Guidance Documents for Inert Ingredients

These guidance documents provide information on various inert ingredient issues, including the general process for submitting petitions or requests for new uses, including a food use petition for the establishment of a new/amended inert ingredient tolerance or tolerance exemption, for the establishment of a new inert ingredient tolerance exemption for a food use Low Risk Polymer under 40 CFR 180.960 or for the approval of a nonfood use Low Risk Polymer, or for submitting a nonfood use request. If you are the manufacturer of a trade name inert ingredient and wish to have your trade name inert ingredient included in the publicly‐available “Trade Name Inert Ingredient” database please fill out the “Statement of Non‐confidentiality” as indicated in the "Adding trade product names and approved uses" document below.

• Inert ingredients guidance to petition new or amended food use tolerance (pdf) (288.71 KB)
• Inert ingredients guidance for low risk polymer submission (pdf) (274.38 KB)
• Inert ingredients guidance for new nonfood use (pdf) (275.39 KB)
• Inert ingredients guidance for open literature database search (pdf) (40.07 KB)
• Adding trade product names and approved uses (pdf) (142.56 KB)
• Phase 1 - ‘In-Kind’ Substitution Mechanism (pdf) (239.64 KB)
• Phase 2 - ‘Not In-Kind’ Substitution Mechanism (pdf) (184.51 KB)
• Phase 1 and 2 Extension (pdf) (656.15 KB)
• Commodity Inert Ingredients-Guidance for PRIA Category I018 (pdf) (166.07 KB)