evaluation of the data fails to establish revoke the approval or otherwise ensure We declined to file these portions of the that the proposed use of the food submission as a food additive petition additive, under the conditions of use to that the food additive is no longer in because those requests were not within be specified in the regulation, will be use. [...] To determine whether a 409 of the FD&C Act and § 170.18 Provided To Support Assignment of the food additive is safe, section 409(c)(5) of After our review of the relevant ADI for DEHP to All 28 Ortho- the FD&C Act requires FDA to consider information, we conclude that the Phthalates among other relevant factors the petition’s arguments for treating the 28 An ADI is the amount of a substance follow. [...] presented evidence to show that section common mechanism of action, and do Accordingly, the lower the NOAEL for 409(c)(5)(B) of the FD&C Act is even not have effects on the same or similar a specific substance, the lower the applicable to the proposed class target or system (i.e., the reproductive resulting ADI for the substance. [...] To the extent calculated dietary exposure to the food 409(c)(5)(B) of the FD&C Act, we note as the petition suggests that the proposed additive (i.e., the estimated daily intake, a preliminary matter that the petition class grouping is required by section or EDI) at or below the ADI is has not presented sufficient evidence to 409(c)(5)(B) of the FD&C Act and/or considered consistent with a reasona. [...] As the petition does not the NOAEL to an ADI, the petition has investigations made with respect to the address these studies or others that may not sufficiently supported the safety of a food additive and not omit, impact the appropriateness of the cited application of additional safety factors without explanation, any reports of NOAEL for human risk assessment of to the proposed NOAEL.
- Pages
- 14
- Published in
- Canada
