# C_2021471EN.01001601.xml

| 22.11.2021 | EN | Official Journal of the European Union | C 471/16 |
| --- | --- | --- | --- |

22.11.2021

EN

Official Journal of the European Union

C 471/16

---

Request for a preliminary ruling from the Oberlandesgericht Düsseldorf (Germany) lodged on 9 July 2021 — Orthomol pharmazeutische Vertriebs GmbH v Verband Sozialer Wettbewerb e.V.

(Case C-418/21)

(2021/C 471/23)

Language of the case: German

Referring court

Oberlandesgericht Düsseldorf

Parties to the main proceedings

Defendant and appellant: Orthomol pharmazeutische Vertriebs GmbH

Applicant and respondent: Verband Sozialer Wettbewerb e.V.

Questions referred

| 1. | Under what circumstances are there other medical nutrient requirements pursuant to the second alternative in Article 2(2)(g) of the FSG Regulation, (1)

  namely:
  do they require — in addition to the limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food, as referred to in the first alternative — that there is an increased nutrient requirement brought about by illness, which is to be covered by the food,
  or is it sufficient if the patient [...] generally benefits from the intake of that food because substances contained therein counteract the disorder or alleviate its symptoms? |
| --- | --- |

1.

Under what circumstances are there other medical nutrient requirements pursuant to the second alternative in Article 2(2)(g) of the FSG Regulation, (1)

namely:

do they require — in addition to the limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food, as referred to in the first alternative — that there is an increased nutrient requirement brought about by illness, which is to be covered by the food,

or is it sufficient if the patient [...] generally benefits from the intake of that food because substances contained therein counteract the disorder or alleviate its symptoms?

| 2. | In the event that the first question is answered in accordance with the latter alternative:
  Does ‘generally accepted scientific data’ within the meaning of Article 2(2) of the Delegated Regulation (2) in any event presuppose a randomised, placebo-controlled double-blind study which, although not related to the product in question itself, at least provides starting points for the claimed effects? |
| --- | --- |

2.

In the event that the first question is answered in accordance with the latter alternative:

Does ‘generally accepted scientific data’ within the meaning of Article 2(2) of the Delegated Regulation (2) in any event presuppose a randomised, placebo-controlled double-blind study which, although not related to the product in question itself, at least provides starting points for the claimed effects?

---

(1)  Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ 2013 L 181, p. 35).

(2)  Commission Delegated Regulation (EU) 2016/128 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes (OJ 2016 L 25, p. 30).

---