Food Chemical Codex (FCC), an internationally respected food safety organization, recently completed a comprehensive, multi-year review of the monograph for Caramel Color. Needed revisions were made to the monograph including updating analytical testing protocols and instrumentation. FCC also addressed the desire of many organizations to review the maximum level of 4-MethylImidazole (4-MeI) in Caramel Color in the wake of concerns raised by the inclusion of 4-MeI on the State of California’s Proposition 65 list of chemicals.

Effective December 1, 2018 FCC has established a new maximum limit of detectable 4-MeI in Caramel Color of 125 ppm on a color intensity basis. This new limit applies to the Caramel Color itself, not to the finished products the Caramel Color is used in. Both the International and European Technical Caramel Associations were actively involved with FCC in helping to identify the new level.

Sethness Products can no longer manufacture and sell those Caramel Colors that exceed these limits in countries, including the USA, that follow FCC guidelines.

“Sethness had anticipated the possibility of a downward revision of the 4-MeI maximum in the FCC monograph level. A review of the Sethness library of over 80 commercially available Caramel Colors determined that 12 of them would not be able to meet this new maximum limit,” the company said in a statement. “We worked for the last two years to develop replacement Caramel Colors for the ones that must be discontinued. The goal was to have replacement Caramel Colors that were virtually identical to, with the exception of the lower 4-MeI value, the Caramel Colors being discontinued. We have been very successful in achieving that goal and these Caramel Colors are readily available.

“We apologize for the inconvenience that these industry-mandated regulatory changes may have caused you. We feel, however, that we have proactively taken all the necessary steps to keep you and your products ahead of the changes in regulatory mandates.”