Tag Archives: Hans Bouwmeester

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.