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Expert talk with Prof. Clemens Comans

Insects as novel foods

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From 19 to 22 March 2024, Anuga FoodTec will take a look at the versatile market for alternative proteins and present the technological know-how for processing. In addition to plant sources such as peas, field beans and lupins, there is an increasing focus on insects. But before they land on the plates of European consumers, they have to overcome a number of hurdles. Prof. Clemens Comans from the law firm cibus Rechtsanwälte explains what food manufacturers should pay attention to and what legal aspects are involved in the authorisation process.

Prof. Dr. Clemens Comans

Prof. Clemens Comans is a partner and founding member of the law firm cibus Rechtsanwälte. He advises companies on food law compliance matters and publishes articles and papers on legal issues in the field of insect food and vegetarian food.

Prof. Comans, for several years now insects have been promoted as an alternative to beef and pork. So far, only a few companies or start-ups have dared to tackle this topic. Why?

One major reason is the fact that since the beginning of 2018, when the Novel Food Regulation (EU) 2015/2283 came into force, food insects have been considered novel foods that require authorisation. Unlike "conventional, non-novel foods", these may only be placed on the market after going through an elaborate authorisation procedure. Corresponding applications must be submitted to the EU Commission. In addition, there are only a few manufacturers of food insects in Germany and the EU so far. This is why it's often necessary to fall back on sources in third countries, which can represent additional expense and an increased risk, especially for young companies. Another limiting factor is the still rudimentary legal situation for the breeding and processing of insects, which can pose considerable risks for young companies without sound knowledge.

More than two billion people worldwide derive their nourishment from insects, according to estimates by experts. A diet that is quite suitable for the masses in Asia sounds more like a dare for many consumers in this country, if recent surveys are to be believed ...

Food made from insects is currently a niche product in Germany. Many consumers are not (yet) prepared to accept insects as a food or protein source in their daily diet - especially when it comes to products that are still outwardly recognisable as insects. But even in cases where processed products made from insects are used, the products don't meet with universal approval. This is a situation that is also reflected in numerous enquiries on in the first quarter of 2023.

Which aspects have priority on the consumer portal?

Numerous consumers have asked for information on how insects are identified in food, compound ingredients, bulk goods or additives in order to avoid them when buying. Consumers can learn whether a product contains insect ingredients by reading the list of ingredients. Despite all these limiting factors, several procedures for the approval of various insects as novel foods have been initiated in recent years and approvals have meanwhile been granted ...

... which includes the dried yellow mealworm, the first food insect to receive approval in May 2021.

The dried larva of the flour beetle Tenebrio molitor may be sold whole or ground. It can also be used as an ingredient up to a proportion of ten percent in various foods, for example pasta or biscuits. However: Due to underlying protected scientific data, the authorisation exists for a period of five years initially only for the French company making the application.

The approval of insects as food only applies to the applicants?

Yes, provided that the applicant has applied for protection of the scientific data used in the authorisation process and that data protection is granted, the applicant may exclusively distribute the novel food for five years. Two other companies that are allowed to market insects in the EU are from the Netherlands, and one is from Vietnam.

Which insects have been granted authorisations by the European Commission?

As of August 2023, a total of four insect species have been approved as novel foods. These are Acheta domesticus, also called the house cricket, larvae of the grain mould beetle Alphitobius diaperinus, the migratory locust Locusta migratoria and the dried larvae of the flour beetle you mentioned. The authorisations cover different forms - such as whole insects, frozen or dried larvae or defatted powder derived from insects - as well as use in certain foods.

Have any other applications for approvals been submitted?

Additional applications are also pending. These partly affect other insect species, such as the black soldier fly Hermetia illucens and the drone brood, i.e. the male pupae, of the honey bee Apis mellifera. Other applications aim to authorise already authorised insects or products derived from them in other forms or without data protection, so that not only the applicant receives a five-year exclusive marketing right.

The basis for the decisions is a risk assessment carried out by the EFSA, the European Food Safety Authority. Which criteria are examined?

The list is very comprehensive. In addition to the specific chemical, microbiological and physical properties of the product, its manufacturing process is also investigated. Information must be provided on the quantity of the novel food the applicant intends to offer for consumption. If necessary, the safety of the proposed consumption levels must be substantiated with appropriate toxicological studies. Furthermore, a proposal for the labelling of the novel food must be submitted.

Another hurdle to overcome ...

Yes, this also involves checking whether the novel food can be consumed without a quantity restriction or whether a maximum daily dose must be set. Information on nutritional values and the possible allergenic potential must also be provided. This and other information must be prepared according to specific formal requirements and provided to the EFSA for review with comprehensive literature references.

What happens then?

