Authors: Caldeira, C., Garmendia Aguirre, I., Tosches, D., Mancini, L., Abbate, E., Farcal, R., Lipsa, D., Rasmussen, K., Rauscher, H., Riego Sintes, J., Sala, S.
Abstract
This report presents the first application of the European Commission (EC) Safe and Sustainable by Design (SSbD) framework in a case study, on plasticisers in food contact material. Both the SSbD framework and the case study were developed by the EC’s Joint Research Centre. The case study was undertaken to elucidate possibilities for further refinements of the SSbD framework, and to enable its wider application to support innovation for safety and sustainability. Furthermore, two more case studies were developed in parallel by the industry, one that assessed flame retardants (halogen-free) in information and communications technology products, and one that focused on surfactants in textiles. Lessons learned and challenges were extracted from the case studies. A main challenge relates to lack of publicly available data in all steps of the assessment, as well as databases to act as repositories for this data. For example, for the safety aspects in Step 1 data used for classification purposes is Business Confidential Information, in Step 2 the manufacturing and processing are very company specific processes, or in Step 3 product/application specific and very often confidential information as well. For the life cycle assessment, detailed data regarding the production processes is required and it was not possible to obtain it from companies neither in general life cycle databases. Furthermore, data quality and uncertainty is important, and need to be addressed. It was noted that the integration of different disciplines (e.g. risk assessment, lifecycle assessment) enables a very comprehensive assessment, however such expertise is not easily found pointing out for the need of training on SSbD to develop the necessary skills. Nevertheless, the assessment is complex and requires the assessor(s) to have expertise in various fields, which can be particularly challenging for small and medium enterprises. A need was identified for additional case studies to support further developments towards operationalization of the EC SSbD framework, including its alignment with companies design and innovation processes. Additionally, to successfully implement the SSbD framework it is key to develop a system enabling the communication along the supply chain of the information necessary to conduct the assessment.
Management Summary
Context
The European Union’s Chemicals Strategy for Sustainability (CSS) aims to catalyse the shift towards chemicals, materials and products that are safe and sustainable by design (SSbD) throughout their life cycles, i.e. from resources extraction to end-of-life management. Developing SSbD criteria for chemicals and materials is one of the key actions foreseen in the CSS, contributing to reducing negative impacts on human health and the environment associated with chemicals, materials, products and services produced, used or marketed in the EU. To support the CSS implementation concerning SSbD, the European Commission's Joint Research Centre (EC-JRC) developed a framework for the definition of SSbD criteria for chemicals and materials. The framework puts together safety, environmental and socio-economic dimensions of sustainability.
The JRC framework was the basis for the EC Recommendation establishing a European assessment framework for safe and sustainable by design chemicals and materials (EC SSbD recommendation) that is addressed to Member States, industry, academia and research and technology organisations. The framework should make it possible to comprehensively assess the safety and sustainability of chemicals and materials throughout their life cycle and support the design, development, production, and use of chemicals and materials that provide a desirable function while being safe and sustainable. This Recommendation sets a testing period for the framework to receive inputs from stakeholders regarding applicability and challenges encountered.
This report presents the first application of the EC SSbD recommendation to case studies on selected chemicals. This work was presented at the 3rd SSbD stakeholder workshop and the relevant recordings are available here: day 1 and day 2. The case studies allowed to increase the knowledge on the applicability of the framework and to support further refinement thereof, as well as to advance the definition of criteria for SSbD.
Application of the proposed framework for SSbD chemicals and materials to case studies
The SSbD framework consists of two phases: 1) Design (or re-design) phase, where guiding design principles are proposed to support the development of safe and sustainable chemicals and materials, and 2) Safety and sustainability assessment phase, where the safety and sustainability of the chemical(s) or material(s) in question are assessed. The case studies were performed on selected existing chemicals and focussed on phase 2, namely on their safety and sustainability assessment.
Case study 1 Plasticiser (non-phthalate) in food contact material
A case study was developed addressing plasticisers already on the market and simulated a situation in which a chemical of concern was identified and would need to be substituted. The SSbD framework was applied to assess the safety and sustainability performance of the chemical to be substituted and the alternatives, performing a comparative assessment. The chemical of concern identified was di(2-ethyl hexyl) phthalate (DEHP) and the five alternatives are acetyl tributyl citrate (ATBC), di(2-ethyl hexyl) adipate (DEHA), di(2-ethyl hexyl) terephthalate (DEHT), di-isononyl cyclohexanoate (DINCH), and epoxidised soybean oil (ESBO). To apply the framework, a specific use needs to be defined which implies the selection of a product in which the plasticiser is used. After consultation with several stakeholders, and based on their feedback on current market application and data availability, the selected product was a sealing gasket made of a plastic liner placed below the metal cap in glass jars. The SSbD concept adopts a life cycle perspective, therefore the entire life cycle of the plasticiser was considered. Specifically, the safety and sustainability assessment of the sealing gasket consists of four steps:
Step 1: Hazard assessment of the chemical/material. In this step, a hazard assessment was performed using existing available data. The assessment illustrates the process of gathering available data/information, the identification of data gaps and how these in some cases can be justified. Finally, it also provides examples on considerations when generating data using alternative data sources and NAMs.
