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EFSA publishes new food additive research on non-nutritive sweetener saccharine

The European Food Safety Authority (EFSA) has released new recommendations on saccharin and its sodium, potassium and calcium salts (E 954) as food additives.

On 15 November 2024, the European Food Safety Authority (EFSA) published its scientific opinion. The Authority made several key recommendations in its paper, re-evaluating saccharin and its sodium, potassium and calcium salts (E 954) as food additives.

The EFSA explored data from interested parties in response to a call for information and a literature review of studies on saccharins published between January 1994 and February 2024 to reach its conclusions.

Saccharin and its sodium, potassium and calcium salts, or saccharins (E 954) are food additives used in various food products. The additives are non-nutritive sweeteners used in formulations to deliver sweetness without adding calories or nutritional value.

Current scientific opinions on sweeteners

Research on saccharin within the European legislative food landscape dates back almost 30 years, when the EU’s Scientific Committee on Food analysed the food additive in 1995. The EFSA Panel on Food Additives and Flavourings (the FAF Panel) re-evaluated the safety of saccharins to develop its current opinion on the food additive.

Over the past decade, EFSA has published re-evaluations of other sweeteners, including aspartame (E 951) in 2013, thaumatin (E 957) in 2021, neohesperidine DC (E 959) in 2022 and erythritol (E 968) in 2023.

Under Commission Regulation (EU) No 257/2010, the European Commission (EC) established a programme to re-evaluate the safety of food additives that were approved in the European Union (EU) before 20th January 2009. The EC outlined that this needed to be in accordance with Regulation (EC) No 1333/2008 of the European Parliament and the Council on Food Additives. The FAF Panel’s saccharins assessment is part of this programme.

Ingredients Network reached out to EFSA for comment on its recent scientific opinion. “As a Risk Assessment body, we are not able to elaborate a statement on specific industry matters or regulation,” a spokesperson said.

Changes to acceptable daily intake

Within its scientific opinion, the EFSA increased the acceptable daily intake (ADI) of saccharin from 5 to 9 mg/kg of body weight per day. Based on this opinion, 9 mg/kg body weight per day is the ADI determined safe for all population groups. ADI refers to an estimated amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health.

The new ADI replaces the previous amount established by the Scientific Committee on Food in 1995 at 5 mg/kg body weight per day of sodium saccharin or 3.8 mg/kg body weight per day of free saccharin. This lower amount was based on the higher prevalence of bladder tumours in rat studies. Following further understanding, the EFSA said that today, there is scientific agreement that these bladder tumours are linked to male rats and are irrelevant to humans.

Furthermore, the EFSA found that the highest estimates for chronic saccharine exposure are less than the ADI in all population groups. As such, this indicates no safety concern associated with the food additive.

Key recommendations

The EFSA’s FAF panel also recommends the EC considers the revision of the EU specifications of saccharin and its sodium, potassium and calcium salts (E 954).

EFSA’s scientific opinion specifies several key recommendations, stating that the EC should consider several amendments to the EU specifications for saccharins. Firstly, the EFSA has said the EC should include a definition that restricts saccharins manufacturing to the Remsen-Fahlberg process, a chemical process used to produce saccharins.

In addition, the EFSA advises the EC lists the Chemical Abstract Service (CAS) numbers for saccharin, sodium saccharin, and potassium saccharin. Other key guidance includes amendments to the purity of calcium saccharin to not less than 99% on an anhydrous basis. The EFSA also recommends removing the parameter ‘readily carbonisable substances’, which refers to substances that occur as organic impurities in a manufacturing process and can be easily converted into carbon or a carbon-rich material. The body also advises the EC to decrease the lead and arsenic impurities limit.

Years in the making

As part of its re-evaluation, the EFSA’s FAF Panel followed structured protocols based on criteria and methodologies previously established for sweeteners following three public consultations in 2020 and 2023, respectively.

In the first of two outcomes the EFSA published in 2020, the body engaged in a public consultation on a draft protocol for the assessment of hazard identification and characterisation of sweeteners. Secondly, the Authority published a draft protocol for assessing exposure to sweeteners as part of their safety assessment under the food additives re-evaluation programme. In 2023, the EFSA FAF Panel published its revised protocol on hazard identification and characterisation of sweeteners.

The protocols discovered include potential harmful effects (hazard identification), determining the minimum dietary amount that could harm a healthy person (hazard characterisation), and assessing exposure levels in the EU population.

During the scientific evaluation, the EFSA identified and assessed several uncertainties. These included an overestimation of exposure in the EU population, a lack of long-term studies to address the influence of saccharins on blood glucose regulation, and a lack of a clear conclusion on the impact of saccharins on weight gain in humans due to the limited available evidence. After undergoing this process, the body determined that these did not affect its overall safety conclusions.