Every food additive in the European Union has been through a re-evaluation programme. Gellan gum's turn came in 2018, and the resulting opinion is the most useful single document about the safety of E 418 in existence. It is also the document most often cited without being read.
Why the re-evaluation happened
Under Commission Regulation (EU) No 257/2010, all food additives authorised in the EU before 20 January 2009 had to be re-assessed by the European Food Safety Authority. The additives had originally been evaluated in the 1980s and 1990s, using the methods of the time. The re-evaluation programme applied current risk assessment practice to the same substances.
Gellan gum had first been evaluated by the EU's Scientific Committee for Food in 1990, with the opinion published in 1992. That evaluation had allocated an ADI "not specified" on the basis of the toxicological data and typical use levels of 0.1 % to 1 %.
What EFSA concluded
The 2018 re-evaluation reached four main conclusions:
- No numerical ADI is needed. The panel considered the available exposure and toxicity data adequate and concluded there was no safety concern at the refined exposure estimates for reported uses and use levels.
- Gellan gum is unlikely to be absorbed intact, and would not be fermented by human intestinal microbiota. This is the finding most relevant to consumers — it places gellan gum closer to a bulking, non-fermentable fibre than to a fermentable one.
- No concern with respect to carcinogenicity or genotoxicity.
- No adverse effects were reported in chronic studies at the highest doses tested — in mice at 3,627 mg/kg body weight per day and in rats at 1,460 mg/kg body weight per day.
The exposure figures
The panel estimated refined exposure based on reported use levels. The highest exposure group was toddlers at the 95th percentile, at up to 72.4 mg/kg body weight per day.
Two things are worth noting about that number:
- It is the highest-exposure scenario, applying to the smallest consumers eating the most additive-containing products. It is not an average intake.
- It is far below the doses at which no effects were seen in the animal studies — the margin is measured in orders of magnitude, not percentages.
A supporting human study is also relevant: repeated oral intake of up to 200 mg/kg body weight per day for three weeks produced no adverse effects in humans.
The specification recommendations — the part buyers should care about
The EFSA opinion did more than clear the substance. It recommended that the specifications be better defined, naming three specific areas:
- The absence of viable cells of the microbial source.
- The presence of polyhydroxybutyrate (PHB).
- The presence of protein and residual bacterial enzymatic activities.
This is a technical signal, not a safety alarm. It means the panel felt the purity criteria did not fully describe what is in the bag. For buyers, those three items are exactly the parameters worth asking a supplier about, because they are the ones a less rigorous producer may not monitor.
Where the legal framework sits
| Element | Instrument |
|---|---|
| Authorisation to use E 418 | Regulation (EC) No 1333/2008, Annexes II and III |
| Purity criteria and specifications | Commission Regulation (EU) No 231/2012 |
| Re-evaluation obligation | Commission Regulation (EU) No 257/2010 |
| Scientific opinion | EFSA Panel on Food Additives and Nutrient Sources added to Food, 2018 |
Being authorised in Annex II does not mean unrestricted use. Authorisation in the EU is category-specific, with maximum levels or quantum satis conditions attached to individual food categories.
How to use this article
If you are writing a safety summary, a product dossier, or an answer to a customer's question, cite the EFSA re-evaluation rather than a blog summary of it. If you are qualifying a supplier, use the three specification recommendations as questions. Both are more useful than the phrase "EFSA approved".
For material specification data including PHB, nitrogen content and microbiological parameters, see Cinogel.
Part of the E418.org gellan gum knowledge base. This article summarises a published scientific opinion; always refer to the original EFSA Journal text and the current regulation for formal purposes.