title: Commission Implementing Regulation (EU) 2020/1796 of 30 November 2020 concerning the authorisation of L-glutamine produced by Corynebacterium glutamicum NITE BP-02524 as a feed additive for all animal species (Text with EEA relevance)

text:
                  1.12.2020

                  EN

                  Official Journal of the European Union

                  L 402/31

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1796
         of 30 November 2020
         concerning the authorisation of L-glutamine produced by Corynebacterium glutamicum NITE BP-02524 as a feed additive for all animal species
         (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.

                     (2)

                     In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of L-glutamine produced by Corynebacterium glutamicum NITE BP-02524 as a feed additive for all animal species. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (3)

                     The application concerns the authorisation of L-glutamine produced by Corynebacterium glutamicum NITE BP-02524 as a feed additive for all animal species to be classified in the additive category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’, and in the additive category ‘sensory additives’, functional group ‘flavouring compounds’.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 18 March 2020 (2) that, under the proposed conditions of use, L-glutamine produced by Corynebacterium glutamicum NITE BP-02524 does not have an adverse effect on animal health, human health or the environment. The Authority also concluded that the additive is an efficacious source of glutamine for all animal species and that for the supplemental L-glutamine to be fully efficacious in ruminants, it should be protected against degradation in the rumen.

                     (5)

                     As regards the use as flavouring, the Authority states that no further demonstration of efficacy is necessary when used at the recommended dose. The use of L-glutamine as flavouring compound is not authorised in water for drinking. At the recommended dose, L-glutamine as a flavouring compound is unlikely to pose any concern. The fact that the use of the L-glutamine is not authorised as flavouring in water for drinking does not preclude its use in compound feed which is administered via water. Restrictions and conditions should be provided for to allow a better control of L-glutamine as a flavouring compound. For L-glutamine, recommended contents should be indicated on the label of the additive. Where such contents are exceeded, certain information should be indicated on the label of premixtures.

                     (6)

                     The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the reports on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (7)

                     The assessment of L-glutamine produced by Corynebacterium glutamicum NITE BP-02524 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this additive should be authorised as specified in the Annex to this Regulation.

                     (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

               1.   The substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’ is authorised as a feed additive in animal nutrition subject to the conditions laid down in that Annex.

               2.   The substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’ is authorised as a feed additive in animal nutrition subject to the conditions laid down in that Annex.

            Article 2
            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, 30 November 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  EFSA Journal 2020; 18(4):6075

            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

                        mg/kg of complete feed with a moisture content of 12 %

                           Category: nutritional additives. Functional group: amino acids, their salts and analogues

                        3c451

                        -

                        L-glutamine

                           Additive composition:

                        Powder with a minimum content of 98 % L-glutamine

                           Characterisation of the active substance:

                        L-glutamine produced by fermentation with Corynebacterium glutamicum NITE BP-02524
                        IUPAC name: (2S)-2,5-diamino-5-oxopentanoic acid
                        CAS number: 56-85-9
                        Einecs number: 200-292-1
                        Chemical formula: C5H10N2O3

                           Analytical method
                            (1):
                        For the identification of L-glutamine in the feed additive:

                                    —

                                    Food Chemical Codex ‘L-glutamine monograph’

                              For the quantification of glutamine in the feed additive, premixtures, compound feed and feed materials:

                                    —

                                    Ion exchange chromatography coupled to post-column derivatisation and optical detection) (IEC-VIS/FLD).

                        All animal species

                        -

                        -

                        -

                                    1.

                                    L-glutamine may be placed on the market and used as an additive consisting of a preparation.

                                    2.

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

                                    3.

                                    Declaration to be made on the label of the additive and premixture:
                                    ‘The supplementation with L-glutamine shall ensure an adequate amino acid profile in feed and address potential glutamine shortages during critical periods of life.’

                        21.12.2030

                           Category: Sensory additives. Functional group: Flavouring compounds

                        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

                        mg of active substance/kg of complete feed with a moisture content of 12 %

                        3c451

                        -

                        L-glutamine

                           Additive composition:

                        Powder with a minimum content of
                        98 % L-glutamine

                           Characterisation of the active substance:

                        L-glutamine produced by fermentation with Corynebacterium glutamicum NITE BP-02524
                        IUPAC name: (2S)-2,5-diamino-
                        5-oxopentanoic acid
                        CAS number: 56-85-9
                        Einecs number: 200-292-1
                        Chemical formula: C5H10N2O3

                        Flavis number: 17.007

                           Analytical method
                            (1):
                        For the identification of L-glutamine in the feed additive:

                                    —

                                    Food Chemical Codex ‘L-glutamine monograph’

                              For the quantification of glutamine in the feed additive and premixtures:

                                    —

                                    Ion exchange chromatography coupled to visible or fluorescence detection with post-column derivatisation and optical detection) (IEC-VIS/FLD), as described in EN ISO 17180:2013

                        All animal species

                        -

                        -

                        -

                                    1.

                                    L-glutamine may be placed on the market and used as an additive consisting of a preparation.

                                    2.

                                    The additive shall be incorporated into the feed in the form of a premixture.

                                    3.

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

                                    4.

                                    On the label of the additive the following shall be indicated:
                                    ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg’.

                                    5.

                                    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 25 mg/kg.

                        21.12.2030

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


title: Commission Implementing Regulation (EU) 2020/1797 of 30 November 2020 concerning the authorisation of L-valine produced by Escherichia coli KCCM 80159 as a feed additive for all animal species (Text with EEA relevance)

text:
                  1.12.2020

                  EN

                  Official Journal of the European Union

                  L 402/36

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1797
         of 30 November 2020
         concerning the authorisation of L-valine produced by Escherichia coli KCCM 80159 as a feed additive for all animal species
         (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.

                     (2)

                     In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of L-valine. The application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.

