EFSA Draft Guidance on Small Particles including Nanoparticles in Regulated Food and Feed Applications May be Useful for Assessment of Nanoparticles in FCMs

August 7, 2020

The European Food Safety Authority (EFSA) recently released for public consultation a draft guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles, including nanoparticles. The draft guidance document, available Here, establishes requirements that apply to particles requiring specific assessment at the nanoscale in conventional materials that do not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 Novel Food Regulation, (EU) 2015/2283, defines “engineered nanomaterial” as “any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale.” (See Article 3.2(f) of (EU) 2015/2283.)

While the guidance will directly apply to certain regulated food and feed products and provides mandatory information requirements for novel food applications submitted in the context of Regulation (EU) 2015/2283, EFSA explains that certain aspects of the guidance may be of value in assessing particles at the nanoscale in other domains, including food contact materials. Comments on the draft guidance are due by September 9, 2020.