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Commission Implementing Regulation (EU) 2021/428 of 10 March 2021 adopting standard data formats for the submission of applications for the approval or the amendment to the conditions of approval of active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council (Text with EEA relevance)

Commission Implementing Regulation (EU) 2021/428 of 10 March 2021 adopting standard data formats for the submission of applications for the approval or the amendment to the conditions of approval of active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council (Text with EEA relevance)

Implementing Regulation (EU) 2021/428 · Regulation · 3 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Subject matter and scope

Article 1

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.

Adoption of standard data formats

Article 2

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  ( 4 ) , are hereby adopted.

Entry into force and application

Article 3

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.

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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