The European Commission has amended the “introductory text” to the annex of Commission Regulation 231-2012 as follows:
- The maximum residue limit (MRL) of ethylene oxide is set at 0.1 mg/kg; and
2. The limit of the presence of ethylene oxide specified in the purity criteria for the specific food additive in Commission Regulation 231/2012 will be deleted.
Previously, Regulation No. 231/2012 provides the limit on the presence of ethylene oxide specified in selected food additives where said chemical substance is used, i.e. not more than 0.2 mg/kg.
Ethylene oxide is a chemical substance that has multiple uses, including use as a sterilizing agent and as a raw material in the manufacture of various products. However, ethylene oxide is classified in several EU regulations as a substance of-
- carcinogenic, mutagenic, and toxic for reproduction in accordance with Regulation (EC) No. 1272/2008 on classification, labeling, and packaging of substances and mixtures
- not approved as a biocidal product under Regulation (EU) No. 528/2012; and
- nor as an active substance for use in plant protection products in accordance with Regulation (EC) No. 1107/2009
Philippine exporters are encouraged to be comply with the European Commission's MRL of ethylene oxide in food additives.
For information, Commission Regulation No.231/2012 lays down specifications for food additives listed in Annexes II (Union list of food additives approved for use in food additives, food enzymes, food flavourings, nutrients, and their conditions of use) to Regulation 1333/2008 on food additives https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02012R0231-20220720&gid=1660834561521&from=EN
In line with this, please inform our Office of any issues/challenges you may have encountered in exporting to Europe related to the implementation of the amendment of the Commission Regulation 231/2012.