Safety and efficacy of an additive consisting of phyllite, natural mixture of minerals of metamorphic origin, as a feed additive for all animal species (Marmorkalkwerk Troesch GmbH & Co. KG).

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 phyllite, a natural mixture of minerals of metamorphic origin, as a feed additive for all animal species. The additive, specified to contain at least 40% of mica, muscovite, illite, chlorite and talc as the main components, and maximum 60% of quartz, potassium-feldspar, sodium-feldspar and calcite, is intended for use as a technological additive (functional groups: (i) anticaking agents) in premixtures and feedingstuffs for all animal species at a maximum inclusion level of 25,000 mg/kg. The additive is safe for chickens for fattening and chickens reared for laying/breeding at the maximum inclusion level of 25,000 mg/kg feed, with no margin of safety determined. Owing the absence of data in pigs and ruminants and in the absence of data on the potential genotoxicity of the additive, the Panel is not in the position to conclude on the safety of the additive for any other animal species/categories. The additive is considered safe for the consumers and the environment at the proposed conditions of use. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin and eye irritant and skin sensitiser. Exposure via inhalation is considered a risk. The FEEDAP Panel is not in the position to conclude on the efficacy of the additive as an anticaking agent.

Introduction

Background and Terms of Reference

Regulation (EC) No 1831/20031 establishes the rules governing the Community authorisation of additives for use in animal nutrition. In particular, Article 4(1) of that Regulation lays down that any person seeking authorisation for a feed additive or for a new use of a feed additive shall submit an application in accordance with Article 7.

The European Commission received a request from Marmorkalkwerk Troesch GmbH & Co. KG2 for authorisation of the product Phyllite, natural mixture of minerals of metamorphic origin, when used as a feed additive for all animal species (category: technological additives; functional group: anticaking agents).

According to Article 7(1) of Regulation (EC) No 1831/2003, the Commission forwarded the application to the European Food Safety Authority (EFSA) as an application under Article 4(1) (authorisation of a feed additive or new use of a feed additive). The particulars and documents in support of the application were considered valid by EFSA as of 1/3/2016.

According to Article 8 of Regulation (EC) No 1831/2003, EFSA, after verifying the particulars and documents submitted by the applicant, shall undertake an assessment in order to determine whether the feed additive complies with the conditions laid down in Article 5. EFSA shall deliver an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of the product Phyllite, natural mixture of minerals of metamorphic origin, when used under the proposed conditions of use (see Section  ).

Additional information

The additive phyllite is a natural mixture of minerals of metamorphic origin. This product has not been previously assessed or authorised as a feed additive in the European Union.

Data and methodologies

Data

The present assessment is based on data submitted by the applicant in the form of a technical dossier3 in support of the authorisation request for the use of phyllite, a natural mixture of minerals of metamorphic origin as a feed additive.

The FEEDAP Panel used the data provided by the applicant together with data from other sources, such as previous risk assessments by EFSA or other expert bodies, peer‐reviewed scientific papers and other scientific reports to deliver the present output.

EFSA has verified the European Union Reference Laboratory (EURL) report as it relates to the methods used for the control of phyllite in animal feed. The Executive Summary of the EURL report can be found in Annex A.4

Methodologies

The approach followed by the FEEDAP Panel to assess the safety and the efficacy of Phyllite, natural mixture of minerals of metamorphic origin, is in line with the principles laid down in Regulation (EC) No 429/20085 and the relevant guidance documents: Guidance on technological additives (EFSA FEEDAP Panel, 2012a,b), Guidance on studies concerning the safety of use of the additive for users/workers (EFSA FEEDAP Panel, 2012a,b), Guidance on the identity, characterisation and conditions of use of feed additives (EFSA FEEDAP Panel, 2017a), Guidance on the assessment of the safety of feed additives for the target species (EFSA FEEDAP Panel, 2017b), Guidance on the assessment of the safety of feed additives for the consumer (EFSA FEEDAP Panel, 2017c), Guidance on the assessment of the safety of feed additives for the environment (EFSA FEEDAP Panel, 2019) and Guidance on the assessment of the efficacy of feed additives (EFSA FEEDAP Panel, 2018).

Assessment

The product under assessment is a natural mixture of minerals of metamorphic origin containing ■■■■■

The applicant is seeking an authorisation for the use of the product as a technological additive (functional group: (i) anticaking agents) at a maximum content of 25,000 mg/kg complete feed for all animal species.

Characterisation

Characterisation of the additive

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The product is specified to contain at least ■■■■■ ■■■■■ The specifications for the composition of the additive and the characteristics of the main constituents are listed in Table 1.

