Tastings of cultivated foods now and tomorrow

Last month, the conference Regulating the Future of Foods took place in Barcelona,  gathered more than hundred professionals active in the fields of precision fermentation and cellular agriculture. The purpose of the conference was to define hurdles and investigate opportunities in the current regulatory framework applicable to this sector. Many interesting presentations took place discussing the global perspective of our future food system and AXON moderated a workshop targeting tastings of cultivated foods, formulating a number of conversation topics. In this blogpost, we share the outcome of the discussions that took place during this workshop.

Regulatory frameworks for tastings                                                               

Tastings of these products already took place, for instance in Israel. So far however only two countries have developed a legal framework for this purpose, notably Singapore and the Netherlands. In the tastings workshop, the procedure and the data requirements for setting up tastings in these countries have been explained, as you can see in the powerpoint inserted below. Furthermore, the following items were discussed.

1. Should the SGP / NL template become the blueprint for tastings or rather do this under the radar?

As follows from the comparison of the regulatory frameworks in Singapore and the Netherlands, these hugely overlap. Therefore, the question arose if these frameworks should become the blueprint for tastings in other countries. Kind Earth.Tech rightfully pointed out that at the beginning of the cultivated meat industry 10 years ago, all tastings held were illegal. They were however important to demonstrate proof of principle and to create appetite for further research. At the current state of the industry, all participants in the workshop however favoured a framework for tastings. Especially for start-ups, a tastings framework is valuable for showing both press and investors what they are up to. Furthermore, the Dutch initiative is useful to convince other EU Member States to develop similar initiatives. Bluu Seafood pointed out that Germany in particular was pretty shy to do so, as it considered tastings not to be in compliance with the EU Novel Food Regulation. Now German start-ups can point to the Dutch framework and request their authorities to take such initiative.

Another reason why tastings might be useful, is that the regulatory process takes a substantial amount of time. In Singapore, predicted timelines for Novel Food approval are between 9 – 12 months, but in reality, these go up. In fact, we have not seen any approvals for cell-based meat products since those for Good Meat and Upside Foods in Q4 2020. In the EU, the theoretic term for Novel Food approvals is about 18 months, but we know from practice it is more realistic to count 2 – 3 years. For the new industries of cellular agriculture, it remains to be seen if this term will apply as well. Demonstrating proof of principle during tastings can be a welcome deliverable before the final go.

Both in Singapore and the Netherlands, tastings should be done in a confined area, not open to the general public. This was understood by all participants in the workshop. At the same time, the concern was expressed that tastings should not become too clinical. They are meant to enjoy food products after all, not to evaluate medicinal products. Provided that a confined area and a selected audience can guaranteed, they can also be set up in a restaurant. Organising tastings during regular opening hours of restaurants will not yet be feasible, as such would fall within the scope of “placing on the market” under article 3.8 of the EU General Food Law Regulation. And placing on the market of Novel Foods requires pre-market approval.

2. For those previously involved in tastings: are they worth the efforts and did they bring you the data you were looking for?

 The parameters set in the regulatory tasting frameworks are meant to be high enough to ensure food security but not dissuasive for companies to demonstrate safety prior to obtaining market authorization. Nevertheless, it takes considerable efforts to accommodate these parameters. For instance, producing useful microbiology data requires a minimum quantity of the product to be produced, which at this stage is still very expensive.

Obviously, the tastings themselves require substantial product input, often in combination with various non-cultivated carriers creating a hybrid product. This requires investments which for start-up companies can be challenging.

However, tastings have proved most valuable to collect input from chefs who will be working with cultivated products and to provide proof of principle to investors. In particular, repeating tastings with the same chefs offers the advantage that they can monitor and comment progress made and provide suggestions for further improvement, especially to accommodate the local palette.

2. Is the available guidance from the regulators sufficiently clear to decide how to set up the tasting and establish the safety of your product? Has the regulator been helpful in clarifying any company queries?

