Last 12th August 2022, it was published the Commission Regulation (EU) 2022/1396 amending the Annex to Regulation (EU) No 231/2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 as regards the presence of ethylene oxide in food additives.
Ethylene oxide is an important chemical substance having multiple uses, including the use as a sterilising agent and as a raw material in the manufacture of various products. However it is a substance of concern classified as carcinogenic, mutagenic and toxic for reproduction in accordance with Regulation (EC) No 1272/200. It is neither approved as a biocidal product under Regulation (EU) No 528/2012 nor as an active substance for use in plant protection products in accordance with Regulation (EC) No 1107/2009 .
Recently, several RASFF notifications concerning findings of ethylene oxide in a number of foodstuffs, and in particular in a number of food additives used for the manufacture of a variety of foodstuffs. In order to ensure a high level of protection of human health, it is therefore appropriate to lay down that the presence of ethylene oxide, irrespective of its origin, is not authorised for all food additives. For this purpose, a maximum limit for residues of ethylene oxide specific for food additives should be set out at the limit of quantification in those products, that is, at the validated lowest residue concentration.
The Annex to Regulation (EU) No 231/2012 is amended as follows:
- ‘Ethylene oxide may not be used for sterilising purposes in food additives.
No residue above 0,1 mg/kg, irrespective of its origin, of ethylene oxide (sum of ethylene oxide and 2-chloro-ethanol expressed as ethylene oxide (*)) shall be present in food additives listed in Annexes II and III to Regulation (EC) No 1333/2008, including mixtures of food additives.
(*) i.e. ethylene oxide + 0,55* 2-chloroethanol.’;
- in the entries for E 431 polyoxyethylene (40) stearate, E 432 polyoxyethylene sorbitan monolaurate (polysorbate 20), E 433 polyoxyethylene sorbitan monooleate (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 row ‘Ethylene oxide’ is deleted.
This Regulation shall enter into force 1st September 2022. This Regulation shall be binding in its entirety and directly applicable in all Member States.
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