II
(Non-legislative acts)
REGUL ATIONS
COMMISSION REGUL ATION (EU) 2022/63 
of 14 Januar y 2022
amending Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the 
Council as regards the food additiv e titanium dioxide (E 171) 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng 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) thereof,
Havi ng regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008
establishing a common author isation procedure for food additives, food enzymes and food flavourings (2), and in 
particular Article 7(5) thereof,
Whereas:
(1) Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in foods and 
their conditions of use.
(2) Annex III to Regulation (EC) No 1333/2008 lays down a Union list of food additives appro ved for use in food 
additives, food enzymes, food flavourings, nutr ients and their conditions of use.
(3) Titanium dioxide (E 171) is a substance author ised as a colour in certain foods, in accordance with Annex II to 
Regulation (EC) No 1333/2008.
(4) Pursuant to Article 3(1) of Regulation (EC) No 1331/2008, the Union list of food additives may be updated either on 
the initiative of the Commission or followi ng an application.
(5) Article 32(1) of Regulation (EC) No 1333/2008 provides that all food additives that were already permitted in the 
Union before 20 Januar y 2009 are subject to a new risk assessment by the European Food Safety Authority (‘the 
Authority’).
(6) On 14 Sept ember 2016 , the Author ity published a scientifi c opinion on the re-evaluation of the safet y of titanium 
dioxide (E 171) as a food additive (3)concluding that the margins of safety calculat ed in the opinion would not be of 
concer n. Never theless, the Author ity recommended additional toxicological testing, an extended 90-da y study or a 
multigener ation or extended-one generation reproduction toxicity study according to the current OECD guidelines, 
in order to be able to establish a health-based guidance value (acceptable daily intake – ADI) for titanium dioxide (E 
171). The Author ity also recommended amendments to the Union specifications for titanium dioxide (E 171) by 
introducing a character isation of the particle size distr ibution and the percentage of particles in the nanoscale 
present in titanium dioxide (E 171) used as a food additive, and revising the maximum limits for impur ities of toxic 
elements.
(1)OJ L 354, 31.12.2008, p. 16.
(2)OJ L 354, 31.12.2008, p. 1.
(3)EFSA Jour nal 2016;14(9):4545.EN Offi cial Jour nal of the European Union 18.1.2022 L 11/1  (7) On 30 Januar y 2017 , the Commission launched a public call for scientific and technological data on titanium 
dioxide (E 171), targeting the data needs identif ied in the scientific opinion on the re-evaluation of this substance as 
a food additive.
(8) On 2 October 2017 and 29 June 2018 , in view of the recommendations made by the Auth ority, business operat ors 
made a proposal for the amendment of the specifi cations for titanium dioxide (E 171) and submitte d the necessar y 
data. On 7 August 2018 , the Commission requeste d the Auth ority to provide a scientific opinion on whether the 
data provid ed adequately suppor t the proposed amendment of the specifi cations for titanium dioxide (E 171).
(9) On 12 July 2019 , the Author ity published a scientifi c opinion on the proposed amendments of the specifications for 
titanium dioxide (E 171) used as a food additive. The Author ity concluded on additional paramete rs related to 
particle size distr ibution to be included in the specifications and recommended a revision of the definition of the 
food additive titanium dioxide (E 171) in the Union specifications. The Authority also concluded that, based on the 
proposed change in the specif ications, revisiting the toxicological database on titanium dioxide (E 171) as a food 
additive should consequently be conduct ed in line with the data requirements specifi ed in the 2018 ‘Guidance on 
risk assessment of the application of nanoscience and nanotec hnologies in the food and feed chain’ (4).
(10) On 6 March 2020 , the Commission requeste d the Author ity to assess the safety of the food additive titanium dioxide 
(E 171), taking into account the proposed amendments of the specif ications, the data from an extende d one 
generation reproductive study submitted by a consor tium of inter ested business operators in reply to the public call 
for data launched in 2017 as well as all new relevant data available since the completion of the re-evaluation of 
titanium dioxide (E 171) in 2016, including the data considered to be in line with the data requirements specified in 
the 2018 Guidance on nanotec hnology .
