Insects as alternative source of animal protein for food and feed

December is the month of festivities and food. Could insects be part of this tradition in the long run? On 8 and 9 December last, the InsectCentre organized seminar on edible insects in Wageningen. The seminar brought together the insect rearing business of Europe, as well as investors and academics, to discuss opportunities and restrictions for insect rearing in Europe. The seminar covered insect autonomy, insect rearing, economics and legislation. For some background information on the opportunities of insect rearing in the Netherlands, see this document. The focus of this blog will be on the legislation regarding insects in food and feed as discussed in the seminar, combined with our sector knowledge by way of background.

Why the interest in insects?

Insects are extremely versatile and can be put to use in many ways. Insects are the most species rich class of organisms on earth, of which (approximately) 2.500 species are edible. In EFSA’s 2015 report on ‘Risk profile related to production and consumption of insects as food and feed’, 12 of the 2500 edible species are mentioned as having the biggest potential to be used in food and feed. In other parts of the world, insects are a staple food and some insects are even seen as a delicacy. The two most commonly commercially reared insects in the EU for feed applications are the larvae of the black soldier fly and for food applications the lesser mealworm (buffalo) seems to have the best potential. Many insects are pathogenic or too small in size to be commercially interesting to rear. However, during the past years, steady growth in the worldwide demand for alternative protein sources has lead to a renewed interest in insects as a potential source of food and feed. Insects can be viewed as mini short cycled livestock for producing protein. Insect protein is an interesting source of protein due to the quality of the insect protein as opposed to plant-derived protein. Animal protein (so also insect derived protein) has a superior amino acid content compared to plant-derived protein. With a growing world population, the demand for meat production and protein will only increase. Currently soya is imported into the EU for feed purposes. Insects might be a (partial) replacement for this soya in the future, and can even be produced in the EU instead of being imported.

Insects in food

Insects can be reared to produce food as a whole or processed as ingredients for food. As explained in one of our previous blogs, only in some Member States a number of insects are permitted to be used in food, meaning that no enforcement measures regarding such use is taking place. The previously mentioned EFSA report contains the assessment of the risks associated with insects used in food and feed. In short, the overall conclusion was that the safety of farmed insects for use in food and feed strongly depends on both the substrate and the processing of the insects. Further research is needed to be able to fully assess the safety of insects to be used in food and feed.

Current and future regulatory status of insects

Under the current Novel Food Regulation, whole insects are not explicitly regarded as Novel Foods. The rationale therefore is that the category of “food ingredients isolated from animals” are not considered to cover animals (insects) as a whole. However, this will change under the new Novel Food Regulation, entering into force on 1 January 2018, as of when insects will be considered Novel Foods. See our previous blog for further info on the contents of this regulation and the changes in respect of the current Regulation. Under the new Novel Foods regime, it remains to be seen how the competent authorities of the Member States will deal with FBO’s currently using insects in food.

Enforcement as of 1 January 2018

Even if EFSA concluded that additional information is required to assess the safety of insects in food in full, considerable experience has been gained already with the application of insects in food. As far as we are aware, no safety issues have been reported regarding these applications. As safety is the bottom line for enforcement, we take the view that enforcement measures without any safety incidents are not justified just like that. This in particularly applies with respect to products containing only a small percentage of insect derived protein. On the other hand we know that insect manufacturers are using the transition period until 1 January 2018 to compile a full Novel Food dossier based on the Guidelines that were made available in September this year. Taking into account that the new Novel Foods Regulation also contains a regime for data protection, they justify the investment involved to secure a competitive edge the field of alternative protein.

Insects in feed

Two restrictions currently hinder the growth of the insect sector for feed production. The first is a prohibition of certain types of animal protein in feed, commonly referred to as the ‘feed ban’, and secondly, the restrictions on certain types of feed for the insects.

Feed ban

The feed ban, was introduced as a reaction to the BSE crisis, and is laid down in the TSE Regulation. This ban prohibits the use of animal derived protein to be used in feed for farmed animals, unless an explicit exception is made. Insects could have a great potential in feeding farmed animals such as poultry and pigs and also for use in aquaculture. Currently the possibilities for feeding insects to farmed animals and aquaculture animals are limited. However, the European Commission published a draft amendment to the TSE Regulation to partially uplift the feed ban. The amendment will enable the use of certain insects for the production of  Processed Animal Protein (PAP) for the use in aquaculture. Discussions whether the use of PAP could be extended to poultry and pig farming are currently on going.

