Lipid nanoparticles (LNPs) are a groundbreaking delivery system for mRNA vaccines, such as those used for COVID-19. Now, they are pivotal in developing a range of new vaccines and gene therapies. The European Medicines Agency (EMA) and the European Pharmacopoeia are actively updating guidelines and quality requirements to ensure the safe and effective use of LNP-based medicine.

A recent EU ON opinion highlights the potential of advanced materials to support sustainability goals while acknowledging their human health and environmental risks. The European Commission’s 2024 communication emphasises the need for Safe-and-Sustainable-by-Design (SSbD) principles to ensure safety and sustainability.

The degradation of two-dimensional (2D) materials throughout their life cycle can result in the formation of degradation products with different properties and effects on human health and the environment than the original materials.

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.

Several OECD guidelines for testing chemicals have been updated to include nanospecific considerations, which are generally effective. Despite these efforts, challenges remain in standardising the testing of nanomaterials in water, as particles tend to clump together, leading to unstable dispersions and irreproducible results.

Nanoforms of fertilisers or biostimulants sprayed directly onto plant leaves may contribute to more sustainable agricultural practices. However, it needs to be clarified whether the current legislation and methodologies sufficiently addresses the nanospecific properties of these products when assessing the benefits and risks for crops, the environment, and human health.