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, 25 July 2025.

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 ) Commission Decision 2000/500/EC of 24 July 2000 on authorising the placing on the market of ‘yellow fat spreads with added phytosterol esters’ as a novel food or novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council ( OJ L 200, 8.8.2000, p. 59 , ELI: http://data.europa.eu/eli/dec/2000/500/oj ).

( 4 ) Commission Decision 2004/333/EC of 31 March 2004 authorising the placing on the market of yellow fat spreads, salad dressings, milk type products, fermented milk type products, soya drinks and cheese type products with added phytosterols/phytostanols as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council ( OJ L 105, 14.4.2004, p. 40 , ELI: http://data.europa.eu/eli/dec/2004/333/oj ).

( 5 ) Commission Decision 2004/334/EC of 31 March 2004 authorising the placing on the market of yellow fat spreads, milk type products, yoghurt type products, and spicy sauces with added phytosterols/phytostanols as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council ( OJ L 105, 14.4.2004, p. 43 , ELI: http://data.europa.eu/eli/dec/2004/334/oj ).

( 6 ) Commission Decision 2004/335/EC of 31 March 2004 authorising the placing on the market of milk type products and yoghurt type products with added phytosterol esters as novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council ( OJ L 105, 14.4.2004, p. 46 , ELI: http://data.europa.eu/eli/dec/2004/335/oj ).

( 7 ) Commission Decision 2004/336/EC of 31 March 2004 authorising the placing on the market of yellow fat spreads, milk based fruit drinks, yoghurt type products and cheese type products with added phytosterols/phytostanols as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council ( OJ L 105, 14.4.2004, p. 49 , ELI: http://data.europa.eu/eli/dec/2004/336/oj ).

( 8 ) Commission Decision 2004/845/EC of 12 November 2004 on authorising the placing on the market of milk based beverages with added phytosterols/phytostanols as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council ( OJ L 366, 11.12.2004, p. 14 , ELI: http://data.europa.eu/eli/dec/2004/845(2)/oj ).

( 9 ) Commission Decision 2006/58/EC of 24 January 2006 authorising the placing on the market of rye bread with added phytosterols/phytostanols as novel foods or novel food ingredients pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council ( OJ L 31, 3.2.2006, p. 18 , ELI: http://data.europa.eu/eli/dec/2006/58(1)/oj ).

( 10 ) Commission Decision 2006/59/EC of 24 January 2006 authorising the placing on the market of rye bread with added phytosterols/phytostanols as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council ( OJ L 31, 3.2.2006, p. 21 , ELI: http://data.europa.eu/eli/dec/2006/59(1)/oj ).

( 11 ) Commission Decision 2007/343/EC of 15 May 2007 authorising the placing on the market of oil enriched with phytosterols/phytostanols as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council ( OJ L 129, 17.5.2007, p. 63 , ELI: http://data.europa.eu/eli/dec/2007/343/oj ).

( 12 ) Commission Decision 2008/36/EC of 10 January 2008 authorising the placing on the market of rice drinks with added phytosterols/phytostanols as novel food under Regulation (EC) No 258/97 of the European Parliament and of the Council ( OJ L 8, 11.1.2008, p. 15 , ELI: http://data.europa.eu/eli/dec/2008/36(1)/oj ).

( 13 ) Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients ( OJ L 43, 14.2.1997, p. 1 , ELI: http://data.europa.eu/eli/reg/1997/258/oj ).

( 14 ) Annexes 11a and 12a to the application – phytosterol/phytostanol composition of five batches each of Advasterol 90 S F and of Advasterol Ester S; Annexes 17b and 17c – certificates of analysis of Advasterol 90 S F and of Advasterol Ester S.

( 15 ) Annexes 11b and 12b to the application – microbes, heavy metals, pesticides, aflatoxins and sulphated ash of five batches each of Advasterol 90 S F and of Advasterol Ester S.

( 16 ) Annex 11c and 12c to the application – dioxins and polychlorinated biphenyls (PCBs), polycyclic aromatic hydrocarbons (PAH) and residual solvents of five batches each of Advasterol 90 S F.

( 17 ) Annexes 13a and 13b to the application – particle size distribution of Advasterol 90 S F and Advasterol Ester S.

( 18 ) Annex 17a to the application – stability study of Advasterol 90 S F and Advasterol Ester S.

( 19 ) Annex 17e to the application– validation data of the in-house method for the determination of phytosterol content using gas chromatography.

( 20 ) https://doi.org/10.2903/j.efsa.2025.9162 .

( 21 ) Address: Street 14, No 507, Parque Industrial Pilar, B1629, Provincia de Buenos Aires, Argentina.

COMMISSION IMPLEMENTING REGULATION (EU) 2025/1509 of 25 July 2025 amending Implementing Regulation (EU) 2017/2470 as regards the specifications of the novel food phytosterols/phytostanols ANNEX