Provisional text

OPINION OF ADVOCATE GENERAL

CAMPOS SÁNCHEZ-BORDONA

delivered on 19 January 2023 ( )

Case C‑141/22

TLL The Longevity Labs GmbH

v

Optimize Health Solutions mi GmbH,

BM

(Request for a preliminary ruling from the Landesgericht für Zivilrechtssachen Graz (Regional Civil Court, Graz, Austria))

(Reference for a preliminary ruling – Food safety – Food and food supplements – Food production – Novel food – Primary production – Production technique – Sprouted buckwheat flour with a high spermidine content – Hydroponic germination of buckwheat seeds in a nutrient solution containing spermidine)





1. This request for a preliminary ruling affords the Court the opportunity to interpret for the first time (unless I am mistaken) Regulation (EU) 2015/2283 ( ) regulating the placing of novel foods on the market.

2. Regulation 2015/2283, which replaces Regulation (EC) No 258/97 ( ) and Regulation (EC) No 1852/2001, ( ) seeks to simplify the authorisation procedures for novel foods and to take account of recent developments in EU law and adapt it to technological progress.

3. The Court will have to decide whether the food obtained following a process involving the use of a spermidine-rich aqueous solution ( ) to cultivate buckwheat seedlings ( ) and thereafter produce a bio-enriched flour for the preparation of a food supplement can be classified as a ‘novel food’ within the meaning of Regulation 2015/2283.

I. Legal context

A. European Union law

1. Regulation 2015/2283

4. Article 3(2)(a) provides:

‘The following definitions also apply:

(a) “novel food” means any food that was not used for human consumption to a significant degree within the Union before 15 May 1997, irrespective of the dates of accession of Member States to the Union, and that falls under at least one of the following categories:

…

(iv) food consisting of, isolated from or produced from plants or their parts, except when the food has a history of safe food use within the Union and is consisting of, isolated from or produced from a plant or a variety of the same species obtained by:

‑ traditional propagating practices which have been used for food production within the Union before 15 May 1997; or

‑ non-traditional propagating practices which have not been used for food production within the Union before 15 May 1997, where those practices do not give rise to significant changes in the composition or structure of the food affecting its nutritional value, metabolism or level of undesirable substances;

…

(vii) food resulting from a production process not used for food production within the Union before 15 May 1997, which gives rise to significant changes in the composition or structure of a food, affecting its nutritional value, metabolism or level of undesirable substances;

…’.

5. According to Article 6 (‘Union list of authorised novel foods’):

‘1. The Commission shall establish and update a Union list of novel foods authorised to be placed on the market within the Union in accordance with Articles 7, 8 and 9 (“the Union list”).

2. Only novel foods authorised and included in the Union list may be placed on the market within the Union as such, or used in or on foods, in accordance with the conditions of use and the labelling requirements specified therein’.

6. Article 10(1) ( ) reads:

‘1. The procedure for authorising the placing on the market within the Union of a novel food and updating of the Union list provided for in Article 9 of this Regulation shall start either on the Commission’s initiative or following an application to the Commission by an applicant, in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002. The Commission shall make the application available to the Member States without delay. The Commission shall make a summary of the application, based on the information referred to in points (a), (b) and (e) of paragraph 2 of this Article, publicly available’.

2. Regulation (EC) No 178/2002 ( )

7. Article 2 states:

‘…

“Food” shall not include:

(a) feed;

(b) live animals unless they are prepared for placing on the market for human consumption;

(c) plants prior to harvesting;

…’.

8. Article 3 provides:

‘For the purposes of this Regulation:

…

16. “stages of production, processing and distribution” means any stage, including import, from and including the primary production of a food, up to and including its storage, transport, sale or supply to the final consumer and, where relevant, the importation, production, manufacture, storage, transport, distribution, sale and supply of feed;

17. “primary production” means the production, rearing or growing of primary products including harvesting, milking and farmed animal production prior to slaughter. It also includes hunting and fishing and the harvesting of wild products;

…’.

