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Commission consultation, 23 July 2020
Draft Regulation: COMMISSION IMPLEMENTING REGULATION amending Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods
A copy of this draft Regulation is available on this site (click on image). An additional document provides the draft Annex - see: Draft Annex. For more details, see the consultation page at: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12143-Amending-administrative-scientific-requirements-for-applications-for-novel-foods-in-view-of-Transparency-Regulation. The consultation closes on 20 August 2020.
The following are the recitals from the draft regulation:
(1) Regulation (EU) 2015/2283 [see Note 1 below] lays down rules for the placing on the market and use of novel foods in the Union.
(2) Commission Implementing Regulation (EU) 2017/2469 [see Note 2 below] lays down administrative and scientific requirements for applications referred to in Article 10(1) of Regulation (EU) 2015/2283.
(3) Regulation (EU) 2019/1381 of the European Parliament and the Council [see Note 3 below] amended Regulation (EC) No 178/2002 [see Note 4 below] of the European Parliament and of the Council and Regulation (EU) 2015/2283. Those amendments are aimed at strengthening the transparency and the sustainability of the EU risk assessment in all areas of the food chain where the European Food Safety Authority (‘the Authority’) delivers a scientific risk assessment, including in the area of novel foods.
(4) As regards the placing on the market of novel foods, the amendments to Regulation (EC) No 178/2002 introduced new provisions concerning amongst other things: general pre-submission advice by the staff of the Authority at the request of a potential applicant and the obligation to notify studies commissioned or carried out by business operators to support an application and the consequences of non-compliance with that obligation. It also introduced provisions on the public disclosure by the Authority of all scientific data, studies and other information supporting applications, with the exception of confidential information, early on in the risk assessment process, followed up by a consultation of third parties. The amendments also set out specific procedural requirements for the submission of confidentiality requests and the assessment thereof by the Authority in relation to the information submitted by an applicant, where the Commission requests the opinion of the Authority.
(5) Regulation (EU) 2019/1381 also amended Regulation (EU) 2015/2283 to include provisions ensuring consistency with the adaptations of Regulation (EC) No 178/2002 and taking into account sectoral specificities with respect to confidential information.
(6) Given the scope and application of all those amendments, Implementing Regulation (EU) 2017/2469 should be adjusted to accommodate the changes as regards the content, drafting and presentation of applications referred to in Article 10 of Regulation (EU) 2015/2283, the arrangements for verifying the validity of applications, and the information to be included in the opinion of the Authority. In particular, Implementing Regulation (EU) 2017/2469 should make reference to the standard data formats and clarify that applicants should ensure compliance with the notification requirement laid down in Article 32b Regulation (EC) No 178/2002 and provide information demonstrating such compliance. It should also clarify that the assessment of compliance with the notification requirement forms part of the verification of the validity of an application.
(7) Furthermore, taking into account the fact that the Authority is responsible for managing the database of studies in accordance with Article 32b of Regulation (EC) No 178/2002, it should also be made possible for the Commission to consult the Authority as part of the verification of the validity of applications to ascertaining that the application fulfills the relevant requirements that are laid down in that Article.
(8) Where public consultations are performed during the risk assessment in accordancewith Article 32c of Regulation (EC) No 178/2002, the opinion of the Authority should also include the results of those consultations, in accordance with the transparency requirements to which the Authority is subject.
(9) This Regulation should apply from 27 March 2021 and to applications submitted as of that date, which is the date of application of Regulation (EU) 2019/1381.
(10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed.