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  1. Packaging & Food Contact Substances (FCS)

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.

Database Update(s)

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 on which to base 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:

  1. 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.
  2. The listed CEDI values for polymeric FCSs in the database are predominately for exposure to the associated low molecular weight oligomers.
  3. 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)

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