title: Commission Implementing Regulation (EU) 2019/849 of 24 May 2019 amending Implementing Regulation (EU) 2017/1492 as regards the maximum content of cholecalciferol (vitamin D3) in feed for salmonids (Text with EEA relevance.)

text:
                  27.5.2019

                  EN

                  Official Journal of the European Union

                  L 139/4

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/849
         of 24 May 2019
         amending Implementing Regulation (EU) 2017/1492 as regards the maximum content of cholecalciferol (vitamin D3) in feed for salmonids
         (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(2) thereof,
         Whereas:

                     (1)

                     Commission Implementing Regulation (EU) 2017/1492 (2) authorises cholecalciferol (vitamin D3) as nutritional additive for all animal species. In that Regulation, the maximum authorised content of vitamin D3 for fish is 3 000 IU/kg of complete feedingstuff.

                     (2)

                     The Norwegian Food Safety Authority (NFSA) submitted studies on the safety of vitamin D3 for fish and consumers at substantially higher levels (60 000 IU/kg of complete feedingstuff) than the maximum authorised content.

                     (3)

                     For control purposes the results of calculation of tolerance levels can lead to a discrepancy in values between the two units (mg or IU). For this reason, the levels in the authorisation should be established only in International Units.

                     (4)

                     On the basis of the data submitted by the NFSA, the European Food Safety Authority concluded in its opinions of 25 January 2017 (3) and 29 November 2018 (4) that a total level of 60 000 IU of vitamin D3 per kg of complete feedingstuff is safe for consumers and the environment. The European Food Safety Authority also concluded that the levels proposed were safe for salmonids. For other fish, no sufficient data were available to conclude on the safety for a total level of 60 000 IU vitamin D3/kg of complete feedingstuff. Consequently, the authorisation should be restricted to salmonids. It also concluded in the opinion of 13 November 2012 (5) that vitamin D3 is not an irritant to skin and eyes and is not a skin sensitiser. For some formulations of vitamin D3 there is a potential for workers to be exposed to high levels of vitamin D3 by inhalation. Inhaled vitamin D3 is highly toxic. Exposure to dust is harmful to persons handling the additive. As the levels of vitamin D3 have been increased this may have implications for user safety, 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.

                     (5)

                     The Annex to Implementing Regulation (EU) 2017/1492 should therefore be amended accordingly.

                     (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 Annex to Implementing Regulation (EU) 2017/1492 is replaced by the text set out in the Annex to this Regulation.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 24 May 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Implementing Regulation (EU) 2017/1492 of 21 August 2017 concerning the authorisation of cholecalciferol as a feed additive for all animal species (OJ L 216, 22.8.2017, p. 19).

            (3)  EFSA Journal 2017;15(3):4713.

            (4)  EFSA Journal 2019;17(1):5540.

            (5)  EFSA Journal 2012;10(12):2968

            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

                        IU of cholecalciferol (1)/kg of complete feedingstuff with a moisture content of 12 %.

                           Category of nutritional additives. Functional group: Vitamins, provitamins and chemically well-defined substances having similar effect.

                        3a671

                        —

                        ‘Cholecalciferol’ or ‘Vitamin D3’

                           Additive composition

                        Cholecalciferol.

                           Characterisation of the active substance

                        Cholecalciferol
                        C27H44O
                        CAS number: 67-97-0
                        Cholecalciferol solid and resin form, produced by chemical synthesis.
                        Purity criteria:
                        Min. 80 % (cholecalciferol and precholecalciferol) and max. 7 % tachysterol.

                           Method of analysis
                            (2)

                                    —

                                    For the determination of Vitamin D3 in the feed additive: High Performance Liquid Chromatography coupled to UV detection (HPLC-UV, 254 nm) - European Pharmacopoeia method 01/2008:0574,0575,0598.

                                    —

                                    For the determination of Vitamin D3 in premixtures: High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV) - VDLUFA 1997, Methodenbuch, Method 13.8.1.

                                    —

                                    For the determination of vitamin D3 in feedingstuffs:

                                                —

                                                High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV)-VDLUFA 1997, Methodenbuch, Method 13.8.1; or

                                                —

                                                Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821.

                                    —

                                    For the determination of vitamin D3 in water: Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821.

