title: Commission Implementing Regulation (EU) 2018/1594 of 22 October 2018 approving non-minor amendments to the specification for a name entered in the register of traditional specialities guaranteed [Bratislavský rožok/Pressburger Kipfel/Pozsonyi kifli (TSG)]

text:
                  24.10.2018

                  EN

                  Official Journal of the European Union

                  L 265/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1594
         of 22 October 2018
         approving non-minor amendments to the specification for a name entered in the register of traditional specialities guaranteed [Bratislavský rožok/Pressburger Kipfel/Pozsonyi kifli (TSG)]
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,
         Whereas:

                     (1)

                     Pursuant to the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined Slovakia's application for the approval of amendments to the specification for the traditional speciality guaranteed ‘Bratislavský rožok’/‘Pressburger Kipfel’/‘Pozsonyi kifli’, registered under Commission Implementing Regulation (EU) No 729/2012 (2).

                     (2)

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

                     (3)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            The amendments to the specification published in the Official Journal of the European Union regarding the name ‘Bratislavský rožok’/‘Pressburger Kipfel’/‘Pozsonyi kifli’ (TSG) are hereby approved.

            Article 2
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 22 October 2018.

                  For the Commission,

                  On behalf of the President,

               Phil HOGAN

                  Member of the Commission

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

            (2)  Commission Implementing Regulation (EU) No 729/2012 of 8 August 2012 entering a name in the register of traditional specialities guaranteed (Bratislavský rožok/Pressburger Kipfel/Pozsonyi kifli (TSG)) (OJ L 213, 10.8.2012, p. 9).

            (3)  OJ C 19, 19.1.2018, p. 28.


title: Commission Implementing Regulation (EU) 2018/1596 of 23 October 2018 extending the derogation from Council Regulation (EC) No 1967/2006 as regards the minimum distance from the coast and depth granted to shore seines fishing in certain territorial waters of France (Occitanie and Provence-Alpes-Côte d'Azur)

text:
                  24.10.2018

                  EN

                  Official Journal of the European Union

                  L 265/9

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1596
         of 23 October 2018
         extending the derogation from Council Regulation (EC) No 1967/2006 as regards the minimum distance from the coast and depth granted to shore seines fishing in certain territorial waters of France (Occitanie and Provence-Alpes-Côte d'Azur)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EC) No 1967/2006 of 21 December 2006 concerning management measures for the sustainable exploitation of fishery resources in the Mediterranean Sea, amending Regulation (EEC) No 2847/93 and repealing Regulation (EC) No 1626/94 (1), and in particular Article 13(5) thereof,
         Whereas:

                     (1)

                     Article 13(1) of Regulation (EC) No 1967/2006 prohibits the use of towed gears within three nautical miles of the coast or within the 50 m isobath where that depth is reached at a shorter distance from the coast.

                     (2)

                     At the request of a Member State, the Commission may allow a derogation from Article 13(1) of Regulation (EC) No 1967/2006, provided that a number of conditions set out in Article 13(5) and (9) are fulfilled.

                     (3)

                     Derogation from the first subparagraph of Article 13(1) of that Regulation, for the use of shore seines in certain sea areas situated within the territorial waters of France, irrespective of the depth, was granted until 31 December 2014 by Commission Implementing Regulation (EU) No 587/2014 (2).

                     (4)

                     An extension of the derogation was granted until 25 August 2018 by Commission Implementing Regulation (EU) 2015/1421 (3).

                     (5)

                     On 23 May 2018 the Commission received from France a request to extend the derogation which expired on 25 August 2018. France provided up-to-date information justifying the extension of the derogation.

                     (6)

                     France adopted a management plan in accordance with Article 19(2) of Regulation (EC) No 1967/2006 (4).

                     (7)

                     The Scientific, Technical and Economic Committee for Fisheries (STECF) assessed the derogation requested by France in July 2018 (5). STECF highlighted the need for improvement of data collection. France committed to improving the data collection by launching a scientific study to monitor the fishery and increase the sampling effort and also committed to improving the control framework beyond and above the obligations set out for the vessels concerned in Council Regulation (EC) No 1224/2009 (6) by doubling the number of controls, increasing the catch reporting frequency and by mandating the sending of a pre-notification to the control authorities 24 hours before any fishing trip.

                     (8)

                     In 2013 the STECF considered that taking into account the gears characteristics, the low speed of hand-hauling and the fact that the fishermen try to operate on ‘clean’ bottoms, the impact of this activity on the marine environment can be considered negligible.

                     (9)

                     The extension of the derogation requested by France complies with the conditions laid down in Article 13(5) and (9) of Regulation (EC) No 1967/2006.

                     (10)

                     There are specific geographical constraints given the limited width of the continental shelf.

                     (11)

                     Shore seine fishing is carried out from the shore in shallow depths and targets a variety of species. The nature of this type of fishery is such that it cannot be undertaken with any other fishing gear since there is no other regulated gear that can capture the target species.

                     (12)

                     The derogation granted under Commission Implementing Regulation (EU) 2015/1421 concerns a limited number of 23 vessels. The extension of the derogation requested by France concerns only 20 vessels.

                     (13)

                     The management plan adopted by France guarantees no future increase of the fishing effort, as fishing authorisations will only be issued to the specified 20 vessels involving a total effort of 1 386 days that are already authorised to fish by France. In addition, France limited the maximum effort allowed for each gear.

                     (14)

                     The management plan should enable to decrease the fleet with time since the fishing authorizations are linked to the vessels and are automatically withdrawn when the vessel holding the authorization is replaced.

                     (15)

                     The request covers vessels with a track record in the fishery of more than five years.

                     (16)

                     Those vessels are included in a list communicated to the Commission in line with the requirements of Article 13(9) of Regulation (EC) No 1967/2006.

                     (17)

                     The fishing activities concerned fulfil the requirements of Article 4 of Regulation (EC) No 1967/2006 since the French management plan explicitly prohibits fishing above protected habitats.

                     (18)

                     The requirements of Article 8(1)(h) of Regulation (EC) No 1967/2006 are not applicable since they relate to trawlers.

                     (19)

                     As regards the requirement to comply with Article 9(5) establishing the minimum mesh size, the Commission notes that given the fishing activities concerned are highly selective, have a negligible effect on the marine environment and are not carried out above protected habitats, France authorised in line with Article 9(7) of Regulation (EC) No 1967/2006 a derogation from these provisions in its management plan.

                     (20)

                     The fishing activities concerned fulfil the recording requirements set out in Article 14 of Council Regulation (EC) No 1224/2009.

                     (21)

                     The fishing activities concerned do not interfere with the activities of vessels using gears other than trawls, seines or similar towed nets.

                     (22)

                     The activity of shore seines is regulated in the French management plan to ensure that catches of species mentioned in Annex III to Regulation (EC) No 1967/2006 are minimal.

                     (23)

                     Shore seines do not target cephalopods.

                     (24)

                     The French management plan includes derogations to the minimum size of marine organisms for fries of sardine landed for human consumption and targeted by the fishing activities regulated therein, in accordance with Article 15(3) of Regulation (EC) No 1967/2006.

