title: Commission Implementing Regulation (EU) 2020/992 of 9 July 2020 concerning the authorisation of a preparation of 6-phytase, produced by Aspergillus niger (DSM 25770) as feed additive for all avian species for laying (holder of the authorisation BASF SE) (Text with EEA relevance)

text:
                  10.7.2020

                  EN

                  Official Journal of the European Union

                  L 221/73

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/992
         of 9 July 2020
         concerning the authorisation of a preparation of 6-phytase, produced by Aspergillus niger (DSM 25770) as feed additive for all avian species for laying (holder of the authorisation BASF SE)
         (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, produced by Aspergillus niger (DSM 25770). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (3)

                     That application concerns the authorisation of a preparation of 6-phytase produced by Aspergillus niger (DSM 25770) as a feed additive for laying hens and minor poultry and other avian species for laying to be classified in the additive category ‘zootechnical additives’.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 3 July 2019 (2) that, under the proposed conditions of use, the preparation of 6-phytase produced by Aspergillus niger (DSM 25770) does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the additive should be regarded as a dermal sensitiser and 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 has the potential to be efficacious showing improvements of the zootechnical performance and/or phosphorus utilisation in laying hens. This conclusion can be extrapolated to all minor poultry species and other avian species for laying. 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 Aspergillus niger (DSM 25770) 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, 9 July 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  EFSA Journal 2019;17(7):5789.

            ANNEX

                           Identification number of the additive

                           Name of the holder of authorisation

                           Additive

                           Composition, chemical formula, description, analytical method

                           Species or category of animal

                           Maximum age

                           Minimum content

                           Maximum content

                           Other provisions

                           End of period of authorisation

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

                           Category of zootechnical additives. Functional group: digestibility enhancers.

                        4a27

                        BASF SE

                        6-Phytase
                        (EC 3.1.3.26)

                           Additive composition

                        Preparation of 6-phytase (EC 3.1.3.26) produced by Aspergillus niger (DSM
                        25770) with a minimum content
                        of:
                        Solid form: 5 000  FTU (1)/g
                        Liquid form: 5 000  FTU/g
                        -----------------

                           Characterisation of active substance

                        6-phytase produced by Aspergillus

                           niger (DSM 25770)
                        -----------------

                           Analytical method
                            (2)

                        For quantification of phytase activity in the feed additive:

                                    —

                                    colorimetric method based on the enzymatic reaction of phytase on the phytate.

                              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 feedingstuffs:

                                    —

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

                        All avian species for laying

                        -

                        200 FTU

                        -

                                    1.

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

                                    2.

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

                        30.7.2030

               (1)  1 FTU is the amount of enzyme which liberates 1 micromole of inorganic phosphate per minute from sodium phytate 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) 2020/994 of 9 July 2020 concerning the authorisation of monensin and nicarbazin (Monimax) as a feed additive for turkeys for fattening, chickens for fattening and chickens reared for laying (holder of authorisation Huvepharma NV) (Text with EEA relevance)

text:
                  10.7.2020

                  EN

                  Official Journal of the European Union

                  L 221/79

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/994
         of 9 July 2020
         concerning the authorisation of monensin and nicarbazin (Monimax) as a feed additive for turkeys for fattening, chickens for fattening and chickens reared for laying (holder of authorisation Huvepharma NV)
         (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 monensin and nicarbazin (Monimax). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (3)

                     That application concerns the authorisation of monensin and nicarbazin (Monimax) as a feed additive for turkeys for fattening, chickens for fattening and chickens reared for laying to be classified in the additive category 'coccidiostats and histomonostats'.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinions of 29 November 2017 (2), 2 October 2018 (3) and 7 October 2019 (4) that, under the proposed conditions of use, monensin and nicarbazin (Monimax) does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the additive presents a hazard by inhalation, and may act as dermal toxicant. No data are available for the eye irritation potential. Therefore, 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 considered efficacious to control coccidiosis in turkeys and chickens for fattening and chickens reared for laying. It also concluded that a post-market monitoring plan to monitor the Eimeria spp. resistance should be undertaken. The Authority 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 monensin and nicarbazin (Monimax) 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 additive 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 ‘coccidiostats and histomonostats’, 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, 9 July 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  EFSA Journal 2017;15(12):5094.

            (3)  EFSA Journal 2018;16(11):5459.

            (4)  EFSA Journal 2019;17(11):5888.

            ANNEX

                           Identification number of the additive

                           Name of the holder of authorisation

                           Additive

                           (Trade name)

                           Composition, chemical formula, description, analytical method

                           Species or category of animal

                           Maximum age

                           Minimum content

                           Maximum content

                           Other provisions

                           End of period of authorisation

                           Maximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin

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

                           Coccidiostats and histomonostats

                        51776

                        Huvepharma NV.

                        Monensin
                        80 g/kg
                        Nicarbazin 80 g/kg (Monimax)

                           Additive composition:

                        Preparation of:
                        Monensin (as monensin sodium) 80 g/kg
                        (monensin A ≥ 90%, monensin A+B≥ 95%, monensin C 0.2-0.3%)
                        Nicarbazin 80 g/kg
                        (Ratio 1:1)
                        Starch: 15 g/kg.
                        Wheat meal: 580 g/kg.
                        Calcium carbonate: q.s. 1000 g
                        Granular form

                        Chickens for fattening

                        40 mg monensin sodium
                        40 mg nicarbazin

                        50 mg monensin sodium
                        50 mg nicarbazin

                                    1.

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

                                    2.

                                    The additive shall not be mixed with other coccidiostats.

