Scientific opinion on the renewal of the authorisation of SmokEz C‐10 (SF‐005) as a smoke flavouring Primary Product
Abstract The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the smoke flavouring Primary Product SmoKEz C‐10 (SF‐005), for which a renewal application was submitted in accordance with Article 12(1) of Regulation (EC) No 2065/2003. This opinion refers to th...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
EFSA Panel name on Food Additives and Flavourings (FAF) [verfasserIn] Maged Younes [verfasserIn] Gabriele Aquilina [verfasserIn] Laurence Castle [verfasserIn] Gisela Degen [verfasserIn] Karl‐Heinz Engel [verfasserIn] Paul J Fowler [verfasserIn] Maria Jose Frutos Fernandez [verfasserIn] Peter Fürst [verfasserIn] Ursula Gundert‐Remy [verfasserIn] Rainer Gürtler [verfasserIn] Trine Husøy [verfasserIn] Melania Manco [verfasserIn] Peter Moldeus [verfasserIn] Sabina Passamonti [verfasserIn] Romina Shah [verfasserIn] Ine Waalkens‐Berendsen [verfasserIn] Matthew Wright [verfasserIn] Romualdo Benigni [verfasserIn] Polly Boon [verfasserIn] Claudia Bolognesi [verfasserIn] Eugenia Cordelli [verfasserIn] Kevin Chipman [verfasserIn] Ullrika Sahlin [verfasserIn] Maria Carfì [verfasserIn] Carla Martino [verfasserIn] Salvatore Multari [verfasserIn] Vasantha Palaniappan [verfasserIn] Alexandra Tard [verfasserIn] Wim Mennes [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2023 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
In: EFSA Journal - Wiley, 2018, 21(2023), 11, Seite n/a-n/a |
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| Übergeordnetes Werk: |
volume:21 ; year:2023 ; number:11 ; pages:n/a-n/a |
| Links: |
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| DOI / URN: |
10.2903/j.efsa.2023.8367 |
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| Katalog-ID: |
DOAJ097614319 |
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| 520 | |a Abstract The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the smoke flavouring Primary Product SmoKEz C‐10 (SF‐005), for which a renewal application was submitted in accordance with Article 12(1) of Regulation (EC) No 2065/2003. This opinion refers to the assessment of data submitted on chemical characterisation, dietary exposure and genotoxicity of the Primary Product. SmoKEz C‐10 is obtained by pyrolysis of maple, oak, hickory, ash, birch, beech and cherry woods. Given the limitations of the quantification approach employed by the applicant, the Panel could not judge whether the applied methods meet the legal quality criterion that at least 80% of the volatile fraction shall be identified and quantified. At the maximum proposed use levels, dietary exposure estimates calculated with DietEx ranged from 0.01 to 5.1 mg/kg body weight (bw) per day at the mean and from no dietary exposure to 18.1 mg/kg bw per day at the 95th percentile. The Panel concluded that five components in the Primary Product raise a potential concern for genotoxicity. In addition, a potential concern for genotoxicity was identified for the unidentified part of the mixture. The Primary Product contains furan‐2(5H)‐one and benzene‐1,2‐diol, for which a concern for genotoxicity was identified in vivo upon oral administration. Considering that the exposure estimates for these two components are above the threshold of toxicological concern (TTC) of 0.0025 μg/kg bw per day for DNA‐reactive mutagens and/or carcinogens, the Panel concluded that the Primary Product raises concern with respect to genotoxicity. | ||
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| 650 | 4 | |a genotoxicity | |
| 650 | 4 | |a SmoKEz C‐10 | |
| 650 | 4 | |a SF‐005 | |
| 653 | 0 | |a Nutrition. Foods and food supply | |
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| 700 | 0 | |a Gisela Degen |e verfasserin |4 aut | |
| 700 | 0 | |a Karl‐Heinz Engel |e verfasserin |4 aut | |
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| 700 | 0 | |a Romina Shah |e verfasserin |4 aut | |
| 700 | 0 | |a Ine Waalkens‐Berendsen |e verfasserin |4 aut | |
