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Since 7 February 2022 titanium dioxide (E 171) may not be added to any food, food supplements included. Commission Regulation (EU) 2022/63 deleted E 171 from Group II, the food colours authorised at quantum satis, and it was precisely through a reference to Group II that colours reached categories 17.1–17.3 (food supplements in solid, liquid, syrup-type and chewable form). A white capsule shell, a film-coated tablet or a pearlescent dragée containing E 171 now infringes Articles 4(1) and 5 of Regulation (EC) No 1333/2008. The fact that E 171 still appears in Part B of Annex II changes nothing: footnote (**) states that the substance remains listed only because of medicinal products and is not authorised in any food category in Parts D and E.

Legal basis: Commission Regulation (EU) 2022/63 of 14 January 2022 amending Annexes II and III to Regulation (EC) No 1333/2008 as regards the food additive titanium dioxide (E 171), OJ L 11, 18.1.2022, p. 1; entry into force 7.2.2022 (Article 4). Adopted under Article 10(3) of Regulation 1333/2008 and Article 7(5) of Regulation 1331/2008, following the EFSA opinion of 6 May 2021 (EFSA Journal 2021;19(5):6585). Categories 17.1–17.3 and Group II come from Commission Regulation (EU) No 1129/2011.
Diagram: can a product contain titanium dioxide E 171 after Regulation 2022/63
Fig. 1. Whether E 171 is permitted depends on the legal status of the product, not on its form (capsule, tablet) or technological function (colour, opacifier). For food, supplements included, no basis of use remains.

1. What exactly Regulation 2022/63 changed

The Annex to Regulation 2022/63 contains five amendments. Each closes a different route by which E 171 could reach food:

Place in Regulation 1333/2008AmendmentRelevance for supplements
Annex II, Part C point 2 (Group II, quantum satis)E 171 deletedDecisive. Categories 17.1, 17.2 and 17.3 permit “Group II” without listing individual colours. With E 171 deleted, it is in none of them.
Annex II, Part E: categories 04.2.4.1 and 09.2Individual E 171 entries deletedIndirect: no food category is left from which E 171 could pass into a supplement as an ingredient.
Annex II, Part B point 1 (colours)Entry “E 171 Titanium dioxide (**)” with footnoteThe substance stays on the Union list only because of Directive 2009/35/EC on colours in medicinal products. Not authorised in the categories of Parts D and E.
Annex II, Part A point 2(5)E 171 added to colours that may not be sold directly to the consumerConcerns trade in the colour itself, e.g. as a “white food colouring” in an online shop.
Annex III, Part 1 (carriers): E 555Potassium aluminium silicate as a carrier now only in E 172 (iron oxides), no longer in E 171Closes the route for pearlescent pigments based on mica coated with titanium dioxide, used in glossy tablet and dragée coatings.

Recital 12 puts it plainly: in the light of the 2021 EFSA opinion the authorisation to use E 171 in foods should be removed, so “titanium dioxide (E 171) may no longer be used in foods”. The reference to E 171 in the E 555 entry was removed precisely because the substance was no longer authorised in foods.

2. Why the ban covers capsule shells and tablet coatings

Regulation 1333/2008 has no exception for “capsule material”. A gelatin or hydroxypropyl methylcellulose shell, a tablet coating, a printing ink on a tablet and the colour in a gummy are parts of the supplement, which is a food under Article 2(a) of Directive 2002/46/EC. A colour used in the shell is therefore a food additive used in the supplement. Under Article 4(1) of Regulation 1333/2008, only additives on the Union list in Annex II may be used in foods, and only under the conditions specified there. Article 5 prohibits placing on the market any food containing an additive whose use does not comply with those conditions.

In capsules and tablets titanium dioxide is used mainly as a white pigment and opacifier that protects light-sensitive ingredients. Regulation 1333/2008, however, lists it as a colour (Part B point 1), and it could be used only in that class. The opacifying function creates no separate legal basis. Once the authorisation as a colour is gone, every basis for use in food is gone.

The technical consequence for formulation: a replacement must itself have a basis in category 17.1, 17.2 or 17.3. Group II still includes, among others, E 170 (calcium carbonate) and E 172 (iron oxides and hydroxides). Group III colours are subject to a combined maximum (300 mg/kg in category 17.1 and for solid forms in 17.3; 100 mg/kg in category 17.2 and for liquid forms in 17.3). Every replacement must also meet the specifications in Regulation (EU) No 231/2012.

3. Why the Part B entry does not help supplements

Capsule suppliers sometimes argue that “E 171 has not been removed from the list”. That is true, but footnote (**) to Part B point 1 of Annex II limits what the entry means: titanium dioxide “is not authorised in the food categories listed in Part D and E” and remains in list B1 “because it is used in medicinal products in accordance with Directive 2009/35/EC”. Directive 2009/35/EC permits in medicines the colours authorised under food additive law. Without the Part B entry, E 171 would therefore disappear from medicines as well.

