CFSAN/Office of Food Additive Safety
| Launch 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) and acceptable daily intakes (ADIs) for a large number of FCSs. This database is referred to as the CEDI/ADI database. At this time, the database contains CEDI/ADI 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/ADI database. As additional information becomes available, the CEDI/ADI database will be updated.
The CEDIs and ADIs 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. Moreover, as our toxicology guidance is based on a tiered exposure assessment strategy, though an ADI may have been calculated based on available data, additional data may be necessary to ensure safety if exposure increases significantly. Furthermore, FDA continually evaluates the data set of each new chemical exposure with the goal of determining if the data previously generated are still valid for supporting the safe use at the new exposure level.
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 ADIs 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:
Full definitions of the database labels follow:
|MAINTERM||The name of the substance as recognized by CFSAN|
| CAS RN
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 pbb|
|CEDI||Cumulative estimated daily intake determined by OFAS for the food contact substance in mg/kg bw/d.|
|ADI||Acceptable daily intake estimated by OFAS based on animal toxicology or human studies. The ADI is expressed as either a numerical value, (mg/kg bw/d), or as Not Determined (ND)**.|
|Toxicology Study Date||Date that the toxicology study that determined the acceptable daily intake was performed.|
|REGNUM||Regulation numbers in Title 21 of the U.S. Code of Federal Regulations where the substance appears.|
Additional information regarding zip files can be found at CFSAN's help page.
For further information about the food contact substance notification program, please contact the Office of Food Additive Safety.
*The downloadable database is a Microsoft Access 2003 file suitable for use in Windows systems. It is compressed (zipped) into a self-extracting executable (.exe) format (compressed with WinZip Self-Extractor 2.2). This file will decompress into a database (.mdb) file. Please see our CEDI/ADI help page for more information.**Not Determined (ND) signifies a number of situations where a numerical ADI has not been determined. For example, if exposure of the substance is less than 50 ppb and of no concern at this time, a numerical ADI would not be calculated.