Case-by-case Nano assessment ‘not efficient long term approach’

The EU and Switzerland are the only ones to have nano-specific provisions incorporated in existing legislation, while other regions have regulated nanomaterials by building on guidance for industry.

Specific provisions include information requirements for NMs risk assessment and/or legally binding definitions of “nanomaterial”, and/or the obligation to label or report presence in products.

Existing nanomaterial work​

The European Commission definition of 2011 uses size (i.e., size range 1–100nm) as the only defining property of nanomaterials.

Already applications include nano-encapsulated agrochemicals or nutrients, antimicrobial nanoparticles and active and intelligent food packaging.

Expected benefits of nanotechnology-enabled products include increased efficacy of agrochemicals, enhanced bioavailability of nutrients or more secure packaging material.

There is no legislation entirely dedicated to regulation of NMs in the EU or any other country.

The paper reviews how potential risks or the safety of nanotechnology are managed in different countries and recognises implication on the international market of nano-enabled products.

There are challenges in the choice of equipment (technique), metric for defining properties, protocols for sample preparation and for measurements and possibly protocols for conversions of the test result into a parameter of the definition, found the review.

“As applications of nanotechnology are evolving and more advanced new generation nanotechnology products are expected to enter the market, the existence of a proper safety net and adequate regulatory frameworks adapted to products of nanotechnology are of high priority,” ​it said.

“A case-by-case risk assessment of each NM or nanoform – as currently recommended and practised in certain countries – is not the most efficient long term approach to ensure the safety of nanoproduct since it would require too many resources and could be impedimental to innovation.​

“Considering that nanotechnology-based agri/feed/food products may enter the international trade and such products may be obtained via the internet, harmonised approaches addressing NMs marketing and their safe use would be beneficial.”​

The EU Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) recommended in 2009 nanoparticles are assessed on a case-by-case basis with regard to risk.

Nanomaterials in food and FCMs​

The revised Novel Food Regulation is expected to provide a firmer basis for covering foods modified by new production processes such as nanotechnology and nanoscience as well as food, vitamins, minerals and other substances containing or consisting of “engineered nanomaterials”.

The revised “Plastic Food Contact Materials” Regulation (EU) 10/2011 states substances in nanoform shall only be used if they are authorised and mentioned in specifications of Annex I of the regulation.

So far there is only one material named as “nanoparticle” in Annex I: “Titanium nitride for use as additive or polymer production aid”.

Carbon black and amorphous silicon dioxide are listed without being named as “nanoparticle”, but with size ranges specified, which are below or around 100nm.

Nanoparticles in food contact materials are excluded from the functional barrier concept.

Behind a functional barrier, non-authorised substances may be used, provided they fulfil certain criteria (not being carcinogenic, mutagenic or reprotoxic) and migration remains below a given detection limit.

The UK Food Standards Agency (FSA) has published a list of NMs allowed in food/food contact materials including fumed silica, nanoclay, titanium nitride and nano-silver.

Country-specific action​

Mandatory reporting systems for NMs or products containing them have been introduced in France, Belgium and Denmark.

In Switzerland the safety is ensured by existing regulations and procedures dealing with traditional chemicals.

The Federal Office of Public Health (FOPH) and the Federal Office for the Environment (FOEN) published a precautionary matrix for synthetic NMs.

It is not legally binding and can be used on a voluntary basis as an evaluation tool for safe handling of NMs.

In Turkey, a national or regional policy for development of nanotechnology is in progress.

In the US, the Federal Food, Drug, and Cosmetic Act (FFDCA) does not contain any specification for nanotechnology-based products and FDA has not yet adopted a regulatory definition of NMs.

FDA suggests a case-by-case approach when assessing safety of finished products and foreseen use.

The agency said there are no food substances intentionally engineered at nanometer scale for which enough safety data exists so their use can be considered as Generally Recognised as Safe (GRAS).

FDA has not received food or colour additive petitions, or GRAS affirmation petitions, for any uses of food substances with a particle size distribution fully in the nanometer range. 

In Canada, there is no specific regulation for nanotechnology-based food products but they are regulated under existing legislative and regulatory frameworks.

Canadian and US regulatory agencies are working towards harmonising regulatory approaches for NMs under the US-Canada Regulatory Cooperation Council (RCC) Nanotechnology Initiative.

Source: Regulatory Toxicology and Pharmacology Volume 73, Issue 1, October 2015, Pages 463–476

Online ahead of print, DOI: 10.1016/j.yrtph.2015.06.016​

“Regulatory aspects of nanotechnology in the agri/feed/food sector in EU and non-EU countries​”

Authors: Valeria Amenta, Karin Aschberger, Maria Arena, Hans Bouwmeester, Filipa Botelho Moniz, Puck Brandhoff, Stefania Gottardo, Hans J.P. Marvin, Agnieszka Mech, Laia Quiros Pesudo, Hubert Rauscher, Reinhilde Schoonjans, Maria Vittoria Vettori, Stefan Weigel, Ruud J. Peters