62009CC0327_EN
Opinion of the Advocate-General
Opinion of the Advocate-General
I – Introduction
1. The reference for a preliminary ruling from the Bayerischer Verwaltungsgerichtshof (Administrative Court, Bavaria) (Germany) concerns, essentially, the system established by Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients, (2) as well as 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 in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council. (3)
2. That reference was made in the context of a dispute 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 grounds that those products contained ‘ Stevia rebaudiana
Bertoni: plants and dried leaves’ (‘stevia’), which the Commission of the European Communities had determined by Decision 2000/196, not addressed to Mensch und Natur, was a novel food that could not be placed on the Community market as it did not comply with the criteria laid down in Regulation No 258/97.
3. In the observations submitted in this case, neither party disputes that a Commission decision has no general application and in principle binds only its addressees. The question referred to the Court therefore concerns the legal effects which Regulation No 258/97 and Commission decisions adopted pursuant thereto have on the administrative and judicial authorities of Member States.
II – Legal framework
A – Community law
1. The EC Treaty
4. The first paragraph of Article 249 EC states that ‘[i]n order to carry out their task and in accordance with the provisions of this Treaty, the European Parliament acting jointly with the Council, the Council and the Commission shall ... take decisions …’. The fourth paragraph of Article 249 EC states that ‘[a] decision shall be binding in its entirety upon those to whom it is addressed’. (4)
2. Regulation No 258/97
5. 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 …’.
6. Article 1 of Regulation No 258/97 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.’
7. Article 3(1) of that same regulation 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.’
8. The procedure for authorising the placing on the market of products coming within the scope of the regulation comprises, inter alia, the following steps, provided for in Articles 4, 6 and 7 of Regulation No 258/97:
‘Article 4
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.
…
Article 6
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. …
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 decide whether or not the food or food ingredient requires additional assessment in accordance with Article 7.
4. ... 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. …
Article 7
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 labeling 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 258/97 provides:
‘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) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.
…’
3. Decision 2000/196
10. The third citation of Decision 2000/196 states:
‘Having regard 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 rebaudiana Bertoni: plants and dried leaves on the market as a novel food or novel food ingredient’.
11. The recitals of 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 supplementary 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 the Regulation. The Scientific Committee for Food adopted an opinion on 17 June 1999 which essentially confirmed the initial assessment report.
(4) Stevia rebaudiana Bertoni: plants and dried leaves, are a novel food in the sense of Regulation (EC) 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.’
12. Articles 1 and 2 of Decision 2000/196 provide as follows:
‘Article 1
“Stevia rebaudiana Bertoni: 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.’
13. The title of Decision 2000/196 is followed by the words: ‘Only the Dutch text is authentic’.
B – National law
14. Under Paragraph 2(1)(1) of the Bavarian Law on inspection of foodstuffs (Bayerisches Lebensmittelüberwachungsgesetz) of 11 November 1997, (5) the authorities may, in the performance of their duties, take individual decisions in order to prevent or impede infringement of the legislative provisions on foodstuffs.
15. Paragraph 3(1) of the Regulation on novel foods and food ingredients (Neuartige Lebensmittel- und Lebensmittelzutaten-Verordnung) (6) 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 without an authorisation granted under the procedures provided for in Article 3(2) of that regulation.
III – Facts in the main proceedings and questions referred for a preliminary ruling
16. The order for reference indicates that Mensch und Natur produces and markets different varieties of tea. In certain tea varieties, extracts of stevia leaves, originating from South America, 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, who is the addressee of the decision.
18. By decision of 8 April 2003, addressed to Mensch und Natur, the Landratsamt Bad Tölz-Wolfratshausen (district administration, Bad Tölz-Wolfratshausen) prohibited the sale of a number of tea varieties, subject to an administrative fine of EUR 500.
19. The Landratsamt stated, in its decision of 8 April 2003, that the authorisation of stevia as a novel food had been refused by Decision 2000/196, which required all Member States to prohibit the marketing thereof. It found that Mensch und Natur had not demonstrated that the tea varieties in question had already been marketed in the Community for human consumption to a significant degree before the entry into force of Regulation No 258/97 on 15 May 1997.
