Regulatory preparedness for multicomponent nanomaterials: Current state, gaps and challenges of REACH.

In 2018 the European Commission adopted revisions to the Annexes of Regulation (EC) No 1907/2006 concerning registration, evaluation, authorisation and restriction of chemicals (REACH) to introduce nanomaterial-specific clarifications and provisions. Multicomponent nanomaterial (MCNM) is a non-regulatory term that has been used in recent EU-funded projects to describe nanomaterials with a complex structure and/or composition and which are expected to be increasingly used in products in the near future. This paper examines the regulatory preparedness of REACH, and its revised Annexes, for MCNMs.

Re-evaluation of silicon dioxide (E 551) as a food additive in foods for infants below 16 weeks of age and follow-up of its re-evaluation as a food additive for uses in foods for all population groups.

The present opinion is the follow-up of the conclusions and recommendations of the Scientific Opinion on the re-evaluation of silicon dioxide (E 551) as a food additive relevant to the safety assessment for all age groups. In addition, the risk assessment of silicon dioxide (E 551) for its use in food for infants below 16 weeks of age is performed. Based on the newly available information on the characterisation of the SAS used as E 551 and following the principles of the 2021 EFSA Guidance on Particle-TR, the conventional safety assessment has been complemented with nano-specific considerations.

Informing the public about chemical mixtures in the local environment: Currently applied indicators in the Netherlands and ways forward.

The current use of chemicals puts pressure on human and ecological health. Based on the Aarhus Convention, citizens have the right to have access to information on substances in their local environment. Providing this information is a major challenge, especially considering complex mixtures, as the current substance-by-substance risk assessment may not adequately address the risk of co-exposure to multiple substances.

Next Generation Risk Assessment approaches for advanced nanomaterials: Current status and future perspectives.

This manuscript discusses the challenges of applying New Approach Methodologies (NAMs) for safe by design and regulatory risk assessment of advanced nanomaterials (AdNMs). The authors propose a framework for Next Generation Risk Assessment of AdNMs involving NAMs that is aligned to the conventional risk assessment paradigm. This framework is exposure-driven, endpoint-specific, makes best use of pre-existing information, and can be implemented in tiers of increasing specificity and complexity of the adopted NAMs.

Critical aspects in dissolution testing of nanomaterials in the oro-gastrointestinal tract: the relevance of juice composition for hazard identification and grouping.

The dissolution of a nanomaterial (NM) in an simulant of the oro-gastrointestinal (OGI) tract is an important predictor of its biodurability . The cascade addition of simulated digestive juices (saliva, stomach and intestine), including inorganic/organic biomacromolecules and digestive enzymes (complete composition, referred to as "Type 1 formulation"), strives for realistic representation of chemical composition of the OGI tract. However, the data robustness requires consideration of analytical feasibility, such as the use of simplified media.