title: Commission Implementing Regulation (EU) 2021/485 of 22 March 2021 concerning the authorisation as feed additives of ginger essential oil from Zingiber officinale Roscoe for all animal species, ginger oleoresin from Zingiber officinale Roscoe for chickens for fattening, laying hens, turkeys for fattening, piglets, pigs for fattening, sows, dairy cows, veal calves (milk replacers), cattle for fattening, sheep, goats, horses, rabbits, fish and pets and ginger tincture from Zingiber officinale Roscoe for horses and dogs (Text with EEA relevance)

text:
                  23.3.2021

                  EN

                  Official Journal of the European Union

                  L 100/3

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/485
         of 22 March 2021
         concerning the authorisation as feed additives of ginger essential oil from Zingiber officinale Roscoe for all animal species, ginger oleoresin from Zingiber officinale Roscoe for chickens for fattening, laying hens, turkeys for fattening, piglets, pigs for fattening, sows, dairy cows, veal calves (milk replacers), cattle for fattening, sheep, goats, horses, rabbits, fish and pets and ginger tincture from Zingiber officinale Roscoe for horses and dogs
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
         Whereas:

                     (1)

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

                     (2)

                     Ginger essential oil, ginger oleoresin and ginger tincture from Zingiber officinale Roscoe were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. These additives were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003.

                     (3)

                     In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of ginger essential oil from Zingiber officinale Roscoe for all animal species, ginger oleoresin from Zingiber officinale Roscoe for chickens for fattening, laying hens, turkeys for fattening, piglets, pigs for fattening, sows, dairy cows, veal calves (milk replacers), cattle for fattening, sheep, goats, horses, rabbits, fish and pets and ginger tincture from Zingiber officinale Roscoe for horses and dogs.

                     (4)

                     The applicant requested ginger essential oil, ginger oleoresin and ginger tincture from Zingiber officinale Roscoe 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 ginger essential oil, ginger oleoresin and ginger tincture from Zingiber officinale Roscoe in water for drinking should not be allowed.

                     (5)

                     The applicant requested the additives to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (6)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 7 May 2020 (3) that, under the proposed conditions of use ginger essential oil, ginger oleoresin and ginger tincture from Zingiber officinale Roscoe do not have adverse effects on animal health, consumer health or the environment. The Authority also concluded that ginger essential oil, ginger oleoresin and ginger tincture from Zingiber officinale Roscoe should be considered as irritants to skin and eyes and the respiratory tract and as skin sensitisers. 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.

                     (7)

                     The Authority concluded, that ginger essential oil, ginger oleoresin and ginger tincture from Zingiber officinale Roscoe are recognised to flavour food and their function in feed would be essentially the same as that in food, therefore, no further demonstration of efficacy is considered 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.

                     (8)

                     The assessment of ginger essential oil, ginger oleoresin and ginger tincture from Zingiber officinale Roscoe shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of these substances should be authorised [as specified in the Annex to this Regulation].

                     (9)

                     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 additives. Where such content is exceeded, certain information should be indicated on the label of premixtures.

                     (10)

                     The fact that ginger essential oil, ginger oleoresin and ginger tincture from Zingiber officinale Roscoe are not authorised for use as a flavourings in water for drinking, does not preclude their use in compound feed which is administered via water.

                     (11)

                     Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the substances concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

                     (12)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Authorisation
            The substances specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, are authorised as feed additives in animal nutrition, subject to the conditions laid down in that Annex.

            Article 2
            Use in water for drinking
            The authorised substances specified in the Annex shall not be used in water for drinking.

            Article 3
            Transitional measures

               1.   The substances specified in the Annex and premixtures containing these substances, which are produced and labelled before 12 October 2021 in accordance with the rules applicable before 12 April 2021 may continue to be placed on the market and used until the existing stocks are exhausted.

               2.   Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 12 April 2022 in accordance with the rules applicable before 12 April 2021 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.

               3.   Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 12 April 2023 in accordance with the rules applicable before 12 April 2021 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.

