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END OF DATA PROTECTION OF NOVEL FOODS

In the EU, novel foods can benefit from data protection under Regulation (EU) 2015/2283 [1], which provides a form of intellectual property protection for the scientific data submitted during the authorization process.

Companies that invest in generating safety and scientific data for a novel food authorization can receive up to 5 years of data protection. During this period, other companies cannot reference or rely on that proprietary data when applying to market the same or a similar novel food.

Protection applies specifically to newly developed scientific evidence and proprietary data that was required for the authorization. It does not prevent others from generating their own independent data or marketing the same food if they can demonstrate safety through other means.

This incentivizes innovation by allowing companies to recoup their investment in safety studies, toxicological assessments, and other research required for novel food approval—studies that can cost several hundreds of thousands of euros.

Once the protection period ends, subsequent applicants can reference the protected data when seeking authorization for similar products, reducing barriers to market entry.

This is distinct from patent protection and operates alongside other IP mechanisms. It is particularly valuable for novel foods where innovation lies more in demonstrating safety and nutritional properties than in a patentable invention.

Below is an overview of the ingredients for which the data protection period ended or will end in 2025, and those for which it will end in 2026; listed in annex of the Commission Implementing Regulation (EU) 2017/2470.


2025

  • Nicotinamide riboside chloride: 20 February 2025;
  • Lacto-N-tetraose (‘LNT’) (microbial source): 23 April 2025;
  • Vitamin D2 mushroom powder: 27 August 2025;
  • Dried Euglena gracilis: 23 December 2025; and
  • Extract from Panax notoginseng and Astragalus membranaceus: 23 December 2025.

2026

  • Schizochytrium sp. (WZU477) oil: 16 May 2026;
  • Frozen, dried and powder forms of Locusta migratoria: 5 December 2026;
  • 3-Fucosyllactose (3-FL) (microbial source): 12 December 2026;
  • Vitamin D2 mushroom powder (*): 19 December 2026; and
  • Calcium fructoborate: 23 December 2026.

[1] Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods

[2] Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods

(*) different doses and categories

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