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Pre-market Authorisation

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The Regulatory Landscape in the EU for Dairy Products Derived from Precision Fermentation

Part of the book series: SpringerBriefs in Law ((SLRI))

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Abstract

This chapter provides an overview of the market authorisation procedures in the EU. It outlines the essential steps involved in gaining authorisation to place food products on the EU market, specifically focusing on the authorisation processes governed by the Novel Food Regulation and the legal acts governing Genetically Modified Food and Feed. Both of these authorisation pathways impose rigorous regulatory requirements, which can present significant challenges for the growth of the precision fermentation sector, particularly for start-ups and small to medium-sized enterprises. While accurately categorising products can be a complex task, it is imperative for food business operators to gain a comprehensive understanding of the relevant legal framework early in the product development process, as the authorisation pathways differ in their standards.

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Notes

  1. 1.

    Directive 2009/41/EC (2009).

  2. 2.

    Regulation (EC) No 852/2004 (2004); Regulation (EU) 2017/625 (2017).

  3. 3.

    Simpson (2020).

  4. 4.

    As per Article 3(8) GFL.

  5. 5.

    van der Meulen (2018).

  6. 6.

    Department for Exiting the European Union (2017), p. 5.

  7. 7.

    Simpson (2020).

  8. 8.

    FSA from Deloitte LLP (2023).

  9. 9.

    This is the case for novel foods—see Sect. 4.3.1.2.

  10. 10.

    Directive 2009/41/EC (2009) (hereinafter GMM directive).

  11. 11.

    GMM Directive. Article 2(b).

  12. 12.

    GMM Directive. Annex I Part A.

  13. 13.

    GMM Directive. Annex I Part B.

  14. 14.

    Acc. to GMM Directive. Article 2(a).

  15. 15.

    Exceptions thereto are in place for contained uses involving only types of GMMs meeting the criteria which establish their safety for human health and the environment, acc. to GMM Directive. Article 3(1)(b). These (general as well as specific) criteria are listed in GMM Directive. Annex II, Part B.

  16. 16.

    GMM Directive. Article 2(c).

  17. 17.

    GMM Directive. Article 2(e).

  18. 18.

    GMM Directive. Article 4 (1–3 and 5).

  19. 19.

    GMM Directive. Article 6.

  20. 20.

    A conclusive list of all required information is listed in GMM Directive. Annex V Part A.

  21. 21.

    GMM Directive. Annex V Part A.

  22. 22.

    GMM Directive. Article 8.

  23. 23.

    GMM Directive. Article 9.

  24. 24.

    European Food Safety Authority (2005).

  25. 25.

    Figure 1 borrowed from: European Food Safety Authority (2005).

  26. 26.

    EFSA Panel on Biological Hazards.

  27. 27.

    Koutsoumanis et al. (2023).

  28. 28.

    Zenodo (2023).

  29. 29.

    GFL. Article 2: the terms ‘food’ and ‘foodstuff’ describe “any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans”.

  30. 30.

    GFL. Article 14.

  31. 31.

    GFL. Articles 18, 16; national rules GFL. Article 14(9).

  32. 32.

    European Commission (2000).

  33. 33.

    FSA from Deloitte LLP (2023); Holle (2018); Monaco and Purnhagen (2022).

  34. 34.

    Holle (2018); Molitorisová et al. (2021).

  35. 35.

    See for example NFR. Article 4(1).

  36. 36.

    GMFR. Article 3(1).

  37. 37.

    GMFR. Recital 16.

  38. 38.

    Dederer (2021).

  39. 39.

    Regulation (EC) No 1333/2008 (2008).

  40. 40.

    Regulation (EC) No 1333/2008 (2008). Article 3(2)(b).

  41. 41.

    European Commission (2006).

  42. 42.

    European Commission (2006). Section 10.2 and 10.3.

  43. 43.

    van Goethem (2016).

  44. 44.

    rDNA is a compound DNA molecule formed through genetic recombination. In this specific case (precision fermented casein), it refers to the genetically engineered plasmid DNA of the host organism, that contains the inserted gene coding for casein synthesis.

  45. 45.

