Global Regulatory Policies on Food Nanotechnology

Position statements and policies have been issued by various food regulatory authorities worldwide regarding potential applications of nanoscience and nanotechnologies in food and food-related products. The goal of this article is to offer readers an understanding of the current potential regulatory hurdles and future opportunities for nanotechnology applications related to food security, foodborne pathogen detection, food packaging materials, food processing, and/or food ingredient technologies in various international jurisdictions.

United States of America
The U.S. Food and Drug Administration (FDA) is responsible for overseeing the safety of foods, including food ingredients (additives and colors) and food-contact substances. This is done under the Federal Food, Drug, and Cosmetic Act (FFDCA), which deals with statutory classifications and not technologies. The FDA recognizes that nanotechnology may create regulatory challenges that are similar to those posed by other emerging technologies as well as new ones. In 2006, FDA established a Nanotechnology Task Force to determine regulatory approaches that would enable continued development of innovative, safe, and effective FDA-regulated products that use nanoscale materials.

The Task Force released a report with recommendations on various scientific and policy issues (FDA, 2007). The report considered several questions related to the safety of food products made using nanotechnology or containing nanosize ingredients and the adequacy of existing laws, regulations, and science to ensure their safety. The report concluded that the current FDA’s authorities are generally expected to be adequate to meet the challenges, especially for products subject to pre-market authorization. However, because the science is evolving, some instances may warrant a case-by-case approach to satisfy the applicable statutory and regulatory standards. FDA urges the industry to engage the agency’s expertise very early on in research and development in order to assess how potential applications may be viewed and data that may be required for approval. The FDA recently (FDA, 2008) held a public forum to obtain comments and collect data to assist with further implementation of Task Force recommendations. The information is currently under evaluation.

Regarding workplace safety, the National Institute for Occupational Safety and Health (NIOSH) recently (February 2009) issued interim guidance for medical screening and hazard surveillance for workers potentially exposed to engineered nanoparticles.

Canada
Health Canada—in consultation with other federal agencies—requested the Council of Canadian Academies (CCA) to determine the state of knowledge on existing nanomaterials (NMs) properties and their health and environmental risks for regulatory purposes. CCA appointed an expert panel which released a report that concluded that the knowledge to assess overall human and environmental risks posed by introduction of NMs and nanoproducts into society was limiting (CCA, 2008). The report also indicated that there was no evidence that the current applications present risks that cannot be addressed through the available risk management strategies.

Health Canada is also working closely with the Public Health Agency of Canada and the Canadian Institutes of Health Research to gather information, identify areas where additional regulations may be required, and to act as a discussion forum for issues related to nanotechnology. A call for information on the use of NMs in Canada is expected to be issued by Environment Canada in the form of a Canadian Environmental Protection Act (CEPA) Section 71 Notice. The notice is expected to be directed toward persons who manufactured or imported more than a small amount of NMs into Canada during 2008. Response to a Section 71 Notice is mandatory for those identified therein. A provision for stakeholders not covered in the notice is also provided. The information collected should serve to underpin a regulatory framework for NMs in Canada.

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European Union (EU)
The EU has established specialized agencies to carry out assessments that avoid or minimize risks that materials might pose to consumers. The European Food Safety Authority (EFSA) is the agency responsible for food and feed safety. Issues related to consumer safety, public health, and the environment are also addressed by scientific committees managed by Directorate General of Health and Consumer Protection. One of these committees is the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), which focuses on broad complex or multidisciplinary issues requiring comprehensive risk assessment.

Various regulatory gap analyses were conducted on EU food laws and the use of nanotechnology in food (Chaudhry et al., 2008; Food Safety Authority of Ireland, 2008). These assessments concluded that the basic principles of the existing risk assessment framework can be applied to nano-based applications in food and feed. However, current methods for assessment of toxicity and quantification of exposure require modification before they can be applied. The Scientific Committee of the European Food Safety Authority recently (EFSA, 2009) issued a scientific opinion specific to engineered nanomaterials (ENMs) that supports these conclusions. The Committee identified specific risk assessment uncertainties, including (1) difficulty to characterize, detect, and measure ENMs, and (2) limited information available in relation to aspects of toxicokinetics and toxicology. They further recommend a case-by-case evaluation of the specific ENMs, pending development of specific risk assessment processes.

