Commission Implementing Regulation (EU) 2021/428

Contents

THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety^note and in particular Article 39f(2)(b) thereof,Whereas:

(1)Regulation (EU) 2019/1381 of the European Parliament and of the Council^note amended, among others, Regulation (EC) No 178/2002 and Regulation (EC) No 1107/2009 of the European Parliament and of the Council^note in order to strengthen the transparency and the sustainability of the Union risk assessment in all areas of the food chain where the European Food Safety Authority (‘the Authority’) conducts a scientific risk assessment.

(2)Article 7(1) of Regulation (EC) No 1107/2009 provides that an application for the approval of an active substance or for an amendment to the conditions of an approval are to be submitted in accordance with standard data formats.

(3)The Authority has drawn up draft standard data formats, based on the IUCLID software package, for the purposes of the applications for approval and for the amendment to the conditions of approval of active substances, as provided for in Regulation (EC) No 1107/2009 and relevant requests for a scientific output.

(4)In order to ensure a high level of transparency in the activities of the Authority, it is appropriate to enable the efficient processing of requests to the Authority for a scientific output and to allow documents to be submitted, searched, copied and printed, while ensuring compliance with regulatory requirements set out in Union law. Consequently, standard data formats should be adopted for the submission of applications within the meaning of Article 7(1) of Regulation (EC) No 1107/2009.

(5)As this Regulation implements provisions of Regulation (EC) No 178/2002 which apply from 27 March 2021, it should apply from the same date.

(6)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1Subject matter and scope#

1.This Regulation adopts standard data formats for the submission of applications for the approval or for the amendment to the conditions of approval of active substances, within the meaning of Regulation (EC) No 1107/2009 of the European Parliament and of the Council, in accordance with Article 7 of that Regulation.

2.It shall apply to applications, referred to in paragraph 1, submitted on or after 27 March 2021.

Article 2Adoption of standard data formats#

The standard data formats for the approval of an active substance and those for the amendment to the conditions of such an approval, as proposed by the Authority, based on the IUCLID software package and linked with the central submission system to be established in accordance with Article 7(1) of Commission Implementing Regulation (EU) 2020/1740^note, are hereby adopted.

Article 3Entry into force and application#

This Regulation shall enter into force on third day following that of its publication in the Official Journal of the European Union.It shall apply from 27 March 2021.

Commission Implementing Regulation (EU) 2021/428

Article 1Subject matter and scope#

Article 2Adoption of standard data formats#

Article 3Entry into force and application#

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Article 1Subject matter and scope#

Article 2Adoption of standard data formats#

Article 3Entry into force and application#