1. This reference for a preliminary ruling concerns the interpretation of Article 1(1) to (3) 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).
2. The reference was made in the course of proceedings between M-K Europa GmbH & Co. KG (‘M-K Europa’) and Stadt Regensburg concerning the latter’s decision prohibiting the marketing of a food product from Japan called ‘Man‑Koso 3000’ (‘Man-Koso’). Legal context Community legislation
3. Recital 2 in the preamble to Regulation No 258/97 reads: ‘… 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 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: … (d) foods and food ingredients consisting of or isolated from microorganisms, fungi or algae; (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; (f) foods and food ingredients to which has been applied a production process not currently used, where that process gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value, metabolism or level of undesirable substances. 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 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) of the Treaty 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. …’ National legislation
6. Paragraph 2(1)(1) of the Bavarian Law on Inspection of Foodstuffs (Lebensmittelüberwachungsgesetz) of 11 November 1997, in the version applying until 31 December 2002, provides: ‘The authorities may, in the performance of their duties, take individual decisions in order to forestall or prevent … infringement of the provisions of food legislation.’
7. Paragraph 3(1) of the regulation implementing the community provisions on novel foods and novel food ingredients (Neuartige Lebensmittel- und Lebensmittelzutaten-Verordnung), published on 14 February 2000, as last amended by the Law of 6 August 2002 (BGBl. 2002 I, p. 3082) reads: ‘“Foods and food ingredients” within the meaning of Article 1(2) of Regulation … No 258/97 shall not, subject to the provisions of subparagraph 2, be placed on the market by the person responsible for such placing without a licence granted under the procedures laid down in Article 3(2) of Regulation … No 258/97.’ The dispute in the main proceedings and the questions referred for a preliminary ruling
8. According to the order for reference, Man-Koso is a food product obtained from over 50 plant ingredients by means of a fermentation process. It contains, among other things, brown and red algae, burdock roots, lotus roots and akebi or shiso leaves. M-K Europa describes this product as a high-class food with positive health benefits.
9. Man-Koso was introduced to the public on a German television programme, which led the German authorities to take steps to investigate its composition.
10. In the light of the results of a scientific analysis of Man-Koso, Stadt Regensburg, by decision of 24 October 2002, prohibited the marketing of that food product.
11. After the administrative appeal it made to the Regierung der Oberpfalz (Oberpfalz Government) against that marketing ban was rejected by decision of 9 December 2002, M-K Europa brought an action before the Verwaltungsgericht Regensburg, which was dismissed by judgment of 27 October 2003 on the ground that Man-Koso constituted a novel food within the meaning of Regulation No 258/97. By order of 25 October 2005, M-K Europa was granted leave to appeal against that judgment.
12. The referring court considers that an interpretation of Article 1(1) to (3) of Regulation No 258/97 is necessary before it can rule on whether the decision of 24 October 2002 prohibiting the marketing of Man-Koso is permissible.
13. In those circumstances, the Bayerischer Verwaltungsgerichtshof decided to stay proceedings and refer the following questions to the Court of Justice for a preliminary ruling: ‘(1) In determining whether a food within the meaning of Article 1(2) of [Regulation No 258/97] “[has] not hitherto been used for human consumption to a significant degree within the Community” may it be considered significant that shortly before the Regulation entered into force on 15 May 1997 the food was imported into a narrowly defined region of Community territory (in the present case: San Marino) and was available in that locality? (2) For a food not to be considered as novel within the meaning of Article 1(1) and (2) of [Regulation No 258/97], does it suffice to determine that all of the ingredients used in its production have hitherto been used for human consumption to a significant degree within the Community? (3) Must Article 1(2)(d) of [Regulation No 258/97] be interpreted narrowly so as to exclude from the category “foods ... consisting of ... algae” foods containing only such algae as have hitherto been used for human consumption within the Community? (4) May a food be considered as “having a history of a safe food use” within the meaning of Article 1(2)(e) of [Regulation No 258/97] if experience regarding its safety only exists in regions outside Europe (in the present case: Japan)? (5) May a food be considered as “having a history of a safe food use” because it is produced using ingredients with a safe history in accordance with a production or processing technique currently in use, if no experience exists as to that combination of ingredients and techniques? (6) Does it follow from Article 1(3) of [Regulation No 258/97], which states that “[w]here 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”, that in the event of a dispute an undertaking must be regarded as under an obligation to seek that determination and to await the results thereof? May, in addition, any indications be deduced from that provision and from Article 1(2) of [Regulation No 258/97] concerning the burden of producing evidence (Darlegungslast) and the substantive burden of proof?’ The questions referred First question
14. By its first question, the referring court asks whether importation of a food product into San Marino before 15 May 1997 may be a relevant factor for the purposes of classifying it as a novel food within the meaning of Article 1(2) of Regulation No 258/97 as regards the requirement relating to human consumption within the Community.