3. Implementing Regulation (EU) 2017/2470 ( )

9. The annex to that implementing regulation contains Tables 1 and 2 listing, respectively, the ‘authorised novel foods’ and the ‘specifications on novel foods’.

B. National law

10. The Bundesgesetz gegen den unlauteren Wettbewerb 1984 ( ) provides that an undertaking may call upon another undertaking operating in the same market to refrain from placing goods on the market which require prior administrative authorisation, where the latter undertaking is not in possession of such authorisation.

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

11. The company TLL The Longevity Labs GmbH (‘TLL’) produces a food supplement by extracting spermidine from wheat germ without fermentation or germination.

12. On 6 December 2017, TLL notified the Commission of its intention to place a spermidine-rich wheat germ extract (Triticum aestivum) on the market as a novel food ingredient. That novel food is authorised and listed in the Annex to Implementing Regulation 2017/2470. ( )

13. The company Optimize Health Solutions mi GmbH (‘Optimize Health’) produces the food supplement ‘go Optimize Spermidine’ containing sprouted buckwheat flour with a high spermidine content (‘the product at issue’).

14. TLL brought an action before the referring court seeking an order prohibiting Optimize Health from placing the product at issue on the market. It argued that that product was a ‘novel food’ requiring (under Article 6(2) of Regulation 2015/2283) prior authorisation and inclusion in the Union list, both of which it lacks. Without such authorisation and listing, Optimize Health’s conduct amounts to unfair competition.

15. Optimize Health denies that its product is a novel food, claiming that it is a fully dried traditional food obtained without any selective novel extraction stage. Optimize Health adds that spermidine has been available in food supplements in the EU market for more than 25 years.

16. The Landesgericht für Zivilrechtssachen Graz (Regional Civil Court, Graz, Austria), which is to adjudicate on the unfair competition dispute, has concerns about the classification of the product at issue, particularly as regards its production process. In order to allay those concerns, it refers the following questions to the Court of Justice for a preliminary ruling:

‘(1) Is Article 3(2)(a)(iv) of Regulation [2015/2283] to be interpreted as meaning that “sprouted buckwheat flour with a high spermidine content” is a novel food, inasmuch as only sprouted buckwheat flour without a raised spermidine content was used for human consumption to a significant degree within the European Union before 15 May 1997 or has a history of safe food use thereafter, irrespective of how the spermidine comes to be in the sprouted buckwheat flour?

(2) If Question 1 is answered in the negative: Is Article 3(2)(a)(vii) of Regulation [2015/2283] to be interpreted as meaning that the term “production process” for food includes primary production processes?

(3) If Question 2 is answered in the affirmative: Does the novelty of a production process within the meaning of Article 3(2)(a)(vii) of Regulation [2015/2283] depend on whether the production process itself has never before been used for any food or whether it has not been used for the food under assessment?

(4) If Question 2 is answered in the negative: Does the germination of buckwheat seed in a nutrient solution containing spermidine qualify as a primary production process for a plant to which food legislation, including Regulation [2015/2283], does not apply, as the plant is not a food prior to harvesting (Article 2(c) of Regulation (EC) No 178/2002)?

(5) Does it make a difference if the nutrient solution contains natural or synthetic spermidine?’

III. Proceedings before the Court

17. The request for a preliminary ruling was received at the Court on 28 February 2022.

18. Written observations were submitted by TLL, Optimize Health, the Greek Government and the European Commission.

19. It was not considered necessary to hold a hearing.

IV. Assessment

A. Preliminary remarks

1. Product at issue

20. The main function of spermidine, like other polyamines, is to neutralise the charges of nucleic acids in cells and stimulate their functionality. Recent scientific studies suggest that, by aiding the process of cellular autophagy (cleansing), spermidine may help prevent cardiovascular disease and food allergies and combat the symptoms of diabetes. ( ) It has even been suggested that spermidine could increase human lifespan by up to 5.7 years. ( )

21. Given those properties, it is easier to understand the conflicting interests of the two litigants which produce this food supplement, whose market may grow substantially.

