Australia: Case law: Interpreting ‘health claims’ and ‘reduction of disease risk claims’ at the ECJ

Summary

The case law of the ECJ shows that the definitions of 'health claim' and 'reduction of disease risk claim' should be interpreted broadly. Even general descriptions such as 'easily digestible' can, under certain circumstances, be considered a health claim within the meaning of the Claims Regulation.

In addition, a claim does not have to explicitly state that a food product 'significantly' reduces a disease risk to be considered a 'reduction of disease risk claim' under the Claims Regulation.

Health claims and 'reduction of disease risk claims' may only be made if they comply with the requirements set out in the Claims Regulation, if they are authorised in accordance with the provisions of the Claims Regulation and if they are included in the relevant community list of permitted claims.

The rulings (issued on September 6, 2012 and July 18, 2013) relate to European Regulation 1924/2006 on nutrition and health claims made on foods – the Claims Regulation.

The Claims Regulation

The Claims Regulation aims to protect consumers against misleading nutrition and health claims made on foods and to enable consumers to choose their food products on the basis of correct information. It applies to all commercial expressions (such as labelling and advertising) in relation to (pre-packaged) foods supplied to consumers, restaurants, hospitals, schools, canteens, etc. It also applies to any message or information (including illustrations and graphics) voluntarily applied to food products which suggests specific characteristics of a food product. This can take the form of either health claims or claims about the nutritional values of a food product. These claims can only be made if they comply with the requirements set out in the Claims Regulation, if they are authorised in accordance with the provisions of the Claims Regulation and if they are included in the relevant community list of permitted claims.

Deutsches Weintor ruling

Deutsches Weintor ruling
Case C-544/10
September 6, 2012

The ruling of September 6, 2012 relates to a German winegrowers' cooperative named Deutsches Weintor, which markets wines under the description Edition Mild (mild edition) accompanied by a reference to 'gentle acidity'. The labels on the necks of the bottles include the statement that the wines are easily digestible.

The claim

The question was whether these statements made about the wines constitute health claims within the meaning of the Claims Regulation.

The question was whether these statements made about the wines constitute health claims within the meaning of the Claims Regulation.

Deutsches Weintor argued that the description 'easily digestible' does not refer to health but only to general well-being. It stated that the Claims Regulation does not apply to descriptions traditionally used for foods or beverages and which could imply an effect on general well-being, such as 'digestive' for a beverage which aids digestion. In its view, health claims should therefore be given a narrow construction, limited to the long-term effects produced by the foodstuff in question.

The ruling

The ECJ ruled that the starting point for the definition of a 'health claim' within the meaning of the Claims Regulation is the relationship that must exist between a food or one of its constituents and health. The concept of a 'health claim' does not only cover a relationship implying an improvement in health as a result of the consumption of a food, but also any relationship which implies the absence or reduction of effects that are adverse or harmful to health and which would otherwise accompany or follow such consumption. The description on Deutsches Weintor's product suggests that the wine is readily absorbed and digested and implies that the digestive system will remain relatively healthy and intact even after repeated consumption, because of the reduced acidity of the product. Consequently, the claim might suggest a sustained beneficial physiological effect consisting in the preservation of a healthy digestive system, contrary to other wines, which are presumed to result in sustained adverse effects on the digestive system and, consequently, on health.

On this basis the ECJ ruled that the words 'easily digestible', combined with the reference to a reduced acidity, constitute a health claim within the meaning of the Claims Regulation.

Green-Swan Pharmaceuticals ruling

Green-Swan Pharmaceuticals ruling
Case C-299/12
July 18, 2013

The ruling of July 18, 2013 relates to a 'reduction of disease risk claim', which is a specific type of health claim. A 'reduction of disease risk claim' is defined in the Claims Regulation as 'any health claim that states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease'.

The claim

The Inspectorate of the State Agricultural and Food Inspection Authority of the Czech Republic decided that Green-Swan had made health claims on the packaging of food supplement GS Merilin, which infringed article 10, section 1 of the claims regulation and which, under Czech law, was an administrative offence.

The Inspectorate ordered Green- Swan to pay a fine of CZK200,000 (approximately €7,300). Green-Swan brought proceedings against this decision before the Czech courts. Amongst others, they argued that the communication on the packaging of the food supplement could not be considered as a 'reduction of disease risk claim' within the meaning of the claims regulation, as it does not state that it 'significantly' reduces a risk factor.

During the procedure before the highest Czech administrative court, the ECJ was asked to answer the question whether a health claim must expressly state that the consumption of a category of food, a food or one of its constituents 'significantly' reduces a risk factor in the development of a human disease to be considered a 'reduction of disease risk claim'.

The ruling

As a preliminary point, the ECJ referred to the Deutsches Weintor case and repeated that the starting point for the definition of a 'health claim' within the meaning of the Claims Regulation is the relationship that must exist between a food or one of its constituents and health. That definition provides no information as to whether that relationship must be direct or indirect, or as to its intensity or duration, so the term 'relationship' must be understood in a broad sense.

The ECJ also noted that the definition of a 'reduction of disease risk claim' includes the verbs 'suggests or implies' and that this means it is sufficient that a claim may give the average consumer who is reasonably well informed and reasonably observant and circumspect the impression that the reduction of a risk factor is significant.

On that basis, the ECJ ruled that the use of a categorical expression according to which the consumption of the food concerned reduces – or helps reduce –a risk factor is liable to give that consumer the impression of a significant reduction of that risk and therefore, in order to be considered a 'reduction of disease risk claim', a health claim need not necessarily contain the word 'significantly' or a term having the same meaning.

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