Home Ingredients 3'-Sialyllactose (3'-SL)

3'-Sialyllactose (3'-SL)

Evidence Level
Limited
5 Clinical Trials
5 Documented Benefits
2/5 Evidence Score

3'-Sialyllactose (3'-SL) is one of the two most plentiful sialylated oligosaccharides in human breast milk, the HMOs that carry sialic acid. The 3'-SL sold for infant formula, foods and supplements is a human-identical sodium salt made by fermentation with genetically modified E. coli or by enzyme-based synthesis, not taken from breast milk, and the FDA and EFSA have reviewed it for safety. Only two placebo-controlled trials have tested 3'-SL on its own. In adults with knee osteoarthritis, 200 or 600 mg a day for 12 weeks lowered pain from baseline but not compared with placebo, and in people carrying the stomach bacterium H. pylori, 10 or 20 g a day for 4 weeks did not clear it. Infant formulas with 3'-SL in five-HMO blends supported normal growth. Cartilage effects come from lab and animal work, and makers funded or co-authored most studies.

Studied Dose Trials of 3'-SL alone used 200 or 600 mg a day for 12 weeks in adults with knee osteoarthritis and 10 or 20 g a day for 4 weeks in people with H. pylori. Infant formulas held it within five-HMO blends. EFSA assessed supplement use of 0.5 to 1.0 g a day from age 3.
Active Compound 3'-Sialyllactose (3'-SL), also called 3'-N-acetylneuraminyl-D-lactose: an acidic three-sugar carbohydrate (trisaccharide) in which sialic acid (N-acetylneuraminic acid) is joined to the galactose of lactose. Commercial 3'-SL is a human-identical sodium salt (C23H38NO19Na) made by fermentation with genetically modified E. coli strains or by enzyme-based synthesis, not extracted from breast milk.

Benefits

Knee comfort and function in adults

In 60 adults with knee osteoarthritis, 200 or 600 mg a day of 3'-SL for 12 weeks lowered pain and function scores from baseline, but neither score differed from placebo at any time point, the trial's main comparison. The trial was single-blind, the maker made the tablets, and three authors worked for it.

Supported by Trial 1

Stomach bacteria attachment in lab and human studies

3'-SL can stop H. pylori from sticking to human epithelial cells in the lab. In a double-blind trial in 65 people with indigestion who carried H. pylori, 10 or 20 g a day for 4 weeks cleared the bacterium in no one. Breath test values fell in all groups, placebo included, which the authors put down to regression to the mean.

Supported by Trial 2

Growth and stool pattern in formula-fed infants with a five-HMO blend

In two randomized trials in healthy newborns, formula with 5.75 g/L of five HMOs, 3'-SL among them, gave weight gain no different from standard formula, the main outcome, and softer, more frequent stools closer to those of breastfed infants. Each trial was funded by its formula or HMO maker, and 3'-SL was not tested on its own.

Supported by Trial 3, Trial 4

Gut bacteria and gut maturation markers in infants given a five-HMO blend

In a trial in healthy infants, formula with 1.5 or 2.5 g/L of a five-HMO blend including 3'-SL shifted gut bacteria closer to those of breastfed infants, with more B. infantis, lower stool pH and higher secretory IgA at 3 months and about 45% more bifidobacteria at 6 months than standard formula. These were secondary markers in a maker-funded trial, and 3'-SL was not tested alone.

Supported by Trial 5

Cartilage findings in laboratory and animal studies

In cartilage cells and in mice with surgically induced joint damage, 3'-SL limited cartilage breakdown and enzymes that degrade cartilage. In minipigs with joint damage, oral sialyllactose raised blood sialyllactose and sialic acid and lowered these enzymes in the joint lining. These are lab and animal results, not human evidence.

Supported by Trial 5

Mechanism of action

1

Reaching the blood

A review of 15 human studies found that HMOs, the group that includes 3'-SL, appear in the blood and urine of breastfed infants, formula-fed infants and adults taking HMO supplements, and some studies found levels rising with dose. Some structures were not absorbed, and absorption rates and fate in the body are still unknown.

