Clariant Gains FDA Clearance for Bio-Based Licocare RBW Additives in Rigid PVC Food-Contact Uses

Clariant has achieved an important regulatory milestone after receiving approval from the U.S. Food and Drug Administration (FDA) for the use of its bio-based Licocare™ RBW wax additives in rigid polyvinyl chloride (PVC) food-contact applications. The authorization, which became effective on May 7, 2026, broadens the scope of the company’s previous FDA approval that was limited to polyester-based materials, allowing the additives to be used in rigid PVC products intended for food-contact environments.

The FDA authorization applies to Clariant’s entire Licocare RBW portfolio, including the RBW 100 series, RBW 300 series, and the specialty grades Licocare RBW 360 Vita and Licocare RBW 560 Vita. These additives have been approved for several functional roles in rigid PVC manufacturing, such as processing aids, lubricants, release agents, and slip additives. They can be incorporated into both single-use and reusable rigid PVC products designed for contact with a wide range of food types. The only exception is applications involving infant formula and human milk, which remain outside the scope of the approval.

Under the FDA authorization, Licocare RBW additives can be used in direct food-contact applications at concentrations of up to 0.5% by weight for conditions of use ranging from C through H. The approval also permits their use in hot-fill applications at temperatures up to 80°C. In addition, Clariant has secured a Letter of No Objection (LONO), which authorizes the use of these additives at concentrations of up to 1% in repeated-use rigid PVC food-contact articles, particularly those employed in food processing equipment.

This dual regulatory authorization significantly expands the potential application range of the additives. Manufacturers can now utilize them in rigid PVC packaging solutions, food containers, and a variety of food-processing components. Examples include conveyor belts, cutting boards, storage bins, seals, gaskets, and other equipment parts that regularly come into contact with food products. The availability of different approved concentration limits offers formulators greater flexibility in designing products that meet both performance and regulatory requirements.

The latest FDA approval complements Clariant’s growing portfolio of international regulatory clearances. Earlier in February 2026, the European Commission granted authorization for the Licocare RBW range following a favorable assessment by the European Food Safety Authority (EFSA). That approval covered applications in PET, PLA, and rigid PVC materials. The company has also obtained authorization from Japan’s food safety authorities, enabling global manufacturers to comply with food-contact regulations in major international markets.

According to Diederik Goyvaerts, Market Manager for Additives at Clariant, the FDA decision highlights the company’s dedication to developing sustainable solutions that satisfy stringent regulatory standards worldwide. He noted that the approval is the result of years of focused development efforts and creates new opportunities for manufacturers seeking renewable alternatives that maintain compliance with food-safety requirements across North America, Europe, and other regions.

Licocare RBW additives are produced from rice bran wax, making them a renewable substitute for traditional fossil-based montan waxes. The shift toward bio-based alternatives comes at a time when the supply of montan wax, sourced from lignite coal deposits in Germany, is becoming increasingly constrained due to the depletion of available reserves. These limitations have contributed to market shortages and rising costs for manufacturers dependent on conventional waxes.

Beyond their renewable origin, the rice bran wax additives deliver several technical advantages, including improved lubrication, effective mold-release performance, nucleation benefits, and enhanced material dispersion. The products are also biodegradable and industrially compostable, supporting sustainability objectives and improving end-of-life environmental outcomes for packaging and food-contact materials. Furthermore, their production avoids the ecological disturbances and biodiversity impacts associated with lignite mining.

With regulatory approvals now secured from the FDA, EFSA, and Japanese authorities, Clariant has established a strong global compliance framework for its Licocare RBW product family. These approvals provide manufacturers with confidence to adopt renewable, bio-based additives in food-contact applications while meeting regulatory and sustainability goals across key international markets.