Food to feed the insects

In addition to the prohibition on the use of insect protein in feed, the materials that can be lawfully used to feed the insects are limited. From a circular economy point of view, the use of manure to rear insects could be attractive. In this way manure could be used to produce feed and the insects could transform the nitrate contained in the manure, that would otherwise contaminate the environment, into valuable nutrients for poultry. However, when rearing insects to produce feed, the insects are considered to be farmed animals (similar to cows or poultry). The Animal By-products Regulation prohibits the use of certain materials in feed for farmed animals, manure being one of them. The ideal situation for the insect rearing industry would be to be able to use all types of other waste stream for rearing insects. This is not possible. Currently only waste streams fit for human consumption and some waste streams of animal origin, such as milk and milk derived products, can be used as feed for insects.

Conclusion:

During the Wageningen seminar referred to in the introduction, the overall opinion of both the presenters and participants was that European legislation currently restricts commercial use of insects for both food and feed applications. On the one hand, the new Novel Foods Regulation will bring legal certainty on the Novel Food status of insects, on the other hand it will require FBO’s marketing insect based food products to obtain a Novel Food authorization. However, for feed there is light at the end of the tunnel. We conceive the exception for PAP of certain insects to be fed to aquaculture to be a first step in getting insects on the menu for poultry and other farmed animals as well. As always, we will keep you posted on developments regarding the use of insects in both food and feed.

The author has written this post together with her colleague Floris Kets, who attended the seminar organized by the Insects Centre.

Novel Foods continued – draft legislation voted by ENVI Committee

Further developments in Brussels took place since we last reported on the new Novel Foods Regulation. Draft legislation was approved in this respect by the ENVI Committee, awaiting the first reading of the European Parliament (EP). The current status quo was published in a Report dated 26 November 2014. Two particular subjects seized most public attention, notably the moratorium proposed on the use of nanomaterials in food and the compulsory labelling of cloned food products. These two items have been covered here and here inter alia and will be shortly touched upon below. Most of all however, this post will focus on the adjusted Novel Food definition. We consider this subject to be of the essence, whereas so far was not highlighted at all.

Moratorium nanomaterials and change to nano definition

The legislation takes as a starting point that food production processes involving nanotechnologies require specific risk assessment methods. These methods should  have been assessed by EFSA prior to use. Furthermore, an adequate safety assessment on the basis of those methods should have shown that the foods at stake are safe for human consumption. The rationale of all this is the precautionary principle: emerging technologies in food production may have an impact on food safety. On top of that, the definition of nanomaterials was changed, introducing a 10 % nano-particles threshold for a food ingredient to qualify as “nano” instead of a 50 % threshold. This was in line with EFSA recommendations, but it may pose a serious problem to FBO’s currently marketing nano-foods. Using the 10 % threshold would imply that quite a few product currently marketed would, under the new Novel Foods Regulation, qualify as Novel Food whereas it currently does not. This will not benefit to legal certainty.

Compulsory labelling of cloned food products

During the long term discussions on the renewal of the Novel Food Regulation, it was decided that the subject of food from cloned animals would be left out. As a result, the Commission published two separate Directives on food from animal clones and on cloning on certain animal species for farming purposes respectively (the draft “Cloning Directives”) in December 2013. These two proposals have now been turned down by EP, as they did not address the food obtained from clones’s offspring. Until food from cloned animals will be covered by revamped Cloning Directives, cloned meat products have been brought within the scope of the Novel Food Regulation and they should be labeled as such.

Adjusted Novel Foods definition

Contrary to current legislation, the initial draft Novel Food Regulation contained an open product definition, where the listed categories of products merely served as examples. This was heavily criticised by rapporteur James Nicholson. Based on his consultations in the field, such open product definition according to him constituted a source of legal uncertainty. Instead, he suggested re-introducing the former product categories in an updated form in order to make this Resolution future-proof. In fact, this suggestion was followed, but somehow pushed to the extreme. The draft Novel Food definition currently also covers product categories that were never considered as Novel Foods before, such as insects and food obtained from cellular or tissue cultures.

10 categories of Novel Foods

The definition currently proposed for a Novel Food is a food that was not used for human consumption to a significant degree in the Union before 15 May 1997 and that falls under at least one of the ten following categories:

1. Food with a new or intentionally modified primary molecular structure;
2. Food consisting of, isolated / produced from microorganisms, fungi or algae;
3. Food consisting of, isolated / produced from plants, except for plants having a history of safe food use within the Union;
4. Food derived from cloned animals and / or their descendants;
5. Food containing, consisting of, or obtained from cellular or tissue cultures;
6. Food consisting of, isolated / produced from animals or their parts, including whole animals like insects, except where a history of safe use within the Union can be established;
7. Food resulting from a new production process not used for food within the Union before 15 May 1997 affecting its nutritional value inter alia;
8. Food containing nanoparticles;
9. Vitamins and minerals (i) subject to the new production process referred to under (7) or (ii) containing nanoparticles referred to under (8) or (iii) for which a new source of starting material has been used;
10. Food used exclusively in food supplements within the Union before 15 May 1997, where it is intended for use in other foods than food supplements.