20. Mensch und Natur brought an action against the decision of 8 April 2003 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 it had placed hundreds of thousands of those products on the Community market before 15 May 1997, by mail order and through health food shops. The Mensch und Natur company further submitted that Decision 2000/196 had no binding effect on it.
21. The Verwaltungsgericht München upheld that action by judgment of 13 May 2004.
22. The Freistaat Bayern appealed against that judgment before the Bayerischer Verwaltungsgerichtshof.
23. Taking the view that it was necessary to obtain certain clarifications on European Union law in order to make a ruling in the case, the Bayerischer Verwaltungsgerichtshof decided to stay the proceedings and to refer the following questions to the Court 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 the decision, are to be treated in the same way?
(2) Is the 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 and Natur] which at present places [it] on the Community market?’
IV – Analysis
A – Preliminary remarks
24. It should be remembered that Regulation No 258/97 pursues a twofold objective, consisting in ensuring the functioning of the internal market in novel foods and in protecting public health against the risks to which they may give rise. (7)
25. That regulation is designed to establish within the Community common standards in the field of novel foods and novel food ingredients, in particular, as stated in recital 2, by introducing a single safety assessment of such foods and food ingredients through a Community procedure before they are placed on the Community market. (8)
26. The placement of a novel food or novel food ingredient on the market, as defined in Article 1(2) of Regulation No 258/97, requires either an authorisation or a decision addressed to the applicant to the effect that no authorisation is required. To that end, the person responsible for placing on the Community market must 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 must forward a copy of the request to the Commission.
27. An initial assessment is carried out in accordance with Article 6 of Regulation No 258/97. Following the procedure referred to in Article 6(4), the Member State referred to in Article 6(1) is to inform the applicant without delay:
– that he may place the food or the food ingredient on the market, where the additional assessment referred to in Article 6(3) is not required and no reasoned objection has been made in accordance with Article 6(4),
or
– that, in accordance with Article 7, an authorisation decision is required.
28. A notification may lead either to a national decision or to a Commission decision, as the case may be.
29. Under the current system, every decision authorising or prohibiting a novel food or novel food ingredient is an individual decision taken either by the Member State or by the Commission. Moreover, it seems to me that the decision is taken on the basis of information contained in the dossier submitted by the applicant, without any interested third parties being invited to submit comments.
B – Consideration of the questions referred
30. After having examined the order for reference and the observations submitted, I take the view that there is no need to undertake an in-depth analysis of the scope of the concept of decision within the meaning of the fourth paragraph of Article 249 EC in order to give a useful answer to the questions referred. The answer follows from an analysis of the system for monitoring placement on the market provided for by Regulation No 258/97.
31. The two questions referred can be grouped together. The referring court asks, essentially, whether a Commission decision, such as that of 22 February 2000, taken under Regulation No 258/97 and relating to a refusal to authorise a placing on the market, precludes the authority of a Member State from examining, in subsequent administrative or judicial proceedings, whether the food or food ingredient that was the subject-matter of the individual decision was placed on the market to a significant degree by another person before the entry into force of that regulation, in order to establish whether or not the food or food ingredient comes within the scope of that regulation.
1. The system established by Regulation No 258/97
32. Under the system established by Regulation No 258/97, the placing on the market of foods as defined in Article 1(2) must be the subject-matter of a prior authorisation under Article 4(1). In reality, this obligation to submit a notification and request for authorisation constitutes an implicit prohibition on unauthorised placing on the market of a novel food or novel food ingredient.