                                    3.

                                    Indicate in the instructions for use:
                                    ‘Dangerous for equines. This feedingstuff contains an ionophore: avoid simultaneous administration with tiamulin and monitor for possible adverse reactions when used concurrently with other medicinal substances’.

                                    4.

                                    Post-market monitoring programmes shall be carried out by the holder of authorisation for:

                                                —

                                                resistance to bacteria and Eimeria spp.;

                                    5.

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

                        30.7.2030

                        25 μg monensin sodium/kg of wet skin + fat;
                        8 μg monensin sodium/kg of wet liver, kidney and muscle.
                        15 000  μg of DNC/kg of wet liver;
                        6 000  μg of DNC/kg of wet kidney;
                        4 000  μg of DNC/kg for wet muscle and wet skin/fat.

                        Turkeys for fattening

                        16 weeks

                        Chickens reared for laying

                        16 weeks

                           Characterisation of the active substance:

                           Monensin as monensin sodium technical substance (activity ≥ 27%)
                        CAS number 22373-78-0 produced by Streptomyces cinnamonensis 28682 BCCM/LMG S-19095) consisting of:

                                    —

                                    monensin A sodium:
                                    sodium (2-[5-ethyltetrahydro-5-[tetrahydro-3-methyl-5-[tetrahydro-6-hydroxy-6-(hydroxymethyl)-3,5-dimethyl-
                                    2H-pyran-2-yl]-2-furyl]-2-furyl]-9-hydroxy-β-methoxy-α,γ,2,8-tetramethyl-1,6-dioxaspiro-[4.5]decane-7-butyric acid; C36H61NaO11,

                                    —

                                    monensin B sodium: sodium 4-(9-hydroxy-2-(5’-(6-hydroxy-
                                    6-(hydroxymethyl)-3,5-dimethyltetrahydro-2H-pyran-2-yl)-2,3’-dimethyloctahydro-[2,2’-bifuran]-5-yl)-
                                    2,8-dimethyl-1,6-dioxaspiro[4.5]decan-7-yl)-3-methoxy-2-methylpentanoate;
                                    C35H59NaO11,

                                    —

                                    monensin C sodium: sodium 2-ethyl-4-(2-(2-ethyl-5’-(6-hydroxy-6-(hydroxymethyl)-
                                    3,5-dimethyltetrahydro-2H-pyran-2-yl)-3’-methyloctahydro-[2,2’-bifuran]-5-yl)-9-hydroxy-2,8-dimethyl-
                                    1,6-dioxaspiro[4.5]decan-7-yl)-3-methoxypentanoate,; C37H63NaO11

                           Nicarbazin

                        C19H 18N6O 6.

                        CAS number: 330-95-0 equimolecular complex of:

                                    —

                                    4,4-dinitrocarbanilide (DNC) (67.4-73%)
                                    C13H10N4O5,

                                    —

                                    2-hydroxy-4,6-dimethylpyrimidine
                                    (HDP) (27-30%)

                                    —

                                    free HDP ≤ 2.5%.
                                    C6H8N2O

                              Related impurities:

                                    —

                                    p-nitro- aniline (PNA): ≤ 0,1 %

                                    —

                                    methyl(4-nitrophenyl) carbamate (M4NPC): ≤ 0.4 %.

                           Analytical method
                            (1)

                        Quantification of monensin in the feed additive:
                        High Performance Liquid Chromatography using post-column derivatisation coupled to Visible detection (HPLC-VIS)
                        Quantification of monensin in premixtures and feedingstuffs:
                        High Performance Liquid Chromatography using post-column derivatisation coupled to Visible detection (HPLC-VIS) - EN ISO 14183
                        Quantification of nicarbazin in the feed additive:
                        High Performance Liquid Chromatography using post-column derivatisation coupled to UltraViolet detection (HPLC-UV)
                        Quantification of nicarbazin in premixtures and feedingstuffs:
                        High Performance Liquid Chromatography using post-column derivatisation coupled to UltraViolet detection (HPLC-UV) - EN ISO 15782
                        For the quantification of monensin sodium and nicarbazin in tissues:
                        Reversed-Phase High Performance Liquid Chromatography coupled to a triple quadrupole mass spectrometer (RP-HPLC-MS/MS) or any equivalent methods complying with the requirements set by Commission Decision 2002/657/EC

               (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) 2020/993 of 9 July 2020 concerning the authorisation of a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (BCCM/MUCL 49755) as a feed additive for all avian species for fattening other than chickens for fattening, ornamental birds, all weaned porcine species other than weaned piglets and all porcine species for fattening other than pigs for fattening (holder of authorisation Berg und Schmidt GmbH Co. KG) (Text with EEA relevance)

text:
                  10.7.2020

                  EN

                  Official Journal of the European Union

                  L 221/76

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/993
         of 9 July 2020
         concerning the authorisation of a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (BCCM/MUCL 49755) as a feed additive for all avian species for fattening other than chickens for fattening, ornamental birds, all weaned porcine species other than weaned piglets and all porcine species for fattening other than pigs for fattening (holder of authorisation Berg und Schmidt GmbH Co. KG)
         (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)

                     The preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (BCCM/MUCL 49755) was authorised for 10 years by Commission Implementing Regulation (EU) 2018/130 (2) for pigs for fattening and by Commission Implementing Regulation (EU) 2019/929 (3) for chickens for fattening and weaned piglets.

