A drink made from monk fruit – novel food or not?

UK High Court quashes FSA decision on novelty of monk fruit decoctions

Introduction

In the EU, food business operators (FBOs) have the responsibility to ensure that the food they are marketing is not unsafe. Most of the food products do not require prior market authorization, novel foods being one of the exceptions to the rule. For novel foods market authorization is granted based on an extensive safety evaluation by EFSA. If an FBO is unsure if its product / ingredient falls within the scope of the EU Novel Food Regulation, it can submit a voluntary consultation to a Member State, where the FBO intends to first market its product. The Member State competent authority will review the data submitted to establish if a history of use before 1997 can be established. In the affirmative, the product will not be considered novel. Examples of products not considered novel include pea protein concentrate and the Chinese pepper Capsicum chinense.

This blogpost covers the 19 March 2024 decision of the UK High Court on the novelty of a monk fruit decoction evaluated during a national consultation. This procedure was initiated by Guilin GFS Monk Fruit Corporation (Guilin GFS) against a joint decision of the UK Food Standards Agency (FSA) and the Food Standards Scotland (FSS). Guilin GFS is a world leader producer and manufacturer of monk fruit decoctions, having a 50 % global market share. Monk fruit is a small sub-tropical melon originating from China. Monk fruit decoctions can be applied to a wide range of foods and drinks as a sweetener and is popular for its low-calorie profile.

Figure 1 monk fruit image taken from the movie shown at www.monkfruitcorp.com

Applicable test and EC Guidance

After Brexit, the United Kingdom has maintained the EU Novel Food Regulation. Therefore, this decision is also of relevance for EU Member States. Under this applicable framework, the relevant test is whether monk fruit decoctions were used for human consumption to a significant degree in the EU or in the UK prior to 1997 (so-called history of consumption or HoC test). To adduce proof of a HoC, guidance can be taken from the Commission Guidance on Consumption to a Significant Degree dating back to 1997 (EC Guidance). In this context, it is important to note that the EC Guidance itself recognizes the difficulties of proof of significant use by the passage of time. It explicitly states that the examples of use are by no means exhaustive.

Evidence adduced

To meet the test on a HoC, Guilin GFS had adduced substantive evidence, including the following.

• Certificates of origin re. the export of processed foods monk fruits from mainland China to the UK during the period of 1998 – 2000;
• Evidence from a qualitative study from 2018 comprising face to face interviews with 71 participants in the UK and the EU demonstrating that processed foods containing monk fruits were sold in the EU / UK prior to 1997;
• Evidence from over 1.000 questionnaires as part of a quantitative population sample study from 2020 in the UK amongst people from Chinese descent re. their purchases of processed monk fruit;
• A survey in UK / EU supermarkets re. the types of monk fruit products sold before 1998;
• Signed declarations from restaurant owners, FBOs and the London Chinatown Chinese Association attesting the sale and / or consumption of monk fruit decoctions in the UK / EU prior to 1997.

FSA and FFS decision and rationale

On 8 September 2022, FSA and FFS rendered the decision that Guilin GFS did not meet the HoC test (the Decision). FSA and FFS considered the evidence too small in samples and none of this evidence hit the box of “Very Good Evidence”. This is the type of evidence referred to in Table 3 to the EC Guidance reproduced below. The table at stake contains examples of evidence that might be adduced to meet the HoC test, such as invoices detailing the sale of the food product at stake, including evidence of large quantities of the sale in the EU (“Very Good Evidence”), mere invoices detailing the sale of the food at stake (“Good Evidence”) and magazine articles (“Supporting Evidence”). The main reason why FSA and FFS considered the evidence not up to standards was because invoices demonstrating sales of monk fruit decoctions prior to1997 were missing. Also, the FSA considered that personal testimonies were inherently incapable of demonstrating a significant HoC without verification of an independent source.

