Health, safety, and regulation Sucralose




1 health, safety, , regulation

1.1 safety of consumption

1.1.1 potential effects on health


1.2 environmental effects





health, safety, , regulation

sucralose has been accepted safe several national , international food safety regulatory bodies, including fda, joint fao/who expert committee report on food additives, european union s scientific committee on food, health protection branch of health , welfare canada, , food standards australia new zealand. according canadian diabetes association, amount of sucralose can consumed on person s lifetime without adverse effects 9 mg per kg of body weight per day.



in determining safety of sucralose, fda reviewed data more 110 studies in humans , animals. many of studies designed identify possible toxic effects, including carcinogenic, reproductive, , neurological effects. no such effects found, , fda s approval based on finding sucralose safe human consumption. example, mcneil nutritional llc studies submitted part of u.s. fda food additive petition 7a3987 indicated in 2-year rodent bioassays ... there no evidence of carcinogenic activity either sucralose or hydrolysis products ...



safety of consumption

results on hundred animal , clinical studies in fda approval process unanimously indicated lack of risk associated sucralose consumption. when estimated daily intake (edi) compared intake @ adverse effects seen (known highest no adverse effects limit, or hnel) @ 1500 mg/kg bw/day, large margin of safety exists. bulk of sucralose ingested not absorbed gastrointestinal (gi) tract , directly excreted in feces, while 11–27% of absorbed. amount absorbed gi tract largely removed blood stream kidneys , eliminated in urine, 20–30% of absorbed sucralose being metabolized. means between 2–8% of sucralose consumed metabolized, on average.


potential effects on health

despite being recognized safe regulatory agencies based on information multitude of large-scale , clinical studies, sucralose has been subject of few small-scale or animal studies attempting determine yet-unknown effects on illnesses such obesity, diabetes, , cancer.


a duke university animal study funded sugar association found evidence doses of splenda (containing ~1% sucralose , ~99% maltodextrin weight) between 100 , 1000 mg/kg bw/day, containing sucralose @ 1.1 11 mg/kg bw/day, fed rats reduced fecal microflora, increased ph level in intestines, contributed increases in body weight, , increased levels of p-glycoprotein (p-gp). these effects have not been reported in humans. expert panel, including scientists duke university, rutgers university, new york medical college, harvard school of public health, , columbia university reported in regulatory toxicology , pharmacology duke study not scientifically rigorous , deficient in several critical areas preclude reliable interpretation of study results .


the center science in public interest, consumer advocacy group food products, downgraded sucralose safe caution in june 2013, citing unpublished study linking sucralose consumption leukemia risk in rats. study has been criticized being poorly executed , reported. study published on january 29 2016 in peer-reviewed international journal of occupational , environmental health. 1 study linked large doses of sucralose, equivalent 11,450 packets (136 g) per day in person (i.e., ~360 times adi of 5 mg/kg bw/day), dna damage in mice. sucralose has not shown dna-damaging properties in dna repair assays @ normal consumption levels, , no evidence of carcinogenicity.


in small-scale study of 17 obese test subjects, sucralose found affect glycemic , insulin responses, leading increase in peak plasma glucose concentration , insulin secretion rate. in 2014 study, sucralose limited growth of bacteroides bacteria in vitro.


there doubt whether sucralose can achieve weight loss. according research, artificial sweeteners not activate brain s food reward pathways sugar does. because sweetener not provide full satisfaction, user may search for, , ingest, additional high-calorie sweets, leading weight gain.


environmental effects

according 1 study, sucralose digestible number of microorganisms , broken down once released environment. however, measurements swedish environmental research institute have shown sewage treatment has little effect on sucralose, present in wastewater effluents @ levels of several μg/l (ppb). no ecotoxicological effects known @ such levels, swedish environmental protection agency warns continuous increase in levels may occur if compound degraded in nature. when heated high temperatures (over 350 °c or 662 °f) in metal containers, sucralose can produce in resulting smoke polychlorinated dibenzo-p-dioxins , other persistent organic pollutants.


sucralose has been detected in natural waters. studies indicate has virtually no impact on life development of animal species.








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