                        Pigs

                        —

                        —

                        2 000  IU

                                    1.

                                    Vitamin D3 may be placed on the market and used as an additive consisting of a preparation.

                                    2.

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

                                    3.

                                    In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                    4.

                                    Maximum content of the combination of 25-hydroxycholecalciferol with cholecalciferol per kg of complete feedingstuff:

                                                —

                                                ≤ 5 000  IU of vitamin D3 for chickens for fattening and turkeys for fattening,

                                                —

                                                ≤ 3 200  IU for other poultry,

                                                —

                                                ≤ 2 000  IU for pigs.

                                    5.

                                    Simultaneous use with Vitamin D2 is not allowed.

                                    6.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the very hazardous effects of vitamin D3 by inhalation. Where the risks associated to those very hazardous effects 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.

                        11 September 2027

                        Milk replacers for piglets

                        —

                        —

                        10 000  IU

                        Bovines

                        —

                        —

                        4 000  IU

                        Milk replacers for calves

                        —

                        —

                        10 000  IU

                        Ovines

                        —

                        —

                        4 000  IU

                        Chickens for fattening

                        —

                        —

                        5 000  IU

                        Turkeys

                        —

                        —

                        5 000  IU

                        Other poultry

                        —

                        —

                        3 200  IU

                        Equines

                        —

                        —

                        4 000  IU

                        Salmonids

                        —

                        —

                        60 000  IU

                        Other fish species

                        —

                        —

                        3 000  IU

                        Other animal species

                        —

                        —

                        2 000  IU

               (1)  40 IU cholecalciferol = 0,001 mg cholecalciferol

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


title: Commission Implementing Regulation (EU) 2019/850 of 24 May 2019 amending for the 303rd time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the ISIL (Da'esh) and Al-Qaida organisations

text:
                  27.5.2019

                  EN

                  Official Journal of the European Union

                  L 139/8

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/850
         of 24 May 2019
         amending for the 303rd time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the ISIL (Da'esh) and Al-Qaida organisations
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EC) No 881/2002 of 27 May 2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the ISIL (Da'esh) and Al-Qaida organisations (1), and in particular Article 7(1)(a) and Article 7a(5) thereof,
         Whereas:

                     (1)

                     Annex I to Regulation (EC) No 881/2002 lists the persons, groups and entities covered by the freezing of funds and economic resources under that Regulation.

                     (2)

                     On 21 May 2019, the Sanctions Committee of the United Nations Security Council decided to remove one entry from the list of persons, groups and entities to whom the freezing of funds and economic resources should apply. Annex I to Regulation (EC) No 881/2002 should therefore be amended accordingly,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex I to Regulation (EC) No 881/2002 is amended in accordance with 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, 24 May 2019.

                  For the Commission,

                  On behalf of the President,

                  Head of the Service for Foreign Policy Instruments

            (1)  OJ L 139, 29.5.2002, p. 9.

            ANNEX
            Annex I to Regulation (EC) No 881/2002 is amended as follows:
            The following entry under the heading ‘Natural persons’ is deleted: ‘Mazen Salah Mohammed (alias (a) Mazen Ali Hussein, (b) Issa Salah Muhamad). Date of birth: (a) 1.1.1982, (b) 1.1.1980. Place of birth: Baghdad, Iraq. Nationality: Iraqi. Passport No: German travel document (“Reiseausweis”) A 0144378 (revoked as at Sep.2012). Address: 94051 Hauzenberg, Germany. Date of designation referred to in Article 2a(4)(b): 6.12.2005.’


title: Commisson Implementing Regulation (EU) 2019/772 of 16 May 2019 amending Regulation (EU) No 1300/2014 as regards inventory of assets with a view to identifying barriers to accessibility, providing information to users and monitoring and evaluating progress on accessibility (Text with EEA relevance.)

text:
                  27.5.2019

                  EN

                  Official Journal of the European Union

                  LI 139/1

         COMMISSON IMPLEMENTING REGULATION (EU) 2019/772
         of 16 May 2019
         amending Regulation (EU) No 1300/2014 as regards inventory of assets with a view to identifying barriers to accessibility, providing information to users and monitoring and evaluating progress on accessibility
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system within the European Union (1), and in particular Article 5(11) thereof,
         Whereas:

                     (1)

                     Pursuant to Article 7 of Commission Regulation (EU) No 1300/2014 (2), chapter 7 of the Annex of Regulation (EU) No 1300/2014 is to be amended in order to specify the characteristics of the inventory of assets, including the content, data format, functional and technical architecture, operating mode, rules for data input and consultation, and rules for self-assessment and designation of the entities responsible for data provision.

