Regulatory Responses to the Use of Nanoscale Substances in Food in ASEAN

Food safety systems in ASEAN are governed by the respective national leg­islations.^[681] At the regional level, the Member States crafted an ASEAN Food Policy that became the common point of policy and regulatory structures for the ASEAN Food Regulatory Framework.

At the industry level, the manipulation of nanoscale materials into existing products and processes has begun in ASEAN over the past few decades. The policy document addressing nanotechnology development and safety, however, is relatively nascent in this region. Thailand^[683] is the only Member State that has introduced a national nanosafety policy. The policy document highlights national policies and the lack of comprehensive laws covering the entire life­cycle of nanomaterials, which ranges from the production to importation and exportation of nanomaterials. Other countries, such as Malaysia, prepared the National Nanotechnology Strategy and Action Plan, which became the refer­ence document as the draft National Nanotechnology Policy. The government plans to introduce the National Nanotechnology Industry Development Act to regulate activities relating to research, development, and commercialization of nanotechnology. The document also proposes a re-alignment of the exist­ing national laws and obligations under various treaties^[684] and adoption of best risk management practices from other countries.^[685] At the moment, there is no dedicated policy on the safety of nanotechnology in food being formulated at the national and regional level.

A. The Relevance of Current Food Law to Nanotechnology

In the wake of emerging nanotechnology innovation in the food sector, it is timely for the food safety authorities in ASEAN to review the relevance of existing food regulatory frameworks to manage potentially unique risks posed by nanotechnology applications, products, and processes. The laws were also passed without the need of addressing any particular technology at the time of drafting. The absence of dedicated provisions nonetheless does not necessar­ily leave nanotechnology in a regulatory void. The product class approach is sufficiently robust to govern food and its specified condition of use in food at nanoscale level. They are designed in such a way to be inclusive to any kind of novel technologies, including nanotechnologies. The US, Ireland, Hong Kong, Australia, and New Zealand are among prominent jurisdictions that rely on the general food law to regulate nanotechnology products and safety.^[686]

No Member States in ASEAN have introduced additional provisions just to specifically cater to the use and applications of food nanotechnology. In the FAO/WHO Joint Expert Meeting on Nanotehnologies in Food report, Malaysia submitted that:

At present there are no specific regulations applicable to the risk assessment of nanotechnology. All food imported or produced domestically includ­ing those containing nanoscale particles, must comply with the Food Act 1983 and related regulations, and must be safe for human consumption. In addition, risk assessment is conducted to address potential health risks and is not limited to nanotechnology.^[687]

The safety of nanoproducts is routinely seen using the general food safety pro­vision under the food law. Any importation or production of food and food ingredients, including those containing nanoscale substances, must comply

with the general food law.^[688] This has been the common norm of regulatory practice in many jurisdictions as well.^[689] The lack of explicitness in the defini­tion of nanotechnology, the information and notification requirements chal­lenges the food safety authority in coming up with the rules of labeling and marketing authorization upon manufacturers incorporating nanomaterials in food products.

B. Nanomaterials as “Inclusive” Criteria of Existing Product Categories

Within ASEAN, “food” is defined broadly to include any form and substance added to it according to the product category and its specified condition of use. The range of particle size is not the sole factor to determine the risk pro­file of food or food ingredients.^[690] The permissibility level of food additives under the Food Regulations 1985 (Malaysia) is determined by reference to the safety threshold based on the list of authorized ingredients, the proportion of additives or total proportion which does not exceed the maximum residue limits, and where the food containing the additives is not in a greater quantity than those made under proper technological conditions and in line with sound manufacturing practices.

