EFSA Journal (May 2015)
Safety of a change in specifications for the food additive hydroxypropyl methyl cellulose (E 464)
Abstract
Abstract Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion regarding the safety of an amendment to specifications for the food additive hydroxypropyl methyl cellulose (HPMC, E 464). It is requested that the limit of the sum of the two isomers (1‐chloro‐2‐propanol and 2‐chloro‐1‐propanol) of propylene chlorohydrin (PCH) in HPMC be raised from 0.1 mg/kg to 1.0 mg/kg, in order to align it with the limit defined by the Joint FAO/WHO Expert Committee on Food Additives in 2011. The ANS Panel received a dossier from the applicant and subsequently requested additional data. The ANS Panel noted that not all information was made available and that exposure to PCH is likely to be underestimated, since data were provided only for a limited number of authorised uses and that other sources of PCH were not included. The Panel also noted that the available data, for both PCH isomers, were indicative of a genotoxic hazard and that the results available from preliminary studies were deemed insufficient to make any conclusion regarding developmental toxicity. In addition, because no carcinogenic effects were observed in relevant chronic/carcinogenicity studies at the same time, it was impossible to derive a lower benchmark dose level. A margin of exposure approach to impurities, as suggested by EFSA guidance in 2012, was also not possible. Moreover, when considering a threshold of toxicological concern approach to genotoxic effects, the Panel was unable to make any conclusion regarding the absence of risk. Finally, analytical data provided for a total of 12 different batches of HPMC showed that PCH levels were in compliance with current specifications. The Panel concluded that the data available are insufficient to support a change in specification from 0.1 to 1 mg PCH/kg HPMC.
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