    Dederer (2021).

  46. 46.

    Silano et al. (2019).

  47. 47.

    Rychen et al. (2018); Silano et al. (2019).

  48. 48.

    van Goethem (2016).

  49. 49.

    van Goethem (2016).

  50. 50.

    EFSA Panel on Additives and Products or Substances used in Animal Feed.

  51. 51.

    Scientific Panel on Genetically Modified Organisms (GMO); Scientific Panel on Food Additives and Nutrient Sources added to Food (ANS); Panel of Food Contact Material, Enzymes, Flavourings and Processing Aids Panel (CEF).

  52. 52.

    NFR. Article 3(2)(a).

  53. 53.

    NFR. Article 3(2)(a).

  54. 54.

    NFR. Article 4(2).

  55. 55.

    Commission Implementing Regulation (EU) 2018/456 (2018).

  56. 56.

    Novel Food Unit of the Medicines Evaluation Board Agency (2019).

  57. 57.

    Novel Food Unit of the Medicines Evaluation Board Agency (2019).; L-fucose is thereby suggested to fall additionally under novel food category (i) “food with a new or intentionally modified molecular structure, where that structure was not used as, or in, a food within the Union before 15 May 1997”, but this would not be the case for precision fermented casein that is bioidentical to conventionally produced casein.

  58. 58.

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

  59. 59.

    Interestingly, in the Union list of novel foods, one of the specifications for this product in the column “Conditions under which the novel food may be used” is “DNA: Not detectable”.

  60. 60.

    2009/344/EC: Commission Decision (2009); Regulation (EC) No 258/97 (1997).

  61. 61.

    Commission Implementing Regulation (EU) 2020/484 (2020).

  62. 62.

    Commission Implementing Regulation (EU) 2023/7 (2023).

  63. 63.

    Commission Implementing Regulation (EU) 2021/96 (2021).

  64. 64.

    Commission Implementing Regulation (EU) 2023/859 (2023).

  65. 65.

    Commission implementing Regulation (EU) 2019/1979 (2019).

  66. 66.

    Commission Implementing Regulation (EU) 2021/2029 (2021).

  67. 67.

    Commission Implementing Regulation (EU) 2023/52 (2023).

  68. 68.

    See the case of L-fucose produced by (non-GMO) microbial fermentation by the Portuguese company Setenta e Três Mil e Cem Lda regarding the request for consultation in footnote 94.

  69. 69.

    GMFR. Article 4(2).

  70. 70.

    GMFR. Article 4(1).

  71. 71.

    Commission Implementing Regulation (EU) No 503/2013 (2013).

  72. 72.

    GMFR. Article 5.

  73. 73.

    GMFR. Article 6(1,2).

  74. 74.

    GMFR. Article 5(7) and Article 7(1).

  75. 75.

    GMFR. Article 5(7), Article 7(1), and Article 11(1).

  76. 76.

    GMFR. Article 31.

  77. 77.

    European Commission (2023).

  78. 78.

    European Food Safety Authority (2019).

  79. 79.

    European Food Safety Authority (2021b).

  80. 80.

    European Food Safety Authority (2011).

  81. 81.

    European Food Safety Authority (2011), p. 32.

  82. 82.

    Annex to Commission Implementing Regulation (EU) 2017/2470 (2017).

  83. 83.

    NFR. Article 7.

  84. 84.

    The details of this procedure are set out in Commission Implementing Regulation (EU) 2017/2469 (2017).

  85. 85.

    NFR. Article 10(2).

  86. 86.

    European Food Safety Authority (2021a).

  87. 87.

    Turck et al. (2016).

  88. 88.

    NFR. Articles 12(1) and 30(1).

  89. 89.

    NFR. Article 12(1).

  90. 90.

    Volpato (2022).

  91. 91.

    NFR. Article 9(3).

  92. 92.

    NFR. Article 6.

  93. 93.

    Holle (2018).

  94. 94.

    Such information includes inter alia scientific outputs, scientific data and studies.

  95. 95.

    NFR. Article 23 and Chapter V (Articles 26–28).

  96. 96.

    Molitorisová et al. (2021).

