1. This reference for a preliminary ruling concerns the interpretation of the fourth paragraph of Article 249 EC, of Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ 1997 L 43, p. 1), and also of Commission Decision 2000/196/EC of 22 February 2000 refusing the placing on the market of ‘ Stevia rebaudiana Bertoni: plants and dried leaves’ as a novel food or novel food ingredient under Regulation No 258/97 (OJ 2000 L 61, p. 14).
2. The reference has been made in proceedings between Mensch und Natur AG (‘Mensch und Natur’) and the Freistaat Bayern (Free State of Bavaria) concerning the prohibition in Germany on the placing on the market of certain products marketed by that company, on the ground that the composition of those products includes Stevia rebaudiana Bertoni (‘stevia’). Legal context European Union law Regulation No 258/97
3. Recitals 1 and 2 in the preamble to Regulation No 258/97 are worded as follows: ‘(1) … differences between national laws relating to novel foods or food ingredients may hinder the free movement of foodstuffs; … they may create conditions of unfair competition, thereby directly affecting the functioning of the internal market; (2) … in order to protect public health, it is necessary to ensure that novel foods and novel food ingredients are subject to a single safety assessment through a Community procedure before they are placed on the market within the Community; …’
4. Article 1 of that regulation provides: ‘1. This Regulation concerns the placing on the market within the Community of novel foods or novel food ingredients. 2. This Regulation shall apply to the placing on the market within the Community of foods and food ingredients which have not hitherto been used for human consumption to a significant degree within the Community and which fall under the following categories: … (e) foods and food ingredients consisting of or isolated from plants and food ingredients isolated from animals, except for foods and food ingredients obtained by traditional propagating or breeding practices and having a history of safe food use; … 3. Where necessary, it may be determined in accordance with the procedure laid down in Article 13 whether a type of food or food ingredient falls within the scope of paragraph 2 of this Article.’
5. Article 3 of Regulation No 258/97 provides: ‘1. Foods and food ingredients falling within the scope of this Regulation must not: - present a danger for the consumer, - mislead the consumer, - differ from foods or food ingredients which they are intended to replace to such an extent that their normal consumption would be nutritionally disadvantageous for the consumer. 2. For the purpose of placing the foods and food ingredients falling within the scope of this Regulation on the market within the Community, the procedures laid down in Articles 4, 6, 7 and 8 shall apply on the basis of the criteria defined in paragraph 1 of this Article and the other relevant factors referred to in those Articles. …’
6. Under Article 4 of Regulation No 258/97: ‘1. The person responsible for placing on the Community market (hereinafter “the applicant”) shall submit a request to the Member State in which the product is to be placed on the market for the first time. At the same time, he shall forward a copy of the request to the Commission. 2. An initial assessment as provided for in Article 6 shall be carried out. Following the procedure referred to in Article 6(4), the Member State referred to in paragraph 1 shall inform the applicant without delay: - that he may place the food or food ingredient on the market, where the additional assessment referred to in Article 6(3) is not required, and that no reasoned objection has been presented in accordance with Article 6(4), or - that, in accordance with Article 7, an authorisation decision is required. 3. Each Member State shall notify to the Commission the name and address of the food assessment bodies responsible in its territory for preparing the initial assessment reports referred to in Article 6(2). 4. Before the date of entry into force of this Regulation, the Commission shall publish recommendations concerning the scientific aspects of: - the information necessary to support an application and the presentation of such information, - the preparation of the initial assessment reports provided for in Article 6. …’
7. Article 6 of that regulation provides: ‘1. The request referred to in Article 4(1) shall contain the necessary information, including a copy of the studies which have been carried out and any other material which is available to demonstrate that the food or food ingredient complies with the criteria laid down in Article 3(1), as well as an appropriate proposal for the presentation and labelling, in accordance with the requirements of Article 8, of the food or food ingredient. In addition, the request shall be accompanied by a summary of the dossier. 2. Upon receipt of the request, the Member State referred to in Article 4(1) shall ensure that an initial assessment is carried out. To that end, it shall notify the Commission of the name of the competent food assessment body responsible for preparing the initial assessment report, or ask the Commission to arrange with another Member State for one of the competent food assessment bodies referred to in Article 4(3) to prepare such a report. The Commission shall forward to the Member States without delay a copy of the summary provided by the applicant and the name of the competent body responsible for carrying out the initial assessment. 3. The initial assessment report shall be drawn up within a period of three months from receipt of a request meeting the conditions laid down in paragraph 1, in accordance with the recommendations referred to in Article 4(4), and shall decide whether or not the food or food ingredient requires additional assessment in accordance with Article 7. 4. The Member State concerned shall without delay forward the report of the competent food assessment body to the Commission, which shall forward it to the other Member States. Within a period of 60 days from the date of circulation of the report by the Commission, a Member State or the Commission may make comments or present a reasoned objection to the marketing of the food or food ingredient concerned. The comments or objections may also concern the presentation or labelling of the food or food ingredient. Comments or objections shall be forwarded to the Commission, which shall circulate them to Member States within the period of 60 days referred to in the first subparagraph. The applicant shall, where a Member State so requests, provide a copy of any pertinent information appearing in the request.’