            Article 4
            Entry into force
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 22 March 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

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

            (3)  EFSA Journal 2020;18(6):6147.

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

                           Category: Sensory additives

                           Functional group: Flavouring compounds

                        2b489-eo

                        -

                        Ginger essential oil

                           Additive composition

                        Essential oil derived by steam distillation from the dried rhizomes of Zingiber officinale Roscoe.

                           Characterisation of the active substance

                        Essential oil derived by steam distillation from the dried rhizomes of Zingiber officinale Roscoe as defined by the Council of Europe (1).

                                    —

                                    α-zingiberene: 29–40 %

                                    —

                                    β-sesquiphellandrene: 8–14 %

                                    —

                                    ar-curcumene: 5–12 %

                                    —

                                    α-farnesene: 4–10 %

                                    —

                                    camphene: 2–10 %

                                    —

                                    β-bisabolene: 2–9 %

                              CAS number: 8007-08-7,
                        EINECS number: 283-634-2
                        FEMA number: 2522
                        CoE number 489
                        Liquid form

                           Analytical method
                            (2)

                        For the quantification of alpha-zingiberene, beta-sesquiphellandrene and ar-curcumene in the feed additive:

                                    —

                                    Gas chromatography coupled to mass spectrometry (GC-MS) (full scan mode) using Retention Time Locking (RTL) methodology (or standard substances of the phytochemical markers) with (or without) gas chromatography coupled to flame ionisation detection (GC-FID) based on the ISO 11024 standard method.

                        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 premixtures, the storage conditions and stability to heat treatment shall be indicated.

                                    3.

                                    On the label of the additive and premixtures the following shall be indicated:
                                    ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %:

                                                —

                                                veal calves (milk replacer): 80 mg,

                                                —

                                                other species or categories of animals: 20 mg.’

                                    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 premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

                                    5.

                                    The mixture of ginger essential oil with other authorised additives obtained from Zingiber officinale Roscoe shall be not be allowed in feedingstuffs.

                                    6.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. 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, safety glasses and gloves.

                        12 April 2031

                        2b489-or

                        Ginger oleoresin

                           Additive composition

                        Ginger oleoresin obtained by steam distillation and solvent extraction of dried rhizomes of Zingiber officinale Roscoe.

                           Characterisation of the active substance

                        Ginger oleoresin obtained by steam distillation and solvent extraction of dried rhizomes of Zingiber officinale Roscoe as defined by the Council of Europe (1).
                        Essential oil: 25-30 (w/w)
                        Total gingerols: 0,5–8 % (w/w)

                                    —

                                    6-Gingerol

                                    —

                                    8-Gingerol

                                    —

                                    10-Gingerol

                              Total shogaols: 3–6 % (w/w)

                                    —

                                    6 Shogaol

                                    —

                                    8-Shogaol

                              Humidity and volatiles: 25-30 (w/w)
                        CoE number: 489
                        Liquid form

                           Analytical method
                            (2)

                        For the quantification of the phytochemical markers: total gingerols and total shogaols in the feed additive (ginger oleoresin):

                                    —

                                    High performance liquid chromatography (HPLC) with spectrophotometric (UV) detection – ISO 13685

                                    —

                                    Chickens for fattening

                                    —

                                    Laying hens

                                    —

                                    Turkeys for fattening.

                                    —

                                    Piglets

                                    —

                                    Pigs for fattening

                                    —

                                    Sows

                                    —

                                    Dairy cows

                                    —

                                    Veal calves (milk replacers)

                                    —

                                    Cattle for fattening

                                    —

                                    Sheep and goats

                                    —

                                    Horses

                                    —

                                    Rabbits

                                    —

                                    Fish

                                    —

                                    Pets

                        -

                        -

                        -

                                    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 premixtures, the storage conditions and stability to heat treatment shall be indicated.

                                    3.

