EFSA approves sweetener sucralose for infant medical foods

By Annie Harrison-Dunn

- Last updated on GMT

EFSA looks at 2010 request from trade association IDACE (now Specialised Nutrition Europe (SNE)). Photo credits: iStock.com
EFSA looks at 2010 request from trade association IDACE (now Specialised Nutrition Europe (SNE)). Photo credits: iStock.com

Related tags Nutrition European parliament European commission

It is safe to include the sugar-derived sweetener sucralose in special medical foods for young children, the European Food Safety Authority (EFSA) has concluded.

The safety assessment​ saw the authority’s panel on food additives and nutrient sources added to food (ANS) extend the okay for added sucralose (E 955) to these special products for children aged one to three.

Sucralose is a calorie-free artificial sweetener up to 650 times sweeter than sugar.

EFSA’s predecessor the Scientific Committee on Food (SCF) already established an acceptable daily intake of 15 mg/kg body weight for sucralose back in 1991, which was echoed by a joint FAO/WHO expert committee on additives (JECFA) in 2000.

However, neither report looked at the use of sweeteners in foods for special medical purposes for young children.

Under EU regulation​ ‘food for special medical purposes’ is defined as: “Food specially processed or formulated and intended for the dietary management of patients, including infants, to be used under medical supervision; it is intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved by modification of the normal diet alone.”

The issue was forwarded to EFSA by the European Commission following a 2010 application by trade association IDACE (now Specialised Nutrition Europe (SNE)).

“According to the applicant, the use of sweeteners is required to ensure palatable foods for the dietary management of patients whose compliance with the dietary regimen (prescribed by health care professionals) is a key factor to their health,”​ EFSA wrote in its opinion.

After reviewing the case, EFSA said: “The ANS Panel concluded that the proposed extension of use of sucralose (E 955) at the requested level of 400 mg/kg product in FSMP [food for special medical purposes] for young children aged from 1 to 3 years would not be of safety concern.”​ 

IDACE’s application concerned several sweeteners and colours: acesulfame K (E 950) at 450 mg/kg; sucralose (E 955) at 400 mg/kg; carotenes (E 160a) at 5 mg/kg5​ and beetroot red, betanin (E 162) at 20 mg/kg.

The safety of mixed carotenes and beta-carotene was re-evaluated in 2012 by EFSA, which concluded the use of synthetic beta-carotene and mixed beta-carotenes from palm fruit oil, carrots and algae as a food colour was not of safety concern at normal food intakes ranges of 5–10 mg/day.

This latest opinion comes at a time of big change for the governance of food for special medical purposes (FSMP), with draft regulation currently making its way through the European Parliament after two years in development.

In a plenary today members of the European Parliament (MEPs) voted to rethink rules on sugar levels for baby food as part of this draft.

The vote centered on objections tabled by UK Green MEP Keith Taylor in December.

Two other objections from Taylor on infant formula were scrapped by the European Parliament’s Environment, Public Health and Food Safety Committee (ENVI) last week and therefore did not make it to the Strasbourg plenary today.

Related news

Show more

Related products

show more

Has your supplement reached its full potential?

Has your supplement reached its full potential?

Content provided by Rousselot | 04-Apr-2024 | Infographic

In today's wellness-driven market, meet consumer demands with Peptan!
Rousselot's bioactive collagen peptide brand Peptan offers a holistic...

Innovation in convenient formats: vegan gummies

Innovation in convenient formats: vegan gummies

Content provided by Cambridge Commodities | 05-Mar-2024 | Product Brochure

Supplements and vitamins in pill form have been around for decades, but consumers are now seeking alternatives that fit with their busy lifestyles and...

Related suppliers

1 comment

Sucralose should not be in food for young children

Posted by Susan Schiffman, PhD,

Some of the biological effects of sucralose are:

1) metabolism of sucralose in the gastrointestinal tract to metabolites whose identity and safety profile are unknown,
2) induction of cyctochrome P450 (CYP) and P-glycoprotein (P-gp) in the gastrointestinal tract to levels that may limit the bioavailability of therapeutic drugs (note, immature CYP, P-gp, and clearance mechanisms in infants and children would lead to
bioaccumulation of sucralose)
3) reduction in the number and balance of beneficial bacteria in the gastrointestinal tract,
4) histopathological findings in gastrointestinal tract including lymphocytic infiltrates into epithelium, epithelial scarring, mild depletion of goblet cells and glandular disorganization in the colon,
5) alterations in insulin, blood glucose, and glucagon-like peptide 1 (GLP-1) levels,
6) decomposition and generation of chloropropanols (a potentially toxic class of compounds) during baking, and
7) mutagenic alterations using several types of biological assays including cancer in mice

1) Susan S. Schiffman & Kristina I. Rother (2013) Sucralose, A Synthetic Organochlorine Sweetener: Overview Of Biological Issues, Journal of Toxicology
and Environmental Health, Part B: Critical Reviews, 16:7, 399-451


2) Rother KI, Sylvetsky AC, Schiffman SS. Non-nutritive sweeteners in breast milk: perspective on potential implications of recent findings. Arch Toxicol.
2015 Oct 14.


Report abuse

Follow us


View more