                     (25)

                     The STECF considered that derogation should be requested from the minimum mesh size together with the minimal distance from the shore or minimum depth. However, the European Commission considers that the relevant conditions listed in the Mediterranean Regulation are complied with: as per Article 9(5), the minimum mesh size applicable for surrounding nets such as shore seines shall be 14 mm, as per Article 15(3), the minimum mesh size shall not apply to fries of sardine landed for human consumption if a national management plan for shore seines is in place and the French management plan legally sets a 2 mm minimum mesh size for shore seines targeting sardine juveniles.

                     (26)

                     The STECF considered that the impact of the fishery may not be fully evaluated because certain species caught by this fishery are not scientifically assessed. However, the European Commission considers that the impact of this fishery should be assessed in light of the actual magnitude of this fishery, which is minimal: the poutine fishery targeting in particular sardine juveniles concerns only 10 vessels whose yearly catches are only 1,6 tonnes.

                     (27)

                     The French management plan includes measures for the monitoring of fishing activities, as provided for in the third subparagraph of Article 13(9) of Regulation (EC) No 1967/2006.

                     (28)

                     The region Languedoc-Roussillon changed name to Occitanie on 28 September 2016 (7). Consequently, references to ‘Languedoc-Roussillon’ have to be replaced by ‘Occitanie’.

                     (29)

                     The requested extension of the derogation should therefore be granted.

                     (30)

                     France should report to the Commission in due time and in accordance with the monitoring plan provided for in the French management plan.

                     (31)

                     A limitation of the duration of the derogation will allow ensuing prompt corrective management measures in case the monitoring of the management plan will show a poor conservation status of the exploited stock, while providing scope to enhance the scientific basis for an improved management plan.

                     (32)

                     The French management plan for shore seines has no expiry date and therefore its period of application shall extend beyond that of the derogation requested. There is consequently no risk of legal gap.

                     (33)

                     Accordingly, the derogation should apply until 25 August 2021.

                     (34)

                     The measures provided for in this Regulation are in accordance with the opinion of the Committee for Fisheries and Aquaculture,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Derogation
            Article 13(1) of Regulation (EC) No 1967/2006 shall not apply in territorial waters of France adjacent to the coast of Occitanie and Provence-Alpes-Côte-d'Azur to shore seines used by vessels:

                        (a)

                        bearing the registration number mentioned in the French management plan;

                        (b)

                        Having a track record in the fishery of more than five years and not involving any future increase in the fishing effort deployed; and

                        (c)

                        Holding a fishing authorisation and operating under the management plan adopted by France in accordance with Article 19(2) of Regulation (EC) No 1967/2006.

            Article 2
            Monitoring plan and reporting
            France shall communicate to the Commission, within one year following the entry into force of this Regulation, a report drawn up in accordance with the monitoring plan established in the management plan referred to in Article 1(c).

            Article 3
            Entry into force and period of application
            This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
            It shall apply until 25 August 2021.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 23 October 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 409, 30.12.2006, p. 11.

            (2)  Commission Implementing Regulation (EU) No 587/2014 of 2 June 2014 derogating from Council Regulation (EC) No 1967/2006 as regards the minimum distance from the coast and depth for shore seines fishing in certain territorial waters of France (Languedoc-Roussillon and Provence-Alpes-Côte d'Azur) (OJ L 164, 3.6.2014, p. 13).

            (3)  Commission Implementing Regulation (EU) 2015/1421 of 24 August 2015 extending the derogation from Council Regulation (EC) No 1967/2006 as regards the minimum distance from the coast and depth granted to shore seines fishing in certain territorial waters of France (Languedoc-Roussillon and Provence-Alpes-Côte d'Azur) (OJ L 222, 25.8.2015, p. 1).

            (4)  JORF no 0122 of 27 May 2014 page 8669, text no 6, NOR: DEVM1407280A.

            (5)  https://stecf.jrc.ec.europa.eu/documents/43805/2147402/STECF+PLEN+18-02.pdf

            (6)  Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, p. 1).

            (7)  https://www.legifrance.gouv.fr/eli/decret/2016/9/28/INTB1617888D/jo/texte/fr


title: Commission Implementing Regulation (EU) 2019/133 of 28 January 2019 amending Regulation (EU) 2015/640 as regards the introduction of new additional airworthiness specifications

text:
                  29.1.2019

                  EN

                  Official Journal of the European Union

                  L 25/14

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/133
         of 28 January 2019
         amending Regulation (EU) 2015/640 as regards the introduction of new additional airworthiness specifications
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and repealing Regulation (EC) No 216/2008 (1), and in particular Article 17(1)(h) thereof,
         Whereas:

                     (1)

                     Commission Regulation (EU) 2015/640 (2) sets out additional airworthiness requirements for aircraft, the design of which has already been certified. Those additional airworthiness requirements are needed to support continuing airworthiness and safety improvements. This is because when certification specifications (‘CS’) issued by the European Union Aviation Safety Agency (the ‘Agency’), pursuant to Article 76(3) of Regulation (EU) 2018/1139, are updated by the Agency in order to ensure that CS remain fit for purpose, an aircraft, the design of which has already been certified is not required to comply with the updated version of CS when it is produced or while in service.

                     (2)

                     In order to maintain a high level of aviation safety and environmental requirements in Europe it might therefore be necessary to mandate the compliance of aircraft with additional airworthiness requirements which were not mandated by the Agency at the time of certification of design, because they were not included in the relevant CS at that time. This amendment to Regulation (EU) 2015/640 concerns three evolutions of the CS.

                     (3)

                     First, in 1989 the Joint Aviation Authorities (JAA) introduced new design standards for the dynamic conditions of passenger and cabin crew seats of large aeroplanes, offering an improved protection of occupants. Those standards aimed at mitigating the risk of injuries or deaths in the event of emergency landing. They were transposed in the Agency's certification specifications for large aeroplanes (CS-25), but they apply only to large aeroplanes of which the certification of the design has been applied for after 1989. Considering that certain large aeroplanes might not comply with those standards, additional airworthiness specifications should be therefore introduced. Having due regard to the nature and risk of operations with large aeroplanes while maintaining a high uniform level of civil aviation safety in the Union, it is considered proportionate and cost-efficient to introduce those additional airworthiness specifications only to large aeroplanes newly produced on the basis of a design which has already been certified by the Agency. Those additional airworthiness specifications should not apply to flight deck crew seats and seats in low-occupancy aeroplanes involved in on-demand non-scheduled commercial air transport operations because it is not considered proportionate or cost-efficient.

