The Danish Veterinary and Food Administration has changed its practice concerning the use of so-called on-hold health claims. In Denmark, health claims that are still in limbo in the authorisation procedure may no longer be used to support unspecific statements according to Article 10(3) in EU Regulation no. 1924/2006 on nutrition and health claims made on foods. It is our understanding that in other Member States, it is possible to use on-hold health claims together with unspecific statements. An EU ruling (C-533/20) determines that vitamins and minerals must be declared in the list of food ingredients by their so-called popular names, such as vitamin A or D, not by stating the sources of the vitamins and minerals. Moreover, the Veterinary and Food Administration has changed its practice concerning statements regarding the absorbability of vitamins and minerals in the human body. Such statements will no longer be considered as nutrition claims under EU Regulation no. 1924/2006, but will instead be assessed in accordance with general labelling rules (fair information practice).

New Danish practice concerning the use of on-hold health claims

Background
According to Article 10(3) of Regulation (EC) 1924/2006, reference to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being may be declared only if accompanied by a specific health claim included in the lists provided for in Article 13 or 14.

In 2012, the list of permitted health claims according to Article 13 of Regulation (EC) 1924/2006 was published. At the same time, many claims, mainly on botanicals, where – and still are – blocked in the EU system. In order not to disrupt the market, as the claims in general were already used on the market, according to transitional measures in EU Regulation no. 1924/2006, the claims could be used even though the claims had not been subject to the EU authorisation procedure.

Change in DVFA practice
The DVFA accepts the use of on-hold health claims in themselves. However, it has come to our knowledge that the DVFA no longer accepts the use of on-hold health claims used as support for unspecific statements according to Article 10(3). The DVFA refers to the wording of Article 10(3) and concludes that on-hold health claims cannot be used in that regard, as the claims are not authorised. The consequence of this strict reading of the wording in the article is that only health claims authorised under Article 13 or 14 may be used to support unspecific statements.

Apparently, the DVFA is of the opinion that the above is not a change in the authority practice. As such, at present we do not have information concerning whether the DVFA intends to publish information or update its guidance document on nutrition and health claims concerning this matter.

BB interpretation
In our view, no one expected or anticipated that we would have health claims on hold for more than 10 years. But here we are today, with the EU list of permitted health claims since 2012. In that EU regulation (no. 432/2012), it is stated in recitals 10 + 11: "(10) The Commission has identified a number of claims submitted for evaluation, referring to effects of plant or herbal substances, commonly known as ‘botanical’ substances, for which the Authority has yet to complete a scientific evaluation. In addition, there are a number of health claims for which either a further evaluation is required before the Commission is able to consider their inclusion or otherwise in the list of permitted claims, or which have been evaluated, but due to other legitimate factors consideration cannot be completed by the Commission at this time.

(11) Claims whose evaluation by the Authority or whose consideration by the Commission has not yet been completed will be published on the website of the Commission (1) and may continue to be used pursuant to Article 28(5) and (6) of Regulation (EC) No 1924/2006."

It is our assessment that the on-hold health claims may be used in the same way as the authorised health claims. This means, in our view, that if you can use the on-hold health claim on its own, you can also use it as support for an unspecific statement according to Article 10(3).

It is our understanding that other local EU food authorities accept the use of on-hold health claims, no matter whether you are using on-hold health claims in themselves or as support for unspecific statements.

Declaration of vitamins and minerals – EU ruling (C-533/20) determines a new practice

EU ruling ensures clearer food information and contributes to ensuring high level of consumer protection
A ruling by the EU Court of Justice on 24 March 2022; Somogy Megyei Kormányhivatal vs Upfield Hungary Kft., determines that vitamins and minerals must be declared in the list of food ingredients by their popular names, such as vitamin A or D, not by stating the sources of vitamins or minerals, such as retinol or cholecalciferol.

Under the EU labelling Regulation (no. 1169/2011), Article 18, ingredients must be designated by their specific names in the list of ingredients. Some EU authorities have interpreted this provision so that for vitamins and minerals the sources must be stated, as listed in Annex II of the EU regulation on the addition of vitamins and minerals and of certain other substances to foods (no. 1925/2006).

The EU Court of Justice was asked to review this issue in connection with the mentioned EU case, in which Upfield had marketed a margarine, Flora ProActive, designating "vitamins (A, D)" on its labelling.

Court's conclusion
The EUCJ concluded that there are no requirements in food legislation to state vitamin or mineral sources. Further, the Court noted that the purpose of the labelling regulation is to ensure a high level of consumer protection as regards food information. This purpose is expressed in Article 7(2) of the Regulation, stating that food information must be accurate, clear and easy to understand for the consumer. Partly on this basis, the Court concludes that by declaring vitamins by their names, such as vitamin A and D, the provision's requirement is ensured for the generally well-informed and reasonably observant and circumspect average consumer.

The Court also concluded that the sources of vitamins are not to be stated in the list of ingredients, and the Court finds that stating the sources involves the risk of making the information less clear and less easily understandable for the average consumer. The Court actually indicates that it is not allowed to state the sources of vitamins or minerals, as this does not comply with the requirement for clarity in Article 7(2) of the EU labelling Regulation.

Briefly on the absorption of nutrients
In relation to labelling of vitamins and minerals, we may also mention that the Danish Veterinary and Food Administration has changed its practice as regards statements concerning the absorbability of vitamins, for instance "Chromium with up to 10 times improved absorbability". Originally, the Danish Veterinary and Food Administration considered such statements as being unlawful nutrition claims pursuant to EU Regulation no. 1924/2006 on nutrition and health claims.

After consulting the EU Commission, the Veterinary and Food Administration changed its practice so that such statements are no longer considered subject to EU Regulation no. 1924/2006 on nutrition and health claims on foods but instead are assessed in accordance with the rules on fair information practice (Article 7) of the EU labelling Regulation no. 1169/2011.

The Administration has not changed the interpretation in its guidance on nutrition and health claims, but it has included an explanatory note on its website.

Overall conclusion
The DVFA no longer accepts the use of on-hold health claims as support for unspecific statements.

According to EU ruling, declaration of vitamins and minerals in the list of ingredients must be limited to include popular/general names and not the sources of vitamins or minerals.

Statements as to the absorbability of vitamins and minerals are no longer considered unlawful nutrition claims. Instead, statements are assessed in accordance with the general labelling rules, including the rules on misleading information.

At Bech-Bruun, we have a strong team of advisers on food legislation, who are all experts in how food legislation is implemented and interpreted in practice. We advise and assist on actual control visits and are happy to answer questions specifically related to the above and on food legislation in general. Feel free to contact us if you are interested in learning more about e.g. inspection campaigns or are preparing for a possible inspection visit from the Veterinary and Food Administration.