2

Food for some gut bacteria

HMOs are not digested in the upper intestine. In lab cultures of 25 gut bacteria, 3'-SL gave moderate growth of several Bifidobacterium longum strains and two Bacteroides species, which made lactate and short-chain fatty acids, while Clostridium and E. coli strains did not use it. This is lab work, not a human result.

3

Decoy receptor idea

3'-SL resembles sialic acid-containing sugars on cell surfaces, and in the lab it can block some microbes, such as H. pylori, from attaching to human cells. In the one human trial of this idea, 3'-SL did not reduce H. pylori in the stomach.

4

Signals in cartilage cells (lab and animal work)

In cartilage cells, 3'-SL raised type II collagen production and the activity of Sox9, a factor that drives it, and blocked inflammatory NF-kB signaling and the cartilage-degrading enzymes Mmp3, Mmp13 and Cox2. These signals were measured in cells and mice, not in people taking 3'-SL.

Clinical trials

1
3'-Sialyllactose 200 or 600 mg a Day for 12 Weeks in Knee Osteoarthritis
PubMed

Randomized, single-blind, three-arm pilot trial versus placebo tablets; primary outcome VAS pain, with KWOMAC as the secondary outcome; no trial registration number is given in the paper. Supported by Korean government grants (MOTIE and KIAT); the 3'-SL tablets were made by GeneChem Inc., which employed three authors, one of whom held its stock (Park et al. 2024, Nutrients)

60 Korean adults over 40 with knee osteoarthritis (Kellgren and Lawrence grades 1 to 4), 20 per group; 56 completed.

Pain and KWOMAC scores fell from baseline at 12 weeks in the 3'-SL groups and not on placebo, but neither score differed between groups at any time point. No serious adverse events were reported; the 12 adverse events were all mild, most often nausea, indigestion and heartburn.

2
3'-Sialyllactose 10 or 20 g a Day for 4 Weeks in People With H. pylori
PubMed

Randomized, double-blind, placebo-controlled trial of 3'-SL sodium salt at 10 or 20 g a day in three doses before meals for 4 weeks, with breath tests during treatment and 4 weeks after stopping; the aim was to suppress or clear H. pylori. Funding is not stated in the abstract (Parente et al. 2003, Helicobacter)

65 people with indigestion and H. pylori infection confirmed by histology and breath test; 61 completed per protocol (17 on 10 g, 22 on 20 g, 21 on placebo).

No one became breath test negative during or after treatment. Breath test values fell in both 3'-SL groups and on placebo, which the authors attributed to regression to the mean. No serious adverse events occurred, and the authors judged it safe and well tolerated.

3
Infant Formula With a Five-HMO Blend (5HMO-Mix): Growth and Tolerance
PubMed

Multicenter, randomized, controlled parallel-group trial of formula with 5.75 g/L of five HMOs (52% 2'-FL, 13% 3-FL, 26% LNT, 4% 3'-SL, 5% 6'-SL) versus formula without HMOs for 4 months, with a breastfed reference group; primary outcome daily weight gain (NCT03513744). Funded by Chr. Hansen HMO GmbH; all four authors were employees of Chr. Hansen or its predecessor Jennewein Biotechnologie (Parschat et al. 2021, Nutrients)

341 healthy term infants aged 14 days or younger were enrolled; 225 were randomized to the two formulas and the rest were exclusively breastfed.

Weight, length and head circumference gains did not differ between the two formula groups. Infants on the HMO formula, like breastfed infants, had softer and more frequent stools than the control formula group. Adverse events were equivalent in all groups. 3'-SL was not tested on its own.

4
Infant Formula With a Five-HMO Blend at 5.75 g/L: Growth and Gut Tolerance
PubMed

Randomized, double-blind, controlled parallel feeding trial of milk-based formula with five HMOs (2'-FL, 3-FL, LNT, 3'-SL and 6'-SL; 5.75 g/L) versus control formula, with a human milk reference group; primary outcome weight gain per day from day 14 to day 119 (NCT04105686). Funded by Abbott Nutrition, which employed all authors (Lasekan et al. 2022, Nutrients)

Healthy term infants: 130 on the HMO formula, 129 on control formula and 104 fed human milk.

