On August 3, 2021, the European Food Safety Authority (EFSA) released guidance documents on the technical requirements for measurement and risk assessment of nanomaterials in the food and feed chain. The Guidance on Technical Requirements defines the “criteria for assessing the presence of a fraction of small particles, and … requirements for applications in the regulated food and feed product areas” including food contact materials. The Guidance on Risk Assessment uses “relevant scientific studies” on the properties and potential hazards of nanomaterials to detail “aspects relating to exposure assessment, hazard identification, and characterization” to consider. The Guidance on Risk Assessment also introduces a “tiered framework for toxicological testing” and draws attention to “nanospecific considerations relating to in vitro/in vivo toxicological studies.”
The Guidance on Technical Requirements is described as applying to “chemical materials either as substances or mixtures to be assessed by EFSA” unless the applicant can confirm they do not contain small particles in suspension. This includes non-intentionally added substances in the food that may transfer from food contact materials (FCMs). However, if the levels of a chemical migrating into food are below 60 mg/L and “can be considered to be solubilized… before ingestion of the packed food”, a conventional FCM risk assessment may be sufficient because the migrant complies with EU Regulation 10/2011 and is not a particle. While much of the technical guidance focuses on which materials require assessment and how to perform assessments of nanomaterials, it also outlines how and when an applicant can incorporate ‘existing scientific studies’ into any application.
According to the Guidance on Risk Assessment, measuring the exposure to nanomaterials from food is “essentially the same as for non-nanomaterials and will require consideration of the likely exposure scenarios” including transfer from FCMs. The guidance includes a subsection specific to FCMs in which they state nanomaterials included in an FCM may “structurally differ from the pristine nanomaterial… Therefore, in addition to the characterization of the nanomaterial used for manufacture of a FCM, the need arises for characterization of the nanomaterial as present in the FCM, and possibly when being released from the FCM.”
The two guidance documents were finalized after a public consultation period from July 9th to September 9th, 2020. EFSA received 25 comments on the draft documents from industry associations, consultants, EU institutions, national authorities, and scientists. A report on the comments received and how the Working Group on Nanotechnologies addressed them was published together with the guidance documents.
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EFSA (August 3, 2021). “Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles.” EFSA Journal
EFSA (August 3, 2021). “Guidance on risk assessment of nanomaterials to be applied in the food and feed chain: human and animal health.” EFSA Journal
EFSA (August 3, 2021). “Outcome of the public consultation on the draft Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles.” EFSA Journal
European Commission (January 14, 2011). “Commission Regulation (EU) No 10/2011 of 14 January 2011, on plastic materials and articles intended to come into contact with food.” Official Journal of the European Union (pdf)
European Commission (February 21, 2014). “Union Guidelines on Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food.” (pdf)
