Cumulative Estimated Daily Intake (CEDI)

Database updated May 2024

As part of the premarket notification process for food contact substances (FCSs), the Office of Food Additive Safety (OFAS) maintains a database of cumulative estimated daily intakes (CEDIs) for a large number of FCSs. This database is referred to as the CEDI database and is publicly available. FDA updates the CEDI database as additional information becomes available.

The CEDIs in the database were calculated using information currently available at the time and may be subject to revision on the basis of new information as it is made available and evaluated or existing information is re-evaluated by OFAS.

Information for FCS Notifiers

As the safety evaluation is the responsibility of the notifier, potential notifiers are encouraged to approach OFAS through a prenotification consultation to determine if their proposed use is supported by the available data. This is especially critical if the current CEDI may change substantially as a result of the intended use. Notifiers are also encouraged to contact OFAS with new information that may be used to calculate CEDIs and include such information in notifications. See Preparation of Food Contact Notifications and Food Additive Petitions for Food Contact Substances: Chemistry Recommendations. Concerning the database, OFAS notes the following:

• The CEDI values listed in the database are primarily for FCSs that are regulated under 21 CFR 175-178 and/or authorized by a Food Contact Substance Notification. Information on constituents, such as monomers, and other impurities may not currently be available.
• The listed CEDI values for polymeric FCSs in the database are predominately for exposure to the associated low molecular weight oligomers.
• The CEDI values are expressed as both cumulative dietary concentration (CDC, parts-per-billion, ppb) and as cumulative estimated daily intake (CEDI, microgram/kilogram body weight/person/day, µg/kg bw/d).

Search and display hints:

• Select the specific substance below to view additional information (other names) for that esubstance.
• Select the specific regulation (21 CFR), to view the text of that regulation.
• To sort by a specific field, click on the column header for that field.
• To browse the records, use the Show All, First/Previous/Next/Last, and Jump To options at the bottom of the data table.
• To search for a specific substance/term, enter the term in the Search box and select Show Items to display only those records that contain the selected term. (The search results also includes terms not shown on this page, but included in the full record on the detail page.)
• The search results will return hits of records containing words that include the search term. For example, a search for the color red will return results that include terms such as reduce, ingredient, and cultured. To limit results to only the searched term, place a space before and after the word in the basic search or in the advanced search “this exact phrase” field.

*Definitions

• CAS Reg. No. (or other ID): Chemical Abstract Service (CAS) Registry Number© for the substance or a numerical code (other ID) assigned by CFSAN to those substances that do not have a CAS Registry Number (977nnn-nn-n or 809777nnn-nn-n series).
• Substance: A name of the additive or impurity as recognized by CFSAN.
• Calculation/Update Date: The date on which the CEDI was calculated or re-evaluated.
• CDC: Cumulative Dietary Concentration (CDC, parts-per-billion, ppb)
• CEDI: Cumulative Estimated Daily Intake (micrograms/kilogram body weight/person/day, µg/kg bw/d)
• 21 CFR: The Code of Federal Regulations, Title 21 is the preferred reference to determine the regulatory status of Indirect Food Additives. Substances whose names appear in 21 CFR, parts 175-178 are authorized for specified intended users and conditions of use as stated in the regulation. Note that substances may appear in more than one regulation, or several times in the same regulation. Note that if a substance is mentioned in 21 CFR parts 175-178 and thus, is listed above, any other citations for the same substance in other sections of 21 CFR dealing with food additives (parts 1-199 inclusive) may also be cited.