REEVALUATION OF ERYTHRITOL ADDITIVE IN HUMAN FOOD.

EFSA conducts the safety evaluation of the use of this additive, to determine its acceptable daily intake level, its possible adverse effects, and the possible presence of contaminants, among others.

In December 2023, the European Food Safety Authority (EFSA) carried out the re-evaluation of the food ingredient erythritol used as a food additive in products intended for human consumption, within the re-evaluation program of all food additives whose use authorization took place before January 2009.

Several safety evaluations have been published so far for this food additive, both by the Scientific Committee on Food (SCF) and by the EFSA, starting with the first one in 2003, and followed by others in the years 2010, 2013, and 2015.

In all of them, it is generally concluded that it is a safe additive for the food use for which it is intended, although there are certain aspects that must be taken into account when considering the consumption of this food ingredient, as we will see at the end of this post.

Firstly, this additive should be framed within Regulation 1333/2008 of the European Parliament and of the Council on food additives, where it is classified both in group I of additives (for purposes other than sweetening), as in the group of sweeteners as well as in the group of polyalcohols. In total, it is authorized for 66 different types of food categories, including its use in dietary supplements both solid and liquid, framed in Group I as IV of food additives.

No maximum amount for its use as additive in dietary supplements has been established, neither used as group I for purposes other than sweetening nor used as a polyalcohol, but it can be used in quantum satis. This means that the substance can be used in an amount not exceeding what is necessary to achieve the intended purpose for which it was added.

For the approach of the study carried out by the EFSA, the identification of possible harmful effects of erythritol, the determination of the minimum amount in diet that could cause some adverse effect, and the evaluation of the level of exposure of the EU population to this additive were taken into account.

The European Commission also asked EFSA to evaluate whether it would be possible to exempt from warning of possible laxative effects associated with the consumption of products containing more than 10% of added polyalcohols, among which is the polyalcohol erythritol.

The general conclusions reached by EFSA after the safety evaluation were as follows:

• That the process of obtaining erythritol from certain strains of non-genetically modified yeasts is safe.
• That the only impurity that can be found after the manufacturing process of erythritol is lead. This contribution must be taken into account when establishing a daily intake without adverse effects (IDA).
• That precisely to minimize the presence and intake of lead present in erythritol, a no observed adverse effect level (NOAEL) for this additive of 0.5 g/kg body weight per day is set.
• That erythritol is quite stable in foods at different temperatures, does not require the establishment of microbiological criteria as it is unlikely to be contaminated with microorganisms, and is not genotoxic.
• That scientific evidence shows in a limited but consistent manner that erythritol does not affect the glycemia of its consumers.
• That current evidence does not show a relationship between the consumption of foods containing erythritol and an increased risk of cardiovascular disease or risk factors for it. However, any future new study on this may be advisable.
• Regarding the need or not to indicate the warning about its laxative effect, this is maintained for erythritol. In fact, it is observed that the lowest level of consumption for which no diarrhea or immediate laxative effects are observed is 0.5 g/kg weight/day of erythritol, however, the daily exposure both acute and chronic in certain population groups is much higher than that dose, so these populations may be at risk of suffering these undesirable effects both after a single and repeated exposure to erythritol.

In addition to these conclusions, EFSA recommends that the European Commission gather more detailed data on how much erythritol is present in foods, modify the specifications related to erythritol to list which permitted microorganisms can be used in its manufacture, as well as the reduction of the maximum limit of lead that can contain as a contaminant this additive to reduce its intake in regular consumers of erythritol.

Therefore, for now, this safety re-evaluation of the use of the erythritol additive does not affect the market for food supplements, remaining as a safe and permitted additive in the manufacture of these products for the purposes for which it is allowed.

If you have any doubts about this or other additives and their use in food or dietary supplements, at LexSupplements Food Legal Consultancy we advise you. We keep up to date with legislative news.