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Operational question: is E 999 authorised in food supplements (17.1/17.2), from when, at what saponin-based ML, and which new specifications apply from 9 May 2026? Answer from the act: yes — from 9 November 2025, ML 3,350 (footnote 45: expressed as saponins) in 17.1 (mg/kg) and 17.2 (mg/l), excluding food supplements for infants and young children; new Reg. 231/2012 specifications from 9 May 2026. CELEX 32025R2084.

Scope: conditions of use for E 999 in Annexes II and III to Reg. 1333/2008 and purity/definition in Reg. 231/2012. This is not a novel-food authorisation, does not open health claims (1924/2006), and does not replace Poland’s GIS food-supplement notification.
Path: FS application 2023, EFSA e9140, act 2025/2084, EIF 9 Nov 2025, specs 9 May 2026
Fig. 1. From the food-supplement use application (3 Apr 2023) via EFSA opinion e9140 (13 Dec 2024) and the Commission act (17 Oct 2025) to uses EIF on 9 Nov 2025 and specifications from 9 May 2026.

1. What exactly does the act do?

Commission Regulation (EU) 2025/2084 of 17 October 2025 (OJ L series 2025/2084, 20.10.2025; ELI: http://data.europa.eu/eli/reg/2025/2084/oj; EUR-Lex: CELEX 32025R2084) amends:

  • Article 1 / Annex I — Part E of Annex II to Regulation (EC) No 1333/2008: E 999 levels in 14.1.4, 14.2.3 and new entries in 17.1 and 17.2;
  • Article 2 / Annex II — Part 4 of Annex III to 1333/2008: E 999 as emulsifier in flavourings used in named final food categories (carry-over as saponins);
  • Article 3 / Annex III — the Annex to Regulation (EU) No 231/2012: full replacement of the “E 999 Quillaia extract” entry.

The food-supplement application was submitted on 3 April 2023 (emulsifier in solid and liquid form, categories 17.1 and 17.2, excluding food supplements for infants and young children). A separate earlier strand covered flavourings (application of 11 February 2013).

Primary source: act text verified against the OJ / ELI extract eli/reg/2025/2084/oj. Language versions: EN, PL, DE.

2. Technological rationale (food supplements)

Recital (12): as an emulsifier in food supplements, E 999 improves water or lipid solubility, allowing poorly soluble ingredients into the final matrix. It enables sachets of powder to be diluted in water, gummies, ready-to-drink liquids and liquid shots in place of conventional pills, gels or tablets. That is technological rationale — not a health claim under 1924/2006.

3. EFSA: ADI, specifications, extension vs Commission decision

Three FAF Panel opinions underpin the act:

  • 2019 (e5622) — re-evaluation of E 999: ADI 3 mg saponins/kg bw per day; recommendation to express MLs on a saponin basis and amend specifications (EFSA Journal 2019;17(3):5622; DOI 10.2903/j.efsa.2019.5622);
  • February 2024 (e8563) — follow-up: lower Pb/Hg/As limits, Cd and calcium oxalate limits, microbiological criteria, minimum saponin content, CAS, revised definition (EFSA Journal 2024;22:e8563; DOI 10.2903/j.efsa.2024.8563);
  • 13 December 2024 (e9140) — extension of uses in food supplements: typical use levels in currently authorised categories plus the proposed extension would not exceed the ADI in any population group (EFSA Journal 2024;22:e9140; DOI 10.2903/j.efsa.2024.9140).

An EFSA opinion is not a market authorisation. The Commission authorises the limits and new specifications via 2025/2084; the opinions explain safety and technical recommendations.

Matrix: E 999 in 17.1/17.2, drinks and specs from 9 May 2026
Fig. 2. Rule matrix: 17.1/17.2 — YES (3,350 saponins); 14.1.4/14.2.3 — 170; flavouring carry-over; Reg. 231/2012 specs from 9 May 2026.

4. Limits in Annex II (Annex I to the act)

Part E of Annex II to 1333/2008 — key E 999 entries:

CategoryMLUnit / footnoteNotes
14.1.4 Flavoured drinks170(45) Expressed as saponinsreplaces the prior entry
14.2.3 Cider and perry170(45) as saponinsexcluding cidre bouché, cydr jakościowy, perry jakościowe, cydr lodowy, perry lodowe
17.1 Food supplements solid form3350(45) → 3,350 mg/kg as saponinsexcl. FS for infants and young children — new entry
17.2 Food supplements liquid form3350(45) → 3,350 mg/l as saponinsexcl. FS for infants and young children — new entry

Operationally for supplements: measure and declare the limit on a saponin basis, not as raw extract mass without conversion. Infant/young-child forms stay outside these categories.

