Cumulative Estimated Daily Intake/
Acceptable Daily Intake Database

Accessible table (266KB)

Launch Database* (452KB)

Introduction

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.

Database Update(s)

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.

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 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:

1. The CEDI/ADI 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.
2. 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) to facilitate comparison to the applicable ADI value for the FCS.
3. 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).
4. The downloaded database can be searched by: CAS RN or OTHER CODE, MAINTERM, and REGNUM.

Full definitions of the database labels follow:

Label	Definition
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 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.

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*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.