Amino acids in food supplements – CJEU indicates boundaries of what an effective application of the precautionary principle requires
On 19 January 2017, the Court of Justice of the European Union issued a judgment upon request of the Administrative Court of Brunswick for a preliminary ruling under Article 267 TFEU, made by decision of 27 May 2015.
The request concerned the interpretation of Regulation (EC) No 178/2002 laying down the general principles and requirements of food law, Regulation 1925/2006 on the addition of vitamins and minerals and of certain other substances to food and Articles 34 to 36 TFEU.
The question arose in the context of a dispute between Queisser Pharma GmbH & Co. KG ("Queisser Pharma") and the Bundesrepublik Deutschland (the "Federal Republic of Germany"), relating to an application for derogation from the prohibition on the manufacture and marketing of a food supplement containing an amino acid (L-histidine).
Background of the case
Queisser Pharma manufactures a food supplement called "Doppelherz aktiv + Iron + Vitamin C + Histidine + Folic Acid", containing among other ingredients the amino acid L-histidine and iron.
Under § 6 (1)(a) of the German Act on Food and Feed, it is prohibited to use non-approved food additives, whereas the law further provides that amino acids and their derivatives are equally treated like food additives. This equality had been introduced by the German legislator already in the 1970s in order prevent amino acid imbalances, especially in infants and young children. Thus, in absence of a law or decree expressly approving amino acids, their use as food additives is generally prohibited in Germany. The only way to overcome this prohibition is to apply for, and be granted, a derogation by the German authorities in accordance with § 68 LFGB. Under this provision, derogations from the requirements of the LFGB can be issued for a limited period of time, i.e. for a maximum of three years with further extensions being possible.
In the light of these provisions, in March 2006 Queisser Pharma submitted to the Federal Office for Consumer Protection and Food Safety (the "Office") an application for derogation under § 68 LFGB to manufacture and market that product as a food supplement in the territory of the Federal Republic of Germany.
In November 2012, the Office rejected the application, stating that the conditions provided under § 68 LFGB were not met, since there were doubts on the safety of the product because of its iron content.
Following the rejection, Queisser Pharma brought an action before the Administrative Court of Brunswick, seeking a decision establishing that derogation under § 68 LFGB was not necessary to manufacture and market the product at issue. In February 2015, during the proceedings before the referring Court, the Office withdrew its decision and granted to Queisser Pharma the derogation under § 68 of the LFGB for a period of three years, recognising that the iron contained in the product was not to be considered when assessing the requirements of a derogation.
Queisser Pharma, in order to obtain a declaration that it was not necessary to request a derogation under § 68 LFGB at all, maintained the action before the referring Court.
Questions referred to the Court
The Court, unsure about the conformity of national legislation with Regulation No 178/2002 and Regulation No 1925/2006, decided to stay the proceeding and refer to the Court a request of preliminary ruling. In particular, the referring Court inquired whether Article 6, 7, 14, 53 and 55 of Regulation 178/2002, Article 8 of Regulation 1925/2006 and Articles 34 and 36 TFEU shall be interpreted as precluding national statutory provisions which prohibit the manufacture or processing and/or marketing of a food supplement with amino acids, unless a temporary derogation has been issued, for a specific period, by a national authority with discretion in that respect.
Findings of the Court
The Court of Justice preliminary observed that when enacting national legislation concerning food safety, Member States are not completely free, as they must comply with the general principles set forth in Regulation 178/2002, and namely with the principle of risk analysis and the precautionary principle. It follows that national measures introducing restriction to the production and marketing of foods are admissible only insofar that they are non-discriminatory and objective in the light of the mentioned principles.
Although the Court recognises that a Member State may, in accordance with the precautionary principle, adopt protective measures without having to wait until the reality and seriousness of those risks are fully demonstrated, it also states that the risk assessment may not be based on purely hypothetical considerations.
According to the Court, these conditions apparently are not met by the LFGB that prohibits the use of all amino acids and their derivatives, without distinguishing possible categories or types of substances, and clearly identifying the common elements or characteristics of the substances concerned. In the case at issue, the risk analysis and the resulting application of the precautionary principle appear to concern only certain amino acids, and it is therefore insufficient to justify a prior authorisation scheme as the one set forth in LFGB, which applies without distinction to all amino acids.
Finally the Court dispraises the system of derogation set forth in § 68 of the LFGB that – providing derogations from the prohibition are granted for a maximum period of three years, renewable three times only each time for a maximum period of three years – appears to be a disproportionate measure when it is established that the substance is safe.
In the case at issue the Court of Justice provides a new ruling on the conditions of legitimacy of premarket approval schemes under the European Food Legislation. This decision is consistent with the principles set forth in the Commission v. France case (C-333/08), where the Court ruled on the premarket approval scheme for processing aids required under French law.
Premarket approval is a common scheme provided by both the European and national legislations where there is scientific uncertainty regarding the safety of specific substances or products. It applies in particular to substances deemed "a priori" hazardous, or which are potentially hazardous at a certain level of absorption. Under the European law, premarket approval is required for a number of substances (e.g. additives, enzymes and flavourings) and for any food not used for human consumption to a significant degree within the Union before 15 May 1997 (i.e. novel food).
The aim of premarket approval schemes is to allow the competent Authority – which could be the European Food Safety Authority or a the Member State Authority designed to assess the safety of food – to verify if the product/substance poses a risk to human health.
The precautionary principle constitutes, at the same time, the foundation and limit of prior approval schemes that can be applied if and for as long as scientific uncertainty persists. It follows that – as clearly stated by the Court in the case at issue – it is incompatible with the precautionary principle as set forth in Article 7 of Reg. 178/2002 to require scientific proof of safety in situations where a safety risk does not exists because it has already been established that the substance is safe.
