Further to previous communications regarding Ethylene oxide (EtO) contamination, the FSA have now issued an update which, in summary, clarifies that their Risk Management Advice (RMA) applies to the known contamination issues and should not be used to retrospectively look at previously manufactured products where there is no evidence of contamination issues.
The latest FSA advice reads as follows:
Following previous discussions and meetings with industry, we have updated our risk management advice to address an issue with misinterpretation of the previous advice. Whilst the advice fundamentally remains the same as we continue to consider further evidence provided by industry, the wording has been amended to emphasise that the RMA applies to the known contamination issues and should not be used to retrospectively look at previously manufactured products where there is no evidence of contamination issues.
“2-Chloroethanol (2-CE) has been found in varying levels (0.15 mg/kg to 64 mg/kg) within a number of batches of calcium carbonate. Due to the lack of toxicological data and evidence, it is assumed that 2-CE, as a known breakdown product of Ethylene Oxide (EtO), is also a genotoxic carcinogen. As an assumed genotoxic carcinogen, no level can be considered to be without risk to health.
A number of RASFF alerts have been raised by EU Member States where 2-CE has been found in supplements supplied by UK businesses, which has resulted in withdrawals and recalls being issued in these EU Member States. On the basis of risk assessment and taking account of the large number of products that are manufactured using calcium carbonate, risk management advice for this issue has been developed.
Food businesses are advised to discontinue using batches of calcium carbonate to manufacture products where levels of 2-CE have been detected.
Where finished products that have already been placed on the market that have been manufactured with calcium carbonate known to have been contaminated with 2-CE greater than 10 mg/kg (sum EtO and 2-CE), it is advised that they are withdrawn from market.
Finished Products manufactured with calcium carbonate that is known to have been contaminated containing less than 10 mg/kg sum EtO and 2-CE, can remain on the market.”
If there are any questions in relation to this, please contact the FSA Incidents and Resilience Unit at ReceiptAndManagement@food.gov.uk