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.