22. Each undertaking uses different methodologies to obtain spermidine:

‑ TLL extracts it from ungerminated wheat germ by means of a complex and costly chemical process.

‑ Optimize Health uses a hydroponic technique to germinate buckwheat seeds in an aqueous solution containing synthetic spermidine in order to obtain seedlings. After harvesting, the seedlings are washed in water, dried and milled to obtain flour.

2. Placing on the market of novel foods

23. Regulation 2015/2283, like its predecessors, has a twofold objective: to ensure the functioning of the internal market in novel foods and to protect human health against the risks which those foods may pose. ( ) That is in addition to the objective of safeguarding consumers’ interests and ensuring a high level of protection and improvement of the quality of the environment. ( )

24. In order to achieve those objectives, Regulation 2015/2283, again like its predecessor, provides that novel foods must be subject to a risk analysis and obtain prior authorisation in order to be placed on the market. The authorisation procedure becomes a European one and is centrally managed by the Commission. It also has an erga omnes effect, since the authorisation of a novel food is valid for all potential producers. ( )

25. Regulation 2015/2283 provides a definition of novel food, which is a key concept in this reference for a preliminary ruling. ( ) Article 3(2)(a) classifies as a novel food any food meeting the following two conditions:

‑ It was not used ‘for human consumption to a significant degree within the Union before 15 May 1997’. ( )

‑ It falls under at least one of the categories listed in points (i) to (x) of that provision. ( )

26. The referring court seems to have no doubts about the first condition and it is not covered by the questions submitted for a preliminary ruling. My understanding is that the referring court considers it proven that the product at issue did not exist or that its consumption was not significant in the European Union before 15 May 1997.

27. The referring court’s questions are instead concerned with the second condition, specifically the framing of the product at issue either under point (iv) or under point (vii) of Article 3(2)(a) of Regulation 2015/2283. ( )

3. Fact subsequent to the reference for a preliminary ruling

28. On 3 June 2022 (that is, several months after the reference for a preliminary ruling was submitted), Austria notified the Commission that sprouted buckwheat flour with a high spermidine content is a novel food within the meaning of Article 3(2)(a)(vii) of Regulation 2015/2283. ( )

29. That fact, which the Greek Government and the Commission mentioned in their written observations, ( ) cannot, however, affect the outcome of the reference for a preliminary ruling, since the referring court was unable to take it into account when submitting its questions.

B. First question referred

30. The referring court wishes to ascertain whether the product at issue can be classified as a novel food falling under Article 3(2)(a)(iv) of Regulation 2015/2283.

31. The category of food covered by that provision is ‘food consisting of, isolated from or produced from plants or their parts, except when the food has a history of safe food use within the Union and is consisting of, isolated from or produced from a plant or a variety of the same species obtained ( ) by:

‑ traditional propagating practices which have been used for food production within the Union before 15 May 1997; or

‑ non-traditional propagating practices which have not been used for food production within the Union before 15 May 1997, where those practices do not give rise to significant changes in the composition or structure of the food affecting its nutritional value, metabolism or level of undesirable substances’.

32. As explained above, flour bio-enriched with spermidine is obtained from the buckwheat plant. The seedlings of that plant, after drying and milling, are used to produce the flour. The basic premiss underlying that category is therefore satisfied.

33. As regards the derogation from the obligation to apply for authorisation if the food has ‘a history of safe food use within the Union’, that concept is not defined in Regulation 2015/2283. Nonetheless, Article 3(2)(b) of that regulation provides that a food has a ‘history of safe food use in a third country’ where ‘the safety of the food in question has been confirmed with compositional data and from experience of continued use for at least 25 years in the customary diet of a significant number of people in at least one third country …’.

