title: Commission Implementing Regulation (EU) 2019/766 of 14 May 2019 derogating from Implementing Regulation (EU) No 809/2014 as regards the final date of submission of the single application, aid applications or payment claims, the final date for notification of amendments to the single application or payment claim and the final date for applications for allocation of payment entitlements or the increase of the value of payment entitlements under the basic payment scheme for the year 2019

text:
                  15.5.2019

                  EN

                  Official Journal of the European Union

                  L 126/18

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/766
         of 14 May 2019
         derogating from Implementing Regulation (EU) No 809/2014 as regards the final date of submission of the single application, aid applications or payment claims, the final date for notification of amendments to the single application or payment claim and the final date for applications for allocation of payment entitlements or the increase of the value of payment entitlements under the basic payment scheme for the year 2019
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1306/2013 of the European Parliament and of the Council of 17 December 2013 on the financing, management and monitoring of the common agricultural policy and repealing Council Regulations (EEC) No 352/78, (EC) No 165/94, (EC) No 2799/98, (EC) No 814/2000, (EC) No 1290/2005 and (EC) No 485/2008 (1), and in particular point (b) of the first paragraph and the second paragraph of Article 78 thereof,
         Whereas:

                     (1)

                     Commission Implementing Regulation (EU) No 809/2014 (2) provides for the final date of submission of the single application, aid applications or payment claims, for the final date for notification of amendments to the single application or payment claim and for the final date for submission of applications for allocation of payment entitlements or the increase of the value of payment entitlements under the basic payment scheme.

                     (2)

                     Member States are implementing changes to their administrative system for area-based payments resulting from the new obligations arising in the context of the General Data Protection Regulation (3), involving, inter alia, a reorganisation of the information technology systems, changes to procedures and awareness-raising activities towards beneficiaries to inform them of the new legal requirements. As a result, exceptional administrative difficulties have been encountered in Member States.

                     (3)

                     That situation has affected the possibility of beneficiaries to submit the single application, aid applications or payment claims and applications for allocation of payment entitlements or the increase of the value of payment entitlements under the basic payment scheme within the time limits provided for in Articles 13(1) and 22(1) of Implementing Regulation (EU) No 809/2014.

                     (4)

                     In view of that situation, it is appropriate to provide for a derogation from Articles 13(1) and 22(1) of Implementing Regulation (EU) No 809/2014 which enables Member States to fix for the year 2019 a final date of submission of the single application, aid applications or payment claims and a final date for submission of applications for allocation of payment entitlements or the increase of the value of payments entitlements under the basic payment scheme that are later than those provided for in those Articles. Since the dates and periods referred to in Articles 11(4), 15(2) and (2a) of Implementing Regulation (EU) No 809/2014 are linked to the final date provided for in Article 13(1) of that Regulation, a similar derogation should be provided for the notification of the results of preliminary checks and of amendments to the single application or payment claim.

                     (5)

                     Since those derogations should cover the single application, aid applications and payment claims, amendments to the single application or payment claim and applications for allocation of payment entitlements for the year 2019, it is appropriate that this Regulation applies to applications and payment claims relating to the year 2019.

                     (6)

                     The measures provided for in this Regulation are in accordance with the opinion of the Committee for Direct Payments and the Committee for Rural Development,

               HAS ADOPTED THIS REGULATION:

            Article 1
            By way of derogation from the first subparagraph of Article 13(1) of Implementing Regulation (EU) No 809/2014, for the year 2019, the final dates to be fixed by Member States by which the single application, aid applications or payment claims have to be submitted shall not be later than 15 June.

            Article 2
            By way of derogation from Article 15(2) of Implementing Regulation (EU) No 809/2014, for the year 2019, in Member States using the derogation provided for in Article 1 of this Regulation the amendments made to the single application or payment claim in accordance with Article 15(1) of Implementing Regulation (EU) No 809/2014 shall be notified to the competent authority by 15 June.

            Article 3
            The derogations provided for in Articles 1 and 2 shall also apply in the Member States concerned for the purpose of calculating the periods of 26, 35 and 10 calendar days, respectively, after the final date of submission of the single application, aid application or payment claims and the final date for notification of amendments as referred to in Articles 11(4) and 15(2a) of Implementing Regulation (EU) No 809/2014.

            Article 4
            By way of derogation from Article 22(1) of Implementing Regulation (EU) No 809/2014, for the year 2019, the date to be fixed by Member States for the submission of applications for allocation of payment entitlements or the increase of the value of payment entitlements under the basic payment scheme shall not be later than 15 June.

