CELEX:62023CC0618: Opinion of Advocate General Campos Sánchez-Bordona delivered on 30 January 2025. SALUS Haus Dr. med Otto Greither Nachf. GmbH & Co. KG v Astrid Twardy GmbH. Request for a preliminary ruling from the Oberlandesgericht Düsseldorf. Reference for a preliminary ruling – Medicinal products for human use – Directive 2001/83/EC – Article 1(29) – Article 16a – Traditional herbal medicinal products – Articles 62 – Information which is useful to the patient – Regulation (EU) 2018/848 – Article 2(1) – Scope – Indications on the outer packaging of a medicinal herbal tea – Use of terms referring to organic production. Case C-618/23.

Campos Sánchez‑Bordona
delivered on 30 January 2025

Case C‑618/23
SALUS Haus Dr. med. Otto Greither Nachf. GmbH & Co. KG v Astrid Twardy GmbH
(Request for a preliminary ruling from the Oberlandesgericht Düsseldorf)
(Reference for a preliminary ruling – Medicinal products for human use – Labelling of organic products – Indications on the outer packaging of a medicinal herbal tea – Use of terms referring to organic production)

1.	In 1991, the European Union adopted Regulation (EEC) No 2092/91 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs. That regulation, which was amended on numerous occasions, was succeeded by Regulation (EC) No 834/2007 and the latter from 1 January 2021, by Regulation (EU) 2018/848, which repeals the preceding regulation.
2.	In 2001, Directive 2001/83/EC establishing the Community code relating to medicinal products for human use was also adopted and was subsequently amended.
3.	Regulation 2018/848 and Directive 2001/83 are the legislative acts the interpretation of which has been requested by the referring court.
4.	While the Court has already ruled with regard to Regulation 2018/848, new questions are raised in this case. Against a backdrop of increased supply of, and demand for, organic products, the relationship between the labelling of medicinal products for human use and that of organic products is considered.
5.	Indeed, in addition to the rules on organic production, Regulation 2018/848 contains those relating to the labelling of organic products. The debate revolves around the application of the latter rules to traditional herbal medicinal products.

I. Legal context

A. European Union law

1. Directive 2001/83

6.	In Title I (‘Definitions’), Article 1(29) states: “For the purposes of this Directive, the following terms shall bear the following meanings: … 29. Traditional herbal medicinal product: a herbal medicinal product that fulfils the conditions laid down in Article 16a(1);”
7.	In Title II (‘Scope’) Article 2 provides, in paragraph 2: “In cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a ‘medicinal product’ and within the definition of a product covered by other Community legislation the provisions of this Directive shall apply.”
8.	In Chapter 2a (‘Specific provisions applicable to traditional herbal medicinal products’) of Title III (‘Placing on the market’), Article 16a(1) states: “A simplified registration procedure (hereinafter ‘traditional‑use registration’) is hereby established for herbal medicinal products which fulfil all of the following criteria: (a) they have indications exclusively appropriate to traditional herbal medicinal products …; (b) they are exclusively for administration in accordance with a specified strength and posology; (c) they are an oral, external and/or inhalation preparation; (d) the period of traditional use as laid down in Article 16c(1)(c) has elapsed; (e) the data on the traditional use of the medicinal product are sufficient; in particular the product proves not to be harmful …”
9.	Article 62, in Title V (‘Labelling and package leaflet’), states: “The outer packaging and the package leaflet may include symbols or pictograms designed to clarify certain information … and other information compatible with the summary of the product characteristics which is useful for the patient, to the exclusion of any element of a promotional nature.”

