Tag Archives: Stefan Weigel

Global overview of nano-enabled food and agriculture regulation

First off, this post features an open access paper summarizing global regulation of nanotechnology in agriculture and food production. From a Sept. 11, 2015 news item on Nanowerk,

An overview of regulatory solutions worldwide on the use of nanotechnology in food and feed production shows a differing approach: only the EU and Switzerland have nano-specific provisions incorporated in existing legislation, whereas other countries count on non-legally binding guidance and standards for industry. Collaboration among countries across the globe is required to share information and ensure protection for people and the environment, according to the paper …

A Sept. 11, 2015 European Commission Joint Research Centre press release (also on EurekAlert*), which originated the news item, summarizes the paper in more detail (Note: Links have been removed),

The paper “Regulatory aspects of nanotechnology in the agri/feed/food sector in EU and non-EU countries” reviews how potential risks or the safety of nanotechnology are managed in different countries around the world and recognises that this may have implication on the international market of nano-enabled agricultural and food products.

Nanotechnology offers substantial prospects for the development of innovative products and applications in many industrial sectors, including agricultural production, animal feed and treatment, food processing and food contact materials. While some applications are already marketed, many other nano-enabled products are currently under research and development, and may enter the market in the near future. Expected benefits of such products include increased efficacy of agrochemicals through nano-encapsulation, enhanced bioavailability of nutrients or more secure packaging material through microbial nanoparticles.

As with any other regulated product, applicants applying for market approval have to demonstrate the safe use of such new products without posing undue safety risks to the consumer and the environment. Some countries have been more active than others in examining the appropriateness of their regulatory frameworks for dealing with the safety of nanotechnologies. As a consequence, different approaches have been adopted in regulating nano-based products in the agri/feed/food sector.

The analysis shows that the EU along with Switzerland are the only ones which have introduced binding nanomaterial definitions and/or specific provisions for some nanotechnology applications. An example would be the EU labelling requirements for food ingredients in the form of ‘engineered nanomaterials’. Other regions in the world regulate nanomaterials more implicitly mainly by building on non-legally binding guidance and standards for industry.

The overview of existing legislation and guidances published as an open access article in the Journal Regulatory Toxicology and Pharmacology is based on information gathered by the JRC, RIKILT-Wageningen and the European Food Safety Agency (EFSA) through literature research and a dedicated survey.

Here’s a link to and a citation for the paper,

Regulatory aspects of nanotechnology in the agri/feed/food sector in EU and non-EU countries by 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. Regulatory Toxicology and Pharmacology Volume 73, Issue 1, October 2015, Pages 463–476 doi:10.1016/j.yrtph.2015.06.016

This is the most inclusive overview I’ve seen yet. The authors cover Asian countries, South America, Africa, and the MIddle East, as well as, the usual suspects in Europe and North America.

Given I’m a Canadian blogger I feel obliged to include their summary of the Canadian situation (Note: Links have been removed),

4.2. Canada

The Canadian Food Inspection Agency (CFIA) and Public Health Agency of Canada (PHAC), who have recently joined the Health Portfolio of Health Canada, are responsible for food regulation in Canada. No specific regulation for nanotechnology-based food products is available but such products are regulated under the existing legislative and regulatory frameworks.11 In October 2011 Health Canada published a “Policy Statement on Health Canada’s Working Definition for Nanomaterials” (Health Canada, 2011), the document provides a (working) definition of NM which is focused, similarly to the US definition, on the nanoscale dimensions, or on the nanoscale properties/phenomena of the material (see Annex I). For what concerns general chemicals regulation in Canada, the New Substances (NS) program must ensure that new substances, including substances that are at the nano-scale (i.e. NMs), are assessed in order to determine their toxicological profile ( Environment Canada, 2014). The approach applied involves a pre-manufacture and pre-import notification and assessment process. In 2014, the New Substances program published a guidance aimed at increasing clarity on which NMs are subject to assessment in Canada ( Environment Canada, 2014).

