Case T‑100/15

Dextro Energy GmbH & Co. KG

v

European Commission

‛Consumer protection — Regulation (EC) No 1924/2006 — Health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health — Refusal to authorise certain claims in spite of EFSA’s positive opinion — Proportionality — Equal treatment — Obligation to state reasons’

Summary — Judgment of the General Court (Fifth Chamber), 16 March 2016

Approximation of laws — Nutritional and health claims concerning foodstuffs — Regulation No 1924/2006 — Health claims other than those referring to the reduction of disease risk and to children’s development and health — Refusal to authorise a health claim concerning the beneficial effects of glucose for the energy-yielding metabolism — Disproportionate restriction on the rights of freedom, security and free enterprise — None

Approximation of laws — Nutritional and health claims concerning foodstuffs — Regulation No 1924/2006 — Health claims other than those referring to the reduction of disease risk and to children’s development and health — Inclusion on the list of permitted claims — Case-law concerning consumer protection by appropriate labelling rather than an advertising ban not applicable

Approximation of laws — Nutritional and health claims concerning foodstuffs — Regulation No 1924/2006 — Conditions for using the said claims — Prohibition of false, ambiguous or misleading claims — Assessment of claims according to the perception of the relevant public — Producer’s intention irrelevant

Approximation of laws — Nutritional and health claims concerning foodstuffs — Regulation No 1924/2006 — Health claims other than those referring to the reduction of disease risk and to children’s development and health — Allegations concerning the beneficial effects of glucose for the energy-yielding metabolism — Opinion of EFSA that, in order to bear that claim, a foodstuff must be a significant source of glucose — Commission refusing authorisation in order not to encourage sugar consumption — Lawfulness

Approximation of laws — Nutritional and health claims concerning foodstuffs — Regulation No 1924/2006 — Health claims other than those referring to the reduction of disease risk and to children’s development and health — Inclusion on the list of permitted claims — Criteria for assessment — Account taken of generally accepted nutrition and health principles — Lawfulness

Approximation of laws — Nutritional and health claims concerning foodstuffs — Regulation No 1924/2006 — Health claims other than those referring to the reduction of disease risk and to children’s development and health — Inclusion on the list of permitted claims — Discretion of the Commission — Judicial review — Limits

Approximation of laws — Nutritional and health claims concerning foodstuffs — Regulation No 1924/2006 — Health claims other than those referring to the reduction of disease risk and to children’s development and health — Inclusion on the list of permitted claims — Opinion of the European Food Safety Agency — Not binding on the Commission

There is no basis on which to conclude that the Commission is required to include health claims, inclusion of which has been applied for in the list of permitted health claims referred to in Article 13(3) Regulation No 1924/2006 on nutrition and health claims made on foods, solely because the European Food Safety Agency has issued positive opinions. Conversely, although, according to recital 17 of Regulation No 1924/2006, scientific justification is the main aspect to be taken into account when using health claims, when taking a decision in accordance with Article 18(4) of Regulation No 1924/2006, the Commission is required to take into account any relevant provisions of EU law and other legitimate factors relevant to the matter under consideration. In addition, the fact that the Commission is not obliged to follow EFSA’s decision is confirmed by Article 18(5) of Regulation No 1924/2006, under which a health claim may also be authorised where EFSA issues an opinion that does not support the inclusion of that claim in the list referred to in Article 13(3) of that regulation. In that regard, EFSA’s examination is of only a limited nature. Under the second subparagraph of Article 18(3) of Regulation No 1924/2006, read with Article 16(3) of that regulation, in order to prepare its opinion, EFSA is required only to verify that the health claim is substantiated by scientific evidence and that the wording of the health claim complies with the criteria laid down in Regulation No 1924/2006. In particular, in practical terms, EFSA must ensure that the health claims are based on and substantiated by generally accepted scientific evidence, in accordance with Article 6(1) of that regulation. (see paras 25, 39)

See the text of the decision. (see paras 29, 92)

Where the Commission rules on an application for authorisation of a health claim on the basis of Article 18(4) of Regulation No 1924/2006, it must be recognised as enjoying a broad discretion in an area which entails political, economic and social choices on its part, and in which it is called upon to undertake complex assessments. In those circumstances, review by the EU judicature is limited to verifying whether there has been a manifest error of assessment or a misuse of powers, or whether those authorities have manifestly exceeded the limits of their discretion. In such a context, the EU judicature cannot substitute its assessment of scientific and technical facts for that of the institutions on which alone the FEU Treaty has conferred that task. Similarly, as regards the review of proportionality, the legality of a measure adopted in that area can be affected only if the measure is manifestly inappropriate having regard to the objective which the competent institution is seeking to pursue. Moreover, since the discretion enjoyed by the competent authorities in determining the balance to be struck between freedom of expression and the objective of protecting health varies for each of the goals justifying restrictions on that freedom and depends on the nature of the activities in question, it should also be recognised that the Commission enjoys a broad discretion in relation, specifically, to the commercial use of freedom of expression, especially in advertising messages. (see paras 30, 31, 80, 81)

