Tiered intake assessment for low- and no-calorie sweeteners in beverages

Figures & data

Figure 1. Stepwise approach to obtain realistic dietary exposure assessment (IPCS, 2009b)

Table 1. LNCS beverage use levels

LNCS	Use Levels (mg kg^−1)
	Average	Reported Maximum (Global)
Acesulfame potassium (AceK)	107	500
Aspartame	262	579
Saccharin	129	230
Steviol glycosides (Steviol equivalent)*	104 (35)	387 (130)
Sucralose	133.3	400

*The molecular weights for steviol glycosides range from 480.62 g/mol for Steviol monoside to the highest of 1,437.6 g/mol for Rebaudioside O; the molecular weight of steviol is 318.45 g/mol. Thus, the conversion factors range from 1.51–4.51, with an average of ~3. Steviol equivalent use levels were estimated by dividing steviol glycosides levels by 3. FDA, 2018

Table 2. Proportion of respective LNCS-sweetened beverage types (based on U.S. market volume) containing specified LNCS

LNCS	LNCS-CSD	LNCS-Juice Drink	LNCS-Powder	LNCS-Sports Drinks	LNCS-Energy drinks	LNCS-RTD Tea	LNCS-Water Based Bev	LNCS-RTD Coffee	LNCS-Tea	LNCS-Coffee	LNCS-Other (14.1.5)
Acesulfame Potassium	89.6	70.1	100.0	98.4	96.4	93.5	76.6	93.5	93.5	93.5	93.5
Aspartame	96.6	36.2	85.1	0.0	27.5	93.5	40.4	93.5	93.5	93.5	93.5
Saccharin*	67.0	56.4	64.4	49.6	50.5	94.0	69.6	94.0	94.0	94.0	94.0
Steviol Glycosides	13.0	35.9	29.2	0.0	3.7	89.0	77.1	89.0	89.0	89.0	89.0
Sucralose	68.7	83.5	43.4	100.0	74.4	100.0	84.2	100.0	100.0	100.0	100.0

*based on average of other 4 LNCS to maintain conservatism; LNCS = Low- and no-calorie sweetener sweetened; CSD = Carbonated Soft Drinks; RTD = Ready-to-Drink

Table 3. Beverage apportioned JECFA ADI

LNCS	JECFA ADI mg kg-bw^−1 day^−1	% of JECFA ADI assigned to beverages
		UK Toddler	UK 1 + y- Average	US Children 2–5 y	US 2 + y
Acesulfame potassium (AceK)	15	40%	40%	50%	50%
Aspartame	40	49%	40%	50%	50%
Saccharin	5	40%	40%	50%	50%
Steviol glycosides (as steviol equivalents)	4	59%	49%	50%	50%
Sucralose	15	40%	40%	50%	50%

Figure 2. Tiered intake assessments framework

Table 4. Tier 2 Deterministic Assessment Scenarios

Types of Assessment	Scenario	LNCS assumptions	Scenario code
Brand loyal – Deterministic	Scenario 1	Reported maximum global use level applied to all beverages.	BLD-1
Brand loyal – Deterministic	Scenario 2	Reported maximum global use level applied to LNCS CSD; average use level applied to all other beverages.	BLD-2
Market Share Deterministic	Scenario 3	Reported maximum global use level applied to LNCS CSD; average use level applied to all other beverages; Corresponding fraction of specific LNCS-containing market share data applied to each beverage type.	MSD

Table 5. Theoretical maximum beverage concentration (TMBC) for LNCS in beverages based on the ‘default’ or ‘refined’ budget methods – US

		TMBC (mg kg^−1)
		Default Budget Method^a		Refined Budget Method^b
LNCS	Maximum reported global use level in beverages (mg kg^−1)	US Young Children 2–5 y	US 2 + y	US Young Children 2–5 y	US 2 + y
Acesulfame potassium (AceK)	500	75	300	500	500
Aspartame	579	200	800	1333	1333
Saccharin	230	25	100	167	167
Steviol glycosides (as steviol equivalents)	130	20	80	133	133
Sucralose	400	75	300	500	500

^aThe default assumption for beverage volume consumed is 0.1 L kg-bw⁻¹day⁻¹ (see Materials and methods)

^bThe refined assumption for beverage volume consumed is 0.06 L kg-bw⁻¹day⁻¹ (see Materials and methods)

