A European court has backed a decision by Greek authorities not to approve a product designed to prevent Listeria in certain products.

The case involves Listex P100, a product from Dutch company Micreos, intended for use against Listeria monocytogenes in ready-to-eat food of animal origin. The court ruled that the EU Commission must approve such a product.

A Greek court requested a preliminary ruling in late 2022 in the case between Micreos Food Safety and the Hellenic Food Authority (EFET).

EFET refused to authorize Listex P100 for the Greek market, as the EU Commission has not approved. The phage-based product is a spray designed to prevent the presence of Listeria monocytogenes in ready-to-eat (RTE) food of animal origin, such as fish, dairy, and meat products.

Long-running case
Following informal contact since 2007, Micreos Food Safety applied to the EU Commission in 2015 to have Listex P100 approved as a decontaminant for RTE food of animal origin.

A draft regulation authorizing use was prepared but never approved. Because of a lack of support from the Standing Committee on Plants, Animals, Food and Feed, the EU Commission formally informed Micreos in February 2018 that it did not intend to pursue the approval process. In the same month, Micreos said Listex was not a decontaminant but was a processing aid under EU regulation. In April, the EU Commission restated its position of not continuing the approval process. 

A complaint by Micreos to the European Ombudsman was rejected in March 2019. In August, Micreos went to the General Court of the European unio, but an application for interim measures was dismissed.

In April 2020, Micreos applied for approval to place Listex P100 on the Greek market as a processing aid for RTE food of animal origin. EFET dismissed the application in June 2020 because of the absence of a clear legal framework regarding processing aids and reservations noted in a 2016 EFSA scientific opinion on the classification and safe use of Listex P100. In September, Micreos brought an action to annul this decision at the referring court.

Listex has been confirmed as GRAS (generally considered safe) by the FDA and USDA. It can be used as a processing aid in several foods in the U.S., Canada, and Australia.

EU Commission approval required
Micreos said Listex is for use outside slaughterhouses in the final stages of the production process, after the thermal processing of food, once it has been decontaminated and is ready for cutting and packaging. The product is not intended to remove contamination but to prevent it if Listeria monocytogenes exceeds the permitted thresholds.

The referring court believed Micreos Food Safety’s action must be dismissed but asked the EU Court of Justice to help interpret EU regulations.

In the EU, food businesses cannot use any substance other than water to remove surface contamination from products of animal origin unless the EU Commission has approved it.

The EU court said the regulation must be interpreted as requiring the EU Commission to approve the use of a product, such as Listex P100, intended to prevent Listeria monocytogenes in RTE food of animal origin.