Scientific opinion on Prosmoke BW 01
Abstract The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of Prosmoke BW 01 as a new smoke flavouring primary product, in accordance with Regulation (EC) No 2065/2003. Prosmoke BW01 is produced by pyrolysis of beechwood (Fagus sylvatica L.) sawdust. Its wat...
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| Format: | Article |
| Language: | English |
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Wiley
2022-05-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2022.7299 |
| _version_ | 1811221853051551744 |
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| author | EFSA Panel on Food Additives and Flavourings (FAF) Maged Younes Gabriele Aquilina Laurence Castle Karl‐Heinz Engel Paul J Fowler Maria Jose Frutos Fernandez Peter Fürst Ursula Gundert‐Remy Rainer Gürtler Trine Husøy Melania Manco Peter Moldeus Sabina Passamonti Romina Shah Ine Waalkens‐Berendsen Detlef Wölfle Matthew Wright Romualdo Benigni Claudia Bolognesi Eugenia Cordelli Kevin Chipman Gisela Degen Karin Nørby Camilla Svendsen Maria Carfì Carla Martino Alexandra Tard Giorgia Vianello Wim Mennes |
| author_facet | EFSA Panel on Food Additives and Flavourings (FAF) Maged Younes Gabriele Aquilina Laurence Castle Karl‐Heinz Engel Paul J Fowler Maria Jose Frutos Fernandez Peter Fürst Ursula Gundert‐Remy Rainer Gürtler Trine Husøy Melania Manco Peter Moldeus Sabina Passamonti Romina Shah Ine Waalkens‐Berendsen Detlef Wölfle Matthew Wright Romualdo Benigni Claudia Bolognesi Eugenia Cordelli Kevin Chipman Gisela Degen Karin Nørby Camilla Svendsen Maria Carfì Carla Martino Alexandra Tard Giorgia Vianello Wim Mennes |
| author_sort | EFSA Panel on Food Additives and Flavourings (FAF) |
| collection | DOAJ |
| description | Abstract The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of Prosmoke BW 01 as a new smoke flavouring primary product, in accordance with Regulation (EC) No 2065/2003. Prosmoke BW01 is produced by pyrolysis of beechwood (Fagus sylvatica L.) sawdust. Its water content is estimated at 56 wt%, the total identified volatile fraction accounts for 28 wt% of the primary product, corresponding to 64% of the solvent‐free mass, while the unidentified fraction amounts to 16 wt% of the primary product. Analytical data provided for three batches demonstrated that their batch‐to‐batch‐variability was sufficiently low. However, for the batch used for the toxicological studies, there were substantial deviations in the concentration of nearly all the constituents compared to the other three batches. The dietary exposure of Prosmoke BW 01 was estimated to be between 6.2 and 9.2 mg/kg body weight (bw) per day, respectively, using SMK‐EPIC and SMK‐TAMDI. Using the FAIM tool, the 95th percentile exposure estimates ranged from 3.2 mg/kg bw per day for the elderly to 17.9 mg/kg bw per day for children. The Panel noted that furan‐2(5H)‐one is present in all batches of the primary product at an average concentration of 0.88 wt%. This substance was evaluated by the FAF Panel as genotoxic in vivo after oral exposure. The Panel considered that the (geno)toxicity studies available on the whole mixture were not adequate to support the safety assessment, due to limitations in these studies and because they were performed with a batch which may not be representative for the material of commerce. Considering that the exposure estimates for furan‐2(5H)‐one are above the TTC value of 0.0025 μg/kg bw per day (or 0.15 μg/person per day) for DNA‐reactive mutagens and/or carcinogens, the Panel concluded that Prosmoke BW 01 raises a concern with respect to genotoxicity. |
| first_indexed | 2024-04-12T08:07:21Z |
| format | Article |
| id | doaj.art-ff1e1644ab924f60bb8654baabfbc17a |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-04-12T08:07:21Z |