                     (3)

                     In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (BCCM/MUCL 49755). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (4)

                     That application concerns the authorisation of a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (BCCM/MUCL 49755) as a feed additive for all other avian species for fattening, ornamental birds and all other weaned porcine species and for fattening, to be classified in the additive category 'zootechnical additives'.

                     (5)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 2 July 2019 (4) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (BCCM/MUCL 49755) does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the additive should be regarded as a potential skin and a respiratory sensitiser. Therefore, 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 in its previous opinions (5) that the additive has the potential to be efficacious in improving zootechnical performance in chickens for fattening, weaned piglets and pigs for fattening and that these conclusions can be extrapolated to all birds for fattening and ornamental birds and to all weaned porcine species and all porcine species for fattening. 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.

                     (6)

                     The assessment of the preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (BCCM/MUCL 49755) 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.

                     (7)

                     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, 9 July 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  OJ L 22, 26.1.2018, p. 120.

            (3)  OJ L 148, 6.6.2019, p. 25.

            (4)  EFSA Journal 2019;17(7):5781.

            (5)  EFSA Journal 2017;15(2):4707 and EFSA Journal 2018;16(10):5457.

            ANNEX

                           Identification number of the additive

                           Name of the holder of authorisation

                           Additive

                           Composition, chemical formula, description, analytical method

                           Species or category of animal

                           Maximum age

                           Minimum content

                           Maximum content

                           Other provisions

                           End of period of authorisation

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

                           Category of zootechnical additives. Functional group: digestibility enhancers.

                        4a26

                        Berg and Schmidt GmbH Co. KG

                        Endo-1,4-beta-xylanase
                        (EC 3.2.1.8)

                              Additive composition

                        Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (BCCM/MUCL 49755) with a minimum activity of 15 000  EPU (1)/g
                        Solid form
                        --------------

                              Characterisation of active substance

                        Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (BCCM/MUCL 49755)
                        --------------

                              Analytical method

                            (2)

                        For quantification of endo-1,4-beta-xylanase activity in the feed additive, premixtures and feedingstuffs:

                                    —

                                    Colorimetric method measuring water soluble dye released by action of endo-1,4- beta-xylanase from azurine cross-linked wheat arabinoxylan substrates.

                        All avian species for fattening other than chickens for fattening
                        Ornamental birds
                        All weaned porcine species other than weaned piglets
                        All porcine species for fattening other than pigs for fattening

                        -

                        1 500  EPU

                        -

                                    1.

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

                                    2.

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

                        30.7.2030

               (1)  One Endopentosanase Unit (EPU) corresponds to the amount of enzyme which liberates 0,0083 μmol of reducing sugars (xylose equivalents) from oat spelt xylan per minute at pH 4,7 and 50 °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) 2020/995 of 9 July 2020 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 26372) as a feed additive for lactating sows (holder of authorisation DSM Nutritional Products Ltd represented by DSM Nutritional Products Sp. Z o.o) (Text with EEA relevance)

text:
                  10.7.2020

                  EN

                  Official Journal of the European Union

                  L 221/84

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/995
         of 9 July 2020
         concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 26372) as a feed additive for lactating sows (holder of authorisation DSM Nutritional Products Ltd represented by DSM Nutritional Products Sp. Z o.o)
         (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 endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 26372). That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.

                     (3)

                     That application concerns the authorisation of a preparation of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 26372) as a feed additive for lactating sows, to be classified in the additive category ‘zootechnical additives’.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 3 July 2019 (2) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 26372) does not have an adverse effect on animal health, consumer safety or the environment. It was also concluded that the additive is considered as a potential respiratory sensitiser and that no conclusion could be drawn on dermal sensitisation potential of the additive. Therefore, appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that the preparation of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 26372) showed an effect in improving the apparent faecal digestibility of the energy in lactating sows. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (5)

                     The assessment of the preparation of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 26372) 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 as set out in the 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, 9 July 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  EFSA Journal 2019;17(8):5790.

            ANNEX

                        Identification number of the additive

                        Name of the holder of authorisation

                        Additive

                        Composition, chemical formula, description, analytical method

                        Species or category of animal

                        Maximum age

                        Minimum content

                        Maximum content

                        Other provisions

                        End of period of authorisation

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

                           Category of zootechnical additives. Functional group: digestibility enhancers.

                        4a1607i

                        DSM Nutritional Products Ltd represented by DSM Nutritional Products Sp. Z o.o

                        Endo-1,4-beta-xylanase
                        (EC 3.2.1.8)

                           Additive composition:

                        Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus oryzae (DSM 26372) having a minimum activity of:
                        Solid form: 1 000  FXU (1)/g
                        Liquid form: 650 FXU/ml

                           Characterisation of active substance:

                        Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus oryzae (DSM 26372)

                           Analytical method
                            (2):
                        For quantification of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 26372) in a feed additive:

                                    —

                                    colorimetric method measuring coloured compound produced by the dinitro salicylic acid (DNSA) and the xylosylic moieties released by the action of xylanase on arabinoxylan.

                              For quantification of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 26372) in premixtures and feedingstuffs:

                                    —

                                    colorimetric method measuring water soluble dye released by action of xylanase from dye-labelled oat spelt azo-xylan.

                        Lactating sows

                        -

                        200 FXU

                        -

                                    1.

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

                                    2.

