Accepted Manuscript

Regulatory aspects of nanotechnology in the agri-feed-food sector in EU and non-EU

countries
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
PII:

S0273-2300(15)30008-8

DOI:

10.1016/j.yrtph.2015.06.016

Reference:

YRTPH 3332

To appear in:

Regulatory Toxicology and Pharmacology

Received Date: 4 December 2014

Revised Date:

9 June 2015

Accepted Date: 25 June 2015

Please cite this article as: Amenta, V., Aschberger, K., Arena, M., Bouwmeester, H., Moniz, F.B.,
Brandhoff, P., Gottardo, S., Marvin, H.J.P., Mech, A., Pesudo, L.Q., Rauscher, H., Schoonjans, R.,
Vettori, M.V., Weigel, S., Peters, R.J., Regulatory aspects of nanotechnology in the agri-feed-food
sector in EU and non-EU countries, Regulatory Toxicology and Pharmacology (2015), doi: 10.1016/
j.yrtph.2015.06.016.
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Regulatory aspects of nanotechnology in the agri-feed-

food sector in EU and non-EU countries1

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Valeria Amenta1, *, Karin Aschberger*1, Maria Arena1, , Hans Bouwmeester2, Filipa Botelho

Moniz1, Puck Brandhoff2, Stefania Gottardo1, Hans J.P. Marvin2, Agnieszka Mech1, Laia

Quiros Pesudo1, Hubert Rauscher1, Reinhilde Schoonjans3, Maria Vittoria Vettori3, Stefan

Weigel2, Ruud J. Peters2

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1: JRC, Nanobiosciences Unit, Institute for Health and Consumer Protection, Ispra, Italy

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2: RIKILT, Wageningen UR, Wageningen, The Netherlands

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3: EFSA, Scientific Committee and FEED additives Unit, Parma, Italy

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*: Current affiliation: ECHA, Substance Identity & Data Sharing Unit, Helsinki, Italy

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: Current affiliation: EFSA, Pesticides Unit, Parma, Italy

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*Corresponding author:

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Karin Aschberger,

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JRC, IHCP Nanobiosciences, Via Fermi 2749, 21027 Ispra, Italy

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E-mail: karin.aschberger@ec.europa.eu

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phone: +39-0332-789618

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The opinions expressed in this publication are those of the authors only and do not represent JRC's, EFSA's or
RIKIL-Wageningen UR's official position.

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Keywords: nano, nanomaterial, food, feed, agriculture, regulation, legislation, safety

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assessment, hazard, risk

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ABSTRACT (200 words max)

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Nanotechnology has the potential to innovate the agricultural, feed and food sectors

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(hereinafter referred to as agri/feed/food). Applications that are marketed already include

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nano-encapsulated agrochemicals or nutrients, antimicrobial nanoparticles and active and

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intelligent food packaging. Many nano-enabled products are currently under research and

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development, and may enter the market in the near future. As for any other regulated

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product, applicants applying for market approval have to demonstrate the safe use of such

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new products without posing undue safety risks to the consumer and the environment.

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Several countries all over the world have been active in examining the appropriateness of

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their regulatory frameworks for dealing with nanotechnologies. As a consequence of this,

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different approaches have been taken in regulating nano-based products in agri/feed/food.

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The EU, along with Switzerland, were identified to be the only world region where nano-

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specific provisions have been incorporated in existing legislation, while in other regions

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nanomaterials are regulated more implicitly by mainly building on guidance for industry. This

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paper presents an overview and discusses the state of the art of different regulatory

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measures for nanomaterials in agri/feed/food, including legislation and guidance for safety

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assessment in EU and non-EU countries.

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1. Introduction

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The rapid development of nanotechnology has opened the door for innovation in many

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industrial sectors, including agricultural production, animal feed and treatment, food

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processing, and food contact materials (hereinafter referred to as agri/feed/food). Some

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applications (Figure 1) are already merchandised while many more are currently under

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research and development (Chaudhry et al. 2008; Parisi C. 2014; RIKILT and JRC 2014).

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Expected benefits of nanotechnology-enabled products in these sectors include increased

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efficacy of agrochemicals, enhanced bioavailability of nutrients or more secure packaging

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material. Such new products or ingredients may however also pose a risk to human health

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and the environment due to their specific properties and to the potential widespread use and

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exposure.

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There are efforts worldwide to address and regulate the production and safe handling/use of

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nanomaterials (NMs) and nanotechnology either by legislation or by (non-binding)

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recommendations and guidances (van der Meulen et al. 2014). There is currently no piece of

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legislation entirely dedicated to regulation of NMs, neither in the EU nor in any other country

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(Arts et al. 2014). Current legislation is considered by many countries sufficient and specific

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enough to regulate NMs and nanotechnology (European Commission 2012; OECD 2013b),

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however, amendments have been suggested by several stakeholders, including the

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European Parliament (European Parliament 2009) and non-governmental organisations

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(NGOs) (BEUC et al. 2014). The need for additional guidance to assess the potential risk

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and for recommendations to ensure the safe use of NMs has been identified, and several

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expert bodies are active in this field, such as the EU Scientific Committees and Agencies, the

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Organisation for Economic Cooperation and Development (OECD), the International

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Standard Organization (ISO) or the US Food and Drug Administration (FDA). Relevant

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regulatory issues to be considered for NMs include a definition of the term "nanomaterial",

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registration or authorisation procedures, specific information requirements for risk

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assessment, risk management and provisions to increase the transparency and traceability

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on the commercial use, by e.g. labelling or by notifying to a register for products containing

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NMs (Falkner and Jaspers 2012; Aschberger et al. 2014).

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In this review we aim to provide an overview of existing legislation, and guidances for risk

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assessment as well as other relevant documents with regard to NMs and nanotechnology in

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agri/feed/food in EU and non-EU countries. Relevant information was gathered from peer-

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reviewed publications through a dedicated search in on-line bibliographic databases,

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websites of the European Commission, European Agencies/Authorities, the Official Journal

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of the European Union, national governments, national and international organisations and

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institutions during the period April to August 2013. Additional information was collected

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through a questionnaire on "Regulation and safety assessment of nanomaterials in

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agri/feed/food applications" issued in October 2013 (RIKILT and JRC 2014). Information on

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non-EU legislation was mainly retrieved from recent reports, such as those published by

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WHO/FAO (FAO/WHO 2013) or OECD (OECD 2013b) and from other relevant sources.

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Here we present and discuss the results by taking into account also the latest developments

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(until May 2015) in the area of regulation and safety assessment of nanomaterials in the

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agri/feed/food sector. Furthermore, we will discuss some of the properties of nanomaterials

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used in agri/feed/food and the impact of such properties on environmental safety in

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agricultural applications and on consumer safety for food and food contact materials. Issues

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surrounding the safe use of nanomaterials in the workplace are not within the scope of this

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paper.

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2. Nanotechnology applications in agri/feed/food and

potential impacts on safety
Nanotechnology in the agri/feed/food sector enables the development and production of

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products or ingredients at the nanometre scale with new beneficial properties (RIKILT and

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JRC 2014) (as summarised in Figure 1). The same properties that are beneficial for certain

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applications may however also have an impact on health and environmental safety

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(Chaudhry and Castle 2011; Cushen et al. 2012).

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In agriculture, nanotechnology can contribute to improved pest management and crop

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protection through better efficacy of pesticides and other agrochemicals such as fertilisers,

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hormones or growth agents (Chaudhry and Castle 2011; Bucheli TD 2013; Kah and

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Hofmann 2014). Other agricultural applications include genetic engineering, identity

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preservation, sensors to monitor soil conditions as well as veterinary medicine (Gogos et al.

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2012), which are however not the focus of this review. Enhanced efficacy of pesticides and

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other agrochemicals can be achieved by different ways (Kah et al. 2012): decreasing the size

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of poorly soluble active ingredients increases their solubility and (bio)availability;

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slow/targeted release of the active ingredients and/or prevention of premature degradation

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by mixing/encapsulating active substances in micro or nano emulsions and nano-dispersions

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allows reducing the dose with the same or even better performance. Any manipulation

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intended to improve efficacy and release, however, is also likely to impact the environmental

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fate and behaviour of pesticides or agrochemicals. Slow release of active ingredients may

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imply higher persistence and consequently higher risk for non-target organisms and

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potentially greater numbers of residues on harvest. The increased concentration of solvents

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and surfactants required for "nanoemulsions" many influence the fate of pesticides or have a

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direct effect due to soil sorption (Bucheli TD 2013; Kah and Hofmann 2014). On the other

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hand a reduced concentration of active ingredients in pesticide products may result in a

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better environmental safety profile due to lower environmental exposure and lower traces of

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residues in treated food products.

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In food production, most nanotechnology applications involve food additives which improve

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the stability of foods during processing and storage, enhance product characteristics, or

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increase the potency and/or bioavailability of nutrients in the food product (Chaudhry et al.

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2010). Some of these applications may also be employed in animal feed where expected

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benefits include reduced use of feed additives, improved bioavailability, less environmental

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impact and removal of toxins in feed (Chaudhry and Castle 2011; RIKILT and JRC 2014).

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Three major classes of NMs in food applications have been identified in the literature

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depending on their occurrence, their solubility and their metabolisation/excretion (Morris

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2011):

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1) Natural food structures include naturally occurring biopolymers (carbohydrates, proteins or

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lipids) that have at least one dimension in the nanometre range or nanostructures introduced

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by processing or cooking (e.g. emulsions such as mayonnaise) (Morris 2011). These

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biopolymers can also be used to design new food structures, e.g. fat reduced emulsions.

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2) Engineered particulate NMs whose components are completely metabolised within the

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body or excreted (Morris 2011) such as nanoemulsions or nanoencapsulations of nutrients

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(e.g. vitamins). The risk assessment has to consider that the biokinetics and toxicity profile in

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target tissues may be different from non-nano counterparts (EFSA Scientific Committee

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2011; Landsiedel et al. 2012).

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3) Persistent or slowly soluble engineered particulate NMs (Morris 2011) such as synthetic

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amorphous silicon (SAS; E551; anti-caking agent), nano-silver (antimicrobial agent), and

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titanium dioxide (food additive). Some of these materials are often not intentionally produced

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in the nanosized range, but may contain a fraction in that size range, as for example titanium

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dioxide as white pigment (Peters et al. 2014). They are only weakly soluble and their

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components are not or slowly dissolved during digestion (Chaudhry and Castle 2011;

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Cushen et al. 2012). Hence these NMs may be absorbed, retained and accumulated within

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the body (Morris 2011).

