Commission Implementing Regulation (EU) 2026/1427 of 2 July 2026 authorising the placing on the market of egg membrane hydrolysate (enzymatically produced) as a novel food and amending Implementing Regulation (EU) 2017/2470
1. Egg membrane hydrolysate (enzymatically produced) is authorised to be placed on the market within the Union.
Egg membrane hydrolysate (enzymatically produced) shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.
2. The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Only the company Eggnovo SL ( 13 ) is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of 5 years from 23 July 2026, unless a subsequent applicant obtains an authorisation for the novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of the company Eggnovo SL.
The scientific data contained in the application file and fulfilling the conditions laid down in Article 26(2) of Regulation (EU) 2015/2283 shall not be used for the benefit of a subsequent applicant for a period of 5 years from the date of entry into force of this Regulation without the agreement of the company Eggnovo SL.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Supplementary provisions
ANNEXSupplementary provisions
ANNEX
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
(1)
in Table 1 (Authorised novel foods) the following entry is inserted in alphabetical order:
Authorised novel food
Conditions under which the novel food may be used
Additional specific labelling requirements
Other requirements
Data protection
‘ Egg membrane hydrolysate (enzymatically produced)
Specified food category
Maximum levels
The designation of the novel food on the labelling of food supplements containing it shall be “egg membrane hydrolysate”.
The labelling of food supplements containing “egg membrane hydrolysate” shall bear a statement that they should not be consumed by persons under 18 years of age, pregnant and lactating women.
Authorised on 23 July 2026. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
Applicant: “Eggnovo SL”, Av. de los Tilos n° 5, 31132 Villatuerta, Navarra, Spain.
During the period of data protection, the novel food egg membrane hydrolysate (enzymatically produced) is authorised for placing on the market within the Union only by “Eggnovo SL” unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of “Eggnovo SL”.
End date of the data protection: 23 July 2031.’
Food supplements as defined in Directive 2002/46/EC, for the general adult population, excluding pregnant and lactating women.
500 mg/day
(2)
in Table 2 (Specifications), the following entry is inserted in alphabetical order:
Authorised novel food
Specification
‘ Egg membrane hydrolysate (enzymatically produced)
Description :
The novel food is a protein hydrolysate produced by enzymatic (food enzyme papain) hydrolysis of chicken ( Gallus gallus domesticus ) egg membranes. The product is a water-soluble cream-yellowish powder.
Characteristics/Composition :
Crude protein (% w/w): ≥ 70
Collagen (% w/w): 15-30
Moisture (% w/w): ≤ 8
Microbiological criteria :
TAMC ( a ): ≤ 5 × 10 4 CFU ( b )/g
TYMC ( c ): ≤ 100 CFU/g
Escherichia coli: Absence in 10 g
Salmonella spp.: Absence in 25 g
Listeria monocytogenes : Absence in 25 g
( a ) TAMC = Total Aerobic Microbial Count; ( b ) CFU = Colony Forming Units; ( c ) TYMC = Total Yeast and Mould Count.’
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.