This article follows our introduction to the alternative protein industry and the legal considerations of the companies and investors operating in it. This article focuses on the regulation of insects as food and feed in the European Union ("EU"), the United Kingdom ("UK"), the United States and Singapore.

Newbies may want to read Part 1 of this series.

Although insects are a traditional food source in parts of Latin America, Asia and Africa, the global insect protein industry is currently experiencing a surge in investment and is expected to be worth more than £3 billion by 2027. [1] This investment growth is driven by two key factors: first, insect protein has excellent nutritional value-insect exoskeleton, called chitin, contains fiber and acts as a prebiotic; second, insect is reduced Our food system is inefficient and a feasible method of environmental cost-insect production can comply with the principles of circular economy. Entocycle in the UK, Ÿnsect in France, Bitty Foods in the US and Nutrition Technologies in Singapore are all active in the insect protein market. However, the industry is currently restricted by consumers' reluctance to try new foods (food neophobia), cost and regulation.

The actions taken by the industry to overcome growth barriers in the EU, the UK, the US and Singapore include:

Regulation (EU) 2015/2283 ("2015 New Food Regulations")

According to the 2015 New Food Regulations, the whole insect and its derived products constitute a “new type” food. The regulation stipulates that in order to sell them on the European market, they must be authorized by the European Commission (that is, they must be authorized by the market).

Obtaining market authorization requires the European Food Standards Agency to conduct a safety assessment of specific foods and obtain approval from EU member states.

Once authorized, the food will be added to the list of new foods authorized by the European Union, and manufacturers can start selling it, provided they meet any conditions specified in the approval.

Producers must also comply with EC Regulation 999/2001 ("TSE Regulation"), which restricts substrates that can feed insects to materials of plant origin. Foods that previously contained meat and fish were not allowed substrates.

The following member states are not part of the above system: Finland, Sweden, Estonia, Latvia, Lithuania, Netherlands, Belgium, Czech Republic and Portugal.

These countries allow the commercialization of entire insects and their derivatives based on the transitional measures introduced in the 2015 new food regulations ("transitional measures"). This allows insect producers who have legally placed specific insect products on the market before the effective date of the new food regulations in 2015 (i.e. January 1, 2018) to continue to do so in accordance with national food safety regulations until the corresponding product is granted by the General Market Authorization . [3]

The 2015 New Food Regulations were implemented in the UK through the 2018 New Food (England) Regulations, but the transitional measures were not implemented.

The Food Standards Agency ("FSA") is now responsible for managing the pre-market authorization process in the UK.

The products of the US insect protein industry are currently subject to the general human and animal food regulations of the US Food and Drug Administration ("FDA"). The FDA has not been involved in formulating rules or issuing guidelines for edible insects.

In response to a request for information, the FDA commented that “If it is intended for use, bugs/insects are considered food.” The FDA also pointed out that insects for human consumption must be clean and sanitary; they must be bred specifically for human food in accordance with current good manufacturing practices; and Mark correctly. This strongly suggests that edible insects in the United States must be bred specifically for human consumption, rather than collected in the wild.

Singapore introduced a new food regulatory framework in 2019. New foods and food ingredients are defined as “the ingredients that have not been consumed by a large population as part of their daily diet for at least 20 years [...] have not reported adverse effects on human health”. [4] According to the Singapore Food Authority ("SFA") [5], insects fall under this definition.

SFA is responsible for approving new foods. In order to obtain approval for products containing new types of food, the company must: (i) Undertake and submit evidence of product safety assessment to cover potential food safety risks, including toxicity, allergies, safety of production methods, and consumption caused by dietary exposure (ii) Disclosure of the materials used in the manufacturing process; (iii) Provide evidence on how to control such processes to prevent food safety risks. Applications are evaluated by SFA on a case-by-case basis, and the review may take three to six months.

At present, SFA has confirmed that Singapore does not allow the import and sale of insects for human consumption. However, we noticed that two Singapore edible insect start-ups (Asia Insect Farms Solution and Altimate Nutrition) have cooperated with insect farms in Southeast Asia, aiming to eventually establish their own production facilities in Singapore. The two companies are expected to obtain regulatory approval in the fourth quarter of 2021.6 to commercialize their products in Singapore

European Commission regulations allow certain insects to be used as animal feed.

Regulation (EU) 2017/893 authorizes the use of (i) processed animal protein from seven species of insects, and (ii) compound feed containing such processed animal protein for feeding aquaculture animals.

In August 2021, Regulation (EU) 2021/1372 authorizes the use of processed animal protein derived from insects in poultry and swine feed. This regulation will take effect in September 2021.

Regulation (EU) 2017/893 also applies to the United Kingdom, but since the United Kingdom left the European Union on January 31, 2020, the new Regulation (EU) 2021/1372 authorizing the use of insect protein in poultry and pig feed does not apply.

Generally speaking, the FDA also has regulatory authority over animal feed, including farm animal food and pet food, as well as cat and dog snacks. At present, the FDA has not issued guidance on insect-eating animals. However, the FDA cooperates with the American Association of Feed Control Officials ("AAFCO") to determine which ingredients can be used.

