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Operational question for QA, regulatory and importers of green-tea-extract supplements: what does Regulation (EU) 2022/2340 still require under Annex III Parts B and C to Reg. 1925/2006 — and how does that differ from traditional infusions and from the highly purified EGCG (≥90%) novel-food track? The act’s answer: daily portion below 800 mg EGCG, the full Part B labelling set, a parallel Part C scrutiny listing, and an explicit infusion / reconstitutable aqueous-extract carve-out. CELEX 32022R2340.

Scope: restriction and Union scrutiny of “other substances” (Art. 8 of Reg. 1925/2006) for green-tea extracts containing EGCG. The act is not a Part A prohibition, does not replace national notification duties, does not unlock health claims (Reg. 1924/2006), and does not replace Union-list conditions for EGCG ≥90% novel food.
Decision path: infusion vs FS extract vs EGCG ≥90% novel food
Fig. 1. Three tracks: traditional infusion / aqueous extract ≈ infusion (footnote exclusion); extract in supplements → Parts B + C; highly purified EGCG ≥90% → novel-food track (recital 17).

1. What the act does

Commission Regulation (EU) 2022/2340 of 30 November 2022 (OJ L 310, 1.12.2022, pp. 7–11; ELI: eli/reg/2022/2340/oj; EUR-Lex: CELEX 32022R2340):

  • Article 1 — inserts “Green tea extracts containing (−)-epigallocatechin-3-gallate” into Annex III Part B (restricted substances) and Part C (substances under Union scrutiny) to Reg. 1925/2006;
  • Article 2 — foodstuffs containing such extracts that do not comply and were lawfully placed on the market before EIF may remain until 21 June 2023;
  • Article 3 — entry into force on the twentieth day after OJ publication → 21 December 2022.

Legal basis: Art. 8(2)(a)(ii) and (b) of Regulation (EC) No 1925/2006. Art. 8 procedure mechanics: Implementing Regulation (EU) No 307/2012 (Arts. 3–5 among others — Member State request, data, assessment).

Primary source: Part B conditions and the exclusion footnote verified against 2022/2340 and the consolidated 1925/2006 text. Language versions: PL, EN, DE.

2. Part B — conditions of use and labelling (exact)

Condition of use: the daily portion of food shall contain less than 800 mg of (−)-epigallocatechin-3-gallate (EGCG).

Additional labelling requirements:
• maximum number of portions for daily consumption and a warning not to consume a daily amount of 800 mg EGCG or more;
• EGCG content per portion of the food;
• the following three warnings (authentic EN wording of the act):
1. “Should not be consumed if you are consuming other products containing green tea on the same day”;
2. “Should not be consumed by pregnant or lactating women and children below 18 years old”;
3. “Should not be consumed on an empty stomach”.

Recital 13 recalls Art. 6(3) of Directive 2002/46/EC (recommended daily portion + “do not exceed”), but stresses that where several green-tea-extract foods may be consumed in one day that background rule is not enough — hence the Annex III duties.

3. Part C — scrutiny ≠ a waiver of Part B

The same substance is listed in Annex III Part C (Union scrutiny). Recitals 11–12 and Art. 8(4)–(5) of Reg. 1925/2006:

  • interested parties may submit data demonstrating safety (Art. 5 of Reg. 307/2012);
  • the Commission shall decide, within four years from entry into force of 2022/2340, whether to list the substance in Part A or Part B, taking account of any EFSA opinion on submitted data;
  • four-year clock from EIF (21.12.2022) → decision by about 21 December 2026.

Operational point: Part C describes a further-scrutiny procedure. It does not suspend the Part B conditions already in force (<800 mg, warnings, EGCG content). Until the Commission decides, extracts in supplements sit under both entries together.

No assumed 2026 Part A ban: as of this analysis (04.10.2026), do not invent an automatic move to Part A or a “new ban” unless a new act is verified on EUR-Lex. Part C remains scrutiny + ongoing Part B duties.

4. EFSA 2018 — scientific basis, not the Commission act

EFSA opinion of 14 March 2018 (EFSA Journal 2018;16(4):5239, DOI 10.2903/j.efsa.2018.5239) — cited in recitals 7–9, 14–16:

  • traditionally prepared infusions and reconstituted drinks of equivalent composition: generally safe under the presumption of safety at Member State–reported intakes (mean ~90–300 mg EGCG/day from infusions);
  • for supplements: doses ≥800 mg EGCG/day — statistically significant increase in serum transaminases (liver-injury marker) in interventional trials;
  • uncertainties: no safe intake advice for the general population and subgroups; composition variability; fasting/bolus increase exposure; no intervention data for pregnancy/lactation/children under 18.

An EFSA opinion is not a Commission regulation. Market restriction flows from 2022/2340 / Annex III, not from the Journal alone.