                     (2)

                     Pursuant to Article 5(1) of Regulation (EU) 2016/796 of the European Parliament and of the Council (3) and Article 7(2) of Regulation (EU) No 1300/2014 a working party was established in order to make a proposal for a recommendation as regards the minimum structure and content of data to be collected for the inventory of assets with a view to identifying barriers to accessibility, providing information to users and monitoring and evaluating progress on accessibility. That working party completed its work in May 2017, and as a result, the Agency finalised the recommendation ERA-REC-128 for amending Regulation (EU) No 1300/2014.

                     (3)

                     The Inventory of Assets is a static tool indicating the existence of the equipment and is therefore not intended to provide information on the status and functioning of the equipment.

                     (4)

                     Where a station, or elements thereof, undergoes an upgrade, renewal or any work foreseen by a national implementation plan in accordance with Article 8 of Regulation (EU) No 1300/2014, the information related to the compliance of that work with Regulation (EU) No 1300/2014 of the station, or elements thereof, should be collected.

                     (5)

                     The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 51(1) of Directive (EU) 2016/797,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Regulation (EU) No 1300/2014 is amended as follows:

                        (1)

                        The following Article 7a is inserted after Article 7

                           ‘Article 7a
                           Collection, maintenance and exchange of accessibility data

                              1.   Within nine months after 16 June 2019, each Member State shall decide which entities are in charge of collecting, maintaining and exchanging the accessibility data.

                              2.   Member States may ask the Commission for an extension of the time limit. This extension shall be exceptional, duly justified and limited in time. In particular it is considered to be justified if the data collection tool and the operating modes as set out in the Annex of this regulation are not made available and fully operational by the European Union Agency for Railways two months following its entry into force.

                              3.   For each station, there shall be an entity responsible for exchanging the accessibility data.

                              4.   Collection and conversion of data shall be finalised within 36 months following the entry into force of this Regulation.

                              5.   Until the architecture for data exchange described in sections 7.2, 7.3 and 7.4 of Annex I to Commission Regulation (EU) No 454/2011 (*1) is completely operational, the exchange of the accessibility data shall consist of transfer of that data to the European Railway Stations Accessibility Database (ERSAD) hosted by the European Union Agency for Railways.

                           (*1)  Commission Regulation (EU) No 454/2011 of 5 May 2011 on the technical specification for interoperability relating to the subsystem “telematics applications for passenger services” of the trans-European rail system (OJ L 123, 12.5.2011, p. 11).’"

                        (2)

                        The Annex is amended in accordance with the Annex to this Regulation.

            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, 16 May 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 138, 26.5.2016, p. 44.

            (2)  Commission Regulation (EU) No 1300/2014 of 18 November 2014 on the technical specifications for interoperability relating to accessibility of the Union's rail system for persons with disabilities and persons with reduced mobility (OJ L 356, 12.12.2014, p. 110).

            (3)  Regulation (EU) 2016/796 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Railways and repealing Regulation (EC) No 881/2004 (OJ L 138, 26.5.2016, p. 1).

            ANNEX
            The Annex to Regulation (EU) No 1300/2014 is amended as follows:

                        (1)

                        In Chapter 2, section 2.3, the following paragraph is inserted after the first sentence:
                        ‘Accessibility data

                        Accessibility data consists of the information related to the accessibility of passenger railway stations that needs to be collected, maintained and exchanged, that is to say, of a description of the characteristics and equipment of the passenger railway stations. Where relevant that description is complemented by the information regarding the stations' state of conformity to this TSI.’

                        (2)

                        In Chapter 7, section 7.2, sub-section 7.2.1, the following sub-sections are inserted:
                        ‘7.2.1.1.   Inventory of assets — infrastructure

                        7.2.1.1.1.   Functional and technical architecture
                        The functions of the inventory of assets consist of:

                                    (1)

                                    identifying the existing obstacles and barriers to accessibility;

                                    (2)

                                    providing practical information to users;

                                    (3)

                                    monitoring and evaluating progress on accessibility.