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10.2903/j.efsa.2023.8367 doi (DE-627)DOAJ097614319 (DE-599)DOAJ63c7e64e3f284316bd03f2e9ef44d373 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel name on Food Additives and Flavourings (FAF) verfasserin aut Scientific opinion on the renewal of the authorisation of SmokEz C‐10 (SF‐005) as a smoke flavouring Primary Product 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the smoke flavouring Primary Product SmoKEz C‐10 (SF‐005), for which a renewal application was submitted in accordance with Article 12(1) of Regulation (EC) No 2065/2003. This opinion refers to the assessment of data submitted on chemical characterisation, dietary exposure and genotoxicity of the Primary Product. SmoKEz C‐10 is obtained by pyrolysis of maple, oak, hickory, ash, birch, beech and cherry woods. Given the limitations of the quantification approach employed by the applicant, the Panel could not judge whether the applied methods meet the legal quality criterion that at least 80% of the volatile fraction shall be identified and quantified. At the maximum proposed use levels, dietary exposure estimates calculated with DietEx ranged from 0.01 to 5.1 mg/kg body weight (bw) per day at the mean and from no dietary exposure to 18.1 mg/kg bw per day at the 95th percentile. The Panel concluded that five components in the Primary Product raise a potential concern for genotoxicity. In addition, a potential concern for genotoxicity was identified for the unidentified part of the mixture. The Primary Product contains furan‐2(5H)‐one and benzene‐1,2‐diol, for which a concern for genotoxicity was identified in vivo upon oral administration. Considering that the exposure estimates for these two components are above the threshold of toxicological concern (TTC) of 0.0025 μg/kg bw per day for DNA‐reactive mutagens and/or carcinogens, the Panel concluded that the Primary Product raises concern with respect to genotoxicity. benzene‐1,2‐diol catechol furan‐2(5H)‐one genotoxicity SmoKEz C‐10 SF‐005 Nutrition. Foods and food supply Chemical technology Maged Younes verfasserin aut Gabriele Aquilina verfasserin aut Laurence Castle verfasserin aut Gisela Degen verfasserin aut Karl‐Heinz Engel verfasserin aut Paul J Fowler verfasserin aut Maria Jose Frutos Fernandez verfasserin aut Peter Fürst verfasserin aut Ursula Gundert‐Remy verfasserin aut Rainer Gürtler verfasserin aut Trine Husøy verfasserin aut Melania Manco verfasserin aut Peter Moldeus verfasserin aut Sabina Passamonti verfasserin aut Romina Shah verfasserin aut Ine Waalkens‐Berendsen verfasserin aut Matthew Wright verfasserin aut Romualdo Benigni verfasserin aut Polly Boon verfasserin aut Claudia Bolognesi verfasserin aut Eugenia Cordelli verfasserin aut Kevin Chipman verfasserin aut Gisela Degen verfasserin aut Ullrika Sahlin verfasserin aut Maria Carfì verfasserin aut Carla Martino verfasserin aut Salvatore Multari verfasserin aut Vasantha Palaniappan verfasserin aut Alexandra Tard verfasserin aut Wim Mennes verfasserin aut In EFSA Journal Wiley, 2018 21(2023), 11, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:21 year:2023 number:11 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2023.8367 kostenfrei https://doaj.org/article/63c7e64e3f284316bd03f2e9ef44d373 kostenfrei https://doi.org/10.2903/j.efsa.2023.8367 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 21 2023 11 n/a-n/a |
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10.2903/j.efsa.2023.8367 doi (DE-627)DOAJ097614319 (DE-599)DOAJ63c7e64e3f284316bd03f2e9ef44d373 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel name on Food Additives and Flavourings (FAF) verfasserin aut Scientific opinion on the renewal of the authorisation of SmokEz C‐10 (SF‐005) as a smoke flavouring Primary Product 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the smoke flavouring Primary Product SmoKEz C‐10 (SF‐005), for which a renewal application was submitted in accordance with Article 12(1) of Regulation (EC) No 2065/2003. This opinion refers to the assessment of data submitted on chemical characterisation, dietary exposure and genotoxicity of the Primary Product. SmoKEz C‐10 is obtained by pyrolysis of maple, oak, hickory, ash, birch, beech and cherry woods. Given the limitations of the quantification approach employed by the applicant, the Panel could not judge whether the applied methods meet the legal quality criterion that at least 80% of the volatile fraction shall be identified and quantified. At the maximum proposed use levels, dietary exposure estimates calculated with DietEx