34. The concept of ‘history of safe food use in a third country’ can be transposed to the concept of ‘history of safe food use within the Union’. However, based on the information provided, there is no evidence that the type of flour at issue here has a history of safe food use within the Union.

35. As the second condition for the application of the exception it is necessary that the plant used for the preparation of the product at issue:

‑ is obtained by traditional propagating practices which have been used for food production within the Union before 15 May 1997, for the purposes of the first of the two indents cited above;

‑ is also not obtained by non-traditional propagating practices which have not been used before 15 May 1997, where those practices do not give rise to the changes referred to in the second of the two indents cited above.

36. Again, according to the information on the file, the use of an aqueous solution of spermidine for the hydroponic cultivation of buckwheat seedlings is not a plant propagation (multiplication) technique, but a production process or technique for enriching the seedlings in order to achieve a high spermidine content.

37. The use of that technique also leads to significant changes in the composition or structure of the food affecting its nutritional value, as I will explain in more detail below. Since the product at issue has a very high level of spermidine (which distinguishes it from food obtained without using an aqueous solution for the germination of buckwheat seeds), the changes in its composition may affect its nutritional value.

38. Therefore, sprouted buckwheat flour with a high spermidine content falls under point (iv) of Article 3(2)(a) of Regulation 2015/2283. It remains to be seen whether it can be classified also as a novel food under point (vii) of that provision.

C. Second question referred

39. The referring court seeks to ascertain whether Article 3(2)(a)(vii) of Regulation 2015/2283 can be interpreted ‘as meaning that the term “production process” for food includes primary production processes’.

40. Under that provision, a novel food is ‘food resulting from a production process not used for food production within the Union before 15 May 1997, which gives rise to significant changes in the composition or structure of a food, affecting its nutritional value, metabolism or level of undesirable substances’ (emphasis added).

41. The dispute therefore turns on whether the product at issue is obtained by means of a ‘production process’ not used within the Union before 15 May 1997 which causes significant changes in the composition or structure of the food affecting its nutritional value, metabolism or level of undesirable substances. ( )

1. Production process

42. The fact that they result from a ‘production process’ is what differentiates novel foods falling under point (vii) of Article 3(2)(a) of Regulation 2015/2283 from those falling under point (iv) thereof, referred to above:

‑ Point (iv) covers foods obtained by traditional or non-traditional plant propagating practices giving rise to new plants.

‑ Point (vii) covers foods resulting from techniques used in procedures for food production.

43. In my opinion, the germination of buckwheat seeds in a spermidine-rich nutrient solution is not, I repeat, a propagation technique, because the seedlings are collected before they produce leaves in order to be dried and milled and to produce the flour. Buckwheat seeds do not multiply during germination, as each seed generates a seedling which is collected, as Optimize Health submits.

44. By contrast, the cultivation of the seeds in an aqueous solution with a high content of synthetic spermidine is a technique forming part of the production process of a food ingredient.

45. Regulation 2015/2283 does not define what is meant by ‘production process’. However, Article 3(1) of that regulation states that ‘… the definitions laid down in Articles 2 and 3 of Regulation (EC) No 178/2002 apply’.

46. Although Regulation No 178/2002 does not directly define the concept of ‘production’ either, it does contain several references to it. ( ) In particular:

‑ Recital 12 ( ) refers to the fact that the food production chain forms a continuum from and including primary production (the first link in the chain) to supply to the final consumer.

‑ Article 3(16) defines ‘stages of production, processing and distribution’ as ‘any stage, including import, from and including the primary production of a food, up to and including its storage, transport, sale or supply to the final consumer …’ (emphasis added).

‑ Article 3(17) defines ‘primary production’ as ‘the production, rearing or growing of primary products including harvesting, milking and farmed animal production prior to slaughter. It also includes hunting and fishing and the harvesting of wild products’.