33. At present, no explicit prohibition on placing novel foods and novel food ingredients on the market is laid down in Regulation No 258/97 itself; rather, it is to be found in the national laws that set out the detailed rules for its implementation. (9) I would point out that a future system proposed by the Commission does introduce such a prohibition. (10)
34. Two observations must be made. On the one hand, if a food or food ingredient does not come within the scope of Regulation No 258/97 (for example, because its human consumption was significant before the entry into force of that regulation), (11) no notification or authorisation is required thereunder. On the other hand, if a food or food ingredient does meet the definition laid down in Regulation No 258/97, it cannot be placed on the market without authorisation or a decision to the effect that no authorisation is required. (12)
35. A request for authorisation may lead to an administrative decision that either grants or refuses the authorisation requested. If authorisation is not granted, the general rule provided for in Regulation No 258/97 applies, namely, the prohibition on placing a product falling within the scope of that regulation on the market. It makes little difference, moreover, whether the Commission has taken a positive or negative decision following a request for authorisation concerning the same food or food ingredient made by another applicant: Mensch und Natur would still have to submit its own request for authorisation to the authorities under Regulation No 258/97.
36. It follows that Mensch und Natur’s legal position is not affected by a positive or a negative decision by the Commission addressed to another person. On the other hand, if the procedure provided for by the regulation had led to the finding by the national authority or by the Commission that stevia was not a novel food, Mensch und Natur could have relied on that fact before any national authority .
37. Next, it is appropriate to examine which questions have been resolved by the Commission decision. As is often the case with administrative decisions, it sets out a certain description of the facts and determines the consequences which, in its assessment, follow under the applicable regulatory framework.
38. The categorisation of stevia as a novel food within the meaning of Regulation No 258/97 was established in recital 4 of Decision 2000/196.
39. It is on that basis that the Commission examined the request to place the product in question on the market and found that, in the absence of sufficient information about its safety, an authorisation under the regulation could not be granted. (13)
2. The legal effects of Decision 2000/196
40. The principal legal effect of Decision 2000/196 is that there is no positive decision authorising the placing of the product in question on the market. The addressee of that decision is prevented from placing the product on the market as a novel food. The direct consequence of there being no positive decision is that the prohibition provided for by Regulation No 258/97 is fully upheld for the product in question .
41. However, the fact that the Commission refuses a person’s request does not prevent that same person from submitting a new request. The same is true for a request submitted by another person: a negative decision by the Commission does not resolve the question once and for all.
42. All the parties are agreed that the Commission’s decision is an individual decision. It is clear, in the light of the fourth paragraph of Article 249 EC and from the very wording of Decision 2000/196, that it is binding only on the person to whom it is addressed. That decision refused the applicant an authorisation that would have granted an exception to the prohibition on placing a novel food or novel food ingredient on the market. However, the question at hand is whether that decision may nevertheless have effects on another person and on the authorities of a Member State assessing the actions of that other person.
43. Where the Commission issues a negative decision, the principle of loyalty requires the Member States to ensure that the product that is the subject-matter of the negative decision not be placed on the market by the applicant, that is, by the addressee of the decision. It is also their responsibility to see to it that the food in question is deemed unauthorised within the framework of the monitoring of food markets and where a national authority examines a new notification concerning the same product submitted by another applicant. The national authorities must take due account of the Commission’s decision containing such a finding.
44. If, however, the Commission takes a positive decision, that is, a decision to grant authorisation to a person, a new authorisation could then be granted to other persons for a substantially equivalent novel food or novel food ingredient under the simplified procedure.
3. No binding force for findings of fact
45. Mensch und Natur submits, however, that stevia is not a novel food or novel food ingredient.
46. The administrative procedure established by Regulation No 258/97 involves the applicant, the Member States and the Commission. Unless I am mistaken, third parties do not have procedural rights. It is not necessary or possible to allow a third party to submit observations formally, and a third party who is not directly concerned will have no right of recourse against a Commission decision that is not addressed to him.
47. As the instrument adopted by the Commission is a decision and not a regulation, it follows that the national authorities may examine whether the food or food ingredient covered by a subsequent request is truly novel. The same is true for administrative and penal proceedings intended to monitor the placing on the market of a food the classification of which as a novel food is called into question. This is because the binding force of findings of fact by an administrative authority is limited to the aspects it examined in the course of the individual decision-making process undertaken in response to a request.
