Following protests from trading partners and food chain operators in the EU, the European Commission has introduced a tolerance threshold on ethylene oxide in food additives.
The new implementing regulation – reg. EU 2022/1386, in force since 1.9.22 – does, however, in turn present some not insignificant margins of uncertainty in turn worthy of further study.
1) Ethylene oxide. Foreword
Ethylene oxide (ETO) is a colorless, highly explosive and reactive gas. It is used in the production of chemical derivatives that form the basis of major consumer goods. As well as in the petroleum industry-thanks to ethylene oxide’s ability to emulsify fluids and thus drag drill cuttings to the surface-and in antifreeze fluids. The ability of ethylene oxide to damage DNA makes it an effective
sterilizing agent. It is therefore used in the agrochemical industry as a pesticide, (1) the chemical-pharmaceutical industry, medical devices and hospitals.
At the same time, its mutagenic action causes serious health hazards, which have also been ascertained by IARC (WHO), which has listed ethylene oxide as a Group I (human carcinogen) substance. (2)
The main routes of human exposure to ethylene oxide are inhalation and ingestion, which can occur through occupational, consumer or environmental exposure. The general population may be exposed through tobacco smoke and the use of products sterilized with ethylene oxide, such as medical devices, cosmetics, and beekeeping equipment. (3)
2) Ethylene oxide, the most disruptive alert in RASFF history.
The largest food recall operation in EU history began on 9.9.20. With an unbroken series of alert notifications in theRapid Alert System on Food and Feed (RASFF) system for ethylene oxide contamination of a myriad of foods. (4) In just under two years, 863 cases have been notified in the European early warning system, out of:
- Spices and spice mixes (ex. chili peppers, curry, black pepper, herbs and medicinal herbs of all kinds, sesame seeds,
- Food supplements, ice cream, (5) noodles and various other food products, which contain certain food additives, such as
- guar gum and xanthan gum, carob gum(locust bean gum), coming from Asia and India.
Raw materials of Indian origin, in the vast majority of notifications. Except for a few cases from South Korea, China and very rare others (e.g., Uganda).
3) Risk analysis, risk management
The risk analysis conducted by different member states has often been inconsistent both with respect to the levels of contamination from time to time detected in food additives, ingredients and finished products, and with respect to previous decisions of the same and other countries. Uncertain(undecided) assessment, in not a few cases.
The European Commission, DG Sante, has convened at least six online meetings of the Food and Feed Safety Crisis Coordination Committee. The ‘zero tolerance’ imposed by Brussels has also come under criticism, from Belgium and Denmark among others, as it could lead to perhaps unsustainable food waste (6,7).
7) Reg. EU 2021/2246
On 12/15/21, the Commission adopted reg. EU 2021/2246 to extend enhanced border controls on imports of food of plant origin with a food safety risk to certain products-a narrow range of agricultural and food commodities covered by hundreds of alerts. (8)
Verification of ‘ethylene oxide residues (sum of ethylene oxide and 2-chloro-ethanol, expressed as ethylene oxide)‘ was indeed prescribed only on:
- gombi (okra) and curry leaves (pesticide MRL analysis. See note 9) of Indian origin,
- Locust beans, locust bean seeds and their mucilage coming from Morocco (food and feed)
- Dietary supplements with botanical ingredients and instant-cooking noodles(noodles) from South Korea.
8) Reg. EU 2022/1396
On 11.8.22 the Commission adopted reg. EU 2022/1396, effective 1.9.22. In partial reform of the Annex to reg. EU 231/2012 where the specifications of food additives in Annexes II and III of reg. EC 1333/08 ‘regardingthe presence of ethylene oxide in food additives‘. (10)
The revision was justified by the difficulty of applying the previous rules due to uncertainty about the source of ethylene oxide whose use to disinfect food is banned in the EU. The Commission, in reaffirming this ban, introduced an ETO tolerance threshold of 0.1 mg in additives.
8.1) Ethylene oxide in food additives, tolerance threshold and ban
‘It is not allowed The presence of ethylene oxide residues (sum of ethylene oxide and 2-chloro-ethanol, expressed as ethylene oxide [11]) exceeding 0.1 mg/kg, regardless of their origin, in the food additives listed in Annexes II and III of Regulation (EC) No. 1333/2008, including mixtures of food additives.’
