ELI: http://data.europa.eu/eli/reg_impl/2024/1023/oj 1/3COMMISSION IMPLEMENTING REGUL ATION (EU) 2024/1023 
of 8 Apr il 2024
amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel 
food lactitol 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng regar d to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on 
novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing 
Regulation (EC) No 258/97 and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,
Whereas:
(1) Regulation (EU) 2015/2283 provides that only novel foods author ised and included in the Union list may be placed 
on the mark et within the Union.
(2) Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Imple menting Regulation (EU) 2017/2470 (2)has 
established a Union list of novel foods.
(3) The Union list set out in the Annex to Implementing Regulation (EU) 2017/2470 includes lactitol as an author ised 
novel food.
(4) Commission Implementing Decision (EU) 2017/450 (3)author ised, in accordance with Regulation (EC) No 258/97 
of the European Parliament and of the Council (4), the placing on the mark et of lactitol as a novel food to be used in 
capsule or tablet form in food supplements as defined in Directive 2002/46/EC of the European Parliament and of 
the Council (5)and intended for the adult population.
(5) Commission Implementing Regulation (EU) 2018/1293 (6)author ised an extension of the use of the novel food 
lactitol in powder form at the existing maximum author ised level in accordance with Regulation (EU) 2015/2283.
(6) On 31 October 2023 , the compan y H.C. Clover Productos y Servicios, S.L., submitt ed an application to the 
Commission to chang e the conditions of use of the novel food lactit ol in accordance with Article 10(1) of 
Regulation (EU) 2015/2283. The applicant request ed to include ampoules of liquids, drop dispensing bottles and 
other similar forms of liquids, as allowed forms of lactitol, to be used in food supplements.
(7) The Commission considers that the request ed update of the Union list is not liable to have an effect on human health 
and that a safety evaluation by the European Food Safet y Author ity (‘the Author ity’) in accordance with Article 10(3) 
of Regulation (EU) 2015/2283 is not necessar y. The safety assessment under pinning the author isation of lactit ol at a 
(1)OJ L 327, 11.12.2015, p. 1.
(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 Implementing Decision (EU) 2017/450 of 13 March 2017 author ising the placing on the market of lactitol as a novel 
food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 69, 15.3.2017, p. 31, ELI: 
http://data.europa.eu/eli/dec_im pl/2017/450/oj ).
(4)Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 Januar y 1997 concer ning novel foods and novel food 
ingredients (OJ L 43, 14.2.1997, p. 1, ELI: http://data.europa.eu/eli/reg/1997/258/oj ).
(5)Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the appro ximation 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 ).
(6)Commission Implementing Regulation (EU) 2018/1293 of 26 Sept ember 2018 amending Implementing Regulation (EU) 2017/2470 
as regar ds the conditions of use of the novel food lactitol (OJ L 243, 27.9.2018, p. 2, ELI: http://data.europa.eu/eli/reg_impl/2018/ 
1293/oj ).
Offi cial Jour nal  
of the European Union EN 
L series    
2024/1023  9.4.2024ELI: http://data.europa.eu/eli/reg_impl/2024/1023/oj 2/3maximum level of 20 g/da y in food supplements is not linked to a specif ic form in which the food supplements are 
made available to the consumer and theref ore, the form does not affect the safet y profile of the novel food. At the 
time of the author isation, the forms of this novel food were limite d to capsules, tablets or powders simply because 
these were the forms proposed by the respective applicant. As the proposed uses in this application concer n only 
forms in ampoules of liquids, drop dispensing bottles, and other similar forms of liquids, while maintaining the 
author ised maximum levels of lactitol in food supplements, the Commission considers that the conditions of use of 
lactitol should be limited to the generic reference to food supplements and their forms defined in Article 2 of 
Directive 2002/46/EC. This will be consiste nt with the other author isations of novel foods used in food 
supplements for which the form of the food supplement is not of relevance for the safety of the novel food.
(8) The information provid ed in the application gives sufficient grounds to establish that the request ed changes to the 
conditions of use of the novel food lactitol by including any allowed form of lactit ol to be used in food supplements 
are in accordance with Article 12 of Regulation (EU) 2015/2283 and should be approved .
(9) The Annex to Implementing Regulation (EU) 2017/2470 should theref ore be amended according ly.
(10) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGUL ATION:
Article 1
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day followi ng 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, 8 Apr il 2024 .
For the Commission
The President
Ursula VON DER LEYENOJ L, 9.4.2024 EN  ELI: http://data.europa.eu/eli/reg_impl/2024/1023/oj 3/3ANNEX 
In Table 1 (Author ised novel foods) of the Annex to Implementing Regulation (EU) 2017/2470, the entr y for ‘Lactito l’ is replaced by the following:
Authorised novel food Conditions under which the novel food may be used Additio nal specific labelling requirements Other requirements
‘Lactito l Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the food supplements 
containing it shall be “Lactitol ”’Food supplements as defined in 
Directive 2002/46/EC intended for 
the adult population20g/da yOJ L, 9.4.2024 EN