Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive
Abstract The Scientific Panel on Food Additives and Flavouring (FAF) provides a scientific opinion on the safety evaluation of annatto E and an exposure assessment of the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive, taking into account new proposed uses and...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
EFSA Panel on Food Additives and Flavourings (EFSA FAF Panel) [verfasserIn] Maged Younes [verfasserIn] Laurence Castle [verfasserIn] Karl‐Heinz Engel [verfasserIn] Paul Fowler [verfasserIn] Maria Jose Frutos Fernandez [verfasserIn] Peter Fürst [verfasserIn] Rainer Gürtler [verfasserIn] Ursula Gundert‐Remy [verfasserIn] Trine Husøy [verfasserIn] Wim Mennes [verfasserIn] Peter Moldeus [verfasserIn] Agneta Oskarsson [verfasserIn] Romina Shah [verfasserIn] Ine Waalkens‐Berendsen [verfasserIn] Detlef Wölfle [verfasserIn] Riccardo Crebelli [verfasserIn] Jean‐Charles Leblanc [verfasserIn] Alexandra Tard [verfasserIn] Gabriele Aquilina [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2019 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
In: EFSA Journal - Wiley, 2018, 17(2019), 3, Seite n/a-n/a |
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| Übergeordnetes Werk: |
volume:17 ; year:2019 ; number:3 ; pages:n/a-n/a |
| Links: |
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| DOI / URN: |
10.2903/j.efsa.2019.5626 |
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| Katalog-ID: |
DOAJ015324001 |
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| 520 | |a Abstract The Scientific Panel on Food Additives and Flavouring (FAF) provides a scientific opinion on the safety evaluation of annatto E and an exposure assessment of the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive, taking into account new proposed uses and use levels. In 2016, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of annatto extracts (E 160b) as a food additive. In that opinion, the Panel concluded that the toxicological database was sufficient to derive an acceptable daily intake (ADI) of 6 mg bixin/kg body weight (bw) per day and an ADI of 0.3 mg norbixin/kg bw per day. The Panel was not able to conclude on the safety of annatto E. Dietary exposure for annatto (E 160b), bixin‐ and norbixin‐based annatto extracts was estimated taking into account the maximum permitted levels (MPLs) as set in the Annex II to Regulation (EC) No 1333/2008, the use levels provided by food industry as well as the proposed use levels from an applicant for an extension of use. Exposure estimates for bixin were below the ADI for all population groups and for all refined exposure scenarios, including the proposed extension of use. For norbixin, exceedance was observed for the extension of use at the 95th percentile for some population groups. In the 2017 EFSA statement related to the exposure assessment of colouring principles bixin and norbixin considering new proposed uses and use levels, the dietary exposure for bixin did not exceed the ADI. For norbixin, dietary exposure exceeded the ADI at the high level (95th percentile) for toddlers and children. In the current opinion, the Panel concluded that food colour annatto E does not raise concern for genotoxicity. Accordingly, the ADIs established in 2016 for the two colouring principles bixin and norbixin can be applied also to the annatto E. For bixin, none of the exposure estimates exceeded the ADI of 6 mg/kg bw per day. For norbixin, the ADI was reached at the high level (p95) for toddlers in the refined exposure assessment scenarios in one country. Considering the uncertainties and the very likely overestimation of the exposure, the Panel concluded that the level of exposure does not raise a health concern. | ||
| 650 | 4 | |a annatto extracts | |
| 650 | 4 | |a E 160b | |
| 650 | 4 | |a bixin | |
| 650 | 4 | |a norbixin | |
| 650 | 4 | |a comet assay | |
| 650 | 4 | |a exposure assessment | |
| 653 | 0 | |a Nutrition. Foods and food supply | |
| 653 | 0 | |a Chemical technology | |
| 700 | 0 | |a Maged Younes |e verfasserin |4 aut | |
| 700 | 0 | |a Laurence Castle |e verfasserin |4 aut | |
| 700 | 0 | |a Karl‐Heinz Engel |e verfasserin |4 aut | |
| 700 | 0 | |a Paul Fowler |e verfasserin |4 aut | |
| 700 | 0 | |a Maria Jose Frutos Fernandez |e verfasserin |4 aut | |