Shaded cells are where maximum reported global use levels exceed TMBC

Table 6. Theoretical maximum beverage concentration (TMBC) for LNCS in beverages based on the ‘default’ or ‘refined’ budget methods – UK

		TMBC (mg kg^−1)
		Default Budget Method^a		Refined Budget Method^b
LNCS	Maximum reported global use level in beverages (mg kg^−1)	UK Toddlers (1.5–3 y)	UK 1.5 + y	UK Toddlers (1.5–3 y)	UK 1.5 + y
Acesulfame potassium (AceK)	500	60	240	600	600
Aspartame	579	196	640	1960	1600
Saccharin	230	20	80	200	200
Steviol glycosides (as steviol equivalents)	130	24	78	236	196
Sucralose	400	60	240	600	600

^aThe default assumption for beverage volume consumed is 0.1 L kg-bw⁻¹day⁻¹ (see Materials and methods)

^bThe refined assumption for beverage volume consumed is 0.04 L kg-bw⁻¹day⁻¹ (see Materials and methods)

Shaded cells are where maximum reported global use levels exceed TMBC

Figure 3. Per consumer estimated daily intake of acesulfame potassium (AceK), aspartame, saccharin, steviol glycosides (as steviol equivalents), and sucralose, mg kg-bw⁻¹ day⁻¹, 2-day average; US NHANES 2013–2016

JECFA ADI = Joint (FAO/WHO) Expert Committee on Food Additives Acceptable Daily Intake; BLD = Brand-Loyal Deterministic Scenarios; MSD = Market-Shared adjusted Deterministic (See Supplemental Materials Appendix III).

Figure 4. Per consumer estimated daily intake of acesulfame potassium (AceK), aspartame, saccharin, steviol glycosides (as steviol equivalents), and sucralose, mg kg-bw⁻¹ day⁻¹, 4-day average; UK NDNS RP 1–9

JECFA ADI = Joint (FAO/WHO) Expert Committee on Food Additives Acceptable Daily Intake; BLD = Brand-Loyal Deterministic Scenarios; MSD = Market-Shared adjusted Deterministic (See Supplemental Materials Appendix IV).

Table 7. US Daily intake of LNCS foods, beverages, food/beverage additions (FBA) by diabetes status, g day-1, day 1; NHANES 2013–2016

			Diabetes Status
			Yes	No
Population	LNCS Category	LNCS Consumers	Mean ± SE (g day^−1)
US 19 + y	Unweighted N	2,570	662	1,908
	Food	9.3 ± 1.63	10.4 ± 2.19	9.0 ± 1.78
	Beverages	495 ± 18.0	516 ± 33.8	491 ± 22.0
	FBA	3.4 ± 0.30	5.1 ± 0.63	2.9 ± 0.31*
	Total	508 ± 18.0	532 ± 33.3	503 ± 22.3

*Indicates statistically significant difference (p-value < 0.05) between diabetes status groups; adjusted Wald test. FBA = Food beverage additions such as tabletop additions including coffee creamer, whipped topping, sugar substitutes, syrup, and jelly.

Table 8. UK Daily intake of LNCS foods, beverages, food/beverage additions (FBA) by diabetes status; g day-1, 4-day average; NDNS RP 1–9

			Diabetes Status
			Yes	No
Population	LNCS Category	LNCS Consumers	Mean ± SE (g day^−1)
US 19 + y	Unweighted N	2,036	149	1,887
	Food	15.7 ± 1.02	21.9 ± 4.36	15.2 ± 1.04
	Beverages	256 ± 10.7	275 ± 50.2	254 ± 10.8
	FBA	0.8 ± 0.06	2.3 ± 0.41	0.7 ± 0.06*
	Total	272 ± 10.7	300 ± 50.0	270 ± 10.8

*Indicates statistically significant difference (p-value < 0.05) between diabetes status groups; adjusted Wald test. FBA = Food beverage additions such as tabletop sugar substitutes.

[IPCS] International Programme on Chemical Safety. 2009b. Environmental health criteria 240: principles and methods for the risk assessment of chemicals in food. Chapter 6: dietary exposure assessment of chemicals in food. Geneva (Switzerland): World Health Organization.

 Google Scholar

[FDA] Food and Drug Administration. GRAS Notice (GRN) No. 768. accessed 2019 Jul 31. https://www.accessdata.fda.gov/scripts/fdcc/index.cfm?set=GRASNotices&id=768.

 Google Scholar