Canadian and US regulatory agencies are working towards harmonising the regulatory approaches for NMs under the US-Canada Regulatory Cooperation Council (RCC) Nanotechnology Initiative.12 Canada and the US recently published a Joint Forward Plan where findings and lessons learnt from the RCC Nanotechnology Initiative are discussed (Canada–United States Regulatory Cooperation Council (RCC) 2014).

Based on their summary of the Canadian situation, with which I am familiar, they’ve done a good job of summarizing. Here are a few of the countries whose regulatory instruments have not been mentioned here before (Note: Links have been removed),

In Turkey a national or regional policy for the responsible development of nanotechnology is under development (OECD, 2013b). Nanotechnology is considered as a strategic technological field and at present 32 nanotechnology research centres are working in this field. Turkey participates as an observer in the EFSA Nano Network (Section 3.6) along with other EU candidate countries Former Yugoslav Republic of Macedonia, and Montenegro (EFSA, 2012). The Inventory and Control of Chemicals Regulation entered into force in Turkey in 2008, which represents a scale-down version of the REACH Regulation (Bergeson et al. 2010). Moreover, the Ministry of Environment and Urban Planning published a Turkish version of CLP Regulation (known as SEA in Turkish) to enter into force as of 1st June 2016 (Intertek).

The Russian legislation on food safety is based on regulatory documents such as the Sanitary Rules and Regulations (“SanPiN”), but also on national standards (known as “GOST”) and technical regulations (Office of Agricultural Affairs of the USDA, 2009). The Russian policy on nanotechnology in the industrial sector has been defined in some national programmes (e.g. Nanotechnology Industry Development Program) and a Russian Corporation of Nanotechnologies was established in 2007.15 As reported by FAO/WHO (FAO/WHO, 2013), 17 documents which deal with the risk assessment of NMs in the food sector were released within such federal programs. Safe reference levels on nanoparticles impact on the human body were developed and implemented in the sanitary regulation for the nanoforms of silver and titanium dioxide and, single wall carbon nanotubes (FAO/WHO, 2013).

Other countries included in this overview are Brazil, India, Japan, China, Malaysia, Iran, Thailand, Taiwan, Australia, New Zealand, US, South Africa, South Korea, Switzerland, and the countries of the European Union.

*EurekAlert link added Sept. 14, 2015.

Summary of EHS studies on nanotechnology funded through Europe’s 7th Framework Programme

I was a little shocked to see how many EHS (environment, health, and safety) projects focussed on nanotechnology that the European Union (EU) funded as part of its overarching science funding efforts, the 7th Framework Program, due to be superseded in the near future (2013)) by the Horizon 2020 program. The June 18, 2012 Nanowerk Spotlight article submitted by NanoTrust, Austrian Academy of Sciences provides the reasoning for the EU  effort (Note: I have removed footnotes.),

The Action Plan, presented by the EU Commission in 2004, envisioned integrating “the social dimension into a responsible technology development” and strengthening efforts related to “health, safety, environmental aspects and consumer protection“.

This encompassed (1) the systematic study of safety-relevant aspects at the earliest possible date, (2) integrating health- and environment-relevant aspect in research and development, (3) conducting targeted studies on toxicology and ecotoxicology and, finally, (4) adapting risk assessment approaches to nano-specific aspects in all phases of product life-cycles.

The primary goal was to improve the competitiveness of European industry. The draft presented in mid-2011 for the planned research priorities continues this strategic focus.

The EU Parliament had already discussed the Nano Action Plan developed by the Commission before the start of the current Framework Program. From the onset, the relevant parliamentary resolution called for an improved coordination with the Member States and more risk research, consideration of the precautionary principle and a deepened dialogue with citizens.

The EU Parliament clearly felt that the rules require urgent adaptations in order to adequately consider nano-risks: In the resolution of April 2009 the parliamentarians underlined the existence of a considerable “lack of information about the use and safety of nanomaterials that are already on the market”.

The overall scope of the projects on nanotechnology, materials and production (NMP) funded by the 7th RP is listed at about 3.475 mill. €. According to EU sources, about 102 mill. € were earmarked for safety aspects (nanosafety research).The comparison with the much more modest Nano-EHS-budget in the past clearly shows the change here (5th RP: about 2.5 mill. €, 6th RP 6 about 30 mill. €).

