Melamine case could trigger wave of environmental or health claims

Below, we look at two related cases that came before the EU’s General Court, what the court ruled, and the potential widespread impact the rulings could have if they are not overturned.

Background

Melamine is a chemical substance found in many products, such as toys and vehicles, as well as construction materials, kitchen countertops and furniture.

In late 2022, following a request by Germany, the European Chemicals Agency (ECHA) added melamine to a list of substances that cannot be used in the EU without specific authorisation or exemption. The ECHA determined (5-page / 117KB PDF) that melamine was of equivalent level of concern to other ‘very high concern’ substances already on the list and that it has probable serious effects on human health and the environment.

Some companies that use melamine challenged the ECHA’s decision. Some of the companies are based in the EU, including in Germany, Poland, Spain, and the Netherlands, but others are based outside the EU, in the US and Trinidad and Tobago respectively. The companies raised legal proceedings before the EU’s General Court, seeking annulment of the ECHA’s decision. The companies argued the ECHA was responsible for “manifest errors of assessment” in how melamine had been categorised and in relation to its claimed effects on health and the environment.

Earlier this month, on 9 July, the General Court dismissed their applications in two judgments issued.

The role of the General Court and its rulings

EU case law is clear that EU judges cannot substitute their own assessment of scientific and technical facts for that of the EU authorities entrusted to make such assessments under the Treaty on the Functioning of the EU – in this case, the ECHA.

The General Court acknowledged the case law and said that it meant it could only consider the evidence the ECHA assessed and determine whether it was factually accurate, reliable and consistent; whether that evidence contains all the information which must be taken into account in order to assess a complex situation; and whether it is capable of substantiating the conclusions the ECHA drew from it.

The court highlighted how the ECHA had concluded that the intrinsic properties of melamine that justified its categorisation on the list of substances of ‘very high concern’ were its “very high persistence, high mobility in water, potential for transport over long distances and toxicity”. It further accepted the ECHA’s conclusions about the serious effects of that on human health and the environment.

In relation to health effects, the General Court said: “It must be held that ECHA did not make a manifest error of assessment in finding that there were probable serious effects on human health on account of the urinary tract toxicity and carcinogenicity of melamine. However, it has not established to the requisite legal standard the existence of probable serious effects on human health on account of the reproductive toxicity of melamine.”

“The applicants’ arguments must therefore be rejected and it must be held that it is established that the intrinsic properties of melamine indicate that it is capable of being toxic to the urinary tract and carcinogenic,” the court said, adding that melamine can also be a cause of kidney stones.

The effects of melamine on the environment were also acknowledged by the General Court on the strength of the evidence the ECHA had examined, which the ECHA had found showed a “moderate degree of toxicity to fish”. It reflected on underlying studies that the ECHA cited to rely on its conclusions that the environmental effects were serious.

“ECHA states that, although the studies do not reveal any effects on fish mortality, sub-lethal effects were observed,” the court said. “Similarly, in long-term studies, sub-lethal effects were observed in the kidneys, liver and gills. ECHA concluded generally, taking into account all the identified effects on the environment, that such effects, as well as yet unknown effects, could occur in the environment and lead to irreversible effects on the population, due to long-term exposure, taking into account continuous exposure via water and potentially increasing concentrations.”

The implications of the ruling

The General Court’s rulings are not the end of the matter. It is just the first-instance court and its judgments are subject to appeal to the on appeal to the EU’s highest court, the Court of Justice of the EU (CJEU). However, if the rulings stand, the decisions will need to be respected by companies that use melamine in their products or supply products containing melamine – not only companies based in the EU, but by non-EU companies importing into the EU market too.

As such, the judgments reflect a continuation of a trend we have been seeing of EU law and standards being imposed and exported in the international legal order.

The judgments of July 9, 2025, illustrate the new extraterritoriality of EU law, a characteristic that was previously the exclusive domain of US law.

For businesses and investors that wish to import goods and sell their products and services – including major online e-commerce platforms active in the European market – the ruling has significant commercial and legal implications due to the ubiquitous presence of melamine in a wide range of everyday products and the ease with which it can be released into the environment through industrial use – even when unintended.

If these judgments are upheld by the CJEU, it is likely that manufacturers of products containing melamine and businesses that import, distribute or sell those products, will face environmental- or health-based claims in litigation – including potential class-action style lawsuits – in European markets and, potentially, elsewhere around the world.