                     (4)

                     Second, in 2009 the Agency introduced new flammability standards for thermal or acoustic insulation materials improving certain characteristics of the insulation materials installed in the fuselage to resist flame propagation and flame penetration in the certification specifications for large aeroplanes (CS-25 Amendment 6). Those new flammability standards apply only to large aeroplanes of which the certification of the design has been applied for after 2009. Considering that certain large aeroplanes might not comply with those standards, additional airworthiness specifications should be introduced. Having due regard to the nature and risk of operations with large aeroplanes while maintaining a high uniform level of civil aviation safety in the Union, it is considered proportionate and cost-efficient to introduce the additional airworthiness specifications addressing the risk of flame propagation in flight to large aeroplanes newly produced on the basis of a design which has already been certified by the Agency. Those additional airworthiness specifications should also apply to large aeroplanes which are in service when thermal or acoustic insulation materials are replaced. Finally, the additional airworthiness specifications addressing the risk of flame penetration into the aeroplane after an accident should be introduced for large aeroplanes with a passenger capacity of 20 or more and apply only to aeroplanes newly produced on the basis of a design which has already been certified by the Agency.

                     (5)

                     Third, to gradually mitigate the environmental impact of halon used in the firefighting equipment, the International Civil Aviation Organization (ICAO) has issued new standards by amending ICAO Annex 6 applicable as from 15 December 2011. In order to comply with those standards, additional airworthiness specifications should be introduced to newly produced large aeroplanes and large helicopters the design of which has already been certified by the Agency on the basis of certification specifications which allowed the use of halon as a suitable agent.

                     (6)

                     Commission Regulation (EU) 2015/640 should therefore be amended accordingly.

                     (7)

                     The measures provided for in this Regulation are based on opinions issued by the Agency in accordance with Article 76(1) of Regulation (EU) 2018/1139.

                     (8)

                     The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 127(3) of Regulation (EU) 2018/1139,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Regulation (EU) 2015/640 is amended as follows:

                        (1)

                        Article 2 is amended as follows:

                                    (a)

                                    point (b) is replaced by the following:

                                                ‘(b)

                                                “large aeroplane” means an aeroplane that has the Certification Specifications for large aeroplanes “CS-25” or equivalent in its certification basis;’

                                    (b)

                                    the following points (c) and (d) are added:

                                                ‘(c)

                                                “large helicopter” means a helicopter that has the Certification Specifications for large rotorcraft “CS-29” or equivalent in its certification basis;

                                                (d)

                                                “low-occupancy aeroplane” means an aeroplane that has a maximum operational passenger seating configuration of:

                                                            (1)

                                                            up to and including 19 seats, or;

                                                            (2)

                                                            up to and including one third of the maximum passenger seating capacity of the type-certified aeroplane, as indicated in the aeroplane type-certificate data sheet (TCDS), provided that both of the following conditions are met:

                                                                        (a)

                                                                        the total number of passenger seats approved for occupancy during taxiing, take-off or landing does not exceed 100 per deck;

                                                                        (b)

                                                                        the maximum operational passenger seating configuration during taxiing, take-off or landing in any individual zone between pairs of emergency exits (or any dead-end zone) does not exceed one third of the sum of the passenger seat allowances for the emergency exit pairs bounding that zone (using the passenger seat allowance for each emergency exit pairs as defined by the applicable certification basis of the aeroplane). For the purpose of determining compliance with this zonal limitation, in the case of an aeroplane that has deactivated emergency exits, it shall be assumed that all emergency exits are functional.’

                        (2)

                        Annex I (Part-26) is amended in accordance with Annex to this Regulation.

            Article 2
            Entry into force and application
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 28 January 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 212, 22.8.2018, p. 1.

            (2)  Commission Regulation (EU) 2015/640 of 23 April 2015 on additional airworthiness specifications for a given type of operations and amending Regulation (EU) No 965/2012 (OJ L 106, 24.4.2015, p. 18).

            ANNEX
            Annex I is amended as follows:

                        (1)

                        the table of content is replaced by the following:
                        ‘CONTENTS
                        SUBPART A — GENERAL PROVISIONS
                        26.10 Competent authority
                        26.20 Temporary inoperative equipment
                        26.30 Demonstration of compliance
                        SUBPART B — LARGE AEROPLANES
                        26.50 Seats, berths, safety belts, and harnesses
                        26.60 Emergency landing — dynamic conditions
                        26.100 Location of emergency exits
                        26.105 Emergency exit access
                        26.110 Emergency exit markings
                        26.120 Interior emergency lighting and emergency light operation
                        26.150 Compartment interiors
                        26.155 Flammability of cargo compartment liners
                        26.156 Termal or accoustic insulation materials
                        26.160 Lavatory fire protection
                        26.170 Fire extinguishers
                        26.200 Landing gear aural warning
                        26.250 Flight crew compartment door operating systems — single incapacitation
                        SUBPART C — LARGE HELICOPTERS
                        26.400 Fire extinguishers’;

                        (2)

                        the following point 26.60 is inserted:
                        ‘26.60 Emergency landing — dynamic conditions

                        Operators of large aeroplanes used in commercial air transport of passengers, type-certified on or after 1 January 1958, and for which the individual certificate of airworthiness is first issued on or after 18 February 2021 shall demonstrate for each seat type design approved for occupancy during taxiing, take-off or landing that the occupant is protected when exposed to loads resulting from emergency landing conditions. The demonstration shall be made by one of the following means:

                                    (a)

                                    successfully completed dynamic tests;

                                    (b)

                                    rational analysis providing equivalent safety, based on dynamic tests of a similar seat type design.

                              The obligation set out in the first paragraph shall not apply to the following seats:

                                    (a)

                                    flight deck crew seats,

                                    (b)

                                    seats in low-occupancy aeroplanes involved only in on-demand non-scheduled commercial air transport operations.’;

                        (3)

                        the following point 26.156 is inserted:
                        ‘26.156 Thermal or acoustic insulation materials

                        Operators of large aeroplanes used in commercial air transport, type certified on or after 1 January 1958, shall ensure that:

                                    (a)

                                    for aeroplanes for which the first individual certificate of airworthiness is issued before 18 February 2021, when new thermal or acoustic insulation materials are installed as replacements on or after 18 February 2021, those new materials have flame propagation resistance characteristics which prevent or reduce the risk of flame propagation in the aeroplane;

                                    (b)

                                    for aeroplanes for which the first individual certificate of airworthiness is issued on or after 18 February 2021, thermal and acoustic insulation materials have flame propagation resistance characteristics which prevent or reduce the risk of flame propagation in the aeroplane;

                                    (c)

                                    for aeroplanes for which the first individual certificate of airworthiness is issued on or after 18 February 2021 and with a passenger capacity of 20 or more, thermal and acoustic insulation materials (including the means of fastening the materials to the fuselage) installed in the lower half of the aeroplane have flame penetration resistance characteristics which prevent or reduce the risk of flame penetration into the aeroplane after an accident and which ensure survivable conditions in the cabin for a time needed to evacuate the aeroplane.’;

                        (4)

                        the following point 26.170 is inserted:
                        ‘26.170 Fire extinguishers

                        Operators of large aeroplanes shall ensure that the following extinguishers do not use halon as an extinguishing agent:

                                    (a)

                                    built-in fire extinguishers for each lavatory waste receptacle for towels, paper or waste in large aeroplanes for which the first individual certificate of airworthiness is issued on or after 18 February 2020;

                                    (b)

                                    portable fire extinguishers in large aeroplanes for which the first individual certificate of airworthiness is issued on or after 18 May 2019.’;

