Annex

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

1. (1)

   in Annex I, point 1.5 is replaced by the following:

   1. 1.5.

      ‘ Enclosures

      1. ☐

         complete dossier;

      2. ☐

         summary of the dossier in accordance with Article 7(3)(h) of Regulation (EC) No 1831/2003;

      3. ☐

         scientific summary of the dossier;

      4. ☐

         all information concerning the notification of the studies in accordance with Article 32b of Regulation (EC) No 178/2002;

      5. ☐

         confidentiality request in accordance with Article 18 of Regulation (EC) No 1831/2003;

      6. ☐

         copy of the administrative data of the applicant(s);

      7. ☐

         three samples of the feed additive to the CRL in accordance with Article 7(3)(f) of Regulation (EC) No 1831/2003;

      8. ☐

         to the CRL: material safety data sheet;

      9. ☐

         to the CRL: certificate of identification and analysis; and

      10. ☐

          confirmation that the fee to the CRL has been paid (Article 4 of Commission Regulation (EC) No 378/2005^f1).’;

2. (2)

   Annex II is amended as follows:

   1. (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.’;

   2. (b)

      in point 1.1 under Section I, the title is replaced by the following:

      1. 1.1.

         ‘ Summary in accordance with Article 7(3)(h) of Regulation (EC) No 1831/2003 ’;

   3. (c)

      point 1.1.1(d) is replaced by the following:

      1. (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;’.