            Article 5
            This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.
            It shall apply to applications and payment claims relating to the year 2019.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 14 May 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 347, 20.12.2013, p. 549.

            (2)  Commission Implementing Regulation (EU) No 809/2014 of 17 July 2014 laying down rules for the application of Regulation (EU) No 1306/2013 of the European Parliament and of the Council with regard to the integrated administration and control system, rural development measures and cross compliance (OJ L 227, 31.7.2014, p. 69).

            (3)  Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).


title: Commission Implementing Regulation (EU) 2019/802 of 17 May 2019 correcting the Greek language version of Implementing Regulation (EU) 2018/775 laying down rules for the application of Article 26(3) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers, as regards the rules for indicating the country of origin or place of provenance of the primary ingredient of a food (Text with EEA relevance.)

text:
                  20.5.2019

                  EN

                  Official Journal of the European Union

                  L 132/21

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/802
         of 17 May 2019
         correcting the Greek language version of Implementing Regulation (EU) 2018/775 laying down rules for the application of Article 26(3) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers, as regards the rules for indicating the country of origin or place of provenance of the primary ingredient of a food
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (1), and in particular Article 26(8) thereof,
         Whereas:

                     (1)

                     The Greek language version of Commission Implementing Regulation (EU) 2018/775 (2) contains errors in Article 1(1) and (2) as regards the scope of that Regulation.

                     (2)

                     The Greek language version of Implementing Regulation (EU) 2018/775 should therefore be corrected accordingly. The other language versions are not affected.

                     (3)

                     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

               (does not concern the English language)

            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, 17 May 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 304, 22.11.2011, p. 18.

            (2)  Commission Implementing Regulation (EU) 2018/775 of 28 May 2018 laying down rules for the application of Article 26(3) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers, as regards the rules for indicating the country of origin or place of provenance of the primary ingredient of a food (OJ L 131, 29.5.2018, p. 8).


title: Commission Implementing Regulation (EU) 2019/805 of 17 May 2019 concerning the authorisation of a preparation of muramidase produced by Trichoderma reesei DSM 32338 as a feed additive for chickens for fattening and minor poultry species for fattening (holder of authorisation DSM Nutritional Products Ltd, represented in EU by DSM Nutritional Products Sp. Z o.o) (Text with EEA relevance.)

text:
                  20.5.2019

                  EN

                  Official Journal of the European Union

                  L 132/33

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/805
         of 17 May 2019
         concerning the authorisation of a preparation of muramidase produced by Trichoderma reesei DSM 32338 as a feed additive for chickens for fattening and minor poultry species for fattening (holder of authorisation DSM Nutritional Products Ltd, represented in EU 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 muramidase produced by Trichoderma reesei DSM 32338. 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 muramidase produced by Trichoderma reesei DSM 32338 as a feed additive for chickens for fattening and minor poultry species for fattening, to be classified in the additive category ‘zootechnical additives’.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 14 June 2018 (2) that, under the proposed conditions of use, the preparation of muramidase produced by Trichoderma reesei DSM 32338 does not have an adverse effect on animal health, consumer safety or the environment. It was also concluded that the additive may have a skin/eyes irritancy potential and skin sensitisation potential. 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 also concluded that the additive showed improvements of the feed to gain ratio in chickens for fattening. The Authority considered that this conclusion can be extrapolated to minor poultry 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.

                     (5)

                     The assessment of the preparation of muramidase produced by Trichoderma reesei DSM 32338 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 ‘other zootechnical additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down 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, 17 May 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  EFSA Journal 2018;16(7):5342.

            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: other zootechnical additives (improvement of the feed to gain ratio)

                        4d16

                        DSM Nutritional Products Ltd represented in the EU by DSM Nutritional Products Sp. Z o.o

                        Muramidase
                        (EC 3.2.1.17)

                           Additive composition

                        Preparation of muramidase (EC 3.2.1.17) (lysozyme) produced by Trichoderma reesei (DSM 32338) having a minimum activity of 60 000  LSU(F)/g (1)

                        Solid and liquid forms

                           Characterisation of the active substance

                        Muramidase (EC 3.2.1.17) (lysozyme) produced by Trichoderma reesei (DSM 32338)

                           Method of analysis
                            (2)

                        For the quantification of muramidase:
                        fluorescence-based enzyme assay method that determines the enzyme-catalysed depolymerisation of a fluorescein-labelled peptidoglycan preparation at pH 6,0 and 30 °C.

                        Chickens for fattening
                        Minor poultry species for fattening

                        —

                        25 000  LSU(F)

                        —

                                    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 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 protections.