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In food packaging applications nano polymer composites offer new lightweight properties and

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at the same time stronger materials that can keep food products secure during

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transportation, fresh during long storage and safe from microbial pathogens (Chaudhry et al.

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2010; Chaudhry and Castle 2011). Metal/metal oxide nanoparticles in "active" packaging and

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nanocoatings on food contact surfaces serve to prevent microbial growth and keep food

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fresher over relatively longer periods. "Smart" packaging can either slowly release food

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preservatives and/or incorporate nano-sized (bio)sensors to monitor the condition of food .

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The main concern about (any) food contact materials, is their (potential) migration into

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foodstuffs which is addressed by specific legislation (e.g. (European Commission 2011) (see

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also 3.4).

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The safe use of all these applications is ensured by specific legislation and/or dedicated

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guidance, which are presented hereunder.

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[place Figure 1 about here]

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3. Regulatory aspects of NMs in agri/feed/food in the EU

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In the EU, horizontal and sector specific legislation provides a binding framework for

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manufacturers, importers and users to ensure the safety of substances and products on the

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market. This framework covers NMs and nano-enabled products too. The need of adapting

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existing legislative provisions to NMs and nano-enabled products however, has been

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recognised in some cases and this has led to amendments to the legal text of certain

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regulations. Table1 gives an overview of the current EU legislation and to what extent NMs

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are explicitly addressed in that legislation for each type of agri/feed/food application. EU

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legislation is accessible and searchable on-line at http://EUR-LEX.europa.eu/.

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NMs are either implicitly or explicitly covered by different pieces of legislation. Currently, EU

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legislation explicitly addressing NMs includes the Regulation on the Provision of Food

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Information to Consumers (1169/20119), the Regulation on Plastic Food Contact Materials

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and Articles (10/2011), the Regulation on Active and Intelligent Materials and Articles

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(450/2009), the Biocidal Products Regulation (528/2012) and the Cosmetic Products

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Regulation (1223/2009). Other pieces of legislation are currently under revision to better

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address NMs, e.g. Novel Food Regulation (258/97) (European Commission 2013), or the

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Annexes to the REACH (Registration, Evaluation, Authorisation and Restriction of

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Chemicals) Regulation (1907/2006) (European Commission 2012).

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3.1

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Legislative provisions that explicitly address NMs need to refer to a definition to identify and

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distinguish them from other materials (for definitions of a nanomaterial in the EU see Annex

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I). The European Commission (EC) published a "Recommendation on the definition of

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nanomaterial" to promote consistency in the interpretation of the term "nanomaterial" for

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legislative and policy purposes in the EU (European Parliament and Council 2011). This

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definition is not legally binding but serves as a reference that is broadly applicable across

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different regulatory sectors and can be adapted to specific product legislation. The EC

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definition uses size (i.e., size range 1 100 nm) as the only defining property of the material.

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The size refers to the external dimensions of the constituent particles of a material which can

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be unbound but also may be in a form of agglomerates and/or aggregates. The EC definition

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applies to all particulate NMs irrespective of their origin, i.e. natural, incidental or

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manufactured. A material is a nanomaterial if 50% or more of its constituent particles,

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regardless whether they are unbound or part of agglomerates or aggregates, in the number-

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Definition of "nanomaterial"

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based particle size distribution has one or more external dimensions between 1 nm and 100

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nm. In specific cases that threshold of 50% can be lowered to values between 1-50%. The

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EC definition is under review in 2015 (Rauscher et al. 2014; Roebben et al. 2014).

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Prior to the publication of the EC Recommendation, definitions of a nanomaterial were

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already adopted in certain sector-specific regulations. Those definitions are legally binding

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and differ in some aspects from the EC Recommendation. The definition of "engineered

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nanomaterial" in the Provision of Food Information to Consumers (FIC) Regulation refers to a

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size range consistent with the EC Recommendation, i.e. external dimensions in the order of

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100 nm or less, however without clear size boundaries, and it covers only intentionally

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produced NMs, i.e., NMs that are manufactured to perform a specific function in the food

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matrix. According to the EC definition all materials with a content of particles equal to or

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above the threshold of 50 % for the fraction of particles in a particle size distribution of 1-100

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nm size range are defined to be nanomaterials. The FIC definition currently does not include

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such a threshold value. The EC intends to amend the definition of engineered NMs in the FIC

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Regulation and to harmonise it with the EC Recommendation, but this process is still

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ongoing. The European Parliament in November 2014 voted to adopt a 10% threshold of

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particles in the nanorange to be applied in the definition of NM in food. Such a threshold

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would pose a major challenge for detection, quantification and thus implementation

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(Roebben et al. 2014) of the definition. The proposal for a revision of the Novel Food

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Regulation (European Commission 2013) does not include its own definition of

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"nanomaterial" but makes reference to the FIC Regulation and its definition of "engineered

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nanomaterial". Any change of the definition in the FIC Regulation would therefore

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automatically apply to novel food.

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The NM definition included in the Biocidal Products Regulation (European Parliament and

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Council 2012) incorporates most of the EC Recommendation criteria. However, it does not

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mention the criteria referring to the specific surface area (>60m2/cm3) which, according to the

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EC Recommendation, can also be used to define NMs if technically feasible and required in

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specific legislation. Neither does it include the possibility to reduce the size distribution

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threshold to values lower than 50%. Other regulations concerning agri/feed/food do not

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contain a "nanomaterial" definition (see overview in Table 1).

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The use of different definitions allows addressing NMs in a way that is tailored to the needs

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of specific application areas (e.g. food or industrial applications) however, it can also lead to

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confusion and regulatory inconsistency as the same substance could be regarded as NM by

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one legislation but not by another. An alignment of these sector-specific definitions with the

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EC Recommendation is still being discussed in 2015. Possible changes include for example

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the alignment for the number based particle size distribution for NMs in food applications as

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defining feature or the alignment of the specific threshold (see above).

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The implementation of any definition based on quantitative criteria requires validated and

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harmonised measurement methods to correctly classify a material. The use of a multi-

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method approach is recommended (Linsinger et al. 2012), since at the moment no single

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method is able to cover the whole size range and all the different types of NMs. An important

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issue to implement a definition is the specification at which stage(s) of its life cycle a

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nanomaterial should be identified, as pointed out by EFSA Scientific Committee (EFSA

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Scientific Committee 2011), because the NM can change at each of these steps, e. g. in

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terms of size, agglomeration/aggregation state or surface properties. There are challenges in

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the choice of equipment (technique), metric for defining properties, protocols for sample

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preparation, protocols for the measurements and possibly protocols for conversions of the

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test result into a parameter of the definition. For these reasons, existing methods need to be

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further developed and improved, especially if they are to be applied in complex matrices

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such as food (Calzolai et al. 2012; Peters et al. 2014).

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3.2

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Pesticides are chemical compounds that are mainly applied to kill, repel or control pests and

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weeds, to protect crops before and after harvest or to influence the life processes of plants.

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Legal acts for Pesticides Risk Assessment

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Pesticides are regulated by the Plant Protection Products (PPP) Regulation (EC) 1107/2009

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(European Parliament and Council 2009a), which requires a pre-market authorisation

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procedure at EU level for active substances and at Member State level for plant protection

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products. Active substances and products are assessed on a case-by-case basis, which

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provides the possibility to assess the risk of ENMs as active substances even if they are not

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explicitly mentioned in the legislation (RIVM 2012). Environmental fate studies are usually

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only undertaken with the active ingredient or a representative formulation but not with each

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formulation. The potential interaction between active substances of formulants and their

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influence on long term processes such as degradation and distribution however have to be

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addressed (Kah and Hofmann 2014). Authorisation of plant protection products is only

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granted under the conditions that not only the active substance, but also safeners (added to

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eliminate or reduce phytotoxic effects) and synergists (to enhance the activity of the active

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ingredient) included in the product have been approved; co-formulants must not be included

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in a negative list (Annex III PPP Regulation). Pesticides containing nanoforms or nano-

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encapsulations of approved active substances could be considered as a different pesticidal

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product and as such would require a separate risk assessment and authorisation.

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3.3

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The basis for assurance of high level of protection of human health and consumers interest

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in relation to food, is provided by Regulation 178/2002 (European Parliament and Council

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2002b) which lays down the "General Principles and Requirements of Food Law". There are

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separate directives/regulations for novel foods and novel foods ingredients, food additives,

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feed additives, food supplements, vitamins, minerals and food contact materials. A regulation

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on the provision of food information to consumers, is described below. Depending on the

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type of nanomaterial or the purpose of its use as food/feed or part of food/feed, it would fall

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under its respective legislation. Definitions for the different terms and their sources are given

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in the supplementary information (Annex II). Although not explicitly mentioned, the use of

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nanotechnology in food production is currently covered by EC Regulation No 258/97

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concerning "novel foods" and "novel food ingredients" (European Parliament and Council

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1997). "Novel food" is food not consumed to any significant degree in the EU prior to May

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1997 and comprises newly developed, innovative food, or food produced using new

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technologies and production processes. This Regulation is currently under revision and the

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proposal for the revised Novel Food Regulation (European Commission 2013) should

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provide a firmer basis for covering foods modified by new production processes such as

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nanotechnology and nanoscience as well as food, vitamins, minerals and other substances

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containing or consisting of "engineered nanomaterials".

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Substances added to food for a technological purpose (e.g. synthetic amorphous silica

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(E551) and titanium dioxide (E171)) or to improve solubility, flavour or bioavailability, are

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covered by the "Food Improvement Agent Package". It includes: Regulation (EC) 1332/2008

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on food enzymes (European Parliament and Council 2008b), Regulation (EC) 1333/2008 on

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food additives (European Parliament and Council 2008c) and Regulation (EC) 1334/2008 on

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flavourings and certain food ingredients with flavouring properties (European Parliament and

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Council 2008e). Minerals or vitamins are regulated by Directive 2002/46/EC on food

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supplements (European Parliament and Council 2002a) and only those listed in its Annex I

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(vitamins and minerals) or Annex II (vitamin and mineral substances) can be used.

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Nanoforms of minerals or vitamins (e.g. encapsulations) require a safety evaluation under

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the Novel Food Regulation, due to the differences in production, potential differences in

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nutritional value and bioavailability when compared to macro-scale counterparts (European

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Commission 2013). Feed for food-producing (e.g. cattle, species normally used for human

296

consumption) and non-food producing (e.g. pet, zoo or fur) animals is regulated by

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Regulation 767/2009 on feed marketing (European Parliament and Council 2009b).