                     (3)

                     The application concerns the authorisation of L-valine produced by Escherichia coli KCCM 80159 as a feed additive for all animal species, to be classified in the additive category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 18 March 2020 (2) that, under the proposed conditions of use, L-valine produced by Escherichia coli KCCM 80159 when supplemented to diets in appropriate amounts does not have an adverse effect on animal health, human health or the environment. Further, the Authority concluded that it is considered an efficacious source of the essential amino acid L-valine for animal nutrition and that in order to be efficacious in ruminants, the additive should be protected against degradation in the rumen. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the reports 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 L-valine produced by Escherichia coli KCCM 80159 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this substance should be authorised as specified in the Annex to this Regulation.

                     (6)

                     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 substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, is authorised as a feed additive in animal nutrition subject to the conditions laid down in that Annex.

            Article 2
            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, 30 November 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  EFSA Journal 2020;18(4):6074.

            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

                        mg/kg of complete feed with a moisture content of 12 %

                           Category of nutritional additives. Functional group: amino acids, their salts and analogues

                        3c370

                        -

                        L-valine

                           Additive composition

                        Powder with a minimum content of L-valine of 98 % (on a dry matter basis) and a maximum content of 1,5 % water

                        All species

                        -

                                    1.

                                    L-valine may be placed on the market and used as an additive consisting of a preparation.

                                    2.

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

                                    3.

                                    The label of the additive and premixture shall indicate the following: ‘The supplementation with L-valine should take into account all essential and conditional essential amino acids in order to avoid imbalances.’

                        21.12.2030

                           Characterisation of the active substance

                        L-valine ((2S)-2-amino-3-methylbutanoic acid) produced by Escherichia coli KCCM 80159
                        Chemical formula: C5H11NO2

                        CAS number: 72-18-4

                           Analytical method
                            (1)

                        For the identification of L-valine in the feed additive:

                                    —

                                    Food Chemical Codex "L-valine monograph"

                              For the quantification of valine in the feed additive:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS)

                              For the quantification of valine in premixtures, feed materials and compound feed:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) – Commission Regulation (EC) No 152/2009 (2) (Annex III, F)

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

               (2)  Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1).


title: Commission Implementing Regulation (EU) 2020/1799 of 30 November 2020 concerning the authorisation of a preparation of 6-phytase produced by Komagataella phaffii CGMCC 12056 as a feed additive for laying hens and other laying birds (holder of authorisation: Andrés Pintaluba S.A.) (Text with EEA relevance)

text:
                  1.12.2020

                  EN

                  Official Journal of the European Union

                  L 402/43

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1799
         of 30 November 2020
         concerning the authorisation of a preparation of 6-phytase produced by Komagataella phaffii CGMCC 12056 as a feed additive for laying hens and other laying birds (holder of authorisation: Andrés 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.

                     (2)

                     In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of a preparation of 6-phytase. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (3)

                     The application concerns the authorisation of a preparation of 6-phytase produced by Komagataella phaffii CGMCC 12056 as a feed additive for laying hens and other laying birds to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 7 May 2020 (2) that, under the proposed conditions of use, the preparation of 6-phytase produced by Komagataella phaffii CGMCC 12056 does not have an adverse effect on the health of laying hens and other laying birds, consumer safety or the environment. It was also concluded that the additive should be considered as a potential respiratory sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority concluded that the additive is efficacious as a zootechnical additive in improving the digestibility of the diets in laying hens and other laying birds. 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 6-phytase produced by Komagataella phaffii CGMCC 12056 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)

                     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 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 that Annex.

            Article 2
            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, 30 November 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  EFSA Journal 2020;18(5): 6142.

            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

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

                           Category of zootechnical additives. Functional group: digestibility enhancers

                        4a31

                        Andrés Pintaluba S.A.

                        6-phytase
                        (EC 3.1.3.26)

                           Additive composition

                        Preparation of 6-phytase (EC 3.1.3.26)
                        produced by Komagataella phaffii (CGMCC 12056) having a minimum activity of:
                        Solid form: 20 000  U (1)/g
                        Liquid form: 20 000  U/ml

                        laying hens and other laying birds

                        -

                        300 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 its 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 breathing protection.

                        21.12.2030

                           Characterisation of the active substance

                        6-phytase (EC 3.1.3.26) produced by fermentation with Komagataella phaffii CGMCC 12056

                           Analytical method
                            (2)

                        For the quantification of phytase activity in the feed additive:

                                    —

                                    colorimetric method based on the enzymatic reaction of phytase on the phytate – VDLUFA 27.1.4

                              For the quantification of phytase activity in premixtures:

                                    —

                                    colorimetric method based on the enzymatic reaction of phytase on the phytate -VDLUFA 27.1.3

                              For the quantification of phytase activity in feed materials and compound feed:

                                    —

                                    colorimetric method based on the enzymatic reaction of phytase on the phytate – EN ISO 30024

               (1)  One unit is the amount of enzyme which releases one micromole of inorganic phosphate from phytate per minute at pH 5,5 and 37 °C.

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


title: Commission Implementing Regulation (EU) 2020/1800 of 30 November 2020 concerning the authorisation of monosodium glutamate produced by fermentation with Corynebacterium glutamicum KCCM 80188 as a feed additive for all animal species (Text with EEA relevance)

text:
                  1.12.2020

                  EN

                  Official Journal of the European Union

                  L 402/46

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1800
         of 30 November 2020
         concerning the authorisation of monosodium glutamate produced by fermentation with Corynebacterium glutamicum KCCM 80188 as a feed additive for all animal species
         (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.

                     (2)

                     In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of monosodium glutamate produced by fermentation with Corynebacterium glutamicum KCCM 80188. This application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (3)

                     The application concerns the authorisation of monosodium glutamate produced by fermentation with Corynebacterium glutamicum KCCM 80188 as a feed additive for all animal species. The applicant requested this additive to be classified in the additive category ‘sensory additives’.

                     (4)

                     The applicant requested the feed additive to be authorised for use also in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorisation of ‘flavouring compounds’ for use in water for drinking. Therefore, the use of monosodium glutamate produced by fermentation with Corynebacterium glutamicum KCCM 80188 in water for drinking should not be allowed. The fact that the additive is not authorised for use as a flavouring in water for drinking does not preclude its use in compound feed administered via water.