What’s new actually?

Some of the categories mentioned above were already included in the 1997 Regulation, being those mentioned above under (1), (2), (3) and (7). Others were introduced in the initial Commission proposal for a new Novel Foods Regulation, notably those mentioned above under (8), (9) and (10). Truly new are therefore only the categories consisting of food derived from cloned animals (4), food obtained from cellular or tissue cultures (5) and food produced from whole animals such as insects and from animal parts (6). As explained above, the category consisting of food obtained from cloned animals is likely to be temporary. As soon as specific legislation covering this topic will be in place, such legislation will be applicable to cloned food products instead of the Novel Foods legislation. What are the consequences of the introduction the two other new categories? This will be discussed below.

Food obtained from cellular or tissue cultures are Novel Foods

As a good example of foods obtained from cellular cultures, the in-vitro burger engineered by Prof. Mark Post from the University of Maastricht (see picture from neontommy.com) can be mentioned. This burger was constructed on the basis of a tiny part of meat, using stem cell technology. For this purpose muscle cells harvested from a living cow were fed and nurtured, so that the single strand of cells multiplied to produce numerous new strands. In the end, 20.000 of those strands were assembled and put together in a hamburger. Obviously, the cell production used for this purpose will have to be increased for this technology to become a viable meat production method. However, now that the feasibility of this method in essence has been demonstrated, its application is not inconceivable. When in future, lab-burgers like the one from Maastricht will be marketed as food products, they will need to obtain pre-market authorization based on the current draft for the new Novel Food Regulation. This is understandable, as the use of this technique and starting material for food production is completely new and their safety needs to be established.

Food produced from insects are also Novel Foods

For numerous companies this may come as some surprise. Contrary to the use of cellular tissue for the production of food, the use of insects as food goes back to biblical times. Actually, in various European countries including the Netherlands and Belgium, insects are being offered for sale as food. For instance, Dutch supermarket chain JUMBO offers edible insects for sale as of October 2014. This has incentivised national authorities to investigate the safety of consumption of insects and to formulate basic requirements for rearing facilities. As a result, recommendations were made in the Netherlands that a specific number of insects, such as the mealworm beetle and the locust, should be considered as foods under the General Food Law Regulation (see our previous blogpost for more detailed information also covering other European countries). It should be observed that not all European countries are at the same page here. In Luxemburg for example, the marketing of edible insects, pending an EFSA opinion awaited for July this year, is prohibited.

Discussion

We welcome that the open product definition for Novel Foods has been abandoned, as this increases legal certainty. It is questionable though to what extent it was wise to re-integrate food derived from cloned animals and / or their descendants into the Novel Food Regulation. During previous revision efforts of this Regulation, this topic was exactly the bottleneck why the revision could not be completed. Also, this does not serve as an incentive for the Commission to adjust its previous proposals for the Cloning Directives at short notice. We are more positive with respect to the introduction of the new category of Novel Foods relating to food produced from cellular cultures. This is exactly the type of high tech sustainable food, which in essence is a Novel Food. The same does not apply however with respect to insects. It is striking that up to and including the first Report by Rapporteur James Nicholson, whole animals such as insects never formed part of the Novel Food product definition. We are under the impression that they now landed therein by way of surprise. This is not consistent with current practise of various Member States and will pose a problem for many FBO’s actually marketing food produced from insects. Furthermore, there seems to be a substantial amount of evidence for safe consumption of insects, at least in the Netherlands. Therefore, instead of qualifying whole animals as insects instantly as Novel Foods, as an alternative for providing international industry standards, it could be considered to include a list of recommended edible insects into the Codex Alimentarius.

Conclusion

It is expected that the current draft legislation for the new Novel Foods Regulation will not be the final text. We expect active lobbies from FBO’s marketing nano-foods to oppose the adjusted definiton for nanomaterials. Likewise we expect, and we recommend, that FBO’s marketing insects or food from insects will oppose the fact that food made from whole animals like insects qualify as Novel Foods per se. The chances of success will depend, inter alia, on the expected EFSA report on certain risks of the production and consumption of insects. As of now however, there is already safety evidence which could be relied on pending the final text of the Novel Foods Regulation.

Further update on new Novel Foods Regulation

In one of our previous blog posts this year, we provided a summary of the Commission’s proposal for a new Regulation on Novel Foods. We reported that the proposal contained an open product definition and that it introduced a central authorisation procedure. We also pointed out that the new Regulation provided for a simplified authorisation procedure for traditional foods and for a data protection regime. Meanwhile, the European Parliament appointed James Nicholson as a Rapporteur. Mr. Nicholson consulted with local producers, industry experts and food business operators about the Commission’s proposal. As a result, a draft EP legislative Resolution is available, which is the subject of this blogpost.

