21 Nov 2023

Regulatory Challenges and Opportunities


On 19 October 2023, the European Parliament (EP) adopted the European Protein Strategy resolution (EP, 2023), urging the European Commission (EC) to take swift action to boost protein production within the European Union (EU). The resolution highlights the EU's heavy reliance on imports of protein crops from third countries, making it vulnerable to disruptions as witnessed during events like the COVID-19 pandemic and Russia's invasion of Ukraine. To address this, the resolution calls for the development of a sustainable protein strategy for both animal- and plant-based proteins for both human consumption and animal feed within the EU. This strategy should be science-based and aligned with the principles of the circular economy, focusing on production within the EU. It also identifies viable alternative protein sources, such as insects, cell-based foods (cultivated meat), fungi and fermentation products, and algae.

Regulatory Obstacles

The resolution acknowledges the challenges in bringing cultured cells from animals and plants to the EU market, and points out that Regulation (EC) 2015/22831 is not fit for purpose for authorising these products in the EU. This is evidenced by the fact that no cultivated meat applications have so far been submitted. The strategy document calls on the EC to provide a scientific and technical guidance to enhance the existing novel food guidance for applicants. The European Food Safety Authority (EFSA) recently held a colloquium on cell-cultured meat, where they announced their ongoing efforts to update the novel food guidance to include cell culture–‍derived foods and precision fermentation (EFSA, 2023). When drafted, the updated guidance will be available for public consultation, with the final version expected in early 2024.

The path to market for cultivated meat in Europe has faced other challenges. For example, Romania has proposed legislation to ban the sale of "lab-grown synthetic meat," which has received approval from the Romanian Senate but awaits adoption by the Chamber of Deputies for full passage (DIGI 24, 2023). Italy also proposed a ban on laboratory-produced food and animal feed earlier this year, with support by the agriculture industry, although the Technical Regulation Information System (TRIS) notification was recently withdrawn (GFI, 2023).

Recent Developments

In 2023, efforts to bridge the gap between the Novel Foods Regulation and Regulation 1829/2003 on genetically modified food and feed in the EU (REF) have been underway, mirroring similar developments in the United Kingdom (UK).2 Specifically, the EC has proposed a regulation concerning plants obtained by new genomic techniques and their associated food and feed. This regulation would allow for more precise and targeted genome modifications compared to earlier techniques (EC, 2023). It covers "plants produced by targeted mutagenesis and cisgenesis (including intragenesis), products containing or consisting of these plants and food and feed containing, consisting or produced from these plants," following the conclusion by EFSA that targeted mutagenesis and cisgenesis have no associated hazards.  

Overall, the path to market for cell-cultured meats in the EU remains challenged by regulatory and scientific hurdles. Nonetheless, the European Protein Strategy resolution underscores the EP's commitment to developing strategies that support this crucial aspect of EU food sustainability.

How Can We Help?

Intertek boasts substantial regulatory expertise in facilitating the authorisation of regulated products globally. We have approximately 70 scientists dedicated to regulatory applications in various jurisdictions, including the EU. If you would like to speak to one of our experts, we will be attending Food Ingredients Europe. Please contact us here to arrange a meeting: food.assuris@intertek.com.

More information on our services can be found here: www.intertek.com/food/consulting.

1. Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001. Available online: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02015R2283-20210327.


Ellen Thornton Intertek headshot

Ellen Thornton,
Senior Associate – Toxicology & Regulatory Affairs, Intertek Assuris

Ellen Thornton is a chemist and regulatory toxicologist, involved in the assessment of data packages and the preparation and filing of regulated product applications, including novel foods, food enzymes and food additives in the EU, UK, and U.S. She also assists in regulatory assessments of food products and developing routes to market, and has established a program for notifying studies on behalf of applicants to meet the requirements of Regulation (EU) 2019/1381.3

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