                     (5)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 19 March 2020 (2) that, under the proposed conditions of use monosodium glutamate produced by fermentation with Corynebacterium glutamicum KCCM 80188 does not have adverse effects on animal health, consumer health or the environment. The Authority concluded in the opinion that the additive is not toxic by inhalation, not irritant to skin or eyes and is not a dermal sensitiser. The Authority also concluded, that the effect of monosodium glutamate for increasing the taste of food is well proven, and therefore, no further demonstration of its efficacy in feed is necessary. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (6)

                     The assessment of monosodium glutamate produced by fermentation with Corynebacterium glutamicum KCCM 80188 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 substance should be authorised as specified in the Annex to this Regulation.

                     (7)

                     Restrictions and conditions should be provided for to allow better control. In particular, a recommended content should be indicated on the label of the feed additive. Where such content is exceeded, certain information should be indicated on the label of premixtures.

                     (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
            The substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, is authorised as a feed additive in animal nutrition, subject to the conditions laid down in that Annex.

            Article 2
            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, 30 November 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  EFSA Journal 2020;18(4):6085.

            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

                        mg of active substance/kg of complete feedingstuff with a moisture content of 12 %

                        Category: Sensory additives. Functional group: Flavouring compounds

                        2b621i

                        -

                        Monosodium glutamate

                           Additive composition:

                        Monosodium glutamate

                           Characterisation of the active substance:

                        Monosodium L-glutamate
                        Produced by fermentation with Corynebacterium glutamicum KCCM 80188
                        Purity: ≥ 99 % assay
                        Chemical formula:
                        C5H8NaNO4•H2O
                        CAS number 6106-04-3

                           Method of analysis
                            (1)
                           :

                        For the identification of monosodium L-glutamate in the feed additive: Food Chemical Codex ‘Monosodium L-glutamate monograph’.
                        For the quantification of monosodium L-glutamate in the feed additive: ion-exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS), as described in Commission Regulation (EC) No 152/2009 (Annex III, F) (2).
                        For the quantification of monosodium L-glutamate in premixtures: ion-exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS), Commission Regulation (EC) No 152/2009 (Annex III, F).

                        All animal species

                        -

                        -

                        -

                                    1.

                                    The additive shall be incorporated into the feed in the form of a premixture.

                                    2.

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

                                    3.

                                    On the label of the additive the following shall be indicated:
                                    ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg’.

                                    4.

                                    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 25 mg/kg.

                        21.12.2030

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

               (2)  Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1).


title: Commission Implementing Regulation (EU) 2020/1810 of 25 November 2020 approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications ‘Figue de Solliès’ (PDO)

text:
                  2.12.2020

                  EN

                  Official Journal of the European Union

                  L 404/2

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1810
         of 25 November 2020
         approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications ‘Figue de Solliès’ (PDO)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,
         Whereas:

                     (1)

                     Pursuant to the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined France’s application for the approval of amendments to the product specification for the protected designation of origin ‘Figue de Solliès’, registered under Commission Implementing Regulation (EU) No 1367/2011 (2).

                     (2)

                     Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union (3) as required by Article 50(2)(a) of that Regulation.

                     (3)

                     As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The amendments to the product specification published in the Official Journal of the European Union regarding the name ‘Figue de Solliès’ (PDO) are hereby approved.

            Article 2
            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, 25 November 2020.

                  For the Commission,

                  On behalf of the President,

               Janusz WOJCIECHOWSKI

                  Member of the Commission

            (1)  OJ L 343, 14.12.2012, p. 1.

            (2)  Commission Implementing Regulation (EC) No 1367/2011 of 19 December 2011 entering a name in the register of protected designations of origin and protected geographical indications [Figue de Solliès (PDO)] (OJ L 341, 22.12.2011, p. 31).

            (3)  OJ C 257, 5.8.2020, p. 5.


title: Commission Implementing Regulation (EU) 2020/1811 of 1 December 2020 amending Regulation (EC) No 684/2009 as regards the identification of economic operators in Northern Ireland

text:
                  2.12.2020

                  EN

                  Official Journal of the European Union

                  L 404/3

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1811
         of 1 December 2020
         amending Regulation (EC) No 684/2009 as regards the identification of economic operators in Northern Ireland
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union, and in particular Article 113 thereof, in conjunction with Article 131 of the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (1),
         Having regard to Council Directive 2008/118/EC of 16 December 2008 concerning the general arrangements for excise duty and repealing Directive 92/12/EEC (2), in particular Article 29(1),
         Whereas:

                     (1)

                     The United Kingdom withdrew from the European Union on 31 January 2020 based on the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (‘the Withdrawal Agreement’).

                     (2)

                     Article 126 of the Withdrawal Agreement provides for a transition period ending 31 December 2020. Until that date, Union law applies in its entirety to and in the United Kingdom.

                     (3)

                     At the end of the transition period, the Union rules on excise duties will no longer apply to the United Kingdom. However, in accordance with Article 8 of the Protocol on Ireland/Northern Ireland, which is part of the Withdrawal Agreement, Union rules on excise duties will continue to apply in Northern Ireland (3) after the transition period as regards goods so as to avoid a hard border between Ireland and Northern Ireland.

                     (4)

                     In accordance with Article 19 of Council Regulation (EU) No 389/2012 (4), each Member State shall maintain an electronic database containing a register of economic operators (authorised warehousekeepers, registered consignees, and registered consignors) within the meaning of Article 4, of Directive 2008/118/EC. Regarding the two-letter country code, Article 1 of Commission Regulation (EU) No 612/2013 (5), governs the structure of the identification number of the traders indicating that the Trader Excise Number is made up of two fields. The first one is the alphabetic country code being the Identifier of the Member State where the economic operator or tax warehouse is registered. This code is taken from code list 3 of Annex II to Commission Regulation (EC) No 684/2009 (6). Moreover, the procedures are computer-based and supported by pan-European IT systems called Excise Movement and Control System (EMCS) for movement control and System for Exchange of Excise Data (SEED) for registering excise economic operators.