Recitals 15–16 explain this by reference to the European Medicines Agency analysis of 8 September 2021: replacing E 171 in medicines would require product-by-product assessment and risk shortages. Article 3 obliged the Commission to review the need to keep E 171 in medicines within three years of entry into force, i.e. by 7 February 2025. EMA delivered its updated analysis on 1 April 2024. The Commission set out its position in Staff Working Document SWD(2025) 244 final of 4 August 2025, which confirms continued use of E 171 in medicines. No formal act amending Annex II was adopted. On 7 October 2025 the association Avicenn brought an action for failure to act before the General Court (Case T-690/25, OJ C/2025/6211), arguing that the working document does not discharge the Article 3 obligation.

None of this concerns food. Deleting E 171 from Part B would close the exception for medicines. Keeping the entry does not open a route for supplements. The dividing line is the product’s status: a preparation authorised as a medicinal product is governed by pharmaceutical law and may contain E 171. A product notified to the Polish Chief Sanitary Inspectorate (GIS) as a food supplement is a food and may not contain it, even if it looks like a medicine and uses the same shell.

4. Carry-over and premixes: no loophole

Article 18 of Regulation 1333/2008 permits the presence of an additive in a compound food where it is permitted in one of the ingredients (paragraph 1(a)), or in a food to which an additive, enzyme or flavouring has been added, where the carried-over additive is permitted in that preparation under Annex III and has no technological function in the final food (paragraph 1(b)). After Regulation 2022/63 none of these conditions can be met for E 171:

  • No ingredient in which E 171 is permitted. It was deleted from Group II and from the last individual entries (categories 04.2.4.1 and 09.2). Carry-over from a compound ingredient therefore has no basis.
  • No Annex III entry. The only reference to E 171 in Part 1 of Annex III (the E 555 carrier) was removed. A coloured vitamin premix, granulate or flavouring containing E 171 cannot lawfully bring the substance into a supplement.
  • Technological function in the final food. A pigment in a shell or coating always has a technological function (colouring, opacifying) in the final product, so the condition in paragraph 1(b)(iii) could not be met even in theory.
Specification trap: pearlescent pigments described as “E 555 + E 171” or “mica-based pearlescent pigment” in a tablet or dragée coating. After the Annex III amendment, potassium aluminium silicate may be a carrier only in iron oxides (E 172), at up to 90% relative to the pigment. A pearlescent pigment based on titanium dioxide has no basis in food.
Diagram: where to look for titanium dioxide in supplement documentation and how to assess compliance
Fig. 2. Documentation check: shell, coating, ink, premix, pearlescent pigment. The entries on the left are example wordings from specifications and ingredient lists, not specific products.

5. Transitional period: what may still be sold in 2026

Article 2 of Regulation 2022/63 provides a single transitional rule. Foods produced in accordance with the rules applicable before 7 February 2022 could be placed on the market until 7 August 2022. After that date they may remain on the market until their date of minimum durability or “use by” date. Recital 13 justifies this period by the fact that EFSA identified no immediate health concern.

Three conclusions follow for practice in 2026:

  • The production date must precede 7 February 2022, and first placing on the market must have occurred by 7 August 2022 at the latest. A batch produced later from a stock of old capsules is not covered by Article 2.
  • In October 2026, relying on Article 2 would require a date of minimum durability more than about 4 years and 8 months after production. For supplements such a batch is the exception, and the burden of proving the dates lies with the operator selling the product.
  • The transition concerned placing on the market, not the place of production. Goods produced in a third country under local rules enjoy no additional period on import into the EU.

6. Import, e-commerce and the GIS notification

Most non-compliance today concerns products designed outside the EU and capsules bought as a finished component. A documentation check should cover every place where the pigment may be recorded:

DocumentWording pointing to E 171Assessment
Ingredients list on the label“E 171”, “titanium dioxide”, “colour: …” next to the shellNon-compliant with Articles 4(1) and 5 of Regulation 1333/2008 (save for the narrow Article 2 case of Regulation 2022/63).
Capsule or coating specification“CI 77891” (Colour Index number of titanium dioxide), “opacifier: TiO2”, “white opaque shell”Ask for the quantitative shell composition and a supplier statement that it contains no E 171.
Premix, granulate, pearlescent pigment“E 555 + E 171”, “pearlescent”, “mica/TiO2”No basis in Annex III. Replacement: E 555 carrier only in E 172.
Tablet printing inkwhite ink with TiO2The ink is part of the supplement; the same assessment applies.

Notification of the first placing of a supplement on the Polish market to the Chief Sanitary Inspector (Article 29 of the Polish Act on food and nutrition safety) does not confirm that the composition complies with Regulation 1333/2008. The food business operator is responsible for compliance under Article 17(1) of Regulation (EC) No 178/2002. Switching from a white E 171 shell to another shell is a change of composition that should be reconciled with the current label in the notification file. The procedure is described in our guide to the GIS notification. A similar “food category decides the additive” mechanism is discussed in the analysis of shellac E 904 in FSMP tablets.