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

                        30.7.2020

               (1)  1 FXU is the amount of enzyme which liberates 7,8 μmol of reducing sugars (xylose equivalents) from azo-wheat arabinoxylan per minute at pH 6,0 and 50 °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) 2020/997 of 9 July 2020 concerning the authorisation of L-lysine base, liquid, L-lysine sulphate and L-lysine monohydrochloride, technically pure, as feed additives for all animal species (Text with EEA relevance)

text:
                  10.7.2020

                  EN

                  Official Journal of the European Union

                  L 221/90

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/997
         of 9 July 2020
         concerning the authorisation of L-lysine base, liquid, L-lysine sulphate and L-lysine monohydrochloride, technically pure, as feed additives 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(1) of Regulation (EC) No 1831/2003, applications were submitted for the authorisation of L-lysine base, liquid, and L-lysine monohydrochloride, technically pure, produced by Corynebacterium glutamicum NRRL-B-67439 or Corynebacterium glutamicum NRRL B-67535 and L-lysine sulphate and L-lysine monohydrochloride, technically pure, produced by Corynebacterium glutamicum CGMCC 7.266 as nutritional feed additives for use in feed and in water for drinking for all animal species. These applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (3)

                     These applications concern the authorisation of L-lysine base, liquid, and L-lysine monohydrochloride, technically pure, produced by Corynebacterium glutamicum NRRL-B-67439 or Corynebacterium glutamicum NRRL B-67535 and L-lysine sulphate and L-lysine monohydrochloride, technically pure, produced by Corynebacterium glutamicum CGMCC 7.266 as feed additives 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 opinions of 7 October 2019 (2) and 28 January 2020 (3) that, under the proposed conditions of use, L-lysine base, liquid, and L-lysine monohydrochloride, technically pure, produced by Corynebacterium glutamicum NRRL-B-67439 or Corynebacterium glutamicum NRRL B-67535 and L-lysine sulphate and L-lysine monohydrochloride, technically pure, produced by Corynebacterium glutamicum CGMCC 7.266 do not have an adverse effect on animal health, consumer health or the environment. It could not conclude on the potential toxicity by inhalation of L-lysine monohydrochloride, technically pure, produced by Corynebacterium glutamicum NRRL-B-67439 or Corynebacterium glutamicum NRRL B-67535 and anticipated that L-lysine base, liquid, produced by Corynebacterium glutamicum NRRL-B-67439 or Corynebacterium glutamicum NRRL B-67535 is corrosive to skin and eyes and poses an inhalation risk. For L-lysine sulphate and L-lysine monohydrochloride, technically pure, produced by Corynebacterium glutamicum CGMCC 7.266, the Authority could not exclude that the additives are toxic by inhalation, irritant to skin or eyes, or on their potential to be a dermal sensitiser. Therefore, 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 L-lysine base, liquid, and L-lysine monohydrochloride, technically pure, produced by Corynebacterium glutamicum NRRL-B-67439 or Corynebacterium glutamicum NRRL B-67535 and L-lysine sulphate and L-lysine monohydrochloride, technically pure, produced by Corynebacterium glutamicum CGMCC 7.266 are effective sources of the essential amino acid L-lysine for all animal species. For the supplemental L-lysine to be fully efficacious in ruminants, it should be protected against degradation in the rumen. In its opinions mentioned above, the Authority referred to a previous statement concerning potential nutritional imbalances for amino acids, when they are administered via water for drinking. However, the Authority did not propose a maximum content for the supplementation with L-lysine. Thus, it is appropriate to indicate on the label of the additive, and premixtures containing it, an alert to take into account the dietary supply with all the essential and conditionally essential amino acids, particularly in the case of supplementation with L-lysine as amino acid via water for drinking.

                     (5)

                     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.

                     (6)

                     The assessment of L-lysine base, liquid, and L-lysine monohydrochloride, technically pure, produced by Corynebacterium glutamicum NRRL-B-67439 or Corynebacterium glutamicum NRRL B-67535 and of L-lysine sulphate and L-lysine monohydrochloride, technically pure, produced by Corynebacterium glutamicum CGMCC 7.266 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.

                     (7)

                     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 substances specified in the Annex are authorised as feed additives in animal nutrition in the additive category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’, 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, 9 July 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  EFSA Journal 2019;17(10):5886.

            (3)  EFSA Journal 2020;18(2): 6019.

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

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

                        3c320

                        -

                        L-lysine base, liquid

                           Additive composition:

                        Aqueous solution of L-lysine with a minimum of 50 % L-lysine
                        -----------------

                           Characterisation of the active substance:

                        L-lysine produced by fermentation with Corynebacterium glutamicum NRRL-B-67439 or

                           Corynebacterium glutamicum NRRL B-67535.
                        Chemical formula: NH2-(CH2)4-CH(NH2)-COOH
                        CAS Number: 56-87-1
                        -----------------

                           Analytical methods
                            (1):
                        For the quantification of lysine in the feed additive and premixtures containing more than 10 % lysine:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS/FLD) – EN ISO 17180

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

                                    —

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

                              For the quantification of lysine in water:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD)

                        All species

                        -

                        -

                        -

                                    1.

                                    The lysine content shall be indicated on the labelling of the additive.

                                    2.

                                    L-lysine base, liquid, may be placed on the market and used as an additive consisting of a preparation.

                                    3.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation and for the skin and eyes. 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, skin and eye protection.

                                    4.

                                    The additive may be also used via water for drinking.

                                    5.

                                    Declarations to be made on the labelling of the additive and premixtures: ‘The supplementation with L-lysine, in particular via water for drinking, should take into account all essential and conditional essential amino acids in order to avoid imbalances.’