The publication from where this information was drawn is no.30 in the NanoTrust Dossier series. It was published in May 2012 (from pp. 2-6),

ENNSATOX

Title: Engineered Nanoparticle Impact on Aquatic Environments: Structure, Activity and Toxicology

Coordinator: Andrew Nelson,
Centre for Molecular Nanosciences (CMNS), School of Chemistry, University of Leeds, UK
Duration: July 2009 to July 2012
Project costs: 3,655 mill. €
EU funding: 2,816 mill. €
Homepage: www.ennsatox.eu

The goal of ENNSATOX is to investigate the environmental effects of various synthetic nanoparticles from the time of their release to their potential uptake by organisms, particularly in rivers and lakes. …

ENPRA

Title: Risk Assessment of Engineered Nanoparticles

Coordinator: Lang Tran,
Institute of Occupational Medicine (IOM), Edinburg, UK
Duration: July 2009 to July 2012
Project costs: 5,13 mill. €
EU funding: 3,7 mill. €
Homepage: www.enpra.eu

ENPRA is examining the impacts of selected and commercially used nanomaterials, whereby the different target organs (lungs, cardiovascular system, kidneys etc.) and different mechanisms of damage (see Nano Trust-Dossier 012en) are being determined. …

HINAMOX

Title: Health Impact of Engineered Metal and Metal Oxide Nanoparticles Response, Bioimaging and Distribution at Cellular and Body Level

Coordinator: Sergio E. Moya,
Centro de Investigación Cooperativa en Biomateriales (Spanien)
Duration: October 2009 to October 2012
Project costs: 2.93 mill. €
EU funding: 2.3 mill. €
Homepage: www.hinamox.eu

HINAMOX deals with the impacts of several metal-oxide nanoparticles – TiO2, ZnO, Al2O3, CeO2 etc. – on human health and on biological systems. …

InLiveTox

Title: Intestinal, Liver and Endothelial Nanoparticle Toxicity – development and evaluation of a novel tool for high-throughput data generation

Coordinator: Martha Liley,
CSEM (Centre Suisse d’Electronique et de Microtechnique SA)
Duration: May 2009 to July 2012
Project costs: 3.42 mill. €
EU funding: 2.4 mill. €
Homepage: www.inlivetox.eu

In InLiveTox, an improved in-vitro model is being developed to describe the effects of nanoparticles taken up via food, especially effects on the gastrointestinal tract and the liver.  …

MARINA

Title: Managing Risks of Nanomaterials

Coordinator: Lang Tran,
IOM (Institute of Occupational Medicine) Edinburgh, UK
Duration: November 2011 to November 2015
Project costs: 12.48 Mio. €
EU funding: 9.0 mill. €
Homepage: www.marina-fp7.eu and http://www.iom-world.org

A total of almost 50 industrial companies (including BASF) and scientific facilities are combined in the very large joint project MARINA, coordinated by the Institute of Occupational Medicine of the University of Edinburgh; other organizations that are involved in employee protection and occupational safety are also participating (FIOH/Finland, IST/Switzerland, RIVM/The Netherlands). …

ModNanoTox

Title: Modelling nanoparticle toxicity: principles, methods, novel approaches Toxicology

Coordinator: Eugenia Valsami-Jones,
Natural History Museum, London, UK
Duration: November 2011 to November 2013
Project costs: 1.28 mill. €
EU funding: 1.0 mill. €
Homepage: (under construction) lib.bioinfo.pl/projects/view/32734

The goal of ModNanoTox is to develop welldocumented models on the long-term behavior of synthetic nanoparticles in organisms and in the environment. …

NanEx

Title: Development of Exposure Scenarios for Manufactured Nanomaterials

Coordinator: Martie van Tongeren,
Institute of Occupational Medicine (IOM), Edinburgh UK
Duration: December 2009 to November 2010
Project costs: 1.01 mill. €
EU funding: 0.95 mill. €
Homepage: www.nanex-project.eu, lib.bioinfo.pl/projects/view/12016

In NanEx, a catalog of realistic scenarios is being developed for potential impacts of synthetic nanoparticles at industrial workplaces, of various uses by consumers as well as of delayed releases into the environment. …

