Scientific opinion on the safety assessment of medium viscosity white mineral oils with a kinematic viscosity between 8.5 – 11 mm<sup>2</sup>/s at 100 °C for the proposed uses as a food additive
The Panel on Food Additives and Nutrient Sources added to Food (ANS) delivers a scientific opinion evaluating the safety in use of medium viscosity white mineral oil (MVMO) (kinematic viscosity between 8.5 – 11 mm2/s at 100 °C) as a food additive. In 2009, EFSA evaluated the safety of high viscosity...
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| Format: | Article |
| Language: | English |
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Wiley
2013-01-01
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| Series: | EFSA Journal |
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| Online Access: | http://www.efsa.europa.eu/en/efsajournal/doc/3073.pdf |
| _version_ | 1818572631420436480 |
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| author | EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) |
| author_facet | EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) |
| author_sort | EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) |
| collection | DOAJ |
| description | The Panel on Food Additives and Nutrient Sources added to Food (ANS) delivers a scientific opinion evaluating the safety in use of medium viscosity white mineral oil (MVMO) (kinematic viscosity between 8.5 – 11 mm2/s at 100 °C) as a food additive. In 2009, EFSA evaluated the safety of high viscosity white mineral oils (HVMO) (kinematic viscosity ≥ 11 mm2/s at 100 °C). In this evaluation, the ANS Panel considered as pivotal a 2-year feeding study in the rat on chronic toxicity and carcinogenicity of two mineral oils: MVMO and HVMO. Based on the results of the study the Panel concluded that no carcinogenic effect was observed in F344 rats tested with MVMO and HVMO. The ANS Panel considered the NOAEL for both MVMO and HVMO in the above study to be 1200 mg/kg bw/day, the highest dose tested. Presently the Panel confirmed this conclusion and established a group ADI of 12 mg/kg bw/day for HVMO (kinematic viscosity ≥11 mm2/s at 100 °C) and for MVMO (kinematic viscosity between 8.5 - 11 mm2/s at 100 °C). The Panel noted that conservative estimates indicated that the potential dietary intake of MVMO and/or HVMO from the proposed uses and use levels as food additive in high consumers would reach up to approximately 10.1 mg/kg bw/day for toddlers. This exposure is below the established group ADI. The Panel also noted that additional exposure to MVMO and/or HVMO via other sources could represent a major source of exposure. With the data presently available it is difficult to draw conclusions as to the magnitude of exposure and the number of consumers affected by this potential additional exposure. |
| first_indexed | 2024-12-15T00:00:11Z |
| format | Article |
| id | doaj.art-185999129fa74c7c82fa4f5e923c7b5c |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-12-15T00:00:11Z |
| publishDate | 2013-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-185999129fa74c7c82fa4f5e923c7b5c2022-12-21T22:42:57ZengWileyEFSA Journal1831-47322013-01-0111110.2903/j.efsa.2013.3073Scientific opinion on the safety assessment of medium viscosity white mineral oils with a kinematic viscosity between 8.5 – 11 mm<sup>2</sup>/s at 100 °C for the proposed uses as a food additiveEFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)The Panel on Food Additives and Nutrient Sources added to Food (ANS) delivers a scientific opinion evaluating the safety in use of medium viscosity white mineral oil (MVMO) (kinematic viscosity between 8.5 – 11 mm2/s at 100 °C) as a food additive. In 2009, EFSA evaluated the safety of high viscosity white mineral oils (HVMO) (kinematic viscosity ≥ 11 mm2/s at 100 °C). In this evaluation, the ANS Panel considered as pivotal a 2-year feeding study in the rat on chronic toxicity and carcinogenicity of two mineral oils: MVMO and HVMO. Based on the results of the study the Panel concluded that no carcinogenic effect was observed in F344 rats tested with MVMO and HVMO. The ANS Panel considered the NOAEL for both MVMO and HVMO in the above study to be 1200 mg/kg bw/day, the highest dose tested. Presently the Panel confirmed this conclusion and established a group ADI of 12 mg/kg bw/day for HVMO (kinematic viscosity ≥11 mm2/s at 100 °C) and for MVMO (kinematic viscosity between 8.5 - 11 mm2/s at 100 °C). The Panel noted that conservative estimates indicated that the potential dietary intake of MVMO and/or HVMO from the proposed uses and use levels as food additive in high consumers would reach up to approximately 10.1 mg/kg bw/day for toddlers. This exposure is below the established group ADI. The Panel also noted that additional exposure to MVMO and/or HVMO via other sources could represent a major source of exposure. With the data presently available it is difficult to draw conclusions as to the magnitude of exposure and the number of consumers affected by this potential additional exposure.http://www.efsa.europa.eu/en/efsajournal/doc/3073.pdfHigh viscosity white mineral oilsmedium viscosity white mineral oilsmineral oils (medium and low viscosity) Class ICAS 8042-47-5P100 oilP70(H) oil |
| spellingShingle | EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) Scientific opinion on the safety assessment of medium viscosity white mineral oils with a kinematic viscosity between 8.5 – 11 mm<sup>2</sup>/s at 100 °C for the proposed uses as a food additive EFSA Journal High viscosity white mineral oils medium viscosity white mineral oils mineral oils (medium and low viscosity) Class I CAS 8042-47-5 P100 oil P70(H) oil |
| title | Scientific opinion on the safety assessment of medium viscosity white mineral oils with a kinematic viscosity between 8.5 – 11 mm<sup>2</sup>/s at 100 °C for the proposed uses as a food additive |
| title_full | Scientific opinion on the safety assessment of medium viscosity white mineral oils with a kinematic viscosity between 8.5 – 11 mm<sup>2</sup>/s at 100 °C for the proposed uses as a food additive |
| title_fullStr | Scientific opinion on the safety assessment of medium viscosity white mineral oils with a kinematic viscosity between 8.5 – 11 mm<sup>2</sup>/s at 100 °C for the proposed uses as a food additive |
| title_full_unstemmed | Scientific opinion on the safety assessment of medium viscosity white mineral oils with a kinematic viscosity between 8.5 – 11 mm<sup>2</sup>/s at 100 °C for the proposed uses as a food additive |
| title_short | Scientific opinion on the safety assessment of medium viscosity white mineral oils with a kinematic viscosity between 8.5 – 11 mm<sup>2</sup>/s at 100 °C for the proposed uses as a food additive |
| title_sort | scientific opinion on the safety assessment of medium viscosity white mineral oils with a kinematic viscosity between 8 5 11 mm sup 2 sup s at 100 °c for the proposed uses as a food additive |
| topic | High viscosity white mineral oils medium viscosity white mineral oils mineral oils (medium and low viscosity) Class I CAS 8042-47-5 P100 oil P70(H) oil |
| url | http://www.efsa.europa.eu/en/efsajournal/doc/3073.pdf |
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