Chapter V of Regulation (EU) 2015/2283 on novel foods, establishes a framework for data protection.[1]
Data protection can be requested by the applicant if it is supported by appropriate and verifiable information and 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 their 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 the five-year period, other food business operators can 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 annex of the Union List. [2]
In the table below the ingredients for which the data protection period expired past year and will expire this year.
[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%3A02017R2470-20241107
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