title: Commission Implementing Regulation (EU) 2019/111 of 24 January 2019 concerning the authorisation of hop extract (Humulus lupulus L. flos) as a feed additive for weaned piglets, pigs for fattening and minor porcine species weaned and for fattening (Text with EEA relevance.)

text:
                  25.1.2019

                  EN

                  Official Journal of the European Union

                  L 23/14

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/111
         of 24 January 2019
         concerning the authorisation of hop extract (Humulus lupulus L. flos) as a feed additive for weaned piglets, pigs for fattening and minor porcine species weaned and for fattening
         (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, and in particular Article 9(2) thereof (1),
         Whereas:

                     (1)

                     Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition.

                     (2)

                     In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of hop extract (Humulus lupulus L. flos) as a feed additive for all animal species. The application was accompanied by the particulars and documents required under Article 7(3) of that Regulation. The applicant requested that the additive be classified in the additive category ‘sensory additives’.

                     (3)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 3 October 2018 (2) that, under the proposed conditions of use, hop extract (Humulus lupulus L. flos) does not have adverse effects on animal health, human health or the environment. The Authority concluded that the tolerance study made with weaned piglets shows that the additive is safe for the proposed dose of 50 mg/kg of complete feed and can be extrapolated to pigs for fattening and to minor growing porcine species weaned and for fattening. It is therefore appropriate to authorise hop extract as a feed additive only for those species and categories. The Authority also concluded that since harvested hop and its extracts are universally recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy was necessary. Therefore, that conclusion can be extrapolated for feed.

                     (4)

                     The Authority further noted that the additive is a potential respiratory and skin sensitiser for users and contains a variety of compounds known to cause allergic reactions in sensitive persons. Consequently, appropriate protective measures should be taken.

                     (5)

                     The Authority did not consider that there was 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 this additive 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)

                     Having regard to the use level proposed by the applicant, the Authority considered that the maximum proposed use level is safe. For the purpose of official controls along the food chain, the recommended maximum content of the active substance should be indicated on the label of the feed additive and the incorporation into the feedingstuffs should be done via premixtures.

                     (8)

                     The fact that the use of the substances concerned in water for drinking is not authorised should not preclude their use in compound feed, which is administered via water.

                     (9)

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

            Article 2
            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, 24 January 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  EFSA Journal 2018;16(10):5462

            ANNEX

                        Identification number of the additive

                        Name of the holder of authorisation

                        Additive

                        Composition, chemical formula, description, analytical method.

                        Species or category of animal

                        Maximum age

                        Minimum content

                        Maximum content

                        Other provisions

                        End of period of authorisation

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

                           Category: Sensory additives. Functional group: Flavouring compounds

                        2b233

                        —

                        Hop extract (strobiles) rich in beta acids

                           Additive composition

                        Preparation of supercritical carbon dioxide extract of Humulus lupulus L. flos extract treated with potassium hydroxide to form potassium salts of the beta acids and dissolved in propylene glycol.
                        The specifications of the additive are:

                                    —

                                    Beta-acids: 40 ± 1,5 %

                                    —

                                    Alpha acids: 0,4 ± 0,3 %

                                    —

                                    Hop oils: 1,5 ± 0,3 %

                                    —

                                    Propylene glycol: 20 ± 15 %

                                    —

                                    Moisture < 8 %

                                    —

                                    Ash: 10 ± 2 %

                                    —

                                    Other resins: 25 ± 8 %

                                    —

                                    8-Prenylnaringenin < 500 mg/kg

                                    —

                                    Xanthohumol < 500 mg/kg

                                    —

                                    2-Methyl-2-buten-2-ol < 10 mg/kg

                           Characterisation of the active substance

                           Humulus lupulus L. flos flowers (strobiles) pelleted and further extracted with supercritical carbon dioxide extraction
                        Liquid viscous form
                        CAS number: 8060-28-4
                        CoE No 233

                           Analytical method
                            (1)

                        For the quantification of hops beta-acids in the feed additive:

                                    —

                                    reversed phase high performance liquid chromatography with UV detection (HPLC-UV) – ring-trial validated European Brewery Convention (EBC) method 7.7

                                    —

                                    Weaned piglets and pigs for fattening

                                    —

                                    Minor porcine species weaned and for fattening

                        —

                        —

                        —

                                    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 additive of complete feedingstuff with a moisture content of 12 %: 50 mg/kg’

                                    4.

                                    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.

                        14 February 2029

               (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) 2019/112 of 24 January 2019 on the minimum selling price for skimmed milk powder for the 31st partial invitation to tender within the tendering procedure opened by Implementing Regulation (EU) 2016/2080

text:
                  25.1.2019

                  EN

                  Official Journal of the European Union

                  L 23/18

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/112
         of 24 January 2019
         on the minimum selling price for skimmed milk powder for the 31st partial invitation to tender within the tendering procedure opened by Implementing Regulation (EU) 2016/2080
         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),
         Having regard to Commission Implementing Regulation (EU) 2016/1240 of 18 May 2016 laying down rules for the application of Regulation (EU) No 1308/2013 of the European Parliament and of the Council with regard to public intervention and aid for private storage (2), and in particular Article 32 thereof,
         Whereas:

                     (1)

                     Commission Implementing Regulation (EU) 2016/2080 (3) has opened the sale of skimmed milk powder by a tendering procedure.

