
Article 1 

1. Egg membrane hydrolysate as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.
2. For a period of five years from the date of entry into force of this Regulation only the initial Applicant:
 Company: Biova, LLC
 Address: 5800 Merle Hay Rd, Suite 14 PO Box 394 Johnston 50131, Iowa USA;is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for the novel food without reference to the data protected pursuant to Article 2 of this Regulation or with the agreement of Biova, LLC.
3. The entry in the Union list referred to in the first paragraph shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.
4. The authorisation provided for in this Article shall be without prejudice to the provisions of Directive 2002/46/EC.
Article 2 
The study contained in the application file on the basis of which the novel food referred to in Article 1 has been assessed by the Authority, claimed by the applicant as fulfilling the requirements 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 five years from the date of entry into force of this Regulation without the agreement of Biova, LLC.
Article 3 
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Article 4 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 31 October 2018.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

((1)) the following last column is added in Table 1 (Authorised novel foods):
'Data Protection'
((2)) the following entry is inserted in Table 1 (Authorised novel foods) 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 Specified food category Maximum levels The designation of the novel food on the labelling of the foodstuffs containing it shall be “egg membrane hydrolysate”.  Authorised on 25 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Biova, LLC., 5800 Merle Hay Rd, Suite 14 PO Box 394 Johnston 50131, Iowa USA. During the period of data protection the novel food egg membrane hydrolysate is authorised for placing on the market within the Union only by Biova, LLC. 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 Biova, LLC.End date of the data protection: 25 November 2023’.
Food Supplements as defined in Directive 2002/46/EC intended for the general adult population 450 mg/day
((3)) the following entry is inserted in Table 2 (Specifications) in alphabetical order:

Authorised Novel Food Specification
‘Egg membrane hydrolysate 
The egg membrane hydrolysate is derived from the eggshell membranes of chicken eggs. The eggshells undergo hydro-mechanical separation in order to obtain the egg membranes, which are then further processed using a patented solubilisation method. Following the solubilisation process, the solution is filtered, concentrated, spray-dried and packaged.
Characteristics/Composition
Chemical parameters Methods
Total nitrogen-containing compounds (% w/w): ≥ 88 Combustion according to AOAC 990.03 and AOAC 992.15
Collagen (% w/w): ≥ 15 SircolTM Soluble Collagen Assay
Elastin (% w/w): ≥ 20 FastinTM Elastin Assay
Total glycosaminoglycans (% w/w): ≥ 5 USP26 (chondroitin sulphate K0032 method)
Calcium: ≤ 1 % 

pH: 6,5 – 7,6

Ash (% w/w): ≤ 8

Moisture (% w/w): ≤ 9

Water activity: ≤ 0,3

Solubility (in water): soluble

Bulk density: ≥ 0,6 g/cc

Arsenic ≤ 0,5 mg/kg

Aerobic plate count: ≤ 2 500 CFU/g

Escherichia coli: ≤ 5 MPN/g

Salmonella: Negative (in 25 g)

Coliforms: ≤ 10 MPN/g

Staphylococcus aureus: ≤ 10 CFU/g

Mesophilic spore count: ≤ 25 CFU/g

Thermophilic spore count: ≤ 10 CFU/10 g

Yeast: ≤ 10 CFU/g

Mould: ≤ 200 CFU/g

CFU: Colony Forming Units; MPN = Most Probable Number; USP: United States Pharmacopeia.’