To be or not to be novel - CJEU clarifies the conditions under which naturally occurring substances qualify as novel food ingredients
In a judgment issued on 9 November 2016, the European Court of Justice has clarified the interpretation to be given to the expression "new primary molecular structure", used in the definition of "novel food" and "novel ingredient", as currently laid down in Regulation (EC) No 258/97 (the "Novel Food Regulation"). The Court confirmed that the expression relates to foods or food ingredients which were not used for human consumption in the territory of the European Union before 15 May 1997 –an interpretation that is in line with the wording of the impending new regulation on novel food, which will enter into force on 1st January 2018.
Background of the case
The facts that gave rise to the case relate to a food product named "De Tox Forte", of which the sole ingredient was a mineral substance of volcanic origin (clinoptilolite), commercialised in Germany by a company named Davitas. Following the results of a sample analysis performed by the Office of the State of Bavaria for Health and Food Safety, ordered by the municipality of Aschaffenburg, an expert report issued in March 2013 found that clinoptilolite should be regarded as a novel food ingredient, as no evidence had been produced of significant consumption of that ingredient within the EU before 15 May 1997.
As a result, the municipality prohibited Davitas from marketing its product until the grant of an authorisation to place it on the market pursuant to the provisions of the Novel Food Regulation.
The company challenged the decision of the municipality before the Bavarian Administrative Court, claiming that clinoptilolite did not have a "new primary molecular structure" within the meaning of indent (c) of Article 1(2) of the Novel Food Regulation, since clinoptilolite was present in nature before 15 May 1997 with the same molecular structure as that used for the preparation of the product Davitas marketed in Germany. Davitas thus claimed that clinoptilolite did not qualify as a novel food ingredient.
The first jurisdiction dismissed the action and the case was appealed by Davitas before the Higher Administrative Court of Bavaria.
Questions referred to the Court
The Higher Court decided to stay the proceedings and to refer questions to the Court of Justice for a preliminary ruling that pertained to determining whether, in order to fulfil the condition that a particular food or ingredient has a new molecular structure within the meaning of Article 1(2)(c) of Regulation No 258/97, it suffices that the product at stake was not yet being used as a food prior to 15 May 1997, or it is also necessary that that product is produced by means of a production process which results in a new or intentionally modified molecular structure. In essence, the Court asked whether the substance must be a substance which did not previously exist in nature in the form under which it is marketed.
Findings of the Court
The Court first recalls in its judgment that in order to be categorised as novel under the Novel Food Regulation, a given product or ingredient must satisfy two cumulative conditions: (i) not having been subject to significant human consumption within the European Union before 15 May 1997 and (ii) falling within one of the categories expressly described in Article 1(2), (c) to (f) of the Novel Food Regulation. All substances that fulfil those two conditions qualify as novel food and must be authorised before being allowed on the EU market.
The questions referred to the Court related in particular to the category defined in Article 1(2)(c) of the Novel Food Regulation. The difficulty in the interpretation of that provision resided in the fact that the Novel Food Regulation does not define the terms nor specifies whether the category in Article 1(2)(c) includes foods or food ingredients which were not used for human consumption in the EU before 15 May 1997, or whether it only covers foods or food ingredients whose primary molecular structure was created ex novo or modified compared to that already existing in nature before that date. In line with settled case law, the Court applied the rule of interpretation whereby the meaning and scope of terms is determined (i) by reference to their usual meaning in everyday language and (ii) taking account of the context in which they occur and the purposes of the rules they relate to.
In line with Advocate General Szpunar's opinion, the Court considered that the only interpretation that is compatible with the context of the regulation is the interpretation according to which the expression "new primary molecular structure" relates to foods or food ingredients not used for human consumption in the EU before 15 May 1997.
Further to this, the Court recalled that besides ensuring the functioning of the internal market in novel foods, the regulation pursues an objective of protection of public health against the risks to which novel food may give rise, and organises to that purpose a single safety assessment of those foods and food ingredients through a Community procedure before they are placed on the EU market. The Court held that achieving this objective is only possible if the expression "new primary molecular structure" used in Article 1(2)(c) of the Novel Food Regulation is interpreted as capturing all foods or food ingredients which were not used for human consumption in the EU before 15 May 1997. Otherwise, all substances existing on 15 May 1997, even if they have not been used for human consumption, would be exempt of safety assessment under the Novel Food Regulation. The possible risk to health posed by such substances would as a consequence not be evaluated.
Based on these considerations, the Court concluded that Article 1(2)(c) of Regulation No 258/97 must be interpreted as meaning that the expression "new primary molecular structure" relates to foods or food ingredients which were not used for human consumption in the territory of the EU before 15 May 1997.
The judgment gives a clear answer as to the way the expression "new primary molecular structure" must be interpreted, and illustrates the fact that one of the fundamental objectives of European food law, notably enshrined in the General Food Law Regulation No 178/2002, is the protection of public health. In its judgment, the Court indeed provides for an interpretation that is oriented towards that objective.
The Novel Food Regulation will be repealed as of 1st January 2018, and be replaced by a new regulation.
Interestingly, the new regulation specifies, in respect of the category at stake in case C-448/14, that the regulation applies to food with a new or intentionally modified molecular structure "where that structure was not used as, or in, a food within the Union before 15 May 1997". This new provision leaves thus no more doubt as to the fact that the category "food and food ingredients with a new molecular structure" is intended to apply to the substances that were not used as food or as food ingredient in the EU before 15 May 1997. Furthermore, the new regulation also further defines new categories of novel food, among which a separate category for "food consisting of, isolated from or produced from material of mineral origin". This new category includes clinoptilolite beyond doubt, which did not exist at the time the product was marketed for the first time.