Study for the strategy for a non-toxic environment of the 7th EAP Sub-study a: Substitution, including grouping of chemicals & measures to support substitution Written by Marco Camboni (Risk & Policy Analysts) August 2017 EUROPEAN COMMISSION Directorate-General for Environment Directorate B — Circular Economy & Green Growth Unit B.2 — Sustainable Chemicals European Commission B-1049 Brussels EUROPEAN COMMISSION Study for the strategy for a non-toxic environment of the 7th EAP Sub-study a: Substitution, including grouping of chemicals & measures to support substitution Directorate-General for Environment Sustainable Chemicals August 2017 EUROPEAN COMMISSION Directorate-General for Environment Sustainable Chemicals August 2017 This sub-study report has been prepared by Marco Camboni of Risk & Policy Analysts (RPA). The views expressed herein are those of the consultants alone and do not necessarily represent the official views of the European Commission. Milieu Ltd (Belgium), Chaussée de Charleroi 112, B-1060 Brussels, tel.: +32 2 506 1000; e-mail: [email protected]; web address: www.milieu.be Sub-study a: Substitution, including grouping of chemicals & measures to support substitution TABLE OF CONTENTS LIST OF TABLES ...................................................................................................................... 7 LIST OF FIGURES .................................................................................................................... 7 LIST OF BOXES ...................................................................................................................... 7 ABSTRACT ............................................................................................................................. 8 EXECUTIVE SUMMARY .......................................................................................................... 9 ABBREVIATIONS USED ........................................................................................................ 12 1 INTRODUCTION ........................................................................................................... 14 2 OVERVIEW OF THE STATE OF PLAY OF THE SUBSTITUTION PRINCIPLE IN THE CHEMICAL FIELD ......................................................................................................... 16 2.1 The application and implementation of the substitution principle ............. 16 2.1.1 The Substitution Principle and its interpretations .............................. 16 2.1.2 Policy means requiring and promoting substitution ........................ 17 2.2 Drivers of and barriers to substitution ............................................................... 26 2.3 Regrettable substitutions .................................................................................... 32 2.4 Grouping of chemicals ...................................................................................... 35 3 AVAILABLE TOOLS TO ADDRESS GAPS AND DEFICITS ............................................... 44 3.1 Gaps and deficits................................................................................................ 44 3.2 Reasons for gaps and deficits ........................................................................... 44 3.2.1 Information gaps and insufficient methodologies ........................... 44 3.2.2 Regulatory issues ................................................................................... 45 3.2.3 Lack of resources .................................................................................. 46 3.3 Available tools to address gaps and deficits .................................................. 46 3.4 Intervention instruments ..................................................................................... 48 4 CONCLUSIONS ............................................................................................................ 49 5 REFERENCES ................................................................................................................. 59 APPENDIX 1: LITERATURE REVIEW ....................................................................................... 62 A1.1. General Literature review on the sub-study area ............................................ 62 A1.1.1. Defining the substitution principle ........................................................ 62 A1.2. Historical use of the substitution principle .......................................................... 64 A1.3. Stakeholders affected by substitution of hazardous substances ................... 67 A1.4. Pros and cons of regulatory requirements on substitution .............................. 68 A1.5. Guidance for assessing substitutes ..................................................................... 70 A1.5.1. Overview ................................................................................................. 70 A1.5.2. Examples of Guidance and Information Sources ............................. 71 A1.6. Substitution in practice ......................................................................................... 76 A1.6.1. Barriers to substitution ............................................................................ 76 A1.7. Green chemistry .................................................................................................... 78 A1.8. Grouping of chemicals ........................................................................................ 79 APPENDIX 2: SURVEY RESULTS ............................................................................................ 84 A2.1. Introduction ........................................................................................................... 84 A2.2. Drivers and Obstacles to the Substitution of Hazardous Chemicals .............. 86 A2.3. Experience with Substitution ................................................................................ 88 A2.4. Experience with substitution assessments & use of analyses of alternatives 90 A2.5. Analysis of alternatives ......................................................................................... 93 A2.6. Enhancing substitution efforts ............................................................................. 95 LIST OF TABLES Table 1: Overview of existing tools for chemical alternative assessment ...................... 23 Table 2: Drivers and barriers to substitution ........................................................................ 26 Table 3: Groups of chemicals in REACH Authorisation list ................................................ 37 Table 4: Ideas for improvement ........................................................................................... 51 LIST OF FIGURES Figure 1: Drivers of substitution (industry stakeholders’ survey)....................................... 28 Figure 2: Benefits of substitution (industry stakeholders’ survey) ..................................... 29 Figure 3: Obstacles to substitution (industry stakeholders’ survey) ................................ 29 Figure 4: Challenges of substitution (industry stakeholders’ survey) ............................... 30 Figure 5: Resources dedicated to supporting substitution initiatives .............................. 31 Figure 6: Areas of expertise of staff supporting substitution initiatives ............................ 31 Figure 7: Expertise diversity within respondents ................................................................. 32 Figure 8: Archetypal cases of incremental substitution for selected phase-out chemicals used in large applications in conmumer products (Fankte et al, 2015) ..... 33 Figure 9: Obstacles to substitution (industry stakeholders’ survey) ................................. 35 LIST OF BOXES Box 1: Bisphenol A .................................................................................................................. 33 Box 2: Halogenated flame retardants ................................................................................ 34 ABSTRACT The present paper examines the implementation of the substitution principle in European chemical legislation, along with the practices and challenges faced by the companies when substituting hazardous chemicals in processes and products. In particular, it investigates how regulatory incentives results in the occurrence of regrettable substitutions, i.e. the substitution of hazardous substances with substances with similar chemical structure and similar hazard properties or with substances with other effects of similar concern. It explores the extent to which grouping strategies could be used to enhance the efficiency and effectiveness of the regulatory process. Finally, it presents and discusses the measures recommended by the literature and by relevant stakeholders to facilitate and improve the substitution of hazardous substances. Milieu Ltd Study for the strategy for a non-toxic environment of the 7th EAP, Sub-study a: Substitution, including Brussels grouping of chemicals & measures to support substitution, August 2017 / 8 EXECUTIVE SUMMARY The principle of substituting hazardous substances has been used in international agreements and in European and national legislation as a tool of risk management for many years. The Seventh Environment Action Programme recognises innovation and the development of sustainable substitutes, including non-chemical solutions, as basic aspects of a strategy for a non-toxic environment. Key findings on substitution The problem The prevailing use of hazardous substances