Scientific Opinion on the safety and efficacy of clinoptilolite of sedimentary origin for all animal species

Abstract

The additive clinoptilolite of sedimentary origin contains at least 80 % clinoptilolite (hydrated calcium aluminosilicate) and a maximum of 20 % clay minerals. Regarding the limited database and partly controversial findings, the FEEDAP Panel concluded that 10 000 mg clinoptilolite/kg complete feed could be considered to be safe for all animal species. Clinoptilolite is essentially not absorbed and is excreted with the faeces. There is no evidence that clinoptilolite will be degraded during its passage through the gastrointestinal tract of target animals. The consumer is therefore not exposed to clinoptilolite as a result of its use in animal nutrition; consequently, no risk for the consumer will arise. With regard to the high dusting potential of the additive, and in the absence of data on its irritation and sensitisation potential, the FEEDAP Panel considers it prudent to treat the additive as an irritant to the skin and eyes, a dermal sensitiser and an inhalation toxicant. The use of clinoptilolite in animal nutrition does not pose a risk for the environment. Based on data on a large variety of compound feeds, the additive is considered to have the potential to be effective as an anticaking agent. No data were available to allow conclusions to be drawn on its efficacy as a pellet binder. However, as the physical properties required for an anticaking and a pellet-binding additive are similar, and the efficacy of clinoptilolite as an anticaking agent is proven, the FEEDAP Panel considers it likely that the additive also has the potential to be effective as a pellet binder. SUMMARYFollowing 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 clinoptilolite of sedimentary origin as a technological additive, functional group binder.The additive clinoptilolite of sedimentary origin contains at least 80 % clinoptilolite (hydrated calcium aluminosilicate) and a maximum of 20 % clay minerals.Regarding the limited database and partly controversial findings, the FEEDAP Panel concluded that 10 000 mg clinoptilolite/kg complete feed could be considered to be safe for all animal species.Clinoptilolite is essentially not absorbed and is excreted with the faeces. There is no evidence that clinoptilolite will be degraded during its passage through the gastrointestinal tract of target animals. The consumer is therefore not exposed to clinoptilolite as a result of its use in animal nutrition; consequently, no risk for the consumer will arise.With regard to the high dusting potential of the additive, and in the absence of data on its irritation and sensitisation potential, the FEEDAP Panel considers it prudent to treat the additive as an irritant to the skin and eyes, a dermal sensitiser and an inhalation toxicant.The use of clinoptilolite in animal nutrition does not pose a risk for the environment.

Some Aspects of Using Clinoptilolite in Calves Feeding

“…As a result, the antibody level, vaccination efficacy, phagocytes, immunoglobulins and lymphocytes activity decrease the animal productivity [14]. It should be noted that the feed contamination with several mycotoxins leads to their simultaneous entry into the body, depending on their absorption rate, mycotoxins have a synergistic or additional effect, DON increases the fumonisins adsorption and zearalenone increases the negative effect of DON [3].…”

“…There is no evidence that clinoptilolite will decompose during its travel through the gastrointestinal tract of the target animals. Therefore, the consumer is not affected by clinoptilolite as a result of its use in the animal feed; therefore, there is no risk for the consumer [3].…”

Clinical Evaluation of a Defined Zeolite-Clinoptilolite Supplementation Effect on the Selected Blood Parameters of Patients

“…Nevertheless, controlled clinical studies with the focus on the safety of clinoptilolite materials have not been extensively performed so far. This is probably due to the generally accepted safety of the material in animals and humans at EFSA recommended dosages ( 13 ). Still, mineral and metal homeostasis in the organism underlies all biological processes and eventual changes in this domain may be crucial in health outcomes.…”

“…PMA (Panaceo Micro Activation)-zeolite (patent WO2018/100178A1) is a certified European medical device subjected to required toxicology tests performed according to the OECD and ISO guidelines. The dosage was adjusted according to the certification of the PMA-zeolite material and EFSA safety data on clinoptilolite materials ( 13 ). The treatment period was adjusted according the pathology study and in agreement with medical doctors leading the trials.…”