Happy Novel Year !

Years come and years go. The years that have gone are the years that we know. Some were good, some were even better, and some were bad. The years that come are the ones we don’t know. They are novel. We don’t know what they will bring us. At the beginning of each novel year, we wish that it will be a happy one and we light the fireworks to celebrate and keep the evil demons at a distance …

Foods come and foods go. The foods that came are the ones we know. Some of them stayed, because they were good. Others vanished for reasons mostly forgotten. The foods that are coming are the ones we don’t know. They are novel. They may come from far away or they may be the result of newly developed agricultural or technological practices.

In the year 1997, the European legislature placed novel foods under its exclusive control. Until then, all foods, known and novel, were placed on the market under the responsibility of the respective food business operators. This regulatory practice reflected the fact that, until 1997, the Prohibition Proviso (i.e. the prohibition ex post evaluation) was the overriding normative paradigm in European Food Law.

The Prohibition Proviso concerns market exit.

Under European Community law, foods – be it with full responsibility of the food business operator for the safety of his product – were not subjected to a Prohibition with an Approval Proviso (i.e. a prohibition ex ante evaluation). It was not up to the food business operator to make an effort of obtaining an authorization to legitimately market a food-product ex ante placing it on the market. Until 1997, in the regulation of foods, known and novel, it was up to the European and/or national authorities to take action in case they felt that marketability had to be restricted.

The Prohibition with an Approval Proviso concerns market entry.

In 1997, the European Community embraced the Prohibition with an Approval Proviso paradigm to commence prohibiting certain categories of food before an evaluation of their safety had taken place. With the exception perhaps of infant formulae and follow-on formulae, which were “positively” regulated in 1991, [i] novel food was this new paradigm’s first target.

In 2002, the EC took control over vitamins and minerals. In 2006, nutrition and health claims were subjected to the combination of an ex ante prohibition and an authorization proviso. Under the new paradigm, the Union now controls market entry of certain categories of foods and food-ingredients as well as the use of all nutrition and health claims in commercial communication.

In the year 2015, the European legislature reaffirmed its control over novel foods by updating the 1997 Regulation 258/97/EC concerning novel foods and novel food ingredients. On the first day of 2018, novel foods will be regulated by Regulation 2015/2283/EU. Not only was the Prohibition with an Approval Proviso upheld in the new Regulation. In addition to this provisio, the Union’s co-legislators decided that in the authorization of novel foods the Precautionary Principle must also be applied.

Per Article 12 of the new Regulation, the Commission, when preparing a draft implementing act authorising the placing on the market of a novel food and/or updating the Union list of novel foods, will not only take into account the European Food Safety Authority’s (EFSA’s) opinion concerning the novel food’s safety, but also “any relevant provision of Union law, including the precautionary principle as referred to in Article 7 of Regulation (EC) No 178/2002.”

The explicit mentioning of the Precautionary Principle in a Prohibition with an Approval system is rather curious. In and of itself, the Regulation is a permanent precautionary measure. It entails an across the board prohibition of all novel foods and only permits the authorization and market entry of such foods after an evaluation of their safety.

In Article 11, the co-legislators assigned to the EFSA the task of considering whether:

(a) the novel food concerned is as safe as food from a comparable food category already placed on the market within the Union;
(b) the composition of the novel food and the conditions of its use do not pose a safety risk to human health in the Union;
(c) a novel food, which is intended to replace another food, does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.

According to Article 7 of the Union’s General Food Law, the Precautionary Principle applies when “[i]n specific circumstances where, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, […].” Per Article 11.2 of the new Novel Food Regulation, EFSA must ascertain – i.e. establish with certainty – whether the novel food is safe. There’s no room for “scientific uncertainty” in EFSA’s Opinions. When safety cannot be definitely ascertained, the Commission will most certainly refrain from preparing a draft implementing act authorizing the placing on the market of the novel food in question.

This begs the question, why would the Precautionary Principle be explicitly mentioned in a prohibitive measure that in and of itself forms a shining example of this principle. When safety is ascertained and secured, what more is there precaution ? Perhaps the answer can be found by reading more closely Article 12.1, which provides that in addition to safety, the Commission may also consider “any relevant provision of Union law, including the precautionary principle as referred to in Article 7 of Regulation (EC) No 178/2002” and “any other legitimate factors relevant to the application under consideration.”