  97. 97.

    European Commission (2023).

  98. 98.

    European Food Safety Authority (2021a).

  99. 99.

    EFSA Panel on Dietetic Products, Nutrition and Allergies (2021).

References

  • Dederer H (2021) rDNA traces in fermentation products using Genetically Modified Microorganisms (GMMs). StoffR 18:135–147. https://doi.org/10.21552/stoffr/2021/3/6

    Article  Google Scholar 

  • EFSA Panel on Dietetic Products, Nutrition and Allergies (2021) Guidance on the preparation and submission of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283 (Revision 1)2. EFS2 19:e06555. https://doi.org/10.2903/j.efsa.2021.6555

    Article  Google Scholar 

  • European Commission (2000) Communication from the Commission on the precautionary principle. https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2000:0001:FIN:en:PDF Accessed 1 January 2024

  • European Commission (2006) Report from the Commission to the Council and the European Parliament on the implementation of Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM%3A2006%3A0626%3AFIN Accessed 1 January 2024

  • European Commission (2023) E -SUBMISSION: Food Chain platform. https://webgate.ec.europa.eu/esfc/#/applications. Accessed 11 Aug 2023

  • European Food Safety Authority (2005) Opinion of the Scientific Committee on a request from EFSA related to a generic approach to the safety assessment by EFSA of microorganisms used in food/feed and the production of food/feed additives. EFS2 3:226. https://doi.org/10.2903/j.efsa.2005.226

    Article  Google Scholar 

  • European Food Safety Authority (2011) Guidance on the risk assessment of genetically modified microorganisms and their products intended for food and feed use. EFS2 9:2193. https://doi.org/10.2903/j.efsa.2011.2193

    Article  Google Scholar 

  • European Food Safety Authority (2019) Administrative guidance on the submission of applications for renewal of authorisation of genetically modified food and feed under Articles 11 and 23 of Regulation (EC) No 1829/2003. EFS3 16. https://doi.org/10.2903/sp.efsa.2019.EN-1668

  • European Food Safety Authority (2021a) Administrative guidance for the preparation of applications on novel foods pursuant to Article 10 of Regulation (EU) 2015/2283. EFS3 18. https://doi.org/10.2903/sp.efsa.2021.EN-6488

  • European Food Safety Authority (2021b) Administrative guidance for the preparation of renewal applications on genetically modified food and feed. EFS3 18. https://doi.org/10.2903/sp.efsa.2021.EN-6474

  • FSA from Deloitte LLP (2023) Novel Foods Regulatory Framework Review: Executive Summary. https://www.food.gov.uk/print/pdf/node/17626. Accessed 7 Aug 2023

  • Goethem, B van (2016) Letter from the EC to EFSA, Subject: Fermentation products obtained from Genetically Modified Microorganisms (GMMs): Ref. Ares(2016)6016209 - 19/10/2016, SANTE/E3/TD/nn sante.ddg2.e.3(2016)6287877’ (Brussels 16 October 2016)

    Google Scholar 

  • Holle M (2018) Pre-market approval and its impact on food innovation: the novel foods example. In: Bremmers H, Purnhagen K (eds) Regulating and managing food safety in the EU. Springer International Publishing, Cham, pp 291–330

    Chapter  Google Scholar 

  • Koutsoumanis K, Allende A, Álvarez-Ordóñez A, Bolton D, Bover-Cid S, Chemaly M, de Cesare A, Hilbert F, Lindqvist R, Nauta M, Peixe L, Ru G, Simmons M, Skandamis P, Suffredini E, Cocconcelli PS, Fernández Escámez PS, Maradona MP, Querol A, Sijtsma L, Suarez JE, Sundh I, Vlak J, Barizzone F, Hempen M, Correia S, Herman L (2023) Update of the list of qualified presumption of safety (QPS) recommended microorganisms intentionally added to food or feed as notified to EFSA. EFS2 21. https://doi.org/10.2903/j.efsa.2023.7747

  • Molitorisová A, Monaco A, Purnhagen KP (2021) An analysis of the regulatory framework applicable to products obtained from mushroom and mycelium. SSRN J. https://doi.org/10.2139/ssrn.3955899