ranged from 0.01 to 5.1 mg/kg body weight (bw) per day at the mean and from no dietary exposure to 18.1 mg/kg bw per day at the 95th percentile. The Panel concluded that five components in the Primary Product raise a potential concern for genotoxicity. In addition, a potential concern for genotoxicity was identified for the unidentified part of the mixture. The Primary Product contains furan‐2(5H)‐one and benzene‐1,2‐diol, for which a concern for genotoxicity was identified in vivo upon oral administration. Considering that the exposure estimates for these two components are above the threshold of toxicological concern (TTC) of 0.0025 μg/kg bw per day for DNA‐reactive mutagens and/or carcinogens, the Panel concluded that the Primary Product raises concern with respect to genotoxicity. benzene‐1,2‐diol catechol furan‐2(5H)‐one genotoxicity SmoKEz C‐10 SF‐005 Nutrition. Foods and food supply Chemical technology Maged Younes verfasserin aut Gabriele Aquilina verfasserin aut Laurence Castle verfasserin aut Gisela Degen verfasserin aut Karl‐Heinz Engel verfasserin aut Paul J Fowler verfasserin aut Maria Jose Frutos Fernandez verfasserin aut Peter Fürst verfasserin aut Ursula Gundert‐Remy verfasserin aut Rainer Gürtler verfasserin aut Trine Husøy verfasserin aut Melania Manco verfasserin aut Peter Moldeus verfasserin aut Sabina Passamonti verfasserin aut Romina Shah verfasserin aut Ine Waalkens‐Berendsen verfasserin aut Matthew Wright verfasserin aut Romualdo Benigni verfasserin aut Polly Boon verfasserin aut Claudia Bolognesi verfasserin aut Eugenia Cordelli verfasserin aut Kevin Chipman verfasserin aut Gisela Degen verfasserin aut Ullrika Sahlin verfasserin aut Maria Carfì verfasserin aut Carla Martino verfasserin aut Salvatore Multari verfasserin aut Vasantha Palaniappan verfasserin aut Alexandra Tard verfasserin aut Wim Mennes verfasserin aut In EFSA Journal Wiley, 2018 21(2023), 11, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:21 year:2023 number:11 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2023.8367 kostenfrei https://doaj.org/article/63c7e64e3f284316bd03f2e9ef44d373 kostenfrei https://doi.org/10.2903/j.efsa.2023.8367 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 21 2023 11 n/a-n/a |
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10.2903/j.efsa.2023.8367 doi (DE-627)DOAJ097614319 (DE-599)DOAJ63c7e64e3f284316bd03f2e9ef44d373 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel name on Food Additives and Flavourings (FAF) verfasserin aut Scientific opinion on the renewal of the authorisation of SmokEz C‐10 (SF‐005) as a smoke flavouring Primary Product 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the smoke flavouring Primary Product SmoKEz C‐10 (SF‐005), for which a renewal application was submitted in accordance with Article 12(1) of Regulation (EC) No 2065/2003. This opinion refers to the assessment of data submitted on chemical characterisation, dietary exposure and genotoxicity of the Primary Product. SmoKEz C‐10 is obtained by pyrolysis of maple, oak, hickory, ash, birch, beech and cherry woods. Given the limitations of the quantification approach employed by the applicant, the Panel could not judge whether the applied methods meet the legal quality criterion that at least 80% of the volatile fraction shall be identified and quantified. At the maximum proposed use levels, dietary exposure estimates calculated with DietEx ranged from 0.01 to 5.1 mg/kg body weight (bw) per day at the mean and from no dietary exposure to 18.1 mg/kg bw per day at the 95th percentile. The Panel concluded that five components in the Primary Product raise a potential concern for genotoxicity. In addition, a potential concern for genotoxicity was identified for the unidentified part of the mixture. The Primary Product contains furan‐2(5H)‐one and benzene‐1,2‐diol, for which a concern for genotoxicity was identified in vivo upon oral administration. Considering that the exposure estimates for these two components are above the threshold of toxicological concern (TTC) of 0.0025 μg/kg bw per day for DNA‐reactive mutagens and/or carcinogens, the Panel concluded that the Primary Product raises concern with respect to genotoxicity. benzene‐1,2‐diol catechol furan‐2(5H)‐one genotoxicity SmoKEz C‐10 SF‐005 Nutrition. Foods and food supply