Figure 2: Table 3 to the EC Guidance on Consumption to a Significant Degree

Revision procedure and disclosure of FSA decision making process

Guilin GFS did not agree and initiated a revision procedure before the UK High Court on 2 December 2022, for which the hearing took place on 29 February 2024. The beauty of this procedure is that it provides full disclosure on all relevant documentation leading up to the Decision, including internal FSA correspondence conducted by its Novel Food policy advisors, as well as input from the FSA Social Sciences Team. This is an independent expert team, providing strategic advice to FSA. Contrary to the Novel Food FSA policy advisors, the Social Sciences Team considered the qualitative and the quantitative studies of Guilin to be reliable and robust. The Social Sciences Team did have a few verification requests to FSA’s Novel Food policy officers. However, according to Judge Calver, FSA’s Novel Food policy officers placed these questions out of statistic context to which they relate to validate the conclusion they reached earlier.  Also, FSA’s Novel Food policy officers did not ask clarification questions to Guilin GFS when they reached their conclusion that monk fruit concoctions should be considered novel within the UK. Strikingly enough, they even reached this conclusion before the official validation of the dossier.

Debate during revision procedure

Guilin GFS opposed the Decision based on three legal grounds.

(1) It is incorrect that evidentiary requirements of the test for novelty under the Novel Food Regulation could not be met in the absence of pre-1997 sales invoices and data.

(2) It is incorrect that personal testimonies were categorically incapable to demonstrate a significant HoC unless verified by independent source.

(3) It is incorrect that it was necessary to demonstrate that monk fruit was consumed “exclusively for food uses”.

In reply, the Agencies served four witness statements from Novel Food policy advisors to “elucidate the reasons for the Decision.” Justice Calver states that based on the fact that these statements were made 15 months after the Decision, these need to be carefully scrutinized as there is a temptation to bolster and rationalize the Decision under challenge. Evidence that goes beyond elucidation and clarification is not permitted. When evaluating the witness statements, Justice Calver concludes the following.

Ad (1) The Agencies applied Table 3 to the EC Guidance too rigidly. Instead of considering “the whole picture” of evidence submitted by Guilin GFS, the Agencies saw that according to Table 3 the study results submitted by Guilin GFS did not qualify as “Very Good Evidence” or “Good Evidence”. They have then classified them as amounting “only” to “supporting evidence” “as defined in the Guidance”. This sentence makes clear that the Agencies consider anything other than invoices pre-1997 to be an inferior type of evidence as a category, amounting only to supporting evidence, which is not sufficient in itself to demonstrate a significant HoC.

Ad (2) The Agencies erroneously take the view that the evidence submitted by Guilin GFS’s should have been independently verified. There is no such requirement in the law or in the EC Guidance. Furthermore, the studies handed in by Guilin GFS had been qualified as reliable and robust by the Social Sciences Team. Also, with respect to personal testimonies, it is hard to conceive how these should be verified by third parties. As rightfully pointed out by Guilin GFS, such a requirement would frequently render personal testimonies redundant.

As a result, Judge Calver accepts grounds (1) and (2) and he considers the Decision flawed at these points. Moreover, he does not accept the four witness statements, as they try to re-write the reasoning in the Decision, which cannot stand with the wording of that document itself.

Ad (3) Finally, Judge Calver rules that the Agencies misapplied the relevant test when stating in the Decision that it was necessary to demonstrate that monk fruit was consumed “exclusively for food uses. The fact that the evidence submitted by Guilin GFS demonstrated a mixed use of monk fruit, in addition to food uses also including plant based medicinal products and even toothpaste, does not preclude establishing food use prior to 1997 in the EU or in the UK.

As a result, the claim for judicial review succeeds, the Decision is quashed, and the Agencies are ordered to re-consider the Claimant’s application in the light of this judgement. We can now see in the press that the Irish Food Safety Authority is reconsidering the novel food status of monk fruit extract and also the UK’s Food Standards Agency (FSA) has changed its stance regarding these products. The FSA now concludes that monk fruit concoctions are not a novel food, meaning that they can be used in food and beverages marketed in the UK. Reliable sources informed me that in the next weeks the Irish authorities – on behalf of the EU – are expected to issue a similar opinion to the UK.

Does this UK decision also apply for the EU?