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Substances added to feed (feed additives) for technological, nutritional, organoleptic or zoo-

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technical purposes (e.g. animals performance) or as coccidiostats and histomonostats are

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regulated by Regulation (EC) No 1831/2003 on additives for use in animal nutrition

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(European Parliament and Council 2003) and Regulation (EC) No 429/2008 describes the

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detailed rules for the implementation of this regulation (European Parliament and Council

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2008d).

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Food additives, enzymes and flavourings must undergo a common (EU-wide) assessment

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and authorisation prior marketing, for which Regulation (EC) 1331/2008 (European

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Parliament and Council 2008c) (see Table 1) lays down the common procedure. Pre-market

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approval is also required for feed additives, novel food and food supplements. The

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authorisation procedure based on a scientific risk assessment should ensure that only safe

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ingredients are contained in food and feed. Changes in the starting material used in the

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production method of an additive (e.g. change of particle size) are not covered by existing

311

authorisation and must undergo a new safety evaluation (European Parliament and Council

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2008c). All food additives that were permitted before 2009 are currently under re-evaluation

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(European Commission 2010). This includes also some of the common particulate food/feed

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additives, which have been in use for years, such as anti-caking/free-flow powders, pigments

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and others (e.g. SiO2 E551, TiO2 E171, CaCO3 E170, vegetable carbon E153, silver

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E174, gold E175 and iron oxide E172) (European Commission 2010). Some of these

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materials may meet the criteria of the NM definition (e.g. E551 having the constituent particle

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size in the nanorange) (Dekkers et al. 2011) or at least contain a fraction in the size range

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below 100 nm (e.g. titanium dioxide) (Weir et al. 2012; Peters et al. 2014). Evaluation

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finalised so far did not point to health concerns for calcium carbonate (E170) as food additive

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(EFSA Panel on Food Additives and Nutrient Sources added to Food 2011) or silicon dioxide

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silanated in FCMs (EFSA Panel on Food Contact Materials 2014). The re-evaluation of SAS

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(E551) as a food additive is expected to be completed in 2016 (European Commission (DG

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SANCO) 2013). Recently, a risk assessment on SAS (E551) attempted to integrate the

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potential risks of the nanoparticle fraction (van Kesteren et al. 2014). Some results suggest

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that SAS in food may pose a health risk. However the authors also conclude that the

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assumptions made can induce several sources of uncertainty which make it difficult to draw

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firm conclusions. Also for nano-silver knowledge gaps have been identified (Wijnhoven et al.

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2009). It is intended that these studies are taken into account by EFSA as the responsible

330

regulatory body for scientific safety re-evaluation, in order to be delivered to the EC for

331

decision making.

332

3.4

333

Regulation (EC) No. 1935/2004 is a framework regulation that covers all materials and

334

articles intended to come into contact with food (food contact materials = FCM). Specific

335

measures for groups of materials and articles exist (e.g. active/ intelligent materials and

336

articles, adhesives, ceramics, plastics). So far only two legislative pieces explicitly refer to

337

NMs in the legal text, although they do not contain a definition of the term "nanomaterial".

338

While Regulation (EC) 450/2009 (European Commission 2009) on "Active and Intelligent

339

Materials and Articles" is rather general with regard to NMs and requires a case-by-case risk

340

assessment of nanoparticles in intelligent packaging systems until more information is

341

known, the revised "Plastic Food Contact Materials" Regulation (EU) 10/2011 (European

342

Parliament and Council 2011) is more specific. It states that substances in nanoform shall

343

only be used if the nanoform is explicitly authorised and mentioned in the specifications of

344

Annex I of the regulation. So far there is only one material named as "nanoparticle" in Annex

345

I: "Titanium nitride for use as additive or polymer production aid". In addition, carbon black

346

and amorphous silicon dioxide are listed without being specifically named as "nanoparticle",

347

but with size ranges specified, which are below or around 100 nm. An important issue to

348

consider is that nanoparticles in food contact materials are excluded from the functional

349

barrier concept. The functional barrier consists of one or more layers within food contact

350

materials or articles preventing the migration of substances from behind that barrier into the

351

food. Behind a functional barrier, non-authorised substances may be used, provided they

352

fulfil certain criteria (e.g. not being carcinogenic, mutagenic or reprotoxic) and their migration

353

remains below a given detection limit (European Commission 2011). Nanoparticles have to

354

be assessed on a case-by-case basis with regard to their risk and can only be used in food

355

contact material if explicitly authorised.

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Substances released from active food contact materials (e.g. nanosilver as antimicrobial) into

357

the food matrix are considered intentionally added to food. Thus for these applications, the

358

conditions set out in the relevant Community or national provisions for their use in food apply,

359

i.e. an authorisation as food additive may be required (European Commission 2009). Other

360

European legislative acts for food contact materials (e.g. Directive 84/500/EEC on ceramic

361

articles) do not contain provisions for NMs (yet).

362

3.5

363

The Biocidal Products Regulation (BPR) (EU) No 528/2012 (European Parliament and

364

Council 2012) specifies the provisions for the use of non-agricultural pesticides by both

365

professional users and consumers. The 22 different biocidal product types (as described in

366

Annex V of the BPR) cover uses such as insect repellents, disinfectants or industrial

367

chemicals like anti-fouling paints for ships and material preservatives. The most common

368

biocidal NM is nanosilver, which is largely used for its antimicrobial properties. The

369

antimicrobial activity of silver (also the bulk form) is caused by the release of silver ions,

370

which increases, when the particle size decreases. Comparable to pesticides, biocidal active

371

substances and biocidal products have to undergo an authorisation procedure (European

372

Parliament and Council 2009a) at EU and MS level respectively. The BPR includes a

373

definition (see section 3.1 and supplementary information in Annex I) and specific provisions

374

for NMs. The approval of an active substance for biocidal use does not cover NMs, except

375

where explicitly mentioned. Biocidal products containing NMs are not eligible for a simplified

376

authorisation procedure. To approve NMs as active substances and for subsequent product

377

authorisation, the test methods applied to the NMs shall be accompanied by an explanation

378

addressing their scientific appropriateness taking into consideration the specific

379

characteristics of each NM.

380

Regulation (EC) No 1907/2006 called Registration, Evaluation, Authorisation and Restriction

381

of Chemicals (REACH) (European Parliament and Council 2006) has the aim to improve the

RI
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protection of human health and the environment from the risks that can be posed by

383

chemicals and applies horizontally to all chemical substances. Substances used in food or

384

feedingstuffs are exempted from registration under REACH for these applications.

385

Substances used as plant protection products or biocides are regarded as registered under

386

REACH. NMs that are applied as e.g. food contact materials (e.g. SAS, TiO2, nanosilver etc.)

387

or in industrial sectors (e.g. TiO2 in paints), are not exempted from registration under

388

REACH, and therefore the REACH provisions apply to them. REACH currently does not

389

explicitly address NMs in the legal text, however, it addresses chemicals in whatever size,

390

shape or physical form and therefore its provisions also apply to NMs. The Annexes of

391

REACH Regulation are currently under revision to more explicitly address NMs (European

392

Commission 2012).

393

NMs, as any other substance, have to be classified for hazardous properties if they show the

394

corresponding properties according to the Regulation on Classification, Labelling and

395

Packaging (CLP) (European Parliament and Council 2008a). Products containing hazardous

396

substances or NMs have to be labelled (depending on the concentration and concentration

397

limit). The responsible body to manage all REACH, Biocides and CLP tasks is the European

398

Chemicals Agency (ECHA). The European Commission plays an important role in taking

399

decisions in a number of REACH processes, in particular authorisation and restriction

400

processes.

401
402

TABLE 1 Overview of EU legal frameworks governing authorisation procedures and

nanomaterial provisions in agri/feed/food applications

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Application

Authorisation

Nano-Definition

Nano-Label

Guidance

No

No

EFSA guidance (for

oral intake via food)

Agriculture - Pesticides
Plant protection
products

(EC) No 1107/2009

(EFSA Scientific
Committee 2011)

Authorisation required means that substances/products have to undergo pre-market approval

17

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Food/Feed:
Novel food/feed

(EC) 258/97

COM(2013) 894
final 2013/0435
(COD) reference
to (EU) No
1169/2011

(EU) No 1169/2011

EFSA guidance

(EU) No 1169/2011

EFSA guidance

(EC) 1333/2008

No

Enzymes

(EC) 1332/2008

No

Flavourings

(EC) 1334/2008

No

Food supplements

Dir 2002/46/EC

No

No

No

Feed ((EC)
767/2009)

Not required

Feed additives

(EC) 1831/2003

No

No

EFSA guidance

(EC) 1935/2004

Plastic food contact

materials

(EC) 20/2011

Active and Intelligent

Materials and
Articles

(EC) 450/2009

Biocides/Chemicals

SC
No

No

EFSA guidance

No

No

EFSA guidance

No

No

EFSA guidance

(EU) No 528/2013

(EU) No 528/2013

Pending (information
requirements)

No

No

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Food contact
materials

M
AN
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(EC) 429/2008

Food contact
materials

(EU) No 528/2013

Chemical
substances

(EC) 1907/2006
(REACH)
(authorisation
required for certain
hazardous
substances)

ECHA guidance
(ECHA 2012)

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Biocides

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Food additives

403

404

3.6

Available guidances for risk assessment of nanomaterials

405

Existing Risk assessment methods and test methods are to a large extent considered

406

applicable to NMs, however some aspects, including sample preparation, characterisation,

407

dosimetry, effect endpoints, exposure data and models require further development of

408

standardised and validated methods (SCENIHR 2007; OECD 2013a). The EU Scientific
18

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Committee on Emerging and Newly Identified Health Risks (SCENIHR) has recommended a

410

case-by-case approach for the risk assessment of NMs (SCENIHR 2009).

411

Guidance for risk assessment focussing on NMs' specific properties has been released from

412

official bodies. EFSA published in 2011 a "Guidance on the risk assessment of the

413

application of nanoscience and nanotechnologies in the food and feed chain" (EFSA

414

Scientific Committee 2011) providing a practical approach for assessing potential risks

415

arising from applications of nanoscience and nanotechnologies in food additives, enzymes,

416

flavourings, food contact materials, novel foods, feed additives and pesticides. Furthermore,

417

it presents 6 exposure scenarios and corresponding testing approaches to identify and

418

characterise hazards arising from the properties of NMs. It includes guidance for data

419

generation by applicants on the physico-chemical characterisation and on testing

420

approaches to identify and characterise hazards arising from the properties of nanomaterials.