47. The inclusion of primary production in the process for obtaining a food is in line with the main objective of Regulations No 178/2002 and No 2015/2283, which is to ensure a level of food safety that is as comprehensive as possible.

48. Accordingly, the term ‘production process’ in Article 3(2)(a)(vii) of Regulation 2015/2283 encompasses primary production as well as all subsequent stages of processing of a novel food. ( )

49. Applying those premisses to the subject matter of the dispute, my view is that the hydroponic cultivation of buckwheat seeds in an aqueous solution containing synthetic spermidine, for the purpose of collecting the seedlings, drying them and producing flour that is highly bio-enriched with spermidine, is part of a production process in the sense examined above.

50. The technique used here is a technique applied to primary production in order to obtain a food supplement. As the Commission and TLL point out, it is no different from the technique used in other novel foods which have been accepted by the European Food Safety Authority and the Member States’ authorities in the context of the procedure under Article 4 of Regulation 2015/2283.

51. That is the case for mushrooms (Agaricus bisporus) bio-enriched with selenium, grown in a selenium-rich nutrient solution; ( ) lupin sprouts (Lupinus angustifolius) bio-enriched with iron, obtained from disinfected seeds germinated in a solution of iron sulphate; ( ) mushrooms treated with ultraviolet light after harvesting to increase their levels of vitamin D2; and yeast biomass bio-enriched with selenium or chromium through cultivation in a medium enriched with one of those minerals.

2. Significant changes in the composition or structure of the food

52. Having established the meaning of ‘production process’ and determined that it applies to the product at issue, it is necessary to ascertain whether the technique used is a new one and causes ‘significant changes in the composition or structure of the food affecting its nutritional value, metabolism or level of undesirable substances’.

53. The referring court does not seem to be in any doubt that the technique used in this case is new. Nor does it refer to evidence of the use, prior to 15 May 1997, of an aqueous solution containing a high level of spermidine to cultivate buckwheat seeds hydroponically, in the manner described above.

54. That cultivation technique gives rise to significant changes in the composition or structure of the food affecting its nutritional value. The level of spermidine in the product at issue, according to the analyses provided by TLL, is 3.51 mg/g, which is 106 times higher than the level of that substance under normal cultivation conditions in buckwheat seed, which is 0.03305 mg/g.

55. Spermidine bio-enrichment alters the composition and nutritional value of sprouted buckwheat flour to such an extent that it becomes a novel food. According to the scientific studies referred to, although increased spermidine intake may have health benefits, too much might be harmful for cells. That is why prior authorisation of the product at issue under Regulation 2015/2283 is essential to ensure food safety and prevent risks to the consumer.

D. Third question referred

56. The referring court asks the Court, if its reply to the second question is in the affirmative (as I suggest), to clarify whether ‘the novelty of a production process within the meaning of Article 3(2)(a)(vii) of Regulation [2015/2283] depend[s] on whether the production process itself has never before been used for any food or whether it has not been used for the food under assessment’.

57. Article 3(2)(a)(vii) of Regulation 2015/283 does not provide a clear-cut answer to that question. It is therefore necessary to interpret that provision in the light of its context and purpose. ( )

58. As regards the context, recitals 1 ( ) and 9 ( ) of Regulation 2015/2283 militate in favour of an interpretation which focuses on the particular food concerned by the production process. It is the very effect of the production process on the composition and nutritional value of that food which must be assessed.

59. The objective of Article 3(2)(a)(vii) of Regulation 2015/2283 also militates in favour of assessing the effect of the new production technique only on the food itself and not in general. The same (new) production process may have one effect on some foods and a different effect on others. Its effects must therefore be assessed only in relation to the food under examination in each individual case. ( )

60. It will be for the referring court to determine whether or not the production process consisting of hydroponic cultivation in an aqueous solution rich in spermidine has been used for the cultivation of buckwheat seedlings before 15 May 1997.