Chemical technology Maged Younes verfasserin aut Gabriele Aquilina verfasserin aut Laurence Castle verfasserin aut Gisela Degen verfasserin aut Karl‐Heinz Engel verfasserin aut Paul J Fowler verfasserin aut Maria Jose Frutos Fernandez verfasserin aut Peter Fürst verfasserin aut Ursula Gundert‐Remy verfasserin aut Rainer Gürtler verfasserin aut Trine Husøy verfasserin aut Melania Manco verfasserin aut Peter Moldeus verfasserin aut Sabina Passamonti verfasserin aut Romina Shah verfasserin aut Ine Waalkens‐Berendsen verfasserin aut Matthew Wright verfasserin aut Romualdo Benigni verfasserin aut Polly Boon verfasserin aut Claudia Bolognesi verfasserin aut Eugenia Cordelli verfasserin aut Kevin Chipman verfasserin aut Gisela Degen verfasserin aut Ullrika Sahlin verfasserin aut Maria Carfì verfasserin aut Carla Martino verfasserin aut Salvatore Multari verfasserin aut Vasantha Palaniappan verfasserin aut Alexandra Tard verfasserin aut Wim Mennes verfasserin aut In EFSA Journal Wiley, 2018 21(2023), 11, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:21 year:2023 number:11 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2023.8367 kostenfrei https://doaj.org/article/63c7e64e3f284316bd03f2e9ef44d373 kostenfrei https://doi.org/10.2903/j.efsa.2023.8367 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 21 2023 11 n/a-n/a |
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10.2903/j.efsa.2023.8367 doi (DE-627)DOAJ097614319 (DE-599)DOAJ63c7e64e3f284316bd03f2e9ef44d373 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel name on Food Additives and Flavourings (FAF) verfasserin aut Scientific opinion on the renewal of the authorisation of SmokEz C‐10 (SF‐005) as a smoke flavouring Primary Product 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the smoke flavouring Primary Product SmoKEz C‐10 (SF‐005), for which a renewal application was submitted in accordance with Article 12(1) of Regulation (EC) No 2065/2003. This opinion refers to the assessment of data submitted on chemical characterisation, dietary exposure and genotoxicity of the Primary Product. SmoKEz C‐10 is obtained by pyrolysis of maple, oak, hickory, ash, birch, beech and cherry woods. Given the limitations of the quantification approach employed by the applicant, the Panel could not judge whether the applied methods meet the legal quality criterion that at least 80% of the volatile fraction shall be identified and quantified. At the maximum proposed use levels, dietary exposure estimates calculated with DietEx ranged from 0.01 to 5.1 mg/kg body weight (bw) per day at the mean and from no dietary exposure to 18.1 mg/kg bw per day at the 95th percentile. The Panel concluded that five components in the Primary Product raise a potential concern for genotoxicity. In addition, a potential concern for genotoxicity was identified for the unidentified part of the mixture. The Primary Product contains furan‐2(5H)‐one and benzene‐1,2‐diol, for which a concern for genotoxicity was identified in vivo upon oral administration. Considering that the exposure estimates for these two components are above the threshold of toxicological concern (TTC) of 0.0025 μg/kg bw per day for DNA‐reactive mutagens and/or carcinogens, the Panel concluded that the Primary Product raises concern with respect to genotoxicity. benzene‐1,2‐diol catechol furan‐2(5H)‐one genotoxicity SmoKEz C‐10 SF‐005 Nutrition. Foods and food supply Chemical technology Maged Younes verfasserin aut Gabriele Aquilina verfasserin aut Laurence Castle verfasserin aut Gisela Degen verfasserin aut Karl‐Heinz Engel verfasserin aut Paul J Fowler verfasserin aut Maria Jose Frutos Fernandez verfasserin aut Peter Fürst verfasserin aut Ursula Gundert‐Remy verfasserin aut Rainer Gürtler verfasserin aut Trine Husøy verfasserin aut Melania Manco verfasserin aut Peter Moldeus verfasserin aut Sabina Passamonti verfasserin aut Romina Shah verfasserin aut Ine Waalkens‐Berendsen verfasserin aut Matthew Wright verfasserin aut Romualdo Benigni verfasserin aut Polly Boon verfasserin aut Claudia Bolognesi verfasserin aut Eugenia Cordelli verfasserin aut Kevin Chipman verfasserin aut Gisela Degen verfasserin aut Ullrika Sahlin verfasserin aut Maria Carfì verfasserin aut Carla Martino verfasserin aut Salvatore Multari verfasserin aut Vasantha Palaniappan verfasserin aut Alexandra Tard verfasserin aut Wim Mennes verfasserin aut In EFSA Journal Wiley, 2018 21(2023), 11, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:21 year:2023 number:11 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2023.8367 kostenfrei https://doaj.org/article/63c7e64e3f284316bd03f2e9ef44d373 kostenfrei https://doi.org/10.2903/j.efsa.2023.8367 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 21 2023 11 n/a-n/a |