Weight gain per day did not differ among the three groups. Stools on the HMO formula were softer, more frequent and more yellow than on control formula, like those of breastfed infants. Adverse events did not differ, while more control formula infants saw a health care professional for illness by days 56 and 84, a secondary result.

5
Infant Formula With a Five-HMO Blend at 1.5 or 2.5 g/L: Gut Bacteria and Gut Maturation Markers
PubMed

Multicenter randomized controlled trial of standard formula or the same formula with 1.5 or 2.5 g/L of five HMOs (2'-FL, 2',3-difucosyllactose, LNT, 3'-SL and 6'-SL), with a human milk-fed reference group; this paper reports secondary outcomes, as the co-primary outcomes were growth at 4 months and respiratory infections at 15 months (NCT03722550). Funded by Nestle Nutrition, which helped design, analyze and write the study; four authors were Nestle employees (Bosheva et al. 2022, Front Nutr)

Healthy infants aged 7 to 21 days, with stool samples analyzed from about 150 per formula group at baseline, 140 at 3 months and 115 at 6 months, plus a breastfed reference group.

Gut bacteria in both HMO groups moved closer to those of breastfed infants, with more B. infantis and, by 6 months, about 45% more bifidobacteria than on standard formula. Toxigenic C. difficile was 75 to 85% lower, stool pH was lower and secretory IgA was higher at 3 months. These are markers, and 3'-SL was not tested alone.

Side effects and drug interactions

Common Potential side effects

In adults taking 200 or 600 mg a day of 3'-SL for 12 weeks, no serious adverse events occurred; all 12 reported adverse events among the 60 participants were mild, most often nausea, indigestion and heartburn.
In adults taking 10 or 20 g a day of 3'-SL for 4 weeks, no serious adverse events occurred and the authors judged it well tolerated.
In infant formula trials of five-HMO blends that included 3'-SL, growth and adverse events were no different from standard formula, and stools were softer and more frequent, like those of breastfed infants.
Maker-run safety studies of 3'-SL sodium salt found no genetic toxicity and no adverse effects in rats at up to 2,000 mg/kg body weight a day for 90 days or in newborn piglets fed it for 21 days. EFSA states that 3'-SL supplements are not meant for days when other foods with added 3'-SL, or breast milk for young children, are consumed.

Important Drug interactions

No drug interaction studies of 3'-SL were found in the research reviewed here.
H. pylori treatment: in the one trial, 3'-SL did not clear H. pylori. Take any prescribed treatment as directed.
Infants: use 3'-SL only as part of an infant formula or as advised by a pediatrician, and ask a doctor before giving adult supplements to children.

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Frequently asked questions about 3'-Sialyllactose (3'-SL)

What is 3'-sialyllactose (3'-SL)?

3'-SL is a three-sugar carbohydrate that carries sialic acid and occurs naturally in human breast milk, at about 0.09 to 0.35 g per liter according to one infant formula trial report. Supplement and formula versions are human-identical copies made by fermentation with genetically modified E. coli or by enzyme-based synthesis, not taken from breast milk.

How much 3'-SL has been studied?

Adult trials of 3'-SL alone used 200 or 600 mg a day for 12 weeks and 10 or 20 g a day for 4 weeks. Infant formulas supplied it as part of five-HMO blends. EFSA assessed food supplement use of 0.5 to 1.0 g a day from age 3. Follow the product label.

Does 3'-SL help knee comfort?

Not shown so far. In the only trial, 60 adults with knee osteoarthritis took 200 or 600 mg a day or placebo for 12 weeks. Pain and function scores improved from baseline on 3'-SL but did not differ from placebo at any time point. Cartilage benefits so far come from cell and animal studies.

Is 3'-SL safe?

The FDA has responded with no questions to seven GRAS notices for 3'-SL, and EFSA has judged several fermentation-made versions safe in infant formula, foods and supplements. In adult trials of up to 12 weeks, no serious adverse events occurred, and those reported in the knee trial were mild. Long-term adult data are lacking.