8. Article 7 of Regulation No 258/97 provides: ‘1. Where an additional assessment is required in accordance with Article 6(3) or an objection is raised in accordance with Article 6(4), an authorisation decision shall be taken in accordance with the procedure laid down in Article 13. 2. The decision shall define the scope of the authorisation and shall establish, where appropriate: - the conditions of use of the food or food ingredient, - the designation of the food or food ingredient, and its specification, - specific labelling requirements as referred to in Article 8. 3. The Commission shall without delay inform the applicant of the decision taken. Decisions shall be published in the Official Journal of the European Communities .’
9. Article 13 of Regulation No 258/97provides: ‘1. Where the procedure defined in this Article is to be implemented, the Commission shall be assisted by the Standing Committee for Foodstuffs, hereinafter referred to as the “Committee”. 2. Matters shall be referred to the Committee by the Chairman either on his own initiative or at the request of the representative of a Member State. 3. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time-limit which the Chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in [Article 205(2) EC] in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote. 4. (a) \tThe Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee. …’
10. In accordance with Article 15 of Regulation No 258/97, that regulation entered into force 90 days following its publication in the Official Journal of the European Communities . Decision 2000/196
11. The third citation in the preamble to Decision 2000/196 refers to ‘the request submitted by Professor J. Geuns of the KUL Laboratory of Plant Physiology to the Belgian competent authorities on 5 November 1997 for placing “[stevia]: plants and dried leaves” on the market as a novel food or novel food ingredient’.
12. The recitals in the preamble to Decision 2000/196 read as follows: ‘(1) The initial assessment report drawn up by the Belgian competent authorities concluded that, based on the information provided, the product should not receive an authorisation to be placed on the market. (2) The applicant, in reaction to the initial assessment report, had provided supplemen tary documentation to the Commission, who brought this information to the attention of the Member States and the Scientific Committee for Food. (3) An additional assessment was carried out in accordance with Article 7 of [Regulation No 258/97]. The Scientific Committee for Food adopted an opinion on 17 June 1999 which essentially confirmed the initial assessment report. (4) [Stevia]: plants and dried leaves, are a novel food in the sense of Regulation … No 258/97. [Since it] has not been demonstrated that the product complies with the criteria laid down in Article 3(1) of the Regulation, it shall not be placed on the market in the Community. (5) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee for Foodstuffs.’
13. Articles 1 and 2 of Decision 2000/196 provide: ‘Article 1 “[Stevia]: plants and dried leaves” may not be placed on the Community market as [a] food or food ingredient. Article 2 This Decision is addressed to Professor J. Geuns, KUL, Laboratory of Plant Physiology, Kardinaal Mercierlaan 92, 3001 Heverlee, Belgium.’ National law
14. Under Paragraph 2(1)(1) of the Bavarian Law on inspection of foodstuffs (Bayerisches Lebensmittelüberwachungsgesetz) of 11 November 1997, the authorities may, in the performance of their duties, take individual decisions in order to prevent or impede infringement of the provisions of legislation on foodstuffs.
15. Paragraph 3(1) of the Regulation on novel foods and novel food ingredients (Neuartige Lebensmittel- und Lebensmittelzutaten-Verordnung) provides that foods and food ingredients within the meaning of Article 1(2) of Regulation No 258/97 may not be placed on the market by the person responsible for such placing unless authorisation has been granted under the procedures referred to in Article 3(2) of that regulation. The facts in the main proceedings and the questions referred for a preliminary ruling
16. Mensch und Natur produces and markets a number of varieties of tea. In some of those varieties extracts of stevia leaves are used as sweeteners.
17. In Decision 2000/196, the Commission decided that stevia could not be placed on the market in the European Union as a food or food ingredient. That decision was taken following the request submitted by Professor Geuns, to whom the decision is addressed.
18. By decision of 8 April 2003 addressed to Mensch und Natur, the Landratsamt Bad Tölz-Wolfratshausen (district administration, Bad Tölz-Wolfratshausen) prohibited the marketing of several tea varieties, on pain of an administrative fine.
19. In that decision, that authority found that the application for authorisation of stevia as a novel food had been rejected by Decision 2000/196, which required all Member States to prohibit the marketing of that substance. It also found that Mensch und Natur had not demonstrated that the tea varieties in question had already been marketed in the European Union for human consumption to a significant degree before Regulation No 258/97 entered into force on 15 May 1997.
20. Mensch und Natur brought an action against the decision of 8 April 2003 of the Landratsamt Bad Tölz-Wolfratshausen before the Verwaltungsgericht München (Administrative Court, Munich), submitting that its predecessors had developed products containing stevia as early as the beginning of the 1990s and that significant quantities of those products had been placed on the European Union (‘EU’) market prior to 15 May 1997, by way of mail-order sales and through health food shops. Mensch und Natur further submitted that Decision 2000/196 had no binding effect in relation to it.
