 Assessment tools on substitution at various levels _______________ 36 2.4.1 Basic principles of decision aid methods ______________________________________ 36 2.4.2 Assessment tools for substance risk assessment _______________________________ 39 2.4.3 Assessment tools for evaluation of risk reduction measures ______________________ 42 2.4.4 Assessment tools used by industry __________________________________________ 46 2.4.5 Assessment tools from eco-labels for consumer products ________________________ 48 2.5 Examples of substitution policies and management_______________ 53 2.5.1 Procedure for granting of discharge permits in the Netherlands and Denmark________ 53 2.5.2 Substitution policy: Lists and licenses in Sweden and Ireland _____________________ 58 2.5.3 The case “Oeko-Tex-Standard” - Substitution policy via voluntary labels ____________ 65 2.6 Case studies_____________________________________________ 72 2.6.1 Methodology ____________________________________________________________ 72 2.6.2 Summaries of the 10 individual case studies___________________________________ 74 2.6.3 Key factors influencing substitution __________________________________________ 85 3 RESULTS AND CONCLUSIONS ______________________________94 3.1 Definition of substitution ___________________________________ 94 3.2 The enterprise as the place for substitution_____________________ 94 3.2.1 Core requirements of enterprises in the substitution process _____________________ 94 3.2.2 Motivation to consider substitution in an operating process_______________________ 95 3.2.3 Assessment of options by decision makers ____________________________________ 97 3.2.4 Driving factors for substitution______________________________________________ 98 3.2.5 Actors involved in practical implementation of substitution ______________________ 101 3.3 The role of authorities ____________________________________ 103 3.4 Overall conclusions ______________________________________ 104 3.4.1 Conceptual considerations on substitution ___________________________________ 104 3.4.2 Public policy framework __________________________________________________ 105 3.4.3 Trade and industries’ tools to support informed choices ________________________ 105 3.4.4 Factors driving substitution at company level _________________________________ 106 References_______________________________________________107 References of section 2.1 ______________________________________ 107 References of section 2.2 ______________________________________ 107 References of section 2.4 ______________________________________ 107 References of section 2.5.1 _____________________________________ 108 References of section 2.5.2 _____________________________________ 108 References of section 2.5.3 _____________________________________ 109 Annexes Annex I Legislation, policy and programs in the EU: Standardised short descriptions 2 Annex II Standardised short descriptions of guidance documents 15 Annex III Standardised short descriptions of the assessment tools 25 Annex IV Extended case descriptions 40 Annex V Conference proceedings 176 List of Tables Table 1 Example: losses from consumer products – risk reduction strategies 7 Table 2 Example: emission from processes– risk reduction strategies 8 Table 3 Communication in substitution cases 11 Table 4 Restrictive policies 18 Table 5 List of substance-, product- or process-specific guides 35 Table 6 Classification of substances in the Dutch concept (RIZA 97) 55 Table 7 Comparison of substance-oriented limit values required for Oeko-Tex vs. official Eco-labels for textiles 68 Table 8 Analytical categories for evaluation of case studies 73 Table 9 Definition of characterising factors 74 Table 10 Key influence factors promoting or hindering substitution 86 Table 11 Communication requirements of enterprises depending on size of substitution case 98 TABLES OF FIGURES Figure 1 Risk reduction approaches for different use pattern of substance to achieve a common risk reduction level (originally based on AHRENS 2001) 8 Figure 2 Company view and political view 12 Figure 3 Conceptual model of public policy making and regulatory drivers 15 Figure 4 Typical steps in guidance for substitution 27 Figure 5 Scheme of the assessment proposed in the GDS 32 Figure 6 Concept of the Dominance Analysis 37 Figure 7 Concept of Positional Analysis 38 Figure 8 Concept of Elimination by Aspects (EBA) procedure 38 Figure 9 Schematic Scheme of the “Quick Scan” for substances proposed in the Netherlands 40 Figure 10 Assignment of PBT criteria to levels of concern 41 Figure 11 Assignment of “in principle” measures on the basis of level of concern 41 Figure 12 Schematic draw of the Risk Benefit Analysis 43 Figure 13 Example of presentation of results in eco-efficiency analysis 47 Figure 14 Eco-label-criteria concerning the presence of hazardous substances during the lifetime of a product 49 Figure 15 Illustrative examples of Öko-Tex Standards 66 [...]... approach, definition and perspective Approach and definition: The findings of this study are based on literature reviews and stakeholder consultation 1 SUBSTITUTION OF HAZARDOUS CHEMICALS IN PRODUCTS AND PROCESSES FINAL REPORT 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... article 138 and 175 of the Amsterdam Treaty 14 Kooperationsstelle Hamburg SUBSTITUTION OF HAZARDOUS CHEMICALS IN PRODUCTS AND PROCESSES • FINAL REPORT 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... SUBSTITUTION OF HAZARDOUS CHEMICALS IN PRODUCTS AND PROCESSES FINAL REPORT 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... are presented in some more detail in Annexes II and III 3 SUBSTITUTION OF HAZARDOUS CHEMICALS IN PRODUCTS AND PROCESSES FINAL REPORT 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 and industry (see section 2.2.5); 15 Kooperationsstelle Hamburg SUBSTITUTION OF HAZARDOUS CHEMICALS IN PRODUCTS AND PROCESSES FINAL REPORT • 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. .. 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 18 Kooperationsstelle Hamburg SUBSTITUTION OF HAZARDOUS CHEMICALS IN PRODUCTS AND PROCESSES • FINAL REPORT... 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 22 Kooperationsstelle Hamburg SUBSTITUTION OF HAZARDOUS CHEMICALS IN PRODUCTS AND PROCESSES FINAL REPORT... Hamburg SUBSTITUTION OF HAZARDOUS CHEMICALS IN PRODUCTS AND PROCESSES FINAL REPORT 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... 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... 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) 17 Kooperationsstelle Hamburg SUBSTITUTION OF HAZARDOUS CHEMICALS IN PRODUCTS AND PROCESSES FINAL REPORT 2.2.2.2 Substitution within authorisation The introduction of the substitution principle” into authorisation processes is the . to in Sections 2.3 and 2.4 are presented in some more detail in Annexes II and III. SUBSTITUTION OF HAZARDOUS CHEMICALS IN PRODUCTS AND PROCESSES FINAL. illustrate the broad range of understanding of what substitution means. SUBSTITUTION OF HAZARDOUS CHEMICALS IN PRODUCTS AND PROCESSES FINAL REPORT 8 Kooperationsstelle