                     (5)

                     The movement of excise goods between the Union and Northern Ireland will be treated as intra-Union movements. Consequently, for economic operators established in Northern Ireland intending to move excise goods under duty suspension arrangement to and from Member States, it is necessary to be registered and authorised in SEED as well as use the Union excise procedures and the EMCS. Member State Codes and Country Codes are set out in Regulation (EC) No 684/2009 by reference to the ISO Alpha 2 code (ISO 3166). While the UK economic operators use the code ‘GB’, Northern Ireland has no specific code under this system. As the ISO foresees the possibility to use X-codes for territories that do not have a specific code, and for reasons of alignment with the Commission Implementing Regulation (EU) 2020/1470 (7), it is appropriate to use the code ‘XI’ as to distinguish economic operators in Northern Ireland carrying out movement of excise goods.

                     (6)

                     Regulation (EC) No 684/2009 should therefore be amended accordingly.

                     (7)

                     The measures provided for in this Regulation are in accordance with the opinion of the Committee on Excise Duty,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Regulation (EC) No 684/2009 is amended as follows:

                        (a)

                        in Annex I, Table 1, point 17.2 Box of line c, column F, is replaced by the following:
                        ‘Provide a Country Code other than one of the Country Codes of the Member States.’;

                        (b)

                        Annex II is amended as follows:

                                    (i)

                                    Code list 3 is replaced by the following:
                                    ‘3.   COUNTRY CODES
                                    Must be identical to the codes established in the nomenclature of countries and territories for the European statistics on international trade in goods set out in Annex I to Commission Implementing Regulation (EU) 2020/1470 (*1), except:

                                                —

                                                For Greece, where EL instead of GR must be used.

                                       (*1)  Commission Implementing Regulation (EU) 2020/1470 of 12 October 2020 on the nomenclature of countries and territories for the European statistics on international trade in goods and on the geographical breakdown for other business statistics (OJ L 334, 13.10.2020, p. 2).’;"

                                    (ii)

                                    Code list 4 is deleted;

                                    (iii)

                                    Code list 5 is replaced by the following:
                                    ‘5.   CUSTOMS OFFICE REFERENCE NUMBER (COR)
                                    The COR is composed of an identifier of the Country Code of the Member State followed by a 6-digit alphanumeric national number, example IT0830AB.’.

            Article 2
            This Regulation shall enter into force on 1 January 2021.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 1 December 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 29, 31.1.2020, p. 7.

            (2)  OJ L 9, 14.1.2009, p. 12.

            (3)  Subject to the democratic consent, referred to in Article 18 of the Protocol on Ireland/Northern Ireland, to the continued application of Article 8 thereof.

            (4)  Council Regulation (EU) No 389/2012 of 2 May 2012 on administrative cooperation in the field of excise duties and repealing Regulation (EC) No 2073/2004 (OJ L 121, 8.5.2012, p. 1).

            (5)  Commission Implementing Regulation (EU) No 612/2013 of 25 June 2013 on the operation of the register of economic operators and tax warehouses, related statistics and reporting pursuant to Council Regulation (EU) No 389/2012 on administrative cooperation in the field of excise duties (OJ L 173, 26.6.2013, p. 9).

            (6)  Commission Regulation (EC) No 684/2009 of 24 July 2009 implementing Council Directive 2008/118/EC as regards the computerised procedures for the movement of excise goods under suspension of excise duty (OJ L 197, 29.7.2009, p. 24).

            (7)  Commission Implementing Regulation (EU) 2020/1470 of 12 October 2020 on the nomenclature of countries and territories for the European statistics on international trade in goods and on the geographical breakdown for other business statistics (OJ L 334, 13.10.2020, p. 2).


title: Commission Implementing Regulation (EU) 2020/1812 of 1 December 2020 laying down rules on the online data exchange and the notification of EU type-approvals under Regulation (EU) 2018/858 of the European Parliament and of the Council

text:
                  2.12.2020

                  EN

                  Official Journal of the European Union

                  L 404/5

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1812
         of 1 December 2020
         laying down rules on the online data exchange and the notification of EU type-approvals under Regulation (EU) 2018/858 of the European Parliament and of the Council
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (1), and in particular the second subparagraph of Article 12(4) and Article 27(3) thereof,
         Whereas:

                     (1)

                     Article 12(4) of Regulation (EU) 2018/858 requires Member States to use a common secure electronic exchange system in order to make accessible to the public as from 1 September 2022 a list of the EU type-approvals for vehicles, systems, components and separate technical units that they have granted, amended, refused or withdrawn, as well as a list of the technical services which have performed the tests for the respective EU type-approvals.

                     (2)

                     Article 27 of Regulation (EU) 2018/858 requires approval authorities to use that same system in order to make certain documents pertaining to EU type-approvals available to the approval authorities of the other Member States, to the market surveillance authorities and to the Commission, as well as to inform the approval authorities of the other Member States and the Commission of the refusal or withdrawal of any EU type-approval, including the reasons therefor.

                     (3)

                     The European Type Approval Exchange System (‘ETAES’) is a software application accessible via the internet and developed by the Member States in order to assisting the EU type-approval authorities with the practical implementation of information exchange requirements laid down in Union acts by providing a centralised communication mechanism to facilitate cross-border exchange of a copy of the EU type-approval certificate together with the attachments. A similar system, the Database for the Exchange of Type Approval documentation and information system, has been established under the auspices of the United Nations Economic Commission for Europe. It is therefore appropriate to designate ETAES as the common secure electronic exchange system referred to in Article 27(3) of Regulation (EU) 2018/858.

                     (4)

                     To preserve confidential data, requirements on access to ETAES and the use of secure data exchange protocols should be laid down.

                     (5)

                     In order to make ETAES a searchable online database, requirements regarding the upload of the EU type-approval documents referred to in Article 27(1) of Regulation (EU) 2018/858 should be laid down.