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10.2903/j.efsa.2023.8367 doi (DE-627)DOAJ097614319 (DE-599)DOAJ63c7e64e3f284316bd03f2e9ef44d373 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel name on Food Additives and Flavourings (FAF) verfasserin aut Scientific opinion on the renewal of the authorisation of SmokEz C‐10 (SF‐005) as a smoke flavouring Primary Product 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the smoke flavouring Primary Product SmoKEz C‐10 (SF‐005), for which a renewal application was submitted in accordance with Article 12(1) of Regulation (EC) No 2065/2003. This opinion refers to the assessment of data submitted on chemical characterisation, dietary exposure and genotoxicity of the Primary Product. SmoKEz C‐10 is obtained by pyrolysis of maple, oak, hickory, ash, birch, beech and cherry woods. Given the limitations of the quantification approach employed by the applicant, the Panel could not judge whether the applied methods meet the legal quality criterion that at least 80% of the volatile fraction shall be identified and quantified. At the maximum proposed use levels, dietary exposure estimates calculated with DietEx ranged from 0.01 to 5.1 mg/kg body weight (bw) per day at the mean and from no dietary exposure to 18.1 mg/kg bw per day at the 95th percentile. The Panel concluded that five components in the Primary Product raise a potential concern for genotoxicity. In addition, a potential concern for genotoxicity was identified for the unidentified part of the mixture. The Primary Product contains furan‐2(5H)‐one and benzene‐1,2‐diol, for which a concern for genotoxicity was identified in vivo upon oral administration. Considering that the exposure estimates for these two components are above the threshold of toxicological concern (TTC) of 0.0025 μg/kg bw per day for DNA‐reactive mutagens and/or carcinogens, the Panel concluded that the Primary Product raises concern with respect to genotoxicity. benzene‐1,2‐diol catechol furan‐2(5H)‐one genotoxicity SmoKEz C‐10 SF‐005 Nutrition. Foods and food supply Chemical technology Maged Younes verfasserin aut Gabriele Aquilina verfasserin aut Laurence Castle verfasserin aut Gisela Degen verfasserin aut Karl‐Heinz Engel verfasserin aut Paul J Fowler verfasserin aut Maria Jose Frutos Fernandez verfasserin aut Peter Fürst verfasserin aut Ursula Gundert‐Remy verfasserin aut Rainer Gürtler verfasserin aut Trine Husøy verfasserin aut Melania Manco verfasserin aut Peter Moldeus verfasserin aut Sabina Passamonti verfasserin aut Romina Shah verfasserin aut Ine Waalkens‐Berendsen verfasserin aut Matthew Wright verfasserin aut Romualdo Benigni verfasserin aut Polly Boon verfasserin aut Claudia Bolognesi verfasserin aut Eugenia Cordelli verfasserin aut Kevin Chipman verfasserin aut Gisela Degen verfasserin aut Ullrika Sahlin verfasserin aut Maria Carfì verfasserin aut Carla Martino verfasserin aut Salvatore Multari verfasserin aut Vasantha Palaniappan verfasserin aut Alexandra Tard verfasserin aut Wim Mennes verfasserin aut In EFSA Journal Wiley, 2018 21(2023), 11, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:21 year:2023 number:11 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2023.8367 kostenfrei https://doaj.org/article/63c7e64e3f284316bd03f2e9ef44d373 kostenfrei https://doi.org/10.2903/j.efsa.2023.8367 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 21 2023 11 n/a-n/a |
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EFSA Panel name on Food Additives and Flavourings (FAF) @@aut@@ Maged Younes @@aut@@ Gabriele Aquilina @@aut@@ Laurence Castle @@aut@@ Gisela Degen @@aut@@ Karl‐Heinz Engel @@aut@@ Paul J Fowler @@aut@@ Maria Jose Frutos Fernandez @@aut@@ Peter Fürst @@aut@@ Ursula Gundert‐Remy @@aut@@ Rainer Gürtler @@aut@@ Trine Husøy @@aut@@ Melania Manco @@aut@@ Peter Moldeus @@aut@@ Sabina Passamonti @@aut@@ Romina Shah @@aut@@ Ine Waalkens‐Berendsen @@aut@@ Matthew Wright @@aut@@ Romualdo Benigni @@aut@@ Polly Boon @@aut@@ Claudia Bolognesi @@aut@@ Eugenia Cordelli @@aut@@ Kevin Chipman @@aut@@ Ullrika Sahlin @@aut@@ Maria Carfì @@aut@@ Carla Martino @@aut@@ Salvatore Multari @@aut@@ Vasantha Palaniappan @@aut@@ Alexandra Tard @@aut@@ Wim Mennes @@aut@@ |
