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Will EU Nutrition and Health Claims Regulation Ever Be Clear Enough?

Date: Mar 24, 2020

Once again the Court of Justice of the European Union (CJEU) has moved to clarify the rules applicable to health claims.

Recently, the CJEU had the opportunity to further clarify the provisions of Regulation (EC) n°1924/2006 on Nutrition and Health Claims made on foods (the NHC Regulation), in particular the requirements applicable to health claims.

Under the NHC Regulation, health claims are defined as “any [message or representation, which is not mandatory under EU or national legislation, including pictorial, graphic or symbolic representation, in any form], which states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health[1]

The NHC Regulation distinguishes between different types of health claims. These fall into three categories:

1. First of all,  the ‘Function Health Claims’ (Article 13) referring to the role of a nutrient in the growth, development and functions of the body, to psychological and behavioral functions or to slimming or weight-control. An example of this is the claim “Activated charcoal contributes to reducing excessive flatulence after eating”(article 13).

2. Secondly the ‘Risk Reduction Claims’ (Article 14(1)(a)) referring to the reduction of a risk factor in the development of a disease. “Chewing gum sweetened with 100% xylitol has been shown to reduce dental plaque. High content/level of dental plaque is a risk factor in the development of caries in children” is a claim that would fall in this category (article 14 (1) (a)).

3 Finally, the regulation considers ‘Claims Referring to Children’s Development’[2] , such as “Calcium is needed for normal growth and development of bone in children.” (article 14 (1) (b))

Health claims cannot be used unless authorized[3] by the European Commission following a scientific review by the European Food Safety Authority (EFSA). Depending on the types of health claims, different procedures must be followed but generally the approval of a new health claim is both costly[4] and  long, with an average of 2.5 years for the approval.

Health Claim Applications and Risk of Rejection

Regarding the first category of health claims, after several years of work and hundreds of claims assessments by EFSA, the European Commission published in 2012 a first list of health claims which can be made on foods in compliance with the conditions set out in the annex of the regulation[5]. Today, more than 260 health claims are authorized under EU law.

But unfortunately for the FBOs most of the specific dossiers under article 14 are rejected.

Even under article 13 a bad surprise can happen at the very end of the procedure as it happened to Dextro  Energy 2011, when requesting authorization to use several health claims in relation to glucose and its effect on health.[6] In this instance, EFSA gave positive advice considering that a cause-and-effect link could be established between the consumption of glucose and normal energy-yielding metabolism. However, the European Commission did not approve the claims, in particular because “the use of such a health claim would convey a conflicting and confusing message to consumers, because it would encourage consumption of sugars for which, on the basis of generally accepted scientific advice, national and international authorities inform the consumer that their intake should be reduced.”[7] The Court considered that the European Commission must, as a risk-management measure, take into account the applicable EU legislation as well as other legitimate and relevant factors, and confirmed that the European Commission may refuse to approve health claims, even after a  positive scientific assessment[8].

A (Small) Margin to Manoeuvre

In addition to those specifically authorized health claims, the NHC Regulation leaves a (small) margin to manoeuvre for food business operators wishing to present their products positively.

This is for instance the case for trademarks and other brand names already existing before 1 January 2005 and which may be construed as nutrition or health claims. In principle, the NHC Regulation applies to those trademarks and brand names and provides severe restrictions to the use thereof. However, a specific transition period is foreseen under Article 28 of the Regulation. Products bearing trademarks or brand names existing before 1 January 2005 which do not comply with the NHC Regulation may continue to be marketed until 19 January 2022. After that date, they may only be marketed if they fully comply with the NHC Regulation.

Secondly, the NHC Regulation provides for the possibility to make general health claims that refer to a general benefit of a nutrient or food for overall good health or health-related well-being. Under Article 10(3) of the NHC Regulation such general health claims may be made provided that they are accompanied by a specific authorized health claim.

The NHC Regulation allows the use of easy and attractive statements which make reference to general benefits. However, such statements could be misunderstood or misinterpreted by consumers hence the Commission clarified in its Decision 2013/63/EU[9] that the specific authorized health claim accompanying the general health claim should bear some relevance to the general reference and be made ‘next to’ or ‘following’ such statement. In this regard, the Court of Justice recently had the opportunity to clarify the meaning of “accompanied”.

In Case C-524/18 Dr. Willmar Schwabe GmbH & Co. KG v Queisser Pharma GmbH & Co. KG[10], a general health claim appeared on the front of the outer packaging. The accompanying specific authorized health appeared only on the back of that packaging, and without a clear reference, such as an asterisk, between the two.

In the present case, the outer package of a food supplement featured in front of the outer packing general claims such as “B vitamins and zinc for the brain, nerves, concentration and memory” while the back of the outer packaging featured several specific health claims such as “Vitamin B1 and vitamin B12 contribute to normal energy metabolism and normal function of the nervous system as well as supporting normal mental capacity.” The Court was asked to clarify if this packaging meets the requirements of Article 10(3) of the NHC Regulation.

