Toxicology and the data gap problem
The EFSA Panel on Food Additives and Flavourings completed a re-evaluation of E907 in 2020. Animal and human studies are very limited. No long-term carcinogenicity or reproductive/developmental toxicity studies exist specifically for this substance. The Panel set a provisional acceptable daily intake of 20 mg/kg body weight per day, derived from a subchronic (90-day) rat study, with an uncertainty factor applied to cover the missing long-term data. This is a recognised data gap, not a finding of harm.
EFSA established a provisional ADI of 20 mg/kg body weight per day based on a NOAEL from a 90-day rat study, noting the absence of long-term carcinogenicity, reproductive and developmental toxicity data as a data gap.
2020Regulatory reviewEFSA Panel on Food Additives and Flavourings (FAF), EFSA Journal 2020;18(3):6034
Estimated dietary exposure from authorised uses ranged from no exposure in infants to approximately 2.35 mg/kg body weight per day in toddlers, well below the provisional ADI.
2020Regulatory reviewEFSA Panel on Food Additives and Flavourings (FAF), EFSA Journal 2020;18(3):6034
In available studies, hydrogenated poly-1-decene showed low acute toxicity and did not raise concern for genotoxicity.
2020Regulatory reviewEFSA Panel on Food Additives and Flavourings (FAF), EFSA Journal 2020;18(3):6034
What the missing studies mean
EFSA's approach when carcinogenicity and reproductive studies are absent is to apply a larger uncertainty factor to the available short-term data and set the ADI accordingly. This is standard regulatory practice when a substance has a long history of low-level use and no signals of harm in the available data. The data gap is a record-keeping limitation rather than an identified risk at current food use levels.
The Panel applied an uncertainty factor of 200 (a standard 100-fold inter- and intra-species factor plus a further 2-fold for the incomplete toxicological database) to derive the provisional ADI.
2020Regulatory reviewEFSA Panel on Food Additives and Flavourings (FAF), EFSA Journal 2020;18(3):6034