The gap analyses also concluded that potential uses of nanotechnologies for food and feed will be covered by the existing regulatory framework, either by the principles of the general food law (EC 178/2002) or by specific approval processes such as the “novel food” regulation. The novel food regulation applies to foods or ingredients that were not consumed to a significant degree within the EU before May 15, 1997, as well as new processes applied to food or food ingredients that cause significant changes in composition or structure that affect nutritional value, metabolism, or level of undesirable substances.

The authorization process requires a safety assessment to be done by a Member State, and reviewed by all other Member States. If one Member State objects to the marketing of the novel food, an additional assessment is requested from EFSA prior to the Commission drafting a decision to authorize or reject the product. The safety assessment addresses composition, nutritional value, toxicology, and allergenicity, among other issues. Although particle size is not a criterion for determination of the novelty, it may have a potential effect on the evaluated attributes and thus could be part of the assessment.

In March 2009, the EU Parliament adopted and sent to the EU Council and European Commission for consideration extensively revised requirements for the marketing of novel foods, including materials produced using nanotechnology. The revised legislation relies heavily on the application of the “Precautionary Principle”, which shall be applied in the event of insufficient scientific certainty or lack of data. In such cases, the food in question is recommended not to be included in the Community list.

Current legislation for food additives appears to be sufficiently broad to cover NMs in general terms, although the laws do not specifically differentiate between conventional chemical additives and those produced through nanotechnology. Food additives are defined by the European Commission as substances that are not normally consumed as food itself, but are intentionally added to food with a specific functional purpose, such as food preservation (Commission of the European Communities, 2008). Their use in the EU is controlled by The European Parliament and Council legislation, and it is based on the principle that only additives that are explicitly authorized may be used (Chaudhry et al., 2008). Prior to authorization, all additives must comply with specific purity criteria and their safety must be assessed by EFSA (Commission of the European Communities, 2008).

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The recent food additive regulation (EC 1333/2008) published on December 31, 2008, specifically indicates that a significant change in the particle size, including the use of nanotechnology, would require re-evaluation of approved food additives (see preamble 13 and Article 12). If new information shows that a product endangers human health although it complies with the pertinent regulation, a Member State may temporarily suspend or restrict its use within its territory. Consequently, the Commission may consider an amendment to the regulation (Commission of the European Communities, 2008). Regulation (EC) 1935/ 2004 controls the composition, properties, and use of food-contact materials in the EU (Food Safety Authority of Ireland, 2008). This legislation is effective only if the package components are tested and their potential hazard and dose-response are identified, which is not always the case with NMs.

Registration, Evaluation, and Authorization of Chemicals (REACH) is another EU regulatory program relevant to nanotechnology. The program’s mission is to ensure that new chemicals be denied a market in the absence of convincing safety data. The REACH regulation’s section on operational conditions specifies that the physical form in which the substance is manufactured(REACH, Annex I, section 5.1.1) and the properties of materials have to be described in terms corresponding to the form of application (Annex IV of Directive 67/548/EEC) (VCI, 2008). The REACH for chemical substances, besides chemical composition, accounts for all physical states, crystal structures, and dimensions of particles and thus can be applied to NMs.

The SCENIHR’s recent opinion on nanotechnology indicates that there are major gaps in the knowledge necessary for risk assessment of NMs including nanoparticle characterization, detection, and measurement, and dose-response, fate, and persistence in humans and in the environment among others. They concluded that no adequate methods to assess the safety of NMs exist and that NMs should be assessed on the basis of nano-specific non-animal tests. Until such tests are available, use of NMs in foods should be prohibited in order to protect human health and to prevent animal testing.