21. The Verwaltungsgericht München upheld that action by judgment of 13 May 2004.
22. The Freistaat Bayern appealed against that judgment to the Bayerischer Verwaltungsgerichtshof (Bavarian Higher Administrative Court).
23. Taking the view that it was necessary to obtain certain clarifications on the interpretation of EU law in order for it to rule in the case, the Bayerischer Verwaltungsgerichtshof decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling: ‘1. Does the fourth paragraph of Article 249 EC preclude a Commission decision which, according to its wording, is addressed to a particular person from being interpreted as being also binding on other undertakings which, according to the spirit and purpose of [that] decision, are to be treated in the same way? 2. Is [Decision 2000/196], under Article 1 of which [stevia] may not be placed on the Community market as a food or food ingredient, also binding on [Mensch und Natur] which at present places [it] on the Community market?’ Consideration of the questions referred
24. By its two questions, which it is appropriate to consider together, the national court requests the Court, essentially, to clarify the legal effects of a Commission decision, taken on the basis of Article 7 of Regulation No 258/97, refusing authorisation to place a product on the EU market as a food or food ingredient.
25. The fourth paragraph of Article 249 EC provides that ‘[a] decision shall be binding in its entirety upon those to whom it is addressed’. That provision has now become the fourth paragraph of Article 288 TFEU, which provides that ‘[a] decision shall be binding in its entirety. A decision which specifies those to whom it is addressed shall be binding only on them’.
26. The nature of the procedure established by Regulation No 258/97 also precludes an expansive interpretation concerning the addressees of a decision taken pursuant to that measure.
27. It should be observed in that regard, first, that that regulation is applicable only to novel foods and novel food ingredients within the meaning of Article 1(2) thereof. Classification as such depends on whether or not human consumption of those foods or food ingredients was or was not significant in the European Union prior to the entry into force of that regulation.
28. Article 1(3) of Regulation No 258/97 introduces merely the possibility of determining, ‘where necessary’, whether a type of food or food ingredient falls within the scope of that regulation under what is known as the ‘comitology’ procedure laid down in Article 13 thereof (see Case C‑383/07 M‑K Europa [2009] ECR I‑115, paragraph 40). However, it is not incumbent on an undertaking to initiate the procedure laid down in Article 13 ( M‑K Europa , paragraph 43).
29. Second, a Commission decision refusing authorisation to place a product on the market is based essentially on a request by a person concerning the placing of the product in question on the market and on the information provided by that person, as follows from, inter alia, Articles 4(1) and 6(1) of Regulation No 258/97.
30. It does not appear conclusively from the text of Decision 2000/196 that the Commission examined the question of whether or not human consumption of the product concerned was significant within the European Union prior to the entry into force of that regulation.
31. On the other hand, the Member States, which are bound by the obligation of sincere cooperation expressed in Article 10 EC and, currently, Article 4(3) TEU, must comply with Regulation No 258/97 and, consequently, ensure that a food or food ingredient which is ‘novel’ within the meaning of Article 1(2) of that regulation and for that reason comes within its scope is not marketed on their territory in the absence of a determination by the competent authority of the Member State concerned that no authorisation is required under Article 4 of that regulation and, where relevant, in the absence of authorisation from the Commission under Article 7 thereof.
32. Under Article 7(3) of Regulation No 258/97, decisions taken pursuant to that article must be published in the Official Journal of the European Union .
33. In those circumstances, when the authorities of a Member State have in their possession information to the effect that products are being marketed in their territory the characteristics of which appear to match those of products for which marketing authorisation in the European Union has been refused by the Commission, they must establish the circumstances of that marketing on the basis of the provisions of that regulation and, where necessary, prevent the marketing of those products.
34. First of all, their task consists in determining whether or not the product in question is a novel food or novel food ingredient within the meaning of Article 1(2) of Regulation No 258/97 by giving the party concerned the opportunity to prove that that product was marketed to a significant degree in the European Union prior to the entry into force of that regulation.
35. Next, if it established that that product is a novel food or novel food ingredient, the competent authority of the Member State concerned must take the measures necessary to ensure that the provisions of Regulation No 258/97 are actually applied, which may include an order requiring the party concerned to submit a request pursuant to Article 4 of that regulation in order to be able to continue to market that product.
36. In the light of the foregoing, the answer to the questions referred is that a Commission decision taken on the basis of Article 7 of Regulation No 258/97 and refusing authorisation to place on the market of the European Union a food or food ingredient is not binding on any persons other than the person or persons whom that decision specifies as its addressees. By contrast, the competent authorities of a Member State must ascertain whether a product marketed in the territory of that Member State, the characteristics of which appear to match those of the product which was the subject-matter of that Commission decision, is a novel food or novel food ingredient within the meaning of Article 1(2) of that regulation and, where necessary, they must require the person concerned to comply with the provisions of that regulation. Costs
37. Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.