It cannot validly be disputed that the generally accepted nutrition and health principles taken into account by the Commission are a legitimate factor relevant to the determination of whether health claims at issue can be authorised under Regulation No 1924/2006. The fact that those principles are taken into account provides a high level of consumer protection. The relevance of the generally accepted nutrition and health principles to the examination of whether a health claim may be authorised is also expressly referred to by the EU legislature in recital 18 of Regulation No 1924/2006, where it is stated that a nutrition or health claim should not be made if it is inconsistent with those principles. (see para. 34)

See the text of the decision. (see para. 46)

Where application is made for inclusion of a health claim in the list of permitted claims referred to in Article 13(3) of Regulation No 1924/26, and EFSA delivers opinions according to which a foodstuff, in order to be able to bear those claims, must be a significant source of glucose, the Commission does not err in taking the view that the use of that health claim would encourage the consumption of sugar. As stated in recital 10 of Regulation No 1924/2006, foods promoted with claims may be perceived by consumers as having a nutritional, physiological or other health advantage over similar or other products to which such nutrients and other substances are not added. That may encourage consumers to make choices which directly influence their total intake of individual nutrients or other substances in a way which run counter to scientific advice. As is apparent from recital 19 of Regulation No 1924/2006, the grant of a nutrition or health claim confers a positive image on the foods concerned. (see para. 55)

In the words of point (a) of the second paragraph of Article 3 of Regulation No 1924/2006, the use of nutrition and health claims is not to be false, ambiguous or misleading. As is apparent from recital 16 of Regulation No 1924/2006, in order to resolve the question whether or not a claim is misleading, it is necessary to refer to the presumed expectations in relation to that claim which an average consumer who is reasonably well informed, and reasonably observant and circumspect, would have. Health claims highlighting the contribution of glucose to the energy-yielding metabolism must be regarded as incomplete, and thus ambiguous and misleading, if they highlight only a certain quality likely to improve that metabolism, while remaining silent as to the fact that, irrespective of the proper functioning of the energy-yielding metabolism, dangers inherent in the consumption of more sugar are neither ruled out nor limited. By highlighting only the beneficial effects for the energy-yielding metabolism, the health claims at issue are likely to encourage consumption of sugars and, in fact, to increase the risks for consumer health inherent in the excessive consumption of sugars. Moreover, for the purpose of establishing that the health claims at issue are ambiguous and misleading, the question whether the producer was aware of the recommendations of national and international authorities concerning the reduction of sugar consumption is irrelevant. Similarly, The finding that a claim is misleading, within the meaning of point (a) of the second paragraph of Article 3 of Regulation No 1924/2006, does not depend on whether the applicant acted with knowledge of that misleading nature or even intentionally. (see paras 65, 66, 68, 71)

See the text of the decision. (see para. 79)

Whilst the case-law shows that, where there is a national prohibition on advertising, consumer protection might be sufficiently guaranteed by an appropriate labelling requirement, such as a label ensuring the transparency of offers to consumers, that case-law concerns national non-harmonised measures. That does not apply in the case of a Commission regulation refusing to authorise certain health claims for foodstuffs, which has as its legal basis Article 18(4) of Regulation No 1924/2006, that latter regulation itself being based on Article 95 EC, according to which the legislature is to adopt the measures for the approximation of the provisions laid down by law, regulation or administrative action in Member States which have as their object the establishment and functioning of the internal market. In that regard, the first subparagraph of Article 168(1) TFEU provides that a high level of human health protection is to be ensured in the definition and implementation of all EU policies and activities, and Article 95(3) EC and Article 114(3) TFEU explicitly require that, in achieving harmonisation, a high level of protection of human health is to be guaranteed. (see paras 89, 90)

Whilst it is true that the Commission’s prohibition, on the basis of Article 18(4) of Regulation No 1924/2006, of health claims referring to the beneficial effects of glucose for the energy-yielding metabolism imposes certain restrictions on the applicant’s business activity in one specific respect, compliance with those freedoms is none the less assured in the essential respects. Far from prohibiting the production and marketing of the applicant’s products or the advertising of those products, the contested regulation merely controls, pursuant to Article 1(2) of Regulation No 1924/2006, the presentation of the foods in question and the advertising of those products, with the aim of protecting public health, which constitutes an objective of general interest justifying a restriction of a fundamental freedom. Thus, a refusal to authorise health claims does not in any way affect the actual substance of the freedoms recognised by Articles 6 and 16 of the Charter of Fundamental Rights of the European Union and must be regarded as complying with the requirement that is intended to reconcile the various fundamental rights involved and to strike a fair balance between them. (see para. 93)

See the text of the decision. (see para. 95)

See the text of the decision. (see para. 99)