In my opinion, this question should be answered positively. Rationale: according to the EC Guidance, an “established history of food use to a significant degree in at least one EU Member State is sufficient to exclude the food from the scope of Regulation (EU) 258/97.” The United Kingdom was an EU Member State during the period to which the evidence collected by Guilin GFS relates. The fact that Brexit occurred in 2020 does not change this. This also follows from the following statement in the EC Guidance: “The deadline 15 May 1997 is applicable to all Member States, irrespective from the date of accession to the EU.” By analogy, the same should apply in case of withdrawal of a Member State from the EU.

What can we learn from this decision?

In the first place, that it is a tough job to collect relevant evidence to establish a history of food use prior to 15 May 1997 in the EU (or the UK), especially since we are more and more moving away from this date. But it is doable. When looking at Guilin GFS, we can see that collecting product information, in combination with qualitative and quantitative data and affidavits can actually help to succeed in establishing such history of food use. Provided of course, you have a skilled lawyer at work to present your case. In the case at hand, the lawyers at work did an excellent job. One of these skilled lawyers is Brian Kelly, with whom I have been working together for more than 10 years now. Kudos to Brian!

First ECJ ruling on current Novel Food Regulation

On May 25, the European Court of Justice (ECJ) ruled in a dispute arising between two manufacturers of food supplements. This is the first decision on the interpretation of the current Novel Food Regulation (applicable since Jan. 1, 2018). The dispute concerned the method of production of the functional ingredient spermidine. The dispute was hoped to clarify the question of what exactly a “new production process” under the Novel Food Regulation entails. The decision follows a request from a court in Austria, where this answer was needed to resolve a national dispute. This answer is also relevant to other countries, as the Novel Food Regulation applies EU-wide.

Why do people consume spermidine?

Spermidine supplementation takes place with a view to supporting cellular autophagy, or cell renewal. This could promote the prevention of cardiovascular disease, prevent food allergies, and control the symptoms of diabetes. It has even been suggested that spermidine could extend human lifespan by 5 to 7 years. So says Advocate General (A-G) Campos Sánchez-Bordona in his opinion on the case dated Jan. 19 this year, citing various scientific sources (see footnotes 12 and 13 of this opinion). The A-G is an important advisor to the ECJ, which generally follows his or her opinions.

Background to this dispute.

The dispute in Austria was brought by The Longevitiy Labs (TLL), which markets the spermidine supplement spermidineLIFE. TLL extracts spermidine from ungerminated wheat germs through a complex and expensive chemical process. TTL applied for and obtained an EU Novel Food authorization for this food product (see Union List, entry “spermidine-rich wheat germ extract“). Then competitor Optimize Health Solutions enters the market with its own spermidine supplement. This is produced using a much simpler and therefore cheaper production process based on hydroponic cultivation of buckwheat seeds in an aqueous solution with synthetic spermidine. After harvesting the seedlings are washed in water, dried and milled to obtain flour. TLL believes that Optimize Health also needs a Novel Food authorization to market its product. It instituted proceedings seeking an injunction against further marketing of Optimize Health’s product without such an authorization.

Optimize Health argues it does not need a Novel Food authorization, because its product is not covered by the Novel Food Regulation. It is a fully dried traditional food obtained without any selective novel extraction method. Furthermore, it states spermidine has been available in food supplements in the EU market for more than 25 years. The germination of the buckwheat seeds of which its product is made would be a primary production process, to which the EU Hygiene Regulation applies, not the Novel Food Regulation. Furthermore, the Novel Food Regulation does not apply because its product involves “plants prior to harvesting” and these do not count as food under the EU General Food Law Regulation. The Austrian court decided that clarification of European law was needed to resolve this dispute and referred five questions to the ECJ.

Questions from the Austrian referring court

National judges who refer questions to the ECJ usually go for as many anchors as possible and thinking three steps ahead. If a possible answer by the ECJ to one question leads to a follow-up question by the inquiring national court, that follow-up question will be submitted upfront as well.  The downside of this system is that if answering the first question is the end of the matter, answering the remaining questions is no longer needed. That is what we call procedural economy. In summary, the referring Austrian court asks the following questions:

1. Should a food consisting of flour from buckwheat seeds with a high spermidine content be qualified as Novel Food in the category “foods isolated from (parts of) plants?”
2. If not, might it be a Novel Food because a new production process has been used and does that term include primary production processes?
3. If it is a novel production process, does it matter whether that process was not applied at all or only not applied to spermidine?
4. If primary production processes are not covered by the term “new production process”, is it correct that the process of germinating buckwheat seeds in a nutrient solution containing spermidine is not covered by the Novel Food Regulation because it does not apply to plants prior to harvesting?
5. Does it make a difference whether the nutrient solution contains natural or synthetic spermidine?

