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Commission Consultation, 19 July 2017
The Commission has published a draft Regulation for consultation. The following are the introductory recitals in the document. The full draft Regulation is available on this site as well a document containing draft new Annex. The consultation closes on the 16th August 2017. For more details, see: https://ec.europa.eu/info/law/better-regulation/have-your-say_en
(1) Regulation (EU) 2015/2283 lays down rules for the placing on the market and use of novel foods in the Union.
(2) Pursuant to Article 20 of Regulation (EU) 2015/2283 the Commission has to adopt implementing acts laying down administrative and scientific requirements concerning traditional foods from third countries.
(3) Without prejudice to Articles 5, 15 and 16 of Regulation (EU) 2015/2283, the Commission should verify whether the notification falls within the scope of that Regulation and the validity of the notification or the application.
(4) Notifications referred to in Articles 14 of Regulation (EU) 2015/2283 should contain sufficient information and scientific documentation to allow the Commission to verify the validity and enable Member States and the Authority to evaluate the history of safe use of the traditional food from a third country.
(5) Applications referred to in Article 16 of Regulation (EU) 2015/2283 should contain sufficient information and scientific documentation to allow the Commission to verify the validity and enable the Authority to conduct comprehensive risk assessments.
(6) Where the applicant submits a notification or an application to modify the conditions of use, the specifications or additional specific labelling requirements of an authorised traditional food from a third country, it may not be necessary for the applicant to provide all the data required for the safety assessment where the applicant provides adequate verifiable justification.
(7) The exchange of information between the Member States and the Authority is necessary in order to ensure that duly reasoned safety objections are developed and submitted to the Commission.
(8) The opinion of the Authority should provide sufficient information to ascertain whether the authorisation of the proposed use of the traditional food from a third country is safe for consumers.
(9) Pursuant to Article 35(3) of Regulation (EU) 2015/2283 the Commission has to adopt implementing acts laying down the requirements referred to in Article 20 of that Regulation.
(10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed.