Safety and efficacy of guanidinoacetic acid as feed additive for chickens for fattening

Following a request from European Commission, the European Food Safety Authority (EFSA) was asked to deliver a scientific opinion on guanidinoacetic acid. The additive (trade name: CreAminoTM) is described by the applicant as a nutritional additive under the functional group amino acids, their salts and derivatives. CreAminoTM, a granulated product, contains a minimum of 96 % chemically synthesised guanidinoacetic acid (GAA) as active substance. Cyanamide (≤ 0.03 %) and dicyandiamide (≤ 0.5 %) are impurities arising from the production process. GAA, a glycine derivative, occurs naturally in the body of animals (and humans) and acts as a precursor of creatine. The metabolic step from GAA to creatine requires methyl groups (from methyl donators) and methyl transferring enzymes. Based on data from five efficacy trials, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that 600 mg GAA kg-1 feed for chickens for fattening can be considered as the minimum dose improving performance characteristics. However, the FEEDAP Panel notes that the effects are most consistently seen at 800 mg GAA kg-1 feed, which is in line with the dose level recommended by the applicant. The FEEDAP Panel considers that the safety for the target animal at the applied dose range 600–1200 mg kg-1 feed has not been demonstrated. The lowest proposed dose, 600 mg GAA kg-1 feed, could be considered safe. The highest recommended dose (1200 mg GAA) was not tested but 1500 mg showed adverse effects on blood parameters. The product did not show mutagenic or genotoxic properties. The effects reported in the 28- and 90-day studies in laboratory animals generally reflect physiological responses to high exposures to a metabolic intermediate and do not identify any novel or unexpected toxicity. The FEEDAP Panel considers that the use of CreAminoTM as a feed additive for chickens for fattening at the levels proposed would not give rise to residues of concern to the consumer, neither from the active substance or the identified impurities. The FEEDAP panel has no concerns regarding user safety for CreAminoTM, provided that the recommendations of the safety data sheet are followed. The FEEDAP Panel concludes that the use of CreAminoTM as a feed additive would not pose a risk to the environment. The FEEDAP Panel commented on the proposed category of the additive and made a recommendation for the product’s specifications.