title: Commission Implementing Regulation (EU) 2018/1566 of 18 October 2018 concerning the authorisation of the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) as a feed additive for weaned piglets and minor porcine species (weaned) and amending Regulation (EC) No 1453/2004 (holder of authorisation Andrès Pintaluba S.A.) (Text with EEA relevance.)

text:
                  19.10.2018

                  EN

                  Official Journal of the European Union

                  L 262/27

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1566
         of 18 October 2018
         concerning the authorisation of the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) as a feed additive for weaned piglets and minor porcine species (weaned) and amending Regulation (EC) No 1453/2004 (holder of authorisation Andrès Pintaluba S.A.)
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
         Whereas:

                     (1)

                     Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

                     (2)

                     The preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) was authorised in accordance with Directive 70/524/EEC without a time limit as a feed additive for weaned piglets by Commission Regulation (EC) No 1453/2004 (3). That preparation was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003.

                     (3)

                     In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that Regulation, an application was submitted for the re-evaluation of the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) as a feed additive for weaned piglets and minor porcine species (weaned). The applicant requested that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinions of 8 October 2013 (4), 16 May 2017 (5) and 17 April 2018 (6) that, under the proposed conditions of use, of the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) does not have an adverse effect on animal health, human health or the environment. The Authority also concluded that the use of that preparation has the potential to improve the final body weight and the feed to gain ratio in weaned piglets and that conclusion can be can be extrapolated to minor porcine species (weaned). The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (5)

                     The assessment of the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.

                     (6)

                     As a consequence of granting the authorisation for the preparation Regulation (EC) No 1453/2004 should be amended accordingly.

                     (7)

                     Since there are no safety concerns requiring the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

                     (8)

                     The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Authorisation
            The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in the Annex.

            Article 2
            Amendment to Regulation (EC) No 1453/2004
            In Annex II to Regulation (EC) No 1453/2004 entry E 1612 on the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase and alpha-amylase is deleted.

            Article 3
            Transitional measures
            The preparation specified in the Annex, and feed containing that preparation, which are produced and labelled before 8 May 2019 in accordance with the rules applicable before 8 November 2018 may continue to be placed on the market and used until the existing stocks are exhausted.

            Article 4
            Entry into force
            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, 18 October 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 268, 18.10.2003, p. 29.

            (2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

            (3)  Commission Regulation (EC) No 1453/2004 of 16 August 2004 concerning the permanent authorisation of certain additives in feedingstuffs (OJ L 269, 17.8.2004, p. 3).

            (4)  EFSA Journal 2013; 11(10):3430.

            (5)  EFSA Journal 2017; 15(6):4856.

            (6)  EFSA Journal 2018; 1(5):5271.

            ANNEX

                        Identification number of the additive

                        Name of the holder of authorisation

                        Additive

                        Composition, chemical formula, description, analytical method

                        Species or category of animal

                        Maximum age

                        Minimum content

                        Maximum content

                        Other provisions

                        End of period of authorisation

                        Units of activity/kg of complete feedingstuff with a moisture content of 12 %

                           Category of zootechnical additives. Functional group: digestibility enhancers

                        4a1612i

                        Andrés Pintaluba S.A.

                        Endo-1,3(4)-beta-glucanase
                        EC 3.2.1.6
                        Endo-1,4-beta-xylanase
                        EC 3.2.1.8
                        Alpha-amylase
                        EC 3.2.1.1

                           Additive composition

                        Preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) having respectively a minimum activity of.

                                    —

                                    Endo-1,3(4)-beta-glucanase 900 U (1)/g;

                                    —

                                    Endo-1,4-beta-xylanase 1 000  U (2)/g;

                                    —

                                    Alpha-amylase 3 000  U (3)/g

                              Solid form

                           Characterisation of the active substance

                        endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222

                           Analytical methods
                            (4)

                        Determination in the feed additive of:

                                    —

                                    endo-1,3(4)-beta glucanase: colorimetric method based on the enzymatic reaction of glucanase on barley betaglucan substrate in the presence of 3,5-dinitrosalicylic acid (DNS) at pH 4,0 and 30 °C;

                                    —

                                    endo-1,4-β-xylanase in the feed additive: colorimetric method based on the enzymatic reaction of xylanase on rye arabinoxylan substrate in the presence of DNS at pH 4,0 and 30 °C;

                                    —

                                    alpha-amylase: colorimetric method based on the enzymatic reaction of amylase on wheat starch substrate in the presence of DNS at pH 5,0 and 30 °C.

