Health claims on botanicals, the Court of Justice provides clarity

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On 10.9.20, the EU Court of Justice finally clarified how to apply the Nutrition and Health Claims regulation on botanicals. The use of health claims-in labels and advertisements for foods and supplements that contain botanicals and their extracts (so-called botanicals)-can come based on different levels of scientific evidence. Without demanding onerous double-placebo scientific studies on healthy individuals, as suggested so far by the European Commission.

Health claims on botanicals, the controversy

The Intellectual Property and Trade Court has been asked to rule on the legality of certain health claims (relating to ginger, rose hip, boswellia, artichoke, dandelion, and blueberry) on the labels of natural food supplements produced by the company Mezina AB. Following appeal from the Consumer Protection Ombudsman in Sweden (Konsumentombudsmannen, KO).

Therefore, the Swedish court referred a question to the European Court of Justice (ECJ) for a preliminary ruling on the application of the NHC Regulation (in conjunction with Articles 3, 5, 28.5) and the Unfair Commercial Practices Directive (dir. 2005/29/EC) to health claims related to botanicals in food.

The interpretive question

The ECJ was asked to interpret the meaning of ‘generally accepted scientific evidence‘ on the basis of which, under Reg. EC 1924/06, must be based on the health claims offered in the marketing information of food and food supplements.

In fact, the European Commission has not to date ruled on applications for approval of more than 3,000 health claims on botanicals and some microorganisms. (2) Although he had to have done so by 1/31/10. (3) Instead, it suspended this procedure, in September 2010, following complaints (including by this writer) about the discrimination of food against traditional herbal medicines. (4)

Health claims, asymmetries in favor of Big Pharma

On 29.7.10, the European health products manufacturers association (Ehpm) had complained to the European Ombudsman about the Commission’s maladministration in handling health claims files related to botanicals.

Manufacturers of natural ingredients, medicinal herbs and their derivatives-represented also by the European Botanical Forum (EBF)-complained about the disparity of criteria adopted in assessing the scientific substantiation of identical health claims on the same substances, depending on the sectors:

Directive 2004/24/EC(Traditional Herbal MedicinalProducts, or Herbal Directive) had in fact introduced a simplified procedure, which allowed practitioners to register health claims on ‘traditional medicines’ with theEuropean Medicine Agency (EMA) with a minimum level of evidence,

– Regulation (EC) No. 1924/06as interpreted until then (and until the ECJ ruling under review) by the European Commission, instead prescribed an authorization based on even more stringent level of evidence than that established for conventional drugs (see next paragraph).

On 27.7.10, the European Commission withdrew from the litigation by asking EFSA to discontinue the evaluations and committing to ensure ‘consistent processing‘ of applications for authorization related to botanicals and microorganisms (probiotics). However, without resolving, to date, the unacceptable discrimination of functional foods against traditional medicines. (5)

The levels of scientific evidence so far prescribed for botanicals in foods.

Reg. EC 1924/06 requires that health claims on food products-subject to scientific evaluation by EFSA(European Food Safety Authority) and subsequent authorization by the European Commission-be based on ‘generally accepted scientific evidence‘ (Art. 6.1).

However, the Brussels executive demanded that the so-called. physiological claims, that is, those related to a food’s contribution to the body’s normal functions (Article 13), would be subjected to the same level of scientific proof established for claims related to the prevention of disease risk factors and child development (Article 14). Demanding in all cases that the applicant submit randomized double-blind versus placebo clinical trials on healthy individuals. (6) A novelty for the scientific community itself, since in many cases it is arduous (if not impossible) to assess the significance of changes in health levels in the context of homeostasis.

Court of Justice, the decision

The Court of Justice clarified how health claims-even in the case of a ‘transitional’ regime, such as the one that persists on botanicals-can legitimately be affixed ‘under the responsibility of food business operators.’ (EC Reg. 1924/06, Art. 28.5). Provided that they comply with the regulation itself-including the general requirements in Articles 3 and 5-and any applicable national provisions (7).

‘Health claims must be scientifically substantiated, taking into account the totality of available scientific data and evaluating the evidence.’

One must therefore refer toobjective and scientific elements.’ So that ‘the benefits of the substances to which these health claims relate enjoy, as stated in recital 14 of the 1924/2006, of sufficient scientific consensus.’ The NHC regulation, the Court points out, regulates neither the requirements types of evidence nor how they are to be collected. ‘Such matters remain subject to national law, subject to the application of the principles of equivalence and effectiveness.’ (7)

Application implications

The beneficial properties of herbs and medicinal plants can therefore be boasted on the basis of objective and scientifically agreed upon evidence, without claiming clinical trials. One can refer, among other things, to the valuable BelFrIt list, developed by the Italian Ministry of Health in agreement with those of France and Belgium, where the plant substances and preparations allowed in food supplements are listed. (8)


Last but not least.
, the Court of Justice ruled the inapplicability of the Unfair Commercial Practices Directive (dir. 2005/29/EC, implemented in Italy by the Consumer Code, Legislative Decree 206/05) to health claims, since they are regulated by specific sector legislation. (9)

Fiat justitia!

Dario Dongo

Notes

(1) ECJ(European Court of Justice) Judgment 10.9.20, Case C-363/19, Konsumentombudsmannen vs.
Mezina AB, at http://curia.europa.eu/juris/document/document.jsf?text=health%2Bclaims&docid=230863&pageIndex=0&doclang=IT&mode=req&dir=&occ=first&part=1&cid=6118350#ctx1
(2) The European Commission put the process of authorizing claims related to botanicals on standby back in 2010, excluding herbal preparations from the (paltry) list of 222 health claims subsequently authorized by reg. EU 432/12 V. EU register on health claims https://ec.europa.eu/food/safety/labelling_nutrition/claims/register/public/?event=search
(3) Regulation (EC) No. 1924/06, Article 13.5
(4) Dario Dongo’s complaints about the mismanagement of health claim authorization processes (2010, 2011), recalled in the articles https://ilfattoalimentare.it/qualche-interrogativo-sui-criteri-di-valutazione-dellefsa-per-le-diciture-sulle-etichette.html, https://ilfattoalimentare.it/indicazioni-salutistiche-in-etichetta-in-attesa-di-sintonia.html, https://ilfattoalimentare.it/per-le-diciture-salutistiche-sulle-etichette-la-commissione-ue-ascolta-lindustria-e-corregge-il-tiro.html
(5) European Commission. Questions and Answers on the list of permitted Health Claims. MEMO/11/868, 5.12.11, on.
https://ec.europa.eu/commission/presscorner/detail/en/MEMO_11_868
(6) The EC guidelines on the application of Reg. EC 1924/06 in fact report that ”classification has no impact on the level of substantiation required for authorization. The presentation and content of the scientific dossier are the same for both types of claims‘. V. ‘ Guidance on the implementation of Regulation (EC) N° 1924/2006 on nutrition and health claims made on foods conclusions of the Standing Committee on the food chain and animal health’ (2007), at https://ec.europa.eu/food/sites/food/files/safety/docs/labelling_nutrition_claim_reg-2006-124_guidance_en.pdf
(7) See ECJ judgment referred to in Note 1, paragraphs 45-54.
(8) Decree Min. Sal. 9.7.12. Regulation of the use in food supplements of herbal substances and preparations. In G.U. General Series 21.7.12, no. 169. https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2012-07-21&atto.codiceRedazionale=12A07895&elenco30giorni=false
(9) SEE https://www.foodagriculturerequirements.com/archivio-notizie/nutrition-health-claims-approfondimento-sul-decreto-sanzioni