| 700 | 0 | |a Peter Fürst |e verfasserin |4 aut | |
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| 700 | 0 | |a Trine Husøy |e verfasserin |4 aut | |
| 700 | 0 | |a Wim Mennes |e verfasserin |4 aut | |
| 700 | 0 | |a Peter Moldeus |e verfasserin |4 aut | |
| 700 | 0 | |a Agneta Oskarsson |e verfasserin |4 aut | |
| 700 | 0 | |a Romina Shah |e verfasserin |4 aut | |
| 700 | 0 | |a Ine Waalkens‐Berendsen |e verfasserin |4 aut | |
| 700 | 0 | |a Detlef Wölfle |e verfasserin |4 aut | |
| 700 | 0 | |a Riccardo Crebelli |e verfasserin |4 aut | |
| 700 | 0 | |a Jean‐Charles Leblanc |e verfasserin |4 aut | |
| 700 | 0 | |a Alexandra Tard |e verfasserin |4 aut | |
| 700 | 0 | |a Gabriele Aquilina |e verfasserin |4 aut | |
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10.2903/j.efsa.2019.5626 doi (DE-627)DOAJ015324001 (DE-599)DOAJdbc2d2dc9ba34fec8b4f9ec4560bf256 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Food Additives and Flavourings (EFSA FAF Panel) verfasserin aut Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The Scientific Panel on Food Additives and Flavouring (FAF) provides a scientific opinion on the safety evaluation of annatto E and an exposure assessment of the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive, taking into account new proposed uses and use levels. In 2016, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of annatto extracts (E 160b) as a food additive. In that opinion, the Panel concluded that the toxicological database was sufficient to derive an acceptable daily intake (ADI) of 6 mg bixin/kg body weight (bw) per day and an ADI of 0.3 mg norbixin/kg bw per day. The Panel was not able to conclude on the safety of annatto E. Dietary exposure for annatto (E 160b), bixin‐ and norbixin‐based annatto extracts was estimated taking into account the maximum permitted levels (MPLs) as set in the Annex II to Regulation (EC) No 1333/2008, the use levels provided by food industry as well as the proposed use levels from an applicant for an extension of use. Exposure estimates for bixin were below the ADI for all population groups and for all refined exposure scenarios, including the proposed extension of use. For norbixin, exceedance was observed for the extension of use at the 95th percentile for some population groups. In the 2017 EFSA statement related to the exposure assessment of colouring principles bixin and norbixin considering new proposed uses and use levels, the dietary exposure for bixin did not exceed the ADI. For norbixin, dietary exposure exceeded the ADI at the high level (95th percentile) for toddlers and children. In the current opinion, the Panel concluded that food colour annatto E does not raise concern for genotoxicity. Accordingly, the ADIs established in 2016 for the two colouring principles bixin and norbixin can be applied also to the annatto E. For bixin, none of the exposure estimates exceeded the ADI of 6 mg/kg bw per day. For norbixin, the ADI was reached at the high level (p95) for toddlers in the refined exposure assessment scenarios in one country. Considering the uncertainties and the very likely overestimation of the exposure, the Panel concluded that the level of exposure does not raise a health concern. annatto extracts E 160b bixin norbixin comet assay exposure assessment Nutrition. Foods and food supply Chemical technology Maged Younes verfasserin aut Laurence Castle verfasserin aut Karl‐Heinz Engel verfasserin aut Paul Fowler verfasserin aut Maria Jose Frutos Fernandez verfasserin aut Peter Fürst verfasserin aut Rainer Gürtler verfasserin aut Ursula Gundert‐Remy verfasserin aut Trine Husøy verfasserin aut Wim Mennes verfasserin aut Peter Moldeus verfasserin aut Agneta Oskarsson verfasserin aut Romina Shah verfasserin aut Ine Waalkens‐Berendsen verfasserin aut Detlef Wölfle verfasserin aut Riccardo Crebelli verfasserin aut Jean‐Charles Leblanc verfasserin aut Alexandra Tard verfasserin aut Gabriele Aquilina verfasserin aut In EFSA Journal Wiley, 2018 17(2019), 3, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:17 year:2019 number:3 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2019.5626 kostenfrei https://doaj.org/article/dbc2d2dc9ba34fec8b4f9ec4560bf256 kostenfrei https://doi.org/10.2903/j.efsa.2019.5626 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 17 2019 3 n/a-n/a |