                        30.7.2030

                        3c322

                        L-lysine monohydrochloride, technically pure

                           Additive composition:

                        Powder of L-lysine monohydrochloride with a minimum of 78 % L-lysine and a maximum moisture content of 1,5 %.
                        -----------------

                           Characterisation of the active substance:

                        L-lysine monohydrochloride produced by fermentation with

                           Corynebacterium glutamicum NRRL-B-67439 or

                           Corynebacterium glutamicum NRRL B-67535 or

                           Corynebacterium glutamicum CGMCC 7.266.
                        Chemical formula: NH2-(CH2)4-CH(NH2)-COOH
                        CAS Number: 657-27-2

                           Analytical methods1:

                        For the identification of L-lysine monohydrochloride in the feed additive:

                                    —

                                    Food Chemical Codex "L-lysine monohydrochloride monograph"

                              For the quantification of lysine in the feed additive and premixtures containing more than 10 % lysine:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS/FLD) – EN ISO 17180.

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

                                    —

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

                              For the quantification of lysine in water:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD); or

                                    —

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

                        All species

                        -

                        -

                        -

                                    1.

                                    The lysine content shall be indicated on the labelling of the additive.

                                    2.

                                    L-lysine monohydrochloride, technically pure, may be placed on the market and used as an additive consisting of a preparation.

                                    3.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation. 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.

                                    4.

                                    The additive may be also used via water for drinking.

                                    5.

                                    Declarations to be made on the labelling of the additive and premixtures: ‘The supplementation with L-lysine, in particular via water for drinking, should take into account all essential and conditional essential amino acids in order to avoid imbalances.’

                        30.7.2030

                        3c325

                        L-lysine sulphate

                           Additive composition:

                        Granulate with a minimum L-lysine content of 52 % and a maximum content of 24 % sulphate.
                        -----------------

                           Characterisation of the active substance:

                        L-lysine sulphate produced by fermentation with Corynebacterium glutamicum CGMCC 7.266
                        Chemical formula: C12H28N4O4•H2SO4/[NH2-(CH2)4-CH(NH2)-COOH]2SO4

                        CAS number: 60343-69-3
                        -----------------

                           Analytical methods1:

                        For the quantification of lysine in the feed additive and premixtures containing more than 10 % lysine:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS/FLD) – EN ISO 17180

                              For the identification of sulphate in the feed additive:

                                    —

                                    European Pharmacopoeia Monograph 20301

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

                                    —

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

                              For the quantification of lysine in water:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD)

                        All species

                        -

                        -

                        10 000

                                    1.

                                    The L-lysine content shall be indicated on the labelling of the additive.

                                    2.

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

                                    3.

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

                                    4.

                                    The additive may be also used via water for drinking.

                                    5.

                                    Declarations to be made on the labelling of the additive and premixtures: ‘The supplementation with L-lysine, in particular via water for drinking, should take into account all essential and conditional essential amino acids in order to avoid imbalances.’

                        30.7.2030

               (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) 2020/998 of 9 July 2020 concerning the renewal of the authorisation of astaxanthin-dimethyldisuccinate as a feed additive for fish and crustaceans and repealing Regulation (EC) No 393/2008 (Text with EEA relevance)

text:
                  10.7.2020

                  EN

                  Official Journal of the European Union

                  L 221/96

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/998
         of 9 July 2020
         concerning the renewal of the authorisation of astaxanthin-dimethyldisuccinate as a feed additive for fish and crustaceans and repealing Regulation (EC) No 393/2008
         (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 and for the renewal of an authorisation of additives for use in animal nutrition and for the grounds and procedures for granting and renewing such authorisation.

                     (2)

                     Astaxanthin-dimethyldisuccinate was authorised for 10 years as a feed additive for salmon and trout by Commission Regulation (EC) No 393/2008 (2).

                     (3)

                     In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of astaxanthin-dimethyldisuccinate (the name of the additive changed from astaxanthin dimethyldisuccinate in the existing authorisation to astaxanthin-dimethyldisuccinate in the application, that is the correct name to refer to this additive) as a feed additive for salmon and trout, for a new use that extends the authorisation of astaxanthin dimethyldisuccinate as a feed additive for all fish and crustaceans according to Article 4(1) of that Regulation and for the modification of the existing conditions of authorisation of astaxanthin-dimethyldisuccinate as a feed additive to allow the use of the additive with no limitation of age or weight.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 13 November 2019 (3) that, under the proposed conditions of use astaxanthin-dimethyldisuccinate, does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that there is no evidence that would lead to reconsider the previous conclusions as regards the users of the additive. No dermal or ocular risk for the users is likely to occur under practical conditions. In the absence of a toxicology study, it is not possible to establish a risk inhalation toxicity. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the health of users of the additive, including when it is used in the form of a preparation. The Authority further concluded that astaxanthin-dimethyldisuccinate is effective in adding colour to food of animal origin. 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 astaxanthin-dimethyldisuccinate shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of that additive should be renewed and the terms of its authorisation modified as specified in the Annex to this Regulation.

                     (6)

                     As a consequence of the renewal of the authorisation of astaxanthin-dimethyldisuccinate as a feed additive under the conditions laid down in the Annex to this Regulation, Regulation (EC) No 393/2008 should be repealed.

                     (7)

                     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 authorisation of the additive specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘colourants: (ii) substances which, when fed to animals, add colours to food of animal origin’ for all salmon and trout species, is renewed and the terms of its authorisation are modified subject to the conditions laid down in that Annex.

            Article 2
            Regulation (EC) No 393/2008 is repealed.

            Article 3
            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, 9 July 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  Commission Regulation (EC) No 393/2008 of 30 April 2008 concerning the authorisation of astaxanthin dimethyldisuccinate as a feed additive (OJ L 117, 1.5.2008, p. 20).

