EN   EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10116/2020 
(POOL/E2/2020/10116/10116-EN.docx)  
D066794/03 
[…](2020) XXX  draft 
 
COMMISSION REGULATION (EU) …/… 
of XXX  
amending the Annex t o Regulation (EU) No 231/2012 laying down s pecifications for food 
additives listed in Annexes II  and III to Regulation (EC) No 13 33/2008 of the European 
Parliament and of the Council a s regards specifica tions for tit anium dioxid e (E 171) 
(Text with EEA relevance) 
 EN 1  EN COMMISSION REGULATION (EU) …/… 
of XXX  
amending the Annex to Regulat ion (EU) No 231/2012 laying down s pecifications for food 
additives listed in Annexes II and III to Regulation (EC) No 13 33/2008 of the European 
Parliament and of the Council as regards specifications for tit anium dioxide (E 171) 
(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 P arliament and of the 
Council of 16 December 2008 on food additives1, and in particular Article 14 thereof, 
Having regard to Regulation (EC) No 1331/2008 of the European P arliament and of the 
Council of 16 December 2008 establishing a common authorisation  procedure for food 
additives, food enz ymes and food flavourings2, and in particular Article 7(5) thereof,  
Whereas:  (1) Commission Regulation (EU) No 231/2012
3 lays down specifications for food 
additives listed in Annexes II a nd III to Regul ation (EC) No 13 33/2008. 
(2) Those specifications may be update d in accordance with the comm on procedure 
referred to in Article 3(1) o f Regulation (EC) No 1331/2008, ei ther on the initiative of 
the Commission or follo wing an application. 
(3) Titanium dioxide (E 171) is a substance authorised as a colour in a variety of foods in 
accordance with Annex II to Regulation (EC) No 1333/2008.  
(4) Article 32(1) of Regulation (E C) No 1333/2008 provides that all  food additives that 
were already permitted in the Union before 20 January 2009 are subject to a new risk 
assessment by the European Food Safety Authority (ʻthe Authorit y’). Commission 
Regulation (EU) No 257/20104 provides that the re-evalua tion of food colours was to 
be completed by 31 December 2015. On 14 September 2016, the Aut hority published 
a scientific opinion on the re-evaluation of the safety of tita nium dioxide (E 171) as a 
food additive5. The Authority concluded that on the basis of the database ava ilable and 
the considerations on the abso rption of titanium  dioxide (E 171 ), the margins of safety, 
which were calculated consideri ng the no observed adverse effec t level (NOAEL) of 2 
250 mg titanium dioxide/kg body weight per day identiﬁed in the  toxicological data 
 
1 OJ L 354, 31.12.2008, p. 16. 
2 OJ L 354, 31.12.2008, p. 1. 
3 Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food 
additives listed in Annexes II and III to Regulation (EC) No 13 33/2008 of the European Parliament and 
of the Council (OJ L 83, 22.3.2012, p. 1). 
4 Commission Regulation (EU) No 257/2010 of 25 March 2010 settin g up a program for the re-
evaluation of approved food add itives in accordance with Regula tion (EC) No 1333/2008 of the 
European Parliament and of the Council on food additives (OJ L 80, 26.3.2010, p. 19). 
5 EFSA Journal 2016;14(9):4545. EN 2  EN available and the exposure to t itanium dioxide (E 171) obtained  from the reported 
use/analytical levels, would not be of concern.  In the opinion, the Authority 
recommended additional toxicological testing in order to enable  the Authority to 
establish a health-based guidance value (acceptable daily intak e - ADI) for the food 
additive titanium dioxide (E 171) . The Authority also recommend ed that the Union 
speciﬁcations for titanium di oxide (E 171) should include a cha racterisation of particle 
size distribution and that the maximum limits for the impuritie s of arsenic, lead, 
mercury and cadmium should be rev ised in order to ensure that t itanium dioxide (E 
171) as a food additive will not be a significant source of exp osure to those elements 
in foods. 
(5) On 30 January 2017, the Commission launched a public call for s cientific and 
technological data on titanium dioxide (E 171)6, targeting the data needs identified in 
the scientific opinion on the re- evaluation of this substance a s a food additive. 
Information on the actual use of  alumina (aluminium oxide) for the coating of titanium 
dioxide (E 171) was also requested , to determine what would be the contribution of 
titanium dioxide (E 171) coated with alumina to the exposure to  aluminium through 
food. 
(6) On 2 October 2017, business operato rs submitted information on the lowest achievable 
limits for the impurities of arsenic, lead, mercury and cadmium  in titanium dioxide 
(E 171) as well as information on the actual use of alumina (al uminium oxide) for the 
coating of titanium dioxide (E 171). On 18 July 2019, business operators submitted 
analytical data on current lev els of antimony, arsenic, lead, m ercury and cadmium in 
the food additive titanium dioxide (E 171). 
(7) On 29 June 2018, business operators submitted data on particle size and particle size 
distribution for titanium dioxide  (E 171), including a proposal  for the specifications 
for E 171 with respect to particle size and particle size distr ibution. On 7 August 2018, 
the Commission requested the Authority to provide a scientific opinion on   whether 
the analytical data provided by business operators adequately s upport the proposed 
amendment of the specifications  for the food additive titanium dioxide (E 171), with 
respect to the inclusion of addi tional parameters  related to it s particle size. 
(8) As requested, on 12 July 2019, the Authority published a scient ific opinion on the 
proposed amendment of the speciﬁcations for titanium dioxide (E  171) with respect to 
the inclusion of additional parameters related to its particle size distribution7. It 
concluded that, on the basis of  the available data and taking i nto account measurement 
uncertainty, a speciﬁcation shoul d be inserted setting out that  t h e  m e d i a n  m i n i m u m  
external dimension by number of t he constituent particles measu red by electron 
microscopy is higher than 100 nm, which is equivalent to less t han 50% of constituent 
particles by number wi th a minimum extern al dimension below 100  nm.   
(9) The Authority also recommended that, in view of the additional information submitted 
by interested business operators , the definition of the food ad ditive titanium dioxide 
(E 171) should be revised in the current Union specifications t o indicate that, as a food 
additive, it may contain small  quantities (< 0.5%) of constitue nt particle growth and 
crystal phase control agents (alumina, sodium or potassium in c ombination with 
phosphate), but it has no surface treatments or coatings. Furth ermore, the Authority 
clarified that, in its view, potassium aluminium silicate-based  pearlescent pigments are 
 
