NOVEL FOODS: WHAT IS A HISTORY OF SAFE USE?
The Longevity Labs C-141/22
SUMMARY
Source: https://shop.go-optimize.com/
No history of safe consumption covering 25 years could be shown for the spermidine flour
The technique applied was not a plant propagation but a production process for growing seedlings and thus synonymous with other novel foods techniques demonstrated as novel in the EU
The production process (hydroponic growth of seeds) was considered as new a spermidine rich solution was not used prior to May 1997
The technique clearly changed the composition of the food and as spermidine has been increased then thus so will the novel food defining ‘nutritional value’.
The court made no distinction of the solution the seeds were grown in being a synthetic or natural solution as it relates to Nf classification. The rational being the outcome e.g., bio-enrichment of the flour will be the same if the purity of the medium is the same.
FACTS OF THE CASE
A company selling a food supplement containing a buckwheat flour with a high spermidine content (go Optimize Spermidine). Spermidine being a component in many foods including wheats up to around 250mg/kg and is a polyamine that provides many metabolic functions in the human body from combating symptoms of diabetes to lifespan extension.
A competitor company that has also a spermidine rich extract although from a wheat germ extract brought an action to the Austrian authorities to prohibit the sale of the go Optimize Spermidine on the grounds it was not an authorised novel food (Nf) as was their product.
The two litigants use very different methods to enhance the levels of spermidine in their extracts. The wheat germ version uses and extraction method to concentrate the spermidine whereas the buckwheat version germinates the seed hydroponically in a solution containing synthetic spermidine resulting in a high content of spermidine in the resulting seedlings which can then be harvested and powdered.
The owners of go Optimize Spermidine denied this stating their buckwheat flour containing high spermidine was not novel and had been on the market over 25years.
On this basis the Austrian courts referred a number of questions to the European Court of Justice.
THE LAW
The novel foods regulation contains a number of provisions for the classification of how a food may be considered as novel in this instance the main points of relevant are:
Article 3(2)(a)(iv) – food consisting of, isolated from or produced from plants or their parts, EXCEPT when the food has a history of safe food use within the Union and is consisting of, isolated from or produced from a plant or a variety of the same species obtained by:
— traditional propagating practices which have been used for food production within the Union before 15 May 1997; or
— non-traditional propagating practices which have not been used for food production within the Union before 15 May 1997, where those practices do not give rise to significant changes in the composition or structure of the food affecting its nutritional value, metabolism or level of undesirable substances;
Article 3(2)(a)(vii) - food resulting from a production process not used for food production within the Union before 15 May 1997, which gives rise to significant changes in the composition or structure of a food, affecting its nutritional value, metabolism or level of undesirable substances;
We highlight (underlined) the main points of discussion within the case.
THE PRIMARY FINDINGS OF THE COURT
The focus here will be on the opinion of the AG and at the end of the article the court. The reason being is the court does not provide a binding response to 4 of the 5 questions referred to it by the Austrian courts.
As can be seen in Article 3(2)(a(iv) there is a derogation (exception) for a food being novel if it can be shown to have a safe history of consumption, is a traditional propagating practice (pre-May 1997) OR as in this case a non-traditional propagating practice (e.g., hydroponic cultivation in synthetic medium) that DOES NOT give rise to significant changes in its nutritional value (etc).
The court found:
No history of safe consumption for 25 years could be shown for the high spermidine buckwheat flour (only for buckwheat flour)
The technique applied was not a plant propagation practice (multiplication) but a production process for growing seedlings (not a full plant with leaves). This was found to be synonymous with other novel foods techniques such as Mushrooms bio-enriched in a selenium solution.
The production process was considered as new as the hydroponic growth of seeds in a spermidine rich solution was not used prior to May 1997 (according to court docs but this is for referring court to consider)
The technique clearly changed the composition of the food (increased spermidine by 106 time the levels found in non-processed buckwheat seeds) and as spermidine has been increased then thus so will the nutritional value.
The court made no distinction of the solution the seeds were grown in being a synthetic or natural solution of spermidine as it relates to Nf classification. The rational being the outcome e.g., bio-enrichment of the flour will be the same if the purity of the medium is the same.
QUESTIONS THAT REMAIN UNANSWERED
Although the opinions of the AG are not legally binding there are very instructive on how the court may consider such issues. Even so some issues remain unclear.
The Nf regulation as it relates to this case provides no legal definition on the meaning of a “history of safe food use “ within the Union. The AG uses such a concept from foods from third countries (as separate area of novel foods law related to customary diet over 25years) but in this case no such safe use can be found for the buckwheat flour high in spermidine.
A question raised was is it the novelty of the production process on any food or just on the food at question that results in a novel classification. In this the AG considered that it must be viewed in light of the specific product of which some food may have a change in nutritional value from the application of x process and other not.
In the final judgement of the court rather than that of the AG it simply that the product cannot demonstrate safe use for at least the last 25years in a significant number of people in at least one country of the EU. The result being it cannot meet the exception under Article 3(2)(a)(iv) for requiring approval as a novel food. Therefore, there is no need to respond to the 2-5th questions.
Of note is that the court will now seem to accept that the concept of A “History of safe use” can be viewed through the lens of Article 3(2)(b) of Regulation 2015/2283, which is proof of safe use from:
“compositional data and from experience of continued use for at least 25 years in the customary diet of a significant number of people”
SOURCES
Novel foods regulation: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32015R2283#:~:text=1.,human%20health%20and%20consumers%27%20interests.
AG Opinion: