Safety and efficacy of 25-hydroxycholecalciferol as a feed additive for poultry and pigs

Following a request from European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 25-hydroxycholecalciferol (E 670 a) as feed additive for poultry and pigs. This additive is already authorised for use without a time limit in chickens for fattening, turkeys and laying hens. The applicant is now asking for a re-evaluation of the existing authorisation and for an extension of the authorisation to all poultry and pigs. The additive ROVIMIX® HyD® 1.25% contains 12.5 g 25-OH-D3 kg-1 as active substance, which is a physiological precursor of the vitamin D3 active hormone. 25-OH-D3 from ROVIMIX® Hy D® 1.25% is efficacious in all poultry species and pig categories when substituting for vitamin D3 in feed. ROVIMIX® Hy D® 1.25% is considered safe for the target animals at maximum contents of 0.100 mg 25-OH-D3 kg-1 complete feed for chickens and turkeys for fattening, of 0.080 mg 25-OH-D3 kg-1 complete feed for all other poultry species and of 0.050 mg 25-OH-D3 kg-1 for all pig categories. After reassessing the in vivo toxicological studies on laboratory animals submitted, the FEEDAP Panel confirms its earlier conclusions that the ‘effects seen in the toxicity studies which have been conducted are entirely consistent with a physiological overload of Vitamin D or its metabolites and are not indicative of any unexpected toxicity arising from the source or production method of the substance. There is no new information which would require a modification of the formerly proposed UL of 10 μg 25-OH-D3 adult person-1 day-1 and 5 μg 25-OH-D3 child-1 day-1. Exposure calculation of the consumer was based on former tissues and product deposition data in poultry and new data in pigs. The total intake was estimated to amount to 6.9 μg 25-OH-D3 person-1 day-1. This value complies with the provisional UL for adults (69 %) but is above that for children (138 %, based on the intake of adults). Refined calculation (more realistic consumption data) reduced the estimated exposure to 2.44 μg 25-OH-D3 person-1 day-1, which is below the provisional UL for both the adults (24 %) and the children (49 %). The FEEDAP Panel concludes that the total exposure resulting from the use of 25-OH-D3 in all poultry species and pig categories, at the proposed maximum doses, would not present a risk for the consumer. The additive ROVIMIX® Hy•D® 1.25% is not irritant to the skin or eye. Data on sensitisation as well as on respiratory toxicity were not provided. The most likely route of workplace exposure to 25-OH-D3 is by inhalation. A worst case calculation scenario results in a potential daily inhalation of about 4 μg for workers preparing premixtures containing ROVIMIX® Hy•D® 1.25%. This figure is included in the part of the UL not covered by food consumption. The use of 25-OH-D3 in feedingstuffs does not represent a risk for the environment. The FEEDAP Panel has made some recommendations concerning the specification of the additive, focusing on the safety of the 25-OH-D3 formulation for the target animals and the user.