                                    On the label of the additive and premixtures the following shall be indicated:
                                    ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 % and for milk replacers with a moisture content of 5,5 %:

                                                —

                                                chickens for fattening: 5 mg;

                                                —

                                                laying hens and rabbits: 7 mg;

                                                —

                                                turkeys for fattening: 6 mg;

                                                —

                                                piglets: 8mg;

                                                —

                                                pigs for fattening: 10 mg;

                                                —

                                                sows: 13 mg;

                                                —

                                                dairy cows: 12 mg;

                                                —

                                                veal calves (milk replacers): 21 mg;

                                                —

                                                cattle for fattening: 19 mg;

                                                —

                                                sheep, goats, horses and fish: 20 mg;

                                                —

                                                pets: 1 mg.’

                                    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 premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

                                    5.

                                    The mixture of ginger oleoresin with other authorised additives obtained from Zingiber officinale Roscoe shall be not be allowed in feedingstuffs.

                                    6.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. 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, safety glasses and gloves.

                        12 April 2031

                        2b489-t

                        Ginger tincture

                           Additive composition

                        Ginger tincture obtained by extraction of ground dried rhizomes of Zingiber officinale Roscoe using an ethanol/water mixture.

                           Characterisation of the active substance

                        Ginger tincture is obtained by extraction of ground dried rhizomes of Zingiber officinale Roscoe using an ethanol/water mixture as defined by the Council of Europe (1)

                        Solvent (ethanol/water, 90/10): 97-98 % (w/w)
                        Dry matter: 2-3 % (w/w)
                        Total gingerols: 0,14-0,11 % (w/w)

                                    —

                                    6-Gingerol

                                    —

                                    8-Gingerol

                                    —

                                    10-Gingerol

                              Total shogaols: 0,043-0,031 % (w/w)

                                    —

                                    6 Shogaol

                                    —

                                    8-Shogaol

                           Analytical method
                            (2)

                        For the quantification of the phytochemical markers: total gingerols and total shogaols in the feed additive (ginger tincture):

                                    —

                                    High performance liquid chromatography (HPLC) with spectrophotometric (UV) detection – ISO 13685

                                    —

                                    Horses

                                    —

                                    Dogs

                        -

                        -

                        -

                                    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 premixtures, the storage conditions and stability to heat treatment shall be indicated.

                                    3.

                                    On the label of the additive and premixtures the following shall be indicated:
                                    ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %:

                                                —

                                                Horses 1,58 mL

                                                —

                                                Dogs 1,81 mL’

                                    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 premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

                                    5.

                                    The mixture of ginger tincture with other authorised additives obtained from Zingiber officinale Roscoe shall be not be allowed in feedingstuffs.

                                    6.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. 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, safety glasses and gloves.

                        12 April 2031

               (1)  Natural sources of flavourings – Report No. 2 (2007)

               (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) 2021/505 of 23 March 2021 concerning the denial of authorisation of phosphoric acid 60 % on silica carrier as a feed additive belonging to the functional group of preservatives (Text with EEA relevance)

text:
                  24.3.2021

                  EN

                  Official Journal of the European Union

                  L 102/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/505
         of 23 March 2021
         concerning the denial of authorisation of phosphoric acid 60 % on silica carrier as a feed additive belonging to the functional group of preservatives
         (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 or denying such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

                     (2)

                     Orthophosphoric acid was authorised without a time limit by Directive 70/524/EEC as a feed additive for all animal species. The additive was subsequently entered in the Register of Feed Additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

                     (3)

                     In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, two applications for re-evaluation of orthophosphoric acid were submitted to the Commission.

                     (4)

                     The first of those applications concerned a preparation of orthophosphoric acid (67 %-85,7 %) w/w (aqueous solution). That preparation was authorised by Commission Implementing Regulation (EU) No 1055/2013 (3) for 10 years as a feed additive for all animal species.

                     (5)

                     The second application was submitted for the re-evaluation of phosphoric acid 60 % on silica carrier as a feed additive for all animal species. The applicant requested the additive to be classified in the additive category ‘technological additives’ and in the functional group ‘preservatives’. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (6)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 17 March 2020 (4) that considering the limited data provided in the original dossier and the absence of response from the applicant to the several requests from the Authority for additional information, initially on 22 July 2011 and finally on 3 March 2020, the Authority was not in a position to deliver an opinion on the safety and efficacy of phosphoric acid 60 % on silica carrier as a feed additive for all animal species.

