Canada: Is Clinoptilolite Classed As A 'Novel Food'?

Last Updated: November 22 2016
Article by Ina Gerstberger

If the current novel food classification in the EU just depended on the name of a specific substance, the answer to this question would certainly be straightforward. But it is not the barely pronounceable name of this substance which is pivotal, but rather the question of whether consumers had already eaten it in sufficient amounts before May 1997. Plus, whether this substance would also fall within one of the categories expressly described in Article 1 (2) lit. c) to f) of the Regulation (EC) 258/97 on novel foods.

What is Clinoptilolite?

Clinoptilolite is a naturally occurring zeolite, formed by the devitrification (ie the conversion of glassy material to crystalline material) of volcanic ash in lake and marine waters millions of years ago. Clinoptilolite of sedimentary origin contains at least 80% hydrated calcium aluminosilicate and a maximum of 20% clay minerals. It is currently predominantly used in drinking water purification and as a binder, emulsifier or thickener in animal feed (additive), but what if it is marketed as a food supplement or other food product?

New novel food category

In contrast to the revised EU Novel Food Regulation 2015/2283, which introduces in its Art. 3 (2) lit. a) (iii) a new category of foods "consisting of, isolated from or produced from material of mineral origin" the current four food categories of Regulation (EC) 258/97 lack any such similar reference. This would normally mean that Clinoptilolite can be used in foods without the need of any prior authorisation according to Regulation (EC) 258/97, at least until 01 January 2018, and provided it is safe (cf. Art. 14 Regulation (EC) 178/2002). After that date the respective, then "new", novel food product may only continue to be marketed following a (finally successful) application for authorisation, as novel food which has to be submitted at the latest until 2 January 2020. That is the theory, but the practice currently looks a bit different.

The background of the case

In the southern part of Germany there were strong doubts on the marketability of Clinoptilolite in or as a foodstuff. The municipality of Aschaffenburg eventually prohibited a company from marketing  a food product consisting solely of powdered Clinoptilolite as unauthorised novel food. The company concerned brought an action for the annulment of that decision before the Bavarian Administrative Court Würzburg. Although it conceded that Clinoptilolite had not been used for human consumption "to a significant degree" in the EU before 15 May 1997, it argued that the ingredient could not be categorised as "novel" because it did not fall under any of the food categories defined in Art. 1 (2) lit. c) to f) of Regulation (EC) 258/97. In particular Clinoptilolite did not have a "new primary molecular structure" within the meaning of that provision, since that ingredient was present in nature before 15 May 1997 with the same molecular structure as that used for the respective product.

The national decisions

By judgment of 23 April 2014 the Bavarian Administrative Court Würzburg dismissed the company´s action on the ground that, for the purposes of the application of Article 1(2) lit. c) of Regulation (EC) 258/97, it was immaterial that Clinoptilolite existed in nature before 15 May 1997 with a similar molecular structure to that used for the preparation of the product in dispute, since it had been shown that the ingredient was not at that time consumed as a food. The Higher Administrative Court of Bavaria to which the company appealed against that judgment, however entertains reasonable doubts as to the interpretation of Article 1(2) lit. c) Regulation (EC) 258/97. It decided to stay the proceedings and to refer the following questions to the Court of Justice of the European Union (CJEU) for a preliminary ruling:

  • Is the product marketed by the appellant as a food or food ingredient with a new molecular structure within the meaning of Article 1(2) lit. c) Regulation No 258/97?
  • In particular, does it suffice, in order to be able to answer this question in the affirmative, that that product, which contains the substance Clinoptilolite in its particular primary molecular structure, was not yet being used as a food prior to 15 May 1997? Or is it also necessary that the product is produced by means of a production process which results in a new or intentionally modified molecular structure, therefore, it must be a substance which did not previously exist in nature in that form?

The CJEU judgement

The CJEU held the view, in its recently published judgment of 09 November 2016 (Case C‑448/14), that the expression "new primary molecular structure" would necessarily have to cover foods or food ingredients which were not used for human consumption in the EU before 15 May 1997. Only that interpretation would make it possible to ensure the effective protection of public health against potential risks produced by novel foods and food ingredients.  A single safety assessment will be required whenever a substance which has not hitherto been consumed by man as a food is proposed for human consumption.

Conversely, the CJEU argued that, if the concept of foods or food ingredients with a "new primary molecular structure" covered only substances which did not exist in nature with the same primary molecular structure before 15 May 1997, any substance existing on that date which has not yet been used for human consumption and does not fall within any of the specific categories in Article 1(2) d) to f) of Regulation No 258/97 would be automatically exempted from the safety assessment laid down by that regulation before being put on the market in the EU, without it being possible to evaluate the possibility of a risk to health.

Analysis  

The CJEU is wrong in its wide interpretation of the respective food category. The current novel food definition is based on two requirements which shall complement and not substitute each other so that the food category requirement would become legally meaningless. If the term "new primary molecular structure" were interpreted in a way of "newly used in human food" it would have the same meaning than the negatively worded requirement "not been used for human consumption to a significant degree before 15 May 1997". Given the original purpose of Regulation (EC) 258/97 in establishing an authorisation requirement primarily for biotechnologically and genetically modified foodstuffs, the technical aspect may not be left aside here when it comes to the interpretation of the wording "new primary molecular structure".

Such food must necessarily be man-made newly created or modified – but not only existing in nature – in order to guarantee the "practical effect" of the respective food category. It would also not have made much sense for the EU legislator in creating the new food category of "material of mineral origin" if the same would already be covered by any other existing food category. The respective food category should have also been interpreted more strictly given that any non-compliance may also be subject to criminal sanctions under the national law of the EU member states legislation.

Final thoughts

Interestingly, such mere formal considerations on the legally incorrect classification of Clinoptilolite as "novel food" were already ignored in the past when another company applied for a novel food authorisation for this substance with the UK Food Standards Agency (FSA) - Advisory Committee on Novel Foods and Processes (ACNFP) on 05 January 2004. As a general rule, once an application for authorisation is made, the novelty is assumed irrespective of the food is formally or factually novel.

The Clinoptilolite application was eventually rejected on 03 September 2008 when the ACNFP came to the conclusion that the application did not meet the criteria for authorisation pursuant to Art. 3 (1) Regulation (EC) 258/97. The safety data provided for the approval of Clinoptilolite as a novel food ingredient were considered "inadequate" by that time. The former applicant would have had to provide additional data to address the concerns by the ACNFP Committee and to reassure the safety of Clinoptilolite which he did not.  

Due to its structural properties Clinoptilolite is discussed as a detoxifier for heavy metals, pesticides and other toxins which would open an alternative route for its future marketing should the novel food classification turn out to be a dead end. A substance which primarily does not supply nutrients but rather absorbs substances may rather classify as a medical device (provided it also serves a medical purpose) than as a foodstuff. So there is still hope that products containing this substance may legally survive even doubtful interpretation decisions by the CJEU.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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