2. Regulation 2018/848

10.	Recital 10 reads: “Experience gained so far with the application of Regulation (EC) No 834/2007 shows the need to make clear to which products this Regulation applies. Primarily, it should cover products originating from agriculture … It should also cover processed agricultural products for use as food or feed because the placing of such products on the market as organic products provides a major outlet … For reasons of clarity, such other products not listed in Annex I to the TFEU should be listed in an Annex to this Regulation.”
11.	Recital 16 states: “This Regulation should apply without prejudice to related legislation, in particular in the fields of safety of the food chain, animal health and welfare, plant health, plant reproductive material, labelling and the environment.”
12.	In Chapter I (‘Subject matter, scope and definitions’), Article 2 (‘Scope’) states: “1. This Regulation applies to the following products originating from agriculture, including aquaculture and beekeeping, as listed in Annex I to the TFEU and to products originating from those products, where such products are, or are intended to be, produced, prepared, labelled, distributed, placed on the market, imported into or exported from the Union: (a) live or unprocessed agricultural products, including seeds and other plant reproductive material; (b) processed agricultural products for use as food; (c) feed. This Regulation also applies to certain other products closely linked to agriculture listed in Annex I to this Regulation …”
13.	Article 30 (‘Use of terms referring to organic production’) states: “1. For the purposes of this Regulation, a product shall be regarded as bearing terms referring to organic production where, in the labelling, advertising material or commercial documents, such a product … is described in terms suggesting to the purchaser that the product … has been produced in accordance with this Regulation. In particular, the terms listed in Annex IV and their derivatives and diminutives, such as ‘bio’ and ‘eco’, may be used … 2. For the products referred to in Article 2(1), the terms … shall not be used … for a product which does not comply with this Regulation. Furthermore, no terms … shall be used … if they are liable to mislead the consumer …”
14.	Article 32 (‘Compulsory indications’) provides: “1. Where products bear terms as referred to in Article 30(1), including products labelled as in‑conversion products …: (a) the code number of the control authority or control body … shall also appear in the labelling; (b) in the case of pre‑packed food, the organic production logo of the European Union … shall also appear on the packaging … 2. Where the organic production logo of the European Union is used, an indication of the place where the agricultural raw materials … shall appear in the same visual field as the logo.”
15.	Article 33 (‘Organic production logo of the European Union’) states: “1. The organic production logo of the European Union may be used in the labelling, presentation and advertising of products which comply with this Regulation.”
16.	Annex I (‘Other products referred to in Article 2(1)’) contains the entry: “– plant‑based traditional herbal preparations.”
17.	Annex V (‘Organic production logo of the European Union and code numbers’) contains detailed provisions on the presentation of the logo and the format of the code numbers.

B. German law

18.

In accordance with Paragraph 10(1), fifth sentence, of the Arzneimittelgesetz (Law on medicinal products) transposing Article 62 of Directive 2001/83: “Additional information which is not provided for in a regulation of the European Community or European Union or which is not already permitted pursuant to such a regulation shall be permitted in so far as it is related to the use of the medicinal product, is useful for the patient’s health education and does not conflict with the information referred to in Paragraph 11a.”