| publishDate | 2022-05-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-ff1e1644ab924f60bb8654baabfbc17a2022-12-22T03:41:07ZengWileyEFSA Journal1831-47322022-05-01205n/an/a10.2903/j.efsa.2022.7299Scientific opinion on Prosmoke BW 01EFSA Panel on Food Additives and Flavourings (FAF)Maged YounesGabriele AquilinaLaurence CastleKarl‐Heinz EngelPaul J FowlerMaria Jose Frutos FernandezPeter FürstUrsula Gundert‐RemyRainer GürtlerTrine HusøyMelania MancoPeter MoldeusSabina PassamontiRomina ShahIne Waalkens‐BerendsenDetlef WölfleMatthew WrightRomualdo BenigniClaudia BolognesiEugenia CordelliKevin ChipmanGisela DegenKarin NørbyCamilla SvendsenMaria CarfìCarla MartinoAlexandra TardGiorgia VianelloWim MennesAbstract The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of Prosmoke BW 01 as a new smoke flavouring primary product, in accordance with Regulation (EC) No 2065/2003. Prosmoke BW01 is produced by pyrolysis of beechwood (Fagus sylvatica L.) sawdust. Its water content is estimated at 56 wt%, the total identified volatile fraction accounts for 28 wt% of the primary product, corresponding to 64% of the solvent‐free mass, while the unidentified fraction amounts to 16 wt% of the primary product. Analytical data provided for three batches demonstrated that their batch‐to‐batch‐variability was sufficiently low. However, for the batch used for the toxicological studies, there were substantial deviations in the concentration of nearly all the constituents compared to the other three batches. The dietary exposure of Prosmoke BW 01 was estimated to be between 6.2 and 9.2 mg/kg body weight (bw) per day, respectively, using SMK‐EPIC and SMK‐TAMDI. Using the FAIM tool, the 95th percentile exposure estimates ranged from 3.2 mg/kg bw per day for the elderly to 17.9 mg/kg bw per day for children. The Panel noted that furan‐2(5H)‐one is present in all batches of the primary product at an average concentration of 0.88 wt%. This substance was evaluated by the FAF Panel as genotoxic in vivo after oral exposure. The Panel considered that the (geno)toxicity studies available on the whole mixture were not adequate to support the safety assessment, due to limitations in these studies and because they were performed with a batch which may not be representative for the material of commerce. Considering that the exposure estimates for furan‐2(5H)‐one are above the TTC value of 0.0025 μg/kg bw per day (or 0.15 μg/person per day) for DNA‐reactive mutagens and/or carcinogens, the Panel concluded that Prosmoke BW 01 raises a concern with respect to genotoxicity.https://doi.org/10.2903/j.efsa.2022.7299Prosmoke BW 01smoke flavouring primary productfuran‐2(5H)‐onegenotoxicity |
| spellingShingle | EFSA Panel on Food Additives and Flavourings (FAF) Maged Younes Gabriele Aquilina Laurence Castle Karl‐Heinz Engel Paul J Fowler Maria Jose Frutos Fernandez Peter Fürst Ursula Gundert‐Remy Rainer Gürtler Trine Husøy Melania Manco Peter Moldeus Sabina Passamonti Romina Shah Ine Waalkens‐Berendsen Detlef Wölfle Matthew Wright Romualdo Benigni Claudia Bolognesi Eugenia Cordelli Kevin Chipman Gisela Degen Karin Nørby Camilla Svendsen Maria Carfì Carla Martino Alexandra Tard Giorgia Vianello Wim Mennes Scientific opinion on Prosmoke BW 01 EFSA Journal Prosmoke BW 01 smoke flavouring primary product furan‐2(5H)‐one genotoxicity |
| title | Scientific opinion on Prosmoke BW 01 |
| title_full | Scientific opinion on Prosmoke BW 01 |
| title_fullStr | Scientific opinion on Prosmoke BW 01 |
| title_full_unstemmed | Scientific opinion on Prosmoke BW 01 |
| title_short | Scientific opinion on Prosmoke BW 01 |
| title_sort | scientific opinion on prosmoke bw 01 |
| topic | Prosmoke BW 01 smoke flavouring primary product furan‐2(5H)‐one genotoxicity |
| url | https://doi.org/10.2903/j.efsa.2022.7299 |
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