Caramel color leaders stress FCC compliance as new maximum limit on detectable 4-MeI enters force in California

Caramel color leaders stress FCC compliance as new maximum limit on detectable 4-MeI enters force in California

06 Dec 2018 --- Major caramel colors suppliers Sethness and DDW The Color House (DDW) have stressed their compliance with Food Chemical Codex (FCC) revised limits in light of the implementation of California’s Proposition 65 (Prop 65) list of chemicals.

Effective from December 1, 2018, FCC has established a new maximum limit of detectable 4-MeI in caramel color of 125ppm 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.

The FCC, an international food safety organization, recently completed a comprehensive, multi-year review of the monograph for Sethness Caramel Colors. FCC has 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 (Prop 65) list of chemicals. Fellow supplier, DDW, confirmed that “all of DDW’s caramel colors already meet the revised FCC limits.” 

August 30, 2018, marked the start of the full effect of Proposition 65 (Prop 65) in the State of California which requires companies to call out specific names of potentially harmful chemicals that have been included on the list and add a warning symbol on the product if they exceed acceptable levels. Also known as the Safe Drinking Water and Toxic Enforcement Act, the full effect of Prop 65 has been a long time coming and  August 30, 2018, marked the beginning of the regulation that was initially adopted in the US in August 2016.

Prop 65 requires the State of California to maintain and update a list of chemicals known to the state to cause cancer or reproductive toxicity and has large-scale implications for products that need to carry a warning and warning symbol (an exclamation mark against a yellow background).

Founded in the US in 1880, Sethness is a producer of high-quality caramel color for the food & beverage sectors, thanks to four manufacturing facilities located in the US, France, India and China. It provides a large selection of caramel colors (in liquid and powdered forms) as well as a variety of clean label caramel color options, which are non-GMO, certified organic, gluten-free and allergen-free.

Required revisions to the monograph include updated analytical testing protocols and instrumentation, according to the FCC.

With over 150 years of innovation in the development and supply of caramel coloring, DDW says they “take food safety and product quality very seriously.”

In light of the recent FCC compliance, Global Quality Manager at DDW, Sibusiso Ngubeni, sent the following statement to FoodIngredientsFirst: “DDW has always complied with FCC standards. During the latest monograph review of caramel color, our industry supplied purity data and analytical methods to the FCC to consider new limits. All of DDW’s caramel colors already meet the revised FCC limits.”

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 US, that follow FCC guidelines, the company notes.

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 more than 80 commercially available caramel colors determined that 12 of them would not be able to meet this new maximum limit.  

For the past two years, the company has developed 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, says the company. Sethness has been successful in achieving that goal and these caramel colors are readily available, according to reports. 

In September, Roquette completed the acquisition of Sethness, further leveraging both companies' global capabilities in caramel colors. Before the acquisition, Sethness and Roquette already had a strong partnership and operated two successful joint-ventures in France (Merville) and China (Lianyungang).

To contact our editorial team please email us at