15. In that regard, it should be noted that Article 1(2) of Regulation No 258/97 delimits the regulation’s scope, in particular by defining what is to be understood by novel foods and food ingredients. According to that definition, ‘novel’ food and food ingredients are those ‘which have not hitherto been used for human consumption to a significant degree within the Community’ (Joined Cases C‑211/03, C‑299/03 and C‑316/03 to C‑318/03 HLH Warenvertrieb and Orthica [2005] I‑5141, paragraph 82).
16. San Marino is not a Member State of the Community. Nor is that State one of the territories to which the EC Treaty applies under Article 299 EC.
17. Consequently, the answer to the first question is that importation of a food product into San Marino before the entry into force of Regulation No 258/97 is not a relevant factor for assessing whether that product meets the requirement relating to human consumption to a significant degree within the Community, within the meaning of Article 1(2) of that regulation. Second and fifth questions
18. By its second and fifth questions, which may appropriately be dealt with together, the referring court asks whether certain characteristics of the constituents of a particular food product are relevant for the purposes of classifying it as a novel food within the meaning of Regulation No 258/97.
19. Thus, on the one hand, the referring court seeks to ascertain how to interpret, for the purposes of such classification, the fact that all the constituents of a food product must meet the requirement relating to human consumption to a significant degree within the Community, within the meaning of Article 1(2) of Regulation No 258/97.
20. On the other hand, the referring court asks whether a food product comes into the category of foods which have a ‘history of safe food use’, and hence of foods that do not fall within the scope of Regulation No 258/97, where it is produced using ingredients with a safe history in accordance with a production technique which the court describes as being ‘currently in use’, even though no experience exists as to the combination of those ingredients and techniques.
21. In its pleadings, M.-K. Europa submits that all the ingredients of Man-Koso have been used to a significant degree within the Community, in particular in the catering industry.
22. In that regard, it is important to note that Regulation No 258/97 has the twofold objective of ensuring the functioning of the internal market in new foodstuffs and protecting public health against the risks to which they may give rise (see, to that effect, Case C‑236/01 Monsanto Agricoltura Italia and Others [2003] ECR I‑8105, paragraph 74).
23. 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.
24. As regards in particular the relevance, first, of human consumption of the constituents of a food product to a significant degree and, second, of the safety of such ingredients, it must be observed that it follows from Article 1(2)(f) of Regulation No 258/97 that the production process is of clear importance when it comes to classifying the end product as a novel food within the meaning of that regulation.
25. That provision states that the category of ‘novel foods’ covers foods and food ingredients to which has been applied a production process not currently used, where that process gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value, metabolism or level of undesirable substances.
26. In that regard, as Stadt Regensburg, the Greek, Cypriot and Polish Governments and the Commission contended in their written observations to the Court, the mere fact that all the ingredients of a food product have been used for human consumption to a significant degree within the Community is not sufficient for the end product not to be regarded as a novel food within the meaning of Regulation No 258/97.
27. Since it cannot be ruled out that the production process may give rise within the structure of a food product to physical, chemical or biological changes in its ingredients that may have serious consequences for public health, even though the end product is made up of ingredients which individually meet the requirement laid down in Article 1(2) of Regulation No 258/97, it is necessary to examine the consequences of that process.
28. The issue concerning the production process in relation to the classification of a food product as a novel food within the meaning of Regulation No 258/97 is all the more relevant since it is established that there is no experience in the Community of using the production process in question in connection with the ingredients concerned.