                     (7)

                     In addition, on 8 May 2020 the Commission requested the applicant to communicate information on the follow-up of the application concerned, but no response was provided.

                     (8)

                     According to Article 5(1) of Regulation (EC) No 1831/2003, the applicant must adequately and sufficiently demonstrate, in accordance with the implementing measures (5) to Regulation (EC) No 1831/2003, that the additive satisfies the conditions for authorisation laid down in that Regulation.

                     (9)

                     As the applicant did not provide the requested information and data allowing the Authority to assess the safety and efficacy of phosphoric acid 60 % on silica carrier, it has not been established that, under the proposed conditions of use, the additive does not have an adverse effect on animal health, human health or the environment, and that it has at least one of the characteristics set out in Article 5(3) of Regulation (EC) No 1831/2003.

                     (10)

                     The assessment of phosphoric acid 60 % on silica carrier shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are not satisfied. Accordingly, the authorisation of the additive should be denied.

                     (11)

                     Therefore, phosphoric acid 60 % on silica carrier, as an existing product within the meaning of Article 10 of Regulation (EC) No 1831/2003, as well as feed containing it, should be withdrawn from the market. However, a limited period should be allowed for the withdrawal from the market of the existing stocks of the additive and its premixtures, and feed containing them, in order to enable operators to comply properly with the withdrawal obligation.

                     (12)

                     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
            Denial of authorisation
            The authorisation of phosphoric acid 60 % on silica carrier as a feed additive, belonging to the additive category ‘technological additives’ and to the functional group ‘preservatives’, is denied.

            Article 2
            Withdrawal from the market

               1.   Existing stocks of the additive referred to in Article 1, and of premixtures containing it, shall be withdrawn from the market by 13 October 2021.

               2.   Feed materials and compound feed intended for food-producing animals, which have been produced with the additive or the premixtures referred to in paragraph 1 before 13 October 2021, shall be withdrawn from the market by 13 April 2022.

               3.   Feed materials and compound feed intended for non-food-producing animals, which have been produced with the additive or the premixtures referred to in paragraph 1 before 13 October 2021, shall be withdrawn from the market by 13 April 2023.

            Article 3
            Entry into force
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 23 March 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

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

            (3)  Commission Implementing Regulation (EU) No 1055/2013 of 25 October 2013 concerning the authorisation of a preparation of orthophosphoric acid as a feed additive for all animal species (OJ L 288, 30.10.2013, p. 57).

            (4)  EFSA Journal 2020;18(4):6064.

            (5)  Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (OJ L 133, 22.5.2008, p. 1).


title: Commission Implementing Regulation (EU) 2021/507 of 23 March 2021 concerning the renewal of the authorisation of pyridoxine hydrochloride (vitamin B6) as a feed additive for all animal species and repealing Implementing Regulation (EU) No 515/2011 (Text with EEA relevance)

text:
                  24.3.2021

                  EN

                  Official Journal of the European Union

                  L 102/8

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/507
         of 23 March 2021
         concerning the renewal of the authorisation of pyridoxine hydrochloride (vitamin B6) as a feed additive for all animal species and repealing Implementing Regulation (EU) No 515/2011
         (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 and renewing such authorisation.

                     (2)

                     Pyridoxine hydrochloride (vitamin B6) was authorised for 10 years as a feed additive for all animal species by Commission Implementing Regulation (EU) No 515/2011 (2).

