Smoke flavorings succumb to EU grilling

A food ingredients supplier challenged how regulators assessed its products, but judges found the studies provided did not resolve concerns about DNA damage.(CN) — A smoky taste is no substitute for proof of safety, an EU court ruled Wednesday, rejecting a bid to greenlight three smoke flavorings.The General Court of the European Union dismissed Wisconsin- and U.K.-based food ingredients supplier Kerry’s challenge to European Commission decisions refusing to renew the products’ approvals and removing them from the EU’s authorized list.Smoke flavorings deliver taste without the smoker. Made from processed wood smoke, they give foods such as cheese, chips and sauces a smoky flavor, including foods that would never traditionally be smoked.But keeping those products on the market meant showing they were safe, the court held. The responsibility rested with Kerry; regulators did not have to prove that consumers had already been harmed.The European Food Safety Authority had identified two ingredients shown in oral-exposure tests to damage DNA, the genetic material inside cells. It then estimated how much consumers could get from food. Those amounts exceeded a reference level for low health concerns, and the court found the authority had properly examined exposure as well as the ingredients’ potential to cause harm.Kerry argues examining ingredients separately misses what happens when they are mixed together, and that regulators overlooked tests of the finished products. The court found the authority had considered those studies but explained why they did not resolve its concerns.The court wrote: “It must be noted that the existence of a scientific debate on the best methodology to be applied is not a sufficient ground to make the methodology used by EFSA in its opinions implausible.” Kerry had not demonstrated sufficient scientific agreement that the authority’s approach should be abandoned.Bernd van der Meulen, director and food law specialist at the European Institute for Food Law, found the ruling convincing. He highlighted how deeply the court examined the science despite giving regulators considerable freedom on technical questions. He also welcomed its lack of reference to the precautionary principle — taking protective action when risks remain uncertain — because he considered the scientific findings and Kerry’s responsibility to prove safety sufficient.Years on the market did not guarantee another approval. EU permissions lasted 10 years, and renewal required safety evidence updated to reflect scientific advances. Kerry applied in June 2022 and supplied more data the following February.When the authority reassessed eight flavorings in 2023, it identified DNA damage concerns in six and lacked enough information to rule out concerns for the other two. The commission refused renewals in July 2024, giving businesses transition periods to adapt recipes and production.Natacha Cingotti, campaign strategy lead working on consumer protection at foodwatch international, said the organization had welcomed that precautionary approach. She wanted similar caution applied more often when approving flavorings and additives, arguing that too many substances raising health concerns are still allowed in food.Kerry also argues restrictions could push manufacturers back toward potentially riskier traditional smoking. The court found the companies had not demonstrated such a shift would happen. Even if it did, that would not justify approving flavorings whose safety had not been established. Transition periods addressed the economic consequences.Alie de Boer, associate professor in nutrition and food information at Maastricht University, saw a possible missed opportunity to compare the risks of alternatives, though she understood the legal reasoning. She stressed that considering a company’s evidence did not mean accepting its conclusions: The court’s acceptance of EFSA’s assumption that DNA-damaging substances have no safe exposure threshold made scientific uncertainty especially important, while its rejection of Kerry’s alternative method showed how difficult it is to challenge established science without a validated approach.Luca Knuth, an EU law researcher at Maastricht University and Kiel University, considered the approach defensible, based on public documents and a brief reading of the judgment. He stressed that regulators’ scientific freedom still required meaningful court scrutiny. He viewed the responsibility to prove safety as reflecting precaution: Approval could be refused when a company failed to answer credible safety concerns. Choices about handling uncertainty still needed clear, scientifically sound explanations, he said.The commission defended its position, saying the judgment confirmed the basis for its July 2024 refusal to renew approvals for eight smoke flavorings, including Kerry’s three — SmokEz C-10, SmokEz Enviro-23 and Zesti Smoke Code 10.Kerry expressed disappointment but stood by the science behind its products. It maintained that extensive data supported their safe use and would review the judgment alongside its concerns about how the flavorings had been assessed.For customers, however, the company’s message was to keep preparing for their removal: Existing requirements remained unchanged. “Our focus is on supporting customers through this transition,” Kerry said, reaffirming its commitment to food safety and continued cooperation with regulators.The court ordered Kerry to pay its own costs and the commission’s. The company can appeal to the Court of Justice within two months and 10 days of notification, but only on legal grounds. The refusals remain in place, with transition arrangements allowing Kerry’s three primary flavoring products to be placed on the market until July 1, 2029.Courthouse News reporter Eunseo Hong is based in the Netherlands.Subscribe to our free newslettersOur weekly newsletter Closing Arguments offers the latest about ongoing trials, major litigation and rulings in courthouses around the U.S. and the world, while the monthly Under the Lights dishes the legal dirt from Hollywood, sports, Big Tech and the arts.Additional Reads