Decision of the ECJ

The ECJ answers question 1 – be it with some reservation – in the affirmative. Optimize Health’s product is a Novel Food because there is no evidence that this product was used for human consumption to any significant degree within the EU before 1997. This short answer is somewhat disappointing, as it makes answering the remaining questions irrelevant. Still, the ECJ does share two interesting considerations regarding the current Novel Food Regulation. It points out that the concept of “history of safe use within the Union” is not defined with respect to Novel Foods that must undergo the full authorization process. However, it is defined with respect to traditional foods from third countries. These are products that have been used as food outside the EU for considerable time, such as chia seeds. These products are subject to the requirement that the safety of the food has been confirmed by compositional data and experience of continued use for at least 25 years in the usual diet of a significant number of people in at least one third country. The ECJ finds that this requirement must be applied by analogy to the spermidine in question and concludes that said data have not been provided.

Propagation methods vs. complete production process

Another consideration of the ECJ concerns the Novel Food category of “food isolated from (parts of) plants”. An exception applies to products made by non-traditional propagation methods, which do not result in significant changes in the composition or structure of the food in question. The ECJ ruled that a distinction must be made between:

(1) propagation processes of which the purpose is to produce new plants; and

(2) processes involving the entire production process of a food product.

The process applied to Optimize Health’s product to achieve a high spermidine content falls into the second category. In other words, a manufacturing technique to enrich a product is not the same as a propagation technique. The ECJ instructs the Austrian court to take this into account when deciding the case at the national level. This reduces the likelihood that the exception to the Novel Food category above will apply and puts the ECJ’s reservation into perspective. Good chance, therefore, that the Austrian national court will indeed determine that Optimize Health’s product is a Novel Food.

New production procedure according to the A-G

With the above answer, the question of the Austrian court has been answered and the ECJ does not get to the remaining four questions. It is of course unfortunate that we will not know the ECJ’s decision on this. Therefore, it is interesting to see how the A-G ruled on this. Well: according to the A-G, enriching buckwheat seeds with spermidine should be considered a new production process. He argues that bio-enrichment with spermidine changes the composition and nutritional value of the buckwheat seeds flour. Indeed, its spermidine content becomes 106 times higher than that of un-enriched buckwheat seeds. The A-G cites studies according to which a higher spermidine content may be beneficial to health, but which also indicate that too high an amount of spermidine could be harmful to cells.

The A-G therefore concludes that prior authorization of Optimize Health’s product is indispensable to ensure food safety and avoid risks to consumers. He also refers to products such as selenium-enriched mushrooms and mushrooms treated with ultraviolet light after harvest to increase their vitamin D2 content, where such authorization has also taken place. Furthermore, the A-G argues that the effects and thus the safety of a new production process should be assessed in each individual case and thus not in general. The same production process may affect one foodstuff differently from another.

Conclusion

This spermidine case clarifies the criterion that should be applied to determine whether a food has a history of safe use in the EU and thus qualifies or not as Novel Food. By the way, this is not entirely new – there has already been a guidance document from the European Commission “Human Consumption to a Significant Degree” since 1997 that argues essentially the same thing. However, when this judgment is considered in conjunction with the A-G’s opinion, it does provide relevant new information for determining how to establish whether there is a new production process.

This is the case if it is established that an applied process significantly alters the composition and nutritional value of a foodstuff compared to a foodstuff to which such a process has not been applied. Thus, in such a case, a food must obtain authorization under the Novel Food Regulation. The A-G recognizes that the question whether it is relevant if the production process has been previously applied to any foodstuff (rather than to the foodstuff specifically) cannot simply be answered based on the legal text. So that requires interpretation of the specific article of the Novel Food Regulation on new production processes in the light of its context and purpose. For now, we do not yet know whether the ECJ supports his interpretation. Hopefully we will find out in another case. It does sound plausible to me.