The European Commission (EC) intends to establish a digital infrastructure for advanced materials called the ‘Materials Commons’. This initiative intends to enhance the design, development, and testing of advanced materials. A key aspect of the platform will involve the use of artificial intelligence tools, which can potentially be used for optimized hazard and risk assessment of advanced materials.

A recent critical perspective argues that nanomaterials should be regulated as biological rather than chemical entities. The researchers emphasise the importance of using existing knowledge about the biological interactions of nanomaterials and their impact on human health and the environment. The authors list various well-known challenges regarding the safety assessment of nanomaterials.

The European Food Safety Authority (EFSA) has introduced new guidance for evaluating nanoparticles in food that may dissolve in lipids before consumption. By using the 1-octanol-water partition coefficient (KOW) method nanospecific considerations for safety assessments may potentially be waived.

Titanium dioxide (TiO2), previously banned as a food additive (E 171) in 2022 due to safety concerns, is used in medicines as an excipient. French scientists have estimated the intake of TiO2 from oral medications, finding that 54% contained TiO2, with an average daily intake of 1.71 mg. This is lower compared to the exposure from food when E 171 was still allowed.

Ex vivo exposure of human placentas to realistic concentrations of titanium dioxide (TiO2) and silicium dioxide (SiO2) nanoparticles affect placental protein secretion, which slowed the growth of new blood vessels in an in vitro model. Current regulatory guidelines do not sufficiently address placental toxicity, highlighting the need for improved testing methods to evaluate the reproductive and developmental toxicity of nanomaterials.

Two recent studies have proposed new methods to detect the presence of nanoparticles in food and cosmetics. The first study suggests a two-step approach to detect the banned food additive E 171. This involves screening for elemental titanium, followed by detecting nano-sized titanium dioxide. The second study used a quick screening tool to identify the presence of seven different nanoparticles in facial cosmetics. However, both methods have only been partially validated, and further improvements are required. There is a lack of reliable data on background titanium concentrations in food. A lack of reference matrices with known amounts of nanoparticles in consumer products is another challenge that needs to be addressed.

The use of Artificial Intelligence (AI) applications is quickly increasing and has the potential to revolutionize chemical risk assessment. For predicting the toxicity of nanomaterials, current models only work for relatively simple nanomaterials. There is a need to anticipate current developments and strategies to prepare for future AI implementation in chemical regulation.

Researchers from the EU Graphene Flagship have highlighted the complexity of assessing the safety of graphene and related materials. Such assessment requires detailed knowledge of safety-related physicochemical properties and the development of harmonised test methods. These lessons must receive ample attention in future innovation programmes on new materials.

By 2023, two European research projects related to the Malta Initiative were completed: Gov4Nano and NanoHarmony. These projects provided scientific support to thirteen OECD projects aimed at developing or modifying OECD Test Guidelines or Guidance Documents. However, more work is needed to finalise the OECD documents. The Malta Initiative has also identified further needs for harmonised test methods for future (advanced) materials and animal-free safety testing. The NanoHarmony White Paper guides on how to continue developing these test methods. However, it is uncertain how to identify and address future needs in the absence of resources for funding.

The safety of fullerenes in cosmetic products is uncertain, according to the EU Scientific Committee on Consumer Safety (SCCS). The information provided by the Notifier on the possible genotoxicity of fullerenes and other concerns was insufficient. The European Commission has recently proposed a new rule requiring the industry to provide additional data in the short term. If the industry fails to do so, fullerenes will be banned for use in cosmetic products, like other nanomaterials.