In Singapore, a safe additives must conform to the limits of the types of additives prescribed under the Food Regulations.^[691] As for preservatives, the approved limits must not exceed 4% of the substance itself, 400 milligrams of benzoic acid, and an acidity regulator as permitted conditioner. As for flavor­ing substances, certification issued by the national food authorities from the country of origin and manufacture, and the approval of the director general of Ministry of Health is required.^[692] In the US, Australia, and New Zealand, the permissible limits are determined by reference to the positive and negative lists of additives. The list bucket system does not apply in the ASEAN food safety system. In this regard, the national food safety authorities will rely on the risk assessment results published by reputable authorities, such as EFSA, US-FDA, Food Standards Australia New Zealand (FSANZ), or JECFA/CAC.^[693]

C. Novel Food

Some Member States, such as Thailand and Singapore, consider the regulation of food incorporating nanomaterials under the scope of novel food. The clas­sification of novel food is made based on the “history of safe use” approach, where

the substance used as food or food ingredients has not been currently used in a production process that gives rise to significant changes in the composition or structure of such food which affect their nutritional value, metabolism or level of undesirable substances.^[694]

In Thailand, there must neither be any history of consumption over the last 15 years nor current usage in a production process, whereas in Singapore, there must be a minimum period of at least 20 years without any report of adverse health effects.^[695]

The guidelines on safety assessment issued by the Singapore Food Agency (SFA) indicate the information required for the application: the length of con­sumption or use of the ingredients, that is, how many years the ingredients have been consumed as food or used in food; the extent of particular ingre­dients being used or consumed by the respective population; the quantity of use; and the purpose of use or any available evidence suggesting side effects to human health during the period of use as food.^[696] With regard to the sub­stance, the SFA will look into the information on the use of the substance in the manufacturing process; the intended use and proposed use levels of the substance in food; in-vitro and in-vivo toxicity studies, such as acute, short-term, and long-term toxicity studies, carcinogenicity studies, reproductive toxicity studies, developmental toxicity studies, and genotoxicity studies; or metabolism or toxicokinetic studies, where relevant, including absorption, distribution, metabolism, and excretion (ADME) studies.^[697] Where no local safety assessment data is available, the SFA may consult reports published by other credible food safety authorities, such as Australia, Canada, New Zealand, Japan, the EU, and the US on the definition, scope, and legal processes verifying novel food and food ingredients; published or unpublished scientific studies; or any studies that have been carried out in accordance with the reference documents published by national and international risk assessment agencies, such as US-FDA, EFSA, and JECFA.

The legal position of nanofood and food ingredients as novel foods in ASEAN is not fully explored yet. While it fits within the definition of novel food as food prepared using unconventional processes, it remains to be seen how the food safety authorities will evaluate the specific properties of nanomaterials and whether the history of safe consumption would still apply. In the first draft of a public consultation document, the SFA illustrated a category of novel to include “food consisting of intentionally engineered nanomaterial.”^[698] It was removed in the final version, presumably because the industry and authorities prefer the guidelines to be general and not restricted to nanotechnologies. This could possibly suggest the market authorization procedure and safety assessment of nanofood could dispense with the history of consumption.

V. Conclusion

The primary goal of food safety regulation is to ensure a high level of health protection to the consumer against food-related hazards. The rise of food products and ingredients incorporating nanomaterials in the food market has pushed national food authorities around the world and in the ASEAN region to assess how far the existing legal and safety standards are still relevant to man­age potential risk associated with them. Except for the EU, the current regu­latory frameworks make no reference to particle size to determine the safety threshold of a food category. The frameworks are sufficiently robust, but the use of specific properties of nanomaterials used in food as additives, flavoring, enzymes, coloring, or contaminants may require a re-evaluation of food safety. Hence, a comprehensive review of the safety assessment and pre-marketing authorization procedures, particularly on food additives, among the Member States should be emphasized at the regional level. Some substances, such TiO2, have been widely used as nanoscale additives despite not being mentioned as permitted additives in food regulations. As a newly developed food additive, the substance needs to pass through the evaluation of a safety assessment and pre-market review. The ASEAN Member States also should verify the safety data with other reputable risk assessment bodies. The existing intergovern­mental platform can be leveraged to promote the exchange of best practices, including the publication of stable and low-risk nanomaterials in food. They can also extrapolate useful lessons from the regulatory practices of developed countries on how they manage the regulatory competencies and expertise in dealing with nanomaterial use in food. As such, any safety measure must be grounded in sound and available science and be carried out with ultimate trans­parency to improve the public trust placed in them in protecting human health.