The product ePhyt is a feed additive that contains 3-phytase. The product is authorised for use in the EU in chickens, turkeys and pigs for fattening. Both liquid and solid forms of the additive are available. The phytase product is expected to be authorised for use in pigs for fattening and turkeys for fattening.

Table 1. Technical specifications ePhyt® (solid or Liquid)

EU category Zoo-technical additives
Functional group of additives Digestibility enhancer
Active substance 3-Phytase (EC 3.1.3.8)
Phytase activity in the product Solid product: 10 000 FTU/g
Liquid product: 1 000 U/ml
EU approval, minimum content Chickens for fattening: minimum 500 FTU/kg feed
Chickens reared for laying: minimum 500 FTU/kg feed
Minor poultry species for fattening or reared for laying or breeding purposes: minimum 500 FTU/kg feed
Laying hens: 1000 FTU/kg feed
Turkeys for fattening: 500 FTU/kg feed
Turkeys reared for breeding purposes: 500 FTU/kg feed
Pigs for fattening: 500 FTU/kg feed
Minor porcine species for fattening: 500 FTU/kg feed
End of period of EU authorisation Solid product, below species authorised until 5 June 2029
Chickens for fattening: 
Chickens reared for laying
Minor poultry species for fattening or reared for laying or breeding purposes
Laying hens
Authorised until 17 March 2031:
Turkeys for fattening
Turkeys reared for breeding purposes
Pigs for fattening
Minor porcine species for fattening

Liquid product
Chickens for fattening: 14 June 2027
Laying hens: 14 June 2027
Chickens reared for laying: 20 February 2029
Minor poultry species for fattening or reared for laying or breeding: 20 February 2029
Turkeys for fattening: 17 March 2031
Turkeys reared for breeding purposes: 17 March 2031
Pigs for fattening: 17 March 2031
Minor porcine species for fattening: 17 March 2031
EU code 4a25
Production organism Genetically modified Komagataella pastoris, CECT 13094
Donor organism Serratia odorifera
Product storage stability Liquid product:
Samples from three batches were collected and stored for six months at 4°C, 25°C or 40°C. When stored at 4°C for six months no losses were observed. The analytical results showed that more than 61% of the initial activity was recovered when stored at 25°C for six months. Storage at 40°C had a considerable negative effect on the break-down of phytase as only 19.7-24.3% of the initial activity could be recovered.

Solid product:
Three batches of the product were stored for 6 months at either 25°C or 40°C. After 6 months of storage, there was no decrease in enzyme activity.
Storage stability in feed Liquid product:
Samples of mash chicken or layer feed supplemented with 250 FTU/kg or 500 FTU/kg were collected. The samples were stored in paper bags for 3 months at either 25°C or 35°C. When stored at 25°C 86 - 94% of the initial phytase activity in the chicken feed could be recovered. At the higher temperature, 74% of the initial phytase activity could be measured. In the layer feed, there was no loss when 250 FTU/kg was added and stored at 25°C and a recovery of 90% in the 500 FTU/kg layer feed. When the layer feed was stored at 35°C the activity was reduced to 68 % and 62%.

Solid product:
Three batches of the product were added to a vitamin/mineral premix and stored for 6 months at room temperature. After 6 months of storage, the remaining phytase activity ranged from 81% to 88% of the initial activity.
Heat stability The liquid product is for post-pelleting use only.
Three batches of the solid product were added to a chicken mash feed and subsequently pelleted at 80-85 °C. The pelleting process reduced the phytase activity by 12%. Samples of the pelleted feed and the mash feed were furthermore stored for 3 months at either 25°C or 35°C.  No reduction in phytase activity compared with the initial one could be detected when the pelleted and mash feed were stored at 25°C.  Mash feed stored at 35°C did also not show any reduction whereas the pelleted feed stored at 35°C showed a 20% reduction in phytase activity.
Homogeneity Liquid product:
Three batches of chickens feed were used for determining the capacity of the additive to mix homogeneously. Ten subsamples of each batch were collected and analysed. In mash feed, the CV was ≤12.5% and in pelleted feed <18%.

Solid product:
Samples of both mash and pelleted feed were collected and the distribution of the additive in the feed was determined. In the mash feed, the CV was <6% and in the pelleted feed the CV was <19% 
Carrier/composition Liquid product:
enzyme protein: 1.2 g/L, sorbitol: 28-32%; sodium acetate anhydrate: 0.4-0.6%; potassium sorbate: 0.08 - 1.20%; water: 68-72%

Solid product:
1.2 % protein; wheat bran: 90%; sodium citrate: 5%; water: 2-8%
Physical properties Liquid product:
Bulk density in three batches of the product ranged from 1.11 to 1.14 kg/L. Viscosity ranged from 2.68 to 3.80 cP.

Solid product:
Dusting potential was measured in two batches of the product. The analytical results showed a dusting potential of 45mg/m3 for inhalable particles and 0.5 mg/m3 respirable particles. An analysis of the particle size in the product showed that 22% of the particles were < 100 µm, 13% < 50µm and 3% < 10µm.  The bulk density of the product ranged from 640 to 656 kg/m3
Handling May cause sensitisation by inhalation.  Wear suitable protective equipment.
Producer GlobalFeed

List of references

EFSA (2016). Safety and efficacy of 3-phytase FLF1000 as a feed additive for chickens for fattening and laying hens. EFSA Journal 2016;14(11):4622

EFSA (2019). Safety and efficacy of 3-phytase FSF1000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species. EFSA Journal 2019;17(1):5543

EU (2017). Commission Implementing Regulation (EU) 2017/895 of 24 May 2017 concerning the authorisation of a preparation of 3-phytase produced by Komagataella pastoris (CECT 13094) as a feed additive for chickens for fattening and laying hens (holder of authorisation Fertinagro Nutrientes S.L.). Official Journal of the European Union. L 138/120-122  

EU (2019). Commission Implementing Regulation (EU) 2019/144 of 28 January 2019 concerning the authorisation of a preparation of 3-phytase produced by Komagataella pastoris (CECT 13094) as a feed additive for chickens reared for laying and minor poultry species for fattening or reared for laying or for breeding (holder of authorisation Fertinagro Nutrientes S.L.). Official Journal of the European Union. L 27/8-10

EU (2019). Commission Implementing Regulation (EU) 2019/781 of 15 May 2019 concerning the authorisation of a preparation of 3-phytase produced by Komagataella pastoris (CECT 13094) as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species for fattening, for breeding and reared for laying (holder of authorisation Fertinagro Nutrientes S.L.). Official Journal of the European Union. L 127/1-3 

EU (2021). Commission Implementing Regulation (EU) 2021/330 of 24 February 2021 concerning the authorisation of a preparation of 3-phytase produced by Komagataella phaffii CECT 13094 as a feed additive for pigs for fattening, minor porcine species, turkeys for fattening and reared for breeding. (holder of authorisation Fertinagro Biotech S.L.). Official Journal of the European Union. L 65/43-46