                     (3)

                     In accordance with Article 14 of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of pyridoxine hydrochloride as a feed additive for all animal species, requesting the additive to be classified in the additive category ‘nutritional additives’. That application was accompanied by the particulars and documents required under Article 14(2) of that Regulation.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 30 September 2020 (3) that the applicant has provided evidence that the additive complies with the existing conditions of authorisation. The Authority concluded that pyridoxine hydrochloride under the current authorised conditions of use does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the additive is non-irritant to skin and eyes and is not a skin sensitiser but it may cause photosensitisation and in the absence of inhalation toxicity studies, adverse effects in the respiratory tract could not be fully excluded. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards to the users of the additive. The Authority also concluded that there is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

                     (5)

                     The assessment of pyridoxine hydrochloride 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.

                     (6)

                     As a consequence of the renewal of the authorisation of pyridoxine hydrochloride as a feed additive, Implementing Regulation (EU) No 515/2011 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 ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemical well-defined substances having a similar effect’ for all animal species, is renewed subject to the conditions laid down in that Annex.

            Article 2
            Implementing Regulation (EU) No 515/2011 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, 23 March 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  Commission Implementing Regulation (EU) No 515/2011 of 25 May 2011 concerning the authorisation of vitamin B6 as a feed additive for all animal species (OJ L 138, 26.5.2011, p. 40).

            (3)  EFSA Journal 2020;18(11):6289.

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

                           Category of nutritional additives

                           Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect

                        3a831

                        ‘Pyridoxine hydrochloride’ or ‘vitamin B6’

                           Additive composition

                        Pyridoxine hydrochloride
                        C8H11NO3·HCl
                        Purity criteria: not less than 98,5 %

                           Characterisation of active substance

                        Pyridoxine hydrochloride

                        All animal species

                        -

                        -

                        -

                                    1.

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

                                    2.

                                    Pyridoxine hydrochloride or vitamin B6 may be used also via water for drinking.

                                    3.

                                    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.

                        13 April 2031

                           Analytical method
                            (1)

                        For the determination of pyridoxine hydrochloride (Vitamin B6) in the feed additive:

                                    —

                                    Titration with perchloric acid (Ph. Eur. 10th edition, monograph 0245)

                              For the determination of pyridoxine hydrochloride (Vitamin B6) in premixtures:

                                    —

                                    Reversed phase High Performance Liquid Chromatography coupled to UV detector (RP-HPLC-UV) - VDLUFA Bd.III, 13.9.1 method

                              For the determination of pyridoxine hydrochloride (Vitamin B6) in feedingstuffs and water:

                                    —

                                    Reversed phase High Performance Liquid Chromatography coupled to fluorescence detector (RP-HPLC-FLD) – method based on EN14164:2008

               (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) 2021/508 of 23 March 2021 concerning the renewal of the authorisation of a preparation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for weaned piglets and repealing Regulation (EU) No 170/2011 (holder of authorisation: Prosol S.p.A.) (Text with EEA relevance)

text:
                  24.3.2021

                  EN

                  Official Journal of the European Union

                  L 102/11

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/508
         of 23 March 2021
         concerning the renewal of the authorisation of a preparation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for weaned piglets and repealing Regulation (EU) No 170/2011 (holder of authorisation: Prosol S.p.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 and renewing such authorisation.

                     (2)

                     The preparation of Saccharomyces cerevisiae MUCL 39885 was authorised for 10 years as a feed additive for weaned piglets by Commission Regulation (EU) No 170/2011 (2).

                     (3)

                     In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted by the holder of that authorisation for the renewal of the authorisation of the preparation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for weaned piglets, requesting the additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 14(2) of that Regulation.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 30 September 2020 (3) that the applicant has provided evidence that the additive complies with the existing conditions of authorisation. The Authority further concluded that the preparation of Saccharomyces cerevisiae MUCL 39885 does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the preparation is considered as a potential skin and eye irritant and a skin and respiratory sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards to users of the additive. The Authority 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.

                     (5)

                     The assessment of the preparation of Saccharomyces cerevisiae MUCL 39885 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.

                     (6)

                     As a consequence of the renewal of the authorisation of the preparation of Saccharomyces cerevisiae MUCL 39885 as a feed additive, Regulation (EU) No 170/2011 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 preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is renewed subject to the conditions laid down in that Annex.