                        (5)

                        the following Subpart C is added:
                        ‘SUBPART C — LARGE HELICOPTERS

                           26.400 Fire extinguishers

                        Operators of large helicopters shall ensure that the following extinguishers do not use halon as an extinguishing agent:

                                    (a)

                                    built-in fire extinguishers for each lavatory waste receptacle for towels, paper or waste in large helicopters for which the individual certificate of airworthiness is first issued on or after 18 February 2020;

                                    (b)

                                    portable fire extinguishers in large helicopters for which the individual certificate of airworthiness is first issued on or after 18 May 2019.’


title: Commission Implementing Regulation (EU) 2019/218 of 1 February 2019 approving an amendment to the specification for a Protected Designation of Origin or a Protected Geographical Indication (‘Vinos de Madrid’ (PDO))

text:
                  6.2.2019

                  EN

                  Official Journal of the European Union

                  L 34/8

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/218
         of 1 February 2019
         approving an amendment to the specification for a Protected Designation of Origin or a Protected Geographical Indication (‘Vinos de Madrid’ (PDO))
         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 99 thereof,
         Whereas:

                     (1)

                     The Commission has examined the application for the approval of an amendment to the specification for the Protected Designation of Origin ‘Vinos de Madrid’, sent by Spain in accordance with Article 105 of Regulation (EU) No 1308/2013.

                     (2)

                     The Commission has published the application for the approval of an amendment to the specification in the Official Journal of the European Union, as required by Article 97(3) of Regulation (EU) No 1308/2013 (2).

                     (3)

                     No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013.

                     (4)

                     The amendment to the specification should therefore be approved in accordance with Article 99 of Regulation (EU) No 1308/2013.

                     (5)

                     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
            The amendment to the specification published in the Official Journal of the European Union regarding the name ‘Vinos de Madrid’ (PDO) is hereby approved.

            Article 2
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 1 February 2019.

                  For the Commission,

                  On behalf of the President,

               Phil HOGAN

                  Member of the Commission

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

            (2)  OJ C 398, 5.11.2018, p. 8.


title: Commission Implementing Regulation (EU) 2019/219 of 31 January 2019 entering a name in the register of protected designations of origin and protected geographical indications (‘Bulot de la Baie de Granville’ (PGI))

text:
                  7.2.2019

                  EN

                  Official Journal of the European Union

                  L 35/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/219
         of 31 January 2019
         entering a name in the register of protected designations of origin and protected geographical indications (‘Bulot de la Baie de Granville’ (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(2) thereof,
         Whereas:

                     (1)

                     Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, France's application to register the name ‘Bulot de la Baie de Granville’ was published in the Official Journal of the European Union (2).

                     (2)

                     As no statement of objection under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Bulot de la Baie de Granville’ should therefore be entered in the register,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The name ‘Bulot de la Baie de Granville’ (PGI) is hereby entered in the register.
            The name specified in the first paragraph denotes a product in Class 1.7. Fresh fish, molluscs and crustaceans and products derived therefrom, as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).

            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, 31 January 2019.

                  For the Commission,

                  On behalf of the President,

               Phil HOGAN

                  Member of the Commission

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

            (2)  OJ C 303, 29.8.2018, p. 7.

            (3)  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).


title: Commission Implementing Regulation (EU) 2019/221 of 6 February 2019 amending Regulations (EC) No 785/2007, (EC) No 379/2009, (EC) No 1087/2009, (EU) No 9/2010, (EU) No 337/2011 and Implementing Regulations (EU) No 389/2011, (EU) No 528/2011, (EU) No 840/2012, (EU) No 1021/2012, (EU) 2016/899, (EU) 2016/997, (EU) 2017/440 and (EU) 2017/896 as regards the name of the holder of the authorisation and the representative of the holder of the authorisation for certain feed additives (Text with EEA relevance.)

text:
                  7.2.2019

                  EN

                  Official Journal of the European Union

                  L 35/28

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/221
         of 6 February 2019
         amending Regulations (EC) No 785/2007, (EC) No 379/2009, (EC) No 1087/2009, (EU) No 9/2010, (EU) No 337/2011 and Implementing Regulations (EU) No 389/2011, (EU) No 528/2011, (EU) No 840/2012, (EU) No 1021/2012, (EU) 2016/899, (EU) 2016/997, (EU) 2017/440 and (EU) 2017/896 as regards the name of the holder of the authorisation and the representative of the holder of the authorisation for certain feed additives
         (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 13(3) thereof,
         Whereas:

                     (1)

                     In accordance with Regulation (EC) No 1831/2003 of the European Parliament and of the Council, 6-phytase, endo-1,4-beta-xylanase, subtilisin, alpha-amylase, endo-1,3(4)-beta-glucanase, preparation of Bacillus amyloliquefaciens (PTA-6507), Bacillus amyloliquefaciens (NRRL B-50013) and Bacillus amyloliquefaciens (NRRL B-50104) were authorised by Commission Regulations (EC) No 785/2007 (2), (EC) No 379/2009 (3), (EC) No 1087/2009 (4), (EU) No 9/2010 (5) and (EU) No 337/2011 (6) and Commission Implementing Regulations (EU) No 389/2011 (7), (EU) No 528/2011 (8), (EU) No 840/2012 (9), (EU) No 1021/2012 (10), (EU) 2016/899 (11), (EU) 2016/997 (12), (EU) 2017/440 (13) and (EU) 2017/896 (14).

                     (2)

                     The holder of authorisation, Danisco Animal Nutrition legal entity Danisco (UK) Ltd, has submitted an application in accordance with Article 13(3) of Regulation (EC) No 1831/2003 proposing to add to the authorisations concerned the name of its representative and, for the authorisations granted by Regulations (EC) No 1087/2009 and (EU) No 9/2010, to change of the name of the authorisation holder.

                     (3)

                     The holder of authorisation has submitted relevant data supporting the fact that, with effect from 30 March 2019, Genencor International B.V. will act as its representative for the feed additives concerned. The holder of authorisation also submitted the relevant information to demonstrate that Finnfeeds International Limited changed its name to Danisco (UK) Ltd.

                     (4)

                     The proposed change of the terms of the authorisations is purely administrative in nature and does not entail a fresh assessment of the additives concerned. The European Food Safety Authority was informed of the application.

                     (5)

                     To allow Genencor International B.V. to act as the representative of the holder of the authorisations, it is necessary to change the terms of the authorisations concerned.

                     (6)

                     Regulations (EC) No 785/2007, (EC) No 379/2009, (EC) No 1087/2009, (EU) No 9/2010, (EU) No 337/2011 and Implementing Regulations (EU) No 389/2011, (EU) No 528/2011, (EU) No 840/2012, (EU) No 1021/2012, (EU) 2016/899, (EU) 2016/997, (EU) 2017/440 and (EU) 2017/896 should, therefore, be amended accordingly.

                     (7)

                     As the data submitted by the holder of authorisation shows that Genencor International B.V. will act as its representative with effect from 30 March 2019, this Regulation should apply from the same date.