(11) On 6 May 2021 , the Author ity published a scientifi c opinion on the safet y assessment of titanium dioxide (E 171) as 
a food additive (5). In light of the opinion on the proposed amendments of the specifications and follo wing the 2018 
Guidance on nanotec hnology , the opinion also takes into account, in addition to all new relevant data, the data on 
the pote ntial genoto xicity of titanium dioxide nanopar ticles published before 2016, that had not previously been 
identif ied as relevant for the 2016 re-evaluation. In its opinion the Authority indicated that, based on all the 
evidence available, a concer n for genoto xicity could not be ruled out, and given the many uncer tainties, it 
concluded that titanium dioxide (E 171) can no longer be considered safe when used as a food additive. The 
Authority neither identif ied nor recommended any new studies that could alleviate the genot oxicity concer n and 
other remaining uncer tainties.
(12) In light of the conclusion of the 2021 Author ity’s opinion about the safet y of titanium dioxide (E 171) when used as 
a food additive, it is appropr iate to remo ve the author isation to use titanium dioxide (E 171) in foods. According ly, 
titanium dioxide (E 171) may no longer be used in foods. As titanium dioxide (E 171) would no long er be 
author ised for use in foods, it is also appropr iate to remo ve the referen ce to it from the entr y on the use of 
potassium aluminium silicate (E 555) as a carrier laid down in Part 1 of Annex III to Regulation (EC) No 1333/2008.
(13) However , given that the Author ity did not identify an immediate health concer n linked to titanium dioxide (E 171) 
used as a food additive and in order to allow for a smooth transition, it is appropr iate that foods that contain 
titanium dioxide (E 171) used in accordance with the rules applicable before the date of entr y into force of this 
Regulation may be placed on the mark et until six months after that date. Those foods may then continue to be 
mark eted until their date of minimum durability or ‘use by’ date .
(4)EFSA Jour nal 2018;16(7):5327.
(5)EFSA Jour nal 2021;19(5):6585.EN Offi cial Jour nal of the European Union L 11/2 18.1.2022  (14) Directive 2009/35/EC of the European Parliament and of the Council (6)restr icts the use of colours in human and 
veteri nary medicinal products to those author ised in accordance with Regulation (EC) No 1333/2008 on food 
additives, for whic h specifications are laid down in Commission Regulation (EU) No 231/2012 (7). Uses of 
excipien ts other than colours in medicinal products are subject to the Union rules on medicinal products and are 
evaluated as part of the overall benefi t risk prof ile of a medicinal product.
(15) In response to a request from the Commission, the European Medicines Agen cy (EMA) provid ed on 8 Sept ember 
2021 a scientifi c analysis on the technical purpose of the use of titanium dioxide (E 171) in medicinal products, the 
feasibility of replacement and possible timeframes for alternati ves. In its conclusions, EMA indicated that titanium 
dioxide is mainly used in medicinal products as a colour and opacifier , even if it has multiple functions. It also 
stressed that titanium dioxide is used frequently in a number of essential medicinal products in oral-solid and oral 
semi-solid dosage forms. EMA also stressed that, from a technical point of view , it should be possible to find 
alternati ves to replace titanium dioxide (E 171)-containing coatings, both as colour and for other uses. However , it 
also underlined that its feasibility is not conf irmed at this stage, as replacing titanium dioxide (E 171) would impact 
in a negative manner the quality , safet y and efficacy of medicinal products. EMA highlight ed the need to carefully 
assess altern atives, notably to ensure their compati bility with the various compo nents of individual phar maceutical 
products. The replacement of titanium dioxide (E 171) in author ised medicinal products would require an 
individual review and assessment, possibly requir ing bioequivalence studies. Further more, EMA concluded that it is 
difficult at this stage to recommend a precise transition period timeframe for the replacement of titanium dioxide (E 
171) used in medicinal products, as the time needed to reformulate each individual product could take several years, 
depending on the compl exity of reformulation and studies required. Finally , consider ing the scale of the use of this 
excipien t and the volume of products impacted, and taking into account global supply chains, EMA stressed that a 
requirement to replace titanium dioxide (E 171) would almost certainly cause signif icant medicines shor tages on the 
Union mark et.