                        9 June 2029

               (1)  One LSU(F) unit is defined as the amount of enzyme that increases the fluorescence of 12,5 μg/ml fluorescein-labelled peptidoglycan per minute at pH 6,0 and 30 °C by a value that corresponds to the fluorescence of approximately 0,06 nmol fluorescein isothiocyanate isomer I.

               (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: Council Implementing Regulation (EU) 2019/855 of 27 May 2019 implementing Regulation (EU) No 267/2012 concerning restrictive measures against Iran

text:
                  28.5.2019

                  EN

                  Official Journal of the European Union

                  L 140/1

         COUNCIL IMPLEMENTING REGULATION (EU) 2019/855
         of 27 May 2019
         implementing Regulation (EU) No 267/2012 concerning restrictive measures against Iran
         THE COUNCIL OF THE EUROPEAN UNION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EU) No 267/2012 of 23 March 2012 concerning restrictive measures against Iran and repealing Regulation (EU) No 961/2010 (1), and in particular Article 46(2) thereof,
         Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,
         Whereas:

                     (1)

                     On 23 March 2012, the Council adopted Regulation (EU) No 267/2012.

                     (2)

                     In accordance with Article 46(7) of Regulation (EU) No 267/2012, the Council has reviewed the list of designated persons and entities set out in Annex IX and Annex XIV to that Regulation.

                     (3)

                     The Council has concluded that 17 entries included in Annex IX to Regulation (EU) No 267/2012 should be updated.

                     (4)

                     Regulation (EU) No 267/2012 should therefore be amended accordingly,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex IX to Regulation (EU) No 267/2012 is amended as set out in the Annex to this Regulation.

            Article 2
            This Regulation shall enter into force on the 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, 27 May 2019.

                  For the Council

                  The President

               N. HURDUC

            (1)  OJ L 88, 24.3.2012, p. 1.

            ANNEX
            Annex IX to Regulation (EU) No 267/2012 is amended as follows:

                        (1)

                        under the heading ‘I. Persons and entities involved in nuclear or ballistic missile activities and persons and entities providing support to the Government of Iran.’, the following entries replace the corresponding entries in the list set out under the subheading ‘A. Persons’:

                                    Name

                                    Identifying information

                                    Reasons

                                    Date of listing

                                    ‘14.

                                    Brigadier-General Mohammad NADERI

                                    Head of Iran's Aviation Industries Organisation (IAIO). Former Head of Iran's Aerospace Industries Organisation (AIO). AIO has taken part in sensitive Iranian programmes.

                                    23.6.2008

                                    23.

                                    Davoud BABAEI

                                    The current head of security for the Ministry Of Defence Armed Forces Logistics' research institute the Organisation of Defensive Innovation and Research (SPND), which is run by UN-designated Mohsen Fakhrizadeh-Mahabadi. The IAEA have identified SPND with their concerns over possible military dimensions to Iran's nuclear programme over which Iran refuses to co-operate. As head of security, Babaei is responsible for preventing the disclosure of information including to the IAEA.

                                    1.12.2011

                                    25.

                                    Sayed Shamsuddin BORBORUDI
                                    a.k.a. Seyed Shamseddin BORBOROUDI

                                    DOB: 21 September 1969

                                    Deputy Head of UN designated Atomic Energy Organisation of Iran, where he is subordinate to UN designated Feridun Abbasi Davani. Has been involved in the Iranian nuclear programme since at least 2002, including as the former head of procurement and logistics at AMAD, where he was responsible for using front companies such as Kimia Madan to procure equipment and material for Iran's nuclear weapons programme.

                                    1.12.2011

                                    27.

                                    Kamran DANESHJOO (a.k.a. DANESHJOU)

                                    Former Minister of Science, Research and Technology. He has provided support for Iran's proliferation-sensitive nuclear activities.

                                    1.12.2011’

                        (2)

                        under the heading ‘I. Persons and entities involved in nuclear or ballistic missile activities and persons and entities providing support to the Government of Iran.’, the following entries replace the corresponding entries in the list set out under the subheading ‘B. Entities’:

                                    Name

                                    Identifying information

                                    Reasons

                                    Date of listing

                                    ‘12.

                                    Fajr Aviation Composite Industries

                                    Mehrabad Airport, PO Box 13445-885, Tehran, Iran

                                    A subsidiary of the IAIO within MODAFL both designated by the EU which primarily produces composite materials for the aircraft industry.

                                    26.7.2010

                                    95.