Is 3'-SL the same as 6'-SL or an HMO blend?

No. 3'-SL and 6'-SL are two forms of sialyllactose that differ in where the sialic acid is attached, and most infant formulas combine 3'-SL with other HMOs. Results from blends apply to the blend, not to 3'-SL alone. See the 6'-sialyllactose and human milk oligosaccharides pages.

What is 3'-Sialyllactose?

3'-Sialyllactose (3'-SL) is one of the two most plentiful sialylated oligosaccharides in human breast milk, the HMOs that carry sialic acid. The 3'-SL sold for infant formula, foods and supplements is a human-identical sodium salt made by fermentation with genetically modified E.

What is 3'-Sialyllactose used for?

NutraSmarts does not list 3'-Sialyllactose under a health category. What the research covers: In 60 adults with knee osteoarthritis, 200 or 600 mg a day of 3'-SL for 12 weeks lowered pain and function scores from baseline, but neither score differed from placebo at any time point, the trial's main comparison.

What is the recommended dosage of 3'-Sialyllactose?

The clinically studied dose is Trials of 3'-SL alone used 200 or 600 mg a day for 12 weeks in adults with knee osteoarthritis and 10 or 20 g a day for 4 weeks in people with H. pylori. Infant formulas held it within five-HMO blends. EFSA assessed supplement use of 0.5 to 1. Always follow the product label and check with a healthcare provider for personal advice.

Does 3'-Sialyllactose interact with any medications?

Possible interactions include: No drug interaction studies of 3'-SL were found in the research reviewed here. H. pylori treatment: in the one trial, 3'-SL did not clear H. pylori. Take any prescribed treatment as directed. If you take prescription medication, check with a pharmacist or doctor before using it.

How strong is the scientific evidence for 3'-Sialyllactose?

NutraSmarts rates the evidence for 3'-Sialyllactose as Limited (2 out of 5). It is backed by 5 study summaries and 16 cited references summarized on this page. A higher rating reflects more, larger, and better-designed human studies.

References(16 citations)

Evidence ratings on NutraSmarts are based on the totality of human clinical research, with emphasis on randomized controlled trials, meta-analyses, and systematic reviews. The references below directly support claims made throughout this page.