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10.2903/j.efsa.2019.5626 doi (DE-627)DOAJ015324001 (DE-599)DOAJdbc2d2dc9ba34fec8b4f9ec4560bf256 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Food Additives and Flavourings (EFSA FAF Panel) verfasserin aut Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The Scientific Panel on Food Additives and Flavouring (FAF) provides a scientific opinion on the safety evaluation of annatto E and an exposure assessment of the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive, taking into account new proposed uses and use levels. In 2016, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of annatto extracts (E 160b) as a food additive. In that opinion, the Panel concluded that the toxicological database was sufficient to derive an acceptable daily intake (ADI) of 6 mg bixin/kg body weight (bw) per day and an ADI of 0.3 mg norbixin/kg bw per day. The Panel was not able to conclude on the safety of annatto E. Dietary exposure for annatto (E 160b), bixin‐ and norbixin‐based annatto extracts was estimated taking into account the maximum permitted levels (MPLs) as set in the Annex II to Regulation (EC) No 1333/2008, the use levels provided by food industry as well as the proposed use levels from an applicant for an extension of use. Exposure estimates for bixin were below the ADI for all population groups and for all refined exposure scenarios, including the proposed extension of use. For norbixin, exceedance was observed for the extension of use at the 95th percentile for some population groups. In the 2017 EFSA statement related to the exposure assessment of colouring principles bixin and norbixin considering new proposed uses and use levels, the dietary exposure for bixin did not exceed the ADI. For norbixin, dietary exposure exceeded the ADI at the high level (95th percentile) for toddlers and children. In the current opinion, the Panel concluded that food colour annatto E does not raise concern for genotoxicity. Accordingly, the ADIs established in 2016 for the two colouring principles bixin and norbixin can be applied also to the annatto E. For bixin, none of the exposure estimates exceeded the ADI of 6 mg/kg bw per day. For norbixin, the ADI was reached at the high level (p95) for toddlers in the refined exposure assessment scenarios in one country. Considering the uncertainties and the very likely overestimation of the exposure, the Panel concluded that the level of exposure does not raise a health concern. annatto extracts E 160b bixin norbixin comet assay exposure assessment Nutrition. Foods and food supply Chemical technology Maged Younes verfasserin aut Laurence Castle verfasserin aut Karl‐Heinz Engel verfasserin aut Paul Fowler verfasserin aut Maria Jose Frutos Fernandez verfasserin aut Peter Fürst verfasserin aut Rainer Gürtler verfasserin aut Ursula Gundert‐Remy verfasserin aut Trine Husøy verfasserin aut Wim Mennes verfasserin aut Peter Moldeus verfasserin aut Agneta Oskarsson verfasserin aut Romina Shah verfasserin aut Ine Waalkens‐Berendsen verfasserin aut Detlef Wölfle verfasserin aut Riccardo Crebelli verfasserin aut Jean‐Charles Leblanc verfasserin aut Alexandra Tard verfasserin aut Gabriele Aquilina verfasserin aut In EFSA Journal Wiley, 2018 17(2019), 3, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:17 year:2019 number:3 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2019.5626 kostenfrei https://doaj.org/article/dbc2d2dc9ba34fec8b4f9ec4560bf256 kostenfrei https://doi.org/10.2903/j.efsa.2019.5626 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 17 2019 3 n/a-n/a |