                     (8)

                     The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Amendment to Regulation (EC) No 785/2007
            In the second column of the Annex to Regulation (EC) No 785/2007 the words ‘Danisco Animal Nutrition’ are replaced by the words ‘Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.’.

            Article 2
            Amendment to Regulation (EC) No 379/2009

               1.   In the title, the words ‘Danisco Animal Nutrition, legal entity Danisco (UK) Limited’ are replaced by the words ‘Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.’.

               2.   In the second column of the Annex to Regulation (EC) No 379/2009 the words ‘Danisco Animal Nutrition, legal entity Danisco (UK) Limited’ are replaced by the words ‘Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.’.

            Article 3
            Amendment to Regulation (EC) No 1087/2009

               1.   In the title, the words ‘Danisco Animal Nutrition, legal entity Finnfeeds International Limited’ are replaced by the words ‘Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.’.

               2.   In the second column of the Annex to Regulation (EC) No 1087/2009 the words ‘Danisco Animal Nutrition, legal entity Finnfeeds International Limited’ are replaced by the words ‘Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.’.

            Article 4
            Amendment to Regulation (EU) No 9/2010

               1.   In the title, the words ‘Danisco Animal Nutrition, Finnfeeds International Limited’ are replaced by the words ‘Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.’.

               2.   In the second column of the Annex to Regulation (EU) No 9/2010 the words ‘Danisco Animal Nutrition (legal entity: Danisco (UK) Limited)’ are replaced by the words ‘Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.’.

            Article 5
            Amendment to Regulation (EU) No 337/2011

               1.   In the title, the words ‘Danisco Animal Nutrition’ are replaced by the words ‘Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.’.

               2.   In the second column of the Annex to Regulation (EU) No 337/2011 the words ‘Danisco Animal Nutrition’ are replaced by the words ‘Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.’.

            Article 6
            Amendment to Implementing Regulation (EU) No 389/2011

               1.   In the title, the words ‘Danisco Animal Nutrition’ are replaced by the words ‘Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.’.

               2.   In the second column of the Annex to Implementing Regulation (EU) No 389/2011 the words ‘Danisco Animal Nutrition’ are replaced by the words ‘Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.’.

            Article 7
            Amendment to Implementing Regulation (EU) No 528/2011

               1.   In the title, the words ‘Danisco Animal Nutrition’ are replaced by the words ‘Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.’.

               2.   In the second column of the Annex to Implementing Regulation (EU) No 528/2011 the words ‘Danisco Animal Nutrition’ are replaced by the words ‘Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.’.

            Article 8
            Amendment to Implementing Regulation (EU) No 840/2012

               1.   In the title, the words ‘Danisco Animal Nutrition’ are replaced by the words ‘Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.’.

               2.   In the second column of the Annex to Implementing Regulation (EU) No 840/2012 the words ‘Danisco Animal Nutrition (legal entity Danisco (UK) Limited)’ are replaced by the words ‘Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.’.

            Article 9
            Amendment to Implementing Regulation (EU) No 1021/2012

               1.   In the title, the words ‘Danisco Animal Nutrition’ are replaced by the words ‘Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.’.

               2.   In the second column of the Annex to Implementing Regulation (EU) No 1021/2012 the words ‘Danisco Animal Nutrition (legal entity: Danisco (UK) Limited)’ are replaced by the words ‘Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.’.

            Article 10
            Amendment to Implementing Regulation (EU) 2016/899

               1.   In the title, the words ‘Danisco (UK) Ltd’ are replaced by the words ‘Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.’.

               2.   In the second column of the Annex to Implementing Regulation (EU) 2016/899, the words ‘Danisco (UK) Ltd’ are replaced by the words ‘Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.’.

            Article 11
            Amendment to Implementing Regulation (EU) 2016/997

               1.   In the title, the words ‘Danisco (UK) Ltd’ are replaced by the words ‘Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.’.

               2.   In the second column of the Annex to Implementing Regulation (EU) 2016/997 the words ‘Danisco (UK) Ltd’ are replaced by the words ‘Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.’.

            Article 12
            Amendment to Implementing Regulation (EU) 2017/440

               1.   In the title, the words ‘Danisco (UK) Ltd, trading as Danisco Animal Nutrition’ are replaced by the words ‘Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.’.

               2.   In the second column of the Annex to Implementing Regulation (EU) 2017/440 the words ‘Danisco (UK) Ltd, trading as Danisco Animal Nutrition’ are replaced by the words ‘Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.’.

            Article 13
            Amendment to Implementing Regulation (EU) 2017/896

               1.   In the title, the words ‘Danisco (UK) Ltd’ are replaced by the words ‘Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.’.

               2.   In the second column of the Annex to Implementing Regulation (EU) 2017/896 the words ‘Danisco (UK) Ltd’ are replaced by the words ‘Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.’.

            Article 14
            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.
            It shall apply from 30 March 2019.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 6 February 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Regulation (EC) No 785/2007 of 4 July 2007 concerning the authorisation of 6-phytase EC 3.1.3.26 (Phyzyme XP 5000G Phyzyme XP 5000L) as a feed additive (OJ L 175, 5.7.2007, p. 5).

            (3)  Commission Regulation (EC) No 379/2009 of 8 May 2009 concerning the authorisation of a new use of 6-phytase EC 3.1.3.26 as a feed additive for chickens for fattening, turkeys for fattening, laying hens, ducks for fattening, piglets (weaned), pigs for fattening and sows (holder of the authorisation Danisco Animal Nutrition, legal entity Danisco (UK) Limited (OJ L 116, 9.5.2009, p. 6).

            (4)  Commission Regulation (EC) No 1087/2009 of 12 November 2009 concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588), subtilisin produced by Bacillus subtilis (ATCC 2107) and alpha-amylase produced by Bacillus amyloliquefaciens (ATCC 3978) as a feed additive for chickens for fattening, for ducks and for turkeys for fattening (holder of authorisation Danisco Animal Nutrition, legal entity Finnfeeds International Limited) (OJ L 297, 13.11.2009, p. 4).

            (5)  Commission Regulation (EU) No 9/2010 of 23 December 2009 concerning the authorisation of the endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588) as a feed additive for chickens for fattening, laying hens, ducks and turkeys for fattening (holder of authorisation Danisco Animal Nutrition, Finnfeeds International Limited (OJ L 3, 7.1.2010, p. 10).

            (6)  Commission Regulation (EU) No 337/2011 of 7 April 2011 concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase and endo-1,3(4)- beta-glucanase as feed additive for poultry, weaned piglets and pigs for fattening (holder of the authorisation Danisco Animal Nutrition) (OJ L 94, 8.4.2011, p. 19).

            (7)  Commission Implementing Regulation (EU) No 389/2011 of 19 April 2011 concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase, subtilisin and alpha-amylase as feed additive for laying hens (holder of authorisation Danisco Animal Nutrition) (OJ L 104, 20.4.2011, p. 7).

            (8)  Commission Implementing Regulation (EU) No 528/2011 of 30 May 2011 concerning the authorisation of endo-1,4-β-xylanase produced by Trichoderma reesei (ATCC PTA 5588) as a feed additive for weaned piglets and pigs for fattening (holder of authorisation Danisco Animal Nutrition) (OJ L 143, 31.5.2011, p. 10).