29. ‘[A] production process not currently used’ within the meaning of Article 1(2)(f) of Regulation No 258/97 must be interpreted in the specific context of the foods in connection with which the process is deemed to be used.
30. Consequently, the answer to the second and fifth questions is that the fact that all the individual constituents of a food product meet the requirement laid down in Article 1(2) of Regulation No 258/97, or have a safe history, cannot be regarded as sufficient for that regulation not to apply to the food product concerned. In order to decide whether that food product should be classified as a novel food within the meaning of Regulation No 258/97, the competent national authority must proceed on a case-by-case basis, taking into account all the characteristics of the food product and of the production process. Third question
31. By its third question, the national court asks whether Regulation No 258/97 should not be applied where a food within the meaning of Article 1(2)(d) of that regulation consists only of algae which themselves meet the requirement relating to human consumption to a significant degree within the Community, within the meaning of Article 1(2) of that regulation.
32. In that regard, it follows from the answer given to the second and fifth questions that the fact that all of the algae contained in a food product within the meaning of Article 1(2)(d) of Regulation No 258/97 meet the requirement relating to human consumption to a significant degree within the Community, within the meaning of Article 1(2) of that regulation, is not sufficient for that regulation not to apply to that product. Fourth question
33. By its fourth question, the referring court asks whether experience regarding the safety of a food product acquired exclusively outside Europe is sufficient in order to consider that that product falls within the category of food products ‘having a history of safe food use’ within the meaning of Article 1(2)(e) of Regulation No 258/97.
34. Article 1(2)(e), second phrase, of Regulation No 258/97 introduces an exception to the applicability of that regulation in the case of foods and food ingredients obtained by traditional propagating or breeding practices and having a history of safe food use.
35. In that regard, as was pointed out in paragraph 23 above, Regulation No 258/97 is designed to establish a single Community safety assessment procedure which novel foods and novel food ingredients are to undergo before they are placed on the Community market.
36. Without denying, in connection with the safety assessment of a novel food product before it is placed on the Community market, that information concerning the use of that product in States that are not members of the European Union could be of interest, it should be noted that the Community legislature intended the term ‘history of safe food use’ in relation to such a product within the meaning of Article 1(2)(e) of Regulation No 258/97 to refer to experience obtained within the Community.
37. As the Polish Government and the Commission point out, owing to differences that may exist in eating habits in particular, between European and non-European consumers, food products considered safe for non-European consumers will not necessarily be classified, when it comes to European consumers, as food and food ingredients with a history of safe food use.
38. In the light of the foregoing, the answer to the fourth question is that experience regarding the safety of a food product acquired exclusively outside Europe is not sufficient to establish that the product concerned falls within the category of food products ‘having a history of safe food use’ within the meaning of Article 1(2)(e) of Regulation No 258/97. Sixth question
39. The grounds of the order for reference make clear that by its sixth question the referring court is asking, first, whether it is incumbent upon an undertaking to initiate the procedure provided for in Article 13 of Regulation No 258/97. Secondly, in respect of that procedure, it asks about the burden of proof as regards classification of a food product as a novel food within the meaning of Regulation No 258/97.
40. In that regard, it should be noted that Article 1(3) of Regulation No 258/97 introduces 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.
41. Article 13 of that regulation provides that matters are to be referred to the Committee by the Chairman either on his own initiative or at the request of the representative of a Member State.
42. Without prejudice to any procedures that may be implemented in the Member State concerned in accordance with the provisions of the applicable national law, it should be noted that the comitology procedure laid down in Article 13 of Regulation No 258/97 involves exclusively the opinion of the Committee, a decision taken by the Commission where the measures envisaged are in accordance with that opinion, and lastly, if those measures are not in accordance with the opinion of the Committee, a Council vote adopted by a qualified majority.
43. The answer to the sixth question is therefore that it is not incumbent on an undertaking to initiate the procedure laid down in Article 13 of Regulation No 258/97.
44. With regard to the foregoing, there is no need to rule on the question of burden of proof in so far as the procedure provided for in Article 13 of Regulation No 258/97 is concerned, since the question of burden of proof is not relevant to that procedure. Costs
45. 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.