Commission Implementing Regulation (EU) 2020/1773 of 26 November 2020 amending Regulation (EC) No 429/2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (Text with EEA relevance)
Amendments to Regulation (EC) No 429/2008
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 ( *1 ) , 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.
( *1 ) 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 ( OJ L 31, 1.2.2002. p. 1 ).’;"
(2)
Annexes I and II are amended in accordance with the Annex to this Regulation.
Entry into force and application
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.
Supplementary provisions
ANNEXSupplementary provisions
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:
‘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 ( *1 ) ).
( *1 ) Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives ( OJ L 59, 5.3.2005, p. 8 ).’;"
(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:
‘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:
‘(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;’.
( *1 ) Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives ( OJ L 59, 5.3.2005, p. 8 ).’;’
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