421

In total 6 scenarios are described, depending on the possible transformations of the NM

422

before and after ingestion of the food/feed. For each scenario the type of data needed to

423

conduct a risk assessment are specified. The guidance provides for reduced information

424

requirements when no exposure to NMs is verified by data indicating no migration from food

425

contact materials or when complete degradation/dissolution is demonstrated with no possible

426

absorption of NMs as such. The guidance specifies that NMs used in food or feed which are

427

transformed to non-nanoforms in a food/feed matrix and before ingestion can be treated as

428

and follow the guidance for non-nanoforms. For NMs completely transformed into non-

429

nanoforms in the gastrointestinal tract, local effects and possible absorption before

430

transformation should be considered. Otherwise existing information should be used or

431

guidance for non-nanoforms should be followed. A comparison should indicate whether the

432

nanoform has increased, less or similar hazard as compared to the non-nanoform. An expert

433

group organised by the International Life Science Institute (ILSI) (Cockburn et al. 2012)

434

prepared a systematic, tiered approach for the safety assessment of NMs in food based on a

435

comparison to the non-nano counterpart (Cockburn et al. 2012). The comparison is based on

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the dissolution rate of both the bulk and the nano form of the same material in water or under

437

gastric conditions. These guidances, as any other guidance, even if published by EU bodies,

438

are not part of the EU legislation and thus not legally binding. EFSA has also established a

439

Network for Risk Assessment of Nanotechnologies in Food and Feed (EFSA Nanonetwork)

440

with the overall goals to facilitate harmonisation of assessment practices and methodologies,

441

to enhance exchange of information and data between EFSA and EU Member States; and to

442

achieve synergies in risk assessment activities3. In 2012 the EFSA Nanonetwork asked for

443

an " Inventory of Nanotechnology applications in the agricultural, feed and food sector" to

444

receive more up-to-date information on the state of the art of nanotechnology applications,

445

which was generated by RIKILT and JRC (RIKILT and JRC 2014) and has become available

446

on the EFSA website since July 2014. It is the basis for the current paper.

447

ECHA has addressed NM specific requirements in its "Guidance on Information

448

Requirements and Chemical Safety Assessment" (IR & CSA) (ECHA 2012). ECHA has also

449

established a specific Nanomaterials Working Group to discuss scientific and technical

450

questions and to give advice in relation to NMs under REACH and CLP. No specific

451

guidance for NMs is yet available for biocides. The guidance on information requirements for

452

biocides is pending the ongoing review by OECD of all existing methodologies in order to

453

identify and implement the necessary changes needed for their application to NMs (ECHA

454

2013).

455

3.7

456

Several stakeholders including the European Parliament, EU Member States, and non-

457

governmental organisations (NGOs) have called for more transparency, traceability and

458

information regarding the use and possible exposure to NMs by either labelling of products

459

containing NMs or making use of nanotechnology and/or by the introduction of registers for

460

such products (Aschberger et al. 2014). Mandatory labelling for the content of NMs (in an

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436

Labelling and reporting schemes for NMs

http://www.efsa.europa.eu/it/supporting/pub/531e.htm

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ingredients list) is already part of EU legislation on food, cosmetics and biocides (see Table

462

1). All ingredients present in food and biocidal products in the form of NMs have to be clearly

463

indicated in the list of ingredients with the names of such ingredients followed by the word

464

"nano" in brackets since December 2014 (European Parliament and Council 2011) and

465

September 2013 (European Parliament and Council 2012), respectively. Voluntary

466

nanoclaims have been observed for some product types, e.g. for biocidal claims on products

467

containing nanosilver. Labelling provides information to consumers at the time of purchase

468

and allows them to make an informed choice. On the other hand consumers may become

469

overstrained by too much information, considering all the other information provided on a

470

label. Moreover, ingredient labelling for nanomaterials could easily be confused with hazard

471

labelling. In addition to a label which is placed directly on the product, information about NMs

472

used in products or products containing NMs can be collected in a product register. Such

473

register or inventory can give a better overview of the overall application of NMs and

474

potential exposure of humans and the environment. In the UK, the Food Safety Authority

475

(FSA) has published a list of NMs that are allowed to be used in food/food contact materials.

476

The list is short and comprised of fumed silica, nanoclay, titanium nitride and nanosilver (UK-

477

FSA). Mandatory reporting systems for NMs or products containing NMs have so far been

478

introduced in three EU Member States, including France, Belgium and Denmark.

480
481

SC

M
AN
U

TE
D

EP
AC
C

479

RI
PT

461

4. Regulatory aspects concerning NMs in agri/food/feed in

non-EU countries

482

Several countries around the world are active in examining the appropriateness of their

483

regulatory frameworks for dealing with nanotechnologies and are applying different

484

approaches to ensure the safety of nano products in agri/feed/food. This section of the paper

485

gives an overview on how NMs in agri/feed/food are regulated in non-EU countries. An

486

overview on responsible organisations, key legislation and relevant online sources is

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presented in Table 2. Those countries, for which sufficient information in English was found,

488

are listed in the paragraphs below.

489

4.1. United States of America

490

In the USA, the Food and Drug Administration (FDA) is responsible to ensure safety of food

491

additives/food contact materials/feed additives that are placed on the market under the

492

authority of the Federal Food, Drug, and Cosmetic Act (FFDCA) (US-FDA). Substances used

493

as food and colour additives are always subject to pre-market authorisation by the FDA,

494

while for some other food substances, such as food ingredients that are generally recognised

495

as safe (GRAS), pre-market authorisation by the FDA is not required. The FFDCA does not

496

contain any specification for nanotechnology-based products and FDA has not yet adopted a

497

regulatory definition of NMs. It has rather embraced a quite broadly comprehensive approach

498

when dealing with nanotechnology-based products (Hamburg 2012). To support industry,

499

FDA has published several guidance documents addressing the issues of nanotechnology

500

e.g.: "Considering Whether an FDA-Regulated Product Involves the Application of

501

Nanotechnology" (US-FDA 2014a). As reported in that guidance, when considering whether

502

a product contains NMs, FDA looks at the material's size (around 1 nm to 100 nm), or

503

properties or phenomena that are attributable to the material's external dimension(s), even if

504

these dimensions are not in the nanoscale range, but instead up to one micrometer (see

505

Annex I). This approach is meant to be broadly applicable to all FDA-regulated products,

506

including food products.

507

The FDA issued also specific guidance for food related applications of nanomaterials/

508

nanotechnology. FDA recommends a preliminary safety assessment of "Food Ingredients

509

and Food Contact Substances produced at nanoscale", which should be based on data

510

relevant to the nanometer version of a food substance (Tyler 2012). FDA does not consider a

511

priori all products containing NMs as intrinsically hazardous but suggests a case-by-case

512

approach when assessing the safety of the finished product and its foreseen use. Regarding

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ACCEPTED MANUSCRIPT
the safety of such products, FDA also states that there are no food substances intentionally

514

engineered at the nanometer scale for which there are at the moment enough safety data so

515

that their use can be considered as GRAS. In the guidance FDA declares to have not

516

received food or colour additive petitions, or GRAS affirmation petitions, for any uses of food

517

substances with a particle size distribution fully in the nanometer range. Similar

518

considerations have been drawn by FDA in the recently published "Draft Guidance for

519

Industry on Use of Nanomaterials in Food for Animals" (US-FDA 2014b).

520

The US Environmental Protection Agency (US-EPA) is responsible for regulating pesticides

521

under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (US-

522

EPA). No specific provisions for NMs are available at the moment under this regulation, the

523

US-EPA webpage "Regulating Pesticides that use Nanotechnology" (US-EPA 2011) is

524

available since July 2011. Here it is reported that US-EPA is seeking for public comments

525

regarding how nanotechnology-based pesticides should be regulated and incorporated into

526

FIFRA. Companies intending to register nanotechnology-containing pesticides are

527

recommended to contact the "US-EPA's pesticide registration Ombudsmen". US-EPA has

528

recently conditionally registered a pesticide product containing nanosilver as a new active

529

ingredient under FIFRA. The antimicrobial pesticide is a silver-based product, and as a

530

condition of registration, US-EPA is requiring additional data on the product to confirm it will

531

not cause unexpected adverse effects on human health or the environment4. US-EPA has

532

also taken actions against a company producing and illegally selling on the market food

533

containers with an unregistered nano silver pesticide5. The agency is also responsible for

534

evaluating new and existing chemicals and their risks under the Toxic Substances Control

535

Act (TSCA)6. Since 2005 US-EPA has received over 100 chemical notices for nanoscale

536

materials and is actively participating in international activities aimed at increasing the actual

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AN
U

SC

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PT

513

http://www.epa.gov/oppfead1/cb/csb_page/updates/2011/nanosilver.html
http://yosemite.epa.gov/opa/admpress.nsf/0/6469952cdbc19a4585257cac0053e637
6
http://www.epa.gov/agriculture/lsca.html
5

23

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knowledge and expertise in the nanotechnology field7. In order to have a more

538

comprehensive view on the NMs that are already on the market, US-EPA has proposed in

539

April 2015 a one-time reporting and recordkeeping requirements under TSCA section 8(a).

540

Under the new proposed rule companies that manufacture certain chemical substances

541

already in commerce as nanoscale materials shall notify EPA and provide information such

542

as production volume, methods of manufacture and processing, exposure and release

543

information, and available health and safety data. The aim of such reporting rule would be to

544

use the information gathered to decide if further actions, such as additional information

545

collection, is needed under TSCA (US-EPA 2015). In order to develop efficient testing

546

strategies for engineered nanomaterials (ENM) US-EPA is studying several NMs: nano

547

silver, carbon nanotubes, cerium dioxide, titanium dioxide, iron and micronised copper. It has

548

published case studies focusing on the specific examples which are organised around a

549

comprehensive environmental assessment (CEA) framework, combining a product life-cycle

550

perspective with the risk assessment paradigm, however without drawing conclusions about

551

potential risks. Instead, they are intended to be used as part of a process to identify what is

552

known and unknown about these materials in a selected application and can be used as a

553

starting point to identify and prioritise possible research directions to support future

554

assessments of NMs. Such case studies include for example "Nanoscale Silver in

555

Disinfectant Spray" (US-EPA 2012).

