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. This database is referred to as the CEDI database. At this time, the database contains information on an initial subset of food-contact substances. OFAS is attempting to collect and review data for approximately 3000 FCSs for inclusion into the CEDI database. As additional information becomes available, the CEDI database will be updated.
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.
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. 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:
- 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). Information on many polymeric FCSs and constituents, such as monomers, are presently not available.
- 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).
- Many of the FCSs listed below are only regulated for use under 21 CFR 175.105. In the absence of appropriate information, such as migration studies, on which to base a numerical estimate of exposure, OFAS assumes a default CEDI of 7 ppb (corresponding to a cumulative intake of 0.00035 mg/kg-bw/d).
- The downloaded database can be searched by: CAS RN or OTHER CODE, MAINTERM, and REGNUM.
Full Definitions of the Database Labels
|MAINTERM||The name of the substance as recognized by CFSAN|
|CAS RN or
Other ID Code
|Chemical Abstract Service (CAS) Registry Number for the substance or a numerical code assigned by CFSAN to those substances that do not have a CAS Registry Number (888nnnnnn or 977nnnnnn-series). CAS RN or other FDA codes are entered into the database with hyphens removed and consist of 9-digit numbers. For example, benzene (CAS RN 71-43-2) would be 000071432.|
|CUM DC||Dietary concentration in the food expressed in ppb|
|CEDI||Cumulative estimated daily intake determined by OFAS for the food contact substance in mg/kg bw/d.|
|REGNUM||Regulation numbers in Title 21 of the U.S. Code of Federal Regulations where the substance appears.|