                                    Samen Industries

                                    2nd km of Khalaj Road End of Seyyedi St., P.O.Box 91735-549, 91735 Mashhad, Iran, Tel.: +98 511 3853008, +98 511 3870225

                                    Shell name for UN-designated Khorasan Metallurgy Industries, subsidiary of Ammunition Industries Group (AMIG).

                                    1.12.2011

                                    153.

                                    Organisation of Defensive Innovation and Research (SPND)

                                    The Organisation of Defensive Innovation and Research (SPND) directly supports Iran's proliferation sensitive nuclear activities. The IAEA has identified SPND with their concerns over possible military dimensions (PMD) to Iran's nuclear programme. SPND is run by UN-designated Mohsen Fakhrizadeh-Mahabadi and is part of the Ministry of Defence For Armed Forces Logistics (MODAFL) designated by the EU.

                                    22.12.2012’

                        (3)

                        under heading II, the following entries replace the corresponding entries in the list set out under the subheading ‘A. Persons’:

                                    Name

                                    Identifying information

                                    Reasons

                                    Date of listing

                                    ‘1.

                                    IRGC Brigadier-General Javad DARVISH-VAND

                                    Former Deputy Minister and Inspector General of MODAFL.

                                    23.6.2008

                                    3.

                                    Parviz FATAH

                                    born 1961

                                    Member of the IRGC. Former Minister of Energy.

                                    26.7.2010

                                    4.

                                    IRGC Brigadier-General Seyyed Mahdi FARAHI

                                    Former head of Iran's Aerospace Industries Organisation (AIO) and former managing director of the UN-designated Defence Industries Organisation (DIO). Member of the IRGC and a Deputy in Iran's Ministry of Defense for Armed Forces Logistics (MODAFL).

                                    23.6.2008

                                    5.

                                    IRGC Brigadier-General Ali HOSEYNITASH

                                    Member of the IRGC. Member of the Supreme National Security Council and involved in formulating policy on nuclear issues.

                                    23.6.2008

                                    12.

                                    IRGC Brigadier-General Ali SHAMSHIRI

                                    Member of the IRGC. Has held senior roles in MODAFL.

                                    23.6.2008

                                    13.

                                    IRGC Brigadier-General Ahmad VAHIDI

                                    Former Minister of the MODAFL.

                                    23.6.2008

                                    15.

                                    Abolghassem Mozaffari SHAMS

                                    Former head of Khatam al-Anbiya Construction Headquarters.

                                    1.12.2011’

                        (4)

                        under heading II, the following entry replaces the corresponding entry in the list set out under the subheading ‘B. Entities’:

                                    Name

                                    Identifying information

                                    Reasons

                                    Date of listing

                                    ‘11.

                                    Behnam Sahriyari Trading Company

                                    Postal address: Ziba Building, 10th Floor, Northern Sohrevardi Street, Tehran, Iran

                                    Involved in the shipment of arms on behalf of the IRGC.

                                    23.1.2012’

                        (5)

                        under the heading ‘I. Persons and entities involved in nuclear or ballistic missile activities and persons and entities providing support to the Government of Iran’, under subheading ‘B. Entities’, the following entry is added:

                                    Name

                                    Identifying information

                                    Reasons

                                    Date of listing

                                    ‘20.

                                                (b)

                                                Iran Communications Industries (ICI)

                                    PO Box 19295-4731, Pasdaran Avenue, Tehran, Iran; Alternative address: PO Box 19575-131, 34 Apadana Avenue, Tehran, Iran; Alternative address: Shahid Langary Street, Nobonyad Square Ave, Pasdaran, Tehran

                                    Iran Communications Industries, a subsidiary of Iran Electronics Industries (listed by the EU), produces various items including communication systems, avionics, optics and electro-optics devices, micro-electronics, information technology, test and measurement, telecommunication security, electronic warfare, radar tube manufacture and refurbishment, and missile launchers.

                                    26.7.2010’

                        (6)

                        under the heading ‘I. Persons and entities involved in nuclear or ballistic missile activities and persons and entities providing support to the Government of Iran’, under subheading ‘B. Entities’, the following entry is removed:

                                    Name

                                    Identifying information

                                    Reasons

                                    Date of listing

                                    ‘19.

                                    Iran Communications Industries (ICI)

                                    PO Box 19295-4731, Pasdaran Avenue, Tehran, Iran; Alternative address: PO Box 19575-131, 34 Apadana Avenue, Tehran, Iran; Alternative address: Shahid Langary Street, Nobonyad Square Ave, Pasdaran, Tehran

                                    Iran Communications Industries, a subsidiary of Iran Electronics Industries (see no 20), produces various items including communication systems, avionics, optics and electro-optics devices, micro-electronics, information technology, test and measurement, telecommunication security, electronic warfare, radar tube manufacture and refurbishment, and missile launchers. These items can be used in programmes that are under sanction per UNSCR 1737.

