Regulating Nanomaterials in Food as Product Category

The legal baseline of food safety practice is to provide safeguards to consumers from adverse health-related hazards. The classification of food is made accord­ing to product category and its intended use rather than technological applica­tions.

A. The United States

The US-FDA’s authority of regulating food additives, food contact materials, and feed additives falls within the ambit of the Federal Food, Drug and Cos­metic Act (FFDCA). The broader regulatory guidance is encapsulated under the General Policy Principles of US Regulation under the Executive Order 13563—Improving Regulations and Regulatory Review. The policy requires all types of health and environmental risk regulation, including FFDCA, to be predictable, based on the best available science, and cost effective to the industry.^[647] It assigns the FDA a wide margin of discretion in ensuring safety measures under the food safety law, and its threshold considers the information on the additive in question together with the chemical and pharmacological state of the substance in the diet.^[648]

The US-FDA has not adopted a formal position on the definition of “nano­technology.” In its view, the general definition of nanomaterials of 1—100 nanometers is sufficiently robust to draw a distinction between nanofood and other products.

It is a general obligation upon manufacturers to carry out pre-market review for new food additives. Food substances categorized under “generally recog­nized as safe” (GRAS) notification, dietary supplements, and prior sanctioned substances are expressly excluded from prior regulatory approval. In relation to nanoscale additives, the focus of US-FDA is to regulate based on product classes and corresponding legal standards. The safety of such additives must be established to a reasonable degree of clarity. Section 409(a) of the FFDCA prohibits the marketing of adulterated food in interstate commerce.^[652] Any kind of food additive is deemed adulterated unless the US-FDA declares its intended use would be safe for human consumption. If an existing food additive exists in nanoscale form and is used for its intended purpose, its regulatory status might change due to the presence and functionality use of the substance in food; hence, it is not established to be safe in case safety issues arise.^[653] The safety level of food additives must also take into consideration information on the addi­tive in question, coupled with the chemical and pharmacological state of the substance in the diet.

The voluntary notification of GRAS is based on the substance at its natu­ral scale and conventional bulk form. There is also no discrimination on the type of substance with reference to its particle size, and no clear permissible safety threshold limit of particle size is available for scientific and regulatory purposes due to the lack of consensus over the definition of nanomaterials. In this situation, it would be difficult for the US-FDA to treat a nanoscale substance as completely safe despite its being a prior sanctioned substance in macroscale form as GRAS. While food manufacturers can submit a statement that they have determined that the intended condition of use for a food ingre­dient is GRAS, the US-FDA has the authority to require a new pre-market review should there be any objection to the previous notification. On science questions, the US-FDA Nanotechnology Task Force outlined two methods of establishing safety for any US-FDA-regulated products: first by understand­ing the interactions of nanomaterials with biological systems and second the adequacy of testing approaches for assessing the safety and quality of products containing nanomaterials.^[654]

GRAS is founded on the basis of determining “the safety of new addi­tives against the benefits of promoting innovation in food science, without exposing to pre-market approval the majority of ingredients that had already been sanctioned for use or that were generally recognized as safe.”^[655] Therefore, nanoproducts need to be regulated or subject to the regulatory intervention of the US-FDA in situations where the risk may threaten human health.^[656] In consequence, companies are not obliged to provide scientific information and undergo application for approval, considering there is substantial equivalence of data already available for the GRAS category of food substances. This, how­ever, would not give the US-FDA any leeway to ensure safety is implemented. The guidance would be useful to provide additional standards and protocols with respect to case-by-case product review.^[657]

B.

The White Paper on Food Safety contains assurance for high-level protection of human and consumer interests in relation to food^[658] and later becomes a guiding legal principle of EU food safety law and policy in Regulation (EC) 178/2002, which lays down General Principles and Requirements for Food Law.^[659] The scientific scheme highlighted in both documents is “to use the best available science in developing food safety measures.”^[660] In order to support science-based risk management practice, the European Food Safety Authority (EFSA) was created as an EU-wide risk assessment body to provide scientific opinion for reference by its Member States and non-EU countries. While the EFSA’s opinion does not have the status of law, any disagreement with or dif­ference from its published opinion is allowable only on the grounds of public health and safety.^[661]

The EU’s approach to nanotechnology challenges the notion that it can be simply covered by the existing authorization procedure. Contrary to the US and other countries’ approach, the EU views that no nanofood would make its way into the consumer market in the absence of sufficient evidence of safety to health and the environment. Several policy and legal documents shed light on using science as a prerequisite to approve the product’s entry into consumer markets—that means no safety data, no market for nanofood.

Regulation of food and food ingredients incorporating nanomaterials in the EU depends on their intended use or purpose, either as novel food and novel food ingredients, food additives, food supplements, vitamins, minerals, or food contact materials. The use of food and feed additives in the EU is controlled by the European Parliament and Council legislation, which sets out lists of permitted additives, the foods in which they can be used, and maximum levels of use.^[662] All permitted additives have been assessed for safety by the independ­ent scientific committees that advise the European Commission, a role now performed by EFSA.^[663] In addition, each additive must comply with specific purity criteria laid down in corresponding European Commission Directives.

The latest novel food law, Regulation (EU) No. 2015/2283, has resolved many years of debates^[664] among EU institutions on whether nanofood should be treated as novel food.^[665] It provides the legal definition of “engineered nanoma­terials,” which maintains the basic range of 1—100 nanometers for nanomateri­als with consideration of the surface, structures, agglomerates, or aggregates. The properties of nanoscale materials include those related to the large specific surface area of the materials or physicochemical properties that are distinct from those of the bulk or non-nano form of the same materials.^[666] Since nanofood is a separate category of novel food, the proof of significant changes in the com­position or structure of food affecting nutritional value, metabolism or level of undesirable substance,^[667] or the prior history of safe use for at least 25 years does not apply.^[668] The EFSA’s scientific opinion and the Organisation for Economic Cooperation and Development (OECD) Council Recommendation are con­sidered, in which general safety testing is appropriate for nanomaterials, but the test method must be adapted to the specific properties of nanomaterials.

The general rules governing food additives, enzymes, and flavoring require pre-market assessment and authorization before entry into the market. The applicable regulations are Regulation (EC) 1332/2008 on food enzymes;^[669] Regulation (EC) 1334/2008 on flavorings and certain food ingredients with flavoring properties;^[670] and Directive 2002/46/EC on food supplements, min­erals, and vitamins.^[671] Regulation (EC) 1333/2008 contains authorization procedures that scientific risk assessment must be carried out to ensure safe ingredients are contained in food.

C. Risk Assessment of Joint FAO/WHO Expert Committee

on Food Additives

Numerous risk assessment policies and procedures in relation to food prod­ucts, such as additives or pesticides, are implemented by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). The role of JECFA is inde­pendent of the Codex Alimentarius Commission structure. It develops princi­ples for safety assessment of chemicals in food consistent with the mainstream thinking of risk assessment and in consideration of comprehensive studies on toxicology and other related disciplines.^[678] In relation to the applicability of nanotechnology in food products,JEFCA emphasizes that “the current risk assessment approach used by the FAO and WHO is suitable for engineered nano-scale in food and agriculture, including the effects on animal health.”^[679] As an international risk assessor, the role of JECFA can benefit the ASEAN food safety authorities about the quality and adequacy of scientific data and safety assessment of food additives. JECFA has noted that neither the specification nor the amount of daily intake (ADI) for food additives has been evaluated to apply to specified intended use in food in nanoscale form.^[680]

IV.