Knowledge Base
Regulatory Status of Food-Grade Ester Gum: A Four-Jurisdiction Overview
This article summarises the publicly available legislation and official regulatory provisions governing the use of glycerol ester of gum rosin (GEGR) and glycerol ester of wood rosin (GEWR) as food additives in the United States, the European Union, Japan, and the United Arab Emirates. Links to primary sources are embedded directly in the text.
Both substances belong to the broader family of ester gums — resin acid glycerol esters derived from pine rosin — and share broadly similar applications as weighting agents in citrus-flavoured beverages and as tackifiers or plasticisers in chewing gum base. However, their regulatory treatment differs considerably across jurisdictions, and the two substances are not always interchangeable from a compliance perspective.
International Reference Framework (JECFA)
Before examining national legislation, it is useful to establish the international scientific baseline. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) is the primary international body that evaluates the safety of food additives and establishes acceptable daily intakes (ADIs). National and regional authorities frequently reference JECFA evaluations when setting their own standards.
The current JECFA positions are as follows:
- Glycerol ester of wood rosin (INS 445(iii)): ADI of 0–25 mg/kg body weight per day, confirmed at the 86th JECFA meeting (2018). The original ADI of 0–25 mg/kg bw was first established in 1996 and reconfirmed in 2013.
- Glycerol ester of gum rosin (INS 445(i)): ADI withdrawn. A temporary group ADI of 0–12.5 mg/kg bw was established at the 71st JECFA meeting (2009), extended conditionally at the 74th meeting (2011), and then formally withdrawn at the 80th meeting (2013) when the required 90-day oral toxicity studies on GEGR in rats were not submitted by the petitioner.
The withdrawal of the GEGR ADI by JECFA has direct downstream consequences for the regulatory status of GEGR in jurisdictions that defer to Codex Alimentarius standards.
United States
In the United States, food additives are regulated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act. Both GEGR and GEWR are regulated as permitted direct food additives under 21 CFR § 172.735 – Glycerol ester of rosin. GEWR is additionally listed as a permitted ingredient in chewing gum base under 21 CFR § 172.615.
GEGR was added to § 172.735 by a Final Rule published on 29 March 2005 (70 FR 15756), amending the regulations to provide for the safe use of GEGR to adjust the density of citrus oils used in the preparation of beverages.
| Item | Glycerol ester of gum rosin (GEGR) | Glycerol ester of wood rosin (GEWR) |
|---|---|---|
| Regulatory instrument | 21 CFR § 172.735 | 21 CFR § 172.735 and § 172.615 |
| Status | Permitted | Permitted |
| Permitted uses | Density-adjustment of citrus oils in beverages | Density-adjustment of citrus oils in beverages; chewing gum base component and plasticiser |
| Maximum level (beverages) | 1,000 mg/kg (1.0 g/kg) in finished beverage | 1,000 mg/kg (1.0 g/kg) in finished beverage |
| Maximum level (chewing gum) | Not listed under § 172.615 | Quantum satis as gum base ingredient |
Both GEGR and GEWR are consolidated within the same CFR section under the shared heading “Glycerol ester of rosin”, reflecting the FDA’s position that the two substances are functionally equivalent for the permitted beverage application.
European Union
Within the EU, food additives are regulated under Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives. Only those additives listed in the Union list in Annex II to that Regulation may be used. Purity criteria are set separately in Commission Regulation (EU) No 231/2012.
GEWR is authorised as E 445. GEGR is not authorised. The EU definition of E 445 explicitly excludes gum rosin-derived material: the additive is defined as a substance derived from the solvent extraction of aged pine stumps, and substances derived from gum rosin (the exudate of living pine trees) are expressly excluded from the specification.
The safety of E 445 has been formally re-evaluated twice in recent years. The EFSA ANS Panel re-evaluation (2018) concluded that the ADI established by the Scientific Committee on Food (SCF) in 1994 should be regarded as temporary pending submission of reproductive and developmental toxicity data. Following submission of those data, the EFSA FAF Panel follow-up opinion (2023) concluded that there was no safety concern for the use of GEWR (E 445) at either the maximum permitted levels or at reported use levels in food.
