Regulation

  —  Column 

A textbook case
for an infringement procedure:
the Italian ban on cell meat?

KEYWORDS 

Lab-grown meat

Novel food regulation

Infringement procedure

European Commission

USDA/FDA

Alternative protein

About the Author

Katia Merten-Lentz

Katia Merten-Lentz, partner resident and founder/manager of the law firm “Food Law Science & Partners”, has been for more than 25 years, a leading practitioner in European food and feed law. Her practice also extends to Biotechnologies, Environmental Law and Cosmetics Law.

She is one of the few lawyers assisting clients from A to Z in the food and feed area obtaining European authorization for new additives, enzymes, novel foods and accompanying them with issues ranging from marketing to innovation.

Partner & Founder – Food Law Science & Partners

With industrial advancements in cultivated meat (or lab-grown/cell meat) spreading all over the world, arises in many countries concerns about its arrival on the market. Related legislative framework is, thus, subject to lots of discussions and debates, due to its particular nature.


For instance, Italy (1), in opposition to the current EU Regulation, recently adopted a law drastically banning the production and marketing of lab-grown meat on its territory (2). Particularly, it prohibits food and feed business operators “from using in the preparation of food, beverages and feed, selling, holding for sale, importing, producing for export, administering or distributing for food consumption or promoting for those purposes food or feed consisting of, isolated from or produced from cell cultures or tissues derived from vertebrate animals”. Penalties are set between 10.000 € and 60.000 €.


Not only the adoption of this law infringes on the principle of the harmonised procedure of Regulation on Novel Foods, under which cultivated meat is regulated, but its adoption did not respect the European procedure preventing technical barriers to trade (TRIS procedure). Under these circumstances, Italy is exposed to an infringement procedure, both based on procedural aspect and more consistent items of the law.

Infringement regarding the TRIS procedure

On July 20 last year, the Italian Senate presented a law proposition, on “Provisions relating to the production and placing on the market of foodstuffs and animal feedstuffs”.

A week later, the law “Provisions relating to the prohibition on the production and marketing of food and feed consisting of, isolated from or produced from cell cultures or tissues derived from vertebrate animals, as well as the prohibition on the designation of processed products containing vegetable proteins as meat”, was subject to a TRIS notification, in compliance with the procedures laid down in Directive (EU) 2015/1535 (3).

But the Italian Government, then, withdrew its notification, to officially await the conclusion of the Parliamentary process.

Against all odds, and without having processed another TRIS notification (which would not have been compliant with the procedure anyway), the amended law was adopted by the Italian Chamber of Deputies on the 16th of November 2023 (4).

More surprisingly, the law was promulgated on the 1st of December 2023 (5), and simultaneously, Italy made a new TRIS notification. The law entered into force in Italy on the 16th of December 2023 (6).

According to the TRIS procedure, the notification, which must be done before the adoption of the law, starts a three-month standstill period during which the Member State should not adopt the legislative act object to notification. At the end of this period, the Commission is supposed to deliver a detailed opinion (but with no obligation to the Member State to take these opinions into account).

However, in this case, the Commission did not even have the opportunity to express an opinion nor provide any comments, since the law was already adopted when notified. Despite the fact that the Italian government proceeded to a new notification along with the publication of the law, in total transgression of the procedure, we wondered whether the Commission did even assess the law. By closing the procedure for violation of the law, did the Commission implicitly answer?

However, the only procedural question which remains pending is whether the European Commission has already initiated the 1st non-formal/official step of a procedure for infringement, based on this violation. Indeed, the Commission could have already sent Italy a non-official opinion on the matter and asked its observation, but it could also be waiting for a more substantive violation of the Novel Food Regulation.

The infringement regarding the core of the law: lab-grown meat under the Novel Food Regulation 

Currently, lab-grown meat falls within the Novel Food Regulation (7) scope, as it is a food consisting of, isolated from or produced from cell culture or tissue culture derived from animals, that was not used for human consumption to a significant degree within the Union before 15 May 1997.

Under this Regulation, novel foods must follow a strict authorization procedure to obtain market authorization from the Commission, with the assessment of the European Food Safety (8).

The legislation and procedure being harmonized at the European level, not only the Italian Decree would undoubtedly alter the free movements of goods principle within the EU, but it is clearly – even anticipatively - a violation of the Novel Food Regulation.

However, no infringement can be fully and formally characterized before any official authorization of a lab-grown meat in the EU is adopted.

At this moment, the violation will practically be substantiated, and we could, then, expect the European Commission to initiate an infringement procedure as well.

Regardless any action from the European Commission, any food business operator could open the debate by filling a complaint which could be (subject to its admissibility) the 1st step of the pre-infringement process known as "EU Pilot" and then, lead to a full infringement procedure against the concerned Member State.

References and notes