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This opinion refers to the assessment of data submitted on chemical characterisation, dietary exposure and genotoxicity of the Primary Product. SmoKEz C‐10 is obtained by pyrolysis of maple, oak, hickory, ash, birch, beech and cherry woods. Given the limitations of the quantification approach employed by the applicant, the Panel could not judge whether the applied methods meet the legal quality criterion that at least 80% of the volatile fraction shall be identified and quantified. At the maximum proposed use levels, dietary exposure estimates calculated with DietEx ranged from 0.01 to 5.1 mg/kg body weight (bw) per day at the mean and from no dietary exposure to 18.1 mg/kg bw per day at the 95th percentile. The Panel concluded that five components in the Primary Product raise a potential concern for genotoxicity. In addition, a potential concern for genotoxicity was identified for the unidentified part of the mixture. The Primary Product contains furan‐2(5H)‐one and benzene‐1,2‐diol, for which a concern for genotoxicity was identified in vivo upon oral administration. 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TX341-641 TP1-1185 Scientific opinion on the renewal of the authorisation of SmokEz C‐10 (SF‐005) as a smoke flavouring Primary Product benzene‐1,2‐diol catechol furan‐2(5H)‐one genotoxicity SmoKEz C‐10 SF‐005 |
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Scientific opinion on the renewal of the authorisation of SmokEz C‐10 (SF‐005) as a smoke flavouring Primary Product |
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Scientific opinion on the renewal of the authorisation of SmokEz C‐10 (SF‐005) as a smoke flavouring Primary Product |
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EFSA Panel name on Food Additives and Flavourings (FAF) Maged Younes Gabriele Aquilina Laurence Castle Gisela Degen 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 Matthew Wright Romualdo Benigni Polly Boon Claudia Bolognesi Eugenia Cordelli Kevin Chipman Ullrika Sahlin Maria Carfì Carla Martino Salvatore Multari Vasantha Palaniappan Alexandra Tard Wim Mennes |
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10.2903/j.efsa.2023.8367 |
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scientific opinion on the renewal of the authorisation of smokez c‐10 (sf‐005) as a smoke flavouring primary product |
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Scientific opinion on the renewal of the authorisation of SmokEz C‐10 (SF‐005) as a smoke flavouring Primary Product |
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Abstract The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the smoke flavouring Primary Product SmoKEz C‐10 (SF‐005), for which a renewal application was submitted in accordance with Article 12(1) of Regulation (EC) No 2065/2003. This opinion refers to the assessment of data submitted on chemical characterisation, dietary exposure and genotoxicity of the Primary Product. SmoKEz C‐10 is obtained by pyrolysis of maple, oak, hickory, ash, birch, beech and cherry woods. Given the limitations of the quantification approach employed by the applicant, the Panel could not judge whether the applied methods meet the legal quality criterion that at least 80% of the volatile fraction shall be identified and quantified. At the maximum proposed use levels, dietary exposure estimates calculated with DietEx ranged from 0.01 to 5.1 mg/kg body weight (bw) per day at the mean and from no dietary exposure to 18.1 mg/kg bw per day at the 95th percentile. The Panel concluded that five components in the Primary Product raise a potential concern for genotoxicity. In addition, a potential concern for genotoxicity was identified for the unidentified part of the mixture. The Primary Product contains furan‐2(5H)‐one and benzene‐1,2‐diol, for which a concern for genotoxicity was identified in vivo upon oral administration. Considering that the exposure estimates for these two components are above the threshold of toxicological concern (TTC) of 0.0025 μg/kg bw per day for DNA‐reactive mutagens and/or carcinogens, the Panel concluded that the Primary Product raises concern with respect to genotoxicity. |