                                    26.7.2010’

                        (7)

                        under heading II, under subheading ‘B. Entities’, the following entry is added:

                                    Name

                                    Identifying information

                                    Reasons

                                    Date of listing

                                    ‘12.

                                    Etemad Amin Invest Co Mobin

                                    Pasadaran Av. Tehran, Iran

                                    A company owned or controlled by IRGC that contributes to financing the strategic interests of the regime.

                                    26.7.2010’

                        (8)

                        under the heading ‘I. Persons and entities involved in nuclear or ballistic missile activities and persons and entities providing support to the Government of Iran’, under subheading ‘B. Entities’, the following entry is removed:

                                    Name

                                    Identifying information

                                    Reasons

                                    Date of listing

                                    ‘10.

                                    Etemad Amin Invest Co Mobin

                                    Pasadaran Av. Tehran, Iran

                                    Close to Naftar and to Bonyad-e Mostazafan, Etemad Amin Invest Co Mobin contributes to funding the strategic interests of the regime and of the parallel Iranian state.

                                    26.7.2010’


title: Commission Implementing Regulation (EU) 2019/857 of 27 May 2019 concerning the renewal of the authorisation of Saccharomyces cerevisiae CNCM I-1077 as a feed additive for dairy sheep and dairy goats and repealing Regulation (EC) No 226/2007 (holder of authorisation Danstar Ferment AG represented by Lallemand SAS) (Text with EEA relevance.)

text:
                  28.5.2019

                  EN

                  Official Journal of the European Union

                  L 140/18

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/857
         of 27 May 2019
         concerning the renewal of the authorisation of Saccharomyces cerevisiae CNCM I-1077 as a feed additive for dairy sheep and dairy goats and repealing Regulation (EC) No 226/2007 (holder of authorisation Danstar Ferment AG represented by Lallemand SAS)
         (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)

                        Saccharomyces cerevisiae CNCM I-1077 was authorised for 10 years as a feed additive for dairy goats and dairy sheep by Commission Regulation (EC) No 226/2007 (2).

                     (3)

                     In accordance with Article 14 of Regulation (EC) No 1831/2003, an application was submitted by the holder of that authorisation for the renewal of the authorisation of Saccharomyces cerevisiae CNCM I-1077 as a feed additive for dairy goats and dairy sheep, requesting that 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 Regulation (EC) No 1831/2003.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 5 July 2018 (3) that the applicant has provided data demonstrating that the additive complies with the conditions of authorisation.

                     (5)

                     The assessment of Saccharomyces cerevisiae CNCM I-1077 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 as specified in the Annex to this Regulation.

                     (6)

                     As a consequence of the renewal of the authorisation of Saccharomyces cerevisiae CNCM I-1077 as a feed additive under the conditions laid down in the Annex to this Regulation, Regulation (EC) No 226/2007 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 ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is renewed subject to the conditions laid down in that Annex.

            Article 2
            Regulation (EC) No 226/2007 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, 27 May 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Regulation (EC) No 226/2007 of 1 March 2007 concerning the authorisation of Saccharomyces cerevisiae CNCM I-1077 (Levucell SC20 and Levucell SC10 ME) as a feed additive (OJ L 64, 2.3.2007, p. 26).

            (3)  EFSA Journal 2018;16(7):5385.

            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

                        4b1711

                        Danstar Ferment AG represented by Lallemand SAS

                           Saccharomyces cerevisiae CNCM I-1077

                           Additive composition

                        Preparation of Saccharomyces cerevisiae CNCM I-1077 with a minimum concentration of:

                                    —

                                    1 × 1010 CFU/g of additive (coated form);

                                    —

                                    2 × 1010 CFU/g of additive (not-coated form);

                           Characterisation of the active substance

                        Viable dried cells of Saccharomyces cerevisiae CNCM I-1077

                           Analytical method
                            (1)

                        Enumeration: pour plate method using chloramphenicol dextrose yeast extract agar (EN15789:2009)
                        Identification: polymerase chain reaction (PCR) method CEN/TS 15790:2008

                        Dairy goats

                        —

                        5 × 108

                        —

                                    1.

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

                                    2.

                                    In the label of feed additive the following shall be indicated: ‘Recommended dose for dairy goats and dairy sheep: 4 × 109 CFU/head/day’

                                    3.

                                    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 and breathing protection.

                        17 June 2029

                        Dairy sheep

                        1,2 × 109

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