Bulletin of Chinese Academy of Sciences (Chinese Version)
Regulation and Guidance for Marketing of Food Ingredients from Biomanufacturing and Policy Suggestions for China
biomanufacturing; food ingredient; novel food; gene editing; synthetic biology; marketing
The tightening policy of market regulation for food ingredients and novel foods produced by genetically modified microorganisms has hindered the development of the bio-economy. Here, the comparative studies have been conducted on the market regulations of food ingredients and novel foods produced by biomanufacturing in EU, USA, Japan, and China. These countries are all very concerned about the regulation of food ingredients and novel foods from biomanufacturing, however, they adopt quite different polices. EU is cautious, USA is positive, and Japan is less cautious. Over the past decades, China has been tightening the approval of food ingredients and novel foods produced by genetically modified microorganisms. At present, the whole world is actively responding to the supervision and access of new food ingredients and foods produced by new technologies. It is suggested that a positive application and approval path should be established, unified, and simplified for promoting the marketing of new products in China.
Bulletin of Chinese Academy of Sciences
Zhang Y-H P, Sun J B, Ma Y H. Biomanufacturing:History and perspective. Journal of Industrial Microbiology & Biotechnology, 2017, 44(4):773-784.
马延和.合成生物学及其在生物制造领域的进展与治理.科学与社会, 2014, 4(4-5):11-25.
Abbott Z. Gene expression system for probiotic microorganisms: US, 20190076489.2018-07-27.
Yang J G, Tian C Y, Zhang T, et al. Development of food-grade expression system for d-allulose 3-epimerase preparation with tandem isoenzyme genes in Corynebacterium glutamicum and its application in conversion of cane molasses to D-allulose. Biotechnology and Bioengineering, 2019, 116(4):745-756.
Mouat M J, Prince R, Roche M M. Making value out of ethics:The emerging economic geography of lab-grown meat and other animal-free food products. Economic Geography, 2019, 95(2):136-158.
Herman L, Chemaly M, Cocconcelli P S, et al. The qualified presumption of safety assessment and its role in EFSA risk evaluations:years past. FEMS Microbiology Letters, 2018, 366(1):fny260.
European Food Safety Authority. Introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA-Opinion of the Scientific Committee. EFSA Journal, 2007, 5(12):587.
European Parliament, Council. Regulation (EU) 2015/of the European Parliament and of the council of November on novel foods. Official Journal of the European Union, 2015, 327:1-22.
EFSA Panel on Biological Hazards (BIOHAZ). Update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA 8:Suitability of taxonomic units notified to EFSA until March 2018. EFSA Journal, 2018, 16(7):5315.
EFSA Panel on Nutrition Novel Foods and Food Allergens (NDA), Turck D, Castenmiller J, et al. Safety of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal, 2019, 17(2):5594.
Spicer A, Molnar A. Gene editing of microalgae:Scientific progress and regulatory challenges in Europe. Biology, 2018, 7(1):21.
Huang S W, Weigel D, Beachy R N, et al. A proposed regulatory framework for genome-edited crops. Nature Genetics, 2016, 48(2):109-111.
Ledford H. US rethinks crop regulation. Nature, 2016, 532:158-159.
Johansen E. Use of natural selection and evolution to develop new starter cultures for fermented foods. Annual Review of Food Science and Technology, 2018, 9:411-428.
Deckers M, Deforce D, Fraiture M, et al. Genetically modified micro-organisms for industrial food enzyme production:An overview. Foods, 2020, 9(3):326.
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Rychen G, Aquilina G, et al. Guidance on the characterisation of microorganisms used as feed additives or as production organisms. EFSA Journal, 2018, 16(3):5206.
EFSA Panel on Biological Hazards (BIOHAZ). Update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA 7:Suitability of taxonomic units notified to EFSA until September 2017. EFSA Journal, 2018, 16(1):5131.
EFSA Panel on Genetically Modified Organisms (GMO). Guidance on the risk assessment of genetically modified microorganisms and their products intended for food and feed use. EFSA Journal, 2011, 9(6):2193.
EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS). Guidance for submission for food additive evaluations. EFSA Journal, 2012, 10(7):2760.
EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids. Guidance on the data required for the risk assessment of flavourings to be used in or on foods. EFSA Journal, 2010, 8(6): 1623.
European Food Safety Authority (EFSA). Guidance of EFSA prepared by the Scientific Panel of Food Contact Materials, Enzymes, Flavourings and Processing Aids on the submission of a dossier on food enzymes for safety evaluation. EFSA Journal, 2009, 7(8):1305.
The European Parliament and the Council of the European Union. Regulation (EC) No 1829/of the European Parliament and of the Council of September on genetically modified food and feed. Official Journal of the European Communities, 2003, 268: L224.
US Food and Drug Administration. GRAS Notices.[2020-07-16]. https://www.accessdata.fda.gov/scripts/fdcc/index.cfm?set=GRASNotices&sort=GRN_No&order=DESC&startrow=151&type=basic&search=.
US Food and Drug Administration. Generally Recognized as Safe (GRAS).[2020-07-16]. https://www.fda.gov/food/foodingredients-packaging/generally-recognized-safe-gras.
赵婷, 姚粟, 葛媛媛, 等.美国食品工业用菌种法规标准简介.食品与发酵工业, 2014, 40(4):108-113.
Appendix XV: Microbial food cultures including probiotics//USP Food Chemicals Codex. 8th ed. Rock-ville, Maryland: The United States Pharmacopeial Convention, 2012: 1709-1715.
Olempska-Beer Z S, Merker R I, Ditto M D, et al. Foodprocessing enzymes from recombinant microorganisms-A review. Regulatory Toxicology and Pharmacology, 2006, 45(2):144-158.
Aldrete-Tapia J A, Miranda-Castilleja D E, Arvizu-Medrano S M, et al. Pursuing the perfect performer of fermented beverages: GMMs vs. Microbial Consortium//Solís-Oviedo R L, Pech-Canul Á D L C. Frontiers and New Trends in the Science of Fermented Food and Beverages. London: IntechOpen, 2018.
Waltz E. Gene-edited CRISPR mushroom escapes US regulation. Nature, 2016, 532:293.
骆鹏杰, 张俭波, 贾海先, 等.日本和韩国食品添加剂管理与法规标准的概述.中国食品添加剂, 2014, (7):88-93.
Dennis Normile. Gene-edited foods are safe, Japanese panel concludes.[2019-03-19]/[2020-07-16]. https://www.sciencemag.org/news/2019/03/gene-edited-foods-are-safejapanese-panel-concludes.
Akada R. Genetically modified industrial yeast ready for application. Journal of Bioscience and Bioengineering, 2002, 94(6):536-544.
Mandel G N, Marchant G E. The living regulatory challenges of synthetic biology. Iowa Law Review, 2014, 100(1):155-200.
Callaway E. CRISPR plants now subject to tough GM laws in European Union. Nature, 2018, 560:16-17.
Fraser R, Davis S C, Brown P O. Secretion of heme-containing polypeptides: US, WO/2015/038796.2014-09-11.
Demao, LI; Yan, ZENG; Ju, ZHOU; Qinhong, WANG; Jibin, SUN; Huifeng, JIANG; and Yanhe, MA
"Regulation and Guidance for Marketing of Food Ingredients from Biomanufacturing and Policy Suggestions for China,"
Bulletin of Chinese Academy of Sciences (Chinese Version): Vol. 35
, Article 12.
Available at: https://bulletinofcas.researchcommons.org/journal/vol35/iss8/12