Companies that already conducted tastings in Singapore considered the Singapore Food Authority (SFA) to be helpful in not only overseeing this process, but also in facilitating it. Where a first tasting takes quite some work in setting up safety documentation and addressing any potential concerns of the regulator, repeated tastings proved to require much less preparations. This is particularly true if all tastings take place at the same location, as it facilitates the medical contingency plan. This requires the indication how much time it takes to reach a medical centre if any problems occur.

Most importantly, permission for tastings being granted is perceived as a quiet vote of confidence by the regulator, as it seems to have a minimum level of comfort with the safety of the product to be tasted.

3. Do you see any value in tastings to be set up at an EU level as opposed to national level only?

No, not really. It is important to create a product that appeals locally, and this may differ from community to community. Also, it was discussed that tastings organized at a central level could induce companies to rely on the greatest common denominator, i.e. a burger. This would in fact be a pity, as cultivated foods offer so much more opportunities than that. This was for instance demonstrated by Vow Foods who made a crème brûlée with its cultivated quail.

4. Any ideas what could be done to prevent that tastings slow down regulatory approvals?

The representative from SFA explained that the total staff available for the safety assessment of Novel Food AND the evaluation of an exemption for the tasting and sensory evaluation of Novel Foods is four to five persons. It is easy to understand that the more time is spent on the evaluation of tastings, the less time can be spent on the safety assessment of Novel Foods as such.

It was discussed that if tastings go wrong, for instance by creating a health problem, they imply a risk, not only for the product at stake, but also for the sector. On the other hand, tastings also spark enthusiasm, as was demonstrated by Solar Foods who even held tastings after obtaining market approval in Singapore.

So the communis opinion was that tastings should be dosed. Do not overdo it, but carefully weigh the advantage it can bring your company at a particular moment of its lifetime, for example during a funding round.

5. Do tastings qualify as studies under the EU Transparency Regulation, that should be notified to EFSA during an application for authorization of a Novel Food?

The EFSA representative present in Barcelona was quite outspoken regarding this question. If you have any concerns about toxicity or any other possible hazard, you do not want to expose your intended audience for tastings to such hazard. A tasting session is not a study. So no, tastings as such do not have to be notified to EFSA under the Transparency Regulation.

What’s next?

In the Netherlands, the CAN Expert Committee is expected to be nominated early 2024 and local companies are already gearing up for organizing tastings in situ. So soon the Dutch will continue to work on their Dutch dream. Watch that space!

Health claims for botanicals? – the ECJ is looking into it

Germany’s highest court, the Bundesgerichtshof, asked the European Court of Justice (ECJ) this summer to explain the use of ‘on hold’ claims for so-called ‘botanicals’. The question is whether these substances may be advertised with health claims or general, non-specific health benefits as long as the assessment by EFSA has not been completed and the European Commission has not yet taken a final decision on the authorization of these claims.

This question stems from proceedings initiated by the German unfair competition association Verband Sozialer Wettbewerb e.V.. We owe many ECJ rulings to this German association, including the famous TofuTown ruling from which it follows that milk designations are reserved for animal dairy products only. We covered the TofuTown case in an earlier blogpost. The current case is against the food supplement company Novel Nutriology, which sells, among other things, an ‘anti-stress’ supplement containing saffron and melon juice extract.

The saffron extract is said to create a more positive mood, according to the seller’s website. This expression is backed by the results of an open study on 50 participants over a 30-day period. Research has shown that the melon juice extract reduces feelings of stress and fatigue, according to the website. Verband Sozialer Wettbewerb e. V. considers these to be unpermitted health claims. It therefore requested Novel Nutriology to stop making these claims, but the supplement company did not listen.

Approved health claims

Health claims are in principle only allowed if they are included in the lists of approved claims under the EU Claims Regulation. This follows from article 10(1) Claims Regulation. References to general, non-specific health benefits such as ‘heart health’ and ‘mental energy’ are allowed if accompanied by a specific, approved claim (article 10(3) Claims Regulation). However, health claims for botanicals are ‘on hold’ and are therefore not included in the lists of approved claims. Therefore, the literal text of Article 10(1) and (3) Claims Regulation cannot be met when making health claims for botanicals.

Claims Regulation nevertheless applicable to botanicals?

