Regulatory status: not found on UK or EU approved lists
The UK Food Standards Agency publishes the definitive list of approved additives and E-numbers. E647 does not appear on that list. The EU's Annex II to Regulation 1333/2008, which governs all permitted food additives across Great Britain (via assimilation) and the EU, also does not contain E647. Some third-party additive databases assign calcium lactobionate the number E399 rather than E647, but neither E399 nor E647 appears as an authorised food additive entry in the primary UK or EU regulatory records checked.
E647 does not appear in the UK FSA approved additives and E-numbers list, the definitive register of food additives permitted for sale in Great Britain.
RegulatoryUK Food Standards Agency, Approved additives and E numbers (food.gov.uk)
Annex II to EU Regulation 1333/2008, governing food additives in the EU, does not contain an entry for E647 or for calcium lactobionate under any E-number in the 600-series 'Other' category.
2008RegulatoryEU Regulation 1333/2008 on food additives, Annex II
Calcium lactobionate chemistry and biological handling
Lactobionic acid is produced from lactose oxidation and is broken down in the gut to galactose and gluconic acid, both of which are metabolised normally. The calcium component is bioavailable. There are no IARC classifications, no reported endocrine disruption signals, no Southampton Six membership, and no EFSA safety opinion specifically dedicated to calcium lactobionate as a food additive for humans. The absence from authorised lists means no formal ADI has been established for food use.
Lactobionic acid hydrolyses in the gut to galactose and gluconic acid; both are normal metabolic substrates. No specific toxicological concerns have been identified in available literature.
LabPubChem Compound Summary: Calcium Lactobionate (CID 11954336)