The CEDI values are expressed as dietary concentration (parts-per-billion, ppb) and as intake (milligram/kilogram body weight/person/day, mg/kg bw/d).Information on many polymeric FCSs and constituents, such as monomers, are presently not available.

The CEDI values listed at this early stage in the development of the database are primarily for FCSs that may be classified as adhesives (21 CFR 175.105), paper and paperboard components (21 CFR 176) and polymer adjuvants and production aids (21 CFR 178).Concerning the database, OFAS notes the following: See Preparation of Food Contact Notifications and Food Additive Petitions for Food Contact Substances: Chemistry Recommendations. Notifiers are also encouraged to contact OFAS with new information on which to base CEDIs and include such information in notifications.

This is especially critical if the current CEDI may change substantially. Information for FCS NotifiersĪs 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. The CEDIs are based on currently available information and may be subject to revision on the basis of new information as it is submitted or made available to OFAS. As additional information becomes available, the CEDI database will be updated. OFAS is attempting to collect and review data for approximately 3000 FCSs for inclusion into the CEDI database. At this time, the database contains information on an initial subset of food-contact substances. This database is referred to as the CEDI database. As part of the premarket notification process for food contact substances (FCSs), the Office of Food Additive Safety (OFAS) is developing and making publicly available a database of cumulative estimated daily intakes (CEDIs) for a large number of FCSs.

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