Chapter V of Regulation (EU) 2015/2283 on novel foods establishes a framework for data protection. For several ingredients, this data protection ended or will end soon. [1]
The applicant can request data protection if supported by appropriate and verifiable information, and it can be granted for a period of 5 years from the date a novel food is authorized. During this time, the proprietary scientific evidence submitted by the initial applicant cannot be used for subsequent applications without the applicant’s consent.
For the data protection to be granted, specific conditions must be met:
- the scientific evidence or data must be designated as proprietary at the time of the initial application;
- the initial applicant must have had exclusive rights to this data when the application was submitted; and
- the novel food could not have been assessed and authorized without this proprietary data.
Data protection is not possible for notifications and applications for traditional foods from third countries.
After five years, other food business operators may market the novel food ingredient in the specified food categories according to the conditions of use and label requirements, if it complies fully and precisely with the specifications of Table 2 in the annex of the Union List. [2]
In the table below, ingredients for which the data protection period expired, or will expire this year or in 2027.
| Novel food ingredient | End data protection |
| 6’-Sialyllactose (6’-SL) sodium salt (microbial source) | 17 February 2026 |
| 3′-Sialyllactose (3′-SL) sodium salt (microbial source) | 18 February 2026 |
| Schizochytrium sp. (WZU477) oil | 16 May 2026 |
| Dried Tenebrio molitor larva (yellow mealworm) | 22 June 2026 |
| Frozen, dried and powder forms of Locusta migratoria (migratory locust) | 5 December 2026 |
| Synsepalum dulcificum dried fruits | 5 December 2026 |
| 3-Fucosyllactose (3-FL) (microbial source) | 12 December 2026 |
| Calcium fructoborate | 23 December 2026 |
| Akkermansia muciniphila (pasteurised) | 1 March 2027 |
| Frozen, dried and powder forms of yellow mealworm (Tenebrio molitor larva) | 1 March 2027 |
| Cetylated fatty acids | 3 March 2027 |
| Frozen, dried and powder forms of Acheta domesticus (house cricket) | 3 March 2027 |
| Mung bean (Vigna radiata) protein | 15 May 2027 |
| Tetrahydrocurcuminoids | 11 July 2027 |
| Jatropha curcas L. (edible variety) kernels | 12 July 2027 |
| Iron hydroxide adipate tartrate | 28 August 2027 |
[1] Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, see https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02015R2283-20210327
[2] Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods, see https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R2470-20260810