                              Determination of the active substances in premixtures and feedingstuffs:

                                    —

                                    Colorimetric method measuring depolymerised soluble fragments released by action of glucanase on azo-barley-glucan;

                                    —

                                    Colorimetric method measuring depolymerised soluble fragments released by action of endo-1,4-β-xylanase on azo-xylan;

                                    —

                                    Colorimetric method measuring depolymerised soluble fragments released by action of amylase on p-nitrophenylmaltoheptaoside.

                        Weaned piglets
                        Minor porcine species
                        (weaned)

                        endo-1,3(4)-beta-glucanase
                        450 U
                        beta-xylanase
                        500 U
                        alpha-amylase
                        1 500  U

                                    1.

                                    In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

                                    2.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment including skin, eyes and breathing protections.

                                    3.

                                    For use in weaned piglets until approximately 35 kg.

                        8 November 2028

               (1)  1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 4,0 and 30 °C.

               (2)  1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from rye arabinoxylan per minute at pH 4,0 and 30 °C.

               (3)  1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from wheat starch per minute at pH 5,0 and 30 °C.

               (4)  Details of the analytical methods are available at the following address of the Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports


title: Commission Implementing Regulation (EU) 2018/1567 of 18 October 2018 correcting Implementing Regulation (EU) 2018/249 concerning the authorisation of taurine, beta-alanine, L-alanine, L-arginine, L-aspartic acid, L-histidine, D,L-isoleucine, L-leucine, L-phenylalanine, L-proline, D,L-serine, L-tyrosine, L-methionine, L-valine, L-cysteine, glycine, monosodium glutamate and L-glutamic acid as feed additives for all animal species and L-cysteine hydrochloride monohydrate for all species except cats and dogs (Text with EEA relevance.)

text:
                  19.10.2018

                  EN

                  Official Journal of the European Union

                  L 262/31

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1567
         of 18 October 2018
         correcting Implementing Regulation (EU) 2018/249 concerning the authorisation of taurine, beta-alanine, L-alanine, L-arginine, L-aspartic acid, L-histidine, D,L-isoleucine, L-leucine, L-phenylalanine, L-proline, D,L-serine, L-tyrosine, L-methionine, L-valine, L-cysteine, glycine, monosodium glutamate and L-glutamic acid as feed additives for all animal species and L-cysteine hydrochloride monohydrate for all species except cats and dogs
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
         Whereas:

                     (1)

                     Commission Implementing Regulation (EU) 2018/249 (2) authorises certain feed additives as flavourings, including glycine, L-cysteine and L-cysteine hydrochloride monohydrate.

                     (2)

                     An error appears in the Annex to Implementing Regulation (EU) 2018/249 in the entry for glycine where, in the column ‘Other provisions’, it is stated that the label of this additive is to indicate that recommended maximum content of the active substance of complete feedingstuff, with a moisture content of 12 % for other categories and species, is 25 g/kg. In accordance with the opinion of the European Food Safety Authority (3) issued for the authorisation of this feed additive, the correct amount is 25 mg/kg.

                     (3)

                     Errors appear in the Annex to Implementing Regulation (EU) 2018/249, in the entries for L-cysteine and L-cysteine hydrochloride monohydrate regarding the manufacturing process of the active substance. In particular, while it is indicated in the column ‘Composition, chemical formula, description analytical method’ that the active substance is produced by chemical synthesis or protein hydrolysis. In this part, it is omitted to indicate that the protein hydrolysis is made with animal or vegetal proteins, so the use of human hair that could be used as a source for hydrolysis to produce this specific additive is not allowed.

                     (4)

                     The erroneous provisions have given rise to confusion for the feed business operators as regards the actual provisions for placing on the market of the additives concerned. That situation has created legal uncertainty as to the applicable regulatory framework. Those errors have therefore resulted in some market disturbance linked to the questioned authorisation to place on the market and use of glycine, L-cysteine and L-cysteine hydrochloride monohydrate. The corrections to Implementing Regulation (EU) 2018/249 should therefore apply retroactively on the day of entry into force of that Implementing Regulation, in order to restore legal certainty in relation to the regulatory status of the additives subject to the errors, to avoid any detrimental consequences for the operators concerned and consequently, to bring stability back to the market.

