New EFSA opinion on the sweetener erythritol (E 968)

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Erythritol

EFSA panel on Food Additives and Flavorings (FAF) has published the new opinion on the sweetener erythritol (E 968), highlighting the risk of lead contamination. The Authority assessed the safety of the additive and examined the request to exempt the label from the laxative risk warning. (1)

1) EFSA opinion on erythritol, laxative effect

Like other polyols authorized as food additives by the reg. (EC) 1333/2008, (2) in fact, the presence of erythritol in food or drink in excess of 10% makes the warning ‘excessive consumption may produce laxative effects’ mandatory on the label. (3)

To avoid adverse effects a ‘tolerable daily intake’ (TDI or DGA, permissible daily dose) of 500 mg of erythritol per kg of body weight is indicated. This intake level corresponds to the ‘no observed adverse effect level’ (NOAEL), therefore capable of protecting both from the immediate laxative effect of erythritol and from any potential long-term adverse effects secondary to diarrhea, such as electrolyte imbalance .

2) Overexposed children and young people

Average consumer exposure however, erythritol is much higher than the TDI / DGA and the scarcity of data provided by the industry was not helpful. Indeed, sector operators have provided EFSA with the levels of use of the sweetener for just 22 categories of food, out of the 66 where it is authorised. The analytical data presented instead concerns just seven food categories.

In light of the data available, the FAF panel estimated levels of chronic and acute exposure (per meal) to erythritol which always see the children and children, with intake levels reaching a maximum peak of 3.531 mg/kg body weight of sweetener per meal.

Monstrous but plausible levels, considering the widespread use of erythritol in ice creams, fermented milk products, jams, spreads, chocolates, sweets, lollipops, marshmallows, chewing gum, breakfast cereals, baked goods, sauces, drinks, etc. Without neglecting the ‘hidden’ presence in the form of support for flavors and nutrients.

3) The warning on the label has been confirmed

In all groups of people Acute and chronic exposure to erythritol is estimated to be higher than the recently established ADI. Individuals with high erythritol intake may experience adverse effects following single or repeated exposure‘, warns EFSA.

The centrality of risk of laxative effects combined with the high exposure of the population to erythritol inevitably led to the rejection of the request for exemption from the warning on the advanced label Cargill R&D Center Europe (also presenting studies already examined by the Authority’s researchers in 2003 and 2015) .

4) Lead contamination

A worrying aspect concerns lead contamination during the sweetener manufacturing process. This heavy metal is neurotoxic and can cause irreversible damage to children’s brains, as we have seen. (4)

The current threshold of lead contamination is equal to 0,5 mg/kg of erythritol and EFSA urges its reduction.

5) Erythritol and cardiovascular risk

Frequent intake of erythritol has previously been associated by some scientific studies with an increase in cardiovascular risk. The hypothesis is not shared in the opinion, but not discarded either.

Current evidence does not demonstrate a link (i.e. a cause-effect relationship) between the consumption of foods containing erythritol and an increased risk of cardiovascular disease and related risk factors. However, further research could be useful to clarify the nature of the association found in some observational studies., concludes EFSA.

6) Additional safety elements

The assessment of the EFSA panel on food additives and flavorings (Food Additives and Flavourings, FAF) is based on scientific studies published up to September 2023, as well as on information presented to the Authority following public calls for data.

Based on this documentation, EFSA concludes that erythritol

– it is not genotoxic,

– does not pose microbiological risks,

– does not affect blood sugar levels in humans.

Marta Strinati

Footnotes

(1) EFSA Panel on Food Additives and Flavorings (FAF), Maged Younes, Gabriele Aquilina, Laurence Castle, Gisela Degen, Karl-Heinz Engel, Paul J. Fowler, Maria José Frutos Fernandez, Peter Fürst, Ursula Gundert-Remy, Rainer Gürtler, Trine Husøy, Melania Manco, Wim Mennes, Peter Moldeus, Sabina Passamonti, Romina Shah, Ine Waalkens-Berendsen, Matthew Wright, Monika Batke, Polly Boon, Ellen Bruzell, James Chipman, Riccardo Crebelli, Rex FitzGerald, Cristina Fortes, Thorhallur Halldorsson, Jean-Charles LeBlanc, Oliver Lindtner, Alicja Mortensen, Evangelia Ntzani, Heather Wallace, Stefania Barmaz, Consuelo Civitella, Lorenzo D’Angelo, Federica Lodi, Marcello Laganaro, Ana Maria Rincon, Camilla Smeraldi, Alexandra Tard. Re‐evaluation of erythritol (E 968) as a food additive
EFSA Journal. 20.12.23 https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2023.p211203

(2) Polyols authorized as food additives, pursuant to the reg. (EC) 1333/2008, are

– sorbitol (E 420),

– mannitol (E 421),

– isomalt (E 953),

– maltitols (E 965),

– lactitol (E 966),

– xylitol (E 967),

– erythritol (E 968).

(3) Marta Strinati. Sorbitol and other polyols, the bulk sweeteners. GIFT (Greta Italian Food Trade). 4.4.18

(4) Marta Strinati. Lead and cadmium in food, risk map and new thresholds in the EU. GIFT (Greta Italian Food Trade). 17.8.21

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Professional journalist since January 1995, he has worked for newspapers (Il Messaggero, Paese Sera, La Stampa) and periodicals (NumeroUno, Il Salvagente). She is the author of journalistic surveys on food, she has published the book "Reading labels to know what we eat".