                     (6)

                     In order to better establish the different access rights to ETAES, approval authorities should upload the documents referred to in Article 27(1) of Regulation (EU) 2018/858 in ETAES separately on the basis of their nature and, where relevant, their status.

                     (7)

                     Considering that ETAES is, in its current version, a communication tool for administrative cooperation between Member States that is not open to the public, it is necessary to harmonise the format and content of the lists referred to Article 12(4) of Regulation (EU) 2018/858 to ensure that the relevant information is made accessible to the public.

                     (8)

                     The empowerments laid down in the second subparagraph of Article 12(4) and in Article 27(3) of Regulation (EU) 2018/858 set out the requirements for the use of the common secure electronic exchange system of EU type-approval information for motor vehicles and their trailers, and for systems, components and separate technical units intended for such vehicles. As those empowerments are closely linked by their subject matter, they should be bundled for the purposes of this Regulation.

                     (9)

                     The measures provided for in this Regulation are in accordance with the opinion of the Technical Committee – Motor Vehicles (TCMV),

               HAS ADOPTED THIS REGULATION:

            Article 1
            Common secure electronic exchange system
            The European Type Approval Exchange System (‘ETAES’) shall be used as the common secure electronic exchange system referred to in Article 27(3) of Regulation (EU) 2018/858.

            Article 2
            Security measures
            The following security measures shall be observed in ETAES in order to prevent unauthorised access:

                        (a)

                        encryption of communication between the ETAES client and the ETAES server, using a https protocol with a Secure Sockets Layer certificate;

                        (b)

                        web security preventing attackers from injecting client-side scripts into the web page(s) and from using multiple layers to trick a user into clicking on a button or link to another web page;

                        (c)

                        a fine grained access control system that makes it possible to grant, read or write permissions for the access of authorised parties.

            Article 3
            Procedure for the exchange of type-approval information

               1.   When informing authorities on the granting of EU type-approvals, on amendments, refusals and withdrawals thereof pursuant to paragraphs 1 and 2 of Article 27 of Regulation (EU) 2018/858, the approval authority shall provide an entry for at least the following attributes in ETAES:

                           (a)

                           the distinguishing number of the Member State, in accordance with point 2.1 of Annex IV to Commission Implementing Regulation (EU) 2020/683 (2), that issued the EU type-approval certificate;

                           (b)

                           the number of the EU type-approval certificate (3);

                           (c)

                           the approval date of the EU type-approval certificate;

                           (d)

                           the name of the technical service responsible for carrying out the tests, where applicable (4);

                           (e)

                           the name of the manufacturer;

                           (f)

                           the type of vehicle, system, component or separate technical unit as specified by the manufacturer in the EU type-approval certificate;

                           (g)

                           the vehicle category pursuant to Article 4 of Regulation (EU) 2018/858, where applicable;

                           (h)

                           the Regulation applying to the EU type approved whole-vehicle-, system-, separate technical unit- or component;

                           (i)

                           the status of the EU type-approval ‘granted’, ‘amended’, ‘refused’ or ‘withdrawn’;

                           (j)

                           the EU type-approval reference to a vehicle, system, component or a separate technical unit.

               2.   In the cases referred to in paragraph 1, the approval authority shall also upload the following documents separately in ETAES, in an electronic searchable format:

                           (a)

                           a copy of the EU type-approval certificate, with the indication ‘CERT’ followed by the EU type-approval certificate number (5) (6);

                           (b)

                           the information items to be attached to the EU type-approval certificate referred to in points (a), (c) and (d) of Article 28(1) of Regulation (EU) 2018/858, with the indication ‘IF’ followed by the EU type-approval certificate number (7);

                           (c)

                           the test report and/or the test results sheet referred to in point (b) of Article 28(1) of Regulation (EU) 2018/858, with the indication ‘TR’ followed by the EU type-approval certificate number (8);

                           (d)

                           any documents other than the ones mentioned in points (a), (b) and (c), with the indication ‘OTHER’ followed by the EU type-approval certificate number (9).

               3.   Where it is necessary to include multiple documents for the uploads referred to in paragraph 2 of this Article, an additional sequential number, starting from 1, shall follow the indications laid down in points (b), (c) and (d) of paragraph 2 of this Article (10).

               4.   In the case documents are amended by a revision, as provided for in Article 34 of Regulation (EU) 2018/858, the indications laid down in points (a), (b), (c) and (d) of paragraph 2 of this Article shall be followed by the indication Rev. and a two-digit sequential number starting from 01 (11).

            Article 4
            List of EU type-approvals

               1.   When Member States make the lists of EU type-approvals and technical services referred to in Article 12(4) of Regulation (EU) 2018/858 accessible to the public using ETAES, they shall do so in a standardised searchable format. Member States shall keep those lists up to date.

               2.   The following information shall be included in the list(s) referred to in paragraph 1:

                           (a)

                           the distinguishing number of the Member State, in accordance with point 2.1 of Annex IV to Implementing Regulation (EU) 2020/683, that issued the EU type-approval certificate;

                           (b)

                           the number of the EU type-approval certificate;

                           (c)

                           the status of the EU type-approval ‘granted’, ‘amended’, ‘refused’ or ‘withdrawn’;

                           (d)

                           the name of the technical service responsible for carrying out the tests, where applicable;

                           (e)

                           the approval date of the EU type-approval certificate.

               3.   A list of EU type-approvals and technical services referred to in Article 12(4) of Regulation (EU) 2018/858 may be published on the website of the Commission

            Article 5
            Entry into force and application
            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, 1 December 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 151, 14.6.2018, p. 1.

            (2)  Commission Implementing Regulation (EU) 2020/683 of 15 April 2020 implementing Regulation (EU) 2018/858 of the European Parliament and of the Council with regards to the administrative requirements for the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (OJ L 163, 26.5.2020, p. 1).

