Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles

Abstract

Following a mandate from the European Commission, EFSA has developed a Guidance on Technical Requirements (Guidance on Particle-TR), defining the criteria for assessing the presence of a fraction of small particles, and setting out information requirements for applications in the regulated food and feed product areas (e.g. novel food, food/feed additives, food contact materials and pesticides). These requirements apply to particles requiring specific assessment at the nanoscale in conventional materials that do not meet the definition of engineered nanomaterial as set out in the Novel Food Regulation (EU) 2015/2283. The guidance outlines appraisal criteria grouped in three sections, to confirm whether or not the conventional risk assessment should be complemented with nanospecific considerations. The first group addresses solubility and dissolution rate as key physicochemical properties to assess whether consumers will be exposed to particles. The second group establishes the information requirements for assessing whether the conventional material contains a fraction or consists of small particles, and its characterisation. The third group describes the information to be presented for existing safety studies to demonstrate that the fraction of small particles, including particles at the nanoscale, has been properly evaluated. In addition, in order to guide the appraisal of existing safety studies, recommendations for closing the data gaps while minimising the need for conducting new animal studies are provided. This Guidance on Particle-TR complements the Guidance on risk assessment of nanomaterials to be applied in the food and feed chain, human and animal health updated by the EFSA Scientific Committee as co-published with this Guidance. Applicants are advised to consult both guidance documents before conducting new studies.

Validation and Demonstration of an Atmosphere-Temperature-pH-Controlled Stirred Batch Reactor System for Determination of (Nano)Material Solubility and Dissolution Kinetics in Physiological Simulant Lung Fluids

“…There are no international standard procedures for testing the dissolution of NMs in physiologically relevant fluids, which is an immediate requirement due to recent changes in regulatory information requirements on NMs regarding both chemicals and food [ 30 ]. Dissolution kinetics (and solubility) are requested to group and read-across different nanoforms and support toxicological findings in biodurability [ 31 , 32 , 33 ] and eventually can reduce animal testing needs.…”

Safety assessment of the substance nano precipitated calcium carbonate for use in plastic food contact materials

“…The assessment was conducted in line with the principles described in the EFSA Guidance on transparency in the scientific aspects of risk assessment (EFSA, 2009 ) and considering the relevant guidance from the EFSA Scientific Committee, such as the Guidance on risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain: Part 1, human and animal health (EFSA Scientific Committee, 2018 ). The update of the Guidance on risk assessment of nanomaterials to be applied in the food and feed chain: human and animal health and the Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles (EFSA Scientific Committee, 2021a , b ) were not published at the moment of the submission of the data by the applicant. They were considered during the assessment, but not for rejecting data compliant with the version from 2018 and not with the versions from 2021.…”

“…If solubility is pH dependent and the dissolution rate criterion 5 is not respected at pH = 7, it is sufficient to demonstrate that the dissolution rate at pH = 3 (pH condition simulating the stomach) ensures full dissolution (EFSA Guidance on technical requirements for nanomaterials, EFSA Scientific Committee, 2021b ). Therefore, for infants older than 16 weeks, children and adults, the dissolution is rapid enough to achieve full solubilisation in the stomach.…”

“…Toxicological data and a review of toxicological studies on calcium carbonate (bulk and nano form), mainly referring to the REACH registration dossiers, were provided. However, in accordance with the EFSA Guidance on technical requirements for nanomaterials (EFSA Scientific Committee, 2021b ), based on the result obtained in the dissolution rate study, an assessment of the particles in nanoform was not necessary and a conventional risk assessment was sufficient.…”

Positionspapier

“…EFSA schlägt in ihrem Leitlinien-Dokument zur Risikobewertung partikulärer Substanzen in der Lebensmittel-und Futtermittelkette für die Identifizierung möglicher gefährlicher Eigenschaften von Nanomaterialien ein schrittweises Vorgehen vor [8,14]. Im ersten Schritt ist eine umfangreiche physikalisch-chemische Charakterisierung der verwendeten partikulären Substanzen erforderlich, um ggf.…”