NANODEVICE

Title: Modelling Novel Concepts, Methods and Technologies for the Production of Portable, Easy-to-Use Devices for the Measurement and Analysis of Airborne Nanoparticles in Workplace Air

Coordinator: Kai Savolainen,
Finnish Institute for Occupational Health (FIOH), Finland
Duration: April 2009 to April 2013
Project costs: 12.28 mill. €
EU funding: 9.49 mill. €
Homepage: www.nano-device.eu

Due to the lack of robust and inexpensive instruments, the nanoparticle concentrations in the air at the workplace cannot be measured at the present time. NANODEVICE is devoted to studying innovative concepts and practicable methods for identifying synthetic nanomaterials, methods that can also be used at the workplace. …

NanoFATE

Title: Nanoparticle Fate Assessment and Toxicity in the Environment

Coordinator: Klaus Svendsen,
NERC (Centre for Ecology and Hydrology),
Wallingford, UK
Duration: April 2010 to April 2014
Project costs: 3.25 mill. €
EU funding: 2.50 mill. €
Homepage: www.nanofate.eu

NanoFATE is devoted to systematically deepening our knowledge about the behavior and the fate of synthetic nanoparticles that enter the environment. …

Nanogenotox

Title: Towards a method for detecting the potential genotoxicity of nanomaterials

Coordinator: Anses – French Agency for Food, Environmental and Occupational Health Safety
Duration: March 2010 to March 2014
Project costs: 6.0 mill. € EU funding: 2.90 mill. € (as co-funding though the program
EU-Health & Consumers)
Homepage: www.nanogenotox.eu/

Nanogenotox is not directly a part of the 7th RP but rather a Joint Action, about half of which is funded by the participating European states. The task of this project is to study the gene toxicity (i.e. the damaging effect on the genetic material of organisms) of selected nanomaterials. …

NanoHouse

Title: Cycle of Nanoparticle-Based Products used in House-Coating

Coordinator: Francois Tardif,
CEA (Commissariat à l’Énergie Atomique et aux Energies Alternatives), Grenoble, Frankreich
Duration: January 2010 to July 2013
Project costs: 3.1 mill. €
EU funding: 2.4 mill. €
Homepage: www-nanohouse.cea.fr

The task of NanoHouse is to comprehensively evaluate environmentally relevant and health-related effects of nanoproducts used in house construction; the focus is on paints and coatings with TiO2- and nanosilver components, whose impacts and fates are being more closely examined. …

NanoImpactNet

Title: The European Network on the Health and Environmental Impact of Nanomaterials

Coordinator: Michael Riediker,
Institut universitaire romand der Santé au Travail, Schweiz (IST)
Duration: April 2008 to April 2012
Project costs: 3.19 mill. €
EU funding: 2.0 mill. €
Homepage: www.nanoimpactnet.eu

This large network of partner institutes from numerous countries is designed mainly to exchange information about new knowledge as well as knowledge gaps in the health- and environment-related impacts of nanoparticles. …

NanoLyse

Title: Nanoparticles in Food: Analytical Methods for Detection and Characterisation

Coordinator: Stefan Weigel,
RIKILT – Institute of Food Safety, Niederlande
Duration: January 2010 to October 2013
Project costs: 4.05 mill. €
EU funding: 2.95 mill. €
Homepage: www.nanolyse.eu

The goal of NanoLyse is to develop approved methods for analyzing synthetic nanomaterials in food and drinks. …

NANOMMUNE

Title: Comprehensive Assessment of Hazardous Effects of Engineered Nanomaterials on the Immune System Toxicology

Coordinator: Bengt Fadeel,
Karolinsk  Institutet, Stockholm
Duration: September 2008 to September 2011 (completed)
Project costs: 4.31 mill. €
EU funding: 3.36 mill. €
Homepage: www.nanommune.eu

NANOMMUNE examined the influence of synthetic nanomaterials on the immune system and their potential negative health effects. …

NanoPolyTox

Title: Toxicological impact of nanomaterials derived from processing, weathering and recycling of polymer nanocomposites used in various industrial applications

