EN    EN  
Document SANCO/12067/2011 rev
EN EN 1   EN  EUROPEAN COMMISSION 
Brussels,  
Draft 
COMMISSION REGULATION (EU) No … 
of […] 
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  
(Text with EEA relevance) 
 
  EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of 
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  
(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 Un ion list of food additives 
approved for use in foods a nd their conditions of use. 
(2) The European Food Safety Authority (EFSA), in its opinion of 22 May 20082 
recommended to lower the tolerable weekly  intake (TWI) for aluminium to 1 mg/kg 
body weight/week. In addition, EFSA consider s that the revised TWI is generally 
exceeded for high consumers, especially childre n, in a significant part of the Union.  
(3) EFSA considers that the major route of  exposure to aluminium compounds for the 
general population is through food, both as a consequenc e of the natural occurrence 
of aluminium in food and the use of aluminium compounds in food processing, 
including food additives. However, EFSA is not able to quantify the respective role 
of each source due to the design of the human dietary studies and the analytical 
methods used, which only determine the total aluminium content in food. 
(4) Annex II to Regulation (EC) No 1333/2008 authorises the use of aluminium-
containing food additives in a wide numbe r of foodstuffs, often at very high 
maximum permitted levels or without any indication of the maximum concentration 
levels ( Quantum satis ).  
(5) Annex II to Regulation (EC) No 1333/2008 and Commission Regul ation (EU) No 
…/EU laying down specifications for food additives listed in Annexes II and III to 
Regulation (EC) No 1333/2008 au thorises the use of some colours that may contain 
                                                 
1 OJ L 354, 31.12.2008, p. 16. 
2Scientific Opinion of the Panel on Food Additives, Fl avourings, Processing Aids and Food Contact Materials 
(AFC) on Safety of aluminium from dietary intake, The EFSA Journal (2008) 754, p. 1. EN 3   EN aluminium in the form of lakes in a wide number of foodstuffs , in general without 
any indication of the maximum concentrati on levels of aluminium in the lakes.  
(6) It is therefore appropriate to amend the current conditions of use and reduce the use 
levels for aluminium-containing food additive s, including aluminium lakes, to ensure 
that the revised TWI is not exceeded. 
(7) Since manufacturing practices using highe r amounts of food additives have been 
applied since decades, a transitional period should be provided to allow the food 
business operators to adapt to the new requi rements laid down in this Regulation for 
the uses of aluminium-containing f ood additives others than lakes. 
(8) Labelling of aluminium content in aluminiu m lakes not intended for sale to the final 
consumer is currently optional. It should become mandatory within 12 months from 
the entry into force of this Regulation in order to  allow food manufacturers using 
aluminium lakes to adapt to the proposed maximum limits for such lakes. Therefore a longer transitional period than 12 months should be provided to allow the food 
business operators to adapt to the new re quirements laid down in this Regulation. 
(9) Annex II as amended by Commission Regula tion (EU) No …/.. is in principle 
applicable from 1 June 2013. In order to facilitate the effective implementation of 
Annex II, it is appropriate to insert in the Annex the periods of application that differ 
from 1 June 2013 and are posterior to th e entry into force of this Regulation. 
(10) The aluminium containing carrier bentonite, E 558 is not used any more according to 
information submitted by food manufacturers. Th erefore, it is not included in Part 1 
of Annex III to Regulation (EC) No 1333/ 2008 and should also be deleted from the 
list of all additives in Part B of Annex II to Regulation (EC) No 1333/2008
. 
(11) The measures provided for in this Regulat ion are in accordance with the opinion of 
the Standing Committee on the Food Chain and Animal Health, and neither the 
European Parliament nor the Council has opposed them, 
HAS ADOPTED THIS REGULATION: 
Article 1 
 
Annex II to Regulation (EC) No 1333/2008 is ame nded in accordance with the Annex to this 
Regulation.  
Article 2 
 
1. Foods not complying with the provisions la id down in this Regulation applicable from 
1 February 2014 that have been lawfully pl aced on the market before 1 February 2014, 
may continue to be marketed until their da te of minimum durability or use-by date.  EN 4   EN 2. By derogation from paragraph 1, foods c ontaining aluminium lakes and not complying 
with the provisions laid down in this Regulation applicable from 1 August 2014, that 
have been lawfully placed on the market before 1 August 2014, may continue to be 
marketed until their date of mini mum durability or use-by date.  
 
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 the Member States. 
Done at Brussels, 
 For the Commission 
 José Manuel BARROSO  The President  
EN 5   EN