EFSA Journal (May 2018)

Safety and efficacy of Taminizer D (dimethylglycine sodium salt) as a feed additive for chickens for fattening

  • EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP),
  • Guido Rychen,
  • Gabriele Aquilina,
  • Giovanna Azimonti,
  • Vasileios Bampidis,
  • Maria de Lourdes Bastos,
  • Georges Bories,
  • Andrew Chesson,
  • Pier Sandro Cocconcelli,
  • Gerhard Flachowsky,
  • Jürgen Gropp,
  • Boris Kolar,
  • Maryline Kouba,
  • Marta López‐Alonso,
  • Secundino López Puente,
  • Baltasar Mayo,
  • Fernando Ramos,
  • Maria Saarela,
  • Roberto Edoardo Villa,
  • Robert John Wallace,
  • Pieter Wester,
  • Giovanna Martelli,
  • Derek Renshaw,
  • Gloria López‐Gálvez,
  • Alberto Mantovani

DOI
https://doi.org/10.2903/j.efsa.2018.5268
Journal volume & issue
Vol. 16, no. 5
pp. n/a – n/a

Abstract

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Abstract 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.

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