Follow-up of the re-evaluation of sulfur dioxide (E 220), sodium sulfite (E 221), sodium bisulfite (E 222), sodium metabisulfite (E 223), potassium metabisulfite (E 224), calcium sulfite (E 226), calcium bisulfite (E 227) and potassium bisulfite (E 228)

Published date:

24 Samhain 2022

Disclaimer

This plain language summary (PLS) is a simplified communication of EFSA’s follow-up to the re-evaluation of sulfur dioxide-sulfites (E 220-228).
Its purpose is to enhance transparency and inform interested parties on EFSA’s work on the topic using simplified language.
Anyone interested in the more analytical results and interpretation, should consult the full EFSA opinion which can be found here.

Sulfites are naturally found in some foods and are also a commonly used food additives.
They are used to maintain appearance, increase shelf-life, and prevent the growth of hazardous microorganisms (e.g., fungi, bacteria).
They are commonly added to fruit juices and wines.
The sulfites used by the food industry are sulfur dioxide (E 220), sodium sulfite (E 221), sodium bisulfite (E 222), sodium metabisulfite (E 223), potassium metabisulfite (E 224), calcium sulfite (E 226), calcium bisulfite (E 227) and potassium bisulfite (E 228).

EFSA is responsible for providing independent scientific advice on food additives to EU risk managers and policy makers.
The former EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) completed a re-evaluation of sulfur dioxide-sulfites (E 220-228) in 2016.
The EFSA ANS Panel noted several uncertainties and limitations in the available data and concluded that the group acceptable daily intake (ADI) was adequate but should be considered temporary while more data were generated.
Following the recommendation on data gaps by the EFSA ANS Panel, the European Commission (EC) issued a call for additional data.
EFSA was mandated to redo the safety assessment for sulfur dioxide-sulfites based on industry data and carry out an extensive literature review.

In response to the request, the EFSA FAF Panel re-assessed the data based on:
- Data submitted by the food industry.
- An extensive literature review of studies published between January 2014 (overlapping the end of the coverage of the 2016 re-evaluation) and March 2022.
- An additional literature search was conducted for pre-2014 inhalation studies not included in the 2016 re-evaluation.
- As the studies reported data on endpoints identified as relevant for the identification of a reference point, the literature search was subsequently extended to include oral studies investigating neurotoxic and reproductive toxicity.
A margin of exposure (MOE) approach was used to assess the risks.
The Panel also carried out a risk assessment for toxic elements present in sulfur dioxide-sulfites (E 220-228) based on data submitted by industry.

Since 2016, few data have been generated to address the identified shortcomings.
The existing ADI was withdrawn because adequate toxicity data were not available.
A reference value was identified to compare exposure levels.
The assessment factor was calculated considering the endpoint used for the reference value and the available data.
The calculated MOEs raises some safety concerns for high consumers of foodstuffs that contain sulfites.
Maximum limits in the EU specifications for arsenic, lead, and mercury should be reduced and a maximum limit for cadmium should be introduced.

The main issue was limited data availability as no new data were generated by industry following the recommendations of the 2016 re-evaluation.
In addition, only limited new data were retrieved in the literature search.