Testing the Applicability of the Safe-by-Design Concept: A Theoretical Case Study Using Polymer Nanoclay Composites for Coffee Capsules

Abstract

The production and use of engineered nanomaterials and nano-enabled products is increasing, enabling innovations in many application areas, e.g., in the sector of food contact materials. However, nanosafety-relevant information for chemical risk assessment is still scarce, leading to a high level of uncertainty and making the early integration of safety to the innovation process indispensable. This study analyzed the strengths, weaknesses, and applicability of the nano-specific Safe-by-Design (SbD) concept using nanoclay-containing polymer coffee capsules as a theoretical case study. In addition, a material flow analysis was conducted to identify exposure pathways and potential risks, and a multi-stakeholder approach was applied to discursively discuss challenges when attempting to combine safety and innovation at an early stage. The results indicate that the SbD concept is generally welcomed by all stakeholders, but there is a lack of clear rules on the transfer of information between the actors involved. Furthermore, a voluntary, practical application usually requires in-depth knowledge of nanotechnology and often additional financial efforts. Therefore, incentives need to be created, as there is currently no obvious added value from a company’s point of view. The SbD concept should be further developed, standardized, and integrated into existing legal frameworks to be implemented effectively.

The meaning of life … cycles: lessons from and for safe by design studies

“…The detailed results of our literature review can be found in the sheet 'review of conceptual S(S)bD lit' of the ESI. † It appears that 5 out of 20 reviewed studies use both the terms SbD and SSbD, 15,37,38,40,45 and another 4 studies add sustainability assessments to safety assessment without mentioning the term SSbD explicitly. 1,6,36,47 Another general finding is that most (18 out of 20) of the reviewed studies focus on engineered nanomaterials (ENMs) and nanoparticles (NPs).…”

“…1,6,36,47 Another general finding is that most (18 out of 20) of the reviewed studies focus on engineered nanomaterials (ENMs) and nanoparticles (NPs). 1,6,16,17,[34][35][36][37][38][39][41][42][43][44][45][46][47][48] We note that all the reviewed studies have been published in between 2017-2022 and that 18 out of the 20 reviewed studies focus on nanomaterials and/or nanoparticles. This short timeframe and focus are most likely explained by the short history of the term SbD (see above) and the recent interest for nano-safety studies.…”

“…Environ. Sci., 2020) 17 Assessing sunscreen lifecycle to minimize environmental risk posed by nanoparticulate UV-filtersa review for safer-by-design products Nguyen (Nanomaterials, 2022) 44 Risk analysis and technology assessment of emerging (Gd,Ce) 2 O 2 S multifunctional nanoparticles: an attempt for early safer-by-design approach Pavlicek (Sustainability, 2021) 45 Testing the applicability of the safe-by-design concept: a theoretical case study using polymer nanoclay composites for coffee capsules Rose (Nano Today, 2021) 34 The SERENADE project; a step forward in the safe by design process of nanomaterials: the benefits of a diverse and interdisciplinary approach Rose (Nano Today, 2021) 46 The SERENADE projecta step forward in the safe by design process of nanomaterials: moving towards a product-oriented approach Salieri (NanoImpact, 2021) 1 Integrative approach in a safe by design context combining risk, life cycle and socio-economic assessment for safer and sustainable nanomaterials Schmutz (Front. Bioeng.…”

“…The results displayed in Table 2 show that none of the reviewed studies seem to focus on the life cycle of a chemical. Pavlicek et al 45 state that life cycle relates to a nano-enabled product, e.g., a coffee capsule. But in their study, they perform a material flow analysis (MFA) of nanoclays applied in coffee capsules as a theoretical example to identify exposure pathways and potential risks.…”

“…For example, one could map all flows of cadmium for all processes and flows handling or containing cadmium in the European Union in 2020. Pavlicek et al 45 claim that they perform an MFA but they do not provide a regional and temporal dimension for their MFA, consider all flows of nanoclays as applied in coffee capsules but ignore all other possible product applications of nanoclays. That does not reflect the life cycle of a nano-enabled product, but rather the life cycle of a (nano)material, e.g., nanoclay, as implemented in a specific nano-enabled product, e.g., coffee capsule.…”