Commission Implementing Regulation (EU) 2018/1647 of 31 October 2018 authorising the placing on the market of egg membrane hydrolysate as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance.)
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.
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.
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
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)
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
Description
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
Sircol TM Soluble Collagen Assay
Elastin (% w/w): ≥ 20
Fastin TM Elastin Assay
Total glycosaminoglycans (% w/w): ≥ 5
USP26 (chondroitin sulphate K0032 method)
Calcium: ≤ 1 %
Physical parameters
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
Heavy metals
Arsenic ≤ 0,5 mg/kg
Microbiological criteria
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.’
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
