Overview
The US Food and Drug Administration (FDA) recently updated the format of its Cumulative Estimated Daily Intake (CEDI) database for food contact substances (FCS), available at: https://cfsanappsexternal.fda.gov/scripts/fdcc/?set=CEDI, to explicitly include the date of the most recent calculation or update for each FCS.
The CEDI database is a valuable source of information for companies interested in evaluating and potentially expanding uses for substances listed in the agency's food additive regulations and by way of Food Contact Notifications (FCNs) – among other mechanisms for premarket approval – in that it provides companies with FDA’s estimate of the amount of the FCS that may be present in the diet from all regulated sources in food contact applications.
The CEDI database lists the following information:
- Chemical Abstracts Service Registry Number (CASRN)
- Chemical name
- Cumulative Estimated Daily Intakes (CEDI)
- Cumulative dietary concentration (CDC)
- Relevant authorization in the food additive regulations (if applicable)
- The date that FDA most recently updated the CEDI and CDC values
The CEDI and CDC values are related to one another, in that the CDC – often expressed in units of parts per billion (ppb) – represents the amount of FCS expected to be present in the diet resulting from its use in food contact applications, whereas the EDI is this same value expressed relative to FDA's default assumptions regarding the body weight (60 kg) and amount of food (3,000 g) consumed by an adult on a daily basis.1For example, a CDC of 50 ppb is equivalent to a CEDI of 2.5 µg/kg bw/d, as follows:
Adult Foods (FCS)
CDC = 50 ppb = 50 µg/kg
EDI = 50 µg/kg × 3 kg/p/d = 150 µg/p/d
EDI = 150 µg/p/d ÷ 60 kg/p = 2.5 µg/kg bw/d
These values, in turn, are used by companies to identify the amount of toxicology and safety information that may be necessary to support such cumulative exposure and presence in the diet, when accounting for other regulated uses, based on the four tiers established in the Agency's Guidance for Industry: Preparation of Food Contact Substance Notifications (Toxicology Recommendations) document, available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-preparation-food-contact-substance-notifications-toxicology-recommendations.
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The recent revision to FDA's CEDI Database provides companies with greater transparency regarding the Agency's current understanding of exposure resulting from regulated uses of the substance in food contact applications – and importantly – the currency of the information, so that they may make informed decisions regarding the scope and extent of data necessary to support the safety of new and innovative uses of food contact substances.
1 For infant foods, FDA assumes that an infant weighs 6.3 kg and consumes 900 g (0.9 kg) food per day. However, the use of CDC and CEDI values are not directly analogous, because the agency assumes that 100% of the diet may be held in single type of packaging material during the first few months of life. Therefore, the CDC and EDI are assumed to be equivalent the actual exposure from any given source of food contact.