            (3)  In case the EU type-approval has been refused and the approval authority has not reserved an EU type-approval certificate number, the approval authority shall use the tab NEWS in ETAES to inform the approval authorities of the other Member States of its refusal.

            (4)  The approval authority shall fill in ‘not applicable’ in the case of a step-by-step type-approval, where the approval authority collects the whole set of EU type-approval certificates or UN type-approval certificates and that authority edited the final whole vehicle EU type-approval certificate.

            (5)  Example: ‘CERT e1*2018/858*00001*00’.

            (6)  In case the EU type-approval has been refused and that the approval authority has not reserved an EU type-approval certificate number, the approval authority shall use the tab NEWS in ETAES to inform the approval authorities of the other Member States of its refusal.

            (7)  Example: ‘IF e4*2018/858*00004*02’.

            (8)  Example: ‘TR e24*2018/858*00001*00’.

            (9)  Example: ‘OTHER e1*2018/858*00001*00’.

            (10)  Example: ‘IF1 e9*2018/858*00001*00’, ‘IF2 e9*2018/858*00001*00’, etc.

            (11)  Example: ‘CERT e5*2018/858*00001*00 Rev.01’.


title: Commission Implementing Regulation (EU) 2020/1820 of 2 December 2020 authorising the placing on the market of dried Euglena gracilis 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:
                  3.12.2020

                  EN

                  Official Journal of the European Union

                  L 406/29

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1820
         of 2 December 2020
         authorising the placing on the market of dried Euglena gracilis 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 of the European Parliament and of the Council 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)

                     On 20 December 2018, the company Kemin Foods L.C. (‘the applicant’) introduced an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place dried whole cell Euglena gracilis on the Union market as a novel food. The application requested for dried whole cell Euglena gracilis to be used as a novel food in a number of food categories for the general population as follows: breakfast, granola and protein bars; yoghurt; yoghurt beverages; fruit juices, smoothies and nectars, vegetable juices; fruit-flavoured drinks; meal replacement beverages. The applicant also requested for dried whole cell Euglena gracilis to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (3), excluding food supplements for infants, and in total diet replacement for weight control as defined by Regulation (EU) No 609/2013 of the European Parliament and of the Council (4), excluding total diet replacement for weight control for infants.

                     (4)

                     The applicant also made a request to the Commission for the protection of proprietary data for a number of studies submitted in support of the application namely, in vitro fermentation studies (5), bacterial reverse mutation test (6), in vivo micronucleus test (7), acute toxicity study in rats (8), 14-day dietary toxicity/palatability study in rats (9), 90-day dietary toxicity study in rats (10).

                     (5)

                     In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘Authority’) on 13 May 2019, asking it to provide a scientific opinion by carrying out an assessment for dried Euglena gracilis as a novel food.

                     (6)

                     On 25 March 2020, the Authority adopted the scientific opinion on the “Safety of dried whole cell Euglena gracilis as a novel food pursuant to Regulation (EU) 2015/2283” (11). That opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

                     (7)

                     In that opinion, the Authority concluded that dried Euglena gracilis is safe at the proposed uses and use levels. Therefore, the opinion of the Authority gives sufficient grounds to establish that dried Euglena gracilis under the specific conditions of use complies with Article 12(1) of Regulation (EU) 2015/2283.

                     (8)

                     In accordance with Commission Delegated Regulation (EU) 2017/1798 (12) total diet replacement for weight control are foods intended for healthy overweight or obese adults who intend to achieve weight reduction. Therefore, dried Euglena gracilis may be authorised for use in total diet replacement for weight control only for adults, excluding infants, children and adolescents.

                     (9)

                     In its opinion, the Authority considered that the data from the 90-day dietary toxicity study in rats served as a basis to establish the safety of the novel food. Therefore, it is considered that the conclusions on the safety of dried Euglena gracilis could not have been reached without the data from the unpublished report of that study.

                     (10)

                     The Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over the 90-day dietary toxicity study in rats, and to clarify its claim to an exclusive right of reference to that study, as referred to in Article 26(2)(b) of Regulation (EU) 2015/2283.

                     (11)

                     The applicant declared that, at the time of the submission of the application, it held proprietary and exclusive right of reference to that study under national law, and that therefore third parties cannot lawfully access or use that study or refer to that data.

                     (12)

                     The Commission assessed all the information provided by the applicant and considered that the applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the 90-day dietary toxicity study in rats contained in the applicant’s file 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. Accordingly, the placing on the market within the Union of dried Euglena gracilis should be restricted to the applicant for that period.

                     (13)

                     However, restricting the authorisation of dried Euglena gracilis and of the reference to the study 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 such authorisation under Regulation (EU) 2015/2283.

                     (14)

                     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.   Dried Euglena gracilis 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: Kemin Foods L.C.,

                           —

                           Address: 2100 Maury Street Des Moines, IA 50317, 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 Kemin Foods L.C.

               3.   The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.

            Article 2
            The data 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 proprietary and without which the novel food could not have been authorised, 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 Kemin Foods L.C.

            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, 2 December 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (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)  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).

            (4)  Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).

            (5)  Prebiotic effects of algal meal and algal-glucan. Examination of growth profile of probiotic bacteria in the presence algal meal and algal glucan. Kemin Corporation, 2016 (unpublished).

            (6)  Dried algae (Euglena gracilis). Bacterial Reverse Mutation Test (Ames Test). Product Safety Labs, 2015a (unpublished).

            (7)  Dried algae (Euglena gracilis). Mammalian Erythrocyte Micronucleus Test (Peripheral Blood, Flow Cytometry – Mouse). Product Safety Labs, 2015b (unpublished).

            (8)  Algamune™ Algae Meal: Oral Toxicity Procedure In Rats. Product Safety Labs, 2014 (unpublished).

            (9)  Dried algae (Euglena gracilis). A 14-day dietary toxicity/palatability study in rats. Product Safety Labs, 2015c (unpublished).

            (10)  Dried algae (Euglena gracilis). A 90-day dietary study in rats. Product Safety Labs, 2015d (unpublished).