48. It is possible, under Article 1(3) of Regulation No 258/97, to make the determination, under the procedure provided for in Article 13, as to whether a type of food or ingredient falls within the scope of the regulation as provided for in Article 1(2) thereof. That procedure may not be initiated by a private individual, however.
49. The legal situation resulting from that process is problematic for the internal market, especially because the authorisation is given separately for each new food or new food ingredient and for each applicant. It seems to me that the Commission has become aware of these problems and that its proposal, referred to above, could clarify the system. In regards to the current system, the Commission has proposed, inter alia, that any authorisations be established in the form of a regulation and that authorisations by name be given only in certain exceptional cases. It has also proposed that the system have a uniform authorisation procedure like the one already in place for certain other substances.
50. In the light of the foregoing, I conclude that Commission Decision 2000/196 does not preclude the authority of a Member State from examining, in administrative or judicial proceedings, whether a food or food ingredient was placed on the market to a significant degree before 15 May 1997, in order to establish whether or not that type of product comes within the scope of Regulation No 258/97.
V – Conclusion
51. In the light of the foregoing, I t herefore propose that the Court answer the questions referred by the Bayerischer Verwaltungsgerichtshof as follows:
A decision of the Commission, such as that of 22 February 2000 refusing authorisation for the placing on the market of ‘ Stevia rebaudiana
Bertoni: plants and dried leaves’ as a novel food or novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients, which is binding in its entirety on the person to whom it is addressed, does not preclude the authority of a Member State from examining, in subsequent administrative or judicial proceedings, whether the food or food ingredient that was the subject-matter of the individual decision was placed on the market to a significant degree by another person before the entry into force of that regulation, in order to establish whether or not the food or food ingredient comes within the scope of that regulation.
(1) .
(2)  –	OJ 1997 L 43, p. 1.
(3)  –	OJ 2000 L 61, p. 14.
(4)  –	Since the dispute in the main proceedings concerns a national decision of 8 April 2003, references to the provisions of the EC Treaty follow the numbering applicable before the entry into force of the Treaty on the Functioning of the European Union.
(5)  –	GVBl. p. 738, in the version applicable until 31 December 2002 (see Paragraph 2 of the Law of 24 December 2002, GVBl. p. 981).
(6)  –	As published on 14 February 2000 (BGBl. 2000 I, p. 123), and amended most recently by the Law of 6 August 2002 (BGBl. 2002 I, p. 3082, 3099).
(7)  –	See, to that effect, Case C‑236/01 Monsanto Agricoltura Italia and Others
[2003] ECR I‑8105, paragraph 74.
(8)  –	Case C‑383/07 M-K Europa
[2003] ECR I‑115, paragraph 23.
(9)  –	See Gerstberger, I., ‘The Proposal for a revised Novel Food Regulation – An Improvement for the Worse?’, European Food and Feed Law Review,
2008, No 4, p. 215.
(10)  –	Proposal for a Regulation of the European Parliament and of the Council concerning novel foods and amending Regulation (EC) No [1331/2008] (COM(2007) 872 final).
(11)  –	See Joined Cases C‑211/03, C‑299/03 and C‑316/03 to C‑318/03 HLH Warenvertrieb and Orthic
[2005] ECR I‑5141, paragraph 88.
(12)  –	Article 1(3) of Regulation No 258/97 provides for a mechanism for clarifying the individual scope. According to the Court’s case law, however, an individual cannot launch such a procedure: see, to that effect, M‑K Europa, paragraph 43.
(13)  –	There have apparently been only three cases where the procedure at Community level culminated in a negative decision by the Commission prohibiting the placing on the market of a product as a novel food or novel food ingredient, of which stevia, which was the subject-matter of Decision 2000/196, was one. For the two other cases, see Commission Decision 2001/17/EC of 19 December 2000 on refusing the placing on the market of ‘Nangai nuts’ ( Canarium indicum L .) as a novel food or food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ 2001 L 4, p. 35), and Commission Decision 2005/580/EC of 25 July 2005 refusing the placing on the market of betaine as a novel food or novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ 2005 L 199, p. 89).