COMMI SSION REGUL ATION (EU) 2018/97 
of 22 Januar y 2018 
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the 
Council as regards the use of sweeteners in fine baker y wares 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 
on food additives (1), and in particular Article 10(3) thereof, 
Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 
establishing a common author isation procedure for food additives, food enzymes and food flavourings (2), and in 
particular Article 7(5) thereof, 
Whereas: 
(1)  Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in food 
and their conditions of use. 
(2)  That list may be updated in accordance with the common procedure refer red to in Article 3(1) of Regulation (EC) 
No 1331/2008, either on the initiative of the Commission or followi ng an application. 
(3)  On the basis of the information provided by the Member States, the Commission has concluded that Annex II to 
Regulation (EC) No 1333/2008 should be amended as regards the use of E 950 Acesulfame K, E 951 Aspar tame, 
E 952 Cyclamic acid and its Na and Ca salts, E 954 Sacch arin and its Na, K and Ca salts, E 955 Sucralose, E 959 
Neohesper idine DC, E 961 Neotame, E 962 Salt of aspar tame-acesulf ame and E 969 Advantame in ‘fine baker y 
products for special nutr itional uses ’. 
(4)  The use of sweet eners in ‘fine bake ry products for special nutr itional uses ’ was author ised by the European 
Parliament and Council Directive 94/35/EC (3). The food ‘fine baker y products for special nutr itional uses ’ 
covered ‘foods for persons suffe ring from carbohydrat e metabolism disorders (diabete s)’ regulate d by Council 
Directive 89/398/EEC (4). This Directive established a common definition for ‘foodstuffs for particular nutr itional 
uses’ and provided that specific provisions could be adopt ed as regar ds ‘food for persons suffering from 
carboh ydrate metabolism disorders (diabetes)’ , a catego ry of food falling within the definition of foodstuffs for 
particular nutr itional uses. 
(5)  Howe ver, as concluded in the Commission's repor t (5) on foods for persons suffering from diabetes , the scientifi c 
basis for setting specific compo sitional requirements for those foods was lacking. Further more, Regulation (EU) 
No 609/2013 of the European Parliament and of the Council (6) has abolished the concept of ‘foodstuffs for 
particular nutr itional uses’, including that of ‘food for persons suffer ing from carbohydrat e metabolism disorders  
(diabete s)’. 
(6)  Theref ore, the author isation of those sweet eners in ‘fine bakery products for special nutr itional uses’ in 
accordance with Article 7(c) of Regulation (EC) No 1333/2008 is no long er justified and those products should 
not continue to be market ed. 23.1.2018 L 17/11 Official Jour nal of the European Union EN     
(1)OJ L 354, 31.12.2008, p. 16. 
(2)OJ L 354, 31.12.2008, p. 1. 
(3)European Parliament and Council Directive 94/35/EC of 30 June 1994 on sweet eners for use in foodstuffs (OJ L 237, 10.9.1994, p. 3). 
(4)Council Directive 89/398/EEC of 3 May 1989 on the appro ximation of the laws of the Member States relating to foodstuffs inten ded for 
particular nutr itional uses (OJ L 186, 30.6.1989, p. 27). 
(5)Repor t from the Commission to the European Parliament and the Council on foods for persons suffering from carbohydrat e metabolism 
disorders (diabetes) of 1 July 2008 (COM (2008) 392 final). 
(6)Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young 
children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, 
Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and 
of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35). (7)  Further more, unif orm application of the conditions for author isation of use of sweeteners would ensure clarity 
and the proper functioning of the internal mark et. 
(8)  Theref ore, the entr ies for food additives E 950 Acesulf ame K, E 951 Aspar tame, E 952 Cyclamic acid and its Na 
and Ca salts, E 954 Sacchari n and its Na, K and Ca salts, E 955 Sucralose, E 959 Neohesper idine DC, E 961 
Neotame, E 962 Salt of aspar tame-acesulfam e and E 969 Advantame referring to the use in ‘only fine bake ry 
products for special nutr itional uses ’ in food catego ry 07.2 fine baker y wares should be deleted. 
(9)  Annex II to Regulation (EC) No 1333/2008 should theref ore be amended according ly. 
(10)  In order to allow economic operators to adap t to the new rules, it is appropr iate to provid e for a transitional 
period during which fine baker y products for special nutr itional uses containing any of those sweet eners may 
continue to be mark eted. 
(11)  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 
Annex II to Regulation (EC) No 1333/2008 is amended in accordance with the Annex to this Regulation. 
Article 2 
Fine bakery products for special nutr itional uses containing E 950 Acesulf ame K, E 951 Aspar tame, E 952 Cyclamic acid 
and its Na and Ca salts, E 954 Sacchari n and its Na, K and Ca salts, E 955 Sucralose, E 959 Neohesper idine DC, E 961 
Neotame, E 962 Salt of aspar tame-acesulfame and/or E 969 Advantame that have been lawfully placed on the mark et 
before the entr y into force of this Regulation, may continue to be mark eted until the stoc ks are exhausted. 
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, 22 Januar y 2018. 
For the Commission 
The President 
Jean-Claude JUNCK ER  23.1.2018 L 17/12 Official Jour nal of the European Union EN     ANNEX 
Part E of Annex II to Regulation (EC) No 1333/2008 is amended as follows :  
1. In food catego ry 07.2 ‘Fine bake ry wares’, the entr ies for the food additives E 950 Acesulf ame K, E 951 Aspar tame, 
E 952 Cyclamic acid and its Na and Ca salts, E 954 Sacch arin and its Na, K and Ca salts, E 955 Sucralose, E 959 
Neohesper idine DC, E 961 Neotame, E 962 Salt of aspar tame-acesulf ame and E 969 Advantame as rega rds the use in 
‘only fine baker y products for special nutr itional uses’ are deleted.  23.1.2018 L 17/13 Official Jour nal of the European Union EN