Lycopene

Foods -> FDA Regulatory Status of Color Additives

FLAVORING AGENT OR ADJUVANT -> FDA Substance added to food

This chemical does not meet GHS hazard criteria for 100% (203 of 203) of all reports.

Not Classified

Aggregated GHS information provided per 203 reports by companies from 1 notifications to the ECHA C&L Inventory.

Regulation (EC) No 178/2002 (amended)

.psi.,.psi.-Carotene: Does not have an individual approval but may be used under an appropriate group standard

A large body of human and animal research suggests that oral forms of lutein and lycopene may provide benefits for eye, prostate, skin and cardiovascular health. The increased awareness and use of lutein and lycopene in dietary supplements warrants a comprehensive review of their safety. The Highest Observed Intake (HOI) risk assessment method indicates that the evidence of safety is strong at intakes up to 20mg/d for lutein and 75 mg/d for lycopene, and these levels are identified as the respective Observed Safe Level (OSL). Much higher levels have been tested without adverse effects and may be safe; however, the data are not sufficient for a confident conclusion of long-term safety.

Lycopenemia, characterized by pigmentation of the skin color from yellow to orange, is caused by the excess consumption of lycopene resources taken through the diet. Lycopene deposits take place in the stratum corneum. The symptoms are eliminated with changes in the diet.

Lycopene is one of the most potent antioxidants, and is found in fruits and vegetables. High-intake of lycopene has decreased the risks of natural toxins, including mycotoxins and bacterial toxins, and chemical toxins, including heavy metals, pesticides and herbicides.

Lycopene is a natural carotenoid found predominantly in tomatoes and tomato-based products. The safety of synthetic lycopene as beadlet formulations includes acute and subchronic safety studies, reproductive studies, genotoxicity studies, metabolic studies, and exploratory studies on the hepatic uptake of lycopene. It has a low order of acute toxicity and no significant toxicity has been observed in rats treated with lycopene in the diet at doses of up to 500 mg/kg bw/day for 14 weeks, or 1000 mg/kg bw/day for 4 weeks. No teratogenic effects were noted in a rat two-generation study (1000 ppm in the diet) or in a teratology study in rats with 1000 mg/kg bw/day lycopene as beadlet formulations. Unformulated pure crystalline lycopene and lycopene as a 10% beadlet formulation were not genotoxic in a comprehensive battery of tests; ,however, improperly stored, unformulated crystalline lycopene can degrade to mutagenic products if exposed to light and air. There is a large margin of safety based on the repeated dose safety and reproductive/teratology studies in rodents. In humans, there is a very long history of dietary exposures, and there is no indication of any significant adverse effects even in for very high exposures from dietary sources.

Lycopene (LYC) has multiple biological activities, including antioxidative, anti-inflammatory, and antiapoptotic effects, and has been shown to have hepatoprotective properties against various liver diseases, e.g., alcoholic liver disease, nonalcoholic fatty liver disease, liver fibrosis, hepatic ischemia/reperfusion injury, hepatocellular carcinoma, fulminant hepatic failure, and radiation-induced liver damage. LYC also protects against drug-induced liver injury caused by tramadol, cisplatin, methotrexate, oestrogen, sulfamethoxazole, and others. It has shown promising hepatoprotective effects for environmental toxins such as Di(2-ethylhexyl) phthalate, atrazine, aflatoxins, 2,3,7,8-tetrachlorodibenzo-p-dioxin, bisphenol A, dichlorvos, and heavy metals. This review discusses LYC's hepatoprotective properties, explores the mechanisms behind this effect, and highlights research directions to further investigate the potential benefits of LYC consumption to treat human liver diseases.

While dietary lycopene during pregnancy and lactation is generally safe, supplemented lycopenes taken during pregnancy are probably not safe. There is not enough information about lycopene supplementation during breastfeeding, and it is recommended to avoid supplementing lycopene during pregnancy and lactation.

Carotenoids (beta-carotene, lutein, lycopene, zeaxanthin) and carrot flavor are transmitted into breastmilk… A study of 39 mothers of preterm infants (24 to 34 weeks gestation) provided 184 milk and 21 plasma samples weekly up to 6 weeks postpartum. Mean lutein, zeaxanthin, beta-carotene, and lycopene concentration decreased as lactation progressed, with the highest concentrations in colostrum. Lycopene (41%) and beta-carotene (36%) were the predominant carotenoids in colostrum and for up to 2 weeks postpartum. The proportion of lutein and zeaxanthin increased with lactation duration to account for 45% of the carotenoids in mature milk. Infant Levels. In a study of 39 mothers and their preterm infants (24 to 34 weeks gestation).. 21 blod samples were obtained from infants at 6 weeks of age. The carotenoid concentrations averaged as follows: lutein 76.2 mcg/l, beta-carotene 24.5 mcg/L, zeaxanthin 13.6 mcg/L and lycopene 11 mcg/L. No correlation was observed in carotenoid content between maternal milk and infant plasma at 6 weeks postpartum.

Serum and tissue lycopene levels have been inversely related to the risk of lung and prostate cancers. Lycopene functions as a very potent antioxidant, and it can trap singlet oxygen and reduce mutagenesis in the Ames test. Lycopene at physiological concentrations can inhibit human cancer cell growth by interfering with growth factor receptor signaling and cell cycle progression. Studies using human and animal cells identified connexin 43, a gene whose expression is upregulated by lycopene and which allows direct intercellular gap junctional communication (GJC). GJC is deficient in many human tumors and its restoration or upregulation is associated with decreased proliferation. The combination of low concentrations of lycopene with 1,25-dihydroxyvitamin D3 exhibits a synergistic effect on cell proliferation and differentiation, and an additive effect on cell cycle progression in the HL-60 promyelocytic leukemia cell line, suggesting some interaction at a nuclear or subcellular level.

Substances that reduce or suppress INFLAMMATION.

Naturally occurring or synthetic substances that inhibit or retard oxidation reactions. They counteract the damaging effects of oxidation in animal tissues.

Drugs used to protect against ionizing radiation. They are usually of interest for use in radiation therapy but have been considered for other purposes, e.g. military.

Agents that reduce the frequency or rate of spontaneous or induced tumors independently of the mechanism involved.

Lycopene is the most effective singlet oxygen scavenger in vitro of all the carotenoids. Foods that contain lycopene and related supplements have been reported to prevent chronic diseases including cancer, asthma, and cardiovascular disorders.

In vitro and in vivo, lycopene has been demonstrated to mitigate oxidative stress-induced metabolic dysfunctions and diseases including inflammation, obesity, and diabetes mellitus. Lycopene has been shown to alleviate metabolic diseases that affect the bone, eye, kidney, liver, lungs, heart, and nervous system.

Food Additives -> COLOUR -> JECFA Functional Classes

Food Additives -> COLOUR -> JECFA Functional Classes

Food Additives -> COLOUR -> JECFA Functional Classes

Cosmetics -> Cosmetic colorant