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10.2903/j.efsa.2019.5626 doi (DE-627)DOAJ015324001 (DE-599)DOAJdbc2d2dc9ba34fec8b4f9ec4560bf256 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Food Additives and Flavourings (EFSA FAF Panel) verfasserin aut Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The Scientific Panel on Food Additives and Flavouring (FAF) provides a scientific opinion on the safety evaluation of annatto E and an exposure assessment of the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive, taking into account new proposed uses and use levels. In 2016, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of annatto extracts (E 160b) as a food additive. In that opinion, the Panel concluded that the toxicological database was sufficient to derive an acceptable daily intake (ADI) of 6 mg bixin/kg body weight (bw) per day and an ADI of 0.3 mg norbixin/kg bw per day. The Panel was not able to conclude on the safety of annatto E. Dietary exposure for annatto (E 160b), bixin‐ and norbixin‐based annatto extracts was estimated taking into account the maximum permitted levels (MPLs) as set in the Annex II to Regulation (EC) No 1333/2008, the use levels provided by food industry as well as the proposed use levels from an applicant for an extension of use. Exposure estimates for bixin were below the ADI for all population groups and for all refined exposure scenarios, including the proposed extension of use. For norbixin, exceedance was observed for the extension of use at the 95th percentile for some population groups. In the 2017 EFSA statement related to the exposure assessment of colouring principles bixin and norbixin considering new proposed uses and use levels, the dietary exposure for bixin did not exceed the ADI. For norbixin, dietary exposure exceeded the ADI at the high level (95th percentile) for toddlers and children. In the current opinion, the Panel concluded that food colour annatto E does not raise concern for genotoxicity. Accordingly, the ADIs established in 2016 for the two colouring principles bixin and norbixin can be applied also to the annatto E. For bixin, none of the exposure estimates exceeded the ADI of 6 mg/kg bw per day. For norbixin, the ADI was reached at the high level (p95) for toddlers in the refined exposure assessment scenarios in one country. Considering the uncertainties and the very likely overestimation of the exposure, the Panel concluded that the level of exposure does not raise a health concern. annatto extracts E 160b bixin norbixin comet assay exposure assessment Nutrition. Foods and food supply Chemical technology Maged Younes verfasserin aut Laurence Castle verfasserin aut Karl‐Heinz Engel verfasserin aut Paul Fowler verfasserin aut Maria Jose Frutos Fernandez verfasserin aut Peter Fürst verfasserin aut Rainer Gürtler verfasserin aut Ursula Gundert‐Remy verfasserin aut Trine Husøy verfasserin aut Wim Mennes verfasserin aut Peter Moldeus verfasserin aut Agneta Oskarsson verfasserin aut Romina Shah verfasserin aut Ine Waalkens‐Berendsen verfasserin aut Detlef Wölfle verfasserin aut Riccardo Crebelli verfasserin aut Jean‐Charles Leblanc verfasserin aut Alexandra Tard verfasserin aut Gabriele Aquilina verfasserin aut In EFSA Journal Wiley, 2018 17(2019), 3, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:17 year:2019 number:3 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2019.5626 kostenfrei https://doaj.org/article/dbc2d2dc9ba34fec8b4f9ec4560bf256 kostenfrei https://doi.org/10.2903/j.efsa.2019.5626 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 17 2019 3 n/a-n/a |
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10.2903/j.efsa.2019.5626 doi (DE-627)DOAJ015324001 (DE-599)DOAJdbc2d2dc9ba34fec8b4f9ec4560bf256 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Food Additives and Flavourings (EFSA FAF Panel) verfasserin aut Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The Scientific Panel on Food Additives and Flavouring (FAF) provides a scientific opinion on the safety evaluation of annatto E and an exposure assessment of the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive, taking into account new proposed uses and use levels. In 2016, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of annatto extracts (E 160b) as a food additive. In that opinion, the Panel concluded that the toxicological database was sufficient to derive an acceptable daily intake (ADI) of 6 mg bixin/kg body weight (bw) per day and an ADI of 0.3 mg norbixin/kg bw per day. The Panel was not able to conclude on the safety of annatto E. Dietary exposure for annatto (E 160b), bixin‐ and norbixin‐based annatto extracts was estimated taking into account the maximum permitted levels (MPLs) as set in the Annex II to Regulation (EC) No 1333/2008, the use levels provided by food industry as well as the proposed use levels from an applicant for an extension of use. Exposure estimates