'Nutrition claims' and nutritional declarations on the labels of food products refer, in the Old Continent, to the categories of some vitamins - eg B1, B2, B3 - rather than to the names of the substances (eg thiamine, riboflavin, niacin).
The various EU regulations, in turn, indicate both the general categories and sub-categories (groups) of vitamins, and their specific names. Even if these names correspond to the single category in a vitamin group.
Consumers, on the other hand, are more familiar with the categories of vitamins in each group than with the names of the related substances. How then to designate vitamins? An in-depth look.
1) Food Supplements
Food Supplements Directive 2002/42/EC specifies that the labels of food supplements must report the name of the category of nutrients' - defined, for the purposes of the application of the Directive, as 'vitamins' and 'minerals' (Article 2.2) - 'or other substances that characterize the product or an indication relating to the nature of these substances' (Article 6.3.a). (1)
The 'Vitamins and minerals permitted in the manufacture of food supplements' listed in Annex I include, as regards group B vitamins:
– vitamin B1 (mg),
– vitamin B2 (mg),
– niacin (mg NE),
– pantothenic acid (mg),
– vitamin B6 (mg)
- folic acid (μg).
2) Nutrition and Health Claims
Nutrition and Health Claims Regulation (EC) No 1924/06 – in Annex, 'Nutritional information and related application conditions' – specifies the conditions of use of 'nutrition claims':
- 'source [name of vitamin(s)] and/or [name of mineral(s). A claim that a food is a source of vitamins and/or minerals and any other claim likely to have the same meaning for the consumer are permitted only if the product contains at least a significant quantity as referred to in the Annex to Directive 90/496/EEC [now EU regulation 1169/11, Annex XIII, part A, ed.] or a quantity provided for by the derogations referred to in Article 6 of Regulation (EC) No. 1925/2006 (…) on the addition of vitamins and minerals and certain other substances to foods',
- 'high in' [name of vitamin(s)] and/or [name of mineral(s). A claim that a food is high in vitamins and/or minerals, and any other claim likely to have the same meaning for the consumer, shall only be permitted if the product contains at least twice the value of a 'source of [name of or of vitamins] and/or [name of mineral(s)]. (2)
'Health claims' authorized pursuant to the NHCR, article 13, instead identify the majority of group B vitamins with the specific names of the substances, with the sole exception of vitamins B6 and B12. Thus you see references to thiamine, riboflavin, niacin, pantothenic acid, biotin, folate, rather than their names B1, B2, B3, B5, B7, B9. (3) In apparent contradiction with the Food Supplements Directive, in the mention of its first group vitamins.
3) Addition of Nutrients
Addition of Nutrients Regulation (EC) No 1925/06 is in turn consistent with the Food Supplements Directive. Where in Annex I, 'Vitamins and minerals that can be added to foods', indicates vitamin B1, vitamin B2, niacin, pantothenic acid, vitamin B6, folic acid, vitamin B12, biotin.
4) Food Information to Consumers
Food Information to Consumers Regulation (EU) No 1169/11, in Annex XIII (Reference consumptions), recalls the general concept of 'vitamins' in the title of its Part A (Daily reference consumptions for vitamins and mineral salts, adults). Only to then mention thiamine, riboflavin, niacin, biotin - instead of, respectively, vitamins B1, B2, B3, B7 - when reporting the average daily requirement of each of them.
5) Exegesis
The four regulations European Unions mentioned above, depending on the case, define:
– conditions and methods of use of vitamins and minerals, and related information, in food supplements and fortified foods in common use ('Food Supplements', 'Addition of Nutrients'. See above, paragraphs 1 and 3),
– information that may be provided on the label of foods and drinks that contain a 'significant quantity' of vitamins and minerals ('Nutrition and Health Claims'. See above, paragraph 2),
– values to be considered for the purposes of calculating the 'significant quantity' and the display of the quantities (as a percentage of the average daily requirement) on the label, in the nutritional declaration ('Food Information Regulation'. See above, paragraph 4).
6) Vitamins, categories or specific names?