Coordinator: Socorro Vázquez-Campos,
LEITAT Technological Centre, Barcelona, Spain
Duration: May 2010 to May 2013
Project costs: 3.30 mill. €
EU funding: 2.43 mill. €
Homepage: www.nanopolytox.eu

NanoPolyTox is tasked with determining the changes in the physical and toxic properties of three different nanomaterials (nanotubes, nano-clay minerals, metal-oxide nanoparticles) that are used in combination with polymers as filling materials.  …

NanoReTox

Title: The reactivity and toxicity of engineered nanoparticles: risks to the environment and human health

Coordinator: Eugenia Valsami-Jones,
Natural History Museum, London, UK
Duration: December 2008 to December 2012
Project costs: 5.19 mill. €
EU funding: 3.19 mill. €
Homepage: www.nanoretox.eu

NanoReTox is designed to better describe the EHS-risks of synthetic nanomaterials based on new research results. …

NanoSustain

Title: Development of sustainable solutions for nanotechnology-based products based on hazard characterization and LCA

Coordinator: Rudolf Reuther,
NordMilijö AB, Sweden
Duration: May 2010 to May 2013
Project costs: 3.2 mill. €
EU funding: 2.5 mill. €
Homepage: www.nanosustain.eu

NanoSustain is designed to develop innovative solutions for all phases in dealing with nanotechnology products – up until the landfill or recycling stage. Four nanomaterials are being examined in greater detail: nano-cellulose, CNT, nano-TiO2, as well as nano-ZnO. …

NanoTransKinetics

Title: Modelling basis and kinetics of nanoparticle interaction with membranes, uptake into cells, and sub-cellular and inter-compartmental transport

Coordinator: Kenneth Dawson,
University College, Dublin, Ireland
Duration: November 2011 to November 2014
Project costs: 1.3 mill. €
EU funding: 0.99 mill. €
Homepage: www.nanotranskinetics.eu

The aim of NanoTransKinetics is to substantially improve the models used to describe biological (and therefore also toxic) interrelationships between nanoparticles and living organisms.  …

NanoValid

Title: Development of reference methods for hazard identification, risk assessment and LCA of engineered nanomaterials

Coordinator: Rudolf Reuther,
NordMiljö AB, Sweden
Duration: November 2011 to November 2015
Project costs: 13.4 mill. €
EU funding: 9.6 mill. €
Homepage: www.nanovalid.eu

The aim of NanoValid is to develop reference methods and materials to identify and assess the risks of synthetic nanomaterials in close cooperation with the similarly oriented project MARINA (see above). …

NEPHH

Title: Nanomaterials-related environmental pollution and health hazards throughout their life-cycle

Coordinator: EKOTEK S.L. (Spanien)
Duration: September 2009 to September 2012
Project costs: 3.1 mill. €
EU funding: 2.5 mill. €
Homepage: www.nephh-fp7.eu

NEPHH seeks to better estimate the environmental and health-related risks of nanostructures over the course of their use. …

NeuroNano

Title: Do nanoparticles induce neurodegenerative diseases? Understanding the origin of reactive oxidative species and protein aggregation and mis-folding phenomena in the presence of nanoparticles

Coordinator: Kenneth Dawson,
University College, Dublin, Ireland
Duration: February 2009 toFebruary 2012
Project costs: 4.8 mill. €
EU funding: 2.5 mill. €
Homepage: www.neuronano.eu

To date, the full details on the factors that allow nanoparticles to pass the blood-brain barrier are unknown15. NeuroNano examines the effect of nanoparticle size, shape and composition, along with the role of the adsorbed corona of biomolecules (see above). …

QNano

Title: A pan-european infrastructure for quality in nanomaterials safety testing

Coordinator: Kenneth Dawson,
University College, Dublin, Ireland
Duration: February 2011 to February 2015
Project costs: 9.2 mill. €
EU funding: 7.0 mill. €
Homepage: www.qnano-ri.eu

Rather than being devoted to a separate research topic, QNano is designed to interlink and support facilities that provide the necessary infrastructure for investigating and characterizing nanosubstances. …

That’s quite the list, eh?