K J Garnett
‘There was an old woman who swallowed a fly … I don’t know why she swallowed a fly. Perhaps she’ll die?’ English nursery rhyme. Origin unknown.
Frederick the Great of Prussia treated coffee and coffee drinkers with the same suspicion that Baron Bomburst (of Chitty Chitty Bang Bang fame) treated children in the fictional Kingdom of Vulgaria. Like Baron Bomburst who employed a child catcher to sniff out any household harbouring children, so Frederick II employed an army of coffee sniffers to sniff out traders roasting coffee and households illicitly drinking it in a back room. According to some sources, by 1784 there were over 400 coffee sniffers pocketing one fourth of the fines imposed on offenders.[1]
“It is disgusting to notice the increase in the quantity of coffee used by my subjects, and the amount of money that goes out of the country as a consequence. Everybody is using coffee; this must be prevented. His Majesty was brought up on beer, and so were both his ancestors and officers. Many battles have been fought and won by soldiers nourished on beer, and the King does not believe that coffee-drinking soldiers can be relied upon to endure hardships in case of another war.” — Frederick the Great of Prussia, 1777 [2]
In France too, the public authorities grappled with this novel dark brew when coffee houses became all the rage in Paris. First, the authorities declared coffee a poison. Then a healing drink. Then a poison. As the French philosopher, Bernard Fontenelle (who lived one month shy of his 100th birthday) is said to have replied to his physician, “If it’s a poison it must be a very slow one.” After the death of Frederick II the coffee edicts were lifted and the rest, as they say is history. Suspicion of food innovation, it seems, is as old as time – typically short-lived and swept away by the currents of history.
Or so we might think. Fast forward to July 2020 and the debate around novel foods remains an unresolved one as the Entoma case on the novelty (or not) of whole insects indicates. In 18th century Europe it was coffee, chocolate, potatoes and tomatoes that perturbed the authorities – today its whole insects, raw stevia and CRISPR Cas-9 novel foods. Plus ça change. Global populations outside of Europe have been consuming whole insects for millennia but suspicion of this unknown food in Europe remains. For example, although the Parisian public authorities are relaxed about their bistros serving a traditional dish of snails coated in butter and garlic in 2016 they forbade the company Entoma from offering whole insects for sale on the grounds that they are too novel and too dangerous to consume. This sentiment, namely the safe ‘traditional way’ (beer soup/snails) and the risky ‘innovative way’ (coffee/whole insects) encapsulate the dichotomy between what is often considered ‘safe’ and ‘natural’ and that which is considered ‘unsafe’ and ‘unnatural’. As in eighteenth century Europe so too with contemporary European societies – the public authorities, industry and consumers often get confused between what is safe and what is not safe, what is conventional and traditional and what is innovative and novel and therefore risky.
Modern food regulations, sadly, fail to heal the confusion.
In Entoma v Ministre de l’Économie et des Finances (C-526/19) Advocate General Bobek asks “Are insects novel foods?” Modern European regulatory law does not employ ‘insect sniffers’ to try and root out anyone roasting whole crickets for a snack on the BBQ. Instead it seeks to define novel foods and assess their risk through the European Food Safety Authority.
Facts of the case
Entoma is an undertaking which markets, amongst others, products consisting of a number of ‘whole’ insects such as mealworms, locusts and crickets intended for human consumption. Some European public authorities, – France and Italy in particular – are troubled by the possibility that the consumption of whole insects could be dangerous for consumers. In 2015 when updating the regulations on novel food it was made explicit that ‘whole insects’ (Recital 8) should be categorised as novel within in the meaning of Regulation 2015/2283 on Novel Foods. (The Novel Food Regulation, 2015).
In January 2016 the préfet de police de Paris suspended the placing on the market of whole insects and ordered their withdrawal for human consumption declaring them novel and dangerous to consume. Entoma appealed arguing that under Regulation 258/1997 whole insects were not deemed novel foods within the meaning of the Regulation and that as such they benefited from a transition period foreseen under Article 35(2) of the 2015 Regulation (2015/2283) until 1 January 2020.