            (3)  EFSA Journal 2019; 17(12):5920

            ANNEX

                        Identification number of the additive

                        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 of kg of complete feedingstuff with a moisture content of 12 %

                           Category: Sensory additives. Functional group: Colourants. (ii) substances which, when fed to animals, add colours to food of animal origin

                        2a165

                        Astaxanthin-dimethyldisuccinate

                           Additive composition:

                        Astaxanthin-dimethyldisuccinate
                        Triphenylphosphine oxide (TPPO) ≤ 100 mg/kg
                        Dichloromethane ≤ 600 mg/kg

                           Characterisation of the active substance:

                        Astaxanthin-dimethyldisuccinate
                        Chemical formula: C50H64O10

                        Solid form produced by chemical synthesis.
                        CAS number 578006-46-9
                        Purity criteria
                        Astaxanthin-dimethyldisuccinate (all-E, 9-Z and 13-Z isomers) ≥ 96 %
                        Other carotenoids ≤ 4 %

                           Analytical method
                            (1)

                        For the quantification of astaxanthin dimethyldisuccinate in the feed additive:

                                    —

                                    spectrophotometry at 486 nm.

                              For the quantification of astaxanthin dimethyldisuccinate in the feed additive, premixtures and feedingstuffs:

                                    —

                                    normal phase high performance liquid chromatography coupled to UV/VIS detection (HPLC-UV/VIS).

                        Fish and crustaceans

                        -

                        -

                        138

                                    1.

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

                                    2.

                                    Astaxanthin-dimethyldisuccinate must be placed on the market and used as an additive consisting of a preparation

                                    3.

                                    If astaxanthin- dimethyldisuccinate is mixed with canthaxanthin and other astaxanthin sources, the total content of the mixture shall not exceed 100 mg astaxanthin equivalent (2)/kg in complete feedingstuffs.

                                    4.

                                    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, including the risks of those additives included in the preparation. 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 eye, skin and breathing protection.

                        30.7.2030

               (1)  https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

               (2)  1,38 mg astaxanthin- dimethyldisuccinate is equivalent to 1 mg astaxanthin.


title: Commission Implementing Regulation (EU) 2020/999 of 9 July 2020 laying down rules for the application of Regulation (EU) 2016/429 of the European Parliament and of the Council with regard to the approval of germinal product establishments and the traceability of germinal products of bovine, porcine, ovine, caprine and equine animals (Text with EEA relevance)

text:
                  10.7.2020

                  EN

                  Official Journal of the European Union

                  L 221/99

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/999
         of 9 July 2020
         laying down rules for the application of Regulation (EU) 2016/429 of the European Parliament and of the Council with regard to the approval of germinal product establishments and the traceability of germinal products of bovine, porcine, ovine, caprine and equine animals
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (1), and in particular Article 96(3) and Article 123 thereof,
         Whereas:

                     (1)

                     Regulation (EU) 2016/429 lays down rules for the prevention and control of animal diseases, which are transmissible to animals or to humans. Those rules cover, inter alia, germinal products of kept terrestrial animals of the bovine, porcine, ovine, caprine and equine species and of other species. It also lays down rules for the registration and approval of establishments for germinal products of bovine, porcine, ovine, caprine and equine animals. Regulation (EU) 2016/429 also lays down rules concerning the traceability and animal health requirements for movements of consignments of germinal products within the Union. It also empowers the Commission to adopt delegated and implementing acts in order to ensure the smooth functioning of the new legal framework established by that Regulation.

                     (2)

                     Commission Delegated Regulation (EU) 2020/686 (2) lays down rules supplementing Regulation (EU) 2016/429 as regards the approval of germinal product establishments and the traceability and animal health requirements for movements of consignments of germinal products of certain kept terrestrial animals within the Union.

                     (3)

                     Accordingly, it is necessary to establish rules for the uniform implementation of the requirements laid down in Regulation (EU) 2016/429, and the supplementing rules laid down in Delegated Regulation (EU) 2020/686, concerning the information to be provided by operators in applications for approval of germinal product establishments for bovine, porcine, ovine, caprine and equine animals, and the time-limits for providing that information. It is also necessary to lay down rules concerning the technical requirements and specifications for the marking of germinal products of bovine, porcine, ovine, caprine and equine animals, and the operational requirements for the traceability of consignments of those germinal products.

                     (4)

                     Article 96(3) of Regulation (EU) 2016/429 provides that the Commission may, by means of implementing acts, lay down rules concerning the information to be provided by operators in applications for approval of germinal product establishments for bovine, porcine, ovine, caprine and equine animals from which germinal products of those animals are to be moved to another Member State, and the time-limits for providing such information. The timeframe for the competent authority to consider such applications should be sufficiently long in order to allow it to carry out an in-depth analysis, but it should not exceed a period of 90 days before the intended date of commencement of activity by operators, so that they are able to start their activity within a reasonable time period.

                     (5)

                     As Delegated Regulation (EU) 2020/686 provides for five different types of approved germinal product establishments, operators should indicate in their applications for approval of germinal product establishments for bovine, porcine, ovine, caprine and equine animals the nature of the activities that they intend to carry out therein. The biosecurity plan for the operation of the germinal product establishment should also be included in such application. In addition, given the important role of the centre and team veterinarians responsible for the activities of approved germinal product establishments, their details should be indicated in applications for approval of germinal product establishments.

