The European Green Deal sets a roadmap for a sustainable future by 2050, aiming for a toxic-free environment and a circular economy. Key strategies include the Zero Pollution Ambition, the Circular Economy Action Plan, and the Chemicals Strategy for Sustainability. Central to these efforts is the Safe and Sustainable by Design (SSbD) approach, balancing safety, sustainability, and socio-economic factors throughout a material’s life cycle.
While regulations like REACH have been adapted for nanomaterials, they may not fully cover advanced materials. Recent legislative actions such as the Corporate Sustainability Reporting Directive and the Ecodesign for Sustainable Products Regulation are steps towards comprehensive sustainability reporting and product design. However, specific guidelines for advanced materials, particularly in waste management, remain underdeveloped.
Moreover, ensuring the safety and sustainability of advanced materials requires harmonised test methods, comprehensive life cycle assessments, and robust data management. Challenges include the multitude of shapes and behaviours of (nano)materials and material transformations during their life cycle. Furthermore, assessing the whole life cycle for emerging technologies prospectively raises challenges.
The MACRAMÉ Project team has assessmbled a ‘Needs Assessment Report of Regulatory & Policy Frameworks’, proposing to address these challenges:
- First, it is crucial to define and categorise advanced materials to identify specific regulatory needs and amend existing legislation accordingly.
- Facilitating life cycle thinking in material design and developing sector-specific methodologies and tools for SSbD, along with incentives to encourage their use, is essential towards innovative safe and sustainable materials.
- Additionally, combined imaging and analytical approaches should be developed to quantify transformed advanced materials. Enhancing data management practices to ensure the availability and reuse of data, including harmonised ontologies, is also vital to support SSbD.
- Finally, adjusting harmonised test methods to be applicable for advanced (nano)materials, incorporating New Approach Methodologies (NAMs), and ensuring harmonised test methods for sustainability assessments are necessary steps forward.
According to the United Nations Brundtland Commission, sustainability may be defined as ‘meeting the needs of the present without compromising the ability of future generations to meet their own needs’.[1] How to assess this, however, is a challenge.
With the SSbD Framework[2] the European Commission aims to facilitate assessment of sustainability. Furthermore, in research programmes the Commission encourages the development of tools, methods for easily implementable strategies to facilitate SSbD. General life cycle-based methods may provide a starting point as tools (Figure 1).
For LCA in a product life cycle, the choice of lifecycle stage(s) considered can add another factor of variability. This brings some categorisation of product life cycle models, depending on the number of stages included (Figure 2):
- Gate-to-gate focuses on what happens to a product at a manufacturing site.
- Cradle-to-gate includes the stages between material extraction (cradle) from the environment and the purchase of a product (before it is distributed to the consumer).
- Cradle-to-grave looks at what happens from material extraction (cradle) until the product is disposed of by the final owner (grave).
- Cradle-to-cradle examines what happens to the product after its end-of-life stage, and how it is used for further manufacturing processes (e.g. whether it was recycled, and how). This approach considers ‘closed loop’ recycling and circularity. Here, a recycling process replaces the waste stage. It considers the feasibility of the disposed material to be reprocessed into the life cycle of the product.
Applicability of Test Methods
For nanomaterials the OECD examined applicability of test methods already in 2009. [4] Issues were identified in (lack of) characterisation methods, both for the pristine material and for methods that distinguish them from a surrounding matrix (including biological tissues). Another remaining challenge for nanomaterials is the sample preparation necessary for determination of physicochemical properties, hazard, toxicokinetics, fate or exposure assessment. Work on adapting test guidelines or developing new ones only gained momentum in recent years, mainly as a result of inclusion of nanospecific requirements in legislation. [5] While several OECD Test Guidelines (TGs) and Guidance Documents (GDs) are now available that are applicable or specific for nanomaterials, [6] this work is not finished yet. Just recently the Malta Initiative published its priority list for further needs for (adaptations of) OECD documents.[7] In addition, ISO has produced a range of documents to clarify vocabulary and provide methodologies for nanomaterials[8]. Despite advanced materials representing a wide group of materials and generalisation is difficult, some lessons can be learned from this progress described for nanomaterials.
Test method development and adjustment can be laborious and time consuming. To allow adequate and timely development of test methods, it is crucial to have knowledge on the necessary steps in the development process.[9] This is independent of the specific purpose of test method development. To facilitate this for method developers the ‘NanoHarmony OECD TG/GD Process Mentor’ has been developed.[10] This also include training material. The knowledge of the key aspects of test method development identified are also applicable for advanced materials and continuous training of test method developers is needed.
Follow this link to read the full Needs Assessment report.
[1] UNEP (1987), Report of the World Commission on Environment and Development : “Our common future”. Paris, France: United Nations Environment Programme (UNEP), World Commission on Environment and Development. https://digitallibrary.un.org/record/133790?v=pdf#files.
[2] EC (2022), Commission Recommendation (EU) 2022/2510 of 8 December 2022 establishing a European assessment framework for ‘safe and sustainable by design’ chemicals and materials. Official Journal of the European Union. L 325/179: 179-205 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022H2510.
[3] C. Caldeira, R. Farcal, C. Moretti, L. Mancini, H. Rauscher, J. Riego Sintes, S. Sala, and K. Rasmussen (2022), Safe and sustainable by design chemicals and materials: review of safety and sustainability dimensions, aspects, methods, indicators, and tools. Luxembourg, Luxembourg: European Commission – Joint Research Centre. https://data.europa.eu/doi/10.2760/879069.
[4] OECD (2009), OECD Series on the Safety of Manufactured Nanomaterials, No. 15. Preliminary Review of OECD Test Guidelines for their Applicability to Manufactured Nanomaterials. Paris, France: Organisation for Economic Co-operation and Development (OECD). https://one.oecd.org/document/ENV/JM/MONO(2009)21/en/pdf.
[5] E.A.J. Bleeker, E. Swart, H. Braakhuis, M.L. Fernández Cruz, S. Friedrichs, I. Gosens, F. Herzberg, K.A. Jensen, F. von der Kammer, J.A.B. Kettelarij, J.M. Navas, K. Rasmussen, K. Schwirn, and M. Visser (2023), Towards harmonisation of testing of nanomaterials for EU regulatory requirements on chemical safety – A proposal for further actions. Regulatory Toxicology and Pharmacology. 139: 105360 https://doi.org/10.1016/j.yrtph.2023.105360.
[6] NANOMET. Towards tailored safety testing methods for nanomaterials. Available from: https://www.oecd.org/en/topics/sub-issues/testing-of-chemicals/nanomet.html.
[7] Malta Initiative (2024), Priority List for making OECD Test Guidelines and Guidance Documents applicable for Nanomaterials and Advanced Materials. Berlin, Germany: The Malta Initiative. https://malta-initiative.org/what/#MI-Priority-List.
[8] On 22 October 2024 a total of 216 different standards were found (www.iso.org/search.html, keyword ‘nano’).
[9] E.A.J. Bleeker, I. De Angelis, F.R. Cassee, M.L. Fernández-Cruz, D. Geiger, A.C. Gutleb, E. Heunisch, K.A. Jensen, S. Kelly, N. Latkovic, E. Morel, A. Pohl, T. Serchi, R. Smith, C. Svendsen, K. Wiench, and T. Kuhlbusch (2023), From Science to Regulation – The NanoHarmony White Paper on Test Guideline Development. Berlin, Germany: BAuA. https://nanoharmony.eu/white-paper/.
[10] NanoHarmony. NanoHarmony OECD TG/GD Process Mentor. Available from: https://testguideline-development.org.