for bixin were below the ADI for all population groups and for all refined exposure scenarios, including the proposed extension of use. For norbixin, exceedance was observed for the extension of use at the 95th percentile for some population groups. In the 2017 EFSA statement related to the exposure assessment of colouring principles bixin and norbixin considering new proposed uses and use levels, the dietary exposure for bixin did not exceed the ADI. For norbixin, dietary exposure exceeded the ADI at the high level (95th percentile) for toddlers and children. In the current opinion, the Panel concluded that food colour annatto E does not raise concern for genotoxicity. Accordingly, the ADIs established in 2016 for the two colouring principles bixin and norbixin can be applied also to the annatto E. For bixin, none of the exposure estimates exceeded the ADI of 6 mg/kg bw per day. For norbixin, the ADI was reached at the high level (p95) for toddlers in the refined exposure assessment scenarios in one country. Considering the uncertainties and the very likely overestimation of the exposure, the Panel concluded that the level of exposure does not raise a health concern. annatto extracts E 160b bixin norbixin comet assay exposure assessment Nutrition. Foods and food supply Chemical technology Maged Younes verfasserin aut Laurence Castle verfasserin aut Karl‐Heinz Engel verfasserin aut Paul Fowler verfasserin aut Maria Jose Frutos Fernandez verfasserin aut Peter Fürst verfasserin aut Rainer Gürtler verfasserin aut Ursula Gundert‐Remy verfasserin aut Trine Husøy verfasserin aut Wim Mennes verfasserin aut Peter Moldeus verfasserin aut Agneta Oskarsson verfasserin aut Romina Shah verfasserin aut Ine Waalkens‐Berendsen verfasserin aut Detlef Wölfle verfasserin aut Riccardo Crebelli verfasserin aut Jean‐Charles Leblanc verfasserin aut Alexandra Tard verfasserin aut Gabriele Aquilina verfasserin aut In EFSA Journal Wiley, 2018 17(2019), 3, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:17 year:2019 number:3 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2019.5626 kostenfrei https://doaj.org/article/dbc2d2dc9ba34fec8b4f9ec4560bf256 kostenfrei https://doi.org/10.2903/j.efsa.2019.5626 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 17 2019 3 n/a-n/a |
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10.2903/j.efsa.2019.5626 doi (DE-627)DOAJ015324001 (DE-599)DOAJdbc2d2dc9ba34fec8b4f9ec4560bf256 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Food Additives and Flavourings (EFSA FAF Panel) verfasserin aut Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The Scientific Panel on Food Additives and Flavouring (FAF) provides a scientific opinion on the safety evaluation of annatto E and an exposure assessment of the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive, taking into account new proposed uses and use levels. In 2016, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of annatto extracts (E 160b) as a food additive. In that opinion, the Panel concluded that the toxicological database was sufficient to derive an acceptable daily intake (ADI) of 6 mg bixin/kg body weight (bw) per day and an ADI of 0.3 mg norbixin/kg bw per day. The Panel was not able to conclude on the safety of annatto E. Dietary exposure for annatto (E 160b), bixin‐ and norbixin‐based annatto extracts was estimated taking into account the maximum permitted levels (MPLs) as set in the Annex II to Regulation (EC) No 1333/2008, the use levels provided by food industry as well as the proposed use levels from an applicant for an extension of use. Exposure estimates for bixin were below the ADI for all population groups and for all refined exposure scenarios, including the proposed extension of use. For norbixin, exceedance was observed for the extension of use at the 95th percentile for some population groups. In the 2017 EFSA statement related to the exposure assessment of colouring principles bixin and norbixin considering new proposed uses and use levels, the dietary exposure for bixin did not exceed the ADI. For norbixin, dietary exposure exceeded the ADI at the high level (95th percentile) for toddlers and children. In the current opinion, the Panel concluded that food colour annatto E does not raise concern for genotoxicity. Accordingly, the