556

4.2. Canada

557

The Canadian Food Inspection Agency (CFIA) and Public Health Agency of Canada (PHAC),

558

who have recently joined the Health Portfolio of Health Canada, are responsible for food

559

regulation in Canada. No specific regulation for nanotechnology-based food products is

560

available but such products are regulated under the existing legislative and regulatory

561

frameworks.8 In October 2011 Health Canada published a "Policy Statement on Health

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AN
U

SC

RI
PT

537

7
8

http://www.epa.gov/oppt/nano/
http://www.hc-sc.gc.ca/sr-sr/pubs/nano/pol-eng.php

24

ACCEPTED MANUSCRIPT
Canada's Working Definition for Nanomaterials" (Health Canada 2011), the document

563

provides a (working) definition of NM which is focused, similarly to the US definition, on the

564

nanoscale dimensions, or on the nanoscale properties/phenomena of the material (see

565

Annex I). For what concerns general chemicals regulation in Canada, the New Substances

566

(NS) program must ensure that new substances, including substances that are at the nano-

567

scale (i.e. NMs), are assessed in order to determine their toxicological profile (Environment

568

Canada 2014). The approach applied involves a pre-manufacture and pre-import notification

569

and assessment process. In 2014, the New Substances program published a guidance

570

aimed at increasing clarity on which NMs are subject to assessment in Canada (Environment

571

Canada 2014).

572

Canadian and US regulatory agencies are working towards harmonising the regulatory

573

approaches for NMs under the US-Canada Regulatory Cooperation Council (RCC)

574

Nanotechnology Initiative9. Canada and the US recently published a Joint Forward Plan

575

where findings and lessons learned from the RCC Nanotechnology Initiative are discussed

576

(Canada-United States Regulatory Cooperation Council (RCC) 2014).

577

4.3. Australia and New Zealand

578

All food products marketed in Australia and New Zealand must fulfill the requirements set

579

under the Australia New Zealand Food Standards Code (the Code) and be assessed as safe

580

for human consumption. Food Standards Australia New Zealand (FSANZ), the agency

581

responsible for regulation of food products in both countries, has adopted a range of

582

strategies to manage potential risks for human health associated with use of nanotechnology

583

in food. One of these strategies includes the amendment of the FSANZ Application

584

Handbook to support new food regulations (Bartholomaeus 2011). FSANZ has not yet

585

received any applications to approve new or novel nanoscale particles for food use10. The

586

National Industrial Chemicals Notification and Assessment Scheme (NICNAS) introduced the

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562

http://nanoportal.gc.ca/default.asp?lang=En&n=5a56cb00-1
http://www.foodstandards.gov.au/consumer/foodtech/nanotech/Pages/default.aspx

10

25

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first regulatory program for "industrial nanomaterials" (January 2011). In that context also a

588

working definition has been adopted (see Annex I). In 2013, NICNAS posted an electronic

589

copy of its Handbook for Notifiers (NICNAS 2013), which provides guidance for importers

590

and manufacturers of industrial chemicals in Australia. Appendix H of that document includes

591

guidance and requirements for notification of new chemicals that are industrial NMs. NICNAS

592

has published information sheets on hazard reviews for nanoforms of TiO2 and Ag, while the

593

Tasmanian Institute of Agriculture has published a comprehensive review on

594

Nanotechnology in Agricultural Products Logistics Management (Bowles and Jianjun 2012;

595

ISO 2013).

SC

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PT

587

M
AN
U

596

4.4. Non-EU European countries

598

From non-EU European countries we found several nano-related activities in Switzerland,

599

Turkey and Russia.

600

In Switzerland the safety of NMs is ensured by existing regulations and procedures dealing

601

with traditional chemicals. NMs used in pesticide products submitted for registration must be

602

reported together with specific information on their composition, shape, particle size, surface

603

area, aggregation state, coatings and functionalisation, as requested by a Swiss Ordinance

604

of 2010 (Schweizerischer Bundesrat 2010). Until 2013 the Federal Office of Public Health

605

(FOPH) had not received any requests for approval of food additives containing NMs

606

(FAO/WHO 2013), nor have applications for nanotechnology-based pesticides been reported

607

(Bucheli TD 2013). Regarding general chemical regulation and risk assessment in

608

Switzerland, an action plan on the risk assessment and risk management of synthetic NMs

609

was launched in 2008. As part of the action plan, FOPH and the Federal Office for the

610

Environment (FOEN) published in 2008 a precautionary matrix for synthetic NMs ((Hck et

611

al. 2008). The precautionary matrix is not legally binding and it can be used on a voluntary

612

basis as an evaluation tool for the safe handling of NMs. It should always be employed in

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parallel to the existing non nano-specific assessment methods. Aim of this matrix is to

614

estimate the risk management measures required for employees, consumers and the

615

environment at each stage of the life cycle. The precautionary matrix is built up on a series of

616

evaluation parameters, including particle's size, reactivity, stability, release potential,

617

concentration of particles11 (Hck et al. 2008). A NM definition is available from a guideline

618

document for the compilation of safety data sheet for synthetic NMs as published by the

619

Swiss Secretariat for Economic Affairs (SECO 2012) (see Annex I).

620

In Turkey a national or regional policy for the responsible development of nanotechnology is

621

under development (OECD 2013b). Nanotechnology is considered as a strategic

622

technological field and at present 32 nanotechnology research centres are working in this

623

field. Turkey participates as an observer in the EFSA Nano Network (section 3.6) along with

624

other EU candidate countries Former Yugoslav Republic of Macedonia, and Montenegro

625

(EFSA 2012). The Inventory and Control of Chemicals Regulation entered into force in

626

Turkey in 2008, which represents a scale-down version of the REACH Regulation (Bergeson

627

et al. 2010). Moreover, the Ministry of Environment and Urban Planning published a Turkish

628

version of CLP Regulation (known as SEA in Turkish) to enter into force as of 1st June 2016

629

(Intertek).

630

The Russian legislation on food safety is based on regulatory documents such as the

631

Sanitary Rules and Regulations ("SanPiN"), but also on national standards (known as

632

"GOST") and technical regulations (Office of Agricultural Affairs of the USDA 2009). The

633

Russian policy on nanotechnology in the industrial sector has been defined in some national

634

programmes (e.g. Nanotechnology Industry Development Program) and a Russian

635

Corporation of Nanotechnologies was established in 200712. As reported by FAO/WHO

636

(FAO/WHO 2013), 17 documents which deal with the risk assessment of NMs in the food

637

sector were released within such federal programs. Safe reference levels on nanoparticles

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AN
U

SC

RI
PT

613

11
12

http://www.bag.admin.ch/nanotechnologie/12171/12174/index.html?lang=en
http://en.rusnano.com/upload/images/documents/RUSNANO_Strategy_2020.pdf

27

ACCEPTED MANUSCRIPT
impact on the human body were developed and implemented in the sanitary regulation for

639

NMs of silver, single wall carbon nanotubes and titanium dioxide (FAO/WHO 2013).

640

4.5. Asia

641

Some Asian countries are quite active in the production and regulation of NMs. Beside

642

national regulations, several countries have established standards and certification systems

643

for nano-enabled products and Japan and Korea are actively participating to OECD Working

644

Party on Manufactured Nanomaterials (WPMN). An overview of the responsible

645

organisations and key legislation is provided in Table 2.

646

In Japan, the safety of food products is regulated by the Food Sanitation Law. No NMs-

647

specific legislation is available to date in Japan but various research activities are ongoing in

648

the nanotechnology field. A "Basic Survey Report on Safety Assessment Information on the

649

Use of Nanotechnology in the Food Sector" was released in March 2010 (FSCJ 2010) and

650

opinions on the current status of the use of nanotechnology in the food sector in Japan can

651

be found in that document (English version available).

652

For the Republic of South Korea the main piece of legislation for foods, food additives, and

653

food packaging is the Food Sanitation Act. No specifications for NMs are available to date

654

(FAO/WHO 2013). As reported in their website, the Korean Food and Drug Administration

655

(KFDA) also establishes food standards such as "Food Code", "Food Additives Code" and

656

"Food Labelling Standards" (KFDA). The Republic of South Korea has established a

657

"National Nano-safety Strategic Plan (2012/2016)". The Ministry of Knowledge and Economy

658

(MKE) and the Korean Agency for Technology and Standards, published in 2011 as a

659

Korean standard the "Guidance on safety Management of Nano-based products", (Mantovani

660

et al. 2012; Park 2012), where nanomaterials are defined as nano-objects and nano-

661

structured materials in a solid form, that are smaller than 100 nm.

662

In India the key piece of regulation for food safety is the Food Safety and Standards Act

663

(2006). The Government had launched in October 2001 a programme called the Nano

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Science and Technology Initiative (NSTI), followed by the programme "Nano Mission" in

665

200713. A series of research activities have been undertaken under this program and only

666

recently some initiatives have started to address risk issues. Standardisation remains an

667

area of concern, as India has only taken initial steps in addressing standardisation issues. As

668

reported in some publications specifically addressing the topic of nanotechnology risk

669

management in India, the nation does not have a legislation that takes in consideration

670

nanoparticles as a hazard (Chugh 2009), has a loose framework of legislation where

671

nanotechnology risks can be addressed (Jayanthi et al. 2012) and lacks resources and

672

expertise to handle nanotechnology risks (Barpujari 2011).

673

In China food safety is regulated under the Food Safety Law, which does not include any NM

674

specifications. The National Centre for Nanoscience and Technology (NCNST) and the

675

Commission on Nanotechnology Standardisation are responsible for developing national

676

standards in the nanotechnology area. One of these standards contains a definition for nano

677

materials (GB/T 19619-2004) (see Annex I) (Park 2012; ISO 2013). Applications of

678

nanominerals or NMs to be used as food ingredients have been rejected so far by the

679

Chinese regulatory authorities (FAO/WHO 2013).

680

In Malaysia a National Nanotechnology Regulatory and Safety Committee, placed under the

681

National Nanotechnology Directorate, was established to monitor and review issues related

682

to health, safety and environment. Regulations to ensure health, safety and environmental

683

aspects of nanotechnology include "The Nanotechnology Industry Development Act" and

684

"The Nanotechnology Safety-Related Act". Revisions of Food Regulations 1985 and The

685

Food Act 1983 are expected to include among others specifications relating to

686

nanotechnology (NanoMalaysia 2013).

