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Commission consultation, 23 July 2020
Draft Regulation: COMMISSION IMPLEMENTING REGULATION amending Commission Regulation (EU) No 234/2011 of 10 March 2011 implementing Regulation (EC) No 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings
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/12144-Amending-the-rules-for-applications-for-food-additives-enzymes-flavourings-in-view-of-the-Transparency-Regulation-. The consultation closes on 20 August 2020.
The following are the recitals from the draft regulation:
(1) Regulation (EC) No 1331/2008 [see Note 1 below] lays down procedural arrangements for updating the lists of substances the marketing of which is authorised in the Union pursuant to Regulation (EC) No 1333/2008 of the European Parliament and of the Council [see Note 2 below] , Regulation (EC) No 1332/2008 of the European Parliament and of the Council [see Note 3 below] and Regulation (EC) No 1334/2008 of the European Parliament and of the Council [see Note 4 below] ( ‘the sectoral food laws’).
(2) Commission Regulation (EU) No 234/2011 [see Note 5 below] lays down provisions regarding the content, drafting and presentation of applications to update the Union lists under each sectoral food law. That Regulation provides for detailed arrangements for checking the validity of applications for food additives, food enzymes and food flavourings and the type of information that should be included in the opinion of the European Food Safety Authority ( ‘the Authority’).
(3) Regulation (EU) 2019/1381 of the European Parliament and the Council [see Note 6 below] amended Regulation (EC) No 178/2002 [see Note 7 below] of the European Parliament and of the Council and Regulation (EC) No 1331/2008. 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 Authority delivers a scientific risk assessment, including in the area of food additives, food enzymes and food flavourings.
(4) As regards the placing on the market of food additives, food enzymes and food flavourings and ingredients with flavouring properties for use in and on foods, the amendments to Regulation (EC) No 178/2002 introduced new provisions concerning, amongst other issues, 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 (EC) No 1331/2008 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, Regulation (EC) No 234/2011 should be adjusted to accommodate the changes as regards the content, drafting and presentation of applications to update the Union lists under each sectoral food law, the arrangements for checking the validity of applications and the information to be included in the opinions of the Authority. In particular, Regulation (EC) No 234/2011 should make reference to the standard data formats, 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 ascertain 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 accordance with Article 32c of Regulation (EC) 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.