| abstractGer |
Abstract The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the smoke flavouring Primary Product SmoKEz C‐10 (SF‐005), for which a renewal application was submitted in accordance with Article 12(1) of Regulation (EC) No 2065/2003. This opinion refers to the assessment of data submitted on chemical characterisation, dietary exposure and genotoxicity of the Primary Product. SmoKEz C‐10 is obtained by pyrolysis of maple, oak, hickory, ash, birch, beech and cherry woods. Given the limitations of the quantification approach employed by the applicant, the Panel could not judge whether the applied methods meet the legal quality criterion that at least 80% of the volatile fraction shall be identified and quantified. At the maximum proposed use levels, dietary exposure estimates calculated with DietEx ranged from 0.01 to 5.1 mg/kg body weight (bw) per day at the mean and from no dietary exposure to 18.1 mg/kg bw per day at the 95th percentile. The Panel concluded that five components in the Primary Product raise a potential concern for genotoxicity. In addition, a potential concern for genotoxicity was identified for the unidentified part of the mixture. The Primary Product contains furan‐2(5H)‐one and benzene‐1,2‐diol, for which a concern for genotoxicity was identified in vivo upon oral administration. Considering that the exposure estimates for these two components are above the threshold of toxicological concern (TTC) of 0.0025 μg/kg bw per day for DNA‐reactive mutagens and/or carcinogens, the Panel concluded that the Primary Product raises concern with respect to genotoxicity. |
| abstract_unstemmed |
Abstract The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the smoke flavouring Primary Product SmoKEz C‐10 (SF‐005), for which a renewal application was submitted in accordance with Article 12(1) of Regulation (EC) No 2065/2003. This opinion refers to the assessment of data submitted on chemical characterisation, dietary exposure and genotoxicity of the Primary Product. SmoKEz C‐10 is obtained by pyrolysis of maple, oak, hickory, ash, birch, beech and cherry woods. Given the limitations of the quantification approach employed by the applicant, the Panel could not judge whether the applied methods meet the legal quality criterion that at least 80% of the volatile fraction shall be identified and quantified. At the maximum proposed use levels, dietary exposure estimates calculated with DietEx ranged from 0.01 to 5.1 mg/kg body weight (bw) per day at the mean and from no dietary exposure to 18.1 mg/kg bw per day at the 95th percentile. The Panel concluded that five components in the Primary Product raise a potential concern for genotoxicity. In addition, a potential concern for genotoxicity was identified for the unidentified part of the mixture. The Primary Product contains furan‐2(5H)‐one and benzene‐1,2‐diol, for which a concern for genotoxicity was identified in vivo upon oral administration. Considering that the exposure estimates for these two components are above the threshold of toxicological concern (TTC) of 0.0025 μg/kg bw per day for DNA‐reactive mutagens and/or carcinogens, the Panel concluded that the Primary Product raises concern with respect to genotoxicity. |
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Scientific opinion on the renewal of the authorisation of SmokEz C‐10 (SF‐005) as a smoke flavouring Primary Product |
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https://doi.org/10.2903/j.efsa.2023.8367 https://doaj.org/article/63c7e64e3f284316bd03f2e9ef44d373 https://doaj.org/toc/1831-4732 |
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Maged Younes Gabriele Aquilina Laurence Castle Gisela Degen 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 Matthew Wright Romualdo Benigni Polly Boon Claudia Bolognesi Eugenia Cordelli Kevin Chipman Ullrika Sahlin Maria Carfì Carla Martino Salvatore Multari Vasantha Palaniappan Alexandra Tard Wim Mennes |
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| score |
7.4010963 |