The text doesn’t state that the Commission must apply Article 7 of Regulation 178/2002/EC. It states that the Commission must apply “the precautionary principle as referred to in Article 7 of Regulation (EC) No 178/2002.” (emphasis added) Clearly, Article 12 opens the door to applying the Precautionary Principle well beyond “the possibility of harmful effects on health” in the preparation of draft implementing acts. It could lead to withholding authorization of a novel food considered as safe by EFSA, when “in specific circumstances, following an assessment of available information, the possibility of harmful effects on _____________ is identified but scientific uncertainty persists.”

Just fill in the blank space with “any other legitimate factor relevant to the application under consideration” and a safe novel food will be subjected to a precautionary measure that will be in line with Article 7.2 of Regulation 178/2002/EC, which provides that such measures “shall be proportionate and no more restrictive of trade than is required to achieve the high level of health protection chosen in the Community, regard being had to technical and economic feasibility and other factors regarded as legitimate in the matter under consideration.” (emphasis added)

Arguably, the Precautionary Pinciple could function as a stopgap when EFSA is not involved in ascertaining a novel food’s safety. Indeed, it is at the discretion of the Commission to request EFSA to ascertain whether a novel food is or isn’t safe. The Commission may also chose not to involve EFSA. Moreover, novel foods coming from “third countries” require no more than a notification demonstrating a history of safe use over at least 25 years in the customary diet of a significant number of people in at least one third country. Their notifications do not automatically involve scrutiny by EFSA.

Anyway, in cases where requests to EFSA are waived, the Commission will most certainly hesitate to undertake the preparation of an implementing act authorizing the novel food when “scientific uncertainty persists.” When it is uncertain whether a food is safe, either because a third country “notificant” fails to show a 25-years history of safe use or because a Union-applicant’s scientific evidence fails to demonstrate that the novel food does not pose a safety risk to human health, the Commission will not prepare an authorization to place it on the market.

In this regard, novel foods from third countries may be novel in the Union but they’re traditional in the third country. Given the fact that such third countries may range from Norway, the United States, Canada, Argentina, Japan, China and Switzerland to Bresil, India and Russia, one wonders what the Union’s legislators had in mind when they determined that notificants of traditional foods produced in “third countries” may follow a simple notification procedure while applicants of novel foods must follow the application procedure. As if novel in the Union isn’t novel when the novel food isn’t novel in the country of origin.

What this does show, however, is that in the approach taken by the Union legislature in this new Novel Foods Regulation, the level of safety based on a 25 years history of safe use is considered equal to the level of safety that applicants of genuinely novel foods must demonstrate, and that these levels of safety should both match the level of safety that is required per Article 7 of Regulation 178/2002/EC. Notificants and applicants must both demonstrate with absolute certainty the full-proof absence of “the risk to life or health identified and the type of scientific information needed to clarify the scientific uncertainty.” [ii]

It is claimed that, compared to the existing Novel Foods Regulation, the new Regulation will enable European citizens to enjoy a broader choice of food. Indeed, the procedures that must be followed by notificants and applicants may be simpler than the one laid down in the 1997 Regulation. But the criteria that will or may be applied as of January 2018 are not in any way simpler or “lighter” than the straightforward one that has been applied since 1997: novel foods “must not present a danger for the consumer.”

In spite of the praise sung by the co-legislators regarding their political agreement on how to deal with novel foods, and notwithstanding the fireworks that will light the world’s skies tonight to celebrate the beginning of 2016, the application of the evil demon named Precautionary Principle and the unknown uncertainties that lie in wait in “any relevant provision under Union law” and “other legitimate factors” will determine the fate of novel foods.

Happy New Year !

Bert Schwitters

[i]Infant formulae and follow-on formulae were regulated in 1991 by Commission Directive 91/321/EEC of 14 May 1991, which provided that member States shall ensure that these products may be marketed within the Community only if they conform to the definitions and rules laid down in this Directive, and that no product other than infant formula may be marketed or otherwise represented as suitable for satisfying by itself the nutritional requirements of normal healthy infants during the first four to six months of life.
[ii] Article 7.2 of Regulation 178/2002/EC.

Health Claims Censored presents compelling arguments as to why the European Health Claims Regulation must be amended or destroyed. This system of controlling truthful speech is excessive, disproportionate and unprecedented.