687

In Taiwan a National Science and Technology Program for Nanoscience and

688

Nanotechnology and "Nano Technology Industrialisation Promotion Plan" were initiated. In

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13

http://nanomission.gov.in/

29

ACCEPTED MANUSCRIPT
cooperation with the Standards Committee of TANIDA (Taiwan Nanotechnology Industry

690

Development Association) a system for certifying nanoproducts, called nanoMark System

691

(Figure 2A) was established with the aim to enhance the quality and image of

692

nanotechnology products, protect consumer's rights, and promote the development of a

693

national nanotechnology industry14. The Asia Nano Forum NEWSLETTER (Issue No. 24)

694

reported that from 2004 to 2014, 39 companies and 1490 products passed the NanoMark

695

certification15. A definition of the term nanomaterial is available from the Council of Labor

696

Affairs of Taiwan, within the context of Chemical Substance Nomination & Notification (David

697

et al. 2013).

SC

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689

699

[place Figure 2 about here]

700

M
AN
U

698

In Iran an Iran Nanotechnology Initiative Council (INIC) was established in 2003 to define the

702

general policies for the development and access to the market of nanotechnology in the

703

country. The main body responsible for the approval of food products is the Food and Drug

704

Organisation (FDO) which established a specific Nanotechnology Committee to develop

705

specific guidelines for the assessment and approval of nanotechnology-based

706

pharmaceuticals, medical equipment, cosmetics, food, beverages and pharmaceutical

707

supplements. A flowchart on approval procedures for nano-health products is available on

708

the website as well as checklists with specification and safety aspects to be considered and

709

reported for the approval of nanotechnology-based food packaging, food additives,

710

supplements raw materials and supplements product16. A list of approved nano-health

711

products is also available and product applications such as supplements, packaging for fruit

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14

http://www.taiwan.gov.tw/ct.asp?xItem=27511&ctNode=1906&mp=1001
http://www.asia-anf.org/admin/upload/files/general/News432_1.pdf.
16
http://nanohealth.ir/pages/static_page.php?id=14&site=1&lang=2
15

30

ACCEPTED MANUSCRIPT
maintenance and disinfectants are mentioned among others17. Iran has also introduced a

713

nano symbol as industrial standard certification18 which applies to "products pertaining to

714

pharmacy, medical equipment, beauty and healthcare, food and beverages, and dietary

715

supplements". Accreditation is obtained through a "nanotechnology committee" associated to

716

the FDO; twelve products have so far received the certification19.

717

In Thailand the Food & Drug Administration of the Ministry of Public Health is responsible for

718

controlling food products. The National Nanotechnology Centre (NANOTEC) has identified

719

10 flagship programmes of national priority, including industrial standards for nano-products

720

in Thailand, called NANO-MARKS, and "Food Quality" aimed at improving and monitoring

721

the quality for Thai Food prepared by applying nanotechnology. The "NanoQ label" (Figure

722

2B) has been introduced for nano products that are certified by the Nanotechnology

723

Association of Thailand20,21,22. The NanoQ label has been so far used in the paint, ceramics,

724

textile, and household plastics industries with the aim to eliminate fake nano products on the

725

market and increase people's trust on the products they are buying. No information was

726

found on the application of such a nano label on food/feed products.

727

4.6. Africa and South America

728

The South African Nanotechnology Initiative (SANi) was established in the year 2002

729

(Leskey M. Cele 2009) and a South African nanotechnology strategy with a 10-year plan for

730

nanotechnology has been created in this context23. No specific legislation for NMs is however

731

currently available and the regulation of nanotechnology-based food products falls under the

732

several pieces of food-specific legislation, i.e. the Foodstuff, Cosmetics and Disinfectant

733

Amendment Act 2007.

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17

http://nanohealth.ir/contents/content_Nanohealth%20product%20list.pdf.
http://www.nano.ir/index.php?ctrl=news&actn=news_view&id=42433&lang=2
19
http://www.nanotechia.org/news/news-articles/iran-introduces-certification-nano-foods-and-health-products
20
http://www.who.int/ifcs/documents/forums/forum6/ppt_nano_thailand.pdf
21
http://nanotech.apctt.org/countryreports/Thailand%20Country%20Report.pdf
22
http://www.oecd.org/science/nanosafety/47556610.pdf
http://www.sani.org.za/pdf/Nanotechnology_10-Year_plan.pdf
18

31

ACCEPTED MANUSCRIPT
In Brazil food products are regulated under several legal documents issued by the Federal

735

Government. Brazil is one of the leading countries in nanotechnology research and

736

development in Latin America (Guillermo Foladori 2007). Several programmes and

737

considerable investments have in fact been undertaken in the nanotechnology sector;

738

however no specific regulation has yet been introduced in the country. A proposal aiming at

739

introducing labelling of food, drugs and cosmetics containing NMs was presented to

740

Congress's Senate in May 2010 but was rejected.

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Country
USA

Responsible
Organisation
US Food and Drug
Administration (FDA)
Environmental Protection
Agency (EPA)

Canadian Food Inspection

Agency (CFIA)

Key legislation

http://www.fda.gov/regulatoryinform
ation/legislation/federalfooddrugand
cosmeticactFDCAct/default.htm
Federal Insecticide,
http://www.fda.gov/Food/default.ht
Fungicide, and Rodenticide m
Act (FIFRA)
http://www.epa.gov/oecaagct/lfra.ht
ml
Food and Drugs Act
http://www.hc-sc.gc.ca/dhp-

Public Health Agency of

Canada (PHAC)

Food Standards Australia

New Zealand (FSANZ)

Switzerland

http://www.foodstandards.gov.au/co
de/Pages/default.aspx
http://www.nicnas.gov.au/communi
cations/issues/nanomaterialsnanotechnology/nicnas-regulatoryactivities-in-nanomaterials
http://www.foodstandards.gov.au/co
nsumer/foodtech/nanotech/pages/d
efault.aspx
http://www.bag.admin.ch/nanotechn
ologie/12171/12174/index.html?lan
g=en
http://www.bag.admin.ch/nanotechn
ologie/12171/12176/index.html?lan
g=en
http://www.bag.admin.ch/themen/le
bensmittel/10380/index.html?lang=
en

Sanitary Rules and

Regulations ("SanPiN")

http://www.rospotrebnadzor.ru/en/d
eyatelnost/bilateral.php

Swiss Federal Office of

Public Health (FOPH)
Federal Office for the
Environment (FOEN)

Russia

The Federal Service for the

Protection of Consumer
Rights and Human WellBeing of the Ministry of
Health and Social
Development
(Rospotrebnadzor)

mps/nano-eng.php
http://lawslois.justice.gc.ca/eng/regulations/C.
R.C.%2C_c._870/

Australia New Zealand

Food Standards Code

EP

Australia
and New
Zealand

Online resources

Federal Food, Drug, and

Cosmetic Act (FFDCA)

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Canada

M
AN
U

TABLE 2: Summary of food legislation in some non-EU countries

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Japan

Ministry of Health, Labour

and Welfare

Food Sanitation Law

Korea

Ministry of Food and Drug

Safety (MFDS)

Food Sanitation Act

http://www.mhlw.go.jp/english/polic
y/health-medical/food/index.html
http://www.jetro.go.jp/en/reports/reg
ulations/

http://www.kfda.go.kr/eng/index.do?
nMenuCode=61
http://www.mfds.go.kr/eng/index.do
http://www.kats.go.kr/english/home/
home.asp?OlapCode=ATSU15

Korean food and Drug

Administration (KFDA)

Food Safety Standard

Authority of India (FSSAI)

China

Ministry of Agriculture
Ministry of Health

Food Safety and Standards http://www.fssai.gov.in/AboutFssai/I

ntroduction.aspx?RequestID=kHte1
Act, 2006
4K1h8e3hHK4iHe_doAction=True
WHO/FAO report, 2013
Food Safety Law of China, http://en.nim.ac.cn/
2009
http://en.nim.ac.cn/division/overvie
w/924

SC

India

RI
PT

Korean Agency for

Technology and Science
(KATS)

National Institute of
Metrology
Ministry of Science
Technology and Innovation

Food Regulations 1985

The Food Act 1983

Iran

Nanotechnology Committee
of Food and Drug
Organisation
Iran Nanotechnology
Initiative Council (INIC)

South
Africa

Food Act B.E.2522

http://irannano.org/nano/index.php?
ctrl=section&actn=get_section&lang
=2&id=22
http://eng.moph.go.th/index.php/saf
ety

Foodstuffs, Cosmetics and http://www.sani.org.za/

Disinfectants Amendment
Act, 2007

National Agency of Sanitary

Surveillance (ANVISA)

EP

Brazil

Food and Drug

Administration of the Ministry
of Public Health

http://nanohealth.ir/pages/static_pa
ge.php?id=9&site=1&lang=2

TE
D

Thailand

http://www.mosti.gov.my/index.php
?option=com_content&view=frontp
age&Itemid=27&lang=en

M
AN
U

Malaysia

http://portal.anvisa.gov.br/wps/porta
l/anvisa-ingles
http://www.agricultura.gov.br/

AC
C

Ministry of Agriculture,
Livestock, and Food Supply
(MAPA)
Ministry of Health (MS)

743
744

745
746

5. Comparison of EU and non-EU regulatory approaches

747

The overview presented in this work shows that several countries or regions all over the

748

world are active in managing the marketing and use of nano-based products in agri/feed/food
33

ACCEPTED MANUSCRIPT
sectors and nanotechnology. The approaches applied to regulate them and to ensure their

750

safe use are however different.

751

The EU, along with Switzerland, were identified to be the only world region where nano-

752

specific provisions have been incorporated in legislation for agri/feed/food, which include

753

specific information requirements for NMs risk assessment and/or legally binding definitions

754

of the term "nanomaterial", and/or the obligation to label or report the presence of NMs in

755

products. Furthermore, in the EU a recommendation for a broadly applicable definition of

756

"nanomaterial" is available. All EU definitions of the term "nanomaterial" intended for

757

regulatory purposes use size as main identifier. The definition in the Cosmetics Regulation

758

No 1223/2009 considers only insoluble and biopersistent materials as NMs. For all other

759

applications, further specific properties, like solubility or degradation are addressed in

760

specific guidance for information requirements and risk assessment.

761

As presented in a recent study by the Committee on Environment, Public Health and Food

762

Safety (ENVI) of the European Parliament (European Parliament 2014), EU legislation is in

763

general considered more stringent than US legislation and more open to consumer opinions.