                     (2)

                     In the light of the tenders received for the 31st partial invitation to tender, a minimum selling price should be fixed.

                     (3)

                     The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,

               HAS ADOPTED THIS REGULATION:

            Article 1
            For the 31st partial invitation to tender for the selling of skimmed milk powder within the tendering procedure opened by Implementing Regulation (EU) 2016/2080, in respect of which the period during which tenders were to be submitted ended on 22 January 2019, the minimum selling price shall be 158,50 EUR/100 kg.

            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 January 2019.

                  For the Commission,

                  On behalf of the President,

               Jerzy PLEWA

                  Director-General

                  Directorate-General for Agriculture and Rural Development

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

            (2)  OJ L 206, 30.7.2016, p. 71.

            (3)  Commission Implementing Regulation (EU) 2016/2080 of 25 November 2016 opening the sale of skimmed milk powder by a tendering procedure (OJ L 321, 29.11.2016, p. 45).


title: Commission Implementing Regulation (EU) 2019/542 of 2 April 2019 entering a name in the register of protected designations of origin and protected geographical indications (‘ស្ករត្នោតកំពង់ស្ពឺ’ (Skor Thnot Kampong Speu) (PGI))

text:
                  3.4.2019

                  EN

                  Official Journal of the European Union

                  L 94/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/542
         of 2 April 2019
         entering a name in the register of protected designations of origin and protected geographical indications (‘ស្ករត្នោតកំពង់ស្ពឺ’ (Skor Thnot Kampong Speu) (PGI))
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(3)(a) thereof,
         Whereas:

                     (1)

                     Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, the application from Cambodia to register the name ‘ស្ករត្នោតកំពង់ស្ពឺ’ (Skor Thnot Kampong Speu) as protected geographical indication (PGI) was published on 3 October 2017 in the Official Journal of the European Union (2).

                     (2)

                     On 22 December 2017 the Commission received the notice of opposition and the related reasoned statement of opposition from the sugar company Sucre Suisse SA based in Switzerland. The Commission forwarded the notice of opposition and the reasoned statement of opposition submitted by Sucre Suisse SA to Cambodia on 9 January 2018.

                     (3)

                     On 3 January 2018 the Commission received also the notice of opposition and the related reasoned statement of opposition from Belgium. The Commission forwarded the notice of opposition and the reasoned statement of opposition sent by Belgium to Cambodia on 9 January 2018. On 8 March 2018 Belgium informed the Commission of the withdrawal of its opposition to the application for registration of ‘ស្ករត្នោតកំពង់ស្ពឺ’ (Skor Thnot Kampong Speu).

                     (4)

                     Sucre Suisse SA opposed to the registration of the name ‘ស្ករត្នោតកំពង់ស្ពឺ’ (Skor Thnot Kampong Speu) because the description of the product ‘palm sugar’ is unspecific and the product does not fulfil definition of sugars as established in Council Directive 2001/111/EC (3) relating to certain sugars intended for human consumption.

                     (5)

                     Finding such opposition admissible, pursuant to Article 51(3) first subparagraph of Regulation (EU) No 1151/2012 the Commission invited Cambodia and Sucre Suisse SA by letter dated 3 April 2018 to engage in appropriate consultations for a period of three months to seek agreement among themselves in accordance with their internal procedures.

                     (6)

                     On 29 June 2018 Cambodia requested the extension of the deadline for the consultations. In accordance with Article 51(3) last subparagraph of Regulation (EU) No 1151/2012 the Commission extended the deadline for the consultations for additional three months starting on 4 July 2018.

                     (7)

                     Following consultations an agreement was reached between the interested parties. Cambodia communicated the results of the agreement to the Commission on 3 October 2018.

                     (8)

                     Cambodia and Sucre Suisse SA agreed that there is no need to modify the Single Document published under Article 50(2) of Regulation (EU) No 1151/2012. The interested parties consider also as useful to clarify what ‘ស្ករត្នោតកំពង់ស្ពឺ’ (Skor Thnot Kampong Speu) is by stating that ‘“Skor Thnot Kampong Speu” is a sugar that comes from palm trees. Palm sugar is not defined in the Directives 2001/111/EC relating to certain sugars intended for human consumption but it may be marketed in EU subject to the general legal requirements. Palm sugar has been used for human consumption across the world for centuries.’

                     (9)

                     As the agreement complies with the provisions of Regulation (EU) No 1151/2012 and EU legislation, the content of the agreement concluded between Cambodia and Sucre Suisse SA should be taken into account.

                     (10)

                     In the light of the above, the name ‘ស្ករត្នោតកំពង់ស្ពឺ’ (Skor Thnot Kampong Speu) should be entered in the Register of protected designations of origin and protected geographical indications,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The name ‘ស្ករត្នោតកំពង់ស្ពឺ’ (Skor Thnot Kampong Speu) is hereby entered in the register.
            The name in the first paragraph identifies a product from Class 1.8. Other products of Annex I to the Treaty (spices etc.) of annex XI of Commission Implementing Regulation (EU) No 668/2014 (4).

            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, 2 April 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  OJ C 331, 3.10.2017, p. 8.

            (3)  Council Directive 2001/111/EC of 20 December 2001 relating to certain sugars intended for human consumption (OJ L 10, 12.1.2002, p. 53).

            (4)  Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (OJ L 179, 19.6.2014, p. 36).