6 http://ec.europa.eu/food/safety/food_improvement_agents/additi ves/re-evaluation_en. 
7 EFSA Journal 2019;17(7):5760. EN 3  EN not covered by the definition of the food additive titanium dio xide (E 171) and 
therefore, that its assessment does not cover titanium dioxide used for the preparation 
of those pigments. 
(10) Pending the submission by business operators, and the evaluatio n by the Authority, of 
new toxicological data expected to enable the Authority to esta blish a health-based 
guidance value (ADI) for titanium dioxide (E 171), some amendme nts should be 
introduced already now to the sp ecifications for titanium dioxi de (E 171),  as 
recommended by the Authority in the Scientific Opinion on the r e-evaluation of the 
safety of titanium dioxide ( E 171) as a food additive, publishe d on 14 September 2016, 
and in the Scientific opinion on the proposed amendment of the EU speciﬁcations for 
titanium dioxide (E 171) with respect to the inclusion of addit ional parameters related 
to its particle size di stribution, published on 12 July 2019.  
(11) On the basis of the analytical data submitted by business opera tors in reply to the 
Commission’s call for data, the Commission was able to derive n ew technically 
achievable limits for the impurit ies of antimony, lead, mercury  and cadmium in 
titanium dioxide (E 171), which are lower than the current limi ts in the specifications 
for titanium dioxide (E 171). 
(12) The Annex to Regulation (EU) No 231/2012 should therefore be am ended 
accordingly. 
(13) Even if titanium dioxide complyi ng with the current specificati ons but not complying 
with this Regulation should no l onger be authorised for use as a food additive, there is 
no indication that it would pose a health concern which would r equire that, with 
immediate effect as of the date of  entry into force of this Reg ulation, it is not at all 
placed on the market or remain on it. Therefore, in order to al low for a smooth 
transition to the amended specifications, it is appropriate to allow that during a 
transitional period titanium di oxide complying with either the old or the new 
specifications can legally be pl aced, and remain, on the market . 
(14) For the same reasons, it is als o appropriate that foods contain ing titanium dioxide 
complying with the currently app licable specification that have  been lawfully placed 
on the market before or during that transitional period may con tinue to be marketed 
until the stocks are exhausted. 
(15) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plan ts, Animals, Food and Feed, 
HAS ADOPTED THIS REGULATION: 
Article 1 
The Annex to Regulation (EU) No 231/2012 is amended in accordan ce with the Annex to this 
Regulation.  
Article 2 
1. Until xxxx (six months after date of entry into force of thi s Regulation), the food 
additive titanium dioxide (E 171) may continue to be placed on the market as such in 
accordance with the specifications applicable before xxxx (date  of entry into force of 
this Regulation).  
2. Until xxxx (six months after date of entry into force of thi s Regulation), foods 
containing titanium dioxide (E 171 ) complying with the specific ations applicable EN 4  EN before xxxx (date of entry into f orce of this Reg ulation), may continue to be placed 
on the market. After that date, they may remain on the market u ntil the exhaustion of 
stocks. 
Article 3 
This Regulation shall enter into force on the twentieth day fol lowing that of its publication in 
the Official Journal of  the European Union . 
This Regulation shall be binding i n its entirety and directly a pplicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President   Ursula VON DER LEYEN