Scientific Opinion on the safety and efficacy of niacin (nicotinic acid and nicotinamide) as a feed additive for all animal species based on a dossier submitted by Lonza Benelux BV

Abstract

The term 'niacin' is used as a generic description of nicotinic acid and nicotinamide with pyridine as the basic structure. Nicotinic acid and nicotinamide function mainly as precursors of the co-enzymes NAD and NADP. Thus, nicotinamide has physiologically critical roles in mitochondrial respiration and in the metabolism of carbohydrates, lipids, and amino acids. Oral administration routes of nicotinic acid and nicotinamide via feed or water for drinking were considered bioequivalent. Niacin is safe for the target animals with a margin of safety that is at least ten times the requirements and use levels. The FEEDAP Panel assumes that exposure figures for a population already include the contribution of edible tissues and products of animals fed niacin-supplemented diets. Information on niacin metabolism and the limited data available on retention in edible tissues and products indicate that supplemental levels in feeds even far higher than the requirements (1-35 mg/kg feed) are highly unlikely to lead the tolerable upper intake level being exceeded. The FEEDAP Panel considers that the use of niacin in animal nutrition is not of safety concern for consumers. Nicotinic acid and nicotinamide are not irritant to skin, but can cause irritancy to eyes and mucous membranes. They are unlikely to cause skin sensitisation. Workers might be exposed to a respirable dust when handling nicotinic acid, which should be regarded as being potentially harmful to their health. Nicotinamide is considered to be of no concern for inhalation exposure. The use of nicotinic acid and nicotinamide in animal nutrition does not pose a risk to the environment. Nicotinic acid and nicotinamide are regarded as effective sources of niacin in animal nutrition. The term 'niacin' is used as a generic description of nicotinic acid and nicotinamide (niacinamide) with pyridine as the basic structure. Niacin is widely distributed and occurs in large quantities in yeasts, brans and food of animal origin. Nicotinic acid and nicotinamide function mainly as precursors of the co-enzymes NAD and NADP. Thus, nicotinamide has physiologically critical roles in mitochondrial respiration and in the metabolism of carbohydrates, lipids, and amino acids.Oral administration routes of nicotinic acid and nicotinamide via feed or water for drinking were considered bioequivalent.Niacin is safe for the target animals with a margin of safety that is at least ten times the requirements and use levels.The FEEDAP Panel assumes that exposure figures for a population already include the contribution of edible tissues and products of animals fed niacin-supplemented diets. Information on niacin metabolism and the limited data available on retention in edible tissues and products indicate that supplemental levels in feeds even far higher than the requirements (1-35 mg/kg feed) are highly unlikely to lead the tolerable upper intake level being exceeded. The FEEDAP Panel considers that the use of niacin in animal nutrition is not of safety concern for consumers.The FEEDAP Pan...

Assessment of the feed additive consisting of niacin (nicotinic acid) for all animal species for the renewal of its authorisation (Arxada Ltd)

“…More than 99% retention was determined. 15 The stability of the product, when added to premixtures, feed and water for drinking was already reported in the previous assessment (EFSA FEEDAP Panel, 2012c). No additional data were submitted by the applicant.…”

“…According to the applicant, niacin (nicotinic acid) is identical to that previously evaluated and the manufacturing has not been changed since the authorisation (EFSA FEEDAP Panel, 2012 c ).…”

“…The safety of niacin (nicotinic acid and nicotinamide) was evaluated in a previous opinion (EFSA FEEDAP Panel, 2012 c ) and the FEEDAP Panel concluded that the additive is safe for the target animals with a margin of safety that is at least 10 times the requirements and use levels. The additive was considered also safe for the consumers and the environment.…”

“…EFSA issued two opinions on the safety and efficacy of niacin (nicotinic acid) when used as a feed additive in all animal species (EFSA FEEDAP Panel, 2012b , c ). In these opinions the term ‘niacin’ was used to identify both nicotinic acid and nicotinamide with pyridine as the basic structure.…”

Assessment of the feed additive consisting of niacinamide for all animal species for the renewal of its authorisation (Arxada Ltd)

“…EFSA issued four opinions on the safety and efficacy of niacinamide when used as a feed additive in all animal species (EFSA FEEDAP Panel, 2012 a , b , c , d ). In two of these four opinions (EFSA FEEDAP Panel, 2012 c , d ), the term ‘niacin’ was used to identify both nicotinic acid and nicotinamide (niacinamide) with pyridine as the basic structure.…”