Efficacy of a feed additive consisting of 6‐phytase produced with Aspergillus oryzae DSM 33737 (HiPhorius™) for all poultry, all porcine species and all fin fish (DSM Nutritional Products Ltd)

TL;DR

This paper evaluates the effectiveness of a feed additive containing 6-phytase for poultry, pigs, and fish, concluding it is potentially effective for all species.

Contribution

The study confirms the efficacy of HiPhorius™ 6-phytase in all poultry and porcine species, addressing previous data gaps.

Findings

The additive is potentially efficacious in all poultry species.

The additive is potentially efficacious in all porcine species.

The additive is efficacious in all fin fish.

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of 6‐phytase produced by the genetically modified strain Aspergillus oryzae DSM 33737 (HiPhorius™) as a zootechnical feed additive for all poultry, all porcine species and all fin fish. In a previous opinion, the FEEDAP Panel concluded that the additive is safe for the target species, consumers and the environment. The Panel also concluded that the additive is not a skin and eye irritant but should be considered as skin and respiratory sensitiser. The Panel concluded that the additive had the potential to be efficacious as a zootechnical additive when included in the diet of poultry for fattening or reared for laying/breeding, reproductive porcine species and all fin fish. However, due to the lack of sufficient data, the Panel was not in the position to conclude on the efficacy for laying and reproductive poultry and growing porcine species. The applicant provided new trials to support the efficacy of the additive in those target species. Based on the data provided in the previous and current applications, the Panel concluded that the additive has the potential to be efficacious in all poultry and all porcine species.

Tables

TABLE 1. Description of the substances.

Category of additive	Zootechnical additives
Functional group of additive	Digestibility enhancers
Description	6‐phytase produced with Aspergillus oryzae DSM 33737
Target animal category	All poultry, all Suidae and all fin fish
Applicant	DSM Nutritional Products Ltd
Type of request	New opinion ‐ Request for scientific opinion pursuant to Article 29(1)(a) of Regulation (EC) No 178/2002

TABLE 2. Effects of 6‐phytase (HiPhorius™) on the performance of laying hens.

Groups (FYT/kg feed)	Average daily feed intake (g)	Initial body weight (g)	Final body weight (g)	Egg weight (g)	Laying rate	Daily egg mass per hen	Feed to egg mass	Mortality and culling (%)
0	108	1764	1892b	60.4a	92.1b	55.9	1.95	3.1
187.5	109	1770	1944a	60.1b	93.6a	56.5	1.94	2.0
375	108	1767	1954a	60.0b	92.9b	56.0	1.94	1.2

Full text

INTRODUCTION

1

Background and Terms of Reference as provided by the requestor

1.1

Regulation (EC) No 1831/20031 establishes the rules governing the Union authorisation of additives for use in animal nutrition; in particular, Article 9 defines the terms of the authorisation by the Commission.

The applicant DSM Nutritional Products Ltd. (represented in the EU by DSM Nutritional Products Sp. zo.o.)2 is seeking a Union authorisation of the feed additive described in Table 1.

On 01.02.2024, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), in its opinion on the safety and efficacy of a feed additive consisting of 6‐phytase produced with Aspergillus oryzae DSM 33737 as a zootechnical additive for all poultry, all Suidae and all fin fish, could not conclude on the efficacy for laying and reproductive poultry and growing Suidae.

The European Commission gave the possibility to the applicant to submit supplementary information and data to complete the assessment and to allow a revision of the EFSA opinion regarding laying and reproductive poultry and growing Suidae.

The supplementary information and data have been transmitted by the applicant using the E‐Submission Food Chain Platform (application number FEED‐2024‐33402) (1).

In view of the above and in accordance with Article 29(1)(a) of Regulation (EC) No 178/2002, the European Commission requests EFSA to deliver a new scientific opinion on a feed additive consisting of 6‐phytase produced with Aspergillus oryzae DSM 33737 as a zootechnical additive for laying and reproductive poultry and growing Suidae under the conditions of Regulation (EC) No 1831/2003, based on the supplementary information and data submitted by the applicant.

Additional information

1.2

The additive is a preparation of 6‐phytase produced with A. oryzae DSM 33737. The additive is currently authorised for use in feed for all poultry species for fattening or reared for laying or reared for breeding, sows of all porcine species3 and all fin fish (4a48).4

EFSA issued one opinion on the safety and efficacy of this product when used in feed for all poultry species for fattening or reared for laying or reared for breeding, sows of all porcine species and all fin fish (EFSA FEEDAP Panel, 2024a).

DATA AND METHODOLOGIES

2

Data

2.1

The present assessment is based on data submitted by the applicant in the form of supplementary information5 to a previous application on the same product.6 The dossier was received on 07/02/2025, and the general information and supporting documentation are available on Open.EFSA at https://open.efsa.europa.eu/questions/EFSA‐Q‐2025‐00143.

