FOODDRINKEUROPE COMMENTS ON THE ADMINISTRATIVE AND SCIENTIFIC REQUIREMENTS CONCERNING TRADITIONAL FOODS FROM THIRD COUNTRIES
FoodDrinkEurope would like to thank the Commission for the opportunity to comment on this Draft Commission Implementing Regulation.
There is no reference in the document to the 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. We think that this reference should be made to facilitate the reading and ensure consistency between the EFSA Guidance document and the draft act.
The intention of the notification procedure for traditional foods from a third country is to enable its authorisation in the EU based on its history of safe use. Article 14 of Regulation (EU) 2015/2283 lays down the information to be included under the notification, which does not requires applicants to demonstrate the safety beyond the demonstration of safe history of use. Nevertheless, the Draft Commission Implementing Regulation extends the required information by requiring a risk assessment of the traditional food from a third country. We think that this is fundamental change that goes beyond the aim of the notification, which will then need to comply with the same rules as an application, creating administrative burden, delays and the need for additional toxicological studies and other safety studies in the light of the safe history of use of the food in the third country.
Based on the aforementioned EFSA guidance, the request of raw data of individual studies (published or not) in Article 6.4 of the proposed Implementing Regulation doesn’t seem appropriate for products whose safety is assessed based on experience of continued use (see EFSA guidance part 2.6).
Article 11: Timings in the transitional measures (1 Jan 2019) does not seem to be in line with the NF regulation (2 Jan 2020).
Annex I lists four different types of applications in line with the wording of Article 9(2) of Regulation (EU) 2015/2283. The Annex does not allow the applicant to request the review of the post-market monitoring measures as listed in the Article, which may consist in requirements different than labelling. As an example, an applicant could be requested to periodically report sales data on a given novel food, which, with time passing and increasing history of use, could become irrelevant.
An example would be an applicant asking the Commission to revisit the post-marketing monitoring requirements under Article 24 Regulation (EU) 2015/2283 and directly addressed to him/her.
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