Step 2: Human health and safety aspects in the chemical/material production and processing phase. In this step, safety aspects related to the exposure to the plasticisers during the production and processing were assessed. Due to the high uncertainty on what happens at the end-of-life of the gasket and how to assess it, this stage has not been assessed. Although using conservative assumptions, the assessment illustrates that the exposure is a key aspect in the safety assessment and that in certain processes the high risk potential due to hazard properties can be reduced to a safety level, using - among other - risk management measures.
Step 3: Human health and environmental aspects in the “final application” phase. In this step, the safety during the gasket application was assessed. The assessment illustrates the difficulties due to the specificity of the case study. Furthermore, it also presents the considerations and different approaches that can be followed during the assessment to be able to draw certain conclusions.
Step 4: Environmental sustainability assessment. In this step, a life cycle assessment was performed. None of the alternatives performed sufficiently better than the reference used for all the impact categories, with the exception of ESBO for the impact category ‘resources use fossil’ due its bio-based nature. Nonetheless, the LCA results could support the chemical producer to improve the environmental performance as it allows identifying what are the most impactful impact category, life cycle stage, and process to be improved. An example on how to use this information in the re-design of a chemical/material production process is provided.
Furthermore, exploratory approaches to social and economic sustainability assessment along the chemical life cycle are proposed in Step 5 to address.
An illustrative scoring system was developed with scores from 0 to 3, considering “SSbD” a minimum score of “2”, to support decision making and facilitate the communication of results. An aggregation method that does not allow compensation was used with underpinning rules that can be adjusted to reflect the degree of ambition on the application of the framework.
Case studies developed by industries
Two case studies were developed by industries. Case study 2 on flame retardants (halogen-free) in information and communication technology products, was developed by Clariant and BASF, comparing halogenated flame retardants with non-halogenated ones. Case study 3 on surfactants in textiles was developed by Novozymes, assessing an enzyme (pectate lyase) that is used for scouring of cotton yarns and fabrics in the textile industry reducing energy and chemical consumption in a scouring process. The participation of these companies was very welcomed and appreciated as it allowed to have a first feedback from companies implementing the framework. Main challenges identified include the high resources needs to perform the assessment, lack of data, and the need for training and skills development to enable SSbD assessment. Despite these challenges, companies see a benefit in implementing the SSbD concept and are willing to explore its integration in their research and development strategies.
Lessons learnt
The development of these case studies shed light on relevant aspects for the application of the SSbD framework. There is, however, a need for additional case studies that can support further developments towards operationalization of the EC SSbD framework. It is relevant to further explore the integration of the SSbD assessment with the design and innovation processes. Stakeholders suggested to explore the development of a tiered approach that should not compromise the comprehensiveness and ambitions of the framework and the CSS. In order to better support the SSbD assessment throughout the development of chemicals/materials, there is the necessity to explore the possibility of integrating the Risk Assessment and Life Cycle Assessment even further. The combination of different disciplines enables a very comprehensive assessment, and requires a team effort by assessors with expertise in various fields.
A key and overarching challenge for all the steps is the availability of data; either the data does not exist (the case of new chemicals and materials) or it does but is not publicly available (chemicals and materials on the market). Data on new chemicals can be developed by means of robust predictive models and related platforms for data sharing. For chemicals on the market, data availability depends significantly on the willingness of stakeholders to share their data and the implementation of communication mechanisms throughout the value chain ensuring confidentiality. Databases with the relevant data for designing and assessing chemicals according to the proposed SSbD framework could be developed with the collaboration of the stakeholders, taking into account already existing databases. Data quality and uncertainty is a concern and data quality assessment should be included and taken into account in the assessment and subsequent decision making. Aside these aspects, for a successful implementation of the SSbD framework it is key to develop a system enabling the communication along the supply chain which will guaranteed the access to necessary information for conducting the assessment.
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David Spichiger, SCS
15.06.2023