EFSA updates assessment of saccharin, raising Acceptable Daily Intake

The European Food Safety Authority (EFSA) has released a new opinion on saccharin and its sodium, potassium, and calcium salts, collectively known as E954, marking a significant update for the regulation of these widely used food additives. The EFSA's assessment concludes that saccharin, produced through the Remsen-Fahlberg method, does not pose genotoxicity concerns.  

Saccharin was the first artificial sweetener to be used in food products. It is commonly found in various food items, particularly those marketed as low-calorie or sugar-free. E954 can be synthesized through two methods: the Remsen-Fahlberg process and the Maumee process. However, due to a lack of analytical data on potential impurities related to the Maumee process, EFSA's evaluation focused solely on the Remsen-Fahlberg method.  

In its review, the EFSA panel examined a range of studies, including both animal and human research. One of the key outcomes of the re-evaluation is the establishment of a new acceptable daily intake (ADI) for saccharin. The updated ADI is set at 9 mg per kilogram of body weight, an increase from the previous limit of 5 mg per kilogram established in 1995. This change reflects advancements in scientific understanding, particularly regarding the relevance of earlier studies that suggested a link between saccharin and bladder tumors in male rats. The EFSA panel clarified that these tumors are not applicable to human health risk assessments.  

The EFSA panel has advised the European Commission to consider revising the EU specifications for saccharin and its associated salts to align with the new ADI and the current scientific consensus.  

This decision is expected to influence the food industry, potentially allowing manufacturers greater flexibility in using saccharin as a sweetening agent in various products while ensuring consumer safety is maintained through updated regulatory standards. As dietary preferences continue to evolve toward lower sugar options, the role of artificial sweeteners like saccharin is likely to remain significant in the food market.    

 

Source:  

EFSA