            Article 2
            Regulation (EU) No 170/2011 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, 23 March 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  Commission Regulation (EU) No 170/2011 of 23 February 2011 concerning the authorisation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for piglets (weaned) and amending Regulation (EC) No 1200/2005 (holder of authorisation Prosol SpA) (OJ L 49, 24.2.2011, p. 8).

            (3)  EFSA Journal 2020;18(11):6284.

            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

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

                           Category of zootechnical additives. Functional group: gut flora stabilisers

                        4b1710

                        Prosol S.p.A.

                           Saccharomyces cerevisiae MUCL 39885

                           Additive composition

                        Preparation of Saccharomyces cerevisiae MUCL 39885 containing a minimum of 1 × 109 CFU/g

                        Weaned piglets

                        -

                        3 × 109

                        -

                                    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 skin, eye and breathing protection.

                        13.4.2031

                           Characterisation of the active substance:

                        Viable cells of Saccharomyces cerevisiae MUCL 39885

                           Analytical method
                            (1)

                        Enumeration: pour plate method using yeast extract glucose chloramphenicol agar (CGYE) (EN 15789)
                        Identification: polymerase chain reaction (PCR) method

               (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) 2021/533 of 24 March 2021 amending Regulation (EC) No 1484/95 as regards fixing representative prices in the poultrymeat and egg sectors and for egg albumin

text:
                  26.3.2021

                  EN

                  Official Journal of the European Union

                  L 106/58

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/533
         of 24 March 2021
         amending Regulation (EC) No 1484/95 as regards fixing representative prices in the poultrymeat and egg sectors and for egg albumin
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1), and in particular Article 183(b) thereof,
         Having regard to Regulation (EU) No 510/2014 of the European Parliament and of the Council of 16 April 2014 laying down the trade arrangements applicable to certain goods resulting from the processing of agricultural products and repealing Council Regulations (EC) No 1216/2009 and (EC) No 614/2009 (2), and in particular Article 5(6)(a) thereof,
         Whereas:

                     (1)

                     Commission Regulation (EC) No 1484/95 (3) lays down detailed rules for implementing the system of additional import duties and fixes representative prices in the poultrymeat and egg sectors and for egg albumin.

                     (2)

                     Regular monitoring of the data used to determine representative prices for poultrymeat and egg products and for egg albumin shows that the representative import prices for certain products should be amended to take account of variations in price according to origin.

                     (3)

                     Regulation (EC) No 1484/95 should therefore be amended accordingly.

                     (4)

                     Given the need to ensure that this measure applies as soon as possible after the updated data have been made available, this Regulation should enter into force on the day of its publication,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex I to Regulation (EC) No 1484/95 is replaced by the text set out in the Annex to this Regulation.

            Article 2
            This Regulation shall enter into force on the day 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, 24 March 2021.

                  For the Commission,

                  On behalf of the President,

               Wolfgang BURTSCHER

                  Director-General

                  Directorate-General for Agriculture and Rural Development

            (1)  OJ L 347, 20.12.2013, p. 671.

            (2)  OJ L 150, 20.5.2014, p. 1.

            (3)  Commission Regulation (EC) No 1484/95 of 28 June 1995 laying down detailed rules for implementing the system of additional import duties and fixing representative prices in the poultrymeat and egg sectors and for egg albumin, and repealing Regulation No 163/67/EEC (OJ L 145, 29.6.1995, p. 47).

            ANNEX

                     ‘ANNEX I

                                 CN code

                                 Description

                                 Representative price
                                 (EUR/100 kg)

                                 Security under Article 3
                                 (EUR/100 kg)

                                 Origin (1)

                                 0207 14 10

                                 Fowls of the species Gallus domesticus, boneless cuts, frozen

                                 164,8
                                 146,2
                                 163,7

                                 48
                                 57
                                 48

                                 AR
                                 BR
                                 TH

                                 0207 27 10

                                 Boneless turkey cuts, frozen

                                 284,2

                                 4

                                 BR

               ’

               (1)  Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories (OJ L 328, 28.11.2012, p. 7).