EFSA ::. Risk assessment of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) on the Smoke Flavouring Primary Product – FF-B

Europäische Behörde für Lebensmittelsicherheit (EFSA)

Europäische Behörde für Lebensmittelsicherheit (EFSA)
Wissenschaftliche Gutachten, Veröffentlichungen & Berichte

Risk assessment of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) on the Smoke Flavouring Primary Product – FF-B

Frage Nr.: EFSA-Q-2005-260

Dokument application/pdf (0.1Mb)

Summary

 The European Food Safety Authority has been asked to provide scientific opinions on the safety of Smoke Flavouring Primary Products used or intended for use in or on foods. This opinion concerns one such Smoke Flavouring Primary Product, named FF-B. 

The Primary Product FF-B is obtained from a specified mixture of the following woods: red oak (Quercus rubra), white oak (Quercus alba), maple (Acer saccharum, Acer nigrum), beech (Fagus grandifolia) and hickory (Carya ovata). The production of FF-B comprises the following steps: (i) screening and drying of the hardwood sawdust, (ii) heating of the dried sawdust in a rotary furnace, (iii) condensing of the released smoke and (iv) separation of the smoke condensate into an oil phase and an aqueous phase. Essential parameters of the manufacturing process have been provided by the applicant.  Identification and quantification of Primary Product constituents have been performed in the batch that was used for the toxicological studies. The water content of the Primary Product is 66 wt.%. The volatile fraction identified by capillary gas chromatographic analysis (GC) accounts for 16 wt.% and the unidentified constituents account for 18 wt.%. Except for benzo[j]fluoranthene, the concentrations of the polycyclic aromatic hydrocarbons (PAH) listed in the EFSA guidance document on submission of a dossier on a Smoke Flavouring Primary Product have been provided. The concentrations of dibenzo[a,e]pyrene, dibenzo[a,h]pyrene, dibenzo[a,i]pyrene, dibenzo[a,l]pyrene were less than 1 μg/kg, the concentrations of the other PAHs analysed were less than 0.5 μg/kg. The levels of benz[a]anthracene and benzo[a]pyrene were below the limits given in Regulation (EC) No 2065/2003. Analysis of five batches revealed no significant batch-to-batch variability. The stability of the Primary Product was demonstrated by GC analysis of a batch over a nine months period.   Use levels of the Primary Product proposed by the petitioner range between 0.1 g/kg food (alcoholic beverages) and 3.5 g/kg food (meat and meat products). Dietary exposure for the Primary Product, as estimated by the petitioner, was 3 mg/kg body weight per day.

The toxicological tests provided included a 90-day oral toxicity study and in vitro and in vivo genotoxicity studies. The genotoxicity studies showed that the Primary Product FF-B was positive in in vitro assays for mutagenicity in bacterial and mammalian cells and was clastogenic in CHO cells. In vivo, FF-B induced statistically significant increase in micronuclei in both sexes of mice when given in the highest recommended dose.   The Panel concludes that the Primary Smoke Flavouring Product FF-B can be regarded as weakly genotoxic in vivo. The Panel cannot establish its safety in use when added to food.



Veröffentlichungsdatum: 21 Juni 2007
Letzte Aktualisierung: 21 Juni 2007