Insects require authorisation under the EU Novel Foods Regulation

EU Regulation 2015/2283 requires food business operators to seek authorisation from the European Commission before placing “novel foods” on the market. The basic idea underpinning the Regulation is to ensure that food that has not been traditionally consumed in the EU is (1) safe for consumers, (2) not misleading, and (3) not nutritionally disadvantageous. The Commission often involves the European Food Safety Authority (EFSA) and also the Member States play a key role in the authorisation process.

Food is considered novel if it meets two cumulative conditions: the food was not used for human consumption to a significant degree in the EU before 15 May 1997 (the date of the old novel food regulation No 258/97) and it falls under at least one of the categories listed in Article 3 of Regulation 2015/2283.

According to the Commission, no Member State has confirmed human consumption to a significant degree prior to 15 May 1997 for any insect species, thus making insects novel under the definition’s temporal criterion.

The list of categories that makes up the definition’s second part is broad. Novel food can be anything from newly developed, innovative food or food produced using new technologies and production processes to food traditionally eaten outside the EU. That said, some confusion existed in the past as to whether (whole) insects were included in the list, in particular under the old Regulation. This has meanwhile been answered negatively by the EU Court of Justice in the Entoma ruling of 1 October 2020. Regulation 2015/2283, which replaces the old regulation and has applied since 1 January 2018, now expressly provides that food consisting of, isolated from or produced from animals or their parts – thus including whole insects - falls within its scope.

In short, insects meet both criteria of the novel food definition. To put them on the market as food, they therefore require authorisation.

Yellow mealworms approved after a lengthy process

In the beginning of 2018, a French company filed an application for dried yellow mealworm, produced from larvae of the mealworm beetle (Tenebrio molitor). The application is the starting point of the authorisation process. It must contain detailed information, including scientific evidence demonstrating that the novel food does not pose any danger to human health. According to the applicant, the dried mealworms can be used in a range of food products, such as bread, cookies, or pasta. It seems that mealworms are a popular delicacy given that various other companies also filed similar applications.

EFSA was asked by the Commission to produce a scientific opinion on the matter in July 2018. After extensive back-and-forth with the applicant, by the end of 2020, EFSA concluded that mealworms are safe. This has eventually led the competent “standing committee”, which is composed of Member State representatives, to vote in favour of the novel food on 3 May 2021. The Commission will soon adopt an implementing act to formally conclude the authorisation process. Thus, dried yellow mealworms will become the first insect species to secure clearance as a novel food.

Once granted, an authorisation under Regulation 2015/2283 is not linked to the applicant, so that any food business operator can - in principle - place dried mealworms on the EU market, provided they respect the authorised conditions of use and the labelling requirements. However, if data protection applies under Article 26 of the Regulation, third parties cannot refer to the proprietary scientific evidence or scientific data submitted by the applicant. The applicant in the present case has requested such data exclusivity, among other things, for the analyses of contaminants in the mealworms and the description of the drying process. If confirmed, dried mealworms will be authorised for placing on the market only by the applicant and other novel food producers will not be able to rely on the proprietary mealworm data submitted by the applicant for a period of 5 years.

Farm to Fork and the EU Green Deal: more insects to come?

It is clear that this novel food authorisation will not be the only one of its kind and should be seen within a broader picture.

Climate and environmental-related challenges are high up on the European agenda. In 2019, the Commission launched the European Green Deal - the EU’s plan to make the economy more sustainable. The EU’s food system, as a policy area, is at the heart of the European Green Deal. With its Farm to Fork Strategy, the EU wants to transition to a more sustainable food system.

It has already been suggested that insects may serve as a valuable protein source that can facilitate the shift towards sustainable diets. For example, the Food and Agriculture Organization of the United Nations has spoken up about the nutritional value of edible insects and the positive impact that the consumption of insects may have on the environment. Also, in the Farm to Fork Strategy, insect-based proteins are quoted as a key area of research. Interestingly, processed protein derived from certain farmed insects (like the yellow mealworm), have already been approved in the EU as feed for farmed animals.

Meanwhile, as part of this sustainable wave, many insect-related novel food applications are currently pending, for example for the house cricket and the black soldier fly. It seems therefore that we will be seeing more edible insects on our plates in the near future.

Insect gastronomers may need to apply some patience though because the regulatory process is burdensome and can take a considerable amount of time. In theory, the Novel Foods Regulation imposes deadlines to keep the timing under control, but these deadlines can be extended in practice - as was the case for the mealworms, resulting in a process that took more than three years. An alternative route that is worth exploring for insects, is the specific notification procedure that applies to traditional foods from third countries. To that end, Article 14 of Regulation 2015/2283 has introduced a simplified assessment procedure for foods new to the EU for which a history of safe food use in a third country can be demonstrated.

Putting insects on the market as food requires authorisation under the Novel Foods Regulation. After a (too?) lengthy process, dried yellow mealworms have been deemed safe by the European Food Safety Authority and on 3 May 2021 the Members States gave the ‘green light’. The Commission will soon publish an implementing regulation, which will finalise the authorisation process.

Dried yellow mealworms are the first insect species to secure clearance as a novel food but other applications are pending. Indeed, also considering the apparent environmental benefits, more insect- foods may soon find their way to the European market.