II. Facts, dispute and questions referred for a preliminary ruling

19.	Astrid Twardy GmbH (‘Twardy’) and SALUS Haus Dr. med. Otto Greither Nachf. GmbH & Co. KG (‘SALUS’) market, inter alia, traditional herbal medicinal products.
20.	SALUS’s product portfolio currently includes the ‘Salus sage leaf medicinal tea’. The company also plans to bring to market an ‘organic nerve‑calming tea’ and an ‘alchemilla’ tea.
21.	Appearing on the outer packaging of the ‘Salus sage leaf medicinal tea’ is the official logo of the European Union, the code number of the control body and the indication ‘non‑EU Agriculture’. The packaging of the ‘organic nerve‑calming tea’ will carry the official logo, a ‘bio’ (organic production) logo belonging to SALUS, the code number of the control body and the indication ‘from organic farming’. The ‘alchemilla’ tea will also carry the official logo and the code number of the control body on its packaging, as well as the indication ‘EU Agriculture’.
22.	Twardy maintains that placing those elements on the outer packaging of the products at issue constitutes an infringement of Paragraph 10(1), fifth sentence, of the Law on medicinal products. It therefore brought an action against SALUS seeking an injunction, information, determination of the obligation to pay damages and reimbursement of the expenses for the formal notice served.
23.	SALUS contested the claim, relying on the provisions of Regulation 2018/848.
24.	On 7 June 2023, the Landgericht Düsseldorf (Regional Court, Düsseldorf, Germany) ordered SALUS to refrain, in the course of trade, from marketing the products at issue and to pay the expenses for the formal notice served. With regard to the infusion ‘sage leaf medicinal tea’, it ordered SALUS to provide certain information. The judgment also ordered the payment of damages.
25.	For the court of first instance: – All of the indications at issue are unlawful pursuant to Paragraph 10(1), fifth sentence, of the Law on medicinal products. – The term ‘regulation of the European Community or European Union’, appearing in the first alternative of that provision, only refers to regulations relating to medicinal products, which is not the case with Regulation 2018/848. – The question of whether Regulation 2018/848 is applicable in this case remains open, as the provisions on labelling in the legislation on medicinal products take precedence over it – even more so when the indications which it regulates are not mandatory. – SALUS cannot rely on the second alternative in Paragraph 10(1), fifth sentence, of the Law on medicinal products, as the indications referred to in Regulation 2018/848 are not directly connected with the taking of the medicinal product by the patient and are therefore not useful for the patient’s health.
26.	SALUS has lodged an appeal against the judgment at first instance, arguing that: – The material scope of Regulation 2018/848 has been extended, in comparison with the previous legislation, to include certain non‑food or feed products, namely ‘plant‑based traditional herbal preparations’, as ‘other products closely linked to agriculture’, provided for in Article 2(1) thereof, read together with Annex I. Consequently, the herbal teas at issue are included in it. – The provisions on labelling in Regulation 2018/848 and Directive 2001/83 apply simultaneously. – In any event, Article 62 of Directive 2001/83 and Paragraph 10(1), fifth sentence, of the Law on medicinal products should be interpreted as meaning that the labelling permitted by Regulation 2018/848 is ‘useful for the patient’.
27.	Twardy submits that the appeal should be dismissed. In its view, even if the material scope of Regulation 2018/848 also extended to ‘plant‑based traditional herbal preparations’, which are to be classified as medicinal products, Article 62 of Directive 2001/83 and Paragraph 10(1), fifth sentence, of the Law on medicinal products would take precedence. In order to protect the customer from excessive information on the outer packaging and in advertising, Article 62 of Directive 2001/83 must be interpreted restrictively, especially since there is no obligation to indicate the organic origin of the plants.
28.	Against that backdrop, the Oberlandesgericht Düsseldorf (Higher Regional Court, Düsseldorf, Germany), which has to determine the appeal, has referred the following questions to the Court of Justice for a preliminary ruling: (1) 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 to be regarded as “plant‑based traditional herbal preparations” within the meaning of Article 2(1) of, in conjunction with Annex I to, Regulation 2018/848? (2) If the first question is answered in the affirmative: Can the labelling provided for in Chapter IV of Regulation 2018/848, in particular – the official organic production logo of the European Union (Article 33), the company’s own organic production logo (Article 33(5)), the code number of the control body (Article 32(1)(a)), the place of production (“EU Agriculture” or “non‑EU Agriculture”) (Article 32(2)), the term “bio” (Article 30(2)), and the reference “from organic production” (Article 30(1)) – be affixed on the outer packaging of a medicinal product without the conditions of Article 62 of the Community code having to be fulfilled? (3) If the first or second question is answered in the negative: Is the labelling specified in the second question “useful for the patient” and not “of a promotional nature” within the meaning of Article 62 of the Community code?

III. Procedure before the Court

29.	The request for a preliminary ruling was received at the Court on 6 October 2023.
30.	Written observations have been submitted by Twardy, SALUS, the French and Italian Governments, and also the European Commission. All of them, with the exception of the Italian Government, attended the hearing held on 27 November 2024.

