EU General Court: Kerry Smoke Flavorings Ban Upheld Over DNA Damage

• The General Court of the European Union dismissed a challenge by Kerry, a food ingredients supplier, regarding the non-renewal of three smoke flavorings.
• The court found that Kerry's studies did not adequately address concerns about potential DNA damage identified by the European Food Safety Authority.
• The European Food Safety Authority's assessment, which identified DNA damage in two ingredients and found exposure levels exceeded health concern thresholds, was upheld by the court.
• The responsibility for proving the safety of food additives rests with the supplier, not with regulators to prove harm.
• EU food additive approvals last 10 years, requiring updated safety evidence for renewal, and the European Commission provided transition periods for affected businesses.

The General Court explicitly stated that the mere existence of a scientific debate regarding the optimal methodology does not render EFSA's chosen approach implausible, concluding that Kerry had not presented sufficient scientific consensus to warrant abandoning EFSA's established methodology.

The General Court of the European Union recently upheld decisions by the European Commission to deny the renewal of approval for three specific smoke flavorings, effectively removing them from the EU's authorized list. This ruling came in response to a challenge brought by Kerry, a food ingredients supplier based in Wisconsin and the U.K., which sought to maintain the market presence of these products. The court's decision, issued on a Wednesday, underscored that the scientific evidence provided by Kerry was insufficient to alleviate regulatory concerns regarding potential DNA damage associated with the flavorings.

Smoke flavorings are widely utilized in the food industry to impart a smoky taste to various products, such as cheeses, chips, and sauces, without requiring traditional smoking processes. These flavorings are derived from processed wood smoke. However, the court emphasized that continued market authorization for such products hinges entirely on demonstrating their safety. The onus of proving safety rests squarely with the supplier, Kerry, and regulators are not required to demonstrate actual consumer harm to justify their decisions.

Central to the General Court's decision was the assessment conducted by the European Food Safety Authority (EFSA). EFSA had previously identified two specific ingredients within the flavorings that, through oral-exposure tests, demonstrated the capacity to damage DNA, which is the genetic material found within cells. Following this, EFSA calculated the potential exposure levels for consumers through food consumption, determining that these amounts surpassed a reference threshold established for low health concerns. The court affirmed that EFSA had appropriately evaluated both the potential for harm and the levels of consumer exposure.

Kerry contended that assessing individual ingredients in isolation failed to account for their interactions when combined in finished products, suggesting that regulators had overlooked studies on these final formulations. However, the court found that EFSA had indeed considered these studies but provided clear justifications for why they did not alleviate the existing safety concerns. The General Court explicitly stated that the mere existence of a scientific debate regarding the optimal methodology does not render EFSA's chosen approach implausible, concluding that Kerry had not presented sufficient scientific consensus to warrant abandoning EFSA's established methodology. This ruling reinforces the European Commission's discretion in assessing scientific methodologies under EU food safety regulations.

The case highlights the stringent nature of EU food safety regulations, particularly concerning food additives like smoke flavorings. EU permissions for such products are granted for a period of ten years, with renewal contingent upon updated safety evidence that incorporates scientific advancements. Kerry's renewal application, submitted in June 2022 with additional data in February 2023, led to EFSA's reassessment of eight flavorings in 2023. This review revealed DNA damage concerns in six of these flavorings, and insufficient data to rule out concerns for the remaining two. Consequently, the European Commission refused renewals in July 2024, though it did provide transition periods for businesses to adjust their recipes and production processes.

Industry experts and consumer advocates have weighed in on the ruling. Bernd van der Meulen, a director and food law specialist, praised the court's thorough scientific examination while acknowledging the considerable freedom granted to regulators on technical matters. He also noted the absence of reference to the precautionary principle, deeming the scientific findings and Kerry's responsibility sufficient. Conversely, Natacha Cingotti of foodwatch international welcomed the precautionary stance, advocating for its more frequent application to other flavorings and additives, citing concerns that numerous substances with health risks remain authorized. Kerry's argument that restrictions might push manufacturers back to potentially riskier traditional smoking methods was also dismissed by the court, which found no demonstration of such a shift and maintained that potential market changes would not justify approving flavorings with unestablished safety.

Food and beverage companies operating in the EU must ensure their product safety data is robust and addresses all regulatory concerns, as the General Court upholds the European Commission's discretion in assessing scientific methodologies and prioritizing potential health risks like DNA damage. Compliance officers should proactively review product portfolios for ingredients with expiring EU approvals, especially those with genotoxicity concerns, to avoid market withdrawal.

Source: Original reporting via Courthouse News