Clariant has secured a significant regulatory milestone in the United States after receiving approval from the US FDA for its bio-based Licocare RBW wax additives in rigid polyvinyl chloride (PVC) food-contact applications.
The authorization expands Clariant’s existing FDA clearance beyond polyester materials and opens the door for the company’s renewable additives to be used in a wide range of rigid PVC food-contact products.
The approval covers the entire Licocare RBW portfolio, including the RBW 100 series, RBW 300 series, and the grades Licocare RBW 360 Vita and RBW 560 Vita.
The additives can now be used as processing aids, lubricants, release agents and slip additives in both single-use and repeat-use rigid PVC applications involving all food types, except infant formula and human milk contact.
Under the FDA authorization, the additives may be used at concentrations of up to 0.5% by weight in direct food-contact applications under conditions of use C through H, including hot-fill applications up to 80°C.
Clariant has also obtained an Opinion Letter of No Objection (LONO), allowing repeated-use food-contact articles made from rigid PVC to contain up to 1% of the additives in food processing equipment.
The dual authorization significantly broadens the potential use of Licocare RBW additives across rigid PVC containers, packaging materials and food-processing components such as conveyor belts, cutting boards, storage containers, seals and gaskets.
Manufacturers can tailor additive concentrations to specific performance requirements while remaining within regulatory limits.
The FDA decision strengthens Clariant’s growing international regulatory position for the Licocare RBW range. Earlier this year, the European Commission published authorization based on a positive opinion from the European Food Safety Authority (EFSA), permitting use of the additives in PET, PLA and rigid PVC materials.
The company has also secured approval from Japan’s food safety authority, creating a regulatory framework that spans three major global markets.
"Achieving FDA approval for our Licocare RBW additives in rigid PVC applications demonstrates Clariant's commitment to delivering sustainable solutions that meet the highest regulatory standards across multiple jurisdictions," said Diederik Goyvaerts, Market Manager, Additives at Clariant.
"This authorization represents years of dedicated work and opens significant opportunities for manufacturers to transition to renewable alternatives while maintaining full compliance with food safety regulations in both North American and European markets."
The approval comes as manufacturers increasingly seek alternatives to traditional fossil-based additives. Derived from rice bran wax, Licocare RBW products offer a renewable solution with a substantially lower carbon footprint than conventional montan waxes, which are sourced from lignite coal deposits in Germany.
Supply challenges in the montan wax market have intensified as lignite resources continue to decline, creating availability constraints and upward pressure on prices. Clariant’s bio-based alternative is positioned to address both sustainability and supply-security concerns for converters and packaging producers.
Beyond regulatory compliance, the additives deliver a range of processing benefits, including improved lubrication, mold release, nucleation effects and enhanced dispersion.
The products are also biodegradable and industrially compostable, supporting growing demand for more sustainable packaging materials and reduced environmental impact throughout the product lifecycle.
With FDA, European and Japanese approvals now in place, Clariant has established one of the most comprehensive regulatory platforms for bio-based wax additives in food-contact applications, providing manufacturers with a clear pathway to adopt renewable alternatives across key global markets.
