REGUL ATIONS 
COMMI SSION IMPLEMENTING REGUL ATION (EU) 2018/1293 
of 26 September 2018 
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, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having 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 provi des that only novel foods author ised and included in the Union list may be 
placed on the market within the Union. 
(2)  Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) 
was adopt ed, which establishes a Union list of author ised novel foods. 
(3)  Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the author isation and on 
the placing on the Union market of a novel food and on the updating of the Union list. 
(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 in food supplements intended for the adult population. 
(5)  On 22 Marc h 2018, the compan y DuP ont Nutr ition Biosciences ApS made a request to the Commission to 
change the conditions of use of the novel food lactit ol within the meaning of Article 10(1) of Regulation (EU) 
2015/2283. The application request ed to include powder as an allowed form of lactitol to be used in food 
supplements. 
(6)  The Commission did not request an opinion from the European Food Safety Auth ority in accordance with 
Article 10(3) as the amendment of the conditions of use of the novel food lactitol by including powder , as an 
allowed form of lactit ol to be used in food supplements is not liable to have an effect on human health. 
(7)  The maximum level of lactit ol author ised by Implementing Decision (EU) 2017/450 as a novel food to be used 
in capsule or tablet in food supplements is 20 g/da y. The proposed use level of the novel food lactit ol in powder 
form in the same food categor y corresponds to the maximum level that is currently author ized. Theref ore, it is 
appropr iate to amend the conditions of use of lactit ol to author ise its use in powder form at the existing 
maximum author ised level. 
(8)  The information provided in the application gives sufficient grounds to establish that the application for changing 
of the conditions of use of the novel food lactitol by including powder , as an allowed form of lactitol to be used 
in food supplements, compl y with Article 12(2) of Regulation (EU) 2015/2283. 27.9.2018 L 243/2 Official Jour nal of the European Union EN     
(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). 
(3)Commission Implementin g 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). 
(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). (9)  Directive 2002/46/EC of the European Parliament and of the Council (1) lays down requirements on food 
supplements. The additional form of lactitol to be used in food supplements should be author ised without 
prejudice to that Directive. 
(10)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
1. The entr y in the Union list of author ised novel foods as provided for in Article 8 of Regulation (EU) 2015/2283 
referring to the substance lactitol shall be amended as specifi ed in the Annex to this Regulation. 
2. The entr y in the Union list refer red to in paragraph 1 shall include the conditions of use and labelling 
requirements laid down in the Annex to this Regulation. 
3. The author isation provided for in this Article shall be without prejudice to the provisions of Directive 2002/46/EC. 
Article 2 
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation. 
Article 3 
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 State s. 
Done at Brussels, 26 September 2018. 
For the Commission 
The President 
Jean-Claude JUNCK ER  27.9.2018 L 243/3 Official Jour nal of the European Union EN     
(1)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). ANNEX 
The entr y for ‘Lactito l’ in Table 1 (Auth orised novel foods) of the Annex to Implementing Regulation (EU) 2017/2470 is replaced by the follo wing: 
Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
‘Lactito l Specif ied food categor y Maximum levels The designation of the novel food on the label ­
ling of the food supplements containing it shall 
be “Lactitol ”’  Food Supplements as defined in Directive 2002/46/EC 
(capsules, tablets or powder) intended for the adult 
population 20 g/da y   27.9.2018 L 243/4 Official Jour nal of the European Union EN