EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10896/2021 ANNEX 
(POOL/E2/2021/10896/10896 -EN 
ANNEX)  D075764/01  
[…](2021) XXX  draft  
ANNEX  
 
ANNEX  
to the  
COMMISSION REGULATION (EU) …/…  
amending Annex II and Annex III to Regulation (EC) No 1333/2008 of the European 
Parliament and of the Council as regards titanium dioxide (E 171)   EN 1  EN ANNEX  
(1) Annex II to Regulation (EC) No 1333/2008 is amended as follows:  
(a) in point 2 of Part A, point 5 is replaced by the following:  
'5. The colours E 123, E 127, E 160b(i), E 160b(ii), E 161g, E 171, E 173 and 
E 180 and mixtures thereof may not be sold directly to the consumer. ' 
(b)  in Part B , point 1 'Colours' is amended as follows:  
1) the entry for the food additive E 171 (Titanium dioxide)  is replaced by 
the following:  
' 
E 171  Titanium dioxide (**)  
'; 
2) the following footnote (**) is added after footnote (*):  
' 
(**) Titanium dioxide is not authorised in the food categories listed in 
Part D and E. The substance is in list B1 because it is used in 
medicinal products in accordance with Directive 2009/35/EC of the 
European Parliament and of the Council (OJ L 109, 30.4.2009, p. 
10). 
'; 
(c) in Part C, point  (2) “Group II: Food colours authorised at quantum satis ”, the 
entry for the food additive  E 171 (Titanium dioxide) is deleted;  
(d) Part E is amended as follows:  
1) In category 04.2.4.1 (Fruit and vegetable preparations excluding 
compote), the entry concerning the food additive E 171 (Titanium 
dioxide) is deleted;  
2) In category 09.2 (Processe d fish and fishery products including molluscs 
and crustaceans), the three entries concerning the food additive E 171 
(Titanium dioxide) are deleted;  
(2) In Part 1 of Annex III to Regulation (EC) No 1333/2008 , the entry concerning the 
food additive E 555 (Potassium aluminium silicate) is replaced by the following:  
' 
E 555  Potassium aluminium 
silicate  90% relative to the 
pigment  In E 172 iron oxides and 
hydroxides  
'. 
 