764

For example REACH requires that all chemicals, thus also NMs, must be registered, which

765

includes the submission of safety data. According to TSCA in US, the submission of safety

766

data is required only in particular cases, although US-EPA recently has proposed (April

767

2015) to use TSCA also for one-time reporting and record-keeping of existing exposure and

768

health and safety information on chemicals currently in the marketplace when they are

769

manufactured or processed as nanoscale materials (US-EPA 2015). Concerning food

770

legislation, the study concluded that the "farm to fork" approach of the EU includes all stages

771

of food production from manufacturing and processing to distribution (European Parliament

772

2014). Monitoring in the US focuses only on "registered facilities" in the manufacturing and

773

processing part of the supply chain with the aim of preventing and intercepting contaminated

774

food. The precautionary approach as followed in the EU takes account of scientific

775

uncertainty to implement measures addressing risks, beside other factors such as economic

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costs and benefits and consumer opinions. The US approach strictly relies on science-based

777

assessments to prove risks and consequently take regulatory actions (European Parliament

778

2014).

779

Several countries outside the EU have rather adopted a broad approach when dealing with

780

regulation of NMs in agri/feed/food. Many non-EU countries have introduced non-mandatory

781

frameworks and consider existing regulatory frameworks able to adapt to and cover the

782

particularities of NMs (e.g. US, Australia and New Zealand, Canada). Some countries (e.g.

783

Malaysia) are adapting their existing regulatory frameworks for agri/feed/food to include

784

specifications for nanotechnology (OECD 2013b).

785

No legally binding definitions could be identified outside EU and rather working definitions of

786

NMs are applied. Beside size, some countries (e.g. US, Canada) consider also other

787

properties or phenomena to define NMs or nanotechnology. This points the focus to NMs

788

which potentially have a different hazard profile and which may be of higher priority for risk

789

assessment. Some non-EU countries such as Iran, Taiwan and Thailand have introduced

790

systems for tracking and labelling consumer products containing NMs (e.g. NanoMark

791

system), which are however substantially different from the labelling requirement in the EU.

792

As applications of nanotechnology are evolving and more advanced new generation

793

nanotechnology products are expected to enter the market, the existence of a proper safety

794

net and adequate regulatory frameworks adapted to products of nanotechnology are of high

795

priority. A case-by-case risk assessment of each NM or nanoform - as currently

796

recommended and practised in certain countries - is not the most efficient long term

797

approach to ensure the safety of nanoproduct since it would require too many resources and

798

could be impedimental to innovation. Several activities are ongoing in research but also by

799

governmental and non-governmental international organisations and industry to identify

800

common determinants of NM risks, which would allow applying more efficient approaches,

801

including grouping of NMs and reading across of hazard or exposure data (Gebel et al. 2014;

802

Arts et al. 2015). In addition, risk management measures to limit exposure to NMs are

AC
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776

35

ACCEPTED MANUSCRIPT
recommended. Exposure limitation may however not be the goal for certain products, e.g.

804

when the nanoform should enable increased bioavailability of nutrients or active substances.

805

Considering that nanotechnology-based agri/feed/food products may enter the international

806

trade and such products may be obtained via the internet, harmonised approaches

807

addressing NMs marketing and their safe use would be beneficial. Guidance and standards

808

on e.g. appropriate (test) methods for risk assessment can be harmonised at international

809

level and periodically adapted to technical progress. Several activities are already ongoing

810

under the umbrella of e.g. OECD and ISO. FAO and WHO have jointly created the Codex

811

Alimentarius Commission, an intergovernmental agency that aims at creating international

812

food standards, guidelines, codes of practice and advisory texts, which could also cover

813

nanotechnology-based products. The development of a solid system for sharing information

814

and experience gained on the use of NMs in agri/feed/food around the globe is also highly

815

desirable in the present era of globalisation.

816

6. Conclusions

817

Applications of nanotechnologies and incorporation of NMs in agri/feed/food are growing and

818

several novel products, currently in development are expected to enter the market in the near

819

future. Therefore, it is becoming increasingly important to have regulatory frameworks that

820

properly address and specifically manage the potential risks of nanotechnology. Several

821

countries over the world have been active in examining the appropriateness of their

822

regulatory frameworks for dealing with nanotechnologies. The overview presented in this

823

work shows that countries within the EU and outside EU follow different approaches in

824

regulating nano-based products in agri/feed/food and nanotechnology in general.

825

The EU, along with Switzerland, were identified to be the only world region where nano-

826

specific provisions have been incorporated in legislation for agri/feed/food. In other regions

827

nano-specific provisions are more implicit, building mainly upon guidance for industry.

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828

Collaboration among countries around the world is required in order to exchange information

829

and to ensure a high level of protection for humans and the environment, while not

830

hampering the development of new beneficial products and their global marketing.

831

RI
PT

832

Acknowledgements

834

The information on "Regulatory aspects concerning nanotechnology in the agri-feed-food

835

sector in EU and non-EU countries" was produced as part of EFSA contract

836

CFT/EFSA/FEED/2012/01, Inventory of Nanotechnology applications in the agricultural,

837

feed and food sector.

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Figure 1 Applications of Nanotechnology and nanomaterials in the agriculture, feed and

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Figure 2 Nanoproducts certification system as introduced by industrial standards

committees in A) Taiwan (Nano)24 and B) Thailand (NanoQ)25

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Regulatory aspects concerning nanotechnology in the

agri-feed-food sector in EU and non-EU countries

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Highlights

Nanotechnology applications in the agri/feed/food sector are growing worldwide

Different approaches are applied to regulate nanotechnology applications

The EU has binding NM definitions and NM-specific provision for some applications

Several non-EU countries regulate NM by mainly building on guidance

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A NNEX I SUPPLEMENTARY I NFORMATION
DEFINITIONS OF THE TERM "NANOMATERIAL" IN EU AND NON-EU COUNTRIES

European Union

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Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25

October 2011 on the provision of food information to consumers1

SC

"engineered nanomaterial" means 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.

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Commission Recommendation of 18 October 2011 on the definition of nanomaterial

(2011/696/EU)2

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"Nanomaterial" means a natural, incidental or manufactured material containing particles, in an

unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles
in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm. In
specific cases and where warranted by concerns for the environment, health, safety or
competitiveness the number size distribution threshold of 50 % may be replaced by a threshold
between 1 and 50 %.
By derogation [], fullerenes, graphene flakes and single wall carbon nanotubes with one or more
external dimensions below 1 nm should be considered as nanomaterials.
[], "particle", "agglomerate" and "aggregate" are defined as follows:

EP

"particle" means a minute piece of matter with defined physical boundaries;

"agglomerate" means a collection of weakly bound particles or aggregates where the resulting
external surface area is similar to the sum of the surface areas of the individual components;

AC
C

"aggregate" means a particle comprising of strongly bound or fused particles.

Where technically feasible and requested in specific legislation, compliance with the definition []may be determined on the basis of the specific surface area by volume. A material should be
considered as falling under the definition [] where the specific surface area by volume of the
material is greater than 60 m2 /cm3. However, a material which, based on its number size
distribution, is a nanomaterial should be considered as complying with the definition [] even if the
material has a specific surface area lower than 60 m2 /cm3.
The EC Definition includes a revision clause which allows taking into account new scientific and
technical insights by the time the definition is reviewed in 2014. (Remark: no revision by June 2015.)

1
2

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:304:0018:0063:en:PDF
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:275:0038:0040:en:PDF

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Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May
2012 concerning the making available on the market and use of biocidal products3

RI
PT

"nanomaterial" means a natural or manufactured active substance or non-active substance

containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50
% or more of the particles in the number size distribution, one or more external dimensions is in the
size range 1-100 nm.
Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions
below 1 nm shall be considered as nanomaterials.

SC

For the purposes of the definition of nanomaterial, "particle", "agglomerate" and "aggregate" are
defined as follows:
- "particle" means a minute piece of matter with defined physical boundaries,

M
AN
U

- "agglomerate" means a collection of weakly bound particles or aggregates where the resulting
external surface area is similar to the sum of the surface areas of the individual components,
- "aggregate" means a particle comprising strongly bound or fused particles;

Regulation (EC) No 1223/2009 of the European Parliaent and of the Council of 30

November 2009 on cosmetic products4

Non-EU countries

TE
D

"Nanomaterial" means an insoluble or biopersistent and intentionally manufactured material with

one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.

EP

United States of America

US-Food and Drug Administration guidance: "Considering Whether an FDA-Regulated Product

Involves the Application of Nanotechnology"5

AC
C

products that involve the application of nanotechnology or nanotechnology products mean

products that contain or are manufactured using materials in the nanoscale range, as well as
products that contain or are manufactured using certain materials that otherwise exhibit related
dimension-dependent properties or phenomena
nanomaterial generally refers to both materials in the nanoscale range and certain materials that
otherwise exhibit related dimension-dependent properties or phenomena

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:167:0001:0123:en:PDF
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:en:PDF
5
http://www.fda.gov/regulatoryinformation/guidances/ucm257698.htm
4

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Canada
Health Canada6 considers any manufactured substance or product and any component material,
ingredient, device, or structure to be nanomaterial if:
a)
It is at or within the nanoscale in at least one external dimension, or has internal or surface
structure at the nanoscale, or

RI
PT

b)
It is smaller or larger than the nanoscale in all dimensions and exhibits one or more
nanoscale properties/phenomena.

Australia

SC

The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) introduced the first
regulatory program for industrial nanomaterials as of January 1, 20117. The working definition
adopted in this context is the following:

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Industrial nanomaterials are Materials intentionally produced, manufactured or engineered to have

unique properties or specific composition at the nanoscale, that is a size range typically between 1
nm and 100 nm, and is either a nano-object (i.e., that is confined in one, two, or three dimensions at
the nanoscale) or is nanostructured (i.e., having an internal or surface structure at the nanoscale).

Switzerland

The Swiss Secretariat for Economic Affairs (SECO) has published a guideline document for the
compilation of safety data sheet for synthetic nanomaterials8. In the chapter on "Applicability of the
guidelines and their individual definition" the following nanomaterial definition is given:

EP

China

TE
D

Nanomaterial is a material whose particle size distribution includes over 1% nanoparticles (1-100
nm) in an unbound state, either as an aggregate or as an agglomerate. Fullerenes, graphene flakes
and single-wall carbon nanotubes are classed as nanomaterials even if they have dimensions of less
than 1 nm. Should the particle size distribution not be known, then any material with an average
grain size less than 500 nm will be classed as a nanomaterial.