            (11)  EFSA Journal 2020;18(5):6100.

            (12)  Commission Delegated Regulation (EU) 2017/1798 of 2 June 2017 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for total diet replacement for weight control (OJ L 259, 7.10.2017, p. 2).

            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:

                                    Authorised novel food

                                    Conditions under which the novel food may be used

                                    Additional specific labelling requirements

                                    Other requirements

                                    Data protection

                                    ‘Dried Euglena gracilis

                                       Specified food category

                                       Maximum levels

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘dried biomass of Euglena gracilis algae’.
                                    The labelling of food supplements containing dried Euglena gracilis shall bear a statement that those food supplements should not be consumed by infants/children under 3 years of age/children under 10 years of age/children and adolescents under 18 years of age (*1).

                                    Authorised on 23 December 2020. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
                                    Applicant: Kemin Foods L.C., 2100 Maury Street Des Moines, IA 50317, USA.
                                    During the period of data protection, the novel food is authorised for placing on the market within the Union only by Kemin Foods L.C. unless a subsequent applicant obtains authorisation for that 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 Kemin Foods L.C.
                                    End date of the data protection: 23 December 2025.’

                                    Breakfast cereal bars, granola bars and protein bars

                                    630 mg/100 g

                                    Yoghurt

                                    150 mg/100 g

                                    Yoghurt Beverages

                                    95 mg/100 g

                                    Fruit and vegetable juices, nectars, fruit/vegetable blend beverages

                                    120 mg/100 g

                                    Fruit-Flavoured Drinks

                                    40 mg/100 g

                                    Meal replacement beverages

                                    75 mg/100 g

                                    Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants

                                    100 mg/day for young children
                                    150 mg/day for children from 3 to 9 years of age
                                    225 mg/day for children from 10 years of age and adolescents (to 17 years of age)
                                    375 mg/day for adults

                                    Total diet replacement for weight control as defined by Regulation (EU) No 609/2013

                                    190 mg/meal

                        (2)

                        in Table 2 (Specifications), the following entry is inserted:

                                    Authorised Novel Food

                                    Specification

                                       ‘Dried Euglena gracilis

                                       Description/Definition:

                                    The novel food is dried whole cell Euglena, which is the dried biomass of the microalga Euglena gracilis.
                                    The novel food is produced by fermentation followed by filtration and a heat-killing step of the microalga to ensure the absence of viable Euglena gracilis cells in the novel food.

                                       Characteristics/Composition:

                                    Total carbohydrates: ≤ 75 %
                                    β-glucan: > 50 %
                                    Protein: ≥ 15 %
                                    Fat: ≤ 15 %
                                    Ash: ≤ 10 %
                                    Moisture: ≤ 6 %

                                       Heavy metals:

                                    Lead: ≤ 0,5 mg/kg
                                    Cadmium: ≤ 0,5 mg/kg
                                    Mercury: ≤ 0,05 mg/kg
                                    Arsenic: ≤ 0,02 mg/kg

                                       Microbiological criteria:

                                    Aerobic plate count: ≤ 10 000  CFU/g
                                    Coliforms: ≤ 100 MPN/g
                                    Yeast and mould: ≤ 500 CFU/g

                                       Escherichia coli: Absence in 10 g

                                       Staphylococcus aureus: Absence in 10 g

                                       Salmonella: Absence in 25 g

                                       Listeria monocytogenes: Absence in 25 g
                                    CFU: colony forming units.
                                    MPN: most probable number’

               (*1)  Depending on the age group the food supplement is intended for.


title: Commission Implementing Regulation (EU) 2020/1821 of 2 December 2020 authorising the placing on the market of an extract from Panax notoginseng and Astragalus membranaceus 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:
                  3.12.2020

                  EN

                  Official Journal of the European Union

                  L 406/34

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1821
         of 2 December 2020
         authorising the placing on the market of an extract from Panax notoginseng and Astragalus membranaceus 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 of the European Parliament and of the Council 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 submit a draft implementing act authorising the placing on the Union market of a novel food and on the update of the Union list.

                     (4)

                     On 7 June 2018, the company NuLiv Science (‘the applicant’) introduced an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place an extract from Panax notoginseng and Astragalus membranaceus on the Union market as a novel food. The applicant requested for an extract from Panax notoginseng and Astragalus membranaceus to be used as a novel food in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (3) for the general adult population, excluding food supplements for pregnant women. The applicant also made a request to the Commission for the protection of proprietary data submitted in the application.

                     (5)

                     In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘Authority’) on 22 October 2018, asking it to provide a scientific opinion by carrying out an assessment for an extract from Panax notoginseng and Astragalus membranaceus as a novel food.

                     (6)

                     On 24 March 2020, the Authority adopted the scientific opinion on the ‘Safety of a botanical extract derived from Panax notoginseng and Astragalus membranaceus (AstraGinTM) as a novel food pursuant to Regulation (EU) 2015/2283’ (4). That opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

                     (7)

                     In its opinion, the Authority concluded that an extract from Panax notoginseng and Astragalus membranaceus is safe at an intake level of 0,5 mg/kg bw per day which corresponds to a maximum intake of 35 mg/day for the target population, i.e. adults excluding pregnant women.

                     (8)

                     The opinion of the Authority gives sufficient grounds to establish that extract from Panax notoginseng and Astragalus membranaceus under the assessed conditions of use complies with Article 12(1) of Regulation (EU) 2015/2283.

                     (9)

                     In its opinion the Authority considered that the toxicological data from the repeated dose 28-day oral gavage toxicity study with AstraGinTM in rats (5), the bacterial reverse mutation test (Ames test) for AstraGinTM (6), the 90-days repeated dose oral toxicity study of Astragin® in Wistar rats (7), the Panax notoginseng proprietary extract: in vitro micronucleus test in CHO-K1 cells (8), and the Astragalus membranaceus extract: in vitro micronucleus test in CHO-K1 cells (9) served as a basis to establish the safety of the novel food. Therefore, it is considered that the conclusions on the safety of extract from Panax notoginseng and Astragalus membranaceus could not have been reached without the data from the unpublished reports of those studies.