                     (6)

                     Rules on the marking of straws and other packages where germinal products of bovine, porcine, ovine, caprine and equine animals are placed should be laid down at Union level in order to ensure their traceability. When setting the standards for that marking, account should be taken of practices in this regard already implemented by Member States, and also of the recommendations of the International Committee for Animal Recording (ICAR) (3). Where a bar code is printed on a straw or other package, the ICAR recommends that it is either of type 128C, or if of a different type, that three more digits corresponding to the international code of each germinal product establishment recorded in the United States National Association of Animal Breeders (NAAB) (4) are added at the beginning of the national bar code.

                     (7)

                     As Regulation (EU) 2016/429 applies from 21 April 2021, this Regulation should also apply from that date.

                     (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
            Subject matter and scope
            This Regulation lays down rules concerning germinal products of bovine, porcine, ovine, caprine and equine animals.
            Those rules cover:

                        (a)

                        the information to be provided by operators in applications for approval of germinal product establishments for bovine, porcine, ovine, caprine and equine animals and the time-limits for providing such information, as well as the time-limits for informing the competent authority of any cessation of activity of such germinal product establishments approved by it;

                        (b)

                        the technical requirements and specifications for the marking of germinal products of bovine, porcine, ovine, caprine and equine animals and the operational requirements for their traceability.

            Article 2
            Definitions
            For the purposes of this Regulation, the definitions laid down in Article 2 of Delegated Regulation (EU) 2020/686 shall apply.

            Article 3
            Information to be provided by operators in applications for approval of germinal product establishments for bovine, porcine, ovine, caprine and equine animals

               1.   Operators applying to the competent authority for approval of germinal product establishments for bovine, porcine, ovine, caprine and equine animals in accordance with Article 94(1)(b) of Regulation (EU) 2016/429 shall include the following information in their applications:

                           (a)

                           the name and address of the operator of the germinal product establishment;

                           (b)

                           the following details concerning the germinal product establishment:

                                       (i)

                                       the address;

                                       (ii)

                                       the name of the centre veterinarian or team veterinarian appointed by the operator in accordance with Article 4(1)(a) of Delegated Regulation (EU) 2020/686;

                                       (iii)

                                       which of the following types of activities are to be carried out at the germinal product establishment:

                                                   —

                                                   the collection, processing and storage of semen,

                                                   —

                                                   the collection, processing and storage of embryos,

                                                   —

                                                   the collection, processing and storage of oocytes and the production, processing and storage of embryos,

                                                   —

                                                   the processing and storage of fresh, chilled or frozen semen, oocytes or embryos,

                                                   —

                                                   the storage of fresh, chilled or frozen semen, oocytes or embryos;

                                       (iv)

                                       a description of how the processing of germinal products is to be carried out, and in the case where all or part of the processing is to be carried out at other germinal product processing establishments, the name and contact details of those germinal product processing establishments;

                                       (v)

                                       the biosecurity requirements for the operation of the germinal product establishment which shall include at least details of the following:

                                                   —

                                                   a structural description and a blueprint of the germinal product establishment,

                                                   —

                                                   the standard operating procedures for the collection, production, processing, storage and transport of germinal products, as appropriate for the type of germinal product establishment,

                                                   —

                                                   the procedures and instructions from the centre veterinarian or team veterinarian for the implementation of animal health and biosecurity requirements at the germinal product establishment,

                                                   —

                                                   a rodent and insect control plan,

                                                   —

                                                   information on the format of records kept in accordance with Article 8 of Delegated Regulation (EU) 2020/686,

                                                   —

                                                   the procedures for the cleaning and disinfection of the facilities and equipment,

                                                   —

                                                   a contingency plan in case of clinical signs of listed diseases or a positive test result for animal pathogens causing listed diseases,

                                                   —

                                                   an undertaking to notify the competent authority prior to the implementation of any significant changes relating to the biosecurity requirements for the operation of the germinal product establishment;

                           (c)

                           as regards the germinal products:

                                       (i)

                                       the type of germinal products to be collected, produced, processed or stored, specifying if they are semen, oocytes or embryos;

                                       (ii)

                                       the species of donor animals, specifying if they are bovine, porcine, ovine, caprine or equine animals;

                                       (iii)

                                       the conditions of storage of the germinal products, specifying if they are fresh, chilled or frozen.

               2.   The application referred to in paragraph 1 shall be in writing, either on paper or in electronic form.

            Article 4
            Time-limits for operators to provide information in applications for approval of germinal product establishments for bovine, porcine, ovine, caprine and equine animals and concerning any cessation of activity

               1.   Each Member State shall establish time-limits for the following:

                           (a)

                           for operators to provide the competent authority with:

                                       (i)

                                       the information required in accordance with Article 3(1);

                                       (ii)

                                       information concerning any cessation of activity of approved germinal product establishments for bovine, porcine, ovine, caprine and equine animals;

                           (b)

                           for the competent authority to inform operators of:

                                       (i)

                                       the obligation to provide the information required in accordance with Article 3(1);

                                       (ii)

                                       any refusal of an application for approval of a germinal product establishment submitted in accordance with Article 3 of Delegated Regulation (EU) 2020/686.

               2.   The time-limits referred to in paragraph 1(a)(i) shall not exceed a period of 90 days prior to the intended date of commencement of activity by the operator at the germinal product establishment.

               3.   Unless the competent authority indicates otherwise, any significant change relating to the biosecurity requirements for the operation of the germinal product establishment referred to in the eighth indent of Article 3(1)(b)(v), shall be deemed to be approved within a period of 90 days from the date of notification by the operator of such change.

