EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANCO/12942/2013 (POOL/E3/2014/12942/12942-EN.doc) […](2014) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of 
the Council as regards the use of caramel co lours (E 150a-d) in b eer and malt beverages 
(Text with EEA relevance) 
 EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of 
the Council as regards the use of caramel co lours (E 150a-d) in beer and malt beverages  
(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, 
Whereas: (1) Annex II to Regulation (EC)  No 1333/2008 lays down a Union list of food additives 
approved for use in foods a nd their conditions of use. 
(2) That list may be amended in accordance with the common procedure referred to in 
Article 3(1) of Regulation (EC) No 1331/2008 of the European Parliament and of the 
Council
2, either on the initiativ e of the Commission or following an application. 
(3) Caramel colours are food col ours currently approved for us e and listed in Annex II to 
Regulation (EC) No 1333/2008. That approval takes into account the Acceptable Daily 
Intakes (ADI) established by the Scient ific Committee for Food in 1987, 1990 and 
1996. 
(4) The European Food Safety Authority ('the Au thority') issued an opinion on 3 February 
2011 as regards the re-evaluation of the safe ty of caramel colours as food additives3. In 
that opinion the Authority established a group ADI of 300 mg/kg bw/day. Within this 
group ADI an individual ADI  of 100 mg/kg bw/day was established for E 150c 
ammonia caramel. The Authority concluded that the anticipated dietary exposure of 
child and adult populations may exceed the ADIs for plain caramel (E 150a), ammonia 
caramel (E 150c) and sulphite ammonia caramel (E 150d).  
(5) On 3 December 2012, the Authority issued a statement providing a refined exposure 
assessment for caramel colours E 150a, E 150c and E 150d and concluded that the 
anticipated dietary exposure was consider ably lower than that estimated in the 
previous opinion4. However, the Authority conclude d that toddlers and adults could 
still exceed the ADI for ammonia caramel (E 150c). Whilst the ADI was only slightly 
exceeded (6%) at the high levels in toddlers in one Member State, for adults the ADI 
was exceeded by 5-51% in five Member St ates. After considering more detailed 
national information about the real uses of ammonia caramel (E 150c), the Member 
                                                 
1 OJ L 354, 31.12.2008, p. 16.  
2 Regulation (EC) No 1331/2008 of  the European Parliament and of  the Council of 16 December 2008 
establishing a common authorisation procedure for food additives, food enzymes and food flavourings (OJ L 354, 31.12.2008, p. 1). 
3 EFSA Journal 2011; 9(3):2004. 
4 EFSA Journal 2012; 10(12):3030. EN 3   EN States concerned demonstrated that the actua l intake is significantly lower. However, 
taking into account that beer is the main c ontributor to the exposure in adults, it is 
appropriate to amend the conditions of use and to establish maximum use levels for 
ammonia caramel (E 150c) in food subcategory 14.2.1 'Beer and malt beverages' to guarantee a high level of pr otection of human health. 
(6) Pursuant to Article 11(4) of Regulation (EC) No 1333/2008 the maximum levels for 
colours shall apply to the qua ntities of colouring principl e contained in the colouring 
preparation unless otherwis e stated. However, the co mplex nature and limited 
knowledge of chemical composition of caramel  colours makes their identification in 
food products a challenge. Therefore, in pe rforming official controls the competent 
authorities could also consider verify ing the level of 2-acetyl-4-tetrahydroxy-
butylimidazole, i.e. the impurity which can be analytically determined and which was 
taken into account in establishing an i ndividual ADI for ammonia caramel (E 150c). 
(7) An application for authorisation of the us e of caramel colours (E 150a-d) in malt 
beverages was submitted on 4 June 2013 and was made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008. 
(8) Beer is not defined in the Union legisla tion and the national definitions vary among 
the Member States. Consequently a partic ular product classified as beer in one 
Member State could be classified as malt beverage in another.  Since there is a 
technological need for caramel colours (E  150a-d) in malt bevera ges and the use of 
caramel colours is authorised in beer onl y, the current situation has a negative impact 
on the internal market and hi nders the free movement of t hose products. Therefore it is 
appropriate to rectify this situation. 
(9) The common characteristic of malt beverages is the absence of malt as such in the 
final product and similarities in the technology and in the ne ed for food additives with 
beers. There is a need for caramel colours to restore a consistent colour which has 
been affected by the production processes a nd/or to make malt be verages made from 
pale malts visually more appe aling. Roasted malts cannot be  used to provide the dark 
colour since they impart strong flavour wh ich is not appropriate for those products. 
(10) Malt beverages are niche produc ts providing an alternativ e to products in which the 
use of caramel colours is currently author ised (i.e. flavoured drinks and beers). 
Therefore, it is not expected that the aut horisation of use of car amel colours in malt 
beverages would have a significant impact on total exposure to caramel colours. 
(11) Pursuant to Article 3(2) of  Regulation (EC) No 1331/2008, the Commission is to seek 
the opinion of the Authority in order to upda te the Union list of food additives set out 
in Annex II to Regulation (EC) No 1333/ 2008, except where such update is not liable 
to have an effect on human health. Since the extension of use of caramel colours 
(E 150a-d) to malt beverages constitutes an upd ate of that list whic h is not liable to 
have an effect on human health, it is not  necessary to seek the opinion of the 
Authority. 
(12) Therefore, Annex II to Regulation (EC) No 1333/2008 should be amended 
accordingly. 
(13) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Animal Health, EN 4   EN 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 
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  José Manuel BARROSO