IV. Analysis

31.	For the purposes of this Opinion, I shall accept the premise underlying the order for reference: the disputed herbal teas fit the definition of ‘traditional herbal medicinal product’, within the meaning of Article 1(29) of Directive 2001/83.
32.	As medicinal products, those herbal teas are subject to the provisions on marketing laid down in Directive 2001/83.
33.	Starting from that premise, the referring court asks whether the herbal teas at issue would be able to make use of the rules on the specific labelling of products from organic farming (assuming, of course, that they satisfy the requirements of Regulation 2018/848): – because they are capable of being classified among the traditional herbal preparations included in the scope of Regulation 2018/848 and the provisions of that regulation should take precedence over those of Directive 2001/83; – or, alternatively, because the logos and particulars which, pursuant to Regulation 2018/848, the manufacturer intends to place on the packaging of the herbal teas comply with the labelling requirements of Directive 2001/83.
34.	The referring court wishes to know whether a ‘traditional herbal medicinal product’, within the meaning of Directive 2001/83, may, at the same time, be regarded as a ‘plant‑based traditional herbal preparation’ for the purposes of Regulation 2018/848.
35.	In my opinion, the answer is that it cannot. Regulation 2018/848 does not apply to traditional preparations based on (organically grown) plants that are ‘medicinal products’ within the meaning of Directive 2001/83.
36.	I do not, however, believe that either of the two arguments (recital 10 of Regulation 2018/848 and the similarity between the final indent of Annex I to Regulation 2018/848 and that of Article 1(32) of Directive 2001/83) is conclusive.
37.	Recital 10 of Regulation 2018/848 does not, of necessity, require the inclusion of medicinal products in that regulation. A ‘plant‑based traditional herbal preparation’, within the meaning of Regulation 2018/848, will only be a ‘traditional herbal medicinal product’ for the purposes of Directive 2001/83 if it also satisfies the conditions of Article 1(2) and (29) of that directive.
38.	The draft European Parliament legislative resolution on the proposal drawn up by the Commission accepted amendments 255 to 275, such that certain entries, relating to ‘other products referred to in Article 2(1)’ were removed from Annex I to the proposal, given that they would already be covered by the definition of ‘food’ in Article 3(21) of that same proposal, and other entries, which would not be encompassed by that definition, were added. According to amendment 275, one of them would be that relating to ‘plant‑based raw materials for traditional herbal medicinal products’.
39.	The final version of the text, however, did not include the reference to those medicinal products. The Council objected to that reference, precisely because the medicinal products in question were outside the scope of Regulation 2018/848.
40.	A later suggestion by the Parliament (to modify amendment 275, replacing the reference to ‘medicinal products’ with the formula ‘plant‑based raw materials for traditional herbal treatments’) was also rejected by the Council, as the term ‘treatment’ implied a medical use for the product.
41.	The formula ‘plant‑based traditional herbal preparations’, appearing in Annex I to Regulation 2018/848, reflects an inter‑institutional compromise. It does not include preparations which, fitting the definition given in Article 1(2) of Directive 2001/83, are medicinal products (specifically, plant‑based medicinal products).
42.	The interpretation proposed is also consistent with the European approach to regulating medicinal products, which tends to reject the double legal classification of products (and the consequent diversity of regimes) which fit the description of ‘medicinal product’.
43.	The Court has observed that, when the same product falls within the definition of a medical product and that of another product, the more rigorous rules relating to medicinal products apply.
44.	In short, in my view, the scope of Regulation 2018/848 does not include organically produced herbal teas having the status of ‘traditional herbal medicinal products’, within the meaning of Articles 1(29) and 16a of Directive 2001/83.
45.	The referring court poses its second question in the event that the preceding question is answered in the affirmative. As I have already proposed answering the first question in the negative, it would not be necessary to address the second.
46.	If, despite everything, the expression ‘plant‑based traditional herbal preparations’ were interpreted to include ‘medicinal products’, it would still be necessary to examine whether such an interpretation implied that Regulation 2018/848 and its rules on the labelling of organic products should displace Directive 2001/83.
47.	In that hypothetical situation, my answer would also be in the negative.
48.	Medicinal products are not like other products. They are not sold or consumed in the same way that organically grown products are sold and consumed. The way in which medicinal products are used is specific and their use is subject to special precautions relating to efficacy and safety.