(16) On the basis of the EMA scientific analysis, and in order to avoid shor tages of medicinal products that could have 
imp acts on public health, titanium dioxide (E 171) should remain provisionally on the list of author ised additives to 
allow its use in medicinal products as a colour , pending the development of adequate altern atives to replace it while 
ensur ing the quality , safet y and effic acy of the medicinal products concer ned. Dur ing this time, titanium dioxide (E 
171) should however be included in the list of colours that may not be sold directly to consumers.
(17) It is of critical importance that the phar maceutical industr y makes any possible efforts to accelerat e the researc h and 
development of altern atives that would be used as a replacement for titanium dioxide (E 171) in medicinal products, 
and to submit the necessar y variation to the terms of the mark eting author isations concer ned. In the absence of such 
efforts, compet ent author ities may request the concer ned stak eholders to submit objective and verifiable reason 
explaining the non-f easibility of the replacement.
(18) The Commission is committed to review the necessity to maintain titanium dioxide (E 171) or other wise delete it 
from the Union list of food additives for excl usive use as a colour in medicinal products within three years after the 
date of entering into force of this Regulation. This review should be based on an updated assessment of the EMA to 
be performed before 1 Apr il 2024 . It should take into account the progress made during this period to develop 
alternati ves to titanium dioxide (E 171) in medicinal products both for new products and for replacing it in 
author ised products, and possible impacts on quality , safety and efficacy , as well as on the availability of medicinal 
products. Where replacement of titanium dioxide (E 171) in medicinal products has not take n place or been 
initiate d within this period, only objective verifiable reasons related to the lack of feasibility of its replacement 
should be taken into account.
(19) Annex es II and III to Regulation (EC) No 1333/2008 should theref ore be amended according ly.
(20) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed,
(6)Directive 2009/35/EC of the European Parliament and of the Council of 23 Apr il 2009 on the colour ing matters whic h may be added 
to medicinal products (OJ L 109, 30.4.2009, p. 10).
(7)Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specificat ions for food additives listed in Annexes II and III 
to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).EN Offi cial Jour nal of the European Union 18.1.2022 L 11/3  HAS ADOPTED THIS REGUL ATION:
Article 1
Annex es II and III to Regulation (EC) No 1333/2008 are amended in accordance with the Annex to this Regulation.
Article 2
Until 7 August 2022 , foods produced in accordance with the rules applicable before 7 Febr uary 2022 may continue to be 
placed on the mark et. After that date , they may remain on the market until their date of minimum durability or ‘use by’ 
date .
Article 3
The Commission shall, followi ng consultation on the European Medicines Agency , review the necessity to maintain 
titanium dioxide (E 171) or to delet e it from the Union list of food additives for the exclusive use as colour in medicinal 
products in Part B of Annex II to Regulation (EC) No 1333/2008 within three years after the date of entering into force of 
this Regulation.
Article 4
This Regulation shall enter into force on the twentieth day followi ng 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, 14 Januar y 2022 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 11/4 18.1.2022  ANNEX 
1.Annex II to Regulation (EC) No 1333/2008 is amended as follo ws:
(a) in point 2 of Part A, point 5 is replaced by the followi ng:
‘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 follo ws:
1.the entr y for the food additive E 171 (Titanium dioxide) is replaced by the following:
‘E 171 Titanium dioxide (**)’;
2.the followi ng footnote (**) is added after footnote (*):
‘(**) Titanium dioxide is not author ised in the food categor ies 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 author ised at quantum satis’, the entr y for the food additive E 171 
(Titanium dioxide) is delet ed;
(d) Part E is amended as follows:
1.In categor y 04.2.4.1 (Fruit and vege table preparations excl uding compo te), the entr y concer ning the food 
additive E 171 (Titanium dioxide) is deleted;
2.In catego ry 09.2 (Processed fish and fisher y products including molluscs and crustaceans), the three entr ies 
concer ning the food additive E 171 (Titanium dioxide) are deleted;
2.In Part 1 of Annex III to Regulation (EC) No 1333/2008, the entr y concer ning 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 hydro xides ’.EN Offi cial Jour nal of the European Union 18.1.2022 L 11/5