E-commerce of dietary supplements: 'health claims' and 'botanicals'

Our industry has suffered the suspension, by Amazon, of the sale of a food supplement regularly notified to the Ministry of Health because the 'health claims' relating to the 'botanicals' it contains (saffron, griffonia) have not yet been authorised at a European level.

Thank you for your opinion on this matter.

[signed letter]

The lawyer Dario Dongo, Ph.D. in international food law, answers

Food supplements: Italian legislation and the inapplicability of Regulation (EC) No. 1924/06

Il Legislative Decree 21 May 2004 n. 169 (2) – implementing Directive 2002/46/EC for the approximation of the laws of the Member States relating to Dietary Supplements (3) – is distinguished by the prescription of the the obligation to indicate on the label:

• 'the nutritional or physiological effect attributed to the product on the basis of its constituents in a way that is suitable for correctly guiding consumer choices.' (Article 6.4.f).

The mandatory nature of such information excludes the applicability of the Nutrition and Health Claims Regulation (EC) No 1924/06, the scope of which is in fact precisely limited to voluntary nutritional and health claims. Article 2.2.1 of the NHCR in fact defines

• '"indication": any message or representation not required pursuant to Community or national legislation, including figurative, graphic or symbolic representations in any form, which states, suggests or implies that a food has particular characteristics'. (4)

'Health claims' relating to 'Botanicals', transitional regime

Without prejudice to the inapplicability of Regulation (EC) No. 1924/06 to the mandatory information prescribed on food supplements produced and marketed in Italy, it is worth remembering that the 'health claim' relating to herbal substances and preparations (so-called 'botanicals') are still subject to a transitional regime, after the European Commission on 27 July 2010 ordered the suspension of their scientific evaluation by EFSA.

La Court of Justice of the European Union (CJEU) The European Union (CJEU) – the only authority, together with the legislator, with the power to officially interpret EU law, binding on all European institutions and administrations and those of the Member States – has expressed itself on two occasions on this specific matter, clarifying that:

• health claims on botanicals subject to the transitional regime may legitimately be placed 'under the responsibility of economic operators in the food sector', provided that they comply with the regulation itself and with any applicable national provisions (5,6).

In this case, the indicazioni referring to saffron (Crocus sativus) and griffonia (Griffonia simplicifolia) are among those currently 'on hold'. The relevant indications are reported in the European Commission list with the following EFSA identification codes:

• ID 2038 – Crocus sativus L.: mental health – promotes good mood / improves mood;

• ID 2446 – Griffonia simplicifolia (Griffonia): nervous system function – improvement
  of the activity of the mind/brain.

Conclusions

In light of the above, the food supplement in question can be legitimately placed on sale both on the Italian market and in the Single Market, subject to the translation of its label into the official languages ​​of the countries of destination and possible notification to the respective health authorities where required by the national regulations implementing the directive.
2002/46 / EC.

Our team of FARE (Food and Agriculture Requirements) is available to operators who need support in activating the procedures aimed at ensuring the maintenance of their products on e-commerce platforms, in compliance with the legislation applicable in the various national markets.

Cordially

Dario Dongo

Photo by Diamond Rehab Thailand

Note

(1) Ministry of Health. National Register of Food Supplements – Updated March 1
2026. See page 945.
https://www.salute.gov.it/new/sites/default/files/INTEGRATORI_NOTIFICATI_ORD_AZ_8.pdf

(2) Legislative Decree 21 May 2004 n. 169. Implementation of Directive 2002/46/EC relating to
Food supplements. Legislation (last updated on July 6, 2007).
https://www.normattiva.it/uri-res/N2Ls?urn:nir:stato:decreto.legislativo:2004-05-21;1693

(3) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the
Approximation of the laws of the Member States relating to food supplements. Text
consolidated: 26/11/2025 http://data.europa.eu/eli/dir/2002/46/2025-11-26

(4) Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006
on nutrition and health claims made on foods. Consolidated text:
13/12/2014 http://data.europa.eu/eli/reg/2006/1924/2014-12-13

(5) Dongo, D. (2020, October 13). Health claims on botanicals, the Court of Justice clarifies. FT (Food Times). https://www.foodtimes.eu/it/consumatori-e-salute/health-claims-sui-botanicals-la-corte-di-giustizia-fa-chiarezza/

(6) Dongo, D. (2025, 1 May). The EU Court ruling on botanicals highlights the urgency of reforming the NHCR. FT (Food Times). https://www.foodtimes.eu/it/consumatori-e-salute/corte-ue-botanicals-riforma-nhcr/

(7) European Commission. (2013). Article 13.1 claims for which the evaluation by the European Food Safety Authority and the
consideration by the Commission and the Member States is not finalised.
https://ec.europa.eu/food/food-feed-portal/backend/claims/files/claims_pending.pdf

(8) European Food Safety Authority (EFSA). (2021, June). Questions on hold – botanical claims [Dataset]. https://www.efsa.europa.eu/sites/default/files/2021-06/questions-on-hold-botanical-claims.xlsx