Table 1

Specified composition of the additive phyllite and characteristics of the main constituents

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■■■■■	■■■■■	■■■■■
■■■■■	■■■■■	■■■■■	■■■■■
■■■■■	■■■■■	■■■■■
■■■■■	■■■■■	■■■■■	■■■■■
■■■■■	■■■■■	■■■■■	■■■■■
■■■■■	■■■■■	■■■■■	■■■■■
■■■■■	■■■■■	■■■■■	■■■■■

■■■■■ Both mineralogical and chemical approaches have been used to characterise the additive. ■■■■■7■■■■■7 The results showed compliance with the specifications. ■■■■■7

Purity

Three batches of the product8 showed concentrations of lead, cadmium, mercury and arsenic ■■■■■ that do not raise safety concern. Data on nickel concentration was not provided.

In the same three batches the sum of dioxins and dioxins‐like polychlorinated biphenyls (PCBs) was ■■■■■ ng WHO‐PCDD/F‐PCB‐TEQ/kg and the sum of non‐dioxin‐like PCBs (ICES = 6) ■■■■■ μg/kg. These concentrations are below the limits set in the Commission Directive 2002/32/EC.9

In addition, a total of 16 batches was analysed by electron‐microscopy scanning with scanning electron microscopy with energy‐dispersive X‐ray microanalysis (SEM/EDX) for mineral fibres.10 No traces of asbestos have been detected.

Physical state of the product

The particle size of the additive (one batch) was measured by sieving ■■■■■11

The dusting potential of the additive was measured in one batch of the additive (four replicate analysis), according to the Stauber–Heubach method12; ■■■■■ The particle size of the dust collected during the Stauber–Heubach method was determined by laser diffraction (triplicate analysis); the fraction of particles with diameter < 100, 50 and 10 μm ■■■■■ respectively, being the average particle size ■■■■■

Stability and homogeneity

Stability studies are generally not required for mineral‐based products, which are assumed to be stable. No data on the capacity of the additive to homogenously distribute in feeds or premixtures were provided.

Conditions of use

The additive is intended to be used in premixtures and feedingstuffs for all animal species and categories, at a maximum content of 25,000 mg/kg complete feed.

Safety

Absorption, distribution, metabolism and excretion

The FEEDAP Panel considers it unlikely that phyllite, in common with other clays, will be degraded during their passage through the gastrointestinal (GI) tract of target animals or absorbed to any appreciable extent and that harmful amounts of residues of any chemical component would occur in edible tissues/products as a consequence of the use of the additive.

Toxicological studies

No specific studies done with the additive under assessment, including genotoxicity studies, were provided. The applicant provided some reports of toxicological studies performed with some of the constituent of the additive (e.g. genotoxicity, carcinogenicity and reproductive toxicity studies ■■■■■). However, since these individual components will likely not be released from the mineral during the passage through the GI tract, the studies submitted are not considered as relevant for the assessment of the safety of phyllite as a feed additive for the target species and the consumer. Therefore, the FEEDAP Panel is not in the position to conclude on the toxicological profile of the additive per se.

Safety for the target species

Three tolerance studies were submitted, one in chickens for fattening, one in weaned piglets13 and one in dairy cows.14 However, in the studies in weaned piglets and dairy cows, no proper replication was included. Therefore, these studies could not be further considered.

Safety for chickens for fattening

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Interactions in vivo

No increase of the excretion of nitrogen, zinc, vitamin E (tocopherol acetate, alpha tocopherol and total tocopherols) and monensin was observed at concentrations up to 50,000 mg additive/kg feed for chickens for fattening (see tolerance study, Section 3.2.3.1). It is therefore expected that the additive, at the maximum recommended concentration of 25,000 mg/kg complete feed will not interfere with the nutrient/micronutrients supply of animals as well as the kinetics of monensin.

Conclusions on safety for the target species

The additive is not expected to interfere with the nutrient/micronutrients supply of animals up to the maximum proposed supplementation level of 25,000 mg/kg feed.

Based on the results of a tolerance study, the additive is considered safe for chickens for fattening at the maximum proposed inclusion level of 25,000 mg/kg complete feed. However, a margin of safety could not be established, due to the adverse effects seen in the blood biochemical parameters in the animals receiving the additive at 50,000 mg/kg. Therefore, such conclusion can be extended to chickens reared for laying/breeding, but not extrapolated to other poultry species/categories.

In the absence of valid studies with piglets and dairy cows, and in the absence of data on the potential genotoxicity of the additive, the Panel is not in the position to conclude on the safety of the additive for any other animal species/categories.

Safety for the consumer

The FEEDAP Panel considers unlikely the degradation and absorption of the additive and that harmful amounts of residues of any chemical component would occur in edible tissues/products from animals as a consequence of the use of the product as a feed additive. Therefore, the use of the additive phyllite in animal nutrition is considered not to pose a risk for the consumer of tissues and products from animals fed the additive.

Safety for user

No specific information on the effects of the additive on skin and eye and respiratory irritancy and sensitisation potential was available.

Considering the dusting potential of the additive (■■■■■) and the particle size of the dust (■■■■■), respiratory exposure of the user is likely.18 The additive ■■■■■ should be regarded as a risk by inhalation.

