Safety of natural mixture of dolomite plus magnesite and magnesium‐phyllosilicates (Fluidol) for all animal species

dolomite, magnesite, magnesium-phyllosilicates, technological additives, anticakingagents, safety, target species
First published in the EFSA Journal
4 May 2018
Adopted
17 April 2018
Type
Scientific Opinion
Abstract

The additive under assessment consists of a natural mixture, mainly composed of dolomite (~ 30%), magnesite (~ 20%) and magnesium‐phyllosilicates (talc (~ 35%) and chlorite (~ 15%)). In 2016, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of natural mixture of dolomite plus magnesite and magnesium‐phyllosilicates. In this opinion, the Panel concluded that 20,000 mg additive/kg complete feed is considered safe for dairy cows and for piglets (weaned). This conclusion was extended to pigs for fattening while no conclusion could be drawn on the safety for poultry or any other species/categories. Following this opinion, the European Commission gave the possibility to the applicant to submit complementary information in order to complete the assessment on the safety for all animal species. The new tolerance studies submitted with cattle for fattening and chickens for fattening showed tolerance of these animal categories to the additive up to approximately fivefold the highest recommended use level. The FEEDAP Panel therefore concluded that 20,000 mg additive/kg complete feed is safe for cattle for fattening and chickens for fattening. The additive at the same dietary concentration was already considered safe in an earlier opinion for piglets and dairy cows. Since the additive at 20,000 mg/kg complete feed is considered safe for four animal categories (three major animal species) with a comparable margin of safety, the conclusion on safety is extrapolated to all animal species. At the safe dietary concentration the additive did not affect the digestibility of the feed (including feed additives).

Panel members at the time of adoption
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, Secundino López Puente, Marta López‐Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester.
Panel on Additives and Products or Substances used in Animal Feed
Contact
feedap [at] efsa.europa.eu
doi
10.2903/j.efsa.2018.5272
EFSA Journal 2018;16(5):5272 [7 pp.].
Question Number
On request from
European Commission