E. Fourth question referred

61. The referring court submits this question if the answer to the second question is in the negative, which I have already ruled out. I will nevertheless examine it should the Court take a different view.

62. The referring court seeks to ascertain whether ‘the germination of buckwheat seed in a nutrient solution containing spermidine qualif[ies] as a primary production process for a plant to which food legislation, including Regulation [2015/2283], does not apply, as the plant is not a food prior to harvesting (Article 2(c) of Regulation [No 178/2002])’.

63. It is true that Article 2(c) of Regulation No 178/2002 excludes plants prior to harvesting from the concept of ‘food’.

64. Optimize Health puts forward the following arguments in support of its position:

‑ Before harvest, obtaining the seedlings in an aqueous solution rich in spermidine constitutes the same operation as cultivating the seed in the field to obtain the plant by fertilising.

‑ The solutions used to obtain the seedlings are not an ingredient of a compound food and, therefore, do not amount to enrichment, in the same way as plant fertilisers in agriculture do not amount to food processing.

‑ As the seedlings develop, the plant itself decides which nutrients to absorb from the solution in the course of the natural process of germination and biological growth of the plant.

65. However, I am not convinced by that line of argument.

66. The use of a hydroponic cultivation technique employing a spermidine-rich aqueous solution to germinate buckwheat seeds and subsequently collect the seedlings before they produce leaves is a form of ‘harvesting’ of those seedlings and does not involve direct consumption of the buckwheat seeds.

67. Moreover, the seedlings are not the end product which has to be classified, or not, as a novel food. The end product is the flour obtained after drying and milling the seedlings. No parallel can be drawn with obtaining seeds.

68. Nor can the use in hydroponic cultivation of an aqueous solution with a high content of synthetic spermidine be treated in the same way as the use of fertilisers. No authorisation has been granted under Regulation (EC) No 2003/2003, ( ) subsequently replaced by Regulation (EU) 2019/1009, ( ) for any fertiliser containing spermidine and that substance is not animal excrement, such as manure or slurry, which can be used in plant cultivation without prior authorisation.

69. Similarly, the use of a spermidine solution is not the standard procedure for germinating seeds, in which potable water or clean water must be used. ( )

70. In short, the fourth question must be answered in the negative: buckwheat seeds germinated in a spermidine-rich solution cannot be regarded as ‘plants prior to harvesting’ and they have the status of food.

F. Fifth question referred

71. The referring court seeks to ascertain whether it makes a difference to the answers to its questions if the nutrient solution used in hydroponic cultivation contains natural or synthetic spermidine.

72. In my opinion, the fact that the spermidine is natural or synthetic has no bearing on whether or not the product at issue can be classified as a novel food.

73. The use of the aqueous solution containing spermidine in hydroponic cultivation is intended to increase the buckwheat seedlings’ spermidine content exponentially. What matters is the purity of the spermidine used, whether synthetic or natural. ( ) If the purity is the same, the bio-enrichment of the flour will be identical.

V. Conclusion

74. In the light of the foregoing considerations, I propose that the Court of Justice give the following reply to the Landesgericht für Zivilrechtssachen Graz (Regional Civil Court, Graz, Austria):

Article 3(2)(a) of Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001

must be interpreted as meaning that,

— a product such as sprouted buckwheat flour with a high spermidine content may be classified as a ‘novel food’ pursuant to point (iv) of that provision;

— the concept of ‘production process’ for food in point (vii) of that provision includes primary production processes;

— the classification of ‘novel food’ depends on whether or not the production process was used, specifically, to produce the product at issue in each individual case;

— buckwheat seedlings germinated in a spermidine-rich solution have the status of food and cannot be classified as ‘plants before harvest’ within the meaning of Article 2(c) of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety;

— the fact that the spermidine is synthetic or natural is irrelevant for the purposes of classifying sprouted buckwheat flour germinated in a spermidine solution as a novel food or not.