            (9)  Commission Implementing Regulation (EU) No 840/2012 of 18 September 2012 concerning the authorisation of 6-phytase (EC 3.1.3.26) produced by Schizosaccharomyces pombe (ATCC 5233) as a feed additive for all avian species for fattening other than chickens for fattening, turkeys for fattening and ducks for fattening and all avian species for laying other than laying hens (holder of authorisation Danisco Animal Nutrition) (OJ L 252, 19.9.2012, p. 14).

            (10)  Commission Implementing Regulation (EU) No 1021/2012 of 6 November 2012 concerning the authorisation of endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588) as a feed additive for minor poultry species other than ducks (holder of authorisation Danisco Animal Nutrition) (OJ L 307, 7.11.2012, p. 68).

            (11)  Commission Implementing Regulation (EU) 2016/899 of 8 June 2016 concerning the authorisation of a 6-phytase produced by Trichoderma reesei (ATCC SD-6528) as a feed additive for all poultry species and all porcine species (other than suckling piglets) (holder of authorisation Danisco (UK) Ltd) (OJ L 152, 9.6.2016, p. 15).

            (12)  Commission Implementing Regulation (EU) 2016/997 of 21 June 2016 concerning the authorisation of endo-1,4-beta-xylanase EC 3.2.1.8 produced by Trichoderma reesei (ATCC PTA 5588) and endo-1,3(4)-beta-glucanase EC 3.2.1.6 produced by Trichoderma reesei (ATCC SD 2106) as a feed additive for lactating sows and minor porcine species (holder of authorisation Danisco (UK) Ltd) (OJ L 164, 22.6.2016, p. 4).

            (13)  Commission Implementing Regulation (EU) 2017/440 of 13 March 2017 concerning the authorisation of the preparation of Bacillus amyloliquefaciens (PTA-6507), Bacillus amyloliquefaciens (NRRL B-50013) and Bacillus amyloliquefaciens (NRRL B-50104) as a feed additive for chickens for fattening, chickens reared for laying, minor poultry species for fattening and minor poultry species reared for laying (holder of authorisation Danisco (UK) Ltd, trading as Danisco Animal Nutrition) (OJ L 67, 14.3.2017, p. 74).

            (14)  Commission Implementing Regulation (EU) 2017/896 of 24 May 2017 concerning the authorisation of a preparation of 6-phytase, produced by Trichoderma reesei (ATCC SD-6528) as a feed additive in solid form for all poultry species and all porcine species (other than suckling piglets) (holder of the authorisation Danisco (UK) Ltd) (OJ L 138, 25.5.2017, p. 123).


title: Commission Implementing Regulation (EU) 2019/366 of 5 March 2019 amending Annex I to Regulation (EU) No 605/2010 as regards the list of third countries or parts thereof from which the introduction into the European Union of consignments of raw milk, dairy products, colostrum and colostrum-based products is authorised (Text with EEA relevance.)

text:
                  6.3.2019

                  EN

                  Official Journal of the European Union

                  L 65/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/366
         of 5 March 2019
         amending Annex I to Regulation (EU) No 605/2010 as regards the list of third countries or parts thereof from which the introduction into the European Union of consignments of raw milk, dairy products, colostrum and colostrum-based products is authorised
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (1), and in particular the introductory phrase of Article 8, the first subparagraph of point (1) and point (4) of Article 8 and Article 9(4) thereof,
         Having regard to Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (2), and in particular Article 11(1) thereof,
         Whereas:

                     (1)

                     Commission Regulation (EU) No 605/2010 (3) lays down the public and animal health conditions and certification requirements for the introduction into the Union of consignments of raw milk, dairy products, colostrum and colostrum-based products and the list of third countries from which the introduction into the Union of such consignments is authorised.

                     (2)

                     Annex I to Regulation (EU) No 605/2010 sets out a list of third countries or parts thereof authorised for the introduction into the Union of consignments of raw milk, dairy products, colostrum and colostrum-based products and indicates the type of treatment required for such commodities.

                     (3)

                     Japan made a request to the Commission for an authorisation to export raw milk, dairy products, colostrum and colostrum-based products to the Union which have undergone a non-specific treatment. From the animal health perspective, Japan is a third country listed by the World Organisation for Animal Health as being free of foot-and-mouth disease where vaccination is not practised and therefore fulfils the Union animal health import requirements.

                     (4)

                     The Commission has recently carried out veterinary controls in Japan. Those controls demonstrate that the competent authority of Japan provides appropriate guarantees as regards compliance with animal health import requirements provided for in Directive 2002/99/EC.

                     (5)

                     In light of the appropriate guarantees provided by the competent authority of Japan and of the favourable animal health situation as regards foot-and-mouth disease in Japan, it is appropriate to include Japan in Annex I to Regulation (EU) No 605/2010. This addition to the list of Annex I should be without prejudice to obligations arising from other provisions of Union legislation concerning imports into, and placing on the market within, the Union of products of animal origin, in particular those relating to the listing of establishments under Article 12 of Regulation (EC) No 854/2004.

                     (6)

                     Regulation (EU) No 605/2010 should therefore be amended accordingly.

                     (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
            In the table set out in Annex I to Regulation (EU) No 605/2010 the following entry is inserted after the entry of Iceland:

                           ‘JP

                           Japan

                           +

                           +

                           +’

            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, 5 March 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 18, 23.1.2003, p. 11.

            (2)  OJ L 139, 30.4.2004, p. 206.

            (3)  Commission Regulation (EU) No 605/2010 of 2 July 2010 laying down animal and public health and veterinary certification conditions for the introduction into the European Union of raw milk, dairy products, colostrum and colostrum-based products intended for human consumption (OJ L 175, 10.7.2010, p. 1).


title: Commission Implementing Regulation (EU) 2019/371 of 7 March 2019 fixing the import duties applicable to certain types of husked rice from 8 March 2019

text:
                  8.3.2019

                  EN

                  Official Journal of the European Union

                  L 68/3

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/371
         of 7 March 2019
         fixing the import duties applicable to certain types of husked rice from 8 March 2019
         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, first paragraph, point (a) thereof,
         Whereas:

                     (1)

                     The Agreement in the form of an Exchange of Letters between the European Community and the United States of America relating to the method of calculation of applied duties for husked rice, approved by Council Decision 2005/476/EC (2), establishes a method for the calculation of applied duties for imports of husked rice.

                     (2)

                     On the basis of the information provided by the competent authorities, the Commission notes that import licences for husked rice falling within CN code 1006 20, other than import licences for basmati rice, have been issued in respect of 265 824 tonnes for the period from 1 September 2018 to 28 February 2019. The import duty for husked rice falling within CN code 1006 20 other than basmati rice, fixed by Commission Implementing Regulation (EU) No 191/2012 (3), should therefore be adjusted.

                     (3)

                     Implementing Regulation (EU) No 191/2012 should therefore be repealed.