The Court concluded that “the requirement of ‘accompanying’, within the meaning of Article 10(3) of that regulation, must be interpreted as requiring not only that the specific health claim should specify the content of the health claim worded in general terms, but also that the location of those two claims on the packaging of the product must enable an average consumer who is reasonably well informed and reasonably attentive and circumspect to understand the link between those claims. Accordingly, the concept of ‘accompanying’ within the meaning of that article, must be interpreted as including both a substantive and a visual dimension.”

Unlike, the position of the Advocate-General Hogan[11], the Court adopted a stricter approach and concluded that ‘accompanied’ encompasses both a substantive dimension and a visual dimension. The substantive dimension means that the general claim must be fully supported by the specific health claim.The visual dimension means that there should be an immediate perception by the average consumer of a direct visual link between the specific health claim and the general health claim.

Only in exceptional cases, it may be possible for the general health claim not to appear in spatial proximity or immediate vicinity of the specific health claim, provided that an explicit reference, such as an asterisk ensures in a “manner that is clear and perfectly comprehensible to the consumer, that, in spatial terms, the content of the health claims and the reference match”. The Court concluded that  “it is therefore for the national courts to verify and determine, in the light of all the circumstances of the case, whether the requirement of visual proximity arising from Article 10(3) of Regulation No 1924/2006 is satisfied by the use of a linking asterisk.”

In the coming months, the Court of Justice will have another opportunity to clarify the provisions of the NHC Regulation by answering the following: “Do Articles 5 and 6, read in conjunction with Articles 10(1) and 28(5) of Regulation No 1924/2006, regulate the burden of proof when a national court is determining whether unpermitted health claims have been made in a situation where the health claims in question correspond to a claim covered by an application under Article 13(2) of Regulation No 1924/2006, but where the application has not yet led to a decision on authorisation or non-authorisation, or is the burden of proof determined according to national law?[12]

This Case law will be a good opportunity to discuss another burning point of the NHC Regulation, what about the hundreds of claims that have been put on hold and in particular the health claims for plant and herbal substances.

This article was first published by FOODNavigator.com on March 24, 2020.
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[1] Article 2(2)(1) and 2(2)(5) of the NHCR read together

[2] E.g. “Calcium is needed for normal growth and development of bone in children.”

[3] Article 10 of the NHC Regulation

[4] The average cost per applicant has been evaluated by the European Commission to range between 0,008/0,2 to 1 million euros. See Commission Staff Working Document - Refit Evaluation of the General Food law (Regulation (EC) No 178/2002), SWD(2018) 38 final.  

[5] Commission Regulation (EU) No 432/2012 of 16 May 2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02012R0432-20170822

[6] E.g. ‘glucose is metabolised within the body’s normal energy metabolism’, ‘glucose contributes to normal energy-yielding metabolism’, ‘glucose supports physical activity’, ‘glucose contributes to normal energy-yielding metabolism during exercise’ and ‘glucose contributes to normal muscle function during exercise’

[7] Commission Regulation (EU) 2015/8 of 6 January 2015 refusing to authorise certain health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health Text with EEA relevance, OJ L 3, 7.1.2015, p. 6–9 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:JOL_2015_003_R_0003

[8] See Case T-100/15, Dextro Energy GmbH & Co. KG v European Commission, ECLI:EU:T:2016:150 and the dismissed appeal C-296/16 P - Dextro Energy v Commission, ECLI:EU:C:2017:437

[9] 2013/63/EU: Commission Implementing Decision of 24 January 2013 adopting guidelines for the implementation of specific conditions for health claims laid down in Article 10 of Regulation (EC) No 1924/2006 of the European Parliament and of the Council Text with EEA relevance, OJ L 22, 25.1.2013, p. 25–28 https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32013D0063

[11] Opinion of Advocate General Hogan delivered on 12 September 2019, Dr. Willmar Schwabe GmbH & Co.KG v Queisser Pharma GmbH & Co. KG., ECLI identifier: ECLI:EU:C:2019:727, see notbaly paragraphs 65 and 66:

In my opinion, the criteria considered in this case-law may be applied by analogy to the present case, so that it may be expected that a consumer reading a general health statement on the front of the packaging of a food product will also consult the further information provided on the back of the packaging, which in addition to a list of ingredients may also include a set of specific health claims that are meant to support the general health claim.

Thus, in my opinion, it cannot be a general requirement that a specific linking tool, such as the use of an asterisk, be deployed in order to guide the consumer from the front to the back of the packaging. However, the situation becomes more complex where the information on the back of the packaging contains a mix of statements, of which only some serve to support the general health claim on the front of the package, as referred to by the Applicant and the Commission.” http://curia.europa.eu/juris/document/document.jsf?text=&docid=217675&pageIndex=0&doclang=en&mode=lst&dir=&occ=first&part=1&cid=7102890

[12] Case C-363/19, Konsumentombudsmannen, Application: OJ C 246 from 22.07.2019, p.11