1.1 Introduction: Substitution in legislation and in practice
A central objective of REACH is to ensure a high level of protection of human health and the environment. There are two principal means in REACH to achieve this goal (ECHA 2018):
► Better knowledge on the properties and uses of chemicals, resulting in safe uses of chemicals and reduction of exposures and emissions;
► Substitution: the use of less dangerous alternatives to substances of very high concern.
Within the context of occupational health and safety, substitution is the most important
protective measure to reduce exposures, emissions and adverse effects. It is the first option to be assessed, prior to technical measures, organizational and personal protective equipment. Also for the protection of consumers and the environment, substitution is an important measure.
The substitution principle as well as the understanding and implementation of this principle have been the subject of discussions and elaborations for decades. A common understanding of this term has been given in ECHA´s substitution strategy:
► The replacement or reduction of hazardous substances in products or processes by less hazardous or non-hazardous substances, or by achieving an equivalent functionality via technological or organisational measures (ECHA 2018, definition cited from Lohse et al.
2003)
Recently, there have been a number of national, European and international activities in support of substitution, e.g. the OECD Substitution and Alternatives Assessment Toolbox
(http://www.oecdsaatoolbox.org/), the foundation of the ISC3, the Swedish Centre for Substitution and the continuation of activities from NGOs, e.g. ChemSEC Marketplace.
In REACH, the authorisation process is the primary element in which the substitution of
substances is explicitly addressed: “Substances of very high concern are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable”. Likewise, however, several other elements of REACH promote substitution by various means. The restriction of specific, problematic uses of a substance (Title VIII), for example, creates the need to find new ways to deliver the desired functionality of the currently restricted use.
Substitution is supported by other chemicals legislations too. According to ECHA´s substitution strategy, REACH, CLP and the Biocidal Products Regulation together intend to provide a much broader perspective than on SVHCs alone.“ They are designed to place pressure on and to
provide incentives for industry to try to replace hazardous substances with less hazardous ones”
(ECHA 2018).
Since REACH entered into force, authorisations and restrictions have led to an enhanced
substitution of SVHC and other substances of concern. These reductions result from a combined effect of various legislations. However, it is difficult to assess substitution quantitatively due to the lack of precise data on actual production volumes, import volumes and export volumes of substances of concern and potential substitutes.
Despite the high priority of substitution in the hierarchy of protection measures, replacement of substances of concern by better and safer substitutions still represents a major challenge for
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companies. In cases where substitutes were already available, frequently chemicals with a similar structure and similar physic-chemical properties have been selected (e.g. replacement of Bisphenol A by Bisphenol S, replacement of long chain chlorinated paraffins by middle chain chlorinated paraffins). They can be used without any major modifications in the production processes. However, these chemicals too are often problematic in terms of adverse effects.
Substitutions with major modifications in the processes or technologies are rare.
For the identification and discussion of potential alternatives, the function of a chemical is of central importance. A substitution process which includes the consideration of functional aspects has been defined as “functional substitution”. In this approach, a differentiation is made between the technical function of the chemical itself (e.g. as a developer or an optical
brightener), the function of the material produced using the chemical (e.g. thermal paper for cash receipts) and the final service that should be delivered, e.g. delivering a receipt to document the purchase of goods.
The following picture gives an example of functional substitutions and the three levels involved.
It shows options to substitute Bisphenol A. On level 1, another chemical is used as a developer in thermal paper. On level 2, another type of thermal paper is used which no longer needs a
developer at all. On level 3, receipts are delivered, but electronically – therefore, a need to provide thermal paper no longer exists.
Figure 4: Functional substitution: Options to replace Bisphenol A, used as a developer in thermal paper to deliver cash register receipts.
Source: own illustration, based on an example from Tickner et al. 2014 (Schweizer und Bunke 2019).
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On each of these three levels, alternatives to a given problematic substance can exist. The first level, the technical function of the chemical itself, often leads to drop-in-chemical replacements.
The second and third level can offer additional options for substitutions including changes of materials, processes and systems.
On all three levels, chemicals can be involved. A robust assessment is needed as to whether they can pose a risk and whether the alternatives are really better and safer. Therefore, data on substances generated under REACH are required on these levels. In addition, level 2 and 3 require a more in-depth understanding of the function of a product and technical options to realise it. This goes far beyond the tasks of the classical chemicals’ management with a focus on the hazard assessment and exposure assessment of substances. As a result, the assessment of options of functional substitution requires stronger cooperation and an enhanced exchange between chemical regulators, technical experts and product designers to find better and safer alternatives.
Even where case studies of successful substitutions are available, the process to transfer these modifications to the situation existing in other companies (with slight or significant differences in process conditions) can be difficult.
1.2 Aim of this study
The aim of this study is to answer the question as to how REACH could support further the principle of substitution and its application – beyond the present state. It provides answers to the following two key questions:
► How does REACH actually support substitution of problematic substances?
► How could changes in REACH or in its implementation enhance the promotion of substitution by REACH?
1.3 Structure of the report
The report is structured as follows:
► Chapter 2 describes which elements and requirements of REACH directly or indirectly support substitution. In addition, a definition of the substitution principle is given. Related key terms are described in Annex 8.
► Chapter 3 shows how REACH actually supports substitution of problematic substances.
Details of the analysis undertaken for this chapter are given in Annex 9.
► Chapter 4 describes examples for substitution of chemicals and lessons learnt regarding actual and potential impacts of REACH.
► In Chapter 5, recommendations are given as to how REACH could further support the substitution principle and its implementation in practice. In addition, chapter 5 gives an outlook (section 5.5) which goes beyond REACH.
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