This threshold, however, coexists with the ban on the ‘use of ethylene oxide in food additives for sterilization purposes‘ (EU Reg. 2022/1396, Annex, item 1). A sword of Damocles thus swings over any operator who imports and/or uses, in the food industry, additives with ETOs within the tolerance threshold. (12)
8.2) OTE, impure purity
‘To the voices related to E 431 polyoxyethylene stearate (40), E 432 polyoxyethylene sorbitan monolaurate (polysorbate 20), E 433 polyoxyethylene sorbitan monoleate (polysorbate 80), E 434 polyoxyethylene sorbitan monopalmitate (polysorbate 40), E 435 polyoxyethylene sorbitan monostearate (polysorbate 60), E 436 polyoxyethylene sorbitan tristearate (polysorbate 65), E 1209 polyvinyl alcohol-polyethylene glycol graft copolymer, and E 1521 polyethylene glycol, under the specification “Purity” the line “Ethylene oxide” is deleted.’ (EU Reg. 2022/1396, Annex, pt. 2).
9) Food safety and excess of power
DG Sante, European Commission, has for the second time in a few months exhibited an excess of power:
- in July 2022, the Eurocrats failed in their duty to question EFSA on the scientific evaluation of the allergen cross-contact risk analysis system adopted by some member states and ignored by others, (13)
- in August 2022, the same Eurocrats decided instead of EFSA that ‘the change in specifications may not have adverse effects on human health‘ and therefore ‘a safety assessment an evaluation by the European Authority is not necessary‘ (reg. EU 2022/1386, recital 7).
Uncertainty reigns supreme, as unfortunately noted above. (14)
Dario Dongo
Notes
(1) The use of ethylene oxide as a pesticide also took place on the Old Continent, until its authorization was not renewed in reg. EC 1107/09
(2) International Agency for Research on Cancer (IARC) Monographs on the Evaluation of Carcinogenic Risks for Humans: Ethylene Oxide. https://monographs.iarc.who.int/wp-content/uploads/2018/06/mono100F-28.pdf World Health Organization (WHO)
(3) Ethylene Oxide. https://www.cancer.gov/about-cancer/causes-prevention/risk/substances/ethylene-oxide National Cancer Institute at the National Institutes of Health (USA). 28.12.18
(4) Dario Dongo. Ethylene oxide, recalls in EU without strengthened border controls. FT (Food Times). 23.9.21
(5) Marta Strinati. Smarties, M&M’s, Bounty, Twix. Even ice cream contaminated with carcinogenic ethylene oxide. https://www.greatitalianfoodtrade.it/sicurezza/smarties-mms-bounty-twix-anche-i-gelati-contaminati-da-ossido-di-etilene-cancerogeno/ FT (Food Times). 21.6.21
(6) Summary record of the Food and Feed Crisis Coordinators meetings of 29.6.21, 30.6.21 and 13.7.21 on the presence of ethylene oxide above the limit of quantification in locust bean gum (food additive E410). https://food.ec.europa.eu/system/files/2021-07/rasff_ethylene-oxide-incident_e410_crisis-coord_sum.pdf European Commission, DG Sante
(7) Summary of the Meeting on Ethylene Oxide (ETO): Regulatory and Technical Aspects. https://food.ec.europa.eu/system/files/2021-12/rasff_ethylene-oxide-incident_e410_crisis-coord_20211004_sum.pdf European Commission, DG Sante. 4.10.21
(8) Reg. EU 2021/2246, amending Implementing Regulation (EU) 2019/1793 on the temporary increase of official controls and emergency measures governing the entry into the Union of certain goods from certain third countries, and implementing Reg. EU 2017/625 and reg. CE178/02 https://bit.ly/3pULg7R
(9) Residual ‘at least of the pesticides listed in the control program adopted under Article 29.2 of Reg. EC 396/05‘ (maximum levels of pesticide residues in or on food and feed products of plant and animal origin), ‘which may be analyzed by multi-residue methods based on GC-MS and LC-MS (pesticides to be monitored only in/on products of plant origin)‘
(10) ‘i.e., ethylene oxide + 0.55* 2-chloro-ethanol.”‘
(11) Reg. EU 2022/1396, amending the Annex to Regulation (EU) No. 231/2012 laying down specifications for food additives listed in Annexes II and III of Regulation (EC) No. 1333/2008 regarding the presence of ethylene oxide in food additives https://eur-lex.europa.eu/eli/reg/2022/1396/oj?locale=it
(12) Who and how can prove that ethylene oxide residues within the permissible tolerance threshold result from causes other than sterilization? Is there a marker, certified procedure or other suitable documents to offer evidence and/or counter-evidence of the legitimacy of the food additive? No, not on the text of the regulation. Any assessment is thus left to the arbitrariness of the authorities of 27 member states. And the European Commission, instead of coordinating them, introduces the legal basis for a new chaos
(13) Dario Dongo. Allergens and RASFF, European blackout. FT (Food Times). 13.7.22
(14) Dario Dongo. Customs blocking of xanthan gum by ethylene oxide? FARE(Food and Agriculture Requirements). 27.8.22
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