James Nicholson

The EP Rapporteur is a 69 years old Irish citizen, who belongs to the European Conservatives and Reformists Group. He shares his opinions on Novel Foods in the movie entitled Novel Foods: lucrative innovation or health hazard? Although it may seem ironic that a seasoned politician from a conservative party is heavily involved in the subject of Novel Foods, he did deliver a substantial job in less than a year. Can we qualify his suggestions for amendments of the Commission’s proposal as substantial enough? That’s questionable – let’s have a look.

3 area’s of concern

Mr. Nicholson indicates in his draft report of 6 October 2014 that he sees 3 area’s of concern in the Commission’s proposal, being:

(1)  the definition of Novel Foods;

(2)  the streamlining of the authorization process;

(3)  robust data protection provisions.

Below, these concerns as well as their potential solution will be discussed.

1. Novel Foods definition

The basic product definition of Novel Foods, notably a food product / ingredient that has not been used for human consumption to a significant degree prior to 1997 within the EU, has not changed. However, the important difference in the new NF proposal is the removal of clearly defined categories of what constitutes a Novel Food. The categories listed in the Commission’s proposal are only examples and not an exhaustive list. After extensive consultation, the Rapporteur found that this open product definition is not satisfactory. It lacks legal certainty and fails to clarify the scope and definition of a Novel Food. As a solution, the Rapporteur suggests re-introducing the previous product categories in an updated form and to add a new product category related to foods for which a new source of starting material has been used. In this way, the new Novel Foods Regulation should be future-proof.

2. Streamlining of authorization process

The current authorisation process has been criticised for being too expensive and too lengthy. Processing a successful Novel Foods application takes in the average about three years (!) This of course did not stimulate food innovation and in particularly prevented SME’s from filing NF applications. It probably also explains why between 2000- 2013, only 70 NF applications have been authorized. Therefore, the move to a centralized authorization process can be welcomed. Making NF applications directly at a Commission level instead of at a national level first will most likely save time. The Rapporteur was concerned however that the Commssion’s proposals do not go far enough in reducing the time factor. He has therefore made amendments consisting of stating deadlines where there were not and shorting deadlines as initially proposed by the Commission. For instance, where the Commission proposal provides that an authorisation decision should be published within 9 months after a positive EFSA opinion, the Rapporteur considers such term could be shortened to 6 months.

3. Robust data protection regime                   

The proposal for the new NF Regulation moves from a personal to a generic authorisation system. This mechanism is aligned to the health claims system, according to which authorized claims can be used by anyone, provided that the conditions of use are met. However, applicants for NF authorisations usually make substantial investments. Under a system of generic authorisations, it is all the more important that those investments are protected, at least for a minimum period of time. The Commission therefore introduced protection for newly developed scientific evidence during a period of five years from the authorization date of the NF application. Although the Rapporteur welcomes this concept, the is concerned that it will restrict the useful contribution of scientific research to the food industry. He therefore proposes that once the conditions for data protection are met, such protection should also be granted if the data at stake are published in a scientific journal.

Discussion

Amongst the measures proposed for the area’s of concern, the one relating to the NF product definition certainly is the best. One can argue about the exact phrasing of the proposed product categories, but taking leave of the open product definition provides the required clarity for entrepreneurs whether or not their product qualifies as a Novel Food. If this is an open end at the beginning of the authorization process, why would one even bother to start it? As for the suggestions made to further streamline the authorization process, these can be considered merely symbolic. Instead of shortening a deadline here and introducing another one there, the most important issue has not been addressed. Under the new NF proposal, the Commission shall take into account the view of the Member States regarding NF applications it received “where applicable”. The text seems to suggest that this will not be a standard procedure, but this is not clear. One can imagine that at this point, this may easily absorb a lot of time. Also, no fixed time frames for Member States to comment the NF application has been set. Finally, the system of data protection seems promising, but experience regarding a similar system contained in the Health Claim Regulation has shown that its effect is limited. If third parties for instance produce the same data as the protected data based on independent research, nothing will prevent them from using those data. Taking this into account, it is completely unclear how data protection can be enforced regarding data that have been published in scientific reviews, as suggested by the Rapporteur.

Conclusion

Should this all be considered as “too little, too late”? No – that would be a sombre conclusion. Provided that the suggestions of the Rapporteur regarding the NF product definition are followed and some more substantial reductions in time in the authorization procedure are achieved, the new proposal is a real improvement. This will all the more be the case, once a corpus of generic authorizations will have been published. In that case, manufacturers and importers of Novel Foods will no longer have to undergo an authorization process at all regarding authorized products. But that will be some dishes away from the present menu.

For some background information on Novel Foods and practical examples, reference is made to the Slides “Novel Foods, sexy or burdensome products“, used for a presenation at the Food Valley Expo on 23 October 2014.