On 14 July 2016, the Court of Justice of the European Union (CJEU) rendered its judgment in Case C-19/15 on the applicability of the Nutrition and Health Claims Regulation (NHC Regulation) to B2B communications.

As expected, the EU judges followed the Advocate General’s opinion and ruled that the NHC Regulation is not only applicable to commercial communications addressed to consumers (B2C) but also to commercial communications addressed to professionals (B2B).

Read our previous newsflash on the subject here.

Background of the dispute

One of the objectives of the NHC Regulation is to protect consumers from misleading nutrition or health claims in any sort of commercial communication relating to food products.

For example, food business operators cannot market a product as being ‘light’ if it does not fulfil certain requirements. Similarly, the label of a food product can only bear a health claim if such a claim has been previously assessed, validated and entered in the public EU Register of Nutrition and Health Claims (for example, ‘contributes to the maintenance of normal blood cholesterol levels’).

In a dispute before the Munich Regional Court, the question arose whether the rules set forth in the NHC Regulation (including the prohibition to refer to non-authorised health claims) were only applicable to communications addressed to the final consumers or were also applicable to B2B communications (for example, commercial communications from a food supplements company to healthcare professionals).

The question referred to the CJEU stems from a dispute between Verband Sozialer Wettbewerb (VSW), an association protecting the commercial interests of its members, and Innova Vital, an undertaking selling nutritional supplements.

Innova Vital markets among others an emulsion containing vitamin D, called ‘Innova Mulsin® Vitamin D3’. In November 2013, the director of Innova Vital sent a written communication exclusively to named doctors stating that his product helped to prevent diseases caused by vitamin D deficiency.

The communication stated in particular:

“You are aware of the situation: 87% of children in Germany have blood vitamin D levels below 30 ng/ml. According to the German Food Association (Deutsche Gesellschaft für Ernährung, DGE), that level should be approximately 50 to 75 ng/ml.

As has already been demonstrated in numerous studies, vitamin D plays an important role in the prevention of several illnesses, such as atopic dermatitis, osteoporosis, diabetes mellitus and MS [multiple sclerosis]. (…)

As a doctor specialising in immunology, I considered this issue and developed a vitamin D3 emulsion (Innova Mulsin® D3) which can be administered in the form of drops. (…)

You can find out how to place direct orders and obtain free information material for your surgery by calling [xxx-xxx]

(…) with a selling price of EUR 26.75, your patients are investing EUR 0.11 per day for balanced vitamin D3 supplement’”.

VSW brought an action for a prohibitive injunction against Innova Vital based on the fact that Innova Vital’s emails to doctors contained non-authorized health claims. VSW’s position is that the NHC Regulation is applicable both to communications addressed to consumers and to professionals.

Innova Vital claims, on the contrary, that the NHC Regulation is not applicable to the case at hand since the emails were exclusively addressed to doctors. It relies in particular on recitals 1, 8 to 10, 15 and 28 as well as Article 5(2) of the NHC Regulation which refer to consumers’ protection and consumers’ perception in relation to nutrition and health claims. Innova Vital argues that these numerous references to the consumers and the general wording of the NHC Regulation tend to prove that the NHC Regulation only covers communications addressed to consumers.

Decision of the CJEU

As expected, the EU judges followed the Advocate General’s opinion and ruled that the NHC Regulation is not only applicable to commercial communications addressed to consumers (B2C) but also to commercial communications addressed to professionals (B2B).

The main elements on which the CJEU based its reasoning are the followings:

  • First, provisions of EU law must be interpreted in light of the context in which it occurs and the objectives pursued by the Regulation, and not only its wording.
  • Second, the concept of a ‘commercial communication’ within the meaning of the NHC Regulation, must be understood as covering, inter alia, a communication made in the form of advertising foods, designed to promote, directly or indirectly, those foods. The CJEU further specified that: “Such a communication may also take the form of an advertising document which food business operators address to health professionals, containing nutritional or health claims(…), in order that those professionals recommend, if appropriate, that their patients purchase and/or consume that food.” As rightfully pointed out by the CJEU, Article 1(2) of the NHC Regulation on its scope of application makes no distinction according to whether that addressee is a final consumer or a health professional. The only condition set by the Regulation is that the food product in question is intended to be sold to a final consumer at the end of the day.
  • Third, the absence of any reference to ‘professionals’ in the recitals and provisions of the NHC Regulation does not mean that that regulation does not apply to the situation where a commercial communication is addressed exclusively to health professionals.
  • Fourth, echoing the opinion of the Advocate general, the CJEU pointed out that “it cannot be ruled out that the health professionals themselves may be misled by nutrition or health claims which are false, deceptive, or even mendacious.” Therefore, the fact that the communication in question is addressed to consumers through a health professional does not eliminate the risk of consumers being misled.
  • Finally, adopting a pragmatic and purposive approach, the CJEU noted that if B2B communications were excluded from the scope of application of the NHC Regulation, there would be a risk that the food business operators would circumvent the obligations laid down by that regulation, addressing the final consumer through health professionals, so that those professionals recommend their foods to that consumer.

The CJEU therefore ruled that Article 1(2) of the NHC Regulation must be interpreted as meaning that nutrition or health claims made in a commercial communication on a food which is intended to be delivered as such to the final consumer, if that communication is addressed not to the final consumer, but exclusively to health professionals, falls within the scope of that regulation.

Practical impact for food business operators

When communicating on a commercial basis with other professionals (e.g. distributor, resellers, doctors, etc.), food business operators, including food supplements or dietary products manufacturers, must be careful not to use any non-authorised nutrition or health claims.

It is important to note however that only commercial communications have to comply with the NHC Regulation. By contrast, these rules do not apply to claims which are made in non-commercial communications, such as scientific publications, information in the press or dietary guidelines issued by public health authorities.

As pointed out by the CJEU indeed, the NHC Regulation does not (and should not) preclude the objective information for health professionals about new scientific developments, involving the use of a technical or scientific terminology, in the situation where the communication is of a non-commercial nature.

The next question that arises is where to draw the line between commercial and non-commercial communications. It is likely that this question is to be appreciated on a case-by-case basis, taking into account all relevant circumstances at hand, such as (1) the person who sent it, (2) the content of the communication, (3) the form of the communication, (4) its (direct or indirect) intended purpose, etc.

The judgment of the CJEU is case C-19/15 can be found here.