49.	For the EU legislature, the peculiar nature of medicinal products resides in the objective of making their free movement compatible with that of ensuring a high level of human and public health protection (Article 168 TFEU). That statement is equally valid for all medicinal products, including traditional herbal medicinal products, whether they are organically grown or not.
50.	In view of the particular risks which they may pose, medicinal products are subject to a strict legal regime, which is more rigorous than that for other regulated products, such as, for example, food or cosmetics.
51.	In justifying the application of the legislation on medicinal products to products that, a priori, could also fall within another definition and be subject to other rules, the Court refers explicitly to the greater rigour of that legislation.
52.	The legislature modified Article 2(2) of Directive 2001/83, as I have already noted, such that, in cases of doubt as to the classification of a product with attributes of a medicinal product and of another class of products, only that directive applies.
53.	It is not plausible that that exclusive preference underlying Directive 2001/83, intended to support the objective of ensuring the protection of public health, should be altered by the fact that a medicinal product is obtained from organically grown plants.
54.	In my opinion, Regulation 2018/848 does not preclude the above.
55.	Regulation 2018/848, adopted years after Directive 2001/83, does not explicitly preserve the priority of the rules on the labelling of medicinal products contained in Directive 2001/83. However: – In accordance with Article 2(4) of that regulation, except where otherwise provided, it is to apply without prejudice to related EU legislation. It then lists fields in which legislation with those characteristics exists. Moreover, it does so in a manner that is not intended to be exhaustive, as may be deduced from the use of the expression ‘in particular’. – In Article 2(5), it states that it applies without prejudice to other specific provisions of EU law relating to the placing of products on the market. The paragraph makes express reference to two regulations: again, with the expression ‘in particular’, it makes it clear that it does so merely by way of example. – Recital 16 states that Regulation 2018/848 ‘should apply without prejudice to related legislation, in particular in the fields of safety of the food chain, animal health and welfare, plant health, plant reproductive material, labelling and the environment.’
56.	With regard to the placing of products on the market, Regulation 2018/848 is, then, not conceived to prevent the application of other preferable provisions of EU law. Among those provisions is, precisely, Directive 2001/83, which establishes the legal regime for medicinal products, including traditional herbal medicinal products.
57.	The third question referred is posed in the event that the first or (as I have proposed) the second question is answered in the negative. It must, therefore, be addressed.
58.	The referring court wishes to know whether the indications referred to in the labelling elements appearing in Chapter IV of Regulation 2018/848 satisfy the requirements of Article 62 of Directive 2001/83 and may, consequently, be placed on the outer packaging of the herbal teas at issue.
59.	According to Article 62 of Directive 2001/83, medical information may only be included in the package leaflet or placed on the outer packaging of a medicinal product if, cumulatively, that information: – is compatible with the summary of the product characteristics; – is useful for the patient; – is not of a promotional nature.
60.	It is my view that the third question referred must also be answered in the negative.
61.	Article 11 of Directive 2001/83 provides for the summary of product characteristics which, pursuant to Article 8(3)(j), is to accompany the application for authorisation to market medicinal products.
62.	The application for the simplified registration of a traditional herbal medicinal product, regulated in Chapter 2a of Title III (‘Placing on the market’) of Directive 2001/83, must also include that summary.
63.	I am inclined to think that the elements at issue in the dispute are not compatible with the summary of the medicinal product’s characteristics. The reason is not that those elements do not appear as such among the information required for that summary, but rather that the summary is to state the ‘qualitative and quantitative composition in terms of the active substances and constituents of the excipient, knowledge of which is essential for proper administration of the medicinal product’.
64.	By themselves, details regarding whether the plants on which the medicinal product is based are organically grown or not, or regarding where they were obtained, or the other indications at issue (logos and code numbers of control bodies), do not correspond materially to the information referred to in Article 11(2) of Directive 2001/83.
65.	It is not necessary to know any of those indications in order to administer the medicinal product correctly. On the other hand, their presence on the packaging of the product could suggest or evoke the impression of a higher quality product and, to the same extent, mislead the user regarding its therapeutic properties or serve to promote the product, contrary to the requirements of Article 62 of Directive 2001/83.
66.	The medical information authorised by Article 62 of Directive 2001/83 must be ‘useful for the patient’.
