Following a request from the 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 guanidinoacetic acid (GAA; CreAMINO®) for chickens for fattening, breeder hens and roosters, and pigs.
CreAMINO®, a granulated product, contains a minimum of 96% chemically synthesised GAA as active substance. Glycine (≤ 1.5%), cyanamide (≤ 0.03%), dicyandiamide (≤ 0.5%) and melamine (≤ 0.002%) 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 donors) and methyl-transferring enzymes.
The safe level of the product appears to be correlated with the supply of methyl donors. If an adequate supply of methyl donors is provided in the feed, a safe level of 1,200 mg GAA/kg complete feed could be established for chickens for fattening and piglets. The conclusion on piglets can be extended to pigs for fattening. In the absence of adequate data, the FEEDAP Panel cannot conclude on the safety of GAA for breeder hens and roosters.
GAA is not mutagenic. The effects reported in the 28- and 90-day studies do not identify any unexpected toxicity other than physiological effects. Feeding GAA would not result in GAA, creatine or homocysteine concentrations in chicken and pig tissues/organs relevant to consumer safety provided the maximum GAA concentrations in feed considered safe are respected.
GAA is not an irritant to eyes and skin and not a dermal sensitiser. Significant inhalation exposure may occur. However, due to the absence of data on respiratory toxicity, no risk assessment can be performed.
The use of GAA in animal nutrition is not expected to pose a risk to the environment.
Considering the data previously assessed and the two new studies, the FEEDAP Panel concludes that GAA is able to improve the performance in chickens for fattening at the minimum dose of 600 mg/kg. In the absence of adequate data, the FEEDAP Panel cannot conclude on the efficacy of GAA in breeder hens and roosters. In piglets, only one study was available showing that 1,200 mg GAA/kg complete feed improved growth. When the assessment is based on zootechnical parameters, at least three studies are required; therefore, the FEEDAP Panel is not in a position to conclude on the basis of this single study.
The Working Group made two recommendations (one on the specification of the additive, and the other on the need to ensure that the feed contains sufficient methyl donors other than methionine).