Methodologies

2.2

The approach followed by the FEEDAP Panel to assess the efficacy of 6‐phytase produced with a genetically modified strain of A. oryzae DSM 33737 (HiPhorius™) is in line with the principles laid down in Regulation (EC) No 429/20087 and the relevant guidance documents: Guidance on the assessment of the efficacy of feed additives (EFSA FEEDAP Panel, 2024b).

ASSESSMENT

3

The additive under assessment consists of 6‐phytase produced with a genetically modified strain of A. oryzae DSM 33737. The additive is intended to be used in feed for all poultry, all porcine species and all fin fish as a zootechnical additive (functional group: digestibility enhancers) at a minimum level of 187.5 FYT8/kg complete feed. The additive, with the trade name ‘HiPhorius’, is available in two solid (HiPhorius 10 and 40) and two liquid (HiPhorius 20L and 50L) formulations with an enzyme activity ranging from 10,000 to 50,000 FYT/g.

The additive was fully characterised in a previous opinion (EFSA FEEDAP Panel, 2024a). In that opinion, the Panel concluded that the use of the additive at the proposed conditions of use is safe for the target species, the consumers and the environment. The Panel concluded that the liquid formulations are not skin and eye irritants, but the solid formulations should be considered skin and respiratory sensitisers.

In that opinion, the FEEDAP Panel concluded that the additive has the potential to be efficacious in all poultry for fattening and reared for laying/breeding and all reproductive porcine species at 200 FYT/kg complete feed, and in all fin fish at 1000 FYT/kg complete feed. Due to the lack of sufficient data, the Panel was not in the position to conclude on the efficacy for laying and reproductive poultry and porcine species for fattening or reared for reproduction. The applicant has submitted new efficacy trials which are assessed below.

Efficacy

3.1

Efficacy in poultry

3.1.1

In the previous opinion, the FEEDAP Panel concluded that the additive has the potential to be efficacious in all poultry for fattening and reared for laying/breeding at 200 FYT/kg complete feed, but no conclusion could be reached for reproductive poultry (EFSA FEEDAP Panel, 2024a). In that assessment, the applicant provided two long‐term and one short‐term trials in laying hens to support the efficacy of the additive in laying hens (EFSA FEEDAP Panel, 2024a). One of the long‐term trials was not considered further because it did not align with standard farming practices within the EU (i.e. individual housing of the animals). Regarding the other two trials, the hens supplemented with the additive from 187.5 FYT/kg feed showed an improved laying performance (higher laying rate, daily egg mass and egg weight) in the long‐term one and a higher P utilisation in the short‐term one compared to the hens in the control groups.

In the current application, the applicant submitted one long‐term trial in laying hens aiming at evaluating the effect of 6‐phytase on the laying performance. In that trial, 768 24‐week‐old Novogen Brown laying hens were distributed in 96 enriched cages with eight hens per cage, which were randomly allocated to three experimental groups (32 cages per treatment). A basal diet based on maize and soya bean meal was either not supplemented or supplemented with HiPhorius™ 10 to provide 187.5 and 375 FYT/kg feed. The enzyme activity in the feed was analytically confirmed.9 The feed was offered ad libitum in mash form for 113 days.

The general health status of the animals was monitored daily and the mortality recorded, including the most likely cause of death. Average body weight was measured individually at the beginning (day 1) and at the end of the trial (day 113). The feed intake per cage and the egg production and weight were recorded every 4 weeks. The average daily feed intake, laying rate, average egg mass per hen and feed‐to‐egg mass ratio were calculated and corrected for mortality. The egg quality (including number of broken/unsaleable eggs, egg size classification, shell weight, shell percentage and shell index10) was monitored every 4 weeks. The experimental data were analysed with a mixed model, with the diet, time (period of 4 weeks) and interaction diet × time as fixed effects, the block (location of cages in the room) as random effect and the laying rate prior to the start of the trial as a covariate. The cage was used as the experimental unit. When differences were observed between groups, means were compared with a Dunnett's test. The significance level was set at 0.05. The main results are shown in Table 2.

The mortality averaged 2.1% and did not differ between groups. The hens receiving the diet supplemented with the additive at 187.5 FYT/kg feed showed higher final body weight and laying rate compared to the control group. Egg weight of the hens treated with the additive was lower in the supplemented groups compared to the control; however, since the daily egg mass per hen showed no differences between groups, the effect was not considered relevant. The egg quality parameters (number of broken/unsaleable eggs, shell percentage and shell index) were improved in the groups supplemented with the additive (data not shown).