7. What the ban does not decide

  • “Free from titanium dioxide” statements. Since no supplement in the EU may contain E 171, highlighting “E 171-free” as a distinguishing feature suggests a special characteristic that all similar products possess. Article 7(1)(c) of Regulation (EU) No 1169/2011 prohibits such misleading information. It is not a nutrition claim within Regulation 1924/2006, so it is assessed under Article 7 FIC.
  • The CLP classification of titanium dioxide. By its judgment of 1 August 2025 in Joined Cases C-71/23 P and C-82/23 P (ECLI:EU:C:2025:601) the Court of Justice dismissed the appeals of France and the Commission. It thereby upheld the annulment of the classification of titanium dioxide in powder form as a category 2 carcinogen by inhalation. That judgment concerns Regulation 1272/2008 and inhalation exposure. It has no effect on Regulation 2022/63, which rests on EFSA’s assessment for ingestion (a genotoxicity concern could not be ruled out).
  • The future of the medicines exception. The outcome of Case T-690/25 or any amendment of Part B will affect medicinal products. For supplements the legal position stays the same whatever the outcome.
  • Nanoparticle assessment of other additives. The 2021 EFSA opinion concerns E 171. It does not decide the safety of other pigments, including E 172 or E 170.

8. Checklist: an E 171-free supplement

  1. Product status. Confirm that the product is a food supplement (a food). The Part B exception applies only to medicinal products.
  2. All components. Check the shell, coating, ink, premixes, granulates and pigments, not only the list of active ingredients.
  3. Codes and synonyms. Search for “E 171”, “TiO2”, “CI 77891”, “titanium dioxide”, “pearlescent”.
  4. Replacement. Make sure the substitute colour has a basis in categories 17.1–17.3 (Group II or III, or an individual entry) and meets the Regulation 231/2012 specification.
  5. E 555 carrier. Permitted only in E 172, up to 90% relative to the pigment.
  6. Old batches. Sell products with E 171 only with documented production before 7.2.2022, placing on the market by 7.8.2022 and an unexpired date of minimum durability.
  7. Label and communication. Update the ingredients list after the shell change. Do not highlight “E 171-free” as a distinguishing feature.

Glossary

Group II
Food colours authorised at quantum satis, listed in Part C point 2 of Annex II to Regulation 1333/2008. Food categories refer to the group as a whole.
Quantum satis
No numerical maximum; the additive is used in accordance with good manufacturing practice at a level not higher than necessary to achieve the intended purpose.
Carry-over (Article 18)
Permitted presence of an additive in a food where it was permitted in an ingredient or in an added preparation and the conditions of Article 18 are met.
List B1
Part B point 1 of Annex II to Regulation 1333/2008: the list of all authorised colours.
CI 77891
Colour Index number of titanium dioxide as a pigment, found in technical specifications.

Conclusion

A food supplement may not contain titanium dioxide in any component: not in the capsule shell, the coating, the ink or a premix. Regulation 2022/63 closed every route: it deleted E 171 from Group II, to which categories 17.1–17.3 refer, removed the last individual entries in Part E and its mention in Annex III, so the carry-over principle fell away too. The Part B entry exists only for medicinal products and gives food no basis, and the dispute over its future (SWD(2025) 244, Case T-690/25) concerns medicines. The Article 2 transition covers only foods produced before 7 February 2022 and placed on the market by 7 August 2022, until their date of minimum durability.

B2B educational material, not legal advice. This analysis is based on Regulation (EU) 2022/63, Regulations (EC) No 1333/2008 and (EU) No 1129/2011, the 2021 EFSA opinion, SWD(2025) 244 and notices in the Official Journal. Manufacturers, importers and distributors: B2B contact.

Primary sources

  1. Commission Regulation (EU) 2022/63 of 14.01.2022, OJ L 11, 18.1.2022: recitals 11–18, Articles 1–4, Annex.
  2. Regulation (EC) No 1333/2008 on food additives: Articles 4, 5, 18; Annexes II and III.
  3. Commission Regulation (EU) No 1129/2011: Annex II Part C (colour groups) and Part E, categories 17.1–17.3.
  4. Commission Regulation (EU) No 1130/2011: Annex III Part 1 (carriers), original E 555 entry.
  5. EFSA FAF Panel, EFSA Journal 2021;19(5):6585: safety assessment of titanium dioxide (E 171) as a food additive.
  6. European Commission, SWD(2025) 244 final of 4.08.2025: use of titanium dioxide in medicinal products.
  7. Case T-690/25 Avicenn and Others v Commission: action brought on 7.10.2025, OJ C/2025/6211.
  8. CJEU judgment of 1.08.2025, C-71/23 P and C-82/23 P, ECLI:EU:C:2025:601 (CLP classification of titanium dioxide powder).
  9. Directive 2009/35/EC on the colouring matters which may be added to medicinal products.
  10. Regulation (EU) No 1169/2011: Article 7(1)(c).
  11. Regulation (EC) No 178/2002: Article 17(1).