Published in the EFSA Journal, the findings are a direct response to allegations made by Italian researcher Morando Soffritti of the Ramazzini Institute.
The Institute’s trials with mice were suggestive of sucralose’s harmful effects but its results were largely dismissed by the food industry, critical of its study design and methodology.
EFSA concluded that "the available data did not support the conclusions of the authors,” agreeing that the researchers used an unconventional design resulting in inconclusive, unreliable data.
The Panel also noted the lack of a mode of action and failure to meet considerations for a cause–effect relationship between sucralose intake and tumour development.
Moreover, there was no reliable evidence of in vivo genotoxicity.
ISA response
The International Sweeteners Association’s (ISA) chairman Robert Peterson welcomed the findings commenting that “this scientific opinion from EFSA is entirely consistent with the global scientific and regulatory consensus that sucralose is safe.”
The association added that sucralose can be a useful tool, when used in place of sugar and as part of a balanced diet, in helping reduce overall sugar and calorie intake, as well as manage blood glucose levels.
“Low calorie sweeteners are also non-cariogenic, which means that they do not contribute to tooth decay.”
Scrutiny of sucralose stretches back to 1989, when EFSA (known as Scientific Committee on Food (SCF)) first conducted a safety assessment of the sweetener.
This was followed up in 2000, where an acceptable daily intake (ADI) of 15 milligrams per kilogram of body weight mg/kg was set.
Fast forward to the end of 2015, where EFSA decided to expand the sweetener’s use in foods for special medical purposes for children.
Sucralose, listed as E 955 in Europe, is around 600 times sweeter than sugar that is used in over 4,500 food, beverage and pharmaceutical products around the world.
In 2011, sucralose accounted for 27.9% of the global sweetener market worth €1.015 billion ($1.146 bn), according to Leatherhead Food Research.
Source: EFSA Journal
Published online ahead of print: doi.org/10.2903/j.efsa.2017.4784
“Statement on the validity of the conclusions of a mouse carcinogenicity study on sucralose (E 955) performed by the Ramazzini Institute.”
Authors: Fernando Aguilar et al.