ADIs established in 2016 for the two colouring principles bixin and norbixin can be applied also to the annatto E. For bixin, none of the exposure estimates exceeded the ADI of 6 mg/kg bw per day. For norbixin, the ADI was reached at the high level (p95) for toddlers in the refined exposure assessment scenarios in one country. Considering the uncertainties and the very likely overestimation of the exposure, the Panel concluded that the level of exposure does not raise a health concern. annatto extracts E 160b bixin norbixin comet assay exposure assessment Nutrition. Foods and food supply Chemical technology Maged Younes verfasserin aut Laurence Castle verfasserin aut Karl‐Heinz Engel verfasserin aut Paul Fowler verfasserin aut Maria Jose Frutos Fernandez verfasserin aut Peter Fürst verfasserin aut Rainer Gürtler verfasserin aut Ursula Gundert‐Remy verfasserin aut Trine Husøy verfasserin aut Wim Mennes verfasserin aut Peter Moldeus verfasserin aut Agneta Oskarsson verfasserin aut Romina Shah verfasserin aut Ine Waalkens‐Berendsen verfasserin aut Detlef Wölfle verfasserin aut Riccardo Crebelli verfasserin aut Jean‐Charles Leblanc verfasserin aut Alexandra Tard verfasserin aut Gabriele Aquilina verfasserin aut In EFSA Journal Wiley, 2018 17(2019), 3, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:17 year:2019 number:3 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2019.5626 kostenfrei https://doaj.org/article/dbc2d2dc9ba34fec8b4f9ec4560bf256 kostenfrei https://doi.org/10.2903/j.efsa.2019.5626 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 17 2019 3 n/a-n/a |
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EFSA Panel on Food Additives and Flavourings (EFSA FAF Panel) @@aut@@ Maged Younes @@aut@@ Laurence Castle @@aut@@ Karl‐Heinz Engel @@aut@@ Paul Fowler @@aut@@ Maria Jose Frutos Fernandez @@aut@@ Peter Fürst @@aut@@ Rainer Gürtler @@aut@@ Ursula Gundert‐Remy @@aut@@ Trine Husøy @@aut@@ Wim Mennes @@aut@@ Peter Moldeus @@aut@@ Agneta Oskarsson @@aut@@ Romina Shah @@aut@@ Ine Waalkens‐Berendsen @@aut@@ Detlef Wölfle @@aut@@ Riccardo Crebelli @@aut@@ Jean‐Charles Leblanc @@aut@@ Alexandra Tard @@aut@@ Gabriele Aquilina @@aut@@ |
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In 2016, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of annatto extracts (E 160b) as a food additive. In that opinion, the Panel concluded that the toxicological database was sufficient to derive an acceptable daily intake (ADI) of 6 mg bixin/kg body weight (bw) per day and an ADI of 0.3 mg norbixin/kg bw per day. The Panel was not able to conclude on the safety of annatto E. Dietary exposure for annatto (E 160b), bixin‐ and norbixin‐based annatto extracts was estimated taking into account the maximum permitted levels (MPLs) as set in the Annex II to Regulation (EC) No 1333/2008, the use levels provided by food industry as well as the proposed use levels from an applicant for an extension of use. Exposure estimates for bixin were below the ADI for all population groups and for all refined exposure scenarios, including the proposed extension of use. For norbixin, exceedance was observed for the extension of use at the 95th percentile for some population groups. In the 2017 EFSA statement related to the exposure assessment of colouring principles bixin and norbixin considering new proposed uses and use levels, the dietary exposure for bixin did not exceed the ADI. For norbixin, dietary exposure exceeded the ADI at the high level (95th percentile) for toddlers and children. In the current opinion, the Panel concluded that food colour annatto E does not raise concern for genotoxicity. Accordingly, the ADIs established in 2016 for the two colouring principles bixin and norbixin can be applied also to the annatto E. For bixin, none of the exposure estimates exceeded the ADI of 6 mg/kg bw per day. For norbixin, the ADI was reached at the high level (p95) for toddlers in the refined exposure assessment scenarios in one country. 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TX341-641 TP1-1185 Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive annatto extracts E 160b bixin norbixin comet assay exposure assessment |
