Abstract
This chapter conducts a comprehensive comparison to assess whether the findings related to products derived from precision fermentation can be extrapolated to other product categories. Towards the end, it also juxtaposes the legal requirements governing the European market with those in the United States and Singapore.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Notes
- 1.
BRAIN Biotech AG (2023).
- 2.
- 3.
van Goethem (2016).
- 4.
van Goethem (2016).
- 5.
FIR. Article 9 (1)(a).
- 6.
FIR. Annex VII Part B (17); CMO. Annex VII Part I.
- 7.
- 8.
Sochirca (2018).
- 9.
Bundesministerium für Ernährung und Landwirtschaft; retrieved: Bundesministerium für Ernährung und Landwirtschaft (2018).
- 10.
Southey (2022).
- 11.
CMO. Article 78(1)(e).
- 12.
CMO. Article 78(2).
- 13.
CMO. Annex II Part VII.
- 14.
Examples of this stringent production requirement are “produced by hens of the species Gallus gallus” in Article 1 (k) of Regulation (EC) No 589/2008 (2008).
- 15.
FIR. Article 7.
- 16.
Tortajada and Hongzhou (2016), p. 1.
- 17.
Hamburg has a size of 755 qm2 Hamburg (2019).
- 18.
Ludher (2016), p. 131.
- 19.
Ludher (2016), p. 133.
- 20.
Ludher (2016), p. 136.
- 21.
Agri-Food and Veterinary Authority of Singapore (2020).
- 22.
Singapore Food Agency (2022a).
- 23.
Requirements for the Safety Assessment of Novel Foods and Novel Food Ingredients Singapore Food Agency (2022b), p. 2.
- 24.
Singapore Food Agency (2023).
- 25.
Singapore Food Agency (2022b), p. 10.
- 26.
Full list see: Singapore Food Agency (2022b), p. 10 ff.
- 27.
Quan (2023).
- 28.
Quan (2023).
- 29.
Dang (2023).
- 30.
These procedures differ especially in relation to who accesses and reviews the scientific data and information provided for the determination Gaynor (2018).
- 31.
- 32.
Federal Food, Drug and Cosmetic Act (2022), Section 201(s).
- 33.
U.S. Food and Drug Administration (2022).
- 34.
Code of Federal Regulations. § 170.30 (2016); National Archives; Shield et al. (2017).
- 35.
U.S. Department of Health and Human Services (2022).
- 36.
Steele et al. (2016).
- 37.
- 38.
- 39.
- 40.
Keller and Heckman (2019).
- 41.
References
Agri-Food and Veterinary Authority of Singapore (2020) New Singapore Food Agency to Oversee Food Safety and Security. https://www.sfa.gov.sg/food-for-thought/article/detail/new-singapore-food-agency-to-oversee-food-safety-and-security. Accessed 16 June 2023
BRAIN Biotech AG (2023) Three examples of precision fermentation. https://www.brain-biotech.com/alternative-proteins/three-examples-of-precision-fermentation. Accessed 12 June 2023
Bundesministerium für Ernährung und Landwirtschaft (2018) Leitsätze für vegane und vegetarische Lebensmittel mit Ähnlichkeit zu Lebensmitteln tierischen Ursprungs: Neufassung vom 04. Dezember 2018 (BAnz AT 20.12.2018 B1, GMBl 2018 S. 1174). https://www.bmel.de/SharedDocs/Downloads/DE/_Ernaehrung/Lebensmittel-Kennzeichnung/LeitsaetzevegetrarischeveganeLebensmittel.pdf?__blob=publicationFile&v=5. Accessed 9 June 2023
Carlson S (2021) Re: GRAS Notice No. GRN 000967. https://www.fda.gov/media/152289/download. Accessed 16 June 2023
Center for Food Safety and Applied Nutrition (2005) CPG Sec 500.200 Food Additives –“GRAS”: COMPLIANCE POLICY GUIDE (CPG). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-500200-food-additives-gras#:~:text=Section%20409%20of%20the%20Federal,substance%20may%20be%20safely%20used. Accessed 16 June 2023
Dang LH (2023) Precision fermentation adds value to food supply chain, not competition – Perfect Day. https://www.foodnavigator-asia.com/Article/2023/01/24/precision-fermentation-adds-value-to-food-supply-chain-not-competition-perfect-day#. Accessed 16 June 2023
Eder M (2023) Precision Fermentation simply explained. https://www.susupport.com/knowledge/fermentation/precision-fermentation#:~:text=Precision%20fermentation%20uses%20microbial%20hosts,pharmaceutical%20industry%20to%20produce%20biopharmaceuticals. Accessed 7 Aug 2023
Ettinger J (2022) Remilk’s precision fermentation dairy is the second to earn U.S. GRAS Status. https://www.greenqueen.com.hk/remilk-u-s-gras-status/. Accessed 16 June 2023
European Parliament (2020) Amendments adopted by the European Parliament on 23 October 2020 on the proposal for a regulation of the European Parliament and of the Council amending Regulations (EU) No 1308/2013 establishing a common organisation of the markets in agricultural products, (EU) No 1151/2012 on quality schemes for agricultural products and foodstuffs, (EU) No 251/2014 on the definition, description, presentation, labelling and the protection of geographical indications of aromatised wine products, (EU) No 228/2013 laying down specific measures for agriculture in the outermost regions of the Union and (EU) No 229/2013 laying down specific measures for agriculture in favour of the smaller Aegean islands. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020AP0289 Accessed 1 January 2024