In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin and eye irritant and skin sensitiser. Exposure via inhalation is considered a risk.

Safety for the environment

The components of the additive (■■■■■) are ubiquitous in the environment, being natural components of soil. Therefore, it is not expected that phyllite, used as feed additive, would adversely affect the environment.

Efficacy

An in vitro study was provided to support the efficacy of the additive as an ■■■■■19 ■■■■■ A statistical analysis was not performed owing to the absence of adequate number of replicates.

■■■■■

Although positive numerical effects of the supplementation were observed ■■■■■ owing the absence of statistical analysis, the FEEDAP Panel is not in the position to conclude on the efficacy of the additive.

Conclusions

The additive is safe for chickens for fattening and chickens reared for laying/breeding at the maximum inclusion level of 25,000 mg/kg feed, with no margin of safety identified. Owing the absence of appropriate data in pigs and ruminants, and in the absence of data on the potential genotoxicity of the additive, the FEEDAP Panel is not in the position to conclude on the safety of the additive for any other animal species/categories.

The additive is considered safe for the consumers and the environment at the proposed conditions of use.

In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin and eye irritant and skin sensitiser. Exposure via inhalation is considered a risk.

Due to the absence of adequate studies the FEEDAP Panel is not in the position to conclude on the efficacy of the additive as an anticaking agent.

Documentation as provided to EFSA/Chronology

Abbreviations

alanine transaminase

alkaline phosphatase

aspartate aminotransferase

Chemical Abstracts Service

creatine phosphokinase

European Chemicals Agency

European Union Reference Laboratory

EFSA Panel on Additives and Products or Substances used in Animal Feed

gamma‐glutamyltranspeptidase

GI gastrointestinal

glutamate dehydrogenase

haemoglobin

lactate dehydrogenase

limit of quantification

mean corpuscular haemoglobin

mean corpuscular volume

molecular weight

polychlorinated biphenyl

polychlorinated dibenzo‐p‐dioxins and dibenzofurans

packed cell volume

red blood cell count

electron‐microscopy scanning with energy dispersive x‐ray microanalysis

total mixed ration

white blood cell count

World Health Organization

X‐ray diffraction

In the current application authorisation is sought under article 4(1) for phyllite, under the category/functional group 1(i) ‘technological additives’/‘anticaking agents’, according to the classification system of Annex I of Regulation (EC) No 1831/2003. The authorisation is sought for the use of the feed additive for all animal species. According to the Applicant the feed additive is a finely ground powder derived from mountain rocks. The feed additive consists of a natural mixture of minerals of metamorphic origin containing a minimum of 40% of phyllo‐ and alumo‐/alumohydrosilicates such as muscovite, illite, chlorite and talc. The feed additive is intended to be used directly in feedingstuffs or through premixtures to ensure flowability within the storage silos. The Applicant proposed a maximum inclusion level of the feed additive of 25 g/kg complete feedingstuffs. For the characterisation of the phyllite the Applicant submitted the EN 13925 standard method based on X‐Ray diffraction (XRD) to determine its mineralogical composition. Furthermore, the Applicant applied X‐Ray fluorescence spectrometry (XRF) as described in the EN ISO 12677 standard to determine the elemental composition in the feed additive. Based on the experimental data provided, the EURL recommends for official control the XRD and XRF methods described in the EN 13925 and EN ISO 12677 standards for the characterisation of the feed additive. The Applicant provided no experimental data or any analytical method for the quantification of phyllite in premixtures and feedingstuffs as the unambiguous determination of the feed additive added to the matrices is not achievable experimentally. Therefore, the EURL cannot evaluate nor recommend any method for official control for the determination of phyllite in premixtures and feedingstuffs. Further testing or validation of the methods to be performed through the consortium of National Reference Laboratories as specified by Article 10 (Commission Regulation (EC) No 378/2005) is not considered necessary.

Table 2

Mineralogical composition of five batches of phyllite (■■■■■)

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■■■■■	■■■■■	■■■■■	■■■■■	■■■■■	■■■■■	■■■■■

Table 3

Elemental composition of five batches of phyllite (■■■■■)

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Date	Event
08/01/2016	Dossier received by EFSA. Phyllite, natural mixture of minerals of metamorphic origin Submitted by Marmorkalkwerk Troesch GmbH & Co. KG.
19/01/2016	Reception mandate from the European Commission
01/03/2016	Application validated by EFSA – Start of the scientific assessment
03/06/2016	Comments received from Member States
17/06/2016	Request of supplementary information to the applicant in line with Article 8(1)(2) of Regulation (EC) No 1831/2003 – Scientific assessment suspended. Issues: safety for the target species
29/09/2017	Reception of supplementary information from the applicant ‐ Scientific assessment re‐started
02/02/2017	Reception of the Evaluation report of the European Union Reference Laboratory for Feed Additives
05/05/2021	Opinion adopted by the FEEDAP Panel. End of the Scientific assessment