On November 2, 2023 the U.S. Food & Drug Administration (FDA) proposed to revoke the regulation authorising the use of brominated vegetable oil (BVO) in food. The FDA conducted studies that clearly show adverse health effects in animals in levels more closely approximating real-world exposure. Therefore, the FDA can no longer conclude that this use of BVO in food is safe.

The studies were conducted in collaboration with the National Institute of Environmental Health Sciences’(NIEHS) Division of Translational Toxicology (formerly the Division of the National Toxicology Program), to assess unresolved toxicological questions. Results from these studies demonstrate bioaccumulation of bromine and toxic effects on the thyroid – a gland that produces hormones that play a key role in regulating blood pressure, body temperature, heart rate, metabolism and the reaction of the body to other hormones.

BVO is a vegetable oil that is modified with bromine. As authorised, it is used in small amounts, not to exceed 15 parts per million, as a stabiliser for fruit flavouring in beverages to keep the citrus flavouring from floating to the top. When used, BVO is required to be listed as an ingredient on the label as “brominated vegetable oil” or as the specific oil that has been brominated, such as “brominated soybean oil”.

Over time, many beverage makers have reformulated their products to replace BVO with an alternative ingredient. Today, few beverages in the US contain BVO.

Krones is pleased to announce it has successfully completed the process of validating its Contipure AseptBloc DN system, and gained its approval from the US Food and Drug Administration (FDA).

The Contipure AseptBloc DN is part of the standard aseptic equipment portfolio from Krones, and consists in a bloc configuration system with both aseptic filling and blowmolding of PET containers. Decontamination of primary packaging materials, consisting in preforms and closures, is performed with gaseous hydrogen peroxide (H2O2).

The system, already 3-A Certified, is now FDA approved for the filling of sterile low acid foods that can be stored and distributed at ambient temperature conditions. To gain the approval, the necessary validation activities were performed on the equipment by Krones, a third party process authority, and Krones’ major food and beverage partner and customer in the Midwest. All the required validation documentation, including multiple primary packaging material sizes and closures, was then satisfactorily received from the FDA.

Contipure AseptBloc DN is automatically cleaned and sterilized in less than two-and-a-half hours, providing its users the most line availability in the aseptic technology market. The system can also run continuous production without need of cleaning and sterilization cycles for over a week. All the sterile surfaces of the equipment are also sterilized with gaseous hydrogen peroxide, eliminating the need of hazardous chemicals and massive water consumption.

The state-of-the-art system from Krones also includes additional benefits such zero product waste at beginning of the production cycle, precise equipment high speed motion guaranteed by the integration of servo drives, and the best-in-class blowmoulding and filling expertise from Krones.