  1. Park EJ, Kim LL, Go H, Kim SH. Effects of 3'-Sialyllactose on Symptom Improvement in Patients with Knee Osteoarthritis: A Randomized Pilot Study. Nutrients. 2024;16(19):3410. doi: 10.3390/nu16193410.PubMedUsed to support: Randomized, single-blind pilot trial in 60 adults over 40 with knee osteoarthritis taking 200 mg or 600 mg of 3'-SL or placebo once a day for 12 weeks; 56 completed. VAS pain (the primary outcome) and KWOMAC scores fell from baseline in the 3'-SL groups, but neither differed between groups at any time point. No serious adverse events occurred; the 12 adverse events were mild. Funded by Korean government grants (MOTIE and KIAT); the tablets were made by GeneChem Inc. from 3'-SL produced in its enzyme-based one-pot process, and GeneChem employed three authors, one of whom held GeneChem stock.
  2. Parente F, Cucino C, Anderloni A, Grandinetti G, Bianchi Porro G. Treatment of Helicobacter pylori infection using a novel antiadhesion compound (3'sialyllactose sodium salt). A double blind, placebo-controlled clinical study. Helicobacter. 2003;8(4):252-6. doi: 10.1046/j.1523-5378.2003.00152.x.PubMedUsed to support: Randomized, double-blind, placebo-controlled trial in 65 people with indigestion and H. pylori infection taking 3'-SL sodium salt at 10 or 20 g a day or placebo for 4 weeks; 61 completed per protocol. No one became breath test negative during or 4 weeks after treatment, and breath test values fell in all groups including placebo, which the authors attributed to regression to the mean. No serious adverse events occurred. The background notes that 3'-SL blocks H. pylori adhesion to human cells in vitro. Funding is not stated in the abstract.
  3. Parschat K, Melsaether C, Jäpelt KR, Jennewein S. Clinical Evaluation of 16-Week Supplementation with 5HMO-Mix in Healthy-Term Human Infants to Determine Tolerability, Safety, and Effect on Growth. Nutrients. 2021;13(8):2871. doi: 10.3390/nu13082871.PubMedUsed to support: Funded by Chr. Hansen HMO GmbH; all four authors were employees of Chr. Hansen or its former affiliate Jennewein Biotechnologie (NCT03513744). Randomized, controlled trial in which 225 healthy newborns were fed formula with 5.75 g/L of five HMOs (52% 2'-FL, 13% 3-FL, 26% LNT, 4% 3'-SL and 5% 6'-SL) or formula without HMOs for 4 months, with breastfed infants as a reference. Weight gain, the primary outcome, and length and head circumference gains did not differ; stools were softer and more frequent on the HMO formula; adverse events were equivalent. The paper gives 0.09 to 0.35 g/L as the range of 3'-SL in breast milk.
  4. Lasekan J, Choe Y, Dvoretskiy S, Devitt A, Zhang S, Mackey A, Wulf K, Buck R, Steele C, Johnson M, Baggs G. Growth and Gastrointestinal Tolerance in Healthy Term Infants Fed Milk-Based Infant Formula Supplemented with Five Human Milk Oligosaccharides (HMOs): A Randomized Multicenter Trial. Nutrients. 2022;14(13):2625. doi: 10.3390/nu14132625.PubMedUsed to support: Funded by Abbott Nutrition, which employed all authors (NCT04105686). Randomized, double-blind trial in healthy term infants fed control formula (n = 129), formula with 5.75 g/L of five HMOs including 3'-SL (n = 130), or human milk (n = 104). Weight gain per day from day 14 to 119, the primary outcome, did not differ (all p of 0.337 or more). Stools on the HMO formula were softer and more frequent, like those of breastfed infants; adverse events did not differ, and more control formula infants were seen for illness by days 56 and 84.
  5. Bosheva M, Tokodi I, Krasnow A, Pedersen HK, Lukjancenko O, Eklund AC, Grathwohl D, Sprenger N, Berger B, Cercamondi CI. Infant Formula With a Specific Blend of Five Human Milk Oligosaccharides Drives the Gut Microbiota Development and Improves Gut Maturation Markers: A Randomized Controlled Trial. Front Nutr. 2022;9:920362. doi: 10.3389/fnut.2022.920362.PubMedUsed to support: Funded by Nestle Nutrition, which took part in design, analysis and writing; four authors were Nestle employees (NCT03722550). Randomized trial in healthy infants of standard formula or formula with 1.5 or 2.5 g/L of five HMOs (2'-FL, 2',3-difucosyllactose, LNT, 3'-SL and 6'-SL). In secondary outcomes, gut bacteria moved closer to those of breastfed infants, with more B. infantis and bifidobacteria, 75 to 85% less toxigenic C. difficile, lower stool pH and higher secretory IgA at 3 months than on standard formula.
