GP/EFSA/NUTRI/2017/01 – Tasking Grants - Entrusting preparatory work for the safety assessment on Novel Foods and Traditional Foods from third countries
Novel foods (NF) are foods and food ingredients that have not been used for human consumption to a significant degree in the EU before 15 May 1997. Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods11, repealing Regulation (EC) No 258/97, introduces a centralised assessment and authorisation procedure, as of January 2018. All applications for the authorisation of novel foods (pursuant to Article 10) shall be submitted to the European Commission (EC) who may then request a safety assessment by EFSA. Regulation (EU) 2015/2283 also introduces a special procedure for safety assessment for traditional foods from third countries (TF), based on a history of safe food use. In this case, a notification for the placing on the market of a traditional food from a third country (pursuant to Article 14) is sent to the EC who forwards it to all the Member States (MSs) and EFSA. Within four months from receipt of a valid notification, a MS or EFSA may submit duly reasoned safety objections on the placing on the market of the notified TF. In this latter case, the applicant may transform the notification into an application (pursuant to Article 16), for which a safety assessment will be requested from EFSA.
- Data requirements for NF applications pursuant to Article 10 are outlined in EFSA Guidance on the preparation and presentation of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283 (EFSA-Q-2014-00216)12,
- Data requirements for TF notifications (pursuant to Article 14) and applications (pursuant to Article 16) are outlined in EFSA Guidance on the preparation and presentation of the notification and application for authorisation of traditional foods from third countries in the context of Regulation (EU) 2015/2283 (EFSA-Q-2015- 00108)13
As laid down in Regulation (EU) 2015/2283, EFSA shall adopt its opinion within 9 months from the date of receipt of a valid NF application pursuant to Article 10, and within 6 months from the date of receipt of a valid TF application pursuant to Article 16. The final output provided by EFSA on the safety of the concerned NF serves as the scientific basis for EU Decisions on authorisation of the NF on the EU market.
MAIN OBJECTIVE The aim of this call is to conclude Framework Partnership Agreements (FPA’s) in cascade in order to identifying organisations to which preparatory work for the safety assessment of Novel Foods and Traditional Foods from third countries can be entrusted by EFSA.
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