Safety evaluation of blue galdieria extract as a food additive.

The EFSA Panel on Food Additive and Flavourings (FAF Panel) provides a scientific opinion on the safety of blue galdieria extract as a food additive. Blue galdieria extract is an enzymatically treated C-phycocyanin extract derived from the lysed biomass of the microalgae Galdieria sulphuraria. The extract is mainly composed of C-phycocyanin (over 25%), along with other proteins, carbohydrates and dietary fibres. Information and studies provided showed that its components, including the chromophore phycocyanobilin, were metabolised like normal dietary constituents and with a similar fate and efficiency as bile pigments. Blue galdieria extract was not genotoxic. In the 90-day oral toxicity study, no treatment-related adverse effects were observed up to the highest dose tested. The risk for allergenicity of blue galdieria extract was expected to be low. The Panel acknowledged the similarity of C-phycocyanins from G. sulphuraria and Arthrospira platensis (commonly known as spirulina) and therefore considered existing toxicity data on spirulina. The Panel derived an acceptable daily intake (ADI) of 7 mg/kg bw per day expressed as C-phycocyanin, based on a no observed adverse effect level (NOAEL) of 4000 mg blue galdieria extract/kg bw per day, corresponding to 1332 mg C-phycocyanin/kg bw per day, from the 90-day toxicity study, applying an uncertainty factor (UF) of 200, to account for the uncertainties associated with the results of the developmental toxicity studies on spirulina. At the proposed maximum use levels, the Panel noted that the 95th percentile estimates of dietary exposure exceeded or was at the level of the ADI of 7 mg C-phycocyanin/kg bw in toddlers and children, respectively. The Panel concluded that there is no safety concern for blue galdieria extract as a food additive at the proposed uses and typical use levels. The Panel could not conclude on the safety for the proposed uses at quantum satis as a Group II food additive due to the absence of use levels to estimate the resulting exposure.