Refined exposure assessment of Brown HT (E 155)

The European Food Safety Authority (EFSA) carried out an exposure assessment of Brown HT (E 155) taking into account additional information on its use in foods as consumed. In 2010, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the re-evaluation of Brown HT and concluded that dietary exposure in both adults and 1-10 year old children at the high level may exceed the Acceptable Daily Intake (ADI) for Brown HT of 1.5 mg/kg body weight (bw)/day at the upper end of the range. Following this conclusion, the European Commission requested EFSA to perform a refined exposure assessment for this food colour. Data on the presence of Brown HT in foods were requested from relevant stakeholders through a call for usage and concentration data. Usage levels were provided to EFSA for six out of 37 food categories in which Brown HT is authorised. A limited number of analytical results were also reported to EFSA, all below the limit of detection (LOD) or limit of quantification (LOQ). Exposure assessment was performed using the EFSA Comprehensive Food Consumption Database. Three different scenarios were considered, including i) exposure estimates based on Maximum Permitted Levels (MPLs), ii) a combination of MPLs and reported maximum use levels and iii) reported maximum use levels only. Considering the first two scenarios, high exposure levels (95th percentile) exceeded the ADI for all age groups, with exception for the elderly. In comparison to the previous assessment, for both children and adults, the current mean exposure estimates are of the same order of magnitude, while the 95th percentile exposure is lower, particularly in adults. The mean and high level exposure estimates of Brown HT are below the ADI for all population groups when considering the reported use levels only

Scientific Opinion on the re-evaluation of hexamethylene tetramine (E 239) as a food additive

Hexamethylene tetramine (HMT) is a food additive, currently only permitted in EU for use in Provolone cheese. The maximum permitted level is 25 mg/kg residual amount, expressed as formaldehyde, the break down product of HMT under acidic conditions. HMT has been previously evaluated by the Joint Expert Committee on Food Additives (JECFA, 1974) who established an ADI of 0.15 mg/kg bw/day based on a reproductive study with a NOEL of 15 mg/kg bw/day. Due to the limitations in the database the Panel could not identify a critical study and therefore to derive an ADI. However, the Panel noted that the exposure to formaldehyde from HMT of high level consumers of Provolone cheese equalled 18 µg formaldehyde/kg bw/day in adults and could be as high as 87 µg formaldehyde/kg bw/day in children according to a theoretical conservative assumption that all ripened cheese consumed was Provolone cheese. Considering the estimated exposure from the very limited permitted use, the toxicological database on HMT, the data from use of HMT therapeutically, the available oral toxicity and toxicokinetic data of formaldehyde and the magnitude of the potential effect on intracellular formaldehyde levels arising from this use of HMT, the Panel concluded that the use of HMT in Provolone cheese at the MPL of 25 mg/kg residual amount, expressed as formaldehyde, would not be of safety concern. However the Panel considered that any increase in the permitted uses of HMT or increases in the MPL of 25 mg /kg residual amount, expressed as formaldehyde would need detailed assessment which might require new toxicity data as well as use levels and/or an evaluation of its impact on formaldehyde levels in vivo