Request for a preliminary ruling from the Oberlandesgericht Düsseldorf (Germany) lodged on 6 October 2023 – SALUS Haus Dr. med Otto Greither Nachf. GmbH & Co. KG v Astrid Twardy GmbH

(Case C-618/23, SALUS)

Language of the case: German

Referring court

Oberlandesgericht Düsseldorf

Parties to the main proceedings

Defendant and appellant: SALUS Haus Dr. med Otto Greither Nachf. GmbH & Co. KG

Applicant and respondent: Astrid Twardy GmbH

Questions referred

Are herbal medicinal teas which are to be classified as ‘traditional herbal medicinal products’ within the meaning of point 29 of Article 1 and Article 16a of Directive 2001/83/EC, ¹ inserted by points (1) and (2) of Article 1 of Directive 2004/24/EC, ² (‘the Community code’) to be regarded as ‘plant-based traditional herbal preparations’ within the meaning of Article 2(1) of, in conjunction with Annex I to, Regulation (EU) 2018/848 ³ (‘the Regulation on organic production’ or ‘the Regulation’).

If the first question is answered in the affirmative:

Can the labelling provided for in Chapter IV of the Regulation, in particular

–    the official organic production logo of the European Union (Article 33 of, in conjunction with Annex V to, the Regulation),

–    the company’s own organic production logo (Article 33(5) of the Regulation),

–    the code number of the control body (Article 32(1)(a) of the Regulation),

–    the place of production ‘EU Agriculture’ or ‘non-EU Agriculture’ (Article 32(2) of the Regulation),

–    the term ‘bio’ (Article 30(2) of the Regulation), and

–    the reference ‘from organic production’ (Article 30(1) of the Regulation),

be affixed on the outer packaging of a medicinal product without the conditions of Article 62 of the Community code having to be fulfilled?

If the first or second question is answered in the negative:

Is the labelling that is specified in the second question labelling that is ‘useful for the patient’ and is not ‘of a promotional nature’?

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¹ Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67).

¹ Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ 2004 L 136, p. 85).

¹ Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ 2018 L 150, p. 1).