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EU-Nanomaterials used in Food Contact Materials applications

Latest Info

Nanomaterials are increasingly influencing the food packaging area. Using nanomaterials in food packaging can change the flexibility of the FCM, enhance the barrier and antibacterial properties of packaging materials, preserve food, and extend the shelf life of food. As part of new food contact materials, it is important to understand the properties and characteristics of nanomaterials and determine whether they will cause any potential human health or environmental concerns.
For plastic FCM, the substances in nano-form shall only be used if explicitly authorised and mentioned in the specifications in Annex I to Regulation (EU) No 10/2011. At present, there are three authorised substances in their nano-form, namely: titanium nitride, nanoparticles (FCM No 807), zinc oxide, nanoparticles, coated with [3-(methacryloxy) propyl] trimethoxysilane (FCM No 1046) and zinc oxide, nanoparticles, uncoated (FCM No 1050).  In order for a new FCM substance in its nano-form to be listed in Annex I, one can apply to EC to obtain an authorisation. EFSA is responsible for the risk assessment considering the use of nanomaterials in food and feed, as well as in FCM. 

So far, EFSA has issued two guidance documents on nanomaterials, both published on 3 August 2021.

Guidance on risk assessment of nanomaterials in the food and feed chain: animal and human health (Scientific Committee Guidance on nano risk assessment (SC Guidance on Nano-RA))

The SC Guidance on Nano-RA covers the application areas such as novel food, FCM, food/feed additives, and pesticides. It details aspects relating to exposure assessment and hazard identification and characterization. In particular, nano specific considerations relating to in vitro / in vivo toxicological studies are discussed and a tiered approach for toxicological testing is outlined. Furthermore, in vitro degradation, toxicokinetics, genotoxicity, local and systemic toxicity as well as challenges relating to testing of nanomaterials are described.

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

The Guidance on Particle-TR defines 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, FCM, and pesticides). This guidance outlines appraisal criteria grouped in three sections, to confirm whether or not the conventional risk assessment should be complemented with nano specific considerations.

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References: 
https://www.efsa.europa.eu/en/efsajournal/pub/6768

https://www.efsa.europa.eu/en/efsajournal/pub/6769

 

Angelique Downey
Angelique Downey
Head of Division, Food & Food Contact Materials