GEGR was separately evaluated in 2010 following a petition for its authorisation as a stabilising and emulsifying agent in certain beverages. The EFSA ANS Panel scientific opinion (2010) concluded that the available data were too limited to support a safety conclusion at the proposed use levels. The petition was rejected and GEGR has not been added to the Union list.
| Item | Glycerol ester of gum rosin (GEGR) | Glycerol ester of wood rosin (GEWR) — E 445 |
|---|---|---|
| Regulatory instrument | — | Regulation (EC) No 1333/2008, Annex II; specifications in Regulation (EU) No 231/2012 |
| Status | Not authorised | Authorised |
| Non-alcoholic flavoured cloudy drinks | — | 100 mg/l |
| Cloudy spirit drinks | — | 100 mg/l |
| Confectionery (incl. breath-freshening microsweets) | — | 320 mg/kg |
| Surface-treated fresh fruit and vegetables | — | Quantum satis |
| Key specification limits (E 445) | — | Free neoabietic acid ≤ 0.05 wt.%; Acid value 3–9; Lead ≤ 2 mg/kg; Mercury ≤ 1 mg/kg; Cadmium ≤ 1 mg/kg; Arsenic ≤ 3 mg/kg |
The UK retained the E 445 authorisation after leaving the EU. The current UK status is reflected in the retained EU law version of Commission Regulation (EU) No 231/2012 as published by the King’s Printer.
Japan
In Japan, food additives are regulated under the Food Sanitation Act (食品衛生法). Since April 2024, responsibility for setting food additive standards has transferred from the Ministry of Health, Labour and Welfare (MHLW) to the Consumer Affairs Agency (CAA). Risk assessments continue to be conducted by the Food Safety Commission of Japan (FSCJ).
Only substances designated by the Prime Minister (and formerly by the MHLW Minister) as designated additives — or those falling within specific exempted categories — may be used as food additives in Japan. The current list of 476 designated additives is published by the Japan Food Chemical Research Foundation (FFCR).
Ester Gum (エステルガム) appears as No. 69 in the designated additives list. Under the Standards for Use (FFCR English edition) and confirmed in the Japan’s Standards and Specifications for Food Additives, 10th edition (2024), Ester Gum is restricted as follows:
“Ester Gum shall not be used for purposes other than as a chewing gum base.”
(エステルガムは、チューインガム基礎剤以外の用途に使用してはならない。)
| Item | Glycerol ester of gum rosin (GEGR) | Glycerol ester of wood rosin (GEWR) |
|---|---|---|
| Regulatory instrument | Food Sanitation Act; Designated Additives List (No. 69 — Ester Gum) | Separate designation sought but risk assessment withdrawn by FSCJ on 3 February 2009 |
| Status | Permitted (as “Ester Gum”, No. 69) | Not separately designated; petition withdrawn |
| Permitted food categories | Chewing gum only | — |
| Maximum level | Quantum satis within chewing gum base | — |
| Beverages permitted? | No | No |
It should be noted that Japan’s designation of “Ester Gum” is understood, per JPEC safety data and JECFA cross-references, to correspond principally to GEWR in terms of chemical definition. A separate designation request for GEWR specifically — aimed at obtaining approval for its use as an emulsifier and manufacturing agent in non-alcoholic beverages — was submitted in 2006 but was ultimately withdrawn after the FSCJ began its risk assessment review. As a result, neither GEGR nor GEWR is currently approved for use in beverages in Japan.
United Arab Emirates
In the UAE, food additives are regulated by the Emirates Authority for Standardisation and Metrology (ESMA) under UAE.S 192:2019 — Additives Permitted for Use in Food Stuffs. This standard, approved by the ESMA Board of Directors in October 2019, supersedes the previous edition UAE.S 192:2016 and remains the current operative standard.
2023 Amendment. UAE.S 192:2019 was subsequently amended by Cabinet Resolution No. 24 of 2023 (effective 1 April 2023; Official Gazette No. 748, 31 March 2023). The sole change introduced by this amendment — designated “Amendment 1” — was to prohibit the use of Titanium Dioxide (E171) as a food additive. No other additives were affected, and the amendment has no impact on ester gum (INS 445) status. This framework is confirmed in the 2024 APEDA/USDA FAIRS country report, which states: “According to Emirates Standard UAE.S 192:2019 and Amendment 1 2023, the Codex Alimentarius standard number 192 ‘General Specification of Articles Food Additives’ is the first reference for identifying approved food additives.”
