EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10217/2017 
(POOL/E2/2017/10217/10217-EN.doc) 
D052936/02 […](2017) XXX  
  
COMMISSION REGULATION (EU) …/… 
of XXX  
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of 
the Council as r egar ds the use of sw eetener s in fine baker y w ar es 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION REGULATION (EU) …/… 
of XXX  
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 bakery wares 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard 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 Ar ticle 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 co mmon authorisation procedure for food 
additives, food enzymes and food flavourings2, 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 referred to in 
Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the 
Commission or following an application. 
(3) On the basis of the information provide d 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 Aspartame, E952 Cyclamic acid and its 
Na and Ca salts, E 954 Saccharin and its Na , K and Ca salts, E 955 Sucralose, E 959 
Neohesperidine DC, E 961 Neotame, E 962 Salt of aspartame-ace sulfame and E 969 
Advantame in 'fine bakery products  for special nutritional uses'. 
(4) The use of sweeteners in 'fine bakery pr oducts for special nutritional uses' was 
authorised by the European Parliament and Council Directive 94/35/EC
3. The food 
'fine bakery products for special nutritional uses' covered 'foods for persons suffering 
from carbohydrate metabolism disorders (dia betes)' regulated by Council Directive 
89/398/EEC4. This Directive established a common definition for ‘foodstuffs for 
particular nutritional uses’ and provided th at specific provisions could be adopted as 
regards ‘food for persons suffering from carbohydrate metabolism disorders 
(diabetes)’, a category of food  falling within the definition of foodstuffs for particular 
nutritional uses. 
                                                 
1 OJ L 354, 31.12.2008, p. 16. 
2 OJ L 354, 31.12.2008, p. 1. 
3 European Parliament an d Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in 
foodstuffs (OJ L 237, 10.9.1994, p. 3). 
4 Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States 
relating to foodstuffs intended for particular nutritional uses (OJ L 186, 30.6.1989, p. 27).  
EN 3   EN (5) However, as concluded in the Commission's report5 on foods for persons suffering 
from diabetes, the scientific basis for setting specific compositional requirements for those foods was lacking. Furthermore, Re gulation (EU) No 609/2013 of the European 
Parliament and of the Council
6 has abolished the concept of  ‘foodstuffs for particular 
nutritional uses’, including that of ‘food for persons suffering from carbohydrate 
metabolism disorders (diabetes)’. 
(6) Therefore, the authorisation of those sweeteners in 'fine bakery products for special 
nutritional uses' in accordance with Article 7(c) of Re gulation (EC) No 1333/2008 is 
no longer justified and thos e products should not con tinue to be marketed. 
(7) Furthermore, uniform application of the conditions for authorisation of use of 
sweeteners would ensure clarity and the pr oper functioning of the internal market. 
(8) Therefore, the entries for food additives E 950 Acesulfame K, E 951 Aspartame, E952 
Cyclamic acid and its Na and Ca salts, E 954 Saccharin and its Na, K and Ca salts, E 955 Sucralose, E 959 Neohesperidine DC, E 961 Neotame, E 962 Salt of aspartame-
acesulfame and E 969 Advantame referring to th e use in 'only fine bakery products for 
special nutritional uses' in food category 07.2 fine bakery wares should be deleted.  
(9) Annex II to Regulation (EC) No 1333/2008 should therefore be amended accordingly. 
(10) In order to allow economic operators to adapt to the new rules, it is appropriate to 
provide for a transitional period during which fine ba kery products for special 
nutritional uses containing any of those sw eeteners may continue to be marketed.  
(11) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGULATION: 
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 nutritiona l uses containing E 950 Acesulfame K, E 951 
Aspartame, E952 Cyclamic acid and its Na and Ca salts, E 954 Saccharin and its Na, K and Ca salts, E 955 Sucralose, E 959 Neohesper idine DC, E 961 Neotame, E 962 Salt of 
aspartame-acesulfame and/or E 969 Advantame that  have been lawfully placed on the market 
before the entry into force of th is Regulation, may continue to be  marketed until the stocks are 
exhausted. 
                                                 
5 Report  from the Commission to the European Parliament and the Council on foods for persons suffering 
from carbohydrate 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 chil dren, food for special medical pur poses, 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).  
EN 4   EN Article 3 
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, 
 For the Commission 
 The President  Jean-Claude JUNCKER