Australia and New Zealand
According to the Monash Regulatory Studies Centre (2007), all current Australian regulatory frameworks applying to conventional ingredients throughout a product lifecycle also apply to NMs. A long-term effort is foreseen across multiple regulators and regulatory agencies as new knowledge on hazards, exposure, and monitoring tools becomes available.

The Food Standards Australia New Zealand (FSANZ) is responsible for ensuring public protection throughout Australia and New Zealand. FSANZ was created as a result of the FSANZ Act of 1991. FSANZ is responsible for developing and maintaining the national Australia New Zealand Food Standards Code (FS Code). The FS Code sets quality or composition and labeling requirements for food prepared, imported, and sold in Australia and New Zealand (Ludlow et al., 2007). There are no standards in the FS Code that specifically regulate NMs. Thus, the current FSANZ Regulatory Framework applies to NMs in food and food-related products as it does for conventional materials. Nanomaterials will be regulated as food additives when intentionally incorporated into food or when they intentionally migrate into food products from food packaging or contact materials for specific functionality. Those that unintentionally migrate into food from packaging or contact materials will be regulated as contaminants (FSANZ, 2007).

If a NM is considered different than its conventional counterpart and is able to migrate into food or comes into contact with it, the food will also be considered contaminated. In that case, the NM in question should not be used (FSANZ, 2007).

All manufactured or imported packaging materials must also comply with the standard that regulates materials in contact with food. This standard forbids materials to be in contact with food based on their likelihood to cause bodily harm (FSANZ, 2007). Lack of evidence of the effects of NMs and their “likelihood” to harm implies that this provision is unlikely to prevent its use at this time.

If a food item is not specifically regulated by the FS Code, it can be sold legally in Australia without the application of the FSANZ Regulatory Framework. However, state or territory legislation requires the food to be safe and fit for human consumption. FSANZ may provisionally adopt sanitary or phytosanitary measures if it considers scientific evidence to be insufficient. In such cases, necessary information must be obtained, within a reasonable time, for a more objective risk analysis and a review of such measures (FSANZ, 2007).

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Asia
In Japan, several national institutes are working together to facilitate public acceptance of nanotechnology (Ata et al., 2006). The Ministry of Education, Culture, Sports, Science, and Technology (MEXT) is responsible for research and development, and is building industry-academia-government cooperative research platforms to promote research and development in nanotechnology and materials science. In parallel, the Ministry of Economic, Trade, and Industries (METI) works to standardize testing methods for safety and evaluation of nanoparticles, and the Ministry of Health, Labor, and Welfare (MHLW) develops methods to evaluate health impacts of NMs. In general, MEXT is responsible for doing research on basic science for public acceptance of nanotechnology, while METI and MHLW are working on the regulatory aspect of nanotechnology (Chau et al., 2007).

In March 2003, the Chinese Academy of Sciences (CAS) and Ministry of Education in China co-founded the National Center for Nanoscience and Technology (NCNST). The NCNST consists of several divisions engaged in basic and applied research in nanoscience. These divisions include (1) laboratory of nanoprocessing and nanodevices, (2) laboratory of NMs and nanostructures,(3) laboratory of nanomedicine and nanobiotechnology, (4) laboratory of nanostructure characterization and testing, and (5) coordination laboratory (NCNST, 2005).

In 2005, the Commission on Nanotechnology Standardization, which is affiliated with the NCNST, was established and was given the responsibility to develop national standards including terminology, protocol, and safety requirements for NMs and nanodevices. The Commission governs and guides the assessment and authorization of nanoproducts, enabling nanotechnology industries to improve product quality and reduce health risks associated with new product development (NCNST, 2005).

Other Organizations
Several other international organizations are engaged in activities that will help inform regulators around the globe. They include the International Organization for Standardization (ISO Technical committee 229), the International Risk Governance Council, and the Organization for Economic Co-operation and Development.

In conclusion, there is uncertainty over the regulation of nano-based products in part due to a lack of necessary safety data needed to help inform the regulatory bodies. This calls for analysis-specific research needs and increased research funds to address the potential safety, environmental, and health implications of nanoscale materials in foods.

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