                     (4)

                     The applicable duty must be fixed within 10 days of the end of the period mentioned above. This Regulation should therefore enter into force immediately,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The import duty for husked rice falling within CN code 1006 20 shall be EUR 65 per tonne.

            Article 2
            Implementing Regulation (EU) No 191/2012 is repealed.

            Article 3
            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, 7 March 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)  Council Decision 2005/476/EC of 21 June 2005 on the conclusion of an Agreement in the form of an Exchange of Letters between the European Community and the United States of America relating to the method of calculation of applied duties for husked rice and amending Decisions 2004/617/EC, 2004/618/EC and 2004/619/EC (OJ L 170, 1.7.2005, p. 67).

            (3)  Commission Implementing Regulation (EU) No 191/2012 of 7 March 2012 fixing the import duties applicable to certain husked rice from 8 March 2012 (OJ L 69, 8.3.2012, p. 12).


title: Commission Implementing Regulation (EU) 2017/2312 of 13 December 2017 concerning the authorisation of a new use of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for sows, suckling piglets and dogs (holder of the authorisation Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office) (Text with EEA relevance. )

text:
                  14.12.2017

                  EN

                  Official Journal of the European Union

                  L 331/41

            COMMISSION IMPLEMENTING REGULATION (EU) 2017/2312
      of 13 December 2017
      concerning the authorisation of a new use of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for sows, suckling piglets and dogs (holder of the authorisation Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office)
      (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, applications were submitted for a new use of the preparation Bacillus subtilis C-3102 (DSM 15544). Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                  (3)

                  The applications concern the authorisation of a new use of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for sows, suckling piglets and dogs to be classified in the additive category ‘zootechnical additives’.

                  (4)

                  The preparation of Bacillus subtilis C-3102 (DSM 15544), belonging to the additive category of ‘zootechnical additives’, was authorised for 10 years as a feed additive for chickens for fattening by Commission Regulation (EC) No 1444/2006 (2); for weaned piglets by Commission Regulation (EU) No 333/2010 (3); for chickens reared for laying, turkeys, minor avian species and other ornamental and game birds by Commission Regulation (EU) No 184/2011 (4), and for laying hens and ornamental fish by Commission Implementing Regulation (EU) 2016/897 (5).

                  (5)

                  The European Food Safety Authority (‘the Authority’) concluded in its opinions of 21 March 2017 (6) that, under the proposed conditions of use, the preparation of Bacillus subtilis C-3102 (DSM 15544) does not have an adverse effect on animal health, human health and the environment. It also concluded that the additive has the potential to improve the zootechnical performance parameters of sows and suckling piglets and to increase the faecal dry matter in dogs. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                  (6)

                  The assessment of the preparation of Bacillus subtilis C-3102 (DSM 15544) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.

                  (7)

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

            HAS ADOPTED THIS REGULATION:
      Article 1
      The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.
      Article 2
      This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

         This Regulation shall be binding in its entirety and directly applicable in all Member States.
         Done at Brussels, 13 December 2017.

               For the Commission

               The President

            Jean-Claude JUNCKER

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

         (2)  Commission Regulation (EC) No 1444/2006 of 29 September 2006 concerning the authorisation of Bacillus subtilis C-3102 (Calsporin) as a feed additive (OJ L 271, 30.9.2006, p. 19).

         (3)  Commission Regulation (EU) No 333/2010 of 22 April 2010 concerning the authorisation of a new use of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets (holder of authorisation Calpis Co. Ltd Japan, represented in the European Union by Calpis Co. Ltd Europe Representative Office (OJ L 102, 23.4.2010, p. 19).

         (4)  Commission Regulation (EU) No 184/2011 of 25 February 2011 concerning the authorisation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for chickens reared for laying, turkeys, minor avian species and other ornamental and game birds (holder of authorisation Calpis Co. Ltd Japan, represented by Calpis Co. Ltd Europe Representative Office) (OJ L 53, 26.2.2011, p. 33).

         (5)  Commission Implementing Regulation (EU) 2016/897 of 8 June 2016 concerning the authorisation of a preparation of Bacillus subtilis (C-3102) (DSM 15544) as a feed additive for laying hens and ornamental fish (holder of authorisation Asahi Calpis Wellness Co. Ltd) and amending Regulations (EC) No 1444/2006, (EU) No 333/2010 and (EU) No 184/2011 as regards the holder of the authorisation (OJ L 152, 9.6.2016, p. 7).

         (6)  EFSA Journal 2017; 15(4):4760 and EFSA Journal 2017; 15(4):4761.

         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

                     4b1820

                     Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office

                        Bacillus subtilis

                     DSM 15544

                        Additive composition

                     Preparation of Bacillus subtilis C-3102
                     DSM 15544 containing a minimum of 1 × 1010 CFU/g additive in solid form

                        Characterisation of the active substance

                     Viable cells of Bacillus subtilis
                     DSM 15544

                        Analytical method

                     Enumeration: spread plate method using tryptone soya agar in all target matrices (EN 15784:2009)
                     Identification: pulsed-field gel electrophoresis (PFGE).

                     Sows
                     Suckling piglets

                     —

                     3 × 108

                     —

                                 1.

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

                                 2.

                                 Indicate in the instruction for the use:
                                 ‘The additive shall be fed to lactating sows and suckling piglets simultaneously’

                                 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 breathing protection.

                     3 January 2028

                     Dogs

                     1 × 109


title: Commission Implementing Regulation (EU) 2017/2308 of 13 December 2017 concerning the authorisation of the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) as a feed additive for suckling piglets (holder of authorisation Chr. Hansen A/S) (Text with EEA relevance. )

text:
                  14.12.2017

                  EN

                  Official Journal of the European Union

                  L 331/19

            COMMISSION IMPLEMENTING REGULATION (EU) 2017/2308
      of 13 December 2017
      concerning the authorisation of the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) as a feed additive for suckling piglets (holder of authorisation Chr. Hansen A/S)
      (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 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

                  (2)

                  The preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive, for pigs for fattening and piglets by Commission Regulation (EC) No 2148/2004 (3). That preparation 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. That preparation was authorised for 10 years for weaned piglets, pigs for fattening, sows, calves for rearing and turkeys for fattening by Commission Implementing Regulation (EU) 2017/447 (4).

                  (3)

                  In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that Regulation, an application was submitted for the re-evaluation of the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) as a feed additive for piglets. The application was also for the assessment of this preparation for a new use in water for drinking. The applicant requested that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                  (4)

                  The European Food Safety Authority (‘the Authority’) concluded in its opinion of 12 July 2016 (5) that, under the proposed conditions of use, the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) does not have an adverse effect on animal health, human health or the environment. The Authority considered that the additive has the potential to improve weight gain in suckling piglets when used in feed or in water for drinking. 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 Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) 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
      Authorisation
      The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an 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, 13 December 2017.

               For the Commission

               The President

            Jean-Claude JUNCKER

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

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

         (3)  Commission Regulation (EC) No 2148/2004 of 16 December 2004 concerning the permanent and provisional authorisations of certain additives and the authorisation of new uses of an additive already authorised in feedingstuffs (OJ L 370, 17.12.2004, p. 24).