5. Carry-over in flavourings (Annex II to the act)

In Part 4 of Annex III to 1333/2008, E 999 is inserted as emulsifier in flavourings used in named categories — final-food limits (expressed as saponins):

  • 05.2 Other confectionery… — 4 mg/kg;
  • 05.3 Chewing gum — 2 mg/kg;
  • 12.5 Soups and broths — 2 mg/l;
  • 14.1.5 Coffee, tea, herbal and fruit infusions… — 1.2 mg/l;
  • 15.1 Potato-, cereal-, flour- or starch-based snacks — 0.2 mg/kg.

6. New E 999 specifications (from 9 May 2026)

Article 3 applies from 9 May 2026. The new Reg. 231/2012 entry includes, inter alia:

  • Definition — aqueous extraction of Quillaia saponaria Molina or other Quillaia species (Rosaceae); clarification, filtration, ultrafiltration, concentration, pasteurisation; triterpenoid saponins (glycosides of quillaic acid), polyphenols, carbohydrates, and to a minor extent proteins;
  • CAS — 68990-67-0;
  • Assay — saponin content not less than 20% on dried basis;
  • pH — 3.7–5.5 (4% solution);
  • Water — ≤ 6.0% (Karl Fischer; powder form only);
  • Metals (per kg saponins): As ≤ 5; Pb ≤ 3; Hg ≤ 0.5; Cd ≤ 0.5 mg/kg; calcium oxalate ≤ 6 g/kg saponins;
  • Micro: TAC ≤ 100 CFU/g; Salmonella absent in 25 g; S. aureus absent in 1 g; E. coli absent in 1 g; yeast ≤ 10 CFU/g; moulds ≤ 10 CFU/g.

7. Entry into force and transition

Article 5: the Regulation enters into force on the twentieth day following OJ publication. Publication: 20 October 2025 → EIF 9 November 2025. Uses under Articles 1–2 apply from EIF. Article 3 (specifications) applies from 9 May 2026.

Article 4: E 999 lawfully placed on the market before 9 May 2026 may be added to food in accordance with Annexes II and III to 1333/2008 until stocks are exhausted. Foods containing such E 999 may be placed on the market until their date of minimum durability or use-by date.

8. What the act does not do

  • It does not cover food supplements for infants and young children (explicit exclusion in 17.1/17.2 wording).
  • It is not a basis for a health claim (1924/2006).
  • It is not a novel-food authorisation (Reg. 2015/2283).
  • It does not remove Poland’s GIS food-supplement notification duty.

9. Operator compliance checklist

  1. Category: 17.1 or 17.2 (not IYC), or 14.1.4 / 14.2.3, or flavouring with carry-over.
  2. Limit: 3,350 (saponins) in supplements; 170 in drinks/cider-perry (with 14.2.3 exclusions).
  3. From 9 May 2026: CoA matches the new 231/2012 entry (CAS, ≥20% saponins, metals, micro).
  4. Before 9 May 2026: stock transition plan under Article 4.
  5. PL: GIS notification + FIC labelling; no “E 999” health claims.

Glossary

E 999 / quillaia extract
Soapbark extract from Quillaia spp. — food additive with emulsifier function; MLs expressed as saponins.
Footnote (45)
“Expressed as saponins” — ML counted on saponin content, not raw extract mass without conversion.
Cat. 17.1 / 17.2
Food supplements in solid / liquid form in Annex II to Reg. 1333/2008, excluding supplements for infants and young children.
ADI
Acceptable daily intake — here 3 mg saponins/kg bw/day (EFSA 2019 e5622).

Conclusion

From 9 November 2025, Regulation (EU) 2025/2084 allows E 999 in food-supplement categories 17.1 and 17.2 (excl. IYC) at ML 3,350 expressed as saponins, updates drinks and cider/perry, and flavouring carry-over. From 9 May 2026, the tighter Reg. 231/2012 specification applies (inter alia ≥20% saponins, CAS 68990-67-0, metals and micro). EFSA opinions support safety; the Commission regulates the market. In PL, GIS notification and the ban on unauthorised claims remain separate.

Educational material, not legal or medical advice. The text is based on Regulation (EU) 2025/2084 (CELEX 32025R2084) and EFSA opinions e5622 / e8563 / e9140; product qualification depends on category, saponin conversion and supplier documentation.

Primary sources

  1. Commission Regulation (EU) 2025/2084 — CELEX 32025R2084; ELI eli/reg/2025/2084/oj. Uses EIF: 9 Nov 2025; Art. 3: 9 May 2026.
  2. Regulation (EC) No 1333/2008 — food additives (Annexes II and III).
  3. Regulation (EU) No 231/2012 — specifications (E 999).
  4. EFSA 2019 — re-evaluation quillaia extract E 999 (DOI 10.2903/j.efsa.2019.5622).
  5. EFSA 2024 — follow-up specs E 999 (DOI 10.2903/j.efsa.2024.8563).
  6. EFSA 2024 — extension of uses E 999 (food supplements) (DOI 10.2903/j.efsa.2024.9140).
  7. Regulation (EC) No 1924/2006 — nutrition and health claims.