Listen to the article:

The operational question is precise: does Regulation (EU) 2026/189 allow a shellac (E 904) coating on adult / non-infant FSMP tablets, at what maximum level, and which specification replaces wax-containing shellac? The act’s answer: yes — category 13.2, ML 46,000 mg/kg, tablet and coated tablet only; wax-containing shellac deleted from the specs. CELEX 32026R0189.

Scope: use conditions for E 904 in category 13.2 and purity / definition under Reg. 231/2012. This is not a novel-food authorisation, does not unlock health claims (1924/2006), and does not amend gums / E 1450 under Regulation (EU) 2026/196.
Path: 2018 application, EFSA 2024, act 2026/189, entry into force 18 Feb 2026, ML 46,000
Fig. 1. From the application (25 Oct 2018) through EFSA (1 Aug 2024, e8897) and the Commission act (28 Jan 2026) to entry into force on 18 Feb 2026 and the 46,000 mg/kg ML in category 13.2.

1. What does the act do?

Commission Regulation (EU) 2026/189 of 28 January 2026 (OJ L, 2026/189, 29.1.2026; ELI: http://data.europa.eu/eli/reg/2026/189/oj; EUR-Lex: CELEX 32026R0189) amends:

  • Article 1 / Annex I — Part E of Annex II to Regulation (EC) No 1333/2008: in category 13.2 inserts E 904 between E 491–495 and E 950;
  • Article 2 / Annex II — the Annex to Regulation (EU) No 231/2012: Definition, Description and Wax for E 904.

The application was submitted on 25 October 2018: E 904 as a glazing agent in foods for special medical purposes as defined by Regulation (EU) No 609/2013, category 13.2, excluding products from food category 13.1.5, only for foods in tablet and coated tablet forms.

Primary source: act text verified against the OJ extract / ELI eli/reg/2026/189/oj. Language versions: EN, PL, DE.

2. Technological rationale

Recital (6): shellac (E 904) used as a glazing agent provides a protective coating of FSMP in tablet and coated tablet forms. In particular, when applied to the external surface of tablets it protects them from disintegration until reaching the intestines, which ensures that active ingredients are appropriately supplied. That is the technological rationale of the application — not a health claim under 1924/2006.

3. EFSA (1 Aug 2024): ADI and recommendations vs Commission decision

The FAF Panel issued Re-evaluation of shellac (E 904) as a food additive and a new application on the extension of use of shellac (E 904) in dietary foods for special medical purposes (EFSA Journal 2024;22(8):e8897; DOI 10.2903/j.efsa.2024.8897). From recital (7) of the Commission act, the Authority:

  • derived an ADI of 4 mg/kg bw per day for wax-free shellac (E 904) produced by physical decolouring;
  • noted that for several age groups the ADI was exceeded at the 95th percentile of exposure, but — given the low exceedance and conservative exposure and toxicological evaluation — considered that the exceedance would not indicate a safety concern;
  • recommended deleting information on wax-containing shellac from the specifications (not used as a food additive; no data to confirm safety);
  • recommended further data: organochlorine impurities, temporary ADI for chemically bleached shellac, separate specifications for chemical bleaching vs physical decolouring, lower lead limits and limits for other toxic elements.

EFSA opinion ≠ market authorisation. The Commission authorises the 13.2 use and cleans wax-containing shellac from the specs; not every further-data recommendation is implemented as a full E 904 reform in this act.

Matrix: E 904 allowed in 13.2 tablets; none in 13.1.5; wax-free specs
Fig. 2. Rule matrix: cat. 13.2 — YES (46,000 mg/kg, tablets only); cat. 13.1.5 — NO; Reg. 231/2012 specs — wax-free, wax ≤ 0.2%.

4. Maximum level and use conditions (Annex I)

In category 13.2 ‘Foods for special medical purposes as defined by Regulation (EU) No 609/2013 (excluding products from food category 13.1.5)’ the following entry is inserted:

AdditiveNameMaximum levelRestrictions / exceptions
E 904Shellac46,000 mg/kgonly in tablet and coated tablet forms

Operationally: the product must be FSMP in category 13.2, the form must be tablet / coated tablet, and E 904 must not exceed 46,000 mg/kg. Other forms (powder, liquid, gel) in 13.2 are not covered by this entry.

