This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 10 April 2024.

For the Commission

The President

Ursula VON DER LEYEN

( 1 ) OJ L 327, 11.12.2015, p. 1 , ELI: http://data.europa.eu/eli/reg/2015/2283/oj .

( 2 ) Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods ( OJ L 351, 30.12.2017, p. 72 , ELI: http://data.europa.eu/eli/reg_impl/2017/2470/oj ).

( 3 ) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements ( OJ L 183, 12.7.2002, p. 51 , ELI: http://data.europa.eu/eli/dir/2002/46/oj ).

( 4 ) ANNEX 1_Friederich_Beck, master data calcifediol_PROPRIETARY UNPUBLISHED DATA.pdf

( 5 ) ANNEX 2_Beck 2016_RD 00053392_ PROPRIETARY UNPUBLISHED DATA.pdf

( 6 ) ANNEX 3_Beck et al 2017a_ PROPRIETARY UNPUBLISHED DATA.pdf

( 7 ) ANNEX 4_Beck et al 2017b_ PROPRIETARY UNPUBLISHED DATA.pdf

( 8 ) ANNEX 5_Weber & Arcelin_2004b_ PROPRIETARY UNPUBLISHED DATA.pdf

( 9 ) ANNEX 6_Remus_2016a_skin irritation_ PROPRIETARY UNPUBLISHED DATA.pdf

( 10 ) ANNEX 7_Remus_2016b_BCOP_ PROPRIETARY UNPUBLISHED DATA.pdf

( 11 ) ANNEX 8_Remus 2016c_MLA_ PROPRIETARY UNPUBLISHED DATA.pdf

( 12 ) ANNEX 9_Remus_2016d_LLNA_PROPRIETARY UNPUBLISHED DATA.pdf

( 13 ) ANNEX 10_Remus 2016e_in vivo MNT_PROPRIETARY UNPUBLISHED DATA.pdf

( 14 ) ANNEX 11_Woehrle & Sokolowski 2013_PROPRIETARY UNPUBLISHED DATA.pdf

( 15 ) ANNEX 12_Weber & Schulz 2005_PROPRIETARY UNPUBLISHED DATA.pdf

( 16 ) ANNEX 13_Thiel et al 2014c_PROPRIETARY UNPUBLISHED DATA.pdf

( 17 ) ANNEX 14_Thiel et al 2007_PROPRIETARY UNPUBLISHED DATA.pdf

( 18 ) ANNEX 15_Wittwer 2015_D-Dose_study_PROPRIETARY UNPUBLISHED DATA.pdf

( 19 ) ANNEX 16_Kunz et al_2016_PROPRIETARY UNPUBLISHED DATA.pdf

( 20 ) Report DSM_EFSA_Calcifediol_CONF_DATA PROT_NEW_2_0121 (initial report submitted in December 2020 and further updated and replaced by a new version in January 2021) Report DSM_EFSA_Calcifediol_CONF_DATA PROT_NEW_0321; Report Annex 1_1A_CONF_DATA PROTECTED_NEW_280121; Report Annex 1_1B_CONF_DATA PROTECTED_NEW_280121; Report Annex 1_2A_CONF_DATA PROTECTED_NEW_280121; Report Annex 1_2B_CONF_DATA PROTECTED_NEW_280121; Report Annex 1_2C_CONF_DATA PROTECTED_NEW_280121; Report Annex 2_CONF_DATA PROTECTED_NEW_280121; Report_Annex I_1 2_CONF_DATA PROT_202103; Report_Annex I_3_CONF_DATA PROT_202103; Report_Annex I_4_CONF_DATA PROT_202103.

( 21 ) EFSA Journal 2021;19(6):6660.

( 22 ) Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 ( OJ L 304, 22.11.2011, p. 18 , ELI: http://data.europa.eu/eli/reg/2011/1169/oj ).

( 23 ) EFSA Journal 2023;21(8):8145.

( 24 ) 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 , ELI: http://data.europa.eu/eli/reg/2002/178/oj ).

( 25 ) EFSA Journal 2024;22:e8520.

( 26 ) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use ( OJ L 311, 28.11.2001, p. 67 , ELI: http://data.europa.eu/eli/dir/2001/83/oj ).

( 27 ) Address: Wurmisweg 576, 4303 Kaiseraugst, Switzerland.

COMMISSION IMPLEMENTING REGULATION (EU) 2024/1052 of 10 April 2024 authorising the placing on the market of calcidiol monohydrate as a novel food and amending Implementing Regulation (EU) 2017/2470 ANNEX