To determine whether Novel Nutriology violates the prohibition on making unauthorized health claims, it is essential to know whether Article 10(1) and (3) of the Claims Regulation apply to botanicals. If not, violation of these provisions is out of the question.

As can be seen from the summary of the request for the preliminary ruling, the view is generally taken that references to general health benefits of botanicals must comply with Article 10(3) Claims Regulation. The requirements of this provision are met if the generic health benefit is accompanied by the full, specific health claim that is ‘on hold’. That full ‘on hold’ claim, although not officially authorized, may be used in accordance with the transitional measures in Article 28(5) and (6) Claims Regulation. It would not be compatible with the purpose of Article 10(1) and (3) Claims Regulation to exclude these provisions entirely for botanicals. Such would namely mean that botanical substances may be advertised with non-specific health claims without a scientific assessment of the specific claim supporting them.

Alternative views

Nevertheless, the Bundesgerichtshof finds it unclear whether Article 10(1) and (3) Claims Regulation apply to botanicals. As an argument against applicability, the German court states that the Union legislator would have considered an absolute ban on general health benefits as too broad. Therefore, the Union legislator intended to ban such only if the general claim is not accompanied by an approved, specific health claim.

It is currently however impossible to obtain approval for botanical claims that are ‘on hold’ due to the European Commission’s inaction. By making Article 10(3) Claims Regulation applicable to these substances, the prohibition becomes broader than the Union legislator would have intended. It should therefore be assumed that general health benefits for botanicals are not regulated until the European Commission continues the authorization procedure for ‘on hold’ claims. Based on this alternative view, Article 10(3) of the Claims Regulation should not apply until then.

A second argument raised against the applicability of Article 10(1) and (3) Claims Regulation to botanicals is that the European Commission has not taken action on ‘on hold’ claims for many years. Upholding the applicability of Article 10(1) and (3) Claims Regulation, which cannot be met for ‘on hold’ claims, would lead to a disproportionate restriction of the interests of companies making such claims.

Previous ECJ rulings

Whether the aforementioned alternative views are sufficient to exclude botanicals from the scope of Article 10(1) and (3) Claims Regulation remains to be seen. As highlighted in a report published last September, companies are able to make health claims for botanicals that are included in the ‘on hold’ list under the transitional regime of Article 28(5) and (6) of the Claims Regulation. Moreover, the ECJ ruled in previous cases that companies making ‘on hold’ claims are not disproportionately disadvantaged. Since they can make claims without EFSA having assessed these and/or without a final decision from the European Commission, they are in fact favored.

Aforementioned report also highlights that the ECJ previously made explicit that Article 28(5) Claims Regulation makes an exception for the use of specific health claims as referred to in Article 13(1)(a) Claims Regulation that have not yet been officially approved. The report therefore concludes that the mentioned transitional regime only applies to the full specific claim and not to general health benefits. General health benefits would therefore not be allowed, although it is recognized that some EU member states do accept general health benefits for botanicals when accompanied by the full ‘on hold’ claim.

Relevance for practice

Health claims for botanicals are currently accepted in the Netherlands if the roadmap of the Dutch agency regulating health products (the Keuringsraad) in cooperation with the NVWA, is met (see here, in Dutch). In brief, this means that (i) the substance and claim are present on the ‘on hold’ list, (ii) potential conditions of use such as a daily dosage are included on the label, (iii) the claim is in line with the wording accepted on KOAG KAG’s ‘indicative list’, and (iv) a disclaimer regarding the ongoing approval procedure is made.

If the ECJ rules that Article 10(1) and (3) Claims Regulation does not apply to botanicals, it is uncertain whether the Keuringsraad roadmap can be upheld. It is however more likely that the ECJ will clarify that botanicals do fall within the scope of the aforementioned provisions. In that case, various outcomes are still possible. In connection with the transitional provisions of Article 28 Claims Regulation, a difference may arise for full ‘on hold’ claims and general health benefits. Such will partly depend on whether the ECJ sticks to the literal text of the transitional provisions (which would prohibit the use of general health benefits), or takes into account current practices (in which case advertising with general health benefits remains allowed under certain conditions). To be continued!