Inattention of the officials of the European Commission (DG Sanco, now Sante) and of the legal departments of the European Parliament and Council which have followed one another over two decades has caused a fair amount of confusion in identifying B vitamins.
The European legislator Furthermore, it has never excluded the possibility of designating each vitamin - on the label of food products - with the category code rather than the name of the substance (i.e. vitamin B1 rather than thiamine).
Main goal of the 'Food Information Regulation' is to guarantee the clarity and comprehensibility of commercial information addressed to consumers in relation to food. The optimal choice on how to designate a vitamin should therefore consider the practices in use in each country, in commercial information but also in public health information campaigns.
7) Court of Justice of the European Union
Court of Justice of the European Union – the only official interpreter of European law, whose decisions have a binding nature erga omnes – expressed its opinion on a case similar in some respects to the issue under examination, with the ruling of 24 March 2022, in case C-533/20. (6) The Court of Justice was called upon to express its opinion on the correctness of the designation of vitamins A and D with the specific names of the sources used in the ingredient list of a food product.
CJEU considered the general objectives of transparency and comprehensibility of information aimed at consumers, noting that none of the regulations cited in the previous paragraphs - 'Addition of Nutrients', 'Food Information to Consumers', 'Nutrition and Health Claims' - prohibits the use of the names 'vitamin A' and 'vitamin D'. Vitamins are at the same time nutrients (whose indication in the nutritional declaration remains optional, in general) and ingredients.
7.1) Designation of vitamins in the ingredients list
The ingredients, in turn, can be designated by their 'legal name' and, in its absence, by the 'customary name'. Furthermore, since the discrepancies highlighted in the previous paragraphs do not allow us to derive a legal name for the various vitamins, it is legitimate to refer to the category to which they belong rather than to the specific names of the substances. Without even needing to report, ça va sans dire, to their sources.
'The designation, in a coherent and exclusive manner, of vitamins under names such as 'Vitamin A' or 'Vitamin D' in the nutrition declaration and in the list of ingredients provided for in Regulation No 1169/2011 is capable of ensuring that the information provided is accurate, clear and easy to understand for an average consumer who is reasonably well-informed and reasonably observant and circumspect' (CJEU, judgment on the case C-533/20). (6)
8) Provisional conclusions
Vitamins they can simply be designated by the name of their category, as established by the EU Court of Justice. Without excluding the addition of their specific names, on a voluntary basis, also taking into account public health promotion campaigns that may induce sensitivity to some names (e.g. folate) among consumers in the individual countries of destination of the products.
Please note: on the part of the operators and authorities responsible for official controls, it should rather be dedicated to two fundamental aspects:
– the use only of sources of vitamins permitted for commonly used foods, 'foods for specific groups' (5) and food supplements,
– zero tolerance, in default, compared to the declared values if the presence or richness of vitamins is the subject of 'nutrition and health claims'. (7)
Dario Dongo
Footnotes
(1) Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements. Consolidated text, 30.9.22 https://tinyurl.com/mt32b9mf
(2) Regulation (EC) No 1924/2006 on nutrition and health claims made on foods. Consolidated text, 13.12.14 https://tinyurl.com/2pumd5ts
(3) Commission Regulation (EU) No 432/2012 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. Consolidated text, 17.5.21 https://tinyurl.com/mejknbr9
(4) Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods. Latest consolidated version, 22.6.23 https://tinyurl.com/4rzn2j24
(5) Specific conditions of use and information on the presence of vitamins and minerals are also established in the Food for Specific Groups Regulation (EU) No 609/2013 and its implementing regulations. See for example the previous article by Dario Dongo. Dysphagia and risk of malnutrition of vulnerable sections of the population. GIFT (Great Italian Food Trade).
(6) Court of Justice of the European Union (CJEU), case C-533/20 (Somogy Megyei Kormányhivatal v Upfield Hungary Kft).
Judgment of the Court (Seventh Chamber) of 24 March 2022 https://tinyurl.com/ptt3pzpr
(7) Dario Dongo. Nutrition and health claims, what tolerances on the declared values? GIFT (Great Italian Food Trade). 29.6.23
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