SFA is also responsible for overseeing the feed of animals and birds. As part of the licensing requirements for companies that raise insects to produce animal feed, SFA requires that the materials used to raise insects be properly handled and traceable to ensure the safety of insect-derived animal feed. 7 

In the United States, manufacturers operating in this field still lack legal certainty. According to the Food, Drug, and Cosmetic Act ("FDCA"), the FDA may consider insects for human consumption as food additives. A food additive is a substance that "its intended use causes or may reasonably be expected to cause [...] to become an integral part of any food or otherwise affect the characteristics of any food", 21 USC § 321(s). Food additives need to obtain pre-market approval from the FDA, unless they are generally considered safe ("GRAS"). For new types of foods, this requires a consensus from qualified experts. Given the wide variety of insects and the complicated evaluation process, GRAS certification may be challenging for insects for human consumption. At the same time, the best practice for manufacturers is to ensure that their food is "healthy", hygienic and not mislabeled.

The EU system is complex and compliance costs are high. Considering that the transitional measures introduced by the new food regulations in 2015 led to different approaches between member states, this is also difficult to navigate.

The fact that the UK's New Food (England) Regulations 2018 did not extend the transitional measures is a problem for UK companies, who must now go through the expensive and time-consuming FSA pre-market authorization process. This is a setback for the industry in the UK and also frustrating insect producers, as the FSA has established a transitional arrangement for cannabidiol (CBD) products (these products are also subject to the new UK food regulations in the EU and the UK) .

In addition, since the United Kingdom is no longer a member of the European Union, the United Kingdom has the freedom to legislate in this area, but the FSA has not deviated from the essence of EU regulations. The industry in the UK called for the relaxation of legislation and reconsideration of the market authorization system. It is hoped that the British government can introduce a system to protect consumers and ensure the quality and safety of products, while allowing the industry to realize its full potential.

Singapore is well-known for accepting alternative proteins for human consumption, and apparently has invested heavily in this area. SFA was recently established and organized a new food regulatory framework and a working group to support the framework within a short period of time, and called on the Singapore government to provide research and development funding. The aim is to constantly review the regulatory framework so that it can be updated as the new food industry develops. SFA hopes that this will provide companies with a viable space for competitive innovation and ensure that any food safety risks can be identified and managed early in the process.

Allowing the use of insect protein in poultry and pig feed is big news for the EU's animal feed industry and will significantly promote the development of the European insect industry. However, it is still necessary for producers to comply with TSE regulations, which means that they will limit the substrates they can feed the insects produced in poultry and pig feed.

The UK has not taken similar measures to allow the use of insect protein in poultry and pig feed. However, given the predictions about its potential use published in a report commissioned by the World Wide Fund for Nature and Tesco, such a move makes sense. The report pointed out that "by 2050, the total demand for insect meal in the UK's swine, poultry and salmon sectors may reach approximately 540,000 tons per year." [6] If the legislation is not relaxed to allow insect protein to be used as feed for pigs and poultry, the British insect protein industry is at risk of falling behind.

In the United States, AAFCO voted to allow black water fly larvae to be added to adult dog food. As of now, no other insect ingredients in the United States have been approved for use in animal feed

In Singapore, black water fly larvae are also approved for fish feed. In 2019, Enterprise Singapore, the Singapore government agency responsible for supporting enterprise development, announced its investment in Nutrition Technologies, a Singapore-based agri-food technology company that aims to build the largest high-tech commercial-scale black water horsefly larva production facility. [7]

Regulation remains a major constraint to the growth of the insect protein industry. We have seen great progress, but if regulators want the industry to reach its potential, they need to go further (faster).

It is recommended that insect protein producers and investors interested in this field pay close attention to regulatory developments to ensure that they can seize opportunities when they arise. Acknowledging that our food system needs to adapt to prepare for the future, especially that they must be changed to avoid the worst effects of climate change, insect protein seems to be a key part of our future food system.

Julia Kotamäki, a trainee lawyer in London, contributed to the drafting of this alert.

[1] https://www.meticulousresearch.com/product/edible-insects-market-5156.

[2] https://noma.dk/the-weather-report/the-project-insects-as-a-food-for-the-future/.

[4] https://www.sfa.gov.sg/docs/default-source/food-import-and-export/Requirements-on-safety-assessment-of-novel-foods_23-Nov-2020.pdf.

[5] https://www.sfa.gov.sg/food-information/risk-at-a-glance/safety-of-alternative-protein.

[6] https://www.wwf.org.uk/sites/default/files/2021-06/The_future_of_feed_July_2021.pdf.

[7] https://www.enterprisesg.gov.sg/media-centre/media-releases/2019/july/nutrition-technologies-raises-series-a-funding-from-openspace-ventures-and-seeds-capital -Establish the largest insect protein production facility in Southeast Asia.

Disclaimer: Due to the general nature of this update, the information provided here may not be applicable in all situations, and action should not be taken without specific legal advice based on specific circumstances.

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