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EFSA Panel on Food Additives and Flavourings (EFSA FAF Panel) Maged Younes Laurence Castle Karl‐Heinz Engel Paul Fowler Maria Jose Frutos Fernandez Peter Fürst Rainer Gürtler Ursula Gundert‐Remy Trine Husøy Wim Mennes Peter Moldeus Agneta Oskarsson Romina Shah Ine Waalkens‐Berendsen Detlef Wölfle Riccardo Crebelli Jean‐Charles Leblanc Alexandra Tard Gabriele Aquilina |
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safety of annatto e and the exposure to the annatto colouring principles bixin and norbixin (e 160b) when used as a food additive |
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Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive |
| abstract |
Abstract The Scientific Panel on Food Additives and Flavouring (FAF) provides a scientific opinion on the safety evaluation of annatto E and an exposure assessment of the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive, taking into account new proposed uses and use levels. In 2016, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of annatto extracts (E 160b) as a food additive. In that opinion, the Panel concluded that the toxicological database was sufficient to derive an acceptable daily intake (ADI) of 6 mg bixin/kg body weight (bw) per day and an ADI of 0.3 mg norbixin/kg bw per day. The Panel was not able to conclude on the safety of annatto E. Dietary exposure for annatto (E 160b), bixin‐ and norbixin‐based annatto extracts was estimated taking into account the maximum permitted levels (MPLs) as set in the Annex II to Regulation (EC) No 1333/2008, the use levels provided by food industry as well as the proposed use levels from an applicant for an extension of use. Exposure estimates for bixin were below the ADI for all population groups and for all refined exposure scenarios, including the proposed extension of use. For norbixin, exceedance was observed for the extension of use at the 95th percentile for some population groups. In the 2017 EFSA statement related to the exposure assessment of colouring principles bixin and norbixin considering new proposed uses and use levels, the dietary exposure for bixin did not exceed the ADI. For norbixin, dietary exposure exceeded the ADI at the high level (95th percentile) for toddlers and children. In the current opinion, the Panel concluded that food colour annatto E does not raise concern for genotoxicity. Accordingly, the ADIs established in 2016 for the two colouring principles bixin and norbixin can be applied also to the annatto E. For bixin, none of the exposure estimates exceeded the ADI of 6 mg/kg bw per day. For norbixin, the ADI was reached at the high level (p95) for toddlers in the refined exposure assessment scenarios in one country. Considering the uncertainties and the very likely overestimation of the exposure, the Panel concluded that the level of exposure does not raise a health concern. |
| abstractGer |
Abstract The Scientific Panel on Food Additives and Flavouring (FAF) provides a scientific opinion on the safety evaluation of annatto E and an exposure assessment of the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive, taking into account new proposed uses and use levels. In 2016, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of annatto extracts (E 160b) as a food additive. In that opinion, the Panel concluded that the toxicological database was sufficient to derive an acceptable daily intake (ADI) of 6 mg bixin/kg body weight (bw) per day and an ADI of 0.3 mg norbixin/kg bw per day. The Panel was not able to conclude on the safety of annatto E. Dietary exposure for annatto (E 160b), bixin‐ and norbixin‐based annatto extracts was estimated taking into account the maximum permitted levels (MPLs) as set in the Annex II to Regulation (EC) No 1333/2008, the use levels provided by food industry as well as the proposed use levels from an applicant for an extension of use. Exposure estimates for bixin were below the ADI for all population groups and for all refined exposure scenarios, including the proposed extension of use. For norbixin, exceedance was observed for the extension of use at the 95th percentile for some population groups. In the 2017 EFSA statement related to the exposure assessment of colouring principles bixin and norbixin considering new proposed uses and use levels, the dietary exposure for bixin did not exceed the ADI. For