The sources are 5’-deoxyadenosylcobalamin and methylcobalamin which have been deemed safe by EFSA’s Scientific Panel on Food Additives and Nutrient Sources (ANS) added to food.
The ANS was asked to assess the safety and bioavailability of the B12 (cobalamin) nutrients by the European Commission for use in food supplements and found there were no overriding safety concerns.
Its opinion while not related specifically to B12 but to its precursors, was in alliance with earlier opinions given by the body EFSA grew out of, the Scientific Committee on Food (SCF) in 2000, that found no safety issues around B12 consumption.
Vitamin B12 levels are important as low levels of the vitamin have been linked to increased risk of cognitive impairment and neurodegenerative disorders, cardiovascular disease, and certain types of cancer. Up to 25 per cent of the elderly may be B12 deficient.
In the diet, B12 comes from meat, fish, dairy, other animal products, and fortified breakfast cereals. Vegetarians and vegans are also at risk of B12 deficiency.
Not of safety concern
The UK Food Standards Agency’s Expert Group on Vitamins and Minerals (EVM) reached similar conclusions in 2003.
It concluded the use of 5’-deoxyadenosylcobalamin and methylcobalamin “as a source of vitamin B12 in food supplements for the general population at the proposed uses and use levels is not of safety concern.”
It added:“Assuming that in case of vitamin B12 the ligand will not influence the biological activity of the main molecule significantly, the Panel concludes that methylcobalamin and 5’-deoxyadenosylcobalamin will be bioavailable, and that the metabolic fate and biological distribution of methylcobalamin and 5’-deoxyadenosylcobalamin are expected to be similar to that of other sources of vitamin B12 in the diet.”
5’-deoxyadenosylcobalamin and methylcobalamin function as naturally occurring endogenous derivatives of vitamin B12. Methylcobalamin can be made from genetically modified micro-organisms but the ANS said this source was outside its current opinion.Vitmain B12, from whatever source, is transformed to either methylcobalamin or 5’-deoxyadenosylcobalamin. The proposal called for 500µg of methylcobalamin or 5’-deoxyadenosylcobalamin proposed to be used in food supplements.
Both the SCF and EVM have recommended levels significantly higher than this, yet typical intakes are much lower. The EVM issued a guidance of 2000 µg/day.
Average intakes of B12 to be about 32 µg/day have been reported among elderly Dutch subjects. For the UK upper intake levels (97.5th percentile) from food sources were reported to be 22.9 and 17.8 µg/day for males and females respectively. Total intakes were only marginally higher.The majority of B12 that enters the body via nutrition is stored in the liver. B12 is the name given to a group of related compounds containing cobalt as the central ion in a corrin ring.
Petitions that prompted the current opinion were lodged by the UK Health Food Manufacturers’ Association and two Dutch companies – Natuur & GezondheidsProducten Nederland and Biovitaal.