                     (5)

                     The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The Annex to Implementing Regulation (EU) 2018/249 is corrected in accordance with Annex to this Regulation.

            Article 2
            Entry into force
            This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.
            It shall apply from 15 March 2018.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 18 October 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 268, 18.10.2003, p. 29.

            (2)  Commission Implementing Regulation (EU) 2018/249 of 15 February 2018 concerning the authorisation of taurine, beta-alanine, L-alanine, L-arginine, L-aspartic acid, L-histidine, D,L-isoleucine, L-leucine, L-phenylalanine, L-proline, D,L-serine, L-tyrosine, L-methionine, L-valine, L-cysteine, glycine, monosodium glutamate and L-glutamic acid as feed additives for all animal species and L-cysteine hydrochloride monohydrate for all species except cats and dogs (OJ L 53, 23.2.2018, p. 134).

            (3)  EFSA Journal 2014; 12(5):3670

            ANNEX
            Annex to Implementing Regulation (EU) 2018/249 is corrected as follows:

                        (1)

                        in the entry concerning substance 2b17034 glycine, the column ‘Other provisions’ is corrected as follows:

                                    (a)

                                    point 3 is replaced by the following:

                                                ‘3.

                                                On the label of the additive the following shall be indicated: “Recommended maximum content of the active substance of complete feeding stuff with a moisture content of 12 %:

                                                            —

                                                            20 g/kg for cats and dogs;

                                                            —

                                                            25 mg/kg for other species and categories.”’;

                                    (b)

                                    point 5 is replaced by the following:

                                                ‘5.

                                                The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feeding stuff with a moisture content of 12 % exceeds:

                                                            —

                                                            20 g/kg for cats and dogs;

                                                            —

                                                            25 mg/kg for other species and categories.’;

                        (2)

                        in the entry concerning substance 2b17033 L–cysteine, in the column ‘Composition, chemical formula, description, analytical method’, the text ‘Produced by chemical synthesis or protein hydrolysis’ is replaced by the text ‘Produced by chemical synthesis or hydrolysis of animal or vegetal protein’;

                        (3)

                        in the entry concerning substance 2b920 L–cysteine hydrochloride monohydrate, in the column ‘Composition, chemical formula, description, analytical method’, the text ‘Produced by chemical synthesis or protein hydrolysis’ is replaced by the text ‘Produced by chemical synthesis or hydrolysis of animal or vegetal proteins’.


title: 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.)

text:
                  5.11.2018

                  EN

                  Official Journal of the European Union

                  L 274/51

         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)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,
         Whereas:

                     (1)

                     Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union.

                     (2)

                     Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) establishing a Union list of authorised novel foods was adopted.

                     (3)

                     Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on updating the Union list.

                     (4)

                     On 5 August 2016, the company Biova, LLC (‘the Applicant’) made a request to the competent authority of Denmark to place egg membrane hydrolysate on the Union market as a novel food ingredient within the meaning of point (e) of Article 1(2) of Regulation (EC) No 258/97 of the European Parliament and of the Council (3). The application seeks to have egg membrane hydrolysate to be used in food supplements for the general adult population.

                     (5)

                     Pursuant to Article 35(1) of Regulation (EU) 2015/2283, any request for placing a novel food on the market within the Union submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97, and for which the final decision has not been taken before 1 January 2018, shall be treated as an application submitted under Regulation (EU) 2015/2283.

                     (6)

                     While the request for placing egg membrane hydrolysate on the market as a novel food within the Union was submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97, the application also meets the requirements laid down in Regulation (EU) 2015/2283.

                     (7)

                     On 7 June 2017, the competent authority of Denmark issued its initial assessment report. In that report, it concluded that egg membrane hydrolysate meets the criteria for a novel food ingredient set out in Article 3(1) of Regulation (EC) No 258/97.

                     (8)

                     On 12 June 2017, the Commission forwarded the initial assessment report to the other Member States. Reasoned objections were raised by other Member States within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97 with regard to the manufacturing process, composition, toxicological data and potential drug interaction between the novel food and medication taken by people with joint pain.

                     (9)

                     In a subsequent application submitted on 5 January 2018, the Applicant made a request to the Commission for protection of proprietary data for a number of studies submitted in support of the application namely, a detailed manufacturing process description, the Generally Recognized as Safe (GRAS) Status of BiovaFlex. Expert Panel Report (4), an analysis of solubilized egg shell membrane using Radioallergosorbent Test Inhibition (5), quantitative egg allergen test results (6), an in vitro mammalian cell micronucleus assay in TK6 cells (7), an acute oral toxicity study (8), a bacterial reverse mutation assay (8), a human clinical safety and efficacy pilot (9), guinea pig sensitization (Buehler) study (10), and a haematology and blood biochemistry data and study report (11).

