EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANCO/10802/2014 Rev. 1 
(POOL/E3/2014/10802/10802R1-EN.doc) D033636/03     […](2014) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Annex II to Regulati on (EC) No 1333/2008 of the Eu ropean Parliament and of 
the Council as regards the use of aluminium lakes of riboflavins (E  101) and cochineal, 
carminic acid, carmines (E 120)  in certain food categories and Annex to Regulation (EU) 
No 231/2012 as regards the specific ations for riboflavins (E 101) 
(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 aluminium lakes of riboflavins (E 101) and cochineal, 
carminic acid, carmines (E 120) in certain fo od categories and Annex to Regulation (EU) 
No 231/2012 as regards the specifica tions for ribofl avins (E 101) 
(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 Article 10(3) and 
Article 14, 
Whereas: (1) Annex II to Regulation (EC)  No 1333/2008 lays down a Un ion list of food additives 
approved for use in foods a nd their conditions of use. 
(2) Commission Regulatio n (EU) No 231/2012
2 lays down specifications for food 
additives listed in Annexes II a nd III to Regulation (EC) No 1333/2008. 
(3) The Union list of food additives and the sp ecifications may be updated 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 either on th e initiative of the 
Commission or following an application3. 
(4) The European Food Safety Authority (hereina fter: 'the Authority'), in its opinion of 
22 May 20084 recommended to lower the tolerable weekly intake (TWI) for 
aluminium to 1 mg/kg body weight/week. In addition, the Authority considered that 
the revised TWI was generally exceeded for high consumers,  especially children, in a 
significant part of the Union. In order to ensure that the revised TWI is not exceeded, 
the conditions of use and the use levels for food additives containing aluminium, 
including aluminium lakes were am ended by Commission Regulation (EU) 
No 380/20125. 
                                                 
1 OJ L 354, 31.12.2008, p. 16. 
2 Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food 
additives listed in Annexes II and III to Regulation (E C) No 1333/2008 of the European Parliament and 
of the Council (OJ L 83, 22.3.2012, p. 1). 
3 Regulation (EC) No 1331/2008 of  the European Parliament and of  the Council of 16 December 2008 
establishing a common authorisati on procedure for food additives, food enzymes and food flavourings 
(OJ L 354, 31.12.2008, p. 1). 
4 Scientific Opinion of the Panel on Food Additiv es, Flavourings, Processing Aids and Food Contact 
Materials (AFC) on Safety of aluminium from dietary intake, ( The EFSA Journal  (2008) 754, p. 1). 
5 Commission Regulation (EU) No 380/2012 of 3 May 2012 amending Annex II to Regulation (EC) 
No 1333/2008 of the European Parliament and of the Council as regards the conditions of use and the 
use levels for aluminium-containing food additives (OJ L 119, 4.5.2012, p. 14). EN 3   EN (5) Regulation (EU) No 380/2012 provides that aluminium lakes prepared from all 
colours listed in Table 1 of Part B of Annex II to Regulation (EC) No 1333/2008 are 
authorised until 31 July 2014. From 1 A ugust 2014 only aluminium lakes prepared 
from the colours listed in Table 3 of Part A of Annex II to Regulation (EC) 
No 1333/2008 are authorised a nd only in those f ood categories where provisions on 
maximum limits on aluminium coming from lakes are explicitly stated in Part E of that Annex.  
(6) Applications for authorisation of the use of  aluminium lakes of riboflavins (E 101) and 
the extension of use of alum inium lakes of cochineal, carminic acid, carmines (E 120) 
were submitted in the course of 2013 and have been made available to the Member States pursuant to Article 4 of Regula tion (EC) No 1331/2008. While considering the 
applications a special attention was paid to  a possible exposure to aluminium in order 
not to undermine Regulation (EU) No 380/2012.  
(7) In aluminium lakes of colours the dye is re ndered insoluble and functions differently 
to its dye equivalent (e.g. improved light, pH and heat stability, preventing colour 
bleed and providing a different colour shad e to dye colours) making the lake form 
suitable for certain specific technical applications. 
(8) The authorisation of aluminium lakes of riboflavins provides an alternative to 
aluminium lakes of other yellow colours in foods in which the use of aluminium lakes 
is authorised. The use levels requested for aluminium lakes of cochineal, carminic acid, carmines are low and the extension of use is either to niche products or to 
products which are not consum ed by children. A higher use level for pasteurised fish 
roe is needed due to the heat  treatment to guarantee a stable colour during the shelf life 
of the product. It is not expected that the authorisation of aluminium lakes of 
riboflavins and the extension of use of aluminium lakes of cochineal, carminic acid, 
carmines would have a significant impact on the total exposure to aluminium.  
(9) 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 authorisation of aluminium lakes of 
riboflavins and the extensions of use of al uminium lakes of cochineal, carminic acid, 
carmines constitute updates of that list which are not liable to have an effect on human health, it is not necessary to seek  the opinion of the Authority.  
(10) Annex to Regulation (EU) No 231/2012 stipulat es that a colour may be used in the 
form of aluminium lakes only where explicitly  stated. Therefore, the authorisation of 
aluminium lakes of riboflavins (E 101) requ ires modification of the specifications for 
that food additive provided in the Annex to Regulation (EU) No 231/2012 with regard to use of aluminium lakes of colours. 
(11) Therefore, Annex II to Regulation (EC) No 1333/2008 and Annex to Regulation (EU) 
No 231/2012 should be amended accordingly. 
(12) 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 ame nded in accordance with Annex I to this 
Regulation. 
Article 2 
Annex to Regulation (EU) No 231/2012 is amende d in accordance with Annex II to this 
Regulation. 
Article 3 
This Regulation shall enter into  force on the twentieth day follo wing 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