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The protocol of the EU member states experts meeting by July 13th on regulatory and technical aspects of the ethylene oxide (ETO) findings in food and feed has been published on Oct. 4th.
We like to summarise the major conclusions of the expert panel:
- The residue definition (“ethylene oxide and 2-chloroethanol expressed as ethylene oxide”) is based on Regulation (EC) No 396/2005 and applied to all food and feed. According to the protocol, the EU Commission assumes that contamination as a result of ethylene oxide treatments is avoidable, thus no distinction is made so far between active treatment and contamination in the case of food.
- Harmonised "analytical limits of determination" have been agreed for food and feed, which are to be regarded as "official analytical limits of determination" (better: reporting limits) within the meaning of Regulation (EC) No 396/2005. They may thus differ from actual analytical limits of determination. The assessment is carried out on the basis of these reporting limits.
- In Regulation (EC) No. 396/2005, exist maximum residue levels (MRLs) for some substances "at the level of the official analytical limit of determination" (= so-called “asterisk * MRLs”), including "ethylene oxide". The lowest *-MRL for "ethylene oxide" (see definition above) is 0.02 mg/kg (i.e. 0.01 mg/kg for ETO and 0.01 mg/kg for 2-chloroethanol). If the agreed reporting limit is exceeded, foods are considered unfit for human consumption, regardless of the jurisdiction to which they are subject. Therefore, in the Commission's view, these foods are classified also as "not safe".
- For food additives and feed additives, a general reporting limit of 0.1 mg/kg per substance has been agreed. This "official analytical determination limit" is at the same time considered to be the maximum content - and thus the assessment limit for sterilisation (disinfection) of additives. In the case of additives for which separate process-related maximum levels for ethylene oxide (in fact only ETO) are already set in Regulation (EU) No 231/2012, these maximum levels shall apply as a priority. (For compound feed a reporting limit of 0.02 mg/kg was agreed)
- For compound foods a reporting limit of 0.02 mg/kg was agreed. At the same time, this is to be used as the maximum residue level for such compound end products for which more detailed information on the recipe and/or processing factors are not available. If processing factors for processed products are missing, the processing factor 1 will be applied. If it is unknown whether a non-compliant raw material/ingredient has been used the MRL of 0.02 mg/kg should be applied. But if it is known that a non-compliant raw material/ingredient was used, the end product would be still regarded as being not marketable and unsafe.
- A reporting limit of 0.1 mg/kg was agreed for food supplements (end product). This also applies to empty capsules for the production of food supplements.
- For baby food (end products) it was reconfirmed that the general MRL of 0.01 mg/kg applies for the sum parameter. Baby foods that do not comply with this requirement should be withdrawn from the market or recalled. This also applies if a food additive that does not comply with the law has been used.
- For compound feed - analogous to compound food - a reporting limit of 0.02 mg/kg was agreed. If a non-compliant feed material or a non-compliant feed additive has knowingly been used in a compound feed and the "ethylene oxide" content in the compound feed for the sum parameter is above 0.02 mg/kg, the compound feed must be withdrawn from the market if it is a product for food-producing animals (farm animals). Pet food must also be recalled from consumers, taking into account that pets may be affected by cancer due to longer lifetimes.
Your PLUS : The laboratory experts at AGROLAB maintain an overview and reliably assess the results in accordance with the applicable legal requirements. Ethlylene oxide measurement capacities have been recently expanded in AGROLAB Dr. Verwey and AGROLAB LUFA offering express services.
Link:
AGROLAB Produktinfo: Product Information Food - Ethylene Oxide
Author: Dr. Frank Mörsberger
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