Conclusions on the efficacy for all poultry

3.1.1.1

A total of three trials in laying hens (one from the current submission and two from the previous one) showed a positive effect on key parameters related to the claimed effect of the additive when supplemented at 187.5 FYT/kg to the feed. Therefore, the Panel concludes that the additive has the potential to be efficacious in laying hens at the proposed conditions of use. Considering that efficacy was also demonstrated in the previous opinion in chickens for fattening at the same level, the Panel concludes that the additive HiPhorius has the potential to be efficacious in all poultry at the minimum recommended use level of 200 FYT/kg complete feed.

Efficacy in porcine species

3.1.2

Efficacy for weaned piglets

3.1.2.1

In the previous opinion, the FEEDAP Panel concluded that the additive has the potential to be efficacious in all reproductive porcine species at 200 FYT/kg complete feed but could not conclude on the efficacy for growing porcine species (EFSA FEEDAP Panel, 2024a). In that assessment, two long‐term and two short‐term trials were provided to support the efficacy of the additive in weaned piglets. However, one long‐term trial was excluded due to copper levels exceeding the maximum limits for feed in the EU. Additionally, the other long‐term trial and one short‐term trial were conducted simultaneously at the same location with similar diets; thus, these studies were not considered as independent, and the data were pooled and analysed as a single study. The results of the pooled study showed an improved zootechnical performance of the piglets, and those of the short‐term trial showed a positive effect on P utilisation when the additive was supplemented at the proposed use level.

In the current dossier, the applicant submitted one long‐term and one short‐term trial aiming to evaluate the efficacy of the additive supplementation on the growth performance (long‐term trial) or P utilisation (short‐term) in weaned piglets. However, the data reported in the long‐term trial suggested a poor adaptation of the piglets from the control group to the experimental conditions, reflected by a reduced growth compared to EU commercial standards (< 300 g/day) and the removal of a relevant number of animals (25%) due to health‐related issues. Therefore, the long‐term trial was not considered further as supporting evidence of the efficacy.

In the short‐term trial, 20 castrated male hybrid11 piglets (start weight = 8.8 ± 0.4 kg) were individually housed in metabolic cages and randomly allocated to two experimental groups. A basal diet based on maize, soya bean meal, full fat soya bean, rapeseed meal and whey powder was either not supplemented or supplemented with HiPhorius™ 10 to provide 187.5 FYT/kg feed. The enzyme activity was confirmed analytically.12 The experimental diets contained an external marker for digestibility analysis and were offered twice per day in pelleted form for 10 days.

The health status of the animals was monitored daily. The body weight of the animals was recorded at the start and end of the trial, and the feed intake was recorded for the overall period. The animals were allowed to adapt to the experimental diets and husbandry conditions for 5 days, and afterwards, faecal and urine samples were individually collected (total collection method) for 5 days and pooled per animal. The feed, faecal and urine samples were analysed for the content of dry matter, external marker, calcium and phosphorus, and the mineral retention was calculated. The experimental data were analysed with a one‐way analysis of variance (ANOVA), with the animal as the experimental unit and the diet as a fixed effect. The significance level was set at 0.05.

The health status of the animals was adequate, and no piglet died during the trial. No differences were observed in the zootechnical parameters between groups. The piglets fed with diets with the additive at 187.5 FYT/kg feed showed higher phosphorus retention (43.0%) than the control group (31.8%).

Conclusions on the efficacy for Suidae

3.1.2.2

A total of three studies in weaned piglets (one in the present application and two in the previous opinion) showed a positive effect of the supplementation of the diets with the additive at 187.5 FYT/kg feed. Therefore, the Panel concludes that the additive has the potential to be efficacious in weaned piglets at the proposed conditions of use. Considering that efficacy was demonstrated in sows at 200 FYT/kg feed, the Panel concludes that the additive HiPhorius has the potential to be efficacious in all porcine species at the proposed conditions of use.

Conclusions on efficacy

3.1.3

The Panel concludes that the additive has the potential to be efficacious in all poultry and all porcine species at the minimum proposed use level of 200 FYT/kg complete feed.

Post‐market monitoring

3.2

The FEEDAP Panel considers that there is no need for specific requirements for a post‐market monitoring plan other than those established in the Feed Hygiene Regulation13 and good manufacturing practice.

CONCLUSIONS

4

The FEEDAP Panel concludes that the additive 6‐phytase (HiPhorius™) has the potential to be efficacious in all poultry and all porcine species at the minimum proposed use level of 200 FYT/kg complete feed.ABBREVIATIONSADFIaverage daily feed intakeADGaverage daily gainANOVAanalysis of varianceBWbody weightDMdry matterFEEDAPEFSA Scientific Panel on Additives and Products or Substances used in Animal Feed

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2025‐00143

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PANEL MEMBERS

Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López‐Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto‐Maradona, Ilen Röhe, and Katerina Theodoridou.