AC
C

China has released several standards related to nanotechnology. A definition of nanomaterial can be
found for China in "GB/T 19619-2004: (Terminology for nanomaterials)"9:
Nanomaterial is the material which has a structure in the three-dimensional space in at least one
dimension in the nanometer scale (from 1 nm to 100 nm range of geometric dimensions), or
constituted by the nano-structure unit and a material with special properties.

Taiwan

The Council of Labor Affairs of Taiwan, within the context of Chemical Substance Nomination &
Notification (2012), provides the following definition of nanomaterial:
6

http://www.hc-sc.gc.ca/sr-sr/pubs/nano/pol-eng.php [Accessed 3rd June 2015]

http://www.nicnas.gov.au/regulation-and-compliance/nicnas-handbook/handbook-appendixes/guidanceand-requirements-for-notification-of-new-chemicals-that-are-industrial-nanomaterials/nicnas-workingdefinition-of-industrial-nanomaterial
8
Safety data sheets (SDS): Guidelines for synthetic nanomaterials, SECO, 2012;
http://www.seco.admin.ch/dokumentation/publikation/00009/00027/04546/index.html?lang=en
9
http://www.egg2012.de/tl_files/pdf/Paper/EGG2012_C6_1_Park_presentation_slides.pdf
7

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A nanomaterial is one which is intentionally manufactured or designed and meets any of the
following conditions:
A) Material with one or more external dimensions or an internal or surface structure on the scale
from 1-100 nm;

RI
PT

B) It is smaller or larger than the nanoscale above in all spatial dimensions and exhibits one or more
nanoscale phenomena/property (for example, increased intensity and chemical reactivity).

ISO
ISO/TS 80004-1:201010

SC

Nanomaterial is a material with any external dimension in the nanoscale or having internal structure
or surface structure in the nanoscale.
ISO/TS 27687:200811

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Nanoparticle: Nano-object with all three external dimensions in the nanoscale.

Nanoscale means a size range from approximately 1 nm to 100 nm.

AC
C

EP

TE
D

More information on definitions of the term nanomaterials can be found in the JRC report: Towards
a review of the EC Recommendation for a definition of the term "nanomaterial"; Part 1: Compilation
of information concerning the experience with the definition by Rauscher et al. (2014)12.

10

ISO/TS 80004-1:2010, Nanotechnologies - Vocabulary Part 1: Core terms

ISO TS 27687:2008, Terminology and definitions for nano-objects Nanoparticle, nanofibre and nanoplate
12
https://ec.europa.eu/jrc/sites/default/files/lbna26567enn.pdf
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A NNEX II SUPPLEMENTARY INFORMATION
DEFINITION OF RELEVANT TERMS IN THE AGRI-FEED- FOOD SECTOR AND PIECE OF EU
LEGISLATION WHERE IT CAN BE FOUND

products, consisting of or containing active

substances, safeners or synergists, and intended for
one of the following uses:
(a) protecting plants or plant products against all
harmful organisms or preventing the action of such
organisms, unless the main purpose of these
products is considered to be for reasons of hygiene
rather than for the protection of plants or plant
products;
(b) influencing the life processes of plants, such as
substances influencing their growth, other than as a
nutrient;
(c) preserving plant products, in so far as such
substances or products are not subject to special
Community provisions on preservatives;
(d) destroying undesired plants or parts of plants,
except algae unless the products are applied on soil
or water to protect plants;
(e) checking or preventing undesired growth of
plants, except algae unless the products are applied
on soil or water to protect plants.

Regulation (EC) No 1107/2009

concerning the placing of plant
protection products on the market
Article 2

any substance not normally consumed as a food in

itself and not normally used as a characteristic
ingredient of food, whether or not it has nutritive
value, the intentional addition of which to food for a
technological purpose in the manufacture,
processing, preparation, treatment, packaging,
transport or storage of such food results, or may be
reasonably expected to result, in it or its by-products
becoming directly or indirectly a component of such
foods;
any substance or product, including additives,
whether processed, partially processed or
unprocessed, intended to be used for oral feeding to
animals

AC
C

EP

Food additive

Active substances: substances, including microorganisms having general or specific action against
harmful organisms or on plants, parts of plants or
plant products.
Any substance or product, whether processed,
partially processed or unprocessed, intended to be,
or reasonably expected to be ingested by humans.
Food includes drink, chewing gum and any
substance, including water, intentionally
incorporated into the food during its manufacture,
preparation or treatment.

TE
D

Food (or foodstuff)

M
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SC

Product

Piece of EU Legislation

RI
PT

Plant Protection

Definition

Feed (feeding stuff)

Feed additives

means substances, micro-organisms or

preparations, other than feed material and
premixtures, which are intentionally added to feed or
water in order to perform, in particular, one or more
of the functions mentioned in Article 5(3):
The feed additive shall: (a) favourably affect the
characteristics of feed,

Regulation (EC) No 178/2002

laying down the general principles
and requirements of food law,
establishing the European Food
Safety Authority and laying down
procedures in matters of food
safety.
Article 3
Regulation (EC) No 1333/2008 on
food additives
Article 3

Regulation (EC) No 178/2002

(General food law) Article 3
Regulation (EC) No 767/2009 on
the placing on the market and use
of feed makes reference to
Regulation (EC) No 178/2002;
Regulation (EC) No 1831/2003 on
additives for use in animal
nutrition
Article 2

Regulation (EC) No 258/97

concerning novel foods and novel
food ingredients
Article 1

AC
C

Flavouring

EP

Food enzyme

TE
D

M
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SC

Novel food

(b) favourably affect the characteristics of animal

products,
(c) favourably affect the colour of ornamental fish
and birds,
(d) satisfy the nutritional needs of animals,
(e) favourably affect the environmental
consequences of animal
production,
(f) favourably affect animal production, performance
or
welfare, particularly by affecting the gastro-intestinal
flora
or digestibility of feedingstuffs, or
(g) have a coccidiostatic or histomonostatic effect.
foods and food ingredients which have not been
used for human consumption to a significant degree
within the Community (before 1997) and which fall
under the following categories:
(c) foods and food ingredients with a new or
intentionally modified
primary molecular structure;
(d) foods and food ingredients consisting of or
isolated from microorganisms,
fungi or algae;
(e) foods and food ingredients consisting of or
isolated from plants
and food ingredients isolated from animals, except
for foods and food ingredients obtained by
traditional propagating or breeding practices and
having a history of safe food use;
(f) foods and food ingredients to which has been
applied a production process not currently used,
where that process gives rise to significant changes
in the composition or structure of the foods or food
ingredients which affect their nutritional value,
metabolism or level of undesirable substances.
a product obtained from plants, animals or microorganisms or products thereof including a product
obtained by a fermentation process using microorganisms:
(i) containing one or more enzymes capable of
catalysing a specific biochemical reaction; and
(ii) added to food for a technological purpose at any
stage of the manufacturing, processing, preparation,
treatment, packaging, transport or storage of foods;
(a) flavouring means products:
(i) not intended to be consumed as such, which are
added to food in order to impart or modify odour
and/or taste;
(ii) made or consisting of the following categories:
flavouring substances, flavouring preparations,
thermal process flavourings, smoke flavourings,
flavour precursors or other flavourings or mixtures
thereof;
(b) flavouring substance shall mean a defined
chemical substance with flavouring properties;
(c) natural flavouring substance
Natural flavouring substances correspond to
substances that are naturally present and have
been identified in nature;
(a) foodstuffs the purpose of which is to supplement
the normal diet and which are concentrated sources
of nutrients or other substances with a nutritional or
physiological effect, alone or in combination,
marketed in dose form, namely forms such as
capsules, pastilles, tablets, pills and other similar

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Food supplements

Regulation (EC) No 1332/2008 on

food enzymes
Article 3

Regulation (EC) No 1334/2008 on

flavourings and certain food
ingredients with flavouring
properties for use in and on foods
Article 3

Directive 2002/46/EC on the

approximation of the laws of the
Member States relating to food
supplements
Article 2

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material

Plastic food contact

Regulation (EC) No 10/2011 on

plastic materials and articles
intended to come into contact with
food
Article 3

SC

material

Regulation (EC) No 1935/2004 on

materials and articles intended to
come into contact with food
Article 1

RI
PT

Food contact

forms, sachets of powder, ampoules of liquids, drop

dispensing bottles, and other similar forms of liquids
and powders designed to be taken in measured
small unit quantities;
(b) nutrients means the following substances: (i)
vitamins, (ii) minerals.
materials and articles, including active and
intelligent food contact materials and articles, which
in their finished state:
(a) are intended to be brought into contact with food;
or
(b) are already in contact with food and were
intended for that purpose; or
(c) can reasonably be expected to be brought into
contact with food or to transfer their constituents to
food under normal or foreseeable conditions of use.
plastic materials and articles means
(a) materials and articles referred to in points (a), (b)
and (c) of Article 2(1);

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(a) materials and articles and parts thereof

consisting exclusively of plastics;
(b) plastic multi-layer materials and articles held
together by adhesives or by other means;
(c) materials and articles referred to in points a) or
b) that are printed and/or covered by a coating;
and
(b) plastic layers referred to in Article 2(1)(d) and
(e);

materials and
articles

Intelligent food

Materials and articles which monitor the condition of

packaged food or the environment surrounding the
food;

AC
C

contact materials

Materials and articles that are intended to extend

the shelf-life or to maintain or improve the condition
of packaged food. They are designed to deliberately
incorporate components that would release or
absorb substances into or from the packaged food
or the environment surrounding the food;

EP

active food contact

TE
D

(d) plastic layers or plastic coatings, forming gaskets

in caps and closures, that together with those caps
and closures compose a set of two or more layers of
different types of materials;
(e) plastic layers

and articles

Biocidal product

any substance or mixture, in the form in which it is

supplied to the user, consisting of, containing or
generating one or more active substances, with the
intention of destroying, deterring, rendering
harmless, preventing the action of, or otherwise
exerting a controlling effect on, any harmful
organism by any means other than mere physical or
mechanical action

Regulation (EC) No 1935/2004 on

materials and articles intended to
come into contact with food
Article 2
Regulation (EC) No 450/2009 on
active and intelligent materials
and articles intended to come into
contact with food
Article 3
Regulation (EC) No 1935/2004 on
materials and articles intended to
come into contact with food
Article 2
Regulation (EC) No 450/2009 on
active and intelligent materials
and articles intended to come into
contact with food
Article 3
Regulation (EU) No 528/2012
concerning the making available
on the market and use of biocidal
products
Article 2