
Article 1 
Regulation (EC) No 429/2008 is amended as follows:

((1)) in Article 2, paragraph 2 is replaced by the following:
'
2. Prior to the adoption of standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002 of the European Parliament and of the Council, the application and the dossier shall be submitted through the electronic submission system provided by the Commission, in an electronic format allowing for the downloading, printing and searching of documents. After the adoption of the standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, the application and the dossier shall be submitted through the electronic submission system provided by the Commission in accordance with those standard data formats.';
((2)) Annexes I and II are amended in accordance with the Annex to this Regulation.
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 27 March 2021 and to applications and dossiers submitted from that date.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 26 November 2020.
For the Commission
The President
Ursula VON DER LEYEN
ANNEX

Annexes I and II to Regulation (EC) No 429/2008 are amended as follows:

((1)) in Annex I, point 1.5 is replaced by the following:
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1.5. Enclosures

☐ complete dossier;
☐ summary of the dossier in accordance with Article 7(3)(h) of Regulation (EC) No 1831/2003;
☐ scientific summary of the dossier;
☐ all information concerning the notification of the studies in accordance with Article 32b of Regulation (EC) No 178/2002;
☐ confidentiality request in accordance with Article 18 of Regulation (EC) No 1831/2003;
☐ copy of the administrative data of the applicant(s);
☐ three samples of the feed additive to the CRL in accordance with Article 7(3)(f) of Regulation (EC) No 1831/2003;
☐ to the CRL: material safety data sheet;
☐ to the CRL: certificate of identification and analysis; and
☐ confirmation that the fee to the CRL has been paid (Article 4 of Commission Regulation (EC) No 378/2005).';
((2)) Annex II is amended as follows:

((a)) in the part ‘General aspects’, the penultimate paragraph before the heading ‘Safety assessment’ is replaced by the following:
'Each dossier shall contain a summary and a scientific summary in order to enable the additive concerned to be identified and characterised.';
((b)) in point 1.1 under Section I, the title is replaced by the following:
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1.1. Summary in accordance with Article 7(3)(h) of Regulation (EC) No 1831/2003';
((c)) point 1.1.1(d) is replaced by the following:
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((d)) studies on safety and efficacy of the additive, along with all information concerning the notification of the studies in accordance with Article 32b of Regulation (EC) No 178/2002;'.
