- 04/04/2026
- Posted by: Marta
- Category: Questions and answers
Dear Dongo lawyer,
I'm referring to your previous article on selling dietary supplements online to bring to your attention a product sold on Amazon by GEN – German Elite Nutrition, containing arginine and citrulline. The product is presented on the e-commerce platform with multilingual information, but the actual packaging only has a German-language label. Is it sufficient for the information to be displayed on the website?
Thank you very much, [signed letter]
Unfortunately, the regulation of food supplements is an exemplary case of a lack of harmonization of rules at the European level. Food supplements are, in fact, included in the definition of food – pursuant to Regulation (EC) No. 178/02, General Food Law, Article 2 – but their specific regulation is still entrusted to a directive, the Food Supplements Directive 2002/46/EC, which leaves ample room for concurrent national legislation.
Food supplements: Notification of labels to the competent authorities
La Food Supplements Directive provides that 'In order to facilitate effective control of food supplements, Member States may require that the manufacturer or the person responsible for placing the product on the market in their territory inform the competent authority of such marketing by transmitting a sample of the product label itself.'(Article 10).
The Italy – like many other Member States – has in fact prescribed the advance notification of labels of all food supplements intended for placing on the market in the national territory, in article 10 of legislative decree no. 169/04 which implements the Food Supplements DirectiveTo this end, the Ministry of Health has introduced an electronic notification system, starting from July 2018, and a National Register of Food Supplements, since the beginning of 2021 (Italian Ministry of Health, ed.).
The dietary supplement in question—ARGININ + CITRULLIN—is indeed listed in the National Registry and appears to have been registered, under code 136597, by VITAMINVERSAND24 GMBH DE. This company, in turn, is listed as the distributor of the product in its presentation on the Amazon website.
Labelling of food supplements
The labelling of food supplements is subject to the general criteria and requirements set out in the Food Information Regulation (EU) No 1169/11, as well as the specific requirements set out in Food Supplements DirectiveIn addition to the mandatory general information, Directive 2002/46/EC requires the following information to be included on the labels of food supplements:
- 'the name of the categories of nutrients or other substances characterising the product or an indication of the nature of such substances;
- the recommended daily dose of the product;
- a warning not to exceed the recommended daily doses;
- the indication that food supplements should not be considered a substitute for a varied diet;
- the indication that the products must be kept out of the reach of small children'(Article 9.3).
This information is actually present, also in Italian, in the multilingual information published on the Amazon website.
Food labels, language requirements
Il Food Information Regulation (EU) No 1169/11 requires that:
- 'le Required Information on foods appear in an easily understood language by consumers in the Member States in which the food is marketed.
- On their territory, the Member States in which a food is marketed they can impose that such indications are provided in one or more official languages of the Union.
In Italy Legislative Decree 231/2017 – which integrates Regulation (EU) No. 1169/11 in the parts reserved for concurrent legislation, and defines its regulatory framework – establishes the obligation to report on the label the Mandatory information in Italian (Articles 19.10, 23.3). This principle actually applies to the majority of products intended for end users, already on the basis of the Consumer Code (Legislative Decree 206/2005 and subsequent amendments, Article 9).
Conclusions
The product in question appears to have been legitimately placed on the Italian market. The delivery of a package of the dietary supplement with only a German-language label, while perhaps attributable to a logistical error, is not compliant with applicable legislation.
From a broader perspective, we hope for a reform of the European regulation on food supplements aimed at ensuring the free movement of goods, which is currently merely unrealistic, given the burdens and costs of prior notification of labels required in most member states.
Language requirements for labelling should also be simplified, requiring only the mandatory information to be shown in the most widely used language, English, on the physical label, and the information in other languages on the electronic label.
Cordially
Dario Dongo
Bibliography
- Legislative Decree 21 May 2004, n. 169. Implementation of Directive 2002/46/EC on food supplements. Regulation (Last updated on 06/07/2007). https://www.normattiva.it/uri-res/N2Ls?urn:nir:stato:decreto.legislativo:2004-05-21;169
- Legislative Decree 15 December 2017, no. 231. Sanctions for violations of the provisions of Regulation (EU) no. 1169/2011, relating to the provision of food information to consumers and the adaptation of national legislation to the provisions of the same Regulation (EU) no. 1169/2011 and Directive 2011/91/EU, pursuant to Article 5 of Law no. 170 of 12 August 2016 «European Delegation Law 2015. Legislation. https://www.normattiva.it/esporta/attoCompleto?atto.dataPubblicazioneGazzetta=2018-02-08&atto.codiceRedazionale=18G00023
- Legislative Decree 6 September 2005, n. 206. Consumer Code, pursuant to Article 7 of Law 29 July 2003, n. 229. Normattiva (Last updated: 03/12/25 https://www.normattiva.it/uri-res/N2Ls?urn:nir:stato:decreto.legislativo:2005-09-06;206)
- 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. Consolidated text: 11/26/2025 http://data.europa.eu/eli/dir/2002/46/2025-11-26
- Dongo, D. (2026, January 5). Food supplements: Italian leadership and market trends. GIFT (Great Italian Food Trade). https://www.greatitalianfoodtrade.it/integratori-alimentari/integratori-alimentari-mercato/
- Italian Ministry of Health (nd). Register of food supplements. https://www.salute.gov.it/new/it/tema/alimenti-fini-medici-speciali-ed-integratori/registro-degli-integratori-alimentari/
- Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. Consolidated text: 01/01/2026 http://data.europa.eu/eli/reg/2002/178/2026-01-01
- Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004. Consolidated text: 01/04/2025 http://data.europa.eu/eli/reg/2011/1169/2025-04-01
