On 10–19 June, 2025, the Food and Agriculture Organization of the United Nations (FAO)/World Health Organization (WHO) Joint Expert Committee on Food Additives (JECFA) met to evaluate the safety of eight food additives and one processing aid, and to revise the specifications of one additive and six processing aids. The latest meeting represents the 100^th session of JECFA.

The toxicology and dietary exposure for the following substances were reviewed:

• Adipates: JECFA concluded that the estimates of dietary exposure are overestimated and greatly exceed the current established group Accepable Daily Intake (ADI) of 0–5 milligrams per kilogram of bodyweight (mg/kg BW). However, there is still the potential for exceedances of the current group ADI as a result of normal daily consumption amounts of an individual food. Since the ADI was established in 1965, a reevaluation of the toxicology of adipic acid is needed.
• Amyloglucosidase from Rasamsonia emersonii expressed in Aspergillus niger: Due to a lack of concern for allergenicity and genotoxicity, as well as a high Margin of Exposure (MOE) based on a No Adverse Effect Level (NOAEL) of 1,500 Total Organic Solids (TOS)/kg BW/day and a dietary exposure estimate of 9 mg TOS/kg day, JECFA removed the previous ADI and established a “not specified” ADI for the substance when used at specified levels and in accordance with Good Manufacturing Practices (GMPs). The NOAEL was identified in a 13-week oral toxicity study in rats, in which no adverse effects were observed even at the highest dose tested.
• Ascorbyl palmitate: The established ADI of 0–1.25 mg/kg BW/day was revised to “not specified” in light of new science showing that ascorbyl palmitate was rapidly and extensively hydrolysed pre-systemically to ascorbic acid and palmitic acid, and that hydrolysis of ascorbyl palmitate is mediated by carboxylesterases.
• Carob bean gum: Specifically, the safety of carob bean gum in infant formula was evaluated. Based on a neonatal pig study, JECFA identified a NOAEL of 2,400 mg/kg BW/day, the highest dose tested. Considering the high dietary exposure estimates of carob bean gum for infants, JECFA calculated MOEs of the substance used at 1,000 mg per liter (L) and 6,000 mg/L in infant formula to be 9 and 1.5, respectively, indicating low risk. The high-end use of carob bean gum at 10,000 mg/L has an MOE of less than 1, indicating a potential risk. However, based on the available data and the short exposure period involved, JECFA concluded that there is no concern for the disruption of the intestinal microbiota by carob bean gum used as a thickener in infant formula.
• Dioctyl sodium sulfosuccinate (DSS): JECFA established an ADI of 0–0.1 mg/kg BW/day for DSS in 1995. The high dietary exposure estimates of DSS up to 0.3 mg/kg BW per day for children aged 1–17 years could exceed this ADI. The estimates for adults were all below the ADI. Because exposure estimates are conservative, JECFA concluded that the use of DSS as a food additive in soft drinks and fruit-flavored water-based desserts does not pose a safety concern.
• Gardenia (Genipin) Blue: JECFA identified a NOAEL of 50 mg/kg BW per day for geniposide (an impurity in Gardenia Blue) based on hepatoxic (liver-damaging) effects observed at high doses in rat and mice studies, and selected a NOAEL of 700 mg/kg BW per day for the Gardenia Blue polymer from the carcinogenicity study as a point of departure for the safety evaluation of Gardenia Blue. JECFA established an ADI of 0–7 mg/kg BW per day for Gardenia Blue, expressed on the basis of the Gardenia Blue polymer, by applying an uncertainty factor of 100 to the NOAEL to account for inter- and intraspecies variabilities. Comparison of the NOAEL of 50 mg/kg BW per day with the theoretical high dietary exposure to geniposide of 1 microgram (μg)/kg BW per day yields an MOE of 50,000. Based on the MOE and no concern for genotoxicity, JECFA concluded that dietary exposure to geniposide as an impurity in Gardenia Blue does not pose a safety concern.
• Glycolipids: A proportion of the glycolipids is hydrolyzed by intestinal microflora to their components, all of which are normal parts of the human diet, and the remaining unchanged glycolipids are eliminated from the body as waste. JECFA therefore established an ADI “not specified” for glycolipids.
• Rosemary extract: A new study of rat pups exposed to rosemary extract showing thyroid effects resulted in a Benchmark Dose Lower Limit (BMDL) of 97 mg/kg BW/day. This BMDL is higher than the NOAEL (64 mg/kg BW/day) on which the current ADI for rosemary extract is based. Additionally, considering the most recent literature on reproductive studies, the relevant uncertainty factor was no longer necessary to incorporate, so the previous ADI of 0–0.3 mg/kg BW/day was withdrawn and a new ADI of 0–0.6 mg/kg BW/day was established. Estimated high dietary exposures to rosemary extract were up to 0.84 mg/kg BW per day for children and up to 0.32 mg/kg BW per day for adults. The MOE between the BMDL for thyroid effects in rat pups during the rodent study and the estimated high dietary exposure for children was more than 100, and is considered sufficient. JECFA did not consider the slight exceedance of the ADI, which was only by children, to be a safety concern.
• Thaumatin II: Based on the amino acid sequence similarity of thaumatin I, thaumatin II, and recombinant thaumatin II, JECFA revised the ADI of “not specified” for thaumatin to a group ADI of “not specified” including thaumatin and thaumatin II produced by recombinant methods in the seeds of the tobacco plant Nicotiana tabacum. The high dietary exposure to thaumatin was estimated to be up to 0.33 mg/kg BW per day for children. JECFA concluded that the dietary exposure to thaumatin does not present a safety concern.

JECFA also considered the following food additives and processing aids for specifications, resulting in the removal of “not specified” ADIs for three types of α-Amylase, asparaginase, β-Amylase, and xylanase. Additionally, new specifications for low-acyl clarified gellan gum were generated and the existing specifications monograph for gellan gum were revised.

Finally, during the evaluation of some additives used in infant formula—carob bean gum and gellan gum—JECFA noted that the use of these substances at proposed levels could result in an exceedance of the existing Maximum Level (ML) for lead in infant formula (0.01 mg/kg BW/day), if lead were present in the gums at the specified limit (2 mg/kg). Therefore, JECFA noted that lower lead limits in the specifications (e.g., 0.5 mg/kg for carob bean gum and gellan gum) would result in neither of the additives exceeding the ML for lead in the final infant formula. JECFA reaffirmed that the responsibility for ensuring that the final infant formula (as consumed) comply with the ML for lead remains with infant formula producers. In the future, JECFA recommends that lower lead limits be introduced in the specifications for additives used in infant formula.

Read the entire summary and conclusions of the 100^th JECFA meeting here.