  • Monaco A, Purnhagen KP (2022) Risk triggers as innovation triggers? Risk analysis and innovation’s promotion under the Novel Food Regulation. EFFL 17:219–227

    Google Scholar 

  • Novel Food Unit of the Medicines Evaluation Board Agency (2019) Consultation request to determine the status of L-fucose (produced by microbial fermentation), pursuant to Article 4(2) of Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods. https://food.ec.europa.eu/system/files/2019-09/novel-food_consult-status_l-fucose.pdf. Accessed 16 June 2023

  • Rychen G, Aquilina G, Azimonti G, Bampidis V, Bastos ML, Bories G, Chesson A, Cocconcelli PS, Flachowsky G, Gropp J, Kolar B, Kouba M, López-Alonso M, López Puente S, Mantovani A, Mayo B, Ramos F, Saarela M, Villa RE, Wallace RJ, Wester P, Glandorf B, Herman L, Kärenlampi S, Aguilera J, Anguita M, Brozzi R, Galobart J (2018) Guidance on the characterisation of microorganisms used as feed additives or as production organisms. EFS2 16:e05206. https://doi.org/10.2903/j.efsa.2018.5206

    Article  Google Scholar 

  • Silano V, Barat Baviera JM, Bolognesi C, Brüschweiler BJ, Cocconcelli PS, Crebelli R, Gott DM, Grob K, Lampi E, Mortensen A, Rivière G, Steffensen I-L, Tlustos C, van Loveren H, Vernis L, Zorn H, Glandorf B, Herman L, Aguilera J, Chesson A (2019) Characterisation of microorganisms used for the production of food enzymes. EFS2 17:e05741. https://doi.org/10.2903/j.efsa.2019.5741

    Article  Google Scholar 

  • Simpson C (2020) Issues concerning the definition of ‘placing on the market’ under Regulation (EC) No 178/2002. EFFL 2020:540–547

    Google Scholar 

  • Turck D, Bresson J-L, Burlingame B, Dean T, Fairweather-Tait S, Heinonen M, Hirsch-Ernst KI, Mangelsdorf I, McArdle H, Naska A, Neuhäuser-Berthold M, Nowicka G, Pentieva K, Sanz Y, Siani A, Sjödin A, Stern M, Tomé D, Vinceti M, Willatts P, Engel K-H, Marchelli R, Pöting A, Poulsen M, Salminen S, Schlatter J, Arcella D, Gelbmann W, de Sesmaisons-Lecarré A, Verhagen H, van Loveren H (2016) Guidance on the preparation and presentation of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283. EFS2 14. https://doi.org/10.2903/j.efsa.2016.4594

  • Volpato A (2022) Novel foods in the EU integrated administrative space: an institutional perspective. In: Scaffardi L, Formici G (eds) Novel foods and edible insects in the European Union. Springer International Publishing, Cham, pp 15–36

    Chapter  Google Scholar 

  • Zenodo (2023) Updated list of QPS-recommended microorganisms for safety risk assessments carried out by EFSA. https://zenodo.org/record/7554079#.ZGTdKXZByUk. Accessed 16 June 2023

  • van der Meulen B (2018) The safe food principle: a critical reflection on the key concept of EU food safety law. EIFL Working Paper Series

    Google Scholar 

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Authors and Affiliations

  1. Faculty of Life Sciences: Food, Nutrition and Health. Chair of Food Law, University of Bayreuth, Kulmbach, Germany

    Federica Ronchetti & Laura Springer

  2. Faculty of Life Sciences: Food, Nutrition and Health. Chair of Food Law, University of Bayreuth, Kulmbach, Bayern, Germany

    Kai P. Purnhagen

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  1. Federica Ronchetti
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  2. Laura Springer
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  3. Kai P. Purnhagen
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Ronchetti, F., Springer, L., Purnhagen, K.P. (2024). Pre-market Authorisation. In: The Regulatory Landscape in the EU for Dairy Products Derived from Precision Fermentation. SpringerBriefs in Law(). Springer, Cham. https://doi.org/10.1007/978-3-031-49692-9_4

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