5. E 904 specification (Annex II / Reg. 231/2012)

The act replaces three fields in the ‘E 904 Shellac’ entry:

  • Definition — Shellac is the purified and bleached lac, the resinous secretion of the insect Laccifer (Tachardia) lacca Kerr (Fam. Coccidae). The wax is removed by filtration.
  • Description — Wax-free bleached shellac – off-white to light yellow, amorphous, granular resin.
  • Wax — not more than 0.2%.

Recital (9): wax-containing shellac is not used as a food additive and no safety data were available — hence deletion of wax-containing information from the specifications. For CoAs and purchasing: require wax-free bleached and wax ≤ 0.2%.

6. Entry into force

Article 3: the Regulation enters into force on the twentieth day following that of its publication in the Official Journal of the European Union. Publication: 29 January 2026. The twentieth day following publication is 18 February 2026. There is no later separate “applies from” date — from 18 Feb 2026 the entry and specification apply directly.

7. What the act does not do

  • It does not authorise E 904 in category 13.1.5 (infant / young-child FSMP branch of the list).
  • It does not change gums / E 1450 rules under Regulation (EU) 2026/196 (same act date, different scope: IF and infant FSMP hydrocolloids).
  • It does not regulate repeating mandatory nutrition elements on FSMP labels — that is Reg. (EU) 2016/128; Art. 6(2) of that Regulation is a derogation from Art. 30(3) of Regulation (EU) No 1169/2011 (absolute ban on repeating), not producer discretion. Related: repeating nutrition information on FSMP / supplement labels (if present on site).
  • It is not a health-claim authorisation (1924/2006).

8. Allergens / insect origin

Shellac is an insect-derived resin (Laccifer lacca). Insect origin alone does not make it a substance listed in Annex II to Regulation (EU) No 1169/2011 (allergen emphasis list). FIC duties on ingredients and any vegetarian / vegan claims are a separate labelling analysis — this act neither creates nor removes them.

9. Compliance checklist

  1. Category: 13.2 FSMP (609/2013), not 13.1.5.
  2. Form: tablet or coated tablet.
  3. E 904 level ≤ 46,000 mg/kg.
  4. Raw material: wax-free bleached; wax ≤ 0.2% under 231/2012 as amended by 2026/189.
  5. Do not derive health claims from additive status; do not confuse with 2026/196.

Glossary

FSMP
Food for special medical purposes — Regulation (EU) No 609/2013.
Category 13.2
FSMP in Annex II to Reg. 1333/2008, excluding products from 13.1.5.
Glazing agent
Technological function of E 904 in this entry.
Wax-free shellac
Shellac with wax removed by filtration; wax ≤ 0.2% in the specification.

Conclusion

From 18 February 2026, Regulation (EU) 2026/189 allows E 904 (shellac) as a glazing agent in FSMP category 13.2 only in tablet and coated tablet forms, at an ML of 46,000 mg/kg, and imposes a wax-free specification (wax ≤ 0.2%). Infant FSMP (13.1.5) stays outside this entry. EFSA opinion e8897 underpins the act; the Commission regulates the market.

Educational material, not legal or medical advice. Based on Regulation (EU) 2026/189 (CELEX 32026R0189) and recitals citing EFSA e8897; product qualification depends on category, form and supplier documentation.

Primary sources

  1. Commission Regulation (EU) 2026/189 — CELEX 32026R0189; ELI eli/reg/2026/189/oj. Entry into force 18 Feb 2026.
  2. Regulation (EC) No 1333/2008 — food additives (Annex II, category 13.2).
  3. Regulation (EU) No 231/2012 — additive specifications (E 904).
  4. Regulation (EU) No 609/2013 — FSMP.
  5. EFSA 2024 — shellac E 904 re-evaluation + FSMP extension (DOI 10.2903/j.efsa.2024.8897; Journal 2024;22(8):e8897).
  6. Regulation (EU) 2026/196 — contrast: gums and E 1450 in IF / infant FSMP.
  7. Regulation (EC) No 1924/2006 — nutrition and health claims.