  6. Kim D, Gurung RB, Seo W, Lee AW, Woo J. Toxicological evaluation of 3'-sialyllactose sodium salt. Regul Toxicol Pharmacol. 2018;94:83-90. doi: 10.1016/j.yrtph.2018.01.020.PubMedUsed to support: Animal and lab safety study by four GeneChem-affiliated authors and one from NutraSource. Mutation and chromosome damage tests were negative, the median lethal dose in rats was well above 20 g/kg body weight, and 28- and 90-day studies in rats at 500 to 2,000 mg/kg a day found no treatment-related abnormalities, giving a no observed adverse effect level above 2,000 mg/kg a day. It is not a human study.
  7. Monaco MH, Gurung RB, Donovan SM. Safety evaluation of 3'-siallylactose sodium salt supplementation on growth and clinical parameters in neonatal piglets. Regul Toxicol Pharmacol. 2019;101:57-64. doi: 10.1016/j.yrtph.2018.11.008.PubMedUsed to support: Animal safety study, with one GeneChem author, of enzyme-made 3'-SL sodium salt added to milk replacer at 0, 140, 200 or 500 mg/L for 21 days in 45 newborn piglets. Growth matched the control group, and blood chemistry, blood counts and organ tissue were unaffected. It is not a human study.
  8. Jeon J, Kang LJ, Lee KM, Cho C, Song EK, Kim W, Park TJ, Yang S. 3'-Sialyllactose protects against osteoarthritic development by facilitating cartilage homeostasis. J Cell Mol Med. 2018;22(1):57-66. doi: 10.1111/jcmm.13292.PubMedUsed to support: Lab and mouse study. In cartilage cells, 3'-SL restored type II collagen and proteoglycan production, increased Sox9 activity, and blocked Mmp3, Mmp13 and Cox2 induced by inflammatory signals, partly through NF-kB and Erk pathways. In mice with surgically induced joint damage, it protected cartilage on tissue analysis. No people were studied.
  9. Park DB, Kim L, Hwang JH, Kim KT, Park JE, Choi JS, An HJ. Temporal quantitative profiling of sialyllactoses and sialic acids after oral administration of sialyllactose to mini-pigs with osteoarthritis. RSC Adv. 2023;13(2):1115-1124. doi: 10.1039/d2ra05912f.PubMedUsed to support: Animal study with two GeneChem-affiliated authors; the authors declared no conflicts. In minipigs with joint damage, oral sialyllactose raised plasma sialyllactose and sialic acid compared with controls and lowered the expression of cartilage-degrading matrix metalloproteinases in the joint lining. No people were studied.
  10. Schenk S, Bode L, Jensen SR, Schönknecht YB, Simon MC. Systemic Availability of Human Milk Oligosaccharides in Infants and Adults: A Narrative Review. Adv Nutr. 2025;16(9):100488. doi: 10.1016/j.advnut.2025.100488.PubMedUsed to support: Narrative review of 15 human studies, including searches for 3'-SL. HMOs were found in the blood and urine of breastfed and HMO formula-fed infants and of adults taking HMO supplements, with levels rising with dose in some studies, though some structures were not absorbed and absorption rates and fate remain unknown. Two authors were employees of Novonesis, an HMO producer.
  11. Yu ZT, Chen C, Newburg DS. Utilization of major fucosylated and sialylated human milk oligosaccharides by isolated human gut microbes. Glycobiology. 2013;23(11):1281-92. doi: 10.1093/glycob/cwt065.PubMedUsed to support: Lab study of 25 human gut bacterial isolates grown on single HMOs. 3'-SL and 6'-SL promoted moderate growth of several Bifidobacterium longum strains, Bacteroides vulgatus and B. thetaiotaomicron, which produced lactate or short-chain fatty acids, while Clostridium, Staphylococcus, Enterobacter and E. coli K12 did not consume milk oligosaccharides. No people were studied.
  12. EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Turck D, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Kearney J, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pelaez C, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Cubadda F, Engel KH, Frenzel T, Heinonen M, Marchelli R, Neuhäuser-Berthold M, Poulsen M, Schlatter JR, van Loveren H, Colombo P, Knutsen HK. Safety of 3'-Sialyllactose (3'-SL) sodium salt as a novel food pursuant to Regulation (EU) 2015/2283. EFSA J. 2020;18(5):e06098. doi: 10.2903/j.efsa.2020.6098.PubMedUsed to support: EFSA opinion on an application by Glycom A/S for 3'-SL sodium salt made by fermentation with a genetically modified E. coli K-12 DH1 strain. It concludes the ingredient is safe in foods including infant formula and in food supplements at up to 0.5 g a day from age 3, because intake would not exceed that of breastfed infants per kg body weight. Supplements are not meant for days when other foods with added 3'-SL, or breast milk for young children, are eaten. It is a safety opinion, not an efficacy assessment.