UAE.S 192:2019 adopts the Codex Alimentarius General Standard for Food Additives (GSFA) as its primary reference. Additives that are listed in the Codex GSFA with defined provisions are generally permitted in the UAE under those same conditions. Where an additive is not covered by the Codex GSFA, UAE.S 192:2019 designates EU Regulations (including Regulation (EC) No 1333/2008 and related instruments) as a secondary reference. Competent authorities may also evaluate individual applications on the basis of scientific and legislative justification submitted by a petitioner, though this route is described as rarely utilised. Further guidance is available through the USDA GAIN Report on UAE Food and Agricultural Import Regulations and Standards (2019), the USDA FAS UAE FAIRS Annual Country Report 2023, and the APEDA/USDA FAIRS UAE Country Report 2024.
| Item | Glycerol ester of gum rosin (GEGR) | Glycerol ester of wood rosin (GEWR) |
|---|---|---|
| Regulatory instrument | UAE.S 192:2019 (ESMA), by reference to Codex GSFA | UAE.S 192:2019 (ESMA), by reference to Codex GSFA INS 445(iii) |
| Status | Uncertain — no current Codex GSFA ADI; JECFA ADI was withdrawn in 2013 | Permitted under Codex GSFA provisions |
| Codex GSFA food categories (GEWR) | — | Surface-treated fresh vegetables; confectionery; flavoured cloudy drinks; and other categories per Codex GSFA tables |
| Secondary reference | EU regulations may apply, but GEGR is not authorised in the EU either | EU Regulation (EC) No 1333/2008 (E 445 — 100 mg/l in flavoured cloudy drinks) |
For GEWR, the UAE regulatory position is relatively clear: it is permitted under the Codex GSFA framework adopted by UAE.S 192:2019, subject to the use levels and food categories specified in the Codex GSFA tables. For GEGR, the position is less straightforward. Because JECFA withdrew the GEGR ADI in 2013, and the EU has not authorised GEGR, neither the primary Codex reference nor the secondary EU reference in UAE.S 192:2019 provides a clear basis for GEGR’s use. Any application for GEGR use in food products destined for the UAE market would therefore likely require a case-by-case submission to the competent authority.
Comparative Summary
| Jurisdiction | GEGR — Status | GEGR — Permitted Uses | GEWR — Status | GEWR — Permitted Uses |
|---|---|---|---|---|
| United States | Permitted | Beverages (density adjustment of citrus oils); max. 1,000 mg/kg | Permitted | Beverages (max. 1,000 mg/kg); chewing gum base (quantum satis) |
| European Union | Not authorised | — | Authorised (E 445) | Flavoured cloudy drinks (100 mg/l); cloudy spirit drinks (100 mg/l); confectionery (320 mg/kg); surface-treated fresh fruit and vegetables (quantum satis) |
| Japan | Permitted as “Ester Gum” (No. 69) | Chewing gum base only | Not separately designated | — (designation petition withdrawn 2009) |
| UAE | Uncertain (no Codex ADI; no EU authorisation) | Case-by-case competent authority ruling required | Permitted (via Codex GSFA) | Per Codex GSFA provisions; secondary reference to EU Regulation (EC) No 1333/2008 |
Key Regulatory Distinctions
1. GEGR and GEWR are not interchangeable in regulatory terms. Although the two substances share similar physicochemical properties and technological functions, international and national authorities treat them as distinct food additives. The difference in their regulatory status across jurisdictions reflects outstanding gaps in the toxicological dataset for GEGR — particularly the absence of multi-generation reproductive and developmental toxicity studies.
2. The EU definition of E 445 explicitly excludes gum rosin. Commission Regulation (EU) No 231/2012 specifies that E 445 is derived from the solvent extraction of aged pine stumps, and that substances derived from gum rosin — the exudate of living pine trees — are excluded from this specification. Manufacturers seeking to export GEGR-containing products to the EU must therefore not represent GEGR as equivalent to E 445.
3. Japan’s “Ester Gum” designation covers chewing gum only. The use of ester gum in beverages, which is permitted in the United States and the EU, is not currently allowed under Japanese food additive law. Any beverage application in Japan would require a new designation procedure, including a full FSCJ risk assessment.
4. The UAE follows the Codex GSFA framework (UAE.S 192:2019 as amended 2023). A 2023 amendment (Cabinet Resolution No. 24 of 2023) modified UAE.S 192:2019 exclusively to ban Titanium Dioxide (E171); no other additives were affected, and ester gum (INS 445) status is unchanged. Exporters to the UAE should verify that their specific use of GEWR falls within one of the food categories covered by the Codex GSFA INS 445(iii) provisions. For GEGR, no Codex provision exists, and prior approval from ESMA or the relevant competent authority is strongly advisable.
5. The JECFA ADI for GEGR is currently withdrawn. As a result of the failure to submit required toxicity data, JECFA has no current ADI for GEGR. This contrasts with the widely quoted group ADI of 0–12.5 mg/kg bw that appeared in JECFA publications between 2009 and 2013. Regulatory submissions or product documentation that cite this figure should note that it is no longer valid.