norbixin, dietary exposure exceeded the ADI at the high level (95th percentile) for toddlers and children. In the current opinion, the Panel concluded that food colour annatto E does not raise concern for genotoxicity. Accordingly, the ADIs established in 2016 for the two colouring principles bixin and norbixin can be applied also to the annatto E. For bixin, none of the exposure estimates exceeded the ADI of 6 mg/kg bw per day. For norbixin, the ADI was reached at the high level (p95) for toddlers in the refined exposure assessment scenarios in one country. Considering the uncertainties and the very likely overestimation of the exposure, the Panel concluded that the level of exposure does not raise a health concern. |
| abstract_unstemmed |
Abstract The Scientific Panel on Food Additives and Flavouring (FAF) provides a scientific opinion on the safety evaluation of annatto E and an exposure assessment of the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive, taking into account new proposed uses and use levels. In 2016, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of annatto extracts (E 160b) as a food additive. In that opinion, the Panel concluded that the toxicological database was sufficient to derive an acceptable daily intake (ADI) of 6 mg bixin/kg body weight (bw) per day and an ADI of 0.3 mg norbixin/kg bw per day. The Panel was not able to conclude on the safety of annatto E. Dietary exposure for annatto (E 160b), bixin‐ and norbixin‐based annatto extracts was estimated taking into account the maximum permitted levels (MPLs) as set in the Annex II to Regulation (EC) No 1333/2008, the use levels provided by food industry as well as the proposed use levels from an applicant for an extension of use. Exposure estimates for bixin were below the ADI for all population groups and for all refined exposure scenarios, including the proposed extension of use. For norbixin, exceedance was observed for the extension of use at the 95th percentile for some population groups. In the 2017 EFSA statement related to the exposure assessment of colouring principles bixin and norbixin considering new proposed uses and use levels, the dietary exposure for bixin did not exceed the ADI. For norbixin, dietary exposure exceeded the ADI at the high level (95th percentile) for toddlers and children. In the current opinion, the Panel concluded that food colour annatto E does not raise concern for genotoxicity. Accordingly, the ADIs established in 2016 for the two colouring principles bixin and norbixin can be applied also to the annatto E. For bixin, none of the exposure estimates exceeded the ADI of 6 mg/kg bw per day. For norbixin, the ADI was reached at the high level (p95) for toddlers in the refined exposure assessment scenarios in one country. Considering the uncertainties and the very likely overestimation of the exposure, the Panel concluded that the level of exposure does not raise a health concern. |
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| title_short |
Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive |
| url |
https://doi.org/10.2903/j.efsa.2019.5626 https://doaj.org/article/dbc2d2dc9ba34fec8b4f9ec4560bf256 https://doaj.org/toc/1831-4732 |
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Maged Younes Laurence Castle Karl‐Heinz Engel Paul Fowler Maria Jose Frutos Fernandez Peter Fürst Rainer Gürtler Ursula Gundert‐Remy Trine Husøy Wim Mennes Peter Moldeus Agneta Oskarsson Romina Shah Ine Waalkens‐Berendsen Detlef Wölfle Riccardo Crebelli Jean‐Charles Leblanc Alexandra Tard Gabriele Aquilina |
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Maged Younes Laurence Castle Karl‐Heinz Engel Paul Fowler Maria Jose Frutos Fernandez Peter Fürst Rainer Gürtler Ursula Gundert‐Remy Trine Husøy Wim Mennes Peter Moldeus Agneta Oskarsson Romina Shah Ine Waalkens‐Berendsen Detlef Wölfle Riccardo Crebelli Jean‐Charles Leblanc Alexandra Tard Gabriele Aquilina |
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TX - Home Economics |
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10.2903/j.efsa.2019.5626 |
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TX341-641 |
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2024-07-03T14:18:18.065Z |
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| score |
7.399708 |