67.	The presence on the outer packaging of the medicinal product of information such as that at issue here (organic production logos and other similar logos) could produce a confusing effect: the patient would be confronted with an inflation of information, with references of various kinds, among which he or she would hardly be able to distinguish the relevant information, in therapeutic terms, from that with no bearing on his or her health.
68.	Placing the indications at issue here on the packaging of the medicinal product could, moreover, give rise to the risk of two other errors on the part of the patient: – the equating of the medicinal products with organic consumer products on which, generally speaking, those particulars appear; – the belief that the preparation has greater therapeutic efficacy. It should not be forgotten that the purchase of a traditional herbal medicinal product is possible (and usually occurs) without a prescription, i.e. without the prior involvement of a healthcare professional.
69.	In the light of recital 40 of Directive 2001/83, it is my view that information that is ‘useful for the patient’ is that which illustrates how to use the product correctly. The objective stated in that recital is to protect the patient, offering him or her ‘full and comprehensible’ indications, with a specific purpose – that of ensuring the medicinal product is used correctly. The purchaser, I repeat, is considered in the capacity of patient, which is not the same as that of any other consumer.
70.	The original wording of Article 62 of Directive 2001/83 required additional information in the package leaflet or on the outer packaging to be useful ‘for health education’, as opposed to the current ‘useful for the patient’. The reformulation was intended to improve the wording of the text: it did not alter its purpose of informing the patient, in his or her capacity as such.
71.	It is not useful for the patient, in therapeutic terms, to know whether or not the plants on which the medicinal product is based are organically grown or where they were obtained.
72.	Article 62 of Directive 2001/83 authorises the placing of certain indications on the outer packaging and in the package leaflet of the medicinal product ‘[excluding] any element of a promotional nature’.
73.	In my opinion, the addition of an indication to the labelling that is not useful for the correct use of the medicinal product by the patient suggests that that indication is probably of a promotional nature.
74.	Article 86(2) of Directive 2001/83 states that Title VIII (‘Advertising’) does not cover either labelling or the package leaflet. That exclusion is logical, as labelling and the package leaflet are governed by Title V, which specifically prohibits placing promotional information on them.
75.	However, the case‑law established with regard to the provisions of Title VIII may be useful in relation to Article 62 of Directive 2001/83, for the sole purpose of clarifying what messages or content are promotional in relation to medicinal products.
76.	Article 86(1) of Directive 2001/83 defines advertising as “any form of door‑to‑door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products”.
77.	The definition applies to all medicinal products. However, the rules relating to advertising aimed at the general public vary: advertising medicinal products only available on prescription to the general public is prohibited; medicinal products available without a prescription may be advertised, although subject to conditions and restrictions.
78.	The judgment of MSD Sharp & Dohme showed that purely objective information may also have promotional intent. The Court observed that, in order to classify the dissemination of information as ‘promotional’, the following were useful indicators: – the identity of the person disseminating the information; – the purpose of the communication; – its content; – possibly other factors, such as the media used and the groups addressed.
79.	The Court concluded that the labelling elements regulated in Chapter IV of Regulation 2018/848 are promotional in nature when: – those elements or indications have no value in healthcare terms; – purchasing the medicinal product is possible without a prescription; – the elements provided for in Chapter IV of Regulation 2018/848 do not equate to any of those provided for in the summary of the product characteristics, but are in addition to them; – the information is easily accessed by the general public.
80.	In short, it is my view that the labelling elements regulated in Chapter IV of Regulation 2018/848 do not satisfy the conditions laid down in Article 62 of Directive 2001/83 and cannot, therefore, be placed on the outer packaging of a traditional herbal medicinal product.

V. Conclusion

In the light of the foregoing, I propose that the response to the Oberlandesgericht Düsseldorf (Higher Regional Court, Düsseldorf, Germany) should be as follows:

1. Herbal teas classified as “traditional herbal medicinal products” within the meaning of Articles 1(29) and 16a of Directive 2001/83 cannot be regarded as ‘plant‑based traditional herbal preparations’ for the purposes of Article 2(1) of Regulation 2018/848 (together with Annex I).
2. The rules on labelling set out in Chapter IV of Regulation 2018/848 do not take precedence over the provisions on labelling in Directive 2001/83.
3. The labelling elements provided for in Chapter IV of Regulation 2018/848 do not satisfy the conditions laid down in Article 62 of Directive 2001/83.