Suchergebnisse

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Taminizer D (dimethylglycine sodium salt) as a feed additive for chickens for fattening, based on a dossier submitted for the modification of the terms of authorisation of the additive. The product is authorised in the European Union for chickens for fattening at the maximum content of 1,000 mg/kg complete feedingstuffs. The applicant proposed the introduction of an additional manufacturing process, which introduces an impurity (dimethylamino-ethanol (DMAE)) in the additive at concentrations up to 0.09%. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considered that the proposed modification would not substantially affect the previous assessment as related to the safety of the environment and the efficacy of the product. Since the safety of the active substance was established, the current assessment has dealt with the impurity DMAE. Considering the toxicological profile of DMAE, the estimated intake by the target animal and consumers, and making use of the Threshold of Toxicological Concern (TTC) approach, the Panel concluded that Taminizer D, manufactured by the DMAE route, is safe for both chickens for fattening and consumers, up to the maximum level of 1,000 mg/kg feed. The FEEDAP Panel extends its conclusions about Taminizer D produced by the original method to cover also Taminizer D produced by the new DMAE method. There is minimal risk to users from dust produced as a result of normal handling of the additive. Taminizer D is not irritant to skin but may be irritant to eyes; it is regarded as a potential skin sensitiser. The FEEDAP Panel recommended to set a specification for the DMAE content in the additive.

L-Glutamic acid, N,N-diacetic acid, tetrasodium salt (GLDA-Na4) (Kelforce®) is sought to be used as a zootechnical feed additive in chickens for fattening to improve the absorption of zinc from feed, reducing zinc emissions through manure and thus, affecting favourably the environment. The product has not been authorised in the European Union as a feed additive. Kelforce® is intended to be marketed as a liquid and solid formulation, containing ≥ 47% and ≥ 30% of GLDA-Na4, respectively. Kelforce® is safe for chickens for fattening at the maximum level of 1,000 mg GLDA-Na4/kg complete feed. Based on the toxicological profile of GLDA-Na4 and the consumer exposure to GLDA-Na4 and to nitrilotriacetic acid trisodium salt (NTA-Na3; an impurity of the additive), the use of Kelforce® at the maximum proposed level in feed of chickens for fattening is of no concern for consumer safety. Due to its low inhalation toxicity, the exposure to GLDA-Na4 is unlikely to pose a risk by inhalation. However, owing to the high-dusting potential of the solid formulation, a risk from such high level of dust, even if toxicologically inert, cannot be excluded. Kelforce® is not a skin/eye irritant or skin sensitiser. No risks for the terrestrial compartment were identified at the maximum use level of the additive. Risks for the aquatic compartment cannot be excluded based on the secondary effect of the additive on green algae. In the absence of data, the Panel cannot conclude on the safety for the sediment compartment or the possible ground water contamination. The risk of bioaccumulation and secondary poisoning caused by the additive is considered very low. Owing to the inconsistent and conflicting results from the studies assessed, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) cannot conclude on the efficacy of the additive. The Panel made a recommendation regarding the levels of formaldehyde and cyanide in the active substance.

Lancer (lanthanide citrate) is a feed additive mainly consisting of two rare earth elements, lanthanum (La) and cerium (Ce), in their citrate forms. Lancer has not been previously authorised in the European Union. In 2013, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of Lancer as a zootechnical feed additive for weaned piglets. In its opinion the FEEDAP Panel could not conclude on the safety of the additive for the target species, on the safety for the consumer and on the safety for the environment. As a result of the additional information provided by the applicant, the FEEDAP Panel concluded that the additive Lancer is safe for weaned piglets when used at the maximum recommended dose of 250 mg/kg complete feed. In view of concerns over the possible developmental neurotoxicity of La, the many gaps in the available toxicological information on Ce and La, the absence of studies of long-term toxicity, carcinogenicity, reproductive toxicity and developmental toxicity of Lancer, and the absence of residue data in edible tissues, the FEEDAP Panel cannot conclude on the safety of Lancer for the consumer. In the absence of adequate data the FEEDAP Panel cannot conclude on the safety of Lancer for the environment.