Case C-448/14, Davitas – is a mineral-based detox a novel food? [judgment 2016, ECLI:EU:C:2016:839]

Micro-porous minerals have many industrial and agricultural applications in the sifting or storing of liquids or gases, or indeed the exchange of ions. However, one such mineral has now been milled and ground into a foodstuff for humans. Does that make it a ‘novel food’ for the purposes of the EU’s ‘novel foods and novel food ingredients’ Regulation (EC) No 258/97?

Facts
Davitas distributed a ‘detox’ product whose sole ingredient was Clinoptilolite, a type of micro-porous mineral known as a zeolite.

Davitas was forced to stop distribution of this product in 2013 when it was banned by the relevant food safety body in the German state of Bayern.

The reason for the ban was that Clinoptilolite was an ingredient that had not been widely consumed in Germany prior to 1997 (the relevant time for EU foodstuff law). Consequently, the German food-safety body took the view that for regulatory purposes, Davitas’ product had to be deemed a ‘novel’ food, with ‘a novel food ingredient’.

The 2013 ban on Davitas’ product led to repeated bouts of litigation. The matter ended up at Bayern’s administrative court, the Bayerischer Verwaltungsgerichtshof. The salient legal question was whether the product should be described as a novel food.

The German court took as its starting point the EU’s Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ [1997] L43).

Article 1(2) of the Regulation provides:

This Regulation shall apply to the placing on the market within the Community of foods and food ingredients which have not hitherto been used for human consumption to a significant degree within the Community and which fall under the following categories:
(a) foods and food ingredients containing or consisting of genetically modified organisms within the meaning of Directive 90/220/EEC;
(b) foods and food ingredients produced from, but not containing, genetically modified organisms;
(c) foods and food ingredients with a new or intentionally modified primary molecular structure;
…

The German court noted Davitas’s argument, which was that the ban was incorrect because its food product or food ingredient did not have a new or intentionally modified molecular structure. There were three main reasons for that submission.

First, Recital 5 made it quite plain that the EU Regulation was a legislative response to genetically modified organisms. Consequently, substances which already existed in nature prior to the Regulation could not fall within its scope.

Second, Clinoptilolite was already being used in animal food. The fact that it was now being used as human food could not make that ingredient qualify as a new ingredient or a new food. If a new use meant that an ingredient or food would be defined as “new”, then that would be such a disproportionate interpretation of the law that it would infringe the EU’s legal principle of proportionality.

Third, the primary molecular structure of Clinoptilolite was neither new nor had it been modified. Of course, the mineral rock had been ground and milled but this ancient technical process had not changed the molecular structure of Clinoptilolite.

On hearing this argument, the German court recorded the view of the food safety authority. It had submitted that technical processes which produced new, and for humans potentially harmful foodstuffs, should not be shielded from safety-checks. The German court also noted that Davitas and the court itself were in favour of asking questions of the CJEU, notwithstanding the baseless objections of the Bayern state food safety body. Consequently, the Bayerischer Verwaltungsgerichtshof decided to make a reference to the CJEU.

Questions Referred
My unofficial translation of the questions asked by the Bayerischer Verwaltungsgerichtshof reads:

1. Does the product distributed by the claimant constitute a food or a food ingredient with a new molecular structure within the meaning of Article 1(2)(c) of Regulation (EC) No 258/97?

2. For the purposes of answering this question in the affirmative, will it suffice in particular that this product, whose ingredient Clinoptilolite, in its defined primary molecular structure, was not used as food before 15 May 1997; or is a further requirement that this product be produced by means of a process that leads to a new or intentionally modified molecular structure – in other words, that this concerns a substance which did not exist in nature prior to that date?