            Article 5
            Technical requirements and specifications for the marking of germinal products of bovine, porcine, ovine, caprine and equine animals and operational requirements for their traceability

               1.   Operators marking germinal products of bovine, porcine, ovine, caprine and equine animals as required by Article 121(1) of Regulation (EU) 2016/429 shall ensure:

                           (a)

                           that each straw or other package, in which semen, oocytes or embryos, whether or not separated into individual doses, are placed, stored and transported, is marked in accordance with the traceability requirements laid down in Article 10 of Delegated Regulation (EU) 2020/686 and the technical requirements and specifications for marking set out in Part 1 of the Annex to this Regulation;

                           (b)

                           compliance with the operational requirements for the traceability of germinal products set out in Part 2 of the Annex.

               2.   Each Member State shall establish, based on the technical requirements and specifications for marking set out in Part 1 of the Annex, rules concerning the characteristics and form of the marking of straws and other packages, in which the germinal products are placed, stored and transported, used in its territory and it shall transmit that information to the Commission and to the other Member States.

            Article 6
            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.
            It shall apply from 21 April 2021.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 9 July 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 84, 31.3.2016, p. 1.

            (2)  Commission Delegated Regulation (EU) 2020/686 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards the approval of germinal product establishments and the traceability and animal health requirements for movements within the Union of germinal products of certain kept terrestrial animals (OJ L 174, 3.6.2020, p. 1).

            (3)  https://www.icar.org/

            (4)  https://www.naab-css.org/

            ANNEX
            Technical requirements and specifications for the marking of straws and other packages of germinal products of bovine, porcine, ovine, caprine and equine animals and operational requirements for their traceability, as referred to in Article 5

               Part 1

               Technical requirements and specifications for the marking of straws and other packages in which semen, oocytes or embryos are placed, stored and transported

                        1.

                        The marking on the straws and other packages must be clearly legible and all information included in the marking must be distinctly printed or written.

                        2.

                        The marking on the straws and other packages referred to in point 1, whether or not in the form of a code, must include the following information:

                                    (a)

                                    the date of collection or production of the semen, oocytes or embryos expressed at least in one of the following formats: ddmmyy, yymmdd, dd/mm/yy, yy/mm/dd, dd.mm.yy, yy.mm.dd, or, provided the conditions of point 2 of Part 2 are fulfilled at all times, the number of days since a fixed date expressed in a 5-digit code;

                                    (b)

                                    the species of donor animal(s);

                                    (c)

                                    the identification code(s) of donor animal(s) as defined in point (18) of Article 2 of Commission Delegated Regulation (EU) 2019/2035 (1) or, in case of porcine animals, at least the unique registration number of the establishment of birth of the donor animal(s) as defined in point (15) of Article 2 of that Delegated Regulation, or, in the case of equine animals, the unique code as defined in point (17) of Article 2 of that Delegated Regulation;

                                    (d)

                                    the unique approval number or unique registration number of the establishment of either collection or production, processing and storage of the semen, oocytes or embryos which must include the name or ISO 3166-1 alpha-2 code of the country of origin.

                        3.

                        The information on species of donor animal(s) referred to in point 2(b) may be omitted in the marking referred to in point 1, where the species of donor animal(s) may be established based on information printed or written on the straw or other package related to either

                                    (a)

                                    the unique approval number of the germinal product establishment of collection or production, processing and storage of the semen, oocytes or embryos, or the unique registration number of the establishment of collection, processing and storage of the semen of ovine and caprine animals, or

                                    (b)

                                    the breed of donor animal(s).

                        4.

                        Where a single straw or another package contains either semen collected from more than one donor animal or embryos and there is not enough space on the straw or another package to print or write the identification of each donor animal, the codes or numbers referred to in point 2(c) may be presented in the form of a numeric code.

                        5.

                        The marking on the straws and other packages referred to in point 1 may include any other relevant information (such as the name of donor animal(s), breed, an indication of sex of the sex-sorted semen or the individual identification number of the donor porcine animal(s)).

                        6.

                        In the case of sex-sorted semen, when the semen was sex-sorted at a germinal product processing establishment, the marking on the straws and other packages referred to in point 1 must include the unique approval number of the germinal product processing establishment where it was sex-sorted.
                        Where there is not enough space on the straw or another package to print or write the unique approval number of the germinal product processing establishment, that unique approval number may be presented in the form of a numeric code.

                        7.

                        All or parts of the information referred to in points 2 to 6 may be coded electronically on the straws or other packages.

               Part 2

               Operational requirements for the traceability of semen, oocytes or embryos

                        1.

                        Each consignment of germinal products must be accompanied by specifications explaining marking printed or written on the straws and other packages in which semen, oocytes or embryos are placed.

                        2.

                        The system for showing the date of collection or production of semen, oocytes or embryos referred to in point 2(a) of Part 1 must be indicated in the specifications referred to in point 1 of this Part.
                        Where the date is shown as the number of days since a fixed date expressed in a 5-digit code, the fixed date must be specified.

                        3.

                        Where the marking on a straw or other package includes any numeric code referred to in point 4 or in the second subparagraph of point 6 of Part 1, the specifications referred to in point 1 of this Part must include information explaining which information is coded.

                        4.

                        Where the marking on a straw or other package includes any electronic code referred to in point 7 of Part 1, a reader which enables that electronic code to be decoded shall be made available by the operator responsible for the consignment of germinal products.

               (1)  Commission Delegated Regulation (EU) 2019/2035 of 28 June 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for establishments keeping terrestrial animals and hatcheries, and the traceability of certain kept terrestrial animals and hatching eggs (OJ L 314, 5.12.2019, p. 115).