                     (10)

                     The Commission consulted the European Food Safety Authority (‘the Authority’) on 20 April 2018, asking it to carry out an additional assessment for egg membrane hydrolysate as a novel food in accordance with Regulation (EU) 2015/2283.

                     (11)

                     On 27 June 2018, the Authority adopted ‘Scientific Opinion on the safety of egg membrane hydrolysate as a novel food pursuant to Regulation (EU) 2015/2283’ (12). This opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

                     (12)

                     That opinion gives sufficient grounds to establish that egg membrane hydrolysate, in the proposed uses and use levels when used as an ingredient in food supplements, complies with Article 12(1) of Regulation (EU) 2015/2283.

                     (13)

                     In its opinion on egg membrane hydrolysate as a novel food, the Authority considered that the data on the manufacturing process served as a basis to assess the safety of egg membrane hydrolysate. Therefore, the Authority considers that the conclusions on the safety of egg membrane hydrolysate, could not have been arrived at without the data from the unpublished report of this process.

                     (14)

                     Following the receipt of the Authority's opinion, the Commission requested the Applicant to further clarify the justification provided with regard to their proprietary claim over the studies and to clarify their claim to an exclusive right of reference to those studies, as referred to in points (a) and (b) of Article 26(2) of Regulation (EU) 2015/2283.

                     (15)

                     The Applicant also declared to hold proprietary and exclusive rights to the studies under national law at the time the application was submitted, and that therefore third parties could not lawfully access or use those studies. The Commission has assessed all the information provided by the Applicant and considers that the Applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283.

                     (16)

                     Accordingly, as provided for under Article 26(2) of Regulation (EU) 2015/2283, the detailed manufacturing process description contained in the Applicant's file and without which the novel food could not have been assessed by the Authority should not be used by the Authority for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation. As a consequence, the placing on the market within the Union of the novel food authorised by this Regulation should be restricted to the Applicant for a period of five years.

                     (17)

                     However, restricting the authorisation of this novel food and of the reference to the detailed manufacturing process description contained in the Applicant's file for the sole use of the Applicant does not prevent other applicants from applying for an authorisation to place on the market the same novel food provided that their application is based on legally obtained information supporting the authorisation under this Regulation.

                     (18)

                     As the source of the novel food comes from eggs, which is listed in Annex II to Regulation (EU) No 1169/2011 of the European Parliament and of the Council (13) as one of a number of substances or products which cause allergies or intolerances, food supplements containing egg membrane hydrolysate should be appropriately labelled following the requirements of Article 21 of that Regulation.

                     (19)

                     Directive 2002/46/EC of the European Parliament and of the Council (14) lays down requirements on food supplements. The use of egg membrane hydrolysate should be authorised without prejudice to that Directive.

                     (20)

                     The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

               HAS ADOPTED THIS REGULATION:

            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

            (1)  OJ L 327, 11.12.2015, p. 1.

            (2)  Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).

            (3)  Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, p. 1).

            (4)  Biova, LLC; February 2015 (unpublished).

            (5)  Food Allergy Research and Resource Program, University of Nebraska, Lincoln; April 2014 (unpublished).

            (6)  Food Allergy Research and Resource Program, University of Nebraska, Lincoln; February 2008b (unpublished).

            (7)  BioReliance Corporation, Rockville (MD) for NIS Labs, Klamath Falls (OR); January 2016 (unpublished).

            (8)  ST&T Consultants, San Francisco (CA) for Biova LLC, Johnston (IA); January 2009a (unpublished).

            (9)  ST&T Consultants, San Francisco (CA) for Biova LLC; July 2009c (unpublished).

            (10)  ST&T Consultants, San Francisco (CA) for Biova LLC, Johnston (IA); February 2009a (unpublished).

            (11)  ST&T Consultants, San Francisco (CA); July 2009c (unpublished).

            (12)  EFSA Journal 2018; 16(7):5363

            (13)  Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, p. 18).

            (14)  Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).

            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

                                    SircolTM Soluble Collagen Assay

                                    Elastin (% w/w): ≥ 20

                                    FastinTM 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.’