The use of nutrition and health claims -in labeling and advertising-must be responsive to the actual composition of food products, including tolerances (over and under) from stated values. Insight.
1) Nutrition and health claims, EU rules. Introduction
Any voluntary information provided in marketing communication that suggests, even if implicitly, a favorable relationship between the consumption of a food – or a category thereof, or a substance contained therein – and the health of the consumer qualifies as a
health claim
. Any claim regarding energy value, nutrients or other substances that the food ‘contains, contains in reduced or increased proportions, or does not contain’ qualifies as a
nutrition claim
.
Nutrition & Health Claims
Regulation (EC) No 1924/06 first prescribes compliance of the contents of:
- nutritional claims, under the general conditions set forth in the exhaustive list in Annex to the NHC Regulation, (1)
- health claims, under the conditions provided for only the claims authorized in reg. EU 432/12 as amended (2,3).
1.1) General principles of information
The NHC regulation also requires compliance with certain general information principles, which include a number of prohibitions on:
- False, ambiguous and misleading information,
- ‘give rise to doubts about the safety and/or nutritional adequacy of other foods.’
- ‘toencourage or tolerate excessive consumption of an item‘,
- ‘to suggest (…) that a balanced and varied diet cannot generally provide adequate amounts of all nutrients‘,
- refer, in text and images, ‘to changes in bodily functions that could arouse or exploit fear in the consumer‘ (EC Reg. 1924/06, Article 3).
1.2) General conditions
Nutrition and health claims are also subject to general conditions, which preside over:
- relevance of news to human health and nutrition, in relation to amounts of food that can be reasonably consumed as part of a balanced diet,
- comprehensibility of the news, to be referred to the consumption of the product according to the indications offered,
- scientific and analytical foundation of the claims,
- bioavailability, where appropriate, of the substances boasted (EC Reg. 1924/06, Article 5).
1.3) Health claims, supplementary information
Health claims should always come with the following additional information:
- ‘a wording regarding the importance of a varied and balanced diet and a healthy lifestyle.’
- ‘the amount of the food and how to consume it to achieve the indicated beneficial effect‘,
- warnings for‘people who should avoid consuming the product‘, and
- ‘an appropriate warning for products that could present a health risk if consumed in excessive quantities.’ (EC Reg. 1924/06, Article 10.2).
1.4) Health claims, prohibitions
Health claims(health claims) must never contain:
- ‘indications suggesting that health could be compromised by not consuming the food.’
- ‘claims that refer to the percentage or extent of weight loss.’
- ‘claims that refer to the opinion of an individual physician or other health professional or other association‘ (EC Reg. 1924/06, Article 12).
2) Tolerances
The European Commission – in agreement with member state representations meeting at the Standing Committee on Plants, Animals, Food and Feed(PAFF Committee) – adopted in December 2012 the ‘European Commission guidance document for competent authorities for the control of compliance with EU legislation on Reg. EU 1169/11‘ (4,5).
The guidelines in question, a brief excerpt of which follows, have no official legal status. The Court of Justice of the European Union(EUCJ), it should be recalled, is in fact the only institution-besides the legislature itself-allotted the power of official interpretation of EU rules. In any case, the document expresses the shared orientation of the European executive and national governments and therefore deserves attention.
2.1) Tolerances on values covered by nutrition and health claims. Nutrients and other substances
‘To ensure that consumers are not misled by nutrition and health claims, particularly when the claimed nutritional and/or physiological effect is achieved by a certain amount of a nutrient or other substance for which the claim is made, at one side of the Declared level of the nutrients or other substances specified in the conditions of use of the indication is applied a tolerance which includes only themeasurement uncertainty.
At the other side of the stated levels, a wider tolerance of analytical uncertainty may be accepted. Levels of nutrients and other substances for the use of nutrition and health claims can be minimum or maximum levels. In cases where only a maximum level but not a minimum level is specified, only the measurement uncertainty applies for deviations to the maximum side, while deviations to the minimum side can be accepted within the tolerance range given in Table 3.
In cases where only a minimum but not a maximum level is specified, only the measurement uncertainty applies for deviations to the minimum side, while deviations to the maximum side can be accepted within the upper tolerance range given in Table 3′. (4)
2.2) Vitamins and minerals, tolerances in foods.
‘For vitamins and minerals, only the measurement uncertainty applies for deviations on the minimum side, while deviations on the maximum side can be accepted within the upper tolerance range given in Table 3, but
-levels must not exceed the maximum amounts of vitamins and minerals harmonized at the EU level according to the provisions of Regulation (EC) No. 1925/2006 on the addition of vitamins and minerals and certain other substances to foods and Directive 2002/46/EC on food supplements.
In the absence of harmonized standards on maximum amounts in foods and food supplements, member states may establish national rules in accordance with Articles 34 and 36 of the Treaty on the Functioning of the European Union. However, in doing so, they must also follow the criteria set forth in Regulation (EC) No. 1925/2006 and by Directive 2002/46/EC‘. (4)
2.3) Vitamins and minerals, tolerances in dietary supplements
‘The tolerances for vitamins and minerals in dietary supplements are established by including all factors of variation. Tolerance values listed include the measurement uncertainty associated with a measured value. Therefore, in deciding whether a measured value conforms to the declared value, it is not necessary to take into account the measurement uncertainty‘. (4)
3) Interim Conclusions.
Claims such as ‘source of…’and ‘rich in…’nutrients (e.g., protein, dietary fiber, Omega-3, ), micronutrients (e.g., vitamins, minerals) or other substances covered by nutrition and health claims must be supported by their actual contents in foods, within the narrow margins of the tolerances indicated above.
The values given, it should be noted, must be maintained throughout the shelf-life of the products. This involves performing and recording appropriate analytical tests, having regard to the storage conditions to which the various products are normally subjected, including on the basis of label claims.
Dario Dongo
Notes
(1) Dario Dongo. ABC nutritional claims. GIFT (Great Italian Food Trade). 26.5.18
(2) A transitional arrangement is granted to health claims on foods and supplements containing plants and their extracts. V. Dario Dongo. Health claims on botanicals, the Court of Justice provides clarity. GIFT (Great Italian Food Trade).
(3) The responsible operators decided to adopt lexical variations that would not alter the meaning of the claims. V. Nutrition and health claims, periphrases and lexical variants allowed? Lawyer Dario Dongo answers.. FARE (Food and Agriculture Requirements). 29.4.23
(4) European Commission guidance document for competent authorities for the control of compliance with EU legislation on Reg. EU 1169/11. https://tinyurl.com/39ej4ty2 Dec. 2012
(5) For tolerances on values declared in nutrition tables that do not constitute the subject of nutrition and health claims, see Dario Dongo. Nutrition statement on the label. The ABC of EU rules. FARE (Food and Agriculture Requirements). 30.10.16
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