Only after the dossier has been comprehensively reviewed, any existing questions have been answered to the EFSA's satisfaction and the overall data has been evaluated, does the EFSA issue a recommendation on whether and under what conditions the novel food should be authorised. Within this framework, the EFSA also makes a recommendation on whether a maximum level is required, how the novel food should be labelled and whether additional warnings may be needed.

When eating insects, many consumers automatically think of allergic reactions. What needs to be considered here?

According to Annex II of the Food Information Regulation (EC) No. 1169/2011, food insects and processed products made from them do not legally constitute allergens that have to be highlighted in the list of ingredients. In the Risk Opinion (Risk profile related to production and consumption of insects as food and feed) of 5 October 2015, the EFSA found that people allergic to crustaceans and products derived from them, as well as to house dust mites, may also be allergic to insect protein. Further research into the allergenic potential of insects was therefore encouraged. The findings were taken into account in the context of the individual authorisations of insects as novel foods.

What does this mean in practice for the labelling of products?

On the one hand, it is planned that the labelling of foodstuffs to which, for example, the dried larvae of Tenebrio molitor are added, must be provided with a corresponding warning that this ingredient can cause allergic reactions in the case of allergies to crustaceans or molluscs and their products as well as to house dust mites. The corresponding notice must be placed in the immediate vicinity of the list of ingredients.

... but that alone is not enough?

No, moreover, the authorisations of insects, and consequently also the Union list of authorised novel foods, provide that they must bear a unique name specified in the respective authorisation. For example, "Dried larva of Tenebrio molitor (flour beetle)" or "Acheta domesticus (house cricket), dried".

In addition, criteria for the safe processing of the insects are defined in the approval procedure. What aspects are involved?

As already explained, numerous factors are examined as part of the approval process. The evaluation also includes the specific production method used to process the food insects. For example, comprehensive parameters such as temperature, time or pressure are examined and evaluated. In addition, various chemical parameters such as protein, fat and moisture content, heavy metals, mycotoxins and other microbiological tests are also undertaken. The parameters responsible for the essential character of the product are then included in the authorisation of the novel food and specified in Regulation (EU) 2017/2470 Table 2.

Do special hygiene standards have to be observed?

No, more extensive hygiene standards or specific requirements for the processing of the product are not specified. The hygiene standards to be observed in the production of food insects are derived from the Food Hygiene Regulation (EC) No. 852/2004 and Regulation (EC) No. 853/2004, i.e. from the hygiene rules for food of animal origin.

You've already mentioned it: The approval of the four insects is initially valid for the applicants for a period of five years in each case. What does this mean for food producers who themselves want to market corresponding products with the approved insects?

Other manufacturers may only market the products in this special phase, which is due to data protection. This is only possible if, on the one hand, it is ensured that the novel food complies with the specific characteristics laid down in the Union list and, on the other hand, the consent of the authorisation holder has been granted for marketing. Alternatively, marketing is also permitted if another applicant receives authorisation for the same novel food without making reference to the proprietary scientific evidence or scientific data in the authorisation procedure.

What options does this ultimately offer food producers in practice?

Companies interested in producing and marketing corresponding products must decide whether they will also submit a - cost-intensive - application for authorisation of the same novel food in order to obtain their own authorisation. Or whether they will obtain the authorisation of the current authorisation holder, for which the latter is usually compensated financially. Otherwise, the only option is to wait until the data protection period of five years has elapsed. Once this period has expired, any company can make use of the authorisation.

Unlike in other parts of the world, insects are not yet part of the usual diet in Europe. How do you see the situation in Asia and the USA?

In the USA, food made from insects was already being marketed before the issue came into focus in Europe under the old Novel Food Regulation (EC) No. 258/97. I don't know the details of the legal requirements for the use of food insects in the United States. The fact is, however, that insects have been an integral part of the diet in the Asian region for many decades, if not centuries.

What opportunities are there for German manufacturers to export corresponding products to these markets?

In order to be able to export food insects to the USA or Asia, for example, it is usually necessary for the exporting companies to be specifically approved for this purpose or to be registered with the responsible authorities in the other countries. In addition, the exported products must meet the legal requirements of the country of destination. This also results from Art. 12 (1) of Regulation (EC) No. 178/2002. If there are no specific legal requirements in the third country to which the goods are to be exported and there are also no bilateral agreements, the exported foodstuffs must comply with the relevant European food law requirements.

Roasted Insects as food in a bowl
Many consumers are not (yet) ready to accept insects as part of their daily diet."

Prof. Dr. Clemens Comans

As of August 2023, a total of four insect species are approved as Novel Food in the European Union.

Prof. Dr. Clemens Comans

Once the data protection period has expired, any company can make use of the authorisation.

Prof. Dr. Clemens Comans