Intake estimates based on the applicant’s proposed use levels of polyethylene glycol as a food additive and on conservative assumptions lead to a calculated intake estimate up to 120 mg/day, amounting to 2 mg/kg bw/day assuming 60 kg bw. Additional exposure to polyethylene glycol may also occur from use of pharmaceutical products both tablets and capsules, for which coating with polyethylene glycol-containing films has been approved. Assuming similar levels of use and intake of pharmaceutical products and food supplements per day the combined intake from food supplements and pharmaceutical products would be about 4 mg/kg bw/day. Limited additional exposure in the EU could occur from the approved use of polyethylene glycol 6000 as a carrier for sweeteners, as well as from the use of the PEG in food contact materials. The estimated daily intakes of the polyethylene glycols from the use as a coating agent for food supplements are below the ADI of 0-10 mg/kg body weight allocated by JECFA and the group TDI of 5 mg/kg body weight established by the SCF for the polyethylene glycols. Therefore, overall the data support the conclusion that consumption of polyethylene glycols (PEG 400, PEG 3000, PEG 3350, PEG 4000, PEG 6000, and PEG 8000) through use as plasticizers in film-coating formulations for food supplement tablets and/or capsules at the intended use level are not of safety concern.

the use of polyethylene glycol (PEG) as a film coating agent for use in food supplement products

GRILLI, SANDRO;
2007

Abstract

Intake estimates based on the applicant’s proposed use levels of polyethylene glycol as a food additive and on conservative assumptions lead to a calculated intake estimate up to 120 mg/day, amounting to 2 mg/kg bw/day assuming 60 kg bw. Additional exposure to polyethylene glycol may also occur from use of pharmaceutical products both tablets and capsules, for which coating with polyethylene glycol-containing films has been approved. Assuming similar levels of use and intake of pharmaceutical products and food supplements per day the combined intake from food supplements and pharmaceutical products would be about 4 mg/kg bw/day. Limited additional exposure in the EU could occur from the approved use of polyethylene glycol 6000 as a carrier for sweeteners, as well as from the use of the PEG in food contact materials. The estimated daily intakes of the polyethylene glycols from the use as a coating agent for food supplements are below the ADI of 0-10 mg/kg body weight allocated by JECFA and the group TDI of 5 mg/kg body weight established by the SCF for the polyethylene glycols. Therefore, overall the data support the conclusion that consumption of polyethylene glycols (PEG 400, PEG 3000, PEG 3350, PEG 4000, PEG 6000, and PEG 8000) through use as plasticizers in film-coating formulations for food supplement tablets and/or capsules at the intended use level are not of safety concern.
F. Aguilar; H. Autrup; S. Barlow; L. Castle; R. Crebelli; W. Dekant; K.-H. Engel; N. Gontard; D. Gott; S.Grilli; R. Gürtler; J. C. Larsen; C. Leclercq; J.-C. Leblanc; F. X. Malcata; W. Mennes; M. R. Milana; I. Pratt; I. Rietjens; P. Tobback; F. Toldrá.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11585/89986
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