Gaynor P (2018) How U.S. FDA’s GRAS Notification Program Works. https://www.fda.gov/food/generally-recognized-safe-gras/how-us-fdas-gras-notification-program-works#authors. Accessed 16 June 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)
Hamburg (2019) Hamburg in Zahlen: Fakten & Zahlen. https://www.hamburg.de/info/3277402/hamburg-in-zahlen/. Accessed 16 June 2023
Informa Markets (2020) Perfect Day’s animal-free dairy protein earns Generally Recognized as Safe (GRAS) status. https://www.ingredientsnetwork.com/perfect-day-s-animalfree-dairy-protein-earns-news083312.html. Accessed 16 June 2023
Keller and Heckman (2019) GRAS Notice for Non-Animal Whey Protein from Fermentation by Trichoderma reesei. https://www.fda.gov/media/136754/download. Accessed 16 June 2023
Ludher EK (2016) Singapore’s smart governance of food. In: Deakin M, Borrelli N, Diamantini D (eds) The governance of city food systems: case studies from around the world, pp 131–154
National Archives Code of Federal Regulations: A point in time eCFR system. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-170/subpart-E?toc=1;. Accessed 16 June 2023
Pig Progress (2021) EU parliament decides fate of ‘veggie meat’. https://www.pigprogress.net/home/eu-parliament-decides-fate-of-veggie-meat/#:~:text=In%20a%20recent%20vote%2C%20the,how%20products%20can%20be%20marketed. Accessed 16 June 2023
Quan TY (2023) Risk at a glance: new foods from fermentation. https://www.sfa.gov.sg/food-information/risk-at-a-glance/new-foods-from-fermentation
Remilk Ltd (2022a) Remilk Secures Self-Affirmed GRAS for Non-Animal, Real Dairy Protein. https://www.remilk.com/newsroom/remilk-secures-self-affirmed-gras-for-non-animal-real-dairy-protein-2. Accessed 16 June 2023
Remilk Ltd (2022b) Remilk Self-Affirms GRAS Status for Precision Fermentation Dairy. https://www.newprotein.net/news/remilk-self-affirms-gras-status-for-precision-fermentation-dairy. Accessed 16 June 2023
Schweizer E (2022) What consumers should ask about precision fermentation. https://www.forbes.com/sites/errolschweizer/2022/03/02/what-should-consumers-be-asking-about-precision-fermentation/. Accessed 7 Aug 2023
Shield J, Kuler J, Gurnani A (2017) Regulatory constraints on new product development and approval procedures in the United States. In: Developing new functional food and nutraceutical products. Elsevier, pp 123–148
Singapore Food Agency (2022a) Singapore Food Statistics 2022. https://www.sfa.gov.sg/docs/default-source/default-document-library/20230518-sfa-media-release%2D%2D-singapore-food-statistics-2022.pdf. Accessed 16 June 2023
Singapore Food Agency (2022b) Requirements for the safety assessment of novel foods and novel food ingredients. https://www.sfa.gov.sg/docs/default-source/food-import-and-export/Requirements-on-safety-assessment-of-novel-foods_26Sep.pdf. Accessed 16 June 2023
Singapore Food Agency (2023) Novel Food. https://www.sfa.gov.sg/food-information/novel-food. Accessed 16 June 2023
Sochirca N (2018) The European legal framework on vegan and vegetarian claims. EFFL 2018:514–521
Southey F (2022) Vegan ‘steak’ on the back burner? France suspends ban on ‘meaty’ terms for plant-based products. Accessed 16 June 2023
Steele EA, Breen C, Campbell E, Martin R (2016) Food regulations and enforcement in the USA. In: Reference module in food science. Elsevier
The EVERY Company (2023) EVERY. All Protein. No Animal. https://theeverycompany.com/. Accessed 12 June 2023
Tortajada C, Hongzhou Z (2016) Food policy in Singapore. In: Reference module in food science. Elsevier
U.S. Department of Health and Human Services (2022) Best practices for convening a GRAS panel: guidance for industry. https://www.fda.gov/media/109006/download. Accessed 16 June 2023
U.S. Food and Drug Administration (2022) Generally Recognized as Safe (GRAS). https://www.fda.gov/food/food-ingredients-packaging/generally-recognized-safe-gras. Accessed 16 June 2023
Watson E (2020) Perfect Day secures no objections letter from FDA for non-animal whey protein. https://www.foodnavigator-usa.com/Article/2020/04/14/Perfect-Day-secures-no-objections-letter-from-FDA-for-non-animal-whey-protein#:~:text=Perfect%20Day%2C%20a%20startup%20producing,non%2Danimal’%20whey%20protein. Accessed 16 June 2023
Watson E (2021) Clara Foods rebrands as The EVERY Company, launches ‘nearly invisible’ animal-free egg protein (without chickens). https://www.foodnavigator-usa.com/Article/2021/10/05/Clara-Foods-rebrands-as-The-EVERY-Company-launches-nearly-invisible-animal-free-egg-protein-without-chickens. Accessed 16 June 2023
Author information
Authors and Affiliations
Rights and permissions
Copyright information
© 2024 The Author(s), under exclusive license to Springer Nature Switzerland AG
About this chapter
Cite this chapter
Ronchetti, F., Springer, L., Purnhagen, K.P. (2024). Comparative Analysis. 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_6
Download citation
DOI: https://doi.org/10.1007/978-3-031-49692-9_6
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-031-49691-2
Online ISBN: 978-3-031-49692-9
eBook Packages: Law and CriminologyLaw and Criminology (R0)