Contrast matrix: infusion vs FS extract vs NF ≥90% EGCG
Fig. 2. Contrast: infusion (exclusion) vs extract in FS (Parts B+C) vs highly purified EGCG ≥90% (novel-food track).

5. Infusion vs extract vs EGCG ≥90% (novel food)

Track2022/2340 scopeKey dutiesDo not confuse
Traditional infusion / aqueous extract reconstitutable ≈ infusionFootnote exclusion (*)EFSA presumption of safety at typical reported intakesDoes not unlock 1924/2006 claims; does not replace FIC
Green-tea extract in supplements / foods (not ≈ infusion)Parts B + C<800 mg EGCG/day; max portions; EGCG content; 3 warningsPart C ≠ free pass; Art. 6(3) 2002/46 ≠ full Annex III set
Highly purified EGCG ≥90% from Camellia sinensis leavesRecital 17 — not governed as Part B “green tea extracts”Conditions/specs of novel-food list 2017/2470 / Reg. 2015/2283Do not equate with any commercial “EGCG” extract blend

Footnote (*) to both entries: excluding aqueous green tea extracts containing (−)-epigallocatechin-3-gallate which after reconstitution in beverages have a composition comparable to traditional green tea infusions. Comparability turns on reconstituted composition — not on the marketing word “tea” on a capsule.

6. What the act does not do

  • does not list the substance in Part A (prohibition) — today it is Part B (restriction) + Part C (scrutiny);
  • does not suspend Part B merely because Part C applies;
  • does not replace GIS / national food-supplement notification duties;
  • does not authorise health claims on EGCG / green tea;
  • does not fold highly purified EGCG ≥90% into Part B “green tea extracts” rules (recital 17).

7. Operator checklist

  1. Is the SKU an infusion / aqueous ≈ infusion, an extract in FS, or NF EGCG ≥90%?
  2. Assay: EGCG per portion and daily total — is daily portion <800 mg?
  3. Label: max portions/day + warning not to consume ≥800 mg EGCG/day?
  4. Label: EGCG content per portion (not only “green tea extract X mg”)?
  5. Three warnings in the authentic language of the label (EN empty stomach / pregnancy-lactation-<18 / other green-tea products)?
  6. Does the team treat Part C as “still free of Part B”?
  7. Is Art. 6(3) 2002/46 used as a substitute for Annex III warnings?
  8. Does the NF ≥90% track keep its own 2017/2470 conditions — without mixing into Part B?
  9. Is same-day stacking with other “green tea” SKUs covered in IFU / communication?

Glossary

EGCG
(−)-epigallocatechin-3-gallate — principal green-tea catechin.
Part B (Annex III 1925/2006)
Restricted substances — here: <800 mg + labelling.
Part C
Substances under Union scrutiny — data gathering; Commission decision within 4 years of the listing act’s EIF.
Art. 8 Reg. 1925/2006
Procedure for prohibition / restriction / scrutiny of “other substances”; implementing rules: 307/2012.
Infusion exclusion
Footnote: aqueous extracts reconstitutable to a composition comparable to traditional infusions.
EGCG ≥90% NF
Highly purified green-tea leaf extract — novel-food track (2015/2283 / 2017/2470), recital 17.

Conclusion

From 21 December 2022 (with a transition until 21.06.2023 for pre-EIF stock), green-tea extracts containing EGCG — unless they fall within the infusion footnote — are subject to Part B restriction and Part C scrutiny in parallel. For supplement operators the checklist is concrete: <800 mg EGCG/day, content per portion, max portions, and three warnings (stacking / vulnerable groups / empty stomach). Part C’s four-year decision window closes around end-2026, but that is not a waiver of Part B. Infusions and highly purified EGCG ≥90% remain separate tracks.

B2B educational material, not legal or medical advice. Based on Regulation (EU) 2022/2340 (CELEX 32022R2340) and EFSA Journal 2018;16(4):5239. SKU qualification depends on composition, form, labelling and the full annex text. Manufacturers, importers and distributors: B2B contact.

Primary sources

  1. Commission Regulation (EU) 2022/2340 — CELEX 32022R2340; ELI eli/reg/2022/2340/oj; OJ L 310, 1.12.2022, pp. 7–11; EIF 21.12.2022; Art. 2 until 21.06.2023.
  2. Regulation (EC) No 1925/2006 — Annex III Parts B and C; Article 8.
  3. EFSA Journal 2018;16(4):5239 — Safety of green tea catechins; DOI 10.2903/j.efsa.2018.5239.
  4. Implementing Regulation (EU) No 307/2012 — Art. 8 rules (Arts. 3–5).
  5. Directive 2002/46/EC — Art. 6(3) (daily portion; background in recital 13).
  6. Implementing Regulation (EU) 2017/2470 — Union list of novel foods; EGCG ≥90% (recital 17 of 2022/2340).