  13. EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Turck D, Bohn T, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pelaez C, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Cubadda F, Frenzel T, Heinonen M, Marchelli R, Neuhäuser-Berthold M, Poulsen M, Prieto Maradona M, Schlatter JR, van Loveren H, Colombo P, Noriega Fernández E, Knutsen HK. Safety of 3'-sialyllactose (3'-SL) sodium salt produced by derivative strains of Escherichia coli BL21 (DE3) as a Novel Food pursuant to Regulation (EU) 2015/2283. EFSA J. 2022;20(5):e07331. doi: 10.2903/j.efsa.2022.7331.PubMedUsed to support: EFSA opinion on an application by Chr. Hansen A/S for 3'-SL sodium salt (at least 88% 3'-SL) made by fermentation with two genetically modified E. coli BL21 (DE3) strains. It describes 3'-SL as an acidic trisaccharide of glucose, galactose and sialic acid, records the 3'-SL made with E. coli K-12 DH1 as already on the EU novel food list, and concludes the new ingredient is safe, including food supplement use of up to 0.70 g a day from age 3. It is a safety opinion, not an efficacy assessment.
  14. EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Turck D, Bohn T, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Aguilera-Gómez M, Cubadda F, Frenzel T, Heinonen M, Marchelli R, Neuhäuser-Berthold M, Peláez C, Poulsen M, Prieto Maradona M, Schlatter JR, Siskos A, van Loveren H, Colombo P, Noriega Fernández E, Knutsen HK. Safety of 3'-sialyllactose (3'-SL) sodium salt produced by a derivative strain (Escherichia coli NEO3) of E. coli W (ATCC 9637) as a Novel Food pursuant to Regulation (EU) 2015/2283. EFSA J. 2023;21(9):e08224. doi: 10.2903/j.efsa.2023.8224.PubMedUsed to support: EFSA opinion on an application by Kyowa Hakko Bio Co., Ltd. for 3'-SL sodium salt made by fermentation with a genetically modified E. coli W strain. It concludes the ingredient is safe, including food supplement use of up to 1.0 g a day from age 3, which is below the estimated highest mean daily intake of 3'-SL in breastfed infants. It is a safety opinion, not an efficacy assessment.
  15. EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Turck D, Bohn T, Cámara M, Castenmiller J, De Henauw S, Jos Á, Maciuk A, Mangelsdorf I, McNulty B, Naska A, Pentieva K, Siani A, Thies F, Aguilera-Gómez M, Frenzel T, McArdle HJ, Moldeus P, Neuhäuser-Berthold M, Schlatter JR, van Loveren H, Fernández EN, Hirsch-Ernst KI. Safety of 3'-sialyllactose (3'-SL) sodium salt produced with a derivative strain (Escherichia coli K-12 MG1655 INB-3SL_01) of E. coli K-12 MG1655 (ATCC 700926) as a novel food pursuant to Regulation (EU) 2015/2283. EFSA J. 2026;24(3):e10009. doi: 10.2903/j.efsa.2026.10009.PubMedUsed to support: EFSA opinion on an application by Inbiose N.V. It records that 3'-SL sodium salt made by fermentation with genetically modified E. coli K-12 DH1, E. coli BL21 (DE3) or E. coli W is already authorized on the EU list of novel foods, and concludes that 3'-SL made with a new E. coli K-12 MG1655 strain is safe at the same uses. It is a safety opinion, not an efficacy assessment.
  16. U.S. Food and Drug Administration. GRAS Notices inventory: search results for sialyllactose FDA Human Foods Program (GRAS Notice Inventory). 2026;Online database, accessed November 2026..SourceUsed to support: Not PubMed-indexed; FDA database and notice detail pages read in November 2026. Lists seven GRAS notices for 3'-SL sodium salt, all closed with 'FDA has no questions': GRN 766 (GeneChem, Inc., September 2018; term infant formula up to 238 mg/L), GRN 880 (Glycom A/S, February 2020), GRN 921 (Jennewein Biotechnologie, October 2020; infant formula at 0.28 g/L), GRN 1015 (Chr. Hansen A/S, July 2022), GRN 1052 (Kyowa Hakko Bio, April 2023), GRN 1074 (Inbiose N.V., April 2023) and GRN 1299 (Synaura Biotechnology (Shanghai), May 2026, made by fermentation).