“Over the course of human history,” Bobek notes, “the consumption of whole insects is certainly not novel.” This is true. Many global regions – East Asia and Africa, in particular, are known for consuming edible, wild insects (whole and in parts) and have done so for millennia. “However, in the eyes of EU law, the answer is said to be less clear.” (Bobek, para 1). Clarity is certainly not a word that could be used to describe EU Food Law, caught up as it is, in the crosshair of food imports from third countries, food innovation, bio-tech industries, modern processing methods and novel forms of plant breeding. The International Platform of Insects for Food and Feed (IPIFF), for example, list ten regulations (secondary, implementing and EFSA authorisation applications) which a producer of whole insects must comply with before placing their product on the market. If Bobek’s answers appear convoluted and complex it is merely a reflection of the convoluted, complex and confused nature of the EU’s novel food regulations, which is why I don’t intend to go into all the judicial details of the case but to highlight some of the points he raises as an example of how to approach novel foods from a new perspective.
For those interested, Bobek concludes, ‘whole insect’ are not novel within the context of the 1997 Novel Food Regulation and according to his opinion they could have benefited from the transition period until 1 January 2020. The CJEU might of course rule otherwise but for that we have to wait and see. Further, the EFSA is expected to present its opinion on the sale of whole insects shortly and it is assumed they will clear the path for market authorisation.
The real interest for anyone following matters pertaining to legal innovation in food law is that this case highlights some of the confusion with which the EU defines ‘novel foods’. It is clear that in 1997, in the wake of GMOs and other food innovations the legislature wanted to ensure that untested, new foods would be properly regulated. The novel food and food ingredients regulations – then and now – are based on Article 114 TFEU in that they are harmonising instruments trying to marry the smooth functioning of the single market with the need to protect consumers from potentially dangerous novel foods. The twin objectives are to be achieved by a single safety assessment. Novel foods are defined firstly temporally – any food or food ingredient not consumed ‘to a significant degree’ before May 1997. Second, substantively – a list of categories that could be considered novel. There are two potential challenges with this approach.
The challenge of defining novel foods temporally
First the temporal issue. The year 1997 is used as the cut-off point in Europe because that is when the first novel food and food ingredients Regulation was approved by the EU institutions. Within the context of innovative foods, however, 1997 is an arbitrary date linked to no meaningful or objective criteria. Take whole insects, as an example. It is fair to suggest that the consumption of whole insects in Europe ‘is not significant’ – neither in 1997 nor in 2020 – but then neither was coffee, potatoes, tomatoes, chilli peppers, chocolate or peanuts in eighteenth century Europe and today they are common place with few regarding them as “..presenting a danger for the consumer” (Article 3, Regulation 258/97). They have, in short, become conventional. Eating whole insects may not appeal to many European consumers today – but they are a hugely popular snack in the regions which have traditionally eaten them. Unknown is not always the same as unsafe. Simply because a food has not been eaten ‘significantly’ in Europe prior to 1997 does not necessarily make them dangerous or risky.
The 2015 Novel Food Regulation, to be fair, has been amended to reflect the approach that if it’s been consumed for longer than 25 years in a third country then it is probably not dangerous and safe to authorise for sale. A speedier application procedure has been introduced for traditional foods from third countries. Nevertheless, Article 3 (2) (b) Regulation 2015/2283 still defines whole insects, as Bobek admits, as novel foods within the meaning of the 2015 Regulation. This unbalances the harmony of the novel food regulations. It is, after, all entitled the Novel Food and Food Ingredients Regulation – not the Novel Foods and Traditional Food from Third Country Regulation.
Is it not an anomaly to have a whole section on the regulation of Traditional Food from Third Countries (Section II, Article 14) within a Novel Food Regulation? The two categories are complete opposites with different risks associated with them and as a result sit awkwardly and uncomfortably next to each other. The EU has created separate Regulations for : GMO’s, food flavourings, food enzymes, food additives and food solvents – all of which are typically novel innovations added to food – one would have thought the EU would have the wherewithal to develop a separate regulation for traditional foods from third countries rather than grouping them within a Regulation designed to address the unknown risks of innovative, novel foods with an arbitrary year – 1997 – as the cut-off date.