                     (10)

                     Following the Authority’s opinion, the Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over the repeated dose 28-day oral gavage toxicity study with AstraGinTM in rats, the bacterial reverse mutation test (Ames test) for AstraGinTM, the 90-days repeated dose oral toxicity study of Astragin® in Wistar rats, the Panax notoginseng proprietary extract: in vitro micronucleus test in CHO-K1 cells, and the Astragalus membranaceus extract: in vitro micronucleus test in CHO-K1 cells, and to clarify their claim to an exclusive right of reference to that data, as referred to in Article 26(2)(b) of Regulation (EU) 2015/2283.

                     (11)

                     The applicant declared that, at the time of the submission of the application, they held proprietary and exclusive right of reference to those studies, and that therefore third parties cannot lawfully access or use those studies or refer to that data.

                     (12)

                     The Commission assessed all the information provided by the applicant and considered that the applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the toxicological data from the studies contained in the applicant’s file which served as a basis for the Authority to establish the safety of the novel food and to reach its conclusions on the safety of extract from Panax notoginseng and Astragalus membranaceus, 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 any subsequent applicant for a period of five years from the date of entry into force of this Regulation. Accordingly, the placing on the market within the Union of an extract from Panax notoginseng and Astragalus membranaceus should be restricted to the applicant for that period.

                     (13)

                     However, restricting the authorisation of extract from Panax notoginseng and Astragalus membranaceus and of the reference to the studies 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 such authorisation under Regulation (EU) 2015/2283.

                     (14)

                     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.   Extract from Panax notoginseng and Astragalus membranaceus 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: NuLiv Science,

                           —

                           Address: 1050 W. Central Ave., Building C, Brea, CA 92821, 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 that novel food without reference to the data protected pursuant to Article 2 of this Regulation or with the agreement of NuLiv Science.

               3.   The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.

            Article 2
            The data 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 proprietary and without which the novel food could not have been authorised, 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 NuLiv Science.

            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, 2 December 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (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)  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).

            (4)  EFSA Journal 2020;18(5):6099.

            (5)  Pasics Szakonyiné I, 2011 (unpublished study report). Repeated dose 28-day oral gavage toxicity study with AstraGinTM in rats. Study No: 413.407.3084. Toxi-Coop Zrt., Hungary.

            (6)  Zin HM, 2016 (unpublished study report). Bacterial reverse mutation test (Ames test) for AstraGinTM. Study code: GLP/J165/2016/48). Environmental Technology Research Centre (ETRC). Shah Alam, Selangor, Malaysia.

            (7)  Upadhyaya S and Wang R, 2017 (unpublished study report). 90-days repeated dose oral toxicity study of Astragin® in Wistar rats. 161101/NVS/PC. July 2017. 319pp. Vedic Life Sciences Pvt, Ltd. Mumbai, India.

            (8)  Vedic Lifesciences, 2019a (unpublished study report). Panax notoginseng proprietary extract: in vitro micronucleus test in CHO-K1 cells. Study Nr. 190503/NL/PC. Mumbai, India.

            (9)  Vedic Lifesciences, 2019b (unpublished study report). Astragalus membranaceus extract: in vitro micronucleus test in CHO-K1 cells. Study Nr. 190502/NL/PC. Mumbai, India.

            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:

                                    Authorised novel food

                                    Conditions under which the novel food may be used

                                    Additional specific labelling requirements

                                    Other requirements

                                    Data protection

                                    ‘Extract from Panax notoginseng and Astragalus membranaceus

                                       Specified food category

                                       Maximum levels

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Extract from Panax notoginseng and Astragalus membranaceus’
                                    The labelling of food supplements containing extract from Panax notoginseng and Astragalus membranaceus shall bear a statement that those food supplements should not be consumed by the population under 18 years of age and by pregnant women.

                                    Authorised on 23 December 2020. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
                                    Applicant: NuLiv Science, 1050 W. Central Ave., Building C, Brea, CA 92821, USA.
                                    During the period of data protection, the novel food is authorised for placing on the market within the Union only by NuLiv Science, unless a subsequent applicant obtains authorisation for that 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 NuLiv Science.
                                    End date of the data protection: 23 December 2025. ’

                                    Food supplements as defined in Directive 2002/46/EC for the general adult population, excluding food supplements for pregnant women

                                    35 mg/day

                        (2)

                        in Table 2 (Specifications), the following entry is inserted:

                                    Authorised Novel Food

                                    Specification

                                    ‘Extract from Panax notoginseng and Astragalus membranaceus

                                       Description/Definition:

                                    The novel food contains two extracts. One is an ethanol extract of the roots of Astragalus membranaceus (Fisch.) Bunge. The other is a hot water extract of the roots of Panax notoginseng (Burkill) F.H. Chen that is further concentrated using absorption on a resin and subsequent elution with 60 % ethanol. At the end of the manufacturing process both extracts are mixed (45–47,5 % of each extract) with maltodextrin (5–10 %).

                                       Characteristics/Composition:

                                    Total saponins: 1,5-5 %
                                    Ginsenoside Rb1: 0,1-0,5 %
                                    Astragaloside I: 0,01-0,1 %
                                    Carbohydrates: ≥ 90 %
                                    Protein: ≤ 4,5 %
                                    Ash: ≤ 1 %
                                    Moisture: ≤ 5 %
                                    Fat: ≤ 1,5 %

                                       Heavy metals:

                                    Arsenic: ≤ 0,3 mg/kg

                                       Microbiological criteria:

                                    Total plate count: ≤ 5 000  CFU/g
                                    Total yeast and mould count: ≤ 500 CFU/g
                                    Enterobacteriaceae: < 10 CFU/g

                                       Escherichia coli: Absence in 25 g

                                       Salmonella: Absence in 375 g

                                       Staphylococcus aureus: Absence in 25 g
                                    CFU: colony forming units’