         (4)  Commission Implementing Regulation (EU) 2017/447 of 14 March 2017 concerning the authorisation of the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) as a feed additive for sows, weaned piglets, pigs for fattening, calves for rearing and turkeys for fattening and amending Regulations (EC) No 1453/2004, (EC) No 2148/2004 and (EC) No 600/2005 (holder of authorisation Chr. Hansen A/S) (OJ L 69, 15.3.2017, p. 19).

         (5)  EFSA Journal 2016; 14(9):4558.

         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

                     Minimum content

                     Maximum content

                     Other provisions

                     End of period of authorisation

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

                     CFU/l of water for drinking

                        Category of zootechnical additives. Functional group: gut flora stabilisers

                     4b1700i

                     Chr.Hansen A/S

                        Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749)

                        Additive composition

                     Preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) containing a minimum of 3,2 × 1010 CFU/g of additive
                     (1:1 ratio)
                     Solid form

                        Characterisation of the active substance

                     Viable spores of Bacillus subtilis

                     (DSM 5750) and Bacillus licheniformis (DSM 5749)

                        Analytical method
                         (1)

                     Identification and enumeration of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) in the feed additive, premixtures, feedingstuffs and water:

                                 —

                                 Identification: Pulsed Field Gel Electrophoresis (PFGE)

                                 —

                                 Enumeration: Spread plate method using tryptone soya agar — EN 15784.

                     Suckling piglets

                     —

                     1,3 × 109

                     —

                     6,5 × 108

                     —

                                 1.

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

                                 2.

                                 The additive may be used in water for drinking.

                                 3.

                                 For use of the additive in water for drinking a homogeneous dispersion of the additive shall be ensured.

                                 4.

                                 Indicate in the instructions for use:
                                 ‘The additive shall be fed to lactating sows and suckling piglets simultaneously’

                                 5.

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

                     3 January 2028

            (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) 2017/2314 of 13 December 2017 fixing the allocation coefficient to be applied to the quantities covered by the applications for import licences lodged from 20 November 2017 to 30 November 2017 and determining the quantities to be added to the quantity fixed for the subperiod from 1 July 2018 to 31 December 2018 under the tariff quotas opened by Regulation (EC) No 2535/2001 in the milk and milk products sector

text:
               14.12.2017

               EN

               Official Journal of the European Union

               L 331/53

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/2314
   of 13 December 2017
   fixing the allocation coefficient to be applied to the quantities covered by the applications for import licences lodged from 20 November 2017 to 30 November 2017 and determining the quantities to be added to the quantity fixed for the subperiod from 1 July 2018 to 31 December 2018 under the tariff quotas opened by Regulation (EC) No 2535/2001 in the milk and milk products sector
   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 188 thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 2535/2001 (2) opened annual tariff quotas for imports of products of the milk and milk products sector.

               (2)

               For some quotas, the quantities covered by the applications for import licences lodged from 20 November 2017 to 30 November 2017 for the subperiod from 1 January 2018 to 30 June 2018 exceed those available. The extent to which import licences may be issued should therefore be determined by establishing the allocation coefficient to be applied to the quantities requested, calculated in accordance with Article 7(2) of Commission Regulation (EC) No 1301/2006 (3).

               (3)

               The quantities covered by the applications for import licences lodged from 20 November 2017 to 30 November 2017 for the subperiod from 1 January 2018 to 30 June 2018 are, for some quotas, less than those available. The quantities for which applications have not been lodged should therefore be determined and these should be added to the quantity fixed for the following quota subperiod.

               (4)

               In order to ensure the efficient management of the measure, this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

         HAS ADOPTED THIS REGULATION:
   Article 1
   1.   The quantities covered by the applications for import licences lodged under Regulation (EC) No 2535/2001 for the subperiod from 1 January 2018 to 30 June 2018 shall be multiplied by the allocation coefficient set out in the Annex to this Regulation.
   2.   The quantities for which import licence applications have not been lodged pursuant to Regulation (EC) No 2535/2001, to be added to the subperiod from 1 July 2018 to 31 December 2018, are 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, 13 December 2017.

            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)  Commission Regulation (EC) No 2535/2001 of 14 December 2001 laying down detailed rules for applying Council Regulation (EC) No 1255/1999 as regards the import arrangements for milk and milk products and opening tariff quotas (OJ L 341, 22.12.2001, p. 29).

      (3)  Commission Regulation (EC) No 1301/2006 of 31 August 2006 laying down common rules for the administration of import tariff quotas for agricultural products managed by a system of import licences (OJ L 238, 1.9.2006, p. 13).

      ANNEX

         I.A

                  Order No

                  Allocation coefficient — applications lodged for the subperiod from 1.1.2018 to 30.6.2018
                  (%)

                  Quantities not applied for, to be added to the quantities available for the subperiod from 1.7.2018 to 31.12.2018
                  (kg)

                  09.4590

                  —

                  —

                  09.4599

                  —

                  —

                  09.4591

                  —

                  —

                  09.4592

                  —

                  —

                  09.4593

                  —

                  —

                  09.4594

                  —

                  —

                  09.4595

                  —

                  —

                  09.4596

                  —

                  —

         I.F

                  Products originating in Switzerland

                  Order No

                  Allocation coefficient — applications lodged for the subperiod from 1.1.2018 to 30.6.2018
                  (%)

                  Quantities not applied for, to be added to the quantities available for the subperiod from 1.7.2018 to 31.12.2018
                  (kg)

                  09.4155

                  —

                  —

         I.H

                  Products originating in Norway

                  Order No

                  Allocation coefficient — applications lodged for the subperiod from 1.1.2018 to 30.6.2018
                  (%)

                  Quantities not applied for, to be added to the quantities available for the subperiod from 1.7.2018 to 31.12.2018
                  (kg)

                  09.4179

                  —

                  2 707 600

         I.I

                  Products originating in Iceland

                  Order No

                  Allocation coefficient — applications lodged for the subperiod from 1.1.2018 to 30.6.2018
                  (%)

                  Quantities not applied for, to be added to the quantities available for the subperiod from 1.7.2018 to 31.12.2018
                  (kg)

                  09.4205

                  —

                  —

                  09.4206

                  —

                  —

         I.K

                  Products originating in New Zealand

                  Order No

                  Allocation coefficient — applications lodged for the subperiod from 1.1.2018 to 30.6.2018
                  (%)

                  Quantities not applied for, to be added to the quantities available for the subperiod from 1.7.2018 to 31.12.2018
                  (kg)

                  09.4514

                  —

                  7 000 000

                  09.4515

                  —

                  4 000 000

                  09.4182

                  —

                  16 806 000

                  09.4195

                  —

                  20 540 500

         I.L

                  Products originating in Ukraine

                  Order No

                  Allocation coefficient — applications lodged for the subperiod from 1.1.2018 to 30.6.2018
                  (%)

                  Quantities not applied for, to be added to the quantities available for the subperiod from 1.7.2018 to 31.12.2018
                  (kg)

                  09.4600

                  —

                  3 777 000

                  09.4601

                  —

                  1 250 000

                  09.4602

                  0,608872

                  —