European court backs 'high-risk' label for melamine despite industry challenge

BRUSSELS (CN) — A European court dismissed a challenge by chemical manufacturers to overturn the classification of melamine as a substance of “very high concern.” The Wednesday ruling upholds regulators’ authority to restrict chemicals based on environmental persistence and human health risks while creating potential new trade barriers for U.S. manufacturers.

The General Court of the European Union — the EU’s second-highest court — dismissed two separate challenges from chemical companies that sought to block the European Chemicals Agency’s classification of melamine as a “very high concern” substance. This classification places melamine on a candidate list for potential restrictions that would require regulatory approval before companies can manufacture, import or use the chemical.

“The General Court Fifth Chamber hereby dismisses the action,” Vice-President Savvas Papasavvas announced, also ordering the losing companies to pay legal costs incurred by the European Chemicals Agency.

Melamine is found in everyday American products including plastic dinnerware, countertop laminates, adhesives and food packaging. The chemical gained notoriety in the U.S. in 2007 when Chinese-made pet food contaminated with melamine caused kidney failure in thousands of cats and dogs, according to FDA investigations. International food safety standards now limit melamine to 1 mg/kg in powdered infant formula and 2.5 mg/kg in other foods and animal feed under United Nations guidelines.

Louisiana-based Cornerstone Chemical Co. was among the primary companies that challenged the classification in court proceedings, highlighting American industry concerns about EU regulations that often exceed U.S. standards. The company faced potential costs and disclosure requirements that could affect its European business operations.

The unsuccessful legal challenge brought together an international coalition including Fritz Egger GmbH & Co. OG, LAT Nitrogen Piesteritz GmbH, Poland’s Grupa Azoty, Netherlands-based OCI Nitrogen BV, Cornerstone Chemical and Spain’s Sonae Arauco SA.

The industry coalition argued that melamine serves as a safer alternative to formaldehyde and that environmental mobility shouldn’t trigger restrictions. Germany and the European Commission intervened as legal supporters of the chemical agency’s position in court.

The court found that melamine’s “very high persistence, high mobility in water, potential for transport over long distances and toxicity” justified the classification. Regulators were particularly concerned about the chemical’s ability to contaminate water supplies and resist removal through conventional treatment methods.

American manufacturers of melamine-containing products may need to reformulate items for European export or face disclosure requirements affecting marketing.

The European decision adds to growing EU chemical restrictions that exceed U.S. regulations, creating compliance challenges for American exporters. The ruling could eventually restrict imports of melamine-containing products into the EU, the world’s second-largest economy.

The melamine classification also illustrates broader regulatory divergence between the U.S. and EU on chemical safety. While American regulators typically require proof of harm before restricting chemicals, European authorities can act based on potential risks and environmental persistence.

The decision comes as U.S. companies already grapple with EU restrictions on other chemicals commonly used in American manufacturing. These include a broad PFAS “forever chemicals” restriction proposal under evaluation by the European Chemicals Agency that received over 5,600 public comments, and polybrominated diphenyl ethers, or PBDE, flame retardants banned by the EU in 2003-2008 but only phased out voluntarily by U.S. manufacturers through 2013.

The court emphasized that classification “has no immediate bearing on the use of melamine,” as it only adds disclosure obligations. However, inclusion on the candidate list typically represents the first step toward eventual authorization requirements.

Diverging regulations between major markets increase compliance costs and could push manufacturing toward regions with less stringent oversight.

For American consumers, immediate impact remains limited since melamine products remain legal in U.S. markets. However, some manufacturers may voluntarily reformulate products to maintain consistent global supply chains, potentially affecting product availability or pricing.

The ruling can be appealed to the European Court of Justice, the EU’s highest court.