Substantive challenges with categorising novel food
Second the substantive definition. The 2015 Regulation extends the concept of altering food at the molecular level by adding, amongst others, engineered nanomaterial to the list of categories considered novel food and novel food ingredients as well as cell cultures and vitamins and minerals. “The original six categories” Bobek points out, ‘had a rather clear common denominator: food or food ingredient being modified either genetically, or at the molecular level, at the micro-biological level or through a new production process not currently used changing the composition of the food.’ (para 43). This is a fair point. Indeed, a closer examination of the new categories added as novel food by the 2015 Regulation such a nano-engineered food amplifies this assumption. What we see is the regulator looking to ensure that novelty applies to food which has been engineered using a technical, non-natural process for which there is no history of safe use and which could not have been produced through a natural, traditional process.
If, however, the categories of food and food ingredients considered novel has been extended then so too have the exemptions. What the regulation gives with one hand it takes away with the other. For example, “any food consisting of, isolated from or produced from plants or their parts” according to Article 3 (2) (a) (iv) is novel .Except where such food has a “history of safe use” or it is a “traditional method of plant breeding”.
Applying the simple logic:
“traditional = known risks (history of safe use)”
“innovative = unknown risk (no history of safe use)”
this makes sense.
However, exempted from Article 3 (2) (a) (iv) are
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.
By exempting ‘non-traditional’ propagating practices the novel food regulation is once again unbalancing the core objective of the regulation – to control innovative, untested foods. A novel, engineered method for breeding plants through technological means and with no history of safe use is exempted from European regulations designed to regulate novel, engineered foods yet, traditional food from third countries are defined as novel within the meaning of the novel food regulation (albeit their approval procedure has been simplified). Further exempted from the ‘novel’ food regulation are many novel food ingredients such as additives, flavourings, emulsifiers and GMOs which are typically engineered, technologically or chemically altered.
The mixing up of traditional approaches with non-traditional approaches may be one of the reasons why European food law is often contentious and fraught with disagreement. The leitmotiv running through the wording of European food law – be it the GMO Directive, the General Food Law or even the Novel Food and Food Ingredients regulation is to assume that ‘history of safe use’, ‘conventional’ and ‘traditional’ do not require market authoristion. It is the innovative, the radically new and the novel – for which there is no history of use – which requires regulation. Such engineered foods are quite distinct from and different to traditional food from third countries (such as whole insects) – or indeed any traditional/conventional or natural food found within Europe.
The wording running through European food law recognises this but then gets confused by setting out contradictory, prescriptive rules and exemptions. There is indeed, as Bobek points out a “clear denominator” connecting novel foods and distinguishing them from traditional, conventional foods deemed safe – namely modification thereof at a molecular level – be it through genetic engineering, CRISPR CAS-9 technique, cell culture or at a nanoscale – none of which applies to traditional foods safely consumed either within or outside of Europe. This distinction is what could and perhaps should be clarified and built upon in order to find a more balanced, harmonious approach to European food law.
Drinking coffee in Prussia and elsewhere in 1781 was revolutionary, exciting and new but it was not novel. The coffee bean originates in Ethiopia where it was roasted and ground for use in a drink. From there the habit of drinking coffee spread through Yemen and into the Middle East. In short, coffee drinking has a history of safe use with known risks. The coffee may have been ‘new’ to European populations but not it was not ‘novel’. An engineered coffee bean which has been altered at a molecular level through a non-natural, laboratory technique such as CRISPR CAS-9 technology, on the other hand could, indeed, should be considered novel within the meaning of the novel food regulation given the unknown risks attached to it.
Every morning I am grateful for my German roasted Milde Tschibo coffee relaxed in the knowledge that no sniffer is prowling around my property waiting for an opportunity to fine me for drinking my morning brew. The intervening centuries have not really helped the regulator understand the difference between being a benign protector of consumer’s health and an interfering busy-body sniffing out perfectly safe and delicious foods. With the EU committed to developing a Green New Deal where everything is open for discussion and reappraisal now may be an opportune moment to have a meaningful discussion on how to move this debate forward sensibly and applying common sense.
[1] Robert Liberles, Jews welcome Coffee: Tradition and Innovation in Early Modern Germany, Brandeis University Press, 2012.
[2] William H. Ukers, All About Coffee, “The Introduction of Coffee to Germany,” The Tea and Coffee Trade Journal, New York 1922.
BLING 