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FINAL-Sodium Formate GRAS Notification July 2016

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FINAL-Sodium Formate GRAS Notification July 2016 1 Introduction ............................................................................................................... 2 2 Importance of Formate in the Production of Microbial Food Cultures ............... 4 3 Description of Sodium formate ................................................................................ 8 4 Manufacturing Process ............................................................................................. 9 4.1 Typical Starting Materials .................................................................................... 9 4.2 Typical Process for Sodium Formate ................................................................... 9 5 Quality Control for Sodium Formate .................................................................... 10 6 Common use in Food ............................................................................................... 11 6.1 Formic Acid........................................................................................................ 11 6.2 Sodium Formate ................................................................................................. 11 7 Intended Uses/Use Levels ........................................................................................ 12 8 Exposure ................................................................................................................... 13 9 Safety Testing ........................................................................................................... 18 9.1 Animal studies .................................................................................................... 18 9.2 Repeated Dose Toxicity ..................................................................................... 19 9.3 Human studies .................................................................................................... 19 10 Safety Assessment ................................................................................................ 20 11 Regulatory Status of Sodium Formate ............................................................... 21 11.1 USA............................................................................................................... 21 11.2 Australia and New Zealand ........................................................................... 21 11.3 JECFA ........................................................................................................... 21 11.4 European Union ............................................................................................ 22 11.5 France ............................................................................................................ 22 11.6 Denmark ........................................................................................................ 23 12 Conclusion ............................................................................................................ 25 13 References ............................................................................................................. 26 14 Appendix ............................................................................................................... 32 14.1 Product Descriptions ..................................................................................... 32 14.2 Certificates of Analysis ................................................................................. 32 14.3 Expert Panel Report ...................................................................................... 32 14.4 Expert Panelist Curriculum Vitae ................................................................. 32 Page 1 of 32 Confidential Information – Do Not Copy or Duplicate 1 Introduction Sodium formate is the sodium salt of formic acid. It is a white crystalline powder which does not have flammable or explosive properties. It is also completely soluble in water. The proposed use of sodium formate is to support the symbiotic growth of streptococcus, lactobacillus and leuconostoc species in fermented dairy and soy products, where the level initially added does not exceed 20 ppm, and the final concentration after fermentation is not increased over the naturally-occurring formate concentration in the fermented product when formate is not added. The Microbial Food Culture (MFC) industry produces a variety of dairy cultures which are used by food producers for the manufacture of specific cheese and fermented milk products (yogurt, sour cream, cream cheese, etc.). In most cases, two or more species of MFCs are used for the fermentation. Some of these MFCs utilize symbiotic growth and benefit from a mutual exchange of metabolites. One metabolite, formate is produced by both Streptococcus thermophilus and Lactococcus lactis species, which then is used as an essential nutrient in the fermentation of other species as well as the species themselves. During the harvesting and concentration of industrially produced MFC through centrifugation or ultrafiltration, the formate which is naturally formed during the growth of the MFCs, is washed out in the supernatant liquid. Formate also occurs naturally in milk; however, the concentration varies depending on geography, season and feed for the cows as well as the heat treatment used on the milk. A low level of formate results in a delayed and uneven growth of the cultures, slow development of lactic acid and inconsistent quality. Some industrial MFCs are therefore standardized with formate to achieve optimal growth conditions in the start-up of the fermentation process of the food product, where formate is essential. When the MFCs grow, S. thermophilus and L. lactis will produce formate, which then can be used, for example, by lactobacilli or cocci as a part of their metabolism. Standardization of formate in the MFCs results in a uniform quality in all cases independent of milk conditions, regardless of the amount of formate lost during concentration of MFCs. Since food ingredients in the United States must either be approved food additives, or exempted GRAS substances, the industry has undertaken a determination of the safety of sodium formate for use in fermented dairy and soy products in which addition of sodium formate supports the growth of the MFCs in the finished food product. Application areas are currently envisioned to include cultured milk products, such as cultured milk, sour cream, yogurts; frozen fermented milk products, e.g. frozen yogurt; strained cultured milk products, e.g. quark, fresh cheese, greek yogurt; fermented soy milk and fermented soy milk products; and cheeses, e.g. asiago cheese, caciocavallo siciliano cheese, cheddar cheese, colby cheese, cottage cheese, gruyere cheese, monterey and monterey jack cheese, mozzarella and scamorza cheese, blue cheese, provolone cheese, romano cheese, and swiss cheese. Page 2 of 32 Confidential Information – Do Not Copy or Duplicate For the safety determination, we have established (1) general recognition by experts that use of this substance in processing of MFCs is safe; (2) the experts are qualified by scientific training and experience; and (3) the experts have based their safety judgment on scientific procedures 21 CFR 170.30. Page 3 of 32 Confidential Information – Do Not Copy or Duplicate 2 Importance of Formate in the Production of Microbial Food Cultures Formate production by S. thermophilus and L. lactis has been reported since late1960’s (Galesloot et al., 1968) and its importance for improving mixed starter culture performance has been acknowledged since the 1970’s as described in a thesis by Tamime 1977 reported in 2000 in Yogurt Science and Technology (Tamime and Robinson, 2000). The growth of S. thermophilus in milk is limited by the availability of peptides and free amino acids which are present in relatively low concentrations in milk (Higashio et al., 1978; Goff and Hill, 1993). Streptococcus and lactococcus bacteria produce formate, pyruvate and carbon dioxide all of which stimulate the growth of streptococcus, lactobacillus and lactococcus (Driessen et al., 1982; Chandan and O’Rell, 2006; Verdamuthu, 2006). Due to a formate-induced increase in proteolytic activities by the Lactobacillus bulgaricus, it in turn provides sufficient amino acids and peptides to stimulate growth of S. thermophilus and its own growth (Sieuwerts et al., 2010). This association is necessary for consistent manufacturing of fermented foods and can be briefly described as each organism providing compounds which benefits itself and the other organisms. Figure 1: Favorable interactions of S. thermophilus and L. bulgaricus This relationship is also referred to as proto-co-operation which means that they have mutually favorable interaction but are not dependent on this coexistence (Courtin and Rul, 2004). Each will grow as a mono-culture in milk but when present together, will grow and acidify the final food product faster (Tamime and Robinson, 2000). Page 4 of 32 Confidential Information – Do Not Copy or Duplicate Figure 2: Mutually favorable interaction. Figure from page 417 in Tamime, 2000 Formate is produced by MFCs during fermentation when pyruvate is converted into acetyl-CoA and formate via the pathway catalyzed by the enzyme pyruvate formate lyase (PFL) (Derzelle et al., 2005). The activity of the PFL enzyme in L. lactis and S. thermophilus is regulated in the presence of oxygen; hence, it is active only under strict anaerobic conditions (Yamada et al., 1985; Arnau et al., 1997; Chandan, 2006). When the milk is inoculated with the starter cultures,
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