                              The architecture for the exchange of accessibility data is provided for in Regulation (EU) No 454/2011 (TAP TSI).
                        The following standards shall apply for the formatting and exchange of accessibility data:

                                    (1)

                                    CEN/TS 16614-1:2014 Public transport — Network and Timetable Exchange (NeTEx) — Part 1: Public transport network topology exchange format 2014-05-14

                                    (2)

                                    EN 12896-1:2016 Public transport. Reference data model. Common concepts (Transmodel)

                              For the intended particular usage, a harmonised specific transmodel profile as is provided for in the technical documents referred to in Appendix O, index 1.
                        7.2.1.1.2.   Rules for the input and self-assessment of accessibility data
                        The rules for the input and self-assessment of accessibility data shall be the following:

                                    (1)

                                    entities that collect the accessibility data relative to assets need not be independent from the daily management of those assets;

                                    (2)

                                    during the first collection of accessibility data pursuant to the entry into force of Commission Implementing Regulation (EU) 2019/772 (*1), the state of conformity of stations to this TSI may be inventoried as unassessed;

                                    (3)

                                    where a station, or elements thereof, undergoes an upgrade, renewal work or any type of work foreseen by a national implementation plan for this TSI, the corresponding accessibility data shall be updated, including the state of conformity to this TSI, where relevant;

                                    (4)

                                    the state of conformity to this TSI may be updated on the basis of an ISV as described in point 6.2.4 of this TSI;

                                    (5)

                                    the working order of the equipment does not need to be inventoried.

                              A data collection tool, the operating modes of which are described in the technical documents referred to in Appendix O, index 2, shall be made available by the Commission.
                        Alternatively, where structured accessibility data exist and may be converted to the harmonised profile, those data may be transferred after conversion. The methodology for the conversion of existing accessibility data and the communication protocol are provided for in the technical documents referred to in Appendix O, index 3.
                        7.2.1.1.3.   Rules for consultation
                        From the ERSAD:

                                    (1)

                                    the public shall be able to access information from a public website hosted by the European Union Agency for Railways;

                                    (2)

                                    registered national authorities shall be able to retrieve all accessibility data that are relevant to the Member State;

                                    (3)

                                    the Commission and the Agency shall be able to retrieve all accessibility data.

                              The ERSAD database hosted by the Agency shall not be linked to other database(s).
                        7.2.1.1.4.   Rules for the management of user feedback
                        Feedback from users may take the form of:

                                    (1)

                                    institutional feedback from users associations, including organisations representing persons with disabilities: existing structures may be used as long as they include representatives from organisations of persons with disabilities and persons with reduced mobility and reflect the situation at an appropriate level, not necessarily at a national level. The procedure for giving user feedback shall be organised so as to permit the participation of those organisations on an equal basis;

                                    (2)

                                    individual feedback: website visitors shall be provided with the possibility to report incorrect information about accessibility data regarding a particular station and get an acknowledgement that their comment has been received.

                              In both situations, the feedback from users shall be adequately considered by the entity(ies) responsible for collecting, maintaining and exchanging the data.

                           (*1)  Commission Implementing Regulation (EU) 2019/772 of 16 May 2019 amending Commission Regulation (EU) No 1300/2014 as regards inventory of assets with a view to identifying barriers to accessibility, providing information to users and monitoring and evaluating progress on accessibility (OJ L 139 I, 27.5.2019, p. 1).’"

                        (3)

                        The following Appendix is added:

                              ‘Appendix O

                                 List of technical documents

                                          Index No

                                          Label

                                          1

                                          Harmonised specific Network and Timetable Exchange (NeTEx) profile used for the description of stations.

                                          2

                                          Data collection tool operating modes

                                          3

                                          Methodology for the conversion of existing accessibility data including description of the external interface and of the communication protocol.

               (*1)  Commission Implementing Regulation (EU) 2019/772 of 16 May 2019 amending Commission Regulation (EU) No 1300/2014 as regards inventory of assets with a view to identifying barriers to accessibility, providing information to users and monitoring and evaluating progress on accessibility (OJ L 139 I, 27.5.2019, p. 1).’’